The FDA Food Safety Modernization Act represents the most significant expansion of food safety requirements and FDA food safety authorities since enactment of the FD&C Act in 1938.  It grants FDA substantial new enforcement authorities and imposes far reaching new regulatory requirements.  While some provisions of the new law take effect immediately, full implementation of the FSMA will require FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.  

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FDA Announces Creation of Food Safety Preventive Controls Alliance - January 5, 2012

The FDA, in cooperation with the Illinois Institute of Technology's Institute for Food Safety and Health (IIT IFSH), has announced the creation of the Food Safety Preventive Controls Alliance (FSPCA) (click here to view announcement).

The FSPCA will develop training courses and materials, as well as commodity-specific and industry sector-specific guidelines, to help the food industry comply with the Food Safety Modernization Act's (FSMA) requirement to conduct a hazard analysis and implement preventive controls. FDA is expected to issue two proposed rules on preventive controls, one for human food and one for animal feed, later this month.

FDA Guidance on Prevention of Salmonella Enteritidis in Shell Eggs - December 28, 2011

The Food and Drug Administration (FDA) has published a revised guidance document, entitled "Guidance for Industry: Prevention of Salmonella Enteritidis [SE] in Shell Eggs During Production, Storage, and Transportation" (Dec. 2011) (available at http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/UCM285137.pdf), to assist egg producers in complying with the agency's governing regulations. Notice of the availability of this guidance document, modified pursuant to evaluation of comments submitted on the draft guidance document (see 75 Fed. Reg. 48,973 (Aug. 12, 2010)), was published at 76 Fed. Reg. 81, 513 (Dec. 28, 2011) (available at http://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33292.pdf). Comments on the current guidance document may be submitted to FDA at any time.

Food Source Attribution - Notice of Public Meeting - December 27, 2011

The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS), in collaboration with FDA and the Centers for Disease Control and Prevention (CDC), will host a public meeting on January 31, 2012, from 8:30 AM until 4 PM EST, at USDA in Washington, DC, to:

• Discuss efforts to advance understanding of "food source attribution" (i.e., the attribution of foodborne illness to specific foods and/or settings);
• Develop harmonized food source attribution estimates (useful in establishing food safety strategies);
• Introduce the Interagency Food Safety Analytics Collaboration (IFSAC), formed to collaborate on analytic projects (see OFW Law's memorandum dated July 22, 2011); and
• Present the IFSAC's draft Strategic Plan for Attribution.

A notice of the public meeting is published at 76 Fed. Reg. 80, 873 (Dec. 27, 2011) (available at http://www.gpo.gov/fdsys/pkg/FR-2011-12-27/pdf/2011-33018.pdf).

FDA and USDA Agencies Enter Into a Memorandum of Understanding for Sharing of Food Safety Information - December 2, 2011

The FDA has entered into a memorandum of understanding (MOU) with the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service, Food Nutrition Service, and Farm Service Agency to share information regarding the safety of FDA-regulated "USDA Foods." 76 Fed. Reg. 74791 (Dec. 1, 2011). For purposes of this MOU, "USDA Foods" means commodities procured by USDA for use in domestic nutrition assistance programs. The MOU became effective on September 29, 2011.

FDA at a Crossroads Conference - November 15, 2011

The George Washington University School of Public Health and Health Services and the Union of Concerned Scientists co-hosted a conference entitled "FDA at a Cross Roads."

The goal of the conference was to develop recommendations to address emerging challenges facing the Food and Drug Administration (FDA), such as new technologies, efficacy and food/drug safety concerns, budget limitations, and scientific integrity difficulties. FDA Commissioner, Dr. Margaret Hamburg, delivered the keynote address.

FDA Reopens Comment Period for Guidance on Hazard Analysis and Preventive Controls for Specific Foods - November 1, 2011

FDA has reopened the comment period for its May 23, 2011, notice requesting information and comments to inform development of guidance on hazard analysis and preventive controls for specific types of food. 76 Fed. Reg. 67465 (Nov. 1, 2011). The reopened comment period will close on December 20, 2011. As required by the Food Safety Modernization Act (FSMA), FDA is developing regulations that will require registered food facilities to conduct a hazard analysis and implement a written preventive controls plan. In addition, FDA has said it will issue guidance documents that will explain how the hazard analysis and preventive controls requirements apply to specific product categories.

FDA Extends Comment Period for Notice Regarding FY 2012 Re-inspection Fees - October 26, 2011

FDA has published a Federal Register notice extending the comment period for its August 1, 2011, notice regarding the fiscal year (FY) 2012 re-inspection fees mandated by the FDA Food Safety Modernization Act (FSMA). Comments are now due on November 30, 2011.

FDA Extends Comment Period for Notice Regarding Re-inspection Fees' Burden on Small Business - October 18, 2011

FDA has published a Federal Register notice extending the comment period for its August 1, 2011 notice regarding the burden of re-inspection fees on small business. 76 Fed. Reg. 64354 (Oct. 18, 2011). Comments are now due on November 30, 2011.

FDA Issues Guidance Document on Reinspection Fees - October 4, 2011

FDA has issued a guidance document regarding the agency's plans for implementation of its new authority to collect fees for reinspections and failure to comply with a recall order, entitled: Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act. The guidance is available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm274176.htm).

FDA Announces New Effort to Create an Integrated Food Safety System - September 23, 2011

FDA has announced new steps to create an integrated food safety system in which federal and state agencies work together seamlessly (available at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm272566.htm). According to FDA, such an integrated system is one of the key mandates of FSMA.

FDA Announces Plans for Pilot Projects on Product Tracing - September 7, 2011

FDA has issued a press release and other documents discussing the agency's plans for implementation of the FSMA provisions dealing with traceability and recordkeeping (available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm270827.htm). The Institute of Food Technologists will conduct two pilot projects on food product tracing under an existing contract with FDA. The pilot projects will help determine what data are most needed to trace a product that has been distributed widely in the marketplace back to a common source. They will also determine what data are needed to trace a food, such as a contaminated ingredient, forward.

FDA Issues Correction Regarding FY 2012 Fee Rates for Reinspections and Failure to Comply with a Recall Order - August 26, 2011

FDA has issued a correction to the fiscal year (FY) 2012 fee rates to be charged for reinspections and failure to comply with a recall order. 76 Fed. Reg. 53478 (Aug. 26, 2011). On August 1, 2011, FDA published the FY 2012 hourly rates the agency will use to calculate fees for certain reinspections of domestic and foreign food facilities, reinspections of importers, and failure to comply with a recall order. These new fees are authorized by FSMA. The hourly rates announced on August 1 were $224 if no foreign travel is required, and $335 if foreign travel is required. FDA has now issued a correction stating that the hourly rate when foreign travel is required is $325, not $335.

FDA Announces FY 2012 Fee Rates and Seeks Public Comment on the Burden of Such Fees on Small Business- August 1, 2011

FDA has published two notices concerning user fees mandated by FSMA:

•· "Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012." 76 Fed. Reg. 45820 (Aug. 1, 2011).

•· "Burden of FDA FSMA Fee Amounts on Small Business." 76 Fed. Reg. 45818 (Aug. 1, 2011).

FDA Holds Public Meeting on Implementation of the Food Safety Modernization Act – Inspection and Compliance – June 8, 2011

Today, the FDA held a public meeting on June 6, 2011 on implementation of the FDA Food Safety Modernization Act (FSMA) provisions relating to inspections and compliance. FDA has created a separate docket for these provisions of FSMA (Docket No. FDA-2011-N-0366) and is requesting comments, which must be submitted by July 6, 2011.

The purpose of this public meeting was to obtain public input that will inform the agency’s development of implementing regulations and guidance documents. While FDA officials offered some information about the agency’s plans for implementation, the meeting was primarily a listening session in which FDA sought the views of stakeholders. FDA is requesting written comments on the inspection and compliance provisions of FSMA.

FDA Opens New Docket to Receive Information on Preventive Controls Associated with Specific Types of Food and Specific Processes – May 23, 2011

Today, the FDA has published a notice announcing the creation of a new docket to receive information about preventive controls to address hazards associated with specific types of food and specific processes. 76 Fed. Reg. 29767 (May 23, 2011). Comments and information are due by August 22, 2011.

The Food Safety Modernization Act (FSMA) requires food facilities registered with FDA to conduct a hazard analysis and implement preventive controls to significantly minimize or prevent the hazards identified. FSMA requires FDA to issue regulations implementing this hazard analysis and preventive controls requirement. FDA officials have indicated that the agency anticipates using guidance documents to explain how the hazard analysis and preventive controls requirement applies to specific product categories.

FDA Issues Interim Final Rules Required by the Food Safety Modernization Act -- Administrative Detention of Food; Prior Notice of Imported Food – May 5, 2011

The FDA has issued two interim final rules required by the Food Safety Modernization Act (FSMA):

• Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption; 76 Fed. Reg. 25,538(May 5, 2011); and 
• Information Required in Prior Notice of Importer Food; 76 Fed. Reg. 25,542 (May 5, 2011).

Both interim final rules will become effective on July 3, 2011. FDA is requesting comments on both rules, which are due by August 3, 2011. Comments on the second interim final rule’s information collection must be submitted to the Office of Management and Budget by June 6, 2011.


FDA Holds Public Meeting on Implementation of the Food Safety Modernization Act Provision on Preventive Controls - April 22, 2011

The FDA held a public meeting on April 20, 2011 on implementation of the provision of the FDA Food Safety Modernization Act (FSMA) requiring registered food facilities to implement preventive controls. FDA has created a separate docket for this provision of FSMA (Docket No. FDA-2011-N-0251) and is requesting comments, which must be submitted by May 20, 2011.

Section 103 of FSMA (new Section 418 of the Federal Food, Drug, and Cosmetic Act) provides that the owner, operator, or agent in charge of every food facility that is required to register with FDA must conduct a hazard analysis and implement a written preventive controls plan to significantly minimize or prevent the hazards identified. FDA is required to issue regulations establishing standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting their implementation. FDA is also required to issue guidance to industry regarding hazard analysis and preventive controls.

FDA Announces a Public Meeting on Implementation of the FSMA Provision on Preventive Controls – April 13, 2011

FDA has announced a public meeting on implementation of the Food Safety Modernization Act (FSMA) provision on hazard analysis and preventive controls. The all-day meeting will be held at FDA’s White Oak campus on April 20, 2011. FDA is also requesting comments, which must be submitted by May 20, 2011.


FDA Holds Public Meetings on Import Provisions of Food Safety Modernization Act – April 6, 2011

The FDA held two public meetings this week on implementation of the import provisions of the FDA Food Safety Modernization Act (FSMA):

• A public meeting on March 29, 2011 entitled “FDA Food Safety Modernization Act Title III: New Paradigm for Importers”
• A public hearing on March 30-31, 2011 entitled “Ensuring the Safety of Imported Foods and Animal Feed: Comparability of Food Safety Systems and Import Practices of Foreign Countries”

While FDA officials offered some information about the agency’s plans for implementation of the FSMA, these meetings were mainly listening sessions in which FDA sought the views of various stakeholders. As Michael Taylor, FDA Deputy Commissioner for Foods, explained in his opening statement, of all the provisions of the FSMA, those dealing with imported foods represent the most dramatic paradigm shift. Therefore, FDA intends to move forward in an open process with input from all interested parties.

Senate Appropriations Subcommittee Reviews FY 2012 Budget Request for FDA – March 17, 2011

The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing to review the Fiscal Year (FY) 2012 FDA budget request.  FDA Commissioner Margaret Hamburg, M.D., discussed the agency’s FY 2012 initiatives with the Subcommittee Members, as well as Food Safety Modernization Act implementation activities, the new law’s focus on prevention, the law’s menu-labeling provision, and the shift towards ensuring food safety at the producer and processor level.  Subcommittee Members queried Commissioner Hamburg on such issues as preparation levels for natural disasters or biological attacks, FDA’s ability to fulfill its duties without a budget increase, FDA’s efforts regarding the farming community, user-fees, use of antibiotics in livestock production, and nanotechnology, among other matters. 

FDA Announces Public Meeting for March 29th entitled “FDA Food Safety Modernization Act: Title III—A New Paradigm for Importers” – March 14, 2011

FDA announces a public meeting entitled “FDA Food Safety Modernization Act: Title III—A New Paradigm for Importers.” The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of the import safety provisions of the recently enacted FDA Food Safety Modernization Act. Specifically, FDA seeks information on importer verification, the Voluntary Qualified Importer Program, import certifications for food, and third-party accreditation.

FDA to Convene Public Hearing on March 30th-31st on the Safety of Imported Foods and Animal Feed – March 14, 2011

FDA announces that it will hold a public hearing regarding new FDA initiatives for ensuring the safety of foods and animal feed imported into the United States. The purpose of the public hearing is to provide stakeholders the opportunity to discuss FDA’s use of international comparability assessments as a mechanism to enhance the safety of imported foods and animal feed and lessons learned through equivalence determinations.

House Agriculture Appropriations Committee Hearing on FDA's FY 2012 Budget Request – March 11, 2011

The Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies of the House Appropriations Committee held a hearing to review the Fiscal Year (FY) 2012 budget request for FDA. Dr. Margaret Hamburg, Commissioner of the FDA, was the sole witness at this hearing.  There was substantial discussion of the budget request for the Food Safety Modernization Act and the need for funding to address the types and number of food borne illnesses currently occurring.

FDA Announces Initiative to Improve Food Safety Practices at Retail & Food Service Establishments – February 10, 2011

FDA recently began an initiative to assist retail and food service establishments with improving their food safety practices. This initiative includes distributing food safety posters and flyers that are specifically designed for establishments that use commercial deli slicers to slice meats and cheeses. Proper sanitation of such equipment is the main focus of these food safety materials.

CRS Releases Report on “Food Safety Issues for the 112th Congress” – February 10, 2011

The 111th Congress passed comprehensive food safety legislation in December 2010 (FDA Food Safety Modernization Act (FSMA). Although numerous agencies share responsibility for regulating food safety, this newly enacted legislation focuses on foods regulated by FDA and amends the agency’s existing structure and authorities.  This CRS Report examines the oversight and appropriations issues related to implementation of the FSMA, as well as additional food safety policy issues that may be considered this Congress.

IOM and NRC Hold Discussion Forum on FDA’s Role in Ensuring Safe Food – January 28, 2010

Today, the Institute of Medicine (IOM) and the National Research Council (NRC) held a discussion forum entitled “FDA’s Role in Ensuring Safe Food.” The discussion forum focused on the recently released IOM/NCR report entitled “Enhancing Food Safety: The Role of the Food and Drug Administration” (June 2010).

CRS Releases Report on “Food Safety on the Farm” – January 18, 2011

Given the major outbreaks of foodborne illness involving both domestically produced and imported foods over the past few years, there is continued interest in examining on-farm practices.  Food safety experts agree that an effective, comprehensive food safety system should include consideration of potential hazards at the farm level.  However, opinions differ on the need for more stringent, government-enforced safety standards for farms.  This CRS Report reviews the various federal food safety programs and the impact of the Food Safety Modernization Act on small farms and food processors, as well as organic, direct-to-market, and sustainable farming operations.

President Obama Signs the FDA Food Safety Modernization Act into Law – January 4, 2011

This evening, President Obama signed the long-awaited “FDA Food Safety Modernization Act of 2010” into law (P.L. 111-353).  

Congress Passes the FDA Food Safety Modernization Act – December 21, 2010

Congress has passed the “FDA Food Safety Modernization Act of 2010.”  In a surprise development, the Senate passed SA 4890, a manager’s amendment to S. 510, on December 19th, and the House passed the Senate bill today.