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 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.
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.