Remarks at the Pet Food Forum
April 4, 2012
Michael R. Taylor
Deputy Commissioner for Foods
U.S. Food and Drug Administration
It’s a pleasure to be here today with pet food industry leaders from around the world. At the FDA, we recognize the important role your industry plays—not only regarding the health of companion animals but regarding the health of their owners.
The convergence of human and animal health is a topic you understand well, but many consumers still have a high learning curve. For example, many people don’t realize that the basic principles of food safety apply to their pets’ food too. We advise consumers on foodsafety.gov—the Federal government’s web site for food safety—that they should wash their hands after handling pet food. Many don’t understand that if pet food is contaminated and is not handled properly, it can cause serious illness in people, especially children.
The incredible growth in the pet food industry is good news to this audience. But with this growth comes a responsibility to ensure these products are as safe as they possibly can be for both pets and their owners. We must recognize that just as the pet food supply is global, food safety must be global as well. So it makes sense for all of us to make food for humans and pets as safe as it can possibly be.
I believe that the Food Safety Modernization Act is taking us in the right direction. Congress has made prevention the foundational principle of the new law. FSMA shifts our food safety focus from reaction and response to prevention—from catching food safety problems after the fact to systematically building in prudent preventive measures across the food system.
The law also codifies the principle that the primary responsibility for prevention rests with the food and feed industries. Within the preventive controls framework, FDA plays its role most effectively by setting science-based, prevention-oriented standards and working to ensure high rates of industry compliance with the new standards.
Recognizing the globalization of the food supply, FSMA embraces the prevention principle for imported food and feed and calls for a fundamental shift in how FDA oversees the rapidly rising volume of imports.
And finally, the law calls for partnerships to make needed changes both domestically and internationally.
Key Foundational Proposed Rules
Implementing the new law is a big job, so we have been prioritizing our work. We have completed a number of initial actions mandated by Congress. For example, we have issued interim final rules on criteria for administrative detention and have used this authority several times. We have issued interim final rules on prior notice for imported food and an interim final rule and draft guidance on records maintenance and access.
But the first major milestone in implementing FSMA will be the issuance of four foundational proposed rules that are critical to fulfilling the FSMA vision of a modern, prevention-oriented food safety system. We hope to publish them soon. They are:
Preventive controls for animal food
Preventive controls for human food
Foreign supplier verification program
The general principles for the rules are the same. They are science- and risk-based, flexible to address the diversity of operations, and sensitive to small businesses.
The first two proposals require preventive controls for human food and animal food. Prevention is not new, but Congress has given FDA explicit authority to use the tool more broadly. Facilities will be required to establish modern preventive controls that are consistent with the internationally recognized principles of HACCP-- or Hazard Analysis and Critical Control Points.
We are developing separate rules for human food and animal food to take into account some differences in how preventive controls would work in these facilities. The animal food rule will address issues specific to animal food and will not address issues that pertain only to human food. For example, the animal food proposed rule does not require controls for allergens, since severe allergic reactions are not common in animals.
And there are several areas addressed by the animal food rule that are not in the rule for human food. The proposed rule will require that pet food and animal feed are correctly labeled as to the species for which they are intended since nutritional requirements differ considerably among species. In addition, nutrient content will need to be controlled for optimal health, which of course is extremely important considering animals may eat the same food their entire lives.
The animal food rule also addresses hazards that could affect human health, and here is where the convergence of human and animal health comes into play. An example is aflatoxin, which would not generally be harmful for dairy animals but could end up as a carcinogenic residue in milk consumed by humans. In the same way, Salmonella must be controlled in pet food not because it can harm cats and dogs but because it could affect humans through cross contamination if mishandled in the home.
The third rule addresses the safety of produce. Farms that grow fresh produce must take a preventive approach as well, but because of the nature of these operations, the preventive controls will be different from those in facilities that manufacture food and feed. The produce safety rule will set carefully targeted science- and risk-based standards for the safe production and harvesting of fruits and vegetables.
The fourth rule addresses import safety, and it is closely tied to the preventive controls and produce safety requirements. The proposed rule on Foreign Supplier Verification calls for a fundamental paradigm shift. Rather than placing primary reliance on FDA inspectors detecting and correcting problems at the port of entry, importers must manage their supply chains to ensure the safety of imported foods. FSMA makes importers accountable for verifying, in a manner transparent to FDA, that the food they import has been produced in accordance with U.S. standards, or under modern preventive controls that provide the same level of public health protection. The FSVP rule will lay out how importers can meet this new requirement.
Having preventive control requirements apply to both domestic and imported products is, of course, essential for food safety and for consumer confidence in today’s global marketplace. Together, these closely interconnected requirements –preventive controls for facilities and farms and importer verification that imported food meets U.S. standards – establish the central core of the regulatory framework envisioned by FSMA. The four proposed rules establishing this framework are in the final stages of review and should be published for public comment soon.
Accredited Third Party Certification
Following closely behind these four rules will be a proposed regulation on accredited third party certification. The FSVP program that importers use to show they are managing their supply chains is a central element of the new import safety system envisioned by Congress, but it is not the only element. Rather, it is part of a larger tool kit for import safety that includes FDA conducting more foreign inspections and working closely with foreign governments to strengthen food safety oversight.
In addition, Congress has recognized the important role already being played in the international arena by private sector third-party audits. Congress and FDA recognize that some of these audits are rigorous and add significant food safety value—and that some do not. To build on the strengths of this private effort, Congress has given FDA a mandate to establish an Accredited Third-Party Certification Program.
Under this program, FDA will recognize accrediting bodies and set standards for accreditation of private third-party auditors that will help ensure the rigor, objectivity and transparency of privately conducted audits. Transparency means that the audit results will be available to FDA, which in turn means that we can rely on private audits as a legitimate part of the public system of assurances and accountability for food safety.
I want to emphasize, though, that in our vision of the future, we see third-party audits—even those conducted under FDA’s program—complementing but not replacing direct regulatory oversight. We are on a pathway to strengthened partnership and we want to reply on the efforts of others, but government oversight at ports of entry and elsewhere across the system will continue to be critical.
We know that building the new food safety system mandated by FSMA requires partnership with the many public and private parties who play critical roles in the system. Thus, stakeholder engagement is a key part of our implementation strategy. It is an important way to help determine reasonable, practical and effective ways to implement the provisions. What we’ve done differently under FSMA is to engage stakeholder even before the proposals are written, which is not common for regulatory agencies to do.
Since FSMA enactment, we have held three public meetings, made more than 350 presentations to groups nationwide, including those representing the animal food industry. In fact, I met with the board of directors of the Pet Food Institute just a few months ago. We have opened numerous dockets for early comments on what the proposed rules and guidance materials should cover. We toured farms and facilities, including a feed mill.
Outreach with the international community has been a priority as well. This includes both our regulatory partners and industry stakeholders. Outreach with our international partners is important in implementing the various FSMA provisions, since they apply to imported products as well. It is also a way to avoid potential trade disputes. At each stage of the implementation process, we are making every effort to ensure that our proposed activities, policies and measures are consistent with the World Trade Organization.
I have led a number of delegations overseas to inform foreign governments and stakeholders about FSMA and in particular how the import provisions will affect foreign countries. For example, I have made several trips to China and have visited Mexico, Canada and the EU.
Outreach and Technical Assistance Moving Forward
Outreach will continue as we move forward. Once the proposed rules are published, it will be important for us to explain them so we can get the best input possible before issuing final rules. We thus will hold additional public meetings, give presentations and have listening sessions during the comment period. We also will be providing technical assistance through three Alliances that have been established with partner organizations—the Produce Safety Alliance, the Preventive Controls, and the Sprouts Safety Alliance. They will provide education, training and technical assistance for industry and government food safety officials. The Preventive Controls Alliance will address both human and animal food, so your industry will have a place to go for technical assistance.
And we also will publish a number of guidance documents both with the final rules and later so that industry and FDA inspectors alike can have a common understanding of what’s expected.
Infrastructure Improvements within FDA
As we proceed with FSMA implementation, we also are focusing on infrastructure changes within FDA to operate more efficiently and effectively in the FSMA environment.
Under a recent FDA reorganization, the Center for Veterinary Medicine and the Center for Food Safety and Applied Nutrition now comprise the Foods and Veterinary Medicine program. This change was made to better integrate food and feed safety, nutrition, and other critical areas.
Within the Foods and Veterinary Medicine Program, just recently, Dr. Linda Tollefson joined our staff as Associate Commissioner. She will serve as a full deputy to me and work closely with senior management at CVM, CFSAN and Office of Regulatory Affairs on all of our issues. Dr. Tollefson is a commissioned officer in the U.S. Public Health Service, a veterinarian, and has a Masters of Public Health degree. She has more than 25 years of experience at FDA and has held positions in both CVM and CFSAN. So she knows the issues that your industry cares about.
In closing, we have a lot of work ahead of us and want to continue our partnership to make sure the rules we have in place, and the other changes implemented, are reasonable and practical for industry while improving the safety of all products we regulate.
The pet food industry has customers with high expectations. We all know that by the calls we get when something goes wrong. The melamine contamination of pet food in 2007 is a good example; we received more than 14,000 reports in the first four weeks after the contamination was discovered.
The changes we are making through FSMA will improve public health, animal health, and also improve consumer confidence in the global food and feed supply. These are benefits for all of us.
I encourage you to provide your input when our proposed rules publish—in fact, we will be depending heavily on your input to ensure we have the best regulations possible.
Thank you for this opportunity to be here today.