FSMA

OUR CONTRIBUTOR
Steve Mavity
steven.mavity@bumblebee.com ♦ Sr VP – Technical Services & Corporate Quality Bumble Bee Seafoods Foods

Food Safety Modernization Act

FSMA Ruling Link

FSMA is the biggest overhaul of the food safety system since the first national law was passed over a century ago. This law requires FDA to to fundamentally change its approach to implementing food safety rules, including how FDA works with other governments and the food industry to achieve food safety success. The rules apply to both home-grown and imported food. Food Safety News: The Future is Now for FSMA

Questions for FDA: Use this link to ask FDA questions about FSMA. They want to hear from you.  FSMA Questions to FDA

The FSMA Mandate

The FSMA mandate is broad and challenging. FSMA instructed FDA to overhaul its food safety program, with these major new directions:

  • Prevention: Shifting from an old, antiquated system of chasing after problems once they occur to a new focus on prevention.
  • Federal-state integration: Leveraging and integrating state and local food safety systems with Federal efforts to enhance nationwide quality, consistency, and efficiency.
  • Modernized and expanded import oversight: Implementing an entirely new import oversight program that relies on importers taking greater responsibility for the foods they bring into the U.S., enhances FDA’s risk-based import screening program, expands foreign inspections and collaboration with foreign governments, and facilitates trade in safe food.
  • Risk-based: Improving resource management to improve food safety through risk-based priority setting and resource allocation.
  • Increased, targeted inspections: Increasing the frequency of inspections and enhancing the targeting of inspections based on food safety risk and performance through modernized data collection and information systems. FDA: Presidents 2016 Budget Request

 FSMA FDA Logo

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law by President Obama on

January 4, 20011, is intended to allow FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law contains important new tools to better ensure the safety of imported foods and encourages partnerships with State, local, tribal, and territorial authorities. A top priority for FDA are those FSMA-required regulations that provide the framework for industry’s implementation of preventive controls and enhance their ability to oversee their implementation for both domestic and imported food. To that end, FDA proposed the following foundational rules:

FSMA Elements

The major elements of FSMA can be divided into five key areas

FSMA Elements

  • Preventive controls- For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply.
  • Inspection and Compliance- The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food; thus, the law specifies how often FDA should inspect food producers. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.
  • Imported Food Safety- FDA has new tools to ensure that those imported foods meet US standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
  • Response- For the first time, FDA will have mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls.
  • Enhanced Partnerships- The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials.

Published Foundational Rules for Implementation of FSMA

  1. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (78 FR 3646, January 16, 2013)
  2. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (78 FR 3504, January 16, 2013)
  3. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (78 FR 64736, October 29, 2013)
  4. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (78 FR 45730, July 29, 2013)
  5. Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (78 FR 45782, July 29, 2013)
  6. Focused Mitigation Strategies To Protect Food Against Intentional Adulteration (78 FR 78014, December 24, 2013)
  7. Sanitary Transportation of Human and Animal Food (79 FR 7006, February 5, 2014)

Published Supplemental Notices

  1. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (79 FR 58524, September 29, 2014)
  2. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (79 FR 58434, September 29, 2014)
  3. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (79 FR 58476, September 29, 2014)
  4. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (79 FR 58574, September 29, 2014)

For additional information on FSMA check out the following websites:

  • FDA Food Safety Modernization Home page  FDA: Food Safety Modernization Act You may also like to sign up for their email list to keep up to date on changes.
  • FSPCA The Food Safety Preventive Controls Alliance (FSPCA) is a broad-based public private alliance consisting of key industry, academic and government stakeholders whose mission is to support safe food production by developing a nationwide core curriculum, training and outreach programs to assist companies producing human and animal food in complying with the preventive controls regulations that will be part of the Food Safety Modernization Act (FSMA). FSPCA: Food Safety Prevention Control Alliance . There is a long list of resources that may assist you, as well

 

 

PowerPoint from workshop 9/2015 Mavity – FSMA 2015 Document Icon

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