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                Food Safety Modernization Act (FSMA)

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          Food Safety Modernization Act (FSMA)
          FSMA Final Rule on Produce SafetyFood Safety Modernization Act (FSMA) FSMA Final Rule on Produce Safety
  
  					Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
	
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    PrintAbout the Final Rule

Federal Register Notice announcing the Final Rule
	Docket Folder FDA-2011-N-0921 provides full text of the Rule
	Questions & Answers
	Coverage and Exemptions/Exclusions Flowchart (Color, PDF - 95KB)
	Coverage and Exemptions/Exclusions Flowchart (Black & White, PDF - 67KB)
	What the Produce Safety Rule Means for Consumers
	What to Expect Now That Larger Farms Must Comply with the FSMA Produce Safety RuleThe Produce Safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part of the agency’s ongoing efforts to implement the FDA Food Safety Modernization Act. The final rule went into effect January 26, 2016.

Compliance Dates
	**For covered activities, other than those involving sprouts (which have additional requirements and earlier compliance dates):**

**January 26, 2018**: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000.
	**January 28, 2019**: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $250,000 but not more than $500,000 (small businesses).
	**January 27, 2020**: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $25,000 but **no more than $250,000** (very small businesses).**Covered activities involving sprouts covered under Subpart M have separate compliance dates and are subject to all the requirements in the Produce Safety rule including specific requirements for sprout operations noted in Subpart M. The compliance dates for sprout operations are as follows:**

**January 26, 2017**: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $500,000.
	**January 26, 2018**: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $250,000 but not more than $500,000 (small businesses).
	**January 28, 2019**: Covered farms for which, on a rolling basis, the average annual monetary value of produce the farm sold during the previous 3-year period is more than $25,000 but **no more than $250,000** (very small businesses).Additional compliance dates for farms eligible for certain exemptions can be found on the FDA’s FSMA Compliance Dates web page.

The definition of “farm” and related terms were revised in the final Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), and the same definitions of those terms are used in this rule to establish produce safety standards. Operations whose only activities are within the farm definition are not required to register with FDA as food facilities and thus are not subject to the preventive controls regulations. However, on January 4, 2018, FDA announced its intention to initiate rulemaking that could change the way the requirements in both the PC Human Food and PC Animal Food rules apply to certain facilities that conduct activities similar to those that occur on farms. The FDA intends to exercise enforcement discretion for the requirements in the PC rules for these specific entities and activities until the completion of future rulemaking related to farm activities. For more information see: Enforcement Discretion for Certain FSMA Provisions fact sheet.

For operations that meet the farm definition, exemptions and modified requirements for the Produce Safety rule are explained in “Exemptions and Variances” and in the Coverage and Exemptions/Exclusions flowchart (PDF - 95KB).

Key Requirements
	1. Agricultural Water

Below are the agricultural water requirements as they are currently written in the Produce Safety rule. Sprouts, because of their unique vulnerability to contamination, remain subject to applicable agricultural water requirements in the final rule and their original compliance dates. On December 2, 2021, the FDA announced a proposed rule which if finalized would replace the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with systems-based agricultural water assessments. FDA also is proposing to require expedited mitigation for hazards related to certain activities associated with adjacent and nearby lands. For additional information, see FSMA Proposed Rule on Agricultural Water and the Federal Register Notice announcing the Proposed Rule on Agricultural Water.

**Requirements:**

**Water quality:**The final rule adopts the general approach to water quality proposed in the supplemental rule, with some changes. The final rule establishes two sets of criteria for microbial water quality, both of which are based on the presence of generic *E. coli*, which can indicate the presence of fecal contamination.

	No detectable generic *E. coli* are allowed for certain uses of agricultural water in which it is reasonably likely that potentially dangerous microbes, if present, would be transferred to produce through direct or indirect contact. Examples include water used for washing hands during and after harvest, water used on food-contact surfaces, water used to directly contact produce (including to make ice) during or after harvest, and water used for sprout irrigation. The rule establishes that such water use must be immediately discontinued and corrective actions taken before re-use for any of these purposes if generic E. coli is detected. The rule prohibits use of untreated surface water for any of these purposes.
		The second set of numerical criteria is for agricultural water that is directly applied to growing produce (other than sprouts). The criteria are based on two values, the geometric mean (GM) and the statistical threshold (STV). The GM of samples is 126 or less CFU of generic *E. coli* per 100 mL of water and the STV of samples is 410 CFU or less of generic E. coli in 100 mL of water.
		The GM is an average, and therefore represents what is called the central tendency of the water quality (essentially, the average amount of generic *E. coli* in a water source).
			STV reflects the amount of variability in the water quality (indicating*E. coli*levels when adverse conditions come into play—like rainfall or a high river stage that can wash waste into rivers and canals). Although this is an over simplification, it can be described as the level at which 90 percent of the samples are below the value.
			The FDA is exploring the development of an online tool that farms can use to input their water sample data and calculate these values.
			These criteria account for variability in the data and allow for occasional high readings of generic E.coli in appropriate context, making it much less likely (as compared to the originally proposed criteria for this water use) that a farm will have to discontinue use of its water source due to small fluctuations in water quality.
			These criteria are intended as a water management tool for use in understanding the microbial quality of agricultural water over time and determining a long-term strategy for use of water sources during growing produce other than sprouts.
		If the water does not meet these criteria, corrective actions are required as soon as is practicable, but no later than the following year. Farmers with agricultural water that does not initially meet the microbial criteria have additional flexibility by which they can meet the criteria and then be able to use the water on their crops. These options include, for example:
		Allowing time for potentially dangerous microbes to die off on the field by using a certain time interval between last irrigation and harvest, but no more than four consecutive days.
			Allowing time for potentially dangerous microbes to die off between harvest and end of storage, or to be removed during commercial activities such as washing, within appropriate limits.
			Treating the water.
	**Testing:** The final rule adopts the general approach to testing untreated water used for certain purposes proposed in the supplemental notice, with some changes. The rule still bases testing frequency on the type of water source (i.e. surface or ground water).
	In testing untreated surface water—considered the most vulnerable to external influences—that is directly applied to growing produce (other than sprouts), the FDA requires farms to do an initial survey, using a minimum of 20 samples, collected as close as is practicable to harvest over the course of two to four years. The initial survey findings are used to calculate the GM and STV (these two figures are referred to as the “microbial water quality profile”) and determine if the water meets the required microbial quality criteria.
		After the initial survey has been conducted, an annual survey of a minimum of five samples per year is required to update the calculations of GM and STV.
			The five new samples, plus the previous most recent 15 samples, create a rolling dataset of 20 samples for use in confirming that that the water is still used appropriately by recalculating the GM and STV.
		For untreated ground water that is directly applied to growing produce (other than sprouts), the FDA requires farms to do an initial survey, using a minimum of four samples, collected as close as is practicable to harvest, during the growing season or over a period of one year. The initial survey findings are used to calculate the GM and STV and determine if the water meets the required microbial quality criteria.
		After the initial survey has been conducted, an annual survey of a minimum of one sample per year is required to update the calculations of GM and STV.
			The new sample, plus the previous most recent three samples, create a rolling dataset of four samples for use in confirming that that the water is still used appropriately by recalculating the GM and STV.
		For untreated ground water that is used for the purposes for which no detectable generic *E. coli* is allowed, the FDA requires farms to initially test the untreated ground water at least four times during the growing season or over a period of one year. Farms must determine whether the water can be used for that purpose based on these results.
		If the four initial sample results meet the no detectable generic *E. coli*criterion, testing can be done once annually thereafter, using a minimum of one sample. Farms must resume testing at least four times per growing season or year if any annual test fails to meet the microbial quality criterion.
		There is no requirement to test agricultural water that is received from public water systems or supplies that meet requirements established in the rule (provided that the farm has Public Water System results or certificates of compliance demonstrating that the water meets relevant requirements), or if the water is treated in compliance with the rule’s treatment requirements.
		In September 2017, the FDA posted a list of methods it has determined to be scientifically valid and at least equivalent to the U.S. Environmental Protection Agency’s method 1603, which is referenced in the Produce Safety rule.2. Biological Soil Amendments

**Raw Manure**: The FDA is conducting a risk assessment and extensive research on the number of days needed between the applications of raw manure as a soil amendment and harvesting to minimize the risk of contamination. (A soil amendment is a material, including manure, that is intentionally added to the soil to improve its chemical or physical condition for growing plants or to improve its capacity to hold water.)

	At this time, the FDA does not object to farmers complying with the USDA’s National Organic Program standards, which call for a 120-day interval between the application of raw manure for crops in contact with the soil and 90 days for crops not in contact with the soil. The agency considers adherence to these standards a prudent step toward minimizing the likelihood of contamination while its risk assessment and research is ongoing.
		The final rule requires that untreated biological soil amendments of animal origin, such as raw manure, must be applied in a manner that does not contact covered produce during application and minimizes the potential for contact with covered produce after application.
	**Stabilized Compost**: Microbial standards that set limits on detectable amounts of bacteria (including *Listeria monocytogenes*, *Salmonella*spp., fecal coliforms, and *E. coli*0157:H7) have been established for processes used to treat biological soil amendments, including manure. The rule includes two examples of scientifically valid composting methods that meet those standards. Stabilized compost prepared using either of these methods must be applied in a manner that minimizes the potential for contact with produce during and after application.
	Biological Soil Amendments of Animal Origin (PDF - 132KB)
	Spanish Translation of Biological Soil Amendments of Animal Origin  (en español, PDF - 169KB)3. Sprouts

The final rule includes new requirements to help prevent the contamination of sprouts, which have been frequently associated with foodborne illness outbreaks. Sprouts are especially vulnerable to dangerous microbes because of the warm, moist and nutrient-rich conditions needed to grow them.
	Between 1996 and 2014, there were 43 outbreaks, 2,405 illnesses, and 171 hospitalizations, and 3 deaths associated with sprouts, including the first documented outbreak of *Listeria monocytogenes*associated with sprouts in the United States. Requirements specific to sprouts include, for example:
	Taking measures to prevent the introduction of dangerous microbes into or onto seeds or beans used for sprouting, in addition to treating seeds or beans that will be used for sprouting (or relying on prior treatment by the seed/bean grower, distributor, or supplier with appropriate documentation).
		Testing of spent sprout irrigation water from each production batch of sprouts, or in-process sprouts from each production batch, for certain pathogens. Sprouts cannot be allowed to enter commerce until it is ascertained that these required pathogen test results are negative.
		Testing the growing, harvesting, packing and holding environment for the presence of Listeria species or Listeria monocytogenes.
		Taking corrective actions if spent sprout irrigation water, sprouts, and/or an environmental sample tests positive.
	In January 2017, FDA issued a draft guidance to help sprout operations comply with the applicable requirements in the Produce Safety rule.
	The first compliance date for the largest sprout operations began on January 26, 2017.4. Domesticated and Wild Animals

The rule addresses concerns about the feasibility of compliance for farms that rely on grazing animals (such as livestock) or working animals for various purposes. It establishes the same standards for these animals as it does for intrusion by wild animals (such as deer or feral swine). Farmers are required to take all measures reasonably necessary to identify and not harvest produce that is likely to be contaminated.
	At a minimum, this requires all covered farms to visually examine the growing area and all covered produce to be harvested, regardless of the harvest method used.
		In addition, under certain circumstances the rule requires farms to do additional assessment during the growing season, and if significant evidence of potential contamination by animals is found, to take measures reasonably necessary to assist later during harvest. Such measures might include, for example, placing flags outlining the affected area.
	Although the final rule does not require establishing waiting periods between grazing and harvest, the FDA encourages farmers to voluntarily consider applying such intervals as appropriate for the farm’s commodities and practices. The agency will consider providing guidance on this practice in the future, as needed.
	Farms are not required to exclude animals from outdoor growing areas, destroy animal habitat, or clear borders around growing or drainage areas. Nothing in the rule should be interpreted as requiring or encouraging such actions.5. Worker Training and Health and Hygiene

Requirements for health and hygiene include:
	Taking measures to prevent contamination of produce and food-contact surfaces by ill or infected persons, for example, instructing personnel to notify their supervisors if they may have a health condition that may result in contamination of covered produce or food contact surfaces.
		Using hygienic practices when handling (contacting) covered produce or food-contact surfaces, for example, washing and drying hands thoroughly at certain times such as after using the toilet.
		Taking measures to prevent visitors from contaminating covered produce and/or food-contact surfaces, for example, by making toilet and hand-washing facilities accessible to visitors.
	Farm workers who handle covered produce and/or food-contact surfaces, and their supervisors, must be trained on certain topics, including the importance of health and hygiene.
	Farm workers who handle covered produce and/or food contact surfaces, and their supervisors, are also required to have a combination of training, education and experience necessary to perform their assigned responsibilities. This could include training (such as training provided on the job), in combination with education, or experience (e.g., work experience related to current assigned duties).6. Equipment, Tools and Buildings

The rule establishes standards related to equipment, tools and buildings to prevent these sources, and inadequate sanitation, from contaminating produce. This section of the rule covers, for example, greenhouses, germination chambers, and other such structures, as well as toilet and hand-washing facilities.
	Required measures to prevent contamination of covered produce and food contact surfaces include, for example, appropriate storage, maintenance and cleaning of equipment and tools.

En español and Other Translations
	La FDA propone ampliar la fecha de cumplimiento de los requisitos de agua de uso agrícola utilizada antes de la cosecha (en español) 
	Spanish Translation of FDA Proposes Compliance Date Extension for Pre-Harvest Agricultural Water Requirements
	Factores por Considerar como Parte de una Evaluación de Agua de Uso Agrícola (en español)
	Spanish Translation of Expanded Table on Factors to be Considered as Part of Agricultural Water Assessment
	Traducción al español del Texto Codificado de la Parte 112 – Estándares para el Cultivo, Cosecha, Empaque y Almacenamiento de los Productos Agrícolas Frescos para el Consumo Humano (en español, PDF - 437KB)
	Spanish Translation of the Produce Safety Rule
	Para Imprimir - Traducción al español del Texto Codificado de la Parte 112 de Estándares para el Cultivo, Cosecha, Empaque y Almacenamiento de los Productos Agrícolas Frescos para el Consumo Humano (en español, PDF - 457.4KB)
	Printer-Friendly Booklet Version of the Spanish Translation of the Produce Safety Rule
	Estándares de Inocuidad de Productos Agrícolas Frescos - Cobertura y Exenciones / Exclusiones para el Título.21 Parte 112 (en español, PDF - 392KB)
	Spanish Translation of Coverage and Exemptions/Exclusions Flowchart
	Mejoradores Biológicos de Suelo de Origen Animal (en español, PDF - 169KB)
	Spanish Translation of Biological Soil Amendments of Animal Origin
	Capacitación Requerida para una Huerta Cubierta (en español, PDF - 151KB)
	Spanish Translation of Required Training for Covered Farms
	Productos Agrícolas Frescos "Raremente Consumidos Crudos" (en español, PDF - 155KB)
	Spanish Translation of Rarely Consumed Raw Produce
	Productos Agrícolas Frescos Cubiertos Caídos (en español, PDF - 135KB)
	Spanish Translation of Dropped Covered Produce
	Folleto Informativo para Agricultores - "Qué esperar de Una inspección regulatoria" (en español, PDF - 162KB)
	Spanish Translation of "What to Expect of a Regulatory Inspection” - Informational Handout for Farmers
	Metodología de Ensayos Equivalentes para Agua de Uso Agrícola (en español, PDF - 148KB)
	Spanish Translation of Equivalent Testing Methodology for Agricultural Water
	La ciclosporosis y los productos agrícolas frescos (en español, PDF - 316KB)
	Spanish Translation of Cyclosporiasis and Fresh Produce Factsheet
	Normas para o Cultivo, Colheita, Embalagem e Armazenagem de Productos Agrícolas Frescos para Consumo Humano (em português, PDF - 543KB)
	Portuguese Translation of Produce Safety Rule
	农产品安全法规中文译本 (中文, PDF - 1.59MB)
	Chinese Translation of Produce Safety Rule
	사람이 소비하는 농산물의 재배, 수확, 포장, 보관에 관한 표준 (한국어 PDF - 842KB) 
	Korean Translation of the Produce Safety Rule
	농산물 안전규칙 팩트 시트 (한국어 PDF - 571KB)
	Korean Translated Factsheet of the Produce Safety Rule
	農産物の栽培、収穫、包装及び保管に関する基準 (日本 PDF - 670KB)
	Japanese Translation of the Produce Safety Rule

Exemptions
	The rule does not apply to:

Produce that is not a raw agricultural commodity (RAC). A raw agricultural commodity is any food in its raw or natural state.
	The following produce commodities that FDA has identified as rarely consumed raw: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts
	Food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g. cotton seed, flax seed, rapeseed, soybean, and sunflower seed)
	Produce that is used for personal or on-farm consumption
	Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or lessThe rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, under certain conditions.

The rule also provides a qualified exemption and modified requirements for certain farms.

To be eligible for a qualified exemption, the farm must meet two requirements:
	The farm must have food sales averaging less than $500,000 per year during the previous three years; and
		The farm’s sales to qualified end-users must exceed sales to all others combined during the previous three years. A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away.
	A farm with the qualified exemption must still meet certain modified requirements, including disclosing the name and the complete business address of the farm where the produce was grown either on the label of the produce or at the point of purchase. These farms are also required to establish and keep certain documentation.
	A farm’s qualified exemption may be withdrawn as follows:
	If there is an active investigation of an outbreak of foodborne illness that is directly linked to the farm, or
		If FDA determines it is necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions associated with the farm that are material to the safety of the farm’s produce that would be covered by the rule.
	Before FDA issues an order to withdraw a qualified exemption, the agency:
	May consider one or more other actions to protect public health, including a warning letter, recall, administrative detention, refusal of food offered for import, seizure and injunction.
		Must notify the owner, operator, or agent in charge of the farm, in writing, of the circumstances that may lead FDA to withdraw the exemption, provide an opportunity for response within 15 calendar days of receipt of the notification, and consider actions taken by the farm to address the issues raised by the agency.
	A withdrawn exemption may be reinstated if (as applicable):
	The FDA determines that the outbreak was not directly linked to the farm, and/or
		The FDA determines that the problems with conduct or conditions material to the safety of the food produced or harvested at the farm have been adequately resolved, and continued withdrawal of the exemption is not necessary to protect public health or prevent or mitigate an outbreak of foodborne illness.

Variances
	The rule also permits states, tribes, or foreign countries from which food is imported into the U.S. to submit a petition, along with supporting information, to FDA requesting a variance(s) from one or more of the requirements of this rule.

The rule enables a state, tribe, or country, if it concludes that meeting one or more of the rule’s requirements would be problematic in light of local growing conditions, to request variances to those requirements. The state, tribe, or foreign country must demonstrate that the requested variance is reasonably likely to ensure that the produce is not adulterated and provides the same level of public health protection as the corresponding requirement(s) in the rule.
	The final rule makes it clear that federally recognized tribes may submit a variance petition.
	The request for a variance must be submitted by a competent authority, meaning a person or organization that is the regulatory authority for food safety for the state, tribe, or foreign country.
	A foreign government does not need to have a systems recognition arrangement or equivalence agreement with the FDA to obtain a variance.
	The variance request must include relevant and scientifically valid information specific to the produce or activity. Information could relate to crops, climate, soil, geography or environment, as well as the practices of that particular region.
	Examples of types of variances that may be granted include a variance from the agricultural water microbial quality criteria for water used during growing covered produce (other than sprouts) using a direct water application method, a variance from the microbial die-off rate used to determine the time interval between the last irrigation and harvest and/or the accompanying maximum time interval; and a variance from the approach or frequency for water testing for water uses subject to the rule’s microbial quality criteria.Compliance dates for modified requirements for farms eligible for a qualified exemption are:

For labeling requirement (if applicable): January 1, 2020
	For retention of records supporting eligibility for a qualified exemption: Effective date of the final rule
	For all other modified requirements:
	Very small businesses, four years after the effective date of the final rule
		Small businesses, three years after the effective date of the final ruleFor more information, see FSMA Compliance Dates.

Environmental Impact Statement
	The FDA has also released the Final Environmental Impact Statement (EIS), which places the Produce Safety rule in the context of its likely impact on the environment, including human health and socioeconomic effects. The Draft EIS was published in January 2015. The FDA considered public comments submitted in the two months that followed in drafting the Final EIS. The FDA considered the findings of the Final EIS in finalizing the produce rule.

The EIS evaluated actions that FDA proposed in the original and supplemental rules, as well as a number of alternative actions for each of the provisions identified as having the potential to result in significant environmental impacts. The provisions of the final rule represent FDA’s preferred alternatives, which are detailed in a Record of Decision (ROD). The ROD addresses how the EIS findings were incorporated into decisions about the final rule. The agency’s preferred alternatives are those that the FDA believes best fulfill the agency’s statutory mission and responsibility, giving consideration to economic, environmental, technical and other factors.
	A significant beneficial impact on public health is expected due to the anticipated decrease in the number of illnesses tied to produce contamination.
	As in the Draft EIS, the Final EIS notes that any produce regulation that causes a farmer to use ground water instead of surface water could exacerbate existing groundwater shortages, although added flexibility in the water provisions make such a management decision unlikely.
	The Final EIS also concludes that Native American farmers may be disproportionately affected by any increases in operating costs necessitated by the produce rule since their average income is 30 percent less than that of other farmers.

Assistance to Industry
	Required Training for Covered Farms (PDF - 175KB)

	Spanish Translation of Required Training for Covered Farms (en español, PDF - 151KB)
	The FDA has established the Produce Safety Network to support the efforts of state regulators with implementing the Produce Safety rule and to support the efforts of farmers and other key stakeholders with complying with the Produce Safety rule. The network is comprised of produce safety experts from the Center for Food Safety and Applied Nutrition (CFSAN) and specialized investigators from the Office of Regulatory Affairs (ORA). Farmers, extension agents, state regulators, and other stakeholders that have questions about the rule should contact the network through their regional representative, which can be found in the Produce Safety Network Directory. See also Building the Produce Safety Network.
	The FDA has developed and is developing several guidance documents on subjects that include:
	General guidance on implementation and compliance.
		A Small Entity Compliance Guide that explains the actions a small or very small business must take to comply with the rule.
		A draft guidance for sprout operations
	The FDA is also working with stakeholders to develop and provide training and technical assistance. The efforts underway include:
	The FDA has established the FSMA Food Safety Technical Assistance Network, which serves as a central source of information to support industry understanding and implementation of FSMA.
	The FDA is working with partners to develop training. These partners include:
	The Produce Safety Alliance (PSA);
		The Sprout Safety Alliance (SSA);
		The National Institute of Food and Agriculture in the U.S. Department of Agriculture (to administer a grant program to provide food safety training, education and technical assistance to small and mid-size farms and small food processors, beginning farmers, socially disadvantaged farmers, and small produce merchant wholesalers); and
		Cooperative agreement partners (to develop training programs for sustainable agriculture and tribal operations).
		The Native American Tribal Center for Food Safety Outreach, Education, Training and Technical Assistance has been established by an agreement with the Indigenous Food and Agriculture Initiative (IFAI) at University of Arkansas School of Law.
			The Local Food Safety Collaborative has been established with National Farmers Union Foundation with the Local Food Safety Collaborative (LFSC).
			FDA has entered into a cooperative agreement with National Association of State Departments of Agriculture (NASDA) to help with the implementation of the produce safety regulations.
		The establishment of the Produce International Partnership for Education and Outreach (PIP), a joint effort by the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and Produce Safety Alliance (PSA) to share food safety training with the international community.
		Additionally, the FDA has established the FSMA Collaborative Training Forum as a space for dialogue, information sharing, alignment, and collaboration on training efforts.
	Additional Information on Raw Manure
	Supplier Evaluation Resources
	Industry Resources on Third-Party Audit Standards and FSMA Supplier Verification Requirements
	Accredited Third-Party Certification Program Voluntary Audit Templates
	FSMA Inflation Adjusted Cut Offs
	Rarely Consumed Raw Produce (PDF - 157KB)
	Spanish Translation of Rarely Consumed Raw Produce (en español, PDF - 155KB)
	Dropped Covered Produce (PDF - 121KB)
	Spanish Translation of Cropped Covered Produce (en español, PDF - 135KB)
	Decision Tree for Test Methods Requirements of*Salmonella* and *E. coli*O157:H7 in Spent Sprout Irrigation Water (or Sprouts) (PDF - 210KB)
	Decision Tree for Determining Coverage under Subpart M of the Produce Safety Rule (PDF - 400KB)

Inspections
	Produce Safety Inspections
	FSVP and Produce Inspections
	"What to Expect of a Regulatory Inspection” - Informational Handout for Farmers
	Spanish Translation of "What to Expect of a Regulatory Inspection” - Informational Handout for Farmers (en español, PDF - 162KB)

Related Guidance
	Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption
	Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption
	Guidance for Industry: Transition from Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
	Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting
	Guidance for Industry: Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions
	Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
	Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
	Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide
	Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507
	Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA
	Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs
	Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds

Meetings and Webinars
	FDA and USDA/FAS Outreach Webinars for Industry Stakeholders on the Produce Safety Rule (PSR) and Foreign Supplier Verification Program (FSVP) July/August 2021
	Webinar on the Final Rule
	Transcript of the Industry Call Concerning the Final Rule - November 13, 2015
	Audio of the Industry Call Concerning the Final Rule - November 13, 2015 [ARCHIVED]
	Environmental Impact Statement for the Proposed Rule - February 10, 2015 [ARCHIVED]
	Supplemental Notices of Proposed Rulemaking - November 13, 2014 [ARCHIVED]

Supporting Materials
	Efficacy Protocol for Reduction of Foodborne Bacteria in Preharvest Agricultural Water
	Leafy Greens STEC Action Plan
	Cyclospora Prevention, Response and Research Action Plan
	Final Qualitative Assessment of Risk to Public Health From On Farm Contamination of Produce (PDF - 986 KB)
	Final Regulatory Impact Analysis
	Record of Decision

Testing Methodologies
	How Did FDA Establish Requirements for Water Quality and Testing of Irrigation Water?
	Decision Tree for Test Methods Requirements of*Salmonella* and *E. coli*O157:H7 in Spent Sprout Irrigation Water (or Sprouts) (PDF - 210KB)
	Testing Methodologies for*E. coli*O157:H7 and *Salmonella*species in Spent Sprout Irrigation Water (or Sprouts) (PDF - 622KB)
	Testing Methodology for *Listeria*species or*Listeria monocytogenes*in Environmental Samples (PDF - 109KB)
	Equivalent Testing Methodologies for *Listeria*species and *Listeria monocytogenes*in Environmental Samples
	Equivalent Testing Methodologies for *E. coli*O157:H7 and *Salmonella*in Spent Sprout Irrigation Water or Sprouts Samples (PDF - 75KB)
	Equivalent Testing Methodology for Agricultural Water (PDF - 152KB)
	Spanish Translation of Equivalent Testing Methodology for Agricultural Water (en español, PDF - 148KB)

Additional Information
	Adjacent and Nearby Land Use and its Impact on Produce Safety
	Cyclosporiasis and Fresh Produce
	Letter from Commissioner Gottlieb to National Association of State Departments of Agriculture (NASDA) 2018 (PDF - 100KB)
	Letter from Commissioner Gottlieb to Secretary Perdue Recognizing Joint Produce Safety Achievement Under Formal Agreement
	Letter from Commissioner Gottlieb to National Association of State Departments of Agriculture (NASDA) 2017 (PDF - 893KB)
	Letter in Response to Correspondence over Winegrapes and the FSMA Produce Rule March 15, 2018
	Request for Information: Consumption of Certain Uncommon Produce Commodities in the United States August 2020
	Protecting the Food Supply from Intentional Adulteration, such as Acts of Terrorism
	CFSAN’s Senior Science Advisor Aims to Build Bridges to Advance Produce Safety
	Video Blog: Coming Together to Talk About FSMA
	5 Steps Toward Working with FDA on Human and Animal Food Guidance Documents
	Case Study: Food Safety Guidelines for Cantaloupes

Contact Us
	How to Contact FDA about FSMA(Technical Assistance Network)

                                                                                  Content current as of:
      09/28/2023
              
              
Regulated Product(s)
		 Food & BeveragesLaw(s) & Regulation(s)
			  Food Safety Modernization ActFood Safety Modernization Act (FSMA)

          
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