The authors recently attended a webcast of the second 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 second of what is sure to be several more public meetings examining FDA's implementation of FSMA. For more information on the first hearing, which focused on import provisions, please see Faegre & Benson's summary.
FDA Opening Remarks
FDA Deputy Commissioner for Foods Michael Taylor gave introductory remarks. Mr. Taylor noted the preventive control measures were the conceptual heart of FSMA, a base upon which most other provisions build. He elaborated that Congress recognized the use of Hazard Analysis & Critical Control Points (HACCP) in other industries, including meat and seafood, and intended to mandate HACCP-like controls as the norm across the food-processing industry. He identified three core challenges in implementing these preventive control measures: (1) creating a regulatory framework that works across the broad and diverse range of companies and foods represented in the industry; (2) making regulations science- and risk-based, and appropriately targeted; and (3) harmonizing with international standards.
Next, FDA Senior Policy Advisor Charlotte Christian gave an overview of FSMA and its provisions. FDA views FSMA as being divided into four key components: (1) Prevention; (2) Imported Foods; (3) Inspections, Compliance & Response; and (4) Enhanced Partnerships. With respect to the Produce Safety provisions, Ms. Christian indicated FDA views them as going beyond simply Good Agricultural Practices (GAPs) or Good Manufacturing Practices (GMPs), and that FDA is developing these rules already. She emphasized there is a significant amount of work for FDA to undertake, much of which has already begun, but that changes will not appear overnight. FDA's implementation approach is therefore focused on building coalitions, assuring the process is transparent, focusing on public health protection, and engaging stakeholders to determine reasonable and practical methods of implementing these provisions.
Donald Kraemer, the chair of FDA's Preventive Control Implementation Team, then presented his team's implementation strategy. Within the preventive controls section, the hazard analysis regulations will be split between those for food for human consumption and animal feed/pet food. However, the intentional contamination provisions, which apply to both human and animal food facilities (including dairies and certain produce farms/packing facilities) will likely be covered by a single regulation. He emphasized that the preventive control measures would build on Current GMPs (CGMPs).
With respect to record-keeping for preventive plans, Mr. Kraemer indicated FDA would not be specifying a particular format in which records would need to be created and maintained, so companies will not need to reinvent their records procedures. Perhaps most importantly for industry, Mr. Kraemer noted the preventive control measures must be flexible. Even if FDA mandates specific controls in particular instances, he indicated FDA will accept alternative controls if they are properly validated. Mr. Kraemer explained there would be an additional hearing to allow for more public input once the proposed rules are published.
Several breakout listening sessions followed. One focused on FDA's preparation of guidance documents for industry on preventive controls. A key issue here was how FDA should group foods, facilities, or industries for the purposes of providing guidance documents. FDA recognizes it cannot provide a guidance document for each type of food or each type of facility. Industry representatives urged FDA to develop models, templates, and/or toolkits, starting with the guidance documents, to help businesses comply with the new requirements.
Another breakout session focused on the relationship between CGMPs and the preventive controls. FDA last revised its CGMP regulations for food in 1986. Prior to the passage of FSMA, FDA was in the process of revising its CGMPs. Now that FSMA has passed, FDA indicated one of the proposed regulations to be passed with respect to preventive controls would focus on modernizing the CGMPs. Participants noted that FSMA specifies seven specific preventive controls, but not all are applicable to animal feed manufacturers. A significant question that arose was whether the preventive controls requirement was in essence a HACCP requirement. The consensus was that Congress intended preventive controls to be broader than just having a HACCP plan. Industry participants urged FDA to look to existing international standards, such as GFSI and CODEX, rather than reinvent the wheel in implementing the preventive control measures.
Preventive Controls Listening Session
The final session of the day consisted of presentations by representatives of consumer groups, the food and feed industries, state regulators, and small businesses. A representative for the Consumer Union advocated for FDA to state clearly and explicitly what elements should be included in preventive plans, for required microbial sampling at high-risk firms, and to require all registered facilities to submit their initial preventive controls plans to FDA. Industry representatives responded that because preventive control plans would be living and constantly changing documents, and given the hundreds of thousands of plans to be submitted, it would not be a good use of FDA resources. Further, both industry representatives and state regulators agreed that the plans would be of little benefit to FDA without seeing the actual facility.
Citing the diverse nature of the food and feed industry, representatives for industry indicated FDA should allow significant flexibility with respect to hazard controls, so long as companies are meeting FDA-set benchmarks. State regulators noted the significant challenge in training their frontline staff to evaluate preventive control plans, especially with reduced state agency funding. A representative for the artisanal cheese industry encouraged FDA to assure whatever standards it adopted would be compatible with EU and other global standards to assist in exporting their products outside of the U.S.
- The Preventive Control measures will be broader than HACCP, although existing HACCP plans and adherence to CGMPs will be a good start.
- FDA appears to agree with industry that there must be flexibility as to which controls are required to control particular hazards.
- CGMPs will be an integral part of the preventive control measures.
- Updated CGMPS will be a part of the forthcoming rules implementing the preventive control measures.
- FDA wants to work with industry and is not afraid to borrow from either industry standards, third-party certification programs, or international standards.
- Consumer advocate groups are active in providing comments on these regulations. Industry groups should assure their viewpoints are heard by providing comments.
- Comments can be submitted until May 20, 2011 at http://www.regulations.gov on docket FDA-2011-N-0251.
Finally, Mr. Kraemer noted there will be at least one more upcoming listening session regarding implementation of FSMA, along with other significant opportunities for comment, once FDA publishes proposed rules. Faegre & Benson will continue to monitor and report back on future hearings and meetings as FDA moves forward with implementing various sections of FSMA.