Monthly Archives :

March 2018

PRIA 3 Extension Included in Omnibus Spending Bill Signed Into Law

On March 23, 2018, the President signed into law the omnibus spending bill that provides funding for government operations through the remainder of the 2018 federal fiscal year ending September 30th.  CPDA is pleased to report that included in the omnibus spending measure is an extension of current PRIA (PRIA 3) through September 30th of this year.  The legislation funds EPA’s pesticide program at current levels and includes an additional $6.96 million increase for product review activities associated with PRIA.


As reported previously, PRIA has been extended in a series of stop-gap funding measures or Continuing Resolutions (CR) since September 30th of last year. While the measure enacted as part of the omnibus spending bill extends PRIA 3 through September 30, 2018, reauthorizing legislation still needs to be enacted to ensure the continuation of the statute beyond that date.  Importantly, PRIA 4 as a legislative proposal could still be considered by Congress and passed into law. The main issues CPDA is concerned with regarding the current status of PRIA are as follows:


Funding:  The industry would like to see the modification of funding mechanisms that allow fees to be “sequestered” when they do not equal federal appropriations.  CPDA’s position, in line with other stakeholders and EPA leadership, is that this system should be changed so that when fees are collected they can be used to process applications. This should help in addressing any delays or backlogs. This change is included in PRIA 4.


Reauthorization period: While the House version of PRIA 4 extends the program for 7 years, the Senate changed the reauthorization to 3 years. CPDA’s position, in line with other stakeholders and EPA leadership, is that it would be better to have the extended reauthorization period but not at the cost of the legislation failing to pass. CPDA will continue to work with stakeholders and the Agency in developing an acceptable resolution of this issue.


During the weeks leading up to passage and enactment of the omnibus spending measure, CPDA made a series of House and Senate office visits in seeking Congressional support for inclusion of PRIA as part of the funding package.  CPDA also asked its member companies to supplement these lobbying activities by writing to their Senators and Representatives urging support for PRIA as part of the next budget bill.  To all those CPDA member companies who participated in this grass roots effort, we would like to convey our thanks.  The calls and letters of our member companies to their senators and representatives helped CPDA’s advocacy efforts on PRIA.


Nevertheless, much work remains to be done.  In the months ahead, CPDA will dedicate its efforts in securing the enactment of legislation to reauthorize PRIA beyond September 30th.  To this end, CPDA continues to work closely with other members of the PRIA Coalition in building consensus and Congressional support for this critical legislation.


CPDA will keep its members informed of further developments as they occur.  In the interim, should you have any questions, please contact CPDA Director of Legislative Affairs Don Davis.

EPA Seeks Public Comment on Final Biological Opinion Addressing ESA Effects of Chlorpyrifos, Malathion and Diazinon

In the March 23, 2018 Federal Register, EPA announced that it is seeking public comment on the final Biological Opinion issued pursuant to the Endangered Species Act (ESA) by the National Marine Fisheries Service (NMFS) on the potential effects of chlorpyrifos, malathion and diazinon on listed species and their critical habitats.  Comments are due by May 22, 2018 and may be submitted via identified by docket number EPA-HQ-OPP-2018-0141.


Under Section 7(a)(2) of the ESA, if EPA determines that a pesticide is likely to adversely affect a listed species or its designated critical habitat, the Agency must consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (collectively known as the “Services”).  Following consultation, the Service(s) prepares a Biological Opinion (BiOp) on whether the registration action will jeopardize or adversely affect a listed species or habitat and, if so, may include reasonable and prudent alternatives and/or reasonable and prudent measures to avoid or minimize such impacts.




On December 29, 2017, in response to a deadline issued by the U.S. District Court for the Western District of Washington in the case of Northwest Coalition for Alternatives to Pesticides, et. al. v. NMFS, the National Marine Fisheries Service transmitted its final BiOp to EPA which addresses the potential effects of chlorpyrifos, malathion and diazinon on 77 listed species and 50 designated critical habitats as part of registration review.


In its Opinion, NMFS concluded that EPA’s proposed registration of pesticides containing chlorpyrifos is likely to jeopardize the continued existence of 38 of the 77 listed species, and adversely modify 37 of the 50 designated critical habitats.  Likewise, for diazinon, NMFS found jeopardy for 25 of the 77 listed species and adverse modification of 18 of the 50 designated critical habitats. NMFS also determined that registration of pesticides containing malathion is likely to jeopardize 38 of the 77 listed species and adversely modify 37 of the 50 designated critical habitats.  NMFS set forth a series of Recommended Prudent Alternatives (RPAs) which, according to the Service, were drafted using “the best available information on current agricultural practices and pesticide reduction strategies to reduce pesticide exposure to aquatic species and their habitats.”  The RPAs include a list of chemical alternatives as well as specific measures to reduce loading of pesticide chemicals into aquatic habitats.


However, EPA contends that the court’s failure to extend the deadline for issuance of the Opinion did not allow for appropriate public input and is “at odds” with an interim approach developed by the Agency in 2013, with the support of the Services and USDA, for assessing the potential ESA effects of pesticides.  According to EPA, this interim approach is intended to establish an “open and transparent process” for ESA consultations.  The Agency emphasizes that “stakeholder input is critical to the development and evaluation of any measures EPA may implement to address risks to listed species and designated critical habitat.”  As such, EPA is seeking public comment and stakeholder input before making a decision on whether to reinitiate consultation with NMFS or move forward with implementing the measures contained in the Opinion.  The Biological Opinion appears in the public docket established by EPA which may be accessed by clicking here.  Should you have any questions, please contact CPDA’s offices.

EPA Publishes Final PR Notice 2018-1 on Determination of Minor Use Under FIFRA

On March 22, 2018. EPA published on its web site PR Notice 2018-1, titled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(II),” which provides guidance to registrants as to how the Agency determines a “minor use” as applicable to the registration of a pesticide.  Specifically, PR Notice 2018-1 describes the Agency’s revised approach in evaluating “sufficient economic incentive” under FIFRA when determining the eligibility of a pesticide use for classification as a minor use.  Under FIFRA Section 2(II), a minor use is defined as either:  1) the use of a pesticide on a crop for which the total acreage in the United States is less than 300,000 acres; or, 2) the use does not provide sufficient economic incentive to support the initial or continued registration of a pesticide.  These provisions in FIFRA are intended to encourage the continuation of minor use registration of pesticides that might otherwise be discontinued for economic reasons alone.  Under FIFRA, registrants of minor uses may receive a new or extended exclusive use period for data submitted in support of a minor use registration thereby providing the company an economic incentive to pursue new or existing minor use registrations and ensuring the availability of products used on low-acreage crops and other small-volume uses.


To date, EPA has relied on the guidance contained in PR Notice 97-2 in its interpretation of what constitutes an economic minor use – namely, the standard adopted in PR Notice 97-2 holds that a use is minor under FIFRA section 2(II) if gross revenues at full market potential do not cover the costs of registration including data generation, registration fees, and the cost of paperwork burden associated with the registration process.  EPA, however, believes that the standard in PR Notice 97-2 does not consider all relevant factors for determining whether there is insufficient economic incentive to pursue a new minor use registration or continue to support an existing minor use registration.


EPA bases its revised methodology as set forth in PR Notice 2018-1 on the concept of the registration of a pesticide as being an investment.  In so doing, EPA will consider:


  • The difference in time between incurring costs of generating data for registration and obtaining revenue from product sales,
  • The multiple years over which revenue is generated, and
  • The costs of producing and distributing the product.


The Agency states that evaluating registration costs as an investment results in several measures by which EPA can assess whether there are sufficient incentives for the registration of a pesticide use and that each of these measures “provides insight into the magnitude of the incentive to register or maintain the registration of a pesticide.”


In its other provisions, PR Notice 2018-1 clarifies that minor use under FIFRA is based on acreage reported in the USDA Census of Agriculture.


A draft of PR Notice 2018-1 was published for public comment on June 6, 2016.  Public comments received by the Agency and EPA’s response document may be accessed at (Docket identification number EPA-HQ-OPP-2015-0813).

Register for the CPDA Adjuvants & Inerts Conference!

Registration for the CPDA Adjuvants & Inerts Conference, to be held May 1-3, 2018 in San Antonio, Texas, is now open!  The conference provides a forum for education and information exchange on the latest developments shaping the agrotechnology industry.  This event also provides important networking opportunities for catching up with established business contacts and making new ones. The Adjuvants & Inerts Conference continues to be CPDA’s flagship event of the year drawing a diverse audience of manufacturers, formulators, distributors, importers, suppliers and users of adjuvant and inert ingredient products as well as registered end use products.  Over the years, the CPDA Adjuvants & Inerts Conference has built its reputation as a conference developed by industry for industry.


The theme of this year’s conference is “Agrotechnology Challenges in Today’s Ever-Changing Market” and will feature keynote speaker Dr. Matthew Phillips.  His address will focus on the ways companies are navigating and repositioning themselves to remain competitive amid the many multi-national corporate mergers and consolidations taking place across the agrotechnology industry.  The conference program will also include panel discussions and presentations on an array of key topics of pivotal importance to your company and others in the agrotechnology industry.  We hope to see you in San Antonio this May!  For more information and to register, please click here.

CPDA 2018 Regulatory Conference Speaker Presentations Now Available

Speaker presentations from the very productive 2018 CPDA Regulatory Conference, held on Tuesday, March 13th in Arlington, Virginia, are now accessible on CPDA’s web site.  The program featured an array of speakers who addressed key topics such as market forces and economic factors shaping trends in corporate mergers within the agricultural chemicals industry, an update on priority activities underway within EPA’s Office of Pesticide Programs (OPP) including the Agency’s inert ingredient assessment branch, an overview of FIFRA related developments with a special focus on the status of the reauthorization of PRIA, efforts to synchronize the consultation process under the Endangered Species Act, and related topics impacting the agrotechnology industry, the status of OSHA’s plans to revise its Hazard Communication Standard (HCS) to better align it with the latest iteration of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and the implications of new product labeling requirements that will take effect at the end of August 2018 under California’s Proposition 65 ballot initiative.  The CPDA Regulatory Conference concluded with a meeting at the headquarters of the Office of Pesticide Programs where attendees had the opportunity to engage with EPA personnel on important regulatory issues of importance to Council members and the industry.


The CPDA Regulatory Conference speaker presentations may be accessed by clicking the links below.


“Impact of Mergers in Agricultural Chemical Markets,” James MacDonald, U.S. Department of Agriculture


“2018 FIFRA Regulatory Outlook,” Sheryl Lindros Dolan, Bergeson & Campbell, P.C.


“Overview of OPP Priorities and Issues,” Michael Goodis, U.S. Environmental Protection Agency


“Pesticide Inert Ingredient Activities,” P.V. Shah, U.S. Environmental Protection Agency


“Impact of Upcoming Changes to California Proposition 65,” Dave Lawson, Western Plant Health Association


“Hazard Communication Standard and GHS Update,” Maureen Ruskin, U.S. Occupational Safety and Health Administration

Representative Rodney Davis Writes to EPA Administrator Scott Pruitt Expressing Concerns About a Possible Lapse in PRIA

Representative Rodney Davis (R-IL), Chairman of the Subcommittee on Biotechnology, Horticulture and Research of the House Committee on Agriculture, released a letter he sent to EPA Administrator Scott Pruitt on February 22, 2018 expressing his concerns about the potential of a lapse in PRIA.  In his letter, Chairman Davis wrote, “PRIA ensures that companies regulated under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) can confidently invest in the research and development of new products because they know that there is a prescribed timeline in which the EPA must review registrations.  To support PRIA’s prescribed timeline, companies pay fees to provide a predictable level of funding which augments the EPA’s annual appropriations.”
Chairman Davis’ letter was prompted by the looming March 23rd deadline by which Congress must either pass legislation to fund the federal government for the remainder of the FY 2018 fiscal year ending September 30th or adopt yet another stop-gap spending measure to avert a government shutdown.  As reported previously, since October 1, 2017 the federal government has been operating under a series of short-term Continuing Resolutions which have temporarily extended EPA’s authority to collect the full level of registration service fees under PRIA which expired at the end of last September.  If Congress fails to extend EPA’s fee collection authority as part of the next funding measure, fees would continue at a reduced rate over a two-year phase-out period established under PRIA before terminating altogether in FY 2020.  However, while fees would be collected during this phase-out period, PRIA timelines for product review would no longer be in effect.
In his letter to Administrator Pruitt, Chairman Davis asked for an analysis of the impact of both a possible lapse in PRIA and the continuation of current law focusing on such activities as staffing levels of EPA’s pesticide program, the collection of product registration service fees and maintenance fees, the Agency’s ability to adhere to timelines for registration and registration review, and other areas directly affected by PRIA.
As a member of the Pesticide Policy Coalition (PPC), CPDA is working closely with Chairman Davis and other members of the House and Senate Agriculture Committees in an effort to secure a permanent, long-term reauthorization of PRIA.  CPDA applauds Chairman Davis for recognizing the importance of PRIA and for his leadership as he works to secure the continuation of the statute.  CPDA will keep its members apprized of further developments on PRIA and the federal budget process as they occur.  To read a copy of Chairman Davis’ letter, please click here.

EPA Responds to Chairman Davis’ Letter with a Detailed Analysis of the Impact of a Lapse in PRIA

On March 7, 2018, EPA responded to Chairman Davis (see previous story) with a detailed analysis of what the impact would be on the Agency under three scenarios including a lapse in PRIA, a continuation of authority under the existing PRIA 3, and the passage and enactment of PRIA 4.


Approximately 33% of the funding of the Agency’s pesticide program activities comes from PRIA in the form of registration service fees for new product submissions and annual maintenance fees for products currently in the marketplace.  The bulk of maintenance fees collected is used to support EPA’s implementation of registration review which has a statutory deadline for completion of October 1, 2022.


EPA’s analysis indicates that a lapse in PRIA would ultimately result in the loss of some 166 FTEs at the end of the statute’s two-year phase out period during which the Agency would be allowed to collect registration service fees but at a reduced rate (i.e., fees would be reduced 40% in FY 2018 and 70% in FY 2019).  In addition, EPA would no longer have the authority to collect maintenance fees which, according to the Agency, would severely impact its ability to conduct registration review and other maintenance-fee supported activities such as the processing of fast-track amendments and notifications.


In contrast, PRIA 4 is projected to generate an additional $1 million in registration service fees due to the establishment of new fee categories and changes to existing fees.  Maintenance fees collected under PRIA 4 would increase $3.2 million annually above the $27.8 million/year authorized under law for a projected total of $31 million/year.  Moreover, PRIA 4 would remove the existing matching appropriations constraint under current law thus freeing up EPA’s ability to spend collected maintenance fees that now remain frozen on pesticide review activities.  EPA states, “The provision in section 4(k)(2) [of PRIA] prohibiting EPA from spending maintenance fee dollars without matching with appropriation dollars would be removed with enactment of PRIA 4, allowing EPA to better access carryover maintenance fee funds that have built up partially as a result of this provision.  This would provide additional resources to the activities for which these funds can be spent, foremost of which is meeting the statutory obligation under registration review to complete decisions on 725 chemical cases by October 1, 2022.”  The Agency signals that the additional registration service fees and maintenance fees anticipated under PRIA 4 would allow EPA to retain current staffing levels and possibly hire additional FTEs in support of pesticide registration, registration review, inert ingredient review, and expedited processing of substantially similar product submissions and amendments.


As a member of the Pesticide Policy Coalition (PPC), CPDA is working closely with Chairman Davis and other members of the House and Senate Agriculture Committees in an effort to secure a permanent, long-term reauthorization of PRIA.  CPDA applauds Chairman Davis for recognizing the importance of PRIA and for his leadership as he works to secure the continuation of the statute.  CPDA will keep its members informed of further developments on PRIA and the federal budget process as they occur.


EPA Issues Final Guidance Clarifying Placement of First Aid Statements on Pesticide Label Panels

EPA has released final guidance which clarifies where first aid statements should appear on the label of pesticide products.  In December 2016, EPA released a memorandum titled  Guidance for Pesticide Registrants in which the Agency set forth its proposed interpretation and clarification of the definition of a label “panel” and the placement of first aid statements on such labels based on the product’s Toxicity Category.  The Agency initially established a 30-day public comment period on its proposal and then subsequently granted a 60-day extension for comment that ended March 7, 2017.


In its memorandum, the Agency articulated its interpretation of the term “panel” as being that portion of a label that is immediately visible on a pesticide product at the time the pesticide is sold or distributed.  EPA maintained that first aid language must be readily seen on a visible panel (front, side or back depending on Toxicity Category) and may not be placed inside multi-page labeling (i.e., “extended text,” “accordion,” “saddle stitched,” “pull-out,” “booklet,” or other type of formatted labels) that would be accessible only by manually opening a booklet or unfolding accordion style pages.


In both the response document released at the end of the public comment period and the recently issued final guidance document, EPA affirms that it will continue to require that Toxicity Category I products have first aid statements visible on the front panel except in cases where a variation has been approved.  Toxicity Categories II and III products must have statements on a front, back, side or inside panel (any panel).  These statements are optional for Toxicity Category IV products.  In addition, EPA provides the following recommendations:


  • For Toxicity Category I products, the Agency strongly recommends that registrants consider placing duplicative first aid language on the very back page of the booklet/accordion/saddle stitch label that is immediately stuck to the container in case the booklet/accordion/saddle stitch label is accidentally removed.


  • Regardless of whether a registrant chooses to place the first aid statements for Toxicity Categories II and III products on a visible front, back, side or inside panel, it is recommended that duplicative first aid language appear on the very back page of the booklet/accordion/saddle stitch label that is immediately attached to the container in case the booklet/accordion/saddle stitch label is accidentally removed. EPA states that this recommendation is not intended to suggest other information that registrants typically include on the very back page should be moved elsewhere.


  • The Agency recommends that the registrant community consider designing new booklets/accordion/saddle stitch labels that are not easily removed from the containers. Per 40 CFR part 156.10(a)(4) the labels are to be “securely attached” to the immediate container of the pesticide product. However, the Agency believes that in many instances these labels are easily removed which is why many registrants have already chosen to put the duplicative first aid statements on the very last page (as recommended above) of the label that is attached to the container.

The final guidance document may be accessed by clicking here.

CPDA and Other Members of the PPC Address ESA Consultation Process for Pesticides

This month, CPDA and other members of the Pesticide Policy Coalition (PPC) sent a letter to members of the House and Senate Agriculture Committees as part of an outreach effort aimed at developing a more efficient and coordinated process by which pesticides are assessed for their potential impacts to listed species and habitats under the Endangered Species Act (ESA).  Under Section 7(a)(2) of the ESA, federal agencies are required to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (collectively known as the “Services”) to ensure a federal action does not jeopardize the continued existence of a listed species or adversely modify its critical habitat.  This ESA directive applies to all EPA pesticide licensing activities.


When EPA registers a pesticide, the Agency is required under FIFRA to ensure that the proposed action does not cause any unreasonable adverse effect to listed species or the environment.  Unfortunately, EPA and the Services historically have differed in their approach to assessing pesticides for ESA impacts.  This conflict has given rise to lengthy delays in the consultation process as well as endless litigation brought against EPA by environmental and public interest groups citing the lack of a procedural framework for FIFRA-ESA consultation.  In addition, ambiguity in the definition of “best available scientific data” upon which ESA decisions are made has further contributed to the challenges of developing a streamlined process for consultation on the ESA effects of pesticides.  Ultimately, farmers and growers are denied access to the beneficial pesticides they need because of the undue delay in bringing these products to market.


CPDA and other members of the PPC are working with Congress with the goal of establishing a more streamlined ESA consultation process for pesticides that eliminates the wasteful duplication of complicated study reviews and avoids the inordinate delays that impede the mechanism currently in place.  In its letter to the House and Senate Agriculture Committees, the PPC stated:


“As the agency charged by Congress with regulating the human health and environmental safety of pesticides, EPA has decades of issue area expertise with these products and their impacts on the environment, including their potential toxicity and exposure to wildlife. That experience should be supplemented with the species expertise of the Services, but its work should be neither ignored nor duplicated. Potential threats to protected species and their habitat can be better assessed and more effectively regulated to encourage a more efficient, timely process, providing enhanced species review, along with greater regulatory certainty for growers, other users and manufacturers.”


CPDA will keep its members informed of this ongoing effort to improve and better coordinate the ESA consultation process between EPA and the Services.