Regulatory Developments

EPA Withdraws Several Pesticide-Related Rulemakings from the Regulatory Agenda

May 7, 2018

On May 7, 2018, the U.S. Environmental Protection Agency (EPA) announced that it is withdrawing certain proposed rules for which EPA no longer intends to issue a final rule.  83 Fed. Reg. 20004. EPA notes that its withdrawal of these proposed rules does not preclude it from initiating the same or a similar rulemaking at a future date. Withdrawing the proposed rules officially terminates the ongoing rulemaking activities, allowing EPA to close out the individual entries for these rulemakings in EPA’s Semiannual Regulatory Agenda. Should EPA decide at some future date to initiate the same or similar rulemakings, EPA states that it will add an appropriate new entry to its Semiannual Regulatory Agenda to reflect the initiation of the action, and EPA will issue a new notice of proposed rulemaking.

Groundwater and Pesticide Management Plan Rule

On June 26, 1996, EPA issued a proposed rule to implement a key component of its 1991 Pesticides and Ground-Water Strategy. Through the development and use of State Management Plans (SMP), EPA proposed to restrict the use of certain pesticides by providing states with the flexibility to protect ground water in the most appropriate way for local conditions. Using the proposed SMP approach, EPA proposed to restrict the legal sale and use of five pesticides identified as either “probable” or “possible” human carcinogens -- alachlor, atrazine, cyanazine, metolachlor, and simazine. Because of their potential to contaminate ground water, EPA states that it determined that these pesticides may cause unreasonable adverse effects on the environment in the absence of effective management measures provided by a SMP. The proposed rule announced that the labels of these pesticides would be changed to require use in accordance with an EPA-approved SMP. The proposed rule also contained proposed revisions to pesticide labeling regulations to clarify general labeling requirements.
 
On February 23, 2000, EPA solicited public comments on additional information about metolachlor. Specifically, EPA sought comment on data it received pertaining to the products containing metolachlor, S-metolachlor, and R-metolachlor.

Why EPA Is Withdrawing the Proposed Rule

According to the notice, EPA delayed action on the proposed rule while it reconsidered the scope of the program to determine whether the program could be expanded to address water quality issues in addition to ground water, and to determine the best partnership approach to implementation.  More importantly, EPA states, it also reexamined the risk level associated with the named pesticides as part of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) reregistration process concluded in 2006. As part of that process, EPA determined that all five of the chemicals identified in the SMP proposal met the “no unreasonable adverse effects on the environment” standard for FIFRA registration without the steps identified in the proposed rule. EPA states that these reregistration determinations “necessarily mean that the rule is unnecessary to prevent unreasonable adverse effects on the environment,” and EPA is therefore withdrawing its proposed rule.

Registration Requirements for Antimicrobial Pesticide Products

On September 17, 1999, EPA proposed to establish procedures for the registration of antimicrobial products, as well as implement certain new provisions of FIFRA, as amended by the Food Quality Protection Act (FQPA). EPA also proposed to establish labeling standards for antimicrobial public health products to ensure that these products are appropriately labeled for the level of antimicrobial activity they demonstrate; to modify its notification process for antimicrobial products to conform to the statutorily prescribed process; and to exempt certain antimicrobial products from FIFRA regulation.  EPA proposed new procedures and provisions intended to streamline and improve the registration process, increase consistency and certainty for antimicrobial producers, reduce the timeframes for EPA decisions on antimicrobial registrations, increase public health protection by ensuring the continued efficacy of antimicrobial public health pesticides, and promote international harmonization efforts. EPA proposed to interpret the applicability of the new FIFRA definition of “pesticide” that excludes liquid chemical sterilants from FIFRA regulation and includes nitrogen stabilizers, and to describe requirements pertaining to use dilution labeling.  EPA states that it anticipated the proposed rule would provide technical, conforming, and organizational changes to portions of its regulations on pesticide registration and labeling for clarity and understanding.

Why EPA Is Withdrawing the Proposed Rule 

On December 14, 2001, EPA issued a final rule, entitled “Pesticide Labeling and Other Regulatory Revisions,” effective February 12, 2002, that revised certain labeling regulations for pesticide products for clarity and published an interpretation of FIFRA as it applies to nitrogen stabilizers. The final rule also revised regulations that contain statutory provisions excluding certain types of products from regulation as pesticides.
 
The 2003 Pesticide Registration Improvement Act (PRIA), which was reauthorized October 1, 2007, by the Pesticide Registration Improvement Renewal Act (PRIA 2), and reauthorized again on October 1, 2012, by the Pesticide Registration Improvement Act (PRIA 3), established deadlines and pesticide registration service fees for registration actions. The statues prescribe the category of action, the amount of the pesticide registration service fee, and the corresponding decision review periods by year.  According to the notice, these statutory enactments were intended to create a more predictable evaluation process for affected pesticide decisions, and couple the collection of individual fees with specific decision review periods.  They also promote shorter decision review periods for reduced-risk applications. EPA states that it now actively provides guidance for PRIA-driven streamlined regulatory determinations for most major pesticide registration actions that is applicable to all pesticide registration types, not just antimicrobial products.
 
According to EPA, the passage and implementation of PRIA and the implementation of EPA’s December 14, 2001, final rule regarding pesticide labeling and other regulatory revisions have rendered the remainder of what was proposed in the proposed rule moot. For these reasons, EPA is withdrawing the remainder of what was proposed in its proposed rule.

Exemption for Plant-Incorporated Protectants (PIP) Derived
through Genetic Engineering from Sexually Compatible Plants

On November 23, 1994, EPA proposed to exempt from FIFRA regulation PIPs (then called plant-pesticides) that are not likely to present new exposures to non-target organisms. EPA based its proposal on the assumption that if a plant typically produces a pesticidal substance, organisms that typically come into contact with the plant have likely been exposed to the substance in the past, perhaps over long periods of time. In defining those substances for which no new exposures would occur, EPA proposed to base its approach on the concept of sexual compatibility. EPA did not specify in the proposed rule that the genetic material of a PIP could be moved from the donor to the sexually compatible recipient plant, whether through conventional breeding or genetic engineering techniques.
 
On July 19, 2001, EPA issued a final rule exempting certain PIPs moved among plants in a sexually compatible population. EPA defined sexually compatible as meaning a viable zygote is formed only through the union of two gametes through conventional breeding. The final rule did not include the part of the proposal addressing PIPs that were moved among plants in a sexually compatible population through genetic engineering, but instead requested additional public comment on the issues raised by scientific information discovered since 1994, in public comment submitted in 1994, and by issues raised by the 2000 report of the National Academies of Sciences’ (NAS) National Research Council (NRC).

Why EPA Is Withdrawing the Proposed Rule

EPA states that it is withdrawing this proposed action because, as its experience with PIPs and greater scientific knowledge have increased, it has become evident that if EPA pursued an exemption for certain PIPs moved that were among plants in sexually compatible populations through genetic engineering, EPA should develop “more appropriate, scientifically current” criteria for describing the exempted PIPs, rather than relying on the criteria proposed in 1994.
 
EPA states that in 2001, it concluded that a high probability exists that PIPs that were moved between plants in sexually compatible populations through conventional breeding would not present novel exposures to nontarget organisms. Notwithstanding that conclusion, given the limitations of the modification techniques available at the time, EPA could not draw the same conclusion for PIPs moved between plants in sexually compatible plant populations through genetic engineering. In addition, EPA came to agree with the 2000 NRC report that recommended that “[g]iven that transfer and manipulation of genes between sexually compatible plants could potentially result in adverse effects in some cases … EPA should reconsider its categorical exemption of transgenic [plant-incorporated protectants] derived from sexually compatible plants.” According to the notice, the NRC report pointed out that EPA’s proposed language would exempt genetic material moved among plants in sexually compatible populations through genetic engineering without considering whether the moved genetic material would be expressed in the same pattern and at the same levels as occur naturally in the plant.  EPA states that its proposal “is not supported by a sufficient basis to finalize the proposed exemption, especially in light of the scientific developments that have taken place in the last decade.”
 
Recently, newer, more precise techniques of genetic engineering have been developed based on scientific discoveries since the 1994 proposal and the 2001 rule were issued. According to EPA, these developments will allow it to “craft criteria that are scientifically more current and that more accurately describe the PIPs that would be exempted as well as procedures to better ensure that all the PIPs in an exempted category meet the FIFRA section 25(b)(2) exemption standard.” Consequently, if EPA were to pursue such an exemption today, EPA would issue a new proposal based on knowledge of the types of products possible with the newest technology. EPA states that “[‌i]t is also worth noting that the Agency’s proposal to exempt certain types of pesticide products from regulation under FIFRA is entirely a discretionary action; there is no requirement in FIFRA that the Agency promulgate a regulation to exempt products that might satisfy the exemption standard in FIFRA section 25(b)(2).” EPA is therefore withdrawing the remainder of this proposal.

Exemption for PIPs that Act by Primarily Affecting the Plant

On November 23, 1994, EPA proposed, under FIFRA Section 25(b)(2), to exempt from most of the requirements of FIFRA those PIPs (then called plant-pesticides) that act primarily by affecting the plant under the assumption that such PIPs are less likely to be directly toxic to either target pests or to nontarget organisms. The proposed criteria describe PIPs that act primarily by affecting the plant as a pesticidal substance so that the target pest is inhibited from attaching to the plant, penetrating the plant, or invading the plant’s tissue in at least one of three ways: (a) the pesticidal substance acts as a structural barrier to attachment of the pest to the host plant, a structural barrier to penetration of the pest into the host plant, or a structural barrier to spread of the pest in the host plant; (b) the pesticidal substance acts in the host plant to inactivate or resist toxins or other disease-causing substances produced by the target pest; or (c) the pesticidal substance acts by creating a deficiency of a plant nutrient or chemical component essential for pest growth on/in the host plant.
 
EPA also indicated in 1994 that it was considering whether to extend the exemption to include substances such as plant hormones, because plant hormones act within the plant to “primarily affect the plant” and do not act directly on a target pest.
 
On July 19, 2001, EPA reopened the comment period on the proposed exemption to allow the public an opportunity to comment on the information, analyses, and conclusions pertaining to PIPs that act primarily by affecting the plant in the 2000 NRC report entitled Genetically Modified Pest-Protected Plants: Science and Regulation, and to comment on several risk issues raised in public comments on the 1994 proposal.

Why EPA Is Withdrawing the Proposed Rule

According to the notice, because of new scientific discoveries in the area of genetics and molecular biology, EPA has concluded that neither the original 1994 proposal nor the subsequent 2001 supplemental proposal presents a sufficient basis for making the statutory finding required under FIFRA Section 25(b)(2) to exempt this class of PIPs. EPA states that “[‌i]n essence, the more limited technological capabilities and understanding of science in 1994 led EPA to propose criteria for a generic exemption that current technologies and scientific understanding have rendered inappropriate.” While there may be some PIPs that act primarily by affecting the plant that would meet the FIFRA Section 25(b)(2) standard for exemption, EPA no longer considers its proposed criteria for a generic exemption to restrict fairly available products to only those that “are of a character which is unnecessary to be subject to” regulation under FIFRA. EPA is therefore withdrawing this proposal.

Commentary

True to his word, Administrator Pruitt is continuing his deregulatory mission and ridding the EPA Regulatory Agenda of initiatives for one reason or another as outlined above. Admittedly, some of the above noted rules seem a bit worse for the wear and the passage of time may well have rendered them moot or unnecessary, at least in their current form.  Whether the underlying reasons supporting the initiation of each proposal have been thoroughly addressed is another matter and the answer remains unclear. That scientific discoveries have occurred since a proposal has been issued does not necessarily moot the need for a new rule. Often such new information is addressed in a rulemaking by re-opening the record, not discontinuing the initiative. And whether these newly “closed out” initiatives will facilitate new rules under the “2 for 1” Executive Order 13771 is also unclear, as how the Office of Management and Budget actually applies the 2 for 1 mandate is one of life’s great mysteries. As noted, EPA could decide, Lazarus-like, that any of these closed out rules could return as a new proposed rule, but presumably only after two existing rules meet their demise.


 
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