ANNOUNCED AS TEMPORARYNo
Import-related non-tariff measure, nes
On January 4, 2011 President Obama signed into law the "FDA Food Safety Modernization Act" (H.R.2751), a bill that extensively modies the existing rules for the inspection of domestic and imported food. Earlier versions of the bill had included provisions that may have been considered discriminatory against imports, but those concerns appear to have been assuaged. Some of the requirements (e.g., for tracing food to its origins) may nonetheless be more difficult for smaller suppliers, especially in developing countries, to meet.
The Obama administration and Congress had been working on new food-safety requirements since early 2009. The administration released the key findings of its Food Safety Working Group on July 7, 2009.'1' The group favored a traceback and response system to be used in the event of an outbreak of illness stemming from adulterated or contaminated food. It also called upon Congress to write legislation mandating preventive controls and sanitation requirements for food facilities. The Working Group set a goal of three months for the Food and Drug Administration (FDA) to issue draft guidance for the food industry on developing industry product tracing systems to detect the source of foodborne illness. The administration also plans to work with Congress to write legislation giving FDA, the Food Safety Inspection Service, and other relevant Federal agencies authority to require sanitation and preventive controls based on scientific hazard analysis at food facilities. The legislation is intended to authorize access for Federal agencies to basic food-safety records at food facilities and use resources flexibly to target high-risk foods, and give the agencies the authority to issue mandatory recalls.
Congress began developing legislation even before the working group issued its report. The Energy and Commerce Committee in the House of Representatives approved on June 17, 2009 the 'Food Safety Enhancement Act of 2009' (see H.R.2749 for the bill as introduced, click here for the amended version adopted by the Energy and Commerce Committee; click here for the bill as approved by the House). The bill was then referred to the Agriculture Committee in the House of Representatives, which held a hearing on the matter on July 16, 2009.
Much of the bill builds upon existing law. A few other provisions of the bill apply requirements to imported food and to foreign facilities that appear to be broadly consistent with the corresponding rules for domestic facilities, but may differ to some degree. Whether that difference is discriminatory may be a question that is answered more in practice than in principle, insofar as the law would give administrative discretion to the FDA and other agencies. For example, a new section 805 would be added to the Federal Food, Drug, and Cosmetic Act creating a Foreign Supplier Verification Program, providing for verification that imports meet the requirements of U.S. law. The bill leaves some discretion to the FDA, however, in devising the specific guidelines.
One provision in the original version of the bill would have imposed a higher country-of-origin labeling (COOL) requirement on imported food, but the Energy and Commerce Committee removed that provision from the bill during its mark-up of the legislation. The provision in question would have amended the law (codified at 21 U.S.C. 343) to require that the labels on imported, processed food identify 'the country in which the final processing of the food occurs,' and that 'the Web site for the manufacturer of the food ... identify the country (or countries) of origin for each ingredient in the food' (emphasis added). This would appear to be a substantial expansion beyond the current COOL requirements in the United States. The only COOL provisions remaining in the bill at present require that unprocessed food be labeled with the country of orign, and that processed food be labeled with the country in which final processing occurred.
The House of Representatives approved the bill on July 30, 2009 by a vote of 283-142. The Senate had approved one version of this law on November 30, 2010, but was then required for constitutional reasons to enact a new version on December 19, 2010 (the problem being that the earlier version had violated the rule by which any bill approving new taxes'or fees' must be introduced in the House and not the Senate). The House then approved the Senate's version of the bill on December 21, 2010, clearing it for the president's signature.
On December 13, 2016 the U.S. Food and Drug Administration (FDA) issued afinal rule to establish a user fee program for a voluntaryaccreditation program under the FDA Food Safety Modernization Act. Thefinal rule provides for a user-fee program to assess fees and requirereimbursement for the work the agency performs to establish andadminister the third-party certification program. This program accreditsthird-party certification bodies to conduct food-safety audits offoreign food entities, and to certify that foreign food facilities andfood produced by such facilities meet applicable FDA requirements. Importers may use these audits and certifications to establish theireligibility for the Voluntary Qualified Importer Program. The FDA mayalso require certifications as a condition of granting admission intothe U.S. market when food-safety risks have been identified. The ruleallows the FDA to assess fees for the work it performs to establish andadminister the third-party certification program. For the period ofJanuary 13, 2017 through September 30, 2017, FDA will assess a $35,100initial application fee for certification bodies seeking directaccreditation
'1' Established by President Obama in March, this body was chaired by Secretary of Health and Human Services Kathleen Sebelius and Secretary of Agriculture Tom Vilsack. Other agencies involved in the group are the Food and Drug Administration, the Food Safety and Inspection Service, the Centers for Disease Control and Prevention, the departments of Homeland Security, Commerce, and State, the Environmental Protection Agency, and several offices within the White House.
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