The Food and Drug Administration recently issued three new guidance documents to help simplify compliance with Food Safety Modernization Act (FSMA) regulations and programs.
On November 7, the agency released new draft guidance on registration of food facilities. The expanded registration introduced by FSMA is a key change that underpins all other FSMA requirements and I would encourage you to read the new draft as it includes substantive information in a useful question-and-answer format, including details on the timing of the biennial registration renewals and other new information. For example, it is not necessary to wait until after October 1 to renew registration.
On November 10, FDA released final guidance on compliance with the Voluntary Qualified Importer Program (VQIP). The eligibility criteria for taking part in this voluntary, fee-based program include compliance with the Foreign Supplier Verification Program (FSVP). But the VQIP importer may be located either inside or outside the U.S., whereas the designated importer under the FSVP must be U.S.-based, the agency says.
In addition, the VQIP importer may be, but need not be, the importer of record listed with U.S. Customs and Border Protection (CBP). CBP defines the importer of record for a food as the person or firm responsible for making entry and payment of import duties, fees, and taxes for the food. So there is some potential for confusion of the various roles. Willingness to participate in the VQIP program may depend on such practical issues of eligibility and compliance, as well as on the bottom line analysis of the program’s costs and benefits.
On October 31, the agency released final guidance for small entities on compliance with the Preventive Controls for Human Foods (PCHF) rule. Because the guidance is designed for companies that may not have in-house expertise in the fundamentals of hazard analysis and current good manufacturing practices (cGMPs) it takes nothing for granted and is a useful introduction to the rule’s requirements, whether or not a company is a “small entity.”
One PCHF requirement that is likely to be a challenge for all sizes of companies is the required risk-based supply chain program for raw materials and other ingredients for which a hazard has been controlled before receipt.
If a registered facility identifies a hazard that requires a control and that control is applied in the supply chain before receipt, the facility must have a supply-chain program, FDA explains. Food facilities covered by the regulation must ensure raw materials and other ingredients for their products are received “only from approved suppliers, or — if received on a temporary basis from unapproved suppliers — ensuring those materials are subject to verification activities before being accepted for use,” the agency says.
If an applied control is applied by an entity other than the receiving facility’s supplier, the receiving facility must either verify the applied control or obtain verification documentation from another entity, the agency explains. Supplier verification activities can include onsite audits, testing of raw materials and other ingredients, review of the supplier’s food safety records, as well as other appropriate supplier verification activities. What’s appropriate will depend on the risk associated with the raw material or ingredient and on the supplier’s performance, the agency says.
The compliance dates for the supply chain program will depend on the size of the receiving facility and the status of the supplier. For example, if a facility is not a small or very small business and its supplier will not be subject to the human preventive controls rule or the FSMA produce safety rule, the compliance date is March 17, 2017. If the receiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule, compliance is required by September 18, 2017.
If the supplier will be subject to the human preventive controls rule or the produce safety rule, the compliance date will be six months after the supplier is required to comply with the applicable rule.
So many registered facilities covered by the PCHF and produce rules have another round of compliance deadlines to look forward to in 2017.