Tag Archives: FSMA

FDA Publishes Draft Guidance Concerning “Refusal of Inspection”

Section 807(b) of the Federal Food, Drug, and Cosmetic Act, added by section 306 of the Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to refuse imported food from being admitted into the United States if the Agency is not permitted to inspect the foreign establishment that produced the food. … Continue Reading

FSMA For Cotton Ginners?

Are cotton farmers and ginners subject to FDA’s Food Safety Modernization Act (FSMA)?  If you are a cotton ginner that is not a farm the answer is currently yes. FDA is currently exploring the extent to which cotton ginners should be covered by FSMA. Cotton farmers and ginners, of course, produce the fabrics that we use … Continue Reading

FDA Issues Guidance to Allow “Co-Manufacturers” Additional Time to Implement Certain Supply-Chain Program Requirements

As our readership is well aware, three of the rules created to implement the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs – have requirements for a supply-chain program for certain raw materials and other ingredients. FDA has designed the … Continue Reading

FSMA Update: FDA Launches Web Page with Compliance Dates

The U.S. Food and Drug Administration (FDA) introduced a new web page that consolidates the compliance dates for the Agency’s Food Safety Modernization Act (FSMA) rules. The rules that include compliance dates, in the order they became final, are: Preventive Controls for Human Food Preventive Controls for Animal Food Produce Safety Foreign Supplier Verification Sanitary … Continue Reading

FDA Releases Guidance Documents Concerning Animal Food CGMPs and the FSMA “Solely Engaged” Exemptions

As previously covered on this blog, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015) under the Food Safety Modernization Act (FSMA) became effective on November 16, 2015.  Covered large and small businesses are now required to be in compliance … Continue Reading

OIG: “Challenges Remain in FDA’s Inspections of Domestic Food Facilities”

A recently released Office of the Inspector General (OIG) report has found that the U.S. Food and Drug Administration (FDA) is making steady progress on its implementation of the Food Safety Modernization Act (FSMA) with specific regard to inspections of domestic food facilities, but challenges remain. In particular, the OIG found, in part, that: Although … Continue Reading

FDA Releases Training Module for Carriers Subject to the Sanitary Transportation Rule

As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications … Continue Reading

FDA Publishes Proposed Rule Seeking to Extend Compliance Dates for Agricultural Water Standards

FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water … Continue Reading

FDA Issues Compliance Guide for Small Businesses under FSMA Produce Safety Rule

FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here. On September 5, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) … Continue Reading

FDA Releases Sixth Chapter of Draft Guidance for the Human HARPC Rule

As our readership is well aware, the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. To facilitate compliance … Continue Reading

FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule

On May 27, 2016, FDA published its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule. In short, the final rule establishes various food defense measures that registered facilities are … Continue Reading

FDA Launches Food Safety Plan Builder to Facilitate FSMA Compliance

The Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. The new HARPC requirements implemented by the … Continue Reading

FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its … Continue Reading

FDA Delays Preventive Controls Inspections for Large Animal Food Facilities

The second major compliance dates are coming up for the Preventive Controls for Animal Food Rule under FDA’s Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal food facilities must comply with preventive controls requirements mandated by FSMA. These facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016. As … Continue Reading

FDA Issues Guidances on Exemptions from FSMA Rules

As previously reported on this blog, the U.S. Food and Drug Administration issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA) on September 10, 2015. Prior to issuing the FSMA regulations, FDA established: A Seafood Hazard Analysis and Critical Control Point (HACCP) … Continue Reading

FSMA Funds 2017: More Green for Greens

FDA announces FSMA funds to support states’ continued implementation of the produce safety rule. The Food Safety Modernization Act (FSMA) was designed to update and strengthen FDA’s risk-based approach to the oversight of food safety.  The produce safety rule – which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits … Continue Reading

FDA Launches Accredited Third-Party Certification Website

As previously covered on this blog, in November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that established a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such … Continue Reading

FDA Slated to Extend Compliance Dates for Agricultural Water Standards

Agricultural water can be a major conduit of pathogens that can contaminate produce. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards.  In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  In March 2017, the … Continue Reading

Questions (and Answers) on FSVP

As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017 (for a summary of which importers are covered by the general compliance date, see here). The U.S. Food and Drug Administration recently issued additional guidance for importers on … Continue Reading

FDA Issues New Guidance on FSMA’s FSVP Rule

As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017. The U.S. Food and Drug Administration recently issued updated fact sheets, and new guidance on how to identify the importer under the FSVP Rule. The May 30th … Continue Reading

U.S. FDA Recognizes Australia as Having a Comparable Food Safety System

Today, the U.S. Food and Drug Administration (FDA) announced that the Agency has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing each other’s food safety systems as comparable to one another. This follows FDA’s decision to recognize New Zealand and Canada as comparable foreign food safety systems in 2012 and 2016, … Continue Reading

FDA Announces Three Waivers to Sanitary Transportation Rule

By way of background, on April 5, 2016, FDA released a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications for … Continue Reading

FDA May Simplify Produce Safety Rule’s Agricultural Water Standards

By way of background, the Produce Safety Rule under FDA’s Food Safety Modernization Act establishes two sets of criteria for microbial water quality based on the presence of generic coli, which can indicate the presence of fecal contamination. The first does not allow any detectable generic E. coli in agricultural water for certain uses, such as water … Continue Reading
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