Food Safety

Action Alert — Food Safety Modernization Act:
New Draft Rules Comments Due on December 15

FDA3UPDATE 12-20-14:  Read Cornucopia’s full comments to the FDA on the draft food safety rules.  Click Here

In response to recent widespread, and sometimes deadly, outbreaks of foodborne illness, Congress passed the Food Safety Modernization Act (FSMA) charging the Food and Drug Administration (FDA) with improving their oversight of the food industry.

But the intense blowback the FDA received last year from family-scale farmers and consumers over their proposed food safety rules for produce led the agency to withdraw and rewrite their proposed rules. Your comments last year had an impact!

The FDA has now released their new draft, which addresses many of the objections. However, a number of problems and pitfalls for farmers remain in the new draft. The proposal will also be of interest to the customers of local, organic food purchased through farmers markets, CSAs and co-op grocers.

Public comments are due by December 15 on the draft rules.

The Cornucopia Institute, working with other groups, has requested a 90-day extension to allow for fuller and careful analysis of the latest proposal.

You can comment online, but be sure to do so at both of these locations as the regulations impacting family scale farmers are intertwined in both of these FDA dockets:

http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0921-0973
http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-1553

Or you can comment by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Make sure you note that you are commenting on dockets FDA-2011-N-0921-0973 and FDA-2011-N-0920-1553. Your letter needs to be postmarked no later than December 15.

According to the analysis performed by the National Sustainable Agriculture Coalition, growers with sales up to $500,000 would likely spend 4% to 6% of their gross revenue to comply with the new food safety rules.  For small farms, FSMA could consume more than half of their modest profits. It is important that family-scale farmers producing our nation’s fda2best and safest produce be protected from unnecessary and onerous regulations — this could put some farmers out of business and/or reduce the availability of organic and local food and/or increase pricing.

Key Points to Mention in Your Comments:

  • Tell the FDA that the cost to farmers for implementing the proposed rules will endanger the livelihoods of organic farmers and their customers’ access to safe and nutritionally superior local and organic food.

  • Tell the FDA that farms are not facilities, and the regulations should allow for non-contiguous locations and not discriminate against cooperatives and food hubs.
  • Tell the FDA that they must clarify that CSAs and direct market farmers are not facilities.
  • Tell the FDA that changes made to the manure handling regulations are an improvement and that sustainable and organic farmers must be involved with the future study committee assessing risks of manure usage.
  • Tell the FDA that the proposed use of the recreational water standard is an inappropriate and overly restrictive measure for testing the safety of irrigation water.
  • Tell the FDA that they must establish a fair process for any enforcement actions that allows due process, full documentation of any alleged food safety issues, and the opportunity for a hearing to contest any erroneous information.
  • Tell the FDA that the exemption from the food safety rules, guaranteed by the Tester-Hagan amendment, must be respected and determined by the sale of produce covered by the rule, not the total sale of all food grown and raised on a farm.
  • Tell the FDA on-farm conservation practices need explicit support in the food safety rules and that the grazing of livestock is not manure application.
  • Tell the FDA that recordkeeping requirements should be reasonable, limited to one year, and allow for paper records.
  • Tell the FDA to remove the supplier verification program from the Hazard Analysis and Risk-Based Preventive Control (HARPC) food safety rule.
  • Tell the FDA that the new definition of a small business is an improvement.

Please try to personalize your comments by adding two or three sentences. Farmers should let the FDA hear what you grow and the impact of these rules on you. To see the full set of rules visit: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0921-0973

Become an expert in ten minutes: Additional detail on the the revised draft regulations:

1. What is a Farm:

The FDA needs to clarify that farms are not “facilities,” and to ensure that farmer-operated businesses that engage in “farm” activities — growing, harvesting, packing, or holding raw agricultural commodities — are clearly considered farms, not food processing businesses.

The 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; this working structure does 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.

  • Tell the FDA that farms are not facilities, and the regulations should allow for non-contiguous locations and not discriminate against cooperatives and food hubs.

2. Cost:

The FDA admits that the cost of compliance with their proposed rules will be high for farmers, as much as $12,384 for farms with sales of $500,000 or less. This regulatory burden, particularly given some of the questionable testing protocols (see below), is an unacceptable imposition of financial hardship on producers with no history of food safety problems.

  • Tell the FDA their draft proposal will endanger the livelihoods of organic farmers and the access of their customers to safe and nutritionally superior local and organic food.

3. Manure:

One welcome change moves the FDA rules in alignment with National Organic Program standards governing the use of raw manure as a soil fertility adjunct — this is a big win for organic farmers.

The draft also calls for establishment of a study committee to further assess the science and risks posed by manure usage.

Your comments on the manure issue are critical as the draft rules are being vigorously opposed by some consumer groups, including the Center for Science in the Public Interest, which considers manure a “highly risky agricultural input.”

A detailed discussion of the draft rule’s proposals for manure use can be found at http://sustainableagriculture.net/fsma/learn-about-the-issues/manure-and-compost/.

  • Tell the FDA that changes made to the manure handling regulations are an improvement and that sustainable and organic farmers must be involved with the future study committee assessing risks of manure usage.

4. Tester-Hagen and Food Safety Rule Exemptions for Small/Medium Local Farms:

One hard-won gain by farmers and real food advocates, with the original passage of the Food Safety Modernization Act (FSMA) by Congress, was the Tester-Hagan Amendment. Tester-Hagan exempted small-scale, direct-marketing farmers and facilities from some of the new requirements imposed under FSMA. These provisions are necessary for protecting vulnerable, small-scale producers that are providing safe, healthy food for their local communities.

The FDA improperly bases the size requirements for qualifying for the Tester-Hagan exemption (established by Congress as $500,000 in annual sales) on all the food sold by the producer – not just the produce subject to the agency’s jurisdiction or regulated under FSMA.

For example, a grass-fed beef producer with a small orchard who sells $600,000 in beef and $30,000 in fruit would be subject to all of the new costly FSMA requirements for growing and harvesting $30,000 worth of produce — even though the FSMA does not regulate beef!

The determination of the Tester-Hagan exemption should be applied only to the sale of produce covered under the food safety rules.

  • Tell the FDA that the exemption from the food safety rules, guaranteed by Tester-Hagan, must be respected and determined by the sale of produce covered by the rule, not the total sale of all food grown and raised on a farm.  

5. Fairness:

The FDA’s proposed rules fail to provide due process for producers before revoking their Tester-Hagan exemption. A fair process doesn’t risk pushing a small-scale producer out of business with a too-hasty or erroneous decision to revoke their exemption and excruciatingly short deadlines for compliance (which could take place during the busy growing season). The FDA should communicate a specific statement of the reasons in the notice of revocation for food safety concerns, so that the farmer can respond to these specific issues.

The FDA should also be required 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 — this would prevent using a potential revocation as a form of intimidation by government officials.

The FDA should provide appropriate time (at least 90 days) for producers to submit the facts and documentation showing that their exemption should not be withdrawn. The FDA needs to guarantee a hearing, if requested, so that producers can present their case in person before having their exemption revoked.

  • Tell the FDA that they must establish a fair process for any enforcement actions that allows due process, full documentation of any alleged food safety issues, and the opportunity for a hearing to contest any erroneous information.

6. Irrigation Water:

The FDA, as directed by Congress, must take a science- and risk-based approach to regulation. The proposed requirement for irrigation water fails to do so.

The usage of and reliance upon the EPA’s recreational water standard as a measure of irrigation water safety is inappropriate, overly restrictive, and fails to test for potential hazardous pathogens. There is little correlation between generic E. coli, which is ubiquitous in the environment — as measured by the recreational water standard — and the presence of more dangerous pathogens, such as the virulent O157:H7 strain of E. coli and salmonella. This makes the generic E. coli standard a completely inappropriate indicator on which to base national policy.

The draft rules establish requirements for frequent testing of irrigation water. The testing frequencies are overly burdensome, lack scientific justification, and will needlessly impose great costs on farmers to repeatedly test the quality of water.

The FDA needs to hear that before they establish a numeric testing standard for the safety of irrigation water, they must conduct a risk assessment for water used specifically for agricultural purposes.

If you irrigate on your farm in any way, be sure to personalize your comments with facts about your situation, such as where you get your water from and how you monitor the quality of it.

  • Tell the FDA that the proposed use of the recreational water standard is an inappropriate and overly restrictive measure for testing the safety of irrigation water.

7. CSAs and Direct Marketers:

A “retail food establishment,” which sells the majority of its products directly to individual consumers (not restaurants, retailers, or other businesses), is exempt from registering as a facility with the FDA. Under Tester-Hagan, farmers who sell at farmers markets, distribute through drop points, etc. would still be “retail food establishments” and not facilities subject to the extensive regulations required for food facilities.

Yet the FDA has failed to include this definition in the draft regulations – despite clear direction from Congress. The FDA needs to hear that this definition must be made so that CSAs and direct market farmers are not defined as facilities and required to comply with extensive food safety facility regulations.

  • Tell the FDA that they must clarify that CSAs and direct market farmers are not facilities.

8. Supplier Verification Program:

The FDA should remove the supplier verification program from the Hazard Analysis and Risk-Based Preventive Control (HARPC) food safety rule. This is a backdoor approach allowing large produce buyers to impose more stringent and onerous food safety requirements than outlined in the FDA’s food safety rule governing produce.

At an absolute minimum, FDA should remove the onsite audit requirement from the supplier verification program.  Imposing a supplier verification program effectively imposes an entire second layer of regulation on produce farms that are supplying ingredients to wholesalers and processors, an unnecessary burden which was not authorized by Congress when they passed the Food Safety Modernization Act.

  • Tell the FDA to remove the supplier verification program from the Hazard Analysis and Risk-Based Preventive Control (HARPC) food safety rule.

9. Conservation Practices:

The Produce Rule fails to 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. Without explicit support in the rules, conservation practices like planting native plant buffers as bee habitat that are a win-win for conservation and food safety could be discouraged or, worse yet, forcefully removed.

If you have livestock on your farm, be sure to personalize your comments with facts about your situation and how you integrate the operation into any produce you grow.

Additionally, the FDA should not treat grazing like manure application and should not restrict grazing through unrealistic intervals between grazing a field and harvest of a crop. The maximum waiting period should be 4 months, with the option for shorter waiting period if steps are taken to prevent contamination of the crop.

  • Tell the FDA on-farm conservation practices need explicit support in the food safety rules and that the grazing of livestock is not manure application.

10. Recordkeeping:

Records should be limited to those kept in the ordinary course of business, particularly records required of farmers that pack or hold produce from other farms.  Specifically:

FDA should require farms that pack or hold produce from other farms to retain records for no more than one year — in terms of sure food safety there would be little if any utility in that practice.

Records kept in the ordinary course of business that reflect the immediate buyer and/or seller, such as an invoice, should be sufficient to meet the requirements.

FDA should allow paper records, whether typed or handwritten; a requirement that record be kept electronically would be unnecessary, impose undue expense, and discriminate against those farmers with limited access to technology — especially some older and Amish growers.

  • Tell the FDA that recordkeeping requirements should be reasonable, limited to one year, and allow for paper records.

11. Small Business Definition:

In response to comments in the last round, the FDA is now defining “very small business” in the facilities rule as businesses that gross $1 million or less.

“Very small businesses” that engage in only low-risk activities (as defined by FDA) will be exempt from having to develop a Hazard Analysis and Risk-Based Preventive Control plan. This is a very positive development that needs to be supported in comments to ensure that FDA maintains this position.

  • Tell the FDA that the new definition of a small business is an improvement.

 

The Cornucopia Institute thanks the Farm and Ranch Freedom Alliance and the National Sustainable Agriculture Coalition for their help and input with these comments.