Article: Regulations -- May 2009
President Obama’s call for “(a) ‘complete review’ of Food and Drug Administration operations” (as detailed in the February 3 issue of USA Today); the nomination by Obama of two former public health officials, Dr. Margaret Hamburg, to be FDA commissioner, and Dr. Joshua Sharfstein, to be deputy director; and legislation recently introduced in both the House and the Senate (to date, the FDA Food Safety Modernization Act; FDA Globalization Act of 2009; and the Safe Feast Act of 2009) portend an emphasis on food safety in the months ahead.
Congress is proposing enhanced food safety in various forms. For example, facilities that are registered--a new requirement in addition to Bioterrorism 2002 registration--will be required:
* to conduct HACCP-like evaluations of their operations to identify biological, chemical and physical hazards, including the potential for contamination by acts of terrorism;
* to establish and exercise action plans to address the potential hazards identified; and
* to maintain records of actions undertaken to address specific instances of hazards identified in the evaluation process.
Importers also will be affected. They will be expected:
* to develop and implement a program to assure that their imports are not adulterated (including allergens);
* to administer effective record-keeping; and
* to do no business with a foreign facility which does not have an effective food safety program in place.
The FDA’s role also will be broadened, giving the FDA authority (or requiring FDA) to:
* suspend the registration of food facilities for cause;
* conduct periodic reviews and assessments of new or continuing hazards to the food supply;
* establish guidance or regulations for the safe handling of fruits and vegetables, in cooperation with the USDA;
* review current operational practices and develop regulations targeting the potential for intentional adulteration of the food supply;
* adopt a risk-based facilities inspection protocol;
* be given additional records access in regulated facilities;
* implement a third-party certification system for domestic and foreign facilities;
* compel mandatory recalls, when the situation warrants, due to a lack of cooperation from a company; and
* develop regulations to implement an administrative detention authority.
The foregoing references some of the provisions of the legislative proposals which have been introduced, and the bills are not identical. Some or all of the provisions for changes in FDA authority may be combined in a final bill, which results in enactment. Many of the proposed changes were included in bills introduced into the last Congress or have been actively considered previously. However, it is clear that the industry can anticipate an increased and continuing emphasis on food safety in the months ahead.
New Rules on Vitamin D
Also, on March 16, 2009, the FDA published its final rule adding crystalline vitamin D2 to “21 CFR 172 Food Additives Permitted for Direct Addition to Foods for Human Consumption” (74 Federal Register 11019, 2/16/09). The approved, safe use is as a nutrient supplement in soy-based products, defined in the petition as soy beverages, soy beverage products, soy-based butter substitute spreads and soy-based cheese substitutes. Maximum levels for use in food are established for each category of food.