U.S. Court Sets Deadline for U.S. FDA Food Safety Modernization Act (FSMA) Regulations to Be Released

The U.S. District Court of Northern California ordered the U.S. Food and Drug Administration (FDA) to publish all of the Food Safety Modernization Act (FSMA) proposed regulations by November 30, 2013 and the final regulations by June 30, 2015. Registrar Corp will continue to monitor the implementation of the regulations and provide support to industry as the regulations are promulgated.

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The result of this case means that the deadline for FSMA's regulations has been set. Food and Beverage manufacturers must be aware of upcoming FDA FSMA regulations.

Hampton, VA (PRWEB) June 26, 2013

On June 21, 2013, the Hon. Phyllis J. Hamilton, District Judge of the U.S. District Court for the Northern District of California (case No. C 12-4529 PJH), issued an order granting injunctive relief in response to a legal complaint filed by the Center for Food Safety and the Center for Environmental Health on August 29, 2012. Registrar Corp, an FDA compliance firm, continuously monitors the release of new U.S. FDA regulations for the purpose of providing the industry with guidance.

In the original complaint, the Center for Food Safety and Center for Environmental Health alleged that certain proposed and final regulations had not been issued by FDA pursuant to the Administrative Procedures Act ("APA"), within the timeframe set forth by FSMA.

The Court ruled that the FDA violated FSMA and ordered the agency to agree upon new dates for issuance of the regulations by May 20th. The two parties were to meet and prepare a joint written statement stating new proposed deadlines for the missing FSMA regulations. When the two parties could not come to an agreement on new dates, each presented the court with a proposal.

The Center for Food Safety and Center for Environmental Health's proposal set May 1, 2014 as the latest date for submission of the final rules. Meanwhile, the FDA proposed "target timeframes" with "goals" for publication of the proposed rules and set final rules to be released 15-21 months after comment periods.

Judge Hamilton received both proposals and issued an order. The Court orders that FDA publish all proposed regulations by November 30, 2013. The comment period will close no later than March 31, 2014. The final FSMA regulations shall be published in the Federal Register no later than June 30, 2015.

The result of this case means that the deadline for FSMA's regulations has been set. Food and Beverage manufacturers must be aware of upcoming FDA FSMA regulations. Registrar Corp will continue to monitor the developments of FDA's FSMA regulations and inform industry of changes in U.S. FDA regulations.

Registrar Corp is an FDA regulatory compliance firm that assists companies with U.S. FDA regulations. Registrar Corp helps food and beverage manufacturers with Food Facility Registrations, Renewals, and U.S. Agent requirements. Furthermore, Registrar Corp can help companies prepare for a U.S. FDA inspection. Registrar Corp’s Food Safety Department performs Mock FDA Inspections of facilities to help companies prepare for U.S. FDA inspections. FSMA requires FDA to inspect foreign food facilities and to double the number of inspections every year until 2015. This year alone, FSMA requires FDA to perform a minimum of 2400 inspections of foreign facilities. Prepare now for a U.S. FDA inspection.

Registrar Corp will continue to keep you updated on the implementation of FSMA. For more information on how the Food Safety Modernization Act may affect you, Registrar Corp is available by phone at +1-757-224-0177 or 24/7 via online Live Help. To receive regulatory updates, visit: FDA Regulatory Updates by Registrar Corp.


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