The Food Safety Modernization Act (FSMA – P.L. 111-353) was signed into law by President Obama on January 4, 2011. The new law was created to address the estimated 48 million people who are sickened, 128,000 who are hospitalized and 3,000 who die each year as a result of food borne diseases according to the CDC. Leading officials indicate this public health issue is “largely preventable.”
Since the new law was enacted the Food and Drug Administration (FDA) has been busy on several fronts to begin implementation of the new law. It is estimated that 50 new rules, numerous guidance dockets and reports will be required to implement the law over the course of three years.
To date, some of FDA’s more significant strides in food safety include:
- outreach to international trading partners,
- launching two pilot programs to enhance traceability of food products causing food borne illnesses, awarding seven grants to institutions of higher learning to develop food and feed training programs, announcing FY 2012 re-inspection fee schedule, and
- issuing rules on Administrative Detention of Foods, Authority to Suspend Registration of Food Facilities and Prior Notice of Imported Foods.
The FDA Challenges
- About 65% of all FDA inspections of U.S. food manufacturing systems are conducted through cooperative efforts with state and local agencies. But state and local governments continue to operate under significant fiscal constraints.
- The World Trade Organization (WTO) maintains a Sanitary & Phytosanitary (SPS) Committee. The SPS Committee must be notified by member countries upon adoption of a law such as FSMA that will likely impact international trade. The WTO Secretariat published the FSMA on February 14, 2011, serving as notification to the WTO. The SPS Committee is conducting a comprehensive review. As regulatory rules are drafted Member countries are allowed to review and comment on potential impacts to international trade.
How This Will Impact Your Business
It is anticipated that FDA will issue a proposed rule early this year that will require facilities that make or handle food for people and animals to implement measures that help prevent food borne illnesses. Responsibilities for these measures, with a particular focus on IMPORT SAFETY, have been shifted to food companies.
If you are not aware of all the facets of your products (supply chain, ingredients, etc.), this could result in expensive product recalls, your brand reputation could be negatively impacted, and you could be subject to suspension of your food facility registration.
Cansler Consulting & The Food Safety Modernization Act
As a food and agricultural lobbying firm, Cansler Consulting is well versed in the intricacies of the Food Safety Modernization Act.
- Strategic legislative and regulatory advice
- Act as the conduit between FDA and your organization to ensure regulations meet the realities of the industry
- Compliance advisory
Having two decades of experience working closely with congressional leaders on key Committees and regulatory officials, Tim Cansler, Founder and Chief Strategist of Cansler Consulting, continues to successfully achieve legislative and policy initiatives vital to client interests. Tim’s successful strategies have consistently helped educate Members of Congress leading to federal budget authorization and appropriations sought by clients. He has also been successful in working with regulatory officials to ensure programs beneficial to his clients’ interests are implemented as intended.
If your company needs recommendations on how to comply with FSMA requirements or representation before FDA, please contact us today at (202) 714-2822 for a consultation today to see how we can help you.