Agribusiness Alert: FDA Begins Release of Long-Awaited Food Safety Regulations


Food Safety Modernization Act of 2011

On January 4, 2013, the U.S Food and Drug Administration (FDA) released a portion of the long-awaited food safety regulations under the 2011 Food Safety Modernization Act (FSMA). The FSMA was signed into law on January 4, 2011, and amends the Federal Food, Drug, and Cosmetic Act (Act) to expand the authority of the FDA to regulate food products. The Act and the FSMA do not regulate most meat, poultry, and processed egg products. In summary, the FSMA has requirements regarding: (1) mandatory recalls of covered food products, (2) the registration of qualified facilities, (3) the identification of possible contamination sources and preparing a prevention plan, (4) the production of documents to FDA when requested, (5) increased investigations and (6) the promulgation of regulations to give depth to these statutory mandates and to identify risks, ensure safe practices, allocate inspection resources, and trace raw food products.

Proposed regulations

As is often the case with federal statutes, the federal agency that promulgates the regulations under the statute drives the change. The proposed regulations released on January 4 are set forth in two separate rules, and collectively encompass over 1,200 pages of regulations. A summary of the two rules is below:

  • Hazard analysis and risk-based preventive controls. The proposed regulations would require hazard analysis and risk-based preventive controls. Each facility would be required to comply with the hazard analysis and risk-based preventive controls including preparing and implementing a written food safety plan. The proposed preventive controls are science- and risk-based and require controls only when the FDA believes it is necessary to prevent hazards to public health. The written food safety plan that would be required would need to include: (1) a hazard analysis (identifying foreseeable hazards), (2) preventative controls (to minimize the identified hazards), (3) monitoring procedures (to ensure compliance), (4) corrective actions (in the event of a concern), (5) verification (that preventive controls are implemented), and (6) recordkeeping (to evidence compliance).
  • Standards for the growing, harvesting, packing, and holding of produce for human consumption. The second part of the proposed regulations propose the establishment of science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. The regulations propose to address: (1) agricultural water (by proposing standards intended to make agricultural water safe and of adequate sanitary quality for its intended use and mandating periodic inspections and testing of agricultural water), (2) controlling animal waste (by proposing regulations to classify, handle, and store animal waste and restricting livestock and wild animals from grazing in growing areas) and (3) hygienic and training practices by farm workers (by proposing hand washing and personal cleanliness standards).

What is not yet addressed

The following businesses and business activities were not addressed in the recent proposed regulations, but may be impacted by future regulations under the FSMA.

  • Small business exemption. Business with annual sales of less than $500,000 that sell food within the same state or within 275 miles of where it was processed or harvested are initially exempt from the FSMA. However, the FDA may withdraw any exemption if it determines such withdrawal is necessary to protect public health. It is unknown whether the FDA believes it is entitled to withdraw the small business exemption in certain cases and, if so, what factors or standard the FDA will consider when electing to withdraw the exemption. Even if exempt, small business are still required to retain documentation as to where food originated, demonstrate compliance with state and federal food safety laws, and provide name and location of where food originated on the food labels (if required under law) or at the point of purchase.
  • Grain storage facilities and livestock feed suppliers. Grain storage facilities and livestock feed suppliers are within the scope of the Act and the FSMA.  However, grain storage facilities and livestock feed suppliers are granted a discretionary exemption to the FSMA. This means that the FDA has discretion to exempt those that store raw commodities used in the production of animal feed and those that produce animal feed from the FSMA. The FDA has not yet issued regulations on what basis, if any, the FDA will grant this exemption.
  • Foreign facilities and imported food suppliers. Foreign facilities and imported food suppliers are expected to receive attention under future FSMA regulations. The FDA identified imported food as a food safety concern, with future regulations expected to require foreign facilities and imported food suppliers to comply with the same regulations as U.S. facilities and suppliers. Regulations are expected that require foreign facilities and imported food suppliers to register with the FDA, allow for inspections, and verify compliance through a third party certification process. 


The FSMA will have a significant impact on the way food is grown, harvested, distributed, and sold in the United States. The proposed regulations extend beyond recognized produce and other food products that have drawn recent media attention, and interpret the FSMA to include the regulation of agricultural water sources, the storage and removal of livestock waste, and potentially, the regulation of grain storage facilities and livestock feed suppliers. However, considering the current political divide and the significant financial commitment required to fund these regulations, the enforcement of these regulations may be delayed.

Gray Plant Mooty is a full-service law firm with specialized practices in agribusiness and food safety. Contact Jeff Peterson or Hailey Harren if you have any questions regarding this alert.

This article is provided for general informational purposes only and should not be construed as legal advice or legal opinion on any specific facts or circumstances. You are urged to consult a lawyer concerning any specific legal questions you may have.