Now that EPA is again operating, some signals are coming from the Agency as to how the pesticide work backlog will be addressed. Points of interest are:
>As to actions subject to the Pesticide Registration Improvement Act (“PRIA”) for which the decisions deadline fell during the shutdown, EPA intends to renegotiate the deadline with the applicant;
>the budget extender that runs through February 15 was retroactive to December 21 so actions submitted during the shutdown that fall within PRIA are subject to the full PRIA fee and the PRIA timeframes.
>Since reopening EPA has experienced a significantly increased volume of pesticide submissions and expects high submission volumes over the next two weeks because of the uncertainty around another shutdown.
Given the strained circumstances within pesticide program, one certainty is that acknowledgements of pesticide notifications are likely to be very long in coming. Given that certain states require require EPA confirmation of notifications, this logjam is likely to cause certain product changes to take months to implement.
The U.S. Senate recently confirmed the appointment of Alexandra Dunn as Assistant Administrator for Office of Chemical Safety and Pollution Prevention (“OCSPP”) at the U.S. Environmental Protection Agency (“EPA”). Ms. Dunn had most recently been a Trump appointee as EPA Regional Administrator for Region 1, based in Boston.
During Ms. Dunn’s confirmation process Senator Thomas Carper of Delaware raised issues related to the Agency’s regulation of chemicals, including the approach to the use of science in regulation. Most of the emphasis was on the Toxic Substances Control Act (“TSCA”) and the implementation of the related Frank Lautenberg Chemical Safety Act for the 21st Century. However, several significant pesticide policy issues were also raised, including use of science in reviews of pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), as well as regulatory issues related to worker protection and applicator certification. The Agency set forth its position on these issues in a letter from Acting Administrator Wheeler to Senator Carper.
On the science front, at issue was the science policy regulation proposed by OCSPP last April. See 83 Federal Register 18768 (April 30, 2018). The proposal, entitled “Strengthening Transparency in Regulatory Science” The stated overall aim of the proposal was to “ensure that the data and models underlying scientific studies that are pivotal to regulatory action are available to the public.” This change was proposed notwithstanding the fact that multiple Courts have found EPA’s existing practices in relying science to be legally acceptable. See American Trucking Associations v EPA, 283 F.3d 355 (2002.)
In fact the proposal raised significant alarm in the scientific community. Concern was expressed that rather than promoting sound science, the proposal would undermine EPA’s reliance on science because it would rule out otherwise valid studies whose underlying data was confidential. See for example a letter from the editors of four major journals, who objected to the proposed policy and EPA’s assertion that the policy was in line with the policies of the journals in question. http://science.sciencemag.org/content/360/6388/eaau0116 Acting Administrator Wheeler has now committed to having the proposed policy reviewed by the National Academy of Science. Although the outcome of such a process will be somewhat influenced by the charge which is given to the NAS in referring the issue, many critics are likely pleased by this outcome.
In the same exchange policy changes were also announced with respect to pesticide Worker Protection Standards and applicator certification rules. EPA had spent several years developing a new certified applicator rule, which was promulgated on January 4, 2017. See 82 Fed. Reg. 952.
The most controversial aspect of the rule changes was the imposition of a nationwide requirement that person applying restricted use pesticide must be at least 18 years of age. Notwithstanding an exemption for family members under 18 applying pesticides under the supervision of a family member, agricultural interests still pushed back on the age restriction. As a result EPA had proposed extending the effective date of the rule and reconsidering the age restriction. See 82 Fed. Reg.60196 (December 19, 2017). Mr. Wheeler has now announced that EPA will withdraw its proposed revisions from the Office of Management and Budget, and will not lower the age restriction nor designated representative provisions, another controversial aspect of the worker protection rule. Wheeler did state that there may reconsideration of the application exclusion zone (AEZ”) aspect of the worker protection rule, but if so would do so through a public notice and comment process.
The U.S. Environmental Protection Agency’s Office of Pesticide Programs has issued the following guidance to the registrants and producers of pesticides describing the impacts of the partial closing of the U.S. government, which includes EPA:
Due to the government shutdown, any submissions to EPA after December 28, 2018, will not be considered received or processed until after a change in EPA’s operational status for work to resume. Please note that the Pesticide Registration Improvement Renewal Act (PRIA 3) expired on December 21, 2018. Per phase out provisions described in FIFRA sec. 33(m)(2)(B), registration service fees for new applications received after that date will be reduced by 70% from the fiscal year 2017 levels. In addition, such applications will not be subject to the decision review time frames specified in PRIA 3. Pending a change in EPA’s operational status, applications received after December 21, 2018 will be subject to these new provisions, and applications received on or prior to December 21, 2018, will continue to be reviewed under the decision time frames specified in PRIA 3.
Aside from the obvious impact that work will not be performed while OPP employees are furloughed, the major impact will be on parties seeking new registrations or amendments to existing registrations. PRIA is a fee-for-service statute governing all major pesticide regulatory actions by EPA. Each covered action is assigned a review period and a processing fee. PRIA has added certainty to regulatory process, providing applicants with a firm decision date that facilitates regulatory and business planning. With PRIA now suspended, no deadline will apply to any applications filed during the closure, although a reduced fee will still apply. It is highly unlikely that many parties will continue with filings during this period, as there can be no estimate of when EPA might complete processing of the application.
A resolution of the closure will likely include the enactment of a new PRIA. Once PRIA is again operative, EPA will likely see a wave of applications filed, putting any application not subject to PRIA in further uncertainty. Depending upon EPA’s position on these applications once business resumes, parties who filed during this period of ambiguity may want to consider refiling in order to become subject to the new PRIA.
The budget bill which passed the House on March 22 contains the Rohrabacher (R-CA)-Blumenauer (D-OR) amendment, which prohibits the expenditure of Federal funds to take any enforcement action against anyone acting in compliance with a state medical marijuana program. Enactment by the Senate and signing by the President is anticipated. Assuming enactment the protection will continue until September 30, 2018, the end of the Federal fiscal year. Efforts by the Colorado delegation to extend protection to state recreational marijuana programs failed.
In a win for Monsanto Co. and U.S. farmers, California’s proposed labels warning that glyphosate is a cancer-causing chemical were suspended. Commonly sold under the moniker “Roundup”, glyphosate is the widely used herbicide in agriculture and is extensively used by consumers. In 2015, the International Agency for Research on Cancer (IARC) listed glyphosate as “probably carcinogenic,” triggering California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). Proposition 65 requires businesses to inform consumers of products that contain chemicals known to cause cancer or birth defects.
While the IARC listed glyphosate as being “probably carcinogenic,” multiple organizations including the EPA have come out against the IARC, stating there is no evidence that glyphosate is carcinogenic.
The U.S. Environmental Protection Agency announced an agreement with Amazon Services LLC to settle allegations that Amazon committed nearly four thousand violations of the Federal Insecticide, Fungicide and Rodenticide Act, including selling and distributing imported pesticide products that were not registered for sale in the United States. In addition to paying a penalty of $1,215,700, Amazon will develop a multi-language online training course on pesticide regulations available to the public and marketers. Amazon will require that all marketers that are planning to sell pesticides on their website complete this training course.
For more information go to https://www.epa.gov/enforcement/amazon-services-llc-fifra-settlement.