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FDA’s Busy Implementing FSMA – Significant New Food Safety Rules are Coming

The FDA has proposed two new rules issued under the Food Safety Modernization Act (FSMA) that is part of a broader effort to prevent food borne illness and ensure the safety of imported and domestically produced foods. If you want your voice heard, you have until May 16, 2013 to submit your comments to the FDA on the proposed rule. The FDA does take comments seriously, we’re here to help if you want assistance in drafting your comments. This rule is expected to be published shortly following the conclusion of the comment period on May 16, 2013.

The proposed rules would apply to facilities that manufacture, process, pack or hold human food. The rules focus on commonly identified routes of microbial contamination of produce, including:

(1) agricultural water

(2) farm worker hygiene

(3) manure and other additions to the soil

(4) animals in growing areas, and

(5) equipment, tools and buildings.

In general the facilities that are required to register include manufacturers, processors, warehouses, storage […]

By Jennifer Diaz|2022-07-07T09:32:30-04:00January 30, 2013|FDA Issues, Food, FSMA, Import|0 Comments

The U.S. Food and Drug Administration (FDA) extended the deadline for the biennial registration renewal for food facilities until January 31, 2013. Your time is almost up to re-register! If your not re-registered, enforcement will begin on February 1, 2013. FDA will cancel your Bioterrorism Act registration and your importations will be significantly delayed. Your facility will NOT be able to import, distribute or sell food products in the U.S.

Here’s what you need to know about FDA’s new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food, alcoholic beverages, and/or dietary supplements for consumption in the U.S. are required to register the facility with the FDA.

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration […]

By Jennifer Diaz|2013-01-22T21:40:00-05:00January 22, 2013|Food, FSMA, U.S. Food and Drug Administration (FDA)|0 Comments

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

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.

Re-Inspection 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 […]

By Jennifer Diaz|2022-07-08T15:53:43-04:00December 18, 2012|Bioterrorism Act, Enforcement, FSMA, U.S. Food and Drug Administration (FDA)|0 Comments

Don’t Let Your Bioterrorism Act Registration Lapse

has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse.

New Biennial Registration Requirements
FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 1 – December 2012 registration renewal period.

U.S. Agent
FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

live or maintain a place of business in the U.S. and
be physically present in the U.S.

The U.S. Agent is also responsible for the payment of “reinspection fees” of foreign facilities and failure to comply with recall orders. 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 […]

By Jennifer Diaz|2022-07-06T13:47:59-04:00August 29, 2012|Food, FSMA, Import|0 Comments

2012 International Boston Seafood Show

The annual International Boston Seafood Show is today and tomorrow at the Boston Convention Center. The Show attracts 19,000 visitors, and is the largest seafood show in North America. See www.bostonseafood.com. I am again lecturing on the Food Safety and Compliance Track with emphasis on the implementation of the Food Safety Modernization Act of 2011: What every food importer and customs broker needs to know – now.

My topic is “Food Safety Compliance under the New Food Safety Modernization Act of 2011.” My fellow panelists discussing the FSMA, and import safety generally, include Ted Poplawski from the FDA, Judith Webster from U.S. Customs and Border Protection (CBP), Howard Tennen from Quirch Foods, Dean Leaman of ABC Research Laboratories, and Dan Fone of NSF International. Since 80% of the seafood consumed in the United States is imported, compliance with the food safety laws and regulations that have now been implemented by the FDA, in cooperation with CBP, is critical.

There were a record number of FDA Import Alerts for seafood in 2011, and a higher number of imported shipments of seafood are now the subject of Detention Without Physical Examination (DWPE). What is surprising to many people is that the seafood is not just being stopped and inspected from China, but also Vietnam, Chile, and Canada, to name a few. Moreover, seafood fraud in many forms such as species substitution or false country of origin to avoid the payment of anti-dumping duties is now being discovered by the FDA, CBP, and NOAA. Criminal prosecutions and civil penalties by […]

By Jennifer Diaz|2015-12-01T06:52:54-05:00March 12, 2012|Food, FSMA|0 Comments

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FSMA

FDA’s Busy Implementing FSMA – Significant New Food Safety Rules are Coming

On February 1, 2013 Many Food Facilities Face Suspension

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

Don’t Let Your Bioterrorism Act Registration Lapse

2012 International Boston Seafood Show