Follow this link for step-by-step instructions on how to comment

To make it easy, check out the comment templates below:

Comment Template For Consumers

(Sample Comment for Consumers.doc)


Comment Template For Farmers/Business Owners

(Sample Comment for Farmers or Businesses.doc)

Click the links below to read CFSA’s official comments sent to FDA

CFSA Comments on Produce Rule

CFSA Comments on Preventative Controls Rule

To make the FDA sit up and take notice of your comment, check out the 411 on the most crucial issues – 

There are a number of issues in the proposed Produce (PR) and Preventive Controls (PCR) rules that are problematic for farmers and food processors.  Read below for a brief summary of the issues of most concern to the sustainable agriculture community.  Click each link to get more information.

Manure and Compost
Conservation Practices
Agricultural Water
Diversified Farming Systems (the good rule)
Value-Added Processing
Direct-to-Customer Marketing
All Food vs. Regulated Food
Definition of Very Small Business
Loss of Protection for Local Food
Excessive Compliance Costs

 

 

Issue: Manure and Compost (PR)

The Produce Rule standards for using manure and compost make it effectively impossible for farmers to use manure and create barriers to the use of compost – in direct contradiction with established federal organic standards and the public interest in promoting the use of these natural soil amendments instead of chemicals.

  • Example – Farmers – particularly sustainable and organic farmers – depend on natural fertilizers as their primary tool to improve the health of their plants and soil. Under the rules, the waiting periods between when a farmer could apply these amendments and harvest crops are so long that they effectively make it impossible for a farmer to use them.  For instance, FDA is proposing a nine-month interval between applying untreated manure to a field and harvesting crops from it.

In the final produce safety regulations, FDA must align its standards for the use of manure and compost with the National Organic Program (NOP) regulations.  Specifically:

  • The interval between application of untreated manure and harvest should not be greater than the NOP.
  • For compost, there should be no interval between application and harvest if the compost is treated consistently with NOP or similarly rigorous composting standards.
  • To align with current best management practices, insulation of compost should not be required as part of an acceptable treatment process for compost.

For more details on manure and compost standards –http://sustainableagriculture.net/fsma/learn-about-the-issues/manure-and-compost/

TAKE ACTION:  The Produce Rule directly conflicts with established federal organic standards around using manure and compost – making it effectively impossible for farmers to use manure and creating barriers to the use of compost.

Help FDA understand why this matters: Do you use biological soil amendments of animal origin in your farming system?  If yes, what kind? Will these requirements discourage you from using manure or compost that includes animal waste? If you are a certified organic farmer, how will these requirements conflict with year practices?

Recommendation to FDA:In the final produce safety regulations, FDA must align its standards for the use of manure and compost with the National Organic Program (NOP) regulations. Specifically:

  1. The interval between application of untreated manure and harvest should not be greater than the NOP.
  2. For compost, there should be no interval between application and harvest if the compost is treated consistently with NOP or similarly rigorous composting standards.
  3. To align with current best management practices, insulation of compost should not be required as part of an acceptable treatment process for compost.

 How To Comment

 

 

Issue: Conservation Practices (PR)

The Produce Rule fails to protect and promote on-farm conservation practices that help protect our soil, water, and wildlife habitat and places arbitrary restrictions on integrating grazing animals into farm fields.

  • Example – Without explicit protection in the rules, conservation practices like planting native plant buffers as habitat for bees that are a win for conservation and a win for food safety could be discouraged and worse yet forcefully removed.

FDA must incorporate stronger support for on-farm conservation that supports food safety and protects our soil, water, and wildlife habitat. Specifically:

  • FDA should state support for sustainable conservation practices in the final regulations and should prohibit the destruction of conservation practices as a condition of complying with food safety rules.
  • As part of the personnel training standards in the Produce Rule, FDA should include requirements to train on-farm personnel on how conservation practices support food safety goals.
  • FDA should not treat grazing like manure application and should not restrict grazing through unrealistic intervals, such as nine months, between grazing a field and harvest of a crop.
  • FDA should conduct a full Environmental Impact Statement and subsequently incorporate the findings into a new set of proposed rules.

For more details on conservation issues: http://sustainableagriculture.net/fsma/learn-about-the-issues/conservation/

And on animal standards: http://sustainableagriculture.net/fsma/learn-about-the-issues/animals-domesticated-and-wild/

TAKE ACTION:  The Produce Rule fails to protect and promote on-farm conservation practices that help protect our soil, water, and wildlife habitat and places arbitrary restrictions on integrating grazing animals into farm fields

Help FDA understand why this matters: Do you use conservation practices on your farm? What kind? Have those practices helped you address a food safety issue? Is nine months too long a waiting interval between grazing animals in a field and harvest? Have you had to remove conservation practices to comply with industry or buyer food safety requirements? How can FDA make these standards better support diversified farming systems and biodiversity?

Recommendation to FDA: FDA must incorporate stronger support for on-farm conservation that supports food safety and protects our soil, water, and wildlife habitat. Specifically:

  1. FDA should state support sustainable conservation practices in the final regulations and should prohibit the destruction of conservation practices as a condition of complying with food safety rules.
  2. As part of the personnel training standards in the Produce Rule, FDA should include requirements to train on-farm personnel on how conservation practices support food safety goals.
  3. FDA should not treat grazing like manure application and should not restrict grazing through unrealistic intervals, such as nine months, between grazing a field and harvest of a crop.
  4. FDA should conduct a full Environmental Impact Statement and subsequently incorporate the findings into a new set of proposed rules.

How to Comment

 

 

Issue: Agricultural Water (PR)

The Produce Rule includes costly, burdensome, and unscientific standards for irrigation water – including water testing and treatment requirements.

  • Example – A farmer who uses water from a stream on his property to irrigate his fields would be required to take weekly water quality samples (costing up to several thousand dollars a year) and test for generic E. coli – even though generic E. coli is not indicator of pathogen presence.  In the event of positive test results above acceptable thresholds, the farmer must immediately stop using the water and fix the problem – even if the source of the problem is not on his farm.

FDA must take a reasonable, risk-based approach to agricultural water that allows farmers to respond to specific risks in their water systems. Specifically:

  • In the final regulations, FDA should not include numerical thresholds for presence of pathogens or fecal contamination indicators (i.e., generic E. coli) in water.  Such information should be included in guidance after sufficient research indicates appropriate numerical standards, which might vary according to the region.
  • FDA should not require weekly water testing; FDA should instead require farmers to collect baseline information about their water systems in the first growing season and to base future actions and testing frequencies on those results.
  • FDA should not require treatment of irrigation water with chemicals.

For more details on water: http://sustainableagriculture.net/fsma/learn-about-the-issues/agricultural-water/

TAKE ACTION:  The Produce Rule includes costly, burdensome, and unscientific standards for irrigation water – including water testing and treatment requirements.

Help FDA understand why this matters: Do you test your water?  If yes, what do you test for, how often do you test, what method do you use to test, and what does testing cost you?  If no, what do you do to monitor the quality of your water? Will these standards conflict with the way you use water on your farm?

Recommendation to FDA: FDA must take a reasonable, risk-based approach to agricultural water that allows farmers to respond to specific risks in their water systems. Specifically:

  • In the final regulations, FDA should not include numerical thresholds for presence of pathogens or fecal contamination indicators (i.e., generic E. coli) in water.  Such information should be included in guidance after sufficient research indicates appropriate numerical standards, which might vary according to the region.
  • FDA should not require weekly water testing; FDA should instead require farmers to collect baseline information about their water systems in the first growing season and to base future actions and testing frequencies on those results.
  • FDA should not require treatment of irrigation water with chemicals.

How to Comment

 

 

Issue: Diversified Farming Systems (PR)

The Produce Rule acknowledges the importance of diversified farming systems by taking an “integrated” approach to the standards that does not set separate requirements for each kind of fruit and vegetable.  This is a good decision that FDA should retain.

  • Example – The rules don’t require separate rules for each kind of fresh produce – meaning a grower who raises tomatoes, lettuce, and peaches won’t need to follow separate and different food safety rules for each type crop but rather will be able to take a whole-farm approach – which is much less complicated and less costly for farmers!

FDA should adopt this integrated approach in the final regulations.

For more details on the integrated vs. commodity approach: http://sustainableagriculture.net/fsma/learn-about-the-issues/integrated-approach-vs-commodity-specific-approach/

TAKE ACTION:  This is a good issue that FDA needs to retain, not change – the Produce Rule acknowledges the importance of diversified farming systems by taking an “integrated” approach to the standards that does not set separate requirements for each kind of fruit and vegetable. 

Help FDA understand why this matters: If you are a farmer, how many different types of fruits and vegetables do you grow?  Which of these would be covered by the proposed Produce Rule? If FDA chooses a commodity-specific approach, how will that impact the type of farming that you do and your costs of complying with food safety regulations?

Recommendation to FDA: FDA should adopt this integrated approach in the final regulations.

How to Comment

 

 



Issue: Value-Added Processing (PCR)

Farmers and local food entrepreneurs adding value to crops through low-risk processing should not be subject to the same regulations as high-risk processors.  The Preventive Controls Rule includes a good initial list of low-risk processing activities, but FDA fails to include additional activities like making pickles and salsa that are already considered low-risk by many states.  Whatsmore, even though FDA recognizes a large number of food processing activities as low-risk, it still proposes to apply the strictest level of regulation if the processing activity takes place anywhere other than a farm.

  • Example – A farmer who turns her fresh cucumbers into pickles and her fresh berries into jam would have to cope with the complication, added expense, and paperwork of separate rules for the two products based on FDA’s incomplete list of which processing activities are or aren’t low-risk.
  • Example – A cooperative that stores and packs fresh produce from multiple participating farms would be regulated just like a 500-employee food manufacturing factory.

FDA should include a fuller range of low-risk processing activities in the final regulations, including:

  • Acidifying, pickling, and fermenting low-acid fruits and vegetables made in compliance with existing Good Manufacturing Practices
  • Baking activities involving grain products
  • Roasting grains for animal feed
  • Extracting oils for seeds
  • Extracting virgin olive oil
  • Making molasses from sugarcane and sugar beets
  • Making syrups from sorghum, rice, and malted barley

And FDA should change the definitions of ‘farm’, ‘facility’ and ‘manufacturing/processing’ to align with the common-sense understanding that the basic packing, handling and storing activities that farms have traditionally performed in preparing intact fruits and vegetables for marketing are not in fact food ‘manufacturing’ or ‘processing.’

For more details on on-farm value-added processing and the definitions of farms and facilities:
http://sustainableagriculture.net/fsma/on-farm-processors/

https://www.carolinafarmstewards.org/july-12/

TAKE ACTION:  Farmers and local food entrepreneurs adding value to crops through low-risk processing should not be subject to the same regulations as high-risk processors.  The Preventive Controls Rule includes a good initial list of low-risk processing activities, but FDA fails to include additional activities like making pickles and salsa that are already considered low-risk by many states.  Whatsmore, even though FDA recognizes a large number of food processing activities as low-risk, it still proposes to apply the strictest level of regulation if the processing activity takes place anywhere other than a farm.

Help FDA understand why this matters: Do you process your own fresh produce using any of the low-risk methods below? If so, which ones? Are your processing activities already regulated at the state or county level for food safety? How would additional regulation impact your operation?

Recommendation to FDA: FDA should include a fuller range of low-risk on-farm processing activities in the final regulations, including:

  • Acidifying, pickling, and fermenting low-acid fruits and vegetables made in compliance with existing Good Manufacturing Practices
  • Baking activities involving grain products
  • Roasting grains for animal feed
  • Extracting oils from seeds
  • Extracting virgin olive oil
  • Making molasses from sugarcane and sugar beets
  • Making syrups from sorghum, rice, and malted barley

And FDA should change the definitions of ‘farm’, ‘facility’ and ‘manufacturing/processing’ to align with the common-sense understanding that the basic packing, handling and storing activities that farms have traditionally performed in preparing intact fruits and vegetables for marketing are not in fact food ‘manufacturing’ or ‘processing’ under the Produce Standards or Preventive Controls rules.

How to Comment



Issue: Direct-to-Consumer Marketing (PCR)

The rules fail to clarify that Community Supported Agriculture (CSAs) and other direct-to-consumer businesses are not subject to regulation as food ‘facilities,’ despite clear instructions from Congress in FSMA to do just that.  Without this clarification, CSAs and other direct farmer-to-consumer farms that do light processing activities or include produce from another farm in their boxes will be subject to inappropriate, excessive regulations designed for industrial food facilities.

  • Example – If a farmer opts to include some of her neighbor’s peaches in her weekly CSA box a few times during the growing season, her farm would be considered a facility – potentially subjecting her to substantial and costly additional regulation.

In the final regulations, FDA must clarify in the Preventive Controls Rule that CSAs, roadside stands, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and are not facilities that must register with FDA and, therefore, are not subject to the Preventive Controls Rule.

For more details on direct-to-consumer marketing:
http://sustainableagriculture.net/fsma/learn-about-the-issues/direct-to-consumer-marketing-preventive-controls-rule/

http://sustainableagriculture.net/fsma/who-is-affected/

https://www.carolinafarmstewards.org/july-12/

July 22 – Why You Don’t Want to be a “Facility”

TAKE ACTION:  The rules fail to clarify that Community Supported Agriculture (CSAs) and other direct-to-consumer businesses are not facilities subject to regulations for food facilities, despite clear instructions from Congress in FSMA to do just that.  Without this clarification, CSAs and other direct farmer-to-consumer farms that do light processing activities or include produce from another farm in their boxes will be subject to inappropriate, excessive regulations designed for industrial food facilities.

Help FDA understand why this matters: Do you operate a CSA, farmers’ market, or other direct-to-consumer outlet? Do you aggregate or otherwise include produce from multiple farms in your CSA box? What measures do you already take to ensure the safety of this food? How might being subject to additional regulation as a facility impact your operation?]

Recommendation to FDA: In the final regulations, FDA must clarify in the Preventive Controls Rule that CSAs, roadside stands, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and are not facilities that must register with FDA and, therefore, are not subject to the Preventive Controls Rule.

How to Comment

 



Issue: All Food vs. Regulated Food (PR and PCR)

Even though not all food produced on farms is governed by the new FSMA rules, the value of everything produced on a farm counts toward exemptions and modified regulations – which will make it hard for mid-size farms to diversify their operations.

  • Example – If a farmer is growing over $500,000 of corn and soybeans – which aren’t covered by the rules – and wants to diversify with a small u-pick strawberry patch, that patch would be subject to the most stringent industrial-scale produce rules, even if they only sell $5,000 worth of strawberries, which would make it prohibitively expensive for them to start such a side venture.

FDA should count the value of only FSMA-covered (or regulated) product or produce and not “all food” when:

  • Determining whether a farm or facility is eligible for the modified requirements through the Tester-Hagan provisions,
  • In the exemption from the Produce Rule for farms grossing less than $25,000, and
  • In the definition of “very small business” in the Preventive Controls Rule.

For more details on all food vs. covered products: http://sustainableagriculture.net/fsma/learn-about-the-issues/all-food-covered-product/

TAKE ACTION:  Even though not all food produced on farms is governed by the rules, the value of everything produced on a farm counts toward exemptions and modified regulations – which will make it hard for mid-size farms to diversify their operations.

Help FDA understand why this matters: Do you have a variety of income streams from farming? What are they? Do you gross more than $500,000 in food other than produce or processed food?  If yes, do you also grow produce or process food?  If no, would you like to diversify into produce or processing? How will the “all food” sales threshold affect you?

Recommendation to FDA: FDA should count the value of only covered (or regulated) product or produce and not “all food” when:

  • Determining whether a farm or facility is eligible for the modified requirements through the Tester-Hagan provisions,
  • In the exemption from the Produce Rule for farms grossing less than $25,000, and
  • In the definition of “very small business” in the Preventive Controls Rule

How to Comment

 

 

Issue: Definition of “Very Small Business” (PCR)

The rules set modified requirements for small and very small businesses, but FDA has not settled on a definition for “very small business” and most of their options are unrealistic.  Without a realistic definition, many very small businesses – including food hubs and thousands of farms – will be regulated like big industrial food manufacturers.

  • Example – If FDA’s definition of “very small business” is not reasonable, small start-up operations – like a farmer making jam from her fruit or a food hub helping get healthy local food into schools – could be regulated well beyond their risk and with compliance costs too high for them to stay in business.

FDA should adopt a threshold of at least $2,000,000 for a very small business and make sure that it is based on the value of FSMA-regulated food, not the value of all food produced at that farm or business.  USDA analysis shows that a food hub business needs annual sales of at least $1 million to $2 million to be economically viable, with 80% of that revenue typically going back to the farmers.  With such tight margins, food hubs can’t afford to spend the 3 to 6% of revenue that the Preventive Controls rule would require.  Changing the ‘very small business’ threshold would focus the full regulations on the entities that produce the vast majority of covered farm and food products, while focusing modified requirements on smaller farms and businesses that represent the majority of producers but only a tiny minority of product in the food supply.

For more details on the “very small business” definition:
http://sustainableagriculture.net/fsma/learn-about-the-issues/definition-of-very-small-business-preventive-controls-rule/

https://www.carolinafarmstewards.org/july-12/

https://www.carolinafarmstewards.org/july-22-why-you-dont-want-to-be-a-facility/

TAKE ACTION:  The rules set modified requirements for small and very small businesses, but FDA has not settled on a definition for “very small business” and their options are unrealistic.  Without a realistic definition, many very small businesses will be regulated like big manufacturing plants.

Help FDA understand why this matters: If you operate a processing facility, food hub, or do processing on your farm, which option for the definition of “very small business” would you fall under, if any? If FDA calculated the definition of “very small business” not based on all food but based on processed food, how would that change your status, if at all?

Recommendation to FDA: FDA should adopt a $2,000,000 threshold for a very small business and make sure that it is based on the value of FSMA-regulated food, not the value of all food produced at that farm or business.  USDA analysis shows that a food hub business needs annual sales of at least $1 million to $2 million to be economically viable, with 80% of that revenue typically going back to the farmers.  With such tight margins, food hubs can’t afford to spend the 3 to 6% of revenue that the Preventive Controls rule would require.  Changing the ‘very small business’ threshold would focus the full regulations on the entities that produce the vast majority of covered farm and food products, while focusing modified requirements on smaller farms and businesses that represent the majority of producers but only a tiny minority of product in the food supply.

How to Comment

 

 

Issue: Loss of Protections for Local Food (Exemptions and Modified Requirements) (PR and PCR)

As currently proposed, FDA has broad authority to take away the exemptions and modified requirements certain farmers and facilities are eligible for and subject them to the full weight of the regulations if they think there is a food safety problem on the farm – but the rules do not require FDA to have proof of a problem, and there is no defined way to get that status back once FDA revokes it.

  • Example – If FDA suspects that a farm may have a food safety problem, they can immediately revoke that farmer’s exemption based on that farm or facility’s “material conditions” – even without any proof of wrongdoing, and even if no problem is ever found – without any due process or opportunity for the farmer to get it back, subjecting him to thousands of dollars in new compliance costs and rules.

In the final regulations, FDA must make a robust and fair regulatory framework for the qualified exemptions and modified requirements. Specifically,

  • FDA should define “material conditions” as scientifically measurable traits that can be clearly identified in individual cases, and never by conjecture be applied to a whole class of persons, types of operations, or broad description of food being produced.
  • FDA should require credible and substantial evidence to justify a withdrawal.
  • FDA should establish a clear and fair process for reinstituting a farm or facility’s status if that operation has had their exemption or modified requirement withdrawn.

For more details on modified requirements in the Preventive Controls Rule: http://sustainableagriculture.net/fsma/learn-about-the-issues/modified-requirements-for-qualified-facilities/

And on exemptions and modified requirements in the Produce Rule: http://sustainableagriculture.net/fsma/learn-about-the-issues/qualified-exemptions-and-modified-requirements/

TAKE ACTION:  FDA has the unlimited ability to take away the exemptions and modified requirements certain farmers and facilities are eligible for and subject them to the full weight of the regulations if they think there is a food safety problem on the farm – but the rules do not require FDA to have proof of a problem, and there is no way to get that status back once FDA revokes it.

Help FDA understand why this mattersAre the modified requirements feasible?  Do you anticipate significantly increased costs in complying with the requirements? What type of evidence of a problem should FDA include in a withdrawal order? What type of documentation do you regularly keep that could be used to appeal a withdrawal order?

Recommendation to FDA: In the final regulations, FDA must make a robust and fair regulatory framework for the qualified exemptions and modified requirements. Specifically:

  • FDA should define “material conditions” as scientifically measurable traits that can be clearly identified in individual cases, and never by conjecture be applied to a whole class of persons, types of operations, or broad description of food being produced.
  • FDA should require credible and substantial evidence to justify a withdrawal.
  • FDA should establish a clear and fair process for reinstituting a farm or facility’s status if that operation has had their exemption or modified requirement withdrawn.

How to Comment

 

 

Issue: Excessive Compliance Costs

The costs of compliance are substantial and put an unfair burden on smaller growers.  As a result of the high costs of compliance, FDA anticipates that some farmers will go out of business, fewer people will start to farm, and more farmers will have to seek off-farm jobs to keep farming.

  • Example – Farms defined as “small” by FDA and subject to the complete Produce Rule would face nearly $13,000 in compliance costs each year – which could eat up 50% or more of a produce farm’s already very slim margins.

FDA must find ways to decrease the costs of compliance with the new rules, especially for small and very small farms. FDA must also base the costs on realistic assumptions about length of growing season, farm net income, and feasibility of water testing.

For details on Produce Rule costs:
http://sustainableagriculture.net/fsma/learn-about-the-issues/costs-to-farmers-and-consumers-produce-rule/

https://www.carolinafarmstewards.org/what-will-fsma-compliance-cost-farmers-and-consumers/

Preventive Controls Rule costs:
http://sustainableagriculture.net/fsma/learn-about-the-issues/preventive-controls-rule/

https://www.carolinafarmstewards.org/july-22-why-you-dont-want-to-be-a-facility/

TAKE ACTION:  The costs of compliance are substantial and put an unfair burden on farmers, especially small- and mid-sized farms.  Farms defined as “small” by FDA and subject to the complete Produce Rule would face nearly $13,000 in compliance costs each year – which could eat up 50% or more of a produce farm’s already very slim margins.  Moreover, FDA has substantially understated the costs of compliance, based on assumptions that small farms are only producing crops three months out of the year, when in fact thousands of fruit and vegetable operations are growing crops year round.  Even with its unrealistically low estimate of the costs of compliance, FDA anticipates that some farmers will go out of business, fewer people will start to farm, and more farmers will have to seek off-farm jobs to keep farming.

Help FDA understand why this matters: How will the estimated costs of compliance impact your operation?  Will you be able to absorb these costs? What is your hourly wage?  What do you pay other employees? How long is your growing season? Will you have compliance costs from both the Produce Rule and Preventive Controls Rule? Please share any cost data on food safety plans or HACCP/HARPC requirements that you have and are comfortable sharing with FDA. Please share any cost data on practices for agricultural water; soil amendments; health and hygiene; domesticated and wild animals; equipment, tools, and buildings; and training that you have and are comfortable sharing with FDA.

Recommendation to FDA: FDA must find ways to decrease the costs of compliance with the new rules, especially for small and very small farms. FDA must also base the costs on realistic assumptions about length of growing season, farm net income, and feasibility of water testing.

How to Comment

 

Sample Comment for Consumers

(Sample Comment for Consumers.doc)

[Remember – you’ll need to submit this online or mail in a hard copy to the destinations noted above.]

Re:  Preventive Controls Rule: FDA-2011-N-0920, Produce Standards Rule: FDA-2011-N-0921

I am a [concerned consumer, parent, entrepreneur, etc.] writing because I am concerned about the impact that FDA’s proposed FSMA rules will have on [the farms that I buy food from, my business, my family’s ability to find local food, the environment]. I ask you to ensure that new regulations do not put family farms out of business, harm farmers’ soil, water, and wildlife conservation efforts, or shut down the growth of local and regional healthy food systems!

[Customize your comment: Do you make an effort to buy from farms that use sustainable practices like organic?  Why? If local farms went out of business due to the rules, how would that limit your access to fresh produce? Why is it important to you that farmers be able to support habitat for honeybees and wildlife?]

I urge you to go back to the drawing board and issue new proposed rules with respect to Preventive Controls and Produce Standards.  And in that next round of proposed rules, I urge you to modify the rules so that they:

Allow farmers to use sustainable farming practices, including those already allowed and encouraged by existing federal organic standards and conservation programs. Specifically, FDA must not exceed the strict standards for the use of manure and compost used in certified organic production and regulated by the National Organic Program.

Ensure that diversified and innovative farms, particularly those pioneering models for increased access to healthy, local foods, continue to grow and thrive without being stifled. Specifically, FDA needs to clarify two key definitions: first, as Congress required, FDA must affirm that farmers markets, CSAs, roadside stands, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and are therefore not facilities subject to additional regulation. Second, FDA should adopt the $2,000,000 threshold for a very small business and base it on the value of ‘regulated product,’ not ‘all food,’ to ensure smaller farms and businesses (like food hubs) fall under the scale-appropriate requirements and aren’t subject to high cost, industrial-scale regulation.

Provide options that treat family farms fairly, with due process and without excessive costs. Specifically, FDA must clearly define the “material conditions” that lead to a withdrawal of a farmer’s protected status in scientifically measurable terms. FDA  must also outline a clear, fair, process for justifying the withdrawal of a farmer’s protected status and for how a farmer can regain that status.

Thank you for your consideration,

[Full name, city and state, email address]

How to submit your comments

 

 

Sample Farmer/Business Comment

Comment Template For Farmers/Business Owners

(Sample Comment for Farmers or Businesses.doc)

Re:  Preventive Controls Rule: FDA-2011-N-0920, Produce Standards Rule: FDA-2011-N-0921

I am a ____ [farmer, entrepreneur, processor, parent…].

[Customize your comment with your story: What is the name and location of your farm? What do you grow? How long have you been in operation? Where do you sell your products and how do you already ensure their safety?]

I am writing because I am concerned about the impact that FDA’s proposed FSMA rules will have on [my farm / business operation, the practices I use on my farm, other farmers in my community, the farms that I buy food from, etc…]. I ask you to ensure that new regulations do not put safe farms out of business, harm farmers’ soil, water, and wildlife conservation efforts, or shut down the growth of local and regional healthy food systems!

Because of all of the specific issues described below, I urge FDA to publish a second round of draft rules for public comment before finalizing the produce safety and preventive controls regulations.  The state regulators who know the most about agriculture and food agree with this recommendation:  In a statement on Sept. 20, 2013, the National Association of State Departments of Agriculture (NASDA) observed that FDA has little to no experience inspecting farms, and that the rules have to potential to tilt the playing field in favor of foreign producers.  NASDA noted that “FDA needs to recognize legitimate farming practices – merely changing farming practice will likely drive some producers out of the marketplace rather than assure safer food,” and recommended that  FDA publish a second proposed rule draft for public comment before seeking to make the rules final.

<at this point you can comment on one, or several of the specific issues above that apply to your farm or business>

How to submit your comments

 

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