The American Herbal Products Association (AHPA) urged the Food and Drug Administration (FDA) to significantly modify its proposed rule implementing the "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals" requirements established by the Food Safety Modernization Act (FSMA).
AHPA's comments and recommended revisions are intended to ensure the final animal food rule will meet the Congressional intent behind FSMA, maximize flexibility for compliance and be written in a manner that eliminates confusion for affected businesses. AHPA also encouraged FDA to rethink its approach to animal food regulation to avoid imposing costs and burdens on animal food manufacturers that are even greater than those imposed on human food manufacturers.
In previous comments submitted to FDA, AHPA recommended significant revisions to proposed rules for "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption," "Preventive Controls for Human Food Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food," and "Foreign Supplier Verification Programs for Importers of Food for Humans and Animals." These three proposed rules have direct relevance to the proposed animal food rule and AHPA recommended that FDA coordinate changes to all four proposed rules.
AHPA noted that other organizations have suggested significant revisions to the proposed animal food rule and that FDA should not issue a final rule as the next step in the animal food rulemaking process. Instead, AHPA recommended FDA publish a second proposed rule and invite additional comments, specifically on provisions that are newly-proposed or that changed significantly between the first and second draft.
"AHPA views the proposed animal food rule as a complex new set of regulations with large and broad economic and cultural consequences and is suggesting significant revisions," said AHPA President Michael McGuffin. "AHPA supports effective implementation of FSMA in a manner that minimizes the costs and burdens that will be borne by the regulated industries that will be impacted by the regulations and ultimately by consumers."