Essay #1 - Food Safety Modernization Act

THIS IS THE FIRST OF A SERIES OF ESSAYS ON THE FSMA WRITTEN BY CHARLES WOODHOUSE

THESE ESSAYS ARE DRAWN FROM THE MONTHLY FOOD SAFETY COLUMN WRITTEN BY CHARLES WOODHOUSE IN THE AMERICAN AGRICULTURAL LAW ASSOCIATION'S PUBLICATION AGRICULTURAL LAW UPDATE

January 4, 2011 – President Obama Signs the FSMA

With the Senate vote of December 22, the 111^th Congress passed the Food Safety Modernization Act of 2010. This legislation will be signed into law by President Obama as PL 111-322 and in due course will be integrated into the United States Code.

Margaret A. Hamburg, Commissioner of the FDA made the following statement on December 22, 2010

“Today's passage of the Food Safety Modernization Act has laid the critical foundation for a prevention-based 21st Century food safety system. This law makes everyone responsible and accountable at each step in today's global food supply chain. Under this new law, FDA will now have new prevention-focused tools, as well as a clear regulatory framework, to help make substantial improvements in our approach to food safety. Preventing foodborne illness is a core public health principle that is especially critical in an increasingly complex and globalized world. This law helps us take the critical steps toward strengthening the food safety system that is vital to the health and security of the American people.”

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm238000.htm

The burden of foodborne illness upon Americans is considerable. The CDC estimates that in a typical year, 1 out of 6 people in the United States—48 million people--suffer from foodborne illness, 138,000 are hospitalized, and 3,000 die. 

Source documents for this information are posted on our weblog (Dec. 16, 2010 posting) at: www.food-label-compliance.com

For a recent technical analysis of foodborne disease outbreaks see Surveillance for Foodborne Disease – United States 2007, Morbidity and Mortality Weekly Report, 59(31), pp.973-979, 13 August 2010. In 2007, the most recent year with complete data, there were 1,097 outbreaks of foodborne disease with 25,079 confirmed hospitalizations associated with these outbreaks. Readers are encouraged understand the significance of these statistics by reviewing the definitions of clusters and outbreaks in Principles of Epidemiology in Public Health Practice, 3d Ed, Centers for Disease Control. 2010 which may be viewed at

http://www.ihs.gov/MedicalPrograms/PortlandInjury/PDFs/PrinciplesOfEpidemiologyInPublicHealthPractice.pdf

For a contrarian view readers are encouraged to read the November article written by Diane Katz for the Heritage Foundation. The article is entitled New FDA Powers: the Wrong Remedy for a Phony Crisis.

http://www.heritage.org/research/reports/2010/11/new-fda-powers-the-wrong-remedy-for-a-phony-crisis

Additionally, we do need to enter a cautionary comment on the implementation of the FSMA. We need to remember that FDA will require funding to be appropriated by Congress and the implementation of the FSMA is expected to require $1.4 billion in new funding over the next five years. It remains to be seen whether or not the recession combined with increased Republican control in the 112^th Congress will significantly delay implementation efforts by FDA.

However, we also note that even a single food safety crisis such as the 2010 shell-egg recalls can be “game-changer” making it politically untenable to delay funding and implementation of the FSMA. Few politicians would be willing to publicly oppose funding directly related to an ongoing food safety crisis.

Finally, the author of our Weblog (www.food-label-compliance.com) is not expressing any opinion regarding the Hoover Foundation analysis or the highly positive statements made by FDA officials. Rather, the author merely expresses the wish that our readers have direct access to contrarian and critical views as well as FDA pronouncements. As our long-time readers know, our Weblog endeavors to provide our readers with original documents, when not copyright protected, and citations and references to sources when copyright restrictions apply. We also recognize that readers without university or research institutional affiliations often do not have access to the major on-line science-journal services. Therefore, when permissible, we do post abstracts of scientific articles.

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General Discussion of FSMA

Please note that section numbers referenced below are those of the Enrolled Senate version of HR-3082-ES that was passed by the senate on December 22. After signature by the President, the GPO will issue a final version of PL 111-322 which may have differing section numbers. The text of the FSMA posted on our Weblog and referred to below is that of HR-3082-ES.

Section 6103 of the FSMA has given FDA a legislative mandate to require comprehensive, prevention-based controls across the food supply. This will change FDA’s approach to food safety from a “response” mode to a pro-active “prevention” stance.  Food facilities will now be required to evaluate the hazards in their operations, implement and monitor effective measures to prevent contamination, and have a plan in place to take any corrective actions that are necessary. 

Section 6201 of the FSMA addresses inspection and compliance and will greatly expand inspections as a means of holding industry accountable for food safety. FDA will now allocate its inspection resources in a risk-based prioritization arrived at by objective scientific criteria.

Sections 6202 and 6203 of the FSMA will establish an accreditation system for food analytical laboratories.

Mandatory Recall Authority

In perhaps the most significant development in food safety since President Roosevelt signed the FD&C Act in 1938, Section 6206 of the FSMA will finally give FDA mandatory recall authority. This provision, with a major impact on the entire Food Industry, will be the subject of another follow-up essay in this series.

Produce Industry Rules

Section 6105 of the FSMA requires USDA, within one year, to issue proposed rules to establish science-based standards for the safe production and harvesting of fruits and vegetables. This provision, with a direct and immediate impact on the produce Industry will be the subject of a follow-up essay in this series.

Imported Food Safety

 The legislation provides significant enhancements to FDA’s ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year.  An estimated 15 percent of the U.S. food supply is imported, including 60 percent of fresh fruits and vegetables and 80 percent of seafood. 
 
Section 6301 of the FSMA directs FDA, within one year, to issue proposed rules to require importers to perform supplier verification activities to ensure imported food is safe and authorizes FDA to refuse admission to imported food if the foreign facility or country refuses to allow an FDA inspection

Section 6302 of the FSMA provides an incentive for importers to take additional food safety measures by directing FDA to establish a Voluntary Qualified Importer Program (VQIP) through which imports may receive expedited review if the importer has taken measures to assure food safety. FDA is required to issue proposed rules on VQIP within 18 months of the enactment of the FSMA.

Section 6307 of the FSMA will establish mechanisms for the accreditation of third-party auditors.

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As soon as the final GPO issued version of PL 111-322 is available, the FSMA portion of the PL will be posted on our Weblog and then, with corrected section numbers we will address three specific issues:

Specific Discussion of Aspects of FSMA Affecting the Produce Industry

Specific Discussion of Aspects of FSMA Affecting the Food Import Sector

Specific Discussion of Aspects of FSMA Affecting Mandatory Recall Authority

We will also address the Tester Amendment and the proposed rules providing exemptions to small business and businesses which are deemed not to enter products into interstate commerce.

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As a final comment we will offer an opinion that the FSMA, after its full enactment, will set a series of rules and standards for the US food industry – from “farm to fork”. This system will make it far easier for attorneys representing plaintiffs in foodborne illness litigation to establish the “duty” and “breach of duty” that are a necessary part of successful product liability actions against food producers, importers, and distributors. The FSMA will also make it far more important for these same manufacturers, importers, and distributors to have in-place comprehensive Food Safety Plans to demonstrate their responsible and pro-active actions to promote food safety and to demonstrate their commitment to the highest standards of food safety in connection with the duty to supply safe and wholesome food products. Rigorous attention to compliance will be the first line of defense for food producers, importers, and distributors.

We are entering a dangerous period for food manufacturers, importers, and distributors. The “rules” are being set by the FSMA and scientific advances are making the “pin-pointing” of the etiology of foodborne illness far easier. Only the most responsible and pro-actively safety conscious food industry participants will be safe from liability for foodborne illness.

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Charles F. Woodhouse (BA Dartmouth, MBA Wharton, JD Rutgers, Grad. Cert. International Food Law, Michigan State)  practices at Woodhouse Shanahan PA and is currently completing the Michigan State University Master of Science - Food Safety  graduate program (MS Food Safety degree expected 2011). Details of his practice, education, and career are on his law firm's website     www.seafood-and-produce-law.com

His Weblog on Food Labeling and Food Safety receives more than 4,000 visits per month from Food Safety professionals    www.food-label-compliance.com

Charles Woodhouse is admitted to the Practice of Law before the Bars of Pennsylvania, Florida, and the District of Columbia and to practice before the US Court of International Trade in New York City and the US Court of Appeals for the Federal Circuit in Washington, DC.

Charles Woodhouse writes the Food Safety column in the American Agricultural Law Association's monthly publication Agricultural Law Update.

He is a member of the Institute of Food Technologists, the American Agricultural Law Association, the American Bar Association, and the Customs and International Trade Bar Association. He serves (pro bono) as Chair of the Aquaculture Certification Council which certifies Food Safety, Social, and Environmental Compliance for the worldwide aquaculture industry. Visit the ACC at: www.aquaculturecertification.org

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