By Lynn L. Bergeson and Carla N. Hutton
The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.” The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE organisms. APHIS requested comment on issues to be considered in preparing the EIS, as well as how to define the scope of the alternatives and environmental impacts. Comments are due July 30, 2018.
Our full memorandum provides some background, context, and a commentary regarding APHIS’ announcement.
By Carla N. Hutton and Jessie Nguyen
On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan. OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.” Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) that are related to pesticides:
- Pesticides; Expansion of Crop Grouping Program (RIN 2070-AJ28): EPA is revising in phases the current pesticide crop grouping regulations to create new crop groupings, add new subgroups, and expand existing crop groups by adding new commodities. EPA plans to propose a fifth phase by February 2019 and a sixth phase by August 2019;
- Pesticides; Procedural Rule Amendment; Requirement for Certain Pesticide Actions to Publish Notices in the Federal Register (RIN 2070-AK06): EPA is considering revising several procedural regulations that require it to use a notice published in the Federal Register “to provide information and notice concerning registration of a pesticide product with a new active ingredient or new use; announce approvals of specific quarantine and public health exemptions; and summaries of certain state registrations.” Instead, EPA would provide the same information on a consolidated website. EPA plans to issue a notice of proposed rulemaking (NPRM) in September 2018;
- Pesticides; Certification of Pesticide Applicators Rule; Reconsideration of the Minimum Age Requirements (RIN 2070-AK37): In spring 2017, EPA solicited comments on regulations that may be appropriate for repeal, replacement, or modification. EPA states that it received comments specific to the January 4, 2017, certification rule and has decided to reconsider one requirement of the final rule. EPA intends to publish an NPRM in September 2018; and
- Pesticides; Agricultural Worker Protection Standard (WPS); Reconsideration of Several Requirements (RIN 2070-AK43): As reported above, in spring 2017, EPA solicited comments on regulations that may be appropriate for repeal, replacement, or modification. EPA received comments suggesting specific changes to the 2015 revised WPS requirements. Based on comments raised, EPA intends to publish an NPRM in September 2018.
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 Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda. The U.S. Environmental Protection Agency’s (EPA) Agency Rule List included several pesticide rulemakings in the proposed rule stage, as well as the Certification of Pesticide Applicators rulemaking that is in the final rule stage. The five items in the proposed rule stage are:
- RIN 2015-AA00: Revision of Procedural Rules for Hearings on Cancellations, Suspensions, Changes in Classifications, and Denials of Pesticide Registrations. The agenda states that this proposed rulemaking is a “revision of the Rules of Practice governing the conduct of licensing adjudications under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).” The issuance of the proposed rule is scheduled for January 2018.
- RIN 2070-AK00: Pesticides; Technical Amendments to Data Requirements. The agenda states that to satisfy one of the commitments in a settlement agreement reached with the American Chemistry Council (Docket ID Number EPA-HQ-OPP-2008-0110-0139), EPA is proposing a correction pertaining to the 200 parts per billion (ppb) level described in 40 C.F.R. Section 158.2230(d) that was originally used by the U.S. Food and Drug Administration with respect to the “concentration of residues in or on food for tiering of data requirements for indirect food use biocides.” Through this rulemaking, the agenda states that EPA intends to “clarify that the 200 ppb level is based on total estimated daily dietary intake for an individual and not on the amount of residue present on a single food.” The issuance of the proposed rule is scheduled for July 2017.
- RIN 2070-AK06: Pesticides; Procedural Rule Amendment; Requirement for Certain Pesticide Actions to Publish Notices in the Federal Register. In the agenda, EPA states that as the as the Federal Register is “no longer the most cost effective or efficient way for providing notice or sharing information with the public,” it is considering changing the way that it provides notice on or shares information with the public -- specifically, by no longer publishing certain information in the Federal Register, but instead providing the same information on a consolidated website which the agenda states “will be more accessible to the public and other interested parties, as well as a more cost effective and efficient mechanism for providing timely updates.” The agenda lists the following kinds of notification it is considering making this change regarding: (1) reregistration of a pesticide product with a new active ingredient or new use; (2) announcing approvals of specific, quarantine and public health exemptions; and (3) Summaries of certain state registrations. For Registration Review, the agenda state that EPA “intends to announce availability of the documents that are currently announced in the Federal Register on the EPA's Registration Review Website.” For notices of availability announced in the Federal Register, the agenda states that “EPA intends to direct the public to a case-specific docket on Regulations.gov to view pertinent registration review documents and provide comment.” The issuance of the proposed rule is scheduled for April 2018.
- RIN 2070-AK40: Extension of Compliance Date(s); Agricultural Worker Protection Standard. As reported in our memoranda summarizing the Worker Protection Standard (WPS) final rule, EPA Publishes Worker Protection Standard Final Rule, the WPS final rule was issued on November 2, 2015, but has not yet been made effective. More information on the delay of its effective date is available in our blog item EPA to Delay Agricultural WPS Indefinitely; Cites Issues with Guidance and Training. This proposed rulemaking will adjust the compliance date. The issuance of the proposed rule is scheduled for July 2017 and the issuance of the final rule is scheduled for November 2017.
- RIN 2080-AA13: Updates to 40 C.F.R. § 26 Subpart K to reflect recent changes to 40 C.F.R. Subpart A (The Common Rule). As reported in our blog item Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects, on January 19, 2017, EPA, together with a host of other federal agencies, released a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991, and is now codified in 40 C.F.R. § 26, Subpart A. These revisions, scheduled to become effective on January 19, 2018, will create a conflict within some of the EPA-specific subparts, in particular, Subpart K of 40 C.F.R. 26 (Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intention Exposure of Non-Pregnant, Non-Nursing Adults) which regulates third party pesticide research. The agenda states that this proposed rulemaking is “intended to resolve proposed rulemaking discrepancies created by the recent revision to Subpart A, and will not alter the fundamental protections for human subjects, including vulnerable populations.” The issuance of the proposed rule is scheduled for January 2018.
The two items in the final rule stage are:
- RIN 2070-AJ20: Pesticides; Certification of Pesticide Applicators. As reported in our memoranda summarizing the Certification of Pesticide Applicators’ final rule, Final EPA Rule Requires Stronger Standards for Applying Riskiest Pesticides, the final rule was issued on January 4, 2017. More information on the delay of its effective date is available in our blog item EPA Delays Effective Date of Certification of Pesticide Applicators Final Rule. On June 2, 2017, a Federal Register publication was issued that delayed the effective date until May 22, 2018.
- RIN 2070-AK13: Procedural Rule to Remove Obsolete Information. The agenda states that this final rule will remove information from EPA’s existing pesticide regulations that is now out of date or obsolete and will “provide clearer and more reliable information to those seeking to register a pesticide product.” The agenda further states that as rulemaking is intended to be a non-substantive, procedural rulemaking “since the EPA does not intend to make any substantive changes to the existing requirements,” EPA is considering issuing this as a final rule and not going through the notice and comment period. The issuance of the final rule is scheduled for January 2018.
Much of the work noted emphasizes potential procedural efficiencies and clarifications. The potential move to more announcements on the websites and away from the Federal Register is, at least in part, likely intended as a cost-saving measure. It is also a change that will be closely watched. For example, in recent years, EPA has seen registrations challenged based on assertions of an alleged lack of appropriate notice concerning the receipt or processing of registration applications, and these past challenges will likely influence any new procedures that EPA may adopt.
Of more interest is the new Administration’s call for suggestions of what rules or policies should be changed as part of a broader push for economic growth and less regulatory costs, which may result in more substantive regulatory changes and some likely controversial decisions about what rules or programs will be modified or eliminated -- but that exercise is not part of this announcement. The delay in the compliance date for the WPS regulation is more substantive, but changes that may be proposed have not yet been announced.
By Lynn L. Bergeson and Margaret R. Graham
In June 2017, the U.S. Environmental Protection Agency (EPA) issued a draft Office of Chemical Safety and Pollution Prevention (OCSPP) National Program Manager Guidance for Fiscal Year (FY) 2018-2019, which sets forth the strategies and actions that EPA and its state and tribal partners will undertake to protect human health and the environment via six key programmatic activities. EPA uses an Annual Commitment System (ACS) to track annual regional performance information and results. Below is a listing of the six programmatic activities and their ACS measures, if applicable:
- Strengthening state and tribal partnerships through continued effective management of pesticide cooperative agreements. The guidance states that the “National Pesticide Program depends on cooperative agreements with states and tribes to implement many of the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and to help ensure [EPA’s] regulatory decisions and programs achieve intended protections. For the ACS measure, the commitment target is 100 percent of pesticide program required activities included in grantee work plans completed under pesticide program portion of the FIFRA Grant Guidance. More information on the activities is listed in the guidance.
- Assisting in national, regional, and local pollinator protection efforts. EPA states that “through risk assessment, mitigation, education, and outreach, EPA’s Office of Pesticides Programs’ goal for pollinator protection is to ensure all pollinators, including managed pollinators such as honey bees, and native pollinator including Monarch Butterflies, are protected from adverse effects of pesticide exposure.” More information on the activities is listed in the guidance. EPA is not proposing any ACS measures to be associated with this area of focus for FY2018-2019.
- Effectively implementing the revised pesticides worker protection standard rule. More information on this rule is available on our blog under key phrase Worker Protection Standard. EPA states that no ACS measure is proposed to be associated with this area of focus for FY2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.”
- Effectively implementing the revised certification of pesticide applicators rule. Same as above, EPA states that no ACS measure is proposed to be associated with this area of focus for FY2018-2019 to “allow regional offices the flexibility to direct their efforts where they are most needed, and to select the activities and level of effort appropriate for the needs of their region.” More information on this rule is available on our blog under key phrase pesticide applicators.
- Focusing region-specific pesticide priorities on those areas of greatest need nationally. EPA states that region-specific pesticide priority areas “support the agency’s national pesticide program efforts. In addition, these projects support one or more of the agency’s Strategic Plan goals and strategies, and directly benefit states and/or tribes. The region-specific pesticide priority areas to choose from are: (1) promotion of state and tribal pesticide program coordination and communication; (2) bed bug outreach and assistance; (3) promotion, development or support of integrated pest management efforts; (4) support of water quality risk assessment and mitigation; (5) spray drift outreach and incident data collection; and (6) support of emerging public health pesticide issues. The ACS measure commitment target is one project or initiative contributing to the implementation and enhancement of the region-specific pesticide program priority areas.
- Toxics Release Inventory (TRI). For the TRI program, EPA includes three ACS measures on the number of TRI data quality checks:
- The TRI-1 measure allows EPA to track performance of the TRI program, and aid in improving the accuracy and reliability of environmental data. This measure will provide valuable information as more than 21,000 facilities report to the TRI program annually.
- For FY2018, TRI-1 is a non-commitment measure of data quality calls and emails to 600 facilities in total across all regional offices.
- For FY2019, TRI-1 will be a commitment measure of data quality calls and email to 600 facilities in total across all regional offices.
By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham
In a two-page order issued on April 10, 2017, the U.S. District Court for the Middle District of North Carolina granted in part a motion for summary judgment filed by “me-too” registrants, Willowood, LLC, Willowood USA, LLC, Willowood Azoxystrobin, LLC, and Willowood Limited (Defendants), regarding Syngenta Crop Protection, LLC’s (Plaintiff) claims of copyright infringement. Syngenta Crop Protection, LLC v. Willowood, LLC, Case No. 1:15-CV-00274. The claims at issue (Counts V and VI of Plaintiff’’s complaint) were based on the Defendants’ use of Syngenta’s label. The court stated that it was granting this part of Defendants’ motion “because the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) precludes copyright protection for the required elements of pesticide labels . . . of me-too registrants.”
Counts V and VI of Plaintiff’s complaint stated that Defendant copied and used substantial portions of Syngenta’s copyrighted work, and that this infringement is “willful and knowing.” The Defendants’ motion for summary judgment stated with regard to the copyright infringement counts of the complaint:
- Counts V and VI fail as a matter of law because Defendants’ labels comply with applicable federal regulations and contain language that is mandated by federal law. Moreover, under settled law, the portions of Plaintiff’s labels that Plaintiff asserts Defendants have copied are not entitled to federal copyright protection. Finally, to the extent that any portions of Plaintiff’s labels are entitled to copyright protection, Defendants’ copying is permitted under the fair use doctrine.
The order states that “in enacting FIFRA, Congress intended narrow exception to copyright protection for the required elements of pesticide labels as against me-too registrants.” The court expressly rejects the lengthy 2005 decision issued by the District Court for the Eastern District of Pennsylvania, which reached a different conclusion in a similar case, stating that it finds the analysis in that decision “unconvincing.” FMC Corp. v. Control Solutions, Inc., 369 F. Supp. 2d 539, 555-71 (E.D. Pa. 2005). The court states: “FIFRA contemplates that a ‘me-too’ applicant will copy from the original pesticide label in ways that would otherwise infringe a copyright.”
Of interest, the court states that its grant of the summary judgment motion with respect to the copyright claims does not need to take into account an expert report or declarations by, among others, former EPA Office of Pesticide Programs (OPP) officials Debra Edwards and Lois Rossi, filed by Defendants because “the Court is granting the summary judgment motion on legal grounds unrelated to the proffered evidence.”
Plaintiff filed its complaint on March 27, 2015. The complaint included seven counts against Defendants: the infringement of four patents in violation of 35 U.S.C. § 271(a) (Counts I-IV), the two copyright infringement counts (Counts V-VI), and a violation of the Unfair and Deceptive Trade Practices Act (N.C. Gen. Stat § 75-1.1) (Count VII). Count VII of the complaint was dismissed on August 12, 2016, and on March 24, 2017, the court granted Plaintiff’s motion for summary judgment regarding the infringement of two of the four patents; a decision on the infringement of the remaining two patents is still pending.
This opinion, which squarely rejects the 2005 conclusion of another district court, is likely to be of controversy and is the most recent decision in a long-standing debate on this issue between basic registrants and me-too registrants. EPA in the past has appeared to side with the me-too registrants. For example, in an August 3, 2005, letter to the Chemical Producers and Distributors Association (CPDA), written in response to the FMC decision, EPA stated that it “has been the practice of [OPP] since the enactment of FIFRA section 3(c)(7)(a) in 1978 to strongly encourage ‘me-too’ product labels to be identical or substantially similar to the labels of the products on which their registrations are based.” In that letter, EPA stated further: “Conveying application instructions and safety messages for similar products in different ways increases the likelihood that the product will be misused.” EPA at the time noted that there were over 650 mostly “me-too” products for just one herbicide (2,4,-D) -- and that having 650 products each having to say some of the required use instructions differently would be impossible.
Nonetheless, some elements of the label might be viewed as proprietary -- the “look and feel” of a product label, perhaps certain fonts, and trademarked product name (as opposed to the active ingredient name). It remains to be seen whether the April 10, 2017, order is the last judicial word on this subject or whether the issue will continue to be litigated. It is an issue that all registrants should monitor closely.
By Susan M. Kirsch
On November 1, 2016, the U.S. Environmental Protection Agency (EPA) published its Final National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit for Point Source Discharges from the Application of Pesticides in the Federal Register, which regulates discharges to waters of the United States from the application of biological pesticides and chemical pesticides that leave a residue. 81 Fed. Reg. 75816. The 2016 NPDES Pesticide General Permit (PGP) replaces the 2011 PGP, which expired on October 31, 2016. The PGP applies to the following geographic areas where EPA serves as the NPDES permitting authority:
- The States of: Massachusetts, New Hampshire, New Mexico, and Idaho;
- District of Columbia;
- All U.S. territories except the U.S. Virgin Islands;
- Federal facilities in Delaware, Vermont, Colorado, and Washington;
- Discharges in Texas that are not under the authority of the Texas Commission on Environmental Quality, including activities associated with oil and gas exploration (see Appendix A of the Final 2016 PGP for further description); and
- All areas of Indian Country that are not covered by an EPA-approved permitting program (see Appendix A for Indian Country covered within each EPA Region).
Similar to the 2011 PGP, the 2016 PGP contains additional permit conditions and modifications that some states and tribes added through the Clean Water Act (CWA) Section 401 certification process and/or the Coastal Zone Management Act process. Part 9 of the 2016 PGP provides a detailed breakdown of any additional requirements. Forty-six states have delegated authority to administer state versions of the PGP. The majority of states recently revised and reissued their respective state PGPs for another five-year permit cycle.
The 2016 PGP applies to the same pesticide use patterns covered by the 2011 PGP, which are:
- Mosquito and Other Flying Insect Pest Control -- control of public health/nuisance and other flying insect pests (including mosquitoes and black flies) that develop or are present during a portion of their life cycle in or above standing or flowing water.
- Weed and Algae Pest Control -- control of weeds, algae, and pathogens that are pests in water and at water’s edge, including ditches and/or canals.
- Animal Pest Control -- control of animal pests, including fish, lampreys, insets, mollusks, and pathogens, in water and at water’s edge.
- Forest Canopy Pest Control -- application of a pesticide to a forest canopy to control the population of a pest species (e.g., insect or pathogen) where, to target the pests effectively, a portion of the pesticide unavoidably will be applied over and deposited to water.
The 2016 PGP requirements are nearly identical to those in the 2011 PGP, with the exception of the following two updates included in the 2016 PGP:
- Electronic reporting (Part 7.8) -- All reporting under the 2016 PGP (i.e., Notice of Intent (NOI), Annual Report, and Notice of Terminations (NOT) submissions) must be submitted via EPA’s eNOI system to be consistent with EPA’s Electronic Reporting Rule. EPA will make these reports publicly available through a searchable index tool -- eNOI search. More information on electronic reporting, and access to the Central Data Exchange for NOI, Annual Report, and NOT submissions is available here.
- Updated definition of the National Marine Fisheries Service (NMFS) Listed Resources of Concern -- Following consultation between EPA and NMFS, as required under Section 7 of the Endangered Species Act (ESA), EPA expanded the Listed Resources of Concern to include additional species not included in the 2011 PGP definition. Under Part 126.96.36.199, pesticide discharges that overlap with NMFS Listed Resources of Concern trigger additional NOI requirements to certify that the discharges and discharge-related activities are not likely to adversely affect federally listed “endangered” or “threatened” species, or federally-designated “critical habitat.” Permittees may consult EPA’s PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool to determine whether a discharge activity will overlap with these Resources of Concern. Appendix I provides endangered species instructions for affected permittees. EPA states in the corresponding Fact Sheet for the 2016 PGP that it continues to estimate that less than two percent of the total number of Operators in the PGP coverage areas will need to meet additional permit requirements in order to meet ESA-related provisions.
The 2016 PGP permit conditions went into effect on October 31, 2016, and the PGP will expire in five years on October 31, 2021. 2016 PGP coverage is automatic through January 12, 2017, without the submission of an NOI, but pesticide Operators (i.e., pesticide applicators) must comply with all 2016 PGP conditions as of October 31, 2016. For any discharges commencing on or before January 12, 2017, that will continue after this date, a decision-maker must submit an NOI no later than January 2, 2017, to ensure PGP coverage, and for any discharges subsequent to January 12, 2017, an NOI submission is required no later than 10 days before the first discharge. Table 1-1 at Part 1.2.3 outlines which decision-makers must submit NOIs based on the particular pesticide use pattern, location (i.e., if discharging to a designated Outstanding National Resource Water), and acreage thresholds. Table 1-2 at Part 1.2.3 provides applicable NOI submission deadlines, including grace periods for NOI filing for discharges in response to a Declared Pest Emergency.
EPA’s webpage for pesticide NPDES permitting includes links to the final 2016 PGP, a related fact sheet, the permitting decision tool, and information on eNOI and ESA procedures.
Although the 2016 PGP largely mirrors the 2011 version of the permit, it will be important for decision-makers to familiarize themselves with the new electronic reporting requirements (Part 7.8). EPA’s eNOI system is publicly searchable and could subject PGP permit holders to additional scrutiny by citizens and advocacy groups concerned about potential environmental and public health implications of pesticide applications in their areas. Decision-makers should consult EPA’s PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool and the Alternative PGP Sources of Information for NMFS Listed Resources of Concern to determine where discharges may overlap with these areas and trigger additional permit conditions.
By Lisa R. Burchi and Margaret R. Graham
On September 2, 2016, the U.S. Environmental Protection Agency (EPA) issued guidance to registrants on the process for making claims against emerging viral pathogens not on EPA-registered disinfectant labels (Guidance). A draft of this guidance was issued in April 2016 and comments were sought at that time. More information concerning the draft guidance is available in our blog item EPA Combats Emerging Pathogens Through Updating Guidance for Antimicrobial Pesticide Products.
The current Guidance document, which EPA states “provides general guidance to registrants that can be used to identify effective disinfectant products for use against emerging viral pathogens and to permit registrants to make limited claims of their product’s efficacy against such pathogens,” includes changes incorporated following EPA’s review of the three public comments received in response to that draft.
The Guidance retains the voluntary two-stage process, but amends the first stage as indicated:
- In the first stage, which may be performed prior to any outbreak, registrants with an eligible disinfectant product may submit a request, via label amendment or during the registration of a new product, to control a specific emerging viral pathogen to add a designated statement to the master label and additional terms to the product registration. If the product meets the eligibility criteria suggested in this Guidance, [EPA] generally will approve the amendment. Approval of the amendment would include additional terms and conditions of registration regarding how the designated statement may be published and communicated.
In its response to comments document, EPA responded to several comments, including:
- Changes were made to EPA’s mandated non-label statements to remove certain language that could be considered redundant.
- EPA is developing a coordinated process with the Centers for Disease Control and Prevention for the purpose of providing a more standardized and consistent approach to emerging viral pathogen outbreaks. Once this process is established, the agency expects to consult with the U.S. Department of Agriculture to develop a similar approach.
- The Guidance document allows for the addition of emerging pathogen claim language to the master label during the new product registration process if the product is eligible. Additional language has been added to multiple locations in the Guidance document to clarify that the process is appropriate for new product registrations.
- EPA “may consider allowing use of additional modes of claim communication under future versions of this Guidance document, however, hangtags and other promotional materials are not authorized at this time. Because the statements authorized under this Guidance are pesticidal claims that do not meet the FIFRA registration criteria, it is essential that these off-label claims are not made outside of an emerging pathogen outbreak as described in the Guidance. Accordingly, the Guidance limits these off-label claims primarily to communications outlets that are wholly within the registrant’s control (800 numbers, social media and websites) from which the off-label claims can be immediately removed. Hangtags and other promotional materials directed towards general consumers are largely out of the registrant’s control once the products enter the chain of commerce, and may persist long after the period during which the off-label claims are authorized.”
EPA also notes that this Guidance document “provides general guidance to EPA, pesticide registrants, applicants for pesticide registrations, and the public. This guidance is not binding on EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice.”
By Lisa M. Campbell and Lisa R. Burchi
In response to the increasing concerns regarding emerging viral pathogens that are not on U.S. Environmental Protection Agency (EPA)-registered disinfectant labels, EPA announced on April 7, 2016, that it was updating its Guidance regarding emerging viral pathogens. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is authorized to evaluate the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health. Many believe that the process under which registrants can identify “effective disinfectant products for use against emerging pathogens,” and the process for EPA to “permit registrants to make limited claims of their product’s efficacy against such pathogens,” have not been clear and efficient. EPA notes, for example, that “[emerging] pathogens are often unavailable commercially, and standard methods for laboratory testing may not have been developed,” such that it “can be difficult to assess the efficacy of EPA-registered disinfectants against such pathogens in a timely manner and to add these viruses to existing product registrations.”
EPA hopes that its Guidance will “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens associated with certain human or animal disease outbreaks.
EPA’s new draft Guidance document, Draft Guidance to Registrants: Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels, describes “a voluntary two-stage process to enable the use of certain EPA-registered disinfectant products against these emerging viral pathogens, uses not previously identified on the product label”:
- First Stage: This stage may be performed prior to any outbreak. EPA summarizes the first stage as follows: “registrants with an eligible disinfectant product may submit a request, via label amendment, to add a designated statement to the master label and additional terms to the product registration. If the product meets the eligibility criteria suggested in this Guidance, [EPA] generally will approve the amendment. Approval of the amendment would include additional terms and conditions of registration regarding how the designated statement may be published and communicated.”
- Second Stage: This stage would occur only during a human or animal disease outbreak caused by an emerging virus. EPA summarizes this stage as follows: “In this stage, registrants of products with the previously mentioned label amendment and terms of registration would be allowed to use the designated statement in off-label communications intended to inform the user community/public that the disinfectant product(s) may be used against the specific emerging viral pathogen. These off-label statements can inform the public about the utility of these products against the emerging pathogen in the most expeditious manner and can be more easily removed once the outbreak has ended than statements on a label.”
Comments related to clarity of this Guidance will be accepted until May 6, 2016. For more information, please see our memorandum EPA Announces Updated Guidance for Antimicrobial Pesticide Products Intended to Combat Emerging Pathogens.
By Lisa M. Campbell, James V. Aidala, and Carla N. Hutton
On March 25, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) sent a memorandum to Jim Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), announcing that it plans to begin preliminary research to assess EPA’s management and oversight of resistance issues related to herbicide tolerant genetically engineered (GE) crops. OIG states that its review will include the Office of Pesticide Programs (OPP), as well as other applicable headquarters and regional offices. OIG’s objectives are to determine:
- What processes and practices, including alternatives, EPA has provided to delay herbicide resistance;
- What steps EPA has taken to determine and validate the accurate risk to human health and the environment for approved pesticides to be used to combat herbicide resistant weeds; and
- Whether EPA independently collects and assesses data on, and mitigates actual occurrences of, herbicide resistance in the field.
OIG states that the anticipated benefit of the project “is a greater understanding of herbicide resistance[,] which will lead to an enhancement of EPA’s herbicide resistance management and oversight.”
Pesticide resistance is not a new issue and is one that EPA has affirmatively addressed when granting registrations for new products, GE or not, for some time. In fact, that newer chemistries often have a more niche mode of action to reduce potential toxicity concerns has led some observers to speculate that greater resistance is one potential trade-off for the development of less toxic materials.
This “investigation” may appear to some to be a response to concerns raised by critics of GE crops generally and to a recent EPA decision to approve Enlist Duo herbicide, a new formulation of 2,4,D- and glyphosate designed to address the problem of weed resistance to glyphosate-tolerant crops. Glyphosate tolerant crops were first approved some years ago, and their use was so broadly and readily adopted that issues have arisen with regard to potential resistance to some weed species. EPA is currently expected to approve another GE strain, Dicamba-tolerant crops, to control glyphosate tolerant weeds.
To critics of GE crops, using more herbicides to control problems caused by what they claim is overuse of another herbicide is evidence of a troubling “pesticide treadmill,” which they believe should not have been allowed to occur in the first place. Rebutting this criticism, others assert that resistance is a problem for all pesticides, not only genetically modified ones, and that with sufficient controls, resistance can be delayed, if not avoided. Registrants point out that it is very much in their self-interest to take steps to avoid resistance to their products -- once that occurs, the market viability of the product is significantly reduced.