By Lisa R. Burchi and Lisa M. Campbell
On January 3, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-01: Expanding Use of Pesticide Products Under Reevaluation. Under Notice 2018-01, effective immediately, DPR will not act upon an Application for Pesticide Registration or an Application to Amend a Pesticide Product if it determines the registration or acceptance would potentially “expand use” of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.
DPR states that it commences a reevaluation of an existing registered pesticide when it finds, based on an investigation of all reported episodes and information received, that a significant adverse impact to human health or the environment has occurred or is likely to occur. DPR states that the policy set forth in Notice 2018-1 is needed for pesticides under reevaluation because until DPR reviews existing data for substances under reevaluation, determines whether additional data to satisfy reevaluation data requirements must be submitted, and then receives and assesses additional data applicable to the reevaluation that can mitigate the concern that prompted the initiation of the reevaluation, DPR “is not in a position to determine that an expanded use will not cause a ‘significant adverse environmental impact,’ as required under its certified regulatory program (3 CCR section 6254).” Once the reevaluation process is completed, DPR states that it will then be in a position, in light of its reevaluation determination, to consider applications for product registration or amendment.
Scope of Notice 2018-1
DPR is currently reevaluating certain pesticide products containing the following active ingredients:
- Copper-based antifouling paints (copper oxide, copper hydroxide, and cuprous thiocyanate);
- Diazinon; and
- Nitroguanidine neonicotinoids (imidacloprid, thiamethoxam, clothianidin, and dinotefuran).
This notice applies to new pesticide products that include these active ingredients, including supplemental distributor registrations (subregistrations) and amendments to currently registered pesticide products, when “expanding use” of the active ingredient relevant to the concern that prompted the reevaluation.
Specifically, DPR states in Notice 2018-1 that it interprets the following types of actions, related to a new or amended product containing the active ingredient under reevaluation, as examples of “expanding use”:
- A proposed new pesticide product, including any Special Local Needs registration or Experimental Use Permit, with a label bearing uses or exposure scenarios relevant to the concern that prompted the reevaluation. This includes any product label that is identical or substantially similar to a currently registered product in California.
- Amendment of a currently registered product to add or modify uses or exposure scenarios relevant to the concern that prompted the reevaluation, even if such use is already on other currently registered pesticide products in California. Examples of such changes include:
- New or modified uses (e.g., new crops, pests, or use sites);
- New or modified use patterns (e.g., adding aerial, aquatic, soil applications, or outdoor use);
- Significant formulation changes (unless prompted by the reevaluation);
- Increased application rates or total use amount allowed (e.g., acreage or frequency of application); and
- Other label additions or changes that may increase pesticide exposure in a manner that is relevant to the basis for the reevaluation.
This notice does not preclude expanded use of a product if the expansion is not consistent with uses or exposure scenarios relevant to the concern that prompted the reevaluation. As an example, DPR states that an application containing an active ingredient that is under reevaluation over concerns regarding exposure to wildlife would not be precluded under this notice as an expanded use is if the product is labeled solely for indoor use, with no potential wildlife exposure.
DPR also acknowledges that a pest management or public health need could arise during a reevaluation that would support the issuance of an Emergency Exemption request under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In those cases, with regard to the potential applicability of Notice 2018-1, DPR states that it “will assess the request by relying on currently available information and risk mitigation strategies.”
DPR’s reevaluation process can take years to complete, so not only are pending affected submissions for products containing the active ingredients at issue effectively frozen, but future submissions for active ingredients newly entering the reevaluation process could be halted potentially for lengthy periods of time, despite the fact that DPR may ultimately determine that any identified “expanded uses” do not cause a significant adverse environmental impact. It is an initiative that many in industry are monitoring closely.
More information on other California DPR-related issues is available on our blog under key phrase California DPR.
By Lisa M. Campbell, Heather F. Collins, M.S., and Margaret R. Graham
On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017. Comments now must be received by EPA on or before December 5, 2017. The notice states that it will “allow stakeholders additional time to submit comments on the proposed guidance.” Eleven comments were filed in the docket, most of which expressed significant concern with changes EPA is proposing, in addition to requesting an extension to the previous deadline which was set to end on October 6, 2017.
EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” A full summary of the changes in the draft guidance is available in our blog item "EPA Releases Draft Guidance for Pesticide Registrants on Notifications, Non-notifications, and Minor Formulation Amendments."
Some of the more substantive comments noted the following issues:
- Several commenters stated objections to the provisions in the draft PR Notice that would eliminate the ability of registrants of formulated products to use notification to add or change sources of either registered technical active ingredients or inert ingredients. Concerns expressed with this proposed change included the effect it would have on the ability of registrants to respond quickly to market changes and conditions, including the availability and price of technical and inert ingredients needed for formulations.
- One commenter had concerns with regard to the proposed changes to the inert ingredient disclosure statement, as EPA is “considering whether the notification method or the non-notification method is an appropriate avenue for industry requested inert disclosure based upon third-party vendor requirements.” The commenter stated that it “believes there is an approach that satisfies third-party vendors while minimizing the burden on the Agency’s resources,” and “a significant delay to this issue could have third-party vendor impacts.”
- Commenters also expressed disappointment with EPA’s notification delivery, stating that EPA “provided very little notice to Stakeholders of this major change in its policies regarding notification” and “as a result, many potentially affected registrants may overlook this change and fail to file comments on it.”
More information on this draft notice and other pesticide registration notice issues is available on our blog under key phrase Pesticide Registration Notice.
By J. Brian Xu, M.D., Ph.D., DABT®
On September 29, 2017, the Ministry of Agriculture of China (MOA) issued the final revisions to Data Requirements on Pesticide Registration (MOA Proclamation No. 2569). The revisions will become effective on November 1, 2017, under the new Regulation on Pesticide Administration (RPA) and Pesticide Registration Management Measures (MOA Order No. 3, 2017). The draft revisions to Data Requirements on Pesticide Registration were initially released for public comment on June 30, 2017. The new Data Requirements include 10 chapters and 14 annexes and a category of pesticides for specialty minor crops has been added. More information on China’s new pesticide regulations is available in our blog under key word China.
MOA Order No. 3, 2017 requires chemistry and toxicology tests to be completed in laboratories located in China approved by the MOA or overseas laboratories that have a mutual recognition agreement with the relevant Chinese Authority. The new Data Requirements on Pesticide Registration do not provide any additional information about the acceptance of data generated in overseas laboratories.
It remains unclear whether, for example, for literature or data prepared in a foreign language, entire study reports/articles, or only summaries, must be translated into Chinese. In addition, the final revision of Data Requirements on Pesticide Registration deletes the category of “Pesticides for Overseas Uses Only” that was set forth in the draft revision of Data Requirements on Pesticide Registration.
The new RPA, MOA Order No. 3, 2017, and the Data Requirements on Pesticide Registration significantly change the registration requirements and the registration process for pesticides in China. These new requirements, and the many ambiguities they contain, will likely extend the time for obtaining registrations and impose additional challenges on manufacturers to overcome, particularly foreign manufacturers who wish to bring pesticide products to the Chinese market.
By Margaret R. Graham
On September 22, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register (82 Fed. Reg. 44406) announcing the availability of two final Pesticide Registration Notices (PRN):
- PRN 2017-1: Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling, which updates PRN 2001-5 and provides guidance for registrants to follow when developing resistance management information to include on their pesticide labels. It addresses “end-use herbicide, fungicide/bactericide, or insecticide/acaricide products that are intended mainly for agricultural and certain non-crop land areas under commercial or government-sponsored pest management,” and applies in particular to “all field use agricultural pesticide products, as well as pesticides which are labeled for greenhouse production, sod farms, ornamental crops, aquatic vegetation, rights-of way, and pest management along roadways.”
- PRN 2017-2: Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship, which “communicates the agency's approach to address herbicide-resistant weeds.” It is “germane to end-use herbicide products used in agriculture, including commercial turf and sod farms, ornamental production in the open.” It also applies to “non-agricultural use sites such as golf courses, aquatic vegetation, rights-of-way and vegetation management along roadways.”
These final PRNs reflect consideration of public comments submitted on the draft PRNs. Also available in the dockets are EPA’s responses to comments on the draft PRNs: Response to Comments on PRN 2017-1; and Response to Comments on PRN 2017-2. EPA states that “PRNs are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration-related decisions, and to provide guidance to pesticide registrants and OPP personnel.”
More information on PRNs is available on our blog under key phrase pesticide registration notice.
By Lisa M. Campbell, Sheryl L. Dolan, and Barbara A. Christianson
On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of and seeking public comment on draft guidance, Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments. EPA states it is issuing this notice to “align the notification program with the requirements of the Food Quality Protection Act (FQPA) and [the Pesticide Registration Improvement Act (PRIA)] and to clarify the processes for accepting minor, low risk registration amendments to be accomplished through notification, non-notification or as accelerated amendments.” EPA is requesting comments, and specifically information on projected cost implications of this draft updated guidance.
PR Notices are issued by the Office of Pesticide Programs (OPP). EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” The PR Notice lists the changes from PRN 98-10 in a table. Those changes include:
In addition to the changes listed on the table, modifications to PR Notice 98-10 consist of the following:
- F. Product Composition: (1) Pesticide Category -- Under PR Notice 98-10, the pesticide categories "disinfectant" and "sanitizer" were two pesticide categories that were allowed to be added to a label by notification. Under the proposed PR Notice, "disinfectant" and "sanitizer" were removed.
- F. Product Composition: (2) Odor -- Under PR Notice 98-10, the terms "fragrance free" and "unscented" were allowed to be added to a label by a notification provided that the product is odorless or nearly odorless and contains odor-masking ingredient such as a perfume. Under the proposed PR Notice, these terms were removed.
Minor Formulation Amendments
- A. Minor Formulation Amendments: (1) Addition, deletion or substitution of one or more colorants in a formulation -- Under PR Notice 98-10, if a product was intended for a use as a seed treatment or rodenticide, it would not be eligible for an accelerated review; that restriction was deleted from the proposed PR Notice.
- A. Minor Formulation Amendments: (2) Addition, deletion or substitution of one or more inert ingredients (other than colorants and fragrances) in a formulation -- Under the proposed PR Notice, if a product is a dog/cat pet spot-on product or if an inert is a bittering agent or a safener, the product would not be eligible for an accelerated review.
- A. Minor Formulation Amendments: (3) Addition, deletion or substitution of one or more fragrances in a formulation -- Under the proposed PR Notice, fragrances will be eligible for an accelerated review if all fragrance component ingredients are included on the Fragrance Ingredient List; individual fragrance component ingredients that exceed 0.1 percent (by weight) of the total pesticide product composition have existing approval for non-food use as an inert ingredient; and new/modified fragrances for antimicrobial products making public health claims are within the certified limits established for fragrances already approved for the product.
- Under the proposed PR Notice, products that are not eligible for accelerated review under minor formulation amendments are:
- Pet spot-on products;
- Change to an active ingredient source;
- Change to nominal concentration of the active ingredient; or
- Addition of new or additional Confidential Statements of Formula (CSF).
EPA Procedures to Review Notifications
Under the proposed PR Notice, EPA outlines changes to the policy for processing notifications by the Registration Division (RD) and the Biopesticides and Pollution Prevention Division (BPPD), but procedures to process notifications by the Antimicrobials Division remain the same.
One item to note under the proposed notification process for RD and BPPD is that a registrant may distribute or sell a product modified by notification once EPA receives the notification but, if EPA determines that a product has been modified through notification inappropriately, EPA may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application to amend the registration.
Registrants Submitting Minor Formulation Amendments
Under the proposed PR Notice, EPA requires that registrants submit with their application for registration a cover letter listing names and dates of all EPA accepted CSFs. EPA will consider any CSFs not listed in the cover letter as superseded/no longer valid.
Comments on this PR notice are due October 6, 2017, and can be submitted online under Docket ID EPA-HQ-OPP-2016-0671.
Registrants should review the draft PR Notice carefully, as it includes important changes. For example, the consequence for submitting a minor formulation amendment and neglecting to include a list of all current CSFs is severe. As another example, EPA signals in its proposal that proceeding to market with a product revised through the notification process may be risky if the submitter has erred in its judgment regarding what is eligible for a notification. Should the PR Notice be issued without change to this provision, submitters may wish to give close consideration to waiting until it has EPA’s written confirmation that a notification has been accepted before introducing the revised product to market. Comments on issues of concern should be considered.
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, Lisa R. Burchi, and James V. Aidala
On July 18, 2017, a panel of three judges at the U.S. Court of Appeals for the Ninth Circuit issued an order denying petitioners’ Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) Motion for Further Mandamus in the chlorpyrifos proceedings. In that motion, Petitioners asked the court to grant further mandamus relief, asserting that the U.S. Environmental Protection Agency’s (EPA) denial of Petitioners’ petition to revoke all food tolerances and cancel all chlorpyrifos registrations was inadequate because it contained “no new safety findings” and no “final determination as to whether chlorpyifos food tolerances must be revoked.” More information on the motion is available in our blog item Petitioners File Motion for Further Mandamus Relief in Response to EPA’s Order Denying Petition to Ban Chlorpyrifos.
In its order, the panel held that since the prior mandamus proceedings “addressed the timing, not the substance, of EPA’s response,” EPA had “complied with the panel’s previous orders by issuing a ‘final response to the petition.’” The mandamus motion thus was “premature, and its substantive objections to the EPA’s denial must first be made through the administrative process mandated by statute.”
The demand imposed by the court earlier was to make a decision, and EPA met that deadline with its denial. This is a significant win for industry, but is far from the end of this debate, which will continue in a number of different forums. More information on the proceedings is available on our blog under key word chlorpyrifos.
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 J. Brian Xu, M.D., Ph.D., DABT®
On June 1, 2017, in the People’s Republic of China (China), the newly revised Regulation on Pesticide Administration (RPA) became effective. The newly revised RPA was approved during the 164th executive meeting of the State Council of China on February 8, 2017, and published as Decree Number 677 of the State Council of China (China Decree 677) on April 1, 2017. It requires the Ministry of Agriculture (MOA) to formulate relevant rules and measures for its implementation.
The first set of five implementation rules was initially released for public comment on March 17, 2017, and made final on June 21, 2017. The five implementation rules include: Pesticide Registration Management Measures (MOA Order No. 3, 2017), Measures for the Management of Pesticide Production License (MOA Order No. 4, 2017), Measures for the Administration of Pesticide Business License (MOA Order No. 5, 2017), Measures for the Management of Tests Used for Pesticide Registration (MOA Order No. 6, 2017), and Measures for the Administration of Pesticide Labels and Manuals (MOA Order No. 7, 2017). They will become effective on August 1, 2017.
On June 30, 2017, the MOA released the second set of six implementation rules for public comment under the new RPA, which include Data Requirements on Pesticide Registration (Draft); List of Pesticides with Restricted Uses (Draft); Measures for the Management of QR Code Pesticide Label (Draft); Review Rules of Pesticide Production License (Draft); Review Rules of the Test Institutes that Conduct Tests Used for Pesticide Registration (Draft); and Quality Management Practices of Tests Used for Pesticide Registration (Draft). The comment period will end on July 30, 2017, but an implementation date was not provided.
The MOA Order No. 3, 2017 requires that chemistry and toxicology tests should be completed in Chinese laboratories approved by the MOA or overseas laboratories that have a mutual recognition agreement with the relevant Chinese Authority, and that the tests for efficacy, residue, environment, and others that are closely related to environmental conditions and Chinese specific species shall be conducted in China. Since China is not a member country of the Organization for Economic Cooperation and Development’s (OECD) Mutual Acceptance of Data (MAD) system, this requirement could reject all test reports from overseas for pesticide registration in China.
The requirements that literature or data in a foreign language shall be translated to Chinese are moved from the Pesticide Registration Management Measures (Draft) to the new Data Requirements on Pesticide Registration (Draft), but it is still not clear if whole articles/reports or only summaries should be translated into Chinese. In addition, the new Data Requirements on Pesticide Registration (Draft) would add a new category of registration, “Pesticides for Overseas Uses Only.” The registration of “Pesticides for Overseas Uses Only” requires only chemistry and toxicology data for the products at issue; the data that must be submitted include information on the production process, component analysis, quality specifications and analytical methods, acute “six-pack,” Acceptable Daily Intake (ADI), Acute Reference Dose (ARfD), and other safety and toxicology information. The new draft rules would not require any efficacy, residue, or environment tests for registration of “Pesticides for Overseas Uses Only.” The timeline for the second set of six implementation rules under the new RPA is not provided. Considering it took only three months for the first set of five implementation measures to proceed from drafts for public comments to final versions that will become effective about one and half a months later (August 1, 2017), it is expected that the second set of six implementation rules will become effective by the end of the year.
The new RPA and its implementation rules significantly change registrations for pesticides in China. Temporary pesticide registration is no longer an option, and pesticide registration now requires a full set of data, including two-year stability data in the initial submission, and requires that many of the tests must be conducted in China. With these new requirements, the new pesticide registration process may extend the time for manufacturers to bring products to the Chinese market. Because of many ambiguities in the new RPA and its implementation rules, many questions and uncertainties regarding the process for pesticide registration under the new RPA remain.
By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham
On April 27, 2017, Senator Elizabeth Warren (D-MA) and Representative Frank Pallone (D-NJ) sent a letter to Inspector General Arthur Elkins, Jr. at the Office of Inspector General (OIG) at the U.S. Environmental Protection Agency (EPA) requesting the OIG to conduct an investigation into EPA’s March 29, 2017, 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. The letter refers to the March 29, 2017, order as “Administrator Scott Pruitt’s order,” and asks OIG to address questions specifically targeting the rationale, communications, and consideration that Administrator Pruitt took prior to reaching the decision.
The letter states that Administrator Pruitt's “hasty reversal of this decision … appears not to be based on EPA’s existing recent scientific findings about the risk, or any new information that contradicts the findings about the health and safety risks of chlorpyrifos.” Further, the letter asserts that “it does not appear to be consistent with the law, which requires that pesticide products cannot be used unless ‘there is reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical residue.’”
- How did Mr. Pruitt reach the decision he announced on March 29, 2017? What was the timeline leading up to this decision? With whom did he communicate within EPA, the White House, or elsewhere in the Administration? With which outside entities did he communicate? Specifically, did Mr. Pruitt have any communication with staff or representatives of Dow Chemical or any pesticide industry trade groups including CropLife America?
- What was the rationale for Mr. Pruitt's decision, and why did he reverse an agency decision that had been years in the making? How was this rationale developed? Was it based on any new information or evidence?
- Was Mr. Pruitt's decision consistent with the requirements of the Administrative Procedures Act? Did he provide appropriate notice and comment and appropriately consider all relevant comments and information?
- Was Mr. Pruitt's decision consistent with the requirements of the FFDCA, which establishes a standard that, to maintain a pesticide tolerance, there must be "reasonable certainty that no harm will result from the aggregate exposure to the pesticide chemical petitition to revoke tolerances.pdf residue"? Has the EPA met the "reasonable certainty [of] no harm" standard in the law? Why did Mr. Pruitt note that chlorpyrifos was "widely used" when he announced his decision? Was this "wid[e] use" a factor in Mr. Pruitt's decision, and, if so, was this appropriate under the law? What other factors were taken into consideration by Mr. Pruitt?
- Is the EPA accurately and transparently presenting information to the public with regard to previous EPA actions concerning chlorpyrifos? For example, the EPA website for chlorpyrifos on January 2, 2017 contained information indicating that EPA "proposed to revoke all chlorpyrifos tolerances," and contained a link with detailed information about the health risks and the reasons for the EPA action. This reference to the proposed ban, and the link to the detailed EPA analysis are no longer available on the chlorpyrifos web page, and the link to the analysis (as of April 3, 201 7) now gives a "Page Not Found" error.
This letter not surprisingly continues the debate over the appropriate regulatory status of chlorpyrifos. Those disappointed by the recent EPA decision, apparently including Senator Warren and Representative Pallone, want to press EPA to explain in more detail not only the reasons for the decision not to revoke chlorpyrifos tolerances at this time, but also the rationale EPA used to rebut what they believe to be the decision-making record that EPA had accumulated over the last two to three years.
The explanation that the arrival of new leadership at EPA with the Administration led to a change in position is perhaps only part of the answer. The change in Administration did not change the underlying statutory requirements governing EPA’s registration, reregistration, and tolerance decisions, and EPA relied on these requirements as the basis for its decision not to make a decision at this time, as discussed in EPA Denies Petition to Ban Chlorpyrifos.
EPA’s response to any investigation initiated by this letter, as well as the OIG response, will be watched closely by all stakeholders.