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Commenting on the FSMA Proposed Rules

What do I Say?
Comments are Due November 22!

General guidelines:

  • Do your homework. Check out the FSMA talking points on this page. The rules are long and complicated, but these materials will help you understand what you need to know.
  • Remember that your unique story matters. Share how the rules might impact your farm or your business, or your access to local and regional food. Tell FDA how much it will cost to implement these rules on your farm or why the rules won’t work for your operation.  Use your own words – for FDA to count your comment, it must be unique.
  • Make sure you have a clear “ask” for FDA – either about a specific issue or, broadly, about the importance of ensuring both safe food and thriving family farms.

Comments that apply to both rules

  • FDA has underestimated the costs of compliance with these rules.  Provide compliance cost estimates for your farm and explain how compliance costs will affect what you grow or how you market. Ask FDA to develop rules that work for New England.
  • The exemptions and modified compliance measures for small farms that primarily market direct to consumers, co-ops and restaurants should be based only on food sales, not all agricultural sales. Ask FDA to modify the criteria so that the farms that should qualify for the exemption can qualify.  Encourage FDA to specify what conduct or criteria will be used for withdrawal of the exemption.
  • Explain how the record keeping requirements will affect your operation. (Producers will need to track compliance with training, water testing, soil amendment treatments and more.) Ask FDA to scale back.
  • Encourage FDA to complete an Environmental Impact Analysis. The proposed rules could cause significant changes in land use and in economic opportunity for agricultural communities because producers may be forced out of agriculture. Integrated livestock and produce operations could be curtailed.

Comments that apply to the Produce Safety Rule

  • Agricultural Water compliance will be costly, particularly for New England producers who irrigate from multiple surface water sources. The scientific basis for requiring such costly water testing should be developed before these regulations are implemented.
  • The Biological Soil Amendments standards require an unreasonable application interval for compost. The 270 days will take a field out of production for an entire season in New England.
  • The cost of developing effective alternatives should not fall on farmers or land grant institutions.
  • The Wildlife Rules threaten to undo years of conservation effort.

Comments that apply to the Preventive Controls Rule

  • Farms or farm facilities that aggregate or offer for sale products of other farms could be subject to the more stringent and more expensive preventive control rules. Tell FDA how these rules would affect the viability of your operation. Let FDA know how your farm would be affected if food hubs and other aggregation, storage and distribution structures cannot remain viable. Ask FDA to implement group compliance opportunities.
  • For dairy producers, the rule overlaps/conflicts with the Pasteurized Milk Ordinance. Encourage FDA to use the already-established PMO standards.

The nuts and bolts of submitting comments
Comment now — comment deadline is November 15!

  1. Go to www.regulations.gov. This is the government website where you can view the proposed rules. There is a comment form on that site that you can use.
  2. Go to the appropriate rule page in Regulations.gov – either the Produce Rule or the Preventive Controls Rule. Use the search engine on the Regulations.gov website. You can type the docket number into the search field (FDA-2011-N-0921 for the Produce Rule, or FDA-2011-N-0920 for the Preventive Controls rule). You can comment on both rules, but you must comment separately. Some issues affect both rules – this means you’ll have to submit a two separate comments – one on each rule if you want to comment on that issue.
  3. Click on the “Comment Now!” button on the right of the page.
  4. Double-check that you are commenting on the correct rule – the docket number for the Produce Rule is FDA-2011-N-0921 and the docket number for the Preventive Controls is FDA-2011-N-0920.
  5. Enter your personal and business information under Section 1, “Enter Information.”
  6. Enter your comments into the box. We strongly recommend you draft your thoughts ahead of time. There is a 6000-character limit which is about one page of single-spaced typed text. If you think you have more to say, you can upload a separate document with your comments by clicking the “upload” button instead.
  7. Click the “Preview Comment” link to ensure everything is accurate. You cannot edit your comment after you submit it!
  8. Click “Submit” to officially submit your comment to FDA. FDA will read every comment submitted. They may not respond to each comment individually but they will address the substance of these public comments publicly once the comment period has closed.
  9. A screen will appear with a confirmation number for your comment. Copy this down – you can use it later to ensure your comment was received. Your comment may not appear on Regulations.gov right away.
  10. If you have trouble, check out the official Regulations.gov help page or contact the Regulations.gov help desk – by email or phone.
  11. And if you make a mistake, you should submit another comment referring to your previous comment correcting any errors and/or re-stating your position or opinion.

If you are submitting a written comment by mail, send your comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.

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