FOOD SAFETY MODERNIZATION ACT (“FSMA”)

Mark Kinzie
in food,Legislation

By: Patricia A. Hietter and Mark A. Kinzie

Overview. On December 20, 2010, the Senate passed the Food Safety Modernization Act
(S. 510) (“FSMA”), which will overhaul the long-standing Federal Food, Drug, and Cosmetic Act (“FFDCA”)[1] by establishing new regulations to improve the safety of food in the global market.[2] On December 21, 2010, the House of Representatives accepted the Senate version of the food safety bill.[3] It was signed into law by President Obama on January 4, 2011.

This new law responds to recent food scares including tainted milk from China and multiple E.coli and Salmonella poisoning cases, and also responds to accusations that the Food and Drug Administration (“FDA”) is reactive rather than proactive in matters of food protection. It also gives the FDA a mandate to pursue a safety assurance system based on the scientific evaluation of hazards, which is designed to prevent more food-borne illnesses.

Specifically, the FSMA will close the gaps in the U.S. food safety net by focusing on detecting and halting the distribution of contaminated food from both domestic and international food facilities and farms. It provides the FDA with new regulatory powers over the national food supply including the ability to require mandatory food recalls, increased inspection of food processing facilities with a risk-based schedule, and the development of a food trace-back system to pinpoint the origin of food-borne illnesses.

Key Provisions of the Food Safety Modernization Act. A few key provisions of the FSMA include the FDA’s ability to impose a mandatory recall on entities within the food supply chain, increased inspections along the supply chain, and traceability. These three provisions are discussed in greater detail below.

1. Mandatory Recalls. The FSMA increases the FDA’s recall powers through the Health and Human Services Secretary (“Secretary”). Under the prior law, food recalls were voluntary. The FDA operated by threatening or issuing press releases to pressure manufacturers to recall their product. In response, most manufacturers recalled their products voluntarily.

Similarly, under the FSMA, the Secretary may request a voluntary recall if “the use or exposure to such article will cause serious adverse health consequences or death to humans or animals.”[4] However, the Secretary is further authorized to order the responsible party to immediately cease distribution of the article and provide notice to relevant persons if the responsible party does not voluntarily cease distribution of or recall the food.[5] The Secretary may also order a recall if the Secretary determines that removal of the article from commerce is necessary and specify a timetable in which the recall must occur.[6] The Secretary is required to provide an opportunity for an informal hearing before initiating a mandatory recall.[7]

The FMSA also contains related provisions which lower the standard for the administrative detention of food if the FDA has reason to believe that such article is “adulterated or misbranded.”[8] Additionally, the FSMA requires the Administrator of the Environmental Protection Agency (EPA) to assist state, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agricultural or food emergency, including food recalls.[9]

2. Increased Inspections. Additionally, the FSMA authorizes the Secretary to increase the frequency of inspection of all domestic food facilities based on a risk-schedule. [10] The Secretary must identify high-risk facilities based upon specific factors including: the known safety risk of the food manufactured, processed, packed or held at the facility; the facilities compliance history with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards; and, the rigor and effectiveness of the facility’s preventive controls.[11] Depending on the risk assessment assigned to a facility, the inspections may run on a three year or five year schedule, with shorter time intervals immediately following the passage of the Act.[12]

Moreover, the FSMA authorizes the Secretary to enter into arrangements with foreign governments to facilitate the inspection of registered foreign facilities, and requires the Secretary to direct resources to inspections of foreign facilities and supplies.[13] It also requires the Secretary to allocate resources to inspect facilities and articles of food imported into the U.S. based on certain risk profiles.[14]

Lastly, to aid in carrying out the increased inspections of food facilities, the FMSA provides for additional field staff for the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs of the FDA.[15] In the fiscal year of 2011, 4,000 extra staff members will be added in increasing intervals for the next three fiscal years.[16]

3. Food Traceability Requirements. The FSMA charges the Secretary with establishing a product tracing system to receive information that improves the capacity of the Secretary to effectively and rapidly track and trace food in the U.S.[17] To aid in this product tracing, the FMSA requires additional recordkeeping for high-risk foods.[18] The FSMA will establish a list of designated high-risk foods based on: (1) the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food; (2) the likelihood that a particular food has a high potential risk for microbiological or chemical contamination; (3) the point in the manufacturing process of the food where contamination is most likely to occur; (4) the likelihood of contamination and steps taking during the manufacturing process to reduce the possibility of contamination; (5) the likelihood that consuming a particular food will result in a foodborne illness; and (6) the likely or known severity of illness attributed to a particular food.[19] If the Secretary assigns a food as high-risk, it will be subject to increased recordkeeping regulations to be promulgated under the FMSA within two years of its passage.[20] Other pending legislation may ultimately change the final FDA-required traceability system.[21]

There are, however, exemptions from the traceability and recordkeeping requirements for certain types of food, including sales of food that are produced and packaged on a farm if the packaging of the food maintains the integrity of the product, prevents subsequent contamination or alteration of the product and is labeled with the name, address, and business phone number of the farm.[22]

Pertinent Exemptions. The final FSMA contains two pertinent exemptions for certain segments of the food industry. First, it exempts from certain requirements producers who sell the majority of their food directly to in-state consumers, or consumers within a 275-mile radius of where it was produced. It also exempts small producers who bring in less than $500,000 per year in gross sales. Further, because both poultry and eggs are the regulatory province of the U.S. Department of Agriculture (“USDA”), the FSMA does not reach these particular foods.

Conclusion. Due to the sweeping applicability of the FSMA for the majority of food facilities, food manufacturers and other producers must keep abreast of the changes in the form of changing compliance requirements, increased fees, new recordkeeping requirements, and inspections of their facilities to ensure compliance with the new regulatory scheme. Also, new FDA regulations are likely to emerge governing food recalls.


[1] 21 USC § 301 et seq.

[2] Also pending in the Senate is the Food Safety and Tracking Improvement Act, S.425, which proposes to establish a national traceability system under the FDA’s jurisdiction at all stages of manufacturing, processing, packaging, and distribution of food products.

[3] The House version of the food safety bill was previously called the Food Safety Enhancement Act of 2009 (“FSEA”), H.R. 2740. The House passed the Senate version because of the short time remaining in the current session of Congress instead of holding a press conference to reconcile the two bills.

[4] S.510, Section 423 (a).

[5] S.510, Section 423(b).

[6] S.510, Section 423(c),(d).

[7] S.510, Section 423(b).

[8] S.510, Section 423(b).

[9] S.510, Section 423(j).

[10] S.510, Section 421.

[11] S.510, Section 421(a)(1).

[12] S.510, Section 421(a)(2).

[13] S. 510, Section 421(2)(d).

[14] Id.

[15] S.510, Section 401(b).

[16] Id.

[17] S.510, Section 204(c).

[18] S.510, Section 204(d)(1),(2).

[19] S.510, Section 204(d)(2)(A).

[20] S.510, Section 204(d)(2)(B).

[21] See Supra fn 2.

[22] S.510, 204(d)(6).


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