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Food Safety Modernization Act and Animal Feed - Trenton, NJ

The Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination of the food supply to preventing it. The law applies to human food as well as to food for animals, including pets. FDA’s FSMA page contains complete information about the implementation of the law, and the intent of this page is to highlight the FSMA content that will be of most interest to manufacturers and distributors of animal food.

 

What's New?

February 25, 2016 - FDA Holding Public Meeting on FSMA Prevention-Oriented Import System Regulations and Implementation


The U.S. Food and Drug Administration (FDA) announced today a public meeting, entitled “FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation.” The public meeting will provide importers and other interested persons an opportunity to discuss import safety regulations and programs, including final rules for foreign supplier verification programs for importers of food for humans and animals and accreditation of third-party certification bodies. The meeting will be held on March 21, 2016 from 8:30 am - 5:00 pm at the FDA Center for Food Safety and Applied Nutrition (CFSAN), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740.


February 22, 2016 - President’s FY 2017 Budget Requests FSMA Investments in Import Safety and State Partnerships on Produce Safety

In his FY 2017 Budget Request, the President has proposed additional resources that include an increase of $25.3 million of new budget authority to implement the FDA Food Safety Modernization Act (FSMA). The FDA plans to focus on supporting state capacity to implement the produce safety rule and on implementing the FSMA import safety system. For more information: President’s FY 2017 Budget Request: Key Investments for Implementing the FDA Food Safety Modernization Act (FSMA).

Overview of FSMA

The major elements of the law can be divided into five key areas:

  • 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.

 

Fees


feed safety modernization trentonAlthough FSMA does not require a registration fee to be paid by registered facilities and there is no fee for an initial FDA inspection, FSMA authorizes FDA to assess and collect fees related to certain domestic food facility, foreign food facility, and importer reinspections. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems.

These fees affect only those parties in the food and feed industry whose non-compliance results in the following activities:

  • Facility reinspections – follow-up inspections conducted by FDA subsequent to a previous facility inspection that identified noncompliance materially related to a food safety requirement of the Federal Food, Drug, and Cosmetic Act (the Act). The reinspection must be conducted specifically to determine that compliance has been achieved.
  • Recalls – food recall activities performed by FDA that are associated with a recall order with which a responsible party has not complied.
  • Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls
  • Importer reinspections - follow-up inspections of a food offered for import conducted by FDA subsequent to a previous inspection that identified noncompliance materially related to a food safety requirement of the Act. The reinspection must be conducted specifically to determine that compliance has been achieved. As discussed in F.2.2., these fees will not be assessed until the agency has resolved issues associated with these fees and the public has been notified by the agency.

FDA announced in a Federal Register notice the fiscal year 2015 (October 1, 2014 through September 30, 2015) fee schedule. The rates are as follows: $217 an hour if no foreign travel is required and $305 an hour if foreign travel is required.

As stated in FDA’s September 2011 Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act, because FDA recognizes that for some small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms. FDA is currently developing a guidance document to outline the process through which firms may request such a reduction of fees. FDA does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published.

For facility reinspection fees, FDA will invoice the responsible party for each domestic facility and the United States Agent for each foreign facility for the direct hours, including travel, spent to perform the reinspection at the appropriate hourly rate. For recall order fees, FDA will invoice the responsible party for each domestic facility or an importer who does not comply with a recall order under sections 423 or 412 of the Act for the hours spent to cover food recall activities associated with such order. For importer reinspection fees, FDA will invoice the importer for the direct hours spent to perform the reinspection including travel. Detailed payment information will be included in the invoice.


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