PSR.1 What are the key requirements and compliance dates?

More information about the final rule can be found on the FSMA Final Rule on Produce Safety webpage.

PSR.2 Is extra time allowed for smaller farms to come into compliance with the requirements?

The FDA has staggered the compliance dates, based on the size of farms, to provide additional time for small and very small farms to come into compliance with the requirements. Additionally, FDA has issued a final rule extending, for covered produce other than sprouts, the dates for compliance with the agricultural water requirements in Subpart E. Because they present special safety concerns, operations growing sprouts have less time to come into compliance than other farms and do not get additional time to come into compliance with any of the water requirements. Farms with an average annual value of produce sold of $25,000 or less (adjusted for inflation) during the previous three-year period are not covered by the rule.

Produce: Covered and Not Covered

PSR.3 What produce is covered by this rule, and what produce is not covered?

The rule covers produce as that term is defined in 21 CFR 112.3. However, certain produce is excluded from the rule. Specifically, the rule does not cover produce that:

• is grown for personal or on-farm consumption
• is not a “raw agricultural commodity.” (A raw agricultural commodity is any food in its raw or natural state. See Section 201(r) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• is identified as “rarely consumed raw”.  The “rarely consumed raw” list at 21 CFR 112.2(a)(1) is exhaustive and contains the following fruits and vegetables: 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; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.

In addition, produce that will receive commercial processing that adequately reduces microorganisms of public health concern (i.e., a “kill step”) is eligible for exemption from the rest of the rule if certain requirements are followed, including making a disclosure statement and keeping certain documentation.

PSR.4 Are hemp products covered under the produce safety rule?

Hemp greens (including microgreens) used for human consumption would meet the definition of produce and, therefore, would be covered produce and subject to the Produce Safety Rule (PSR) (21 CFR Part 112). Hemp seed sprouts used for human consumption would also be subject to the PSR, because sprouts, regardless of seed source, meet the definition of covered produce in 21 CFR 112.3.

However, hemp can contain cannabinoids such as delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which can be hazardous to health. A food that bears or contains non‐added poisonous or deleterious substances in quantities that would ordinarily make the food injurious to health would be considered adulterated. Selling such a product is prohibited. The cannabinoid content of hemp food products can vary widely and there is a lack of safety data regarding their consumption. It is the responsibility of all food producers to make sure that their products are safe and not adulterated.

COVERED FARMS

PSR.5 Is my farm covered by the Produce Safety Rule?

The Produce Safety Rule does not cover farms that have an average annual value of produce sold during the previous 3-year period of $25,000 or less, adjusted for inflation. To determine whether a farm is potentially a covered farm with respect to the $25,000 threshold in 21 CFR 112.4(a), the farm would need to calculate the average annual monetary value of their produce sales during the previous three years. Available resources include: the flowchart, to determine if the farm may be subject to the Produce Safety Rule; and the webpage, “FSMA Inflation Adjusted Cut Offs”.

QUALIFIED EXEMPTION

PSR.6 Is my farm eligible for a qualified exemption from the Produce Safety Rule?

If a farm’s average annual produce sales exceed $25,000, the farm may still be eligible for a qualified exemption and modified requirements if it meets two requirements: (1) The farm must have food sales averaging less than $500,000 (adjusted for inflation) per year during the previous 3 years; and (2) during that time, the farm’s sales directly to qualified end-users must have exceed sales to others (see 21 CFR 112.5). A qualified end-user is either: (1) The consumer of the food or (2) a restaurant or retail food establishment (as those terms are defined in 21 CFR 1.227) that is located in the same State or the same Indian reservation as the farm or not more than 275 miles from the farm (see 21 CFR 112.3). Read more about the current dollar value for food sales adjusted for inflation related to a qualified exemption.

QUALIFIED END-USER

PSR.7 What is a qualified end-user?

A qualified end-user, with respect to a food, means either the consumer of the food (does not include a business); or a restaurant or retail food establishment (as defined in 21 CFR 1.227) that is located:

(1) In the same State or the same Indian reservation as the farm that produced the food; or
(2) Not more than 275 miles from such farm.

According to 21 CFR 1.227, restaurant means a facility that prepares and sells food directly to consumers for immediate consumption and does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do not prepare and serve food directly to consumers.

(1) Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants; and
(2) Pet shelters, kennels, and veterinary facilities in which food is provided to animals are restaurants.

A retail food establishment is an establishment that sells food products directly to consumers as its primary function, i.e., the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers (see full definition at 21 CFR 1.227). Grocery stores and convenience stores are examples of retail food establishments. The definition of retail food establishment was recently revised in the final rule, Amendments to Registration of Food Facilities (81 FR 45912, July 14, 2016), to provide certain clarifications about what types of sales may be considered sales directly to consumers for purposes of this definition.

More information about the terms “restaurant” and “retail food establishment” can be found in FDA’s guidance document titled Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.

TRAINING OF PERSONNEL

PSR.8 Which personnel must be trained?

All personnel (including temporary, part time, seasonal, and contracted personnel) who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof, must receive adequate training, as appropriate to the person’s duties, upon hiring, and periodically thereafter, at least once annually. See 21 CFR 112.21(a).

PSR.9 How frequently do my personnel need to be trained?

Upon hiring, and periodically thereafter, at least once annually. Training must be repeated as necessary and appropriate in light of observations or information indicating that personnel are not meeting standards established by FDA in the Produce Safety Rule Subparts C through O (21 CFR 112.21).

TRAINING RECORDS

PSR.10 What training records are required by the Produce Safety Rule?

You must establish and keep records of training that document required training of personnel, including the date of training, topics covered, and the person(s) trained (21 CFR 112.30(b)).

STANDARDIZED CURRICULUM

PSR.11 Do we need to obtain a certificate in order to satisfy the Produce Safety Rule training requirement under § 112.22 (c)?

No. We see the value of receiving a “training certificate” or a “food safety certificate” documenting the training farm personnel (including supervisors or responsible parties) have received. However, at this time, we are not requiring use of such a program (either as a new requirement or to satisfy any of the requirements of this rule), nor are we able to develop such a system or recommend a specific certification process or certification body to enable such an approach. Note that although “certificates” are not required, under 21 CFR 112.30(b) you must establish and keep records of training that document required training of personnel, including the date of training, topics covered, and the persons(s) trained (80 FR 74353 at 74418-19, Nov. 27, 2015).

CONTRACT HARVESTERS

PSR.12 Who can train contract harvesters?

Where a covered farm uses contracted harvest personnel to harvest covered produce on the farm’s behalf, the farm continues to be required to fulfill all relevant duties applicable under this rule. Thus, the farm is responsible for ensuring that the harvest personnel has received required training. The farm may rely on the company that provides the harvest personnel to provide or conduct the training, or the farm may provide or conduct the training. For example, if the harvest company provides training to workers who move from farm to farm under the employment of the harvest company, farms that employ such harvest personnel may choose to rely on the harvest company to provide or conduct the training, request relevant certification from the harvest company, and maintain appropriate records to demonstrate compliance with the applicable training requirements. In addition, an operation that harvests crops but does not grow them, such as a contract harvest company, may meet the definition of ‘‘farm’’ (see 21 CFR 112.3). Thus, if they are covered farms, contracted harvest companies also have duties to comply with this rule (80 FR 74353 at 74420).

Measures to prevent ill or infected persons from contaminating covered produce

PSR.13 What measures are required to prevent ill personnel from contaminating covered produce?

You must take measures to prevent contamination of covered produce and food contact surfaces with microorganisms of public health significance from any person with an applicable health condition (such as communicable illnesses that present a public health risk in the context of normal work duties, infection, open lesion, vomiting, or diarrhea).

You must exclude any person from working in any operations that may result in contamination of covered produce or food contact surfaces with microorganisms of public health significance when the person is shown to have, or appears to have, an applicable health condition, until the person’s health condition no longer presents a risk to public health.

You must instruct personnel to notify their supervisor(s) (or a responsible party) if they have, or if there is a reasonable possibility that they have an applicable health condition.

HANDWASHING

PSR.14 When are personnel required to wash their hands?

When handling covered produce or food contact surfaces during covered activities, personnel must thoroughly wash hands before starting work, before putting on gloves, after using the toilet, upon return to the work station after any break or other absence from the work station, as soon as practical after touching animals (including livestock and working animals) or any waste of animal origin, and at any other times when the hands may have become contaminated in a manner that is reasonably likely to lead to contamination of covered produce with known or reasonably foreseeable hazards.

PSR.17 Does the definition of “biological soil amendment of animal origin” in the Produce Safety Rule include seafood-derived material? In other words, are fish considered animals for the purposes of this rule? Does this include shellfish? Does it include shellfish shells after the actual organism is removed?

The definition of BSAAO, in 21 CFR 112.3, means any soil amendment which consists, in whole or in part, of materials of animal origin, such as manure or non-fecal animal byproducts. Non-fecal animal byproduct, which is also defined in 21 CFR 112.3, means solid waste (other than manure) that is animal in origin and is generated by commercial, institutional, or agricultural operations. Examples of non-fecal animal byproduct include fish meal, shellfish waste, and fish emulsions.

HUMAN WASTE

PSR.18 Would the provisions of the Produce Safety Rule impact the use of biosolids for the growing of vegetable crops or other covered produce?

You may not use human waste for growing covered produce, except that sewage sludge biosolids may be used in accordance with EPA regulations in 40 CFR part 503, subpart D (Pathogens and Vector Attraction Reduction), or equivalent regulatory requirements (see 21 CFR 112.53).  “Sewage sludge biosolids” are defined in 21 CFR 112.3  as the solid or semi-solid residue generated during the treatment of domestic sewage in a treatment works within the meaning of the definition of “sewage sludge” in 40 CFR 503.9(w).

TREATMENT PROCESSED

PSR.19 What are some examples of “scientifically valid methods” that may be used to treat raw manure, during the production of stabilized-and-cured compost, so that it can be used in the production of fresh produce as a treated BSAAO?

We would first like to point to a few definitions in the Produce Safety Rule to help clarify our response.

21 CFR 112.3 defines “composting” as a process to produce stabilized compost in which organic material is decomposed by the actions of microorganisms under thermophilic conditions for a designated period of time (for example, 3 days) at a designated temperature (for example, 131°F (55°C)), followed by a curing stage under cooler conditions.

“Curing” is further defined as the final stage of composting, which is conducted after much of the readily metabolized biological material has been decomposed, at cooler temperatures than those in the thermophilic phase of composting, to further reduce pathogens, promote further decomposition of cellulose and lignin, and stabilize composition.  Curing may or may not involve insulation, depending on environmental conditions.

21 CFR §112.54(b) provides two examples of scientifically valid controlled biological processes (e.g., composting) that meet the relevant microbial standard. The first is static composting that maintains oxygenated conditions at a minimum of 131°F (55°C) for 3 consecutive days and is followed by adequate curing. The second is turned composting that maintains oxygenated conditions at a minimum of 131°F (55°C) for 15 days (which do not have to be consecutive), with a minimum of five turnings, and is followed by adequate curing. In either case, the resulting biological soil amendment must be applied in accordance with the applicable requirements of 21 CFR 112.56. Additionally, for a treated BSAAO you produce for your own covered farm, you must establish and maintain documentation that process controls (for example, time, temperature, and turnings) were achieved per 21 CFR 112.60(b)(2).

Note that there may be additional processes in addition to those described in 21 CFR §112.54(b) that satisfy the requirements in 21 CFR §112.54 for treated BSAAOs

MICROBIAL STANDARDS FOR THE TREATMENT PROCESSES

PSR.20 What are the set microbial limits for Listeria monocytogenes, Salmonella spp., fecal coliforms, and E. coli 0157:H7, and do these limits apply to both stabilized compost and raw manure?

We have provided the microbial standards against which treatment processes must be validated (see 80 FR 74353 at 74472 (Comment/Response 288)), and the rule allows for use of controlled physical, chemical, or biological treatment processes, or combinations thereof (including composting) that achieve those microbial standards. The rule does not require microbiological testing of treated BSAAO to ensure that they meet the relevant microbial standards.

For a BSAAO to be considered “treated” for the purposes of 21 CFR 112.51, the BSAAO must be treated via a process described in 21 CFR 112.54 that meets the applicable microbial standards in 21 CFR 112.55.

The following microbial standards apply to the treatment processes in 21 CFR 112.54:

(a) For L. monocytogenes, Salmonella species, and E. coli O157:H7:

Or, (b) Salmonella species are not detected using a method that can detect three MPN Salmonella species per 4 grams (or milliliter, if liquid is being sampled) of total solids; and less than 1,000 MPN fecal coliforms per gram (or milliliter, if liquid is being sampled) of total solids.

Raw manure must be regarded as “untreated” under 21 CFR112.51. See 80 FR 74353 at 74472 (Comment/Response 277). Stabilized compost may be considered “treated” provided that the compost treatment process has been validated to meet the applicable requirements, including satisfying one of the microbial standards in 21 CFR 112.55. Examples of composting that satisfy treatment process requirements in 21 CFR 112.54(b) and satisfy the microbial standard in 21 CFR 112.55(b) are found in 21 CFR 112.54(b)(1) and 21 CFR 112.54(b)(2).

APPLICATION REQUIREMENTS AND MINIMUM APPLICATION INTERVALS

PSR.21 How does the FDA plan to determine how much time should be required between the application of raw manure and the harvest of produce covered by the rule?

The final produce rule contains requirements related to the safe use of biological soil amendments of animal origin, including raw manure, in Subpart F. With regard to the application of untreated biological soil amendments of animal origin, including manure, applied in a manner that does not contact covered produce during application and minimizes the potential for contact with covered produce after application, the FDA is deferring action on an application interval until we pursue certain steps, including a risk assessment and research to supplement the science on an appropriate interval. We anticipate that these efforts will take five to 10 years to complete. Following the completion of the risk assessment and research work, we expect to: (1) provide stakeholders with data and information gathered from scientific investigations and risk assessment; (2) consider such new data and information to develop tentative scientific conclusions and regulatory decisions; (3) provide an opportunity for public comment on our tentative decisions; and (4) consider public input to finalize the provision(s) establishing an appropriate minimum application interval(s). See 80 FR 74353 at 74462-63 (Comment/Response 257).

RECORDS REQUIREMENTS FOR BSAAO

PSR.22 Should bagged grass clippings from lawn care companies be considered BSAAOs due to the possibility of inclusion of domesticated animal feces?

First, we note that the definitions of “yard trimmings” and “pre-consumer vegetative waste” in 21 CFR 112.3 stipulates that these are purely vegetative materials. To the extent that vegetative waste is known to include animal feces, it would not meet the definitions of “yard trimmings” or “pre-consumer vegetative waste,” and a soil amendment made from such material would instead be a biological soil amendment of animal origin included in the scope of the provisions of subpart F. However, we recognize that even in purely vegetative material such as that described in the definition of “yard trimmings” or “pre-consumer vegetative waste,” there is the potential for unknown and unavoidable contamination with animal waste. We have concluded that the likelihood of contaminating produce with pathogens by use of biological soil amendments that are not known to contain, and not likely to contain significant animal waste or human waste (e.g., yard trimmings, pre-consumer vegetative waste) is low, and therefore they are not subject to the requirements of this rule. See 80 FR 74353 at 74464 (Comment/Response 263).

GRAZING ANIMALS, WORKING ANIMALS AND ANIMAL INTRUSTION

PSR.23 If livestock are allowed to graze amongst nut or fruit trees, is it required to remove livestock from the orchard prior to harvest? If so, how many days in advance?

FDA continues to believe that an adequate waiting period between grazing and harvest is an important consideration when, under the circumstances, there is a reasonable probability that grazing animals will contaminate covered produce. As discussed in the 2013 proposed rule and our Qualitative Assessment of Risk, domesticated animals can be a source of human pathogens. Some human pathogens of public health concern (e.g., E. coli O157:H7) that have been associated with produce-related foodborne outbreaks can be transmitted from animals to people. Moreover, domesticated animals, due to their proximity and interaction with humans, are generally more likely to harbor zoonotic pathogens than are wild animals. The likelihood of contaminating produce with human pathogens from excreta from grazing animals is determined by numerous factors, including, but not limited to, the species of the animal and its association with human or domesticated animal activity or waste, the number of animals per unit area of land, agro-ecological conditions, the type of commodity and the time between animal grazing in fields and the harvest of produce.

However, currently available science does not allow us to identify a specific minimum time period between grazing and harvesting that is generally applicable across various commodities and farming practices. Rather, the appropriate minimum time period between grazing and harvesting would need to be determined based on the specific factors applicable to the conditions and practices associated with growing and harvesting the commodity. However, we encourage covered farms to voluntarily consider applying such waiting periods, as appropriate for the farm’s commodities and operations.

Under 21 CFR 112.83, we are requiring that you take the same steps if, under the circumstances there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce (21 CFR 112.83(a)). In such cases, you must assess the relevant areas used for a covered activity for evidence of potential contamination of covered produce as needed during the growing season (based on your covered produce; your practices and conditions; and your observations and experience) (21 CFR 112.83(b)(1)). If you find evidence of potential contamination during that assessment (such as observation of significant quantities of animals, significant amounts of animal excreta, or significant crop destruction), you must evaluate whether the covered produce can be harvested in accordance with the requirements of 21 CFR 112.112, and you must take measures reasonably necessary during growing to assist you later during harvest when under 21 CFR 112.112 you must identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard (21 CFR 112.83(b)(2)).

Assessing the growing areas as needed during the growing season will enable you to identify instances when covered produce cannot be harvested for safe consumption, such as produce that was directly exposed to animal excreta or that may be cross-contaminated during harvest (e.g., contamination of covered produce by contact with a food-contact surface that contacted animal excreta). Depending on the quantity of animals, extent of animal excreta, or extent of crop destruction, the affected growing areas may be localized (for example, a specific area of the field where you allowed grazing) or more widespread. We expect that, in cases of grazing and working animals, in particular, it is more likely that affected areas will be localized because grazing or working animals are expected to be present intermittently and in known areas of the field. Once you identify produce, or an area of produce, that cannot be harvested in accordance with 21 CFR 112.112, 21 CFR 112.83(b)(2) requires you to take measures reasonably necessary during growing to assist you later during harvest in complying with the requirements of 21 CFR 112.112. For example, if you have identified an area with significant animal excreta that is likely to cross-contaminate any covered produce harvested from that area such that the area may not be harvested, you could mark that area in a manner that will ensure it is not harvested, even if weather events or other occurrences remove the animal excreta so it is not visible later during harvest. For example, you might mark such an area by placing flags outlining the affected area. This provides additional protection in the event that the evidence of animal intrusion or other animal activity is no longer visible by the time of harvest, such as if a significant rain event washes away fecal deposits.

FDA recognizes the longstanding co-location of animals and plant food production in agriculture. This rule does not prohibit the use of grazing or working animals on covered farms.

SUBPART K – Growing, Harvesting, Packing, and Holding Activities

Growing, Harvesting, Packing, or Holding both Covered and Excluded Produce

PSR.24 What are the requirements for packing potatoes and parsnips using the same packinghouse equipment?

Parsnip is a covered commodity under the Produce Safety Rule (see 21 CFR 112.1(b)(1), listing parsnips as an example of covered produce). On the other hand, potatoes are not a covered commodity under the Produce Safety Rule (see 21 CFR 112.2(a)(1), listing potatoes as rarely consumed raw). However, we do want to emphasize that potato farms, and potatoes, are still subject to all applicable requirements of the FD&C Act even though they are exempt from the Produce Safety Rule.

There are provisions in the Produce Safety Rule that would be relevant to a covered farm that produces both parsnips and potatoes. For example, when using shared equipment to grow, harvest, pack or hold both covered (e.g. parsnips) and excluded produce (e.g. potatoes) it is important for covered farms to consider 21 CFR 112.111, which requires that if the excluded produce is not grown, harvested, packed or held in accordance with the Produce Safety Rule, you must take measures as applicable, to: (a) Keep covered produce separate from excluded produce (except when covered produce and excluded produce are placed in the same container for distribution); and (b) Adequately clean and sanitize, as necessary, any food contact surfaces that contact excluded produce before using such food contact surfaces for covered activities on covered produce.

As another example, Subpart L of Part 112 contains requirements for covered farms with respect to equipment, tools, buildings, and sanitation. This includes requirements regarding adequacy of equipment, cleaning and sanitizing of equipment, and storage and maintenance of equipment (see especially 21 CFR 112.123).

PSR.15 What is the current status of the PSR agricultural water requirements?

Agricultural water can be a major conduit of pathogens that can contaminate produce. The feedback that the FDA has received is that some of the agricultural water standards in the Produce Safety Rule may be too complex to understand, translate, and implement for some covered farms. These factors can be important to achieving high rates of compliance. In December 2021, the FDA published a proposed rule that would revise subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule to change certain pre-harvest agricultural water requirements for covered produce other than sprouts. The proposal would replace the pre-harvest microbial water quality criteria and testing requirements in subpart E of the Produce Safety Rule with requirements to conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. The comment period closed on April 5, 2022 and the agency is evaluating feedback. On July 19, 2022, FDA reopened the comment period only with respect to the compliance dates for the proposed pre-harvest agricultural water provisions for covered produce other than sprouts.

More information on this proposal can be found: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-agricultural-water

COMPLIANCE WITH CURRENT AGRICULTURAL WATER REQUIREMENTS

PSR.16 While FDA is undertaking rulemaking to revise the pre-harvest agricultural water provisions in the produce safety regulation for covered produce other than sprouts, are non-sprout farms expected to comply with the current agricultural water requirements? 

In March 2019, the FDA issued a final rule extending, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to protect public health. See 84 FR 9706 (March 18, 2019).

In December 2021, FDA published a proposed rule to revise the pre-harvest agricultural water requirements for covered produce other than sprouts. In July 2022 FDA published a supplemental notice of proposed rulemaking (SNPRM) proposing compliance dates for those pre-harvest agricultural water provisions and specifying the duration of the period during which we intend to exercise enforcement discretion for the harvest and post-harvest agricultural water requirements for covered produce other than sprouts

The proposed compliance dates for the pre-harvest agricultural water requirements for covered produce other than sprouts are:

• 2 years and 9 months after the effective date of a final rule for very small businesses.
• 1 year and 9 months after the effective date of a final rule for small businesses; and
• 9 months after the effective date of a final rule for all other businesses

The SNPRM also clarified that we intend to exercise enforcement discretion for the harvest and post-harvest agricultural water requirements of the Produce Safety regulation until the following dates:

• January 26, 2025, for very small businesses.
• January 26, 2024, for small businesses; and
• January 26, 2023, for all other businesses.

While these rulemakings are underway, FDA encourages non-sprout covered produce farms to continue to use good agricultural practices to maintain and protect the quality of their water sources. (See, e.g., FDA’s “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables.”)

Equipment and Tools subject to Requirements of this Subpart

PSR.25 What equipment and tools are subject to the requirements of the PSR?

As explained in 21 CFR 112.121, equipment and tools subject to the requirements of this subpart are those that are intended to, or likely to, contact covered produce; and those instruments or controls used to measure, regulate, or record conditions to control or prevent the growth of microorganisms of public health significance. Examples include, knives, implements, mechanical harvesters, waxing machinery, cooling equipment (including hydrocoolers), grading belts, sizing equipment, palletizing equipment, equipment used to store or convey harvested produce (such as containers, bins, food-packing material, dump tanks, flumes, and vehicles or other equipment used for transport that are intended to, or likely to, contact covered produce).

DOMESTICATED ANIMALS

PSR.26 I operate a hydroponic greenhouse that is a fully-enclosed building. Is It permissible to have a dog or cat in the greenhouse?

The provisions in subpart L of the  Produce Safety Rule apply to any fully or partially-enclosed buildings used for covered activities, including greenhouses (see 80 FR 74353 at 74491 (Comment/Response 344)). Under Subpart L, domesticated animals in and around a fully-enclosed building are not prohibited, however, you must comply with the requirements of 21 CFR  112.127.  For more information, see the next question.

PSR.27 What requirements apply regarding domesticated animals in and around a fully-enclosed building? 

You must take reasonable precautions to prevent contamination of covered produce, food contact surfaces, and food-packing materials in fully-enclosed buildings with known or reasonably foreseeable hazards from domesticated animals by:
(1) Excluding domesticated animals from fully-enclosed buildings where covered produce, food contact surfaces, or food-packing material is exposed; or
(2) Separating domesticated animals in a fully enclosed building from an area where a covered activity is conducted on covered produce by location, time, or partition. (21 CFR 112.127(a))

Guard or guide dogs may be allowed in some areas of a fully enclosed building if the presence of the dogs is unlikely to result in contamination of produce, food contact surfaces, or food-packing materials. (21 CFR 112.127(b))

PSR.28 Why does the final rule contain additional requirements for sprout production?

Sprouts present a special concern with respect to human pathogens compared to other covered produce because of the warm, moist and nutrient-rich conditions in which they grow. They have frequently been associated with outbreaks of foodborne illness. (See 80 FR 74353 at 74367 (Comment/Response 19)). The Produce Safety Rule includes specific requirements in Subpart M for most sprouts, which are in addition to the other applicable provisions of the Produce Safety Rule. Subpart M does not cover sprouts that are soil- or substrate-grown and are harvested without their roots (see 21 CFR 112.141); however, such sprouts are still “covered produce” and, unless exempt or excluded under the provisions of subpart A, are subject to all other applicable requirements of the Produce Safety Rule (see 80 FR 74353 at 74497 (Comment/Response 364)).

RECORD REQUIREMENTS

PSR.29 What are the Produce Safety Rule requirements regarding records?

Except as otherwise specified, all required records must include, as applicable:

1. The name and location of your farm (21 CFR 112.161(a)(1)(i));
2. Actual values and observations obtained during monitoring (21 CFR 112.161(a)(1)(ii));
3. An adequate description (such as the commodity name, or the specific variety or brand name of a commodity, and, when available, any lot number or other identifier) of covered produce applicable to the record (21 CFR 112.161(a)(1)(iii));
4. The location of a growing area (for example, a specific field) or other area (for example, a specific packing shed) applicable to the record (21 CFR 112.161(a)(1)(iv)); and
5. The date and time of the activity documented (21 CFR 112.161(a)(1)(v)).

Except as otherwise specified, required records must also:

1. Be created at the time an activity is performed or observed (21 CFR 112.161(a)(2));
2. Be accurate, legible, and indelible (21 CFR 112.161(a)(3)); and
3. Be dated and signed or initialed by the person who performed the activity documented (21 CFR 112.161(a)(4)).

Certain required records must be reviewed, dated, and signed by a supervisor or a responsible party within a reasonable time after the records are created (21 CFR 112.161(b)). These records include, as applicable:

1. Records related to eligibility for the qualified exemption (21 CFR 112.7(b));
2. Records related to required training of personnel (21 CFR 112.30(b));
3. Records documenting the results of all analytical tests conducted on agricultural water for purposes of compliance (21 CFR 112.50(b)(2));
4. Records documenting the results of water treatment monitoring under 21 CFR 112.43(b) (21 CFR 112.50(b)(4));
5. Records documenting actions you take in accordance with 21 CFR 112.45 (21 CFR 112.50(b)(6);
6. Records related to process controls for treating biological soil amendments of animal origin you produce for your own covered farm(s) (21 CFR 112.60(b)(2));
7. Records related to cleaning and sanitizing of equipment (21 CFR 112.140(b)(1) and (2)); and
8. Records documenting your treatment of seeds or beans to reduce microorganisms of public health significance in the seeds or beans, at your farm; or alternatively, records of documentation (such as a Certificate of Conformance) from your seed supplier that seeds or beans are treated to reduce microorganisms of public health significance and are appropriately handled and packaged following the treatment, in accordance with the requirements of 21 CFR 112.142(e) (21 CFR 112.150(b)(1));
9. Records documenting the results of all analytical tests conducted for purposes of compliance with Subpart M (21 CFR 112.150(b)(4))

• Records documenting actions you take in accordance with 21 CFR 112.142(b) and (c), 112.146, and 112.148 (21 CFR 112.150(b)(6)).

RECORD REQUIREMENTS IN DETERMINING A QUALIFIED EXEMPTION

PSR.30 What types of records do I need to keep if my farm is eligible for a qualified exemption from the Produce Safety Rule?

A farm is required to establish and keep adequate records necessary to show that it satisfies the criteria for a qualified exemption that are described in 21 CFR 112.5, including a written record reflecting that an annual review and verification of the farm’s continued eligibility for the qualified exemption was performed (see 21 CFR 112.7(b)).

You must establish and keep records required under 21 CFR 112.7 in accordance with the requirements of subpart O of this part, except that the requirement in 21 CFR 112.161(a)(4) for a signature or initial of the person performing the activity is not required for sales receipts kept in the normal course of business. Such receipts must be dated as required under 21 CFR 112.161(a)(4) (see 21 CFR 112.7(a)).

PSR.31 Who may request a variance?

A State, Federally-recognized tribe (or “tribe”), or a foreign country from which food is imported into the United States may request a variance from one or more requirements of this part, where they determine that (a) The variance is necessary in light of local growing conditions; and (b) The procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 of the FD&C Act and to provide the same level of public health protection as the requirements of this part.

Process for Requesting a Variance

PSR.32 How may a State, tribe, or foreign country request a variance?

To request a variance from one or more requirements of the Produce Safety Rule, the competent authority (i.e., the regulatory authority for food safety) for a State, tribe, or a foreign country must submit a petition using the petition process in 21 CFR 10.30.

Audits or Certification

PSR.33 Is there an audit or certification process required to prove compliance under the FSMA Produce Safety Rule?

FDA is not establishing requirements in the Produce Safety Rule for audits of covered farms. It is the responsibility of the entities subject to the Produce Safety Rule to ensure that they are in compliance with all of the applicable requirements by the applicable compliance date(s).  Farms may opt to have third parties evaluate their operations, such as through a USDA GAPs audit or GFSI certification; however, we are not establishing requirements in the Produce Safety Rule for audits or certification of covered farms (See 80 FR 74353 at 74507 (Comment/Response 384)).

We do intend to pursue the goal of making third-party audits an important part of our compliance strategy by building on current private audit activity and by working with the produce industry and other government and private partners to improve the rigor and reliability of private audits. We believe that strengthening both the quality and credibility of private audits will help improve food safety, especially if conducted on the basis of the standards in this rule, but it can also be the basis for streamlining current audit practices and making them more efficient. We seek public-private collaboration to achieve this goal (see 80 FR 74353 at 74521).

One example of these efforts is the announcement made by FDA and the USDA in June of 2018 regarding the alignment of the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the FDA Food Safety Modernization Act’s (FSMA’s) Produce Safety Rule. While the requirements of both programs are not identical, the relevant technical components in the FDA Produce Safety Rule are covered in the USDA H-GAP Audit Program. The aligned components include areas such as biological soil amendments; sprouts; domesticated and wild animals; worker training; health and hygiene; and equipment, tools and buildings. The alignment will help farmers by enabling them to assess their food safety practices as they prepare to comply with the Produce Safety Rule. However, the USDA audits are not a substitute for FDA or state regulatory inspections.

While third party audits are not required under the Produce Safety Rule, we do note that private audits may be relevant to some aspects of compliance with the supplier verification requirements in the FSVP and preventive controls regulations, where a farm supplies produce to an importer or receiving facility that seeks to verify that the farm has adequately controlled applicable hazards (see 80 FR 74353 at 74521). Under the final Accredited Third-Party Certification Rule, FDA established a voluntary program for the accreditation of third-party certification bodies, also known as third-party auditors, to conduct food safety audits and issue certifications of foreign entities and the foods for humans and animals they produce. These requirements are intended to help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program. See FSMA Final Rule on Accredited Third-Party Certification