Washington: As the Food and Drug Administration begins the process of implementing the Food Safety Modernization Act (FSMA), a coalition of food industry groups say the agency should only address the highest food safety risks, and all documents should be flexible, cost-effective and science based.
Last week, the U.S. Chamber of Commerce Food Safety Working Group sent a six-page letter to FDA Commissioner Margaret Hamburg outlining a framework of principles to guide the rule making. The group is composed of 19 industry organizations, including the Food Marketing Institute, Grocery Manufacturers of America and The Coca-Cola Co. When drafting guidance and rules under the act, the group wants the FDA to follow White House's Executive Order 13563, a Jan. 18 document that directs federal agencies to identify the "most innovative, and least burdensome tools for achieving regulatory ends."
The letter makes these key points:
A. FDA Should Formulate Guidance and Rules Using a Scientifically Sound, Risk-Based Approach.
"We believe that FSMA guidance and regulations should address the risks of greatest magnitude and highest probability. Furthermore, the risk assessments used to formulate policy and support Agency actions should be based on high quality, up-to-date science and fully comply with all of the provisions of the Information Quality Act, 515 of Public Law 106–554 and the relevant OMB Guidance.
"It is important that risk-based policies are incorporated into all guidance and rules and not as an additional layer of obligation above a base of deterministic regulations. Also, we believe that it is critically important for FDA to ensure its limited resources are focused on scientifically sound and properly defined high-risk concerns. Over-precaution in lower-risk areas will leave the Agency with insufficient resources to deal with the greatest threats to public health."
B. FDA Should Continue to Involve Stakeholders in the Regulatory Process.
"We believe food businesses ought to have a major role in the evaluation and management of risk to promote innovation and regulatory flexibility as Congress has directed. The Working Group and the food industry have a tremendous store of practical knowledge and expertise, and are eager to play a constructive role in FDA’s implementation of FSMA. Cooperation and coordination will benefit all stakeholders.
"Therefore, we are pleased that the Agency has demonstrated it will aggressively solicit stakeholder input regarding FMSA implementation. We are very appreciative of the FDA’s efforts to date and look forward to robust participation and partnerships in the coming months and years. Going forward, we are confident that FDA will ensure comment periods are of adequate length for industry and other stakeholders to fully evaluate regulatory proposals and respond completely, solicit the views of Working Group members in advance of the issuance of proposed guidance or rules, and allow a thorough opportunity for public comment on scientific and technical findings."
C. FDA Should Ensure Inter-agency Integration and Promote Innovation. The food and agricultural sectors are highly regulated and food businesses often face redundant, inconsistent and overlapping rules and regulatory regimes.
"As directed by Section 3 of the President’s Executive Order, FDA should coordinate with other agencies to the maximum extent possible to harmonize FSMA guidance and regulations with existing regulatory schemes. Also, FDA’s internal deliberations should be predicated on the identification and implementation of innovative regulatory approaches. The food industry is constantly innovating food processing and manufacturing methods and American consumers enjoy an unmatched bounty of healthful, convenient and affordable food choices as a result. The Agency must ensure this culture of innovation is promoted and not stifled by FSMA rules and guidance, and that the food industry and American consumers are not chained to a regulatory regime that mandates or promotes outmoded processing or manufacturing methods."
D. FDA Should Adopt the Least Burdensome and Most Flexible Regulatory Approaches.
"As directed by the Executive Order, FDA should at all times identify and employ the least burdensome regulatory approaches, or at least explain why the least burdensome alternative was rejected in any given case. Also, FDA ought to broadly apply RFA analyses and principles to ensure FSMA guidance and rules are as flexible as possible to protect and promote small businesses. Improvident regulation of the food industry will mean higher consumer prices at a time when most Americans are struggling to make ends meet as it is."
E. FDA Should Ensure All Guidance and Rules are Based on a Reasoned Determination that Costs Justify Benefits.
"The Administration directs agencies to propose or adopt regulations “only upon a reasoned determination that its benefits justify its costs.” Therefore, we believe FDA should conduct comprehensive cost-benefit analyses on all rules and guidance issued to implement FSMA to ensure the benefits exceed the costs to the maximum extent practicable."
F. FDA Should Develop and Employ Objective Metrics for Regulatory Efficacy.
"We believe that FDA must have appropriate metrics to evaluate the efficacy of FSMA guidance and regulations. Therefore, we suggest FDA should develop with robust transparency and participation by affected stakeholders and then employ objective and scientifically sound metrics for regulatory efficacy at the earliest practicable time. FDA’s goal should be to assure that guidance documents and regulations demonstrate a measurable and sustained reduction in the incidence of foodborne disease. The failure to meet this goal ought to trigger retrospective analysis and withdrawal, as appropriate."
G. FDA Should Implement FSMA as Congress Intended.
"FMSA grants FDA new legal authorities. However, Congress granted those authorities with the understanding the Agency will implement the law in a common-sense manner that promotes innovation, flexibility and cost effectiveness and with due regard for the protection of trade secrets and intellectual property. Congressional intent, as manifest in the FSMA’s plain language, ought to drive the Agency’s regulatory approach and choices."
The letter was signed by the following organizations:
American Farm Bureau Federation
American Feed Industry Association
American Frozen Food Institute
American Peanut Council
The Coca-Cola Co.
Flavor and Extract Manufacturers Association of the United States Food Marketing Institute
Grocery Manufacturers Association
International Dairy Foods Association
International Association of Color Manufacturers
National Confectioners Association
National Grain and Feed Association
National Grocers Association
National Renderers Association
Pet Food Institute
Snack Food Association
United Fresh Produce Association
U.S. Chamber of Commerce
