Read the series: Lessons Learned from Intentional Adulteration Vulnerability AssessmentsThis week FDA issued a supplemental draft guidance to aid in compliance with the FSMA Intentional Adulteration Rule. The draft, “Mitigation Strategies to Protect Food Against Intentional Adulteration”, includes chapters that address food defense corrective actions and verification, reanalysis and recordkeeping. It also includes appendices on FDA’s Mitigation Strategies Database, along with how business can assess their status as a small or very small business.
This is the third and final installment of the draft guidance for the IA rule.
The FDA is still on schedule to begin routine intentional adulteration inspections next month.
Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.
According to an agency news release, the draft guidance will help facilities in the following areas:
- “Determine whether they need a supply-chain program;
- Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
- Establish frequency of supplier verification activities;
- Meet documentation and recordkeeping requirements; and
- Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”
In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.
The FDA is accepting public comments on the draft for the next 180 days.
Last week FDA released the sixth chapter of the draft guidance, “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food”. The document aims to assist food facilities in establishing and implementing a heat treatment (i.e., baking or cooking) to prevent bacterial contamination.
Learn more about FSMA compliance at the 2017 Food Safety Consortium | November 28– December 1 | The 60-page draft guidance addresses the use of heat treatments as a process control, providing information on understanding potential hazards, design and validation of the heat treatment, establishing and implementing monitoring procedures (and how often), verification, and record keeping.
FDA states that it intends to publish at least 14 chapters of the guidance. In just two weeks, the compliance date for the preventive controls for human food rule falls for small businesses (fewer than 500 full-time employees).
Between 1996 and 2016, sprouts have been responsible to 46 outbreaks in the United States, which has led to nearly 2500 illnesses and three deaths, according to FDA. They have presented a consistent challenge to operators, because sprouts are most often produced in conditions that are ideal for bacteria growth.
Today FDA issued a draft guidance to assist sprout operators in complying with the FSMA Produce Rule, which requires “covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting, test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens, test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes, and take corrective actions when needed.”
Large sprout operators must comply with the Produce Rule (applicable provisions) by January 26. Small business must comply by January 26, 2018 and very small businesses by January 28, 2019.
The draft guidance, Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations, is open for comment for the next 180 days.
FDA has released a draft guidance to help food facilities that manufacture, process, pack or hold food for consumption in the United States. Aptly titled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Draft Guidance for Industry”, the document is a 15-section Q&A addresses Food Facility Registration, of which the renewal period began on October 1 and ends December 31. The seventh edition of the guidance also adds information related to the Amendments to Registration of Food Facilities final FSMA rule.
The agency is accepting comments on the draft guidance until February 6, 2017.
Today FDA released a new draft guidance related to FSMA: Draft Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety Modernization Act (FSMA) details the agency’s current thinking related to “disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules”. These rules are the PC rules for human and animal food, the Produce rule and the Foreign Supplier Verification Program.
“This guidance provides our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be “documents of the trade” for the purpose of the statements accompanying the food,” according to an FDA release.
The draft is available on the Federal Register and is open for comment 180 days after publication (October 31).
Today FDA published a draft guidance to help qualified facilities in complying with the FSMA Preventive Controls (PC) for Human and Animal Food rules. Businesses that are defined as qualified facilities are subject to modified requirements of the PC rules, which can be met by submitting a form to FDA confirming that the site is implementing PCs to address hazards related to its food or is in compliance with non-Federal food safety laws and regulations.
The draft guidance, “Qualified Facility Attestation Using From FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)” discusses how to determine whether a business meets the “qualified facility” definition and how to submit the form that demonstrates this status.
The Federal Register is scheduled to publish the document on May 16, at which point the draft guidance will be available for public comment for 180 days.
About 15% of the U.S. food supply is imported. And within that figure nearly 80% of seafood, 50% of fresh fruit, and 20% of vegetables come from outside the United States, according to FDA. Under FSMA, the commitment to ensuring the safety of imported foods is a high priority. FDA is releasing a proposed rule, and a companion draft guidance document, to aid foreign entities in proving that they are meeting food safety import requirements.
The proposed rule, “User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications”, is scheduled for publication Friday, July 24. FDA has named the following key groups that would be charged fees:
- Accreditation bodies (ABs) submitting applications or renewal applications for recognition in the third-party accreditation program
- Recognized ABs and accredited CBs that are participating in the third-party accreditation program and subject to FDA monitoring
- Certification bodies (CBs) submitting applications or renewal applications for direct accreditation
In addition to naming those subject to the user fee, the proposed rule defines how the fees would be computed and collected, the agency’s public notification process, and what happens if those subject to the fee do not pay it (i.e., suspension of recognition).
In the draft guidance, “Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards”, FDA makes recommendations on third-party auditor/certification body qualifications. If finalized, the document will remain a companion guidance to the final rule.