As a benefit of Organizational Affiliate (OA) membership, AOAC brought together on February 27, 2008, representatives from the dietary supplement, food and beverage, infant formula, test kit, contract laboratory, and instrument companies to discuss their analytical areas of interest and concern with Stephen Sundlof, director of the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN). CFSAN was also represented by Robert Buchanan, Steven Musser, and Don Kramer. A majority of OAs from different sectors took advantage of the opportunity to participate in the first guest speaker teleconference that was intended to foster communication between the group and regulators. By bringing OAs together with regulators, AOAC aimed to provide a forum for OAs to share their needs with regulatory agencies.

“Guest speaker conference calls give us a better understanding of where the agencies are headed and where their increased focus lies,” said Morgan Wallace of Dupont Qualicon.

Ron Johnson of bioMérieux Inc. agrees: “The calls provide a unique forum for OAs to network with key decision makers in the regulatory agencies. It allows us to have access to the most current, relevant information and priorities for the agencies as it relates to food safety. By identifying food safety issues from a regulatory perspective, through direct engagement, OAs can more accurately prioritize and develop solutions to meet the needs of regulators and public safety.”

Kicking off the conference call, Sundlof described the agency’s work under the new FDA Food Protection Plan (available on the CFSAN Web site at http://www.fda.gov/oc/initiatives/advance/food/plan.html), an integrated strategy for protecting the nation’s food supply from unintentional and deliberate contamination, and the Import Safety Action Plan. He also provided insight on current and future issues relating to food safety, discussed CFSAN’s needs for methods, and acknowledged the work of AOAC in food safety.

The call was then opened up for a question and answer session, at which time OAs had the opportunity to discuss issues related to food safety, among other topics of concern. Here, some excerpts from the question and answer session during the first OA guest speaker teleconference.

OAs Voice Interests and Concerns

Third-Party Testing

OAs were interested in knowing if CFSAN has the authority to certify laboratories, adding that the Association is in the very early stages of discussions regarding a coalition of private laboratories interested in providing food safety testing under the Food Protection Plan and the Import Safety Action Plan. CFSAN replied that currently the agency does not have regulatory authority to certify third-party laboratories as a means of enhancing and expanding the testing capabilities for FDA.

The Food Protection Plan states: “The universe of domestic and foreign food establishments subject to FDA inspection is immense and continuing to grow faster than the FDA’s inspection resources. Even with the most sophisticated detection tools and laboratory capabilities, the FDA’s inspection resources are finite. Therefore, legislation to authorize the FDA to accredit independent third parties, or to recognize entities that accredit, to evaluate compliance with FDA requirements would allow FDA to allocate inspection resources more effectively.”

Import Safety and the Role of Industry

Citing, for example, the recent and seemingly intentional contamination of melamine in pet food, in which industrial plastic monomers were misleadingly represented as part of the protein component of wheat gluten and rice protein concentrate, OAs inquired about preventive measures implemented by CFSAN to ensure import safety. In addition, what is the role of industry in this initiative?

Sundlof explained that the FDA’s new Food Protection Plan deals with both food safety and food defense for domestic and imported products. The Plan’s three elements of protection include preventing foodborne contamination, intervening at critical points in the food supply chain, and responding rapidly to minimize harm. The Plan is integrated with FDA’s Import Safety Action Plan.

CFSAN is working toward a preventative control system that would give the agency the ability to inspect product at critical points in the food supply chain. While the agency currently has authority to do this with its own staff, CFSAN does not have authority to accept the results of third-party laboratories. Additional resources (perhaps in the form of third-party laboratories) are required to meet this need. Until then, CFSAN must rely on foreign governments to only export products from those companies that meet criteria compliant with standard operating procedures. “With regard to imports, FDA will also work with foreign governments, which have a greater ability to oversee manufacturers within their borders to ensure compliance with safety standards.” (Food Protection Plan)

Due to limited resources, CFSAN’s first priority is on high-risk foods “that have been shown to pose a threat to public health for U.S. consumers.” OAs pointed out that “high-risk” foods don’t only pertain to those that impact health but also foods with potential for economic fraud as well, such as the intentional contamination of melamine in pet food. So how does CFSAN make decisions on high-risk foods? Are surveillance programs in place to control economic fraud?

Sundlof said that CFSAN needs legislative authority to implement a quality assurance program to issue preventative controls for high-risk foods that would give the agency ability to inspect at critical points in the food supply chain. “The FDA requests explicit authority to issue regulations requiring specific types of foods (those that have been associated with repeated instances of serious health problems or death to humans or animals from unintentional contamination) be prepared, packed, and held under a system of preventive food safety controls. Such authority would strengthen the FDA’s ability to require manufacturers to implement risk-based Hazard Analysis and Critical Control Point (HACCP) or equivalent processes to reduce foodborne illnesses from high-risk foods.” (Food Protection Plan)

No one anticipated the melamine incident, said the OAs. One OA added that wheat, at the time of the melamine in wheat gluten incident, was one-third the price it is now, so the temptation for economic fraud is even greater today. With melamine or any other source of contamination, does CFSAN expect industry to act as “whistle blowers?” According to CFSAN, industry is one of the first to know if there is a bad product on the market. For instance, with melamine, suppliers of pet food learned of the contamination when it affected the animals they were using for taste testing their products and quickly pulled their products off the store shelves because of the contamination. Indeed, CFSAN looks to industry to help identify a potential problem that may indicate a need for intervention, saying that if something is too cheap to be true, it probably is not true. Food companies and processors should be red flagged if they don’t meet U.S. safety requirements. As an example, Sundlof noted the FDA’s import alert on vegetable proteins from China because they may contain the chemical melamine.

Seafood Initiative

Import alerts also expand into the seafood industry. When OAs brought up the seafood initiative, CFSAN said there is indeed a commercial need for screening and monitoring raw material to identify foods that pose a risk. Preventative controls need to be in place. However, FDA cannot force players to the table. The agency suggested that the best way to bring players to the table is to find the commercial need, stating that the seafood issue presents a commercial need beyond FDA, and thus there should be an industry interest for methods.

On the test kit front, OAs were concerned that their kits are impeded by modern techniques such as LC/MS/MS methods that allow for detection limits down to lower levels than the kits attain. What level of sensitivity is enough, asked the OAs. Their argument is that test kits can provide a greater level of food safety because they can be implemented for very widespread use. Whereas LC/MS/MS methods can only be run in a number of sophisticated laboratories, test kits can be run routinely all over the world in relatively unsophisticated laboratories to help keep food safety issues under control. The OAs highlighted the success of test kits to detect the presence of chloramphenicol in honey and seafood.

CFSAN said that the law does not help the test kit manufacturers’ argument because it has not been possible to identify a safe level for some compounds. CODEX is working to establish maximum residue levels, and the limit of detection criteria should then be derived from the maximum allowable residual levels (e.g., action levels). CFSAN noted that this issue is legally complicated and encouraged continued development and validation of test kits to provide a greater level of food safety.

Seafood continued to be a hot topic as an OA wanted to know if CFSAN would be interested in a preservative system. This system would allow for the preservation of seafood while product is detained and held for detection until deemed safe and compliant with regulations. CFSAN responded that fresh and frozen products are treated differently, and that procedures are in place to handle fresh, frozen, and canned seafood while testing is being done. The agency would be interested in a preservative system to extend shelf life if it helps deliver the food safely.

AOAC and CFSAN agreed that the best approach in the seafood initiative would be for all interested parties to come together to the table. In fact, AOAC is planning a seafood stakeholders meeting in May or June to do what the Association does best—bring stakeholders together to reach consensus on standard analytical methods to detect contaminants in seafood.

Produce Initiative

In response to a test kit company’s inquiry about the opportunity for a produce safety initiative (for example, rapid detection of E. coli O157:H7 in lettuce, spinach, etc.), CFSAN said that bringing all interested parties (test kit companies, produce/food companies, regulators, etc.) together would be a good approach. However, this would require industry funding.

Dietary Supplements

With the final GMP rule in effect this June for large companies, to start, OAs were interested in knowing what types of surveillance FDA has in place to handle this daunting effort. Sundlof said that 250 inspections are planned in the coming year and that the effort is funded from existing budget. When asked if major brands are first in line for inspection, Sundlof replied “yes.”

Harmonization of ISO and BAM Methods

One OA inquired if CFSAN plans to harmonize ISO and Bacteriological Analytical Manual (BAM) methods. The agency responded that many methods are tested in FDA field laboratories which are ISO certified. ISO certification demonstrates that a laboratory’s management system meets international quality requirements. CFSAN would like to move toward harmonization of ISO and BAM methods.

The agency is reinvigorating the BAM process by obtaining more formal evaluation of methods such as trial studies in an FDA field laboratory.

Speaking of the BAM, OAs brought up the age-old argument that traditional methods found in the BAM, although still used by developing countries, do not reflect advances in detection technology. OAs said that it is time to bring the methods up to date with modern standards. CFSAN agreed that “we can’t live in an age of ancient techniques.”

When asked if opportunity exists for FDA to work with AOAC and companies to include in the BAM test kits that receive AOAC Research Institute Performance-Tested Methods ^SM certification, CFSAN’s response was positive, yet no specific approach was agreed to. An OA test kit manufacturer suggested the possibility of a call for new methods by FDA (through AOAC) to fulfill the need for rapid detection methods in the BAM.

Regional Laboratories

OAs also took this opportunity to discuss FDA’s direction for effective use of regional laboratories. The agency is looking to improve throughput of laboratories, saying that laboratories can handle a large volume of samples. FDA is examining ways to best utilize laboratories, which will require resources. An OA suggested dividing the work of laboratories by samples or geography.

Health Claims

As functional foods gain in popularity, OAs asked about CFSAN’s initiatives regarding health claims for these types of foods. Functional foods are defined as foods or dietary components that may provide a health benefit beyond basic nutrition. CFSAN said that the Federal Register states that companies are allowed a certain number of health claims (nutrient content claims, structure and function claims, dietary guidance claims, qualified health claims, and health claims). Scientific research and a high standard of evidence are needed to confirm and support these claims.

An OA wanted to know if health claims can cross into food versus drug. CFSAN responded that they cannot, according to law (FDA Amendment Act 2007). Language states that if a product is approved as a drug, it cannot subsequently be approved as a food with health benefits.

Threat Detection

A test kit manufacturer highlighted AOAC’s efforts in support of a contract with the U.S. Department of Homeland Security to validate methods for the detection of biological threat agents in the environmental setting. Of interest to the test kit company was whether to adapt this technology to apply to detection of threat agents in high-risk foods. CFSAN encouraged this kind of technology and reiterated that the agency is relying on outside partners to develop such tests. Sundlof pointed out that this is also stated in the Food Protection Plan.

Conclusion

AOAC hopes to offer more opportunities in the future, such as guest speaker teleconferences, to bring OAs and regulators together to build lines of communication. For more information on the OA program, contact Dawn Frazier at dfrazier@aoac.org or Anita Mishra at amishra@aoac.org. To become a member of AOAC, visit http://www.aoac.org/membership/joinindividual.html.

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