Tag Archives: FSMA

FDA Releases Chapter 14: Recall Plans in the Latest Installment to the Agency’s Multi-Chapter Draft Guidance on the Human HARPC Rule

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  As discussed here, the Food and Drug Administration (FDA) has been rolling out chapters, as they are completed, to provide guidance on complying with FDA’s Final Rule for Preventive Controls for Human Food.  These rules, found in 21 Code of Federal Regulations (CFR) part 117, implement the hazard analysis and risk-based preventive control (HARPC) provisions … Continue Reading

FDA Launches Dashboard to Track FSMA Progress

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On September 30, 2019, FDA announced the establishment of the Food Safety Dashboard, which is designed to measure the progress of the seven foundational rules of the Food Safety Modernization Act (FSMA), to track their impact, and to help FDA to refine its implementation of the rules. As FDA embarks on a New Era of Smarter … Continue Reading

FDA Partners With Leafy Greens Stakeholders in Arizona to Enhance Food Safety

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The FDA has partnered with the University of Arizona, the Wellton-Mohawk Irrigation and Drainage District (WMIDD), and members of the Yuma area leafy greens industry, with support from the Arizona Department of Agriculture, to better understand the ecology of human pathogens in the Yuma agricultural region.  The Yuma agricultural region encompasses Yuma County in Arizona … Continue Reading

FDA Announces Cooperative Agreement to Implement Produce Safety Rule

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As previously reported, both states’ departments of agriculture and FDA have begun visits to produce farms to conduct inspections for compliance with the Produce Safety Rule. The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of … Continue Reading

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

FDA Issues First Warning Letter to Food Importer Under FSVP

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On August 13, FDA announced the issuance of the first warning letter to a U.S. food importer under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP).  As our readers may know, FSVP generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance … Continue Reading

Inspections Begin Under FDA’s Produce Safety Rule

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As our readers may know, the FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here. The compliance dates for the Produce Safety Rule depend on the size … Continue Reading

FDA Suspends Topway/Kazy’s Gourmet Facility Registration

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On July 22, 2019 the Food and Drug Administration (FDA) announced that it had suspended the food facility registration of Topway Enterprises, Inc, doing business as Kazy’s Gourmet of Houston, Texas. The suspension follows inspections conducted by the FDA and the Texas Department of State Health Services earlier this year, where sanitation issues were noted, … 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 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

FDA Finalizes Guidance on “Small Business” Definition under CGMP and Preventive Controls Regulations for Human and Animal Food

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  The FDA Food Safety Modernization Act’s (FSMA) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food are implemented by FDA under 21 C.F.R. Part 117 and Part 507, respectively.  Meeting the “small business” definition has two main implications: (1) Certain small businesses (i.e., “farm mixed-type … 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 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

FDA Extends Application Deadline for VQIP

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The U.S. Food and Drug Administration (FDA) announced that the application period for importers to submit their notice of intent to participate in the Voluntary Qualified Importer Program (VQIP) for the Fiscal Year 2020 benefits period has been extended to July 31, 2019. (In a previous blog, we noted that the VQIP application portal opened … 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

FDA Announces Enforcement Discretion for Certain Commodities Related to Produce Safety Rule

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The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here. In a recently released guidance for industry, “Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, … 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’s Outlines Plans to Modernize Oversight of Imported Food

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The U.S. Food and Drug Administration (FDA) discusses how the Agency is integrating new tools, that are a result of the passage of the Food Safety Modernization Act (FSMA),  with existing ones to improve the safety of imported foods in a newly released publication, “Strategy for the Safety of Imported Food.” (For background information on … 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

NGO Publishes Report on Food Safety

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The United State Public Interest Research Group (PIRG) published “How Safe is Our Food? Recent trends and case studies, and what they mean for our health”, a review and commentary of the food safety system in the United States.  PIRG reviewed trends in food safety, with an emphasis on recalls, as well as case studies … Continue Reading

FDA Publishes Q&A Guidance on Mandatory Food Recalls

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The Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded, and that use or exposure to … Continue Reading
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