The guidance was announced last week and published in the Federal Registrar on Monday. It took effect immediately and pushes enforcement of some regulatory deadlines from this year out to November 2019.
“The NGFA appreciates FDA’s guidance that allows additional time for co-manufacturers and brand owners to work out contractual details associated with the use of supply-chain applied controls within their food safety systems,” David Fairfield, senior vice president of feed services, US National Grain and Feed Association (NGFA) told us.
The guidance applies to producers who take part in co-manufacturing agreements for animal feed or human food production, the agency said. “By ‘co-manufacturing,’ we mean a contractual arrangement whereby one party (the brand owner) arranges for a second party (the co-manufacturer) to manufacture [and or] process human or animal food on behalf of the first party,” it added.
Co-manufacturers may need more information, like details of supplier audits, from brand owners to meet the new requirements set forth in portions of the Food Safety Modernization Act (FSMA).
No enforcement action for two years
The US regulatory body said that it does not intend to take enforcement action on co-manufacturer’s compliance in regard to some supply-chain program requirements for two years.
There was not a period for public comment before the decision, as such a process was found to be neither feasible or appropriate, continued the FDA. “We made this determination because the guidance represents a less burdensome policy consistent with the public health."
Requirements for co-manufactures and supply-chain programs dealing with raw materials have been set in several areas, the agency said. These include Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals and in the Foreign Supplier Verification Programs of Importers of Food for Humans and Animals.
However, the guidance does not apply to co-manufacturers if there are no hazards that call for a supply-chain-applied control regarding the raw materials or ingredients used by the co-manufacturer, the FDA said. In those instances, there is no need for a supply-chain program so the guidance does not apply.
“This guidance is applicable when the brand owner approves and specifies to the co-manufacturer which suppliers must be used and there is a hazard that requires a supply-chain-applied control,” said the FDA. “The brand owner is not considered the supplier of the co-manufacturer under the regulations if the brand owner does not manufacture or process the food, raise the animal, or grow the food that is provided to the co-manufacturer.”