Herb Document
Herb Document
Herb Document
Development of the Commodity Specific Food Safety Guidelines for the Production, Harvest, Post-Harvest, and
Processing Unit Operations of Herbs was made possible by the dedicated contribution of the following individuals:
Industry and academic members (and their affiliation during the guidance development process):
Kathleen Staley, Agricultural Marketing Service, U.S. United States Department of Agriculture
T he diversity of methods in the production of fresh culinary herbs makes a single, universally
applicable approach to food safety planning complicated. For the purposes of this document, the
term, fresh culinary herbs includes all varieties of basil, chervil, chives, cilantro, culantro, dill, lemon
verbena, marjoram, mint, oregano, parsley, rosemary, sage, savory, sorrel, tarragon, and thyme. It
is important that each firm that grows and handles fresh culinary herbs assess its operations and
implement methods to meet their individual needs. What is most important is that basic food safety
program components are implemented by producers to ensure fresh culinary herb product safety
for consumers. Whatever the preferred production method for a single producer, fresh culinary herb
producers and handlers agree that the following basic principles should serve as the foundation for all
food safety programs within their segment of the industry:
• Fresh culinary herbs have occasionally been associated with human pathogens and illness;
therefore, in addressing the potential sources of contamination, fresh culinary herb
food safety programs should pay special attention to planting and growing conditions,
agricultural practices at all phases of production, and harvest and post-harvest fresh
culinary herb handling.
• Fresh culinary herb producers and handlers recognize that once fresh culinary herbs are
contaminated, completely removing or killing pathogens is unlikely; therefore, prevention
of microbial contamination at all steps from production to distribution is strongly favored
over treatments to eliminate contamination after it has occurred.
• Fresh culinary herb producers and handlers support implementation and documentation
of food safety programs that utilize risk assessment techniques in order to identify all
plausible risks, prioritize operation-specific risks, and use a preventive approach to ensure
the safety of fresh culinary herbs.
• Fresh culinary herb producers and handlers also support and encourage routine and
regularly scheduled food safety awareness training for all persons who handle fresh
culinary herbs during production, harvesting and processing operations.
In the sections that follow, the Best Practices were developed to address each identified potential
food safety issue. However, it is the responsibility of individuals and companies involved in the field
to-fork fresh culinary herb supply chain to determine what actions are appropriate in their individual
operations. The potential food safety issues identified in each unit operation section are focused only
on fresh culinary herbs and may or may not apply to other specialty crops. Particular best practices
that address any identified issue are not the only means by which the issue may be addressed.
Individuals and companies are encouraged to use this document to evaluate, develop, and enhance
their own food safety programs.
The document contains a list of reference documents that offer detailed and important background
information regarding how to develop food safety programs. Each company's comprehensive food
safety program and its various components (e.g. employee training, standard operating procedures)
should be developed based upon an analysis of the potential hazards in that specific company's
operations. As presented, this guidance document is not sufficient to serve as an action plan for any
specific operation, but should be viewed as a starting point. This guidance document is intended
to supplement, not replace, already established food safety program components such as Good
Agricultural Practices (GAPs), current Good Manufacturing Practices (cGMPs), and Hazard Analysis
Critical Control Point (HACCP) and/or Hazard Analysis and Risk-Based Preventive Control Point
(HARPC) guidelines for the fresh fruit and vegetable industry.
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
List of Appendices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Regulatory Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Scope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
SeCTIon I: ELEMEnTS oF FooD SAFETy PRoGRAMS RELEVAnT To ALL UnIT oPERATIonS . . .27
6.5 The Best Practices Are: Toilet Facilites and Hand Washing Stations . . . . . . . . . . . . . . . . . 72
8.2 The Best Practices for Fresh Culinary Herbs that Have Come into
8.3 The Best Practices for Fresh Culinary Herbs in Proximity to a Flooded Area
But Where Edible Portions Have not Been Contacted by Flood Waters Are: . . . . . . . . . 75
8.4 The Best Practices for Formerly Flooded Production Ground Are:. . . . . . . . . . . . . . . . . . 75
1.0 Issue: GAPs and cGMPs for Packinghouse and Cooling Facilities. . . . . . . . . . . . . . . . . . 82
5.2 The Best Practices Are: Finished Product Containers, Packaging Materials and Pallets . . 91
6.0 Issue: Packinghouse and Cooling Facilities Construction, Design and Maintenance. . . 92
6.3 The Best Practices Are: Toilets and Hand-Washing Stations Construction and Design . . 94
8.4 The Best Practices Are: Toilets and Hand-Washing Stations Sanitation . . . . . . . . . . . . . . . 99
8.5 The Best Practices Are: Toilets and Hand-Washing Stations Waste Disposal . . . . . . . . . 100
1.0 Issue: Important Considerations About Processed Fresh Culinary Herbs . . . . . . . . . 106
4.3 The Best Practices Are: Ice and Ice Slurry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
5.3 The Best Practices Are: Toilets and Hand-Washing Stations Construction and Design . 117
7.2 The Best Practices Are: Processing Facility Sanitation (non-Food Contact
7.4 The Best Practices Are: Toilets and Hand-Washing Stations Sanitation . . . . . . . . . . . . . . 122
7.5 The Best Practices Are: Toilets and Hand-Washing Stations Waste Disposal . . . . . . . . . 123
12.0 Issue: Labeling of Ready-To-eat (RTe) and Ready-To-Use (RTU) Products . . . . . . . . 128
APPPenDICeS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Forward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Appendix A Sanitary Survey and Remediation Guidelines for Water Resources. . . . . . . . . . . . . . 137
5.2 Crop Land & Water Source Adjacent Land Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
active compost Compost feedstock that is unstable and in the process of being
rapidly decomposed and generating temperatures of at least 50
degrees Celsius (122 degrees Fahrenheit) during decomposition;
or is releasing carbon dioxide at a rate of at least 15 milligrams per
gram of compost per day, or the equivalent of oxygen uptake.7
agricultural material Material of plant or animal origin resulting from the production and
processing of farm, ranch, agricultural, horticultural, aquacultural,
silvicultural, floricultural, vermicultural, or viticultural products,
including manures, orchard and vineyard prunings, and crop
residues.7
animal by-product Most parts of an animal that do not include muscle meat including
organ meat, nervous tissue, cartilage, bone, blood and excrement.
adenosine tri-phosphate (ATP) A high energy phosphate molecule required to provide energy for
cellular function.
ATP test methods Exploits knowledge of the concentration of ATP as related to viable
biomass or metabolic activity; provides an estimate of cleanliness.
clean When food or food-contact surfaces are washed and rinsed and
are visually free of dust, dirt, food residues, and other debris. 1
colony forming units (CFU) Viable microorganisms (bacteria, yeasts, and mold) capable of
growth under the prescribed conditions (medium, atmosphere, time
and temperature) develop into visible colonies (colony forming
units) on agar which are counted.
co-management An approach to conserving soil, water, air, wildlife, and other natural
resources while simultaneously minimizing microbiological hazards
associated with food production.
1 FDA.1998. Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm064574.htm#i
concentrated animal feeding A lot or facility where animals have been, are, or will be stabled or
operation (CAFo) confined and fed or maintained for a total of 45 days or more in
any 12 month period. The number and types of animals covered by
this definition can be found in the Federal Register’s definition of
medium and large CAFos (CFR Title 40, Part 122.23).2
control measure Means any action or activity that can be used to prevent, reduce, or
eliminate a microbiological hazard. 1
critical control point A step at which control can be applied and is essential to prevent
or eliminate a food safety hazard or reduce it to an acceptable
level.3
current Good Manufacturing Practices Regulations that are found in 21 CFR 110 (Current Good
(cGMPs) Manufacturing Practices in Manufacturing, Processing, Packing, or
Holding Human Food).
E. coli Escherichia coli are common bacteria that live in the lower intestines
of animals (including humans). Though generally not harmful, the
presence of generic E. coli is frequently used as an indicator of fecal
contamination.
2 E-CFR. 2010. Title 40: Protection of Environment. Part 122—EPA Administered Permit Programs: The national Pollutant Discharge
Elimination System: Subpart B—Permit Application and Special nPDES Program Requirements http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=e
cfr&rgn=div8&view=text&node=40:21.0.1.1.12.2.6.3&idno=40
3 FDA. 1997. Hazard Analysis and Critical Control Point Principles and Application Guidelines http://www.fda.gov/Food/FoodSafety/
HazardAnalysisCriticalControlPointsHACCP/HACCPPrinciplesApplicationGuidelines/default.htm#defs
4 FDA. 2009. Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Draft Guidance.http://www.fda.gov/
Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm174200.htm#def
field container Containers used in the field to transport fresh culinary herbs to the
packinghouse or processing facility.
finished product container Containers used to hold fresh culinary herbs that are ready for
shipping.Typically waxed fiberboard cartons, wax-less fiberboard
cartons, or plastic returnable produce containers (RPCs).
food contact surface Those surfaces that contact human food and those surfaces from
which drainage onto the food or onto surface that contact the food
ordinarily occurs during the normal course of operations; includes
utensils and equipment surfaces.5
food safety assessment A standardized procedure that predicts the likelihood of harm
resulting from exposure to chemical, microbial, and physical agents
in the diet.
food safety professional Person entrusted with management level responsibility for
conducting food safety assessments before food reaches
consumers; requires training or experience sufficient to establish
a solid understanding of the principles of food safety as applied to
agricultural production.
fresh culinary herbs The green leaves or needles of perennial, biennials, or annual
plants that are typically used as part of a leafy green salad mix or
in relatively small amounts in cooking to add flavor or garnish to
food. Includes all varieties of basil, chervil, chives, cilantro, dill, lemon
verbena, marjoram, mint, oregano, parsley, rosemary, sage, savory,
sorrel, tarragon, and thyme.
5 CFR. 2009. Code of Federal Regulations, Title 21 Part 110.3 Definitions http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.
cfm?cfrpart=110
fresh-cut produce Fresh fruits and vegetables for human consumption that have been
minimally processed and altered in form by peeling, slicing, chopping,
shredding, coring, or trimming, with or without washing, prior to
being packaged for use by the consumer or a retail establishment;
does not require additional preparation, processing, or cooking
before consumption, with the possible exception of washing or the
addition of salad dressing, seasoning or other accompaniments.6
GAPs guide Guidelines set forth in the “Guide to Minimize Microbial Food
Safety Hazards for Fresh Fruits and Vegetables,” which was issued
by FDA in 1998.
geometric mean Mathematical def.: the n-th root of the product of n numbers, or
the n-th root of (X1)(X2)...(Xn), where X1, X2, etc. represent the
individual data points, and n is the total number of data points used
in the calculation.
green waste Any plant material that is separated at the point of generation,
contains no greater than 1.0 percent of physical contaminants by
weight, and meets the requirements of section 17868.5. Green
material includes, but is not limited to, yard trimmings, untreated
wood wastes, natural fiber products, and construction and
demolition wood waste. Green material does not include food
material, biosolids, mixed solid waste, material processed from
commingled collection, wood containing lead-based paint or wood
preservative, mixed construction or mixed demolition debris.7
HACCP plan A written document that delineates the formal procedures for
following the Hazard Analysis and Critical Control Point principles
developed by The national Advisory Committee on Microbiological
Criteria for Foods.8
6 FDA. 2008. Guide to Minimize Microbial Hazards in Fresh-cut Fruits and Vegetables.
8 http://www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/HACCPPrinciplesApplicationGuidelines/default.htm
most probable number (MPn) Estimated values that are statistical in nature used for enumeration
of microbes in a sample when present in small numbers.
nonsynthetic crop treatments Any crop input that contains animal manure, an animal product, and
/ or an animal by-product that is reasonably likely to contain human
pathogens.
oxidation reduction potential (oRP) An intrinsic property that indicates the tendency of a chemical
species to acquire elections and so be reduced; the more positive
the oRP, the greater the species’ affinity for electrons.
packaging material Any item that is used in holding and transporting finished fresh
culinary herbs during storage and shipment.
9 EPA. national Beach Guidance and Required Performance Criteria – Appendix 1C1: Indicator organisms http://water.epa.gov/grants_
funding/beachgrants/app1c.cfm
10 http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/default.htm
11 Centers for Disease Control and Prevention. (http://www.cdc.gov/oralHealth/infectioncontrol/glossary.htm)
pest Any objectionable animals or insects including, but not limited to,
birds, rodents, flies, and larvae.
post-harvest container Containers that are used to transport fresh culinary herbs within
the packinghouse / processing facility.
potable water Water that meets the standards for drinking purposes of the state
or local authority having jurisdiction or water that meets the
quality standards prescribed by the U.S. Environmental Protection
Agency's national Interim Primary Drinking Water Regulations,
published in 40 CFR Part 141.12
raw agricultural commodity (RAC) Any food in its raw or natural state, including all fruits that are
washed, colored, or otherwise treated in their unpeeled natural
form prior to marketing.13
ready-to-eat (RTe) Food that is in a form that is edible without additional preparation
to achieve food safety, as specified under the Food Code; includes
raw fruits and vegetables that are thoroughly washed in water to
remove soil and other contaminants before being cut, combined
with other ingredients, cooked, served, or offered for human
consumption.14
ready-to-use (RTU) Describes fresh culinary herbs that have been minimally processed
– cleaned, trimmed, and possibly cut before being packaged, and
require further washing and preparation prior to consumption.
recirculated water A closed water system, where water is used more than one time
before it is discharged into a wastewater system.
13 FDA. 2010. Federal Food, Drug and Cosmetic Act. Sec. 201, Chapter II – Definitions ( http://www.fda.gov/RegulatoryInformation/ Legislation/
FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm)
14 FDA. 2009. Food Code: U.S. Public Health Service.
Food Safety Guidelines 17 Fresh Culinary Herbs
Glossary
Registered Food Facility Facilities that manufacture, process, pack, or hold food for human
or animal consumption in the United States under FFDCA section
415(a); exempt industries include farms, retail food establishments,
restaurants, nonprofit food establishments, fishing vessels, and
facilities regulated exclusively by the USDA.
Reportable Food Registry An electronic portal for Registered Food Facilities to report
when there is reasonable probability that the use of, or
exposure to, an article of food will cause serious adverse health
consequences or death to humans or animals; a requirement for
Registered Food Facilities.
riparian areas Lands that occur along watercourses and water bodies such
as flood plains and stream banks that are distinctly different
from surrounding lands because of unique soil and vegetation
characteristics strongly influenced by the presence of water.15
sanitary survey An inspection of the entire water system, including water source,
facilities, and equipment, for the purpose of identifying conditions
that may result in microbial contamination. 4
sanitation standard operating A set of written instructions that addresses sanitation conditions
procedures (SSoPs) and practices before, during, and after processing including but not
limited to water quality, food contact surfaces, cross-contamination,
pest control, employee hygiene and health, maintenance of hand-
washing and toilet facilities, etc.
sanitization (food contact surfaces) The application of cumulative heat or chemicals on cleaned food
contact surfaces that, when evaluated for efficacy, is sufficient to
yield a reduction of 5 logs, which is equal to a 99.999% reduction, of
representative disease microorganisms of public health importance.16
soil amendment Elements added to the soil, such as compost, peat moss, or fertilizer,
to improve its capacity to support plant life.
standard operating procedures (SoPs) A set of written instructions detailing all steps and activities
required to perform a given task or in reaction to a given event; the
purpose of which is promote quality by minimizing variation and
facilitating consistency.
touch point Any occasion when the food is handled by a worker or contacts an
equipment surface.
ultraviolet index (UV index) A measure of the solar ultraviolet intensity at the earth's surface;
indicates the day's exposure to ultraviolet rays.The UV index is
measured around noon for a one-hour period and rated on a scale
of 0-15.
water distribution system All pipes, pumps, valves, storage tanks, reservoirs, meters, fittings,
and other components used to carry water from its primary source
to other areas of the property, building, etc.
16 FDA. 2009. Food Code. U.S. Department of Health and Human Services. Public Health Service,
17 United States Department of the Interior – Bureau of Reclamation. Glossary and Acronyms: Pursuant to the Biological Assessment.
http://www.usbr.gov/lc/region/g2000/assess/glossary.htm
Hazards for Fresh Fruits and Vegetables.” The practices Commercial fresh produce processors are one
outlined in this document are collectively known as of the most regulated segments of the produce
Good Agricultural Practices (GAPs) and current Good farm-to-table continuum. Preeminent among
Manufacturing Practices (cGMPs). GAPs provide food these regulations is the U.S. Federal Food, Drug,
safety guidance on critical production steps where and Cosmetic Act (FFDCA) which outlines legal
food safety might be compromised during the growing, standards of performance to assure that foods are
harvesting, transportation, cooling, packing, and storage safe to eat as well as produced and held under
of fresh produce. on the other hand, cGMPs describe sanitary conditions. Management plans or programs
the methods, equipment, facilities, and controls for should be in place to verify with documentation that
producing processed food. a food processing facility is in compliance with all
applicable federal, state, and local statutes.
More specifically, GAP guidance documents inform fruit
and vegetable growers and handlers primarily about Regulatory Background
the potential microbiological hazards associated with
various aspects of the production pipeline including: land While the produce industry has an admirable record of
history, adjacent land use, water quality, worker hygiene, providing the general public with safe, nutritious fruits
equipment sanitation, and product transportation. and vegetables, a few highly visible food safety failures
Physical and chemical hazards are also addressed in have increasingly focused the attention of consumers,
relation to agricultural chemical handling and storage, and consumer advocacy groups, public health organizations,
the presence of physical objects such as glass or other government agencies and buyers on produce food
debris contaminating fresh produce in the field. For the safety. To address the concern, the U.S. Food and Drug
most part, the produce industry has proactively adopted Administration (FDA) promulgated a produce safety
GAPs as part of normal production operations. Indeed, action plan in 2004 that specifically requested produce
the majority of fruit and vegetable producers undergo industry leadership to develop the next generation of
either internal and/or external third-party audits on a food safety guidance for fruit and vegetable production.
seasonal basis to monitor and verify adherence to GAPs. Since then, several commodity-specific food safety
These audit results are often shared with customers as guidelines have been developed to both address
verification of the producer’s commitment to food safety potential issues and to reduce the likelihood of future
and GAPs. foodborne illness outbreak occurrences. For example,
after the 2006 E. coli outbreak in spinach, the leafy
Conversely, cGMPs help to ensure that food for human green industry developed commodity-specific food
consumption is safe and has been prepared, packed, and safety guidelines in 2007, as did the tomato industry in
held under sanitary conditions. Parts 100-169 of Title 2008, and the green onion industry in 2010. The FDA
21 of the Code of Federal Regulations (21 CFR 100 responded by developing the Fresh-cut Guide in 2008
169) prescribe the condition under which food should and drafting food safety guidelines for leafy greens,
be processed, packed, handled, held, labeled, etc. cGMPs tomatoes, and melons in the summer of 2009 (FDA,
are regulations as set forth in 21 CFR 110. cGMPs 2009a; FDA, 2009b; FDA, 2009c).
are enforceable by law and serve as one basis for FDA
inspections. In addition to the cGMPs, FDA published a In 2009 the U.S. House of Representatives introduced a
“Guide to Minimize Microbial Food Safety Hazards of food safety bill (H.R. 2749) that included the regulation
Fresh-cut Fruits and Vegetables” (“Fresh-cut Guide”) in of vegetable production and harvesting. This bill passed
2008.1 FDA developed this guidance to complement in July 2009 and the Senate version known as the FDA
Food Safety Modernization Act, S. 510 (FSMA) passed in
December 2010 and was signed into law on January 4,
2011. The FSMA states, “not later than 1 year after the
1 FDA. 2008. Guidance for Industry: Guide to Minimize Microbial
Food Safety Hazards of Fresh-cut Fruits and Vegetables.http:// date of enactment of the FDA Food Safety Modernization
www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ Act, the Secretary, should publish a notice of proposed
GuidanceDocuments/ProduceandPlanProducts/ucm064458.htm#ch8
rulemaking to establish science-based minimum practices contained herein are intended for fresh
standards for the safe production and harvesting of those culinary herbs only. If these specific practices are
types of fruits and vegetables that are raw agricultural effectively implemented this would constitute the Best
commodities for which the Secretary has determined Practices for a comprehensive food safety program for
that such standards minimize the risk of serious adverse the production, harvest, packing and processing of fresh
health consequences or death.” culinary herbs. When growing any type of produce,
growers should comply with the FDA’s “Guide to
At this time it is unknown if specific commodities Minimize Microbial Food Safety Hazards for Fresh Fruits
will be targeted or if key practices will be addressed; and Vegetables” and requirements established in the
however, cilantro specifically was singled out by the FDA upcoming Produce Safety Rule.2
following detection of Salmonella on cilantro samples. In
March 2011, the FDA issued a letter to firms that grow, Human pathogens that are associated with produce
harvest, sort, pack, or ship fresh cilantro encouraging and cause infection and illness can be present in
these firms “to access hazards unique to production of large numbers in the feces of humans and animals.
cilantro and to develop commodity-specific preventive Therefore, food safety programs for the production
control strategies that would identify potential hazards and handling of fresh culinary herbs should pay special
that may be specific to fresh cilantro.” In light of these attention to controlling, reducing, and eliminating
developments pertaining to fresh produce in general potential fecal contamination through water, soil, people,
and to cilantro specifically, the fresh culinary herb and animals (both domestic and wild).
industry has decided that proactive development of
fresh culinary herb-specific food safety guidelines is In addition to this document, several supplemental
important and that moving forward ahead of an FDA documents have been prepared to explain the rationale
mandate will help increase the safety and security of the for the guidelines and assist the grower with activities
U.S. fresh culinary herb supply chain. in the field.These documents include a technical basis
document that describes in detail and with appropriate
In addition to food safety efforts for fresh culinary citations the bases for the best practices included
herbs in the U.S., the Mexican government, in in this document, a sanitary survey document that
conjunction with its fresh produce industry, has describes the processes for assessing the integrity and
developed food safety standards, and in 2009 the remediation of water systems, crop and soil testing plan
Canadian Horticultural Council (CHC) and its fresh protocol examples, an example of an environmental risk
produce industry members in collaboration with the assessment SoP, a list of resource agency contacts, and
Canadian government developed GAPs for fresh leafy a document describing standards for composting.All of
vegetables including fresh culinary herbs. The CHC- these items can be found as appendices to this document.
managed program, called CanadaGAP is verified by
third-party certification and audit companies that Scope
are approved and subject to oversight by CHC.This
document is designed to complement the Mexican and This document is designed to offer food safety guidance
Canadian governments’ food safety efforts while making for growers and handlers of fresh culinary herbs during
necessary adaptations to meet U.S. requirements. production, harvesting, packing, and shipping operations
(see Figure 1). It includes four sections: 1) Elements of a
Food Safety Programs Relevant to All Unit operations, 2)
Purpose Production and Harvest Unit operations, 3) Post-Harvest
The purpose of this document is to provide fresh Unit operations, and 4) Processing Unit operations.
culinary herb growers, packers, and shippers with
effective guidelines to reduce the potential of microbial This document pertains only to fresh culinary herbs
contamination as well as potential for contamination and does not include fresh culinary herbs that are
related to mishandling of chemicals and the presence
of foreign objects in the production and handling
2 FDA. 1998. Guidance for Industry: Guide to Minimize Microbial
environments. The issues identified are based on Food Safety Hazards for Fresh Fruits and Vegetables. http://
the core elements of GAPs and cGMPs. The specific www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/ProduceandPlanProducts/UCM064574
typically used in medicinal products. Fresh culinary safety education to supply chain partners should be
herbs include all varieties of basil, chervil, chives, made as well. With the commitment of each party
cilantro, dill, lemon verbena, marjoram, mint, oregano, along the supply chain to review and implement these
parsley, rosemary, sage, savory, sorrel, tarragon, and guidelines, the fresh produce industry is doing its part
thyme. This document offers food safety guidance that to provide a consistent, safe supply of fresh culinary
is applicable for fresh culinary herbs grown outdoors herbs to the market place.
in field environments and in controlled environments
such as greenhouse production using both conventional Due to close association between production areas
and organic growing methods. Producers that follow and environmentally sensitive areas in many locations,
organic standards are responsible for satisfying the food consultation with appropriate land and natural resource
safety best practices in this document in accordance management agencies, many of whom are identified
with their organic certification standards. in Appendix Z, is encouraged when any mitigation
strategies that may impact these areas are employed.
Fresh culinary herbs are both mechanically and Growers should implement strategies that not only
manually harvested, and can be packed in the field, protect the safety of their fresh culinary herb crops,
in a packinghouse or in a processing plant. Due to but also support co-management. All parties involved
harvesting by hand, quality sorting, and the practice of with implementing the practices outlined in this
bunching and packing these commodities, there are document should be aware that these guidelines are
numerous “touch points” early in the supply chain. not, in any way, meant to encourage growers to violate
Each of these “touch points” represents a potential environmental regulations or be in conflict with or
opportunity for contamination. Fresh culinary herbs discourage co-management practices and principles.
are primarily sold as a raw and processed product. In
a processing environment, fresh culinary herbs are Users are encouraged to also utilize the services
cleaned, trimmed, sometimes cut, and packed in some of their trade associations, the Center for Produce
form of plastic, protective packaging. Therefore, fresh Safety, the U.S. Food and Drug Administration, the U.S.
culinary herbs offer several unique opportunities to Department of Agriculture, the U.S. Environmental
employ food safety risk management practices to Protection Agency, the Centers for Disease Control
enhance their safety. and Prevention, and state agricultural, environmental,
academic, wildlife and natural resource management
Safe production, packing, processing, distribution, agencies, and public health authorities.
and handling of fresh culinary herbs depend upon a
myriad of factors and the diligent efforts and food
safety commitment of many parties throughout the
distribution chain. no single resource document can
anticipate every food safety issue or provide answers
to all food safety questions. These guidelines primarily
focus on minimizing microbial food safety hazards
by providing options to prevent, reduce, control, or
eliminate microbial contamination of fresh culinary
herbs in the field-to-fork supply chain. Guidelines for
potential chemical and physical hazards are limited to
mishandling and inappropriate storage of agricultural
chemicals and the presence of trash and debris in close
proximity to production and handling areas.
Areas discussed in
Production
Section 1
Harvesting
Icing/Cooling
Areas discussed in
Cold Storage
Re-packing / Re-processing
Transportation
Plant
Retail or Foodservice
Distribution Center
Transportation
Retail/Foodservice
Retail/Foodservice outlet
Processing/Preparation
Consumers
Areas below the dotted
line are outside the scope
of this document
SeCTIon I
Section I:
Elements of Food Safety Programs Relevant to All Unit Operations
as specified under the Bioterrorism Act of 2002. The records that must
be kept are specified in the regulations and are needed to identify the
immediate previous sources and immediate subsequent recipients of
food, including its packaging. These records must include information that
identifies the food product. The regulation requires, among other things, that
records maintained by nontransporters include an “adequate description” of
the food, including brand name and specific variety. The best practices below
complement, but do not supersede, existing recordkeeping requirements in
existing FDA regulations.
3 Lot coding of fresh culinary herb products may be complicated by the fact that many small blocks of land may contribute a "lot" of
product packed at a packinghouse on any particular day. Also, fresh culinary herb ranches / farms may undergo multiple harvests over multiple
Production date
Production code
Expiration date
Quantities
Transporter
• Any tags used in the packing and processing facility should be secured to finished product containers in
a manner that does not create a potential for damaged packaging materials or foreign object inclusion.
Documentation List:
Product Tracing Records
Recall program
Import documents
days or weeks from one contiguous plot of land. A lot should be coded in a way that allows identification of the sources.
SeCTIon II
Section II:
Production And Harvest Unit Operations
Fresh culinary herbs are generally grown in rural areas that may have
adjacent wetlands, wildlands, parks, and/or other areas where animals may be
present. Some animal species are known to be potential carriers of various
human pathogens (Fenlon 1985; Gorski et al. 2011; Jay et al. 2007; Keene et
al. 1997; LeJeune et al. 2008; Perz et al. 2001). Uncertainties in the literature
about which animals might be the most likely to contaminate fields as well
as difficulty excluding some types of animals from fields (i.e., birds, reptiles)
has led to the practice of not harvesting any potentially contaminated
fresh culinary herbs if crop damage from animals or fecal contamination is
detected. In addition, extensive development in certain farming communities
has also created situations with urban encroachment and unintentional
access by domestic animals, livestock, and human activity, which may also
pose varying degrees of risk.
Finally, it is possible that some land uses may be of greater concern than
others when located near production fields. Table II-1B provides a list of
these uses and options for buffer distances.
the introduction of human pathogens. Periodically monitor these factors and assess during the
preseason and pre-harvest assessments (see suggestions in Table II-1A and II-1B).
Pooled water (e.g., from rainfall, irrigation leaks) that persists for several days may present a
contamination risk (i.e., underlying soil has inadequately composted soil amendments, attractant
for animals) and should be part of any land use evaluation.
Assessment of Adjacent Land Use
Evaluate all land and waterways adjacent to fresh culinary herb fields for possible sources of
human pathogen of concern. These sources include, but are not limited to, manure storage,
compost storage, Concentrated Animal Feeding operations (CAFos), grazing / open range
areas, livestock feeding facilities, surface water, sanitary facilities, and composting operations
(see Table II-1B for further detail). If any possible uses that might result in fresh culinary herb
contamination are present, consult with the metrics and contact the appropriate land and/or
Table II-1B provides options for distances and guidance applicable to adjacent land uses that
Control risks associated with encroachment by urban development. Risks may include, but are
not limited to, domestic animal-related crop damage or fecal contamination of production fields
Evaluate and implement practices to reduce the potential for windborne soil including soil
from roads adjacent to fields, aerosols from spray application of SAs, water, or other media
that may be a source of contamination to come into direct contact with fresh culinary herbs.
Such practices may include (but are not limited to) berms, windbreaks, diversion ditches, and
Be aware of runoff from adjacent properties and its proximity to fresh culinary herb fields,
packinghouses, etc.
The location of any adjacent land uses that may be of potential risk should be documented. In
addition, as specified in Table II-1B, any deviations from the provided buffer distances due to
Fencing, vegetation removal, and destruction of habitat may result in adverse impacts to
the environment. Potential adverse impacts include loss of habitat to beneficial insects and
fields and any potential issues from these uses that might
Assessment of Flooding
Evaluate all fresh culinary herb fields for evidence of flooding. If any evidence is found, follow
procedures identified in section 8.0 Flooding.
Documentation List:
Pre-plant environmental assessment
Corrective actions report
Pre-harvest environmental assessment
Harvest environmental assessment
Please see Figure 2. Decision Tree for Conducting Pre-Harvest and Harvest Assessments.
Monitoring
Conduct periodic monitoring, preseason, pre-harvest, and harvest assessments. Evaluate and document any crop damage from animals
or fecal matter in fresh culinary herbs fields and production environments.
Pre-Harvest Assessment
Conduct the Pre-Harvest assessment not more than 1 week prior to harvest.
If fecal contamination is discovered before harvest operations:
• Do not harvest any fresh culinary herbs that have come into direct contact with fecal material.
• Conduct a food safety assessment using qualified personnel. Do not harvest fresh culinary herbs found within a minimum five-foot
radius buffer distance from the spot of the contamination unless corrective action can be found that adequately control the risk. The
food safety professional can increase this buffer distance if deemed appropriate.
Issue Metric Rationale / Corrective Actions
If evidence of crop damage from animals is found in a fresh culinary herb field, conduct a visual food safety assessment to determine
whether the area can be adequately controlled, or whether a three-foot buffer radius non-harvest area should be applied.
Harvest Assessment
If evidence of fecal matter, crop damage or animals are observed in the production area during harvest operations:
Verification • Archive documentation for a period of 2 years following the event. Documentation may include photographs, sketched maps, or
other means of delineating affected portions of fresh culinary herb fields.
Rationale • The basis of these metrics is qualitative assessment of the relative risk from a variety of potential contamination from animals.
Animal feces and crop damage from animals are considered to be of more concern than other signs of animal activity (e.g., tracks).
Because it is difficult to develop quantitative metrics for these types of risks, a food safety assessment is considered appropriate for
this issue.
• Appendix B describes in detail the process used to develop these metrics.
Table II-1B. Crop Land and Water Source Adjacent Land Use
Please keep in mind that all of the buffer distances provided in this table depend on the risk/mitigation factors listed in the column to the right – “Considerations
for Risk Analysis.” Evaluate risks specific to your operation and document the consideration of these risk/mitigation factors.
Composting operations Due to the lack of science-based knowledge at this time, Topography: Uphill from fresh culinary herb fields √
(manure or animal an interim guidance distance of 400 ft. from the edge of
products) crop is proposed. This number is subject to change as Topography: Downhill from fresh culinary herb √
science becomes available. fields
Concentrated Animal Due to the lack of science-based knowledge at this time, Fencing and other physical barriers such as √
Feeding operations (as an interim guidance distance of 400 ft. from the edge of berms, diversion ditches and vegetated strips may
defined in 40 CFR 122.23) crop is proposed. This number is subject to change as be employed to prevent intrusion of domestic
science becomes available. animals, control runoff, etc.
The proximate safe distance depends on the risk / Topography: Uphill from fresh culinary herb fields √
mitigation factors listed to the right. Evaluate risk and
Topography: Downhill from fresh culinary herb √
document consideration of these factors. Research is
fields
being proposed to study the appropriate distance and any
adjustments to the distance due to mitigating fac opportunity for water run off through or from
CAFos √
non-synthetic Soil Due to the lack of science-based knowledge at this time, Access and review CoA for materials in question
Amendment Pile an interim guidance distance of 400 ft. from the edge of √
(containing manure or crop is proposed. This number is subject to change as
animal products) science becomes available. Topography: Uphill from fresh culinary herb fields √
Land Use / Water Source Metric Considerations
(This distance is intended to be established by the for Risk Analysis*
producer and should be increased or decreased
depending on the risks present and any mitigation Risk / Mitigation Factors Increase Decrease
factors employed to reduce that risk.) Distance Distance
The proximate safe distance depends on the risk / Topography: Downhill from fresh culinary herb √
mitigation factors listed to the right. Evaluate risk and fields
document consideration of these factors. Research is
opportunity for water run off through or from √
being proposed to study the appropriate distance and any
non-synthetic soil amendment storage areas
adjustments in distance due to mitigating factors.
opportunity for soil leaching √
Covering on pile to prevent wind dispersion √
Grazing Lands / Domestic Due to the lack of science-based knowledge at this time, Fencing and other physical barriers such as √
Animals (includes an interim guidance distance of 30 ft. from the edge of berms, diversion ditches and vegetated strips can
homes with hobby farms, crop is proposed. This number is subject to change as be employed to prevent intrusion of domestic
and non- commercial science becomes available. animals, control runoff, etc.
livestock)
Topography: Uphill from fresh culinary herb fields √
The proximate safe distance depends on the risk /
mitigation factors listed to the right. Evaluate risk and Topography: Downhill from fresh culinary herb √
document consideration of these factors. Research is fields
being proposed to study the appropriate distance and any
opportunity for water run off through or from √
adjustment in distance due to mitigating factors.
grazing lands
opportunity for soil leaching √
Homes or other Building 30 ft. from the edge of crop to the leach field. Active leach field: < 10 yrs. old √
with a Septic Leach Field.
Active leach field: > 25 yrs. old √
Inactive leach field √
Topography: Uphill from fresh culinary herb fields √
Topography: Downhill from fresh culinary herb √
fields
Physical barriers √
Well Head Distance from 200 ft. separation of untreated manure from wells. Topography: Uphill from manure √
Untreated Manure
Topography: Downhill from manure √
opportunity for water runoff from or through √
untreated manure to well head
opportunity for soil leaching √
Land Use / Water Source Metric Considerations
(This distance is intended to be established by the for Risk Analysis*
producer and should be increased or decreased
depending on the risks present and any mitigation Risk / Mitigation Factors Increase Decrease
factors employed to reduce that risk.) Distance Distance
Surface Water Distance At least 100 feet separation for sandy soil and 200 feet Topography: Uphill from manure √
from Untreated Manure separation for loamy or clay soil (slope less than 6%;
increase distance to 300 feet if slope greater than 6%). Topography: Downhill from manure √
Rationale • The bases for these distances above is best professional judgment of authors, contributors, and expert reviewers to prevent potential
cross-contamination from adjacent land uses, taking into consideration the 200 foot distance cited in FDA (US FDA 2001) for
separation of manure from wellheads and the 30 foot turn-around distance for production equipment. Because of the numerous
factors that must be taken into account to determine appropriate distances, a qualitative assessment of the relative risk from various
types of land use and surface waters was used to determine appropriate distances and may be different for individual operations.
• Appendix B describes in detail the process used to develop these metrics.
*Growers should check for local, state, and federal laws and regulations that protect riparian areas, restrict removal of vegetation or habitat, or restrict
construction of wildlife deterrent fences in riparian areas or wildlife corridors.
Figure 2. Decision Tree for Conducting Pre-Harvest and Harvest Assessment of Animal
Activity in Field (Wild or Domestic)
Pre-season, one week prior to harvest (pre-harvest assessment) and during harvesting
operations, conduct visual assessment of production block. Look for:
• Live or dead animals
• Animal tracks
• Downed fences
• Animal feces or urine
• Crop damage from animals
Is there evidence of contamination in the production block?
YeS no
If contamination is suspected, a food safety assessment should be Document the assessment and
performed by qualified personnel. The following information is continue normal harvest schedule.
important to make a decision regarding corrective actions:
• Type of animal
• Nature and extent of incident
• Crop area affected
no YeS
Corrective action may include:
Production block should • Isolation of affected area
not be marketed as ready- • Elimination of potentially contaminated crops
to-eat or raw agricultural • Fences, barriers, or other deterrents to protect the remainder
commodity; document of the crop. Growers should consider consulting with
the assessment and the appropriate permitting agencies before doing so.
resulting conclu • Document and maintain records of food safety assessments
and corrective actions for at least two years.
Perform a post-corrective action visual inspection.
Have the measures mitigated the identified risks from
animal?
no YeS
Repeat assessment Document the inspection
and possible mitigation and continue normal
measures. harvest schedule.
The water source may also dictate different risk management measures or
provides valuable strategies. From a potential risk perspective, water sourced from surface
water (e.g., a river or an irrigation canal) represents a very different entity
information on than water sourced from a well. For example, for water sourced from a
well, inspection of the well head and periodic microbial testing of the water
trends in microbial would be an excellent risk management strategy. In contrast, microbial
testing of canal-sourced water may not be useful or actionable as the
levels that may sample is only representative for the moment of sampling (i.e., water in a
canal is flowing and microbial populations fluctuate considerably over time,
distance, and environments). Microbial testing of flowing water systems is
be related to primarily designed to establish baseline information on the ability of these
systems to deliver water of acceptable quality. As part of a water quality
environmental management plan, analysis of microbial testing data over time provides
valuable information on trends in microbial levels that may be related to
conditions or environmental conditions or that may indicate the occurrence or existence
of a contaminating source or event. When testing data indicates unusual
microbial levels, the Sanitary Survey (Appendix A) may be used to evaluate
that may indicate the water system.
the occurrence When water is sourced from a canal, risk management strategies should
focus on keeping the laterals within the boundaries of the production
or existence of a area free from the accumulation of debris and other potential sources
of contamination. These strategies should be in place and should include
contaminating routine inspections and corrective action protocols. A management
program for water quality verification should include documentation of
any testing results as well as any preventive or corrective actions taken to
source or event. reduce or eliminate potential contamination.
1 Water quality criteria are based on US EPA recreational and drinking water quality. These standards are being used because there are no
federal agricultural water quality standards. For further information, please see Appendix B,Technical Basis for Metrics.
PRe-HARVeST Target organism: For any given water source (municipal, well, reclaimed water, reservoir or other surface
generic E. coli. water), samples for microbial testing should be taken as close to the point of use as
Foliar Applications practical (as determined by the sampler using sampling methods to ensure the integrity of
Sampling Procedure: the sample as prescribed in this table) where the water contacts fresh culinary herbs, so as
(overhead sprinkler 1 L sample collected aseptically at the point of to test both the water source and the water distribution system. In a closed water system
irrigation, pesticides / use; e.g., one sprinkler head per water source (meaning no connection to the outside) water samples may be collected from any point
fungicide application, etc.) for irrigation, water tap for pesticides. Water within the system, but are still preferred as close to point of use as practical. There is only
utilized in preseason irrigation operations may one sample per month per distribution system under these metrics unless a system has
be tested and utilized. qualified for an exemption. If there are multiple potential point-of-use sampling points in
a distribution system, then samples should be taken from different point-of-use locations
Sampling Frequency: each subsequent month (randomize or rotate sample locations).
one sample per water source should be
collected and tested prior to use if >60 days Water for pre-harvest, direct contact should meet or exceed microbial standards for
since last test of the water source. Additional recreational water, based on a rolling geometric mean of the five most recent samples. If
samples should be collected no less than 18 the water source has not been tested in the past 60 days, the first water sample should be
hr. apart and at least monthly during use from tested prior to use, to avoid using a contaminated water source. After the first sample is
points within the distribution system. shown to be within acceptance criteria, subsequent samples should be collected no less
frequently than monthly at points of use within the distribution system.
Municipal & Well exemption:
For wells and municipal water sources, if Ideally, pre-harvest water should not contain generic E. coli, but low levels do not
generic E. coli levels are below detection necessarily indicate that the water is unsafe. Investigation and / or corrective action
limits for five consecutive samples, test the should be taken when test results are higher than normal or indicate an upward trend.
water for total coliform (TC). If the TC test Investigation and corrective action must be taken when acceptance criteria are exceeded.
is zero/negative, the sampling frequency may
be decreased to once every six months and Corrective Actions: If the rolling geometric mean (n=5) or any one sample exceeds the
the 60 and 30 day sampling are waived.This acceptance criteria, then the water should not be used whereby the fresh culinary herbs
exemption is void if there is a significant are contacted by water until corrective actions have been completed and generic E. coli
source or distribution system change. levels are within acceptance criteria:
• Conduct a Sanitary Survey of water source and distribution system to determine
if a contamination source is evident and can be eliminated. Eliminate identified
contamination source(s).
• For wells, perform a Sanitary Survey and / or treat as described in Appendix A.
• Retest the water after conducting the Sanitary Survey and / or taking corrective
actions to determine if it meets the outlined microbial acceptance criteria for this
use. This sample should represent the conditions of the original water system. If
feasible, this test should be as close as practical to the original sampling point. A more
aggressive sampling program (i.e., sampling once per week instead of once per month)
should be instituted if an explanation for the exceedence is not readily apparent. This
type of sampling program should also be instituted if an upward trend is noted in
normal sampling results.
Use Metric Rationale / Corrective Actions
Test Method: Crop Testing: If water testing indicates that fresh culinary herbs have been directly
FDA BAM method or any US EPA-approved contacted with water exceeding acceptance criteria, fresh culinary herb plants should be
or AoAC-validated method for quantitative sampled and tested for E. coli o157:H7 and Salmonella as well as any other microorganism
monitoring of water for generic E. coli. deemed appropriate as described in Appendix C. If crop testing indicates the presence of
pathogens, these herbs should noT be harvested for human consumption.
Acceptance Criteria:
≤126 MPn (or CFU)*/100 mL Records: Information requirements: Each water sample and analysis should record: the
(rolling geometric mean n=5) and ≤235 type of water (canal, reservoir, well) date, time, field location of the sample, and exact
MPn/100 mL for any single sample. location in the water system and the method of analysis and detection limit. Records
of the analysis of source water may be provided by municipalities, irrigation districts or
*for the purposes of water testing, MPn and other water providers. All test results and corrective actions should be documented and
CFU should be considered equivalent. available for verification from the grower / handler who is the responsible party for a
period of 2 years.
PReHARVeST Target organism, Sampling Procedure, Testing and corrective actions for pre-harvest water that does not come in direct contact
non-Foliar Applications Sampling Frequency Test Method and with edible portions of the crop are the same as for direct contact water, but acceptance
Whereby Edible Portions Municipal Well exemption: as described criteria are less stringent because of the reduced risk of contact of the edible portion with
of the Crop are noT for foliar application. contamination from water. Acceptance criteria
Contacted by Water
Acceptance Criteria:
(e.g., furrow or drip ≤126 MPn /100 mL
irrigation, dust abatement (rolling geometric mean n=5) and ≤576 MPn
water; if water is not /100 mL for any single sample.
used in the vicinity of
produce, then testing is not
necessary)
Use Metric Rationale / Corrective Actions
PoST-HARVeST Direct Microbial Testing Water that directly contacts harvested fresh culinary herbs or is used on food contact
Product Contact or Target organism, Sampling Procedure, surfaces, such as equipment or utensils, should meet the Maximum Contaminant Level
Food Contact Surfaces Test Method, and Municipal & Well Goal of zero or no detection for E. coli in drinking water as specified by US EPA or contain
exemption: as described for PRE-HARVEST, an approved disinfectant at sufficient concentration to prevent cross-contamination.
foliar applications. Microbial or physical / chemical testing should be performed, as appropriate to the specific
operation, to demonstrate that acceptance criteria have been met.
Sampling Frequency: one sample per
water source should be collected and tested Single Pass and Multiple Pass Systems
prior to use if >60 days since last test of the Single pass use – Water should have non-detectable levels (< 2 MPn/100 mL) 26 of E. coli
water source. Additional samples should be and sufficient disinfectant to ensure returned water has no detectable E. coli (minimally 10
collected at intervals of no less than 18 hours ppm chlorine).
and at least monthly during use. Multi-pass use – Water should have non-detectable levels (< 2 MPn/100 mL) 26 of E. coli
and sufficient disinfectant to ensure returned water has no detectable E. coli (minimally 10
Acceptance Criteria: ppm chlorine).
negative or below DL for all samples (< 2
MPn/100 mL) 1 * Single pass and recirculated water treated with chlorine-based disinfectants should be
tested for free chlorine concentration (ppm) and pH oR for oxidation reduction potential
(mV). The selected method should be verified periodically with the alternative process
Physical / Chemical Testing verification method AnD by ensuring that established microbial acceptance criterion for
Target Variable: generic E. coli in water is being met.
Water disinfectant (e.g., chlorine or other
antimicrobial chemical) Corrective Actions:
If any one sample exceeds the acceptance criteria for generic E. coli, then the water should
Single pass and Multi-Pass Water not be used for this purpose unless appropriate disinfectants have been added or until
Acceptance Criteria*: corrective actions have been completed and generic E. coli levels are within acceptance
• US EPA-approved treatments per criteria:
product label for human pathogen • Conduct a Sanitary Survey of the water source and distribution system to determine
reduction in water and used in if a contamination source is evident and can be eliminated. Eliminate identified
accordance with a water system-specific contamination source(s) if applicable.
protocol that has been validated to show • For wells, perform a Sanitary Survey and / or treat as described in the Sanitary Survey
that active disinfectant is present. (Appendix A).
• Chlorine-based disinfectants • Retest the water at the same sampling point after conducting the Sanitary Survey
>10 ppm free chlorine post-contact and and / or taking corrective actions to determine if it meets the outlined microbial
pH 6.5 – 7.0 acceptance criteria for this use.
• ORP > 725 mV
For example, if a water sample for water used to clean food contact surfaces has
detectable E. coli, STOP using that water system, examine the distribution line; source the
inlet as described in the Sanitary Survey (Appendix A), and retest from the same point
1 The method used to test the water should have of use. Continue testing daily for five days at the point closest to use, and do not use
a detection level of <2 MPn/100 mL. For additional the water system until it consistently delivers water that is safe, sanitary, and meets the
discussion on this issue, see Appendix B:Technical acceptance criteria for post-harvest water outlined in this table. If any of the five samples
Basis for the Guidelines taken during the intensive sampling period after corrective actions have been taken, have
Use Metric Rationale / Corrective Actions
Testing Procedure: detectable E. coli, repeat corrective actions and Do noT use that system until the source
• Chemical reaction based colorimetric of contamination can be corrected.
test, or
• Ion specific probe, or Records: All test results and corrective actions should be documented and available for
• ORP,* or verification from the user of the water for a period of 2 years.
• Other as recommended by disinfectant
supplier.
Testing Frequency:
Continuous monitoring (preferred) with
periodic verification by titration oR routine
monitoring if the system can be shown to have
a low degree of variation.
Figure 3A. Decision Tree for Pre-Harvest Water Use (e.g., overhead irrigation, drip
irrigation, pesticide / fungicide applications)
For any given water source (municipal, well, reclaimed water, reservoir or other surface water):
Sampling Frequency: If >60 days since last test of the water source, one sample per water source should be
collected and tested prior to use. Additional samples should be collected no less than 18 hours apart and at
least monthly during use.
• Sample sources as close to the point-of-use as practical, as determined by the sampler to ensure the
integrity of the sample, using sampling methods as prescribed in Table II-2.
• Analyze samples for generic E. coli using a quantitative method that is EPA- or FDA-approved or AoAC-
validated.
• Geometric means, including rolling geometric means should be calculated using the five most recent
samples.
Action Level
> 126 MPn/100mL
(geometric mean of five samples)
oR
>235 MPn/100mL (any single sample)
Acceptance Criteria
< 126 MPn/100mL
(geometric mean of five samples)
AnD
<235 MPn/100mL (all single samples)
Remedial Actions:
1. Discontinue use for any application that has direct
contact with the plant.
2. Examine the water source and distribution system to
determine if a contamination source is evident and
no further action necessary. Water can be eliminated.
from this source may be used for 3. For wells, perform a Sanitary Survey as described in
any pre-harvest use such as pesticide Appendix A.
applications and/or irrigation. 4. After Sanitary Survey and/or remedial actions have
been taken, retest the water at the same sampling
However, when test results are higher point.
than normal or indicate an upward 5. Test daily for five days, approximately 24h apart, at
trend, investigation and/or remedial the point closest to use.
action SHoULD be taken. 6. If any of the next five samples is >235 MPn/ 100mL,
repeat Sanitary Survey and/or remedial action.
7. Do not use water from that water system, in a
manner that directly contacts edible portions of
the crop, until the water can meet the outlined
acceptance criteria for this use.
Crop testing:
• If crop has been directly contacted with water
exceeding acceptance criteria, sample and test
product for E. coli o157:H7 and Salmonella as
described in Appendix C prior to harvest.
• If crop testing indicates the presence of either
pathogen, do noT harvest for human consumption.
For any given water source (municipal, well, reclaimed water, reservoir or other surface water):
Sampling Frequency: one sample per water source shall be collected and tested prior to use if >60 days
since last test of the water source. Additional samples shall be collected no less than 18 hours apart and at
least monthly during use.
• Sample sources as close to the point-of-use as practical using sampling methods as prescribed in Table II-2.
• Analyze samples for generic E. coli using a quantitative method that is EPA- or FDA-approved or AoAC-validated.
• Geometric means, including rolling geometric means shall be calculated using the five most recent samples.
For any given water source (municipal, well, reservoir or other surface water):
Water that directly contacts edible portions of harvested fresh culinary herbs should meet microbial
standards for generic E. coli as outlined in this document, and / or contain an approved disinfectant at sufficient
concentrations to prevent cross-contamination.
Sampling Frequency: one sample per water source should be collected and tested prior to use if >60 days
since last test of the water source. Additional samples should be collected no less than 18 hours apart and a
least monthly during use.
• Sample sources as close to the point-of-use as practical using sampling methods as prescribed in Table II-2.
• Analyze samples for generic E. coli using a quantitative method that is EPA- or FDA-approved or AoAC-
validated.
• Geometric means, including rolling geometric means should be calculated using the 5 most recent samples.
Documentation List:
Water system description
A water quality management plan including validation of water disinfection system
SoP – Water testing
Water test results that describes the methods used for analysis
Water disinfectant monitoring logs
m
3.0 Issue: Soil Amendments
Soil amendments (SAs) are commonly (but not always) incorporated prior to planting into agricultural soils used
for fresh culinary herb production to add organic and inorganic nutrients to the soil as well as to reduce soil
compaction. Human pathogens may persist in animal manures for weeks or even months (Fukushima et al. 1999;
Kudva et al. 1998). Proper composting of animal manures via thermal treatment will reduce the risk of potential
human pathogen survival, but proper storage and handling of composted animal manures is essential in preventing
recontamination. Field soil contaminated with human pathogens from inadequately composted or re-contaminated
composted soil amendments may provide a means of fresh culinary herb contamination. Some studies of human
pathogens conducted in cultivated field vegetable production models point towards a rapid initial die-off from high
pathogen populations but often maintain a characteristic and prolonged low level pathogen survival (Hutchison et
al. 2004; Ingham et al. 2004; Ingham et al. 2005; Islam et al. 2004a; Islam et al 2005; Nicholson et al. 2004). However,
the persistence of many human pathogens in agricultural soils depends on many factors (e.g., soil type, crop planted,
soil moisture, relative humidity, UV index, cultivation practices, stress-adaption) and the effects of these factors
are under extensive investigation (Jiang et al. 2003; Islam et al. 2004a; Islam et al. 2004b; Singh et al. 2010). Human
pathogens may not persist for long periods of time in high UV index and low relative humidity conditions, but may
persist for longer periods of time in cool, moist climates or when SA are incorporated into the soil where UV rays
do not easily penetrate and more moisture is present.
composted or • Any SA that does not contain animal manure should have a
certificate (e.g., ingredient list, statement of identity, letter of
guaranty) from the producer or seller demonstrating that it is
re-contaminated manure-free. The manure-free certificate should be available for
verification before application and should be saved and available
composted soil for inspection for 2 years.
• Implement management plans (e.g., timing of applications,
amendments may storage location, source and quality, transport) that significantly
reduce the likelihood that SAs being used contain human
provide a means of pathogens.
Storage and handling practices should reduce the risk of
fresh culinary herb recontamination after the composting process is complete
and before it is applied to and incorporated into fields.
This is especially critical for SAs that are pelletized, which
contamination. provides a concentrated source of nutrients, and processed
using high heat, which eliminates competing microbiological
populations.
Verify that the time and temperature process used during
the composting process reduces, controls, or eliminates
the potential for human pathogens being carried in the
composted materials. There are validated processes
outlined in regulatory requirements that dictate critical
times and temperatures for different composting methods
(see Table II-3 and Appendix F for details). new research
findings suggest that rapid achievement of critical
temperatures is also important for pathogen die-off.
Do not apply composted SAs less than 45 days before
harvest. Although highly effective at reducing pathogens, composting methods and microbial
testing as provided in Table II-3, do not guarantee pathogen-free SAs. Therefore, an application-
to-harvest interval of greater than 45 days provides an additional hurtle for minimizing the risk of
contamination. When determining appropriate application intervals, consider plant characteristics as
well as climatic and field conditions (i.e., high humidity, low UV may warrant longer application-to
harvest intervals).
• Implement practices that control, reduce or eliminate likely contamination of fresh culinary herb fields
in close proximity to on-farm stacking of manure or storage of other soil amendments (for suggested
buffer distances see Table II-1B).
• Use SA application techniques that control, reduce, or eliminate likely contamination of surface water
and / or crops being grown in adjacent fields.
• Segregate equipment used for SA handling, preparation, distribution, and application or use effective
means of equipment sanitation that effectively reduces the potential for cross-contamination before
subsequent use.
• Compost suppliers should have written SOPs to prevent cross-contamination of finished compost
with raw materials through equipment, runoff, or wind, and growers should obtain proof that these
documents exist.
• Compost operations supplying compost to fresh culinary herb crops should maintain temperature
monitoring and turning records for at least 2 years, and growers should obtain proof that this
documentation exists. This applies to composting operations regulated under Title 14 of California
Code of Regulations (CCR) as well as operations in other states and smaller CA operations that do not
fall under CCR Title 14.2
• Perform microbiological testing of SAs prior to application as provided in Table II-3.
• Retain documentation of all processes and test results by lot (at the supplier) and / or Certificates of
Analysis available for inspection for a period of at least 2 years.
Documentation List:
Product spec sheets
Composted SA process verification paperwork (e.g. CoA, test results)
on-farm compost processing records
SA application dates
Copy of any required applicator’s license
SoP – Cleaning of SA application equipment
Raw manure, biosolids and/ or Do noT USe oR APPLY SAs that contain raw manure, biosolids, un-composted/incompletely composted green and/
incompletely composted green waste, or poultry carcasses, un-composted/incompletely composted or non-thermally treated (e.g., heated) animal manure to
animal manure or poultry carcasses fields which will be used for fresh culinary herb production. If these materials have been applied to a field, wait one year
containing SAs prior to producing fresh culinary herbs,
(see composted manure process
definition below)
Composted SAs (containing animal Please see Figure 4A: Decision Tree for Use of Composted SAs.
manure or animal products)
Composting Process Validation:
Enclosed or within-vessel composting:
• Active compost shall maintain a minimum of 131oF for 3 days
Windrow composting:
• Active compost shall maintain aerobic conditions for a minimum of 131oF for 15 days or longer, with a
minimum of five turnings during this period.
Aerated static pile composting:
• Active compost shall be covered with 6 to 12 inches of insulating materials and maintain a minimum of 131oF
for 3 days
Target organisms:
• Fecal coliforms
• Salmonella spp.
• E. coli o157:H7
Acceptance Criteria:
• Fecal coliforms: <1000 MPN/gram
• Salmonella spp.: negative or < DL (<1/30 grams)
• E. coli o157:H7: negative or < DL (<1/30 grams)
Sampling Plan:
• A composite sample shall be representative and random and obtained as described in the California state regulations
(see Appendix F).
• Sample may be taken by the supplier if trained by the testing laboratory.
• Laboratory should be certified / accredited for microbial testing by an appropriate process authority.
Testing Frequency:
• Each lot before application to fresh culinary herb production fields. A lot is defined as a unit of production equal to
or less than 5,000 cubic yards.
Application Interval:
• Should be applied >45 days before harvest.
Documentation:
• All test results and / or Certificates of Analysis should be documented and available for verification from the grower
(the responsible party) for a period of 2 years.
Rationale:
• The microbial metrics and validated processes are from California state regulations for composting operations (CCR
Title 14 – Chapter 3.1 – Article 7), with the addition of testing for E. coli o157:H7 as a microbe of particular concern.
The fresh culinary herb industry also considered testing for Listeria monocytogenes, but did not include it as a target
organism due to the current lack of validated testing methods for L. monocytogenes in SAs.
• These guidelines provide a multiple hurdle risk reduction approach to using SA containing composted animal manure
– 1) composting with an approved, validated process, 2) passing of specified microbial testing requirements, and 3) use
of application-to-harvest intervals of > 45 days. The greater than 45-day application interval was deemed appropriate
for SAs containing composted animal manure as an additional measure to reduce the risk associated with the
acceptance criteria for fecal coliform (<1000 MPn/gram), and because composting methods and microbial testing do
not guarantee pathogen-free material.
Amendment Metric / Rationale
SAs Containing Animal Manure that • Any process applied to a soil amendment containing animal manure should be validated to assure that the process is
has Been Physically Heat Treated capable of reducing pathogens of human health significance to acceptable levels.
or Processed by other equivalent
Methods Target organism:
• Fecal coliforms
• Salmonella spp.
• E. coli o157:H7
Acceptance Criteria:
• Fecal coliforms: < 10 MPN/gram
• Salmonella spp.: negative or < DL (<1/30 grams)
• E. coli o157:H7: negative or < DL (<1/30 grams)
Sampling Plan:
• Extract at least 12 equal volume samples (identify12 separate locations from which to collect the sub-sample, in case
of bagged product 12 individual bags).
• Sample may be taken by the supplier if trained by the testing laboratory or state authority.
• Laboratory should be certified / accredited by annual review of laboratory protocols based on GLPs by recognized
nGo.
Testing Frequency:
• Each lot before application to fresh culinary herb fields.
• In lieu of the above sampling plan, a Certificate of Process Validation issued by a recognized process authority can
be substituted. This certificate will attest to the process validity as determined by either a documented (included
with Certificate) inoculated pack study of the standard process or microbial inactivation calculations of organisms
of significant risk (included with Certificate) as outlined in FDA CFSAn publication “Kinetics of Microbial
Inactivation for Alternative Food Processing Technologies. overarching Principles: Kinetics and Pathogens of
Concern for All Technologies.”1
1 http://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm100158.htm
Amendment Metric / Rationale
Application Interval:
• If the physical heat treatment process used to inactivate human pathogens of significant public health concern is
validated and the soil amendment produced meets the microbial acceptance criteria outlined above, then no time
interval is needed between application and harvest.
• If the physical heat treatment process used to inactivate human pathogens of significant public health concern is
not validated, but the soil amendment produced meets microbial acceptance criteria outlined above, then a >45-day
interval between application and harvest is recommended.
Documentation
• Fresh culinary herb growers should keep the following documentation for a 2 year period:
Any SA test results and / or Certificates of Analysis should be available for verification from the grower who is the
responsible party
A copy of the SA supplier’s operation validation certificate issued by a process authority
• The documentation should be available for verification before harvest begins and maintained for at least 2 years.
Rationale:
• The microbial metrics and validated processes are from California state regulations for composting operations
(CCR Title 14 – Chapter 3.1 – Article 7), with the addition of testing for E. coli o157:H7 as a microbe of particular
concern. A more stringent level of fecal coliform was also included to address the much more controlled nature of
SAs produced in this manner. The above suggested application interval was deemed appropriate due to the specified
multiple hurdle risk reduction approach outlined. Raw manure should be composted with an approved process and
pass testing requirements before application.
• FDA has established the validity of D-values and Z-values for key pathogens of concern in foods. This method of
process validation is currently acceptable to U.S. regulators. Alternatively, results of an inoculated test pack utilizing
the specific process is also an acceptable validation of the lethality of the process.
SAs not Containing Animal Manure • Any SA that DOES NOT contain animal manure should have documentation that it is manure-free.
or Animal Products (e.g., synthetic • The documentation should be available for verification before harvest begins.
fertilizer) • If there is documentation that the amendment does not contain manure or animal products then no
additional testing is needed, and no application interval is necessary
• Any test results and / or Certificate of Analysis should be available for verification from the grower who is
the responsible party for a period of 2 years.
Figure 4A. Decision Tree for Composted Soil Amendments (SAs)
If raw manure has been directly applied to the field in the past, a one-year waiting period should be observed before
planting any variety of fresh culinary herbs.
Do current and/or past application of SAs contain raw manure, biosolids and/ or
incompletely composted animal manure, poultry carcasses or green waste?
YeS no no
Do not use in SA contains only fully composted animal manure SA does not contain
fresh culinary herb and/or green waste. Verify with compost supplier animal manure, poultry
production. that the active composting process follows the carcasses or green waste.
guidelines outlined below. Also adjust compost Have available a certificate
For previously treated production process to comply with Title 14 CCR, or other applicable
fields, a one-year waiting Chapter 3.1, Article 7 guidelines. documentation verifying
period must be observed these items are not
before planting any variety The compost supplier should be able to provide a included in the SA.
of fresh culinary herbs. certificate verifying their process. Keep records of
certificate for at least
Does the compost supplier provide 2 years (grower is
verification that the SA was produced by a responsible party).
validated process?
YeS no YeS
but microbial levels are above Certificate of Process and microbial levels are below
action levels. Validation is not available. action levels.
Samples may be collected Keep records of certificate
Do not use in fresh by grower or third-party for at least 2 years. observe
culinary herb production. consultant. Microbial testing application time interval of >45
should be performed by days before harvest.
an accredited / certified
laboratory.
Microbial Testing
A composite sample should be representative and random and obtained as described in the California
state regulations (see Appendix F). Submit to a certified/accredited laboratory for testing using the
following acceptance criteria:
• Fecal coliforms: <1000 MPN/gram
• Salmonella spp.: negative or < DL (<1/30 grams)
• E. coli o157:H7: negative or < DL (<1/30 grams)
Are the microbe levels below the corresponding acceptance criteria?
no YeS
Do not use in fresh culinary herb observe application time interval of >45 days
production. before harvest.
Does SA contain physically heat treated animal manure that has been
validated by a recognized authority?
no YeS
Verify with supplier (and obtain documentation) that the obtain documentation of
process is either validated by a recognized authority or validated process.
observes the following process:
Does the supplier provide
• Minimum temp: 300°F (150°C) a Certificate of Analysis
• Process duration: 60 min and Certificate of Process
• Moisture content: <30% dry weight Validation?
YeS no YeS
A Certificate of Analysis and And microbial levels are below
But microbial levels are above Certificate of Process Validation acceptance criteria and/or process
acceptance criteria. are not available. Samples may validation documentation is available..
be collected by grower or third- Keep records of certificate for at least
Do not use in fresh culinary party consultant. Microbial 2 years. For non-validated process,
herb production. testing should be performed observe application time interval of
by an accredited/certified >45 days before harvest; for validated
laboratory. process, no application time interval is
required.
Microbial Testing
Extract at least 12 equal volume samples (identify12 separate locations from which to collect the sub-sample,
in case of bagged product 12 individual bags). Combine samples and submit to a certified/accredited laboratory
for testing using the following acceptance criteria:
• Fecal coliforms: <10 MPN/gram
• Salmonella spp: negative or < DL (<1/30 grams)
• E. coli o157:H7: negative or < DL (<1/30 grams)
Are the microbe levels below the corresponding acceptance criteria?
no YeS
Do not use in fresh culinary herb • For non-validated process, observe
production. application time interval of >45 days before
harvest.
• For validated process, no application time
interval is required.
Documentation List:
Product spec sheets
Composted SA process verification paperwork (e.g. CoA, test results)
on-farm processing records
SA application dates
Copy of any required applicator’s license
SoP – cleaning of SA application equipment
Any crop treatment that contains animal nonsynthetic crop treatments that contain animal products or animal manure that have not been
manure, an animal product, and / or an physically heat treated or processed by other equivalent methods should noT be directly applied to fresh
animal by-product that is reasonably culinary herbs.
likely to contain human pathogens.
Please see Figure 5: Decision Tree for Use of nonsynthetic Crop Treatments.
Examples include (but not limited to):
• Compost teas Process Validation
• Fish emulsions • The physical, chemical, and / or biological treatment process used to render the crop treatment safe for application to
• Fish meal crops should be validated.
• Blood meal
• "Bio-fertilizers" commonly used for Target organism:
pest control, greening, disease control, • Salmonella spp.
fertilizing • E. coli o157:H7
• Other pathogens appropriate for the source material.
Suppliers of these products should disclose
on labels, Certificates of Analysis, or other Acceptance Criteria (at point of use):
companion paperwork whether the product • Salmonella spp.: negative or < DL (<1/30 grams)
contains any animal manure or products. • E. coli o157:H7: negative or < DL (<1/30 grams)
Sampling Plan:
• If solid, 12 point sampling plan composite sample, or if liquid, one sample per batch (if liquid-based, then crop
treatment should meet water quality acceptance levels as described in Table II-2)
• Sample may be taken by the supplier if trained by the testing laboratory.
• Laboratory should be certified / accredited by annual review of laboratory protocols based on GLPs by recognized
nGo.
Testing Frequency:
• Each lot before application to fresh culinary herb fields.
Treatment Metric / Rationale
Application Interval:
• If the physical, chemical, and / or biological treatment process used to render the crop treatment safe for application
to fresh culinary herbs is validated and meets that microbial acceptance criteria outlined above, no time interval is
needed between application and harvest.
• If the physical, chemical, and / or biological treatment process used to render the crop treatment safe for application
to fresh culinary herbs is not validated yet meets the microbial acceptance criteria outlined above, observe a >45-day
time interval between application and harvest.
Documentation:
• All test results and / or Certificates of Analysis should be documented and available from the grower for verification
for a period of 2 years. The grower is the responsible party for maintaining the appropriate records.
Rationale:
The microbial metric for Salmonella spp. is from California state regulations for composting operations (CCR Title 14 –
Chapter 3.1 – Article 7), with the addition of testing for E. coli o157:H7 as the microbe of particular concern. The above
suggested application interval was deemed appropriate due to the specified multiple hurdle risk reduction approach
(validated processing methods, microbial testing requirements). Any nonsynthetic crop treatment that contains animal
manure should use only fully composted manure that meets the requirements outlined in Table II-3 before application to
soils or directly to fresh culinary herbs.
Appendix B describes in detail the process used to develop these metrics.
Figure 5. Decision Tree for nonsynthetic Crop Treatments That Contain Animal Products
no YeS
Does the supplier provide a obtain documentation of validated
Certificate of Analysis and a process.
Certificate of Process Validation?
Does the supplier provide a
Certificate of Analysis and a
Certificate of Process Validation?
YeS no YeS
but microbial levels are above A Certificate of Analysis and microbial levels are below
acceptance criteria. and a Certificate of Process acceptance criteria. Keep
Validation are not available. records of certificate for at least
Do not use in fresh Samples may be collected two years. For non-validated
culinary herb production. by grower or third-party process, observe application
consultant. Microbial testing time interval of >45 days before
should be performed by an harvest
accredited/certified laboratory. For validated process, no
application time interval is
required.
Microbial Testing
Divide each lot/pile into a 3 x 4 grid and extract 12 equivolume samples (or one per batch if a liquid
amendment). Combine samples and submit to a certified / accredited laboratory for testing of using
following acceptance criteria:
• Salmonella spp.: negative or < DL (<1/30 grams)
• E. coli o157:H7: negative or < DL (<1/30 grams)
• other pathogens based on the source material
no YeS
Do not use in fresh • For non-validated process, observe application time interval >45
culinary herb production. days before harvest
• For validated process, no application time interval is required.
For example, SAs containing animal manure that has been physically heat-treated or processed by other equivalent
methods that are mixed with SAs not containing animal manure would require a process certification for the
physically heat-treated (or processed by other equivalent methods) materials, and the components from non-
animal manure would require documentation attesting to its manure-free status. The resulting mixture could then
be applied in accordance with the guidelines associated with the physically heat-treated class of materials (most
stringent limits).
Periodic inspections of the condition of all hand tools and replacement of damaged tools.
Broken, chipped, or otherwise damaged hand tools should not be returned to use until the
deficiency is corrected.
Maintenance of cutting tools so that they are sharp and free from damage such as ragged edges.
An accounting of all hand tools whenever employees leave the harvest line.
Control procedures when equipment is not in use, including policy for removal of equipment from
the work area or site, equipment storage, and the use of scabbards, sheathes, or other hand-held
harvesting tool storage equipment.
• Prepare an SSOP for harvest equipment that addresses the following:
The frequency of equipment cleaning and sanitation by developing a sanitation schedule for harvest
operations.
Harvest tools should be sanitized at the beginning and end of each day.
Additionally, knives or other hand tools should be sanitized when returning to work, after
moving between fields, or if potential contamination occurs (i.e., the tool comes in direct
Proper cleaning and sanitation of all harvest equipment and surfaces that come in contact with fresh
culinary herbs in a manner that will not contaminate fresh culinary herbs or other equipment.
Cleaning of reusable containers before subsequent usage.
Cleaning of containers that come into direct contact with soil between uses.
A proper sanitizing solution should be readily available at the harvesting site. Receptacles with
a sanitizer solution should be provided to store and sanitize all hand-held harvesting tools
that are not in use. These receptacles should be constructed of stainless steel so they can be
Check, adjust (if necessary), and document the sanitizer concentration strength as often as
necessary to assure its effectiveness. note: an employee should be trained in the proper mixing
and use of sanitizers.An MSDS for all sanitizers used should be kept on file.
Evaluate the use of cleaning verification methods for harvesting equipment (e.g., ATP test methods,
environmental swabs, protein test strips).
Locate equipment cleaning and sanitizing operations away from product and other equipment to
reduce the potential for cross contamination.
• Prepare an SOP for the handling and storage of product containers that addresses the following:
overnight storage
Contact with the ground including instructions not to stack soiled bins on top of each other if the
bottom of one bin has had direct contact with soil unless a protective barrier (i.e., liner, cover) is
used to separate the containers.
If liners or other barriers are used, precautions should be taken to prevent them from becoming a
source of contamination.
Proper container assembly (RPC, fiber bin, plastic bin, etc.)
Damaged containers
Use of containers only as intended
If product hydration is performed, handling of water tanks and equipment when not in use.
• All harvesting tools should be collected at the end of each day. Employees should not take these tools
home with them. An inventory control program should be implemented to enforce these practices.
• Employees should not walk, step, sit, or lie on food contact surfaces of equipment.
• If re-circulated rinse or antioxidant solutions are used on the cut surface, take all practicable
precautions to prevent them from becoming a source of contamination.
• Containers should be constructed of materials other than wood that are easy to clean and sanitize.
• Knives should be constructed of stainless steel with plastic or stainless steel handles and smooth seams,
welds and joints so that they can be effectively cleaned and sanitized. Wooden handles do not lend
themselves to efficient sanitation and hand-held tools constructed with standard steel will not hold up
to routine sanitation with most sanitizing or oxidizing agents.
• Use equipment constructed of materials that facilitate cleaning and sanitation of equipment food contact
surfaces (e.g., transportation tarps, conveyor belts).
• All maintenance requiring the use of chemicals, oils, greases, and fuels should be conducted away from
the field.
• Allow adequate distance for the turning and manipulation of harvest equipment to prevent cross
contamination from areas where contamination has been identified. For additional information on this
issue, see Section 7.0 Equipment Facilitated Cross-Contamination.
Documentation List:
SoP – Harvest equipment
SSoP – Harvest equipment
SoP – Harvest equipment/container storage
Harvesting tools inventory log
3 Based on their operation-specific risk assessments, companies may customize these best
practices to their individual operations.
If gloves are used, a procedure for proper glove use should be established, followed, and
documented. Gloves should not be powdered and should be:
Provided by the employer.
Changed as necessary during the harvest day.
Washed and sanitized daily, if reusable.
Changed after any event that may cause gloves to become contaminated.
Gloves should not be permitted to be worn when using the latrine, eating, or handling unsafe or
non-food grade materials.
If fresh culinary herbs are handled with bare hands, hand washing procedures must be documented.
Workers should wear in appropriate, clean protective outer garments when beginning work each
day. Heavily soiled and / or damaged protective outer garments should be replaced.
Workers should not leave hand-held harvesting tools and protective outer garments on top of
harvesting equipment or on the ground.
Workers should not take any tools or protective outer garments inside the toilet facilities.
The storage of personal items away from areas where they may come in contact with fresh culinary
herbs or herb-contact areas. Instructions should be posted regarding this practice.
Smoking, eating, and drinking of beverages other than water should be restricted to designated areas
equipped with covered trash receptacles.
Prohibitions on spitting, urinating, or defecating in the field.
Children should not have access to fresh culinary herb fields as they are often asymptomatic
carriers of foodborne diseases such as hepatitis A .
A written physical hazard prevention program should be developed for fresh culinary herb production and harvest
activities. The program should address the following:29
Appropriate clothing, hair restraints, protective outer garments, gloves, visible jewelry, etc.
Removal of all objects from upper pockets.
Foreign objects in the field – glass, hard plastics, or metal containers, or other objects should not be
brought into the field or areas bordering the field.
Training for supervisors on recognizing symptoms of diarrheal and infectious diseases and
appropriate actions to take in the event of worker injury or illness.
A policy describing procedures for handling / disposing of fresh culinary herbs or food contact
surfaces that have come into contact with blood or other bodily fluids.
First aid kits should be readily available and maintained in accordance with prevailing regulation with
materials kept in sanitary and usable condition.
6.5 The Best Practices Are:Toilet Facilities and Hand Washing Stations
• A field sanitary facility program (i.e., an SOP) should be implemented to address the following issues:
A response plan for leaks or spills.
The number, condition, and placement of field sanitation units and accessibility to the work area
The location of worker hygiene facilities should maximize accessibility and use while minimizing
the potential for the facility to serve as a source of contamination.
Toilet facilities should be placed such that the location minimizes the impact from potential
leaks and / or spills while allowing access for cleaning and service.
Under oSHA regulations, sanitary facilities are required to be within a ¼ mile walk of each
laborer’s position in the field with at least one toilet facility and one hand washing facility
provided for each 20 workers or a fraction thereof.4
The location and sanitary design of toilets and hand washing stations should be optimized to
facilitate the control, reduction and elimination of human pathogens from hands.
Hand washing stations must be supplied with potable running water (e.g., meets local, state, or
US EPA microbial standards for drinking water).
Facility supplies
Toilet facilities should be stocked with toilet paper.
Hand washing stations should have hand soap, water, paper towels, and covered towel disposal
container.
Facility signage
Signage requiring hand washing after use of toilet facilities should be visible and posted in
applicable languages and/or pictures.
Facility maintenance, cleaning and servicing
Establish the frequency and specific protocols of toilet and hand washing facility maintenance /
sanitation.
Establish equipment and supply storage and control procedures when not in use.
Remove trash receptacles from the harvest area at the end of the work shift. Instructions
should be provided on where to empty them and how to clean them.
All portable units should have a tank that captures used hand wash water. Develop an SoP for
the appropriate disposal of the waste water.
Maintain documentation of maintenance and sanitation schedules and any corrective practices
for a period of 2 years.
Documentation List:
Attendance log for worker training sessions
SoP – Worker practices
SoP – Physical hazard prevention
SoP – Health program practices
SoP – Field sanitary facility
SSoP – Field sanitary facility When farm
m equipment has
7.0 Issue: equipment Facilitated Cross-Contamination had direct contact
When farm equipment has had direct contact with raw untreated manure,
untreated compost, waters of unknown quality, crop damaged from with raw untreated
animals, fecal contamination, and animal carcasses, or other potential
human pathogen reservoirs it may be a source of cross-contamination.
Such equipment should not be used in proximity to or in areas where
manure, untreated
it may contact edible portions of fresh culinary herbs without proper
cleaning and sanitation. compost, waters of
7.1 The Best Practices Are: unknown quality,
• Identify any field operations that may pose a risk for cross-
contamination. These include vehicles and farm equipment crop damaged
utilized in the fields, vehicles used to transport workers, as well
as many other possibilities. from animals, fecal
• Segregate equipment used in high-risk operations or potentially
exposed to high levels of contamination (e.g., actively contamination, and
manipulating compost, animal-related operations).
• If equipment was previously used in a high-risk operation, use animal carcasses,
effective means of equipment cleaning and sanitation before
subsequent use in fresh culinary herb production. or other potential
• Develop appropriate means of reducing and controlling the
possible transfer of human pathogens to soil and water that may
directly contact fresh culinary herbs through use of designated
human pathogen
•
equipment.
Maintain appropriate records related to equipment cleaning and
reservoirs it may be
possible cross-contamination issues for a period of 2 years.
a source of cross-
Documentation List: contamination.
SSoP – Equipment for high-risk operations
Cross-contamination event log
5 FDA. 2011. Guidance for Industry: Evaluating the safety of flood-affected food crops for
human consumption. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm274683.htm
Clean and sanitize any equipment that had contact with flooded areas or crops before subsequent
use.
• If a well head is under flood water, complete a sanitary survey including water quality testing to ensure
the integrity of the well before using.
• Document all flooding events and activities related to mitigating flooding events (i.e. take photographs of
the area and activities).
8.2 The Best Practices for Fresh Culinary Herbs That Have Come into Contact with
Flood Waters Are:
• FDA considers any crop that has come into contact with floodwater to be an “adulterated” commodity
that cannot be sold for human consumption.6, 7
• See Table II-6 for criteria for fresh culinary herb production fields that have possibly come into contact
with flood waters. The Appendix B describes in more detail the process used to develop these metrics.
• Fresh culinary herbs that are adulterated by flood waters should be disposed of in a manner to ensure
that they do not contaminate unaffected crops during harvesting, storage or distribution.
8.3 The Best Practices for Fresh Culinary Herbs in Proximity to a Flooded Area but
Where edible Portions Have not Been Contacted by Flood Waters Are:
• Evaluate whether fresh culinary herbs in a field under these conditions should be harvested. Factors to
consider include: 32
The source of flood waters and potential upstream contributors of human pathogens and/or
chemical contaminants.
Type of crop and stage of growth of the edible portion of the crop including how far above the
ground the lowest edible portion of the crop grows.
Conditions such that the crop may have been exposed to prolonged periods of moisture and stress
that could foster fungal and pathogen growth, and possible development of mycotoxins.
• For flood-affected fresh culinary herbs for which the growers have not yet determined whether they
have been contaminated (i.e., the edible portion of crops are not exposed to flood waters), clearly
identify and sufficiently segregate these herbs to prevent them from contaminating non-flood-affected
crops and from entering the food supply inadvertently, pending determination of their disposition.
8.4 The Best Practices For Formerly Flooded Production Ground Are:
• Prior to replanting or soil testing, the designated food safety professional for the grower should
perform a detailed food safety assessment of the production field for potential hazards (see Appendix
E for an example a pre-planting food safety assessment of formerly flooded production ground). This
designated professional will be responsible for assessing the relative merits of testing versus observing
the appropriate time interval for planting, and also will coordinate any soil testing plan with appropriate
third-party consultants and / or laboratories that have experience in this type of testing.
• Evaluate the source of flood waters (drainage canal, river, irrigation canal, elevated water table, etc.)
6 FDA. 2009. A notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and
Transporters of Food Products About the Safety of Food Affected by Hurricanes, Flooding, and Power outages. http://www.fda.gov/Food/
FoodDefense/Emergencies/FloodsHurricanesPoweroutages/ucm112723.htm
7 FDA. 2009. Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Draft Guidance.
for potential significant upstream or subsurface contributors of other contaminants and/or human
pathogens at levels that pose a significant threat to human health.
• Assess the time interval between the flooding event, crop planting, and crop harvest. Comparative
soil samples may be utilized to assess relative risk if significant reductions in indicator microorganisms
(e.g. fecal coliforms) have occurred within this time interval. Comparative soil samples may be
between a baseline (e.g. soil not affected by floodwaters) and post-flooding samples for a given
field or between a flooded field and a nearby field that is managed similarly to the flooded field but
unaffected by floodwaters.
• Do not plant fresh culinary herbs in formerly flooded production ground for at least 60 days following
the receding of floodwaters (unless the ground meets the 30-day testing requirement detailed in the
next bullet and Table II-6). In addition to a waiting period before planting, actively tilling the soil provides
additional protection against the survival of pathogenic organisms.
• If flooding has occurred on the property, soil testing may be conducted prior to planting fresh culinary
herbs. Soil testing may be used to shorten the waiting period to 30 days. If performed, testing should
be negative for Enterohemorrhagic E. coli (EHEC) or Shiga toxin-producing E. coli (STEC) and Salmonella
as outlined in Table II-6. Representative samples should be collected for the entire area suspected to
have been exposed to flooding. See Appendix D for a microbial soil sampling protocol.
• Allow soils to dry sufficiently prior to planting subsequent fresh culinary herbs on formerly flooded
production ground.
• Formerly flooded production ground should not lie stagnant. Rework the soil (e.g. aerating, tilling,
disking) which helps to reduce the survival of pathogenic organisms.
Documentation List:
Flooding event – date of flooding and date when equipment are able to enter field, high water mark,
photographs, etc.
A pre-planting food safety assessment of formerly flooded ground
Soil sampling test results
Flooding Defined The flowing or overflowing of a field with water outside a grower’s control that is reasonably likely to contain
microorganisms of significant public health concern and is reasonably likely to cause adulteration of fresh culinary herbs
in that field. Additional discussion of this definition and implications for production is provided in the text portion of
this document.
Allowable Harvest Distance from • Buffer and do not harvest fresh culinary herbs within 30 ft. of the flooding.
Flooding • Buffer distance may be greater than 30 ft. based on risk analysis by food safety professional.
• If there is evidence of flooding, the production block should undergo a detailed food safety assessment by
appropriately trained food safety personnel (see Glossary) prior to harvest, as defined in the text of this document
(See Appendix E for an example food safety assessment).
Verification • Documentation should be archived for a period of 2 years following the flooding event. Documentation may include
photographs, sketched maps, or other means of delineating affected portions of fresh culinary herb fields.
Time Interval Before Planting Can • Planting can commence 60 days after the flood waters have receded to the point where water is not visible in the
Commence Following the Receding of areas that are to be planted and the soil should be at a moisture level at which the grower can get equipment into the
Floodwaters field for preparation.1
• Appropriate soil testing can be used to shorten this period to 30 days prior to planting. This testing should be
performed in a manner that accurately represents the production field and indicates soil levels of microorganisms
lower than the acceptance criteria listed below. Suitable representative samples should be collected for the entire
area suspected to have been exposed to flooding. For additional guidance on appropriate soil sampling techniques,
see the example soil sampling protocol in Appendix D and consult the “Soil Screening Guidance:Technical Background
Document,” specifically Part 4 that provides guidance for site investigations (US EPA 1996). Reputable third-party
environmental consultants or laboratories provide sampling services consistent with this guidance.
• Appropriate mitigation and mitigation strategies are included in the text portion of the document.
1 Soil moisture test results can also be used to demonstrate moisture levels. Methods typically used by growers to determine
soil moisture content include, but are not limited to, tensiometers, electric resistance blocks, oven drying analysis, or other methods
that are measurable and repeatable.The grower should have historical information available regarding typical moisture content of the
soil so there is comparison data available if it is needed.
Practice Metric / Rationale
Rationale The basis for the 30 foot distance is the turn-around distance for production equipment to prevent cross-contamination
of non-flooded ground or crops in the fields.
Section II:
Production And Harvest Unit Operations
Documentation List:
SoP – Personal hygienic practices
SoP – Packing materials handling and storage
SeCTIon III
Section III:
Post-Harvest Unit Operations
by microbial Fresh culinary herb food safety programs should focus on preventing
adulteration by microbial contamination because these herbs are often eaten
contamination raw and without a “kill step” to reduce or eliminate human pathogen levels.
For that reason, as a general practice these products should be handled
according to the FDA’s “Guide to Minimize Microbial Food Safety Hazards
because these herbs of Fresh-cut Fruits and Vegetables” (“Fresh-cut Guide”) and packinghouse
facilities operate under cGMPs as an extra precautionary measure. This set
are often eaten raw of best practices is primarily based on cGMPs put forward in 21 CFR 110
and the FDA’s “Fresh-cut Guide.”
and without a “kill m
step” to reduce or 2.0 Issue: Transportation to Packinghouses and Cooling
Facilities
eliminate human Conditions of transport from the field to cooler and packinghouse may
pathogen levels. provide opportunities for microbial contamination. Fresh culinary herbs may
be transported to the packinghouse / cooling facilities by numerous modes
of transportation. Transportation of fresh culinary herbs should be managed
to reduce, control, or eliminate the risk of contamination.
Documentation List:
SoP – Product inspection
SoP – Product holding/storage
Product tracing paperwork
m
4.0 Issue: Water Used in Packinghouse and Cooling operations
Packinghouses use a variety of practices in handling fresh culinary herbs. Fresh culinary herbs may or may not be
washed and/or cooled before packing. When used appropriately with water of adequate quality, disinfectants help
minimize survival and growth of microorganisms in the wash water and the subsequent cross contamination of the
product. For a list of chemicals that may be safely used to wash fruits and vegetables, see 21 CFR 173.315.1
The effectiveness of a disinfectant and the amount that should be used depends on the type of product and the
treatment conditions, such as water temperature, acidity (pH), water hardness, contact time, amount and rate of
product throughput, water to product ratio, amount of organic material, and the resistance of pathogens to the
particular disinfectant. If fresh culinary herbs are washed before being packed, packers should consider options for
disinfectants and wash systems that are most appropriate for their operation and verify the washing process by
documenting the levels of sanitizers, water changes, pH control, exposure time, and mass-to-volume ratios in their
wash water.
Ice and / or ice slurries may also be used to cool fresh culinary herbs thus providing another possible contamination
source if ice is not handled appropriately or if contaminated water is used to make the ice. Ice used on fresh
culinary herbs should be included in routine water quality testing as described in the Best Practices below.
If pathogens are present in the wash water, they may contaminate the produce, and subsequent washing will not
reduce levels of these pathogens. Therefore, water used for washing or cooling fresh culinary herbs should contain
sufficient levels of disinfectant to reduce the potential for pathogens to persist in such water. Such practices may
include using antimicrobial chemicals in the wash water or using spray type wash treatments instead of submerging.
Alternatively, fresh herbs may be cooled by means other than hydrocooling.
2 Water quality criteria are primarily based on recreational water use criteria established
by US EPA. The use of this type of information is necessitated by science that is not clear
on appropriate agricultural water standards. For further information, please see Appendix B,
which provides the technical basis for these guidelines.
maintained throughout the process by testing the water disinfectant concentration and pH or oRP
(oxidation reduction potential). Active disinfectant levels should be measured and documented (i.e., free
chlorine and not total chlorine). Continuous monitoring of disinfectant levels is preferred.
• Follow manufacturer’s directions for mixing of disinfectant chemicals to obtain effective concentrations;
a manufacturer’s suggested or allowable level in washing and cooling water should not be exceeded.
• All disinfectant measurement devices should be calibrated daily. Disinfectant measurements and
equipment calibrations should be documented.
• The person monitoring the water disinfectant levels should know when to add disinfectant based on
values obtained.
• Any other substance (e.g., processing aids or organic acids for pH control) used to treat the wash water
should be approved by the US EPA or FDA for use in the manner that it is applied and monitored to
verify correct concentration. Monitoring activities should be documented.
• To ensure efficient operation, routinely inspect and maintain facility water distribution system and
equipment designed to assist in maintaining water quality such as chlorine injectors, filtration systems,
and backflow devices. Inspections and maintenance should be documented.
• All monitoring equipment should be adequately maintained and periodically calibrated. Maintain a log of
maintenance and calibration events.
• Water holding tanks used at the facility should be kept clean and sanitary. All cleaning and sanitation
verification activities should be documented. For more on the care of finished water storage tanks see
the Sanitary Survey in Appendix A.
• When washing or cooling fresh culinary herbs in recirculated water, disinfectant should be present at
sufficient levels and the levels monitored to reduce the potential risk of cross contamination (see Table III-1).
All monitoring activities should be documented.
• When washing or cooling fresh culinary herbs in recirculated water, procedures must be established to
determine when and how often water should be refreshed or completely changed out.
• Water disinfectants levels must be monitored and maintained throughout the process by testing the
water disinfectant concentration and pH or oRP (oxidation reduction potential) as follows:
Any disinfectants used must be used according to the manufacturer’s specifications.
When disinfectants are used in a recirculation system, active disinfectant levels (i.e., free
chlorine and not total chlorine) and pH or oRP (oxidation reduction potential) should be
measured and documented.
Continuous monitoring of disinfectant levels is preferred.
All disinfectant measurement devices should be calibrated daily. Disinfectant measurements and
equipment calibrations should be documented.
The person monitoring the water disinfectant levels should know when to add disinfectant based on
values obtained.
Any other substance (e.g., organic acids for pH control) used to treat the wash water must be
monitored to verify correct concentration. These checks should be documented.
Establish an SoP that outlines corrective actions if system is not operating within the limits and
document them.
All monitoring equipment should be adequately maintained and periodically calibrated. Maintain a
log of maintenance and calibration events.
• Filtering devices should be used to minimize the buildup of organic material in recirculated wash
water. Filters should be back-flushed and sanitized as part of the master sanitation schedule for
packing equipment.
• Appropriate measures should be taken for waste water disposal.
• Any water additive used to wash fresh culinary herbs should be food-grade and compliant with
federal, state or local regulations for the intended use. Copies of MSDS for water additives should be
maintained on file.
• Water used to make ice that directly contacts product and is used in cooling and packinghouse
operations must meet US EPA microbial standards for drinking water.
• The water source used to make ice and ice slurry should be tested periodically at a frequency sufficient
to assure that it is of appropriate microbial quality for its intended use (see Table III-1 on Post-Harvest
Water Use).
Ice used on product should contain an approved water disinfectant at sufficient concentration to
reduce the potential for cross contamination.
• Ice must be handled like a food ingredient. Establish an SOP for transporting, handling, and storing ice
so that it does not become contaminated. The SoP should address the following:
Use of a sanitary underlay when placing unpackaged, block ice on any surface.
Clean and sanitize all equipment that holds or transports ice daily.
Drip pans should be used to collect condensation under augers and conveyors on ice-conveying
systems; drip pans should be emptied directly into the facility drainage system and not onto floor.
Ice should not be stored in close proximity to raw product or chemical storage.
If ice is manufactured and delivered by an outside vendor, ensure the vendor follows your company’s
SoP for handling, storing, and transporting ice.
• If iced product is placed in storage racks above pallets of other product, plastic pallet shrouds should be
used to protect product beneath from potential cross contamination.
Documentation List:
Source water test schedule and results
SoP – Chemicals added to wash water
SoP – Water disinfectant monitoring
Water monitoring equipment calibration logs
MSDS for water disinfectant chemicals
SoP – Ice transporting, handling, and storage
Direct Product Contact Microbial Testing For any given water source (e.g. municipal, well), samples for microbial testing should be
or Food Contact Target organism: taken as close to the point of use as practical (as determined by the sampler to ensure
Surfaces Total coliforms the integrity of the sample) using sampling methods as prescribed in this table where
the water contacts fresh culinary herbs, so as to test both the water source and the
Sampling Procedure: water distribution system. There is only one sample per month per distribution system
1 L sample collected aseptically at the point under these metrics. If there are multiple potential point-of-use sampling points in a
of use distribution system, then samples should be taken from different point-of-use locations
each subsequent month (randomize or rotate sample locations).
Sampling Frequency: one sample per
water source should be collected and tested Water that directly contacts harvested fresh culinary herbs or is used on food contact
prior to use if >60 days since last test of the surfaces such as equipment or utensils, should come from a source that meets the
water source. Additional samples should be Maximum Contaminant Level Goal of zero or no detection for total coliforms in drinking
collected at intervals of no less than 18 hours water as specified by US EPA and once in use, contain an approved disinfectant at sufficient
and at least monthly during use. concentration to prevent cross-contamination.1 Microbial and physical / chemical testing
should be performed, as appropriate to the specific operation, to demonstrate that the
Municipal & Well exemption: disinfectants and corresponding concentrations used are sufficient for the wash system
For wells and municipal water sources, if and that acceptance criteria for total coliforms have been met. Always follow your
total coliform levels are below detection contracting laboratory’s protocol for the collection of water samples.
limits for five consecutive samples, the
sampling frequency may be decreased to Single Pass and Recirculated Water Systems
once every six months and the 60 and 30 • Single pass use – Source water should have non-detectable levels of total coliform
day sampling are waived. This exemption and sufficient disinfectant to ensure water has no detectable total coliform (e.g., a
is void if there is a significant source or minimum of 10 ppm chlorine).
distribution system change. • Recirculated use – Source water should have non-detectable levels of total coliform.
Water used to wash product should have sufficient disinfectant to ensure returned
Test Method: water has no detectable total coliform (e.g., a minimum of 10 ppm chlorine).
FDA BAM method or any US EPA-approved
or AoAC-validated method for quantitative * Single pass and recirculated water treated with chlorine-based disinfectants should be
monitoring of water for total coliforms. tested for free chlorine concentration (ppm) and pH oR for oxidation reduction potential
(mV). The selected method should be verified periodically with the alternative process
verification method AnD by ensuring that established microbial acceptance criterion for
water is being met.
1
Use Metric Rationale / Corrective Actions
Corrective Actions:
Acceptance Criteria: If any one sample exceeds the acceptance criteria for total coliforms, then the water
negative or Below DL for All Samples should not be used for this purpose unless appropriate disinfectants have been added
or until corrective actions have been completed and total coliform levels are within
acceptance criteria:
Physical / Chemical Testing • Conduct a Sanitary Survey of the water source and distribution system to determine
Target Variable: if a contamination source is evident and can be eliminated. Eliminate identified
Water disinfectant (e.g. chlorine or other contamination source(s) if applicable.
disinfectant compound) • For wells, perform a Sanitary Survey and / or treat as described in the Sanitary Survey
(Appendix A).
Acceptance Criteria for Disinfectants: • Retest the water at the same sampling point after conducting the Sanitary Survey
• US EPA-approved treatments per and / or taking corrective actions to determine if it meets the outlined microbial
product label for human pathogen acceptance criteria for this use.
reduction in water and used in
accordance with a wash water system-
specific protocol that has been validated For example, if a water sample for water used to clean food contact surfaces has
to show that active disinfectant is present detectable total coliforms, SToP using that water system, examine the distribution line,
throughout the wash process. source the inlet as described in the Sanitary Survey (Appendix A), and retest from the
• Chlorine-based disinfectants same point of use. Continue testing daily for five days at the point closest to use, and
>10 ppm free chlorine after application do not use the water system until it consistently delivers water that is safe, sanitary, and
and pH 6.5 – 7.0 meets the acceptance criteria outlined in this table. If any of the five samples taken during
• ORP > 725 mV* the intensive sampling period after corrective actions have detectable total coliforms,
repeat corrective actions and Do noT use that water system until the source of
Testing Procedure: contamination can be corrected.
• Chemical reaction based colorimetric
test, or Records: All test results and corrective actions should be documented and available for
• Ion specific probe, or verification from the user of the water for a period of 2 years.
• ORP,* or
• Other as recommended by disinfectant
supplier.
Testing Frequency:
Continuous monitoring (preferred) with
periodic verification by titration oR routine
monitoring if the system can be shown to have
a low degree of variation.
Section III:
Post-Harvest Unit Operations
with individual m
• Properly store equipment, remove litter and waste, and cut weeds or grass around the buildings or
structures that may constitute an attractant, breeding place, or harborage for pests.
• Maintain roads, yards, and parking lots so that they do not constitute a source of contamination in areas
where food is exposed. Roads should be paved or otherwise managed to prevent dust.
• Evaluate adjacent land use to ensure that it does not pose a significant risk of product cross-contamination.
• Adequately drain areas that may contribute contamination to food by seepage, transfer to facility via
foot traffic, or providing a breeding place for pests.
• Operate systems for waste treatment and disposal in an adequate manner so that they do not
constitute a source of contamination in areas where food is exposed.
• The building structure should be maintained such that pests are excluded from gaining entrance to the
facility.
• All exterior doors should have an adequate seal.
• To provide adequate drainage and prevent accumulation of water, floors should be sloped to drains, and
kept in good repair.
• Floor drains should be designed to be accessible for cleaning and capable of preventing pest entry.
• Food contact surfaces should be constructed of materials that are smooth, nonabsorbent, smoothly
bonded, without niches, and sealed so that they are easily cleaned and sanitized and do not serve as
harborage of microbial pathogens.
• Avoid use of hollow structures such as table legs, conveyer rollers, and racks because they may collect
water and debris, and thus, harbor pathogens.
• Equipment lubrication should be managed so as to not contaminate fresh culinary herbs. Food grade
lubricants should be used on packing equipment where food contact may occur. Food-grade and non
food-grade lubricants are to be stored separately.
• Sufficiently elevate food contact surface above the floor to prevent contamination from floor splashes.
• Raw and finished product storage areas should be separated to reduce the potential for cross-
contamination.
• All lights should be adequate for sufficient visibility and designed to prevent the potential for broken
glass contamination of the product (i.e., contain shatter-proof bulbs or be sealed in a protective
covering).
• Cooling systems’ condensation units should drain directly into drainage systems. Emptying of this water
into floor drains should be prohibited.
• Overhead equipment, structures or fixtures, catwalks, walls, pipelines, etc. should be designed to avoid the
potential to be a contamination source for product and packaging (i.e., condensation formation, dirt).
• Facility water systems should be equipped with back-flow prevention devices to prevent potential
contamination of the water supply.
• Waste water collection areas should be designed to prevent product and equipment contamination.
• Provide a designated area not in a food handling area for employees to store personal items.
6.3 The Best Practices Are:Toilets and Hand-Washing Stations Construction and Design
operations with poorly designed and constructed facilities for toilets and hand-washing stations may provide direct
or indirect contamination of fresh culinary herbs and water sources used on the herbs.
• The design and construction of toilet facilities and hand-washing stations including number and location
should be in compliance with applicable local, state, and federal regulations.
• The number of toilets and hand-washing stations should meet OSHA requirements as outlined in 29
CFR 1910.141.3
• Evaluate the location of toilet facilities and hand-washing stations to maximize accessibility and use,
while minimizing the potential for contamination.
• Toilets and hand-washing stations should be constructed of materials that can be easily cleaned and
sanitized using cleaners and / or oxidizing agents.
• If the toilets and hand-washing stations have any openings to the outside (e.g. windows, vents), these
openings should have proper screens to exclude vermin.
• Toilet facilities and hand-washing stations should be constructed with properly designed drainage
systems.
• Doors to the toilet facilities:
Should not open directly into areas where product is located
Should be self-closing
If entry is to a single-person facility, should be lockable from the inside.
• Each individual toilet stall should have doors that are self-closing and lockable from the inside and toilet
paper in a proper holder.
• Hand-washing units where employees wash their hands before returning to their work stations should
be located so that hand-washing can be observed. All hand-washing units should be equipped with:
Potable, hot and cold running water. The quality of the water should be verified by testing to assure
its microbial quality is acceptable according to local standards for potable water.
Soap or other suitable cleansing agents in dispensers.
Single-use paper towels.
Hands-free “on / off” switches for water (i.e., workable without using potentially soiled hands).
Trash containers with covers
Signs indicating that the water is only for hand-washing purposes (in appropriate languages).
Sealed waste water catch basins with plumbing free of leaks.
5 Code of Federal Regulations, Title 21, Part 110 – Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Human Food. http://ecfr.gpoaccess.gov/cgi/t/text/text-id
x?c=ecfr&sid=fe4d3406434fbb5824f74776dadefb66&rgn=div5&view=text&node=21:2.0.1.1.1
0&idno=21
contact and those that are used for general cleaning and may
contact non-food contact surfaces.
• Old, unused equipment should be removed from the packing
and cooling areas and stored in a manner that does not present
a food safety hazard.
• Appropriate signage should be displayed throughout
packinghouse and cooling facility to remind employees to
adhere to company policies related to food safety (e.g. use of
equipment, hygiene).
exclude pests from • All pesticides, traps, bait, and chemicals used in pest control
must be acceptable for use in and around a food packing facility
the packinghouse and used in accordance with local, state, and federal regulations.
Permit the use of insecticides or rodenticides inside the
and cooling areas facility only under precautions and restrictions that will
protect against the contamination of fresh culinary herbs,
and to protect food-contact surfaces, and food-packaging materials. Rodent
bait materials are not to be used within production areas or
against the packaging material storage areas.
These materials must only be used by properly trained
contamination of and accredited personnel. A record of use should be
kept available for inspection along with the appropriate
applicators licenses and documentation. Applicators should
food on the premises also show records of training, continuing education, etc.
If rodent traps are deployed around the inside of the
by pests. facility and bait stations along the outside perimeter of
the facility, detailed maps demonstrating the location of
each trap and bait station should be available for review.
Traps and bait stations should be inspected routinely and
any corrective actions (e.g., cleaning out traps, replacing
damaged traps) documented.
Pest control chemicals and baits should be securely stored if
kept on-site.
A procedure should be in place for the disposal of waste
pest control chemicals and empty containers and for
cleaning of application equipment that protects against
product and production area contamination.
• Measures should be taken to protect packaging materials
When fresh culinary herbs arrive at the packinghouse, they are routinely
cooled to remove field heat. Cooling operations may spread product
contamination if cooling equipment is not cleaned and sanitized regularly. In
addition to cooling equipment, critical control points in the packinghouse
and cooling facilities include any surface that comes into contact with fresh
culinary herbs, toilet facilities for employees, and control of pests. Without
appropriate sanitation practices, packinghouse and cooling facilities may be
a source of microbial contamination. Cleaning and sanitizing of facilities and equipment should be conducted in a
manner that protects against contamination of fresh culinary herbs, herb-contact surfaces, or packaging materials.
6 Appropriate chemical use can be verified in nSF’s White Book™ – nonfood Compounds Listings Directory available at http://www.nsf.
org/usda/Listings.asp
• Packinghouse and cooling facility equipment should be inspected for cleanliness before packing and / or
cooling operations begin each day.
• At minimum all food-contact surfaces should be cleaned and sanitized daily.
• A master sanitation schedule should be developed for all packinghouse and cooling facility equipment.
This schedule should clearly indicate the name or ID number of the piece of equipment, the frequency
with which it is to be cleaned (e.g., daily, weekly, monthly or seasonally) and the process to be used for
cleaning (e.g., wash, sanitize and rinse if necessary).
• Each piece of packinghouse and cooling facility equipment should have written procedures for cleaning
(SSoPs).
• Cleaning and sanitizing of utensils and equipment should be conducted in a manner that protects against
contamination of food, food-contact surfaces, or food-packaging materials.
• Equipment filters should be back-flushed and sanitized as part of the master sanitation schedule for
packing equipment.
• Avoid cleaning and sanitizing equipment during packing operations.
• Verify the efficacy of the equipment cleaning and sanitation with routine environmental testing (e.g.,
conventional or rapid microbiological methods such as total count or bioluminescence testing). Testing
data should be kept on file.
• All equipment inspection, maintenance, cleaning, and sanitizing activities should be documented.
7 FDA. 2008. Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods; Draft Guidance.
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodProcessingHACCP/ucm073110.htm
Food Safety Guidelines 99 Fresh Culinary Herbs
Section III:
Post-Harvest Unit Operations
• Establish a written cleaning and sanitation schedule for toilet and hand-washing facilities.
• Establish SSOPs for toilet and hand-washing facilities including a checklist of facility supplies.
• Maintain written documentation of service and maintenance of toilet facilities and hand-washing stations
that demonstrates compliance with applicable worker health and safety regulations.
8.5 The Best Practices Are:Toilets and Hand-Washing Stations Waste Disposal
operations with poor management of wastes in the packinghouse or cooling facility can significantly increase the
risk of contaminating fresh culinary herbs.
Documentation List:
SSoP – non-food contact surface
non-food contact surface master sanitation schedule
SSoP – Cooling facility
Cooling facility master sanitation schedule
SSoP – Toilet and hand-washing facilities
Toilet and hand-washing facilities master sanitation schedule
SSoP – Equipment
Equipment master sanitation schedule
Pre-operative inspection checklist
Corrective action log
Employee SSoP training records
MSDS for cleaning chemicals
Environmental testing schedule and results
Toilet and hand-washing facilities service and maintenance log
Waste collection schedule
m
9.0 Issue: employee Hygiene and Food Safety Training
Fresh culinary herbs are often extensively handled by employees at the packinghouse and possibly by persons working
with fresh culinary herbs at the cooler or cold storage facility. Handling by employees may transfer microorganisms
of significant public health concern, therefore employee hygiene and sanitary procedures are appropriate in all
environments where fresh culinary herbs and people are in proximity. The importance of employees, supervisors, and
senior management understanding and practicing proper hygiene cannot be overemphasized.
Food Safety Guidelines 100 Fresh Culinary Herbs
Section III:
Post-Harvest Unit Operations
If gloves are reusable, they should be washed and sanitized daily or changed as necessary after any
event that may cause gloves to become contaminated.
If gloves are disposable, they should be changed as necessary during the work day and after any event
that may cause gloves to become contaminated. Powdered disposable gloves should not be used.
Gloves should not be worn in or taken into the toilet facilities, break areas, or when handling unsafe
or non-food grade materials.
• Employees should wear head and facial hair coverings.
• Employees should wear appropriate, clean protective outer garments when beginning work each day.
Heavily soiled and / or damaged reusable protective outer garments should be replaced.
• Protective outer garments such as aprons and gloves should be hung on racks or in a designated area
and not placed on top of product, work surfaces, equipment or packaging material.
• Employees should not take packing-related tools or protective outer garments outside the designated
areas or inside the toilet facilities and employee break areas.
• Prohibit eating, drinking, smoking, or chewing tobacco outside of designated areas to reduce the
potential for product contamination.
• In areas where fresh culinary herbs are present, prohibit employees from activities such as chewing gum
or spitting.
Documentation List:
Employee attendance log for food safety policy/plan training
SoP – Worker hygienic practices
SoP – Employee personal effects storage and control
SoP – Worker health practices
SoP – Glove use
m
10.0 Issue: Cold Storage and Warehousing
In post-harvest unit operations, cold storage and warehouse facilities are often the last area that house fresh
culinary herbs before they are shipped to the next point of the supply chain. The conditions and sanitation
programs of these facilities are critical in maintaining the integrity of the finished product before it exits the facility.
Documentation List:
SoP – Refrigeration unit inspection
Refrigeration unit inspection log
Temperature monitoring device calibration log
SSoP – Warehouse/cold storage area
m
11.0 Issue: Transportation from Packinghouse or Cooling
Facility
Fresh culinary herb products may be transported from cold storage or
distribution facilities by numerous modes of transportation. Conditions
of transport may provide opportunities for microbial contamination.
Transportation of fresh culinary herb products should be managed to
reduce, control or eliminate the risk of contamination.
Implement
11.1 The Best Practices Are:
inspection/ • Vehicles used to transport fresh culinary herbs from the
packinghouse and cooling facility should be clean. Implement
evaluation inspection / evaluation management programs of shipping
trailers to verify that food safety needs are being met. Items
management that may be evaluated include (but are not limited to) the trailer
condition, overall cleanliness, good structural condition, etc.
programs of • Establish procedures to assure that prior loads hauled by
transport vehicles do not potentially contaminate fresh culinary
herb products during transport from the packinghouse or
shipping trailers cooling facility.
• The vehicle operator should have a written sanitation procedure
to verify that food (type and frequency of cleaning and sanitizers) for cleaning
transport vehicles and schedule / log of cleaning activity.
safety needs are • Ensure that equipment in refrigerated vehicles is functioning
properly and designed to circulate cold air uniformly throughout
being met. the vehicle while taking the load layout into consideration.
• The operator should pre-cool and maintain a temperature in
the shipping trailer that is appropriate for the particular herb
product throughout transportation. Develop and implement
an SoP for when and how temperature in the shipping trailer
should be measured and maintain records that document the
temperature.
• Load and unload in a manner that minimizes damage and
contamination.
Documentation List:
SoP – Vehicle inspection
SSoP – Transport vehicle
Vehicle temperature log
SeCTIon I V
Section IV:
Processing Unit Operations
to assess the best Fresh culinary herb food safety programs should focus on preventing
adulteration by microbial contamination because these herbs may be eaten
practices in this raw and without thermal treatment to reduce human pathogen levels. For
that reason, even though RTU fresh culinary herbs are not considered RTE,
document and in as a general practice processing facilities should operate under cGMPs
and handle these products according to the FDA’s “Guide to Minimize
the Fresh-cut Guide, Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” (Fresh
cut Guide).1 This set of best practices are primarily based on cGMPs from
the Code of Federal Regulations Title 21, Part 110 (21 CFR 110) and the
and then tailor its FDA’s Fresh-cut Guide.43
food safety practices GMPs are the commonly agreed upon and scientifically based standards by
which industry and regulators effectively and harmoniously communicate the
to its particular standards of performance and conduct whenever food products are being
prepared, packed, or held (Gorny, 2006). As such, the cGMPs are centrally
important in reducing the risk of product adulteration and food safety risk
operation. to consumers. FDA’s Fresh-cut Guide is not a set of binding requirements
nor does it identify all possible preventive measures to minimize microbial
food safety hazards. Each fresh produce processor is advised to assess the
best practices in this document and in the Fresh-cut Guide, and then tailor
its food safety practices to its particular operation. Alternative approaches
that minimize microbial food safety hazards may be used so long as they are
consistent with applicable laws and regulations.
The food safety program for a processing facility is generally built upon a
number of foundation programs such as: cGMPs, SSoPs, SoPs, traceback
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/
ucm064458.htm#ch8
m
2.0 Issue: HACCP/HARPC Plan Development and
operation
A critical step in developing an effective food safety program is to assess As one component
the food safety risks for an operation and develop preventative measures
to control the identified risks. Hazard Analysis and Critical Control of a comprehensive
Point (HACCP) and Hazard Analysis and Risk-Based Preventive Controls
(HARPC) are systematic preventative approaches to food safety designed to
prevent, reduce to acceptable levels, or eliminate the microbial, chemical, and
food safety
physical hazards associated with food production. The HARPC requirements
are similar to HACCP requirements but incorporate preventive controls to program, HACCP
address hazards that do not have critical control points. As one component
of a comprehensive food safety program, HACCP and HARPC are proactive and HARPC
approaches to prevent food contamination rather than trying to identify
and control contamination after it has occurred. Awareness of common are proactive
risk factors discussed in this document and implementation of either
critical control points or preventive controls determined by a firm to be
appropriate to its individual operations will enhance the safety of fresh
approaches to
culinary herbs.2
prevent food
2.1 The Best Practices Are:
• Develop a flow diagram of the processing operation.
contamination
• Conduct a hazard analysis for the operation. rather than trying to
• Establish critical control points (CCPs) or preventive controls
(PCs) to significantly minimize or prevent the occurrence of the
identified hazard.
identify and control
• Establish parameters or critical limits around the CCPs or PCs. contamination after
• Establish procedures for monitoring the effectiveness of CCPs
or PCs. it has occurred.
• Establish corrective actions to mediate any breach or violation
of established parameters / critical limits.
2 Resources for developing HACCP plans are available at the FDA, the USDA, and the FAo:
FDA. 1997. Hazard Analysis and Critical Control Point Principles and Application Guidelines.
http://www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/
HACCPPrinciplesApplicationGuidelines/default.htm#princ
FAo. 1998. Food Quality and Safety Systems – A Training Manual on Food Hygiene and the
w8088e/w8088e00.htm
Documentation List:
HACCP/HARPC Plan
SoP – CCP/PC inspections
During receiving Corrective action logs
it is critical that m
Documentation List:
Approved supplier list
SoP – Product inspection
SoP – Product holding/storage
Product tracing paperwork
m
Food Safety Guidelines 108 Fresh Culinary Herbs
Section IV:
Processing Unit Operations
If pathogens are present in the wash water, they may contaminate the produce,
levels of disinfectant
and subsequent washing will not reduce levels of these pathogens. Therefore,
water used for washing or cooling produce should contain sufficient levels to reduce the
of disinfectant to reduce the potential for pathogens to persist in such water.
Such practices include using antimicrobial chemicals in the wash water or potential for
using spray type wash treatments instead of submerging produce.
pathogens to persist
4.1 The Best Practices Are: Wash Water
• Source water used for washing product in processing operations in such water.
must meet US EPA drinking water standards.
The wash water source should be tested as specified in
Table IV-1. If a municipal water source is used, microbial
water quality information from the respective municipal
water authority may be obtained and archived if it is
reported as total coliforms. Facilities using municipal water
should periodically test water at the point of use to verify
the integrity of the facility water distribution system.
Develop an action plan in case municipal water authorities
issue a water quality alert or warning such as “boil water
warning.” Document and archive any warning or alerts issued by the water authority as well as
corrective actions taken by your firm to address this issue.
• If fresh culinary herbs are washed during processing, operators should verify the washing process by
documenting wash water system parameters (e.g., the levels of sanitizers, water changes, pH control,
amount and rate of product throughput, exposure time, and mass-to-volume ratios) that are effective in
controlling microbial levels in their system.
• Process wash water should have sufficient levels of disinfectant so as not to result in adulteration of
the product by cross-contamination as specified in Table IV-1. Establish an SoP for monitoring and
maintaining wash water disinfectant levels throughout processing operations. Continuous monitoring of
disinfectant levels is preferred.
Active disinfectant levels (i.e., free chlorine and not chlorine concentration) and pH or oRP
(oxidation reduction potential) should be measured and documented.
Follow manufacturer’s directions for mixing of disinfectant chemicals to obtain effective
concentrations; manufacturer’s suggested or allowable levels in washing and cooling water should
not be exceeded.
All measurement devices (e.g., free chlorine probes, oRP or pH monitoring equipment) should be
calibrated daily. Disinfectant measurements and equipment calibrations should be documented.
The person monitoring the water disinfectant levels should know when to add disinfectant based on
values obtained.
Any other substance (e.g., organic acids for pH control) used to treat water used in processing
operations should be monitored to verify correct concentration. These checks should be
documented.
If the disinfectant level should fall outside the parameters established in the HACCP program,
corrective actions as outlined in the HACCP program should be followed and documented.
• Any water additive used to wash fresh culinary herbs should be food-grade and compliant with federal,
state or local regulations for the intended use. Copies of MSDS should be maintained on file.
• To ensure efficient operation, routinely inspect and maintain facility water distribution system and
equipment designed to assist in maintaining water quality such as chlorine injectors, filtration systems,
and backflow devices. Inspections and maintenance should be documented.
• All monitoring equipment should be adequately maintained and periodically calibrated. Maintain a log of
maintenance and calibration events.
• Water holding tanks used at the facility should be kept clean and sanitary. All cleaning and sanitation
verification activities should be documented. For more on the care of finished water storage tanks see
the Sanitary Survey in Appendix A.
Direct Product Contact Microbial Testing For any given water source (e.g. municipal, well), samples for microbial testing should be
or Food Contact Target organism: taken as close to the point of use as practical (as determined by the sampler to ensure
Surfaces Total coliforms the integrity of the sample) using sampling methods as prescribed in this table where
the water contacts fresh culinary herbs, so as to test both the water source and the
Sampling Procedure: water distribution system. There is only one sample per month per distribution system
1 L sample collected aseptically at the point under these metrics. If there are multiple potential point-of-use sampling points in a
of use distribution system, then samples should be taken from different point-of-use locations
each subsequent month (randomize or rotate sample locations).
Sampling Frequency: one sample per
water source should be collected and tested Water that directly contacts harvested fresh culinary herbs or is used on food contact
prior to use if >60 days since last test of the surfaces such as equipment or utensils, should come from a source that meets the
water source. Additional samples should be Maximum Contaminant Level Goal of zero or no detection for total coliforms in drinking
collected at intervals of no less than 18 hr. and water as specified by US EPA and once in use, contain an approved disinfectant at sufficient
at least monthly during use. concentration to prevent cross-contamination.1 Microbial and physical / chemical testing
should be performed, as appropriate to the specific operation, to demonstrate that the
Municipal & Well exemption: disinfectants and corresponding concentrations used are sufficient for the wash system
For wells and municipal water sources, if total and that acceptance criteria for total coliforms have been met.Always follow your
coliform levels are below detection limits contracting laboratory’s protocol for the collection of water samples.
for five consecutive samples, the sampling
frequency may be decreased to once every Single Pass and Recirculated Water Systems
six months and the 60 and 30 day samplings • Single pass use – Water should have non-detectable levels of total coliform and
are waived. This exemption is void if there sufficient disinfectant to ensure water has no detectable total coliform (e.g., a
is a significant source or distribution system minimum of 10 ppm chlorine).
change. • Recirculated use – Water should have non-detectable levels of total coliform and
sufficient disinfectant to ensure returned water has no detectable total coliform (e.g.,
Test Method: a minimum of 10 ppm chlorine).
FDA BAM method or any US EPA-approved
or AoAC-validated method for quantitative * Single pass and recirculated water treated with chlorine-based disinfectants should be
monitoring of water for total coliforms. tested for free chlorine concentration (ppm) and pH oR for oxidation reduction potential
(mV). The selected method should be verified periodically with the alternative process
verification method AnD by ensuring that established microbial acceptance criterion for
water is being met.
1
Use Metric Rationale / Corrective Actions
Acceptance Criteria:
If any one sample exceeds the acceptance criteria for total coliforms, then investigation
negative or Below DL for All Samples
and corrective actions should be taken to ensure it can meet acceptance criteria under
those operational conditions. then the water should not be used for this purpose unless
appropriate disinfectants have been added or until corrective actions have been completed
Physical / Chemical Testing and total coliform levels are within acceptance criteria:
Target Variable: • Conduct a Sanitary Survey of the water source and distribution system to determine
Water disinfectant (e.g., chlorine or other if a contamination source is evident and can be eliminated. Eliminate identified
disinfectant compound) contamination source(s) if applicable.
• For wells, perform a Sanitary Survey and / or treat as described in the Sanitary Survey
Acceptance Criteria for Disinfectants: (Appendix A).
• US EPA-approved treatments per • Retest the water at the same sampling point after conducting the Sanitary Survey
product label for human pathogen and / or taking corrective actions to determine if it meets the outlined microbial
reduction in water and used in acceptance criteria for this use.
accordance with a wash water system-
specific protocol that has been validated
to show that active disinfectant is present
throughout the wash process. For example, if a water sample for water used to clean food contact surfaces has
• Chlorine-based disinfectants detectable total coliforms, SToP using that water system, examine the distribution line,
>10 ppm free chlorine after application source the inlet as described in the Sanitary Survey (Appendix A), and retest from the
and pH 6.5 – 7.0 same point of use. Continue testing daily for five days at the point closest to use, and
• ORP > 725 mV* do not use the water system until it consistently delivers water that is safe, sanitary, and
meets the acceptance criteria outlined in this table. If any of the five samples taken during
Testing Procedure: the intensive sampling period after corrective actions have been taken, have detectable
• Chemical reaction based colorimetric total coliforms, repeat corrective actions and Do noT use that system until the source of
test, or contamination can be corrected.
• Ion specific probe, or
• ORP,* or Records: All test results and corrective actions should be documented and available for
• Other as recommended by disinfectant verification from the user of the water for a period of 2 years.
supplier.
Testing Frequency:
Continuous monitoring (preferred) with
periodic verification by titration oR routine
monitoring if the system can be shown to have
a low degree of variation.
Section IV:
Processing Unit Operations
Construct wall, ceiling, and floor surfaces with materials that are easily cleaned and sanitized with
chemical cleaners.
• Facility layout – the following practices are suggested to reduce the potential for contamination:
Raw and finished product cooling and storage facilities should be clearly separated to reduce the
potential for cross-contamination.
Locate the maintenance shop close to the process area but well separated so that cross-
contamination cannot occur.
Have rest rooms open into a location other than a processing area.
If a microbiology lab is in the building, it should be operated under the FDA’s Good Laboratory
Practices.4
Any designated employee break area should be physically separate from the processing area.
• The flow of personnel, product, equipment, or air – the following practices are suggested to reduce the
potential for contamination:
Use short direct routes for both product and personnel flow.
Design the plant for one direction of personnel traffic, product, and air flow.
Design product areas to have traffic patterns that separate raw and finished product using either
linear product flow (i.e., raw to finished product) or by physical partition.
Use an air filtration system for central air distribution and airflow that is counter to product flow,
so that filtered air moves with a positive pressure from the cleanest areas (e.g., from packaging and
finished product storage) toward less clean areas (e.g., the receiving area).
Restricting the movement of lift trucks, bins, totes, maintenance tools, cleaning implements, and
people from receiving and storage zones to processing and packaging areas.
Code bins, totes, clothing, cleaning implements, maintenance tools, and other items (e.g., blue aprons
for receiving zones and red aprons for processing and packaging areas) to help achieve separation of
traffic and thereby minimize cross-contamination.
• Entryways – the following practices are suggested to reduce the potential for contamination:
Design all entrances and exits to the process floor to be closable or to provide a barrier so that
outside air cannot enter the plant directly.
Keep the number of entrances and exits to the processing areas to a minimum to reduce the
potential for contamination of intake air.
Locate hand dip and foot bath stations at each employee entrance so that employees must pass
through them to enter the processing and packing area. The hand dip and foot bath stations should
contain an appropriate sanitizer to prevent tracking of microbes from outside into the processing
area.
Locate the door to the outside in an area other than into a processing area.
• Water delivery and drainage systems – to reduce the potential for contamination, design and construct:
Floors so that water drains well.
Floor drains in processing or storage areas to prevent pest entry, water accumulation in or around
the drain and to be accessible for cleaning.
Under-floor drains to carry waste water out of processing areas.
4 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
Cooling systems’ condensation units to drain directly into drainage systems. Emptying of this water
into floor drains should be prohibited.
Waste water collection areas to prevent product and equipment contamination.
Facility water systems equipped with back-flow prevention devices.
overhead equipment, structures or fixtures, catwalks, walls, pipelines, etc. should be designed to
avoid the potential to be a contamination source for product and packaging (i.e., condensation
formation, dirt).
• Food contact surfaces (FCS) – the following practices are suggested to reduce the potential for
contamination:
Construct FCS with materials that are smooth, nonabsorbent, smoothly bonded, without niches,
and sealed so that they are easily cleaned and sanitized and do not serve as harborage of microbial
pathogens.
Protect FCS from contact with non-potable water.
Avoid use of hollow structures such as table legs, conveyer rollers and racks because they may
collect water and debris, and thus, harbor pathogens.
Equipment lubrication should be managed so as to not contaminate fresh culinary herbs. Food grade
lubricants should be used on packing equipment where food contact may occur. Food-grade and
non-food-grade lubricants are to be stored separately.
Sufficiently elevate FCS above the floor to prevent contamination from floor splashes.
• All lights should be adequate for sufficient visibility and designed to prevent the potential for broken
glass contamination of the product (i.e., contain shatter-proof bulbs or be sealed in a protective
covering).
• Provide a designated area separate from food handling areas for employees to store personal items.
5.3 The Best Practices Are: Toilets and Hand-Washing Stations Construction and Design
operations with poorly designed and constructed toilet facilities and hand-washing stations may provide direct or
indirect contamination of the fresh culinary herbs and water sources used on fresh culinary herbs.
• The design and construction of toilet facilities and hand-washing stations, including number and location,
should be in compliance with applicable local, state, and federal regulations. 5
• The number of toilet facilities and hand-washing stations should meet OSHA requirements as outlined
in 29 CFR 1910.141. 6
• Evaluate the location of toilet facilities and hand-washing stations to maximize accessibility and use,
while minimizing the potential for the facility to serve as a source of contamination.
• Toilet facilities should be constructed of materials that can be easily cleaned and sanitized using cleaners
and / or oxidizing agents.
• If the toilet facilities have any openings to the outside (e.g. windows, vents), these openings should have
proper screens to exclude vermin.
• Toilet facilities and hand-washing stations should be constructed with properly designed drainage
systems.
5 The number of toilet and hand-washing stations should meet oSHA requirements as outlined in 29 CFR 1910.141.
8 Code of Federal Regulations, Title 21, Part 110 – Current Good Manufacturing
Practice in Manufacturing, Packing, or Holding Human Food. http://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?c=ecfr&sid=fe4d3406434fbb5824f74776dadefb66&rgn=div5&view=text&node=2
1:2.0.1.1.10&idno=21
• All pesticides, traps, bait, and chemicals used in pest control must be acceptable for use in and around a
food processing facility and used in accordance with local, state, and federal regulations.
Permit the use of insecticides or rodenticides inside the facility only under precautions and
restrictions that will protect against the contamination of fresh culinary herbs, food-contact
surfaces, and food-packaging materials. Rodent bait materials are not to be used within production
areas or packaging material storage areas.
These materials must only be used by properly trained and accredited personnel. A record of
use should be kept available for inspection along with the appropriate applicators licenses and
documentation. Applicators should also show records of training, continuing education, etc.
Rodent traps should be deployed around the inside of the facility and bait stations along the outside
7.2 The Best Practices Are: Processing Facility Sanitation (non-Food Contact
Components of the Facility)
• The non-food contact components of the facility (e.g., walls, ceilings, floors, drains, cooling equipment,
mezzanines, storage areas, employee break areas) must be cleaned and sanitized on a routine basis.
Establish a master sanitation schedule and written procedures (SSoPs) for these areas that clearly
identify cleaning frequency, sanitizing methods, sanitizing agents, precautions, etc. Document all facility
cleaning and sanitizing activities.
• Verify the efficacy of the facility cleaning and sanitation with routine environmental testing (e.g.
conventional or rapid microbiological methods such as total count or bioluminescence testing). Retain
all testing data and related documentation in company records.
• The facility should have a documented environmental microbial testing program screening for Listeria
spp. with testing targeted to areas where moisture, soil or debris may accumulate (e.g., equipment
exterior, floor drains). If test results are positive for Listeria spp., then follow-up tests for Listeria
monocytogenes should be conducted. 10
7.4 The Best Practices Are: Toilets and Hand-Washing Stations Sanitation
Individual toilet and hand-washing units should be properly maintained in a clean and sanitary condition for the
worker’s health, safety, and comfort. Inadequately supplied or improperly maintained restrooms and hand-washing
facilities may provide direct or indirect contamination of the fresh culinary herbs and water sources used on fresh
culinary herbs.
• Establish a written cleaning and sanitation schedule for toilet and hand-washing stations.
10 FDA. 2008. Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods; Draft
Guidance. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodProcessingHACCP/ucm073110.
htm
Training programs should emphasize employee roles and responsibilities in producing a safe product, sanitation
principles and sanitary practices including appropriate and effective hand-washing, glove use and replacement, health-
related policies, etc. Training should be designed to help employees understand what is expected of them and why
these practices are important. This training should be documented and kept on file for review.
Documentation List:
Employee attendance log for food safety policy/plan training
SoP – Worker hygienic practices
Storage and SoP – Employee personal effects storage and control
SoP – Worker health practices
transportation SoP – Glove use
should be under m
9.0 Issue: Cold Storage and Warehousing
conditions that will
Cold storage and warehouse facilities are often the last area that house
protect food against fresh culinary herbs before they are shipped to the next point of the supply
chain. The conditions and sanitation programs of these facilities are critical
in maintaining the integrity of the finished product before it exits the facility.
physical, chemical, Storage and transportation of finished food should be under conditions that
will protect food against physical, chemical, and microbial contamination as
and microbial well as against deterioration of the food and the container.
• Avoid practices that cause condensation to form in the facility (i.e. putting product into storage
before it is properly cooled).
• Condensate / water from evaporator-type refrigeration systems should be contained in catchments
designed to assure that it does not become a source of contamination. Water from refrigeration
catchments should be drained into a drainage line and not onto the floor.
• The storage area should be included in scheduled cleaning and sanitation operations. If finished product
is present during cleaning of ceiling, floors or drains and equipment such as pressure washer/sprayers,
steam or foam cleaners are being used, ensure that water does not splash on product.
• The storage area should be included in the facility pest control program.
• Forklifts and other pallet moving equipment should be included in the master sanitation schedule and
should be cleaned on a regular basis.
• Verify the efficacy of the cold storage and warehouse cleaning and sanitation with routine environmental
testing (e.g., conventional microbiological methods or rapid methods for total bacterial count or
bioluminescence testing). Testing data should be maintained on file.
• Cleaning and sanitation activities should be documented.
Documentation List:
SoP – Refrigeration unit inspection
Refrigeration unit inspection log
Temperature monitoring device calibration log
SSoP – Warehouse/cold storage area
m
10.0 Issue: Finished Product Containers and Packaging Materials
Any material including packaging material that comes into contact with fresh culinary herbs might result in
contamination. Maintaining a program that inspects packaging materials throughout their use (e.g., at arrival,
during use, and after packaging) in a processing operation helps to reduce the potential for these materials to
contaminate products.
• Establish a pallet inspection and repair program (SOP). Pallets used with finished product containers
should be in good condition (i.e., free from loose pieces such as nails or staples) and not used for
anything other than processing activities. Damaged wood pallets should not be used.
Documentation List:
SoP – Finished product and packing materials inspection
SoP – Finished product containers and packing materials storage and handling
m
11.0 Issue: Metal Detection
Fresh culinary herb processors may utilize metal detection to control a significant metal hazard identified in
their HACCP plan, to collect data to verify that metal is not a significant hazard, or to comply with a customer’s
requirements. The following Best Practices apply if metal detection is used.
Documentation List:
Metal detection program
m
12.0 Issue: Labeling of Ready-To-eat (RTe) and Ready-To-Use (RTU) Products
End-users, including consumers, may have difficulty in quickly and easily differentiating RTU and RTE products. RTU
products require washing before consumption, and RTE products do not require washing before consumption. Clearly
label products to avoid end-user confusion regarding whether or not a product needs to be washed before consumption.
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Human Food, Code of
Federal Regulations,Title 21, Part 110.
(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=455b9bcf4b981f8e40db32e79d48356f&rgn=div5&vie
w=text&node=21:2.0.1.1.10&idno=21)
“Food Safety Auditing Guidelines: Core Elements of Good Agricultural Practices for Fresh Fruits and Vegetables.”
United Fresh Produce Association, 2001.
(http://www2.unitedfresh.org/forms/store/ProductFormPublic/)
“Food Safety Begins on the Farm: A Grower Self Assessment of Food Safety Risks,” national GAPs Program Cornell
University, 2003.
(http://www.gaps.cornell.edu/farmassessmentws.html)
“Food Safety Guidelines for the Fresh-Cut Produce Industry,” United Fresh Produce Association, 2001.
(http://www2.unitedfresh.org/forms/store/ProductFormPublic/)
“Food Security Guidelines and Questionnaire for Fresh Fruits and Vegetables,” United Fresh Produce Association,
2001.
(http://www2.unitedfresh.org/forms/store/ProductFormPublic/) “Guide to Federal Food Safety and Security
Inspections: Guidance on Preparing for and Successfully Directing Regulatory Inspections by FDA and other
Food Authorities,” United Fresh Produce Association, 2005.
(http://www2.unitedfresh.org/forms/store/ProductFormPublic/)
“Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,” U.S. Food and Drug
Administration, 1998.
(http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
ProduceandPlanProducts/ucm064574.htm)
“Guide to Minimize Microbial Food Safety Hazards for Fresh-cut Fruits and Vegetables,” U.S. Food and Drug
Administration, 2008.
(http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/
produceandplanproducts/ucm064458.htm)
“Guide to Traceback of Fresh Fruit and Vegetables Implicated in Epidemiological Investigations,” U.S. Food and Drug
Administration, 2001.
(http://www.fda.gov/downloads/ICECI/Inspections/InspectionGuides/ucm109502.doc)
14.0 References
Casteel M, Sobsey M, and Mueller J. 2006. Fecal contamination of agricultural soils before and after hurricane-
associated flooding in north Carolina. Journal of Environmental Science and Health. Part A,Toxic/Hazardous
Substance and Environmental Engineering. 41(2):173-184.
CCR Title 14 – Chapter 3.1 – Article 5. 2007. Article 5. Composting Operation and Facility Siting and Design Standards.
Accessed February 15, 2007. (http://www.ciwmb.ca.gov/regulations/Title14/ch31a5.htm#article5)
Erickson MC,Webb CC, Diaz-Perez JC, Phatak SC, Silvoy JJ, Davey L, Payton AS, Liao J, Ma L, Doyle MP. 2010.
Infrequent internalization of Escherichia coli o157:H7 into field-grown leafy greens. Journal of Food Protection.
73(3):500-506.
Fenlon DR. 1985.Wild birds and silage as reservoirs of Listeria in the agricultural environment. Journal of Applied
Bacteriology. 59:537-543.
Fukushima H, Hoshina K, and Gomyoda M. 1999. Long-term survival of shiga toxin-producing Escherichia coli o26,
o111, and o157 in bovine feces. Applied and Environmental Microbiology. 65(11):5177-81.
Gagliardi JV and Karns JS. 2000. Leaching of Escherichia coli o157:H7 in diverse soils under various agricultural
management practices. Applied and Environmental Microbiology. 66(3):877-83.
Girardin H, Morris CE,Albagnac C, Dreux n, Glaux C, nguyen-The C. 2005. Behaviour of the pathogen surrogates
Listeria innocua and Clostridium sporogenes during production of parsley in fields fertilized with contaminated
amendments. FEMS Microbiology Ecology. 54:287-295.
Golberg D, Kroupitski y, Belausov E, Pinto R, Sela S. 2011. Salmonella Typhimurium internalization is variable in leafy
vegetables and fresh herbs. International Journal of Food Microbiology. 145:250-257.
Gorny J. "Microbial Contamination of Fresh Fruits and Vegetables," Microbiology of Fruits and Vegetables. Ed. Sapers GM,
Gorny JR,yousef AE. Boca Raton, FL: Taylor & Francis, 2006. 3-28. Print.
Gorski L, Parker CT, Liang A, Cooley MB, Jay-Russell MT, Gordus AG,Atwill ER, Mandrell RE. 2011. Prevalence,
distribution, and diversity of Salmonella enterica in a major produce region of California. Applied and
Environmental Microbiology. 77(8):2734-48.
Hutchison ML,Walters LD, Moore A, Crookes KM,Avery SM. 2004. Effect of length of time before incorporation
on survival of pathogenic bacteria present in livestock wastes applied to agricultural soil. Applied and
Environmental Microbiology. 70(9):5111-5118.
Ingham SC, Losinski JA,Andrews MP, Breuer JE, Breuer JR,Wood TM,Wright TH. 2004. Escherichia coli
contamination of vegetables grown in soils fertilized with noncomposted bovine manure: Garden-scale
studies. Applied and Environmental Microbiology. 70(11):6420-6427.
Ingham SC, Fanslau MA, Engel RA, Breuer JR, Breuer JE,Wright TH, Reith-Rozelle JK, Zhu J. 2005. Evaluation of
fertilization-to-planting and fertiliation-to-harvest intervals for safe use of noncomposted bovine manure in
Wisconsin vegetable production. Journal of Food Protection. 68(6):1134-1142
Islam M, Doyle MP, Phatak SC, Millner P, and Jiang X. 2004a. Persistence of enterohemorrhagic Escherichia coli
o157:H7 in soil and on leaf lettuce and parsley grown in fields treated with contaminated manure composts
or irrigation water. Journal of Food Protection. 67(7):1365-70.
Islam M, Morgan J, Doyle M, and Jiang X. 2004b. Fate of Escherichia coli o157:H7 in manure compost-amended soil
and on carrots and herbs grown in an envrironmentally controlled growth chamber. Journal of Food Protection.
67(3):574-578.
Islam M, Doyle MP, Phatak SC, Millner P, Jiang X. 2005. Survival of Escherichia coli o157:H7 in soil and on carrots and
onions grown in fields treated with contaminated manure composts or irrigation water. Food Microbiology.
22:63-70.
Jay MT, Cooley M, Carychao D,Wiscomb GW, Sweitzer RA, Crawford-Miksza L, Farrar JA, Lau DK, o'Connell J,
Millington A,Asmundson RV,Atwill ER, Mandrell RE. 2007. Escherichia coli o157:H7 in feral swine near
spinach fields and cattle, central California coast. Emerging Infectious Diseases. 13(12):1908-11.
Jiang X, Morgan J, and Doyle M. 2003. Fate of Escherichia coli o157:H7 during composting of bovine manure in a
laboratory-scale bioreactor. Journal of Food Protection. 66(1):25-30.
Jiang X, Morgan J and Doyle M. 2002. Fate of Escherichia coli o157:H7 in manure-amended soil. Applied and
Environmental Microbiology. 68(5):2605-2609.
Keene WE, Sazie E, Kok J, Rice DH, Hancock DD, Balan VK, Zhao T, and Doyle MP. 1997.An outbreak of Escherichia
coli o157:H7 infections traced to jerky made from deer meat. Journal of the American Medical Association.
277(15):1229-31.
Kudva IT, Blanch K, Hovde CJ. 1998.Analysis of Escherichia coli o157:H7 survival in ovine or bovine manure and
manure slurry. Applied and Environmental Microbiology. 64(9):3166-3174.
LeJeune J, Homan J, Pearl DL. 2008. Role of the European starling in the transmission of E. coli o157 on Dairy Farms.
Proceeds of the 23rd Vertebrate Pest Conference. http://ddr.nal.usda.gov/dspace/bitstream/10113/23414/1/
InD44157923.pdf.
nicholson FA, Groves SJ, and Chambers BJ. 2004. Pathogen survival during livestock manure storage and following
land application. Bioresource Technology. 96:135-143.
Perz JF, Le Blancq SM. 2001. Cryptosporidium parvum infection involving novel genotypes in wildlife from lower new
york State. Applied and Environmental Microbiology. 67(3):1154-62.
Singh R, Jiang X, Luo F. 2010.Thermal inactivation of heat-shocked Escherichia coli o157:H7, Salmonella, and Listeria
monocytogenes in dairy compost. Journal of Food Protection. 73(9):1633-1640.
Suslow,T.V., M.P. oria, L.R. Beuchat, E.H. Garrett, M.E. Parish, L.J. Harris, J.n. Farber, F.F. Busta. 2003. Production
practices as risk factors in microbial food safety of fresh and fresh-cut produce. Comprehensive Reviews in
Food Science and Food Safety. 2S:38-77.
Takeuchi K and Frank JF. 2000. Penetration of Escherichia coli o157:H7 into lettuce tissues as affected by inoculum
size and temperature and the effect of chlorine treatment on cell viability. Journal of Food Protection.
63(4):434-40.
Takeuchi K, Matute CM, Hassan An, and Frank JF. 2000. Comparison of the attachment of Escherichia coli o157:H7,
Listeria monocytogenes, Salmonella typhimurium, and Pseudomonas fluorescens to lettuce leaves. Journal of Food
Protection. 63(10):1433-7.
US EPA. 1996. Soil Screening Guidance:Technical Background Document. EPA/540/R95/128: office of Solid Waste and
Emergency Response, United States Environmental Protection Agency. (http://www.epa.gov/superfund/
health/conmedia/soil/introtbd.htm)
US EPA. 2003. Center for Environmental Research Information,“Chapter 5: Class B pathogen requirements
and requirements for domestic septage applied to agricultural land, a forest, or a reclamation site,”
Environmental Regulations and Technology: Control of Pathogens and Vector Attraction in Sewage Sludge,
EPA/625/R-92/-13, U.S. Environmental Protection Agency, Cincinnati.
US FDA. 1986. Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding Human Food,
Code of Federal Regulations,Title 21, Part 110. Accessed February 9, 2012. (http://www.accessdata.fda.gov/
SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110)
US FDA. 1998. Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, U.S. Food and Drug
Administration. (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
ProduceandPlanProducts/ucm064574.htm)
US FDA. 2001.Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination
of Microbial Hazards on Fresh and Fresh-Cut Produce. Accessed January 2010. (http://www.fda.gov/Food/
ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm090977.htm)
US FDA. 2004. Federal Food, Drug, and Cosmetic Act. (http://www.fda.gov/RegulatoryInformation/Legislation/
FederalFoodDrugandCosmeticActFDCAct/default.htm)
US FDA. 2009. Kinetics of Microbial Inactivation for Alternative Food Processing Technologies. http://www.fda.gov/
Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm100158.htm
Wachtel MR,Whitehand LC, and Mandrell RE. 2002a.Association of Escherichia coli o157:H7 with preharvest leaf
lettuce upon exposure to contaminated irrigation water. Journal of Food Protection. 65(1):18-25.
Wachtel MR,Whitehand LC, and Mandrell RE. 2002b. Prevalence of Escherichia coli associated with a cabbage crop
inadvertently irrigated with partially treated sewage wastewater. Journal of Food Protection. 65(3):471-5.
APPenDICeS
for the
FoRWARD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Appendix A Sanitary Survey And Remediation Guidelines For Water Resources . . . . . . . . . . . . . . . . . . . 137
T hese appendices are resources created to supplement the Commodity Specific Food Safety Guidelines
for the Production, Harvest, Post-Harvest, and Processing Unit Operations of Fresh Culinary Herbs.
APPenDIx A
1.0 Introduction
The Sanitary Survey and Remediation Guidelines described below are to be used as follow-up to situations
encountered while using the Commodity Specific Food Safety Guidelines for the Production, Harvest, Post-Harvest, and
Processing Unit Operations of Fresh Culinary Herbs. This report provides an action plan when a water sample taken
closest to the point-of-use has levels of generic E. coli (production) or total coliforms (packinghouse or processing
facility) above acceptance criteria.
A sanitary survey of water systems should also be conducted periodically to prevent contamination. Sanitary
surveys:
• Reduce the risk of waterborne disease.
• Provide an opportunity to enhance your knowledge of your water system.
• Identify and document system deficiencies.
This document prescribes a sanitary survey be performed prior to the start of the growing season on water
supplies and distribution systems used in the production of fresh herbs. There are also some remediation
approaches in this document that require that a Sanitary Survey be performed such as when source water used in
packing and processing facilities exceeds the acceptance criteria for total coliforms. In addition, a sanitary survey is
a useful tool for packing and processing facilities in managing their food safety and HACCP programs.
In the Production and Harvest Unit operations section, Figures 3A and 3B have certain “red-box” situations
when water samples taken closest to the point-of-use result in generic E. coli levels above an action level. In these
situations, a sanitary survey is initiated to determine any potential sources of contamination. In general, when
conducting a sanitary survey the reliability, quality, and vulnerability of your water system are being investigated. To
get started:
While irrigating herb production areas, irrigation water tests are above acceptance criteria (this situation brings you
to a red box in a decision tree in Figure 3A or 3B). Continue the investigative process as stated in the blue-box
instructions in the decision tree:
1. Perform a generic E. coli test on a water sample taken at or as close to the source as possible. This
result of this test will help to determine where the source of the contamination might reside.
Depending on the results of this test, additional tests may be used to further narrow the exact location
of the contamination entering the distribution system.
2. Initiate a sanitary survey of your water system:
Begin the sanitary survey process at the water source and continue surveying the water system
between the water source and the site of the positive sample.
For specific water sources, follow the guidelines for conducting Sanitary Surveys and corresponding
remediation outlined below.
1.1.1 Wells
condition of the area surrounding the well. Inspect your wellhead on a regular basis and keep records of inspections
and repairs. Issues to consider when surveying the surrounding area are:
Proximity to:
Tables 1 and 2 below provide guidelines for doing surveys of a well’s components and the condition of the
surrounding area.
Well casing Listen for water running down into the well. *Contact a well contractor or other
If you can hear water, there could be a crack trained individual for well casing repair or
or hole in the casing. If you can move the construction of a new well.
casing by pushing against it, you may also
have a problem with the integrity of the
casing.
Annular space (The space The annular space of the well should have a *Contact a contractor or other trained
between two well casings or minimum of 25 feet of sealing material. individual for correction of a deficient
between the casing and the annular space seal or construction of a new
wall of the drilled hole.) well.
Well cap or seal Well should be completely sealed against Replace any missing plugs and seal any
surface water, insects, or other foreign openings, gaps or cracks.
matter.
*Contact a well contractor or other trained
Look for holes, missing plugs, leaking water. individual to install a new cap and/or
If artesian flow install appropriate check wellhead gasket.
valve.
Well vent Check the cleanliness & integrity of the well Vents must be covered with a screen.
vent screen. Look for tears or holes. Replaced damaged vent screen.
Concrete well pad Look for cracks that would allow water to Seal cracks or re-pour a new concrete pad.
enter well casing.
Ground should slope away from well so that
surface water cannot collect near the well.
Well pump Make sure pump is operating properly; check Clean, repair or replace pump
for corrosion.
*Many California counties’ Departments of Environmental Health have listings of licensed contractors.
Information taken from A Guide For The Private Well Owner, Santa Clara Valley Water District, County of Santa Clara, Department of
Environmental Health and Preparing for a Sanitary Survey: Information to Help Small Water Systems,WA State Dept of Health, DOH
Pub.#331-238.
Gradient There is standing water around the well or Re-grade around the well so the ground
water draining toward the well. slopes away from your well.
Potential contaminant Minimum horizontal distance from: Move potential contaminant source to meet
source the minimum guidelines.
Any sewer 50 ft.
Information taken from DWR – Southern District Water Well Standards, Part II, Section 8 and A Guide For The Private Well Owner,
Santa Clara Valley Water District, County of Santa Clara, Department of Environmental Health
1. A chlorine solution containing at least 50 mg/l (or ppm – parts per Using Tables A-F to make a 50 ppm
million) available chlorine, is added to the well.Tables A-F in Appendices (mg/L) chlorine solution and add it to
1.1-1.5 lists quantities of various chloride compounds required to dose the well.
100 feet of water-filled casing at 50 mg/l for diameters ranging from 2
to 24 inches. If bringing the well back into service quickly is desired
(such as when wells have been repaired or when a pump has been
repaired or replaced), the solution should contain at least 100 mg/l
available chlorine. To obtain this concentration, double the amounts
shown in Tables A-F.
2. To prevent contamination of the well during disinfection, first clean Clean surrounding area & disinfect
the work area around the top of the well. Remove grease and mineral well head. Turn off the pump.
deposits from accessible parts of the well head and flush the outside Remove well cap. Wash sides of well
surfaces with chlorine solution (1/2 cup of laundry bleach in 5 gal of casing, pump column, and anything
water). Turn off the pump. Remove the cap or the well plug on the inserted into the well with chlorine
rubber seal. There are many types of well caps and plugs. If you have solution.
questions, you should contact a licensed well driller. If you have a
submersible pump, you may also want to contact a licensed well driller
for advice on disinfection procedures. Wash the pump column, drop
pipe, or anything inserted into the well with chlorine solution. Try to
coat the sides of the casing as you pour.
3. After it has been placed into position, turn the pump on and off several Mix well water by turning pump on
times so as to thoroughly mix the disinfectant with the water in the and off several times until discharge
well. Repeat this procedure 3-5x at 1-hour intervals. Test for the tests positive for residual chlorine.
presence of chlorine in well discharge with a residual chlorine test; if Repeat 3-5x at 1 hr intervals.
chlorine is not detected, the disinfection process should be repeated.
4. The well shall be allowed to stand without pumping for 24 hours. Let pump/well rest for 24 hours.
5. The waste water shall then be pumped to land and contained.Avoid Pump water to a safe waste location
all water conveyance features such as swales, ditches, canals, creeks or until chlorine is no longer detected.
streams. Do not allow overland flow to reach surface waters. Pump
until presence of chlorine is not detectable. The absence of chlorine is
best determined by testing for available chlorine residual (Inexpensive
color comparator residual chlorine test kits can be purchased from
most large department stores and swimming pool supply companies.).
6. A bacteriological sample shall be taken and submitted to a laboratory for Take a water sample using sanitary
examination. For individual wells, technical advice regarding the collection techniques and submit it to a lab for
of bacteriological samples may be obtained from your local health testing.
departments or from the laboratories that will examine the sample.
7. Testing should be performed and results interpreted. Testing for total If testing shows microbial levels are
coliforms is currently approved by U.S. EPA to verify drinking water still above acceptable action levels,
disinfection with “zero” as the Maximum Contaminant Level Goal repeat the disinfection process.
(MCLG). If the laboratory analysis indicates microbial contamination,
the disinfection procedure should be repeated. Depending on the level
of contamination, it may be necessary to use a higher concentration
chlorine solution (several times that shown in Tables A-F in Appendices
1.1-1.5) and re-test the water. If repeated attempts to disinfect the
well are unsuccessful, a detailed investigation to determine the cause of
the contamination should be undertaken.
See Tables A-F in Appendices 1.1 – 1.5 for the amount of chlorine compound required to dose specific volumes of
water-filled well casing at 50 milligrams per liter (mg/L) 1
1. Some authorities recommend a minimum concentration of 100 mg/L. See instructions given in Appendices to calculate
higher concentrations.
2. HTH, Perchloron, Pittchlor, etc.
3. Where dry chlorine is used, it should be mixed with water to form a chlorine solution prior to placing it into the well.
note that dry chlorine should always be added to water, not vice versa. Further, the chemical should be added slowly.
These precautions are necessary to lessen the possibility of a violent chemical reaction.
4. Household bleaches such as Clorox, etc.
5. Review Material Safety Data Sheets (MSDS) and labels before performing disinfection activities.
Evidence of animal intrusion Look for evidence of animal intrusion Remove animal debris; if animal intrusion is a
around the water source (observed animal in canal, fecal deposits, or regular occurrence, investigate the potential
animal carcasses). cause for intrusion and re-test the source.
Contaminating waters Look for dirty/contaminated water that may Redirect contaminating water with diversion
be draining into the canal. dikes, gradients, inlet/outlet control
structures, etc.
Cleanliness Look for trash and debris accumulation. Remove and dispose of items away from
water.
Evidence of animal intrusion Look for evidence of animal intrusion Remove animal debris. If animal intrusion
around the water source (observed animal in reservoir, fecal deposits, is a regular occurrence consider isolating
carcasses, etc.). reservoir with fences.
Contaminating influent Look for dirty/contaminated water that may Redirect water with diversion dikes,
be draining into reservoir. gradients, drainage pipes, inlet control
structures, etc.
Caution should be exercised when back-
flushing filtration systems so that this water A managed grassed buffer zone around
does not return directly to the source. reservoir (but not on banks) helps prevent
contamination.
overflow pipe observe whether opening is clean and free Cover opening with a mesh screen.
of weeds and debris.
Chlorine may be injected continuously (at concentration of 1-2 ppm) or as a shock treatment
A general formula for calculating the amount of chlorine for injection is: (Clark 1996; see
footnote for an example) 2
IR = Q x C x 0.006/S
2
Example:A grower wishes to use household bleach (naoC at 5.25% active chlorine) to achieve a 3 ppm chlorine level at the injection point.
The flow rate of his irrigation system is 90 gal/min. IR = 90 gal/min x 3 ppm x 0.006/5.25 = 0.31 gallon per hour. At an irrigation flow rate of
90 gal/min, the grower is pumping: 90 gal/min x 60 min = 5400 gal/hr.The goal is to inject 0.31 gallon of bleach into 5400 gallons of water each
hour that injection occurs. If the injector is set for a 300:1 ratio, it will inject 5400/300 or 18 gal/hr.Then, 0.31 gallon of bleach should be added
to 18 gallons of water in the stock solution. note: be careful to use the same time units (hours) when calculating the injection rate.
3 note: Chlorine in solution exists as hypochlorus acid (HoC) and hypochlorite (oC-). HoC is 40-80x more effective at killing
microorganisms than oC- and water with a lower pH increases the amount of HoC. 1
Any physical connection between agricultural water systems and systems with unknown water quality could
allow water of questionable quality to backflow into the agricultural water system. An unintentional, potential
cross connection can occur in places where proper air gaps between water surfaces and water sources are not
maintained and therefore allow flow reversals. An example of an unintentional cross connection is a hose with one
end attached to a water line and the other end lying in a tub of water, a fountain base, or a fish pond.
There are cross-connections in the plumbing Make sure that your plumbing is not connected to another source
system. of water that may be contaminated (e.g. a defunct community water
system, animal waste system).
There is not adequate back-flow protection. Install a back-flow prevention device on every outdoor faucet (available
at most hardware and plumbing supply stores).
There are dead-end or unused water lines Flush lines regularly or remove any used lines or sections of the water
connected to your plumbing system. system.
There are abandoned or inactive wells on my When no longer in use, wells must be destroyed to prevent them from
property. functioning as a vertical conduit for contaminants.
3.0 References
Benham B, Ross B. 2002. Filtration,Treatment, and Maintenance Considerations for Micro-Irrigation Systems,Virginia
Cooperative Extension, Pub. no. 442-757. http://pubs.ext.vt.edu/442/442-757/442-757 pdf.pdf
California Department of Water Resources. Water Well Standards. California Department of Water Resources,
Division of Planning and Local Assistance, Southern District.
CGA. 1995.Article 500 – Well disinfection. Santa Rosa: California Groundwater Association.Adopted July 15, 1995.
https://www.groundh2o.org/standards/article_500.pdf
Clark G, Lamont W, Marr C, Rogers D. 1996. Maintaining Drip Irrigation Systems, Kansas State University,
Commercial Vegetable Production. http://www.ksre.ksu.edu/library/hort2/mf2178.pdf
Miller TH. 2006. Septic Systems and their maintenance. Maryland Cooperative Extension, University of Maryland.
August.
Santa Clara Valley Water District. A Guide For The Private Well Owner. County of Santa Clara, Department of
Environmental Health.
Vogel MP. 2005. Septic Tank and Drainfield Operation and Maintenance. Montana State University Extension Service:
MontGuide. August.
Washington State Department of Health. 2005. Preparing for a Sanitary Survey: Information to Help Small Water Systems.
Washington State Department of Health, Division of Environmental Health, office of Drinking Water.
Sonzogni W, Standridge J, Bussen M. 2002. Preservation and Survival of E. coli in Well Water Samples Submitted for Routine
Analyses.Wisconsin State Laboratory of Hygiene, University of Wisconsin-Madison.
Myres Dn. 2003. Fecal Indicator Bacteria. Field Manual. U.S.Geological Survey.
WHo. 2011a.Technical notes on drinking-water, sanitation and hygiene in emergencies: Cleaning and disinfecting
wells. Geneva:World Health organization. http://www.who.int/water_sanitation_health/publications/2011/
tn1 cleaning disinfecting wells en.pdf
WHo. 2011b.Technical notes on drinking-water, sanitation and hygiene in emergencies: Cleaning and disinfecting
water storage tanks and tankers. Geneva:World Health organization. http://www.who.int/water_sanitation_
health/publications/2011/tn3 cleaning disinfecting tanks en.pdf
Step 2: Determine the well depth (or pipe length) of your well in feet (The company that constructed the well
should be able to provide you with the well depth if you do not have it in your records).
Step 3: Determine the water level of your well in feet from the top of the well.
Step 4: Subtract the water level from the well depth to determine the length of pipe containing water (ft.).
Step 5: Using the table for the particular disinfectant product listed on the next five pages, match your pipe
diameter with your calculated length of pipe containing water to determine the amount of disinfectant (e.g., 70%
calcium hypochlorite) required (Example – If you have a well that has a pipe diameter of 6 inches and a length of
pipe containing water that is 60 ft., you would use 0.84 oz. or 23.8 grams of (70%) calcium hypochlorite).
Step 6: Decide what concentration of chlorine is required for the well disinfection. If you want to use a 50 mg/L
chlorine solution, use the number that you derived in the table. If you want a 100 mg/L chlorine solution, use
the number that you derived in the table multiplied by 2. If you want a 200 mg/L chlorine solution, use the
number that you derived in the table multiplied by 4.
Step 7: noTe — If you are going to weigh out the disinfectant product in grams, use the second Table on
each page — these numbers are metric.
Appendix 1.1: Conversion table for calculating the amount of (65%) Calcium Hypochlorite required to dose specific well volumes at 50 mg/L.
0.17 0.16 0.15 0.14 0.13 0.13 0.12 0.11 0.10 0.09 0.08 0.08 0.07 0.06 0.05 0.04 0.03 0.03 0.02
4 0.67 0.64 0.60 0.57 0.54 0.50 0.47 0.44 0.40 0.37 0.34 0.30 0.27 0.23 0.20 0.17 0.13 0.10 0.07
6 1.51 1.43 1.36 1.28 1.21 1.13 1.06 0.98 0.91 0.83 0.75 0.68 0.60 0.53 0.45 0.38 0.30 0.23 0.15
8 2.68 2.55 2.41 2.28 2.15 2.01 1.88 1.74 1.61 1.48 1.34 1.21 1.07 0.94 0.80 0.67 0.54 0.40 0.27
10 4.19 3.98 3.77 3.56 3.35 3.14 2.93 2.72 2.51 2.30 2.10 1.89 1.68 1.47 1.26 1.05 0.84 0.63 0.42
12 6.03 5.73 5.43 5.13 4.83 4.53 4.22 3.92 3.62 3.32 3.02 2.72 2.41 2.11 1.81 1.51 1.21 0.91 0.60
16 10.73 10.19 9.66 9.12 8.58 8.05 7.51 6.97 6.44 5.90 5.36 4.83 4.29 3.75 3.22 2.68 2.15 1.61 1.07
20 16.76 15.92 15.09 14.25 13.41 12.57 11.73 10.90 10.06 9.22 8.38 7.54 6.71 5.87 5.03 4.19 3.35 2.51 1.68
24 24.14 22.93 21.72 20.52 19.31 18.10 16.90 15.69 14.48 13.28 12.07 10.86 9.66 8.45 7.24 6.03 4.83 3.62 2.41
2 4.8 4.5 4.3 4.0 3.8 3.6 3.3 3.1 2.9 2.6 2.4 2.1 1.9 1.7 1.4 1.2 1.0 0.7 0.5
4 19.0 18.1 17.1 16.2 15.2 14.3 13.3 12.4 11.4 10.5 9.5 8.6 7.6 6.7 5.7 4.8 3.8 2.9 1.9
6 42.8 40.6 38.5 36.4 34.2 32.1 29.9 27.8 25.7 23.5 21.4 19.2 17.1 15.0 12.8 10.7 8.6 6.4 4.3
8 76.0 72.2 68.4 64.6 60.8 57.0 53.2 49.4 45.6 41.8 38.0 34.2 30.4 26.6 22.8 19.0 15.2 11.4 7.6
10 118.8 112.9 106.9 101.0 95.0 89.1 83.2 77.2 71.3 65.3 59.4 53.5 47.5 41.6 35.6 29.7 23.8 17.8 11.9
12 171.1 162.5 154.0 145.4 136.9 128.3 119.8 111.2 102.6 94.1 85.5 77.0 68.4 59.9 51.3 42.8 34.2 25.7 17.1
16 304.1 288.9 273.7 258.5 243.3 228.1 212.9 197.7 182.5 167.3 152.1 136.9 121.7 106.4 91.2 76.0 60.8 45.6 30.4
20 475.2 451.5 427.7 403.9 380.2 356.4 332.7 308.9 285.1 261.4 237.6 213.8 190.1 166.3 142.6 118.8 95.0 71.3 47.5
24 684.3 650.1 615.9 581.7 547.4 513.2 479.0 444.8 410.6 376.4 342.2 307.9 273.7 239.5 205.3 171.1 136.9 102.6 68.4
Appendix 1.2: Conversion table for calculating the amount of (70%) Calcium Hypochlorite required to dose specific well volumes at 50 mg/L.
2 0.16 0.15 0.14 0.13 0.12 0.12 0.11 0.10 0.09 0.09 0.08 0.07 0.06 0.05 0.05 0.04 0.03 0.02 0.02
4 0.62 0.59 0.56 0.53 0.50 0.47 0.44 0.40 0.37 0.34 0.31 0.28 0.25 0.22 0.19 0.16 0.12 0.09 0.06
6 1.40 1.33 1.26 1.19 1.12 1.05 0.98 0.91 0.84 0.77 0.70 0.63 0.56 0.49 0.42 0.35 0.28 0.21 0.14
8 2.49 2.37 2.24 2.12 1.99 1.87 1.74 1.62 1.49 1.37 1.25 1.12 1.00 0.87 0.75 0.62 0.50 0.37 0.25
10 3.89 3.70 3.50 3.31 3.11 2.92 2.72 2.53 2.33 2.14 1.95 1.75 1.56 1.36 1.17 0.97 0.78 0.58 0.39
12 5.60 5.32 5.04 4.76 4.48 4.20 3.92 3.64 3.36 3.08 2.80 2.52 2.24 1.96 1.68 1.40 1.12 0.84 0.56
16 9.96 9.46 8.97 8.47 7.97 7.47 6.97 6.48 5.98 5.48 4.98 4.48 3.98 3.49 2.99 2.49 1.99 1.49 1.00
20 15.57 14.79 14.01 13.23 12.45 11.67 10.90 10.12 9.34 8.56 7.78 7.00 6.23 5.45 4.67 3.89 3.11 2.33 1.56
24 22.41 21.29 20.17 19.05 17.93 16.81 15.69 14.57 13.45 12.33 11.21 10.09 8.97 7.84 6.72 5.60 4.48 3.36 2.24
2 4.4 4.2 4.0 3.8 3.5 3.3 3.1 2.9 2.6 2.4 2.2 2.0 1.8 1.5 1.3 1.1 0.9 0.7 0.4
4 17.7 16.8 15.9 15.0 14.1 13.2 12.4 11.5 10.6 9.7 8.8 7.9 7.1 6.2 5.3 4.4 3.5 2.6 1.8
6 39.7 37.7 35.7 33.8 31.8 29.8 27.8 25.8 23.8 21.8 19.9 17.9 15.9 13.9 11.9 9.9 7.9 6.0 4.0
8 70.6 67.1 63.5 60.0 56.5 53.0 49.4 45.9 42.4 38.8 35.3 31.8 28.2 24.7 21.2 17.7 14.1 10.6 7.1
10 110.3 104.8 99.3 93.8 88.3 82.7 77.2 71.7 66.2 60.7 55.2 49.6 44.1 38.6 33.1 27.6 22.1 16.5 11.0
12 158.9 150.9 143.0 135.0 127.1 119.1 111.2 103.3 95.3 87.4 79.4 71.5 63.5 55.6 47.7 39.7 31.8 23.8 15.9
16 282.4 268.3 254.2 240.1 225.9 211.8 197.7 183.6 169.4 155.3 141.2 127.1 113.0 98.8 84.7 70.6 56.5 42.4 28.2
20 441.3 419.2 397.1 375.1 353.0 331.0 308.9 286.8 264.8 242.7 220.6 198.6 176.5 154.4 132.4 110.3 88.3 66.2 44.1
24 635.4 603.7 571.9 540.1 508.3 476.6 444.8 413.0 381.3 349.5 317.7 285.9 254.2 222.4 190.6 158.9 127.1 95.3 63.5
Appendix 1.3: Conversion table for calculating the amount of (25%) Chloride of Lime required to dose specific well volumes at 50 mg/L.
2 0.44 0.41 0.39 0.37 0.35 0.33 0.31 0.28 0.26 0.24 0.22 0.20 0.17 0.15 0.13 0.11 0.09 0.07 0.04
4 1.74 1.66 1.57 1.48 1.39 1.31 1.22 1.13 1.05 0.96 0.87 0.78 0.70 0.61 0.52 0.44 0.35 0.26 0.17
6 3.92 3.73 3.53 3.33 3.14 2.94 2.75 2.55 2.35 2.16 1.96 1.77 1.57 1.37 1.18 0.98 0.78 0.59 0.39
8 6.97 6.62 6.28 5.93 5.58 5.23 4.88 4.53 4.18 3.84 3.49 3.14 2.79 2.44 2.09 1.74 1.39 1.05 0.70
10 10.90 10.35 9.81 9.26 8.72 8.17 7.63 7.08 6.54 5.99 5.45 4.90 4.36 3.81 3.27 2.72 2.18 1.63 1.09
12 15.69 14.91 14.12 13.34 12.55 11.77 10.98 10.20 9.41 8.63 7.84 7.06 6.28 5.49 4.71 3.92 3.14 2.35 1.57
16 27.89 26.50 25.10 23.71 22.31 20.92 19.53 18.13 16.74 15.34 13.95 12.55 11.16 9.76 8.37 6.97 5.58 4.18 2.79
20 43.58 41.40 39.22 37.05 34.87 32.69 30.51 28.33 26.15 23.97 21.79 19.61 17.43 15.25 13.07 10.90 8.72 6.54 4.36
24 62.76 59.62 56.48 53.35 50.21 47.07 43.93 40.79 37.66 34.52 31.38 28.24 25.10 21.97 18.83 15.69 12.55 9.41 6.28
2 12.4 11.7 11.1 10.5 9.9 9.3 8.6 8.0 7.4 6.8 6.2 5.6 4.9 4.3 3.7 3.1 2.5 1.9 1.2
4 49.4 47.0 44.5 42.0 39.5 37.1 34.6 32.1 29.7 27.2 24.7 22.2 19.8 17.3 14.8 12.4 9.9 7.4 4.9
6 111.2 105.6 100.1 94.5 89.0 83.4 77.8 72.3 66.7 61.2 55.6 50.0 44.5 38.9 33.4 27.8 22.2 16.7 11.1
8 197.7 187.8 177.9 168.0 158.2 148.3 138.4 128.5 118.6 108.7 98.8 89.0 79.1 69.2 59.3 49.4 39.5 29.7 19.8
10 308.9 293.4 278.0 262.6 247.1 231.7 216.2 200.8 185.3 169.9 154.4 139.0 123.6 108.1 92.7 77.2 61.8 46.3 30.9
12 444.8 422.6 400.3 378.1 355.8 333.6 311.4 289.1 266.9 244.6 222.4 200.2 177.9 155.7 133.4 111.2 89.0 66.7 44.5
16 790.8 751.2 711.7 672.1 632.6 593.1 553.5 514.0 474.5 434.9 395.4 355.8 316.3 276.8 237.2 197.7 158.2 118.6 79.1
20 1235.6 1173.8 1112.0 1050.2 988.4 926.7 864.9 803.1 741.3 679.6 617.8 556.0 494.2 432.4 370.7 308.9 247.1 185.3 123.6
24 1779.2 1690.2 1601.3 1512.3 1423.4 1334.4 1245.4 1156.5 1067.5 978.6 889.6 800.6 711.7 622.7 533.8 444.8 355.8 266.9 177.9
Appendix 1.4: Conversion table for calculating the amount of (12.5%) Sodium Hypochlorite required to dose specific well volumes at 50 mg/L.
2 0.84 0.79 0.75 0.71 0.67 0.63 0.58 0.54 0.50 0.46 0.42 0.38 0.33 0.29 0.25 0.21 0.17 0.13 0.08
4 3.34 3.18 3.01 2.84 2.67 2.51 2.34 2.17 2.01 1.84 1.67 1.50 1.34 1.17 1.00 0.84 0.67 0.50 0.33
6 7.52 7.14 6.77 6.39 6.02 5.64 5.26 4.89 4.51 4.14 3.76 3.38 3.01 2.63 2.26 1.88 1.50 1.13 0.75
8 13.37 12.70 12.03 11.36 10.70 10.03 9.36 8.69 8.02 7.35 6.68 6.02 5.35 4.68 4.01 3.34 2.67 2.01 1.34
10 20.89 19.85 18.80 17.76 16.71 15.67 14.62 13.58 12.53 11.49 10.44 9.40 8.36 7.31 6.27 5.22 4.18 3.13 2.09
12 30.08 28.58 27.07 25.57 24.06 22.56 21.06 19.55 18.05 16.54 15.04 13.54 12.03 10.53 9.02 7.52 6.02 4.51 3.01
16 53.48 50.80 48.13 45.46 42.78 40.11 37.43 34.76 32.09 29.41 26.74 24.06 21.39 18.72 16.04 13.37 10.70 8.02 5.35
20 83.56 79.38 75.20 71.02 66.85 62.67 58.49 54.31 50.14 45.96 41.78 37.60 33.42 29.25 25.07 20.89 16.71 12.53 8.36
24 120.32 114.31 108.29 102.28 96.26 90.24 84.23 78.21 72.19 66.18 60.16 54.15 48.13 42.11 36.10 30.08 24.06 18.05 12.03
2 24.7 23.5 22.2 21.0 19.8 18.5 17.3 16.1 14.8 13.6 12.4 11.1 9.9 8.6 7.4 6.2 4.9 3.7 2.5
4 98.8 93.9 89.0 84.0 79.1 74.1 69.2 64.2 59.3 54.4 49.4 44.5 39.5 34.6 29.7 24.7 19.8 14.8 9.9
6 222.4 211.3 200.2 189.0 177.9 166.8 155.7 144.6 133.4 122.3 111.2 100.1 89.0 77.8 66.7 55.6 44.5 33.4 22.2
8 395.4 375.6 355.8 336.1 316.3 296.5 276.8 257.0 237.2 217.5 197.7 177.9 158.2 138.4 118.6 98.8 79.1 59.3 39.5
10 617.8 586.9 556.0 525.1 494.2 463.3 432.4 401.6 370.7 339.8 308.9 278.0 247.1 216.2 185.3 154.4 123.6 92.7 61.8
12 889.6 845.1 800.6 756.2 711.7 667.2 622.7 578.2 533.8 489.3 444.8 400.3 355.8 311.4 266.9 222.4 177.9 133.4 89.0
16 1581.5 1502.4 1423.4 1344.3 1265.2 1186.1 1107.1 1028.0 948.9 869.8 790.8 711.7 632.6 553.5 474.5 395.4 316.3 237.2 158.2
20 2471.1 2347.6 2224.0 2100.4 1976.9 1853.3 1729.8 1606.2 1482.7 1359.1 1235.6 1112.0 988.4 864.9 741.3 617.8 494.2 370.7 247.1
24 3558.4 3380.5 3202.6 3024.6 2846.7 2668.8 2490.9 2313.0 2135.0 1957.1 1779.2 1601.3 1423.4 1245.4 1067.5 889.6 711.7 533.8 355.8
Appendix 1.5: Conversion table for calculating the amount of (5.25%) Sodium Hypochlorite required to dose specific well volumes at 50 mg/L.
2 1.99 1.89 1.79 1.69 1.59 1.49 1.39 1.29 1.19 1.09 0.99 0.90 0.80 0.70 0.60 0.50 0.40 0.30 0.20
4 7.96 7.56 7.16 6.76 6.37 5.97 5.57 5.17 4.77 4.38 3.98 3.58 3.18 2.79 2.39 1.99 1.59 1.19 0.80
6 17.91 17.01 16.11 15.22 14.32 13.43 12.53 11.64 10.74 9.85 8.95 8.06 7.16 6.27 5.37 4.48 3.58 2.69 1.79
8 31.83 30.24 28.65 27.06 25.47 23.87 22.28 20.69 19.10 17.51 15.92 14.32 12.73 11.14 9.55 7.96 6.37 4.77 3.18
10 49.74 47.25 44.76 42.28 39.79 37.30 34.82 32.33 29.84 27.36 24.87 22.38 19.89 17.41 14.92 12.43 9.95 7.46 4.97
12 71.62 68.04 64.46 60.88 57.30 53.72 50.14 46.55 42.97 39.39 35.81 32.23 28.65 25.07 21.49 17.91 14.32 10.74 7.16
16 127.33 120.96 114.59 108.23 101.86 95.50 89.13 82.76 76.40 70.03 63.66 57.30 50.93 44.56 38.20 31.83 25.47 19.10 12.73
20 198.95 189.00 179.05 169.11 159.16 149.21 139.26 129.32 119.37 109.42 99.47 89.53 79.58 69.63 59.68 49.74 39.79 29.84 19.89
24 286.49 272.16 257.84 243.51 229.19 214.86 200.54 186.22 171.89 157.57 143.24 128.92 114.59 100.27 85.95 71.62 57.30 42.97 28.65
100 95 90 85 80 75 70 65 60 55 50 45 40 35 30 25 20 15 10
2 58.8 55.9 53.0 50.0 47.1 44.1 41.2 38.2 35.3 32.4 29.4 26.5 23.5 20.6 17.7 14.7 11.8 8.8 5.9
4 235.3 223.6 211.8 200.0 188.3 176.5 164.7 153.0 141.2 129.4 117.7 105.9 94.1 82.4 70.6 58.8 47.1 35.3 23.5
6 529.5 503.0 476.6 450.1 423.6 397.1 370.7 344.2 317.7 291.2 264.8 238.3 211.8 185.3 158.9 132.4 105.9 79.4 53.0
8 941.4 894.3 847.2 800.2 753.1 706.0 659.0 611.9 564.8 517.8 470.7 423.6 376.6 329.5 282.4 235.3 188.3 141.2 94.1
10 1470.9 1397.4 1323.8 1250.3 1176.7 1103.2 1029.6 956.1 882.5 809.0 735.5 661.9 588.4 514.8 441.3 367.7 294.2 220.6 147.1
12 2118.1 2012.2 1906.3 1800.4 1694.5 1588.6 1482.7 1376.8 1270.9 1165.0 1059.0 953.1 847.2 741.3 635.4 529.5 423.6 317.7 211.8
16 3765.5 3577.2 3389.0 3200.7 3012.4 2824.1 2635.9 2447.6 2259.3 2071.0 1882.8 1694.5 1506.2 1317.9 1129.7 941.4 753.1 564.8 376.6
20 5883.6 5589.4 5295.2 5001.1 4706.9 4412.7 4118.5 3824.3 3530.2 3236.0 2941.8 2647.6 2353.4 2059.3 1765.1 1470.9 1176.7 882.5 588.4
24 8472.4 8048.8 7625.2 7201.5 6777.9 6354.3 5930.7 5507.1 5083.4 4659.8 4236.2 3812.6 3389.0 2965.3 2541.7 2118.1 1694.5 1270.9 847.2
APPenDIx B
5.2 Crop Land & Water Source Adjacent Land Uses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
1.0 Introduction
This document serves as a supplementary source of information to the Commodity Specific Food Safety Guidelines
for the Production, Harvest, Post-Harvest, and Processing Unit operations of Fresh Culinary Herbs (Fresh Culinary
Herbs Guide). The document established measurable best practices and guidelines (“metrics”) for a variety
of process areas judged to be potential contributors to the risk of microbial contamination.The intent of this
document is to provide the basis and rationale for the choice of metrics used in the recommended best practices.
Metrics for fresh culinary herbs are primarily based on the metrics for green onions and/or lettuce and leafy greens.
In those cases, text from the Technical Basis Documents for commodity specific food safety guidelines for lettuce
and leafy greens (Leafy Greens Guide) and/or green onions (Green onions Guide) are provided for context.
In all of these commodity-specific guidelines, a three-tier approach was used to identify appropriate metrics:
1. A comprehensive literature review was conducted to establish whether a scientifically valid basis for
establishing a metric has been published.
2. If the literature review did not identify published scientific support for an appropriate metric, existing
standards or metrics supported by authoritative or regulatory bodies were adopted.
3. If neither scientific studies nor existing standards or metrics from authoritative bodies supported
adoption of a specific metric, consensus among industry representatives and/or other stakeholders was
sought.
The Fresh Culinary Herbs Guide relies on supporting scientific research for the best practices that meet the
following criteria:
The following sections provide a detailed explanation of the processes and rationale for derivation of the metrics.
• Concentrations of pathogenic microbes can vary widely in fecal matter. Hence, if testing focuses on
specific pathogens at the exclusion of others, the presence of fecal contamination may not be detected
even if significant contamination is present (Ashbolt et al. 2001; World Health Organization 2008). While
continuous monitoring or daily testing might more reliably detect these microbes, this approach is
economically unfeasible.
• Existing test methods may not be able to detect the wide variety of pathogenic organisms that might
contaminate water (World Health organization 2008). Even if water is routinely tested for the more
common pathogenic organisms, this does not guarantee other pathogens are not present.
Given the statements above, and guidance and/or comments from various regulatory agencies (US EPA 1986;
California Department of Health Services (CDHS) and California Department of Food and Agriculture (CDFA
2006; US FDA 2006)), use of an “indicator” microbe was determined to be the most effective and efficient testing
approach. Testing for generic E. coli is considered the best available indicator for fecal contamination of a water
source. Generic E. coli is generally non-pathogenic; thus, using this as an indicator organism results in action levels
that are not necessarily health risk-based. Although increasing levels of generic E. coli in a water source are likely to
correlate with increasing health risk, “bright line” levels of generic E. coli above which health risks are unacceptable
cannot rationally be established. Action levels based on generic E. coli concentrations should not be considered
as separating “safe” or “unsafe” levels — they should only be considered as indicators of fecal contamination or
increasing bacteriological densities.
To set generic E. coli action levels for water used in agricultural applications, it was decided that it was not possible
to use one set of levels for all uses. For instance, water that is used post-harvest should likely have more stringent
standards than water that is used pre-harvest. In order to address this issue, use-specific standards for production
and harvest operations were created for two uses determined to be most critical to the safety of fresh culinary
herbs during these operations:
• Pre-harvest applications.
• Post-harvest direct contact applications (e.g. re-hydration, harvest equipment cleaning, bin cleaning,
product cooling, product washing).
For the pre-harvest use category, a rolling average and single sample maximum metric was set. These metrics were
based on water quality standards developed by the US EPA in their risk assessment of E. coli in recreational waters
(US EPA 1986; 2003). To protect against unacceptable risk of waterborne diseases, US EPA determined that the
geometric mean of E. coli in recreational water systems should not exceed 126 MPn E. coli/100 mL. In addition to
this geometric mean value, they also determined single sample maximum values for various beach-use types. These
single sample maximums are based on certain confidence levels of the geometric mean value of 126 MPn. For
a “Designated Beach,” U.S. EPA used the 70% confidence level, which is a value of 235 MPn/100 mL. These two
guidelines were used to establish action levels for pre-harvest water uses. All pre-harvest water uses must meet
the geometric mean requirement of 126 MPn/100 mL and a single sample maximum of 235 MPn/100 mL. The use
of these values is bolstered by the adoption of the 126 MPn/100 mL geometric mean by the state of Arizona as
its irrigation water quality standard. These values are also used in the Green onions Guide and the Leafy Greens
Guide as pre-harvest (direct contact) irrigation water quality metrics.
For post-harvest direct contact applications before herbs reach the packinghouse, it was determined that stringent
requirements should be met due to the potential high-risk for cross-contamination, as well as the lack of additional
steps to remove or reduce contamination for product that goes directly to customers without additional processing
in a packinghouse or processing facility. Hence, the metric for this standard has been set at the US EPA’s Maximum
Contaminant Level Goal for E. coli in drinking water, which is zero or no detection and the detection limit is
currently 2 MPn/100 mL. This value is also used in the Leafy Greens and Green onions Guides for post-harvest
water quality metrics.
A complete list of the various action levels is outlined in Table II-2 in the Fresh Culinary Herbs Guide, while decision
tree explaining their use is shown in Figures 3A and 3B.
When the Leafy Greens Guide was being developed, appropriate locations for water testing were evaluated. Initially,
testing the “source” of the water was thought to be most appropriate. However, several stakeholders commented
that testing at the source may miss contamination introduced into the distribution systems (US FDA 2006). Hence,
this guidance document follows the Leafy Greens Guide in specifying testing as close to the point-of-use as possible.
If water is found to be above action levels at this location, then additional testing and the initiation of a sanitary
survey are required.
Acceptable methods for testing water are similar to the methods in the Leafy Greens Guide. Since the creation of
the Leafy Greens Guide in 2007, newer technologies approved by the US EPA and validated by the AoAC have been
developed to provide more rapid results than the MPn methods such as described in the FDA’s Bacteriological
Analytical Manual. The Leafy Greens Guide has recently been revised to allow for the use of these newer
technologies, and these changes have been incorporated into the Fresh Culinary Herbs Guide. However, unlike
the Leafy Greens and Green onions Guides, the Fresh Culinary Herbs Guide does not allow for presence/absence
testing. The Fresh Culinary Herbs Industry Working Group recommended that because these methods are not
quantitative, they do not represent the “best practices” for preventing potential microbial contamination.
3.1 Manure
The application of manure to fresh culinary herb production fields is thought to be a high risk practice, and industry
discussions have centered on completely disallowing this practice.
The decision to disallow this practice is based on the Leafy Greens and Green onions Guides, and was discussed in
the Technical Basis document for those crops as follows:
Initially, allowing use of manure in fields used for production of lettuce and leafy greens with a suitable application
interval (120 days as suggested in the National Organic Program guidance) (USDA 2002) was considered; however,
this use was prohibited after discussion and comments received from multiple stakeholders. Given the long survival
period of bacteria in raw manure (over 120 days in some references), it was determined that the 120 day period
was not acceptable, and that raw manure should not be used in the production of lettuce and leafy greens.
However, in order not to completely restrict the use of land that has at some point had raw manure applied, a one-
year waiting period prior to planting lettuce and leafy greens was considered appropriate.
The fresh herb industry group discussed reducing the one-year waiting period, but was unable to find unconditional
support for a reduction in light of the varying climate and environmental conditions in herb growing areas
nationwide.
A three hurdle process was considered to be sufficient for safe application of composted SAs to fresh culinary
herbs. The first hurdle recommends use of a validated process for compost production; the second recommends
microbial testing, and the third recommends applying an application interval to minimize risk from remaining
pathogenic microorganisms.
During the development of the Leafy Greens Guide, the use of the national organic Program’s 120-day waiting
period for use of raw manure was suggested for use as an appropriate interval for composted soil amendments.
However, because the 120-day period is specific to raw (uncomposted) manure, it was judged reasonable to shorten
this period to 45-days for soil amendments that underwent an actively monitored composting process.
The Sampling Plan for composted SAs in the Fresh Herb Guide is the same as the Leafy Greens Guide and is based
on practices recommended by compost suppliers.
Due to the stricter testing requirements and more tightly controlled process used with heat treated soil
amendments, if a validated process is used, no application interval is required for these types of amendments. If the
process is not validated, a >45-day application interval was deemed appropriate based on the same decision-making
process that was used for Composted Soil Amendments (described above).
The Sampling Plan for physically heat treated SAs containing animal manure in the Fresh Herb Guide is the same as
the Leafy Greens Guide and is based on practices recommended by compost suppliers.
Due to the stricter testing requirements and used with non-synthetic crop treatments and their intended use as
foliar applicants, if a validated process is used no application interval is required for these products. If the process is
not validated, a >45-day application interval was deemed appropriate based on the same decision-making process
that was used for Composted Soil Amendments (described above).
4.0 Flooding
The definition of flooding used in the Leafy Green Guide was adopted for use as the definition of flooding in
Commodity Specific Food Safety Guidelines for the Production and Harvest of Fresh Culinary Herbs. Therefore the rationale
as provided in the Leafy Greens Guide’s Technical Basis document pertains here.
The distance not to be harvested from the high-water mark of any flood event was selected to be 30 feet, based
on the turn-around distance of farm equipment to prevent cross-contamination. This distance may be increased
if there is the uncertainty about the location of the high-water mark or if some equipment has a greater turning
radius— whether to increase this distance is to be determined by an appropriately trained food safety expert,
with possible consultation with other experts as necessary.
The required waiting period after flooding prior to planting (60 days) was selected based on comments from
regulatory bodies; these comments were consistent with original time periods based on USDA NOP guidance on
use of manure (i.e., it was assumed that the worst-case flooding event would be equivalent to use of raw manure
on fields) (USDA 2002).This 60-day prior to planting time period is roughly equivalent to 120-days prior to
harvest depending on the specific growing season of the crop, and was considered to be easier to implement in
the field.
As did the Leafy Green and Green onions Guides, the Fresh Culinary Herbs Guide provides an option to reduce
this time period to 30 days if growers can demonstrate through a valid sampling program that soil microbial levels
meet specific acceptance criteria.A soil sampling protocol was developed by the Working Group under the direction
of Dr.Trevor Suslow who has significant experience in soil testing following flooding events.
Regardless of the use of the standard 60-day period or the 30-day period, all decisions related to use of flooded
land should be made with the consultation of a qualified food safety professional.This person should have the same
qualifications as described in the Environmental Assessments section below.
Research has shown that not all animals are of equal risk for spreading pathogenic organism to food crops. In
general, due to the likely subjective issues in determining whether or not an animal intrusion is significant and
presents a risk of contaminating fresh culinary herbs, the Fresh Culinary Herb Guide recommends that a trained
food safety professional be involved in decisions related to animal intrusion.The qualifications for this person are as
follows:
• The design and implementation of food safety programs and systems for fresh culinary herb operations
from farm to market is a complex task requiring significant knowledge from several fundamental areas
of science. Personnel entrusted with management level responsibility for food safety in the fresh
produce industry should have training or experience sufficient to establish a solid understanding of the
principles of food safety as applied to agricultural production.
• Each fresh produce production operation involved in growing, harvesting, and / or packing fresh culinary
herbs should have an appropriately qualified individual whose primary job function is development,
implementation, and supervision of a comprehensive food safety program. This person should be
a direct employee; however, for some smaller operations where this is impractical, a continuous,
contractual relationship involving at least quarterly direct involvement with the production operation is
also an acceptable option.
• It is recommended that the individual should have some training or experience in actual food safety
principles related to fresh produce.
These requirements recognize the fact that food safety in the fresh produce industry is an endeavor based on
scientific principles and that significant experience and training is required to prepare individuals for food safety
management responsibilities in the industry.
Because there are too many subjective situations regarding crop damage by animals it was not feasible to develop
metrics for all of them. Food safety professionals should use their best professional judgment to determine whether
or not to harvest fresh culinary herbs, how much buffer distance should be assigned for various crop damage
incidents, and whether remedial options might reduce or eliminate risk from these events. The best practices
recommend a three-foot buffer radius around areas of animal-related crop damage that cannot otherwise be
adequately controlled.The only established metric for this area is the recommendation not to harvest fresh culinary
herbs when there is evidence of fecal material and if fecal material is found, a minimum 5-foot radius buffer distance
from the spot of the contamination should not be harvested. This distance was selected using best professional
judgment based on practicality in the field.
Once the relative risk associated with each type of land or water
environment.A “one size fits all” strategy did not seem reasonable.
accordingly.
The fresh culinary herbs industry group decided that similar metrics were
appropriate for fresh culinary herbs.
6.0 References
Ashbolt n, Grabow W, and Snozzi M. 2001. Indicators of microbial water quality. Water Quality: Guidelines, Standards
and Health:Assessment of Risk and Risk Management for Water-related Infectious Disease, pp. 289–315.
California Department of Health Services (CDHS) and California Department of Food and Agriculture (CDFA).
2006. Meeting with CDHS and CFDA regulators. Sacramento, California, november 27.
CCR Title 14 – Chapter 3.1 – Article 5. 2007. Article 5. Composting Operation and Facility Siting and Design Standards.
Accessed February 15, 2007. http://www.calrecycle.ca.gov/Laws/Regulations/Title14/ch31a5.htm
Commodity Specific Food Safety Guidelines for the Production and Harvest of Lettuce and Leafy Greens. July 10,
2009. http://www.wga.com/DocumentLibrary/scienceandtech/LGMAAcceptedGAPs07.10.09.pdf
Commodity Specific Food Safety Guidelines for the Production, Harvest, Post-Harvest, and Value-Added Unit
operations of Green onions. Vs. 1.0, February 26, 2010. http://www.wga.com/DocumentLibrary/100226_
FinalVersion_II_Production_Harvest_Post_Harvest_Value_Added_Without_numbers_2.pdf
US EPA. 1986. Ambient Water Quality Criteria for Bacteria - 1986. EPA 440/5-84-002: office of Water Regulations and
Standards Criteria and Standards Division, United States Environmental Protection Agency. http://www.epa.
gov/waterscience/criteria/library/ambientwqc/bacteria1986.pdf
US EPA. 1994. A Plain English Guide to the EPA Part 503 Biosolids Rule. EPA/832/R-93/003: United States Environmental
Protection Agency. http://www.epa.gov/owm/mtb/biosolids/503pe/index.htm
US EPA. 2003. Bacterial Water Quality Standards for Recreational Waters (Freshwater and Marine Waters): Status Report.
EPA-823-R-03-008: United States Environmental Protection Agency. http://www.epa.gov/waterscience/
beaches/local/statrept.pdf
US FDA. 2006. Conference call with multiple FDA participants. november 28.
USDA. 2002. U.S. National Standards on Organic Agricultural Production and Handling, Subpart C - Organic Crop,Wild Crop,
Livestock, and Handling Requirements, Preamble.Alternative Farming Systems Information Center, United States
Department of Agriculture. http://www.ams.usda.gov/AMSv1.0/getfile?dDocname=STELDEV3003494
This table is supplied as guidance for testing in the event that irrigation water that exceeds the limits outlined in Table I-2 is applied to fresh herbs. The
protocol outlined below is provided as an example. Please check with your laboratory prior to gathering the sample as the number and weight of samples
may vary based on the size of the production block that received the irrigation water and their laboratory-specific testing methods. It is important to
confirm with your laboratory that they follow AoAC-certified/approved or FDA-approved test methods.
• A composite sample of fresh herbs plants still in the • negative or < DL (<1/125 • Fresh herbs from blocks • After irrigation water that
ground will be collected. Collect 75 to 125 g samples grams) for E. coli o157:H7 which do not pass the exceeds generic E. coli
using a pattern that covers the irrigated field (e.g.,“Z” or Salmonella. measurement criteria water quality standards
or “Σ” patterns that are typically used for pesticide • negative or <DL for any will be destroyed before is used on fresh herbs,
residue analysis). The number of samples depends on other human pathogen harvest. product from the block
the size of the irrigated field and individual operation for which testing was • All equipment utilized to must test negative for
lot definitions but should not exceed 5 ac per sample.1 conducted. destroy the fresh herb the presence of E. coli
Individual samples from 1 ac lots may be combined into a crop must be cleaned and o157:H7 and Salmonella,
composite sample of at least 375 grams (snap or cut-off a sanitized upon exiting the and any other pathogen
bunch and do not remove with roots or soil attached; do field. for which testing was
not remove dead and damaged leaves).2 Sampling should • The field will not be conducted.
occur at the time of the non-compliant water test result re-planted for food • A compliant 5-sample
and within 10 days or less before harvest. Care should be crop production for at geometric mean must be
taken not to step on plants while traversing the field. least 60 days following re-established in the water
• Reasonable aseptic sample collection techniques should incorporation of the source prior to use for
be utilized among defined lots and between samples of contaminated crop. irrigation or other soil
irrigated fields from the same source. • This action should be and crop management
• Tests should include E. coli o157:H7 and Salmonella as documented and available purposes.
well as any other microorganism deemed appropriate.3 for verification from the
• Results should be available for review before harvest of grower responsible party.
the field.
1
Maximum lot size of 5 acres is a crop-specific recommendation for fresh culinary herbs and may not be applicable for other fresh produce commodities.
2
Confirm that your contracted laboratory uses a validated protocol (i.e. standardized temperature, buffer-to-product ratio, etc.).
3
Individual operations may choose to test for additional target organisms (e.g. EHEC/STEC, generic E. coli).
This table is supplied as guidance for taking soil samples for microbial testing prior to replanting after a flooding event. The sampling protocol outlined
below is provided as an example. noTe: Protocol specifics may vary depending on site-specific conditions and laboratory requirements.
Please check with your laboratory prior to gathering the sample as the number and weight of samples may vary based on the size of the
production block that was flooded and laboratory-specific testing methods (AoAC certified/approved technologies are preferred).1
Sampling Protocol 2 Measurement Criteria Remedial Actions Timeline
• Collect soil samples from various locations in • Salmonella spp.: negative or < • If test result for any one If test results for pathogens are
the potentially contaminated area to assure a DL (<1/ 30 grams) pathogen is positive, wait negative, replant after a minimum
representative sample.A map of the flooded • Enterohemorrhagic E. coli 2 weeks and retest for the of 30 days.The 30-day interval
field that identifies the sampling locations is (EHEC) or Shiga toxin- same pathogen. If initial should commence after flood
recommended.At a minimum, collect no less producing E. coli (STEC): testing was quantitative and waters have receded to the point
than 5 individual samples per acre (e.g. soil cores negative or < DL (<1/ 30 the pathogen levels were where they are not visible in the
or scooped soil). Individual samples can be grams) near the lower limits of the areas that are to be planted and
combined into a composite sample of at least 500 • If EHEC/STEC test result is measurement criteria, than a the soil should be at a moisture
grams (with a maximum of 5 acres per composite positive, confirm presence shorter interval for retesting level at which the grower can
sample). of pathogens with further may be warranted. get equipment in to the field for
• The following two methods provide examples of testing.4 • Soil preparation such as preparation or soil moisture test
how to collect samples: If conducting a comparative aerating, tilling, disking, etc. results are in the normal range for
Take soil cores to a depth of 15 cm. analysis:3 helps to reduce the survival that particular field.6
Composite five cores per location into one • Fecal coliforms:5 a significant of pathogenic organisms.
sterile polyethylene bag. difference between flooded • All equipment utilized to till
Using a sterile scoop, remove top 2-3 cm x and non-flooded field(s) contaminated soil should be
2-3 cm of surface soil from a bed (seed-bed cleaned and sanitized upon
or prepared planting row) or furrow at five exiting the field.
locations. Composite per location into one
sterile polyethylene bag
1
Currently no methods for detecting EHEC/STEC in soil are AoAC-approved.
2
From an unpublished protocol from the Suslow Lab, UC Davis.
3
Because the levels and composition of the microbial community in soil often varies widely and “normal” levels, generally speaking, are difficult to define, comparative soil analysis may be
useful in evaluating food safety risks related to a flooding event.An optimal comparison would be microbial test results of soil taken concurrently from flooded and non-flooded areas of the
same field.Alternatively, post-flooding soil microbial testing results could be compared with 1) pre-flooding soil test results if microbial testing was conducted on the field in the past or 2)
concurrent microbial test results from a nearby non-flooded field that has the same soil type and was managed similarly to the flooded field.
4
Because PCR methods may result in false positives or the detection of non-viable organisms, confirming the presence of EHEC/STEC by culturing is recommended.
5
Incubation temperature specific for fecal coliforms (also known as thermotolerant coliforms) is 42-44°C; commonly used lower incubation temperatures (e.g. 35°C) provide results for total
coliforms.
6
Methods typically used by growers to determine soil moisture content include, but are not limited to, tensiometers, electric resistance blocks, oven drying analysis, or other methods that are
2
From an unpublished protocol from the Suslow Lab, UC Davis.
3
Because the levels and composition of the microbial community in soil often varies widely and “normal” levels, generally speaking, are difficult to define, comparative soil analysis may be
useful in evaluating food safety risks related to a flooding event. An optimal comparison would be microbial test results of soil taken concurrently from flooded and non-flooded areas of the
same field. Alternatively, post-flooding soil microbial testing results could be compared with 1) pre-flooding soil test results if microbial testing was conducted on the field in the past or 2)
concurrent microbial test results from a nearby non-flooded field that has the same soil type and was managed similarly to the flooded field.
Area of observation/
Risk Factor observation Point Analysis Rationale
Extent of flooding Degree and duration of soil exposure to Identify the high water mark. Documentation of the flooding event
flood waters and related conditions What area of the field was flooded? to support replanting decisions.
How long was it under water?
Source of flood waters Determine the source of flood waters. Do the flood waters come from: Knowledge of the sources of flood
Potential sources: A flowing surface water source waters will help evaluate the likelihood
• Drainage canal such as a river, stream or creek? of soil contamination by flood waters.
• River A pooled surface water source (e.g.
• Irrigation canal pond, reservoir) that overflowed?
• High water table A saturated groundwater source
• Pond (e.g. rising water table)?
• Reservoir Were the floodwaters flowing over the
• Catch basin field? or
• Saturated water table Were the floodwaters stagnate and
pooled on the field?
Upstream contaminants Identify sources of potential chemical Potential sources include: Flood waters may contain sewage,
contamination Manufacturing facility chemicals, heavy metals, debris, human
Storage facility pathogens, or other contaminants.
Industrial complexes Knowledge of any possible upstream
Equipment & automotive service contributors of microbiological,
industries chemical, or physical contaminants
Mining will help evaluate the likelihood of soil
Landfills contamination by flood waters.
Hazardous waste disposal sites
Area of observation/
Risk Factor observation Point Analysis Rationale
Field conditions Determine the time interval between Document when water was no longer Helpful for assessing when to begin
the flooding event, crop planting, and visible in the field. post-flooding, pre-planting interval.
crop harvest Was the soil reworked after flooding?
If so, how many days after the flooding
event was equipment able to gain access
to the field?
Soil Determine the background level of Has the soil in the flooded field been If testing soil from flooded fields,
indicator organisms or pathogens in the previously tested for coliforms and/or historical data may be helpful in
flooded-affected field pathogens? assessing the test results.
Has the soil in a nearby field that has
been similarly managed been previously
tested for coliforms and/or pathogens?
11.0 Purpose
A food safety assessment is a standardized stepwise process of addressing relevant factors affecting
the safe production of fresh culinary herbs. The objective is to assess the risk to herb products from
uncertain field conditions and identify appropriate remedial actions to reduce or remove the risk.
12.0 Scope
This SoP deals with food safety assessments that must be completed under the scope of the
Commodity Specific Food Safety Guidelines for the Production, Harvest, Post-Harvest, and Processing Unit
Operations of Fresh Culinary Herbs when flooding field. The goal is to provide assurances, in light of
the best available scientific knowledge, that leafy greens are grown and harvested using the safest
available technology.
13.0 Responsibility
The company food safety professional is responsible for conducting the actual food safety
assessment and also will be responsible for updating and revising this SoP annually or as needed.
Do not drive harvest equipment through flooded areas and into non-flooded areas.
Clean and sanitize any equipment that comes in contact with previously flooded soil.
Place markers identifying both the high-water line of the flooding and an interval of at least 30 feet
beyond this line.
• Resuming planting operations after flooding
Following the receding of flood water, wait at least 60 days before beginning planting operations. or
This period could be decreased to 30 days if soil testing indicates soil levels of pathogens lower than
the standard (acceptance criteria) outlined in Table II-6 of the Guidelines.
After soil has dried sufficiently to allow equipment into the field, rework the soil by aerating, tilling,
disking, etc..
If it is decided that soil testing will be useful:
Call a third-party consultant or laboratory with experience in the area to assist with developing
an appropriate sampling strategy. An example soil sampling protocol is provided in Appendix D.
In determining if testing for contaminants other than microbiological is necessary, evaluate
the source of flood waters (e.g. drainage or irrigation canal, river, etc.) for potential significant
upstream contaminants.
Document the sampling strategy and the type of sampling plan used for soil testing.
If it is decided that soil testing is not useful, return to the field 60 days after the floodwaters have
receded and determine whether or not planting may begin based on:
The source of flood waters (e.g. drainage or irrigation canal, river, etc.) for potential significant
upstream contaminants.
Planting operations should begin or resume on previously flooded ground only after the food safety
professional has given approval.
noTe: The regulations contained in this document may change at any time, for updates check: http://www.
calrecycle.ca.gov/Laws/Regulations/Title14/ch31a5.htm#article7
(a) operators shall verify that compost meets the maximum acceptable metal concentration limits specified
in section 17868.2, and pathogen reduction requirements specified in section 17868.3.Verification of pathogen
reduction requirements shall occur at the point where compost is sold and removed from the site, bagged for sale,
given away for beneficial use and removed from the site or otherwise beneficially used.This verification shall be
performed by taking and analyzing at least one composite sample of compost, following the requirements of this
section as follows:
(1) An operator who composts green material, food material, or mixed solid waste shall take and
analyze one composite sample for every 5,000 cubic-yards of compost produced.
(2) An operator who composts biosolids shall meet the sampling schedule described in Table 1 below.
Table 1
Frequencies of Compost Sampling for Biosolids Composting Facilities
(A) The amount of biosolids compost feedstock shall be calculated in dry weight metric tons.
(3) Composite sample analysis for maximum acceptable metal concentrations, specified in section
17868.2, shall be conducted at a laboratory certified by the California Department of Health
Services, pursuant to the Health and Safety Code.
(b) A composite sample shall be representative and random, and may be obtained by taking twelve (12) mixed
samples as described below.
(A) Four samples from one-half the width of the pile, each at a different cross-section;
(B) Four samples from one-fourth the width of the pile, each at a different cross-section; and,
(C) Four samples from one-eighth the width of the pile, each at a different cross-section.
(c) The EA may approve alternative methods of sampling for a green material composting operation or facility
that ensures the maximum metal concentration requirements of section 17868.2 and the pathogen reduction
requirements of section 17868.3 are met.
Table 2
Maximum Acceptable Metal Concentrations
Concentration (mg/kg)
Constituent
on dry weight basis
Arsenic (As) 41
Cadmium (Cd) 39
Mercury (Hg) 17
Selenium (Se) 36
(b) Alternative methods of compliance to meet the requirements of Subdivision (a) of this section, including but not
limited to sampling frequencies, may be approved by the EA for green and food materials composting operations
and facilities if the EA determines that the alternative method will ensure that the maximum acceptable metal
concentrations shown in Table 2 are not exceeded.
(2) At enclosed or within-vessel composting process operations and facilities, active compost shall
be maintained at a temperature of 55 degrees Celsius (131 degrees Fahrenheit) or higher for a
pathogen reduction period of 3 days.
(A) Due to variations among enclosed and within-vessel composting system designs, including
tunnels, the operator shall submit a system-specific temperature monitoring plan with the
permit application to meet the requirements of Subdivision (b)(2) of this section.
(3) If the operation or facility uses a windrow composting process, active compost shall be maintained
under aerobic conditions at a temperature of 55 degrees Celsius (131 degrees Fahrenheit) or
higher for a pathogen reduction period of 15 days or longer. During the period when the compost
is maintained at 55 degrees Celsius or higher, there shall be a minimum of five (5) turnings of the
windrow.
(4) If the operation or facility uses an aerated static pile composting process, all active compost shall
be covered with 6 to 12 inches of insulating material, and the active compost shall be maintained at
a temperature of 55 degrees Celsius (131 degrees Fahrenheit) or higher for a pathogen reduction
period of 3 days.
(c) Alternative methods of compliance to meet the requirements of Subdivision (b) of this section may be approved
by the EA if the EA determines that the alternative method will provide equivalent pathogen reduction.
(d) Compost operations and facilities shall be monitored as follows to ensure that the standards in Subdivision (b)
of this section are met:
(1) Each day during the pathogen reduction period, at least one temperature reading shall be taken per
every 150 feet of windrow, or fraction thereof, or for every 200 cubic-yards of active compost, or
fraction thereof.
(2) Temperature measurements for pathogen reduction shall be measured as follows:
(A) Windrow composting processes and agitated bays shall be monitored twelve (12) to twenty-
four (24) inches below the pile surface;
(B) Aerated static pile composting processes shall be monitored twelve (12) to eighteen (18) inches
from the point where the insulation cover meets the active compost.
(a) The feedstock shall undergo load checking to ensure that physical contaminants are no greater than 1.0 percent
of total weight. Load checking shall include both visual observation of incoming waste loads and load sorting to
quantify percentage of contaminating materials.
(1) A minimum of one percent of daily incoming feedstock volume or at least one truck per day,
whichever is greater, shall be inspected visually. If a visual load check indicates a contamination level
greater than 1.0 percent, a representative sample shall be taken, physical contaminants shall be
collected and weighed, and the percentage of physical contaminants determined.The load shall be
rejected if physical contaminants are greater than 1.0 percent of total weight.
(b) Upon request of the EA, the operator shall take a representative sample of feedstock, physical contaminants shall
be collected and weighed, and the percentage of physical contaminants determined.
(c) Any agricultural material handling operation using this material shall ensure the feedstock meets the metal
concentration limits specified in Table 2 of section 17868.2.
(d) Facility personnel shall be adequately trained to perform the activities specified in this section.
(e) Any operation or facility using this feedstock shall maintain records demonstrating compliance with this section.
note:
Authority cited:
Sections 40502, 43020, and 43021 of the Public Resources Code.
Reference:
Sections 43020 and 43021 of the Public Resources Code.
APPenDIx Z
Appendix Z:
Land and/or Natural Resource Management Agency Contacts
The following list of permitting agencies and technical service providers is meant as a resource to help growers
comply with the metrics in a way that is compatible with environmental protection and permitting requirements.
m
Contact Julie Means if the project proponent plans
to divert or obstruct the natural flow of, or alter the Regional Water Quality Control Boards
bank (including riparian habitat), bed or channel of
a river, stream or lake. The project proponent must The following Regional Water Boards have agricultural
submit a written Notification and appropriate fee waiver programs. They should be contacted regarding
to the Department. Information is available at www. compliance issues with agricultural waivers in the
dfg.ca.gov/1600/. The Department has 30 days to respective regions. The Regional Water Boards should
determine a Notification complete and 60 days from be contacted for all issues that may affect water quality
the date the Notification is determined complete to and by growers who need help with well, pond and other
issue an Agreement. irrigation water disinfection procedures.
Associate Director
430 G Street
(415) 972-3491
(530) 792-5661
pajarillo.jovita@epa.gov
Luana.Kiger@ca.usda.gov
m Curtis Tarver
USDA-nRCS Central Valley Area office
Fresno, CA 93727-1520
William Stevens
Red Bluff, CA 96080-2347
Jim.Spear@ca.usda.gov
William.Stevens@noaa.gov
Salinas, CA 93901-2668
m
Kay.Joy@ca.usda.gov
Jae Lee
USDA-nRCS Southern California/
High Desert Area office
Riverside, CA 92501-3042
(951) 684-3722
Jae.Lee@ca.usda.gov