On March 8, 2019 the President signed into law S. 438, the Pesticide Registration Improvement Extension Act of 2018. Thus the PRIA fee for service program, which had lapsed as of February 19, 2019, is back in force. Presumably anyone who submitted an application since the lapse can if they wish withdraw and refile the application. If one does so, by paying the PRIA fee they would have a guaranteed decision date for their action. More details are expected as EPA implements the new law.
Despite both EPA and industry support, Congress failed to include a renewal of the Pesticide Registration Improvement Act (“PRIA”) in the budget adopted for EPA for the remainder of fiscal year 2019, ending September 30, 2019. PRIA is a fee for service program, under which applicants for pesticide registrations or amendments pay a specified fee for the type of action and in return are given a firm date by which the action can be expected to be completed. Originally enacted in 2004, this enactment would have been the fourth iteration of the program. The program added certainty to process that previously had been chaotic.
In its absence, EPA has advised industry participants that as of February 16, 2019, fees will be reduced by 70%, but no deadlines will apply to actions in question. All applications submitted prior to February 16 will still be subject to the PRIA decision times.
The Senate has passed a stand-alone re-enactment of PRIA, but is future remains uncertain. Until the picture becomes clearer, it might be the wiser course to refrain at the moment from filing any applications. If PRIA is re-enacted, it may retroactively cover filings during the lapse of the Act, but that is by no means a certainty.
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, 2018, was retroactive to December 21, 2019, 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 with pesticide program, one certainty is that acknowledgments of pesticide notifications are likely to be very long in coming.
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 the 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.
In a Final Rule published on December 28, 2015, EPA has revised its regulations to more clearly describe the active and inert ingredients permitted in products eligible for the minimum risk pesticide exemption (40 CFR 152.25(f)). EPA is doing this by codifying the inert ingredients list and reformatting the active and inert ingredients lists, adding specific chemical identifiers (through the use of Chemical Abstracts Service Registry Numbers), where available, for each eligible active and inert ingredient.
In addition, labeling requirements for minimum risk products have been revised so that producers of these products must list designated label display names of ingredients and producers must provide contact information on product labeling. The compliance date for the revised label requirements is February 26, 2019. In anticipation of this date, some states that require registration are expecting revisions to labels to be completed and submitted with a producer’s 2019 renewal.
We assist our clients with reviewing and updating minimum risk labeling and registering minimum risk pesticide products with state agencies. Please contact us if you need our assistance with ensuring your labels comply with new regulations and if you need assistance in submitting updated labels to states that require registration. https://enviroreg.com/contact-us/
The U.S. Environmental Protection Agency (EPA) announced on October 31, 2018, that it is extending the registration of dicamba until December 20, 2020, for “over-the-top” use to control weeds in fields for cotton and soybean plants genetically engineered to resist dicamba. This extension was made in response to EPA’s review of new information and thus determined that the continued registration of these dicamba products meets FIFRA’s registration standards and using these products under the new safety measures will not affect endangered species.
To ensure products can be used effectively and safely around sensitives crops and other plants, the following restrictions were made for the 2019-2020 growing season:
• Only certified applicators may apply dicamba over-the-top (those working under the supervision of a certified applicator may no longer make applications)
• Prohibit over-the-top application of dicamba on soybeans 45 days after planting and cotton 60 days after planting
• For cotton, limit the number of over-the-top applications from 4 to 2 (soybeans remain at two over-the-top applications)
• Applications will be allowed only from 1 hour after sunrise to 2 hours before sunset
• In counties where endangered species may exist, the downwind buffer will remain at 110 feet, and there will be a new 57-foot buffer around the other sides of the field (the 110-foot downwind buffer applies to all applications, not just in counties where endangered species may exist)
• Clarify the training period for 2019 and beyond, ensuring consistency across all three products
• Enhanced tank cleanout instructions for the entire system
• Enhanced label to improve applicator awareness on the impact of low pH’s on the potential volatility of dicamba
• Label clean up and consistency to improve compliance and enforceability
EPA’s Office of Pesticide Programs has released for public comment Atrazine Draft Human Health Risk Assessment.
To support Registration Review for atrazine, the Health Effects Division has evaluated the hazard and exposure data and conducted dietary, residential, aggregate, and occupational exposure assessments to estimate the risk to human health that will result from the registered uses of pesticides.
The Draft Risk Assessment includes updates to neuroendocrine effects using PBPK modeling and to drinking water exposure assessment; and completion of aggregate exposure assessments, non-occupational spray drift exposure assessment, and an occupational exposure assessment.
You may submit comments to EPA by September 24, 2018: https://www.regulations.gov/comment?D=EPA-HQ-OPP-2013-0266-1161
The EPA plans to host a webinar June 21st between 1-3 p.m. ET to focus on the effectiveness of disinfecting agents in hospitals. The EPA is seeking input from registrants of antimicrobial products and laboratory personnel with efficacy testing responsibilities. Additional details on the webinar can be found here. To register for the webinar, you can follow this link.
After the webinar, the docket EPA-HQ-OPP-2018-0265 at www.regulations.gov will be open for comments.
Yesterday, the EPA updated its Pesticide Label Review Manual to streamline its contents so that stakeholders can better comprehend the current policy regarding pesticide labeling process. Specifically, chapters 3: General Labeling Requirements, 7: Precautionary Statements, and 17: Net Contents/Net Weight were adjusted. Chapter 3: General Labeling Requirements was updated to reflect changes in EPA policy regarding the location of the First Aid Statement. Details of the changes to the mentioned chapters can be found here.
In an effort to reduce animal testing, the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) has released a draft Science Policy recommending the use of non-animal alternatives to skin sensitization testing. A Skin Sensitization test is used to evaluate whether a product causes an allergic reaction, inflammation or sensitization of the skin. The EPA currently requires submission or citation of skin sensitization data before a pesticide can be registered in the United States. This draft science policy was developed with the cooperation of several international organizations seeking valid alternative test methods and collaboration between EPA’s Office of Pesticide Programs and Health Canada’s Pest Management Regulatory. Substantive scientific evidence supporting the efficacy of the alternative methodologies compared to animal testing exists. Internationally, the alternative approaches highlighted in the draft policy have seen success in adoption and implementation. By adopting these alternative approaches, the EPA hopes to reduce animal testing. Public comment on the draft policy is open until June 9th, 2018. More information on the draft policy can be found here.