The Food Safety Modernization Act (FSMA) amends key provisions of the Federal Food, Drug, and Cosmetic Act and significantly revises federal food safety laws. While the FSMA represents a sweeping reform to the federal food safety laws, its day-to-day effect on the regulated industry will depend on several developments.
FSMA directs FDA to implement many of its mandates through rulemaking and guidance documents. In addition, many of the mandates imposed on FDA, such as an increased inspection schedule, must be supported by appropriations from the new Congress. ABA’s Food Technical Regulatory Affairs Committee (FTRAC) met with FDA February 9 to discuss FSMA.
The Food Safety Modernization Act (FSMA) establishes sweeping reform to federal food safety laws. New requirements include: preventative process controls; hazard evaluation; traceability; safety of imports; recordkeeping and access; inspection; FDA enforcement powers and recalls. Because of ABA’s efforts during negotiations, user fees were not included in the bill. Additionally, ABA was responsible for language included in the package providing opportunity to seek exemption for facilities that solely hold finished, packaged food.
The President signed FSMA into law on January 4, 2011. During the 112th Congress, a key issue will be securing appropriated funding resources needed to implement the sweeping law with a new Congress that seeks to cut federally budgeted programs. The President’s budget includes language calling for FDA user fees to fully implement FSMA. ABA continues to vehemently oppose such fees. In February, ABA submitted comments to House Oversight and Government Reform Chairman Darrell Issa regarding opposition to FDA user fees to fund FSMA and calling for accountability for fees associated with this new law.
In late May, ABA submitted a similar letter to the House Appropriations Committee opposing such fees prior. In July, ABA spearheaded food industry efforts submitting a preventative control exemption petition calling on FDA to utilize existing cGMP regulations for low risk warehouses and depots. In response to the petition, ABA has had a series of productive dialogues with senior Agency officials regarding the merit of this approach. In August, ABA submitted bakery specific comments to FDA on preventative control procedures in advance of the Agency’s guidance expected later this fall.