About six years ago, the National Sustainable Agriculture Coalition (NSAC) kicked off a comment campaign around the Food Safety Modernization (FSMA) regulations that could negatively impact small farms, local food systems, and sustainable agriculture. Now, a new FSMA regulation is being proposed by the Food and Drug Administration (FDA), and FDA needs to hear organizations, food businesses, and farmers once again.
Background
FSMA included seven initial rules back in 2016, most of which focuses on medium and large food businesses that process and distribute food nationally and internationally. FSMA’s initial language limited the scope of FSMA on farms to the Produce Safety Rule, unless the farm was conducting certain further processing that would require it to be regulated as a “facility.”
Unfortunately, the new Proposed Rule on Requirements for Additional Traceability Records for Certain Foods (“Traceability Proposed Rule”), encompasses farms, even though FSMA and Congress stated it was for facilities.
The rule includes a number of additional recordkeeping requirements for farms, food businesses, grocery stores, processors, some cottage food operators, and anyone else who manufactures, processes, packs or holds products on the FDA’s Food Traceability List (FTL). These recordkeeping requirements might include required electronic spreadsheets, on farm GPS coordinates for where the food was grown and harvested, and the location, date & time that the food is harvested, cooled, packed, received, shipped, or used as an ingredient in another food.
FDA is asking for comments on this proposed rule, before it becomes final. The deadline for comments is Monday, February 22, 2021, at 11:59 pm Eastern Time.
For more information on the proposed rule and it’s impact on farms, visit our posts: What the New FDA Rule Means for Farms Part 1 and Part 2.
FDA Needs to Hear from YOU about their Traceability Proposed Rule
We need your help to ensure farms that are not facilities are removed from the rule, and that the rule ensures inexpensive and practical traceability for small food businesses. NSAC has developed a comment template to help you craft a unique comment, specific to your farm or food business and its traceability system here.
Farms or businesses that might be exempt from the Traceability Rule should still comment. Even exempt farms might still be required to keep extensive records, because the proposed rule requires “first receivers” – businesses that receive food items first from the farm that grew, caught or harvested the food – to keep extensive records on where the food was grown and harvested. For example, a local food hub that is required to record the lot code, growing location, harvester, and farm contact information as a “first receiver” is likely to require the farm it purchases from to send along all of these records, since it is unlikely the food hub will be able to collect all of this information on their own.
FDA only seriously considers unique comments, so please think through the questions on the template and the following questions as you write your comment:
- Do you sell a food item on the food traceability list? Which one(s)?
- Are you a farmer who currently sells to a retailer, restaurant, and/or wholesaler? What records would they require you to send them?
- Are you a food business that purchases food directly from farmers? What records would you require of the farmers you purchase from?
- Would the proposed rule increase your business or farm’s recordkeeping activities? What increased cost might this have on your business?
Top Issues to Comment On
1. Farms should be exempt. The rule should not apply to farms that are not facilities. The proposed rule is not consistent with FSMA’s language that instructed FDA to write a rule “for facilities that manufacture, process, pack, or hold foods that the Secretary designates” as high-risk foods. Applying the rule to farms that are not facilities is not consistent with the law, unduly burdensome for farms, especially local, sustainable farms, and is costly for small farms with thin margins.
2. Ensure farm products that are fully traceable are exempt. The rule should ensure value-added on-farm products that are fully traceable because of their labeling requirements are fully exempt. FSMA required that FDA fully exempt products that are packaged on the farm and maintain the farm’s identity through labeling all the way to the consumer. Unfortunately, FDA is requiring that “first receivers” and others throughout the supply chain still keep records on these products, and that these products are all individually wrapped, creating additional environmental waste. So long as a product remains intact and is fully traceable back to the farm through the label’s information, FDA must ensure it is exempt from the Traceability Rule requirements.
3. Revise the Food Traceability List. The Traceability Proposed Rule’s definition of high risk foods inappropriately includes food items that are not inherently dangerous and have varying scales of food safety risk.
4. Exempt Small Food Businesses. The Traceability Rule must be scale appropriate. The challenges that are faced in a nationwide outbreak with multiple supplier sources are different from a local food retailer with a shorter and more local supply chain. FDA should ensure the Traceability Proposed Rule allows for small business exemptions that are realistic. A 10 employee or less exemption is not realistic when FDA and other federal agencies have used more expansive small business definitions, and when small businesses with a few hundred employees have the exact same supply chain.
5. No technology should be required. The proposed traceability rule states that a business must provide FDA an electronic spreadsheet of all required records within 24 hours if requested. FSMA stated FDA could not require technology. This proposed rule requirement is a violation of FSMA and concerning for small businesses that do not have the technology in place to meet this requirement.
While NSAC will be commenting on a number of other positive and negative pieces of the Traceability Proposed Rule, we wanted to provide the top 5 issues for farmers, organizations, and other businesses to comment on before the deadline. The deadline to submit a comment is Monday, February 22nd! Check out our comment template LINK and submit a comment before then!
1. Farms should be exempt. The rule should not apply to farms that are not facilities. The proposed rule is not consistent with FSMA’s language that instructed FDA to write a rule “for facilities that manufacture, process, pack, or hold foods that the Secretary designates” as high-risk foods. Applying the rule to farms that are not facilities is not consistent with the law, unduly burdensome for farms, especially local, sustainable farms, and is costly for small farms with thin margins.
2. Ensure farm products that are fully traceable are exempt. The rule should ensure value-added on-farm products that are fully traceable because of their labeling requirements are fully exempt. FSMA required that FDA fully exempt products that are packaged on the farm and maintain the farm’s identity through labeling all the way to the consumer. Unfortunately, FDA is requiring that “first receivers” and others throughout the supply chain still keep records on these products, and that these products are all individually wrapped, creating additional environmental waste. So long as a product remains intact and is fully traceable back to the farm through the label’s information, FDA must ensure it is exempt from the Traceability Rule requirements.
3. Revise the Food Traceability List. The Traceability Proposed Rule’s definition of high risk foods inappropriately includes food items that are not inherently dangerous and have varying scales of food safety risk.
4. Exempt Small Food Businesses. The Traceability Rule must be scale appropriate. The challenges that are faced in a nationwide outbreak with multiple supplier sources are different from a local food retailer with a shorter and more local supply chain. FDA should ensure the Traceability Proposed Rule allows for small business exemptions that are realistic. A 10 employee or less exemption is not realistic when FDA and other federal agencies have used more expansive small business definitions, and when small businesses with a few hundred employees have the exact same supply chain.
5. No technology should be required. The proposed traceability rule states that a business must provide FDA an electronic spreadsheet of all required records within 24 hours if requested. FSMA stated FDA could not require technology. This proposed rule requirement is a violation of FSMA and concerning for small businesses that do not have the technology in place to meet this requirement.
Dear FDA,
I oppose the proposed rule on traceability. Many small farms like ours do not have the man poswer to make spread sheets all their required records let alone within 24 hours. I am the farmer, secretary and farm hand. I can not hire extra folks…especially at the proposed minimum wages of this administration! We will NOT be able to provide clean, organically managed food which is important to the environment. You can not have it both ways!
I am also a prescribing healthcare provider. I used to teach microbiology. This is an absurd traceability rule from a health perspective. An exemption of 10 employees or less needs to be written into the language. Our clients can already trace their food to our farm without a spread sheet!
The rule should not apply to farms that are not facilities. The proposed rule is not consistent with FSMA’s language that instructed FDA to write a rule “for facilities that manufacture, process, pack, or hold foods that the Secretary designates” as high-risk foods. Applying the rule to farms that are not facilities is not consistent with the law, unduly burdensome for farms, especially local, sustainable farms, and is costly for small farms with thin margins.
Small local food providing farms should be exempt from onerous record keeping requirements. We supply just 3 small restaurants with salad greens triple washed, broken up and bagged in 1 pound bags, ready to serve.
Each delivery specifies weight and items in those bags on the delivery invoice. The items that may be in the salad mix are clearly displayed on the invoice. We pring duplicate invoices and save 1 copy for our files.
An episode where our process might result in a claim of illness or lack of cleanliness can be traced to 4 or 5 bags (usual daily order at the largest of our small client restaurants) at that establishment.
We see no need for further documentation that is no t required by virtue of the current law, as we do not store such produce on our farm.
As a buyer from small independent farmers I know the struggle these folks have between the weather and rules and regulations. The weather can’t be controlled but the rules can be. These new regulations should not apply to small farms, those that are not facilities or big farming operations. Consider the population that prefers supporting the common man.
I oppose this rule!
Small farm businesses (such as mine) are not facilities that should be required to report the “traceability” of the food produced on site. With a small operation there is no need to prove where the food came from (usually just feet away). We are not capable of providing the necessary information due to the constraints of running a tight operation that pays attention to the health of the product, the soil, and the customers who eat the produce. This rule would make small farming nearly impossible. With so many challenges already at play, we should not be required to provide this technological information (which will not benefit the farmer in any way). Please consider small farms and their product exempt from this rule, as scale matters!
I oppose this rule!
Small farm businesses (such as mine) are not facilities that should be required to report the “traceability” of the food produced on site. With a small operation there is no need to prove where the food came from (usually just feet away). We are not capable of providing the necessary information due to the constraints of running a tight operation that pays attention to the health of the product, the soil, and the customers who eat the produce. This rule would make small farming nearly impossible. With so many challenges already at play, we should not be required to provide this technological information (which will not benefit the farmer in any way). Please consider small farms and their product exempt from this rule, as scale matters!
The rule should not apply to farms that are not facilities. The proposed rule is not consistent with FSMA’s language that instructed FDA to write a rule “for facilities that manufacture, process, pack, or hold foods that the Secretary designates” as high-risk foods. Applying the rule to farms that are not facilities is not consistent with the law, unduly burdensome for farms, especially local, sustainable farms, and is costly for small farms with thin margins.
Thank you for your comment, Barbara! Please submit your comment to the Federal Register here too: https://www.regulations.gov/commenton/FDA-2014-N-0053-0184
Thank you for your comment, Barbara! Please submit your comment to the Federal Register here too: https://www.regulations.gov/commenton/FDA-2014-N-0053-0184
Thank you for your comment, Barbara! Please submit your comment to the Federal Register here too: https://www.regulations.gov/commenton/FDA-2014-N-0053-0184
Thank you for your comment, Barbara! Please submit your comment to the Federal Register here too: https://www.regulations.gov/commenton/FDA-2014-N-0053-0184
Thank you for your comment, Barbara! Please submit your comment to the Federal Register here too: https://www.regulations.gov/commenton/FDA-2014-N-0053-0184