By Lisa M. Campbell, Lisa R. Burchi and Timothy D. Backstrom
On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-73353, the U.S. Environmental Protection Agency (Respondent; EPA) filed a motion for voluntary vacatur and remand of EPA’s registration, as amended, of Dow AgroSciences LLC’s (Dow) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants.
This case commenced in October 2014 when the Natural Resources Defense Council (NRDC) and other environmental groups including the Center for Food Safety (CFS, et al.) (together, Petitioners) filed petitions for review challenging EPA’s decision to register Enlist Duo, a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D. Petitioners argued, in part, that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D.
EPA’s motion reverses EPA previous position that Dow’s application for Enlist Duo satisfied the requirements for issuance of an unconditional registration under FIFRA Section 3(c)(5). EPA states that it is seeking a voluntary remand to reconsider the Enlist Duo registration in light of new information regarding potential synergistic effects referred to as “synergistic herbicidal weed control” between the two active ingredients 2,4-D and glyphosate contained in Enlist Duo on non-target plants. Specifically, EPA is in the process of evaluating information submitted to it by DAS on November 9, 2015, in response to EPA’s request for all available information related to synergistic effects. EPA asserts that none of this information was submitted to EPA prior to EPA’s issuance of the Enlist Duo registration.
EPA states that the claimed synergism could affect EPA’s “assessment of drift reduction measures for avoiding impacts to non-target organisms, including those listed as endangered.” EPA also states that it “cannot be sure, without a full analysis of the new information, that the current registration does not cause unreasonable effects to the environment, which is a requirement of the registration standard under FIFRA” and that its initial review “indicates that the 30-foot buffer included in the registration may not be adequate.”
DAS has until December 7, 2015, to file its response before the court will consider EPA’s motion to remand the registration. Although it has not completed its assessment, EPA states that if the court vacates the Enlist Duo registration, EPA will issue a cancellation order to regulate the sale, distribution, and use of existing stocks of Enlist Duo pursuant to FIFRA. This case is being considered for the March 2016 oral argument calendar but the exact date of oral argument has not been determined at this time. More information regarding this case is available in our blog items Environmental Groups File Opening Briefs Challenging EPA’s Decision to Register Enlist Duo and Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review.
EPA’s request for remand with vacatur rather than a remand without vacatur is a severe action. EPA could have chosen to seek remand without requesting that the registration be vacated, and then demanded prompt revision of the buffer zone that EPA now believes may be inadequate to protect non-target plants from synergistic effects. EPA may have decided to send a message that there will be serious consequences when an applicant fails to submit all of the data in its possession that may be pertinent to EPA’s assessment of the statutory criteria for registration. In any case, Dow reportedly has stated that it does “not expect these issues to result in the long-term cancellation of the Enlist Duo product registration” and that Dow will “continue to prepare for commercial sales of Enlist Duo for the 2016 growing season with enthusiastic grower adoption."
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
In a press release issued on November 22, 2015, the Canadian province of Québec (Quebec) announced its release of Québec Pesticide Strategy 2015-2018. Although the Strategy itself is available only in French, Québec has provided a summary of the Strategy in English, which is available here.
Québec’s press release states that the Strategy “sets out the major directions and goals that will guide government action to protect public health, pollinators, and the environment in the coming years.” One of the ways the Strategy seeks to do this is to impose additional restrictions on the use of the "highest-risk pesticides" which the Strategy states includes atrazine, chlorpyrifos, and neonicotinoid insecticides. To reduce use of high risk pesticides, the Strategy’s “Objectives” to be implemented through legislative and regulatory changes include:
- Requiring agricultural application of such highest-risk pesticides to be "justified by an agronomist in advance of 100% of cases";
- Tripling of the number of pesticides that are banned in urban environments for use on lawns and green spaces;
- Obliging owners of golf courses that use the greatest amount of pesticides to reduce their use of the highest-risk products by 25 percent; and
- Authorizing the "unrestricted sale of all biopesticides by all retailers" and encouraging “the application of the lowest-risk pesticides through economic incentives (levies, permits and compensation fees).”
To lower exposures, the Strategy calls for ensuring adequate qualification levels for employees that apply pesticides and increasing mandatory minimum distance when pesticides are applied near inhabited areas.
With specific regard to neonicotinoid insecticides, Québec seeks to reduce such use with the following “Objectives,” some of which overlap with the Objectives noted above for high risk pesticides:
- Banning the use of all neonicotinoids for lawn and flower bed maintenance;
- Requiring agricultural application of such neonicotinoids to be "justified by an agronomist in advance of 100% of cases"; and
- Encouraging the use of seeds uncoated with neonicotinoids through economic incentives such as levies, permits, and compensation fees.
Québec also intends to obtain additional information about use of treated seeds in Quebec by requiring companies to submit reports on Québec sales of neonicotinoid-treated seeds.
Québec in its Strategy summary also describes the following specific activities it plans to undertake in 2016:
- Amend the Pesticides Management Code to “tighten the conditions under which pesticides may be used”;
- Modernize the Pesticides Act to incorporate coated seeds and strengthen compliance through a system of administrative penalties; and
- Hold pesticide users accountable by “having users of highest-risk pesticides assume a greater share of associated environmental and public health costs.”
Québec’s Strategy to impose additional restrictions on the use of the "highest-risk pesticides," including neonicotinoid insecticides, is part of its efforts following a 2011 strategy aimed at reducing the risks related to pesticide use by 25 percent by 2021. The Canadian province of Ontario also issued final regulations in June 2015 aimed at reducing the area planted with maize and soybean seed treated with neonicotinoid insecticides as discussed in our blog item Canadian Province Finalizes Neonic Reduction Rule, although Quebec’s Strategy goes arguably farther by broadening the scope of the pesticides at issue to include atrazine and chlorpyrifos. It remains to be seen whether different rules in different provinces will create any confusion or other regulatory issues for companies seeking to comply with these restrictions.
In the U.S., the issue of forbidding “prophylactic” use of pesticides has been raised to date primarily at the local level in a relatively few number municipalities. Regarding pollinator issues more generally in the U.S., the U.S. Environmental Protection Agency (EPA) is in the process of reviewing comments it received on its “Proposal to Mitigate the Exposure to Bees from Acutely Toxic Pesticide Products” released earlier this year. The next milestone in EPA activity related to neonicotinoid pesticides is the expected release of a registration review risk assessment document for imadicloprid, a widely used neonicotinoid insecticide, before the end of the calendar year.
More information on pesticides and pollinators is available on our blog under topics "pesticides" and "pollinators."
By Lisa M. Campbell and Lisa R. Burchi
On November 6, 2015, the U.S. Environmental Protection Agency (EPA) announced that it has a new webpage that compiles information about secondary containers and service containers for pesticides. Secondary and service containers are containers that are used by the pesticide industry as part of the process of applying pesticides, not for further sale or distribution. EPA states that the website combines and replaces information previously found on the Labeling Questions and Answers page and in the Label Review Manual, and addresses frequently asked questions. The announcement states “this is not new guidance, but the EPA hopes this new resource will make information on secondary and service containers easier to find and will lead to improved handling of these containers.” According to EPA, the webpage is designed to help pesticide registrants and applicators:
- Understand EPA’s definition of secondary and service containers;
- Learn about EPA’s recommendations for good management practices when labeling secondary and service containers; and
- Learn how to properly identify the contents of a secondary or service container, including when the pesticide is diluted.
Although registrants are not required to submit labels to secondary containers to EPA for review, EPA provides the following Q&A for when EPA will approve such labels if submitted to EPA for review:
Q: If a registrant wishes to submit and have EPA review the secondary container label, what does EPA require?
A: As it isn't required that a secondary container label be submitted, there are no requirements per se. EPA will review them on a case-by-case basis and would be likely to accept them if:
- The EPA-approved master label includes directions for diluting the product.
- The secondary container label is submitted as part of the master label.
- The master label bears a statement that the secondary container must be labeled as presented on the master label (e.g., “When this product is diluted in accordance with the directions on this label, the dilution container must bear the following statements:”)
- The secondary container contains a statement prohibiting further sale or distribution.
- The secondary container may have reduced precautionary language (if supported by dilution-specific acute toxicity data), but not a reduced signal word.
Requirements governing secondary containers are often a source of questions within the regulated community; many may find EPA’s new website a useful source of information on this topic.
NAFTA TWG on Pesticides Meeting
By Lisa M. Campbell and Margaret R. Graham
On November 3-5, 2015, the North American Free Trade Agreement (NAFTA) Technical Working Group (TWG) on Pesticides, established in 1997 to streamline certain pesticide shipments between Canada (CN), Mexico (MX), and the United States (U.S.), held a meeting hosted by the U.S. Environmental Protection Agency in Durham, North Carolina. NAFTA TWG states that its primary objective “is to develop relevant and cost-effective pesticide regulation and trade among the three countries and meet the environmental, ecological, and human health objectives of NAFTA.” Further, TWG partners address trade issues, national regulatory and scientific capacity, governmental review burden, and coordination of regulatory decision making and industry burden reduction.
The topics discussed at its November meeting, a government-stakeholder meeting with the Executive Board, regulatory officials, and interested stakeholders such as growers, industry, and public interest groups, were:
Five-Year Strategic Plan and NAFTA Industry Working Group (IWG) Updates. The presentation was as follows:
Science and Policy Initiatives:
- Updates on Pollinator Protection in the U.S., CN, and MX. The presentations were as follows:
“Update on Pollinator Protection Activities in the U.S.” (Lead: U.S. - Rick Keigwin);
“Pollinator Protection in Canada” (CN - Scott Kirby);
MX’s input regarding “US EPA Guidance for Assessing Pesticide Risks to Bees” (Lead: MX -
SEMARNAT or SENASICA);
“Update on Mexican Project: Preliminary Study on Some Factors That Influence on Bee Colony
Loss in Different Regions of Apicultural Importance in Mexico” (Lead: MX - Nelly Peña); and
“Pollinator Update: US, CN, and MX” - Presentation on Behalf of IWG on Pesticides (Lead: CN -
Maria Trainer, CropLife Canada).
- Re-evaluation of Neonicotinoid Pesticides Update in the U.S. and Canada. The presentation was as follows:
“Update on Re-evaluation of Neonicotinoid Pesticides in the U.S. and CN” (Leads: U.S. -
Don Brady and CN - Margherita Conti).
- Minor Use Program Developments. The presentations were as follows:
“Joint Minor Use Updates” (Leads: U.S. - Susan Lewis and CN - Margherita Conti); and
“IR-4: Update on Local Minor Uses” (Leads: U.S. IR-4 - Dan Kunkel and MX -
Alma Liliana Tovar Diaz).
- Maximum Residue Limits (MRL)/Codex. The presentations were as follows:
“MRL Alignment Activities Update” (Leads: U.S. - Susan Lewis and CN - Yadvinder Bhuller);
“Benefits of Harmonized MRLs” (Lead: CN - Gordon Kurbis, Pulse Canada); and
“Inadvertent Residues” (Lead: CN - Craig Hunter, Ontario Fruit and Vegetable Growers’
Stakeholder Presentations and Discussions:
- Stakeholders’ Lessons Learned on Joint Reviews including Industry’s Experiences and Prospectives of Joint Reviews. The presentations were as follows:
Lead: CN - Tanya Tocheva, Syngenta Crop Protection Canada;
Lead: CN - Gordon Kurbis, Pulse Canada; and
Lead: MX - Hector Guillén, Avocado Growers Association, APAMEX.
- Progress of the TWG’s joint action plan and receipt of input on the next phase of activities.
- Discussion on Future Collaboration Regarding Joint Review.
The presentations, many of which address issues of significant controversy and debate, are of interest to many in industry and to other stakeholders.
By Lisa M. Campbell, Timothy D. Backstrom, and Susan Hunter Youngren, Ph.D.
On October 30, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is requesting comments on a proposal to revoke all tolerances for the insecticide chlorpyrifos. EPA issued this proposal in response to an August 10, 2015, writ of mandamus by the U.S. Court of Appeals for the Ninth Circuit. The court granted this unusual relief in response to a 2007 administrative petition to cancel chlorpyrifos registrations or to revoke chlorpyrifos tolerances by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (together, Petitioners). The court’s August 10, 2015, order required that EPA do one of the following by October 31, 2015: (a) cancel the registrations of all pesticides containing chlorpyrifos; (b) issue a proposed or final rule to revoke chlorpyrifos tolerances; or (c) issue a full and final response to the administrative petition to cancel chlorpyrifos. More information on that decision is available in our blog item Circuit Court Grants Writ of Mandamus Requiring EPA to Act on Petition to Ban Chlorpyrifos.
In its announcement, EPA states that it “is not denying the petition because we are unable to make a safety finding based on the science as it stands currently. EPA is not issuing a final revocation rule because we have not proposed it and have not completed our refined drinking water assessment, leaving certain science issues unresolved.” The court also required EPA to provide the timeline for a final rule should EPA issue a proposed revocation by October 31, and EPA notified the court of an anticipated date for a final rule of December 2016. EPA will release a completed hazard assessment and a completed drinking water analysis for comment prior to issuance of any final rule.
Because EPA has not completed its hazard assessment and drinking water analysis, this means that EPA may resolve the “science issues” without the need for tolerance revocations. The proposal is based not on the risk posed by chlorpyrifos residues in food, but on the incremental risk posed by chlorpyrifos in drinking water in very specific and limited watersheds where chlorpyrifos is heavily used. EPA is required to consider such exposures in evaluating the safety of chlorpyrifos residues in food under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act (FQPA). If the tolerances are revoked, this will result in cancellation of the associated food uses of chlorpyrifos.
The chlorpyrifos registrant Dow AgroSciences and other pesticide industry representatives do not agree with the EPA analysis or the proposal to revoke the tolerances. In particular, questions have been raised about EPA’s decision to retain the use of a 10X FQPA safety factor for infants and children based on certain epidemiology studies. EPA has acknowledged that these studies have significant limitations and that they cannot identify a specific level of concern for quantitative risk assessment. EPA has previously reduced the FQPA safety factor for chlorpyrifos to one based on the completeness of the toxicological database. If the 10X FQPA safety factor were reduced to one or even to three, the results of the current risk assessment would be very different.
Additional information, including the pre-publication version of the proposed rule, is available here.
By Lisa M. Campbell and Lisa R. Burchi
In a November 2, 2015, Federal Register notice, the U.S. Environmental Protection Agency (EPA) issued the final rule revising the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS). EPA previously announced these revisions on September 28, 2015, and stated that it would issue the final rule in the Federal Register within 60 days.
The following are important dates:
- January 4, 2016: The date when the final WPS rule is effective.
- January 4, 2017: The date by which agricultural employers and handler employers will be required to comply with all of the new requirements set forth in the final rule except for the ones listed below.
- January 4, 2018 (Or 180 Days After An EPA Announcement That Training Materials Are Available, Whichever Is Later): The date by which agricultural employers and handler employers will be required to comply with certain new requirements for the content of pesticide safety training for workers and handlers and pesticide safety information display (to be codified at 40 C.F.R. § 170.311(a)(3), 40 C.F.R. § 170.401(c)(3), and 40 C.F.R. § 170.501(c)(3)). EPA states it delayed implementation of the final rule regarding certain training and display materials to provide agricultural employers and handler employers time for such materials to be updated, printed, and distributed as well as to allow time for existing trainers to familiarize themselves with those new materials.
- January 4, 2018: The date by which agricultural employers and handler employers will be required to comply with the requirement that the handler performing an application must immediately suspend a pesticide application if any worker or other person, other than an appropriately trained and equipped handler involved in the application, is in the application exclusion zone described in § 170.405(a)(1) or the area specified in column B of the Table in § 170.405(b)(4) (to be codified at 40 C.F.R. 170.505(b)).
EPA also states that it is “committed to a robust outreach, communications and training effort to communicate the new rule requirements to affected WPS stakeholders.” EPA has stated its intent to do the following to facilitate implementation:
- Issue plain language “how to comply” fact sheets and guidance materials.
- Develop compliance assistance materials that are targeted to specific agricultural sectors and rule requirements, such as respirator requirements or the WPS exemptions and exceptions.
- Develop and disseminate new worker and handler training materials, conduct outreach to potentially affected parties, and provide assistance and resources to States and Tribes for WPS implementation.
- Hold Pesticide Regulatory Education Program courses for State and Tribal pesticide program staff that will focus on WPS implementation, and Pesticide Inspector Residential Training courses for State and Tribal pesticide inspectors that will focus on WPS inspection requirements.
The details of the WPS final rule are discussed in Bergeson & Campbell, P.C.’s (B&C®) blog entry EPA Announces Revisions to Its Worker Protection Standard.
For more information, please see B&C’s memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2015 and James V. Aidala Comments on EPA’s Worker Protection Standards. More information is also available on EPA’s Worker Protection Standard webpage.
By Lisa M. Campbell, Lisa R. Burchi, Timothy D. Backstrom, and James V. Aidala
On October 23, 2015, in the U.S. Court of Appeals for the Ninth Circuit, the Natural Resources Defense Council (NRDC) and other environmental groups including the Center for Food Safety (CFS, et al.) (together, Petitioners) filed separate opening briefs in Case Nos. 14-73353 and 14-73359 (consolidated) arguing that the U.S. Environmental Protection Agency’s (EPA) decision to register Dow AgroScience’s Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on Enlist corn and soybeans should be overturned because it violates the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Endangered Species Act (ESA). EPA approved Enlist Duo for use in six states on October 15, 2014, and granted an amendment on March 31, 2015, to authorize use in an additional nine states. On August 11, 2015, the Court of Appeals denied motions for a stay pending review that were filed by these same environmental Petitioners on December 18, 2014, and February 6, 2015. See “Ninth Circuit Denies Requests to Stay Use of Enlist Duo Herbicide During Judicial Review.”
In its brief, NRDC notes that when EPA proposed to register Enlist Duo, it stated that no new assessment is needed for glyphosate because use of glyphosate on herbicide-resistant crops is not a new use. NRDC argues that there are many new studies concerning glyphosate’s human health effects and impacts on monarch butterflies since EPA reregistered glyphosate and last prepared comprehensive environmental and human health assessments in 1993. NRDC argues that “By failing to consider up-to-date science on glyphosate’s cancer risk, EPA again violated its statutory duty to ensure that registration of Enlist Duo would not cause ‘unreasonable adverse effects on the environment,’ which includes an unreasonable risk to human health.”
In their brief, CFS, et al. argue that EPA violated FIFRA by ignoring its own modelling indicating that risks to wildlife from Enlist Duo exceed EPA’s risk thresholds. CFS, et al. also focus on purported violations of the ESA, arguing that EPA improperly failed to consult with the U.S. Fish and Wildlife Service on the potential impacts of Enlist Duo on protected species and their critical habitat, and that EPA applied an “unlawful approach” to determine whether registration of Enlist Duo “may affect” listed species or critical habitats.
NRDC also filed a motion to supplement the record with three documents that it states were submitted to EPA, but it contends were not considered by EPA before it issued its registration decision for Enlist Duo. The documents include an article published by the World Health Organization’s (WHO) International Agency for Research on Cancer stating that glyphosate is “probably carcinogenic to humans”; a statement published by WHO in conjunction with its cancer finding, and a letter from NRDC and other concerned parties calling on EPA to reconsider its initial decision to register Enlist Duo in light of the WHO’s cancer finding.
Petitioners’ arguments in these opening briefs are not unexpected, as pesticide products containing glyphosate have been challenged and controversial for many years. In briefs opposing the prior stay motions by the Petitioners, EPA and the registrant Dow AgroSciences argued that registration of Enlist Duo will not lead to any increase in the use of glyphosate, and that EPA also considered all of the human health effects of 2,4-D before granting the registration. The Petitioners acknowledge that EPA did not state when it last conducted environmental and human health assessments for glyphosate, and EPA is likely to object to Petitioners' inference that EPA has not reviewed the environmental and health effects of glyphosate since 1993. In the fact sheet concerning its decision to register Enlist Duo, EPA states that it conducted a “rigorous analysis” of all the scientific studies, considered all public comments, and used worst-case estimates when assessing the safety of Enlist Duo. In addition, the Petitioners do not discuss the determination by the the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS), that three varieties of herbicide resistant corn and soybeans on which Enlist Duo will be applied are no longer considered regulated articles under regulations governing the introduction of certain genetically engineered organisms, because they are unlikely to pose a plant pest risk.
EPA and Dow AgroSciences’ answering briefs are due December 18, 2015, and reply briefs are due January 15, 2016. Oral argument has not yet been scheduled.
By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala
On October 27, 2015, 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 Policies and Procedures to Manage Public Pesticide Petitions in a Transparent and Efficient Manner” (OIG Report). OIG evaluated how EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) tracks the receipt, disposition and resolution of public petitions, focusing on OCSPP’s Office of Pesticide Programs (OPP) and its policies and procedures used to ensure consistency and transparency when responding to pesticide-related public petitions. Although pesticide petitions can be submitted to EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), the Administrative Procedure Act (APA), or any combination of these authorities, OIG’s “At a Glance,” a document summarizing the OIG Report, states that OPP “does not have policies or procedures to ensure transparency when managing public pesticide petitions.”
OIG’s Report outlines three main areas for improvement in communication, stating that OPP has not effectively communicated with petitioners in the following manner: (1) acknowledging petition receipt; (2) providing updates about the agency’s work to resolve petitions; and (3) providing petition decisions. For example, OIG noted that since FIFRA does not set forth requirements for EPA to respond to a petition within a specific timeframe, petitioners in many circumstances filed lawsuits claiming EPA had not responded within a reasonable amount of time as required under the APA.
In addition, OIG states that OPP lacks policies and procedures to manage petitions in a generally efficient or effective manner, specifically noting: (1) petition documentation is not readily accessible, which was inconsistent with each of the EPA’s Records Management Policies in place during the timeframe of OIG’s review; (2) some petition data are inaccurate, which results in the duplication of work to confirm data; (3) according to OPP, petitions may take weeks to arrive at the correct office for action, because there is no guidance on how to submit petitions directly to OPP; and (4) OPP does not provide guidance to the public on how to submit complete petitions, which results in some petitioners providing supplemental information, therefore increasing the time and resources to reach petition decisions.
The report makes four recommendations of actions that should be taken by the Assistant Administrator for OCSPP that OIG believes will address the issues. In a memorandum attached to the OIG report, OCSPP agreed with these recommendations, provided corrective actions, and estimated completion dates. OIG’s recommendations and OCSPP’s Corrective Actions in response to them are as follows:
Recommendation 1: Develop policies and standard operating procedures to manage public petitions received by OPP in a transparent and efficient manner, which includes direct communication with petitioners by:
- Providing a letter to the petitioner acknowledging receipt of the petition;
- Communicating petition decisions to the petitioner in writing; and
- Providing updates to petitioners about the status and progress of pending petitions.
Corrective Action 1: OCSPP’s OPP will develop appropriate policies and standard operating procedures (SOP) to manage public petitions received by OPP in a transparent and efficient manner. The procedures will include the direct communication protocols listed in the OIG’s recommendation. Estimated date of completion: October 2016.
Recommendation 2: Train staff managing public pesticide petitions to adhere to the EPA’s Records Management Policy.
Corrective Action 2: The SOPs described in Corrective Action 1 will address maintaining appropriate records for covered petitions. When the SOP is final, OPP will issue a memorandum informing appropriate staff and management of their responsibilities for maintaining these records, and directing the use of the SOPs to meet their responsibilities under the Agency’s Records Management Policy. Estimated date of completion: November 2016.
Recommendation 3: Develop and implement an effective petition tracking system for public pesticide petitions.
Corrective Action 3: The SOPs described in Corrective Action 1 will include procedures for tracking petitions not covered by certain regulations, including petitions seeking FIFRA and APA rulemaking or cancellation of registrations. Estimated date of completion: October 2016.
Recommendation 4: Provide criteria and guidelines for submission of public pesticide petitions that provide sufficient information for EPA review.
Corrective Action 4: OCSPP commits to develop and post to the Agency Pesticides website criteria and guidelines for public submission of pesticide petitions not covered by 40 CFR § 180.7. Estimated date of completion: October 2017.
Petitions under FIFRA have been a relatively obscure tool in the past because of some of the issues this report seeks to address. With no deadline for a response, some petition responses have languished for many years (reportedly up to seven years in some cases). This partly becomes a “chicken and egg problem;” since it was not clear if and when a response would be forthcoming, it was a relatively unused tool. Indeed, as OIG’s report points out, only 40 pesticide petitions were submitted between FY2005 and 2014, with almost half (17) still pending.
In recent years, the Obama Administration has made it a point to respond more timely to FIFRA petitions, and as a result, petition filings may have become more attractive to various stakeholders. One practice that has been a vulnerability for OPP in the past is that not responding whatsoever would more likely lead to a successful “unreasonable delay” suit. OSCPP’s agreement with the OIG Report recommendations to more clearly state rules of engagement and how to frame expectations about a petition response process appears to be a continuation of the emphasis of EPA leadership on responding to petitions in a timely and more predictable manner.
By Lisa M. Campbell and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has launched a new pesticides website: http://www2.epa.gov/pesticides, and a new biopesticides website: http://www2.epa.gov/pesticides/biopesticides, among others. EPA states that this gradual move to new versions of its content is part of a larger EPA effort to build a more user-friendly website.
The updated biopesticides website focuses on providing general information on biopesticides, as well as tools to assist applicants for registration, and is organized into the following areas:
- What are biopesticides?;
- Biopesticide registration information;
- Plant incorporated protectants (PIPs); and
- Where can I find more information on biopesticides?
With this transition, web page addresses will be different which may cause links and bookmarks to break. EPA states that it is working to fix any broken links. The majority of the old pesticide pages will redirect to the new web areas, but bookmarks will still need to be updated. EPA’s new “Page Not Found” notification will help website users find what they are looking for by providing suggested search terms, links to the A-Z index, and other helpful links. The search feature available on every EPA web page and in the archive (archive.epa.gov) can also be useful in finding content.
Other updated pesticide related links are:
By Lisa M. Campbell, Lisa R. Burchi and James V. Aidala
On September 28, 2015, the U.S. Environmental Protection Agency (EPA) announced revisions to its worker protection standard. EPA states that these revisions are intended to “enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective equipment, and the providing of supplies for routine washing and emergency decontamination.”
Among the changes to the WPS are the following:
- Training: The final rule retains proposed content expansions that have been the subject of considerable discussion and concern (e.g., provisions that EPA intends to reduce take-home exposure) and the requirement for employers to ensure that workers and handlers receive pesticide safety training every year (increased from existing rules that require training every five years). EPA has eliminated the proposed training “grace period,” that would have allowed employers to delay providing full pesticide safety training to workers under certain circumstances.
- Notification: The final rule retains the proposed requirements for employers to: (1) post warning signs around treated areas in outdoor production when the product used has a restricted-entry interval (REI) greater than 48 hours; and (2) provide to workers performing early-entry tasks (i.e., entering a treated area when an REI is in effect), information about the pesticide used in the area where they will work, the specific task(s) to be performed, the personal protective equipment (PPE) required by the labeling, and the amount of time the worker may remain in the treated area. EPA has not promulgated the proposed requirement for employers to keep a record of the information provided to workers performing early-entry tasks.
- Hazard Communication: The final rule requires employers to post pesticide application information and a safety data sheet (SDS) for each pesticide used on the establishment at a central location on the establishment (the “central display”). This is a departure from the proposal to eliminate the existing requirement for a central display of pesticide application-specific information. The final rule also requires the employer to maintain and make available to workers and handlers, their designated representatives, and treating medical personnel upon request, the pesticide application-specific information and the SDSs for pesticides used on the establishment for two years. EPA has eliminated the proposed requirement for the employer to maintain copies of the labeling for each product used on the establishment for two years.
- Requirements During Pesticide Applications: The final rule requires an “application exclusion zone,” that is, the area immediately surrounding the application equipment, from which workers and other persons must be excluded. An application exclusion zone of 100 feet horizontally from the application equipment in all directions applies when the pesticide is applied by any of the following methods: (1) aerially; (2) air blast application; (3) as a spray using a spray quality (droplet spectrum) of smaller than medium (volume median diameter of less than 294 microns); or (4) as a fumigant, smoke, mist, or fog. An application exclusion zone of 25 feet horizontally from the application equipment in all directions applies when the pesticide is sprayed from a height of greater than 12 inches from the planting medium using a spray quality (droplet spectrum) of medium or larger (volume median diameter of 294 microns or greater). This “application exclusion zone” differs from the proposed “entry-restricted areas,” that would have extended a specified distance around the entire treated area during application based on the application equipment used. The final rule requires handlers to suspend application, rather than cease application, if they are aware of any person in the application exclusion zone other than a properly trained and equipped handler involved in the application.
- Minimum Age: The final rule increases the minimum age for handlers and workers performing early-entry tasks from a proposed 16 years old to at least 18 years old. EPA states it increased the minimum age from 16 to 18 based on “comments received and an evaluation of existing literature related to adolescents’ development of maturity and judgment.” EPA provides an exemption from minimum age requirements for adolescents working on an establishment owned by an immediate family member. The final rule does not require the employer to record workers’ or handlers’ birthdates as part of the training record, but does require the employer to verify they meet the minimum age requirements.
- PPE: The final rule cross-references certain Occupational Safety and Health Administration (OSHA) requirements for respirator use for which employers will be required to comply. In response to comments, the final rule expands the respirators subject to fit testing beyond the proposal to include filtering facepiece respirators. The final rule maintains the existing exception from the handler PPE requirements when using a closed system to transfer or load pesticides, and adopts a general performance standard for closed systems, which differs from the specific design standards based on California’s existing standard for closed systems discussed in the proposal.
EPA received a significant number of comments on the proposed rule, which has generated significant controversy. While it appears that EPA has modified the final WPS in certain respects in response to concerns raised, there remain many provisions that are controversial and will require significant work, with significant costs, by agricultural and handler employees to meet.
Controversy regarding these new requirements is longstanding. At its most simple form, critics of increasing the stringency of the current regulations ask why significant changes were needed after twenty years of greater protection offered by the existing regulatory requirements. In addition, over the intervening years, for a variety of reasons, many (not all) of the most hazardous pesticides have been removed from the market or otherwise are used less. More complex concerns address potential jurisdictional overreaches and the paltry record supporting what some view as expansive and expensive regulatory requirements. Others, not surprisingly, cite the number of reported (and unreported) incidents as proof for the need nonetheless to improve the extent and effectiveness of the current regulations. What EPA has issued here as the final revisions to the regulations attempts to balance these views.
Some believe that, in similar situations, where industry and activist groups criticize an action, albeit for very different reasons, the EPA action at issue must have struck the correct balance of disparate views. This breezy measure of success in an important health protection program such as this rule addresses by definition is not likely to satisfy either perspective, and complaints about the new requirements can be expected to continue, especially about the economic impact of the new requirements for some, and for others, how the occupational risks of pesticides remain too high and deserve even greater restrictions.
Outside the boundaries of the worker protection regulations, some of the underlying logic and regulation of the updated requirements indicate that EPA, at least under the current Administration, will continue its emphasis on the broader goals of environmental justice and protecting “children” from the hazards of pesticide exposure. (For example, among the most controversial elements of the changes is the prohibition on certain activities for those under the age of 18, while beforehand the cutoff age was 16; this seems partly a result of EPA’s attempt to make its policy of prohibiting testing of pesticides on children consistent with its policy of who might be exposed in occupational settings.)
The final rule will become effective 60 days after it is published in the Federal Register, but agricultural employers and handler employers will not be required to comply with most of the new requirements in the final rule until 14 months after the effective date.
For more information, please see Bergeson & Campbell, P.C.’s (B&C®) memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2015 and James V. Aidala Comments on EPA’s Worker Protection Standards. More information is also available on EPA’s Worker Protection Standard webpage.