“PMA and its members absolutely understand that FDA needs sufficient budgetary resources for food safety tools, infrastructure, and personnel to appropriately implement FSMA,” said Dr. Jim Gorny, PMA’s vice president of food safety and technology. “However, we believe these financial resources should come from the Federal budget rather than unfairly and disproportionally falling on the food industry sector.”
The comments also highlighted three areas of most concern to members:
- Education & Technical Assistance for Industry: Gorny outlined that the Administration’s Federal Budget appropriations request of $11.5M for industry education and technical assistance is, “[…] woefully inadequate given the sheer number of regulated business that will be affected by the FSMA regulations.” The association suggested greater federal government resources need to be authorized and appropriated for FSMA education and technical assistance to industry particularly for Land Grant University Cooperative Extension Services. “It is imperative that sufficient resources be allocated to educate industry about FSMA implementation and compliance before FDA regulates,” said Gorny.
- Guidance Development at FDA: The comments expressed a strong desire to engage early, often and repeatedly with FDA on the development of guidance documents for produce industry operations. Gorny requested that, “[…] FDA consider routinely convening a group composed of industry, academia and government subject matter experts to draft and update model compliance guidance for each of the FDA FSMA implementing regulations […].” The comments suggest that group would make recommendations to the agency as to what preventive controls, policies, procedures or practices would address “hazards” appropriately and deem a business to be “in-compliance” with applicable regulations.
- National Integrated Food Safety System: In the Administration’s FY’ 2016 Federal Budget, the President proposed the possibility of a single Federal Food Safety Regulatory Agency. “While the concept has some merit it would simply be too much, too fast with the impending implementation of FSMA. What’s really needed is a truly national integrated food safety system involving federal, state, local and tribal food safety agencies,” said Gorny. PMA expressed support for the role of state governments assisting with education outreach to produce growers and to perform routine FSMA compliance inspections, “[…] because state governments are best positioned to have in-depth working knowledge about produce growers’ and packers’ procedures, policies and practices in their state.” Additionally, the comments requested that FDA provide sufficient time and resources to train produce industry businesses so that they can comply with final rules, as well as training FDA and state regulatory officials regarding agricultural practices. Gorny encouraged FDA to work with stakeholders to harmonize independent third party produce safety market access audit requirements, and to strongly consider the results of those safety audits to reduce redundant inspections by FDA or states that are verifying compliance with the FSMA produce rule.
To read PMA’s comments, visit www.pma.com/topics/food-safety/fsma.