Senate HELP Committee Moves on Food Safety Legislation

By Ricardo Carvajal –

Late on August 12th, the U.S. Senate Committee on Health, Education, Labor, and Pensions (“HELP”) announced the release its 225-page compromise agreement of the Food Safety Modernization Act (S. 510).  The Congressional Budget Office simultaneously released its estimate of the bill, stating that it would increase spending by about $1.4 billion between 2011 and 2015.

Among the new requirements in the compromise version of S. 510 that would be imposed on industry:

• Domestic and foreign food facilities would have to conduct a hazard analysis and establish risk-based preventive controls, and maintain associated records (dietary supplement facilities in compliance with dietary supplement good manufacturing practice requirements would be exempt);

• Facilities subject to registration under FDC Act § 415 would have to register biennially (but pay no registration fees);

• Facilities subject to reinspection would have to pay resinpection fees.

Among the new authorities that FDA would gain under the compromise version of S. 510:

• Enhanced authority to access records under FDCA § 414;

• Mandatory recall authority (and firms that fail to comply with a recall order would have to pay fees);

• Enhanced authority to administratively detain food under FDCA § 304(h).

Of special interest to importers, FDA would be directed to:

• Implement import certification requirements;

• Establish a program to facilitate importation of food that conforms to safety and security guidelines;

• Require importers to perform “risk-based foreign supplier verification activities” established by regulation.

Among the provisions of specific interest to the dietary supplement industry:

• FDA would be directed to notify the Drug Enforcement Administration if information in a new dietary ingredient notification suggests a potential safety issue due to the presence of an anabolic steroid or analogue thereof;

• FDA would be directed to issue guidance on new dietary ingredient notifications within 180 days of enactment.

There are numerous other provisions that would have significant effects on the food industry, not the least of which is the establishment of whistleblower protections for employees who notify the government of “any” violation of the FDC Act.  Notwithstanding the HELP Committee’s action on the legislation, the prospects for passage of the legislation this year appear to remain uncertain.