Over the years, CVM has developed a comprehensive system for regulating animal feed. More recently, this regulation has been accomplished within the context of the Animal Feed Safety System (AFSS), FDA’s program for animal feed regulation. Aimed at protecting human and animal health AFSS ensures safe feed production and distribution, including pet food. AFSS covers the continuum of agency feed-related activities, which includes:
pre-approving feed additives; establishing feed hazard limits; providing education and training; conducting research; performing inspections; taking enforcement action to ensure removal of unsafe feed from the marketplace, ensuring compliance with FDA regulations; and establishing partnerships with other agencies with responsibility for feed safety.
Since the formation of the AFSS Team, the Food Safety Modernization Act (FSMA) of 2011 became law. In keeping with the overall intent of the new legislation and with the goals of the AFSS project, CVM decided to continue to use AFSS as the title of FDA’s program aimed at protecting human and animal health by ensuring production and distribution of feed that is safe. As FSMA is implemented, the AFSS Team will continue to pursue projects previously identified, to work on assignments to implement FSMA.
The AFSS Team developed a brochure highlighting some of the programs and policies FDA has developed to help ensure the safety of animal feed; Animal Feed Safety System: Coordinating Activities to Improve Food Safety. For copies of AFSS’ brochure, email CVM’s Communications Staff at AskCVM@fda.hhs.gov.
In other outreach efforts, the AFSS Team manned an exhibit booth at the World Pork Expo, and helped operate the CVM exhibit at the International Poultry Expo and the American Veterinary Medical Association annual convention.
We took important steps during the fiscal year to identify risks associated with animal feed while leveraging resources in cooperation with state agencies and designing plans for risk-based inspections. This included accomplishments in the following areas.
Identifying high risk firms. FDA does not have a means of systematically identifying high risk animal feed manufacturing firms. Existing compliance programs focus on medicated feed manufacturing and controls to reduce the likelihood of spreading bovine spongiform encephalopathy (BSE). We began work in FY 2012 developing criteria to assign levels of risk for all firms producing food for animals. The working group for this activity developed a CVM-applicable definition of high-risk facilities and a high-risk model to use for field work planning. The model incorporates all of the high-risk elements of CVM’s current inspection programs, as well as the critical elements of a preventive-focused inspection program. The outcome was a list of high-risk firms and identification of the level of resources needed for inspection of these firms. OSC shared this information with the FDA Field Committee, and it is being used for work-planning for FY13.
Piloting project on risk-based decision-making for animal food facility inspections. CVM’s AFSS Team joined with FDA’s Minneapolis District Office, and the representatives of the states of Minnesota, North and South Dakota, and Wisconsin to initiate a pilot project based on risk assessments. The project developed a harmonized process of establishing inspection priority lists and inspecting high-risk feed manufacturing facilities. The goal was to ensure that high-risk animal feed facilities across the FDA district are identified and inspected in a timely manner using a cooperatively developed, risk-informed work plan approach. The pilot project has identified site-specific risk factors, which will be applied to a consolidated list of feed manufacturers generated by each state and the District Office. The inspection phase began in FY012 and is expected to continue into FY 2013.
The Minnesota District pilot project and the CVM project complement each other. The pilot project is assessing risk factors at individual firms, and the Working Group is taking those risk factors and applying them to the work planning process. The two projects are similar in that both are seeking a way to identify and evaluate facilities based on risk, without the stove-piping (single focus) that can occur (“BSE risk,” “medicated feed risk,” and so on). The pilot project has developed a tool that can be used to compare facilities for a variety of factors, and the CVM project is working on an inspection report form that addresses a wide range of feed safety issues. We are looking at the possibility of using the tool developed by the pilot project to collect and evaluate the information collected by the CVM high-risk inspection project.
Enhancing sampling. Increasing the sampling-based information about the feed supply is vital to improving its safety, and also for transition to the preventive approach mandated by FSMA. OSC has traditionally worked collaboratively with state feed control officials. Consistent with this history, the OSC feed safety team explored expanding the collaboration to include obtaining sample results from the States.
By the end of the fiscal year, 11 States were participating through cooperative agreements funded by FDA and had supplied the results on over 6400 samples. This is a ten-fold increase over the number of samples – approximately 600 – collected by the FDA in recent years. The expanded data will allow CVM to understand better the hazards associated with the feed supply, to take action earlier if warranted, and to develop more informed approaches to preventing hazards from occurring in feeds.
Creating a Rapid Response Team. During the year, OSC developed, tested and implemented a pre-determined virtual rapid response team selected based on skills and knowledge that could be needed for a contamination incident. Formation of the Rapid Response Team (RRT) has led to faster communication and an improved response both within CVM and with the FDA Office of Regulatory Affairs.
The Food Safety Modernization Act (FSMA)
A major FSMA mandate is for the human food and animal feed (including pet food) industries to take steps to prevent unsafe food and feed occurrences. A section of the Act entitled, “Hazard Analysis and Risk-Based Preventive Controls,” provides FDA with the authority to develop regulations for a risk-based, preventive controls food safety system intended to prevent animal food containing hazards from entering into the food supply.
CVM senior staff members have committed to working on FSMA implementation, including taking leadership in FSMA implementations teams and in some working groups. CVM has leadership roles in the Preventive Controls, User Fee, and Federal-State Integration Teams. Many staff members are also working on the Inspection and Compliance team and the International Team. CVM’s work in implementing FSMA will be ongoing; for more information on FSMA implementation, please visit www.fda.gov/fsma.
The Food Safety Preventive Controls Alliance (FSPCA)
CVM has an active role in developing the FSPCA training courses and materials on preventing contamination for both human and animal food during production. The materials to be developed by the alliance will help industry—particularly small- and medium-size companies-- comply with the new preventive control rules under FSMA. The alliance is composed of members from the FDA, local and state food protection agencies, the food industry, and academia. CVM will assist the alliance with developing materials to support the animal food preventive control regulations.
Partnership for Food Protection (PFP)
CVM has also taken leadership in the PFP, with a senior staff member serving on the Executive Committee. FDA established the Partnership for Food Protection in 2008 bringing together federal, state, local, territorial, and tribal representatives with expertise in food, feed, epidemiology, laboratory science, animal health, environment, and public health to develop an Integrated Food Safety System (IFSS). The importance of the work is underscored by FSMA, which codifies an expectation for an IFSS. FSMA, which recognizes that FDA needs to work with partner agencies to meet its inspection requirement, gave FDA the legal mandate to establish an integrated food safety system.
Productive discussions held during the 2012 PFP 50-state workshop centered on the implementing critical foundational components of an IFSS. This includes joint work planning and inspections, integrated state and federal compliance and enforcement teams, immediate notification of egregious conditions observed during inspections, and cross jurisdictional after-action reviews, among other actions. More than 200 federal, state, local and tribal representatives attended including agriculture, public health, and environmental health officials.
Bovine Spongiform Encephalopathy (BSE)
The BSE cow. FDA published BSE feed regulations in 1997 and 2008 to protect against cattle exposure to the BSE agent through animal feed. On April 24, 2012, the FDA was informed by the California Department of Food and Agriculture (CDFA) Animal Health Safety Service Division that a brain sample collected from a cow at a rendering plant in California tested positive for the atypical (L-type) form of BSE.
There is scientific uncertainty about the origin of the L-type strain of BSE. Accordingly, FDA and the CDFA conducted an investigation to try to determine if any feed supplied to the dairy farm and its associated premises since the birth of the cow could have been manufactured with, or cross-contaminated by, ingredients that are prohibited for use in feed for ruminant animals. Based on a review of the inspection histories for 12 feed mills that had supplied the dairy farm, the feed investigation team (consisting of representatives of the FDA Office of Regulatory Affairs (ORA), CVM and the CDFA) did not identify any conditions in which feed ingredients supplied to the dairy farm and associated premises had been manufactured with prohibited material, nor did the team find evidence that any of the feed suppliers did not have adequate safeguards in place to prevent cross-contamination during feed manufacture, storage, or transportation.
BSE inspections. The establishment and amplification of BSE in the domestic cattle herd would have a devastating impact on consumer confidence in the safety of beef and on U.S. trade in beef. During the year, CVM ensured that sufficient resources were allocated to ORA to enable inspection during the year of all known renderers and feed mills processing products containing prohibited material. CVM staff worked with ORA to provide training programs for federal and state inspectors.
In all, ORA inspectors visited 532 such firms, compared with the goal of inspecting 479 firms. In addition, the support and training provided by staff directly contributed to the ability of FDA and the states to perform over 5000 additional BSE inspections. These are firms that had not been identified among the firms that processing or handling prohibited material. We work hard to make sure that the inspections are conducted in a consistent manner. FDA and state personnel receive the same training and use the same forms; results are compiled in one database. The quality and number of these inspections directly contributes to maintaining confidence in the food supply; our actions support the U.S.’s controlled risk status and assure confidence among our trading partners. Our continued close working relationship with USDA and state agencies assures a uniform and rapid response if BSE were detected in U.S. cattle.
Sampling Animal Food for Salmonella
FDA scientists during the year published findings from a study that indicate a decline in Salmonella in animal feed and pet foods including treats. The published paper presented the surveillance data from FDA’s Feed Contaminants Program (2002–2009) and a Salmonella Assignment to the FDA field (2007–2009).
We collected a total of 2,058 samples from complete animal feeds, feed ingredients, pet foods, pet treats, and supplements for pets. Of the samples, 257 were positive for Salmonella (12.5 percent). Salmonella isolates serotyped and tested for antimicrobial susceptibility. Of the 257 Salmonella isolates obtained, 54 isolates (21 percent) were resistant to at least one antimicrobial.
The results presented in the article indicate a significant overall Salmonella reduction in animal feeds, declining from 18.2 percent in 2002 (187 samples tested) to 8.0 percent in 2009 (584 samples tested). Among these samples, feed ingredients and pet foods and treats had the most significant reduction.
The findings provide the animal feed and pet food industries with Salmonella prevalence information that can be used to address Salmonella contamination problems, and credible information to educate pet owners when handling pet foods and treats at home to prevent salmonellosis. The message is that there is continued need for vigilance: salmonellosis is not going to disappear, and is especially significant because it tends to cause sickness in children more so than in animals.
Assuring safety of the animal and human food supplies requires that the ingredients in animal feed are safe for the animal and do not result in harmful residues in human foods of animal origin. Any substance added to an animal food must be used in accordance with a food additive regulation, unless it is generally recognized as safe (GRAS) among qualified experts for its intended use.
The Center for Veterinary Medicine in 2010 began a pilot program allowing individuals and firms to submit notifications to FDA declaring the use of a substance in feed to be GRAS. The GRAS notification pilot program provides a voluntary mechanism for an individual to inform FDA of his or her determination that the use of a substance is GRAS, rather than having to petition FDA to affirm that the use of a substance is GRAS. The GRAS notification pilot program was designed to be a less formal and less cumbersome pathway than the GRAS affirmation process or the food additive petition process which require codification through the federal register process. The program allows FDA to know more about what substances are being added to animal food products, so that animal safety is enhanced. It also provides an alternate mechanism for the animal feed industry to ensure the ingredients it uses meet the requirements of the Federal Food, Drug, and Cosmetic Act.
Under the pilot program, individual and firm notifiers can claim that a substance to be added to feed is GRAS for an intended purpose, and submit the justification for the claim to FDA for evaluation. CVM will evaluate the submitted notice and respond, stating either that the Center has no questions about the substance or that the notice does not sufficiently support the claim that the use of the substance is GRAS. CVM’s response that it has no questions does not represent CVM’s determination that the ingredient is GRAS. Instead, it means that CVM has no questions regarding the notifier’s determination that the use of the substance is GRAS, and the firm may market the substance for that use in feed.
As of the end of FY 2012, CVM had posted online the status of 13 GRAS notices; five did not provide a basis for a GRAS determination, five were withdrawn voluntarily by the notifier, and three resulted in no-question letters from FDA/CVM.
Feed Safety Video
The AFSS Team, with the video production staff of FDA’s Center for Devices and Radiological Health, produced a video about animal feed and pet food issues.FDA and Pet Food describes FDA’s role in regulating pet food. AFSS videos are available on FDA.gov and on YouTube.
"Controlled risk" is a designation given by the OIE based on what we do to monitor and control BSE in the U.S.