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Federal District Court Rules that FIFRA Precludes Claims of Copyright Infringement of the Basic Manufacturer’s Label

In an April 10 decision, the U.S. District Court for the Middle District of North Carolina ruled that FIFRA precludes claims of copyright infringement for the required parts of the labels of “me-too” registered products.  The decision was issued in Syngenta Crop Protection, LLC v. Willowood, LLC., a lawsuit in which Syngenta alleged that Willowood had willfully and knowingly violated copyright protections of one of its product labels when Willowood used substantial portions of the label for a generic me-too version of the product in question.  The North Carolina District court decision rejected the conclusions of the U.S. District Court for the Eastern District of Pennsylvania issued in a previous case, FMC Corp. v. Control Solutions, Inc., involving similar claims of copyright infringement of the pesticide label.

 

In a very lengthy 2005 decision, the Pennsylvania District court found that Control Solutions, Inc. had willfully infringed on the copyright of the label of one of FMC’s proprietary pesticide products (TalstarOne).  The court stated, “…To quickly enter the same market, defendant CSI took an impermissible short-cut.  Instead of investing the resources necessary to develop an independent product label, CSI simply appropriated FMC’s existing copyrighted labels. Wholesale copying, as CSI did with FMC’s label, is not consistent with the statutes, regulations or process mandated by the EPA for having a me-too pesticide registered to permit the sale of a generic pesticide product.”  The Pennsylvania District court issued a temporary injunction against CSI “to prevent further sales or facilitation of sales of any product utilizing a product label that has been approved by the EPA…based upon a me-too submission by CSI that consists of a product label based on the virtually verbatim copying of the TalstarOne label.”

 

However, in its recent ruling, the North Carolina District court found the decision issued in 2005 to be “unconvincing,” concluding instead that federal pesticide law “contemplates that a [generic] applicant will copy from the original pesticide label in ways that would otherwise infringe a copyright…Congress intended a narrow exception to copyright protection for the required elements of pesticide labels as against me-too registrants.”

 

The issue of copyright infringement as it pertains to a generic registrant’s use of a basic manufacturer’s product label for a me-too pesticide has been a contentious legal topic over the years.  Shortly after the decision in FMC Corp. v. Control Solutions, Inc., CPDA wrote a July 11, 2005 letter to Susie Hazen who was then OPPTS Deputy Assistant Administrator at EPA.  In its letter, CPDA voiced concerns that the court decision could trigger a deluge of me-too label changes submitted to the Agency by companies seeking to avert the possibility of copyright infringement legal action brought by the original manufacturer.  CPDA also pointed out the difficulties inherent in making each product label different from other labels so as to avoid the risk of infringing on the copyright while at the same time making sure that any variations would not confuse the user.

 

EPA responded with a letter agreeing with these and other concerns raised by CPDA.  In its letter, the Agency affirmed the practice of the Office of Pesticide Programs (OPP) under FIFRA Section 3(c)(7)(A) to encourage me-too product labels to be identical or substantially similar to the labels of the products on which their registrations are based.  EPA emphasized that similar products need to communicate use instructions and warnings in a clear and consistent manner to ensure that the products are used appropriately.  The Agency cautioned that variations on the label for similar products could diminish EPA’s ability to enforce pesticide labeling in a consistent manner thus defeating the primary purpose of labeling.  CPDA will continue to keep a watchful eye on any further legal developments on this issue should they occur.

EPA Denies Petition Seeking Chlorpyrifos Ban

On March 29, 2017, EPA Administrator Scott Pruitt signed an order announcing the Agency’s decision to deny a 2007 petition filed by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) seeking the revocation of all tolerances for chlorpyrifos and the cancellation of all product registrations for the chemical.  The order appeared in the April 5, 2017 Federal Register.  Among the claims asserted by the petitioners was that EPA failed to adequately assess the potential for chlorpyrifos to cause neurodevelopmental effects in children at exposure levels below the Agency’s existing regulatory standard (10% cholinesterase inhibition).  In an effort to resolve the scientific issues surrounding the potential risks associated with chlorypyrifos, EPA committed to completing the expedited registration review of the chemical several years in advance of the October 1, 2022 statutory deadline.  Although EPA had expedited its registration review, the petitioners were not satisfied with the Agency’s progress in responding to the petition and filed a lawsuit in the 9th Circuit Court of Appeals to compel EPA to either issue an order denying the petition or to grant the petition by initiating the tolerance revocation process.

 

In August 2015, the Court issued a ruling in favor of the petitioners.  Following the judicial ruling, in November 2015 EPA issued for public comment a proposal to revoke all chlorpyrifos tolerances citing the uncertainties pertaining to the chemical’s potential to cause neurodevelopmental effects.  Subsequently, the 9th Circuit announced that it would retain jurisdiction over the chlorpyrifos matter and on August 12, 2016 directed EPA to issue a final decision on the petition no later than March 31, 2017.  In so doing, the Court made it clear that no further extensions in responding to the petition would be granted.  Pursuant to the Court order, in November 2016 EPA published for public comment notice of availability of its revised risk assessment for chlorpyrifos.

 

In its March 29, 2017 decision to deny the petition seeking a ban on the use of chloryprifos, the Agency states:

 

“Following a review of comments on both the November 2015 proposal and the November 2016 notice of data availability, EPA has concluded that, despite several years of study, the science addressing neurodevelopmental effects remains unresolved and that further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos. EPA has therefore concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution on those issues. As noted, Congress has provided that EPA must complete registration review by October 1, 2022. Because the 9th Circuit’s August 12, 2016 order has made clear, however, that further extensions to the March 31, 201 7 deadline for responding to the Petition would not be granted, EPA is today also denying all remaining petition claims.”

 

EPA’s denial of the petition was applauded by Sheryl Kunickis, director of USDA’s Office of Pest Management Policy who called it “a welcome decision grounded in evidence and science.”  Kunickis added, “It means that this important pest management tool will remain available to growers, helping to ensure an abundant and affordable food supply for this nation and the world.  This frees American farmers from significant trade disruptions that could have been caused by an unnecessary, unilateral revocation of chlorpyrifos tolerances in the United States.  It is also great news for consumers, who will continue to have access to a full range of both domestic and imported fruits and vegetables.”

 

It is very likely that the petitioners will turn to the courts in an effort to overturn EPA’s recent decision.  CPDA will report on further developments on this issue as they occur.  The Agency’s decision denying the petition may be accessed by clicking here.

EPA Budget Memo Details Proposed FY 2018 Funding Cuts to EPA’s Pesticide Program Activities

An article appearing in the April 5, 2017 edition of “InsideEPA.com” details severe funding cuts expected to be proposed in the Trump Administration FY 2018 budget request for EPA that promise to impact a number of Agency programs, including the Office of Pesticide Programs.  According to the article, the proposed funding reductions are set forth in a March 21, 2017 budget memo prepared by David Bloom, EPA’s Chief Financial Officer.  The article reports that the President will propose a $5.7 million and 31.7 FTE (full-time equivalent) decrease from OPP FY 2016 enacted funding levels of $6.1 million and 324.8 FTEs for protecting human health from pesticide risk.  In addition, the article states that the President will propose a reduction of $4 million and 18 FTEs from the $4.6 million in FY 2016 funding and 207.9 FTEs for protecting the environment from pesticides.  The reduced OPP funding levels set forth in the memo are accompanied by a statement explaining that the President’s budget will include language to allow the pesticide program to use fees on a broader range of activities in the program thus preventing a reduction or slowing in pesticide reviews.  The memo further states, “The program has nearly $30 million of unspent fee carryover that can help support core work.”  Elsewhere the memo states, “Sizeable unobligated balances in EPA’s FIFRA fee accounts are to be used to offset FY 2018 funding levels.  Additionally, any potential additional fee collections from the upcoming reauthorization of PRIA could help offset reductions to the program.”

 

As reported previously, current FIFRA language states that in order to release funds collected by program participants, Congress must appropriate corresponding funds to support the program.  Funds are then released on a dollar-for-dollar accounting basis.  Fees that do not have a matching appropriation cannot be spent and are held by the Agency.  As a result of dwindling appropriations and hiring freezes over the years, EPA has amassed significant funds that cannot be expended on the activities for which they were intended.  CPDA is now working in an effort to secure appropriations committee report language affirming that these “frozen” funds should be released and used in support of the Agency’s pesticide product review activities.  In addition, CPDA is focusing its efforts in seeking FY 2018 OPP appropriations levels that will ensure EPA is equipped with the resources necessary to conduct product reviews under PRIA in accordance with the statutory time frames established by law.  CPDA will keep its membership apprized of further developments on this issue as they occur.

CPDA Legislative Policy Conference Includes an Overview of the Political and Regulatory Climate Under the Trump Administration

CPDA’s Don Davis Briefs Conference Attendees

CPDA Director of Legislative Affairs Don Davis presided over the Legislative Policy Conference held in Washington, D.C. on March 8th and provided attendees a snapshot of the post-election political landscape and regulatory climate under the Trump Administration.  The following is a summary of the key highlights of Don’s presentation.

 

CPDA Members Review Key Issues in Preparation for Congressional Visits

Across the nation, some 44 state assemblies now fall under Republican control and in 25 states, the GOP controls both the Assembly and Senate in the state legislature. The electoral map of the U.S. also shows that 33 Republicans and 16 Democrats hold the governorship.  The party breakdown at the state level is important in that it plays an important role in what happens at the federal level – especially when it comes time for Congressional redistricting.  Meanwhile in the 115th Congress, 237 Republicans and 193 Democrats make up the House (with 5 seats currently vacant) while 52 Republicans and 48 Democrats make up the Senate.  However, the GOP’s control of 52 seats in the Senate falls short of the 60 votes needed to break a filibuster under current Senate rules.

 

With regard to the current regulatory climate in Washington, the Trump Administration has wasted no time in pushing forward its agenda of regulatory reform and has already signed several Executive Orders of importance to CPDA.  Every President since George Washington has used the power of the presidency to issue Executive Orders as a means of instructing federal agencies on how to implement a law but sometimes as a way of circumventing existing law.  Yet, an Executive Order can be overturned by the Judiciary if it is determined that the EO is unconstitutional or not supported by the underlying statute.  In addition, Congress can pass a new law to override an Executive Order, subject to a Presidential veto.

 

Among the Executive Orders that the President has signed is the directive set forth in a January 20, 2017 White House memorandum that establishes a temporary regulatory “freeze” prohibiting all federal agencies from sending any regulation to the Office of the Federal Register (OFR) for publication until a department or agency head appointed by the President reviews and approves the rule.  Rules that have been sent to the OFR but have not yet been published in the Federal Register must be immediately withdrawn pending review by the Administration.  Another EO, signed by the President on January 30th, requires any executive department or agency that proposes a new regulation to identify two regulations to be repealed.  For fiscal year 2017, the total incremental cost of all new and repealed regulations must be no greater than zero.  Finally, the President signed an EO on February 24 which instructs each federal agency to designate an official as its Regulatory Reform Officer within sixty days of the order.  These officers would oversee the administration’s regulatory reform policy laid out in previous executive orders within their respective agencies.

 

In addition to these White House actions, the Republican controlled House is advancing its own agenda of regulatory reform with the introduction of several legislative initiatives supported by CPDA.  Among these are the Regulatory Accountability Act of 2017, the Congressional Review Act of 2017, and several other measures intended to instill transparency into the federal rulemaking process without imposing unnecessary cost or undue burden on the regulated community.

 

Before dispersing to Capitol Hill, CPDA members received the following “Lobbying 101” tips in preparation for their Congressional office visits:  1) Know the make-up of the political environment within which you are advocating your position; 2) Get to know Members of Congress who play a key role on specific bills of interest (including the majority and minority leadership who sit on the Committee of jurisdiction); 3) Acquire an understanding of the legislative process and how bills move through Congress; 4) Develop a personal relationship with the elected Representative from your Congressional district as well as his/her staff but do not contact them only when you need something; 5) Leave behind a one-page fact sheet summarizing the issue and stance along with your business card; and, 6) Follow up any Congressional office visit with a personal thank you note.

 

With these tips and pointers fresh in hand, Council member company representatives embarked on a very successful and productive “Rally on the Hill” relaying CPDA’s position on key legislation that will have a profound impact on the agrotechnology industry.

President Trump Continues to Push for Regulatory Reform with New Executive Order

On February 24, 2017, President Trump signed an Executive Order (EO) directing the heads of federal agencies to designate a Regulatory Reform Officer to oversee the implementation of regulatory reform initiatives including the directives set forth in his previous EO issued on January 30th.  As reported previously, the January 30th EO establishes a “regulatory cap” for fiscal year 2017 and requires federal agencies that propose for public notice and comment or otherwise promulgate a new regulation to identify at least two existing regulations to be repealed.  In addition, the January 30th EO stipulates that for fiscal year 2017, the total incremental cost of all new regulations, including those that have been repealed, must be no greater than zero unless otherwise required by law or consistent with written guidance from the Office of Management and Budget (OMB).

 

In addition to calling for the appointment of a Regulatory Reform Officer, the February 24th EO directs each federal agency to establish a Regulatory Reform Task Force that will have responsibility for evaluating existing regulations and making recommendations to the agency head regarding the repeal, replacement or modification of existing rules.  Federal agencies that issue few or no regulations could seek a waiver from OMB exempting them from the requirements of the EO.  A list of agencies with current waivers will be published by the OMB at least every three months.

 

In performing its duties, the Regulatory Reform Task Force is instructed to identify regulations that eliminate or inhibit job creation, are unnecessary or ineffective, and impose costs that exceed benefits.  In carrying out its charge, the Regulatory Reform Task Force is directed to solicit input from state, local, and tribal governments, small businesses, consumers, non-governmental organizations, and trade associations.  Within 90 days from issuance of the EO, the Regulatory Reform Task Force must provide a report to the agency detailing its progress in carrying out these obligations.

Health Canada Announces Proposal to Limit the Personal Use Import Exemption for Unregistered Pesticides

Health Canada has announced a draft amendment to the Pest Control Products Regulations to revise the current personal use import exemption to prohibit certain unregistered pesticides from entering Canada.  Currently, the regulations allow unregistered pesticides to be imported into Canada for personal use when the pesticide is 500 grams (g) or 500 milliliters (mL) or less and when the value is $100 or less.  According to Health Canada, the exemption was originally put in place to allow travelers to carry small quantities of a pesticide, such as an insect repellant deemed to pose little or no risk, across the border.  However, Health Canada now cites concerns that the widespread use of the Internet to purchase goods online coupled with the increase in international travel could result in the influx of larger amounts of potentially toxic, unregistered pesticides entering the country.  Health Canada notes that the Canada Border Services Agency lacks the authority under current regulations to intercept these products before they cross the border.

 

In seeking to limit the exemption, the Health Canada proposal would allow the importation of unregistered pesticides only if they meet the following criteria:

 

  • imported directly by the importer for personal use (i.e., online purchases or deliveries would not be permitted),
  • 500 g or 500 mL (or less) per person,
  • it is equivalent to a Canadian registered domestic class product (the same active ingredient and concentration),
  • packaging and labeling is in either English or French,
  • it is in its original packaging with the original label intact, and
  • it must be registered or authorized for use in the country of origin (contains a government registration number on its packaging or label).

 

In announcing its proposal, Health Canada indicated that if left in its current form the importation exemption could erode the integrity of Canada’s pest control products regulatory regime.  For example, importers could circumvent the quantity limit established under the current exemption by placing many separate online orders via the Internet.  According to Health Canada, individuals and businesses could import “virtually unlimited quantities of unregistered pesticides for possible commercial use or resale.”  Consequently, products that have not gone through Canada’s rigorous review and approval process could end up occupying a larger share of the Canadian pesticide market thus resulting in lost sales for pesticide manufacturers and increased public health and safety risks.

 

Health Canada’s proposal was published in the February 11, 2017 edition of the Canada Gazette with a 30-day public comment period.  The proposal may be accessed by clicking here.

House Agriculture Committee Approves PRIA Reauthorization Bill

The 115th Congress of the United States has convened and one of the most important issues that CPDA and its members are working on is the reauthorization of the Pesticide Registration Improvement Act (PRIA).  PRIA was first enacted as part of the Consolidated Appropriations Act of 2004 to establish firm deadlines by which EPA must make decisions on pesticide registration actions submitted to the Agency.  As originally enacted, the Act required Congress to reauthorize the program through legislation every 5 years with the current program set to expire on September 30, 2017.

 

A measure, titled the “Pesticide Registration Enhancement Act of 2017” (H.R. 1029), was introduced in the House on February 14, 2017 by Representative Rodney Davis (R-IL) and was favorably reported out of the House Agriculture Committee by voice vote on February 16th.  Among its provisions, the bill would authorize the collection of $31 million in maintenance fees for each of fiscal years 2017 through 2023 (current maintenance fees are set at $27.8 million/year).  In addition, the measure provides for an increase in the maintenance fee cap for large and small businesses and it continues the current prohibition on the imposition of tolerance fees as well as any other registration fee not specifically authorized by PRIA through fiscal year 2023.  In its other provisions, the measure provides for a set-aside of between 1/9 and 1/8 of maintenance fees collected for the review of inert ingredient submissions and me-too pesticide applications.  The bill also adjusts registration service fees and decision review times for product submissions subject to PRIA and provides for two 5% increases in registration service fees during the effective period of the statute.  A copy of the bill may be accessed by clicking here and a section-by-section summary is available here.

 

While CPDA is generally supportive of the provisions in H.R. 1029, the Council does have some concerns with regard to how the bill, as presently written, would impact appropriations.  Specifically, current PRIA requires that in order to release collected funds, Congress must appropriate corresponding funds to support the program. Funds are then released on a dollar-for-dollar accounting basis.  Fees that do not have a matching appropriation cannot be spent and are held by the Agency.  As a result of dwindling appropriations, EPA has amassed a significant amount of funds totaling approximately $20 million that cannot be expended on the registration activities for which they were intended.  Some have suggested that “de-linking” appropriations and fees in the Act will solve this problem.  CPDA believes that de-linkage is an inappropriate way to release these frozen funds because:

  • The link between fee collection and appropriations is the mechanism that guarantees that Congress will continue to fund PRIA;
  • De-linkage does not solve the ongoing problem of the mismatch between appropriations and fee collections; and
  • The problem of the mismatch between appropriations and fee collections can be easily solved by passing a one-time waiver to release currently frozen funds.

 

CPDA is working with lawmakers to support a waiver process that would allow these funds to be released while maintaining the Congressional incentive to appropriate the necessary funding to support PRIA.  The original intent of PRIA was to create an EPA funding mechanism that would completely support the pesticide registration process through funds collected from industry (maintenance and registration fees) as a supplement to the appropriations enacted by Congress.  However, due to the failure of Congress to enact the base level of appropriations specified in current PRIA, EPA’s registration program has not seen full funding for the past several years.  Over the coming weeks and months, CPDA staff will be visiting with members of Congress to address this issue.

 

With regard to the timing of how PRIA might move through Congress, it is expected that the measure will be the subject of at least one hearing, if not several, all of which will likely wrap up by late spring before the bill is sent to the House floor for a vote.  Once approved by the House, the measure will be sent to the Senate for consideration and passage.  A joint House-Senate committee must then reconcile any differences in the legislation as passed by both chambers.  The bill will then be sent back to the House and Senate floors for a vote before going to the President to be signed into law.  The process of moving a bill through Congress can be slow or fast depending on the issues involved.  PRIA is expected to move in a “normal manner” with a target for completion either right before or soon after the August recess.

 

The reauthorization of PRIA will be one of the key advocacy issues to be discussed during the Congressional office visits we are planning as part of the CPDA Legislative Policy Conference scheduled for March 8, 2017.  We encourage all member company representatives to attend.  Additional information on how to register for the Conference is available by clicking here.

EPA Seeks Public Comment on its Interpretation of the Definition of a Label “Panel” in Relation to Placement of First Aid Statements

EPA is inviting public comment on its 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’s interpretation and clarification were set forth in a December 2016 memorandum in which the Agency explains that while the Code of Federal Regulations (CFR) does not specifically define the term “panel,” the CFR does nonetheless stipulate that first aid statements must appear on the front panel for Toxicity Category I products and any panel for Toxicity Category II and III products.  EPA plans to update its Label Review Manual to reflect this clarification of the term “panel” in relation to the placement of first aid statements on the label for Toxicity Category I products and, in preparation, has established a public comment period ending on March 7, 2017.  Comments may be submitted to EPA docket number EPA-HQ-OPP-2016-0545 which may be accessed by clicking here.

 

In its memorandum, EPA references PR Notice 2001-1 which states, “First aid statements for other than Toxicity Category I products may appear on the front, side or back panel of the label.  Any time first aid statements appear on the side or back panel of the label, EPA expects that a referral statement such as ‘see side/back panel for additional precautionary statements’ will appear on the front panel of the label near the signal word.  First aid statements appearing on the side or back panel of the label would then be grouped near the other precautionary labeling, yet be set apart or distinguishable from the other label text.”

 

The Agency reiterates its long-standing 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.  As such, 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.  EPA states that this interpretation of the term “panel” is consistent with the guidance contained in PR Notice 2001-1.  While EPA acknowledges that it will consider requests for alternative placement of first aid language on a case-by-case basis, the Agency underscores “it is unlikely we would allow Toxicity Category I first aid statements to be placed only within a fold-out label format.”

 

CPDA welcomes feedback from its member companies on the possible ramifications of the Agency’s interpretation of the term “panel.”  Please click here to read EPA’s memorandum.

EPA Delists 72 Inert Ingredients From Use in Pesticides

On December 20, 2016 EPA announced the removal of 72 inert ingredients from its list of chemicals approved for use in pesticide products.  The use of these substances in the future will require that they go through the Agency’s formal inert ingredient re-approval mechanism, a burdensome process that will require the submission of an extensive amount of data developed through very costly and time consuming testing required to demonstrate the safety of the chemical in question.  The type of data needed to evaluate a new inert ingredient includes studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative.

 

Some of the 72 inert ingredients are a subset of a larger list of 371 inert ingredients that were the subject of two petitions submitted to EPA in 2006 identifying these substances as hazardous and requesting that the Agency issue a rule requiring that the identities of these inert ingredients appear on the labels of pesticide products containing any of these chemicals in their formulations.

 

In its initial response to the petitions, EPA proposed an Advanced Notice of Proposed Rulemaking (ANPRM) published in the December 23, 2009 Federal Register.  The ANPRM solicited comment on a range of issues including the question of whether a rulemaking should be limited to mandatory disclosure of potentially hazardous ingredients or broadened in scope to require disclosure of most or all inert ingredient identities, regardless of hazard.  The ANPRM also sought feedback on other questions such as how disclosure would impact CBI protections for inert ingredients under Section 10 of FIFRA.  Subsequently, in a May 22, 2014 letter to the petitioners, EPA announced its decision to abandon pursuit of a rulemaking aimed at mandatory disclosure of inert ingredients.  The Agency cited the many complexities surrounding the issue of inert ingredient disclosure as well as the significant staff time and resources involved in the rulemaking process.  Instead, EPA set forth a series of alternative actions under consideration that it believed would reduce the presence of hazardous inert ingredients in specific pesticide products.  Among these was a proposal to remove from the approved list of inert ingredients those that are no longer being used in pesticide products.

 

The 72 inert ingredients recently delisted by EPA were originally the subject of a Notice published in the October 22, 2014 Federal Register in which the Agency proposed to revoke their approved status.  In the Notice, EPA explained that the list of 72 inert ingredients was generated by an Agency evaluation of pesticide product compositional information to determine which of those 371 chemical substances referenced in the 2006 petitions and listed as inert ingredients on the EPA-approved list are in use or not in use in currently registered pesticide formulations.  The Agency noted that its proposed action would fulfill one of its commitments as described in the May 22, 2014 amended response to the petitioners.

 

On January 20, 2015, CPDA submitted comments to EPA on the delisting proposal, emphasizing that such action is not in accordance with EPA’s clear obligation under FIFRA to make risk-based decisions about registered pesticides (including their inert ingredients) and not hazard-based decisions based on their appearance on non-FIFRA related lists of hazardous substances.  Moreover, CPDA emphasized that removal of these inerts would subsequently require an expensive and time-consuming data generation and reapplication process in order to use them again.  CPDA also pointed out that it was not clear from the proposal whether EPA was focusing only on non-food use inerts, and that this delisting could inadvertently adversely affect tank-mix adjuvants that are used on food crops.  The ingredients in tank-mix adjuvants that are applied to food crops with pesticides must have a tolerance or exemption from a tolerance.  EPA’s review of pesticide formulations to determine whether an inert is currently being used would not have identified those approved inerts that are used in adjuvants applied with pesticides.  CPDA therefore asked EPA to confirm that food-use inerts are not part of this delisting, since they may be currently used in tank-mix adjuvants.  In addition, CPDA noted that one or more of these 72 inerts may be present in approved inerts as low concentrations of residual impurities such as unreacted monomers.  These impurities do not contribute to the function of the inert ingredient, but due to various regulatory list triggers, they may appear in product safety data sheets.  CPDA therefore requested that EPA confirm that these residual impurities are not covered by the proposed action.

 

In the aftermath of EPA’s recent decision to remove the 72 chemical substances from the list of approved inerts, CPDA is seeking a better understanding of what factors prompted the Agency to finalize its proposal at this particular time.  CPDA will also engage with the Agency on appropriate next steps our member companies should take in response to this development.  In so doing, CPDA welcomes input from its member companies on devising a strategy in response to the Agency’s recent and unexpected decision to delist these products.

 

The list of the 72 inert ingredients may be accessed by clicking here.

PMRA Publishes Proposed Changes to Ministerial Agreement

On December 30, 2016, Health Canada’s Pest Management Regulatory Agency (PMRA) published its long-awaited proposed revisions to the Agreement for Data Protection under Section 66 of the Pest Control Products Act (PCPA), currently known as the “Ministerial Agreement” (MA).  The MA governs the process by which an applicant for a generic pesticide registration in Canada obtains the right to use or rely on data provided by the basic registrant under the PCPA.  The MA sets forth the mechanism for entering into negotiations and arbitration over data compensation and specifies the requirements for enforcement of the arbitral award.  PMRA is accepting public comment on the proposed revisions to the MA through February 13, 2017.

 

Concurrent with its release of the draft revisions to the Ministerial Agreement, PMRA has published for public comment a consultation document on the eligibility criteria for compensable protection status for foreign test data.  This draft consultation document describes the situations under which foreign test data will be eligible for 12 years of compensable protection from the initiation date of the Canadian re-evaluation or special review for the active ingredient.  Public comment on this document will be accepted for 45 days from the December 30th publication date of the proposed consultation.

 

The CPDA-Canada Committee is in the process of reviewing both proposed consultations in preparation for the submission of comments to PMRA.  Both documents, along with instructions for submitting comment, may be accessed on PMRA’s web site by clicking here.

 

CPDA-Canada Committee Members Meet with PMRA Staff on December 15, 2016

The publication of the two draft consultation documents comes shortly after a December 15, 2016 meeting during which CPDA-Canada President Sue Ferenc and several members of the CPDA-Canada Committee traveled to Ottawa for an update from PMRA staff on possible changes to the Canadian data compensation and arbitration process.  The December 15th session was a follow up to a July 28th meeting with PMRA representatives during which CPDA-Canada members elaborated on the need for changes to the Ministerial Agreement that would facilitate the establishment of a fair and equitable data compensation scheme and remove some existing barriers to generic registration in Canada.

The December meeting also included a discussion pertaining to a CPDA-Canada Committee “white paper” that was presented to PMRA earlier in 2016.  The white paper included a summary of a literature search that was conducted to determine the number of generic products with newer chemistries that have been registered in Canada as a result of the 2010 changes to the data protection system under the “Protection of Proprietary Interests in Pesticide Data in Canada (PPIP)” regulations.  CPDA-Canada concluded that there were no generic products with newer chemistries registered since PPIP became effective in 2010.  The CPDA-Canada white paper addressed the arbitration regime set forth under the existing MA objecting that it is unworkable.  Specifically, under the arbitration terms of the existing MA, an arbitral tribunal is required to choose either the generic applicant’s “willing-to-pay” final offer or the registrant’s “willing-to-accept” final offer, a scheme referred to as Final Offer Settlement (FOS).  CPDA-Canada emphasized that the FOS approach is inappropriate for arbitration and subjects the generic registrant to inordinate financial risk.  The white paper proposed a series of minimal changes that PMRA could adopt in developing a functional data compensation scheme that levels the playing field for generic pesticides seeking market entry in Canada.

 

Other discussion at the December 15th meeting focused on PMRA’s progress in developing a searchable database for studies in support of pesticide registration submissions and changes to the Agency’s efficacy data requirements in support of the registration of tank-mix adjuvants in Canada.

 

During the meeting, PMRA representatives provided the CPDA-Canada Committee delegation several documents including:  PMRA Guidance on Adjuvants ( Published in April 2016); an Update on the Data Protection Program; and PMRA Registration Requirements for Adjuvant Products.

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