PMA suggests produce-friendly changes to FDA’s FSMA strategy
PMA suggests produce-friendly changes to FDA’s FSMA strategy
WASHINGTON — When the Food & Drug Administration implements the Food Safety Modernization Act, don’t charge any user fees, offer education and technical assistance to any sized sector and let industry help in drafting the guidance documents. These were some of the suggestions offered by the Produce Marketing Association in its 19-page comments to the FDA last week.
FDA asked for comments by May 26 on the FSMA implementation strategy, the key blueprint the agency will follow in developing work plans and setting out priorities before inspectors begin implementing the new food-safety law. Four years after Congress passed FSMA, the agency is planning to publish the final produce safety and preventive control rules by September.
PMA said the agency should stick to financing the program with federally appropriated money, such as the $109.5 million requested by the administration this fiscal year, rather than asking for user fees, inspection fees or registration fees to pick up the tab.
“PMA and its members absolutely understand that FDA needs sufficient budgetary resources for food-safety tools, infrastructure, and personnel to appropriately implement FSMA,” said 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.”
PMA noted the proposed $11.5 million earmarked for industry education and technical assistance will fall far short of meeting the need of the entire food industry. “It is imperative that sufficient resources be allocated to educate industry about FSMA implementation and compliance before FDA regulates,” Gorny said.
“It would be short-sighted for FDA to limit or focus education outreach and technical assistance to any one business sector or enterprise size,” PMA told the FDA in its comments. “As such, PMA respectfully requests that the FDA consider and implement education and training for all produce business sectors irrespective of their size or production practices employed. A healthy food sector is a diverse food sector with all types of operations providing an abundant and safe food supply to American consumers.”
FDA officials have indicated plans to develop guidance documents to help sectors of the industry comply with the far-reaching law, and PMA wants to make sure industry has a role in the drafting of these documents.
“PMA wishes to express a strong desire to engage early, often and repeatedly with FDA on the development of applicable guidance documents for produce industry operations and provide an opportunity to explain and discuss current industry best practices and preventive controls to address identified ‘significant hazards,’” the group said.
“We also request that FDA consider routinely convening an expert group composed of industry, academia and government (state, local, territorial and tribal) subject matter experts to draft and update model [Compliance Policy Guides] for each of the FDA FSMA implementing regulations, make recommendations to the agency as to what preventive controls, policies, procedures or practices would address the identified hazard appropriately and deem the firm to be ‘in-compliance’ with applicable regulations.”
In other comments, PMA asked the FDA to clarify the roles of inspectors, who will be tasked with providing technical assistance to industry while verifying compliance, and to set up an adjudication system when inspectors and industry disagree on interpretation of the law.