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  3. Guidance & Regulation (Food and Dietary Supplements)
  4. Food Safety Modernization Act (FSMA)
  5. FSMA Final Rule on Produce Safety
  1. Food Safety Modernization Act (FSMA)

FSMA Final Rule on Produce Safety

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

About the Final Rule 

The 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.

 

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).

For harvest and post-harvest agricultural water requirements for non-sprout covered produce, the compliance dates are as follows: 

  • January 26, 2022: 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, 2023: 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 26, 2024: 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). 
  • (See the webpage, “Requirements for Harvest and Post-Harvest Agricultural Water in Subpart E for Covered Produce Other than Sprouts” for information related to end dates for FDA’s intended enforcement discretion for these requirements) 

For pre-harvest agricultural water requirements for non-sprout covered produce, the compliance dates are as follows: 

  • April 7, 2025: 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. 
  • April 6, 2026: 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). 
  • April 5, 2027: 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). 

1. Agricultural Water

See Requirements for Harvest and Post-Harvest Agricultural Water in Subpart E

See FSMA Final Rule on Pre-harvest agricultural water requirements

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)

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.

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 less

The 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.

 

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 rule

For more information, see FSMA Compliance Dates.

 

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.

How to Contact FDA about FSMA (Technical Assistance Network)

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