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 Margaret R. Graham

On September 20, 2018, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a webinar titled “Best Practices for Ground Application” on October 25, 2018, from 2:00 p.m. to 3:30 p.m. (EDT).  The announcement states that this webinar is tailored for “growers, pesticide applicators, pest management professionals, and other interested stakeholders who work in crop production.”

The webinar will be presented by Dr. Greg Kruger, a weed science and application technology specialist from the University of Nebraska-Lincoln and will cover different methods of ground application, best practices for reducing pesticide spray particle drift when using ground application equipment, and a discussion of the optimization of weed control.  Registration is available online.

More information on other pesticide applicator issues including the Worker Protection Standard is available on our blog.


 

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 Margaret R. Graham

On April 23, 2018, the California Department of Pesticide Regulation (DPR) circulated a presentation entitled “Top 10 Agricultural Pesticide Use Violations of 2017” that identifies the top ten agricultural most common pesticide use violations of 2017 in California.  The violations are listed from the least common (#10) to the most common (#1):

10.       Handler Training, regulated under Title 3 of the California Code of Regulations (C.C.R.) § 6724(b-e).  Examples of handler training violations listed in the presentation are:  not updating employee training on a new pesticide handled; and not training employees prior to them mixing, loading, or applying pesticides.

9.         Availability of Labeling, regulated under 3 C.C.R. § 6602.  Examples of labeling availability violations listed in the presentation are:  not having relevant Special Local Needs (SLN) labeling at the site when mixing, loading, or applying; and not having the labeling booklet on-site when mixing, loading, or applying.

8.         Handler Decontamination Facilities, regulated under 3 C.C.R. § 6734.  Examples of these types of violations listed in the presentation are:  a handler using a backpack sprayer and not carrying a pint of eyewash when the label requires eye protection; and handlers using hand sanitizer instead of soap and water.

7.         Service Container Labeling, regulated under 3 C.C.R. § 6678.  Examples of service container labeling violations listed in the presentation are:  not including the signal word on a service container label; and only putting the name of the pesticide on the service container.

6.         Hazard Communication for Fieldworkers, regulated under 3 C.C.R. § 6761.  Examples of these types of violations listed in the presentation are:  not completing the required fields on the displayed Pesticide Safety Information Series (PSIS) A-9 leaflet; and not providing Safety Data Sheets (SDS) for the pesticides listed on the pesticide use records.

5.         Annual Registration with County Agricultural Commissioner by Anyone Who Intends to Advertise, Solicit, or Operate as a Pest Control Business in California, regulated under California Food and Agriculture Code (FAC) § 11732.  An example of a violation is not registering with the county in which such a business intends to work prior to performing pest control activities.

4.         Application-Specific Information (ASI) for Fieldworkers, regulated under 3 C.C.R. § 6761.1.  Examples of violations listed in the presentation are:  not including the start and stop times, Restricted Entry Interval (REI), or active ingredient in the displayed information; and not displaying the ASI before fieldworkers work in a treated field.

3.         Emergency Medical Care Requirements, regulated under 3 C.C.R. § 6726.  Examples of violations listed in the presentation are:  not taking employees suspected of a pesticide illness to the doctor immediately; and not posting the name, address, and phone number of the medical facility at the worksite or in the work vehicle before employees begin handling pesticides.

2.         Personal Protective Equipment (PPE) Requirements, regulated under 3 C.C.R. § 6738.  Examples of violations listed in the presentation are:  storing PPE in the same place pesticides are stored; and not cleaning PPE and checking for wear after each use.

1.         Labeling and Permit Condition Compliance, regulated under FAC § 12973.  Examples of violations listed in the presentation are:  not following label-required buffer zone, set back distance, or vegetative buffer strip requirements; and applying a pesticide to a site or crop not listed on the labeling.

DPR states that it “recommends and encourages continuing education (CE) course sponsors [to] integrate this information into … future CE courses,” and asks for help “in promoting lawful pesticide use practices by encouraging [CE] attendees to review these agricultural pesticide use violations as they relate to their operations, to assure they are in compliance with federal and California pesticide use requirements.”


 

By Susan M. Kirsch

On April 12, 2018, House Agriculture Committee Chairman Michael Conaway (R-Texas) released the Committee’s draft Farm Bill reauthorization, the “Agriculture and Nutrition Act of 2018” (H.R. 2). The House Agriculture Committee passed the Farm Bill package on April 18, 2018, setting it up for a floor vote in the House.  The 600-plus page draft legislation includes a number of provisions that will be of interest to pesticide registrants and the pesticide user community, including the following sections:

  • Section 9119. Enactment of Pesticide Registration Improvement Act of 2017: This provision would enact the Pesticide Registration Improvement Extension Act (known as PRIA-4), which authorizes the U.S. Environmental Protection Agency (EPA) to continue to collect $40 million in registration and maintenance fees critical to supporting the pesticide registration process.
  • Section 8303. Consultation under the Endangered Species Act (ESA): Subsection (a) would eliminate ESA Section 7 consultation requirements for U.S. Forest Service projects where a “not likely to adversely affect” determination has been made. Subsection (b) requires ESA Section 7 consultation for forest management activities carried out under the Farm Bill to be completed within a 90-day period.
  • Sections 9117 and 9118. Clean Water Act (CWA) Pesticide Permitting:  Together these two provisions amend the CWA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to eliminate CWA National Pollutant Discharge Elimination System (NPDES) permitting for FIFRA-compliant pesticide applications.  These sections incorporate the regulatory relief language from previously proposed stand-alone bills aimed at eliminating the dual regulation of pesticide applications into, over, and near surface waters, which passed the House in the 115th Congress (H.R. 953) and has been proposed in the Senate (S.340).

The full text of H.R. 2 and a section-by-section summary are available on the House Agriculture Committee Farm Bill webpage along with several related fact sheets.  The Agriculture Committee expects to mark-up the bill this week.


 

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

On March 22, 2018, the U.S. Environmental Protection Agency (EPA) released the Pesticide Registration Notice (PR Notice) 2018-1 issued by the Office of Pesticide Programs (OPP) entitled “Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act Section 2(ll)” (PR Notice 2018-1).  Notice of Availability issued on March 21, 2018.  83 Fed. Reg. 12385.  The PR Notice states that it “describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment.”  It “revises the method and criteria used by EPA for evaluating ‘sufficient economic incentive’ under FIFRA section 2(ll)(2),’” and it “also clarifies that minor use under FIFRA section 2(ll)(1) is based on acreage reported in the [U.S. Department of Agriculture (USDA)] Census of Agriculture.”

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll)(1) defines a minor use of a pesticide as a use on a crop grown on 300,000 acres or less in the United States.  Section 2(ll)(2) of FIFRA defines a minor use of a pesticide as one that lacks sufficient economic incentive to seek or maintain a registration but has private or social value.

PR Notice 2018-1:

  • Clarifies that the USDA’s most recent Census of Agriculture, conducted every five years by the USDA’s National Agricultural Statistics Service (NASS), is the appropriate source for data on acreage or crops grown in the U.S. to establish a minor use under the acreage definition in FIFRA 2(ll)(1);
  • Revises and provides guidance to registrants concerning the method used by EPA for evaluating “sufficient economic incentive” under FIFRA Section 2(ll)(2);  and
  • Explains how qualitative information may be used to inform the quantitative analysis and interpret the results.

Previously, EPA’s interpretation of economic minor use in Section 2(ll)(2) was based on PR Notice 97-2.  EPA states PR Notice 2018-1 supersedes PR Notice 97-2.  EPA states that through PR Notice 2018-1, EPA “seeks to identify and encourage the registration of pesticides for minor uses to protect communities from harmful pests.”  EPA states in PR Notice 2018-1 that “the existing methods for identifying an economic minor use in PRN 97-2 do not consider all relevant factors which could affect the incentives of a registrant to apply to register a minor use,” and that “use of the approach in PRN 97-2 to identify economic minor uses could prevent applicants from registering pesticides that would be beneficial to users and growers, thus limiting the availability of pesticides for certain use sites.”  For this reason, “EPA revised the method to determine an economic minor use.”

PR Notice 2018-1 is significant because it can be applied to conventional pesticides, biopesticides, and antimicrobial pesticides to determine whether they meet the definition of minor use.  The criteria in PR Notice 97-2 only applied to conventional pesticides.

EPA states the rationale for revising the PR Notice to consist of the following:

  • EPA has decided to revise the policy on determining minor use.
  • First, PRN 97-2 is outdated regarding the crops that would not meet the acreage definition of a minor use under FIFRA section 2(ll)(1).  PRN 97-2 contained a fixed list of crops that were grown on more than 300,000 acres in 1997, but cropping patterns change over time and the list of crops provided in PRN 97-2 is no longer accurate.
  • Second, the method in PRN 97-2 does not accurately reflect economic incentive to register pesticides.  Gross revenue is not an appropriate measure for estimating returns on an investment; since it does not account for production and distribution costs, it overstates the returns to the investment.  However, revenue from a single year understates the time period when a firm would receive a return on an investment. Finally, gross revenue at full market potential does not account for the difference in timing between costs of registration and future returns.  Costs are likely to be incurred at the beginning of registration, whereas revenues will occur over multiple, future years.
  • Third, PRN 97-2 applies only to registration actions on conventional pesticides.  The notice specifically states that it does not apply to registrations of biopesticides and antimicrobials (e.g., disinfectants).  The method described in this PRN may be used to evaluate the registration incentive for all types of products registered by each of OPP's registering divisions.

Additionally of note, EPA states in PR Notice 2018-1 that seeking minor use designation is not required as part of the pesticide registration process.  It is an optional designation that an applicant can seek to obtain certain incentives associated with minor uses, such as:

  • Extension of exclusive use of data under FIFRA Section 3(c)(1)(F)(ii); and
  • Qualifying for an exemption from the fee or waiver of a portion of the registration service fee for an application for minor uses of a pesticide under FIFRA Section 33(b)(7)(D).

More information on other PR Notices is available on our blog under key phrase Pesticide Registration Notice.

 


 

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 Heather F. Collins, M.S. and Margaret R. Graham

On February 28, 2018, the U.S. Environmental Protection Agency (EPA) announced the availability of three Group B -- Antimicrobial Efficacy Test Guidelines, under Series 810, Product Performance Test Guidelines.  The guidelines provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides against public health microbial pests.  83 Fed. Reg. 8666.  The three final guidelines are:

EPA states these “test guidelines are part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols for testing that is intended to provide data to inform regulatory decisions.”

EPA issued draft guidelines in June 2015 and solicited comments.  EPA states that some comments received on those draft guidelines have been incorporated into the final versions.  EPA states that the revision “is more user friendly and clarifies topics such as confirmatory data, repeat testing, hard water formulation, wetness determination testing for towelettes, and internal toilet testing … [and] also includes information on supplemental testing policies such as lower certified limits, revision of the AOAC Use Dilution Method performance standards and clarified technical details for efficacy testing.”

Documents pertaining to the revision of the product performance guidelines, including public comment submissions, and the agency’s response to comments are available at www.regulations.gov, in Docket No. EPA-HQ-OPP-2015-0276.  More information on test guidelines is available on our blog.


 

By Lisa M. Campbell and Lisa R. Burchi

On February 14, 2018, the U.S. Environmental Protection Agency (EPA) and Amazon Services LLC (Amazon) entered into a Consent Agreement and Final Order (CAFO) whereby Amazon agreed to pay $1,215,700 in civil penalties for approximately four thousand alleged violations under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the distribution of unregistered pesticide products.  Amazon neither admitted nor denied the specific factual allegations, which included: 

  • Between January 1, 2013, and November 1, 2015, Amazon distributed, held for distribution, held for shipment, or shipped two unregistered pesticide products called “3pcs Cockroach Cockroaches Bugs Ants Roach Kills Chalk”; and “Miraculous Insecticide Chalk” on multiple occasions in the United States. 
  • Between January 1, 2013, and March 1, 2016, Amazon distributed, held for distribution, held for shipment, or shipped three unregistered pesticide products called “HUA Highly Effective Cockroach Killer Bait Powder”; “R.B.T.Z. Safe Highly Effective Roach Killer Bait Powder Indoor”; “HUA Highly Effective Fly Killing Bait Powder”; and “Ars Mat 60 pcs. Refil for ARS Electric Mosquito Killer Convenient, Clean & Smokeless” on multiple occasions in the United States. 

Amazon also agreed to implement a supplemental environmental project (SEP) consisting of the development, deployment, and operation of a publicly available eLearning course, downloadable educational materials, and test on FIFRA requirements and associated regulations (eLearning Project).  Although no monetary amount was specified for the implementation of the SEP, the eLearning Project will be a significant undertaking, as the materials will be available in three languages (English, Spanish, and Chinese) and Amazon will require all of its Amazon.com sellers to complete the eLeaming course and pass an associated test prior to allowing such Amazon.com sellers to sell products identified as pesticides.  The only circumstance when this requirement will not apply to Amazon.com sellers is when a seller can “demonstrate that the seller's existing compliance program is sufficient to ensure products sold via Amazon.com comply with FIFRA.”

More information on FIFRA enforcement issues is available on our blog under key word enforcement.  


 

By Lisa M. Campbell and Lisa R. Burchi

On February 12, 2018, the U.S. Environmental Protection Agency (EPA) announced it has reached an agreement with Syngenta Seeds, LLC (Syngenta), a pesticide company in Hawaii, to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) at its farm in Kekaha, Kauai.  The settlement includes two penalty components:  a $400,000 Supplemental Environmental Project (SEP) for worker protection standard (WPS) training; and $150,000 as a civil penalty.

The Consent Agreement and Final Order (CAFO), issued on February 7, 2018, states the parties are resolving alleged violations under FIFRA Section 12(a)(2)(G) from the use of the registered restricted-use pesticide Lorsban Advanced on an agricultural establishment in Kekaha, Hawaii, “in manners inconsistent with its labeling by not complying with applicable Worker Protection Standard regulations.”  Syngenta neither admitted nor denied the allegations but consented to the assessment of the civil penalty and to the other conditions in the CAFO.

EPA’s Press Release states that under the settlement, Syngenta “will spend $400,000 on eleven worker protection training sessions for growers in Hawaii, Guam, and the Northern Mariana Islands.”  Specifically, the SEP states it “is intended to assist and provide compliance tools to small-scale growers of agricultural plants that face compliance challenges based on cultural, literacy, or language considerations, and/or geographic isolation.”  Further, Syngenta will “also develop compliance kits for use at these trainings and for wider distribution in the agricultural community in English and four other languages commonly spoken by growers and farmworkers in the training locations -- Mandarin, Korean, Tagalog, and Ilocano.”  These compliance kits will include the following practical resources, among others:

  • Summary documents with corresponding videos addressing the major compliance topic areas within the WPS;
  • Worker training resources including, but not limited to, training outlines with materials, tailgate training toolkits, and sign-in sheets; and
  • Sample WPS company policies and procedures.

This CAFO and in particular the SEP will be interesting to monitor considering EPA’s recent WPS revisions that became effective on January 2, 2017, and the additional proposed revisions for which comments are expected to be solicited. 

More information on FIFRA enforcement issues is available on our blog under key word enforcement.  Information on Syngenta’s 2016 CAFO regarding label violations is available in our blog item Syngenta Settles with EPA on Alleged Label Violations.


 

By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) recently announced, in two separate notices, that it is initiating a process to revise (1) certain requirements in the Agricultural Worker Protection Standard (WPS) (82 Fed. Reg. 60576 (Dec. 21. 2017)); and (2) to revise the minimum age requirements in the Certification of Pesticide Applicators (C&T) rule.  82 Fed. Reg. 60195 (Dec. 19. 2017).

For the WPS rulemaking, the provisions at issue were identified as part of the public comments received in response to Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda.  Three provisions in particular were the subject of public comment, and later consideration by the EPA’s Office of Pesticide Programs (OPP) Pesticide Program Dialogue Committee (PPDC) at its November 2, 2017, meeting.  The three provisions are:  minimum age (the 2015 WPS specifies a minimum age of 18 years, with an exemption for owners of agricultural establishments and their immediate family members); designated representative (the 2015 WPS requires employers to provide pesticide application information and safety data sheets to a designated representative of a worker or handler under specified circumstances); and application exclusion zones (AEZ) (the 2015 WPS requires the establishment of AEZs with respect to outdoor production on farms, nurseries, and forests to reduce the number of incidents where workers or others are exposed to pesticides during agricultural pesticide applications). 

EPA also announced that the compliance dates in the revised WPS remain in effect and that EPA has no intent to extend them.  This means that most provisions in the revised WPS went into effect on January 2, 2017, and compliance with two additional requirements will begin on January 2, 2018.  The two requirements include compliance with the display of pesticide safety information, and pesticide handlers must temporarily suspend applications if workers or others enter in the application zone during pesticide applications.  The only requirements in the revised WPS that will not be in effect as of January 2, 2018, are the requirements that the worker and handler pesticide safety training material cover the expanded content at 40 C.F.R. §§ 170.401(c)(3) and 170.501(c)(3).  The 2015 revised WPS provided that compliance with the expanded pesticide safety content in these sections was not required until 180 days after EPA publishes in the Federal Register a notice of availability of certain training materials.  While there are training materials available that meet the expanded content requirement, EPA has not yet published such a Federal Register and apparently does not intend to do so until after the rulemaking announced on December 21 has concluded.

For the C&T rule, EPA expects to “publish a Notice of Proposed Rulemaking to solicit public input on proposed revisions to the rule by the end of FY2018,” and it has no plans to change the implementation dates in the January 4, 2017, final rule.  The C&T notice states that “EPA has determined that further consideration of the rule’s minimum age requirements is warranted through the rulemaking process” after it considered comments received pursuant to EO 13777, revisiting the record, and reviewing the applicable statutory. 

More information on WPS issues is available on our blog under key phrase Worker Protection Standard


 
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