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More Money Needed to Fully Implement Food Safety Overhaul, FDA Says

Tuesday, June 04, 2013

The Food and Drug Administration (FDA) has submitted to Congress a report on progress made and challenges faced in implementing the Food Safety Modernization Act (FSMA). With this the agency will need an additional $400-450 million “to make FSMA a fully successful initiative.” Congress has agreed with $100 million in the FDA budgets for fiscal years 2011 and 2012, which the report calls “a meaningful start.”


The issues discussed in the report are:


  • Standard Setting and Guidance: The FDA states that developing and implementing new prevention standards is its most critical activity in the initial phase of its implementation of FSMA because these standards will be the foundation upon which a new food safety system will be built. The three areas of focus are preventive control standards requiring food processors to identify potential hazards associated with their processes and prevent those hazards from occurring, specific risk-based standards for safe production and harvesting of produce that take account of the diversity of sizes and operations, and importer verification of the safety of foods from foreign suppliers.


  • Imports: The FDA states that it must implement “an entirely new paradigm for import oversight to succeed in ensuring the safety of food coming into the United States.” Imported food now comprises 15% of the total U.S. food supply, and food is imported from more than 110,000 manufacturers in more than 150 countries, “many of which are less developed nations without robust regulatory systems in place.” FSMA provides new authorities to the FDA in this area, including the authority to hold importers accountable for verifying that their foreign suppliers have adequate preventive controls in place to ensure that imported foods are as safe as those produced domestically.


  • Inspections and Compliance: FSMA requires (a) all domestic high-risk food firms to be inspected at least once in the first five years and at least once every three years thereafter, (b) all domestic non-high risk food firms to be inspected at least once in the first seven years and at least once every five years thereafter, and (c) at least 600 foreign food facility inspections in the first year, a number that is to be doubled every year through 2016, when no fewer than 19,200 inspections will be required. To reach this 2016 goal for foreign inspections the FDA “would require hundreds of millions of dollars in new funding, which the agency cannot realistically expect to receive.” Instead, the FDA believes that money would be better spent implementing the FSMA tool kit for imports, which will include the Foreign Supplier Verification Program, the Voluntary Qualified Importer Program, and expanded use of foreign inspection information


FDA Export Certificates for Cosmetics Now Only Available Online

Tuesday, June 04, 2013

Food and Drug Administration export certificates for U.S.-produced cosmetic products are available only online and paper export certificates are no longer available. Some foreign importers and governments may require such certificates to accompany shipments of these goods, but the FDA does not require them.

The FDA adds that these certificates now have a unique identifier that can be used by FDA-authorized foreign government officials to verify the authenticity of the certificates. In addition, exporters need to ensure that the printed certificates are clear and legible.