Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rm.1061
Rockville, MD 20852

RE: Docket No. FDA-2002-N-0323”

Ladies and Gentlemen:

I am a local foods consumer.

I support the list of direct-to-consumer venues in section 1.227(b)(11)(iii), as including door-to-door sales, mail, catalog and internet orders, nonprofit events, and fairs.

I urge the FDA to make the following changes to its proposed rule for facility registration:
1) Comply with the Tester-Hagan language of FSMA, and exempt all facilities that sell more than half of their products directly to consumers at roadside stands, farmers’ markets, and similar locations. The exemption should not be limited to facilities that are located on farms.
2) Similarly, the definition of roadside stands should not be limited to farmers, and the definition of farmers’ market should recognize that food vendors besides farmers may also sell at such markets. I agree that the majority of the vendors at a market should be farmers for it to be classified as a “farmers market,” but artisan food providers have an important role in these markets as well.
3) Clarify the process for getting a waiver from registering electronically. The regulation should specifically recognize religious objections and lack of reasonable access to the internet as reasons to grant a waiver, in addition to such other issues as may be raised by applicants.
4) Provide an exemption for those who do not have email addresses as a regular contact.
5) Eliminate the requirement for a D-U-N-S number or make it optional information to be submitted if the location already has a D-U-N-S number. It does not make sense to require a small business to register with Dun & Bradstreet for the sole reason of then also registering with the FDA.

Thank you for your attention to this matter,

Catherine Austin Fitts
PO Box 181
Hickory Valley, TN 38042

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