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FDA Reports That 12% of Spice Imports Are Contaminated

What is in all of those little spice containers in the your kitchen?  According to the FDA, as recently reported by the New York  Times, about 12% of spice imports are contaminated with “insect parts, whole insects, rodent hairs, and other things.”  Nearly 7% of spices imported contained salmonella.   Under the Food Safety Modernization Act, FDA is looking at new rules to address food imported into the United States, including modifications to the foreign supplier verification program.  Recent changes to those proposed rules, however, are seen by many to weaken the program.  Those changes, which include eliminating the requirement for onsite audits and exemptions for importers doing less than $500,000 in business, would surely impact spice importers (as well as other food importers).

FDA To Conduct Environmental Impact Statement on Draft Produce Rule

FDA announced today that it will conduct an environmental impact statement (EIS) on the draft Produce Safety Rule proposed in January 2013.    An EIS is required under the National Environmental Policy Act for certain government agency actions that may significantly affect the quality of the human environment.  The EIS is a tool used by the agency to tailor the specific action, such as rulemaking, to address environmental concerns.  FDA indicated that it is conducting the EIS “because it has received information through comments and its own analysis that an environmental analysis is needed.”  FDA is also commencing a scoping process to determine the scope of the environmental review.  Comments on the scope of review FDA should undertake are due November 15, 2013, the same day that comments on the substantive provisions of the draft Produce Safety Rule are due.  FDA has indicated that the EIS process is not anticipated

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 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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