Updated February 23, 2021

UPDATE: Read FARFA’s comments here.  While the public comment period ended on 2/22/2021, we will continue working for badly needed reforms to this terrible rule — stay tuned!

The FDA is proposing a new rule that would apply to almost everyone involved in the food system, including farms, cottage food operators, co-ops, and restaurants. For foods that FDA lists as “high risk,” the proposed rule imposes extensive record-keeping requirements, including electronic spreadsheets, GPS coordinates on where the foods are grown, and the location, date and time that the food is harvested, cooled, packed, shipped, or used as an ingredient in another food.

The list of foods that FDA considers to be “high risk” includes leafy greens, cucumbers, eggs, nut butters, herbs, melons, tomatoes, cheese, and much more. See the entire list at https://beta.regulations.gov/document/FDA-2014-N-0053-0056 (Scroll down to Table 2). And the agency is reserving the right to add yet more foods to the list in the future.

The major foodborne illness outbreaks have certainly revealed problems with traceability – but that’s in the large-scale, conventional food system. From spinach to peanut butter, the problems arise because raw ingredients are taken to a central processing facility, which leads to widespread contamination, and then the products are packaged under dozens (if not more) of brand names and shipped all over the country. Small-scale operations with short supply and distribution chains are both inherently lower risk and easier to trace.

While the Food Safety Modernization Act (FSMA) included the Tester amendment to exempt small-scale farms and food businesses from many of its provisions, the exemption doesn’t specifically apply to the provision for additional traceability requirements on high-risk foods. Even so, these requirements should only apply to “facilities,” which would exclude farms and “retail food establishments” (those whose primary purpose is to sell direct-to-consumer, such as grocers, restaurants, and cottage food producers).

But FDA has expanded the scope of this provision to cover everyone who manufactures, processes, packs, or holds food. And the agency interprets those terms to include people who grow the food, i.e. farmers.

The agency has proposed some very small exemptions:

• Food grown or made solely for personal use.
• Farms that sell $25,000 or less of produce annually.
• Businesses that sell $25,000 or less of food annually.
• Egg producers with less than 3,000 hens.
• Nonprofit food establishments, such as food banks or soup kitchens.

And then there are a few exemptions that cover only specific types of sales, rather than the whole business:

• Certain farm sales. In other words, the farm is not exempt as a whole, but only the foods they sell in these specific ways: Foods sold direct-to-consumer (but not to local businesses), food sold in farm-to-school or farm-to-institution programs, and “identity-preserved food” where the food is packaged on the farm and the labeling remains intact all the way to the consumer – but only if the food is individually packaged in sealed plastic or similar packaging.
• Eggs or produce that are commercially processed in a way that kills microorganisms (essentially, pasteurized or irradiated).
• Retail food establishments (grocers, restaurants, and other businesses whose primary purpose is selling direct-to-consumers), but only for foods purchased directly from farms.

The agency is also considering, but has not committed to, exempting businesses with 10 or fewer full-time employees. One option under consideration is to exempt these tiny businesses from having an electronic spreadsheet, but not from the extensive recordkeeping and tracking requirements.

Even if your farm or food business falls within one of these narrow exemptions, you might still find yourself required to keep extensive records. That’s because the agency is requiring “first receivers” – businesses that receive the food items from the original person who grew or made them – to keep extensive records on where it was grown/made, when it was harvested/manufactured, etc. This information can only come from the farmer or original producer. So even exempt farms and small businesses could find themselves pressured to keep massive amounts of paperwork or lose their customers.

TAKE ACTION

We need your help to push back! Our primary position is that the rule’s scope needs to be significantly narrowed so that it only covers facilities and excludes small businesses, consistent with the other FSMA provisions. But in case FDA refuses to narrow it, we also need to address the many other problems with the proposed rule. Our sample comment below explains these issues.

You can submit comments to FDA online at https://beta.regulations.gov/commenton/FDA-2014-N-0053-0184.

Doing this on the last day, and don’t have time for a detailed comment? Don’t worry – you can still help! Just submit a few sentences: (1) who you are and why this matters to you, and (2) urging the agency to make the changes recommended by FARFA. You can read our comments here

You can copy and paste your comments into the text box, or you can upload a file with your comments. Please note all comments and information you provide, including name, address, etc. will be made public. So, while our sample comments include places for your name and state, feel free to provide whatever information you are comfortable making public.

Deadline: Monday, February 22, 2021, at 11:59 pm Eastern Time.

The sample comment below is designed to help you craft your own comment. “Form comments” are generally disregarded by both the agency and lawmakers. So please take the time to modify these comments to fit your situation. It is better to submit a short personal comment than a long standardized one! Our sample comment lists all the changes that we think are needed, and below that is additional information that goes into more detail on each requested change. Dark red text indicates areas that you should personalize (or delete), and you are welcome to put other portions into your own words as well.

If you find it easier to cut and paste from a Word document, you can download the sample comment as a Word file here.

Save a copy of your comments (for example, as a Word document on your computer)! We may need to get Congress involved to rein in the agency, and your personal stories will be important in that effort as well.

SAMPLE COMMENT

I am a ____ [farmer, restaurant owner, cottage food producer, food business …].

[INTRODUCTION:  Briefly explain why you care about these regulations. What do you farm or what does your food business sell? Do you source locally? Are you a consumer who prioritizes getting food from businesses you know and trust, and don’t want new regulations to hurt your food supply?]

Congress recognized in the 2002 Bioterrorism Act that foods can be traced without imposing requirements on the very first or last links in the chain – the farmer/rancher and the entity that sells or serves the food to the consumer (grocers, restaurants, and other “retail food establishments”). Congress re-affirmed that approach to traceability in the Food Safety Modernization Act in 2010. Moreover, Congress recognized the importance of protecting small food businesses from expensive regulations that are not needed for small operations. And in adopting the initial regulations under FSMA, FDA identified that food businesses grossing less than $1 million annually were “very small businesses” in the context of our food system.

Yet in these newest proposed regulations, FDA is contradicting all these principles and imposing costly, burdensome requirements on farms, retail food establishments, and very small businesses.

If FDA’s Additional Traceability Records for Certain Foods Proposed Rule (“Traceability Proposed Rule”) is implemented, it will hurt [my farm / food business, farmers in my community, the farms or food hubs that I buy food from, etc. …].

I urge the agency to make the following changes:

1. Limit the scope of the rule to “facilities,” as that term is used in the other FSMA regulations.
   • Exclude farms, unless they conduct activities that would classify them as “farm mixed type facilities”; and
   • Exclude retail food establishments, whose primary purpose is to sell or serve food directly to consumers.
2. Exempt very small businesses, defined consistent with other FSMA rules and the Small Business Administration’s classifications.
3. Exempt foods that are “identity preserved” from farm to consumer, without requiring that individual items be in sealed plastic packaging.
4. Remove the electronic spreadsheet requirement.
5. If farms are included, remove the requirement for GPS coordinates for where the crops are grown.
6. Modify the requirements for “first receivers,” so that they are not required to keep records that go beyond the underlying requirements for the farms and food manufacturers they receive items from.

[You can stop here, if you like. Add a sentence or two about why this matters to you. Or you can Include more detailed comments on any of the specific items that are particularly important to you – we have additional background info and guidance directly below to help you.]

Sincerely,

[Full name, business name if applicable, state]

Additional Guidance for Your Comments on the Traceability Proposed Rule

We’ve provided more background and sample wording for you to adapt for your personalized comments. These are numbered to correspond with the list in the above sample letter.

1. This rule should not apply to farms or retail food establishments.

The section of FSMA that authorizes FDA to create additional requirements for traceability of high-risk foods specifically states that it applies to “facilities.” This term has consistently not applied to farms over the last 19 years, since its first usage in the 2002 Bioterrorism Act. Throughout FSMA, Congress makes clear the term “facilities” does not include farms that are not processing or manufacturing food in a way that falls within the “facilities” definition. FDA cannot ignore the plain language of the law.

Just as with farms, retail food establishments have been excluded from the term “facility” since the 2002 Bioterrorism Act. These businesses – whether they are grocers, restaurants, cottage food producers or others – have a primary business purpose of selling direct to consumers. While the proposed rule includes a partial exemption for retail food establishments, that only covers foods sold directly from the farm to the retail food establishment. But consumers know who they bought the food from. Requiring these businesses to keep extensive records on numerous products and ingredients is not consistent with the language of FSMA nor with an assessment of the risks posed.

Personalize & explain why this matters:

• Are you a farm worried about having to comply with a rule that is not meant for you, but instead for further processed, value-added products? If you had to comply and keep detailed records of the GPS coordinates where you grow any item on this Food Traceability List, and detailed information for every shipment of these items you send, how much time and money would this cost you?
• Are you a restaurant or cottage food producer? If you had to comply and keep detailed records on the source of all the “high-risk” ingredients you use, and when you prepared each product or dish with them, how much time and money would this cost you?

2. Provide “very small business” exemptions that are consistent with other FSMA rules.

The proposed traceability rule only exempts businesses that sell less than $25,000 annually in food and states that it might exempt those with 10 or fewer full-time employees.

In contrast, FDA defined “very small business” in the Preventive Controls Rule as those that sell less than $1 million in food annually. The Small Business Administration classifies businesses that have fewer than 500 employees as “small” in the food manufacturing industry. The exemption in this proposed rule is absurdly low when placed in context of our agricultural and food system.

The FDA should exempt businesses that sell less than $1 million in food annually, to make this rule consistent with the Preventive Controls Rule. Alternatively, or in addition, the agency should exempt businesses with 50 or fewer full-time employees (one-tenth the size of a “small business” in the food industry as classified by SBA).

Personalize & explain why this matters:

• Are you a small food business? Explain the negative impacts this rule would have on your business.

3. Exempt foods that are “identity preserved” from farm to consumer, without requiring that individual items be in sealed packaging.

FSMA specifically directed FDA to exempt “identity preserved” foods that are packaged on the farm and maintain their farm labeling all the way to the consumer. Unfortunately, in the proposed rule, the agency is proposing a very strict interpretation that effectively requires sealed plastic packaging. 

The examples FDA provides on what packaging is acceptable for this exemption are expensive, resource intensive, and may not be possible for many farmers. For example, FDA recommends that to meet this exemption, farms individually wrap each cucumber in sealed plastic wrap, with the appropriate labeling. 

This type of packaging is not only costly but creates concerns about waste and harmful environmental impact. So long as the products are traceable back to the farm through the label information, there should not be major concerns about the packaging requirements.

Personalize & explain why this matters:

• Do you or the farmers that you purchase food from use more sustainable and safe containers like clamshells or vented crates? What packaging do you use? How much would it cost for you if you were to individually wrap each item in plastic?
• Explain to the FDA the financial and environmental impact this might create.
• Explain to the FDA what types of labels you use to ensure products are fully traceable to the farm.

4. Do not require electronic records or other technology.

The requirement to provide FDA, when requested, with an electronic spreadsheet of all required records within 24 hours is both unduly burdensome and contrary to the statute. In directing FDA to create additional traceability requirements, Congress specifically said that the agency could not “prescribe specific technologies for the maintenance of records.” Small businesses, especially in rural areas, often lack the technology to meet this requirement without significant additional expense. FDA should abolish this requirement in the final rule.

Personalize & explain why this matters:

• Are you a small business that is worried about this requirement? How much would this requirement cost your business?
• Are you a farm that does not have the technology or staff in place to meet this requirement?

5. Remove the GPS requirement.

The requirement to keep records that include the “growing area coordinates” are based on assumptions about large-scale, largely mono-culture agricultural operations, in which a single crop is grown on multiple acres. Diversified sustainable farms operate very differently. Crops are often tightly interspersed with each other, and their planting locations rotated frequently. Depending on the climate, multiple plantings of the same crop may occur in the same year, but in slightly different areas of the farm.

Personalize & explain why this matters:

• Are you a diversified farm? How many different crops do you raise on what acreage, in a typical year?
• If you raise any of the listed produce – leafy greens, tomatoes, melons, peppers, or herbs – are they interspersed with other crops? Are they always grown in the same spot or moved around? How much time would it take you to keep records of the GPS coordinates for each crop?

6. Modify requirements for first receivers.

The proposed rule imposes significant burdens on a “first receiver,” namely the first person (other than a farm) who purchases and takes physical possession of a listed food. These would not only include identifying the person the food was received from, but also the lot code and all the people who originated, harvested, cooled, and packed the food, as well as the location, date, and time of the harvesting, cooling, and packing.

In practical terms, that means that the farm that sells the food to the first receiver must also keep all these records. Exempt farms (such as those selling less than $25,000 of produce) will effectively be forced to undertake the additional expense and hassle to keep these records if they wish to sell to anyone other than individual consumers.

Put another way, local-sourcing businesses, such as value-added producers and restaurants, will have to either stop sourcing from small farms or require that their suppliers compile all this information for every lot of food they sell.

Personalize & explain why this matters:

• Are you a small farm that sells to local businesses and would have to keep additional records under this provision? What would it cost you? How would that affect your profit margin?
• Are you a business that buys ingredients from small farms? Do you think that they would be able to manage the time and expense of providing the information you would need as the “first receiver?” What would it cost you?