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Pushback Prompts FDA To Propose New Food Safety Rules

Law360
November 18, 2014

In January and July of 2013 the U.S. Food and Drug Administration issued four of its proposed food safety rules designed to implement portions of the Food Safety Modernization Act. On Sept. 19, 2014, in response to extensive objections from regulated industry to the provisions outlined in these proposed rules, the FDA proposed significant revisions to these previously published proposed rules. Generally, the FDA would not seek comments on revisions, but in this case the agency is taking an unusual step in order to ensure that the final rules reflect industry input. Also of note is that the FDA entered into a consent decree whereby under court order the agency must meet new deadlines for publication of final rules implementing FSMA to the Federal Register for publication. The new deadlines corresponding to each rule are listed below:

Aug. 30, 2015

  • Preventive Controls for Human Food (FSMA Section 103(a) and 103(c))
  • Preventive Controls for Animal Food (FSMA Section 103(a) and 103(c))

Oct. 31, 2015

  • Foreign Supplier Verification Program (FSMA Section 301(a))
  • Produce Safety Standards (FSMA Section 105(a))

The FDA held a public meeting on Nov. 13, 2014, to solicit stakeholder and public comments on the new content of the supplemental proposed rules. The purpose of the public meeting was also to inform the public about the rulemaking process, including how to submit comments, data and other information to the rulemaking dockets, and to respond to questions about the revised proposed rules.

The four reproposed food safety rules now include several revisions that are outlined below in more detail. Highlights include the following: a hybrid approach for importers to ensure the safety of the products being imported into the country, a tiered approach to the water-quality standards as well as removal of the nine-month time interval between the application of manure and harvesting.

Brief Overview of Reproposals

Risk-Based Preventive Controls for Human Food

The FDA’s new proposed rule would apply to establishments that are required to register as a food “facility” and establishes hazard analysis and risk-based preventive controls requirements for human food, as required by FSMA.

  • Revised definition of farm: Farms packing or holding food from other farms would not be required to register as a food “facility.” The FDA proposed this revision in response to comments that asserted that “the packing and holding of others’ [raw agricultural commodities] is a traditional and common activity by farms.”
  • “Very small business” defined: A very small business would be defined as an entity having less than $1 million in total sales of human food adjusted for inflation. The FDA noted that “businesses with less than $1 [million] in total annual sales of foods produce less than [2] percent of all food produced in the [U.S.]” so such businesses would only “represent a small portion of the potential risk of foodborne illness.”
  • Procedures for withdrawal of exemption: The FDA proposes procedures for the withdrawal of an exemption for a qualified facility for food-safety reasons. These proposed procedures include the consideration of alternatives, advance notification to the facility and providing the facility an opportunity to respond. The FDA also proposes procedures for reinstating an exemption. The FDA acknowledged that “issuing an order to withdraw an exemption would be a rare event.”
  • Product testing, environmental monitoring and a supplier program: A registered food facility would be required to do product testing and environmental monitoring and install a supplier program to verify the implementation and effectiveness of its risk-based preventive controls. Product testing and environmental monitoring requirements would require a facility to develop testing/monitoring procedures and corrective actions and maintain records. Supplier program requirements would require a facility to develop verification activities and responses to supplier nonconformance, conduct annual audits and maintain documentation.
  • Economically motivated adulterations: As part of the hazard identification process, a facility would be required to “consider hazards that may be intentionally introduced for purposes of economic gain,” such as increasing the apparent value of the product or reducing the cost of its production.

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

  • Increased evaluation of foreign supplier risks: As noted by the FDA, the “broader evaluation of risks would require importers to consider such factors as: the nature of hazards in food; the entity that will be applying hazard controls, such as the foreign supplier of the foreign supplier’s ingredient supplier; the foreign supplier’s procedures, processes and practices related to food safety; applicable U.S. food safety regulations and information regarding the foreign supplier’s compliance with those regulations; and the foreign supplier’s food-safety performance history.”
  • Expanded definition of “significant hazard”: A significant hazard is defined under the revised proposal as “a known or reasonably foreseeable hazard in a food for which a person knowledgeable about the safe manufacturing, processing, packing or holding of food would, based on the outcome of a hazard analysis, establish controls to significantly minimize or prevent.” The prior proposed definition has been expanded by proposing a more comprehensive evaluation of food and supplier risks by combining the proposed requirement that an importer conduct a compliance status review of each food to be imported and each foreign supplier being considered, with the proposed requirement than an importer analyze the hazards in each food.
  • Improved flexibility in determining appropriate verification measures: If a hazard may lead to serious injuries or deaths, annual on-site auditing of the supplier would be required. Only if importers can establish that the hazard is controlled may a different approach, such as less frequent auditing, be used. If a foreign supplier is a farm not subject to the produce safety regulations, then the importer would only be “required to obtain written assurance biennially that the supplier is producing the food in compliance with the [Food, Drug, and Cosmetic Act].”
  • Elimination of redundant regulatory requirements: If importers are in compliance with the preventative controls rule’s requirements for supplier programs, then the importers would also be deemed to be in compliance with most of the FSVP requirements. This is avoids redundant regulatory requirements on importers, who are also food facilities.

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

  • Water-quality standard and testing more flexible: The FDA’s proposed rule includes an update on its quality standard for microbials in water applied directly to produce. The proposed rule seeks to update the standard to make it “consistent with the EPA's current recreational water standard.” Additionally, in response to commenters’ opposition to the “lack of allowance for microbial reduction due to natural die-off in the field after application and prior to harvesting of the crop,” the FDA is now permitting a specified microbial die-off rate of 0.5 log per day, with allowance for an alternative die-off rate. The proposed rule further provides for an allowance of microbial reduction “due to pathogen removal during certain post-harvest activities, such as commercial washing, prior to consumption.”
  • Manure strategy to be further studied: In response to “a large majority of [comments] which expressed strong concerns with the proposed [nine]-month minimum application interval” between the application of untreated biological soil amendments of animal origin, such as raw manure, and crop harvesting, the FDA is removing the nine-month minimum time interval. The FDA is deferring its decision on an appropriate time interval until it pursues certain actions, including conducting a risk assessment and extensive research to strengthen scientific support for any future proposal. The proposed rule additionally eliminates the previously proposed 45-day minimum application interval for compost.
  • Covered farms better defined: The proposed rule changes the definition of farms required to comply with the produce safety regulation. The original proposed definition excluded farms with less than $25,000 of food sales annually. After receiving several comments “that farm sizes should be based on the sale of ‘covered produce’ or ‘regulated’ produce, rather than on the sale of all food,” the proposed rule amends this definition to over only farms with an "average annual monetary value of produce ... sold during the previous [three]-year period of more than $25,000."
  • Withdrawal of qualified exemptions process further clarified: The proposed rule establishes procedures for the FDA to withdraw an exemption for a farm for food-safety reasons, as well as procedures for reinstating a withdrawn exemption.
  • Clarifying provisions on wild animals: In response to comments that the proposed rule “would adversely affect wildlife, including threatened or endangered species, and animal habitat,” the FDA clarified that the proposed rule “do[es] not require or permit the use of practices in violation of the ESA.”

Takeaways From the Reproposals

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
In the reproposal, the FDA proposed to adopt a hybrid of what was previously proposed in that, when there is reason to believe a hazard will cause serious injuries or death, an annual on-site audit of the supplier is required. The FDA also stated the importer can use a different approach only if it can provide assurance of food safety. The proposed revisions to the foreign-supplier verification proposed rule give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers. However, this revision may result in more on-site audits and collection of additional documentation for those importers exercising an alternate activity in order to provide adequate assurances of food safety during a FDA inspection.

Risk-Based Preventive Controls for Human Food

The FDA’s amendments to the proposed rule include a change to the definition of farm to include the packing and holding of raw agricultural commodities, regardless where they are grown. The proposed rule would not apply to farms with $25,000 or less in produce sales, rather than setting the threshold based on sales of all foods produced on the farm. The updated proposed rules also propose to simplify what entities are covered by the produce safety rule and which would be covered by the preventive controls rules.

The FDA also defined very small business to be a firm having less than $1 million in total annual sales of human food, which allows for additional time to comply with the rule. Of course, advocates of a stringent food safety system will argue that these changes will spur businesses to be find ways to utilize the exemptions from the provisions though overall food safety is a shared responsibility that does not know a dollar amount. In addition, the FDA is asking for input on whether a facility should be required to address hazards that may be intentionally introduced for purposes of economic gain as part of its hazard analysis, though there is already a separate rule regarding responsibilities as they apply to intentional adulteration.

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

The FDA’s amendments to the proposed rule include changes to the water quality standards as well as testing frequencies, which most likely will result in a reduced burden on farms. However, the FDA’s tiered and more targeted approach may result in different types of enforcement actions against farms out of compliance given that they will have to defend the approach utilized. In addition, the newly outlined farm size thresholds and increase in the number of activities in which a farm can engage without being considered a mixed-type facility will result in more farms being excluded from application of the proposed rule, again reigniting the argument that the FDA’s proposed approach is fragmented in terms of overall food safety.

Next Steps in Rulemaking Process

The issuance of these revised proposed rules marks the continuation of what has been a lengthy and challenging rulemaking proceeding. There are many complex issues and concerns implicated by the reproposed rules and industry may want the FDA to further modify various provisions. The FDA may be flexible on some issues, but on others the agency’s views will be difficult or impossible to change. Knowing where and how to press for reasonable modifications to the proposals and the revisions is crucial, and our attorneys are uniquely attuned to the dynamics of the FDA’s positioning with respect to these policies.

The FDA is accepting comments on its recent revisions to the FSMA Proposed Rules until Dec. 15, 2014, and has stated it will review additional comments received during this period before finalizing the rules in 2015.