View Rule

This regulation, if finalized, will help prevent potentially harmful imported foods from reaching consumers and thereby improve the safety of the U.S. food supply by allowing the agency to require, as a condition of importation of food with known safety risk, a certification or such other assurances as the Agency determines appropriate, that imported food complies with U.S food safety requirements.

Statement of Need:

Imported food is increasingly implicated in U.S. foodborne illness outbreaks. These illnesses emphasize the importance of ensuring imported food meets applicable requirements of the Act.  Historically, FDA has relied on its staff to detect safety problems with imported food by intercepting and examining food products when they are offered for import into the United States or by performing inspections of foreign facilities that produce food for export to the United States.  This rule, if finalized, would establish requirements for implementing import certification as a condition of granting admission to an article of food imported into the United States, pursuant to section 801(q) of the FD&C Act.  We anticipate that this regulation, if finalized, will help prevent potentially harmful imported foods from reaching consumers and thereby improve the safety of the U.S. food supply.

Summary of the Legal Basis:

Section 303 of FSMA, Authority to Require Import Certifications for Food, amended section 801 of the FD&C Act (21 U.S.C. 381) to create a new subsection (q) entitled, Certifications Concerning Imported Foods.  Section 801(q) gives FDA authority to require import certification based on the risk of the food.  FDA also derives authority for these proposed requirements from section 701(b) of the FD&C Act (21 U.S.C. 371(b)), which authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act.  Additionally, sections 311, 361, and 368 of the Public Health Service Act (PHS Act) (42 U.S.C. 243, 264, and 271, respectively), which relate to communicable disease, provide FDA with authority to make and enforce such regulations as in FDA’s judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession (see section 361(a) of the PHS Act) (42 U.S.C. 264(a)).

Alternatives:

None

Anticipated Costs and Benefits:

The primary estimate for annualized costs is $74.3 million, including costs from third-party audits, foreign government inspections, and foreign government certification associated with complying with an import certification requirement.

The primary estimate for annualized benefits is $109.7 million, including food safety benefits to consumers, cost savings from reduced transit and storage time, and cost savings from reduced food testing.

Risks:

During 1996-2014, 195 outbreaks with 10,685 associated illnesses were reported where the implicated food was imported into the U.S., representing an increasing percentage of reported outbreaks during that timeframe.  These illnesses underscore the importance of ensuring imported food meets applicable requirements of the FD&C Act.  This rule, if finalized, would implement a risk-based approach to requiring import certification for food as a condition of admissibility.  FDA would obtain assurances that imported food meets applicable requirements of the FD&C Act and implementing regulations before the food is offered for import into the U.S.  This rule is intended to protect public health by strengthening FDA’s import oversight activities for foods and preventing unsafe foods from reaching domestic markets.