The FDA wants you...to register
Bioterrorism act requires sugarhouses to register by Dec.12
By DARRELL R. BEEBE
dbeebe@atticusine.com

WASHINGTON—The Food and Drug Administration recently enacted regulations requiring most maple producers and packers, as well as other producers and processors of food, to register with the United States government.

The regulation requires domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the FDA by Dec. 12, 2003.

Authors of the regulations said the new requirements would enable the FDA to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food.

“These new requirements represent the latest steps in our ongoing efforts to respond to the new threats and improve the safety of all the foods that we eat in this country,” said HHS Secretary Tommy G. Thompson.

Registration requirements apply to all facilities that manufacture, process, pack or hold food regulated by the FDA, including animal feed, dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives.

While entities like private residences, restaurants, retail food establishments, and even farms and roadside farm stands are exempt from these new regulations, maple syrup producers apparently are not. Although some entities, like the Vermont Department of Agriculture, consider maple operations to be farms, the way the syrup is derived puts it in another class, FDA officials said. Because the boiling down of sap into maple syrup is considered a manufacturing process, maple sugaring operations are not exempt, is the interpretation of Robert Hart, Director of Imports in the FDA’s Buffalo office,

This would mean that every maple syrup producer that sells their product to consumers, whether they only have a handful of taps or thousands of them, is required to register.

Those who tap trees just for the sap and then sell it in bulk to another outfit for processing, however, would be exempt under the proposed regulations, Hart said.

“If in doubt, register, would be my recommendation,” he said. “It’s quick, and it doesn’t hurt you if you don’t need to do it.”

According to the regulations, the owner, operator, or agent in charge of a domestic or foreign food facility must provide the FDA with the name and address of each facility which, and all trade names under which, the registrant conducts business, as well as information about certain categories of food the facility produces. For a foreign facility, the registration must include the name of the U.S. agent for the facility.

The FDA expects about 420,000 facilities to register under this requirement. Failure to register, a prohibited act under the Federal Food, Drug and Cosmetic Act, could subject violators to civil or criminal sanctions.
A second regulation passed with the first, which requires food importers to provide the FDA with advance notice of human and animal food shipments imported or offered for import on or after Dec. 12, 2003

These regulations would effect Canadian maple producers looking to export maple products to the United States.

The two new regulations implement “key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which provided FDA new authority to protect the nation’s food supply against actual or threatened terrorist acts and other food-related emergencies.” according to a press release issued by the U.S. Department of Health and Human Services.
“With input from the private sector, our partners in the federal government and the governments of our trading partners, we will use these regulations to work more effectively than ever to protect America’s food supply, while maintaining the regular, free flow of commerce that is so vital to the well being of our citizens,” said FDA Commissioner Mark B. McClellan, M.D., PhD.

The registration may be submitted electronically, via the Internet at www.FDA.gov, or by paper through surface mail or by fax. Registrations may also be submitted on CD-ROM by mail. A registering facility will receive confirmation of electronic registration and its registration number instantaneously once all the required fields on the registration screen are filled. There is no fee to register.

Both of the new regulations were published as interim final rules in the Oct. 10 issue of the Federal Register. For more information about these new regulations, visit www.fda.gov/bbs/topicslNEWS/2003NEW00960.html or www.hhs.cfsan.fda.gov/~dms/fsbtac15.html or www.fda.gov/oc/bioterrorism/bioact.html

How To Register

Register Online

• Visit www.FDA.gov
• Create an Account by going to the Login screen and choosing Create an Account. Choose the Food Facility Registration Module as the system you want access to, then fill out the series of screens that follow.
• Register a Food Facility
  Before you start, it is recommended that you collect all the information you need. (See Fact Sheet and summary of fields in Form 3537.) If you need to look something up after you start, be aware that the system will automatically log you off after 30 minutes of inactivity. If you stop with a partially completed registration, none of the information will be saved, and you will need to start from the beginning when you log in again.

Mail it in

• Use Form 3537. Forms are available for download at www.fda.gov or write to the
• U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857, or request the form by phone at 800-216-7331 or 301-575-0156
• Fill it out completely and legibly and mail it to U.S. Food and Drug Administration, IEIFS-68 1, 5600 Fishers Lane, Rockville, MD 20857, or FAX it to (301) 210-0247
• FDA will mail or FAX a copy of the registration as entered, confirmation of registration, and the registration number.
• Your facility is considered registered once FDA enters your facility’s registration data and the system generates a registration number.

Article as printed in The Maple News Vol. 2. Issue 7 Nov/Dec 2003

Attention! Important information from the MMSA on FDA registration requirements. Click here for more...