Tag Archives: FSMA

FDA Issues Draft Guidance on Reducing Microbial Hazards in Seed for Sprouting

The U.S. Food and Drug Administration (FDA) has issued a draft guidance, titled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.” This draft guidance document provides food safety recommendations for those that grow, condition, pack, hold or distribute seed for sprouting.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

  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

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FDA Publishes Draft Guidance to Assist in Developing Alternate Curricula to Satisfy Produce Safety Rule Requirements

FDA published a draft guidance to help farmers and educators develop or select alternate curricula to meet the training requirements of the Produce Safety Rule mandated by the Food Safety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

  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

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

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”

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

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

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

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

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

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

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

FDA Will Hold Public Meetings Throughout the U.S. in November and December for Discussion of the New Draft Guidance on Standards for Compliance with the Produce Safety Rule

  As reported last week on The Daily Intake, FDA published two new draft guidance documents on October 19, 2018 to assist processors and farmers in complying with produce safety requirements under the Food Safety Modernization Act (FSMA).  The draft Guide to Minimize Food Safety Hazards of Fresh-cut Produce addresses compliance for fresh-cut produce with … Continue Reading

FDA Issues Draft Guidance on Produce Safety Requirements under FSMA

FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA). The FSMA final rule on Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food (the Preventive Controls Rule) was published on September 17, 2015 (80 … Continue Reading

VQIP Application Portal Will Open October 1st for the Fiscal Year 2020 Benefit Period

The Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP).  VQIP is intended to expedite the review and import entry of human and animal foods into the United States.  To participate in VQIP, importers must meet eligibility criteria and pay a user fee.  Eligibility criteria include ensuring that the foreign supplier’s facility … Continue Reading

FDA Commissioner Discusses FDA’s Efforts to Prevent Foodborne Cyclospora Outbreaks

FDA Commissioner Scott Gottlieb has issued a press release in the aftermath of this summer’s Cyclospora (C. cayetanensis) outbreaks in fresh produce, highlighting the Agency’s efforts to prevent outbreaks of this foodborne illlness.  Cyclospora is an intestinal parasite that is spread through contamination of food with human waste. FDA has been surveying the food supply … Continue Reading

FSMA Update: FDA Issues Final Q&A Guidance and Attestation Forms for Qualified Facilities Under HARPC Rules

On May 16, 2016 (81 FR 30219), FDA issued a draft guidance document intended to assist “qualified facilities” comply with modified requirements under the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA).  A qualified facility is defined as: (1) a very small business (defined with respect to annual … Continue Reading

FDA Expands ANAB Recognition under the Accredited Third-Party Certification Program

The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, which is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies have the authority to accredit third-party “certification bodies,” otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety … Continue Reading

FDA Recognizes a Fourth Accreditation Body Under FSMA’s VQIP

  As previously covered on this blog, the Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP) for expediting the review and import entry of human and animal foods into the United States.  Certification through FDA’s Accredited Third-Party Certification Program is one of the eligibility criteria for participation in the VQIP.  Under … Continue Reading

FDA Releases Q&A for Preventive Controls for Animal Foods

In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections. The … Continue Reading
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