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FDA Extends Comment Period on Produce and Human Food Rules

FDA announced today that it is extending by sixty days the deadline for commenting on the proposed rules for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and the proposed Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.  The new deadline for comments is November 15, 2013, and FDA has indicated that this will be the last extension of time.

The two draft rules were originally proposed in January of 2013 to implement provisions of the Food Safety Modernization Act.  The proposed Human Food rule will, among other things, require hazard analysis and critical control points (HACCP) plans for domestic and foreign facilities that manufacture, process, pack or hold human food.  The proposed Produce Safety Standards are prevention-based standards that require those growing, harvesting, packing or holding produce on foreign or domestic farms to undertake a science-based risk analysis of

FDA Publishes Draft Food Import Rules

FDA today announced two new draft rules to further implement the Food Safety Modernization Act, both impacting the import of food.  One rule, relating to Foreign Supplier Verification Programs, requires importers to verify that their suppliers meet the same safety standards as domestic producers.  A second rule relates to the accreditation of third party auditors to issue certifications for foreign food production facilities.  The rules will be published in the Federal Register on July 29, 2013, and comments are due within 120 days of publication.

FDA Issues Draft Egg Safety Rule Guidance for Producers Who Give Hens Outdoor Access

July 23, 2013

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FDA issued draft guidance Egg Safety Rule today, which can be found here.  From FDA’s press release:

FDA is issuing draft guidance with practical and reasonable food safety controls to help egg producers who provide their laying hens with outdoor access comply with the Egg Safety Rule and thereby prevent Salmonella Enteritidis (SE) in shell eggs. FDA believes the draft guidance will help clarify how the Egg Safety Rule applies to their operations so the egg producers can confidently and efficiently implement the appropriate food safety measures.

The draft guidance describes different types of poultry houses and outdoor access areas and offers practical measures to control for SE by preventing wild birds, rodents, and other animals from entering the outdoor access areas and advice on conducting environmental sampling for SE.  It also discusses considerations related to vaccination of laying hens.

FDA Publishes Guidance on Proposed FSMA Produce Rule

July 15, 2013

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In support of FDA’s proposed produce rule implementing portions of the Food Safety Modernization Act, FDA issued today several publications to help small- and medium-sized growers understand their future obligations under the proposed rule.  FDA has been creating fact sheets to to describe requirements such as the obligation to assess potential routes of microbial contamination of produce.  The new publications include a fact sheet on the proposed agricultural water standards, which is one of those potential routes of microbial contamination.  FDA also issued a second fact sheet on alternatives and variances under the proposed produce rule, which will help producers develop alternative standards to comply with the rules.

FDA’s proposed produce rule remains open for public comment until September 16.  Like the proposed rule, FDA will accept comments on the fact sheets.

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