April 19, 2013
In a hearing about the agency’s proposed Fiscal Year 2014 budget request, Food and Drug Administration (FDA) Commissioner Hamburg fielded questions from Senate Agriculture Appropriations Subcommittee members on a wide-ranging set of issues, from sequestration effects to cosmetics and food safety. Throughout the hearing, Senators raised issues and questions about the FDA’s proposed regulations on produce safety and on safety measures for facilities that process human food. The big news item coming out of the hearing was that Commissioner Hamburg confirmed rumors that FDA is planning to extend the comment period on both rules by 120 days.
In his opening statement, Subcommittee Ranking Member Blunt (R-MO) raised concerns about the burden of the new regulations on small businesses. He cautioned the agency to avoid a “one-size-fits-all” approach, particularly with respect to new regulations for menu labeling. He echoed the same sentiments in his discussion of the two proposed food safety regulations, saying that they would have a significant impact on small entities. He also raised concerns about the new food safety regulations pricing certain producers out of the market, and making it hard for growers to compete with imports.
Senator Tester (D-MT) asked a series of questions about the FDA’s implementation of mandates in the Food Safety Modernization Act (FSMA), particularly with respect to the proposed rule on food facilities. Along with Senator Hagan (D-NC), Senator Tester championed key provisions in FSMA that required FDA to account for the different levels of risk that different supply chains pose to the safety of our food supply.
On the issue of adequate data to inform and assess the impact of the new proposed regulations, Senator Tester asked Commissioner Hamburg about a study that the agency conducted on the food processing sector. Since there are very few data available about the size and characteristics of the food processing sector, FSMA required FDA to conduct a food processing sector study, with a particular focus on collecting information about the number and types of facilities co-located on farms. The study was meant to inform the development of the new regulations, yet FDA released it along with, rather than in advance of, the proposed rules.
Senator Tester asked why the agency delayed the release of the study, and followed up with a question about whom was surveyed for the study, noting that FDA relied on very limited opinion to inform the study. Commissioner Hamburg was not aware of the study and responded that the agency was trying to go forward with an open process and to bring the best science to bear in the development of food safety regulations.
Senator Tester then asked a question about why the agency had failed to clarify the definition of a “retail food establishment” to include direct-market activities. In writing FSMA, Congress directed FDA to clarify that community supported agriculture operations, farmstands, farmers’ markets, and other direct-market venues that are not located on-farm fall under the definition of a retail food establishment. Retail food establishments do not have to register as “facilities” with FDA and, therefore, would not be subject to the preventive controls regulations for food facilities. This is a critical clarification, required by law, that the agency inexplicably has not made in its proposed rules.
Commission Hamburg was confused by the question, and was seemingly unaware that the agency has not issued a rule to implement this requirement of the law. She answered more generally by stating that the agency did not want to take a “one-size-fits-all” approach and was trying to write risked-based regulations. Senator Tester added that we need to fit regulation to the risk.