Monthly Archives

December 2012


FDA Extends Until January 31 for Food Facilities to Re-Register

posted by Jennifer Diaz December 20, 2012 2 Comments

 Below are the latest and greatest updates  regarding compliance with the FDA’s Food Safety Modernization Act (FSMA). It includes background on FSMA, an update from FDA with 2 new guidance documents, FDA’s extension to file biennial registrations, and an update on FDA using its enforcement power to suspend a facilities registration – meaning they can NOT import into the U.S.

FSMA Background

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apples to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year, otherwise, their registration will be cancelled by the FDA.

Reinspection Fees

Importantly, please note that facilities will be charged reinspection fees by the FDA. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year. For FY 2013 (October 1, 2012-September 30, 2013), the fees are $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required. U.S. Agents will be responsible to assure these fees are collected.

FDA Extension

Because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA’s guidance document advised that FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.

FDA Published 2 Guidance Documents:

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition). This guidance document contains helpful questions and answers regarding food facility registration.

Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide. Thus guide was updated to reflect FSMA amendments to the FD&C Act, and discusses: who is required to register pursuant to the Bioterrorism

Suspension of Registration

FSMA also amended section 415 of the FD&C Act to provide FDA with the authority to suspend a food facility’s registration in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. FDA already used this power and suspended the registration of Sunland, a producer of nuts. The full story may be read here.

U.S. Customs and Border Protection (CBP)

New Center of Excellence & Expertise to Arrive in Miami 2013!

posted by Jennifer Diaz December 14, 2012 0 comments
DHS Secretary Janet Napolitano addresses a crowded audience at the 2012 East Coast Trade Symposium while CBP Deputy Commissioner David V. Aguilar listens.
Photo Credit: James Tourtellotte

U.S. Customs and Border Protection (CBP) Deputy Commissioner David V. Aguilar announced at the East Coast Trade Symposium the expansion of the Centers of Excellence and Expertise (Centers), which will create six new Centers in 2013 for the Agriculture & Prepared Products; Apparel, Footwear & Textiles; Base Metals; Consumer Products & Mass Merchandising; Industrial & Manufacturing Materials; and Machinery industries. CEE’s are "virtual "one-stop shops" that provide centralized processing for importers that volunteer to participate. TheCenters are also already a source of information for the entire trading community. Centers are virtual organizations, managed from a strategic location, that link CBP trade personnel by industry to authoritatively facilitate trade."

CBP’s goal is to eventually cover the full range of imported goods.  For now, the Centers to be established in FY 2013 are:

  1. Agriculture & Prepared Products: Miami 
  2. Apparel, Footwear & Textiles: San Francisco
  3. Base Metals: Chicago
  4. Consumer Products & Mass Merchandising: Atlanta
  5. Industrial & Manufacturing Materials: Buffalo
  6. Machinery: Laredo

These virtual centers will provide one-stop processing to lower the Trade’s cost of business, provide greater consistency and predictability and enhance CBP enforcement efforts. The Centers represent CBP’s expanded focus on "Trade in the 21st Century," transforming customs procedures to align with modern business. The Centers will also serve as resources to the broader trade community and to CBP’s U.S. government partners. The current Centers are Electronics in Long Beach; Pharmaceuticals, Health & Chemicals in New York City; Automotive & Aerospace in Detroit; and Petroleum, Natural Gas & Minerals in Houston.

Resources to learn more about the CEE’s:

  • Customs created a new 8 minute video advising on additional benefits the CEE’s provide, including being a "common sense trade processing system," and discussing the assistance with administrative detentions of merchandise the CEE’s can provide. 
  • PowerPoint Presentation on CEE’s.

C-TPAT and ISA members are given priority to apply for admission into CEE’s. 

CEE’s are supposed to provide the uniform decision making the importing community craves.  Import Specialists will eventually all belong to a specific CEE and utilize their specialized knowledge to provide consistent admissibility decisions around the country.  I very much look forward to seeing and reporting on how the Miami CEE progresses.