Subject: Keep Small Farmers and Food Producers in Business
Take Action on FDA’s 2014 Proposed Food Safety Regulations!
If you are a farmer or food business who may be impacted by the proposed rules, you can increase your impact by expanding your comments to show your farm or business would be affected.
The more you personalize your letter, the more effective your comments will be! We encourage you to include personalized comments on as many issues as possible – simple include your additional text after each issue in the sample letter below.
Submit your letter online at: http://bit.ly/produce-rule and http://bit.ly/facilities-rule (submit a copy at both links)
Or mail to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Sample Letter for Farmers or Facilities, With Additional Issues
Re: Preventive Controls Rule: FDA-2011-N-0920, Produce Standards Rule: FDA-2011-N-0921
I am a ____ [farmer, processor, food hub, member of a farmer co-op…].
[Personalize your comment at the beginning with a couple of sentences: What is the name and location of your farm or business? What do you grow/sell? How long have you been in operation? ]
I am writing because I am concerned about the impact that FDA’s re-proposed FSMA rules will have on [my farm / business, other farmers in my community, the farms that I buy raw produce from, etc.]. I urge you to change the proposed rules to ensure that they do not burden small farms and food businesses with unnecessary costs or ambiguous and vague requirements.
I am specifically concerned about the issues discussed below:
1. Definition of a “farm”: FDA should not classify “farms” as “facilities,” and thus impose additional regulations on them, unless there is a specific risk-based reason to do so, not simply because of legal technicalities or unrelated issues. Specifically:
* FDA should clarify the “farm” definition to ensure that farmer-operated businesses that engage in farming activities — growing, harvesting, packing, or holding raw agricultural commodities — are considered farms.
* FDA should remove the phrase “in one general physical location” from the farm definition, to reflect the fact that farms are not always contiguous and that farms may include structures in different locations or on different parcels of land; these aspects do not increase the risk of foodborne illness.
* FDA should remove the phrase “under one ownership” to reflect the fact that farmers may join together in food hubs and cooperatives to market their products without increasing the risk of foodborne illness.
2. How to calculate sales for determining the size of the farm or business: When Congress passed FSMA, it did not give FDA authority over all types of food. This rule creates a lower threshold for regulation of diversified farms by including ALL farm commodities, including livestock, grains, etc. as well as covered vegetable crops. In addition, FDA has already recognized that even some of the types of food within its jurisdiction should not be covered by the new rules.
These limitations on the scope of the FSMA rules should be reflected in the calculations of sales in determining whether and to what extent a farm or food business is covered under the rules. Thus, for all coverage determinations, FDA should base thresholds on sales of “covered produce” under the Produce Rule and “covered human food” under the Preventive Controls rule.
3. Qualified Exemptions under the Tester-Hagan amendment: FDA should implement the Tester-Hagan provisions in a manner that respects normal principles of due process and that doesn’t risk pushing a small-scale producer out of business with a too-hasty or erroneous decision to revoke their exemption and too-short deadlines for compliance.
I support the agency’s inclusion of a procedure to allow for re-instatement of the exemption. I urge the agency to make the following additional changes:
* Require that FDA include a specific statement of the reasons in the notice of revocation, so that the producer can respond to the specific issues of concern.
* Require FDA to have probable cause before initiating an investigation of an exempt farmer or food facility, and to present clear and convincing evidence for revoking the exemption.
* Provide appropriate time (at least 90 days) for producers to submit the facts and documentation showing that their exemption should not be withdrawn.
* Guarantee a hearing so that producers can present their case in person before having their exemption revoked.
* Provide the standard post-decision procedural protections, such as motion for reconsideration and a motion for stay.
* Specify that the reinstatement would occur within a reasonable period of time.
* Provide at least one year for a previously exempt farmer or producer to come into compliance with the FSMA regulations after revocation. Large farms and manufacturers are given a year to come into compliance – requiring these small and micro-businesses to comply in a shorter time period would effectively drive them out of business.
4 Agricultural Water: As directed by Congress in FSMA, FDA needs to take a science- and risk-based approach to regulation. The proposed requirements for irrigation water do not do so.
* The water quality standard, based on recreational use, is both unnecessary and overly restrictive. The FDA should not set a numeric standard until it has conducted a risk assessment specifically for water for agricultural purposes.
* The requirements for testing need to be clarified, including the options for when a farmer may test less frequently or use water that exceeds the standard in accompaniment with a confusing time delay logarithm between irrigation and harvest. The current proposal is extremely confusing and will inevitably lead to both higher costs and violations for farmers who simply can’t figure out how to reasonably comply.
* FDA should reduce the frequency of testing, requiring no more than 3 samples per growing season. As currently proposed, the testing frequencies are overly burdensome, lack scientific justification, and will impose significant costs on farmers.
* FDA should provide farmers with the option to test for pathogens if a water source has exceeded the standards for generic e. coli, rather than having to treat or stop using the water, since the presence of generic e. coli does not mean that pathogens are present.
* I support the FDA’s proposal to allow a farmer to use testing by third parties to monitor his or her water sources. FDA should clarify what facts must be established, such as how far from the farm the third party samples may have been taken and still qualify.
5. Manure and Compost: I fully support FDA’s decision to require no waiting period in between application of compost and harvesting of the crop. I also support FDA’s decision to refrain from establishing a waiting period for the application of manure until further research is done.
As FDA moves forward with the research on the safety of manure applications (which, under FDA’s definitions, would also include applications of vermicompost, static compost, and most compost teas), FDA should provide for an advisory board that includes representatives of all types of agricultural production, including conventional, certified organic, and sustainable production. It is vital that working farmers be included in the process.
6. Domestic Livestock: FDA should not treat grazing like manure application and should not restrict diversified farmers through unrealistic intervals between grazing a field and harvest of a crop. The maximum waiting period should be 120 days, with the option for shorter waiting period if steps are taken to prevent or detect contamination of the crop, including the use of hand harvesting.
7. Conservation Measures: FDA should explicitly support important conservation measures, such as planting native plant buffers as bee habitat and using cover crops. Conservation measures support food safety and food security, and it is vital that the agency’s rules not discourage them.
8. Records and Recordkeeping Requirements: I urge the FDA to limit the recordkeeping requirements, particularly for farms that pack or hold produce from other farms, as follows:
* Accept records kept in the ordinary course of business that reflect the immediate buyer and/or seller, such as an invoice;
* Accept paper records, whether typed of handwritten (a requirement that record be kept electronically would be unnecessary, impose undue expense, and discriminate against those farmers who have no or limited access to technology);
* Require that the records be kept for no more than one year.
9. Supplier Verification Program: FDA should remove the supplier verification program from the HARPC rule. At a minimum, FDA should remove the onsite audit requirement from the supplier verification program. The FDA should also remove the provision that qualified farms or facilities provide written assurances that they meet federal requirements. The supplier verification program effectively imposes an entire second layer of regulation on produce farms who are supplying ingredients to wholesalers and processors, an unnecessary burden that is not authorized by FSMA.
10. Environmental and Product Testing: These provisions vastly increase the cost of the proposed rule and will drive many businesses out of business without necessarily improving food safety. FDA should drop these provisions entirely.
11. Definition of retail food establishments that sell direct to consumers: In the final regulations, FDA must clarify that CSAs, roadside stands, farmers markets, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and are not “facilities” that are subject to the Preventive Controls Rule. Specifically, FDA should issue the separate rulemaking on the retail food establishment clarification immediately, and extend the comment period on the currently proposed rules so that the impact of the proposed rules can be properly understood.
12. Very Small Business: I fully support the definition of “very small business” in the HARPC rule as a business that grosses $1 million or less annually.
[Full name, business name if you have one, city and state]
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