FDA ADVISORY. President Signs Sweeping Food Safety Reform. Title I. January 5, 2011

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1 FDA ADVISORY January 5, 2011 President Signs Sweeping Food Safety Reform On November 30, 2010, the U.S. Senate passed S. 510, the FDA Food Safety Modernization Act, by a vote of 73 to 25. However, following passage in the Senate, a procedural issue arose among House leaders who highlighted that the bill violated a constitutional provision requiring that tax (or revenue-raising) provisions originate in the House. Due to the reinspection and recall fee related provisions of the Senate bill, the legislation temporarily reached a halt, preventing the House from being able to vote on passage of S As a result, the House attached the text of the Senate bill to a continuing resolution bill that it subsequently passed, and food safety reform appeared to be back on track for passage. The food safety bill would encounter a few more hurdles until passage by the U.S. Senate on December 19 of H.R. 2751, the FDA Food Safety Modernization Act (the Act ). The President signed this bill into law on January 4. The final law breaks down into four titles: Title I: Improving Capacity to Prevent Food Safety Problems; Title II: Improving Capacity to Detect and Respond to Food Safety Problems; Title III: Improving the Safety of Imported Food; and Title IV: Miscellaneous Provisions (e.g., funding, jurisdiction, international agreements, whistleblower protections for employees reporting suspected violations of the FFDCA and FDA regulations or refusing to participate in activities they believe are in violation of the FFDCA or FDA regulations, etc.). The establishment registration fees of the House version of the bill and the bisphenol A ban that Sen. Feinstein (D-CA) had proposed to include in the Senate bill did not make it into the final legislation. The first three titles of the Act have the greatest impact on registered food establishments. Following is a brief snapshot of the key titles of the legislation and its expansion of FDA s food safety activities: Title I Gives FDA authority to inspect records related to food. Exempts certain establishments that sell food directly to consumers, such as roadside stands, farmers markets or participants in a community supported agriculture program, from certain requirements of the law. Gives FDA authority to suspend (by order with an opportunity for a hearing) food establishment registrations where the agency determines that food manufactured, processed, packed or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals. Requires each owner, operator or agent in charge of a food facility to identify and implement hazard analyses, preventive controls and written plans to significantly minimize or prevent hazards that could affect food manufactured, processed, packed or held by such facility. Requires FDA to (1) issue guidance documents to reduce the risk from the most significant foodborne contaminants and (2) establish minimum standards for the safe production and harvesting of fruits and vegetables based on known safety risks. This advisory is published by Alston & Bird LLP to provide a summary of significant developments to our clients and friends. It is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.

2 Authorizes FDA to assess and collect fees related to (1) food facility reinspection (where noncompliance previously was found), (2) food recalls, (3) the voluntary qualified importer program and (4) importer reinspection. Title II Requires FDA to (1) allocate resources to inspect facilities and imported food according to the known safety risks of the facilities or food and (2) establish a product tracing system to track and trace food that is in the United States or offered for import into the United States (after conducting pilot tracing projects). Establishes an inspection schedule for domestic and foreign facilities as follows: (1) domestic high-risk facilities will be subject to inspection every three years (but at least once in the five years following enactment); (2) domestic non-high-risk facilities will be subject to inspection every five years (but at least once in the seven years following enactment); and (3) foreign facilities will be subject to increased inspection activities covering not less than 600 foreign facilities in the year following enactment, and at least 1,200 foreign facilities in the second year after enactment (and must continue to double the number of foreign facilities inspected for the first five years following enactment). Directs the Centers for Disease Control and Prevention (CDC) to enhance foodborne illness surveillance systems to improve the collection, analysis, reporting and usefulness of data on foodborne illnesses. Gives FDA mandatory recall authority where the responsible party refuses to voluntarily issue a recall for a food for which there is a reasonable probability that the food is adulterated or misbranded and the use of it will cause serious adverse health consequences or death to humans or animals. Title III Requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and standards for produce safety and is not adulterated or misbranded. Requires FDA to establish a program to expedite review and importation of food offered for importation by U.S. importers who have voluntarily agreed to participate in such a program. Authorizes FDA to (1) require a certification that an article of food imported or offered for import complies with applicable requirements of this Act and (2) enter into arrangements and agreements with foreign governments to facilitate the inspection of registered foreign facilities. Directs the establishment of a system to recognize bodies that accredit third-party auditors and audit agents to certify that foreign entities meet applicable FFDCA requirements for importation of food into the United States. -2-

3 Effective Dates Immediate: While development of a product tracing system, expedited food importation program, expanded CDC surveillance systems and a program to establish accreditation for third-party auditors will take considerable time and resources and will not take effect overnight, other provisions of the final law took immediate effect when the President signed this Act into law. These include the exemptions outlined in the law from compliance with various provisions, expanded records access, mandatory recall authority and the employee protection/whistleblower provisions of the Act. In addition, note that the Act states that beginning on the date of enactment (January 4, 2011), FDA shall increase the frequency of inspection of all facilities. Registered food establishments should update their internal systems and procedures to reflect these authorities and provisions. In addition, registered facilities would be wise to internally audit their procedures and compliance systems to ensure preparedness for increased FDA inspection visits. The Act sets a schedule for implementation of other provisions of the Act. Following are a few noteworthy time points of which industry should be aware with respect to enactment on January 4: Within 120 Days of Enactment: FDA must issue an interim final rule amending FDA s regulations in Part 1, Subpart K, regarding administrative detention to reflect FDA s expanded authority to detain foods upon a FDA officer having a reason to believe (rather than credible evidence or information) that an article of food is adulterated or misbranded. FDA must issue an interim final rule amending its regulations in Part 1, Subpart I, to amend the requirements for prior notice of food imports to include identification of any country to which the article has been refused entry. Within 180 Days of Enactment: The expanded authority for FDA administrative detention of food and the additional prior notice requirement identifying countries refusing entry of the food take effect 180 days following enactment. The Act also directs FDA to update its hazards and controls guidance document relating to fish and fisheries products to account for technological advances by this time point. The Act further directs FDA to issue guidance within 180 days of enactment clarifying when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or supplement should provide FDA with a 75-day notification, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identity of a new dietary ingredient. Within 270 Days of Enactment: FDA, in coordination with the U.S. Department of Agriculture (USDA) and the food industry, must establish pilot projects to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of adulterated food. Within One Year of Enactment: FDA, in coordination with USDA and representatives of state agriculture departments, must publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those fruits and vegetables for which FDA has determined that such safety standards would minimize the risk of serious adverse health consequences or death. Also within one year of enactment, the Act directs the issuance of a guidance document providing updated good agricultural practices for the safe production and harvesting of specific fruits and vegetables. In addition, FDA must issue guidance to assist importers in developing foreign supplier verification programs and issue regulations to provide the content of the foreign supplier verification program. -3-

4 Within 18 Months of Enactment: FDA is required to issue regulations to set standards for the hazard analysis, preventive controls and documentation requirements of the Act, however the general hazard analysis, preventive controls and documentation provisions of the Act take effect 18 months after enactment (with additional time built-in for very small businesses ). The legislation also authorizes FDA to issue an interim final rule implementing the registration suspension provisions of the law. In addition, no later than 18 months after enactment, the Act directs FDA to issue regulations in coordination with the Departments of Agriculture and Homeland Security addressing protections against the intentional adulteration of food (with guidance documents to issue within one year of enactment, including mitigation strategies or measures to guard against such adulteration). The Act gives FDA the option to, within 18 months of enactment, require responsible parties to provide FDA with consumer-oriented information regarding reportable foods, including a description of the reportable food, product identification codes, etc., to assist consumers in identifying reportable foods in their possession. FDA is also required to establish a Voluntary Qualified Importer Program in coordination with the Department of Homeland Security. In addition, FDA must develop model standards, including requirements for regulatory audit reports, and each recognized accreditation body shall ensure that third-party auditors and audit agents of such auditors meet such standards in order to qualify such third-party auditors as accredited third-party auditors under the Act. Within 18 months of enactment, FDA must issue regulations to ensure that there are protections against conflicts of interest between an accredited third-party auditor and the eligible entity to be certified by such auditor or audited by such audit agent. Lastly, the Act directs FDA to issue regulations within 18 months of enactment requiring and prescribing sanitary transportation practices for shippers, carriers by motor vehicle or rail vehicle, receivers and other persons engaged in the transportation of food. Within Two Years of Enactment: FDA must establish a program for the testing of food by accredited laboratories, establish a public registry of accreditation bodies recognized by FDA and require laboratories and accreditation bodies to report any changes impacting recognition or accreditation to FDA. Not later than 30 months after enactment, food testing must be conducted by federal laboratories and non-federal, accredited laboratories using the appropriate sampling or analytical testing methodologies cited by FDA for admission of imported food and where an import alert exists requiring consecutive tests or as otherwise required by FDA to address a suspected food safety problem. In addition, within two years of enactment, FDA must issue a notice of proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack or hold foods designated as high-risk foods (with such designation set to occur no later than one year after enactment). FDA must also establish a system for the recognition of accreditation bodies that accredit third-party auditors to certify that eligible entities meet the applicable FDA requirements. Lastly, two years after enactment, the requirements of the newly created Section 805 of the FFDCA (in Section 301 of the Act) relating to the foreign supplier verification program become effective. * * * A funding battle to support these additional FDA responsibilities under the Act appears to lie ahead in the 112th Congress with a divided Congress and early reports of House Republican unwillingness to fund the legislation, which the Congressional Budget Office had estimated would cost $1.4 billion over five years to implement. Should you have any questions about implementation of the food safety reform legislation and what it means for your business, please contact Julie Tibbets (julie.tibbets@alston.com/ ) or Don Segal (donald.segal@alston.com/ ). -4-

5 If you would like to receive future Food and Drug Advisories electronically, please forward your contact information including address to Be sure to put subscribe in the subject line. For further guidance please contact one of the attorneys or advisors listed below: Washington Office Donald E. Segal Partner Marc J. Scheineson Partner Paula M. Stannard Counsel Julie K. Tibbets Senior Associate Elinor A. Hiller Associate ATLANTA One Atlantic Center 1201 West Peachtree Street Atlanta, GA CHARLOTTE Bank of America Plaza Suite South Tryon Street Charlotte, NC DALLAS Chase Tower Suite Ross Avenue Dallas TX LOS ANGELES 333 South Hope Street 16th Floor Los Angeles, CA NEW YORK 90 Park Avenue New York, NY RESEARCH TRIANGLE 4721 Emperor Blvd. Suite 400 Durham, NC SILICON VALLEY 275 Middlefield Road Suite 150 Menlo Park, CA VENTURA COUNTY Suite Townsgate Road Westlake Village, CA WASHINGTON, D.C. The Atlantic Building 950 F Street, NW Washington, DC Alston & Bird llp 2011