November 4, 2004

FDA Posts Revised Compliance Policy Guides (CPGs) for Registration of Food Facilities and Prior Notice of Imported Food Shipments

FDA has posted further revised CPGs for Registration and Prior Notice on its website. The revised CPG on Registration revises CPG Sec. 110.310, which was issued in December 2003 (the "December CPG"). The revised CPG establishes November 8, 2004 as the date for full implementation of FDA's enforcement policy for domestic food facilities, as articulated in the December CPG. FDA is making only one substantive change in the new CPG. Specifically, the revised CPG provides that, on November 8, 2004, FDA is fully implementing the agency's enforcement policy for domestic food facilities, which policy was set out in the December CPG. This new CPG provides that education of the management of unregistered facilities will continue but that FDA will have the option of proceeding beyond education where the facility's management does not register the facility once notified of the registration requirement. Unregistered facilities will be reminded of the registration requirement at least three times before a legal action is considered.

For foreign facilities, the revised CPG continues to state that, generally, the registration requirement for the facilities of foreign manufacturers and shippers will be enforced through the prior notice of imported food interim final rule and continues to reference the prior notice CPG. The full text of the Registration CPG is available on FDA's website at http://www.cfsan.fda.gov/~furls/cpgreg2.html.

The Prior Notice CPG has been revised to address problems that some submitters have encountered when trying to provide FDA with the required information, and with the 5-day timeframe for submitting prior notice before the anticipated date of arrival of the food at the anticipated port of arrival. FDA, with CBP's concurrence, therefore, has revised this CPG to provide for enforcement discretion in these cases.

This revised CPG will provide for the exercise of enforcement discretion as follows:(1) providing an alternative means for providing the identity of the manufacturer when the manufacturer's registration number is not known; (2) for articles of food imported or offered for import via express courier, the submitter can provide a tracking number in lieu of anticipated arrival and/or planned shipment information; (3) if the item is a gift pack purchased or otherwise acquired by an individual and is being imported for non-business purposes, one prior notice may be submitted and may include the identity of the facility that packed the gift pack in lieu of the identity of the manufacturer; and (4) the prior notice may be submitted via PNSI up to 10 days before the anticipated date of arrival of the food.

FDA and CBP are taking these steps to provide additional flexibility in submitting prior notice in various situations while the final prior notice rule is being developed (scheduled for publication June 2005). The full text of the CPG is available at this website location: http://www.cfsan.fda.gov/~pn/cpgpn4.html.

EEOC and FDA Roll-Out Guide for Restauranteurs and Other Retail Food Employees Addressing Overlap of Disabilities Act and Food Code Rules

Under the umbrella of President Bush's New Freedom Initiative for people with disabilities, the U.S. Equal Employment Opportunity Commission (EEOC) recently announced the availability of "How to Comply with the Americans with Disabilities Act: A Guide for Restaurants and Other Food Service Employers." The guide is designed to assist restaurants and other food service employers in complying with the employment provisions of the Americans with Disabilities Act (ADA). The EEOC worked extensively with FDA in developing this new publication.

Available online at http://www.eeoc.gov/facts/restaurant_guide.html, the guide covers such topics as how the FDA Food Code provisions about restricting and excluding sick employees interact with the ADA's requirements; types of reasonable accommodations, including the use of service animals; and what an employer should do if a charge of discrimination is filed against his or her business.

The complete press release announcing the guide is online at http://www.eeoc.gov/press/10-28-04.html. A summary of the guide is also available at http://www.eeoc.gov/facts/restaurant_guide_summary.html.