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FDA Releases Highly Anticipated Food Safety Rules

posted on Fri, Jan 18 2013 8:54 am by Mathew Swinburne

The Food and Drug Administration (FDA) released two proposed food safety rules on January 4th, generating a lot of excitement. Margaret Hamburg, the FDA Commissioner, stated that “[t]hese rules represent the very heart of the prevention-based reforms envisioned by the landmark FDA Food Safety Modernization Act . . . .” State governments, private industry and consumer advocates are all eager to read the more than 1,200 pages of proposed rules. Foodborne illness costs the United States an estimated $152 billion annually and results in 128,000 hospitalizations each year. These regulations have the potential to be game changers, but part of the reason they were highly anticipated stems from the fact that they are a year late. The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, but the FDA has missed many of the deadlines set for the FSMA’s regulations, which has frustrated many stakeholders. In fact, last year the Center for Food Safety and the Center for Environmental Health sued the FDA and the Office of Management and Budget over the delay.

The New Rules

The first proposed rule addresses preventive controls. This rule applies to domestic and foreign firms that manufacture, process, pack, or hold food. The rule requires these facilities to develop a written food safety plan. This plan must include a hazard analysis of the facility’s operations, measures to minimize identified risks, ways to monitor and verify that safety measures are working, and specific record keeping measures. The rule is flexible and focused, containing several exemptions and modified requirements for facilities that present a low food safety risk. For example, facilities that only store packaged foods that are not exposed to the environment and do not require refrigeration and “very small businesses” are among exempted operations. The rule has proposed three different definitions for “very small businesses,” all based on annual food sales. These preventive measures could have a big impact — the FDA estimates that by reducing incidents of foodborne illness, this rule will result in $2 billion in annual savings. However, industry will bear a substantial economic burden in implementing the rule, an estimated $701 million in the first year alone.

The second proposed rule establishes science-based standards for growing, harvesting, packing and holding produce. The standards address topics like the quality of agricultural water, animal-based fertilizer, hygiene of farm personnel, controlling animal contact with produce to prevent contamination, and training of farm personnel. However, the standards do not apply to all types of produce, and certain low-risk produce is exempt from these standards. For example, produce that is rarely consumed raw, such as sweet potatoes, and produce that is destined for further processing that kills microbes, such as canning, are exempt. Also, “small farms” that average less than $25,000 in annual food sales over the past three years are exempt. Again these new standards come with a cost to industry, estimated at $630 million annually for both domestic and foreign farms.


While the expansive rules have a lot of potential, they face several challenges in their implementation. Michael Taylor, FDA Deputy Commissioner for Food and Veterinary Medicine captured the largest challenge: “[w]e have said right from the beginning we’ll need additional resources to fully implement this.”

Currently, the FDA lacks the resources to inspect food manufacturers and relies heavily on state governments to conduct inspections. In 2009, states conducted 59 percent of the FDA’s domestic facility inspections. With the new regulations, the FDA will likely have to increase this reliance on state regulators. Also, paying for these new regulations in the current fiscal climate is a challenge. The FDA is examining the possibility of charging the food industry fees to cover the cost of these regulations — a move that will likely meet considerable resistance. Finally, these regulations may not be in play for years. After the four-month comment period there will likely be changes, forcing additional review. Even when finalized, farms and facilities have lengthy grace periods to implement the safety standards. For example, most farms have two years to comply with the majority of the produce standards and four years to comply with some of the agricultural water regulations. 

With a problem as big as foodborne illness, these rules are a big deal. However, a lot of work must be done before their effectiveness can be evaluated.

This blog was prepared by Mathew Swinburne, J.D., staff attorney at the Network for Public Health Law – Eastern Region at the University of Maryland School Of Law.

The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this document does not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.

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