Tag Archives: FOOD SAFETY

FDA Sued for Failure to Establish FSMA Accredited Labs Program by Statutory Deadline (subscription to Law360 required)

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On August 19, two consumer groups, Center for Food Safety (CFS) and Center for Environmental Health (CEH), filed suit against the FDA in California federal court for its failure to promulgate final regulations and complete actions by mandatory deadlines set by Congress in the Food Safety Modernization Act of 2011 (FSMA). At issue in the … Continue Reading

A Look at the Food Handler Antiseptic OTC Rulemaking

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On December 7, 2018, the Food and Drug Administration (FDA) established a docket and requested data, information, and comments to “assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter (OTC) human use.”  The request … Continue Reading

Flies Are a Potential E. Coli Vector in Leafy Green Illness Outbreaks

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Researchers with the U.S. Department of Agriculture’s Agricultural Marketing Service have isolated Escherichia (E.) coli O157:H7 from a variety of pest flies in leafy green fields planted up to 180 meters away from cattle feedlots.  Among most fly species captured on sticky traps at leafy green farms, 22.3-29 flies per 1,000 flies carried E. coli O157:H7. … Continue Reading

FDA Announces FSMA Third-Party Certification Program User Fee Rates for Fiscal Year 2020

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On July 23, 2019, FDA published a notice in the Federal Register announcing the fiscal year 2020 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized by the Third-Party Certification Program, as authorized by the 2011 Food Safety Modernization Act (FSMA). Under … Continue Reading

FDA Publishes Final Rule on Tolerances for Animal Drugs in Food

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On July 10 FDA finalized its rule on Updating Tolerances for Residues of New Animal Drugs in Food.  This rule was originally proposed in 2012 with a revision proposed in 2016.  The rule will become effective September 9. As described in the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) Update, the new … Continue Reading

FDA Issues Draft Guidance on Reducing Microbial Hazards in Seed for Sprouting

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The U.S. Food and Drug Administration (FDA) has issued a draft guidance, titled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.” This draft guidance document provides food safety recommendations for those that grow, condition, pack, hold or distribute seed for sprouting. FDA reported that between January 1996 and August 2018, contaminated … Continue Reading

Deadlines Set for FDA to Establish Reporting Requirements for “High-Risk” Foods

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The Food Safety Modernization Act (FSMA), enacted on January 4, 2011, set deadlines for the U.S. Food and Drug Administration (FDA) to (1) designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health; and (2) publish a notice of proposed rulemaking to establish recordkeeping requirements for facilities that … Continue Reading

FDA Deputy Commissioner Yiannis’ Remarks on World Food Safety Day

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June 7 marked the first ever celebration of the United Nations’ World Food Safety Day.  The theme for 2019 is that food safety is everyone’s business.   The United Nations has designated two of its agencies, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), to lead efforts in promoting food safety around … Continue Reading

FDA Publishes Draft Guidance to Assist in Developing Alternate Curricula to Satisfy Produce Safety Rule Requirements

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FDA published a draft guidance to help farmers and educators develop or select alternate curricula to meet the training requirements of the Produce Safety Rule mandated by the Food Safety Modernization Act (FSMA). As our readers may know, the Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of … Continue Reading

Upcoming Presentation on FDA’s 2018 Cyclosporiasis Outbreak Investigations Will Explore Recent Scientific Advances and Continuing Regulatory Challenges

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  Cyclosporiasis is an intestinal illness caused by the microscopic parasite Cyclospora cayetanensis. People can become infected with Cyclospora by consuming contaminated food or water. Past cyclosporiasis outbreaks in the U.S. have been mainly linked to consuming imported fresh produce like cilantro. C. cayetanensis, however, may be an emerging pathogen with an increasing incidence of occurrence and infection. … Continue Reading

Product Recalls Decline Across All Industries in Q1 2019

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As previously reported by Food Industry Executive based on a report and press release from Stericycle Expert Solutions, recalls within the consumer products, automotive, pharmaceutical, medical device, and food and beverage industries were all down in the first quarter of 2019.  This is the first time since 2012 that recalls were down across all industries … Continue Reading

Sharpless: ‘No Pause’ Following Gottlieb’s Departure

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As previously reported on this blog, Ned Sharpless succeeded Scott Gottlieb as Acting FDA Commissioner in April 2019.  Prior to Sharpless’ tenure, it was unclear whether the agency would continue Gottlieb’s efforts in the area of food and tobacco, including reevaluating certain standards of identity, modernizing the oversight of imported food and product recalls, and … Continue Reading

FDA Announces “New Era of Smarter Food Safety”

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On April 30, 2019, Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas announced a “New Era of Smarter Food Safety,” an effort intended to combine the implementation of FSMA with the use of new and emerging technologies. This new approach will start with the development of a “Blueprint for a New Era … Continue Reading

CSPI Calls for National Registry of Gene-Edited Agricultural Crops

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Criticizing the US Department of Agriculture (USDA) and Food and Drug Administration (FDA) for lack of oversight over foods produced with gene editing technology (e.g., Zinc Finger Nucleases, TALENS, or CRISPR/Cas 9), the Center for Science in the Public Interest (CSPI) is calling for a federal registry of all gene-edited agricultural crops. CSPI is not … Continue Reading

FDA Encourages Participation in Voluntary Plant Biotechnology Consultation Program and Revises Guidance on Voluntary Labeling of Foods Derived Plant Biotechnology

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Given the increased prevalence of plant biotechnology to develop innovative foods, FDA is reminding industry of its voluntary consultation program to ensure the safety of and public confidence in plant biotechnology-derived foods.  FDA describes “plant biotechnology” as “certain methods scientists can use to introduce new traits or characteristics to a plant.” FDA has assisted in … Continue Reading

FDA Releases Second Installment of Intentional Adulteration Draft Guidance

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FDA released the second installment of a draft guidance designed to support compliance with the Intentional Adulteration (IA) rRule under the Food Safety Modernization Act (FSMA). The first installment was published in June 2018, and a third installment is to follow. The second installment outlines two flexible methods for how facilities can conduct vulnerability assessments … Continue Reading

FDA Commissioner Scott Gottlieb Resigns

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On Tuesday, March 5, FDA Commissioner Scott Gottlieb announced he would resign at the end of the month. Gottlieb, a physician and former deputy commissioner in the George W. Bush administration, was confirmed as FDA Commissioner in May 2017. The resignation was not sought by the White House, as confirmed by a senior White House … Continue Reading

EFSA Report Indicates Antimicrobial Resistance in EU Is Increasing

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The European Food Safety Authority (EFSA) and the European Center for Disease Prevention and Control (ECDPC) have issued a joint summary report on antimicrobial resistance in the EU based on data from its 28 Member States. The 278-page report summarizes findings that antimicrobial resistance is increasing in bacteria that cause disease when transmitted from animals … Continue Reading

FDA Publishes Findings from Investigation of Romaine Lettuce E. coli Outbreak

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As previously reported on this blog, in November 2018 FDA, in conjunction with the CDC, state officials, and Canadian food and public health officials, investigated an outbreak of E. coli O157:H7 infections in multiple US states and Canadian provinces. The investigation determined the cause of the outbreak was the consumption of contaminated romaine lettuce. Indeed, … Continue Reading
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