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FDA Announces More Changes to FSMA (Food Safety and Modernization Act) Implementation Rules

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many reported incidents of food-borne illness during the 2000s.

FSMA’s goal is to ensure that food in the United States is safe by shifting the focus of federal regulators from responding to contamination to preventing contamination from initially occurring.  The law has given FDA new authority to regulate the way foods in the United States are grown, harvested, and processed.  One means through which FDA exercises this authority is rulemaking.

FSMAThe four rules for which FDA is proposing changes are:

  1. Produce Safety,

  2. Preventive Controls for Human Food,

  3. Preventive Controls for Animal Food, and

  4. Foreign Supplier Verification Programs

The potential changes to these four rules are intended to make the rules “more flexible, practical and targeted,” and are based on thousands of comments from the general public, farmers, and other stakeholders submitted during the comment period.  FDA currently plans to hold a public meeting regarding the revised proposals on November 13, 2014, and will issue its final rules in 2015.

Some of FDA’s proposed changes to the four rules include:

Produce Safety: 

  • More flexible criteria for determining the safety of agricultural water (e.g., the microbial standard for water) for certain uses, and a tiered approach to water testing.

  • Removal of the nine-month proposed minimum time interval between the application of untreated biological soil amendments of animal origin (including raw manure) and crop harvesting.

    • FDA will conduct research and risk assessment of the safe use of raw manure and will work with USDA to implement the changes to the rule.

    • During the interim, farmers may continue to comply with USDA’s National Organic Program standards, which set a 120-day interval between the application of raw manure for crops in contact with soil and a 90 day interval for crops not in contact with soil.

Preventive Controls for Human and Animal Foods:

  • Implement requirements that human and animal food facilities, when appropriate, test products and the facilities’ environments.

    • FDA is seeking comment regarding whether the preventive controls for human and animal foods should require facilities to conduct product testing and environmental monitoring.

    • FDA is also seeking comment regarding what specific language to use in these rules.

  • Explicitly define a “very small business” as “firms having less than $1 million in total annual sales of human food, adjusted for inflation.”

Foreign Supplier Verification Program:

  • Provide a more comprehensive analysis of potential risks associated with foods and foreign suppliers.

  • Create more flexibility for importers in determining appropriate supplier verification measures based on their evaluation of the potential risks.

  • Change definitions of “very small importer” and “very small foreign supplier” to make the proposed rule consistent with other proposed FSMA rules.

  • Set general compliance date for 18 months after publication of the final rule, with some exceptions for the importation of food that is also subject to the preventive controls and produce safety rules.

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About this Author

Dominique Windberg, patent trade secret litigator, Mintz Levin Law Firm

Dominique’s litigation experience includes patent and trade secret cases, structured finance matters, government investigations, and discovery in patent and white collar cases, especially False Claims Act matters.

For a structured finance matter at her previous firm, Dominique prepared the exhibit list, motion in limine, pretrial briefs, direct and cross examinations, and assisted in witness preparation. Her experience with government investigations includes an alleged violation of the Food, Drug, & Cosmetic Act in which she managed...