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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), Office of Regulatory Affairs (ORA), Southwest Regional Small Business Program (Small Business Program), in collaboration with FDA's Center for Food Safety and Applied Nutrition (CFSAN) and the Mid-Continental Association of Food and Drug Officials (MCAFDO) is announcing a public workshop entitled "FDA Food Labeling and Allergen Declaration." This public workshop is intended to provide information about FDA food labeling regulations, allergen declaration and other related matters to the regulated industry, particularly small businesses and startups.

Date and Time: The public workshop will be held on August 14 and 15, 2002 from 8:30 a.m. to 5:00 p.m.

Location: The public workshop will be held at the Center for Community Cooperation, Oak Corner Room, 2900 Live Oak St., Dallas, TX 75204.

Contact: David Arvelo or Sue Thomason, US Food and Drug Administration, 7920 Elmbrook Dr., Suite 102, Dallas, TX 75247, 214-655-8100, ext. 130 or 128, fax 214-655-8114, e-mail oraswrsbr@ora.fda.gov.

Registration: Pre-registration by July 31, 2002 is encouraged. The Mid-Continental Association of Food and Drug Officials has a $25 pre-registration fee to cover the cost of breaks. To pre-register, please complete the form below (or linked PDF document PDF form) and send along with a check or money order for $25 payable to the Mid-Continental Association of Food and Drug Officials  c/o FDA SWR SBR, 4040 N. Central Exwy., Suite 900, Dallas, TX 75204 . As an alternative, the registration form can also be obtained on the Internet at http://www.fda.gov/ora/indust_assit/Default.htm.

Directions to the facility are available at the Center for Community Cooperation web site at http://www.cccdfw.org/pages/location.html. 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 after 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 8:00 a.m. The cost of registration at the site is $35 payable to the Mid-Continental Association of Food and Drug Officials. If you need special accommodations due to a disability, please contact David Arvelo or Sue Thomason at 214-655-8100, ext. 130 or 128, fax 214-655-8114 or e-mail oraswrsbr@ora.fda.gov at least 7 days in advance.

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Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts 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 $0.10 per page.

SUPPLEMENTARY INFORMATION: The workshop is being held in response to the large volume of food labeling inquiries from small food manufacturers and start-ups originating from the Dallas District area. 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. mandatory label elements
  2. nutrition labeling
  3. claims
  4. allergen policy, and
  5. labeling of special cases.

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.

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