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FDA Extends Comment Period on Food Transportation Rule

FDA has extended the public comment period on its proposed “Sanitary Transportation of human and Animal Food” rule, which was originally published on February 15, 2014.  The new due date for comments is July 30, 2014, sixty days from the original due date of May 31, 2014.

Information regarding the proposed rule can be found here.  This rule is part of a series of new rules proposed by FDA to implement the Food Safety Modernization Act of 2011.  As further explained by FDA:

The goal of the proposed rule on the sanitary transportation of human and animal food is to prevent practices that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food during transportation. The proposed rule addresses the sanitary transportation of both human and animal food traveling via motor or rail vehicle by establishing

FDA Revises Guidance on Prior Notice of Imported Foods

April 2, 2014

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On March 31, 2014, FDA opened a sixty-day comment period on revised draft guidance regarding prior notice of imported foods.  As its name suggests, the rule requires notice to FDA prior to importing any food into the United States.  Nearly every Q&A in the guidance document has been updated, and changes have been made to the information that must be provided in a prior notice.  For example, under the new guidance a prior notice will need to indicate whether the food has been refused entry by another country.

This guidance, now in its third edition, has not been updated since May 2004, meaning the impacts of the Food Safety Modernization Act had not been taken into account.  Comments on the draft guidance are currently due May 30, 2014.

FDA Issues Proposed Food Transportation Rule

January 31, 2014

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On January 31, 2014, as part of the ongoing rulemaking changes required by the Food Safety Modernization Act, FDA issued a proposed rule relating to the sanitary transportation of human and animal food.  The rule will require “certain shippers, receivers, and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation.”  The rule also creates criteria for sanitary practices, including refrigeration, vehicle cleaning, protecting food during transportation and training and recordkeeping.  Comments are due by May 31, 2014.  Stay tuned to Digest for more commentary about the proposed rule.

FDA Publishes Draft Rule to Address Intentional Adulteration of Food

FDA published a draft rule today designed to require the largest food businesses in the United States to take steps to address vulnerabilities in their operations to prevent the intentional adulteration of food – “food terrorism,” in other words.  The proposed rule will generally apply to both domestic and foreign facilities that manufacture, process, pack, or hold food and are required to register as a food facility.  Exempted from the rule are small businesses (less than $10 million in annual food sales), farms, food for animals, certain food holding facilities, and certain packing or labeling facilities.  As explained by FDA:

Under the proposed rule, a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process. Facilities then would have to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working,

FDA To Further Amend Draft Rules Implementing FSMA

Yesterday, FDA Deputy Commissions for Foods and Veterinary Medicine, Michael Taylor, announced that FDA would further amend the draft rules on produce safety and preventive controls for human food, which were originally published in draft form in January 2013.  Acccording to Mr. Taylor’s statement:

[W]e believe that significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers. These provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms. We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.

As FDA considers the changes to be significant, it will once again accept comment only on

FDA Extends FSMA Rule Comment Periods

Today, FDA extended the comment periods for four pending rules designed to implement the Food Safety Modernization Act. These rules, and the new due dates for comments, are:

(1) Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Foods (new due date is November 22, 2013)

(2) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (new due date is November 22, 2013)

(3) Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (new due date is January 27, 2014)

(4) Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (new due date is January 27, 2014)

For information on these rules and how to comment, see FDA’s website.

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