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Insights into the Unified Regulatory Agendas of FDA, USDA, and EPA

October 24, 2018


U.S. Department of Agriculture (USDA) Secretary Sonny Perdue, speaking at an interagency cooperation and regulatory reform meeting. Photo credit: Lance Cheung, USDA.

U.S. Department of Agriculture (USDA) Secretary Sonny Perdue, speaking at an interagency cooperation and regulatory reform meeting. Photo credit: Lance Cheung, USDA.

The Trump Administration recently released a snapshot of upcoming regulatory changes: the “Fall 2018 Unified Agendas of Regulatory and Deregulatory Actions.” Among these, the Unified Agendas of the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), and Environmental Protection Agency (EPA) include major regulatory undertakings that will significantly impact the sustainable agriculture community. The National Sustainable Agriculture Coalition (NSAC) has analyzed the implications of these actions, and will carefully monitor their movement in the coming weeks and months.

Food and Drug Administration (FDA)

A glimpse into FDA’s future regulatory actions shows the possibility of revisiting a number of the Food Safety Modernization Act’s (FSMA) rules. A preliminary review suggests that FDA might reduce some of FSMA’s regulatory burden through changes to both the Produce Safety Rule (Produce Rule) and the Preventive Controls Rules.

Preventive Controls Rules

One future rulemaking NSAC will be looking for FDA to make will be to further clarify certain farm-related activities’ exemption from the Preventive Controls Rules. Farms are exempt from the Preventive Controls Rules if their activities fall under a “farm” definition, and some food/farm businesses may also be exempt if they can be considered a “qualified facility.” For more information on exemption qualifications, see NSAC’s resources: “Who is Subject to FDA’s New FSMA Food Facilities Rule? – Part 2” and “Understanding FDA’s FSMA Rule for Food Facilities.” The FDA plans to issue a proposed rulemaking on food facilities registration, which will include the farm definition, in the spring of 2019.

Produce Rule

FDA’s Unified Agenda also indicates a proposed rulemaking to reduce some of the requirements related to the Produce Rule’s commercially processed produce exemption. Any produce that will be commercially processed is exempt from the existing rule. However, in order to qualify for the exemption, a grower must: 1) provide the customer with documents stating the produce is not adequately processed; and 2) obtain a written assurance each year that the customer will ensure they or another entity will adequately process the produce.

While there are not specific details at this time on what changes might be made to the Produce Rule’s commercially processed exemption, the proposed changes to both the Preventive Controls for Human and Animal Food suggest that FDA will remove certain documentation requirements. Overall, farmers and other suppliers might see a reduction in their FSMA recordkeeping requirements if these proposed change are implemented in the near future. FDA is also extending the Produce Rule’s agricultural water provisions’ compliance dates. Produce farmers will have more time to meet the agricultural water requirements, as FDA considers changes to these provisions. No insight has yet been provided on when these proposed changes to the agricultural water provisions might be implemented. In the meantime, however, stay tuned for the November 2018 release of the new agricultural water requirements’ compliance dates.

Food Labeling

FDA’s future rulemakings will also address food labels. In 2019, FDA will revisit its definition of “healthy,” updating the label to incorporate current scientific nutrition information and the most recent federal dietary guidelines. The use of the term healthy on food labels is currently based on nutrition recommendations from the 1990s. FDA plans to rewrite the definition to include either: 1) the current Dietary Guidelines for Americans and other nutrient limits or 2) its 2016 Guidance Document on the Use of the Term “Healthy” in the Labeling of Human Food Products.

FDA will also consider revisiting the process for amending food products’ standards of identity, (aka, the name of the food product). The agency proposes revisiting the proposed rule issued in 2005 to determine the best strategy for “modernizing and updating” standards of identity. It is possible that that this process will eventually impact certain plant-based products’ standards of identity.

U.S. Department of Agriculture (USDA)

The regulatory revisions proposed by USDA cover a range of important issues, including conservation and nutrition, as outlined below.

Conservation Compliance

USDA’s section of the Unified Agenda contains a preview of a rulemaking to alter conservation compliance, which requires that farmers whose land includes highly erodible areas or wetlands must adhere to specific guidelines in order to be eligible for federal farm programs,. These requirements are in place to ensure that our shared natural resources have a minimum level of protection. Under conservation compliance rules, for example, farmers will only qualify to receive farm subsidies if they agree to apply an approved soil conservation system on all highly erodible land and to not drain wetlands.

The upcoming rulemaking in USDA’s Unified Agenda is specifically focused on the wetland provisions within conservation compliance, which prohibit producers from planting an agricultural commodity on a converted wetland or converting a wetland to make possible the production of an agricultural commodity. NSAC and our conservation partners have emphasized the importance of ensuring that wetland determinations are accurate and science-based, and we will once again do so in the upcoming comment period for this interim final rule.

Supplemental Nutrition Assistance Program (SNAP)

USDA also announced that it plans to conduct a rulemaking to revise “Categorical Eligibility” provisions in the Supplemental Nutrition Assistance Program (SNAP). SNAP, also known as food stamps, provides low-income families and individuals with critical nutrition support in the form of cash-like benefits that can be used to purchase staple foods from retail grocers and farmers markets. “Categorical Eligibility” is a component of the program that streamlines eligibility determinations by allowing individuals and families to automatically qualify for SNAP benefits if they have already qualified for another similar federal assistance program. This reduces paperwork for both recipients and for administering agencies.

The future rulemaking on SNAP categorical eligibility seeks to restrict whether or not families and individuals who receive assistance through Temporary Assistance for Needy Families (TANF) would automatically qualify for SNAP. TANF, created as part of President Clinton’s welfare reform efforts, is a block grant program that provides states with resources to implement benefits and services for needy families while helping to transition them from “welfare-to-work.”

Currently, qualifying for any type of TANF assistance, either cash benefits or a TANF-funded service allows that family to automatically qualify for SNAP. USDA’s proposed rulemaking would restrict categorical eligibility to apply only to those receiving “cash assistance or other substantial assistance from TANF.” This would exclude individuals benefiting from TANF-funded services, and would no doubt increase hunger nationwide. The timing of this proposal is also concerning for sustainable agriculture advocates who are keeping their eyes on the ongoing farm bill debates.

One of the major stumbling blocks to finalizing the next farm bill has been disagreement among farm bill negotiators regarding cutting food assistance benefits and introducing new work requirements to SNAP. USDA’s proposal to revise SNAP categorical eligibility provisions is likely to further delay and complicate the ongoing farm bill debate..

Environmental Protection Agency (EPA)

As the Trump Administration’s regulatory rollback agenda has advanced across all departments, EPA has suffered one of the most significant reductions in regulatory activities. NSAC and many others in the conservation and environmental communities have frequently voiced concerns that these actions jeopardize the effectiveness of EPA programs and open our shared natural resources to further damage and degradation.

Transparency in Science

One item on the Unified Regulatory Agenda of particular interest to the sustainable agriculture community is a delay to EPA’s proposal to limit the types of data used in regulatory decision-making. The proposal, Strengthening Transparency in Regulatory Science, was heavily criticized after its introduction in April 2018 by many in the scientific community who saw the move as an attempt to restrict the use of scientific data in policy decisions. Thanks to strong pushback by stakeholders, including NSAC member Union of Concerned Scientists, EPA has put off finalizing the rule until January 2020.

Farmworker Protections

Despite the 2015 strengthening of the Agricultural Worker Protection Standards (WPS), EPA will be reconsidering several requirements that provide baseline protection standards for farm workers exposed to pesticides. According to EPA, there are over 2 million farmworkers who mix, load, or apply pesticides on farms, nurseries, and greenhouses in the U.S. Advocates for farmworker health spent years urging EPA to revise and strengthen protections for these workers, and in 2015 many of their recommendations were incorporated into the updated regulations. Unfortunately, EPA now seems poised to attempt to weaken the WPS requirements.

One major issue with the proposed rulemaking is that EPA is attempting to reverse the WPS requirement that increased the minimum age requirement for workers handling pesticides to 18 years. The agency is also seeking to reduce buffer zones, also known as application exclusion zones, around fields treated with pesticides. The WPS update required employers to keep workers and others out of designated areas around the pesticide application equipment and treated area during a pesticide application. These requirements exempt owners of agricultural establishments and their immediate family. EPA intends to publish a Notice of Proposed Rulemaking for its revisions by January, 2019, with the final rule released in September 2019.

Clean Water Rule

Also included the Unified Regulatory Agenda is a proposal to redefine Waters of the United States (WOTUS). In 2017, the Administration instructed federal agencies to “rescind or replace” WOTUS (aka, the Clean Water Rule of 2015), which clarified waterways that are protected under the Clean Water Act of 1972. WOTUS faced significant backlash from Congress and several litigation challenges after its passage. In 2014, NSAC submitted comments to EPA in support of the rule, encouraging the agency to provide additional clarity for farmers instead of scrapping the changes altogether.

Earlier this year, the rule was suspended for two years – until February 2020 – to provide “certainty and consistency to the regulated community and the public.” A new definition is now being proposed for re-codification to include pre-2015 language. It is scheduled to become final in September 2019.

Next Steps

The Unified Agendas are a preview of what federal agencies plan to achieve in the coming year. Each agency has a different set of timelines for each rulemaking, which can be found in the agency links provided in each of the previous sections. For the proposed rulemakings, comment periods should be available for organizations and individuals to weigh in and make their thoughts heard on regulatory changes.

Depending on the timing, the planned regulatory changes in the Unified Agenda could also substantially affect or be affected by the outcome of the next farm bill. Stay tuned to NSAC’s blog for updates on opportunities for comment and further analysis.


Categories: Conservation, Energy & Environment, Food Safety, Nutrition & Food Access, Research, Education & Extension


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