The Food and Drug Administration (FDA) conducted a public meeting on November 21, 2013, to discuss the Proposed Rule to Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals – otherwise known as the FSMA Preventive Controls and CGMPs rule for animal feed and pet food – which was published October 29, 2013. FaegreBD Consulting's Brad McKinney attended the meeting, along with representatives from key stakeholder organizations and other smaller groups. The crowd heard a largely predictable discussion of the proposal. An additional public meeting was held on November 25 in Chicago, Illinois, and another is scheduled for December 6 in Sacramento, California.
Michael Taylor, Deputy FDA Commissioner for Foods and Veterinary Medicine, stated that the proposed rule for preventive controls for animal feed hews closely to the proposed rule for human food. Taylor cited Hazard Analysis and Critical Control Points (HACCP) principles as the templates on which the preventive controls regulations were based, in addition to the agency's desire to allow for adaptability to different operations.
Some of the key questions and comments raised by audience members and industry stakeholders on the Proposed Rule include the following:
- Industry stakeholders made clear that the proposed rule posed a greater regulatory burden than that to which the animal feed industry has long been accustomed. The Current Good Manufacturing Practices (CGMPs) are a new dynamic to the animal feed industry, and more time may be necessary to adjust. One group specifically requested that the comment period be extended a month through March 2014.
- FDA stated it does not intend to require animal feed manufacturers to extensively convert their manufacturing equipment, despite the fact that much animal feed manufacturing equipment is materially different than equipment used in manufacturing or processing human food. FDA stressed the regulation requires that a hazard presented by a particular type of feed or processing technique be identified and that controls be put in place to prevent that hazard.
- Retailers suggested that facilities simply holding animal food (mainly for pets) for sale should be exempt from the rule.
- FDA admits that procedures for handling and manufacturing feed for animals being raised for human consumption may be different than for feed for companion animals (pets) and stated its intent to be sensitive to those differences. FDA indicated it believes this will be reflected in how new CGMPs will be applied and solicited comments on how those differences can best be addressed.
- Stakeholders also expressed opposition to the concept of environmental testing and domestic supplier verification, similar to the concerns widely raised with respect to the preventive controls rule for human foods. The proposed rules do not currently include those requirements, but, based upon comments FDA has made with respect to the preventive controls rule for human foods, there is concern in the industry that FDA is considering adding these requirements.
The comment period for the proposed rule ends February 26, 2014. Those interested in commenting may do so through www.regulations.gov and entering Docket No. FDA–2011–N–0922. We will continue to monitor and report on FSMA, the proposed regulations, and their implementation.