Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Heather F. Collins, M.S. and Barbara A. Christianson

On May 2, 2018, during the U.S. Environmental Protection Agency’s (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, EPA announced the progress of its electronic pesticide label data submission project, SmartLabel, and its electronic Confidential Statement of Formula (eCSF) submission project.  The SmartLabel and eCSF will be submitted through EPA’s Pesticide Submission Portal (PSP) on the Central Data Exchange (CDX).

EPA is developing the SmartLabel program to improve efficiencies in the submission, review, and approval of pesticide label information.  EPA believes creation of electronic master labels as structured data will improve the accuracy and clarity of pesticide label information and will allow it to be revised easily and efficiently. 

EPA indicated that the SmartLabel program will use CDX for the creation of labels in XML format.  Once uploaded through CDX’s PSP, the label will undergo an internal validation and move through an internal workflow.  EPA anticipates this will aid in faster approvals of labels.

The eCSF is an electronic version of EPA’s current paper CSF (EPA Form 8570-4).  This eCSF submission option will allow applicants to electronically submit product specification data and will:

  • Pre-populate information such as product properties and manufacturing/formulating site addresses from the PSP log in;
  • Link the eCSF to previous electronically submitted product information; and
  • Link chemical names to EPA information sources.

The electronic form is anticipated to result in significant time savings for the applicant and the EPA reviewer.  EPA stated that most submitted CSF actions are modifications to current formulations and not all fields will need to be re-entered when submitting a modification using eCSF.  Additional benefits that EPA believes will result are a reduction in time and effort needed for error corrections, electronic data validation, and less reliance on paper-based processes.

The SmartLabel and eCSF teams are continuing to work with Office of Pesticide Programs (OPP) Divisions to harmonize OPP-wide vocabularies and data validation rules.  The SmartLabel team and eCSF team are also working to harmonize overlapping vocabulary.  Nine registrants are conducting testing on software development and most likely will participate in additional testing of the software.   

EPA anticipates that the SmartLabel and eCSF programs will move EPA from a paper-based workplace to a paperless workplace.  The SmartLabel and eCSF builders are anticipated to be released for voluntary submissions in Summer 2018, and EPA encourages registrants to submit labels and CSFs using the new builders.

EPA stated that any questions or comments on SmartLabel should be sent to Patricia Parrott at .(JavaScript must be enabled to view this email address) and questions or comments on eCSF should be sent to Diane Isbell at .(JavaScript must be enabled to view this email address) or Jimmy Davis at .(JavaScript must be enabled to view this email address).  Registrants should monitor these initiatives closely, as they may result in significant changes to their own internal processes relating to registration submissions and recordkeeping. 


 

By Heather F. Collins, M.S.

On April 24, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has updated Chapters 3, 7, and 17 of the Pesticide Label Review Manual.  The three updated Label Review Manual chapters are:

  • Chapter 3:  General Labeling Requirements;
  • Chapter 7:  Precautionary Statements; and
  • Chapter 17:  Net Contents/Net Weight.

General Labeling Requirements (Chapter 3) changes include:

  • Updating web-distributed labeling by adding an example of container label directions;
  • Updating label submission requirements section to include e-submission methods depending on the type of application package (e.g., paper or electronic);
  • Adding a note that five copies of all draft labeling must be included in paper copy submissions for new registrations and amendments;
  • Updating the final printed labeling section to reflect current practices such as the practice of not requiring final printed labeling to be submitted to EPA until draft label texts have been provisionally accepted by the EPA;
  • Updating the Mode of Action (MOA) classification symbol reference from Pesticide Registration (PR) Notice 2001-5 to the current PR Notice 2017-1; and
  • Updating the first aid statement location per EPA’s February 27, 2018, guidance document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68.”

Precautionary Statements (Chapter 7) changes include:

  • Adding dermal sensitization to the acute toxicity categories in Table 1;
  • Reinstating first aid statements per PR Notice 2001-1, and updating location of first aid statements per the Feb. 27, 2018, First Aid Guidance Document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68”;
  • Adding “Contains the phosphine-producing active ingredient zinc phosphide. Probable mucosal damage may contraindicate the use of gastric lavage” as a Note to Physician for products containing zinc phosphide;
  • Updating the National Pesticide Information Center (NPIC) information in the first aid statements example in Table 9;
  • Changing “Labeling Options” section title to “Modified precautionary statements for diluted products (aqueous solutions only)”;
  • Removing redundant section on NPIC and referenced Chapter 15 for details; and
  • Removing “Optional Labeling/Deviations” section, as the directions moved to their respective sections.

Net Contents/Net Weight (Chapter 17) changes include:

  • Updating the introduction section to include notes on declaring net contents information on the EPA Application for PR Dorm (EPA Form No. 8570-1) and leaving net contents information blank on draft label for refillable containers; and
  • Updating the U.S. Department of Commerce’s National Institute of Standards and Technology’s (NIST) published “Uniform Laws and Regulations in the Areas of Legal Metrology and Engine Fuel Quality,” otherwise known as “NIST Handbook 130,” reference for Bag on Valve unit measurements.

Each updated chapter includes a new section identifying the changes in the updated version.  EPA states that it “also made editorial changes to all chapters, including updated cover pages; adding a table of contents; adding chapter editorial notes; updating hyperlinks; and reformatting text, style and layout for conciseness and readability.”

EPA directs registrants to submit questions or comments on the Label Review Manual by using its Pesticide Labeling Questions & Answers – Form.


 

By Lisa M. Campbell and Lisa R. Burchi

On March 8, 2018, the U.S. Environmental Protection Agency (EPA) announced its release of final guidance clarifying where first aid statements should appear on the label of pesticide products.  EPA also posted a response to public comments.  Links to the final guidance and to the response to public comments documents are below:

EPA states that it was prompted to develop this guidance when it learned “that there was a discrepancy in how the ‘location of first aid statement,’ per [40 C.F.R. Section 156.68(d)] is interpreted by EPA and those in the pesticide registrant community.”  EPA notes that its review and approval of pesticide labeling is generally of a “master” label and thus does not always include a review of the location or placement of specific language on a label.

On December 7, 2016, EPA posted a memorandum for public comment entitled “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement and Clarification on Definition of Label ‘Panel’ per 40 CFR 156.68” to clarify the interpretation of the term “panel” in the context of 40 C.F.R. 156.68 and to clarify where first aid statements must appear on pesticide labels, based on their Toxicity Category.

In its final guidance, EPA states it “will continue to require that Toxicity Category I products have the first aid statements on the front panel except in cases where a variation has been approved.”  Further, based on comments received and the wide reliance by the regulated community on the interpretation that “any panel” includes inside panels, EPA is changing its position from its 2016 memorandum and now “will not require Toxicity Category II and III products to bear the first aid statements on a visible front, back or side panel.” 

EPA also listed three recommendations for registrants to consider when printing their container labels:

  1. For Toxicity Category I products, EPA 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.
  2. 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, EPA recommends 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.
  3. EPA recommends that the registrant community consider designing new booklets/accordion/saddle stitch labels that are not easily removed from the containers.  Per 40 C.F.R. Part 156.10(a)(4), the labels are to be “securely attached” to the immediate container of the pesticide product.  EPA believes that in many instances these labels are easily removed which is why, EPA states, it believes many registrants have already chosen to put the duplicative first aid statements on the very last page of the label that is attached to the container.

Registrants should review this guidance carefully, as this issue has been the subject of concern and controversy for a number of registrants.


 

By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

On March 6, 2018, the U.S. Environmental Protection Agency (EPA) issued a proposed rule (pre-publication version available here) to add hazardous waste aerosol cans to the category of universal wastes regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations (Title 40 of the C.F.R., Part 273), entitled Increasing Recycling: Adding Aerosol Cans to the Universal Waste Regulations.  EPA cites as authority for this change Sections 2002(a), 3001, 3002, 3004, and 3006 of the Solid Waste Disposal Act, as amended by RCRA, as amended by the Hazardous and Solid Waste Amendments Act (HSWA).  EPA states the streamlined Universal Waste regulations are expected to:

  • Ease regulatory burdens on retail stores and other establishments that discard aerosol cans by providing a clean, protective system for managing discarded aerosol cans;
  • Promote the collection and recycling of aerosol cans;
  • Encourage the development of municipal and commercial programs to reduce the quantity of these wastes going to municipal solid waste landfills or combustors; and
  • Result in an annual cost savings of $3.0 million to $63.3 million.

As aerosol cans are “widely used for dispensing a broad range of products” including pesticides, the proposed rule may have implications for chemical companies that create and distribute pesticide products marketed in aerosol cans.  Hazardous waste aerosol cans that contain pesticides are also subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements, including compliance with the instructions on the product label.  Under 40 C.F.R. Section 156.78, a flammability label statement is required for pressurized pesticide product products that states “Do not puncture or incinerate container,” but EPA’s 2004 determination (that will be posted to Docket No. EPA-HQ-OLEM-2017-0463 on www.regulations.gov for this proposed rule) allows for the puncturing of cans.  The proposed rule states:

  • EPA issued a determination that puncturing aerosol pesticide containers is consistent with the purposes of FIFRA and is therefore lawful pursuant to FIFRA section 2(ee)(6) provided that the following conditions are met:  
    • The puncturing of the container is performed by a person who, as a general part of his or her profession, performs recycling and/or disposal activities;
    • The puncturing is conducted using a device specifically designed to safely puncture aerosol cans and effectively contain the residual contents and any emissions thereof; and
    • The puncturing, waste collection, and disposal, are conducted in compliance with all applicable federal, state and local waste (solid and hazardous waste) and occupational safety and health laws and regulations.
  • EPA anticipates that this 2004 FIFRA determination would not be affected by the proposed addition of hazardous waste aerosol cans to the universal waste rules.

Comments will be due 60 days after the proposed rule’s publication in the Federal Register. 


 

By Lisa M. Campbell, Lisa R. Burchi, and James V. Aidala

On February 26, 2018, the U.S. District Court for the Eastern District Court of California issued a memorandum and order on the plaintiff’s motion for preliminary injunction (Order) to “enjoin the listing of glyphosate under Proposition 65 (Prop 65) and the application of its attendant warning requirement pending a final judgment in this case and set a schedule for expedited final resolution of the case.”  The Order (1) grants plaintiffs’ request for a preliminary injunction enjoining the warning requirement of California Health & Safety Code § 25249.6 as to glyphosate; and (2) denies the request for a preliminary injunction enjoining defendants from listing glyphosate as a chemical known to the State of California to cause cancer under California Health & Safety Code § 25249.8.  Specifically, the Order states: “pending final resolution of this action, defendants … are hereby ENJOINED from enforcing as against plaintiffs … California Health & Safety Code § 25249.6’s requirement that any person in the course of doing business provide a clear and reasonable warning before exposing any individual to glyphosate.”  Although this is only a preliminary injunction while the case continues further resolution, it is extremely significant that, for now, glyphosate will continue to be listed on California’s Prop 65 list as a “chemical known to the State of California to cause cancer,” but products containing glyphosate will not be required to comply with the warning requirement.

Plaintiffs’ memorandum supporting its motion for preliminary injunction states that Prop 65’s requirement for products containing glyphosate to include a warning that glyphosate is “known to the State of California to cause cancer” is unconstitutional under the First Amendment, and, if allowed to go into effect, will cause Plaintiffs’ “reputational, competitive, and economic harms for which they cannot be compensated.”  Plaintiffs state that the “legal merit of their First Amendment claim is indisputable and obvious on the face of the attached documents without any need for discovery, and thus the claim is appropriate for expedited judicial resolution.”  California’s Office of Environmental Health Hazard Assessment (OEHHA), the agency responsible for implementing Prop 65, listed glyphosate as a chemical known to the state of California to cause cancer on July 7, 2017, and the attendant warning requirement would have taken effect on July 7, 2018.

In support of denying the request for a preliminary injunction enjoining defendants from listing glyphosate under Prop 65, the court states that plaintiffs “have not shown a likelihood of success on the merits of their claim that the listing of glyphosate violates the First Amendment, because the listing is government speech, not private speech … [and it] is only the upcoming July 2018 deadline for providing the [Prop 65] warning that compels private speech.”  The court noted further that Plaintiffs “have not shown a likelihood of irreparable harm should the court fail to enjoin the listing of glyphosate, because any harm that plaintiffs might suffer is caused by the warning requirements of [Prop 65], rather than the listing itself.”  Accordingly, the court denied a preliminary injunction based on plaintiffs’ claim that the glyphosate listing violates the First Amendment.

On the other hand, in support of granting the request for a preliminary injunction enjoining the application of the attendant warning requirement, the court stated:

  • On the evidence before the court, the required warning for glyphosate does not appear to be factually accurate and uncontroversial because it conveys the message that glyphosate’s carcinogenicity is an undisputed fact, when almost all other regulators have concluded that there is insufficient evidence that glyphosate causes cancer.

The court also stated that the required warnings are “false and misleading” and that plaintiffs “have shown that they are likely to succeed on the merits of their First Amendment claim, are likely to suffer irreparable harm absent an injunction, and that the balance of equities and public interest favor an injunction, the court will grant plaintiffs’ request to enjoin [Prop 65]’s warning requirement for glyphosate.”

This case, while not the end of the story, is a very significant development both for glyphosate specifically and perhaps for Prop 65 warning requirements generally.  Industry should follow this case closely given the implications for glyphosate and potentially other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-regulated pesticides and chemicals generally.  Some in industry have long been concerned that Prop 65 warning requirements contradict conclusions supported by the data and reached by other agencies such as the U.S. Environmental Protection Agency (EPA).  This decision is a huge preliminary win for those with these concerns and, depending on the ultimate outcome of the case, could provide a precedent for additional challenges related to other substances.  The potential reach of the case beyond glyphosate, however, will likely be dictated heavily by the facts of each case. 


 

By Lisa M. Campbell and Heather F. Collins, M.S.

On Friday, November 3, 2017, the California Department of Pesticide Regulation (DPR) issued guidance (California Notice 2017-13) that DPR indicates is intended to align DPR policy with the U.S. Environmental Protection Agency’s (EPA) guidance on secondary container labeling for pesticides.  DPR’s guidance states that secondary containers are used by the pesticide industry as part of the process of applying pesticides and “cannot be sold or distributed.”  The guidance further notes that secondary containers are “most commonly used in institutional settings for concentrated antimicrobials that are diluted prior to use or to hold pesticides filled from a larger container to be used and stored prior to application.” 

Registrants may elect to provide users with labels for secondary containers.  DPR’s new guidance states:  “Secondary container labels are not required to be submitted to U.S. EPA or DPR.”  Under the new DPR policy, however, effective immediately, if a registrant submits a secondary container label to DPR, “it must bear the same signal word as the concentrate label or no signal word.”  DPR states that it will accept a secondary container label with a lesser signal word, precautionary statements, and alternate directions for use for the diluted product only if acute toxicity data are submitted or are currently on file to support these lesser statements.

DPR’s new guidance also incorporates EPA guidance on what a secondary label should contain.  (EPA does not require secondary containers to be labeled, but notes that the applicator remains responsible for following the requirements on the pesticide product’s labeling, and complying with other relevant requirements in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other statutes.)  Although registrants are not required to submit secondary container labels to EPA for review, EPA recommends that the applicator identify the material in the secondary container in the event of a spill to ensure that adequate information regarding the pesticide can be obtained in case of a medical or environmental emergency.  EPA recommends that such labels include the following information:

  • Product name;
  • EPA registration number;
  • Name and percentage of active ingredient of the concentrated product or if known, the percentage of active ingredient in the end-use dilution;
  • If the product in the secondary container is diluted, it should be followed by the phrase:  “The product in this container is diluted as directed on the pesticide product label”;
  • The same signal word as the registered concentrate container label;
  • The same precautionary statements as the registered concentrate container label unless the registrant has acute toxicity data supporting lesser precautionary statements for the diluted product and alternate directions for the diluted product are indicated on the concentrate container label; and
  • The statement:  “Follow the directions for use on the pesticide label when applying this product.”

DPR states:  “If currently registered products have secondary container labels on file with DPR that do not meet the above criteria, registrants should submit revised labels to DPR as an amendment.”

Each submission must include:

  • California Application to Amend Pesticide Product (DPR-REG-035);
  • $25 application fee (payable to:  Cashier, Department of Pesticide Regulation);
  • A copy of the most current EPA stamp-accepted label;
  • Six copies of the concentrate container label; and
  • Six copies of the secondary container label.
    • If the precautionary statement on the secondary container label bears lesser precautionary statements, the submission must be accompanied by acute toxicity data or a reference to data on file with DPR.

As an alternative to submitting revised labels, registrants have the option of requesting that DPR rescind acceptance of the current stamp-accepted secondary container label previously submitted.  Registrants may submit their request in writing on company letterhead to their assigned Regulatory Scientist.  If a secondary container label is inconsistent with the DPR-approved label, DPR will consider the product misbranded, and DPR notes that misbranded products are subject to enforcement action.

Registrants that have previously submitted secondary labels to DPR should review the label in comparison to the DPR-approved concentrate container label and the requirements in this notice.  All inconsistencies must be corrected via amendment submission to DPR or by making a request that DPR rescind acceptance of the current stamp-accepted secondary label so that the product is not considered misbranded and therefore subject to enforcement action.  


 

By Margaret R. Graham

On September 22, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register (82 Fed. Reg. 44406) announcing the availability of two final Pesticide Registration Notices (PRN):

  1. PRN 2017-1:  Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling, which updates PRN 2001-5 and provides guidance for registrants to follow when developing resistance management information to include on their pesticide labels.  It addresses “end-use herbicide, fungicide/bactericide, or insecticide/acaricide products that are intended mainly for agricultural and certain non-crop land areas under commercial or government-sponsored pest management,” and applies in particular to “all field use agricultural pesticide products, as well as pesticides which are labeled for greenhouse production, sod farms, ornamental crops, aquatic vegetation, rights-of way, and pest management along roadways.”
  2. PRN 2017-2:  Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship, which “communicates the agency's approach to address herbicide-resistant weeds.”  It is “germane to end-use herbicide products used in agriculture, including commercial turf and sod farms, ornamental production in the open.”  It also applies to “non-agricultural use sites such as golf courses, aquatic vegetation, rights-of-way and vegetation management along roadways.”

These final PRNs reflect consideration of public comments submitted on the draft PRNs.  Also available in the dockets are EPA’s responses to comments on the draft PRNs:  Response to Comments on PRN 2017-1; and Response to Comments on PRN 2017-2.  EPA states that “PRNs are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration-related decisions, and to provide guidance to pesticide registrants and OPP personnel.”

More information on PRNs is available on our blog under key phrase pesticide registration notice


 

By Barbara A. Christianson

On September 19, 2017, the U.S. Environmental Protection Agency (EPA) announced an update to Chapters 15 and 16 of the Office of Pesticide Programs’ (OPP) Label Review Manual.  

Updates to Chapter 15: Company Name and Address, include removing non-label related instructions on submitting address change requests and updating the National Pesticide Information Center’s contact information, including new hours of operation.  Updates to Chapter 16: Graphics and Symbols, include adding hyperlinks to graphic and logo examples and allowing a QR (Quick Response) code as an acceptable symbol when used only for retail pricing.

EPA states that the Label Review Manual, which began as a guide for EPA label reviewers, serves as a tool to assist registrants in understanding the pesticide labeling process and assists registrants in understanding approaches for how labels should generally be drafted.  Pesticide product labels provide critical information about how to safely and legally handle and apply pesticides.  EPA directs registrants to submit questions or comments on the Label Review Manual by using its Pesticide Labeling Questions & Answers -- Form.


 

By Lisa M. Campbell and Lisa R. Burchi

On May, 24, 2017, the California Department of Pesticide Regulation (DPR) issued guidance regarding its Notice 2015-13 to applicants registering pesticide impregnated materials bearing pesticide claims to be sold and distributed into or within California, per Notice 2015-13, issued December 11, 2015.  Each retailer (or authorized representative) of an affected product must submit an Application for Pesticide Registration (DPR-REG-030) to DPR by July 1, 2017

The guidance includes information on the registration requirements, as well as:

More details on the requirements are available in our blog items California Issues Notice Requiring Registration for Products Made From Pesticide Impregnated Materials and Bearing Pesticide Claims and California DPR Extends Filing Date to Register Pesticide Impregnated Products.


 

By Lisa M. Campbell, James V. Aidala, and Margaret R. Graham

In a two-page order issued on April 10, 2017, the U.S. District Court for the Middle District of North Carolina granted in part a motion for summary judgment filed by “me-too” registrants, Willowood, LLC, Willowood USA, LLC, Willowood Azoxystrobin, LLC, and Willowood Limited (Defendants), regarding Syngenta Crop Protection, LLC’s (Plaintiff) claims of copyright infringement.  Syngenta Crop Protection, LLC v. Willowood, LLC, Case No. 1:15-CV-00274.  The claims at issue (Counts V and VI of Plaintiff’’s complaint) were based on the Defendants’ use of Syngenta’s label.  The court stated that it was granting this part of Defendants’ motion “because the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) precludes copyright protection for the required elements of pesticide labels . . . of me-too registrants.”

Counts V and VI of Plaintiff’s complaint stated that Defendant copied and used substantial portions of Syngenta’s copyrighted work, and that this infringement is “willful and knowing.”  The Defendants’ motion for summary judgment stated with regard to the copyright infringement counts of the complaint:

  • Counts V and VI fail as a matter of law because Defendants’ labels comply with applicable federal regulations and contain language that is mandated by federal law.  Moreover, under settled law, the portions of Plaintiff’s labels that Plaintiff asserts Defendants have copied are not entitled to federal copyright protection.  Finally, to the extent that any portions of Plaintiff’s labels are entitled to copyright protection, Defendants’ copying is permitted under the fair use doctrine.  

The order states that “in enacting FIFRA, Congress intended narrow exception to copyright protection for the required elements of pesticide labels as against me-too registrants.”  The court expressly rejects the lengthy 2005 decision issued by the District Court for the Eastern District of Pennsylvania, which reached a different conclusion in a similar case, stating that it finds the analysis in that decision “unconvincing.”  FMC Corp. v. Control Solutions, Inc., 369 F. Supp. 2d 539, 555-71 (E.D. Pa. 2005).  The court states:  “FIFRA contemplates that a ‘me-too’ applicant will copy from the original pesticide label in ways that would otherwise infringe a copyright.”

Of interest, the court states that its grant of the summary judgment motion with respect to the copyright claims does not need to take into account an expert report or declarations by, among others, former EPA Office of Pesticide Programs (OPP) officials Debra Edwards and Lois Rossi, filed by Defendants because “the Court is granting the summary judgment motion on legal grounds unrelated to the proffered evidence.” 

Plaintiff filed its complaint on March 27, 2015.  The complaint included seven counts against Defendants:  the infringement of four patents in violation of 35 U.S.C. § 271(a) (Counts I-IV), the two copyright infringement counts (Counts V-VI), and a violation of the Unfair and Deceptive Trade Practices Act (N.C. Gen. Stat § 75-1.1) (Count VII).  Count VII of the complaint was dismissed on August 12, 2016, and on March 24, 2017, the court granted Plaintiff’s motion for summary judgment regarding the infringement of two of the four patents; a decision on the infringement of the remaining two patents is still pending.

Commentary

This opinion, which squarely rejects the 2005 conclusion of another district court, is likely to be of controversy and is the most recent decision in a long-standing debate on this issue between basic registrants and me-too registrants.  EPA in the past has appeared to side with the me-too registrants.  For example, in an August 3, 2005, letter to the Chemical Producers and Distributors Association (CPDA), written in response to the FMC decision, EPA stated that it “has been the practice of [OPP] since the enactment of FIFRA section 3(c)(7)(a) in 1978 to strongly encourage ‘me-too’ product labels to be identical or substantially similar to the labels of the products on which their registrations are based.”  In that letter, EPA stated further:  “Conveying application instructions and safety messages for similar products in different ways increases the likelihood that the product will be misused.”  EPA at the time noted that there were over 650 mostly “me-too” products for just one herbicide (2,4,-D) -- and that having 650 products each having to say some of the required use instructions differently would be impossible.

Nonetheless, some elements of the label might be viewed as proprietary -- the “look and feel” of a product label, perhaps certain fonts, and trademarked product name (as opposed to the active ingredient name).  It remains to be seen whether the April 10, 2017, order is the last judicial word on this subject or whether the issue will continue to be litigated.  It is an issue that all registrants should monitor closely.  


 
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