FDA Food Labeling and Allergen Declaration; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA), Southwest Regional Small Business Program (Small Business Program), Office of Regulatory Affairs, in collaboration with FDA's Center for Food Safety and Applied Nutrition, the State of Missouri Department of Public Health, the Kansas City Department of Health and the Missouri Milk, Food and Environmental Health Association is announcing a public workshop entitled “FDA Food Labeling and Allergen Declaration.” This public workshop is intended to provide information about FDA food regulations, food labeling allergen declaration, good manufacturing practices, and other related matters to the regulated industry, particularly small businesses and startups.

Date and Time: The public workshop will be held on January 10 and 11, 2001, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at the Kansas City Department of Health Auditorium, 2400 Troost Ave., Kansas City, MO.

Contact: Gala Jaramillo, Missouri Milk, Food and Environmental Health Association, P.O. Box 105017, Jefferson City, MO 65110-5017, 573-634-6418, or Sue Thomason, FDA, 7920 Elmbrook Dr., suite 102, Dallas, TX 75247-4982, 214-655-8100, ext. 128, FAX 214-655-8114.

Registration: Preregistration by January 3, 2002, is encouraged. The Missouri Milk, Food and Environmental Health Association has a $20 preregistration fee to cover the cost of breaks. To preregister, please complete the form below and send along with a check or money order for $20 payable to The Missouri Milk, Food and Environmental Health Association (address above). As an alternative, the registration form and directions to the facility can also be obtained on the Internet at http://www.fda.gov/ora/indust_assit/Default.htm. Seats are limited, please submit registration form as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive written confirmation. Registration will close when the course is filled. Registration at the site will be done on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $25 payable to The Missouri Milk, Food and Environmental Health Association. If you need special accommodations due to a disability, please contact Leslie Foresberg at 816-513-6315 at least 7 days in advance.

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Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.

SUPPLEMENTARY INFORMATION:

The workshop is being held in response to a request by the State of Missouri to present information that would be helpful to regulated industry. The Small Business Program presents this workshop to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This is consistent with the purposes of the Small Business Program, which are in part to respond to industry inquiries, develop educational materials, sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA's requirements and compliance policies. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as outreach activities by Government agencies to small businesses.

The goal of the workshop is to present information that will enable manufacturers and regulated industry to better comply with labeling requirements, especially in light of growing concerns about food allergens. Information presented will be based on agency position as articulated through regulation, compliance policy guides, and information previously made available to the public. Topics to be discussed at the workshop include: (1) FDA food regulations, (2) food labeling, (3) allergen declaration, (4) good manufacturing practices, and (5) the Nutrition Labeling Education Act. FDA expects that participation in this workshop will provide regulated industry with greater understanding of the regulatory and policy perspectives on food labeling and allergen declaration.