The guide, entitled “What You Need To Know About Prior Notice of Imported Food Shipments: A Small Entity Compliance Guide”, provides an update on the prior notice interim final rule issued under the 2002 Bioterrorism Act, which was published in the Federal Register in November, after it was discovered that it would prove too costly for small companies.
“FDA examined the economic implication of this final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601612) and determined that it would have a significant economic impact on a substantial number of small entities,” the DHHS said in a notice on Thursday.
All companies dealing with foods and food ingredients that enter the US have had to give prior notice of their arrival since 2003, in order to help intercept contaminated products, organize inspections and review information before the product arrives in the US.
More time
Now the FDA is allowing longer for importers to inform it of food product imports, extending the window for doing so from the current five days before arrival to 15 or 30 days, depending on the mode of notification.
Prior notice submissions made through FDA’s Prior Notice System Interface (PNSI) must be made a maximum of 15 days before the anticipated arrival date, while those made through the US Customs and Border Protection’s system must be made a maximum of 30 days in advance.
Food (and feed) covered under the prior notice rule includes food imported for use, storage or distribution in the US, food transported through the US to another country and food imported for future export.
The new guidelines also simplify the information which was required under the interim final rule, allowing a carrier tracking number to be used instead of the anticipated arrival information, bill of lading, or airway bill number and flight number, as long as certain conditions are met.
The FDA has invited comments on the Small Entities Compliance Guide to be submitted via http://www.regulations.gov.
The guide is available online at http://www.cfsan.fda.gov/guidance.html.