New rules proposed by the FDA to improve the purity of animal food are expected to cost producers of feed and pet food almost $130 million annually, the agency calculated as part of the proposal published Tuesday.
The "Preventative Controls of Animal Food" rule, if implemented, will create new manufacturing practices guidelines and require producers to evaluate, implement and document measures for preventing contamination of animal food in line with similar requirements proposed for food intended for humans.
The regulations will apply to businesses that "manufacture, process, pack, and hold ingredients and finished products that are intended to be fed to animals," though partial and full exemptions exist for certain types of grain elevators, warehouses and farms deemed to engage in low-risk activities.
Compliance with the regulation is expected to cost individual "very small" ingredient suppliers, mills, wholesalers and integrators between $14,700 and $21,000 per year.
The FDA is seeking public comment to determine, by gross annual sales, the threshold in which producers will be deemed very small. The proposed limits are $500,000, $1 million and $2.5 million in gross annual sales of animal food. "Small" businesses are classified as those with fewer than 500 employees.
Animal food producers that are not qualified as small, or very small, and are not exempt from the rules will be expected to comply with the law within one year. Small businesses will have two years to comply. Very small businesses will get three.
Very small producers, as defined in the final version of the rules, and those that sell less than $500,000 of animal food primarily within 275 miles of the facility, will be exempt from certain requirements that producers create and implement hazard-based plans that include testing and documentation to prevent contamination.
Instead, those very small producers can be certified by other means, such as through proving compliance with state food safety regulations or by industry certification programs.
In general, however, they will need to comply with the new manufacturing practices guidelines which address worker hygiene, facility sanitation, storage, processes and equipment. Within six months of finalizing the rule, the FDA will publish a guide aimed at helping small businesses understand the regulation and make necessary changes to production.
The rules were created as part of the 2011 Food Safety Modernization Act which granted the FDA broad powers over the food production. Among the expanded powers, it granted the agency the ability to order recalls and assigns the agency responsibility for preventing foodborne illnesses through inspections, rather than solely responding to outbreaks.
The law was passed partially in reaction to the largest recall of pet food in history in 2007 that withdrew Chinese-made pet foods and treats from the market after the death of more than 600 household animals.