By Barbara A. Christianson
On September 19, 2017, the U.S. Environmental Protection Agency (EPA) announced an update to Chapters 15 and 16 of the Office of Pesticide Programs’ (OPP) Label Review Manual.
Updates to Chapter 15: Company Name and Address, include removing non-label related instructions on submitting address change requests and updating the National Pesticide Information Center’s contact information, including new hours of operation. Updates to Chapter 16: Graphics and Symbols, include adding hyperlinks to graphic and logo examples and allowing a QR (Quick Response) code as an acceptable symbol when used only for retail pricing.
EPA states that the Label Review Manual, which began as a guide for EPA label reviewers, serves as a tool to assist registrants in understanding the pesticide labeling process and assists registrants in understanding approaches for how labels should generally be drafted. Pesticide product labels provide critical information about how to safely and legally handle and apply pesticides. EPA directs registrants to submit questions or comments on the Label Review Manual by using its Pesticide Labeling Questions & Answers -- Form.
By Heather F. Collins
On August 28, 2017, the U.S. Environmental Protection Agency (EPA) announced the first of three feature and functionality updates to the Pesticide Submission Portal (PSP) expected this year. The portal is a web-based application allowing registrants to submit pesticide application packages to EPA electronically. The PSP application is accessed through EPA’s Central Data Exchange (CDX) Network which requires user registration.
This new PSP, version 1.4, release expands the feature to allow users to submit voluntary data related to specific registration review cases. Users can submit study citations, data matrices (Form 8570-35), cover letters and studies (protocols, study profiles, supplemental study data) using the new "Voluntary Submission" link on the PSP home page. This new release also allows users to resubmit previously submitted 90-day responses. Once a 90-day response or data submission has been successfully transmitted to the Office of Pesticide Programs (OPP), users may now modify responses to data requirements, cite additional studies, upload additional documents, and change how the product registration is supported. EPA states: “This action is another step in a phased approach that will ultimately lead to EPA’s ability to accept all pesticide applications electronically, a move that will help modernize the pesticide registration process, increase operational efficiencies and reduce paper waste.” EPA indicates that in addition to these changes, this update introduces enhancements and bug fixes.
EPA also released the OPP Pesticide Submission Portal (PSP) User Guide Version 1.4 which provides detailed instructions on how to use the PSP application and guidance on how to prepare a package for electronic submission.
Applicants using PSP need not submit multiple electronic copies of any pieces of their applications; EPA states that the requirement to submit multiple copies of data in Pesticide Registration Notice 2011-3 is applicable only to paper submissions. Pesticide registrants who previously submitted information via paper, CD, or DVD may instead use the portal and forego the courier costs of sending to EPA.
More information about the Electronic Submissions of Pesticide Applications is available on EPA’s website.
By Susan M. Kirsch and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has announced that it will be hosting several events to gather input on regulatory actions that could be repealed, replaced or modified as part of EPA’s regulatory reform efforts under Executive Order (EO) 13777.
The Office of Pesticide Programs (OPP) will host a public meeting on the Pesticide Program Dialogue Committee (PPDC) on May 3, 2017, from 9:00 a.m. to 4:45 p.m. (EDT), and on May 4, 2017, from 8:30 a.m. to 12:00 p.m. (EDT). The session on May 4, 2017, will focus on receiving public feedback on pesticide regulatory reform issues. Registration will be required to attend the May 4, 2017, meeting only. Interested participants may register here. The deadline for registration is April 27, 2017.
The Office of Water (OW) will also host a listening session on May 2, 2017, from 11:00 a.m. to 2:00 p.m. (EDT) and participants may either pre-register here to join by phone (space limited) or join via web conference here. Pre-registration is not required for web participation. The deadline for registration is April 27, 2017.
In the pesticide space, EPA-OW is responsible for the National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit (PGP), which requires NPDES permitting for pesticide applications into, over and near “Waters of the United States,” including mosquito abatement activities. The U.S. Court of Appeals for the Sixth Circuit issued a 2009 decision requiring EPA to regulate pesticides under the NPDES program. Both industry and state co-regulators have criticized PGP requirements as duplicative, burdensome, and unnecessary for pesticides applied in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Attempts to pass legislation that would eliminate NPDES permitting for FIFRA-compliant pesticides applications have not been successful to date. EPA’s actions under EO 13777 may offer an administrative mechanism to repeal the PGP. It is unclear, however, if a repeal would be legally defensible in light of the Sixth Circuit ruling. Alternatively, EPA could modify the PGP to eliminate the reporting and recordkeeping requirements that opponents find overly burdensome. Pesticide stakeholders may wish to join the May 2, 2017, OW listening session to provide recommendations.
Written comments on regulatory reforms on all regulatory reforms, including OW and OPP issues, will also be accepted in docket EPA-HQ-OA-2017-0190, Evaluation of Existing Regulations, currently open through May 15, 2017. More details on the NPDES permit for pesticides are available in our blog item EPA Issues Final 2016 NPDES Pesticide General Permit.
By Lisa M. Campbell and James V. Aidala
On May 9, 2016, Jack Housenger, Director of the U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP), announced the selection of Anna Lowit for the Senior Science Advisor Position in OPP’s Immediate Office.
Lowit has been a toxicologist in OPP’s Health Effects Division since 1998. Housenger’s announcement of Lowit’s selection notes that she has “provided expert technical advice and guidance to senior management on issues related to toxicity testing, human risk assessment, and science policy issues,” and that she “provided substantial input to enhance science quality and ensured that scientifically accepted procedures and consistent criteria were applied, so that OPP’s risk assessments were recognized as reflecting the state-of-the-science.”
In light of the many current and expected issues involving fundamental science policy issues -- such as the application of the Food Quality Protection Act (FQPA) 10X safety factor, endocrine effects tests and their meaning, utilization of information from epidemiological studies, regulatory application of constantly evolving cancer assessment methodologies, and the appropriate approach to evaluating products of synthetic biology -- the Senior Science Advisor position is among the most important positions on the organization chart of OPP.
By Lisa M. Campbell and Timothy D. Backstrom
On February 10, 2016, the U.S. Environmental Protection Agency (EPA) announced it was initiating an external peer review of the updated draft protocol for testing the antimicrobial efficacy of copper-containing surface products. The products in question are hard surface copper-containing surface products such as door handles, light switch panels, and bed rails, which are utilized for their antimicrobial characteristics. EPA states that “the testing described in this draft protocol is designed to support registration of copper-containing surface products (such as door knobs or other items that are not intended for food contact) that bear sanitizer claims.” Numerous changes have been made to the draft, including changes to the test microbes, culture preparation, quality control process, and product characterization. Following completion of the review, EPA states that it will evaluate the findings and revise the draft as appropriate prior to posting the final protocol.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA evaluates the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health. EPA indicates that antimicrobial efficacy testing of copper-containing surface products poses challenges because of the prolonged product life span, the likelihood that cleaning and disinfecting agents would be used on the surfaces, and the wide variation in potential product forms and use patterns. EPA states the following regarding the protocols and how they will affect the test results:
- This protocol is designed to address these issues by including a product characterization component that challenges the product’s physical durability and chemical stability when used as proposed;
- The efficacy assessment component of the protocol involves evaluation of the performance of two product manufacturing lots against two pathogenic microorganisms -- Staphylococcus aureus and Pseudomonas aeruginosa; and
- The efficacy test results, in combination with the product durability/stability component, will be used to determine the sanitizing activity of the copper-containing surface.
More information is available on EPA’s Antimicrobial Pesticide Registration website. Information regarding other antimicrobial pesticide issues is available in our blog items EPA Posts Revised Antimicrobial Pesticides Use Site Index and EPA Releases Guidance Document: Antimicrobial Pesticides Use Site Index.
Products that are intended to have pesticidal efficacy over a protracted period require testing that differs materially from those pesticides that are only effective for a transient period and, thus, must be used repeatedly. Some believe copper-containing surfaces have great promise as antimicrobial sanitizers, particularly in health care environments where limiting patient exposure to potential pathogens has become a critical institutional concern. EPA’s enhanced test protocols are intended to address questions EPA and others have raised concerning the continued efficacy of a copper-containing surface over a prolonged life span, and the potential impact of cleaning and disinfecting agents.
By Lynn L. Bergeson and Lara A. Hall, M.S., RQAP-GLP
On January 9, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that it released a new draft guidance document in its effort to help expand the acceptance of alternative methods for acute toxicity testing. EPA states that the rapid advances in science and continual development of new technologies, it recognizes there is an increasing potential for the use of alternative methods in regulatory risk assessments.
EPA’s goals for alternative testing approaches include:
* Assessing a broader range and potentially more human-relevant adverse effects;
* Generating and reviewing data more quickly and less expensively; and
* Reducing use of laboratory animals in regulatory testing.
The draft guidance, Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies, describes the process for evaluating and implementing alternative methods of testing for acute oral, dermal, and inhalation toxicity, along with skin and eye irritation and skin sensitization. Additionally, there is a discussion of the three major phases of the process, and the implications for reporting information under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2). Successfully putting this process into place will require an open dialogue with stakeholders, other regulatory organizations, and the scientific community.
This draft guidance is one step in the application of OPP’s strategic vision for implementing the 2007 National Research Council report on Toxicity Testing in the 21st Century.
By Susan Hunter Youngren, Ph.D.
On October 15, 2014, the Office of Pesticide Programs (OPP) announced a voluntary program to document the effectiveness of agricultural pesticide spray application technologies on reducing pesticide spray drift. Under the Drift Reduction Technology (DRT) Program, agricultural equipment manufacturers would conduct (or make arrangements for a testing facility to conduct) studies to determine the percent drift reduction according to a verification protocol. Once completed, the manufacturer would submit the study to the U.S. Environmental Protection Agency (EPA) for review and evaluation. As verified, these reductions could then be quantitatively credited in the environmental risk assessments used to develop the drift reduction measures appearing on the label of the pesticide product. EPA will then review the manufacturers’ studies and, based on these data, it will assign spraying devices a rating on a four-star scale:
* Four stars: Device can reduce spray drift by 90 percent or more.
* Three stars: Device can reduce spray drift by between 75 percent to 89 percent.
* Two stars: Device can reduce spray drift by between 50 percent to 74 percent.
* One star: Device can reduce spray drift by between 25 percent to 49 percent.
* No stars: Device can reduce spray drift by less than 25 percent.
EPA allows pesticide manufacturers to include labeling on their products that contain dual-use instructions, one for farmers using devices that have received stars through the DRT program and another for those using devices that do not have a DRT rating.