FDA Releases Detailed Guidance Documents for Importers on FSVP

An additional FDA guidance not yet released by the agency as of Jan. 24 looks set to announce a tentative policy of enforcement discretion for importers of some raw agricultural commodities (RACs). An upcoming notice in the Federal Register announcing the final guidance document says FDA intends to “exercise enforcement discretion for importers of grain RACs that are solely engaged in the storage of grain intended for further distribution or processing with respect to the FSVP regulation,” the notice said. “This intent to exercise enforcement discretion with respect to FSVP also applies to grain importers that do not take physical possession of the grain they import but instead arrange for the delivery of the grain to others for storage, packing or manufacturing/processing,” it said.

Comments on FDA’s draft guidance document on general FSVP compliance and on determinations of equivalence are due May 25, FDA said in upcoming Federal Register announcements. Compliance with the FSVP regulations, issued in November 2015 (see 1511160014), has already been required for many importers since May 2017 (see 1602120038). The next compliance date, for importers from small business suppliers subject to FDA’s preventive controls regulations for human food and current good manufacturing practice requirements for animal food, is on March 19, 2018.

(The following are highlights of FDA’s new guidance documents, with a particular focus on FDA’s draft guidance on general FSVP compliance. See the draft guidance documents for more information on the FSVP importer definition and foods covered by FSVP, requirements for specific FSVP activities like hazard analysis and supplier verification, requirements for qualified individuals, entry requirements, exemptions, record-keeping and enforcement.)

Multiple Owners of Food May Agree to Specify One as FSVP Importer

FDA’s draft guidance provides more clarity on the identity of the FSVP importer in situations in which multiple entities may meet FDA’s definition as the U.S. owner or consignee of the imported food at the time of entry. This may occur if, for example, a U.S. distributor of olive oil has already entered into an agreement to resell the oil to a retail store at the time of entry, causing both the distributor and the retailer to meet the definition of FSVP importer. In these instances, the parties may agree that only one of them will act as FSVP importer, FDA said, as expected (see 1705150048). “We expect that U.S owners and consignees will address the responsibility for FSVP compliance in their contractual agreements when they have a direct commercial relationship,” FDA said.

Multiple importers only if purchase specifies supplier at time of entry. However, if the purchase order between the distributor and the retailer does not specify the source of the food, that retailer would not be considered the FSVP importer, FDA said. Also, an agreement to purchase food after it arrives in the U.S. does not make the purchaser an FSVP importer because that purchaser is not the owner or consignee at the time of entry, it said.

Purchase Agreement Allowing Rejection Doesn’t Negate FSVP Importer Responsibility

A purchase agreement between a U.S. importer and the foreign producer that allows the importer to reject the food if certain quality standards aren’t met does not mean the importer is not the “U.S. importer or consignee” for FSVP purposes, FDA said. The purchaser may still be the FSVP importer because it “has a written agreement to purchase the food at the time of U.S. entry,” even if the “condition regarding quality standards means that the distributor does not own the food unless the quality standards are satisfied,” it said.

Foreign Supplier May Not Be Seller of Food

FDA’s FSVP regulations define the foreign supplier of a food as the establishment that manufactures or processes the food, raises the animal or grows the food exported to the U.S. without further manufacturing or processing, except for further manufacturing or processing that consists only of labeling or similar “de minimis” activity, FDA said. “Because of this, your foreign supplier might not be the entity from which you directly obtain the food you import. If you obtain a food from a foreign warehouse, distributor, broker, or other entity that does not perform any manufacturing/processing of a more-than-de minimis nature, the foreign supplier of the food would be the last entity in the foreign supply chain that conducts significant manufacturing/processing of the food,” it said.

Exemption for Food Imported for Research or Evaluation

The FSVP regulations include an exemption from FSVP requirements for food imported for research or evaluation. According to FDA, that exemption for research on “food for humans may involve analyzing food for characteristics such as protein or fat content, testing or observing physical characteristics such as color or texture, and sensory analysis or evaluation, such as organoleptic analyses for testing the quality of tea. It may also include research for marketing purposes,” it said. “For animal food, research might involve palatability studies or studies to evaluate the impact of an ingredient or diet on animal production characteristics (e.g., growth, milk production, reproduction).”

Small quantity. Food qualifying for the research or evaluation exemption must be imported in a small quantity, not be intended for retail sale, and must be labeled as, “Food for research or evaluation use.” FDA says a “small quantity of food” means a quantity “sufficient to perform the research, analysis, or quality assurance procedures, with no or very little food remaining after completion.” That amount may vary based on the type of food, the nature of the research or evaluation, or other factors such as the number of repetitions required by the research or evaluation process, FDA said.

Trade shows usually don’t qualify. Generally, food imported for consumption or distribution at trade shows “generally” does not qualify for the research and evaluation exemption, FDA said. Because food imported for consumption at trade shows typically is sold or distributed to the public generally (i.e., anyone who attends the trade show), exempting such food from the FSVP regulation would be inconsistent with the exemption, it said. However, food at trade shows would qualify if “used in a defined study, conducted during a trade show, of a food involving a discrete set of test subjects who have agreed to participate in the study, because it does not appear that such food would be sold or distributed to the general public.”

Multiple FSVPs Not Required for Versions of Same Food; Some Foods May Merit Multiple FSVPs

FDA requires that importers establish an FSVP “for each food you import from each of your foreign suppliers,” it said. However, importers “do not need to establish a separate FSVP for different versions of the same food from a single foreign supplier when the differences in the foods do not result in different hazards requiring a control,” FDA said. A single FSVP for multiple versions of the same food may be appropriate for several different packaging sizes or formats of a particular food from a supplier, or different flavors of the same food, provided the hazards and corresponding controls are the same for each. This may apply for “yogurt, cookies, potato chips, chocolate candies, or extruded dog or cat food,” FDA said.

On the other hand, “if the use of different ingredients to make what is essentially the same food could result in different hazards requiring a control or a need for different types of controls, you should either establish separate FSVPs for these foods or create a single FSVP for the foods that separately addresses the differing hazards or controls required,” FDA said. For example, importers might develop separate FSVPs for poultry meal animal foods intended for different animals because the hazard from salmonella is different for each animal. Alternatively, hazards for each animal could be addressed differently within a single FSVP, FDA said.

Regardless of whether a single FSVP could address multiple versions of the same food, or multiple FSVPs may be created for a single food, “your FSVPs must be specific to each foreign supplier of a food,” FDA said. “Thus, if you obtain a food from multiple foreign suppliers, you must have a separate FSVP for each supplier.”