U.S. FDA’s Food Safety Modernization Act (FSMA): The Year in Review
In 2012, the U.S. Food and Drug Administration (FDA) continued to implement the Food Safety Modernization Act (FSMA). With its passage in January 4, 2011, FSMA changed the FDA’s approach to food safety from reactive to proactive. As such, FSMA represents the most significant change in U.S. food safety in more than seventy years. FSMA outlines broad new requirements on manufacturers, processors, packers and distributors of food. Registrar Corp continues to track these new requirements and convey them to the food and beverage industry. Here a few of the most important changes in 2012:
- Increased Food Facility Inspections: FSMA requires FDA inspect no fewer than 600 foreign facilities in the 1-year period following the date of enactment. In each of the 5 years following this 1-year period, FDA must inspect not fewer than twice the number of foreign facilities inspected during the previous year. In FY 2011, FDA inspected 995 foreign food facilities.
- New U.S. FDA Reinspection Fees: FSMA allows FDA to charge reinspection fees if a primary inspection results in compliance issues related to food safety. FSMA sets FDA’s inspections fees at $325 per hour for time outside the U.S. and $224 per hour for associated activities performed in the U.S. Then, on August 1, FDA announced a change in the rates of reinspection fees for FY 2013.
- Email Addresses Required on Food Facility Registrations: In an effort to enhance the communication with the FDA and the food and beverage industry, FSMA requires that food facility registrations include the e-mail address for the contact person of a food facility or, in the case of a foreign facility, the U.S. Agent for the facility. Companies that fail to list an e-mail address may miss important communication.
- FDA Gains Access to Company Records: The records access provisions of FSMA expands FDA’s former records access to include access to records relating to any article of food that is reasonably likely to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals. Also, FSMA permits FDA to access records of articles of food for which could cause adverse health consequences or death to humans or animals. FDA released an Interim Final Rule for these provisions in an effort to expedite compliance.
- Food facilities required to develop plans for hazard analysis, preventive controls and corrective measures: FSMA requires food facilities to develop writer plans for hazard analysis, preventive controls and corrective measures, to be updated with each change in operations or every three years, whichever is more frequent. During a food facility inspection, FDA may ask for these records. As was the case with a seafood company in New York, FDA may deem a facility injurious to health if now hazard plan is present.
- Pet Food Manufacturers Affected by FSMA: Michael Taylor, Deputy Commissioner for Foods at FDA, gave a speech to pet food manufacturers about new FSMA regulations and their need to comply. Mr. Taylor assured the pet food industry that the basic principles of FSMA for food safety apply to pet food, as well as human food.
- FDA Misses Deadline for New FSMA Regulations: FSMA mandated the FDA to release several new regulations on July 4, 2012, including regulations for: Hazard Analysis and Risk-Based Preventive Controls, information on the Voluntary Qualified Importers Program, and Third Party Audits.
- Food Facility Registration Renewals: As of 2012, all food facilities must renew their food facility registrations between October 1 and December 31 of every even-numbered year (i.e. 2012, 2014, 2016, etc.). A food facility may have its registration suspended if its facility is not renewed.
- Food Facilities wait for FDA’s Food Facility Registration System to be available for Renewals: FDA’s Food Facility Registration System became operational on October 22nd. FSMA requires the renewal of U.S. food facility registration with FDA and gives a 3 month period, from October 1 to December 31st.
- FDA Suspends a Food Facility’s Registration for the First Time: Sunland Inc. became the first food facility to have its registration suspended by the FDA, under the new powers described in FSMA. The company was ordered to shut down operations immediately and cannot resume manufacturing, processing, packing, or holding foods unless and until permitted by FDA.
- The Center for Food Safety and the Center for Environmental Health sues FDA: Two public interest advocacy groups filed a lawsuit against FDA for failure to implement FSMA regulations.
- FDA Extends Deadline for Food Facility Registration Renewals: FDA announced that it would exercise enforcement discretion with respect to registration renewals submitted after December 31, for a period of 31 days, until January 31, 2013. FDA made this announcement after the availability of FDA’s new registration renewal system was delayed 22-days.
- FDA Collaborates with China on Food Safety: U.S. FDA and China announced an Agreement on the Safety of Food and Feed. Both countries will work closely together to discuss food safety issues.
- FDA Recognizes New Zealand’s Food Safety System as Comparable: New Zealand became the first country to be identified as having a comparable food safety system by the FDA. This system of recognition is part of FSMA’s process to enhance the safety of food sold in the U.S.
As you can see, FSMA presents dramatic changes for the food and beverage industry. Registrar Corp continues to help the food and beverage industry with new FDA FSMA regulations. For more information about new FDA FSMA regulations or any existing FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.