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Ensuring Feed Safety

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2011 Annual Report

CVM has over the years developed a comprehensive system for regulating animal feed. Most recently, this regulation has been accomplished within the context of the Animal Feed Safety System (AFSS). The AFSS is FDA’s program for animal feed aimed at protecting human and animal health by ensuring production and distribution of safe feed. The AFSS covers the entire continuum of Agency activities, such as: pre-approving additives for use in feed; establishing limits on feed hazards; providing education and training; conducting research; performing inspections, taking enforcement for ensuring the removal of unsafe feed from the marketplace and to ensure compliance with Agency regulations; and establishing partnerships with other agencies with responsibility for feed safety.

FY 2011 brought a major development that will impact the regulation of animal feed for years to come: the FDA Food Safety Modernization Act. CVM leadership and subject matter experts are working closely with representatives from the FDA Office of Foods, the FDA Office of Regulatory Affairs, the FDA Center for Food Safety and Applied Nutrition, and other agency components in the implementation of this new law, which applies to animal feed and pet food, in addition to human food.

We describe the Food Safety Modernization Act’s influence in this section, along with a new initiative related to the regulatory status of feed additives, and other actions.
 

Challenges and Accomplishments

The Major Impact of the Food Safety Modernization Act
 

Signed into law in January 2011, the Food Safety Modernization Act enables FDA to better protect public health by strengthening the food safety system. The Food Safety Modernization Act brings the most extensive change in FDA’s regulation of human food and animal feed (including pet food) since the Federal Food, Drug, and Cosmetic Act was enacted in 1938. A major mandate of the Food Safety Modernization Act is for the human food and animal feed industries to take steps to prevent unsafe food and feed occurrences. The Food Safety Modernization Act enhances FDA’s regulatory toolbox to help ensure industry compliance with the new requirements and to respond more effectively when unsafe food or feed is discovered.

The Animal Feed Safety System, implemented by CVM with the efforts of the FDA Office of Regulatory Affairs and partnerships with state feed control officials, has been FDA’s comprehensive program for animal feed regulation aimed at protecting human and animal health by ensuring production and distribution of feed that is safe. For example, longstanding good manufacturing practices provide a systematic approach for ensuring feed safety through the identification and use of appropriate controls during the manufacturing, packaging, storing, and distributing of feed ingredients and mixed feed.

However, planning for future execution of CVM’s regulation of pet food and animal feed safety is being influenced greatly by the implementation of the Food Safety Modernization Act. The Act provides new authority in five major areas: preventive controls, including measures to control intentional contamination; inspections and compliance; tools for effective response, such as administrative detention of violative products; new authority for regulating imported products; and provisions for enhanced partnerships. Following is an elaboration of certain Food Safety Modernization Act provisions and a summary of action taken by CVM during FY 2011.
 

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Preventive Controls to Avoid Contamination and Other Problems
 

Background. Currently, FDA has regulations governing the controls for manufacturing, processing, packing, and holding of drug premixes and medicated feeds. However, a broader regulatory approach is required that addresses animal food safety issues associated with the manufacturing, processing, packing, and holding of animal food, including pet food, animal feed, and raw materials and ingredients.

The Food Safety Modernization Act modified the Federal Food, Drug, and Cosmetic Act by adding section 418, “Hazard Analysis and Risk-Based Preventive Controls.” The section provides FDA with the authority to develop regulations for a risk-based, preventive controls food safety system intended to prevent animal food containing hazards, which may cause illness or injury to animals or humans, from entering into the food supply.

As directed by Congress, FDA is working to have final animal food preventive control regulations in place by the end of September 2012. Regulations to be drafted under the Food Safety Modernization Act will require, among many other things, written food safety plans for facilities that are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act. FDA published a notice in the Federal Register in May 2011, seeking public comment on preventive control measures in order to help develop guidance for food facilities.

Cross contamination. The Food Safety Modernization Act requires FDA to implement the Safe Food Transportation Act, and that mandate has given the rule-making process a higher priority. The rules under development are intended to minimize the opportunities for cross-contamination during transportation and will strengthen the agency’s ability to regulate the transportation of feed and feed ingredients. CVM is working with FDA’s Center for Food Safety and Applied Nutrition and Office of Foods on this issue.

Intentional contamination. The Food Safety Modernization Act has two sections that specifically address intentional contamination of feed. Section 103, “Hazard Analysis and Risk-Based Preventive Controls,” requires the owner, operator, or agent in charge of a facility to identify and evaluate hazards that may be intentionally introduced, including hazards resulting from acts of terrorism; to identify preventive controls (mitigation strategies) for the identified hazards; to monitor and verify the implementation of the mitigation strategies; and to document how the facilities meet these requirements.
Section 106, “Protection Against Intentional Contamination,” requires FDA to promulgate regulations to protect against the intentional contamination of food and feed using appropriate science-based mitigation strategies or measures to protect the food supply chain at specific vulnerable points.

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Effective Agency Response to Unsafe Products

  • Administrative Detention. As required by the Food Safety Modernization Act, FDA issued an interim final rule, effective in July 2011, which strengthens FDA’s ability to prevent potentially unsafe food from reaching U.S. consumers. It allows FDA to detain food administratively that the agency believes is adulterated or misbranded. Previously, FDA’s ability to detain food products applied only when the agency had credible evidence that the food products were contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals.
  • Imported food and feed. A second interim final rule, also implemented effective in July 2011, requires anyone importing food into the United States to inform FDA if any country has refused entry of the same product, including food for animals. This new requirement will provide the agency with an additional element of information, improving FDA’s ability to target foods that may pose a significant risk to public health. This new reporting requirement will be administered through FDA’s prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

Feed imports have increased dramatically without a significant shift in the way FDA conducts its oversight until recently. All imported feed products are required to meet the same standards as domestic goods. The Food Safety Modernization Act has provided FDA with the authority to establish requirements for import certifications for food and feed. The agency’s relationships with regulatory partners and industry stakeholders will be enhanced through foreign supplier verification programs, accreditation of third-party auditors, and the establishment of a voluntary qualified importer program.

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User Fees
 

The Food Safety Modernization Act represents a critical step in strengthening the U.S. food safety system. However, there are costs associated with achieving full implementation. The Act allows FDA to recover 100 percent of its costs associated with certain domestic and foreign facility re-inspections, failure to comply with recall orders, and certain importer re-inspections through the establishment of user fees. Previously, FDA bore the burden of these costs. The Food Safety Modernization Act User Fee Team – co-led by CVM and consisting of staff from FDA centers, including the Office of Regulatory Affairs, the Center for Food Safety and Applied Nutrition, and the Office of Chief Counsel – was launched in February 2011. The team was charged with establishing the business model and developing the user fee rates for all of the fee provisions required by the Food Safety Modernization Act.

On August 1, 2011, FDA announced three types of fees in a Federal Register notice (re-inspection, recall order and importer re-inspection fees) that were to become effective on October 1, 2011. Also, on August 1, 2011, FDA published an additional Federal Register notice announcing the establishment of a docket to obtain information that would be used to formulate a proposed set of guidelines that consider the burden of user fee amounts on small business. Dockets for both notices were extended to November 30, 2011, to allow more time to gather comments from our stakeholders including industry, small businesses, and the public. Since the announcement of the Federal Register notice, the import re-inspection fee has been put on hold.

The team continues to work on the development of the other user fee provisions: export certification user fees, voluntary qualified importer program, and the third-party auditor’s accreditation.

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Generally Regarded as Safe (GRAS) Voluntary Notification Initiative

In 2010, CVM established a GRAS notification program that will provide the Center with more knowledgeable and current information on substances used in animal feed. A firm may market a substance as GRAS (i.e., not requiring approval of a Food Additive Petition) for use in animal food based on the firm’s own determination. However, the firm markets the substance at its own risk. If FDA does not agree with the firm and concludes that the use of the substance is not GRAS, the agency may take regulatory action against the firm and the substance being marketed.

FDA announced the start of CVM’s GRAS Notification Pilot Program in a June 4, 2010, Federal Register notice. CVM initiated the pilot program to increase its efficiency in ensuring that feed ingredients are used in accordance with the Federal Food, Drug, and Cosmetic Act.

Under this program, a firm will notify CVM of its GRAS determination by submitting a summary of publicly available information in support of its claim that a substance is GRAS under specific conditions of its intended use in animal feed. CVM will evaluate the submitted notice to determine whether it provides a sufficient basis for a GRAS determination, or whether information in the notice (or information otherwise available to CVM) raises issues that cause CVM to question whether use of the substance in feed is GRAS.

The level of participation in the program has substantially increased in FY 2011. As of the end of September 2011, CVM had filed 13 GRAS notices for further review within the Center.

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Bovine Spongiform Encephalopathy (BSE)/Feed Safety Support Program Grants

The Ruminant Feed Ban Support Program, and the cooperative agreements (grants) to state feed regulatory agencies that were initiated in FY 2006 were extended for another 5 years, after modification of the program and re-competition for the grants by interested states. The first 5-year cycle focused solely on BSE by providing supplemental funding to 12 states to help them increase their abilities to find and monitor companies that manufacture, distribute, and transport animal feed or whose operations involve feeding ruminant animals. That program was very successful. In the second 5-year cycle, the program has been broadened to help the state feed regulatory programs address other feed safety issues, in addition to BSE.

The Ruminant Feed Ban/Feed Safety Support Program is supported by the FDA’s Office of Regulatory Affairs, FDA’s Division of Federal-State Relations, and CVM’s Office of Surveillance and Compliance, to enhance state, territorial, and tribal animal feed safety infrastructure and BSE prevention programs. Under these agreements, the state regulatory agencies may use the funds to purchase equipment, conduct inspections, undertake sample collection and laboratory analysis, and/or make educational outreach to increase industry compliance with the ruminant feed ban and other regulations.

The 12 states currently enrolled were awarded up to $250,000 each. These states are Colorado, Florida, Illinois, Iowa, Kansas, Kentucky, Michigan, Nebraska, New York, North Carolina, Texas, and Washington. 
 

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