By Lisa R. Burchi
On March 7, 2019, in the Court of Justice of the European Union (EU), the Eighth Chamber of the General Court issued two judgments in cases regarding access of confidential information related to glyphosate. One of these decisions (Tweedale v. EFSA, Case T-716/14) related to a 2014 request for two toxicity studies that were “key studies” in the determination of glyphosate’s acceptable daily intake (ADI). The second decision (Hautala et al. v. EFSA, Case T-329/17) related to a request from Members of the European Parliament for access to parts (i.e., “material, experimental conditions and methods” and “results and discussions”) of 12 unpublished carcinogenicity studies, described as the “‘most crucial’ studies for the peer review and [EFSA’s] conclusion that glyphosate is unlikely to pose carcinogenic hazard to humans.” Partial access to those studies (i.e., raw data and findings aggregated in tables and figures) had been granted in an earlier 2016 decision.
A prior November 21, 2018, case related to glyphosate (Stichting Greenpeace Nederland and Pesticide Action Network Europe v. European Commission, Case T-545/11 RENV) and the General Court/Fourth Chamber’s judgment to prevent applicants from receiving access to information on the degree of purity of the active substance glyphosate, as well as the identity and quantities of impurities is discussed here. In contrast to the Stichting decision, where access was denied, the court in the March 7, 2019, decisions annulled prior decisions dated October 16, 2017 and March 14, 2017, that refused access to the requested information.
Article 4(2) of Regulation No. 1049/2001 (regarding public access to European Parliament, Council and Commission documents) provides that access to documents should be refused where disclosure would undermine, in part, commercial interests of a natural or legal person, including intellectual property, unless “there is an overriding public interest in disclosure.”
Article 6(1) of Regulation No. 1367/2006 (regarding the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies) provides that, with regard to Regulation No. 1049/2001 Article 4(2), “an overriding public interest in disclosure shall be deemed to exist where the information requested relates to emissions into the environment.” Recital 15 of Regulation No. 1367/2006 also provides: “The grounds for refusal as regards access to environmental information should be interpreted in a restrictive way, taking into account the public interest served by disclosure and whether the information requested relates to emissions in the environment.”
Taken together, the court stated: “that means that an EU institution, hearing a request for access to a document, cannot justify its refusal to divulge it on the basis of the exception relating to the protection of the commercial interests of a particular natural or legal person for the purposes of Article 4(2), first indent, of Regulation No 1049/2001, where the information contained in that document constitutes information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006.”
The General Court/Fourth Chamber thus addressed whether the information contained in the applicants’ requests constituted information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation 1367/2006.
In the March 7, 2019, decisions, the General Court/Fourth Chamber held that EFSA cannot argue that the requested studies do not concern actual emissions or the effects of actual emissions because “an active substance contained in plant protection products, such as glyphosate, in the course of normal use, is intended to be discharged into the environment by virtue of its function, and its foreseeable emissions cannot, therefore, be regarded as purely hypothetical.” The court further held: “It is apparent from that case-law that the concept of information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006 is not limited to information which makes it possible to assess the emissions as such, but also covers information relating to the effects of those emissions.” The Court further stated that the “concept of information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006 must be interpreted as covering not only information on emissions as such, namely information concerning the nature, composition, quantity, date and place of those emissions, but also data concerning the medium to long-term consequences of those emissions on the environment.”
The court also found that EFSA’s “argument that the conditions in which the requested studies were carried out are not linked to emissions is irrelevant. What matters is not the conditions in which the requested studies were carried out, but their purpose.” In these cases, the purpose to define a no observed adverse effect level (NOAEL) from which the ADI was calculated, or to determine the carcinogenic effects of exposing humans to glyphosate, “must be regarded as constituting information which ‘relates to emissions into the environment; for the purposes of Article 6(1) of Regulation No. 1367/2006.”
In sum, the court in Tweedale concluded:
- It follows from the foregoing that the exception relating to the protection of commercial interests, provided for in Article 4(2), first indent, of Regulation No 1049/2001, cannot be relied upon in order to object to the disclosure of the requested studies which are regarded as information which ‘relates to emissions into the environment’ for the purposes of Article 6(1) of Regulation No 1367/2006.
The court in Hautala further stated that “an overriding public interest in disclosing the studies is deemed to exist, and EFSA could not refuse to disclose them on the ground that that would have an adverse effect on the protection of the commercial interests of the owners of the requested studies for the purposes of Article 4(2), first indent, of Regulation No 1049/2001.”
These decisions support transparency but also may add confusion regarding any limitations placed on the scope of what is to be considered “information on emissions into the environment.” The prior 2018 Stichting decision refused access to information on the degree of purity of the active substance glyphosate, as well as the identity and quantities of impurities, finding that such information is excluded from the concept of “information relating to emissions into the environment:”
- Since the use, the conditions of use and the composition of a plant protection product authorised by a Member State on its territory may be very different from those of products evaluated at EU level during the approval of the active substance, it must be held that the information in the document at issue does not relate to emissions whose release into the environment is foreseeable and has, at the very most, a link to emissions into the environment.
These decisions may expand the scope of information that relates to emissions into the environment, including, for example, “data concerning the medium to long-term consequences of those emissions on the environment.” For information that is determined to constitute information that “relates to emissions into the environment,” the decisions appear to create a presumption for disclosure that cannot be countered based on the exception relating to the protection of the commercial interests of a particular natural or legal person.
Companies should continue to monitor these decisions closely, as guidance continues to evolve regarding the scope of disclosure.
More information on glyphosate issues is available on our blog.
This week, Lynn L. Bergeson sat down with Sheryl Lindros Dolan, a senior regulatory consultant here at Bergeson & Campbell (B&C®), to discuss all things pesticides: past, present, and future.
In the discussion, Ms. Dolan provides the historical and legal/regulatory background necessary to understand the current state of pesticide regulation, which the U.S. Environmental Protection Agency (EPA) manages under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as we like to call it. Listen to the full episode and subscribe here.
By Carla N. Hutton
The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. Under the proposed rule, products that combine sunscreens with insect repellents would not be GRASE. Publication of the proposed rule in the Federal Register will begin a 90-day comment period.
Sunscreen-insect repellent products are jointly regulated by FDA as sunscreen drugs and by the U.S. Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). On February 22, 2007, FDA and EPA both issued advance notices of proposed rulemaking (ANPR) requesting comment on the appropriate regulatory status of these products. FDA published a notice seeking information to formulate a regulatory position on insect repellent products that contain OTC sunscreen ingredients. 72 Fed. Reg. 7941. EPA published a similar notice announcing that it was also seeking information to determine how insect repellent-sunscreen combination products should be regulated to complete the reregistration review described in the Reregistration Eligibility Decision document for the insect repellent N,N-diethyl-meta-toluamide (DEET). 72 Fed. Reg. 7979.
In the proposed rule, FDA states that it reviewed comments submitted in response to the 2007 ANPRs, as well as pertinent scientific literature and publicly available EPA regulatory documents. Based on that review, FDA has tentatively concluded that sunscreen-insect repellent combination products, as a class, are not GRASE and are misbranded because conflicting labeling requirements for the sunscreen and insect repellent components cannot be reconciled to create labeling that will sufficiently ensure the safe and effective use of the sunscreen component, as well as adequate directions for use as a sunscreen. FDA states that even if it did not have this labeling concern, it would still tentatively determine that available data regarding the safety and effectiveness of these products for their use as sunscreens are insufficient to classify these sunscreen products as GRASE for such use. Specifically, according to FDA, evidence suggests that interactions between some sunscreen active ingredients and insect repellents may decrease safety by increasing systemic absorption of one or both components, and potential synergistic effects on the efficacy of sunscreen active ingredients apparently have not been studied.
The proposed rule states that FDA tentatively determines that sunscreen-insect repellent combination products are not GRASE for nonprescription sunscreen use. FDA seeks comment on this tentative determination. Publication of the proposed rule in the Federal Register on February 26, 2019, will begin a 90-day comment period. More information on the proposed rule is available in our memorandum, "FDA Will Publish Proposed Rule for OTC Sunscreen Drug Products."
By Heather F. Collins, M.S. and Margaret R. Graham, M.S.
The March 1, 2019, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2018 reporting year is fast approaching. Pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 7 (7 U.S.C. § 136e), “any producer operating an establishment registered [under Section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”
Reports must be submitted on or before March 1 annually for the prior year’s production. The report, filed through the submittal of EPA Form 3540-16: Pesticide Report for Pesticide-Producing and Device-Producing Establishments, must include the name and address of the producing establishment; and pesticide production information such as product registration number, product name, and amounts produced and distributed. The annual report is always required, even when no products are produced or distributed.
EPA has created the electronic reporting system to submit pesticide producing establishment reports using the Section Seven Tracking System (SSTS). Users will be able to use SSTS within EPA’s Central Data Exchange (CDX) to submit annual pesticide production reports. Electronic reporting is efficient, it saves time by making the process faster, and saves money in mailing costs and/or courier delivery and related logistics.
Link to EPA Form 3540-16, as well as instructions on how to report, and how to add and use EPA’s SSTS electronic filing system are available below.
Further information is available on EPA’s website.
By James V. Aidala
The short-term continuing resolution (CR) includes an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) through the duration of the funding measure, February 15, 2019. This was expected, and is welcome news to registrants who have delayed submittal of registration applications due to the shutdown.
The status of applications submitted during the shutdown period is uncertain at best. As described in our earlier blog item Registrants Face PRIA and Shutdown Issues, registrants were advised to not submit applications during the shutdown as the U.S. Environmental Protection Agency (EPA) has previously indicated that applications submitted during the shutdown would not be subject to any PRIA deadline. During this period of budget battles and shutdown uncertainty, it would appear to be prudent to ensure that any applications for registration are submitted while EPA (and PRIA) are operational under appropriated funding.
While this is good news, the uncertainty surrounding the possibility of another shutdown at the end of this period not only makes planning difficult for registrants, it also creates workload management problems at EPA to deal with backlogs and unpredictable resources for processing pending and new applications. EPA will have to clarify what the extended shutdown period means for processing times and priorities. As of today, EPA is still literally sorting out applications and PRIA deadlines along with workload planning to determine how best to proceed.
Stay tuned …
By James V. Aidala, Lisa M. Campbell, and Sheryl Lindros Dolan
Although the Office of Pesticide Programs (OPP) was able to operate through December 28, 2018, despite the current partial federal government shutdown, EPA will now join other parts of the federal service and shut down.
Meanwhile, the Pesticide Registration Improvement Extension Act (PRIA 3) sunset on December 21, 2018, in the absence of a Continuing Resolution (CR) and the onset of the shutdown. According to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 33(m)(2)(B) [7 USC § 136w-8(m)(2)(B)], the fee for any pesticide application that is subject to a service fee and submitted after December 21, 2018, will be reduced by 70 percent below the fee in effect on September 30, 2017, but no corresponding review period will be assigned. Any applications submitted now thus will not have a required EPA review period and thus will likely be the lowest priority for EPA review when the shutdown ends. For this reason, despite the lower fees, registrants should not submit applications until PRIA is enacted and defined review periods once again are established.
The enactment of some version of PRIA is expected soon, especially given the consequences of the current situation for EPA and government functions generally. Most likely any kind of authorization for funding government operations, such as a CR for a limited time period or for Fiscal Year 2019, is expected to include at least a simple reauthorization of the PRIA 3 for the duration of the CR. This would also mean the new Congress will have to act sometime in the next session to reauthorize PRIA either to continue PRIA 3 beyond a new CR time period or approve amendments such as those considered as PRIA 4 during the 115th Congress. Given the difficulty of Congress in reaching agreement on appropriations legislation, it is possible that PRIA reauthorizations continue to be included as part of CRs for an indefinite time period.
This uncertainty about the status of PRIA may also impact generally the program’s ability to plan and schedule review of registration applications.
Regardless of when PRIA is enacted, however, the shutdown will prevent EPA action on newly submitted applications. OPP states on its web site:
- Applications received on or prior to December 21, 2018, will be reviewed under the decision time frames specified in PRIA 3;
- Applications received after December 21, 2018, will be subject to the provisions of FIFRA Section 33(m)(2)(B); and
- Applications received after December 28, 2018, will not be considered as received or processed until the shutdown ends.
Registrants should monitor developments closely.
By James V. Aidala and Lisa M. Campbell
On December 19, 2018, the Senate passed a short-term Continuing Resolution (CR) to prevent a government shutdown and continue funding for the government through February 8, 2019. Currently, however, given the uncertainty over border wall funding, it appears likely that there may well be a government shutdown for some period of time. Until the immigration issue is ultimately resolved in an eventual agreement, however, the majority and Democratic staff of the U.S. House of Representatives Agriculture Committee expect that the Pesticide Registration Improvement Act (PRIA) extension will be included in the CR. Both the majority and minority in both the House and Senate have reportedly agreed to support PRIA in the new year.
The recent House Conference Report for H.R. 2, the Agriculture Improvement Act of 2018, or the Farm Bill, deleted previously inserted provisions regarding the Pesticide Registration Improvement Enhancement Act of 2017. The House version of the Farm Bill included the enactment of the Pesticide Registration Improvement Enhancement Act of 2017 (H.R. 1029, Section 9119), but the Senate version contained no comparable provisions. More information on the Farm Bill Conference Report is available in our memorandum “Congress Passes Farm Bill Conference Report.”
The positive news is that many members of both the House and Senate appear to remain committed to legislative reauthorization of PRIA. At the same time, with the change in party control in the House of Representatives, reauthorization may continue to be delayed as the new Congress with new Committee leadership devotes time and energy to competing priorities.
In addition, as PRIA amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), it could provide an opportunity for amendments to FIFRA outside of the funding context to be offered by members interested in other pesticide-relevant issues. Debate on additional pesticide issues would only likely lead to further delay and uncertainty about long-term reauthorization of PRIA.
By Timothy D. Backstrom
On December 12, 2018, the U.S. Environmental Protection Agency (EPA) announced a proposed joint stipulation and proposed stipulated notice of dismissal for Ellis v. Keigwin, No. 3:13-CV-1266 (N.D. Cal). 83 Fed. Reg. 63865. The Federal Register notice states that the parties are “proposing to reach a settlement in the form of a joint stipulation" that would, among other provisions “set a June 30, 2022, deadline for EPA to complete ESA [Endangered Species Act] effects determination for EPA’s registration reviews of clothianidin and thiamethoxam and, as appropriate, request initiation of any ESA consultations with the FWS [U.S. Fish and Wildlife Service] that EPA may determine to be necessary as a result of those effects determinations.” EPA would “also agree to initiate informal consultation" with the FWS prior to completing its effects determinations. In addition, defendant-intervenors Syngenta, Bayer, and Valent (the registrants of products containing clothianidin and thiamethoxam) have agreed to request that EPA voluntarily cancel the registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(b)(1) for 12 specific products that contain either clothianidin or thiamethoxam. EPA is requesting comments on both the proposed joint stipulation and the stipulated notice of dismissal. Comments are due by January 11, 2019.
The proposed joint stipulation and dismissal have been agreed to by all parties, including the plaintiffs, EPA, and defendant-intervenors Bayer, Syngenta, Valent, and CropLife America. This stipulation was negotiated by the parties after the District Court in the Ellis case issued an order ruling on cross motions for summary judgment on May 8, 2017. In that order, the court dismissed plaintiffs’ claims that EPA improperly denied a petition requesting that EPA immediately suspend products containing clothianidin, and also dismissed other claims that EPA violated FIFRA requirements for products containing clothianidin and thiamethoxam. At the same time, the court granted summary judgment for the plaintiffs on claims arising under ESA Section 7(a)(2), because EPA had failed to consult with FWS before taking particular actions concerning 59 pesticide products containing clothianidin or thiamethoxam. As part of the order, the court directed the parties to schedule a settlement conference to discuss an appropriate remedy, and the proposed stipulation is the result of those settlement discussions.
The Ellis case was brought by beekeepers and honey producers who wanted EPA to take immediate action to ban or restrict clothianidin and thiamethoxam products based on their belief that these neonicotinoid active ingredients pose an unacceptable risk to pollinator species. The court found that the plaintiffs did not demonstrate that these registered pesticidal active ingredients present an "imminent hazard" that would warrant suspension or emergency suspension under FIFRA Section 6(c), and the court also rejected the plaintiffs' other FIFRA claims concerning these products. In contrast, the court granted relief under the ESA because EPA did not make the required effects determinations concerning endangered and threatened species before taking various registration actions for pesticides containing these active ingredients, and the plaintiffs asserted a specific interest in those endangered or threatened species that might be adversely affected by these products. At this juncture, it is unknown whether the ESA review required by the agreed joint stipulation will lead to any further restrictions on these active ingredients that would have a collateral benefit for domesticated pollinators.
The proposed joint stipulation and the proposed stipulated notice of dismissal are available in EPA Docket No. EPA-HQ-OGC-2018-0745.
By Lisa M. Campbell and Timothy D. Backstrom
On December 6, 2018, the U.S. Environmental Protection Agency (EPA) announced it was proposing a rule (83 Fed. Reg. 62760) to harmonize the EPA-specific regulations regarding research involving human subjects conducted or sponsored by EPA or submitted to EPA for regulatory purposes with the revised regulations of the Federal Policy for the Protection of Human Subjects (Common Rule) issued on January 19, 2017 (82 Fed. Reg. 7149). Specifically, EPA is proposing to amend subparts C, D, K, and M of its regulations relating to human research. Subpart K, titled “Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults,” contains the majority of the revisions. Subparts C and D will be revised to update several numerical citations and subpart M will be revised to correct a typographical error.
By way of background, the Common Rule governs research with human subjects conducted or supported by federal agencies, but EPA has also promulgated parallel requirements governing research conducted by third parties and then submitted to EPA for regulatory purposes. In particular, Subpart K addresses human research that may be conducted by third parties and then utilized to support registration of pesticides. Congress mandated various revisions to the Common Rule (including additional requirements for research involving pregnant women, fetuses, and children), and EPA is now modifying the EPA-specific requirements for human research to assure consistency and uniformity. These changes are also intended to assure that a single Institutional Review Board (IRB) review meeting the requirements of the Common Rule will be sufficient for any given study.
The proposed rule states that subpart K, “in establishing a process for review of third-party research involving intentional exposure of human subjects, borrows heavily from the provisions contained in the previous version of the Common Rule,” and that it will be revised to “maintain consistency of [IRB] review between agency-conducted or agency-sponsored human research and third-party human research.” EPA states the consequence of not resolving these discrepancies will be to “create confusion and, more seriously, potential compliance and/or legal liabilities for researchers, institutions, and sponsors who must follow EPA regulations.” Comments on the proposed rule are due by February 4, 2019.
Compliance with the revisions to the Common Rule originally was set for January 19, 2018, but it has been extended to January 21, 2019. The compliance date for the “cooperative research” Section remains January 20, 2020. This proposed rule to revise the requirements for third-party research submitted to EPA would not make substantive changes to the previously adopted final revisions to the Common Rule. The final rule states that cooperative research projects are “those projects covered by this policy that involve more than one institution,” any institution located in the United States that is engaged in cooperative research must “rely upon approval by a single IRB for that portion of the research that is conducted in the United States,” and the reviewing IRB “will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the federal department or agency supporting the research.”
More information on the revision to the Common Rule is available in our blog item “Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects” and on our blog under key phrase Common Rule.
By Lisa M. Campbell and Lisa R. Burchi
On November 7, 2018, the U.S. Environmental Protection Agency (EPA) announced that it was ordering Pool Water Products Inc. to stop selling an improperly registered pesticide, ALL CLEAR 3” Jumbo Chlorinating Tablets. The announcement states that even though the ALL CLEAR 3” Jumbo Chlorinating Tablets product was registered with EPA, Pool Water Products was selling and distributing an unregistered version of the product made in China that has not been evaluated by EPA.
EPA’s action, which it states applies to nationwide distribution, transport and sales of the product, follows a statewide stop-sale order issued earlier this month by the Arizona Department of Agriculture when state inspectors discovered the unregistered pesticide, which is used to disinfect pools, during an August 30 inspection of the company’s Phoenix warehouse.
This case exemplifies the need for companies to understand Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration and amendment requirements, and the importance that a product’s label, formula, and manufacturing process match exactly with the information submitted to EPA and upon which EPA relied in approving the registration. Many composition and processing changes require an amendment to be approved by EPA; failure to do so could result in an enforcement action such as this one.
More information on pesticide registration issues is available on our blog.