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
For more information, see: https://www.epa.gov/ingredients-used-pesticide-products/registration-dicamba-use-genetically-engineered-crops
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
EPA has proposed revisions to the respirator descriptions when required on pesticide labeling and is requesting comments from regulators, registrants, pesticide users, safety educators and other stakeholders on the changes.
It is EPA’s goal to bring the respirator descriptions on pesticide labels into conformance with the current National Institute for Occupational Safety and Health (NIOSH) respirator language, delete outdated statements, and remove descriptions of respirators that no longer exist. Updated label language would ensure that pesticide handlers and their employers can easily obtain the information needed to identify and buy the proper respirator required for needed protection.
After considering comments, EPA will update Chapter 10, “Worker Protection Labeling,” of the Label Review Manual (LRM). After the chapter of the LRM is finalized, EPA will ask registrants submitting labels for other reasons to revise their personal protective equipment (PPE) statements to include the updated descriptions at the same time. Registrants who wish to revise only the PPE statements to incorporate the new respirator descriptions can do so by submitting a fast-track amendment with the changes. For existing products not otherwise updated, EPA will require the submission of labels with the revised descriptions of respirators during the registration review process.
The proposed label revisions can be found at Revised Respirator Section of Label Review Manual Chapter 10. Submit comments on the revised respirator section by email at email@example.com by June 11th, 2018.
The EPA extended the public commenting period for the proposed label revisions to June 11th, 2018 from May 22, 2018.
There has been much discussion among EPA, the states, and registrants on the placement of the First Aid Statement on pesticide product labels. In response, EPA announced the availability of a final guidance document that clarifies where this statement should appear on products labels. The guidance document is available at Docket# EPA-HQ-OPP-2016-0545.
In summary, EPA will continue to require that Toxicity Category I products have first aid statements visible on the front panel. EPA may allow certain exceptions when reviewed and approved by the Agency. Products that are considered Toxicity Categories II and III must have these statements on a front, back, side or inside panel (any panel). First Aid statements continue to be optional for Toxicity Category IV products.
Syngenta Seeds LLC (“Syngenta”), a subsidiary of Swiss agrochemical company Syngenta, reached a settlement with the EPA for violations of The Federal Insecticide, Fungicide, Rodenticide Act (“FIFRA”) Worker Protection Standard. In a Consent Agreement and Final Order (CAFO) document, Syngenta agreed to a civil penalty of $150,000 and to implement a Supplemental Environmental Project (SEP) costing no less than $400,000.
The administrative complaint filed against Syngenta alleged that seasonal workers were exposed to chlorpyrifos and permethrin before the restricted entry interval (REI) of 24 hours had passed, were not warned by Syngenta employees before entering, and were not properly decontaminated after the incident. Exposure events occurred on two occasions in 2016 and 2017. The matter came to EPA attention through a worker reporting adverse reactions after working in the Syngenta field. The complaint goes further stating that the warning sign that notifies workers of pesticide applications was folded up, obscuring its full view from the workers and Syngenta employees failed to verbally inform the workers to not enter the restricted areas.
The resulting SEP will develop and help promote use of Worker Protection Standard (WPS) Compliance Kits, and train employees on how to comply with FIFRA Worker Protection Standards. Due to most of the violations occurring in-house, the SEP will focus on training Syngenta’s full-time employees. While the CAFO does not explain how the EPA came to the $400,000 figure, it explicitly notes the $400,000 “shall not include the following categories of Respondent’s costs: Respondent’s overhead, Respondent’s additional employee time and salary, Respondent’s administrative expenses, Respondent’s legal fees, and Respondent’s costs of oversight of the contractor who will develop and implement the SEP.” More details of the CAFO can be found here.
EPA announced on February 28, 2018, the availability of three final test guidelines for antimicrobial pesticides:
1. OCSPP 810.2000 – General Considerations for Testing Public Health Antimicrobial Pesticides
2. OCSPP 810.2100 – Sterilants, Sporicides, and Decontaminants
3. OCSPP 810.2200 – Disinfectants for Use on Environmental Surfaces.
This guideline series, Series 810 – Product Performance Test Guidelines: Group B – Antimicrobial Efficacy Test Guidelines provides recommendations on the implementation of laboratory studies used to evaluate the effectiveness of antimicrobial pesticides used to help protect public health. More information and documents about the revision of the product performance guidelines can be found at www.regulations.gov, in docket EPA-HQ-OPP-2015-0276.
The Environmental Protection Agency is set to moderately increase the maximum civil monetary penalty for violation of the Federal Insecticide, Fungicide and Rodenticide Act (”FIFRA”) from $19,057 to $19,466 per violation through the 2018 Civil Monetary Penalty Inflation Adjustment Rule. While this adjustment represents a modest increase annually, it is important to note that it is a significant increase from the original civil penalty of $5,000.
Prior to 2015, EPA had adjusted penalties only occasionally. However, under the Federal Civil Penalties Inflation Adjustment Act Improvement Act of 2015, adjustments must now be made annually. The 2018 adjustment rule is the third annual update under the new approach.
As a result of the multiple adjustments which have now been made, multiple levels of FIFRA penalties are possible. To determine the penalty level applicable to an offense, one must first determine when the violation occurred and when the penalty is being imposed. Thus, a given violation which is repeated over a period of time could be subject to differing maximum penalty levels. More information can be found about how to accurately price open cases through the EPA’s 2018 guidance document found here.