The authors recently attended a webcast of the third of several U.S. Food and Drug Administration (FDA) hearings focusing on implementing portions of the Food Safety Modernization Act (FSMA). Following is their summary of the proceedings.
This hearing was the third of a series of public meetings examining FDA's implementation of FSMA. The first hearing on March 29, 2011 focused on the import provisions, while the second hearing, on April 20, 2011, focused on the preventive controls provisions of FSMA.
FDA Opening Remarks
The meeting began with opening remarks from FDA Deputy Commissioner for Foods Michael Taylor. Mr. Taylor indicated FMSA significantly changes the way FDA will need to perform inspections. This results from the change from a reactive to a protective, prevention-focused food safety regime. In particular, he noted that one component of inspections going forward will be a review of a company's preventive measures systems. Mr. Taylor discussed the mandate from Congress that FDA work with states and foreign governments with respect to oversight of food safety matters, which will include FDA's investing in the states' regulatory organizations. Finally, Mr. Taylor expressed his belief that there is a significant need for outreach, education and technical assistance to industry, especially smaller businesses, in complying with FSMA. As a result, he indicated FDA needs to be in the business of providing such outreach, education and technical assistance to assure high rates of compliance.
Barbara Cassens, director of the San Francisco FDA office and chair of the FSMA Inspection and Compliance Team, discussed FSMA implementation generally. She noted that the Inspection and Compliance Team alone consisted of more than 150 members. Ms. Cassens also indicated that the inspectors are FDA's "eyes and ears" and the primary vehicle by which FDA obtains information on facilities they regulate.
Breakout Session One: Frequency and Targeting of Facility Inspections
The first breakout session focused on questions surrounding how FDA should target facilities for inspections and what criteria should be used to determine both the frequency of inspections and classification of facilities as "high risk". One key issue involves the information that exists to assist FDA in making some of these determinations. A common theme was that industry information needed to be made available, at some level, to FDA. This would include internal testing and research data, as well as other types of information companies within the various industries gather internally. While finding the information potentially helpful, industry representatives were concerned about just giving information to FDA, with no assurances the data would be kept confidential or sanitized for confidentiality. They also emphasized FDA should work with other agencies which collect various forms of data, such as USDA, state agencies, and foreign governments to reduce duplication of efforts. One interesting point raised was the potential use of information from third-party certification systems. With more and more food companies voluntarily opting to use these systems, they are not only a possible source of information for FDA but also perhaps a way to help narrow inspection targets. For example, if a company is certified by a respected third-party certification company, does that company get a pass, or perhaps strengthen the odds of not being inspected that year?
FDA also raised the issue of requesting certain information from companies, such as the hazard analysis and prevention plan, prior to appearing for an inspection. Consumer groups argued that obtaining this information for ALL companies would allow FDA to determine what companies within an industry were doing, looking for trends and gaps. In turn, this would allow FDA to have more knowledge and be better prepared going into an inspection, or to determine the risk level for that company. For example, if the hazard prevention plan was thorough and other data indicated it was well implemented, a facility may not be considered high-risk, even if it produces a high-risk product. Industry representatives raised concerns that even if companies produce the same product, no two facilities are the same. Simply compiling certain documents and using them as a comparison might not give a complete picture. There were also concerns that requiring companies to submit hazard prevention plans would greatly increase FDA's workload. Industry representatives also noted that many of these documents and plans are not static, but rather changes as products, ingredients, or other circumstances change.
The final issue discussed in this session involved the difficulty of identifying "high-risk" facilities in a consistent and meaningful manner. There appeared to be some consensus that production of a high-risk product alone should not be enough to classify a facility as "high-risk", but instead something more akin to a matrix-type review would be better. There was also discussion of phasing in the high-risk designation, with a first-cut definition being quite broad, and then narrowing based on specifics of a particular facility.
Breakout Session Two – Enforcement Authorities
In the second breakout session of the day, FDA sought comments on its use of its new enforcement authorities, including administrative detention powers, mandatory recall powers, and suspension of registration for registered facilities. With respect to administrative detention, a consumer representative urged FDA to give inspectors the ability to order a detention immediately on site, while others argued inspectors should be allowed only to recommend detention. FDA raised the issue of when it should use its administrative detention power with respect to misbranded foods. A consumer representative urged that FDA should be allowed to use this power broadly, including where a company makes false or misleading health claims. Others were very concerned with any use of administrative detention with respect to misbranding, outside of failure to label for allergens, suggesting FDA should use its power judiciously and not over minor labeling errors.
The discussion then turned to the facility registration suspension provision. A key issue raised was that Congress included a non-delegation provision in this section, meaning that only the commissioner can suspend a registration. This suggests the registration suspension provision should only be used in the most serious of cases. While the standard was essentially the same as that for a Class I recall, industry urged FDA to reserve this power for use in the most extreme cases, where there has been a history of non-compliance and fair warning, or intentional bad conduct. It urged FDA not to use this power any time there was a Class I recall, as it would punish the good companies which issue recalls to protect consumers. With respect to each of FDA's new enforcement powers, the general consensus was that FDA needed to assure consistency among its various enforcers, needed to provide clear guidance to industry on its enforcement rules and procedures, and needed to do so in a transparent fashion.
Breakout Session Three - Manner of Inspection in a Preventive Controls Environment
The third breakout session of the day focused on issues surrounding inspection strategies. Many of the ideas discussed in this panel were ones raised earlier in the day, such as the use of matrices to determine inspection targets and the potential benefit of requesting information in advance of an inspection. There was substantial focus on the use of documents prior to an inspection. Participants noted third-party auditors often request this type of information prior to an audit, and that it is a key way of ensuring auditors are prepared and well-informed prior to entering an establishment.
There was also consensus that FDA should focus on training of inspectors to ensure consistent application and interpretation of regulations throughout the country. Participants noted this was a prime time for FDA to provide enhanced training and information to inspectors, and also to provide guidance documents to industry. This would allow industry to understand what to expect during inspections and how regulations are interpreted.
A final theme in this discussion, also raised earlier in the day, was how FDA could best use resources to implement the foreign inspection mandate. A common point raised was the need to use partnerships, not only with foreign governments and agencies but also with other U.S. agencies which already have relationships or inspection programs in foreign countries. There was significant discussion about relying on inspections conducted by foreign agencies or by third parties. All participants – industry and consumers – sought consistent application of rules and regulations from FDA as well as the various other federal, state, and local agencies that are involved in food safety.
Listening Session: Focus on Inspections and Compliance
The final listening session involved representatives from various consumer and industry groups, as well as the Canadian Food Inspection Agency, providing a few brief comments and participating in a panel with FDA representatives. The representatives often took their time to provide their own organization's view on various aspects of FSMA. While they addressed diverse topics, there were a few items all generally agreed upon. The first was that the task before FDA is large, and the fact that FDA was involving industry in the process was both necessary and appreciated. There was also general agreement that FDA needs to provide guidance on a variety of topics – whether official guidance documents to industry, training and guidance to inspectors, or a clear set of expectations to states that contract with FDA to conduct inspections or other activities. FDA urged stakeholders to submit comments to the agency on the topics that were the focus of the day, with comments due by July 6, 2011.
Interested parties can submit comments on http://www.regulations.gov to docket FDA-2011-N-0366 by July 6, 2011.