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
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.
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 firstname.lastname@example.org 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.