By James V. Aidala, Sheryl Lindros Dolan, and Susan M. Kirsch
As reported in the trade press on February 14, 2019, following budget negotiations late on Wednesday, February 13, several legislative riders did not make it into the conference report for the final fiscal year (FY) 2019 omnibus spending package. This purportedly includes an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) or the long-awaited Reauthorization known as “PRIA 4.” This may be the result of political pressure to avoid another government shutdown with a “clean bill” package capable of garnering the necessary votes. The Senate and House are expected to vote on the omnibus package today, February 14, 2019, ahead of the expiration of the current budget resolution on February 15. While much is still in flux, the final omnibus package, once passed, will provide a clearer picture on any PRIA implications. At this time it appears that, contrary to past budget resolutions, PRIA 3 will not be extended. More information on the recent PRIA extensions is available in our blog items Continuing Resolution to Re-open the Government Includes PRIA Extension and Registrants Face PRIA and Shutdown Issues.
In the event of a lapse, the “phase-down” provisions in the statute will mean that new submissions require a reduced fee schedule, but submissions will no longer have an associated PRIA deadline for a decision on the application. The U.S. Environmental Protection Agency (EPA) will likely “clarify” in the coming days and weeks what this means for any expectation for an application submitted during this time. During the recent shutdown, EPA stated that applications submitted during that temporary lapse only required the reduced fee. At that time, however, since no deadline was required for such an application, EPA advised that applicants should expect guidance as to when to expect a decision (that is, in effect, do not bother to submit things during the shutdown period since PRIA actions with an associated deadline will have priority for the foreseeable future). When the federal government reopened on January 28, however, EPA processed all applications received during the shutdown as PRIA actions submitted on January 28.
Now with PRIA likely not in effect after February 15, 2019, even with an approved EPA budget for FY2019, EPA will have to evaluate what to communicate to applicants about what to expect during the time of the PRIA 3 phase-down. Any plans for this period may be affected by provisions in PRIA 4. On February 13, 2019, the Senate introduced standalone PRIA 4 legislation (S. 483) with bipartisan support which could facilitate relatively quick Senate action on a PRIA 4 proposal. The House would also need to take action to renew the program.
Because no PRIA action was taken in the budget agreement, important questions now swirl about the program, including:
- What happens to any new submissions?
- Will there be impacts on pending deadlines?
- What exactly will happen to any submissions made during the current “no PRIA” period?
- What might be the longer term impact of this (in)action on general pesticide program operations (e.g., staffing, contracts, schedules for non-PRIA actions)?
EPA will be addressing these and many other important questions over the next few days.
By James V. Aidala
The short-term continuing resolution (CR) includes an extension of the Pesticide Registration Improvement Extension Act (PRIA 3) through the duration of the funding measure, February 15, 2019. This was expected, and is welcome news to registrants who have delayed submittal of registration applications due to the shutdown.
The status of applications submitted during the shutdown period is uncertain at best. As described in our earlier blog item Registrants Face PRIA and Shutdown Issues, registrants were advised to not submit applications during the shutdown as the U.S. Environmental Protection Agency (EPA) has previously indicated that applications submitted during the shutdown would not be subject to any PRIA deadline. During this period of budget battles and shutdown uncertainty, it would appear to be prudent to ensure that any applications for registration are submitted while EPA (and PRIA) are operational under appropriated funding.
While this is good news, the uncertainty surrounding the possibility of another shutdown at the end of this period not only makes planning difficult for registrants, it also creates workload management problems at EPA to deal with backlogs and unpredictable resources for processing pending and new applications. EPA will have to clarify what the extended shutdown period means for processing times and priorities. As of today, EPA is still literally sorting out applications and PRIA deadlines along with workload planning to determine how best to proceed.
Stay tuned …
By Lisa M. Campbell and Lisa R. Burchi
On December 28, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-26 changing its Notice of Decision (NOD) and public report documentation for proposed registration decisions to ensure continued compliance with its certified regulatory program obligations under the California Environmental Quality Act (CEQA). The new changes to the NODs and public report documentation will be effective May 1, 2019.
These changes are as a result of a 2014 lawsuit brought by Pesticide Action Network North America (PANNA), et al. challenging DPR’s acceptance of label amendments for two previously registered dinotefuran pesticide products. The First District Court of Appeal held that DPR’s NODs and public reports supporting the dinoteferan registration actions were deficient because DPR could not demonstrate that it properly considered certain factors specified in CEQA. In essence, the court concluded that certain CEQA requirements that DPR construed as procedural in nature were actually substantive standards that DPR must meet and adequately document in its administrative record. Specifically, the court found that DPR failed to include a checklist or other documentation with meaningful analysis explaining how DPR reached its conclusion that the approval of the proposed label changes would not cause a significant adverse impact to human health, flora, fauna, water, and air.” The court also found DPR’s discussion of alternatives and cumulative impacts inadequate. Information about that case is available in our blog item California Court of Appeal Reverses Trial Court Decision Denying PANNA’s Petition Challenging Approval by DPR of Pesticides Containing Dinotefuran.
CEQA is intended to ensure projects permitted by public agencies consider the long-term protection of the environment. DPR states that CEQA “requires state and local agencies to develop an environmental impact report (EIR) for any proposed or approved project that may have a significant effect on the environment (including human health) or a negative declaration if there is substantial evidence of no significant impacts.” EIRs provide public agencies and the public “with detailed information about a proposed project’s significant effects on the environment, describe ways these effects can be minimized, and indicate alternatives to the proposed project.” CEQA and its implementing regulations set forth in Title 3, California Code of Regulations (3 Cal. Code Regs.) Sections 6254 and 6255, also require DPR to issue a weekly Notice of Proposed Decisions to Register Pesticide Products and Public Report, listing each proposed decision to register and amend pesticide products for a 30-day public comment period.
Changes to the NOD and Public Report Documentation
To address concerns raised by the court and to protect its certified program status, on January 3, 2018, DPR issued California Notice 2018-01 (“Expanding Use of Pesticide Products Under Reevaluation”), providing that, effectively immediately, DPR “will not act upon an Application for Pesticide Registration or Application to Amend Pesticide Product if DPR determines the registration or acceptance would potentially ‘expand use’ … of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation.”
With Notice 2018-26, DPR will change the documentation associated with its environmental analysis in the NODs and public reports. According to Notice 2018-26, the revised NODs and public reports will address the following areas for each pesticide product noticed for registration:
- Discussion of DPR’s certified program under CEQA;
- Relevant DPR regulations for the proposed decision and public report;
- Detailed description of the project;
- Overview of the registration program, scientific evaluation process, and continuous evaluation;
- Environmental and human health factors examined (i.e., checklist containing the following CEQA areas: human health, flora, fauna, water, and air);
- Discussion of feasible alternatives and mitigation;
- Discussion of existing environmental conditions and cumulative impacts; and
- Conclusion explaining DPR’s analysis of potential significant adverse impacts to human health, flora, fauna, water, and air.
In addition, each public report will include the proposed label. For label amendments, DPR will include both the proposed label and currently accepted label.
In summary, effective May 1, 2019, DPR “will no longer post new products and label amendments exiting the formal evaluation process as proposed to register for the 30-day public comment period until DPR completes a public report explaining why the new product or label amendment is not reasonably expected to cause a significant adverse impact to human health, flora, fauna, water, and air.” New products and label amendments that exit the formal evaluation process prior to May 1, 2019, will be posted for the 30-day public comment period using the current NOD documentation.
The impact of these changes could be substantial from a timing and DPR workload perspective and, thus, of significant concern to registrants. DPR has stated it is reviewing its internal processes and procedures and hiring additional staff to accommodate changes in workload as a result of the NOD and public report documentation changes. This is based, in part, on the fact that if current evaluation reports are not available for each CEQA checklist area (i.e., human health, flora, fauna, water, and air), DPR staff may need to review prior evaluation reports, documentation in product files, U.S. Environmental Protection Agency (EPA) risk assessments, and other available information to develop the public report. Moreover, DPR states that if it does not have adequate information to address each CEQA checklist area, the product may need to reenter DPR’s formal evaluation process. All of these factors could significantly extend the amount of time DPR takes to review a new product or amendment, as it must now develop these public reports prior to proposing registration decisions with a 30-day public comment period, and that time could be even longer in cases where DPR determines it requires additional evaluation of the product and/or data necessary to complete such public reports.
By Lynn L. Bergeson and Margaret R. Graham
Due to the government shutdown and to the late notification to applicants, the U.S. Environmental Protection Agency (EPA) has extended the annual maintenance fee submission date for pesticide registrants from January 15, 2019, to February 15, 2019. Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A), each registrant of a pesticide must pay an annual fee by January 15 of each year for each registration; the fee for 2019 is $ 3,392. The notification of the extension is only available if you call the Pesticide Maintenance Fee information line, however; EPA has provided the information in a voice message. More information on the annual maintenance fees is available on EPA’s website.
On another note, on January 2, 2018, we understood that EPA had confirmed that Imports and Notice of Arrivals (NOA) were continuing to be processed by EPA Regional offices notwithstanding the shutdown. We were mistaken. We now understand that EPA is not completely clear if NOAs are being processed during the shutdown. The EPA Regional offices are working with the U.S. Customs and Border Protection (CBP), but no additional information is available at this time on the processing of Imports and NOAs.
By James V. Aidala, Lisa M. Campbell, and Sheryl Lindros Dolan
Although the Office of Pesticide Programs (OPP) was able to operate through December 28, 2018, despite the current partial federal government shutdown, EPA will now join other parts of the federal service and shut down.
Meanwhile, the Pesticide Registration Improvement Extension Act (PRIA 3) sunset on December 21, 2018, in the absence of a Continuing Resolution (CR) and the onset of the shutdown. According to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 33(m)(2)(B) [7 USC § 136w-8(m)(2)(B)], the fee for any pesticide application that is subject to a service fee and submitted after December 21, 2018, will be reduced by 70 percent below the fee in effect on September 30, 2017, but no corresponding review period will be assigned. Any applications submitted now thus will not have a required EPA review period and thus will likely be the lowest priority for EPA review when the shutdown ends. For this reason, despite the lower fees, registrants should not submit applications until PRIA is enacted and defined review periods once again are established.
The enactment of some version of PRIA is expected soon, especially given the consequences of the current situation for EPA and government functions generally. Most likely any kind of authorization for funding government operations, such as a CR for a limited time period or for Fiscal Year 2019, is expected to include at least a simple reauthorization of the PRIA 3 for the duration of the CR. This would also mean the new Congress will have to act sometime in the next session to reauthorize PRIA either to continue PRIA 3 beyond a new CR time period or approve amendments such as those considered as PRIA 4 during the 115th Congress. Given the difficulty of Congress in reaching agreement on appropriations legislation, it is possible that PRIA reauthorizations continue to be included as part of CRs for an indefinite time period.
This uncertainty about the status of PRIA may also impact generally the program’s ability to plan and schedule review of registration applications.
Regardless of when PRIA is enacted, however, the shutdown will prevent EPA action on newly submitted applications. OPP states on its web site:
- Applications received on or prior to December 21, 2018, will be reviewed under the decision time frames specified in PRIA 3;
- Applications received after December 21, 2018, will be subject to the provisions of FIFRA Section 33(m)(2)(B); and
- Applications received after December 28, 2018, will not be considered as received or processed until the shutdown ends.
Registrants should monitor developments closely.
By Lisa M. Campbell and Lisa R. Burchi
On November 21, 2018, in Court of Justice of the European Union (EU), the Fourth Chamber of the General Court (General Court/Fourth Chamber) issued a judgment in the appeal case T-545/11 RENV that denied all three pleas on appeal and prevented applicants Stichting Greenpeace Nederland and Pesticide Action Network Europe (Applicants) from receiving certain documents containing confidential information relating to the first authorization of the placing of glyphosate on the market as an active substance, specifically the complete list of all tests submitted by the operators seeking the inclusion of glyphosate in Annex I to Directive 91/414.
The judgment provides a detailed history of the case, beginning in 2010, when Applicants requested access to the documents in question. In this initial case, the Secretary General of the Commission agreed with the Federal Republic of Germany’s decision to refuse access to the documents (contested decision) on the basis that disclosure in Article 4(2) of Regulation No. 1049/2001 would undermine protection of the commercial interests of a natural or legal person. In upholding Germany’s decision, the Secretary General found that there was “no evidence of an overriding public interest in disclosure” within the meaning of Article 4(2) of Regulation No. 1049/2001, and also that the information “did not relate to emissions into the environment” within the meaning of Article 6(1) of Regulation No. 1367/2006 concerning public disclosure of information on the environmental effects of glyphosate. As such, “protection of the interests of the manufacturers of that substance had to prevail.”
The Applicants brought an action for annulment of the contested decision to the Registry of the General Court. After one of the documents at issue (a draft assessment report issued by Germany prior to the initial inclusion of glyphosate in Annex I to Directive 91/414) was produced to the court (but still not released to the Applicants), the General Court ruled to annul the contested decision. The Commission appealed this annulment, stating that the General Court erred in its interpretation of the term “information [which] relates to emissions into the environment.” The Court of Justice was persuaded by this argument, set aside the initial judgment, and referred the case back to the General Court. The case was then assigned to the Fourth Chamber. The dispute was limited to the part of the document at issue that “contains information on the degree of purity of the active substance, the ‘identity’ and quantities of all the impurities present in the technical material, the analytical profile of the batches, and the exact composition of the product developed.”
The Applicants put forward three pleas in law in support of their action. The pleas, and the basis for the General Court/Fourth Chamber’s rejections of those pleas, are as follows:
- Failure to Take Account of the Scope of Article 4(5) of Regulation No. 1049/2001: Article 4(5) of Regulation No. 1049/2001 provides that a Member State may request an institution not to disclose a document originating from that State without its prior agreement. Applicants submitted that Article 4(5) of Regulation No. 1049/2001 does not constitute a right of veto for a Member State and that the Commission may not rely on the Member State’s opinion regarding the application of an exception provided for by Article 4(2) of that Regulation. The General Court/Fourth Chamber stated that “the argument put forward cannot succeed, since Article 4(5) of Regulation No 1049/2001 is not the basis on which the Commission refused access to that document. Consequently, the first plea in law must be rejected.” Instead, Article 4(2) was the basis for Germany’s decision, and the Commission verified that Germany’s reasons for that decision were “prima facie, well founded.”
- Overriding Public Interest In Disclosing Information Relating to Emissions Into the Environment: Applicants maintained that the exception to the right of access designed to protect the commercial interests of a natural or legal person must be waived, because of an overriding public interest in disclosure of the information requested, which relates to emissions into the environment. Specifically, Applicants argued that information related to the identity and quantity of impurities present in glyphosate and related test information must be disclosed so that it could be determined “which toxic elements are emitted into the environment and are liable to remain there for some time.” With regard to the concept of “information relating to emissions into the environment,” the General Court/Fourth Chamber rejected arguments that the provision must be interpreted restrictively to mean only direct or indirect release of substances from installations. The General Court/Fourth Chamber also found, however, that the concept cannot be interpreted in a way that would “deprive of any practical effect the possibility” that a Member State could refuse to disclose environmental information or “jeopardise the balance which the EU legislature intended to maintain between the objective of transparency and the protection of [commercial] interests.” In rejecting the second plea, the General Court/Fourth Chamber states:
Since the use, the conditions of use and the composition of a plant protection product authorised by a Member State on its territory may be very different from those of products evaluated at EU level during the approval of the active substance, it must be held that the information in the document at issue does not relate to emissions whose release into the environment is foreseeable and has, at the very most, a link to emissions into the environment. Accordingly, such information is excluded from the concept of “information relating to emissions into the environment,” in accordance with paragraph 78 of the judgement on appeal.
- Alleged Infringement of Article 4(2) of Regulation No. 1049/2001 and Article 4 of the Aarhus Convention: Applicants argued that the contested decision is not in accordance with Article 4(2) of Regulation No. 1049/2001 and Article 4 of the Aarhus Convention, on the ground that the Commission did not evaluate the actual risk of damage to the commercial interests invoked. The General Court/Fourth Chamber stated that it must be held “that the Commission correctly weighed up the relevant interests, having set out precisely and specifically the way in which the commercial interests of producers of glyphosate or plant protection products containing it would be jeopardised by the disclosure of the document at issue.”
After rejecting all three pleas, the General Court/Fourth Chamber held that the action must be dismissed in its entirety, and ordered Applicants to pay the costs relating to the various proceedings.
This case has been monitored closely because of the potential implications for companies that have submitted data or other information claimed as confidential that could be disclosed based on “overriding public interest.” The American Chemistry Council (ACC), CropLife America, CropLife International (CLI), the European Chemical Industry Council (Cefic), the European Crop Care Association (ECCA), the Association européenne pour la protection des cultures (ECPA) and the National Association of Manufacturers (NAM) all intervened in support of the form of the order sought by the Commission. The decision, and, in particular, the limitations placed on the scope of what is to be considered “information on emissions into the environment” provides helpful guidance and ensures that the exceptions provided for disclosure do not swallow the general rules under which institutions must refuse access to documents.
More information on glyphosate issues is available on our blog.
By Lisa M. Campbell and Heather F. Collins, M.S.
On November 19, 2018, the U.S. Environmental Protection Agency (EPA) announced that the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum will take place on December 4, 2018, from 12:00 p.m. to 5:15 p.m. (EST) and on December 5, 2018, from 9:00 a.m. to 5:00 p.m. (EST) at the Washington Convention Center, 801 Mt. Vernon Place, in Washington, D.C. The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada. Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation.
During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) will lead a breakout session that will include updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration. The U.S. and Canadian agencies are working together to:
- Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;
- Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;
- Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;
- Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and
- Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.
Additionally, both offices hope to hear feedback from stakeholders to help inform a new three-year pesticide programs work plan for 2019-2021.
Specific times for this and other breakout sessions, as well as more detail, will be made available online. The Stakeholder Forum is open to the public, with advance registration. Space is limited and registrations will be accepted on a first-come-first-served basis. Registration is available online.
By Lisa M. Campbell and Lisa R. Burchi
On November 7, 2018, the U.S. Environmental Protection Agency (EPA) announced that it was ordering Pool Water Products Inc. to stop selling an improperly registered pesticide, ALL CLEAR 3” Jumbo Chlorinating Tablets. The announcement states that even though the ALL CLEAR 3” Jumbo Chlorinating Tablets product was registered with EPA, Pool Water Products was selling and distributing an unregistered version of the product made in China that has not been evaluated by EPA.
EPA’s action, which it states applies to nationwide distribution, transport and sales of the product, follows a statewide stop-sale order issued earlier this month by the Arizona Department of Agriculture when state inspectors discovered the unregistered pesticide, which is used to disinfect pools, during an August 30 inspection of the company’s Phoenix warehouse.
This case exemplifies the need for companies to understand Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration and amendment requirements, and the importance that a product’s label, formula, and manufacturing process match exactly with the information submitted to EPA and upon which EPA relied in approving the registration. Many composition and processing changes require an amendment to be approved by EPA; failure to do so could result in an enforcement action such as this one.
More information on pesticide registration issues is available on our blog.
By James V. Aidala and Margaret R. Graham
On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was accepting public nominations of scientific experts to be considered for ad hoc participation on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) through membership on the Food Quality Protection Act (FQPA) Science Review Board (SRB). 83 Fed. Reg. 49091. EPA states that “all nominees will be considered for ad hoc participation providing independent scientific advice to the EPA on health and safety issues related to pesticides” and requests that any individuals nominated have expertise in one or more of the following areas: biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic (PBPK) modeling; aquatic modeling; pharmacology; ecological risk assessment; environmental exposure and fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; statistics; water quality monitoring; hydrologist; Geographic Information Systems (GIS) specialist; computational toxicology; entomology; veterinary entomology; medical entomology, insect ecology, allergenicity, research veterinarian; inhalation toxicology; volatile organics; endocrinology, alternative testing methods, high throughput testing approaches, adverse outcome pathways, cross species extrapolation, and systematic review. The Designated Federal Officer’s to whom nominations should be provided is listed in the Federal Register notice. Nominations are due by November 13, 2018.
FPQA added this SRB to the previous authorization for the SAP to recognize the expanding universe of scientific questions which often underlie issues surrounding pesticide registration. The FQPA amendment simply adds that “60 scientists who shall be available to the SAP” without specifying any particular disciplines or skills which might be useful to assist with the deliberations and review by the SAP. This was intended to continually allow EPA to adapt to changing or evolving scientific questions without constantly tinkering with the membership of the SAP itself. At the same time, it allows these ad hoc members to be recognized for their contributions and to be compensated in the same manner as SAP members.
By Lisa M. Campbell and Heather F. Collins, M.S.
On March 22, 2018, the U.S. Environmental Protection Agency (EPA) released the Pesticide Registration Notice (PR Notice) 2018-1 issued by the Office of Pesticide Programs (OPP) entitled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(ll)” (PR Notice 2018-1). Notice of Availability issued on March 21, 2018. 83 Fed. Reg. 12385. The PR Notice states that it “describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment.” It “revises the method and criteria used by EPA for evaluating ‘sufficient economic incentive’ under FIFRA section 2(ll)(2),’” and it “also clarifies that minor use under FIFRA section 2(ll)(1) is based on acreage reported in the [U.S. Department of Agriculture (USDA)] Census of Agriculture.”
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll)(1) defines a minor use of a pesticide as a use on a crop grown on 300,000 acres or less in the United States. Section 2(ll)(2) of FIFRA defines a minor use of a pesticide as one that lacks sufficient economic incentive to seek or maintain a registration but has private or social value.
PR Notice 2018-1:
- Clarifies that the USDA’s most recent Census of Agriculture, conducted every five years by the USDA’s National Agricultural Statistics Service (NASS), is the appropriate source for data on acreage or crops grown in the U.S. to establish a minor use under the acreage definition in FIFRA 2(ll)(1);
- Revises and provides guidance to registrants concerning the method used by EPA for evaluating “sufficient economic incentive” under FIFRA Section 2(ll)(2); and
- Explains how qualitative information may be used to inform the quantitative analysis and interpret the results.
Previously, EPA’s interpretation of economic minor use in Section 2(ll)(2) was based on PR Notice 97-2. EPA states PR Notice 2018-1 supersedes PR Notice 97-2. EPA states that through PR Notice 2018-1, EPA “seeks to identify and encourage the registration of pesticides for minor uses to protect communities from harmful pests.” EPA states in PR Notice 2018-1 that “the existing methods for identifying an economic minor use in PRN 97-2 do not consider all relevant factors which could affect the incentives of a registrant to apply to register a minor use,” and that “use of the approach in PRN 97-2 to identify economic minor uses could prevent applicants from registering pesticides that would be beneficial to users and growers, thus limiting the availability of pesticides for certain use sites.” For this reason, “EPA revised the method to determine an economic minor use.”
PR Notice 2018-1 is significant because it can be applied to conventional pesticides, biopesticides, and antimicrobial pesticides to determine whether they meet the definition of minor use. The criteria in PR Notice 97-2 only applied to conventional pesticides.
EPA states the rationale for revising the PR Notice to consist of the following:
- EPA has decided to revise the policy on determining minor use.
- First, PRN 97-2 is outdated regarding the crops that would not meet the acreage definition of a minor use under FIFRA section 2(ll)(1). PRN 97-2 contained a fixed list of crops that were grown on more than 300,000 acres in 1997, but cropping patterns change over time and the list of crops provided in PRN 97-2 is no longer accurate.
- Second, the method in PRN 97-2 does not accurately reflect economic incentive to register pesticides. Gross revenue is not an appropriate measure for estimating returns on an investment; since it does not account for production and distribution costs, it overstates the returns to the investment. However, revenue from a single year understates the time period when a firm would receive a return on an investment. Finally, gross revenue at full market potential does not account for the difference in timing between costs of registration and future returns. Costs are likely to be incurred at the beginning of registration, whereas revenues will occur over multiple, future years.
- Third, PRN 97-2 applies only to registration actions on conventional pesticides. The notice specifically states that it does not apply to registrations of biopesticides and antimicrobials (e.g., disinfectants). The method described in this PRN may be used to evaluate the registration incentive for all types of products registered by each of OPP's registering divisions.
Additionally of note, EPA states in PR Notice 2018-1 that seeking minor use designation is not required as part of the pesticide registration process. It is an optional designation that an applicant can seek to obtain certain incentives associated with minor uses, such as:
- Extension of exclusive use of data under FIFRA Section 3(c)(1)(F)(ii); and
- Qualifying for an exemption from the fee or waiver of a portion of the registration service fee for an application for minor uses of a pesticide under FIFRA Section 33(b)(7)(D).
More information on other PR Notices is available on our blog under key phrase Pesticide Registration Notice.