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Public Comments Result in FDA Revising Proposed Food Safety Rules

September 19, 2014

On September 19, 2014, in response to extensive objections from regulated industry, the U.S. Food and Drug Administration (FDA) proposed significant revisions to four previously published proposed rules (click here and here for more details) designed to implement portions of the Food Safety Modernization Act (FSMA). Outlined below are several of the highlights of FDA’s proposed revisions to these comprehensive food safety rules.

Risk-Based Preventive Controls for Human Food

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 for human food, as required by the Food Safety Modernization Act.

(1) Revised definition of “farm.”  Farms packing or holding food from other farms would not be required to register as a food “facility.”  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.”

(2) “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.  FDA noted that “businesses with less than $1,000,000 in total annual sales of foods produce less than two percent of all food produced in the United States” so such businesses would only “represent a small portion of the potential risk of foodborne illness.”

(3) Procedures for withdrawal of exemption.  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.  FDA also proposes procedures for reinstating an exemption.  FDA acknowledged that “issuing an order to withdraw an exemption would be a rare event.”

(4) Product testing, environmental monitoring and a supplier program.  A 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 non-conformance, conduct annual audits, and maintain documentation.

(5) 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.”  

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

(1) Increased evaluation of foreign supplier risks.  As noted by 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.” [1]

(2) 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.” [2]

(3) 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 could establish that the hazard is controlled could 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 FD&C Act.”[3]

(4) Elimination of redundant regulatory requirements.  If importers are in compliance with the requirements on supplier programs, then the importers would also 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

(1) Water quality standard and testing more flexible.  FDA’s Proposed Rule includes an update on its quality standard for microbials in water applied directly to produce. [4]  The Proposed Rule seeks to update the standard to make it “consistent with the U.S. Environmental Protection Agency’s (EPA) current recreational water standard.” [5]  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,” FDA is now permitting a specified microbial die-off rate of 0.5 log per day, with allowance for an alternative die-off rate. [6]  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.”[7]

(2) Manure strategy to be further studied.  In response to “a large majority of [comments] which expressed strong concerns with the proposed 9-month minimum application interval” between the application of untreated biological soil amendments of animal origin (such as raw manure) and crop harvesting, FDA is removing the 9-month minimum time interval. [8]  The Proposed Rule additionally eliminates the previously proposed 45-day minimum application interval for compost. [9]

(3) 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. [10]  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 3-year period of more than $25,000. [11]

(4) Withdrawal of qualified exemptions process further clarified.  The Proposed Rule establishes procedures for FDA to withdraw an exemption for a farm for food safety reasons, as well as procedures for reinstating a withdrawn exemption. [12]

(5) 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,” FDA clarified that the Proposed Rule “do[es] not require or permit the use of practices in violation of the ESA.” [13]

The issuance of these revised proposed rules marks the continuation of what has been a lengthy and challenging rulemaking proceeding. Wiley Rein’s Food & Drug Practice includes seasoned attorneys with FDA experience, including in the development, implementation, and enforcement of FDA’s food safety policies. There are many complex issues and concerns implicated by the re-proposed rules, and industry may want FDA to further modify various provisions. 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 FDA’s positioning with respect to these policies. We invite affected companies to confer with us regarding options for ensuring your views are fully considered by the FDA as it works to finalize the regulations.

FDA will be accepting comments on its recent revisions to the FSMA Proposed Rules until mid-December and has stated it will review additional comments received during this period before finalizing the rules in 2015.  Wiley Rein’s experienced attorneys in the Food & Drug Practice are available for counseling and to ensure your views are fully considered by FDA as it works to finalize its Proposed Rules.

[1] Proposed Rule for Foreign Supplier Verification Programs (FSVP) Fact Sheet, available at

[2] Proposed Rule for Foreign Supplier Verification Programs of Food for Humans and Animals (“FSVP Rule”) at p. 5.

[3] Id. at p. 8.

[4] Proposed Rule for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (“Product Safety Rule”), at 5.

[5] Id.

[6] Id. at 43-44.

[7] Id. at 47.

[8] Id. at 91.

[9] FSMA Proposed Rule for Produce Safety, Fact Sheet (last updated Sept. 19, 2014), available at

[10] Id.

[11] Product Safety Rule, at 12-14.

[12] FSMA Proposed Rule for Produce Safety, Fact Sheet (last updated Sept. 19, 2014), available at

[13] Product Safety Rule, at 110-12.