by Sally Colby
Anyone involved with food production has likely heard about the proposed Food Safety Modernization Act (FSMA), the most comprehensive makeover of the nation’s food safety laws. With numerous listening sessions in the books and the comment period for the livestock feed rule drawing to a close, numerous questions remain unanswered.
In a conference call with about 50 stakeholders in Harrisburg, PA, Kim Young, deputy director, division of compliance, FDA Center for Veterinary Medicine, provided an outline of the proposed rule then answered stakeholder’s questions regarding the rule.
Young explained that the major rules, most of which are scheduled for implementation in October 2015, include Preventive Controls for Human Food, Preventive Controls for Animal Food, Foreign Supply Verification Program, Produce Safety Standards, Accreditation of Third Party Auditors, Sanitary Transport of Food and Feed, and Intentional Contamination.
“The rule has two major features,” said Young. “It establishes for the first time ‘Good Manufacturing Practices’ for animal food and establishes ‘Hazard Analysis and Risk-Based Preventive Controls.’ Each facility will be required to implement a written food safety plan that focuses on preventing hazards in food.”
Who is covered under the proposed rule? Young says that any facility that manufactures, processes, packs or holds animal food will come under the regulation. In general, organizations required to register under section 415 of the FD&C (Food, Drug and Cosmetic) Act, also known as the Bioterrorism Act, fall under the proposed rule. “A farm is not required to register under the FD&C Act” said Young, “therefore, is not covered under this regulation.”
Many sections of the proposed rule are unclear, including what will be required of integrators who don’t own the land on which animals are raised. Another area that remains unclear is defining the basic elements of CGMP (Current Good Manufacturing Processes). Due to variations among animal food producers and production facilities, hazards and risks can vary greatly. The FDA is requesting comments on whether CGMPs related to human food are appropriate for animal food. Comments are also requested on CGMP requirements by types of animal food — are the requirements appropriate for some and not others, and how can/should the FDA distinguish between food types?
Young noted that the FDA is also seeking comments on establishing GMPs (Good Manufacturing Processes), including health of employees, differentiation between pet and livestock food, and whether human GMPs should be the starting point for developing animal food GMPs. “Should the FDA replace the current recommendations in the CGMPs for personnel education and experience with requirements,” said Young, “and if so, what is the appropriate level of specificity?”
The plan requires that a qualified individual will be responsible for preparing the food safety plan, validating preventive controls, reviewing records and reanalyzing the food safety plan. Plans must be written, and include a recall plan for animal food in which there is a ‘hazard that is reasonably likely to occur.’ Questions remain on the subject of what constitutes a qualified individual and who will be responsible for training.
Hazard analysis will identify ‘known or reasonably foreseeable hazards for each food type to determine whether there are hazards that are reasonably likely to occur.’ Planners must consider both naturally-occurring hazards and those that may be unintentionally introduced. Hazards to be considered include biological, chemical, physical and radiological. Questions for comment include whether or not the FDA should include potential hazards that may be intentionally introduced for economic reasons, and when can economically motivated adulteration of animal food be considered reasonably likely to occur.
Certain storage facilities, including grain elevators and warehouses that only store raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, are exempt from hazard analysis and risk-based preventive controls. Facilities that hold raw agricultural commodities that are fruits and vegetables are not exempt from hazard analysis and risk-based preventive controls, but are exempt with respect to CGMPs. There are several farm-related exemptions, such as activities within the definition of ‘farm’ including farm activities that are covered by the proposed produce rule.
So where is the FDA in regard to the rule-making process? The FDA is currently accepting comments on the proposed rule, but the comment period ends March 31. Several participants in the call stated that they would like to have both an extension of the current comment period and a second comment period after the questions and concerns are answered.
“They’re still working through a full understanding of what they proposed, the same as we are,” said Jay Howes, deputy secretary for consumer protection at the Pennsylvania Department of Agriculture. “It really highlights the need to ask very specific questions during the comment period.” Howes pointed out that while the time frame is referred to as a ‘comment period,’ stakeholders have the opportunity to ask questions and the FDA must respond to those questions.
“This is so big and so comprehensive that I don’t think anyone can expect them to listen to one group of comments and get it right with one re-write,” said Howes. “With the deadline for implementation October 2015, it seems there is ample time for a second comment period for certain parts of the rule. They did do that with the produce rule.”
Stakeholders are encouraged to comment on the proposed rule by visiting and link to information about the proposed rules on