On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released the prepublication version of its final rule regarding
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
(“Produce Safety Rule”). The new rule establishes science-based standards for the handling of produce, and includes provisions addressing worker training
and hygiene, testing and maintenance of agricultural water systems, soil amendments, and equipment and facilities. The release of the Produce Safety Rule
continues FDA’s rollout of seven major rulemakings mandated under the FDA Food Safety Modernization Act (FSMA), and follows the September publication of
the FSMA-mandated preventive controls for human and animal food (“Preventive Controls Rules”), discussed here. Prepublication versions of two
other FSMA rules, regarding foreign suppliers and foreign third-party audits, also were released on November 13.
The Produce Safety Rule imposes sweeping requirements and related recordkeeping obligations on a broad spectrum of day-to-day farming operations. Here are
- The rule imposes rigorous testing and quality requirements for agricultural water and sprout activities.
- Unless a farm handles non-covered produce according to the standards for covered produce, covered and non-covered produce must be separated, and any
food-contact surfaces that come into contact with non-covered produce must be cleaned and sanitized before coming into contact with covered produce.
- A farm must take steps to identify and not harvest produce that is “reasonably likely” to be contaminated, including steps to prevent contamination of
produce from animal waste.
- Cut surfaces of produce must not come into contact with soil, and “dropped covered produce” that falls to the ground before harvesting cannot be
distributed unless it is subject to additional processing.
- The rule sets forth different methods by which soil amendments of animal origin can be treated, and the permissible uses of soil amendments are based on
how extensively the amendment is treated (if at all).
- Produce must be packed in material that is cleanable or designed for single use and is unlikely to support the growth or transfer of bacteria, and
packing material cannot be reused unless it is adequately cleaned.
- A farm must take steps to prevent produce contamination from anyone who is “shown to have” or “appears to have” an “applicable health condition” (e.g.,
infection, open lesion or vomiting).
- The rule imposes training requirements – at hire, at least annually thereafter, and as needed; the training must address hygiene, safety and any
standards that are applicable to the employee’s responsibilities.
- Buildings must be constructed so that they can be cleaned adequately, protect against pests, and do not contribute to contamination (e.g., from drip or
condensate from pipes, ducts or ceilings).
- Hand-washing facilities must be available with running water that meets the same rigorous standards that are applicable to agricultural water used during
harvest and post-harvest activities (more on this below).
- Equipment or tools, including vehicles used for transportation, must be stored, inspected and cleaned as often as necessary to protect against potential
What Is “Produce” Under the Produce Safety Rule?
The Produce Safety Rule applies to the growing, harvesting, packing or holding of “produce,” which means fruits or vegetables, including mushrooms,
sprouts, peanuts, tree nuts and herbs. However, some produce is explicitly exempt from the new requirements, including an exhaustive list identified by FDA
as “produce that is rarely consumed raw,” produce grown for personal or on-farm consumption, and produce that is not a “raw agricultural commodity” (RAC,
meaning a fruit or vegetable in its raw or natural state). The rule also exempts produce that will receive commercial processing adequate to reduce the
threat of microorganisms (e.g., through a “kill-step” by a customer later in the distribution chain), but only if a farm discloses in documents
accompanying the produce that the produce has not been processed, and only if the customer provides annual written assurance that (1) it is adequately
processing the produce; or (2) it will provide a written disclosure about the need for such processing to the next customer in the distribution chain, and
will require that customer to agree in writing either to provide the necessary processing or to disclose the need for such processing to subsequent
customers in the distribution chain. This supply-chain component was not included in either the original or supplemental proposed versions of the rule, and
reflects the same effort by FDA to regulate supply chains that is evident in the Preventive Controls Rules.
What “Farms” Are Covered by the Produce Safety Rule?
The Produce Safety Rule adopts the same definition of “farm” that is used in the Preventive Controls Rules. This means that a “farm” includes not only a
“primary production farm” in one general location that grows and harvests produce, but also a “secondary activities farm” where additional activities (such
as shelling or packing) are conducted on produce that originated from a primary production farm that also holds a majority interest in that secondary
activities farm. Although “farms” are not covered by the Preventive Controls Rules − which apply only to food facilities required to register under Section
415 of the Food, Drug, and Cosmetic Act (FD&C Act) − they are subject to the Produce Safety Rule if their average annual produce sales for the previous
three years on a rolling basis exceed $25,000. Farms also include “farm mixed-type facilities” – i.e., farms that engage in some non-farm activities
requiring registration under Section 415 – if they meet the same rolling three-year sales threshold.
What Are the New Testing and Maintenance Requirements for Agricultural Water?
In perhaps its most significant provisions, the Produce Safety Rule requires “agricultural water” used during covered activities to meet rigorous testing
and quality standards. Each farm must inspect its entire agricultural water system (water source, any equipment and overall distribution system), to the
extent those systems are under its control, at the beginning of each growing season or at least once annually to identify conditions “reasonably likely” to
introduce “known or reasonably foreseeable hazards,” considering factors such as the nature of the water source (i.e., ground or surface water) and uses of
nearby land. In addition to the annual inspection, farms must regularly inspect and adequately maintain their water sources and distribution systems.
Water testing requirements depend on the water source and the activity for which the water will be used. Untreated ground water is not as susceptible as
untreated surface water to the effects of runoff, precipitation and temperature, so it is subject to less stringent requirements. For example, untreated
surface water cannot be used to irrigate sprouts (which are grown in warm and moist conditions often quite conducive to microbial growth) or for certain
harvest and post-harvest activities that are closer to the consumer. But even untreated ground water for these activities must be tested to confirm that
there is no detectable presence of generic Escherichia coli (E. coli) per 100 mL of water. (FDA has adopted E. coli as a proxy for the potential
presence of other dangerous microorganisms.)
Water that is used in “direct application” growing activities (i.e., when water is intended or likely to contact produce) is still far enough from the
consumer that microbes may die off naturally. Accordingly, FDA has not imposed a strict presence-absence standard for these activities. Instead, a farm
must calculate the geometric mean (GM) and statistical threshold value (STV) of generic E. Coli in colony forming units (CFUs) per 100 mL of water to
ensure that the GM and STV are beneath tolerable thresholds. (The GM measures the “central tendency” or average E. coli level, and the STV measures the
extent of the variation in a farm’s water quality levels.) However, while some presence of E. coli is tolerated during direct application growing
activities, the testing requirements are nevertheless stringent: Each farm must develop a “water quality profile” based on an initial survey conducted over
a multiyear period, and it must conduct annual surveys to revise its water profile as appropriate. The requirements of the initial survey and annual
updates are different for ground and surface water. If water used in direct application growing activities does not meet the specified quality thresholds,
the farm must take corrective action as soon as practicable and no later than the following year, such as by treating the water or by calculating a safe
time interval between last irrigation and harvest using a microbial die-off rate per day that achieves a calculated log reduction of the GM and STV to meet
the relevant water quality standards.
The water testing requirements do not apply to certain kinds of agricultural water, including waters that are treated before use and waters from certain
public water systems with adequate supporting documentation. In addition, farms are permitted to develop some of their own water quality criteria – e.g.,
an alternative microbial die-off rate, number of testing samples or indicator of contamination (something besides E. coli) – but any such alternatives must
be supported and documented with “adequate scientific data or information.”
What Requirements Apply to Sprout Farmers Under the Produce Safety Rule?
Sprout farms are required to visually inspect seeds and beans and the packagings used to ship them for signs of potential contamination. All beans and
seeds used to grow sprouts must be treated using a “scientifically valid method” that reduces the threat of microorganisms; however, a farm may rely on
prior treatment earlier in the supply chain, so long as the farmer receives documentation that the prior treatment was conducted using a “scientifically
valid method” to reduce the threat of microorganisms and the treated seeds or beans were appropriately packaged and handled. This permissive use of
documentation is a change from previous drafts of the rule, and once again reflects FDA’s attempt to account for the complexities of modern distribution
Sprouts must be grown in fully enclosed buildings in sanitized conditions and are subject to extensive testing requirements. Each sprout farm must develop
a written environmental monitoring plan that is designed to identify L. monocytogenes and that relies on sampling on at least a monthly basis
for either Listeria or L. monocytogenes. It must also develop a written sampling plan for testing spent sprout irrigation water from each production batch of sprouts for E. Coli O157:H7, Salmonella, or any additional pathogen for which testing is necessary to minimize the
risk of serious adverse health consequences or death and for which a scientifically valid testing method is available. If test results are positive from
sampling the environment or spent irrigation water, a farm must, at a minimum, take certain corrective actions, including appropriate action to prevent any
adulterated food from entering into commerce. Additionally, if a farm knows or has reason to believe that any lot of seeds may be contaminated, it is
required in some circumstances to report that information to the supplier (including the results of any positive microbial testing). This reporting
requirement is another new addition to the final rule.
Are Any Farms Subject to Modified Requirements Under the Produce Safety Rule?
A farm may be subject to a qualified exemption and modified requirements under the Produce Safety Rule if its average annual food sales during the
preceding three years were less than $500,000 and the average annual value of the food sold directly to “qualified end-users” exceeded the value of food
sold to other buyers. A “qualified end-user” is a nonbusiness food consumer, or a restaurant or retail food establishment within a specified proximity to
the producing farm. Although a farm that meets these criteria is exempt from many requirements, it still is subject to some provisions, including
recordkeeping obligations, and it must prominently display its business address on food labels (if a label is required under the FD&C Act) or
point-of-purchase materials (if no label is required). A farm seeking a qualified exemption must document its eligibility for the exemption starting on the effective date of the final rule. The rule also sets forth procedures for FDA to withdraw a qualified exemption and procedures by
which farms can appeal the withdrawal of an exemption.
How Much Time Do Farms Have to Come into Compliance with the Produce Safety Rule?
The Produce Safety Rule is scheduled for publication on November 27, 2015 and will be effective sixty days after publication. Compliance dates under the
Produce Safety Rule differ depending on the size of the farm, whether the farm qualifies for a qualified exemption, and whether the farm conducts any
sprout-related activities. A detailed list of the specific compliance deadlines for different types of farms is available
here at the FDA website.
The food and beverage industry team at McGuire Woods will continue to monitor the rollout of the new FSMA rules. We have extensive experience advising
clients in the food and beverage industry regarding regulatory and litigation matters. We can assist companies who are threatened with potential litigation
or regulatory enforcement and we can provide counsel about how to mitigate these threats and comply with these detailed new regulations.