The Food Safety Modernization Act webinar held Dec. 11, 2013 hosted by “Feedstuffs” magazine and produced by the American Feed Industry Association and the National Grain and Feed Association had 850 downlinked sites, which translates to approximately 2,500 listeners.
Go to: http://bit.ly/1qSSVxS to download the presentation. Enter your email or register, then click “Launch.”
We have had a number of questions on the webinar. Several folks asked us to define the term “animal food.” The Food, Drug and Cosmetic Act defines “food” as “…food for man or animals....” The U.S. Food and Drug Administration has been using the “animal food” term to encompass both pet food and feed and to differentiate it from human food.
Regarding the size of operations and how those relate to FDA’s designations for small and very small business exemptions, the proposed rule provides three annual animal food sales options for very small businesses. These are $500,000, $1,000,000 and $2,500,000 of annual sales of animal food products (including ingredients) from the firm (not just the facility). FDA is asking all persons who comment to pick one of these levels for exemptions based on annual sales of feed products from the firm (not just the facility).
If your firm exceeds the $2,500,000 (or the level FDA selects in the final rule), then you will not become a “qualified facility” and are not exempt. If you are below the annual sales amount level FDA selects, your firm would be a “very small business (VSB).” The firms in this designation category would not need to develop a(n) (animal) food safety plan, but would have some notification and labeling requirements. However, there is no exemption from the current Good Manufacturing Practices (cGMPs) rules for any size firm.
If a firm exceeds the dollar sales amount FDA establishes as a threshold, then the next designation level is less than 500 employees, which is a “small business” (SB). FDA says this is the largest exemption area for the feed firms in the U.S. If your firm is designated a SB, then you will be allowed an extra year to comply with the final rules.
Finally, FDA is reviewing how to calculate these for integrated operations, where there are no sales of feed products. Similarly, concern has been expressed about how employees should be counted in a food firm with feed co-products, where some employees work in both industries. FDA is reviewing this area as well.
For compliance purposes, FDA says regular firms will be given one year to comply with the final rules; SBs, two years; and VSBs, three years. Because of the unfamiliarity with the concepts of cGMPS and preventive controls, AFIA has publicly asked FDA to consider phasing in cGMPs for firms on a one, two and three year basis, and adding the preventive control requirements on a two, three and four year basis after final rule publication. Some FDA officials say the phase-in process makes sense and requests comments from the industry.
Several questioners expressed concern about exemptions for grain elevators as producers of raw agricultural commodities (RACs). Some wondered about elevators that fumigated the grain to the point of adding an excessive amount that could be viewed as a hazard. “Fumigation” is a concern of the grain industry, and some organizations have expressed concern with the FSMA human food proposed rule not allowing an exemption for this process. FDA says that will be fixed in the final rule. Concerns were also expressed for mycotoxins in grains that the elevators are exempt. The law does provide for some raw agricultural commodity exemptions, and FDA is attempting to comply with these provisions. The shift of burden by these exemptions would be to the feed mills and operations purchasing RACs.
Please stay alert for more information in the future, as we hope to host more webinars and events about hazard identification, preventive controls and pet food.
For more information on FSMA, visit the FDA FSMA homepage at www.fda.gov/fsma or contact AFIA Senior Vice President of Legislative and Regulatory Affairs Richard Sellers (firstname.lastname@example.org) or Leah Wilkinson, AFIA’s director of ingredients, pet food and state affairs, (email@example.com) or Henry Turlington, AFIA’s director of quality and manufacturing regulatory affairs (firstname.lastname@example.org).