Settlement Reached for FSMA Final Rule Deadlines

On August 29, 2012, the Center for Food Safety (CFS) and the Center for Environmental Health filed an action against the U.S. Food and Drug Administration (FDA) alleging that the agency had violated the Food Safety Modernization Act (FSMA) and the Administrative Procedure Act (APA) by unlawfully withholding FSMA regulations beyond the required statutory deadlines. The plaintiffs sought declaratory and injunctive relief requiring FDA to issue the regulations pursuant to a court-ordered timeline.

Yesterday, the U.S. District Court for the Northern District of California issued a consent decree whereby the parties agreed to extend and stagger the final rule deadlines beyond the June 2015 deadline initially set by the court last year. In exchange, the FDA has agreed to drop its Ninth Circuit appeal in the dispute with the two consumer advocacy groups.

The regulations required under FSMA were originally scheduled to be promulgated in 2012. However, due to significant delays and budgetary concerns, the FDA failed to meet those deadlines which prompted CFS to file its lawsuit.

According to the consent decree, the new deadlines are as follows:

Final Rule Deadline
Preventive controls for human food August 30, 2015
Preventive controls for animal food August 30, 2015

Produce safety standards

October 31, 2015
Foreign Supplier Verification Program October 31, 2015
Accreditation of third-party auditors October 31, 2015
Sanitary transportation of food March 31, 2016
Intentional adulteration/food defense May 31, 2016

The FDA agreed “in good faith” to issue the final rules by the above deadlines. The dates provided are dates by which FDA will submit the final rule to the Federal Register for publication, rather than the dates by which the final rule will be published. However, the ruling permits FDA to seek further extensions of any of the above deadlines through written agreement of the parties and notice to the court if the agency believes in good faith that it cannot meet them. If the parties are unable to agree on an extension, FDA may seek an extension by filing a motion with the court. FDA would have the burden to prove “good cause and/or exceptional circumstances warranting the delay, and address the effect of the delay on the public health and safety.”

RIP William Keene

Sad news out of Oregon

Much of the work of detecting the cause of outbreaks is art, not science, and by all accounts he was an artist. 

FDA Extends Food Facility Registration Deadline Until January 31

The Food and Drug Administration (FDA) has extended the deadline for food facilities to submit their registration until January 31, 2013.

Under the FDA Food Safety Modernization Act (FSMA), domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to renew their facility registration by December 31, 2012, and every two years after that. FSMA directed that the food facility registration portal would be available starting on October 1, 2012.

However, FDA experienced a delay in implementing the biennial registration renewal for the 2012 cycle. As a result, the registration renewal portal did not become available until October 22, 2012. Food industry members requested that FDA extend the time to register in order to allow companies a full three-month window to complete the renewal requirement. In a new guidance document issued on December 12, 2012, FDA noted that it would exercise its enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013. 

Failure to register a facility, renew the facility registration, or update required registration information can have serious consequences. For instance, the U.S. can bring a civil or criminal action in federal court against a company that handles food without a proper facility registration. In addition, if food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted, the food could be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food until the foreign facility is registered with FDA.

Along with the month-long extension, the FDA released an updated question-and-answer on facility registrations, and a shorter, simplified compliance guidance document for small businesses.

Oregon to Adopt 2009 FDA Food Code

The Oregon Public Health Division’s (OPHD) Foodborne Illness Prevention Program announced that it is moving forward with the adoption of the 2009 Food and Drug Administration (FDA) Food Code.  The new rules will take effect on September 4, 2012. Oddly, however, the agency noted that it would not be adopting the “No Bare Hand Contact” section of the Food Code.

In creating the “No Bare Hand Contact” rule for food handlers, the FDA pointed out that when hands are heavily contaminated, even effective handwashing practices may not be enough to prevent the transmission of pathogens from the hands to ready-to-eat (RTE) foods, such as sandwiches, salads, and other foods that are eaten without further washing or cooking. Accordingly, the rule requires the use of “suitable utensils such as scoops, spoons, forks, spatulas, tongs, deli tissue, single-use gloves, or dispensing equipment” when handling RTE food items to reduce foodborne illness.

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Canada Proposes Single Food Safety Inspection Model

In May 2012, the Canadian Food Inspection Agency (CFIA) published a report called The Improved Food Inspection Model: The Case for Change which outlined the agency's current approach to food inspection, the context for a new food inspection approach, and the proposed components of an improved food inspection model.

The report explains that when CFIA was first established in 1997, it brought together food inspection programs from different federal departments with diverse inspection approaches. As a result, CFIA currently administers eight, separate food inspection programs including:

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Egg Safety Rule Now Effective for Midsized Facilities

Egg-associated illness caused by Salmonella has long been recognized as a serious public health problem. Specifically, Salmonella Enteritidis, a bacterium commonly found inside shell eggs that appear normal, continues to be one of the leading bacterial causes of foodborne illness in the United States. These eggs primarily become contaminated on the farm because of infection in the laying hens.

During the 1990s, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture implemented a series of post-egg production safety efforts such as refrigeration requirements designed to inhibit the growth of bacteria that may be in an egg. Those efforts, as well as egg quality assurance programs (EQAPs) and consumer and retailer education, contributed to a decrease in Salmonella Enteritidis illness during the mid-1990s. However, while these steps limited the growth of bacteria, they did not prevent the initial contamination from occurring. FDA and USDA officials became aware that further reductions in Salmonella Enteritidis illness could not be accomplished without additional federal measures addressing the contamination of shell eggs.

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FDA Updates the Reportable Food Registry

This week, the Food and Drug Administration (FDA) updated the Reportable Food Registry (RFR) to include a Rational Questionnaire incorporating additional data elements as part of an effort to improve the RFR’s information gathering capability.

The additional elements are the following:
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