By Susan M. Kirsch and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has announced that it will be hosting several events to gather input on regulatory actions that could be repealed, replaced or modified as part of EPA’s regulatory reform efforts under Executive Order (EO) 13777.
The Office of Pesticide Programs (OPP) will host a public meeting on the Pesticide Program Dialogue Committee (PPDC) on May 3, 2017, from 9:00 a.m. to 4:45 p.m. (EDT), and on May 4, 2017, from 8:30 a.m. to 12:00 p.m. (EDT). The session on May 4, 2017, will focus on receiving public feedback on pesticide regulatory reform issues. Registration will be required to attend the May 4, 2017, meeting only. Interested participants may register here. The deadline for registration is April 27, 2017.
The Office of Water (OW) will also host a listening session on May 2, 2017, from 11:00 a.m. to 2:00 p.m. (EDT) and participants may either pre-register here to join by phone (space limited) or join via web conference here. Pre-registration is not required for web participation. The deadline for registration is April 27, 2017.
In the pesticide space, EPA-OW is responsible for the National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit (PGP), which requires NPDES permitting for pesticide applications into, over and near “Waters of the United States,” including mosquito abatement activities. The U.S. Court of Appeals for the Sixth Circuit issued a 2009 decision requiring EPA to regulate pesticides under the NPDES program. Both industry and state co-regulators have criticized PGP requirements as duplicative, burdensome, and unnecessary for pesticides applied in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Attempts to pass legislation that would eliminate NPDES permitting for FIFRA-compliant pesticides applications have not been successful to date. EPA’s actions under EO 13777 may offer an administrative mechanism to repeal the PGP. It is unclear, however, if a repeal would be legally defensible in light of the Sixth Circuit ruling. Alternatively, EPA could modify the PGP to eliminate the reporting and recordkeeping requirements that opponents find overly burdensome. Pesticide stakeholders may wish to join the May 2, 2017, OW listening session to provide recommendations.
Written comments on regulatory reforms on all regulatory reforms, including OW and OPP issues, will also be accepted in docket EPA-HQ-OA-2017-0190, Evaluation of Existing Regulations, currently open through May 15, 2017. More details on the NPDES permit for pesticides are available in our blog item EPA Issues Final 2016 NPDES Pesticide General Permit.
By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham
In a two-page order issued on April 10, 2017, the U.S. District Court for the Middle District of North Carolina granted in part a motion for summary judgment filed by “me-too” registrants, Willowood, LLC, Willowood USA, LLC, Willowood Azoxystrobin, LLC, and Willowood Limited (Defendants), regarding Syngenta Crop Protection, LLC’s (Plaintiff) claims of copyright infringement. Syngenta Crop Protection, LLC v. Willowood, LLC, Case No. 1:15-CV-00274. The claims at issue (Counts V and VI of Plaintiff’’s complaint) were based on the Defendants’ use of Syngenta’s label. The court stated that it was granting this part of Defendants’ motion “because the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) precludes copyright protection for the required elements of pesticide labels . . . of me-too registrants.”
Counts V and VI of Plaintiff’s complaint stated that Defendant copied and used substantial portions of Syngenta’s copyrighted work, and that this infringement is “willful and knowing.” The Defendants’ motion for summary judgment stated with regard to the copyright infringement counts of the complaint:
- Counts V and VI fail as a matter of law because Defendants’ labels comply with applicable federal regulations and contain language that is mandated by federal law. Moreover, under settled law, the portions of Plaintiff’s labels that Plaintiff asserts Defendants have copied are not entitled to federal copyright protection. Finally, to the extent that any portions of Plaintiff’s labels are entitled to copyright protection, Defendants’ copying is permitted under the fair use doctrine.
The order states that “in enacting FIFRA, Congress intended narrow exception to copyright protection for the required elements of pesticide labels as against me-too registrants.” The court expressly rejects the lengthy 2005 decision issued by the District Court for the Eastern District of Pennsylvania, which reached a different conclusion in a similar case, stating that it finds the analysis in that decision “unconvincing.” FMC Corp. v. Control Solutions, Inc., 369 F. Supp. 2d 539, 555-71 (E.D. Pa. 2005). The court states: “FIFRA contemplates that a ‘me-too’ applicant will copy from the original pesticide label in ways that would otherwise infringe a copyright.”
Of interest, the court states that its grant of the summary judgment motion with respect to the copyright claims does not need to take into account an expert report or declarations by, among others, former EPA Office of Pesticide Programs (OPP) officials Debra Edwards and Lois Rossi, filed by Defendants because “the Court is granting the summary judgment motion on legal grounds unrelated to the proffered evidence.”
Plaintiff filed its complaint on March 27, 2015. The complaint included seven counts against Defendants: the infringement of four patents in violation of 35 U.S.C. § 271(a) (Counts I-IV), the two copyright infringement counts (Counts V-VI), and a violation of the Unfair and Deceptive Trade Practices Act (N.C. Gen. Stat § 75-1.1) (Count VII). Count VII of the complaint was dismissed on August 12, 2016, and on March 24, 2017, the court granted Plaintiff’s motion for summary judgment regarding the infringement of two of the four patents; a decision on the infringement of the remaining two patents is still pending.
This opinion, which squarely rejects the 2005 conclusion of another district court, is likely to be of controversy and is the most recent decision in a long-standing debate on this issue between basic registrants and me-too registrants. EPA in the past has appeared to side with the me-too registrants. For example, in an August 3, 2005, letter to the Chemical Producers and Distributors Association (CPDA), written in response to the FMC decision, EPA stated that it “has been the practice of [OPP] since the enactment of FIFRA section 3(c)(7)(a) in 1978 to strongly encourage ‘me-too’ product labels to be identical or substantially similar to the labels of the products on which their registrations are based.” In that letter, EPA stated further: “Conveying application instructions and safety messages for similar products in different ways increases the likelihood that the product will be misused.” EPA at the time noted that there were over 650 mostly “me-too” products for just one herbicide (2,4,-D) -- and that having 650 products each having to say some of the required use instructions differently would be impossible.
Nonetheless, some elements of the label might be viewed as proprietary -- the “look and feel” of a product label, perhaps certain fonts, and trademarked product name (as opposed to the active ingredient name). It remains to be seen whether the April 10, 2017, order is the last judicial word on this subject or whether the issue will continue to be litigated. It is an issue that all registrants should monitor closely.
By Lisa M. Campbell and James V. Aidala
On April 5, 2017, Petitioners Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) filed a Motion for Further Mandamus Relief in the Ninth Circuit Court of Appeals proceedings regarding the chlorpyrifos tolerances. In the motion, Petitioners respond to the U.S. Environmental Protection Agency’s (EPA) order signed on March 29, 2017, which denied the petition to revoke tolerances. Petitioners state that EPA’s response to the petition (the order) is “no response at all and not what this Court ordered EPA to do,” and asks the court to “grant further mandamus relief, giving EPA 30 days to act on its findings that chlorpyrifos exposures are unsafe and to establish deadlines for the next steps in the revocation and cancellation processes for chlorpyrifos.” Specifically, Petitioners request that the court order EPA to:
- Take regulatory action within 30 days on its finding that chlorpyrifos is unsafe and “make it abundantly clear that what is required within 30 days is final regulatory action based on the neuro-developmental and other risks posed by chlorpyrifos exposures”;
- Resolve objections to its final regulatory action within 60 days, as opposed to “as soon as practicable after receiving the arguments of the parties,” because, Petitioners assert, EPA otherwise may put off their response for a long period of time;
- Require EPA to issue a notice of intent to cancel all chlorpyrifos uses within 60 days, “consistent with its risk assessments and findings that chlorpyrifos is unsafe,” as it has “found drinking water contamination from all chlorpyrifos uses, including nonfood uses, and will need to take regulatory action to end such uses in addition to stopping food uses”; and
- File six-month status reports until the tolerance revocation process and the cancellation proceedings are complete.
It is no surprise that the Petitioners who were disappointed by EPA’s denial of the petition one week ago have now continued their advocacy against the use of chlorpyrifos. As we note in our previous blog item EPA Denies Petition to Ban Chlorpyrifos, EPA articulated its reason for the denial as of this time, but this in itself did not articulate its determination that the registration and associated tolerances met the requirements of the Food Quality Protection Act (FQPA). EPA’s response to this latest legal skirmish will be of interest, as will the court’s response to it. .
More information on the proceedings is available on our blog under key word chlorpyrifos.
By Lisa M. Campbell and James V. Aidala
On March 29, 2017, U.S. Environment Protection Agency (EPA) Administrator Pruitt signed an order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos. This is the latest EPA action in a long and contentious battle concerning chlorpyrifos tolerances and registrations, and is likely not the end of this story.
EPA’s decision denying the petition addresses each of the petition’s ten claims and the history of EPA’s review and responses to those claims. Much attention will be paid to the order’s discussion of three of the claims, which the order states all relate to the same issue: “whether the potential exists for chlorpyrifos to cause neurodevelopmental effects in children at exposure levels below EPA’s existing regulatory standard (10% cholinesterase inhibition).” The order states that because “Congress has provided that EPA must complete registration review by October 1, 2022,” and because EPA has “concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution” on the issues concerning potential neurodevelopmental effects in children, EPA is denying the claims, given the Ninth Circuit Court of Appeals’ August 12, 2016, order that “made clear” that further extensions to the March 31, 2017, deadline for responding to the petition would not be granted. EPA states that the “science addressing neurodevelopmental effects remains unresolved,” and “further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos.”
The order will become effective as soon as it is published in the Federal Register. More information on the prior proceedings concerning this matter is available on our blog under key phrase chlorpyrifos.
This decision by EPA under the Trump Administration to deny the petition is not surprising, given the rhetoric of reducing regulatory burdens and the need to stop regulatory “overreach” by agencies like EPA which has been accused of making politically driven decisions. EPA's press release captures this, quoting Administrator Pruitt stating (in part): "By reversing the previous Administration’s steps to ban one of the most widely used pesticides in the world, we are returning to using sound science in decision-making -- rather than predetermined results.”
EPA has, however, “kicked the can down the road” to some extent on the key science issue -- whether EPA appropriately evaluated epidemiology studies which reported that exposures to the pesticide had adverse neurological impacts on infants and children -- an issue that affects not only chlorpyrifos, but the other organophosphates (OP) that EPA has concluded are subject to a Food Quality Protection Act (FQPA) 10X factor based on these studies. (See EPA’s September 15, 2015, Literature Review on Neurodevelopment Effects & FQPA Safety Factor Determination for the Organophosphate Pesticides.)
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) members who reviewed EPA’s approach, based on these studies with regard to chlorpyrifos, generally had concerns with its proposed approach. When EPA nonetheless issued its renewed call for revocation of the tolerances in November 2016, eight days after the Presidential election, it was seen by some as partly (if not fully) driven by a “political” calculus which ignored the lack of support of the FIFRA SAP.
The November 2016 proposal was based on more than the epidemiology studies which have proven controversial. At the same time, EPA’s arguments in the November notice relied on some of the earlier findings about the studies and FIFRA SAP’s review to fashion a “hybrid” approach which, not surprisingly, supported EPA’s previous conclusions.
This has led to charges of “politics over science” on all fronts, but in responding to the court deadline for a final decision by March 31, 2017, EPA has now declared it does indeed need more time to resolve the science issues, and argues that the general registration review process, with the chlorpyrifos review scheduled for 2022, gives EPA more time than what the court imposed. EPA has concluded that if a decision is needed now, the required burdens have not been met to change the current status of the pesticide. The order states:
- Following a review of comments on both the November 2015 proposal and the November 2016 notice of data availability, EPA has concluded that, despite several years of study, the science addressing neurodevelopmental effects remains unresolved and that further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos. EPA has therefore concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution on those issues.
EPA has determined it needs more time, however frustrating that may be, to sort out the science. As such, it is allowing chlorpyrifos use to continue, but objections to EPA’s decision are expected by the petitioners who originally pushed for the tolerance revocations. The effect on other OPs with regard to the application of the FQPA uncertainty factor is unclear, at best. The science debate will rage on, with no clear timeline or process for how the ultimate resolution of these questions will be “final.” This political and legal back-and-forth may become the new normal for the Trump Administration as it seeks to balance a more “business friendly” regulatory approach with the stringent requirements of the statutory duties of underlying authorizing legislation across all of EPA’s programs.
By Lisa M. Campbell and Margaret R. Graham
On March 20, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a notice that it was delaying the effective date of five regulations, including the final rule on the certification of pesticide applicators. The effective date for this final rule is now May 22, 2017 (original effective date was March 6, 2017). In the notice, EPA states that it is “taking this action to give recently arrived Agency officials the opportunity to learn more about these regulations and to decide whether they would like to conduct a substantive review of any of these regulations.” The new effective date of May 22, 2017, could be delayed further if EPA officials decide to conduct a substantive review. More information on the pesticide applicator certification rule is available in our memorandum Final EPA Rule Requires Stronger Standards for Applying Riskiest Pesticides.
By Susan M. Kirsch and Lisa M. Campbell
On February 21, 2017, the Northwest Environmental Advocates (NWEA) filed a Clean Water Act (CWA) lawsuit in the U.S. District Court for the Western District that involves a number of pesticide active ingredients in addition to other chemicals. The lawsuit seeks to compel the U.S. Environmental Protection Agency’s (EPA) response to NWEA’s 2013 Petition for Rulemaking to Update the Water Quality Criteria for Toxics in the State of the Washington (NWEA v. EPA, No.: 2:17-cv-00263). NWEA asserts that Washington’s aquatic life water quality criteria (ALC) and human health water quality criteria (HHC) for many chemicals that are classified as “toxic pollutants” are outdated and inadequate. The chemicals at issue include the pesticide active ingredients acrolein, carbaryl, copper, diazinon, demeton, malathion, and methoxychlor. NWEA alleges that Washington’s continued use of outdated criteria violates the CWA and poses a risk to species listed as threatened or endangered under the Endangered Species Act (Act), specifically Chinook Salmon and Southern Resident orca whales.
Under the CWA, states develop and adopt water quality criteria and are required on a triennial basis to review and revise or develop new criteria if appropriate to protect designated uses (e.g., recreation, wildlife protection). As part of this triennial review process, states are required to consider any recommended new or revised quality criteria published by EPA. States may adopt the criteria that EPA publishes, modify EPA’s criteria to reflect site-specific conditions, or adopt different criteria based on other scientifically-defensible methods. Criteria are a component of water quality standards that inform the development of total maximum daily load (TMDL) calculations, discharge limits in permits, and management of nonpoint sources of pollution, including agricultural run-off. If state criteria are inadequate for the protection of designated uses, EPA may step-in to issue updated criteria, and can be compelled to promulgate criteria by citizen suit action.
NWEA alleges that Washington has failed to adopt HHC or ALC for several toxic pollutants since 1992. In November 2016, EPA published a final rule updating Washington’s HHC for toxics. 81 Fed. Reg. 85417. NWEA asserts that the revised HHC do not address the full spectrum of HHC, as updates for arsenic, dioxin, and thallium were not included. NWEA also argues that updated HHC do not alleviate the ongoing risk to aquatic life from Washington’s inadequate ALC. EPA has not responded to NWEA’s complaint.
It is unclear how EPA will respond to NWEA’s suit. Often a state will work simultaneously to develop its own criteria that will meet EPA approval. Registrants associated with the pesticides at issue should prepare for potentially forthcoming proposals of more stringent criteria. The proposal and promulgation of new criteria is a lengthy process and requires public notice and comment. It may well be at least two years before either EPA or Washington issues proposed updates for ALC. A compilation of the latest EPA recommended ALC is accessible here. The criteria values in the table provide some indication of the direction that may be taken in future updates.
By Susan M. Kirsch
President Trump’s February 28, 2017, Executive Order (E.O.) directing the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) to rescind and replace the Clean Water Rule (CWR) is the latest development in the attempt to resolve the long-standing question of which surface waters and wetlands may be federally regulated and subjected to permitting under the Clean Water Act (CWA). Critics of the CWR assert that it would have drastically expanded the reach of the CWA and created regulatory uncertainty around land features and water features that were not previously considered WOTUS, such as dry creek beds, ditches, and isolated wetlands. Since 2011, pesticide applications into, over, or near WOTUS are permitted under the CWA National Pollutant Discharge Elimination System (NPDES) Program due to a 2009 U.S. Court of Appeals for the Sixth Circuit ruling. Agricultural producers and pesticide applicators have opposed the permitting largely on the grounds that it is duplicative and unnecessary to regulate pesticides applied in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Although the CWR would have arguably expanded the scope of the waters requiring pesticide permitting, the replacement or elimination of the CWR will not end NPDES requirements for pesticides. Opponents continue to push for legislation that would eliminate all CWA permitting for FIFRA-compliant pesticide applications. More details on the NPDES permit for pesticides is available in our blog item EPA Issues Final 2016 NPDES Pesticide General Permit.
Additional information on the anticipated fate of WOTUS, as well as a summary and comparison of some of the key concepts and provisions within the CWR are available in our memorandum What’s Next for “Waters of the U.S.” (WOTUS)?
By Lisa M. Campbell and Lisa R. Burchi
On February 22, 2017, the California Department of Pesticide Regulation (DPR) announced it was extending the filing date for applications to register products made from pesticide impregnated materials bearing pesticide claims from March 1, 2017, to July 1, 2017. Specifically, each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017. DPR’s California Notice 2015-13 issued on December 11, 2015, informed pesticide product registrants and stakeholders of DPR’s intention to register products made with pesticide impregnated materials and bearing pesticide claims.
The February 22 notice also states the following in terms of the requirements:
- Each company with products made from pesticide impregnated material and sold under their own company name into or within California is required to register the product(s) as a pesticide;
- The product must bear a federally approved pesticide label; DPR will assign a separate California-only registration number for purposes of tracking sales and use of the products in California;
- Each company will need to obtain at least one registration for each use category of product sold (e.g., the apparel use category includes wearable items such as jackets, shirts, hats, socks, pants, and shorts; the non-apparel use category includes non-wearable items such as bedding, tents, seat covers, chopping blocks, shower curtains, and mouse pads); and
- If items are impregnated with different pesticides or different percentages of the same pesticide, separate registrations will be required.
The requirements set forth in this notice do not apply to products that satisfy the requirements to be a treated article, including the requirement that any claims be related to protection of the article/substance itself. The notice applies instead to those pesticide impregnated materials that include pesticidal claims that are not limited to protection of the material. More information on the December 2015 notice is available in our blog item California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims.
By Lynn L. Bergeson, James V. Aidala, and Margaret R. Graham
On February 14, 2017, in the House of Representatives, Rep. Rodney Davis (R-IL) introduced H.R. 1029, the “Pesticide Registration Enhancement Act of 2017,” which reauthorizes the Pesticide Registration Improvement Act (PRIA). H.R. 1029 was immediately referred to the Agriculture Committee and to the Energy and Commerce Committee; it was passed by the Agriculture Committee on February 16, 2017. Per Agriculture Committee Chair Michael Conaway’s opening statement at the Business Meeting markup of H.R. 1029, changes to PRIA include “reasonable increases in registration fees, funding for Good Laboratory Practices, and a seven year reauthorization as opposed to the five-year reauthorizations of the past.” H.R. 1029 would allow the U.S. Environmental Protection Agency (EPA) to collect up to 31 million in registration fees (up from 27.8 million) per year from fiscal years (FY) 2017-2023. It also includes the following registration increases for FY2017 through FY2023:
- The maximum annual fee for registrants holding 50 pesticide registrations or less would be $129,400 (up from $115,500);
- The maximum annual fee for registrants holding over 50 pesticide registrations would be $207,000 (up from $184,800);
- The maximum annual fee payable for a small business registrant holding 50 pesticide registrations or less would be $79,100 (up from $70,600); and
- The maximum annual fee payable for a small business registrant holding over 50 pesticide registrations would be $136,800 (up from $122,100).
PRIA represents a commitment by the pesticide registrants to help with the continued resource issues of the pesticide regulatory program. This has become an issue of increased concern with the arrival of the Trump Administration after campaign rhetoric about eliminating EPA and cutting budgets. Fees are seldom a popular topic, but an essential program component. Without staff and resources to approve pesticide registrations, registrants would be left with new products destined to pile in EPA in-boxes. PRIA is designed to help maintain some certainty and predictability to the review process.
Of some note is that in recent years Congress has appropriated funds at a level below the statutory minimum that originally was a line in the sand which, if breeched, would de-authorize EPA’s authority to charge application fees. The regulated community has reluctantly supported Congressional action to lower this “minimum” level of funding to hold onto the programmatic progress which has been made since the first PRIA authorization. This appears to be an uneasy acceptance of the budget realities surrounding federal spending on discretionary, non-defense expenditures.
By Lynn L. Bergeson, Sheryl Lindros Dolan, and Margaret R. Graham
On February 17, 2017, the U.S. Environmental Protection Agency (EPA) announced that the Centers for Disease Control and Prevention (CDC) issued guidance revising its recommendation regarding controlling Candida auris (C. auris) infections in U.S. healthcare facilities. The CDC guidance now recommends a “thorough daily and terminal cleaning and disinfection” of patient rooms in which C. auris infection or colonization was present … with the use of an [EPA]-registered hospital-grade disinfectant effective against Clostridium difficile [(C. difficile)] spores.” The new guidance updates the CDC’s clinical alert on C. auris issued in June 2016 after receiving reports from international healthcare facilities that C. auris, “an emerging multidrug-resistant (MDR) yeast, [was] causing invasive healthcare-associated infections with high mortality.” Previously, CDC recommended use of an EPA-registered disinfectant with a fungal efficacy claim.
As EPA is responsible for regulating hospital disinfectants and other antimicrobial pesticides used in healthcare facilities, this updated guidance has particular interest and significance for registrants of hospital disinfectant products. EPA maintains a list of registered antimicrobial products effective against C. difficile (List K) and states that “Guidance to the companies that register antimicrobial products and seek label claims against C. auris is under development.”