FDA to Require New PN Element on Other Countries Refusing Food
The Food and Drug Administration has issued an interim final rule, effective July 3, 2011, that will amend its regulations to require an additional element of information in a prior notice (PN) of imported food, as required by the Food Safety Modernization Act1. This change requires a person submitting PN of imported food, including food for animals, to report the name of any country to which the article has been refused entry.
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FDA invites public comment on this interim final rule by August 3, 2011. FDA states that it will consider modifications to it based on comments made during the comment period.
(FDA’s Prior Notice Center reviews PNs and assesses the risk related to imported food shipments. Personnel at the Prior Notice Center decide on a case-by-case basis whether the article of food needs to be held for examination upon arrival at the port. In calendar year 2010, 10,116,018 PNs were submitted.)
PN Filers to Report Any Country that Refused Entry of Food
FDA will amend its regulations to require a person submitting PN of imported food, including food for animals, to report, in addition to other information already required, the name of any country to which the article has been refused entry.
FDA will be able to use the additional information from this interim final rule to better identify imported food shipments that may pose a safety or security risk to U.S. consumers.
(The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 amended the Federal Food, Drug, and Cosmetic (FD&C) Act by adding section 801(m). This provision created the requirement that FDA receive certain information about imported foods before arrival in the U.S. It also provided that an article of food imported or offered for import is subject to refusal of admission into the U.S. if adequate PN has not been provided to FDA.)
21 CFR to Include New Requirement
The interim final rule will amend 21 CFR 1.281, which describes the information that must be submitted in a PN, paragraphs (a), (b), and (c) to add to the PN requirement list that the PN include the identity of any country to which an article of food has been refused entry.
(21 CFR 1.281(a) is General; (b) is Articles arriving by international mail; and (c) is Refused articles.)
Proposed Information Collection Requirements Contained in Rule
FDA’s s interim final rule contains a proposed information collection notice, which is subject to review by the Office of Management and Budget (OMB). The information collection, entitled Information Required in Prior Notice of Imported Food, covers the additional element on country refusal that persons submitting a PN will have to report.
FDA invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
FDA estimates that there will be 129,757 respondents and the number of responses per respondent will be 22. The total annual responses are estimated to be 2.8 million. The average burden per response is estimated to be 0.016 hours and the total hours to be 44,960. Comments on the proposed information collection are due by June 6, 2011.
1The FSMA (Public Law 111-353) was signed into law on January 4, 2011. The law provides FDA with new enforcement authorities to help it achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA new tools to better ensure the safety of imported foods and directs FDA to build an integrated national food safety system in partnership with State and local authorities.
FDA contact- Anthony Taube (866) 521-2297
(See ITT’s Online Archives or 04/14/11 news, 11041415, for BP summary of FDA saying that it might be difficult for a customs broker to know if food was refused in another country and suggested they put in place a process to ask the importer.
See ITT’s Online Archives or 05/04/11 news, 11050423, for BP summary announcing this rule was available.
See ITT’s Online Archives or 04/25/11 news, 11042529, for BP summary of FDA’s Q&A on FSMA provisions.
See ITT’s Online Archives or 04/14/11 news, 11041415, for BP summary of FDA officials providing an update on the FSMA at a recent trade conference.
See ITT’s Online Archives or 03/07/11 news, 11030720, for BP summary of FDA’s overview of the FSMA.
See ITT’s Online Archives or 01/04/11 news, 11010426, for a comprehensive BP summary of the FSMA.)
FDA press release is available here.