By Lisa M. Campbell and Lisa R. Burchi
The U.S. Environmental Protection Agency (EPA) today released a pre-publication version of a Federal Register notice to be issued on August 16, 2016, extending the deadline to submit comments on draft Pesticide Registration Notice (PRN) 2016-X from August 15, 2016, to September 14, 2016. A discussion of draft PRN 2016-X, which proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor use,” is discussed in our blog item EPA Solicits Comments on Updated Method for Establishing Economic Minor Use.
In the notice extending the comment period, EPA noted that the current comment period is “one of the busiest times of year for pest control experts” and provides an extension that “will allow them extra time to complete their review and comment on the PR Notice.”
There is one comment that already has been submitted by the U.S. Department of Agriculture (USDA), which EPA stated it consulted prior to releasing the draft PRN 2016-X. In its comments, USDA states:
- Regarding acreage cutoffs, USDA supports EPA’s use of acreage estimates from the USDA Agricultural Census, as it is the “most reliable and comprehensive public source for such information in the country.”
- Regarding EPA’s proposal to apply a seven percent discount rate, USDA recommends that EPA be “open to using supplemental information in determining whether or not an alternative discount rate should be considered.”
- Regarding EPA’s proposal that all cases be evaluated using values for costs that range from 60 to 85 percent of gross revenue, USDA requests that EPA provide its rationale as to why this range was chosen. USDA states: “Although USDA understands that EPA is attempting to reveal the ratio of gross revenue to cost associated with the minor use rather than across an entire company, one could assume that a rational company would not pursue registering a minor use if the ratio of costs to gross revenue was exceedingly higher than the average standard ratio for the company. Qualitative information, as suggested by EPA, could then be used to further refine the estimate for this ratio.”
- Regarding EPA’s proposal to use study cost estimates provided by independent laboratories, USDA notes there are instances where data can be significantly more expensive than what would be expected generally and, thus, recommends that EPA “be open to additional, verifiable data a registrant wishes to submit that may indicate that its cost of data generation differs from EPA's standard estimates.” USDA also suggests that EPA “consider making the cost estimates it is using for individual tests available publically to aid registrants in determining whether or not they need to submit alternative incurred costs for studies they have conducted.”
By Lisa M. Campbell and Lisa R. Burchi
The comment deadline of August 15, 2016, is approaching on the June 14, 2016, notice of availability of the draft Pesticide Registration Notice (PRN) 2016-X issued by the U.S. Environmental Protection Agency (EPA), in consultation with the U.S. Department of Agriculture (USDA). Draft PRN 2016-X proposes to update Section 5 of PRN 97-2, and to clarify and update criteria by which EPA classifies crops as “minor use.”
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll) defines “minor use.” One of those definitions at Section 2(ll)(2) defines a minor use, in part, as one that does not provide “sufficient economic incentive.” Current guidance in PRN 97-2 defines a use as minor under FIFRA Section 2(ll)(2) if gross revenues at full market potential do not cover the costs of registration. EPA’s concern with this policy is, in part, that:
- [T]he method in PRN 97-2 does not accurately measure economic incentive to register pesticides. Gross revenue will overstate the registrant’s true return on the cost of registration while reliance on a single year of sales will understate the total stream of revenues. The direction of bias is unknown. Most importantly, it does not account for the difference in timing between costs of registration and future returns.
EPA states that the draft PRN is intended to clarify and update “its interpretation of how economic minor use status under FIFRA section 2(ll)(2) can be determined.” Under the proposed PRN, EPA would interpret a minor use as one that “does not provide sufficient economic incentive to support the … registration” when “the registrant would not obtain sufficient revenues from sales of the pesticide to justify the cost of registration.” Specifically, EPA states:
- This PRN describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment. The registrant incurs costs associated with applying for a registration while the registration once granted allows the pesticide product to be sold, generating a stream of revenue in the future. This approach provides several measures by which EPA can assess whether there are sufficient incentives for the registration of a pesticide use. These measures include the net present value of returns, the benefit-cost ratio, and the internal rate of return, each of which provides insight into the magnitude of the incentive to register or maintain the registration of a pesticide.
With regard to calculating the net present value (NPV) of the investment (in registration), EPA provides the following formula:
In the draft PRN, EPA provides guidance on the four primary components to conduct a quantitative analysis to estimate NPV, the benefit-cost ration (B/C), and the internal rate of return (IRR). These components are: (1) costs of registration (e.g., cost to generate data necessary to show the product can be used safely for the proposed use, PRIA fees, cost to prepare and submit an application); (2) net revenues from sales of the pesticides; (3) the discount rate; and (4) the time of investment. EPA states that, in general, “if a use of a pesticide has a negative NPV, a B/C ratio < 1, and IRR that is lower than average for a particular sector, it will be considered to have insufficient economic incentives to pursue registration.” EPA is not setting a firm threshold, however, and will review minor use determinations on a case-by-case basis.
For a use that the applicant requests a designation of economic minor use under FIFRA Section 2(ll)(2), the applicant should include the following types of information in writing with the application:
- The type of registration action for the specific site/use;
- A list of the registration data requirements for the specific site/use;
- Information to inform future sales, which might include the target pest(s), the application rate, the extent of the pest problem;
- Information to inform the sales price of the pesticide, which might include the price of relevant competitors; and
- A narrative addressing at least one of the criteria described in FIFRA section, 2(ll)(2)(A-D). This summary should contain, at least, a brief description of how the pesticide will be used including the target pest(s) and alternatives.
Applicants may also wish to include the following to improve EPA’s understanding of the incentives they face in producing and/or registering a pesticide for the specific use:
- A narrative describing any relevant factors that influence the cost of manufacturing and, therefore, the net revenue from product sales;
- A narrative describing any relevant factors that influence the fixed costs of registering and marketing the pesticide;
- A narrative describing any aspects of the market that might limit or enhance sales; and
- A narrative describing any other factors which affect the economic incentive to register this use.
EPA states its intent in revising the method and criteria for determining when a potential minor use does not present a sufficient economic incentive is because the current “outdated approach could prevent applicants from obtaining the incentives for registration that should be available to them.” EPA further states that it is interested in developing an approach that is “simple and transparent” because a burdensome process would be “an added deterrent to registration.” The draft PRN would indeed seem to expand the ability of registrants to seek minor use status; since EPA will be making determinations under this revised approach on a case by case basis, how broadly EPA will apply these criteria and what minor use approvals it makes will only be seen over time, however.
It is important to note that EPA’s proposed policy has potential implications beyond minor use determinations. For example, EPA’s discussion of the elements of the costs of registration as well as how those costs for applying for a registration are a part of the registrant’s investment could have implications in FIFRA data compensation contexts:
- The cost of applying for registration can be viewed as an investment toward the eventual marketing of a registered product. Applying for registration is the final step in the process of developing and marketing a pesticide. The costs of applying for registration include the costs of generating data that EPA requires for registration, the registration fees, and the cost of paperwork burden from the registration process. In terms of “economic incentive,” the main question to answer is whether the investment in registration of a particular use is worthwhile to the registrant, that is, whether future returns from sales are sufficiently high to justify the cost of obtaining/maintaining a registration.
The proposal also is significant because it can be applied to conventional pesticides, biopesticides, and antimicrobial pesticides to determine whether they meet the definition of minor use.
Comments are due August 15, 2016.
By Lisa M. Campbell and Lisa R. Burchi
On July 29, 2016, the Environmental Appeals Board (EAB or Board) issued its Final Decision and Order (Order) upholding the Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI) Motion for Accelerated Decision that held that the U.S. Environmental Protection Agency (EPA) was authorized to cancel the conditional flubendiamide registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) and did not need to provide BCS/NAI the full Section 6(b) cancellation process. The Board also upheld EPA’s determination prohibiting BCS/NAI from the continued sale, distribution, and use of existing stocks of flubendiamide products, but found that EPA’s determination to prohibit the continued sale and distribution of existing stocks of flubendiamide end-use products by distributors and retailers other than BCS/NAI was not supported by the record.
Additional information regarding this case is available in our blog items EPA ALJ Issues Initial Decision in Bayer Flubendiamide Cancellation Proceeding, EPA ALJ Denies Bayer’s Motion for Accelerated Decision and Flubendiamide Registrants and EPA File Post-Oral Argument Briefs.
The EAB summarized BCS/NAI’s arguments concerning the overall proceeding with two questions: (1) whether EPA has properly initiated this cancellation action under Section 6(e) rather than Section 6(b); and (2) if the proceeding is properly initiated under Section 6(e), whether BCS/NAI can nonetheless challenge the lawfulness of a condition in their registrations in a Section 6(e) proceeding.
With regard to the first issue, the Board found that EPA appropriately commenced the proceeding under the expedited cancellation procedures set forth in FIFRA Section 6(e) because two criteria were satisfied: (1) the registration must have been issued as a conditional registration under FIFRA Section 3(c)(7); and (2) EPA must have determined that BCS/NAI failed to satisfy a condition of that registration. The Board found that “neither the plain language of the statute, its structure, nor legislative history” supported BCS/NAI’s argument that if EPA “has made an unreasonable adverse effects finding, FIFRA’s general cancellation provision in section 6(b) trumps section 6(e) and bars the Program from initiating a 6(e) cancellation proceeding, even where the elements for a section 6(e) cancellation are met.” The Board further stated: “Bayer and Nichino’s argument that section 6(b) takes priority over section 6(e) is inconsistent with the structure and environmental protection goals of FIFRA.” Instead, EAB states:
- Given Congress’ decision to add an expedited cancellation provision to FIFRA -- separate and independent from section 6(b) -- it is difficult to square FIFRA’s environmental protection goals with Bayer and Nichino’s argument that the Pesticide Program must use the more time-consuming and resource-intensive section 6(b) procedures to cancel a pesticide in circumstances where section 6(e)’s expedited procedures are applicable. That is particularly the case when one considers that, unless the Program issues an “emergency order,” a registrant is allowed to sell and distribute the pesticide during the course of section 6 cancellation proceedings. See FIFRA § 6(b)-(c), 7 U.S.C. § 136d(b)-(c). If the Program were required to initiate cancellation proceedings under section 6(b) instead of under section 6(e), registrants would, in effect, be rewarded with additional time to sell and distribute their pesticides. Had Congress intended such a result, it could have subordinated section 6(e) to section 6(b) when it added the new conditional registration authority (including section 6(e)) to the existing statutory structure in 1978. See S. Rep. No. 95-1188, at 11 (1978) (Conf. Rep.). But Congress did not take such a step. Rather, in creating the possibility of allowing pesticides to be introduced to the market conditionally when they could not meet all the requirements for a general registration, Congress took steps to assure that such pesticide registrations could be promptly canceled when the terms of the conditional registrations were not met.
The Board also found that BCS/NAI could not demand a Section 6(b) cancellation proceeding because they “willingly accepted the termination condition in 2008 and 2009, knowing that it required them to submit a request for voluntary cancellation if the Program were to issue a determination that flubendiamide causes unreasonable adverse effects.” EAB stated: “Given the language of the conditional registrations, Bayer and Nichino’s affirmative concurrence on that language, and the record of negotiations, we find that Bayer and Nichino willingly agreed to the termination condition, knowing that they were agreeing to an approach that could remove the flubendiamide products from the market rapidly. Having knowingly agreed to this procedure, they cannot contest it now.”
With regard to the second issue as to whether BCS/NAI can nonetheless challenge the lawfulness of a condition in their registrations in a Section 6(e) proceeding, EAB found that the scope of a Section 6(e) cancellation is “narrowly limited to the following issues: (1) whether the condition was satisfied, and (2) whether the Pesticide Program’s determination on the appropriate disposition of the existing stocks of the canceled pesticide is consistent with FIFRA.” The Board found that the facts in this particular case demonstrated that BCS/NAI “had ample opportunity to challenge the lawfulness of the termination condition in a timely and permissible way but failed to do so.” EAB noted, for example, that BCS/NAI could have declined to accept the registration terms and challenged EPA’s refusal to grant a conditional registration with terms acceptable to BCS/NAI. The Board further found that BCS/NAI understood the consequences of agreeing to the condition at issue and thus “knew, or should have known given the clarity of section 6(e), that any objection they had to the condition giving the Pesticide Program the option to effectively require cancellation without instituting a section 6(b) proceeding could not be raised in a section 6(e) cancellation for failure to comply with the termination condition.”
As for the specific issues that the Board stated were properly before it in this appeal, it found BCS/NAI did not comply with their obligation to submit voluntary cancellation requests. The Board rejected arguments that BCS/NAI’s failure to request cancellation is excused because EPA did not meet an important pre-condition to the termination condition by “engaging in dialogue” with BCS/NAI regarding the data and EPA’s conclusions related to that data. Specifically, the Board found that this objection was not timely raised and thus was precluded, but that even if it had not been precluded, BCS/NAI had failed to establish by a preponderance of the evidence that EPA did not engage in such dialogue.
One aspect of the EPA’s determination that was overturned relates to whether existing stocks can continue to be sold or distributed. Although the Board upheld as reasonable EPA’s denial of the sale and distribution of existing stocks by BCS/NAI because they violated the termination condition, EAB amended EPA’s existing stocks determination described in the Notice of Intent to Cancel “to allow distributors and retailers other than Bayer and Nichino to sell and distribute end-use flubendiamide products that have been formulated, packaged, and labeled for use and [that] have been shipped or released into commerce to distributors on or before the date of this Final Decision and Order, until those stocks are exhausted.” EAB instead stated that EPA’s “rationale for denying the sale and distribution of existing stocks by Bayer and Nichino -- because they violated the terms of their conditional registrations -- has limited, if any, applicability to non-registrants.” Distributors and retailers other than BCS/NAI can continue to sell and distribute end-use flubendiamide products that were formulated, packaged, and labeled for use and shipped or released into commerce to distributors on or before the date of this Final Decision and Order, until those stocks are exhausted.
Although the resolution of this case has potential implications for current and future registrations, EPA has acknowledged the unique circumstances of this case, and indicated that it is unlikely that a conditional registration like that issued for flubendiamide will be issued again. If a registrant ever finds itself in a similar position to BCS/NAI, or facing a situation, as EPA has indicated, that seeks a condition of registration that would allow a registration to simply expire, such companies should carefully consider how to proceed, including considering options to challenge the lawfulness of the condition proposed by EPA or to demonstrate that the applicant/registrant is entitled to a general, not conditional, registration.
By Lisa M. Campbell and Timothy D. Backstrom
On July 20, 2016, the U.S. Environmental Protection Agency (EPA) issued a memorandum attaching minutes from the April 19-21, 2016, FIFRA Scientific Advisory Panel (SAP) meeting, Transmittal of Meeting Minutes of the April 19-21, 2016 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP or Panel) Meeting Held to Consider and Review Scientific Issues Associated with “Chlorpyrifos: Analysis of Biomonitoring Data.” This SAP was convened to advise EPA regarding the evaluation of biomonitoring chlorpyrifos data from epidemiology studies conducted by the Columbia Center for Children’s Environmental Health (CCCEH).
The minutes indicate that the SAP has significant concerns with EPA’s proposal to use the biomonitoring chlorpyrifos data from the CCCEH epidemiology studies to establish a point of departure (PoD) for chlorpyrifos risk assessment. The minutes state: “Because many uncertainties cannot be clarified, the majority of the Panel does not have confidence that the Columbia Center for Children’s Environmental Health (CCCEH) cord blood data on chlorpyrifos concentrations can accurately be used in quantitative risk assessment to determine a Point of Departure (PoD).” A major source of uncertainty cited by the FIFRA SAP is “the lack of verification and replication of the analytical chemistry results that reported very low levels of chlorpyrifos (pg/g),” because EPA had to impute a finite quantitative value to “a large fraction of cord blood samples included in the analyses presented with levels below [level of detection (LOD)].” Moreover, some SAP members “thought the quality of the CCCEH data is hard to assess when raw analytical data have not been made available, and the study has not been reproduced.”
The SAP also, however, stated that “both epidemiology and toxicology studies suggest there is evidence for adverse health outcomes associated with chlorpyrifos exposures below levels that result in 10% red blood cell (RBC) acetylcholinesterase (AChE) inhibition (i.e., toxicity at lower doses).” Nevertheless, it agreed with EPA that “applying additional safety factors to the AChE PoDs to account for a possible noncholinergic mode of action (MOA) would be problematic because of challenges in justifying any particular value for such an adjustment.”
Of note, the SAP concluded that it would be appropriate to use a “10X intra-species extrapolation factor” in any analysis based on the cord blood data. It also identified other sources of uncertainty that should be considered in such an analysis, including “the inability of single measures of chlorpyrifos concentration in blood to provide information regarding source, frequency, duration and magnitude of exposure, and how these exposures are linked to specific outcomes measured in the CCCEH study participants.” Although EPA suggested in a Status Report filed in the chlorpyrifos litigation pending in the Ninth Circuit Court of Appeals on June 29, 2016, that the FIFRA SAP might recommend a “hybrid approach” that EPA could use in lieu of a PoD based on AChE inhibition, thereby altering the prior EPA analysis for chlorpyrifos, the SAP minutes do not include a recommendation for such a hybrid methodology.
Given the concerns expressed by the SAP regarding EPA’s proposal to derive a PoD from cord blood biomonitoring data collected in the CCCEH epidemiology studies, it may be unlikely that EPA will further pursue this specific approach. It is less clear whether EPA will be inclined to propose any further adjustments to its existing risk assessment for chlorpyrifos, which utilizes a PoD based on animal AChE data, along with intra-species and inter-species uncertainty factors and an additional Food Quality Protection Act (FQPA) 10X factor. EPA’s decision to retain the special FQPA factor in its risk assessment for chlorpyrifos will remain controversial, because it is based on an assessment of the value and significance of several epidemiology studies for chlorpyrifos that many in the pesticide industry strongly dispute. The discussion in the minutes of the uncertainties resulting from the refusal of the CCCEH investigators to provide underlying raw data may provide further support for arguments by industry that EPA should not predicate risk assessments on the epidemiology studies for chlorpyrifos before obtaining and reviewing these data.
More information on the FIFRA SAP and its surrounding legal issues is available in our blog item EPA Requests Six Month Extension of Deadline for Decision on Chlorpyrifos Tolerance Revocation, and more generally on our blog with keyword chlorpyrifos.
By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi
On July 1, 2016, in an administrative appeal of the June 1, 2016, Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI) Motion for Accelerated Decision that held that the U.S. Environmental Protection Agency (EPA) was authorized to cancel the conditional flubendiamide registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) and did not need to provide BCS/NAI the full Section 6(b) cancellation process, the parties in the case filed post-oral argument briefs. The briefs were ordered by the Environmental Appeals Board (EAB or Board) following oral arguments held on June 22, 2016, by BCS/NAI and EPA.
Additional information regarding this case is available in our blog items EPA ALJ Issues Initial Decision in Bayer Flubendiamide Cancellation Proceeding and EPA ALJ Denies Bayer’s Motion for Accelerated Decision.
The EAB requested that the parties submit post-order briefs responding to questions raised by the Board during oral argument, and the responses filed by the parties demonstrate their divergent views on issues related to this conditional registration and the process by which EPA sought to cancel such registration.
The specific questions asked by the Board and BCS/NAI and EPA’s responses are as follows:
1(a). What authority does the Board have in a FIFRA section 6(e) proceeding to consider the lawfulness of a condition of registration, given that section 6(e) proceedings are statutorily limited to two issues: (1) whether a condition of registration has been violated; and (2) whether EPA's determination with respect to disposition of existing stocks is consistent with FIFRA?
BCS/NAI argues that the EAB must resolve questions about the lawfulness of a condition of registration in determining whether the condition has been violated and to ensure that it has jurisdiction over this proceeding. BCS/NAI states: “For the EAB to determine ‘whether the … conditions have been satisfied within the time provided’ under FIFRA § 6(e)(2), the Board must necessarily first consider whether the conditions are valid.” BCS/NAI further argues that its “challenge to the lawfulness of the voluntary cancellation provisions is a challenge to the ALJ’s and EAB’s subject matter jurisdiction over this proceeding, the resolution of which is part of the Board’s inherent authority.” BCS/NAI argues that the EAB should find that it lacks subject matter jurisdiction to administer this dispute and remand to the Office of Pesticide Programs (OPP).
EPA, in contrast, stated that EAB “lacks the authority to rule on an issue clearly beyond the well-defined and narrow scope of section 6(e).” If the EAB disagrees with EPA’s position, EPA states that for all the reasons it set forth in its previous motions, “the challenged condition was clearly lawful.”
1(b). If the Board does possess the authority in a section 6(e) proceeding to consider the lawfulness of a condition of registration, may a third party also challenge the lawfulness of either that condition or any other aspect of the registration?
BCS/NAI argued that the Board’s authority to consider the lawfulness of a condition of registration does not give third parties broad rights to challenge the lawfulness of the condition or all aspects of the registration. On this point EPA seemingly agrees, stating “While EPA would want to do a more thorough study of relevant case law and legislative history before answering this question definitively, EPA has significant doubts that any third party could challenge any condition of registration in a FIFRA section 6(e) proceeding.”
1(c). Finally, if the Board were to conclude that the voluntary cancellation condition in the flubendiamide registrations is unlawful, what effect would such a holding have on the registration itself?
BCS/NAI argues that striking the voluntary cancellation provisions would not invalidate the registrations. Instead, “If the Board concludes that the voluntary cancellation provisions are unlawful, they can be stricken from the registrations and the registrations may continue without consequence other than ensuring that EPA cannot pursue an unlawful process.” BCS/NAI states that if EPA still wishes to proceed with cancellation, it must do so under FIFRA Sections 6(b) and (c).
EPA takes the position that if the EAB “decides it has the authority under section 6(e) to review the lawfulness of the cancellation condition, and finds it unlawful, the EAB should void the flubendiamide registrations.” Specifically, EPA states: “If the condition is found to be unlawful, the whole registration must be voided because it has never been found to meet the standard for registration under FIFRA without the cancellation condition. Although the EAB can rule on the legality of EPA’s actions that are within the scope of this proceeding, the authority to issue a registration on different terms is reserved to OPP.”
2. FIFRA section 6(e) provides that any hearing on a notice of intent to cancel issued under section 6(e) shall be conducted under FIFRA section 6(d). An order issued after a section 6(d) hearing "shall be based only on substantial evidence of record of such hearing." 7 U.S.C. § 136d(d). What standard of proof does this provision require? In answering this question, take into account that FIFRA section 16 requires that a substantial evidence standard be applied by a court in reviewing EPA decisions following a hearing, and the Supreme Court's decision in Steadman v. SEC, 450 U.S. 91 (1981).
BCS/NAI argues that the preponderance of the evidence standard of proof applies to orders issued by the EAB after a Section 6(e) hearing. EPA’s position is that a hearing to address the scope of FIFRA Section 6(e) must be conducted in accordance with FIFRA Section 6(d), which states that an order issued after such a hearing “shall be based only on substantial evidence of record of such hearing.”
3. What "conclusions" are covered by the requirement in the flubendiamide conditional registration that EPA "shall engage in dialogue about the data and the Agency's conclusions?" Does EPA's determination on the toxic endpoint level constitute a "conclusion" within the meaning of the registration?
BCS/NAI argues that EPA was required “to not only engage in general dialogue about the data, but also to disclose and engage in dialogue about the Agency’s final decisions and judgments about the data and whether they support continued registration,” including EPA’s unreasonable adverse effects determination and decisions on toxicological endpoints. Specifically, BCS/NAI states: “It makes sense that a condition requiring good-faith dialogue before demanding cancellation based on an unreasonable adverse effects determination would include dialogue about the final determination. In this case, EPA precluded any opportunity for such dialogue by issuing its determination on the same day as its cancellation demand.”
EPA argues in the first instance that, as the ALJ determined, BCS/NAI did not timely raise the sufficiency of dialogue issue. If EAB considers this issue timely, EPA provides a summary of EPA’s risk assessment process and argues that “the endpoint selection was one of many components that support the conclusions in the risk assessment, but the endpoint selections were not themselves identified as conclusions in the flubendiamide risk assessments.”
4. Appellants argue on appeal that EPA presented "new conclusions in the January 29, 2016 Decision and supporting documents that were not discussed with Registrants." Appeal Brief of Bayer CropScience LP and Nichino America, Inc. at 22. If there were new conclusions presented in these documents, what were they, and where in the record are these conclusions detailed?
BCS/NAI argues that EPA presented at least three new conclusions in the January 29, 2016, documents that were not discussed with registrants: (1) EPA disclosed for the first time on January 29, 2016 its determination that “continued use of flubendiamide as currently registered … will result in unreasonable adverse effects to the environment;” (2) “Second, throughout the Decision Memorandum, EPA refers to its conclusions that exposure concentrations based on EPA’s theoretical modeling exceed or will exceed ‘Agency LOCs [levels of concern]’ within certain time periods based on unspecified toxicological endpoints”; and (3) “Third, and perhaps most critically, the Decision Memorandum and supporting documents contain buried within them EPA’s decision to adopt the 0.28 ppb sediment pore water endpoint from the spiked water study, which had been superseded by an endpoint from the scientifically more relevant and sound spiked sediment study, as the sole basis for its cancellation determination.”
EPA rejects Appellants’ argument that there were any new conclusions in its January 29, 2016, decision and supporting documents. EPA continues to contend that the toxicity endpoint is not a “conclusion” or “new,” instead arguing that risk assessment documents indicate EPA has been relying on the .28 ppb concentration since 2008.
5. EPA relied upon a toxic endpoint level from the Des-iodo Spiked Water 28-Day Study (MRID 46817023), among other evidence, in its January 29, 2016 unreasonable adverse effects determination for flubendiamide. What does the record show as to whether Appellants were notified of EPA's intent to use this toxic endpoint level prior to January 29, 2016?
BCS/NAI argued that EPA deliberately thwarted dialogue on the use of the 0.28 ppb endpoint and did not disclose its final decision until January 29, 2016. While acknowledging that the 0.28 ppb sediment pore water endpoint was calculated back in 2008, BCS/NAI notes that they submitted a spiked sediment study in 2010 based on comments from EPA for its preference for such a study, and that EPA reviewed the spiked sediment study in July 2011 and concluded that it supported a TWA pore water sediment endpoint of 19.5 ppb. After that, BCS/NAI states:
- [T]he record shows that OPP chose not to notify Registrants at a putative final meeting on December 15, 2015 that it had decided to revert to the 0.28 ppb endpoint; briefed the Assistant Administrator on the case for cancellation using analysis employing that endpoint the very next day; precluded meaningful discussion of the use of the lower endpoint by denying the Agency had made that decision at the January 6, 2016 meeting and presenting the lower endpoint as one endpoint among a “suite” of available endpoints; and deliberately obscured its reliance on the unsound endpoint in its final decision documents issued on the same day as the cancellation demand -- which do not even mention the choice, let alone provide the scientific basis for it.
EPA, in contrast, states that the record shows that EPA “openly and consistently treated the chronic toxicity endpoint from the Des-iodo Spiked Water 28-Day Study (MRID 46817023) as the appropriate regulatory endpoint, and neither withheld information regarding the endpoint, or changed its endpoint selection at any time between 2008 and the issuance of the [Notice of Intent to Cancel].”
6. FIFRA section 6(f) mandates that voluntary cancellation requests may not be acted upon by EPA until a notice-and-comment procedure has been completed. If Appellants had requested voluntary cancellation of the flubendiamide registrations under section 6(f), could they have challenged EPA's unreasonable adverse effects determination during the notice-and-comment period?
BCS/NAI argued that if registrants had requested voluntary cancellation under Section 6(f), they could not have effectively challenged EPA’s unreasonable adverse effects determination during the notice-and-comment period. BCS/NAI argues that “in exchange for the opportunity to submit public comments criticizing the lack of scientific support for EPA’s unreasonable adverse effects determination, Registrants would have had to cancel products that they believe should properly remain registered, forgo their statutory rights to a cancellation decision that is subject to interagency review by the Secretary of Agriculture and scientific peer review by the Scientific Advisory Panel and that can be challenged in an administrative proceeding, and, in doing so, potentially jeopardize their ability to seek and obtain judicial review of that decision.” BCS/NAI states further: “No registrant should be forced to sacrifice its statutory and due process rights in order to raise scientific concerns that EPA is free to ignore. Nor should registrants be held to have lost their rights to challenge the conditions by failing to pursue such an unfavorable path, particularly when the conditions of registration at issue themselves point to the right to invoke and seek relief through the § 6(e) process.”
EPA’s position is that “comments submitted during the section 6(f) comment period would become part of the Agency’s records and, to the extent relevant to EPA’s cancellation decision, could be expected to be part of the administrative record if someone appealed EPA’s decision to approve or deny the voluntary cancellation request to the federal courts.”
7. Is the doctrine of laches legally applicable to this proceeding? If so, explain how the record supports this conclusion.
A claim can be barred by laches when “the delay in filing the claim (1) is unreasonable and inexcusable and (2) materially prejudices the defendant.” BCS/NAI argued that the doctrine of laches does not apply here, as there was no unreasonable delay by registrants, and there is no prejudice to EPA. BCS/NAI states that they were justified in not pursuing any of the purported options for an earlier challenge that EPA’s claims were available. Instead, BCS/NAI chose “to generate the required data and satisfy the substantive conditions of registration, trusting that if the data did not show evidence of accumulation to levels of concern (which they did not), EPA would follow the science and the terms of the PAL and grant unconditional flubendiamide registrations.”
While EPA agrees that if the proceeding is limited to the scope set forth by Section 6(e), the laches doctrine would not be applicable. EPA also argues that “if EPA were to determine that the appropriateness of the cancellation condition is an appropriate issue for resolution,” then laches would apply. To support its position, EPA states that there is “substantial evidence in the record” that BCS/NAI waited almost eight years to challenge the condition of their registration that is now at issue. EPA further argues that it would be prejudiced because key negotiators of the cancellation condition and the initial registrations are no longer available and “this lack of available witness testimony could materially prejudice the Agency.”
The questions posed by the EAB, and the respective responses by BCS/NAI and EPA, indicate fundamental differences regarding the facts and application of the law to this case. Although the resolution of this case has potential implications for current and future registrations, EPA has acknowledged the unique circumstances of this case, and indicates that it is unlikely that a conditional registration like that issued for flubendiamide will be issued again.
EPA states: “the structure of the flubendiamide cancellation condition was unprecedented, and the flubendiamide experience shows that a condition requiring a registrant to request cancellation pursuant to section 6(f) is significantly less reliable than a condition that would allow a registration to simply expire. EPA is unlikely to grant in the future a registration with conditions that depend on a registrant requesting cancellation pursuant to section 6(f).” The statement by EPA that it is more likely in the future to impose a condition that would allow affected registrations “to simply expire” leaves unresolved the question of the rights a registrant would have to contest cancellation based on such an expiration date.
By Lisa M. Campbell and Timothy D. Backstrom
In two recent orders issued in the neonicotinoid seed treatment case Anderson v. McCarthy, the U.S. District Court for the Northern District of California declined to take immediate action in response to a motion by the U.S. Environmental Protection Agency (EPA) requesting that the Court dismiss the case for lack of subject matter jurisdiction. This case involves allegations by a coalition of beekeepers, farmers, and non-governmental organizations (Petitioners) that EPA has incorrectly applied the treated article exemption to seeds coated with neonicotinoid pesticides.
The Court issued an order denying the EPA motion to dismiss on May 13, 2016. In that order, the Court concluded that factual issues to be resolved in deciding whether a 2013 EPA guidance document constitutes a final reviewable action are so “intertwined” with the substantive issues in the case that it would be inappropriate to try to resolve the jurisdictional issues until after the filing of summary judgment motions. The Court stated:
- If the 2013 Guidance did consummate a new rule, and thus a final agency action, then defendants clearly violated federal law by failing to comply with rulemaking requirements. If the 2013 Guidance did not constitute final agency action, then subject-matter jurisdiction is lacking, and the case must be dismissed.
In the May 13, 2016, order, the Court also stated that the decision to defer action on the jurisdictional issues was a “close call,” because “defendants put forth a strong argument in support of dismissal of the lawsuit at the Rule 12 stage.”
On May 23, 2016, EPA filed another motion requesting that the Court clarify the May 13, 2016, order. In its clarification motion, EPA pointed out that the May 13, 2016, order addressed only three of the counts in the complaint challenging the 2013 Guidance, but did not address Count II, which alleged a general “failure to act” because EPA has not regulated neonicotinoid coated seeds as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to EPA, resolution of this count involves a “pure issue of law,” because the Petitioners “failed to identify any discrete, legally-required action that EPA has failed to perform.”
The EPA motion for clarification was scheduled to be heard on July 21, 2016, but the Court issued an order on July 14, 2016, vacating that hearing. The new order stated that “defendants raised a fair point,” because “the Court’s order on the motion to dismiss failed to expressly come to grips with that part of the motion directed at the ‘failure to act’ claim for relief.” Nevertheless, the Court concluded that “no harm will be done in postponing resolution of that issue until summary judgment.”
Although the Court has declined to rule on any jurisdictional question concerning the Petitioners’ complaint posed by EPA until after the parties have filed their respective motions for summary judgment, this case may still be dismissed once the Court engages in the requisite fact-finding. When the Court stated that EPA made a “strong argument” in support of immediate dismissal, it appeared to be a clear signal that this case may yet be resolved on jurisdictional issues. The Court may decide based on the record whether the 2013 Guidance was intended to change or to modify the existing policy on applicability of the treated article exemption to coated seeds. The Court may also consider whether or not EPA intended the policy set forth in the 2013 Guidance to be binding in deciding whether or not to bring subsequent enforcement actions. In addition, the Court will need to consider whether it can review a general “failure to act” in the absence of any allegation that EPA was required to take some specific action.
By Lynn L. Bergeson and Margaret R. Graham
On July 18, 2016, the U.S. Environmental Protection Agency (EPA) announced that PuriCore Inc. (PuriCore), paid a $550,000 penalty for the unauthorized distribution of two of its pesticide products, ProduceFresh and FloraFresh, that were used in supermarkets nationwide. Along with the penalty, EPA issued a stop-sale order to PuriCore prohibiting the sale of ProduceFresh. PuriCore’s unauthorized distribution and sale of pesticide products violates the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
ProduceFresh is used as part of a crisping process in the produce section of stores, and FloraFresh is used in floral departments. EPA states that PuriCore had submitted an application to EPA to register ProduceFresh as a pesticide, however, EPA has not completed its review of the risks associated with the product. FloraFresh was registered as a pesticide as of February 12, 2016, but PuriCore had been distributing FloraFresh to supermarkets for at a least a year prior to it being registered.
The recent enforcement action offers a use reminder to FIFRA stakeholders not to market products before they are registered by EPA relevant state agencies. More information on FIFRA requirements and pesticide registration issues can be found on our FIFRA FAQs webpage, as well as this blog -- keywords FIFRA and registration.
By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi
On July 1, 2016, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register an interim final rule adjusting penalty amounts for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations by more than three times the current level, in some cases. The rule also adjusts the level of statutory civil monetary penalty amounts for the other statutes that EPA administers. EPA issued this interim final rule pursuant to 2015 amendments to the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 (DCIA) (collectively the 2015 Act). The 2015 Act sets forth new requirements for agencies to: (1) adjust the level of statutory civil penalties with an initial “catch-up” adjustment through an interim final rulemaking; and (2) beginning January 15, 2017, make subsequent annual adjustments for inflation.
EPA states that the purpose of the 2015 Act is to “provide a mechanism to address these issues by translating originally enacted statutory civil penalty amounts to today’s dollars and rounding statutory civil penalties to the nearest dollar,” and “[o]nce Federal agencies issue the 2016 one-time catchup rule, each statutory civil penalty amount will be adjusted every year to reflect the inflation that has thereafter accrued.”
EPA sets forth a five step procedure to determine the cost-of-living or inflation adjustment to statutory civil penalties. Through this interim final rule, EPA amends 40 C.F.R. Part 19 of EPA’s regulations, Adjustment of Civil Monetary Penalties for Inflation, to include:
- The operative statutory civil penalty levels, as adjusted for inflation, for violations occurring on or before November 2, 2015, and for violations occurring after November 2, 2015, where penalties are assessed before August 1, 2016; and
- The operative statutory civil penalty levels, as adjusted for inflation, where penalties are assessed on or after August 1, 2016, for violations that occurred after November 2, 2015.
Table 2 to 40 C.F.R. Section 19.4 sets forth the specific statutory civil penalty provisions of statutes administered by EPA, with the original statutory civil penalty levels, as enacted, with the last column of which displaying the operative statutory civil penalty levels where penalties are assessed on or after August 1, 2016, for violations that occurred after November 2, 2015. Specific changes to FIFRA penalties in Table 2 are as follows:
- U.S. Code citation: 7 U.S.C. 136(a)(1); Environmental Statute: FIFRA; Statutory civil penalties, as enacted: $5,000; Statutory civil penalties for violations that occurred after November 2, 2015, and assessed on or after August 1, 2016: $18,750; and
- U.S. Code citation: 7 U.S.C. 136(a)(2)*; Environmental Statute: FIFRA; Statutory civil penalties, as enacted: $1,000/500/1,000; Statutory civil penalties for violations that occurred after November 2, 2015, and assessed on or after August 1, 2016: $2,750/$1,772/$2,750.
* Note that 7 U.S.C. 136(a)(2) contains three separate maximum civil penalty provisions. The first mention of $1,000 and the $500 statutory maximum civil penalty amount were originally enacted in 1978 (Pub. L. No. 95-396) and the second mention of $1,000 was enacted in 1972 (Pub. L. No. 92-516).
Despite the large increase in some of the civil penalty amounts, EPA has determined, pursuant to Administrative Procedure Act (APA) Section 553(b)(3)(B), that it “would be impracticable and unnecessary to delay publication of this rule pending opportunity for notice and comment.” According to EPA, notice and comment are not necessary “because the 2015 Act does not allow agencies to alter the rule based on public comment.” This rationale presumes that EPA has correctly determined the size of the initial “catch-up” penalty adjustment mandated by the 2015 Act. Despite EPA’s APA finding, EPA would likely be obligated to consider any comment arguing that EPA did not determine the size of this initial adjustment correctly. Future annual adjustments should be much smaller and, thus, presumably not as likely to be as controversial.
By Lisa M. Campbell and Timothy D. Backstrom
On July 5, 2016, a three judge panel of the U.S. Court of Appeals for the Ninth Circuit issued a brief opinion denying a petition for review of a U.S. Environmental Protection Agency (EPA) order in which EPA declined to “immediately adopt interim prohibitions on the use of toxic drift-prone pesticides … near homes, schools, parks, and daycare centers or wherever children congregate.” Petitioners Pesticide Action Network North America (PANNA), United Farm Workers, and Pineros y Campesinos Unidos del Noroeste (PANNA, et al.) filed an administrative petition in 2009 asking EPA to conduct pesticide-specific drift assessments and to impose interim buffer zones to protect children from pesticide drift.
The Circuit Court agreed with EPA’s contention that the petitioners do not have jurisdiction to review the reregistration and tolerance determinations previously made by EPA pursuant to the Food Quality Protection Act (FQPA), because such challenges are now time barred. EPA agreed with the petitioners that it should consider potential risks from spray drift as part of the registration review under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The petitioners argued that EPA had thereby acknowledged legal error when it previously reregistered food-use pesticides, but EPA has vigorously contested that premise. In 2014, EPA issued a proposal describing the methodology for assessing risk from pesticide drift that EPA will use prospectively in making registration review decisions.
The petitioners requested that EPA adopt interim relief by imposing uniform buffer zones for all pesticides that are registered for application by ground sprayers, broadcast, or aerial application, and that may cause certain human health effects. EPA rejected this request for across-the-board buffer zones as unscientific and inefficient and likely to result in a misallocation of EPA resources. The Circuit Court concluded that “substantial evidence” supports EPA’s decision to deny this interim relief, stating that “[t]he record suggests that the risk of exposure to pesticide draft depends on a number of factors, including pesticide toxicity, the method of application, the size of pesticide droplets, and weather conditions,” and “adequately supports EPA’s conclusion that the imposition of uniform buffer zones is not the most ‘scientifically appropriate’ method for mitigating the risk of exposure to pesticide drift.”
The Circuit Court has clearly recognized that uniform buffer zones like those sought by the petitioners would not be “scientifically appropriate.” While this decision is both welcome by industry and constructive, the evaluation of potential exposure and risk from pesticide drift during the registration review process for individual pesticides will likely remain controversial.
More information on EPA’s spray drift policy is available in our memorandum Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions.
By Lisa M. Campbell and Timothy D. Backstrom
On June 29, 2016, the U.S. Environmental Protection Agency (EPA) submitted a status report in the Ninth Circuit Court of Appeals case concerning a petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke the tolerances and cancel the registrations for chlorpyrifos. The Court of Appeals issued an order on December 10, 2015, requiring EPA to take final action concerning the PANNA and NRDC petition no later than December 30, 2016. To comply with an earlier order, EPA issued a proposed rule to revoke the tolerances for chlorpyrifos before it could complete a refined drinking water assessment or propose a new “point of departure” for chlorpyrifos based on biomonitoring data from an epidemiological study.
EPA’s status report states that it has made “significant progress” towards meeting the December 30, 2016, deadline, but “extraordinary circumstances exist that make it impracticable for the Agency to meet the Court’s deadline.” Based on these extraordinary circumstances, EPA has requested a six-month extension for final action on the petition.
EPA notes that a proposed new point of departure was presented to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP), but was not favorably received. At the same time, EPA states that the SAP “raised concerns about the approach EPA adopted in the Proposed Rule, namely that the continued use of acetylcholinesterase inhibition as the point of departure may not be sufficiently health protective.” EPA infers that the SAP may be disposed to recommend a “hybrid approach,” but the written SAP report will not be issued until the end of July, 2016.
EPA states that it had planned to seek public comment on its refined drinking water assessment and new point of departure for chlorpyrifos immediately after the SAP meeting. EPA now believes that it would be best to obtain the final SAP report before deciding how to establish a point of departure. Accordingly, EPA proposes to seek comment on its refined drinking water analysis and analysis of the epidemiological data by early Fall 2016, and to take final action on the PANNA and NRDC petition by June 30, 2017.
EPA expects that the refined drinking water assessment for chlorpyrifos will allow “tailored risk mitigation” that could eliminate one basis for the proposed revocation of chlorpyrifos tolerances. In contrast, EPA’s concerns about the potential neurodevelopmental effects of chlorpyrifos may not be as readily addressed by risk mitigation. If EPA decides either to retain the Food Quality Protection Act (FQPA) 10X safety factor for chlorpyrifos based on purported neurodevelopmental effects observed in epidemiological studies, or to adopt some “hybrid” risk assessment methodology for neurodevelopmental effects in response to the SAP recommendations, debate on the merits of doing so will likely be strong. The status report does not appear to suggest that EPA is currently considering revisiting its general views on the chlorpyrifos epidemiological data; if EPA is not doing so, considerable continued debate on this issue is also likely.
By Lynn L. Bergeson, Lisa M. Campbell, and Lisa R. Burchi
On June 29, 2016, the U.S. District Court for the Northern District of California (Court) issued an opinion dismissing the complaint and denying the motion for summary judgment of the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (CEH, et al.), and granting the U.S. Environmental Protection Agency’s (EPA) motion for summary judgment.
This case stems from a petition filed in 2006 requesting EPA to initiate a rulemaking to require the labeling of 371 inert ingredients in pesticides. EPA issued an Advance Notice of Proposed Rulemaking (ANPR) in 2009, but did not proceed further with a rulemaking. CEH, et al. filed a second lawsuit in March 2014, alleging that EPA’s failure to complete the rulemaking process started by the ANPR violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Administrative Procedure Act (APA). In May 2014, EPA responded by amending its response to the 2006 petition to explain that it had decided to pursue an approach different from requiring mandatory disclosure on the pesticide label of a hazardous inert ingredient. EPA announced that it would instead pursue a “‘combination of regulatory and focused non-regulatory actions that do not rely on rulemaking’ including potentially: (1) removing over ninety chemicals from the list of inert ingredients approved for pesticide use; (2) evaluating the effect of the 371 inert ingredients on food crops; (3) directing pesticide registrants to modify their registrations by replacing hazardous inert ingredients with less hazardous ones; and (4) seeking to expand the existing voluntary disclosure program.” The Court granted EPA’s motion for judgment on the pleadings in the March 2014 lawsuit, “finding that there was no further relief that [the Court] could offer to plaintiffs and that the action was moot.”
CEH, et al.’s complaint in the case at issue challenges EPA’s May 2014 denial of its rulemaking petition, alleging that under FIFRA and APA, EPA’s decision to deny the rulemaking petition was “arbitrary, capricious, and contrary to [FIFRA].” CEH, et al. requested the court to “set aside the denial and to remand the decision to the EPA to consider ‘the evidence weighing in favor of disclosure of inert pesticide ingredients.’” Background on the complaint is available in our blog item NGOs File Suit Regarding Inert Ingredients’ Disclosure.
In support of its ruling to grant EPA’s motion for summary judgment, the court stated: “EPA is not mandated to require disclosure of the inert ingredients at issue,” since “[p]laintiffs have provided no persuasive evidence that EPA’s decision to forego rulemaking is inconsistent with the ANPR.” The Court noted, for example, that EPA’s regulation governing disclosure of inert ingredients, 40 C.F.R. § 156.10(g)(7), states that “[t]he Administrator may require the name of any inert ingredient(s) to be listed in the ingredient statement if he determines that such ingredient(s) may pose a hazard to man or the environment”; this allows EPA to require applicants to list hazardous inert ingredients, but “does not mandate it.” In addition, the Court found that EPA’s decision “that a series of non-rule actions would achieve a greater reduction in the risks from the use of pesticides and could be implemented in a timelier manner,” was not arbitrary or capricious, even if it “conceivably offers a less effective remedy than what plaintiffs sought.”
The decision supports EPA’s discretionary authority to determine how to best manage and address any inert ingredients that may cause unreasonable adverse effects on the environment. EPA has set forth several actions that it is taking or intends to take in lieu of mandatory label disclosure of inert ingredients. For example, on October 22, 2014, EPA proposed to remove 72 chemical substances from the current listing of inert ingredients approved for use in pesticide products because the inert ingredients are no longer used in any registered pesticide product. Registrants of any pesticides containing a potentially hazardous inert ingredient should monitor how EPA’s regulatory and focused non-regulatory actions affect such substances.
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
On June 7, 2016, the U.S. Environmental Protection Agency (EPA) announced that it was making two draft Pesticide Registration Notices (PR Notices) available for public comment: (1) PR Notice 2016-X: Draft Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling; and (2) PR Notice 2016-XX: Draft Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship. In its news release, EPA states that it has started a “more widespread effort aimed at combating and slowing the development of pesticide resistance,” in an effort to “address the growing issue of resistance and preserve the useful life of pesticides.”
Draft PR Notice 2016-X
Draft PR Notice 2016-X, which revises and updates PR Notice 2001-5, applies to all conventional agricultural pesticides (i.e., herbicides, fungicides, bactericides, insecticides and acaricides). The focus of the updates in PR Notice 2016-X is on pesticide labels and improving information about how pesticide users can minimize and manage pest resistance.
Specifically, EPA is proposing that specific resistance-management statements be included with the Directions for Use section under the heading “Resistance Management Recommendations.” EPA states that the proposed labeling statements “focus on the mitigation of pest resistance and should be used where applicable based on the availability of other pesticides and production practices specific to that crop.” As one example, EPA recommends the following general resistance management labeling statements for insecticide/acaricide products containing only a single active ingredient or multiple active ingredients that are from the same Mode of Action (MOA) group:
- For resistance management, (name of product) contains a Group (mode of action group number) insecticide (or acaricide). Any (insect/mite) population may contain individuals naturally resistant to (name of product) and other Group (mode of action group number) insecticides/acaricides. The resistant individuals may dominate the insect/mite population if this group of insecticides/acaricides are used repeatedly in the same fields.
Since the recommended resistance-management statements depend on an active ingredient’s MOA, PR Notice 2016-X also addresses MOA grouping and identification symbols for agricultural uses of herbicides, fungicides/bactericides, and insecticides/acaricides. The pesticide groupings are provided by the Weed Science Society of America (WSSA), the Herbicide Resistance Action Committee (HRAC), the Fungicide Resistance Action Committee (FRAC) and the Insecticide Resistance Action Committee (IRAC). The MOA groups, and the identifier numbers and/or letters (i.e., symbols or codes) for herbicides, fungicides/bactericides and insecticides/acaricides may be accessed through the websites of the different Resistance Action Committees. For example, for insecticides, IRAC uses a combination of numbers and letters to identify various MOA groups. EPA recommends that the IRAC MOA identifier codes be used for designating insecticide MOA grouping information on labels for pesticides containing insecticides. The IRAC MOA list and identifier codes can be found online.
While current PR Notice 2001-5 contains similar guidance in terms of MOA groupings and general pesticide-resistance statements, the Draft PR Notice 2016-X provides: (1) additional guidance, and recommended format, for resistance management statements or information to place on labels; (2) includes references to external technical resources for guidance on resistance management (e.g., professional scientific societies, resistance action committees for different types of pesticides); and (3) updates the instructions on how to submit changes to existing labels to enhance resistance management language. In addition, while PR Notice 2001-5 states that “implementation of this program is purely voluntary by the pesticide industry,” the language in Draft PR Notice 2016-X is arguably stronger, with EPA “encouraging” registrants to add the appropriate resistance-management statements through notification, amendment, or as part of an application for a new product.
Draft PR Notice 2016-XX
Draft PR Notice 2016-XX, which only applies to herbicides, is intended to provide guidance on labeling, education, training, and stewardship for herbicides undergoing registration review or registration (i.e., new herbicide actives, new uses proposed for use on herbicide-resistant crops, or other case-specific registration actions). EPA states it is focusing on the holistic guidance for herbicides first because:
- Herbicides are the most widely used agricultural chemicals;
- No new herbicide mechanism of action has been developed in the last 30 years; and
- Herbicide-resistant weeds are rapidly increasing. In the future, the Agency plans to evaluate other types of pesticides (e.g., fungicides, bactericides, insecticides, and acaricides) to determine whether and what guidance may be appropriate for these types of pesticides.
Under guidance described in PR Notice 2016-XX, EPA proposes to divide 28 herbicide Mechanisms of Actions into three categories of concern (low, moderate, high) based on the risk of developing herbicide-resistant weeds. Appendix I to PR Notice 2016-XX provides three tables with herbicide Mechanisms of Actions of “Low Concern,” “Moderate Concern,” and “High Concern” for herbicide resistance. EPA states its intent to make these tables available on its website, noting that the tables would need to be “checked periodically to determine if there are changes to the groupings or level of concern categories.” Appendix II to PR Notice 2016-XX sets forth the following eleven elements that are focused on labeling, education, training, and stewardship strategies:
- Element 1. List Mechanism of Action Group Number on label.
- Element 2. List seasonal and annual maximum number of applications and amounts.
- Element 3. Provide Resistance Management language from PR Notice 2016-X, and/or Best Management Practices language from WSSA and HRAC, and/or HRAC proposed guidelines for herbicide labels. Note that Best Management Practices (BMP) should be appropriate to crop and production system.
- Element 4. Instruction to user to scout before and after application.
- Element 5. Provide definition of Likely Resistance.
- Element 6. Instruction to user to report lack of performance to registrant or their representative.
- Element 7. List confirmed resistant weeds in a separate table and list recommended rates for these weeds with the table.
- Element 8. Registrant report new cases of likely and confirmed resistance to EPA and users yearly. This is in addition to any adverse effects reporting.
- Element 9. Provide growers with:
- Resistance Management Plan;
- Remedial Action Plan (to control resistant weeds this season or next season);
- Educational materials on resistance management; and
- Plans should be locally developed and easily modified. EPA recommends that registrants work with Extension, Consultants, Crop Groups, HRAC, and the U.S. Department of Agricultute (USDA).
- Element 10. For combination products with multiple Mechanisms of Action, list which herbicide is controlling which weed (a three-way mixture may only have one effective Mechanism of Action for some problem weeds). List minimum recommended rate if resistance is suspected.
- Element 11. Any additional specific requirements (e.g., mandatory crop rotation, unique agronomic aspects, additional training, time limited registration, etc.).
Elements 1 through 4 are proposed for Mechanisms of Actions of Low Concern, elements 1 through 8 are proposed for Mechanisms of Actions of Moderate Concern, and elements 1 through 11 are proposed for Mechanisms of Actions of High Concern.
The PR Notices are available on www.regulations.gov under Docket Numbers EPA-HQ-OPP-2016-0242 for PR Notice 2016-X; and EPA-HQ-OPP-2016-0226 for PR Notice 2016-XX. Comments are due by August 2, 2016.
With regard to PR Notice 2016-XX, EPA states that while comments are welcome on all aspects of this Notice, EPA is especially interested in comments on the following: (1) the approach, elements and categorization used to address herbicide resistance; (2) limiting the application of these measures during registration review to new herbicide active ingredients, new uses of herbicides proposed for use on herbicide-resistant crops, and other case-specific registration actions; (3) other effective measures to inform the stakeholder community of the occurrence of likely resistance; and (4) other useful strategies that, when implemented, would slow the development of herbicide resistance and prolong the useful life of herbicides.
More information on pesticide resistance management is available on EPA’s website.
Avoiding the onset of resistance to any pesticide product is a widely shared goal of users and registrants of the pesticide to maintain the effectiveness and profitability of the product. There is controversy, however, when EPA suggests specific instructions to the user community, since pesticide applications are site and situation specific, making general “one size fits all” approaches, even “flexible” ones, suspect among much of the user community. When the instructions involve label requirements, which are enforceable, concerns about flexibility and the need to adapt to local conditions increase.
Resistance management has been a stated goal of EPA for some time; here EPA seems to argue it is of the utmost importance to preserve useful pest control tools since it is better to have more “tools in the toolbox.” Yet, when EPA seeks to restrict a product or class of products and users and registrants cite the need for that product for resistance management, few benefits seem to be associated with resistance management in such cases. Overall, there is also suspicion that EPA’s concerns regarding herbicide resistance masks a political response to critics of the widespread adoption of herbicide-resistant genetically engineered crops -- since the high value of resistance management gains little value when EPA attempts to restrict other products. An example is EPA’s approach to organophosphate insecticides, where EPA is currently seeking to eliminate many uses that otherwise are viewed as important for insecticide resistance management.
Having EPA attempt to address resistance management via label instructions will be controversial, notwithstanding broad consensus that avoiding resistance is a shared goal. So, the likely debate will focus less on the goal, and more on the means of achieving the goal, as this issue moves forward.
By Lisa M. Campbell and Sheryl L. Dolan
On June 2, 2016, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) and Health Canada’s Pest Management Regulatory Agency (PMRA) released harmonized product chemistry templates for use by registrants when submitting pesticide registration packages.
These templates were developed by EPA and PMRA under the United States -- Canada Regulatory Cooperation Council (RCC) workplan. EPA stated that the templates are based on the Organization for Economic Cooperation and Development’s (OECD) Harmonized Templates for Reporting Chemical Test Summaries’ format, “but have been streamlined to address a single product/application and will facilitate the review of product chemistry data for global and joint registrations, as well as other actions.” EPA and PMRA are encouraging applicants to begin using these templates to organize and summarize the product chemistry data for each product and/or registration package that is submitted to EPA and PMRA.
More information on these templates is available in the RCC’s Work Planning Format document.
By Lisa M. Campbell and Lisa R. Burchi
On May 10, 2016, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued guidelines on highly hazardous pesticides (HHP) (Guidelines) as part of the International Code of Conduct on Pesticide Management (Code of Conduct). HHPs are defined in the Guidelines as “pesticides that are acknowledged to present particularly high levels of acute or chronic hazards to health or environment according to internationally accepted classification systems such as WHO or GHS or their listing in relevant binding international agreements or conventions. In addition, pesticides that appear to cause severe or irreversible harm to health or the environment under conditions of use in a country may be considered to be and treated as highly hazardous.” The Guidelines state that they are “intended to help national or regional pesticide regulators with limited resources to design a process to address HHPs that follows the three steps of identification, assessment and mitigation,” and they aim “to underscore the importance of adequate pesticide legislation, and risk and needs assessment as part of the registration process.”
In 2006, the FAO Council endorsed FAO participation in the Strategic Approach to International Chemicals Management (SAICM) and noted that the International Code of Conduct on the Distribution and Use of Pesticides was to be considered an important element of the SAICM process. The Council “suggested that the activities of FAO could include pesticide risk reduction, including the progressive banning of Highly Hazardous Pesticides (HHPs).” The Joint FAO/WHO Meeting on Pesticide Management (JMPM) developed the criteria that defines HHPs when the Code of Conduct was revised in 2013.
In 2015, SAICM’s International Conference on Chemicals Management adopted a resolution recognizing “HHPs as an issue of concern and called for concerted action to address HHPs, with emphasis on promoting agro-ecologically based alternatives and strengthening national regulatory capacity to conduct risk assessment and risk management.”
2016 HHP Guidelines
The Guidelines include information on:
Identification of HHPs: The Guidelines set forth the following eight criteria for identifying HHPs (i.e., HHPs should be defined as having one or more of the following characteristics):
- Criterion 1: Pesticide formulations that meet the criteria of classes Ia or Ib of the WHO Recommended Classification of Pesticides by Hazard;
- Criterion 2: Pesticide active ingredients and their formulations that meet the criteria of carcinogenicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS);
- Criterion 3: Pesticide active ingredients and their formulations that meet the criteria of mutagenicity Categories 1A and 1B of the GHS;
- Criterion 4: Pesticide active ingredients and their formulations that meet the criteria of reproductive toxicity Categories 1A and 1B of the GHS;
- Criterion 5: Pesticide active ingredients listed by the Stockholm Convention in its Annexes A and B, and those meeting all the criteria in paragraph 1 of Annex D of the Convention;
- Criterion 6: Pesticide active ingredients and formulations listed by the Rotterdam Convention in its Annex III;
- Criterion 7: Pesticides listed under the Montreal Protocol; or
- Criterion 8: Pesticide active ingredients and formulations that have shown a high incidence of severe or irreversible adverse effects on human health or the environment.
Assessment: The Guidelines set forth guidance to assess the risks to human health and the environment under the conditions of use, as well as the needs for the products. FAO developed a Pesticide Registration Toolkit (Toolkit) to assists registrars in the evaluation for authorization of pesticides and review of registered pesticides. The Guidelines state:
- The Toolkit can best be considered as a web-based registration handbook intended for day-to-day use by pesticide registrars. It supports and facilitates informed decision-making by registrars, but is not an automated system that suggests decisions for registrars.
- Registrars can use the Toolkit to support several of their regular tasks. With respect to highly hazardous pesticides (HHPs), the Toolkit can be used as an aid to implement the three steps described in these guidelines: Identification, Assessment and Mitigation.
Mitigation: The Guidelines provide options for mitigating risks of HHPs currently in use, and for possible new HHPs. Specifically, the Guidelines state the “main lines for risk mitigation are ending, restricting or changing formulations or uses. Selection of the most appropriate option will vary from case to case and depend on risk levels and needs, but also on policies and adequacy of institutional infrastructure for pesticide management.”
Planning: The Guidelines set forth steps for designing an action plan to address HHPs. FAO and WHO note the importance of effective communication and involvement with stakeholders in the pesticide supply chain (e.g., growers, food retailers, consumers) in developing an action plan.
Prevention: The Guidelines discuss elements to prevent future problems with HHPs, particularly possible revision of the registration system, strengthened enforcement, extensive training, and the installation of surveillance systems.
Concerns have been raised previously regarding any potential for efforts by WHO and FAO to eliminate HHPs to be based purely on hazard without consideration of risk. The Guidelines include discussions related to the steps to “assess the risks that [HHP] products are posing to human health and the environment under the conditions of use in that country and to review the needs for these products, taking into consideration available alternatives.” Whether this provision sufficiently addresses past concerns should be examined.
Companies will need to review the Guidelines, and the Toolkit, to determine how their products would be identified, assessed, prioritized, and managed under the Guidelines and Toolkit. While some elements of the Guidelines are relatively straight-forward, others may be more subjective and thus much more controversial, such as, for example, the HHP criteria that a pesticide active ingredient or formulation has “shown a high incidence of severe or irreversible adverse effects on human health or the environment.” In addition, the Toolkit is under development, meaning that several modules are not completed and that webpages may not yet be completed. It, thus, will be important to continue to monitor how the Guidelines and Toolkit are developed and applied.
By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom
On Wednesday, June 1, 2016, Administrative Law Judge (ALJ) Susan L. Biro issued an Initial Decision in the matter of Bayer CropScience LP and Nichino America, Inc. (BCS/NAI), U.S. Environmental Protection Agency (EPA) Docket No. FIFRA-HQ-2016-0001.
This decision was issued following BCS/NAI’s request for a hearing to contest EPA’s Notice of Intent to Cancel Pesticide Registrations (NOIC). BCS/NAI challenged EPA’s position that a conditional registration term in the relevant registrations required BCS/NAI to cancel voluntarily their flubendiamide registrations within one week of notification by EPA that the currently registered flubendiamide products will result in unreasonable adverse effects on the environment, and EPA’s issuance of a NOIC for all BCS/NAI flubendiamide products as a result of BCS/NAI’s decision declining EPA’s request to cancel voluntarily all flubendiamide registrations.
In an earlier order, Biro denied BCS/NAI’s Motion for Accelerated Decision and ruled that as a matter of law EPA was authorized to cancel the conditional registrations under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(e) and did not need to provide BCS/NAI the full Section 6(b) cancellation process. More information regarding that decision is available in our blog item EPA ALJ Denies Bayer’s Motion for Accelerated Decision.
Without the ability to review the bases underlying EPA’s determination that the continued registration of flubendiamide does not meet the Registration Standard under Section 6(b), the only two issues for consideration under Section 6(e) were: (1) whether BCS/NAI “initiated and pursued appropriate action to comply” with the voluntary cancellation provision of their conditional flubendiamide registration; and (2) whether EPA’s existing stocks determination was consistent with FIFRA.
With regard to the first issue, the ALJ found that new arguments offered by BSC/NAI were not timely raised, and even if they had been, the ALJ was “not persuaded by the merits of these objections.” Specifically, in response to the objection that BCS/NAI’s voluntary cancellation condition was excused because “EPA was required to engage in open, measured scientific dialogue before demanding cancellation” but did not do so, the ALJ found instead that “while it is clear from the record that Petitioners were not in agreement with EPA as to the toxicity end-points chosen or the Agency’s ultimate determination, they clearly were aware of them, and the rationale behind them, and had an opportunity to respond to EPA and engage in dialogue with Agency officials about these issues.” The ALJ concluded that BCS/NAI was not excused from the voluntary cancellation provision that was a condition of BSC/NAI’s registrations and did not submit a voluntary cancellation request, thus triggering the Section 6(e) cancellation proceedings.
With regard to the second issue concerning existing stocks, BCS/NAI had challenged EPA’s determination that the use of the flubendiamide technical registration product or the further distribution and sales of the end-use products would be prohibited, but use of the end-use products by end-users would be allowed. BCS/NAI argued that FIFRA is a risk-based statute and the facts supported an existing stocks policy that allows for sale, distribution, and use of the limited existing stocks available at the time of cancellation. The ALJ found, however, that EPA’s decision was consistent with FIFRA since FIFRA grants EPA the discretion to allow the continued sale and use of a cancelled pesticide but does not require that EPA make any “determination” that continued use and sale is consistent with FIFRA’s purposes.
BCS/NAI have indicated they will appeal the matter to the Environmental Appeals Board. A key issue in this forthcoming appeal will be whether EPA had discretion to adopt a condition of registration so restrictive in nature that it deprived BCS/NAI of any meaningful right to contest EPA’s subsequent scientific determinations. Most conditional registrations do not include a comparable condition, but it is common for EPA to issue conditional registrations under FIFRA Section 3(c)(7) that remain in effect only for a limited period during the pendency of data development.
This case illustrates the difficulty that a registrant may encounter subsequently contesting any condition that it has nominally accepted. Applicants should be wary and should carefully scrutinize any conditions that EPA may propose. It may be worthwhile in some instances to consider contesting a particularly onerous condition. FIFRA Section 3(c)(6) affords every applicant the right to contest a decision by EPA to deny an application for a less restrictive registration.