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