Ag Water, Soil Amendments, Exemption Conditions Top List of FSMA Concerns

New federal regulations will likely bring big changes in how food is grown, harvested, packed, and processed in the U.S.; small farms and local and regional food systems will feel it too. The Food Safety Modernization Act, passed in 2011, is currently in the “rulemaking” stage: the U.S. Food and Drug Administration, as the responsible agency, drafts rules and offers them for public comment, before rewriting the rules to address those comments.

The OSU Small Farms Program will submit comments on two draft FSMA rules that matter most to Oregon’s small-scale, sustainable farmers and vibrant local food systems: the produce rule and the preventive controls rule. Comments on both are due September 16.

We strongly encourage all farmers – even if you think you are not covered by the rule or qualify for an exemption – to do the same. Keep in mind that these are still proposed rules, and different sectors of the food system disagree about the exemptions. Farms selling less than $25,000 of food per year are not covered by the produce rule. Farms selling more than that but less than $500,000 per year, with 51% directly to consumer or retail food establishments in the same state or within a 275 mile radius, may be partially exempt but must meet certain conditions and requirements. The rule governing food facilities (packers, handlers) contains similar exemptions.

As discussed, much remains unclear about the exemptions: how you qualify for them, how you can lose them, and how you might regain them.

FSMA Rule Summaries

The produce rule contains standards for growing, harvesting, packing, and holding produce for human consumption. It focuses on microbial contamination and creates standards for personnel qualifications and training; health and hygiene; agricultural water; biological soil amendments; domesticated and wild animals; growing, harvesting, packing, and holding; equipment, tools, buildings, and sanitation; sprouts; and traceability requirements.

The preventive controls rule applies to facilities that manufacture and process food for human consumption. The two major requirements are a hazard analysis and risk-based preventive controls and updated good manufacturing practices. In the draft rule, FDA lists a number of activities and facilities not covered by the rule, including specific low-risk activities by small and very small businesses; farm activities (as defined by FDA); and certain facilities that only store packaged foods or raw agricultural commodities for processing.

Both proposed rules contain exemptions for small-scale farms and businesses that sell primarily into local and regional markets.

For other details on rules and links to useful resources from FDA and other organizations, see the OSU Small Farms program and the Food Safety and Storage topic page in the top menus, or search "FSMA" on this site.

Issues to Watch

Here are some of the issues on which we plan to comment and/or ask for clarification:

Effects on Small Farms and Local Food Systems

The “Tester/Hagen” amendments to FSMA were written to assure that the Act is implemented in a risk-appropriate way. While all farms and food businesses, no matter the size or farming system, are responsible for food safety, “one size fits all” solutions are very likely to unfairly burden small, local farms without improving the safety of our food. FSMA – the legislation itself – therefore directs FDA to do the following:

  • Create scale- and risk- appropriate regulations for small farms serving local and regional markets;
  • Allow on-farm conservation and beneficial wildlife practices;
  • Complement, not contradict, organic standards;
  • Minimize extra regulations for low-risk, value-added processing.

However, analysis of the draft rules raises real concerns that these provisions for sustainable agriculture and local/regional food systems will not be honored.

First, farms and facilities that meet the conditions for “qualified exemptions” must still have traceability systems in place and meet other requirements. That is entirely reasonable and smart: all are responsible to assure food safety. Yet the exemptions are somewhat differently defined in each rule, and farmers that believe they are exempt from one may end up covered by the other – or different parts of their farms may be subject to one or the other rule, or even both.

Second, as the rules are written, the exemptions may be very easy to lose. Both rules contain an open-ended “material conditions” clause that gives FDA full powers to withdraw an exemption if “conduct or conditions associated with a farm that are material to the safety of the food that would otherwise be covered (non-exempt) produce grown, harvested, packed and held at such farm.” But what counts as a “material condition” remains very unclear.

As Steve Gilman, of the Northeast Organic Farming Association, wrote recently, “there are no mandated protocols, compliance timeframes or evidence requirements, while the burden of proof is placed completely on the accused farmer.”

Farmers who lose exemptions may have little recourse. As Gilman explains, a farmer may appeal to FDA, but the rules include “no depiction of what records can stand in as acceptable evidence when the farm was exempt from record-keeping to begin with.” Furthermore, the rules do not address how a farmer can regain an exemption, once the problem is solved – or FDA cannot show a problem. Finally, the rules appear to give FDA the power to withdraw exemptions for a large number of farms in an entire category of produce or production the agency believes might be risky.

Agricultural Water

The produce rule requires all agricultural water to meet EPA’s recreational water quality standards. Farmers must test their water to assure this. The proposed rule requires testing each water source as often as weekly during the growing season, depending on the source (see Table 1). Farmers and even state regulators are concerned about many aspects of the current agricultural water provisions.

First, the standard itself may not be achievable for many Oregon farmers. In public meetings with FDA about FSMA, farmers across Oregon were very concerned that their irrigation districts could not meet the water quality standard. Second, the required testing frequency will be a significant cost to farmers, yet current science is unclear about whether the pathogens farmers must test for are effective indicators for pathogens that cause food-borne illness.

As Jack Gray, of Wintergreen Farms in Noti, told FDA, “it’s clearly a little hard to stomach that we’ll now have to pay over $30,000 a year for the privilege of solving a problem that we don’t seem to have while also subtly chipping away at the foundation of the biological farming system that we have built.”

Third, the rule requires farmers to treat the source of their water to assure it meets the standard. Yet many farmers have little to no control over the source of their water, e.g., in irrigation districts. FSMA gives FDA no jurisdiction over irrigation districts.

Finally, if on-site treatment is a farmer’s only option to achieve the standard, many farmers may end up relying heavily on chlorine and other anti-microbial pesticides. Yet what effect will this have on soils, surface water and farm profitability, especially for ecologically integrated farming systems? The Environmental Protection Agency reports that “sodium and calcium hypochlorite are low in toxicity to avian wildlife, but they are highly toxic to freshwater fish and invertebrates.” This warning is included on Material

Safety Data Sheets. It is unclear what concentration of chlorine materials would be required and whether they are consistent with current NOP limits (4ppm chlorine or 800ppb chlorine dioxide).

From the Draft Produce Rule:

112.43 What treatment of agricultural water is required, and what requirements apply to treating agricultural water?

(a) You must treat any agricultural water that you use (such as with an EPA-registered antimicrobial pesticide product) if you know or have reason to believe that the water is not safe and of adequate sanitary quality for its intended use.

(b) Any method you use to treat agricultural water to satisfy the requirement in paragraph (a) of this section must be effective to make the water safe and of adequate sanitary quality for its intended use.

(c)(1) You must deliver any treatment of agricultural water required by paragraph (a) of this section in a manner to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use.

(c)(2) You must monitor any treatment of agricultural water at a frequency adequate to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use.

Other Issues

Soil amendments

The produce rule requires that crops cannot be harvested until 9 months after application of raw manure. This conflicts with the National Organic Program pre-harvest interval of 3-4 months depending on crop risk.

Worker training

Farms must train their workers in sanitation and hygiene. That makes good sense, but the draft rule provides few specifics about what will satisfy the regulation.

Science for alternatives

For some aspects of the rule (for example, treatment options to meet the agricultural water standard), farmers will be allowed to propose their own alternatives, as long as they can provide scientific back-up for the alternative practice. Yet many farming practices, long proven in the field, may never have been “proven” by peer-reviewed science. What will FDA accept as scientific back-up?

FDA has been hearing from farmers, food businesses, trade associations, consumer safety groups, and just about everyone else on all sides of the issue. Food safety does matter to everyone: how can we achieve it without sacrificing small, sustainable farms and local and regional food systems?

Farmers and local food businesses would be well advised to take the opportunity to weigh in on these rules that will affect them. Tell FDA what you think.

How to Comment to FDA

Comments on both the produce rule and the preventative controls rule are due to FDA by September 16. Thousands of comments have already been submitted. Submit yours and view other comments here.

ODA Also Wants to Hear From You

As the agency that will ultimately implement FSMA in Oregon, the Oregon Department of Agriculture is crafting its own comments for FDA and wants to hear from Oregon farmers. This is a good opportunity to let ODA know about small farm issues and concerns around FSMA. You can email ODA about FSMA at:

For More Information

  • National Sustainable Agriculture Coalition page
  • Small Farm program page, including comments from small farms and local food system stakeholders
  • Steve Gilman, Impact of FDA’s Food Safety Regulations on Farmers – and the Food Movement, Northeast Organic Farming Association

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