MEMORANDUM. Joseph A. Levitt Elizabeth Barr Fawell Maile Gradison Hermida Veronica S. Knapp. Date: January 9, 2013

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1 Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC T F MEMORANDUM From: Joseph A. Levitt Elizabeth Barr Fawell Maile Gradison Hermida Veronica S. Knapp Date: January 9, 2013 Re: FDA Issues Proposed Rule on Produce Safety Under FSMA As part of its implementation of the FDA Food Safety Modernization Act (FSMA), on January 4, 2013, FDA released a proposed rule on produce safety titled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Once finalized, the rule would be FDA s first mandatory regulation of fresh produce. Currently, FDA exercises oversight of produce only through voluntary guidance, including the good agricultural practices (GAPs) Guide, Fresh-Cut Guide, and draft commodity-specific guidance documents. The proposed rule sets out proposed safety standards for six hazards that FDA considers to be potential routes of microbiological contamination of produce. Because FDA identifies the specific hazards that firms are to consider and the control steps needed, the produce safety proposal more closely resembles FDA s current good manufacturing practice (cgmp) regulation for food than the proposed hazard analysis and preventive controls provision in FDA s companion FSMA proposal for packaged food. 1/ The proposed rule has a broad scope: all activities on farms that do not trigger registration with FDA, and thus are not subject to the preventive controls requirements, would be subject to the produce safety rule. The produce safety proposal covers nearly all types of produce in commercial distribution with the exception of: (1) specified produce commodities that are rarely consumed raw; and (2) produce subject to a kill step through commercial processing. Below we summarize the scope of the rule, including: (1) which products, farms, and hazards are covered; (2) the recordkeeping and records access provisions and FDA s asserted legal authority for these proposed requirements; and (3) the proposed safety standards for each of the six identified hazards. Comments on the proposed rule are due May 16, 2013 (120 days from publication in the Federal Register). 2/ 1/ The standards for sprouts are an exception to this principle; as these standards would require each farm to develop a written plan committing itself to specific measures. 2/ Comments on information collection issues are due February 15,

2 SCOPE OF THE PROPOSED RULE Which Categories of Produce Are Covered? Under FSMA, FDA is required to issue a proposed rule establishing science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities (RACs) for which the agency determines such standards are necessary to minimize the risk of serious adverse health consequences or death. 3/ Thus, FDA was charged with issuing safety standards only for those categories of produce that are essentially high-risk. 4/ In determining which categories of produce warrant mandatory standards, FDA proposes an integrated approach that focuses on the likelihood of contamination posed by the agricultural practices applied to the crop and that exempts only the lowest-risk produce. FDA has tentatively concluded that controls should be tailored to the potential routes of contamination that each commodity presents based on the agricultural practices employed, and the characteristics of the commodity and the environmental conditions under which it is grown. The proposed rule includes a lengthy illustrative list of covered commodities. 5/ The agency considered and tentatively rejected a commodity-specific approach that would apply only to higher-risk commodities and exempt a broader range of lower-risk commodities or subject such categories to less stringent standards. FDA found that, Although some types of produce have been repeatedly associated with outbreaks, all types of produce commodities have the potential to become contaminated. FDA is seeking comment on whether a commodity-specific approach, based on, for example, outbreak history or characteristics of a commodity or group of commodities, would be a more appropriate way to define risk-based exemptions. 6/ Following the integrative approach, FDA is proposing that no controls are needed for three categories of produce. In particular, the following types of produce are not covered by the proposed rule: 3/ FSMA 105(a); FFDCA 419(a). 4/ This approach differs from FSMA s treatment of food on the manufacturing side, under which there are only very limited risk-based exemptions. 5/ FDA s proposed rule would cover fruits and vegetables such as almonds, apples, apricots, aprium, asian pear, avocados, babaco, bamboo shoots, bananas, Belgian endive, blackberries, blueberries, broccoli, cabbage, cantaloupe, carambola, carrots, cauliflower, celery, cherries, citrus (such as clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), cucumbers, curly endive, garlic, grapes, green beans, guava, herbs (such as basil, chives, cilantro, mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, other melons (such as canary, crenshaw and persian), mushrooms, nectarine, onions, papaya, passion fruit, peaches, pears, peas, peppers (such as bell and hot), pineapple, plums, plumcot, radish, raspberries, red currant, scallions, snow peas, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer squash (such as patty pan, yellow and zucchini), tomatoes, walnuts, watercress, and watermelon. 6/ FDA noted that 88.5% of produce-associated outbreaks between 1996 and 2010 were attributed to seven commodities: sprouts, leafy greens such as lettuce and spinach, tomatoes, melons, berries, fresh herbs such as basil and parsley, and green onions. FDA also noted that pears, grapefruits, oranges, and lemons are not known to be associated with outbreaks and pose a relatively lower likelihood of contamination. The agency also notes that bananas and coconuts pose a lower risk of illness. Nevertheless, under FDA s proposed integrated approach, these lower risk commodities would be covered by the produce rule. 2

3 (1) A specified list of produce commodities that are rarely consumed raw, such as potatoes, peanuts, and sweet corn; 7/ (2) Produce of any kind that is produced for personal consumption or consumption on the farm or another farm under the same ownership; and (3) Produce that is not a RAC. 8/ In general, produce would be considered to fall outside of this scope if it is subjected to manufacturing or processing that triggers the requirement to register with FDA under FFDCA section / For example, fresh-cut fruits and vegetables would be excluded from the scope of the produce safety proposed rule. These products would, however, be subject to the preventive controls proposed rule. FDA also is providing a partial exemption from the produce safety standards for the following category: (4) Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., a kill step ), as long as certain documentation is kept (e.g., oranges used to make pasteurized orange juice; cucumbers used in pickle production). 10/ This category of produce would be exempt from the safety standards in the proposed rule, but would still be subject to a requirement to keep records of the identity of the recipient of the produce who performs the commercial processing, as well as the compliance and enforcement provisions of the produce safety rule, discussed further below. Which Farms Are Covered? FDA is proposing that the rule would apply to all domestic and foreign farms that grow, harvest, pack, or hold covered produce with average food sales during the previous 3-year period of $25,000 or more. Farms with average sales less than $25,000 during the previous 3-year period would be completely excluded from the rule s coverage. 7/ The following is the proposed exhaustive list of the types of produce that would be exempted on this basis: arrowhead, arrowroot, artichokes, asparagus, beets, black-eyed peas, bok choy, brussels sprouts, chick-peas, collard greens, crabapples, cranberries, eggplant, figs, ginger root, kale, kidney beans, lentils, lima beans, okra, parsnips, peanuts, pinto beans, plantains, potatoes, pumpkin, rhubarb, rutabaga, sugarbeet, sweet corn, sweet potatoes, taro, turnips, water chestnuts, winter squash (acorn and butternut squash), and yams. 8/ Section 201(r) of the FFDCA defines raw agricultural commodity as any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. FDA has previously provided guidance on the types of activities that change a RAC into a processed food, such as canning, chopping, cooking, cutting, pasteurization, etc. Joint EPA/FDA Policy Interpretation, 63 Fed. Reg (Oct. 9, 1998); FDA Guidance for Industry: Antimicrobial Food Additives (July 1999), edientsandpackaging/ucm htm. 9/ Note that as part of the preventive controls rulemaking, FDA is proposing to amend the scope of the registration requirement to expand the scope of the farm exemption and, thus, the scope of activities subject to this produce safety rule. 10/ FDA gives the following examples of such commercial processing: processing in accordance with the requirements of 21 CFR part 113 (low-acid foods), part 114 (low-acid canned foods), or part 120 (juice HACCP); treating with a validated process to eliminate spore-forming microorganisms (such as processing to produce tomato paste or shelf-stable tomatoes); and processing such as refining or distilling produce into products such as sugar, oil, spirits, or similar products. 3

4 If a facility conducts activities that fall within the farm definition as well as activities that trigger the registration regulations, it would be considered a farm mixed-type facility. Under proposed revisions to the registration requirements that accompany the preventive controls proposed rule, such facilities would be required to register with FDA and the non-farm portion of the establishment s activities would be subject to the preventive controls requirements while the farm portion of the activities would be subject to this produce safety rule (unless the farm is subject to an exemption). The agency also is proposing a qualified exemption with modified requirements for farms with average food sales during the previous 3-year period of $500,000 or less that sell primarily to consumers, retail food establishments, or restaurants located within the same state or a 275 mile radius of the farm. 11/ The exemption would apply even if the category of produce grown by the farm is otherwise covered by the rule. FDA can withdraw a farm s qualified exemption in the event of a foodborne illness outbreak directly linked to the farm or if FDA determines it is necessary to protect 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 produce. The qualified exemption is not a complete exemption, but does provide relief from the bulk of the rule (i.e., the safety standards and recordkeeping requirements). These farms would be required to include their name and complete business address on the label or at the pointof-purchase of the otherwise covered produce. Further, these farms would remain subject to the compliance and enforcement provisions of the produce safety rule. Which Hazards Are Covered? The proposed rule s coverage is limited to biological hazards that are introduced unintentionally. FDA does not propose specific standards for chemical, physical, or radiological hazards in this rule; nor does the proposal address hazards that may be intentionally introduced, which FDA plans to cover in a separate rulemaking. FDA seeks comment on each of these limitations. FDA proposes safety standards for six specific hazards, each of which it considers a potential route for microbiological contamination of produce: (1) Worker Training and Health and Hygiene (2) Agricultural Water (3) Biological Soil Amendments (4) Domesticated and Wild Animals (5) Equipment, Tools, and Buildings (6) Sprouts Note that sprouts are the only type of produce with its own commodity-specific requirements, which FDA attributes to their unique risk profile. In the preamble, FDA tentatively concludes that sprouts warrant a specific set of safety standards because their seeds provide an additional potential route of contamination due to their unique growing procedures (i.e., a warm, moist nutrient-rich environment for an extended period of time that supports pathogen growth). 11/ The qualified exception was added to the statute via the Tester amendment. FSMA 103; FFDCA

5 RECORDKEEPING REQUIREMENTS AND FDA LEGAL AUTHORITY In addition to general recordkeeping requirements, the proposed rule would require recordkeeping regarding the following: (1) Documentation of compliance with requirements relating to training, water monitoring and testing, biological soil amendments of animal origin, sanitation, and sprouts; (2) For produce that is exempt because it is subject to further processing that adequately reduces the presence of microorganisms, farms must keep records of the identity of the recipient that receives the produce; and (3) For alternatives that farms may establish and use for certain requirements of the proposed rule, farms would be required to keep records of the scientific data and information used to support such alternatives. FDA also proposes to require that all required records be readily available and accessible for inspection and copying by FDA upon oral or written request. FDA does not cite FSMA as authority for these proposed recordkeeping and records access requirements, but instead cites pre-existing FFDCA authorities as well as the Public Health Service Act (PHSA). In particular, FDA finds that the proposed recordkeeping and records access requirements are authorized under the following authorities: FFDCA Adulteration Provisions: FDA concludes that the proposed recordkeeping requirements are necessary to prevent food from being adulterated under sections 402(a)(3) and (a)(4) of the FFDCA (either because under (a)(3) it consists in whole or part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food, or under (a)(4) it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health). Efficient Enforcement of the FFDCA: FDA also finds that the records provisions are necessary for the efficient enforcement of the FFDCA under section 701(a) of the Act because they will aid farms and FDA in ensuring that food is not adulterated and are essential to confirm compliance and achieve the full benefits of the rule. Public Health Service Act: FDA also relies on its broad authority under the Public Health Service Act to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable disease. 12/ FDA takes the position that the proposed recordkeeping and records access requirements are necessary to prevent the spread of communicable disease because they will aid both farms and FDA in ensuring that food does not become contaminated with human pathogens such as Salmonella, L. monocytogenes, and E. coli O157:H7. 13/ FDA s asserts that reliance on these three authorities allows it to go beyond the scope of the authority specifically granted by FSMA. 12/ 42 U.S.C / FDA has taken similar positions in prior rulemakings. See 21 C.F.R (e) (shell egg safety rule); (e) (juice HACCP); 123.9(c) (seafood HACCP). 5

6 SUMMARY OF STANDARDS FOR SIX SPECIFIC HAZARDS Below we summarize the proposed requirements for each of the six specific hazards: Worker Training and Health and Hygiene: Would establish qualification and training requirements for all personnel who contact covered produce or food-contact surfaces and their supervisors; require documentation of such training; and establish hygienic practices necessary to prevent contamination. Agricultural Water: Would require that water that is intended to, or likely to contact the harvestable portion of covered produce or food-contact surfaces be of safe and sanitary quality for its intended use; establish requirements for inspection, treatment (in certain situations), and quality (in certain situations) of agricultural water; and require recordkeeping. Biological Soil Amendments 14/: Would establish requirements for determining the status of a biological soil amendment of animal origin as treated or untreated, and for their handling, conveying and storing; prohibit the use of human waste for growing covered produce except in compliance with EPA regulations; require the treatment of biological soil amendments; establish application requirements and minimum application intervals for untreated and treated biological soil amendments; and require recordkeeping. Domesticated and Wild Animals: If animals are allowed to graze or are used as working animals in fields where covered produce is grown and there is a reasonable probability that these animals will contaminate covered produce, the proposed rule would require waiting periods between grazing and harvesting; measures to prevent the introduction of known or reasonably foreseeable hazards into covered produce; and monitoring in certain situations. Equipment, Tools, and Buildings: Would establish requirements related to equipment and tools that contact covered produce and instruments and controls, buildings, certain domesticated animals, and sanitation; and require documentation of sanitation practices. Sprouts: Would establish measures that must be taken related to the growing, harvesting, packing, and holding of sprouts and related to seeds or beans for sprouting; require testing for Listeria species or L. monocytogenes, E. coli O157:H7, and Salmonella species and appropriate follow-up actions; and require recordkeeping, including a written environmental monitoring plan and sampling plan and documentation of test results. Note that sprouts are the only produce commodity subject to mandatory testing requirements, as FDA tentatively concluded that product testing would be impracticable as a component of this rule except under these certain circumstances for sprouts. ADDITIONAL CONSIDERATIONS Compliance dates: FDA proposes a staggered schedule of compliance dates based on the size of the farm and of types of requirements, as follows: 14/ Soil Amendments are biological, chemical, or physical materials intentionally added to soil to improve its chemical or physical condition in relation to plant growth or to improve its capacity to hold water (e.g., fertilizer). 6

7 (1) Farms that do not qualify as small or very small businesses (i.e., large businesses) would have two years after the effective date of the final rule to comply; for some of the agricultural water requirements, they would have four years to comply; (2) Small businesses would have three years from the effective date to comply; 15/ and (3) Very small businesses would have four years from the effective date to comply. 16/ Note that all of these compliance dates are from the effective date of the final regulation, not from the date of publication of the final rule or the date of this proposed rule. FDA is seeking comment on the proposed implementation periods. 17/ Enforcement: Under the FFDCA, failure to comply with section 419, covering produce safety, is a prohibited act, and therefore subject to injunction or criminal prosecution. 18/ The plain language of the FFDCA does not, however, deem food to be adulterated where it does not comply with produce safety requirements. Without the regulatory hook of adulteration, FDA does not have the authority to administratively detain or seize fresh produce. 19/ The proposed rule attempts to fill this gap in FDA s authority by stating that produce would be considered adulterated if it does not comply with the produce safety rule, and therefore would be subject to administrative detention and seizure. We also would expect any Warning Letters to assert that non-compliance with the produce safety rule would render the product adulterated under sections 402(a)(3) and (a)(4) of the FFDCA (as FDA now does with Warning Letters citing food cgmp violations). Consistency with National Organic Program (NOP) Requirements: FDA notes that the proposed rule does not include any requirements that conflict with or duplicate the requirements of the NOP. Although the proposal imposes obligations above the beyond those under the NOP, the agency views the proposed rule as consistent with the NOP in the sense that compliance with the produce safety rule would not preclude compliance with requirements for organic certification. FDA seeks comment on this approach. More Extensive Standards: FDA considered and rejected the option of requiring covered farms to conduct operational assessments or to develop food safety plans akin to similar requirements for facilities subject to section 418 of the FFDCA or the juice and seafood HACCP regulations. The agency does, however, recommend that firms engage in these activities because it could help them be more effective in protecting the safety of their produce. FDA seeks comment on whether the agency should mandate these requirements. * * * We will continue to closely monitor all developments related to FDA s implementation of FSMA. If you have any questions regarding the proposed rule, please do not hesitate to contact us. 15/ FDA proposes defining small business as a farm with average sales less than $500,000 during the previous 3-year period. Note that this is different than the proposed definition of this term for the preventive controls rule, which is based on the number of employees. 16/ FDA proposes defining very small business as a farm with average sales less than $250,000 during the previous 3-year period. 17/ These proposed compliance dates are longer than those for packaged food companies under FDA s companion proposal for preventive controls, which would be on a 1-, 2-, and 3-year schedule. 18/ FFDCA 301(vv). 19/ FFDCA