By Lisa M. Campbell and Heather F. Collins, M.S.
On Friday, November 3, 2017, the California Department of Pesticide Regulation (DPR) issued guidance (California Notice 2017-13) that DPR indicates is intended to align DPR policy with the U.S. Environmental Protection Agency’s (EPA) guidance on secondary container labeling for pesticides. DPR’s guidance states that secondary containers are used by the pesticide industry as part of the process of applying pesticides and “cannot be sold or distributed.” The guidance further notes that secondary containers are “most commonly used in institutional settings for concentrated antimicrobials that are diluted prior to use or to hold pesticides filled from a larger container to be used and stored prior to application.”
Registrants may elect to provide users with labels for secondary containers. DPR’s new guidance states: “Secondary container labels are not required to be submitted to U.S. EPA or DPR.” Under the new DPR policy, however, effective immediately, if a registrant submits a secondary container label to DPR, “it must bear the same signal word as the concentrate label or no signal word.” DPR states that it will accept a secondary container label with a lesser signal word, precautionary statements, and alternate directions for use for the diluted product only if acute toxicity data are submitted or are currently on file to support these lesser statements.
DPR’s new guidance also incorporates EPA guidance on what a secondary label should contain. (EPA does not require secondary containers to be labeled, but notes that the applicator remains responsible for following the requirements on the pesticide product’s labeling, and complying with other relevant requirements in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other statutes.) Although registrants are not required to submit secondary container labels to EPA for review, EPA recommends that the applicator identify the material in the secondary container in the event of a spill to ensure that adequate information regarding the pesticide can be obtained in case of a medical or environmental emergency. EPA recommends that such labels include the following information:
- Product name;
- EPA registration number;
- Name and percentage of active ingredient of the concentrated product or if known, the percentage of active ingredient in the end-use dilution;
- If the product in the secondary container is diluted, it should be followed by the phrase: “The product in this container is diluted as directed on the pesticide product label”;
- The same signal word as the registered concentrate container label;
- The same precautionary statements as the registered concentrate container label unless the registrant has acute toxicity data supporting lesser precautionary statements for the diluted product and alternate directions for the diluted product are indicated on the concentrate container label; and
- The statement: “Follow the directions for use on the pesticide label when applying this product.”
DPR states: “If currently registered products have secondary container labels on file with DPR that do not meet the above criteria, registrants should submit revised labels to DPR as an amendment.”
Each submission must include:
- California Application to Amend Pesticide Product (DPR-REG-035);
- $25 application fee (payable to: Cashier, Department of Pesticide Regulation);
- A copy of the most current EPA stamp-accepted label;
- Six copies of the concentrate container label; and
- Six copies of the secondary container label.
- If the precautionary statement on the secondary container label bears lesser precautionary statements, the submission must be accompanied by acute toxicity data or a reference to data on file with DPR.
As an alternative to submitting revised labels, registrants have the option of requesting that DPR rescind acceptance of the current stamp-accepted secondary container label previously submitted. Registrants may submit their request in writing on company letterhead to their assigned Regulatory Scientist. If a secondary container label is inconsistent with the DPR-approved label, DPR will consider the product misbranded, and DPR notes that misbranded products are subject to enforcement action.
Registrants that have previously submitted secondary labels to DPR should review the label in comparison to the DPR-approved concentrate container label and the requirements in this notice. All inconsistencies must be corrected via amendment submission to DPR or by making a request that DPR rescind acceptance of the current stamp-accepted secondary label so that the product is not considered misbranded and therefore subject to enforcement action.
By Susan M. Kirsch
On October 17, 2017, the U.S. Environmental Protection Agency (EPA) issued a “Quick Guide for Disinfectant Products for Drinking Water Use by Public Water Systems” (Quick Guide) which it states was developed “in response to requests to help prospective pesticide registrants gain a basic understanding of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) product registration process and how it relates to the Safe Drinking Water Act (SDWA) requirements.” Further, “applicants seeking to register pesticide products for treatment of drinking water in public water systems [(PWS)] should refer to this [Quick Guide] for a broad overview of the applicability of FIFRA and SDWA and for references to additional relevant resources.” EPA states the Quick Guide can be used to:
- Compare the jurisdictional authority of FIFRA and SDWA;
- Determine whether a product is required to obtain FIFRA registration; and
- Identify SDWA standards that are applicable to pesticide products used in drinking water disinfection.
EPA states that “it does not register or approve disinfection products under the SDWA, but instead imposes requirements on each regulated PWS to deliver water that meets specific standards to persons served by the system,” and that each PWS “must determine what product or combination of products to use to meet the federal and any applicable state, tribal or territorial drinking water requirements.”
A review of the Quick Guide reveals it is a high level decision support and reference tool which lists the basic steps necessary to obtain product approval for drinking water disinfection use by PWSs under both FIFRA and SDWA; and includes a corresponding flow chart that highlights the intersection between the jurisdictional authorities of the two statutes and illustrates more generally the steps for obtaining product approval. The flow chart also ties these steps to relevant EPA guidance/manuals and applicable Code of Federal Regulations citations, and provides online links to these resources. The Quick Guide does not supply details on any applicable state, tribal, or territorial laws. As EPA notes, some states, tribes, and territories have requirements for the regulatory approval, registration, and licensing of disinfectant products that may be used in their PWSs. Similarly, “FIFRA registration does not mean that the product meets state, tribal or territorial laws regarding drinking water products for use by PWSs.”
More information is available on EPA’s website.
By Lisa M. Campbell and James V. Aidala
On September 18, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) issued a report on an evaluation conducted by OIG entitled “EPA Needs to Manage Pesticide Funds More Efficiently.” OIG states that it conducted the audit “to determine whether EPA manages the Pesticides Reregistration and Expedited Processing Fund (known as the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] Fund) and the Pesticide Registration Fund (known as the [Pesticide Registration Improvement Act (PRIA)] Fund) effectively to minimize reliance on appropriated funds.”
In the report, OIG states its finding that “EPA should manage the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] and [Pesticide Registration Improvement Act (PRIA)] Funds more effectively by reducing excess fund balances to within a target range. As of September 30, 2016, [OIG] identified excess funds of approximately $21.4 million for FIFRA and $8.5 million for PRIA, for a total of $29.9 million. A reduction in fund balances would increase the availability of appropriated funds for other environmental purposes.”
In the report, OIG makes the following recommendations to EPA:
- For the Assistant Administrator for Chemical Safety and Pollution Prevention (OCSPP) to “establish a target range for its FIFRA and PRIA Fund balances and develop and implement a plan to reduce excess funds to within the target range”; and
- For the Chief Financial Officer to “reconcile the FIFRA and PRIA Funds’ balances to the corresponding liabilities.”
The report states that EPA concurred with establishing a target range and developing a plan to reduce excess funds for FIFRA Fund balances, but did not agree with establishing a target range and developing a plan to reduce excess funds for PRIA Fund balances, citing the lack of predictability of PRIA collections. OIG stated that it “still believe[s] PRIA has excess funds that should be addressed,” and “[t]he agency agreed to reconcile FIFRA and PRIA balances.”
This report follows two OIG reports issued on August 14, 2017, on audits of the financial statements of (1) the FIFRA Fund; and (2) the PRIA Fund for fiscal years (FY) 2015 and 2016. OIG is required to perform an annual audit of the financial statements of the FIFRA Fund under the Food Quality Protection Act (FQPA), and of the PRIA Fund under PRIA.
OIG states in its reports on the audits for FYs 2015 and 2016, of both the FIFRA and the PRIA Funds, that it “noted a material weakness in that the EPA cannot adequately support its FY 2016 [PRIA/FIFRA] Fund costs.” OIG further stated, however, that this issue has been noted in prior audit reports, and that EPA is taking corrective actions.” For those reasons, OIG stated that it was making “no new recommendations for [these] material weakness[es].” In FYs 2016 and 2015, EPA “lost the audit trail to properly support how much of the [PRIA/FIFRA] payroll expenses were paid for by appropriations.” To address these losses, in October 2016, EPA instituted an enhancement to its timekeeping system’s cost allocation that will allow for “the creation of an audit trail to capture costs incurred by the [PRIA/FIFRA] Fund and other appropriations that support [PRIA/FIFRA]-related activities.”
More information on other EPA OIG reports is available on our blog under key terms OIG and EPA OIG.
The reality of why the FIFRA funds are in surplus is a political response to the overall budgetary politics of Congress. The Office of Pesticide Programs (OPP) has not been authorized to utilize these funds fully or freely hire staff due to the budget agreements of Congress, and, more recently, due to the attempt by the new Administration to keep the Presidential budget proposal more in balance. The OIG knows this also, but “politics” is not the concern of a good audit, and this is not helped by the problem of EPA having “lost the audit trail” of how these monies were spent. PRIA reauthorization is soon to be overdue, and now appears perhaps to be in some jeopardy, at least in the near term. Fortunately for OPP, the surplus in these funds that OIG addresses will be able to buy the program some time to continue relatively “as is” while waiting for PRIA politics to subside to the point where reauthorization is approved and the program can focus more on the improvements suggested by the OIG report.
By Lara A. Hall, MS, RQAP-GLP and Lauren M. Graham, Ph.D.
On September 13, 2017, the U.S. Environmental Protection Agency (EPA) issued three supporting documents for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) meeting regarding the “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.” This FIFRA SAP meeting will be held on November 28-30, 2017, from 9:00 a.m. - 5:00 p.m. (EST) at the EPA Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.
The supporting documents include:
Written comments will be accepted on or before October 16, 2017. Comments may be submitted online via Docket ID EPA-HQ-OPP-2017-0214-0001, mail, or hand delivery.
Updated details regarding other comment periods for the FIFRA SAP are provided below:
A listing of ad hoc panel members, including their biographical sketches, was posted online on August 22, 2017. The public comment period for the proposed panel members closed on September 7, 2017.
The original Federal Register notice announcing the meeting was published on June 6, 2017.
This important meeting, and materials issued in connection with it, will have potentially significant consequences for registrants. Bergeson & Campbell, P.C. (B&C®) will continue to monitor the situation closely and provide additional updates as they become available. More information on EPA’s Endocrine Disruptor Screening Program (EDSP) as well as the FIFRA SAP are available on our blog under key terms EDSP and FIFRA SAP.
By Lara A. Hall
On August 3, 2017, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing revised comment period dates for the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) meeting regarding the “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.” This SAP meeting will be held on November 28-30, 2017, from 9:00 a.m.-5:00 p.m. (EST) at the EPA Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202. Updated details regarding commenting periods are provided below:
- Supporting documents for the FIFRA SAP meeting will be posted online on or before September 1, 2017. Written comments will be accepted on or before October 16, 2017.
The original Federal Register notice announcing the meeting was published on June 6, 2017.
This important meeting, and materials issued in connection with it, will have potentially significant consequences for registrants and should be monitored closely.
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 Lisa R. Burchi, Timothy D. Backstrom, and James V. Aidala
On June 30, 2017, the U.S. Court of Appeals for the D.C. Circuit issued its opinion in Center for Biological Diversity (CBD), et al. v. U.S. Environmental Protection Agency (EPA), Case No. 14-1036, resolving jurisdictional and substantive issues following complaints alleging that EPA violated Section 7(a)(2) of the Endangered Species Act (ESA) by failing to make an effects determination or to consult with the U.S. Fish and Wildlife Service (FWS) or the National Marine Fisheries Service (NMFS) before registering cyantraniliprole (CTP) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Regarding the jurisdictional issue and the appropriate court in which to bring such a challenge, the U.S. District Court for the District of Columbia on May 14, 2015, had dismissed the ESA complaint of CBD, the Center for Food Safety, and the Defenders of Wildlife (Conservation Groups), finding that the Conservation Groups’ “Complaint gives rise to an ‘actual controversy as to the validity’ of the FIFRA Registration Order and is therefore governed by that Act’s jurisdictional grant.” The D.C. Circuit affirmed the U.S. District Court’s ruling to dismiss the ESA petition on jurisdictional grounds, concluding that FIFRA “grants the court of appeals exclusive jurisdiction to review an ESA claim that is ‘inextricably intertwined’ with a challenge to a pesticide registration order.”
The D.C. Circuit also, however, granted the Conservation Groups’ FIFRA petition, finding that EPA registered CTP without having made an effects determination or consulting with the FWS and/or the NMFS as required under ESA Section 7(a)(2). The court remanded the case to EPA for further proceedings, but allowed the CTP registration order to remain in effect until it is replaced by an order consistent with the court’s opinion.
Considering the growing number of complaints that allege a failure to consult with the FWS and/or the NMFS under the ESA, this decision could have broad reaching implications for how these complaints are filed and reviewed.
On February 29, 2012, EPA announced that it had received applications to register pesticide products containing CTP under FIFRA. On June 6, 2013, EPA announced its proposal to register CTP as a pesticide under FIFRA. As part of its review, EPA prepared an “Environmental Fate and Ecological Risk Assessment for the Registration of the New Chemical Cyantraniliprole” in which EPA states that CTP is “highly toxic or very highly toxic” to multiple taxonomic groups, including terrestrial invertebrates such as butterflies and beetles.
On January 24, 2014, EPA registered CTP as a pesticide under FIFRA and approved fourteen end-use products containing CTP. At issue in this case was EPA’s decision to register CTP without having made an effects determination or consulting with the FWS and/or the NMFS as required by ESA Section 7(a)(2) and implementing regulations (50 C.F.R. § 402.13-14).
Under the ESA citizen-suit provision, “any person” may “commence a civil suit on his own behalf … to enjoin any person, including the United States and any other governmental instrumentality or agency … who is alleged to be in violation of any provision of this chapter or regulation issued under the authority thereof.” 16 U.S.C. § 1540(g)(1). “The district courts … have jurisdiction” of ESA citizen suits, id., but no action may be commenced “prior to sixty days after written notice of the violation has been given to the Secretary, and to any alleged violator.” Id. § 1540(g)(2)(A)(i).
FIFRA’s citizen-suit provision at 7 U.S.C. § 136n(b) provides the federal circuit court with exclusive jurisdiction to affirm or set aside an EPA pesticide registration order following a public hearing, provided a challenge is filed within 60 days of the registration decision.
With potentially conflicting statutory provisions regarding the court in which to file a complaint and the timing to do so, the Conservation Groups initiated two actions: a complaint against EPA in D.C. District Court under the ESA’s citizen-suit provision; and a petition for review in D.C. Circuit Court pursuant to FIFRA’s citizen-suit provision.
The D.C. Circuit first addressed the jurisdiction issue, which involved a determination of standing and a resolution of the “dueling jurisdictional provisions of the ESA and of FIFRA.”
On the issue of standing, the D.C. Circuit found that petitioners did in fact have standing, as not only did EPA make procedural omissions through “its failure to make an effects determination and to consult,” but the plaintiffs show that EPA’s failure affected the plaintiffs’ members’ “concrete aesthetic and recreational interests.”
With regard to the appropriate court in which to bring this claim, the D.C. Circuit found that “FIFRA vests the courts of appeals with exclusive jurisdiction over controversies arising from an EPA pesticide registration, so long as, inter alia, registration follows a public hearing.” The court thus also found:
- Because FIFRA’s grant of exclusive jurisdiction to the court of appeals to review registration orders is more specific than the ESA’s citizen-suit provision, we believe the Conservation Groups must bring their ESA section 7(a)(2) challenge to us if 7 U.S.C. § 136n(b) is satisfied. And the Conservation Groups do satisfy the requirements of 7 U.S.C. § 136n(b): they are adversely affected by the registration of CTP; they challenge the validity of the CTP registration order based on the EPA’s failure to make an effects determination and to consult; and their challenge comes after a “public hearing” by way of three notice and comment periods. We therefore have “exclusive jurisdiction” to review their claim under FIFRA and the district court correctly dismissed their ESA citizen suit. (citations omitted).
While the ESA citizen suit was dismissed, the FIFRA citizen suit remained under the D.C. Circuit’s exclusive jurisdiction and review. The court found that EPA violated ESA Section 7(a)(2) by registering CTP before making an effects determination or consulting with the FWS or the NMFS.
Significantly, the court decided to remand the case to EPA for further proceedings without vacating the CTP registration. The court stated that remand without vacatur is appropriate in this case because “[n]otwithstanding the EPA’s failure to make an effects determination and to engage in any required consultation, it did not register CTP in total disregard of the pesticide’s potential deleterious effects; indeed, the Conservation Groups themselves rely heavily on the EPA’s ‘Ecological Risk Assessment for the Registration of the New Chemical Cyantraniliprole.’” The court further stated that “allowing the EPA’s CTP registration order to remain in effect until it is replaced by an order consistent with our opinion will maintain ‘enhanced protection of the environmental values covered by the CTP registration order.’”
This case is significant in at least two respects and should have implications in other cases being brought under ESA and FIFRA citizen suit petitions. First, the court provides the same answer concerning the “dueling jurisdictional provisions of the ESA and of FIFRA” as prior decisions in the Ninth Circuit, finding that FIFRA’s jurisdictional grounds take precedence and that the Courts of Appeal have exclusive jurisdiction to review cases claiming ESA violations in the context of an approved FIFRA pesticide registration. The court found the Conservation Groups’ arguments to the contrary “unavailing,” including but not limited to their argument that the public notice and comment periods that were provided did not constitute a “public hearing” under FIFRA Section 16(b) as well as their argument that the ESA challenge was not “inextricably intertwined” with FIFRA, even though the Conservation Groups were challenging the CTP registration order itself. It also is significant that the court, while remanding the registration order to EPA for further actions under the ESA, did not immediately vacate the existing CTP registration order.
Some observers of the extensive ESA-FIFRA litigation over recent years wondered whether the CTP registrations would be vacated once challenged for conformity to ESA requirements. EPA effectively admitted that it did not follow the full consultation process with FWS and NMFS, in this case substituting a relative risk argument that CTP was an improvement that would provide more species protection compared to the compounds it is expected to replace in the marketplace. The remand without vacatur does not resolve what some have called the “train wreck” scenario, where the need to complete ESA consultation, combined with time and resource constraints at the respective agencies, will result in a virtual freeze on new pesticide product registrations. The court makes it clear that, if EPA makes an affirmative ESA effects determination for CTP, consultation with the FWS and/or the NMFS must follow.
By Lisa M. Campbell and Margaret R. Graham
On June 14, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. 82 Fed. Reg. 27254. EPA states that this test guideline provides “guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA,” and “recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products intended to repel, attract, and/or kill the common bed bug (Cimex lectularius) in connection with registration of pesticide products under the [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” EPA states that this guidance applies to products “in any formulation such as a liquid, aerosol, fog, or impregnated fabric, if intended to be applied to have a pesticidal purpose such as to attract, repel, or kill bed bugs.” This guideline provides appropriate laboratory study designs and methods for evaluating the product performance of pesticides against bed bugs and includes statistical analysis and reporting.
EPA issued the draft guideline on February 14, 2012. This original document was the subject of FIFRA Scientific Advisory Panel (SAP) review conducted on March 6-7, 2012. EPA indicates that the final version of the guideline reflects revisions to the original draft based on comments from the SAP and the public. EPA states that the revisions include the following:
- Decreasing the number of individuals and replicates tested;
- Rescinding the recommendation to test each field strain for its resistance ratio; and including a resistance management statement;
- Clarifying the agency's Good Laboratory Practices (GLP) requirements;
- Reducing the recommended length of time individuals are exposed to insecticides;
- Recommending individuals to be observed up to 96 hours after treatment; and
- Revising the statistical analyses recommendations.
EPA has also placed two other relevant documents in the docket:
By Lynn L. Bergeson and Carla N. Hutton
On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of a nanosilver pesticide product and vacated the conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC) as well as the Center for Food Safety (CFS) and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named NSPW-L30SS (NSPW). The court vacated the conditional registration because, according to the court, “EPA failed to support its finding that NSPW is in the public interest.”
When EPA granted the conditional registration, EPA did so on the basis that NSPW had a lower application rate and a lower mobility rate when compared to conventional-silver pesticides, and thus had the potential to reduce environmental loading and risk caused by silver release. Petitioners disputed these facts. While the court found that substantial evidence supports EPA’s findings that NSPW has lower application and mobility rates, the court agreed that the third premise, that current users of conventional-silver pesticides will switch to NSPW and/or that NSPW will not be incorporated into new products, “impermissibly relies on unsubstantiated assumptions.” According to the court, EPA cites no evidence in the record to support its assumption that current users of conventional-silver pesticides will switch to NSPW (“the substitution assumption”), but contends that it will occur as a “logical matter.” The court states that the lack of evidence supporting the substitution assumption is problematic in light of EPA’s other unsupported assumption, that there will be no new products. The court notes that EPA assumes current users of conventional-silver pesticides will switch to NSPW because of its benefits, but that these same benefits will not prompt manufacturers to incorporate NSPW into new products. EPA could have proved these assumptions, but without evidence in the record to support the assumptions, the court states that it “cannot find that the EPA’s public-interest finding is supported by substantial evidence as required by [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” According to the court, the public interest finding is an “essential prerequisite to conditional registration,” and EPA failed to support that finding for NSPW with substantial evidence. The court vacated the conditional registration in whole, and did not consider the remaining issues raised by petitioners.
More information will be available in Bergeson & Campbell, P.C.’s memorandum Appellate Court Vacates Conditional Nanosilver Registration.
By Lisa M. Campbell and James V. Aidala
On March 29, 2017, U.S. Environment Protection Agency (EPA) Administrator Pruitt signed an order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos. This is the latest EPA action in a long and contentious battle concerning chlorpyrifos tolerances and registrations, and is likely not the end of this story.
EPA’s decision denying the petition addresses each of the petition’s ten claims and the history of EPA’s review and responses to those claims. Much attention will be paid to the order’s discussion of three of the claims, which the order states all relate to the same issue: “whether the potential exists for chlorpyrifos to cause neurodevelopmental effects in children at exposure levels below EPA’s existing regulatory standard (10% cholinesterase inhibition).” The order states that because “Congress has provided that EPA must complete registration review by October 1, 2022,” and because EPA has “concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution” on the issues concerning potential neurodevelopmental effects in children, EPA is denying the claims, given the Ninth Circuit Court of Appeals’ August 12, 2016, order that “made clear” that further extensions to the March 31, 2017, deadline for responding to the petition would not be granted. EPA states that the “science addressing neurodevelopmental effects remains unresolved,” and “further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos.”
The order will become effective as soon as it is published in the Federal Register. More information on the prior proceedings concerning this matter is available on our blog under key phrase chlorpyrifos.
This decision by EPA under the Trump Administration to deny the petition is not surprising, given the rhetoric of reducing regulatory burdens and the need to stop regulatory “overreach” by agencies like EPA which has been accused of making politically driven decisions. EPA's press release captures this, quoting Administrator Pruitt stating (in part): "By reversing the previous Administration’s steps to ban one of the most widely used pesticides in the world, we are returning to using sound science in decision-making -- rather than predetermined results.”
EPA has, however, “kicked the can down the road” to some extent on the key science issue -- whether EPA appropriately evaluated epidemiology studies which reported that exposures to the pesticide had adverse neurological impacts on infants and children -- an issue that affects not only chlorpyrifos, but the other organophosphates (OP) that EPA has concluded are subject to a Food Quality Protection Act (FQPA) 10X factor based on these studies. (See EPA’s September 15, 2015, Literature Review on Neurodevelopment Effects & FQPA Safety Factor Determination for the Organophosphate Pesticides.)
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) members who reviewed EPA’s approach, based on these studies with regard to chlorpyrifos, generally had concerns with its proposed approach. When EPA nonetheless issued its renewed call for revocation of the tolerances in November 2016, eight days after the Presidential election, it was seen by some as partly (if not fully) driven by a “political” calculus which ignored the lack of support of the FIFRA SAP.
The November 2016 proposal was based on more than the epidemiology studies which have proven controversial. At the same time, EPA’s arguments in the November notice relied on some of the earlier findings about the studies and FIFRA SAP’s review to fashion a “hybrid” approach which, not surprisingly, supported EPA’s previous conclusions.
This has led to charges of “politics over science” on all fronts, but in responding to the court deadline for a final decision by March 31, 2017, EPA has now declared it does indeed need more time to resolve the science issues, and argues that the general registration review process, with the chlorpyrifos review scheduled for 2022, gives EPA more time than what the court imposed. EPA has concluded that if a decision is needed now, the required burdens have not been met to change the current status of the pesticide. The order states:
- Following a review of comments on both the November 2015 proposal and the November 2016 notice of data availability, EPA has concluded that, despite several years of study, the science addressing neurodevelopmental effects remains unresolved and that further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos. EPA has therefore concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution on those issues.
EPA has determined it needs more time, however frustrating that may be, to sort out the science. As such, it is allowing chlorpyrifos use to continue, but objections to EPA’s decision are expected by the petitioners who originally pushed for the tolerance revocations. The effect on other OPs with regard to the application of the FQPA uncertainty factor is unclear, at best. The science debate will rage on, with no clear timeline or process for how the ultimate resolution of these questions will be “final.” This political and legal back-and-forth may become the new normal for the Trump Administration as it seeks to balance a more “business friendly” regulatory approach with the stringent requirements of the statutory duties of underlying authorizing legislation across all of EPA’s programs.