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.
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By J. Brian Xu, M.D., Ph.D., DABT®  and Margaret R. Graham

Like so many other regulatory programs in China, pesticide regulations are changing.  At the 8th China High-Level Forum on Pesticides, Ying Ji, Chief Agronomist of the Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA), stated that the future of pesticide regulation in China will see more emphasis placed on industrial development, registration security, the application of more risk assessment techniques, and will focus more on reducing the burden of procuring registrations for minor use crops.  In China, the vast majority of registrations are for major crops and only a few registrations have been issued for minor crops.  The Ministry of Agriculture also intends to prepare a "List of Pests and Pesticide Shortage for Minor Crops.”

Jun Yang, Director of the Efficacy Division, ICAMA, summarized recent trials and registrations of pesticides.  By the end of August 2015, China had a total of 33,029 registered pesticide products, an increase of 4,300 products when compared with 2013.  The total includes insecticides (12,812), fungicides (8,378), herbicides (7,807), and others including acaricides and plant growth regulators (4,032).  Insecticides were down 3 percent and fungicides and herbicides up 2 percent as a proportion of the total when compared with the total at the end of 2013.  The majority of registered products were issued for off-patent products.  The top ten active ingredients for which products were registered as of 2014 were reported to include:  the antifeedant, pymetrozine; the fungicides, azoxystrobin, tebuconazole and difenoconazole; the insecticides, thiamethoxam, emamectin-benzoate, avermectin and imidacloprid; and the herbicide, cyhalofop and glufosinate.  For more information on the report (which is available only in Mandarin), please e-mail Dr. Brian Xu at .(JavaScript must be enabled to view this email address).


 
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By Lisa M. Campbell and Lisa R. Burchi

On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA), announced in the Federal Register a public meeting to be held on October 30, 2015, to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Framework).

The meeting is intended to discuss FDA’s role in responding to the July 2015 memorandum issued by the OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled “Modernizing the Regulatory System for Biotechnology Products,” and will invite oral comments from interested parties.  The July 2015 memorandum and the October 6, 2015, OSTP-issued Request for Information (RFI) to solicit relevant data and information to update the Framework are discussed in our memorandum Biotechnology:  OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology.

The Executive Office memorandum directs FDA, EPA, and USDA -- the three agencies responsible for regulating biotechnology products -- to:

  1. Establish a working group to update the Coordinated Framework to clarify roles and responsibilities, and
  2. Develop a long-term strategy to ensure that the federal regulatory system is equipped to assess any risks while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.

This meeting is another important step in the process to update the Framework, first issued in 1986 and last updated in 1992, to reflect better promising technologies routinely entering the market and, as the July 2015 memorandum provides, “to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.”  Companies with biotechnology interests should monitor and participate in this process as appropriate, given its potential impact on the industry.

The meeting will be held on October 30, 2015, from 9:30 a.m. to 1:00 p.m. (EDT) at FDA’s White Oak Campus, Building 31 Conference Center, the Great Room, 10903 New Hampshire Avenue, Silver Spring, Maryland.  Registering early is recommended due to limited space.  The deadline for written comments is November 13, 2015.

For more information or to register for this meeting, visit FDA’s website.

 


 
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By Lisa M. Campbell and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has launched a new pesticides website:  http://www2.epa.gov/pesticides, and a new biopesticides website:  http://www2.epa.gov/pesticides/biopesticides, among others.  EPA states that this gradual move to new versions of its content is part of a larger EPA effort to build a more user-friendly website. 

The updated biopesticides website focuses on providing general information on biopesticides, as well as tools to assist applicants for registration, and is organized into the following areas:

  • What are biopesticides?;
  • Biopesticide registration information;
  • Plant incorporated protectants (PIPs); and
  • Where can I find more information on biopesticides?

With this transition, web page addresses will be different which may cause links and bookmarks to break.  EPA states that it is working to fix any broken links.  The majority of the old pesticide pages will redirect to the new web areas, but bookmarks will still need to be updated.  EPA’s new “Page Not Found” notification will help website users find what they are looking for by providing suggested search terms, links to the A-Z index, and other helpful links.  The search feature available on every EPA web page and in the archive (archive.epa.gov) can also be useful in finding content. 

Other updated pesticide related links are:


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

On September 28, 2015, the U.S. Environmental Protection Agency (EPA) announced revisions to its worker protection standard.  EPA states that these revisions are intended to “enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective equipment, and the providing of supplies for routine washing and emergency decontamination.”

Among the changes to the WPS are the following:

  • Training:  The final rule retains proposed content expansions that have been the subject of considerable discussion and concern (e.g., provisions that EPA intends to reduce take-home exposure) and the requirement for employers to ensure that workers and handlers receive pesticide safety training every year (increased from existing rules that require training every five years).  EPA has eliminated the proposed training “grace period,” that would have allowed employers to delay providing full pesticide safety training to workers under certain circumstances. 
  • Notification:  The final rule retains the proposed requirements for employers to:  (1) post warning signs around treated areas in outdoor production when the product used has a restricted-entry interval (REI) greater than 48 hours; and (2) provide to workers performing early-entry tasks (i.e., entering a treated area when an REI is in effect), information about the pesticide used in the area where they will work, the specific task(s) to be performed, the personal protective equipment (PPE) required by the labeling, and the amount of time the worker may remain in the treated area.  EPA has not promulgated the proposed requirement for employers to keep a record of the information provided to workers performing early-entry tasks.
  • Hazard Communication:  The final rule requires employers to post pesticide application information and a safety data sheet (SDS) for each pesticide used on the establishment at a central location on the establishment (the “central display”).  This is a departure from the proposal to eliminate the existing requirement for a central display of pesticide application-specific information.  The final rule also requires the employer to maintain and make available to workers and handlers, their designated representatives, and treating medical personnel upon request, the pesticide application-specific information and the SDSs for pesticides used on the establishment for two years.  EPA has eliminated the proposed requirement for the employer to maintain copies of the labeling for each product used on the establishment for two years.
  • Requirements During Pesticide Applications:  The final rule requires an “application exclusion zone,” that is, the area immediately surrounding the application equipment, from which workers and other persons must be excluded.  An application exclusion zone of 100 feet horizontally from the application equipment in all directions applies when the pesticide is applied by any of the following methods:  (1) aerially; (2) air blast application; (3) as a spray using a spray quality (droplet spectrum) of smaller than medium (volume median diameter of less than 294 microns); or (4) as a fumigant, smoke, mist, or fog.  An application exclusion zone of 25 feet horizontally from the application equipment in all directions applies when the pesticide is sprayed from a height of greater than 12 inches from the planting medium using a spray quality (droplet spectrum) of medium or larger (volume median diameter of 294 microns or greater).  This “application exclusion zone” differs from the proposed “entry-restricted areas,” that would have extended a specified distance around the entire treated area during application based on the application equipment used.  The final rule requires handlers to suspend application, rather than cease application, if they are aware of any person in the application exclusion zone other than a properly trained and equipped handler involved in the application.
  • Minimum Age:  The final rule increases the minimum age for handlers and workers performing early-entry tasks from a proposed 16 years old to at least 18 years old.  EPA states it increased the minimum age from 16 to 18 based on “comments received and an evaluation of existing literature related to adolescents’ development of maturity and judgment.”  EPA provides an exemption from minimum age requirements for adolescents working on an establishment owned by an immediate family member.  The final rule does not require the employer to record workers’ or handlers’ birthdates as part of the training record, but does require the employer to verify they meet the minimum age requirements.
  • PPE:  The final rule cross-references certain Occupational Safety and Health Administration (OSHA) requirements for respirator use for which employers will be required to comply.  In response to comments, the final rule expands the respirators subject to fit testing beyond the proposal to include filtering facepiece respirators.  The final rule maintains the existing exception from the handler PPE requirements when using a closed system to transfer or load pesticides, and adopts a general performance standard for closed systems, which differs from the specific design standards based on California’s existing standard for closed systems discussed in the proposal.

EPA received a significant number of comments on the proposed rule, which has generated significant controversy.  While it appears that EPA has modified the final WPS in certain respects in response to concerns raised, there remain many provisions that are controversial and will require significant work, with significant costs, by agricultural and handler employees to meet. 

Controversy regarding these new requirements is longstanding.  At its most simple form, critics of increasing the stringency of the current regulations ask why significant changes were needed after twenty years of greater protection offered by the existing regulatory requirements.  In addition, over the intervening years, for a variety of reasons, many (not all) of the most hazardous pesticides have been removed from the market or otherwise are used less.  More complex concerns address potential jurisdictional overreaches and the paltry record supporting what some view as expansive and expensive regulatory requirements.  Others, not surprisingly, cite the number of reported (and unreported) incidents as proof for the need nonetheless to improve the extent and effectiveness of the current regulations.  What EPA has issued here as the final revisions to the regulations attempts to balance these views. 

Some believe that, in similar situations, where industry and activist groups criticize an action, albeit for very different reasons, the EPA action at issue must have struck the correct balance of disparate views.  This breezy measure of success in an important health protection program such as this rule addresses by definition is not likely to satisfy either perspective, and complaints about the new requirements can be expected to continue, especially about the economic impact of the new requirements for some, and for others, how the occupational risks of pesticides remain too high and deserve even greater restrictions. 

Outside the boundaries of the worker protection regulations, some of the underlying logic and regulation of the updated requirements indicate that EPA, at least under the current Administration, will continue its emphasis on the broader goals of environmental justice and protecting “children” from the hazards of pesticide exposure.  (For example, among the most controversial elements of the changes is the prohibition on certain activities for those under the age of 18, while beforehand the cutoff age was 16; this seems partly a result of EPA’s attempt to make its policy of prohibiting testing of pesticides on children consistent with its policy of who might be exposed in occupational settings.)

The final rule will become effective 60 days after it is published in the Federal Register, but agricultural employers and handler employers will not be required to comply with most of the new requirements in the final rule until 14 months after the effective date.

For more information, please see Bergeson & Campbell, P.C.’s (B&C®) memorandum Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2015 and James V. Aidala Comments on EPA’s Worker Protection Standards.  More information is also available on EPA’s Worker Protection Standard webpage.


 
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By Sheryl L. DolanLisa M. Campbell, and Henry M. Jacoby, M.S.

On September 22, 2105, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register listing its revised registration service fees applicable to specified pesticide applications and tolerance actions for fiscal year (FY) 2016 that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

The Pesticide Registration Improvement Act of 2003 (PRIA) established FIFRA Section 33, creating a registration fee-for-service system for certain types of pesticide applications, establishment of tolerances, and certain other regulatory decisions under FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA).  Section 33 also created a schedule of decision review times for applications covered by the service fee system.  EPA began administering the registration service fee system for covered applications received on or after March 23, 2004.

PRIA has been reauthorized twice, most recently by the Pesticide Registration Improvement Extension Act (PRIA 3) signed on September 28, 2012.  PRIA 3 revised FIFRA section 33, reauthorized the service fee system through fiscal year 2017, and established fees and review times for applications received during fiscal years 2013 through 2017.  The registration fees for covered pesticide registration applications received on or after October 1, 2015, increase by five percent from the fees published for fiscal year 2015 in the Federal Register notice issued September 26, 2013, Pesticides; Revised Fee Schedule for Registration Applications.  The new fees became effective on October 1, 2015

The notice retains the format of prior PRIA tables; it identifies the registration service fees and decision times and is organized according to the three Office of Pesticide Programs (OPP) registration divisions within EPA, with the additional sections for inert ingredients and other actions added as part of PRIA 3.  Thereafter, the categories within main sections of the table are further organized according to the type of application being submitted, including new active ingredients, new uses, new products, and registration amendments  There are 189 categories of activities spread across the three OPP divisions:  Registration Division (63 categories), Antimicrobial Division (39 categories), and Biopesticides and Pollution Prevention Division (69 categories), plus ten inert ingredient and eight miscellaneous categories.  Each has its own decision review time and service fee for FY 2016-2017.  The scale of the fees differs between the three registration divisions.  We note that not all submissions are subject to PRIA 3; generally speaking, any submission requiring data review will be subject to PRIA 3. 

The notice also provides information on how to pay fees, how to submit applications, and the addresses for applications.

More information on the registration fees is available on EPA’s webpage FY 2016/17 Fee Schedule for Registration Applications.


 
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By Timothy D. Backstrom, Lisa M. Campbell, and James V. Aidala

In an opinion issued on September 10, 2015, the U.S. Court of Appeals for the Ninth Circuit vacated the U.S. Environmental Protection Agency’s (EPA) unconditional registration for the pesticide sulfoxaflor and remanded the matter to EPA to obtain further studies and data regarding the effects of sulfoxaflor on bees and bee colonies.  Sulfoxaflor is a new insecticide in the class of insecticides referred to as neonicotinoids, but its mechanism of action is distinct from other neonicotinoids.  The Petitioners in this case were various trade organizations representing commercial beekeepers, as well as some individual beekeepers.  The registrant Dow AgroSciences LLC (Dow) intervened in the action.

EPA granted an unconditional registration for sulfoxaflor on May 6, 2013, subject to a variety of risk mitigation measures, including a lower application rate, longer intervals between applications, and certain crop-specific label restrictions.  EPA had previously proposed to issue a conditional registration for sulfoxaflor in January 2013, citing pollinator data gaps that could be addressed by requiring Dow to conduct and submit further studies.  Under that proposal, use of sulfoxaflor would have been allowed at a reduced application rate during the time needed to complete data development.  The court found that the subsequent decision by EPA to register unconditionally sulfoxaflor was not supported by substantial evidence, as required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 16(b), both because EPA failed to adhere to its own scientific methodology and because the rationale that EPA provided for granting an unconditional registration could not be reconciled with the analysis upon which EPA based its prior proposal to register conditionally sulfoxaflor.

EPA evaluated the potential risk to bees and bee colonies from sulfoxaflor use utilizing the Pollinator Risk Assessment Framework, a scientific risk assessment methodology developed after consultations between EPA, Canada’s Pest Management Regulatory Agency, and the State of California, and presented by EPA to the FIFRA Scientific Advisory Panel in 2012.  The court found that the rationale provided for EPA’s unconditional registration decision could not be reconciled with findings that EPA itself made using this methodology or with the rationale EPA provided for its prior proposal to issue a conditional registration.  EPA had decided it was necessary to proceed to Tier 2 of the pollinator risk assessment after reviewing risk quotients and residue data in Tier 1 of the assessment.  EPA found the available data for Tier 2 to be insufficient to allow indefinite use of sulfoxaflor, even at a reduced application rate.  The court could not reconcile this finding with the subsequent decision to grant an unconditional registration, even with the specified mitigation measures.  The court found that “given the precariousness of bee populations, leaving the EPA’s registration of sulfoxaflor in place risks more potential environmental harm than vacating it.”  The court stated that “EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA.”

EPA argued that with a reduced application rate, the risk quotients and residue analysis in Tier 1  was “close enough” to sufficient to avoid the specified quantitative trigger for a Tier 2 analysis, thereby rendering any deficiencies in the available Tier 2 data irrelevant.  The court effectively stated in response that close enough is not good enough, citing another recent Ninth Circuit decision in which a risk concern that is triggered by a margin of exposure less than or equal to 1000 was held to be triggered when the margin was exactly 1000.  Thus, this court once again placed EPA on notice that it must follow its own methodology with precision, and that EPA cannot justify deviations from its own methodology by simply stating that it is exercising expert judgment.

Commentary

This is an unusual case because the registration of a new pesticidal active ingredient has been vacated on substantive as opposed to procedural grounds.  The court’s rationale reflects a lack of judicial deference to what EPA typically refers to as the scientific “weight of the evidence.”  While the term itself does not appear in the opinion, the court is insisting that EPA must follow its standard methodology without allowing for any deviations based on professional judgment.  Although in this instance the court has supported the position of opponents of pesticide use, judicial reluctance to accept scientific “weight of the evidence” conclusions could also make it harder for EPA to impose additional restrictions when new but inconclusive evidence appears.

This case could cause EPA to be more explicit in adding procedures to its standard analytic methodologies that allow deviations from the methodology based on professional judgment.  The case could also cause EPA to reconsider its recent reluctance to avoid issuing conditional registrations and its preference for unconditional registrations for new active ingredients.  In any case, decisions that afford EPA less discretion to use “weight of the evidence” reasoning when basing scientific conclusions on less than conclusive data or studies could have an impact on a number of EPA practices and policies involving interpretation of scientific data.


 
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By Lisa M. Campbell and Sheryl L. Dolan                                

On September 8, 2015, the Environmental Protection Agency (EPA) announced that it will host a Disinfection Hierarchy Stakeholder Workshop and corresponding webinar on October 7, 2015, from 8:30 a.m. - 5:00 p.m. (EDT).  The “disinfection hierarchy” describes the descending order of susceptibility of classes of microorganisms to antimicrobial chemicals.  Demonstrated efficacy against a representative organism would support a manufacturer’s claims against more susceptible (easier to kill) organisms, potentially eliminating the need to test against, or alternatively, to submit data for each individual organism.  EPA has relied on the disinfection hierarchy concept historically.  For example, EPA relied on the disinfection hierarchy concept to take timely action to address the H1N1 virus in 2009, by allowing reliance on Influenza A data.  More recently, EPA states that it agreed that use of a registered hospital disinfectant with a label claim for use against a non-enveloped virus was appropriate for disinfection of surfaces contaminated with the ebola virus.

EPA is considering expanding its use of disinfection hierarchy concepts for the registration of public health antimicrobial pesticides.  EPA states that its goals for expanding the use of these concepts are:

  1. To provide guidance to health care officials and the public on the most effective type of registered antimicrobial products on the market to combat an emerging pathogen; and
  2. To increase the efficiency of, and lower the costs associated with, registering antimicrobial pesticides, while maintaining a high level of public health protection.

According to the announcement, the workshop will focus on the scientific merits of the hierarchy, and will provide a forum for stakeholders to discuss:

  • The current science on which disinfection hierarchy concepts are based;
  • Scientific issues that may present challenges for use of the disinfection hierarchy in registering antimicrobial pesticide products; and
  • Ideas on how to address these issues.

A panel of approximately 15 stakeholders from the public sector, academia, and industry will address a series of charge questions, followed by the opportunity for audience questions or comments.  The current list of panel members is available here.

EPA’s Office of Pesticide Programs has developed a draft white paper on disinfection hierarchy concepts that will serve as the basis for discussion during the workshop.  The draft white paper includes questions on which EPA states it is seeking input.  The agenda for the workshop is available here

More information on disinfection hierarchy is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum Summary of Ninth Antimicrobial Workshop.


 
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By Lisa M. Campbell and Lisa R. Burchi

On September 2, 2015, the European Chemicals Agency (ECHA) issued an updated list of biocide suppliers as required under Article 95 of the Biocidal Product Regulation (BPR).  Although prior versions of the list were released previously, this list has current legal effect since Article 95 provides that, as of September 1, 2015, a biocidal product cannot be made available in European Union (EU) markets unless the active ingredient supplier or product supplier is listed for the particular product type (PT) (e.g., PT 5 (Drinking water), PT 19 (Repellents and attractants)) to which the biocide product belongs. 

The purpose of Article 95 in creating a list of persons placing active substances in the EU market is to ensure the equal treatment of persons placing active substances on the market and to avoid “free riders.”  Without the requirements in Article 95, a supplier of an active substance that has not supported the approval of that substance (either through the Review Programme of the biocide directive, or as a newcomer under the BPR) could still enter the market without compensating the entity that undertook the costs and effort to have the active substance listed. 

There will be continued updates and revisions made to the list as new suppliers seek inclusion.  In addition, ECHA states that it received 158 applications from suppliers seeking inclusion on the list, and has created a list of pending applications that ECHA is still processing.  ECHA notes:  “The list of pending Article 95(1) applications should not be confused with the list of relevant substances and suppliers (“Article 95 list”) and the presence of a company (per substance/PT/role) on the list of pending applications does not guarantee that the application will be successful and that the company will ultimately be included in the Article 95 list.”  Updates to the list also are expected for certain substances that were not within the scope of the Biocidal Products Directive (BPD) (e.g., some in situ generated active substances, substances benefiting from derogation for food and feed in Regulation 1451/2007), and for which different BPR notification and inclusion dates apply. 

Although enforcement efforts regarding the Article 95 list have not yet been tested, companies placing biocidal products in EU markets must carefully review the list to ensure that they and/or their suppliers are listed not only for the particular active ingredient and/or product at issue, but also for the product’s particular PT.

There is a one year period, until September 1, 2016, to sell existing stocks for biocide products where the suppliers are not included on the List. 


 
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By Lisa M. Campbell, Sheryl L. Dolan, and Margaret R. Graham                                            

On September 1, 2015, the U.S. Environmental Protection Agency (EPA) announced the debut of a new electronic system for pesticide applications, the Pesticide Submission Portal.  According to EPA, this debut is the first step in a phased approach that ultimately will allow EPA to accept all pesticide applications electronically -- a move that will help modernize the pesticide registration process, increase operational efficiencies, and reduce paper waste.  EPA will continue to accept paper, CD and DVD applications, but encourages applicants to take advantage of what EPA states is the new, more efficient option.

The following types of applications will now be accepted through the Pesticide Submission Portal:

  • New pesticide active ingredients;
  • New pesticide products containing already-registered pesticide active ingredients;
  • Amendments to registered pesticide products;
  • Experimental use permits;
  • Inert ingredient requests;
  • Pre-application;
  • Petitions for food or feed tolerance, and
  • Distributor products.

The Portal is accessed through EPA’s Central Data Exchange (CDX) Network and requires user registration.  For registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own builder tools using EPA’s XML guidance, they may use the Portal and forego the courier costs to send to EPA. 

For electronic submissions, applicants do not need to submit multiple copies of any pieces of their application, as the requirement for multiple copies of data and five copies of draft labeling only applies to paper submissions.  Additional benefits of using the Portal include a status indicator that allows registrants to track the movement of their submissions and automatically generated MRID numbers.

Additional information on the Portal, including a user guide and updated XML guidance, is available on EPA’s Electronic Submission for Pesticide Applications page.

Applicants will need to invest some time and resources up-front to register with CDX and become familiar with the electronic submission requirements.  With that investment, however, EPA’s secure portal should make the submission process more efficient for applicants.  Additionally, as EPA now scans all paper submissions upon receipt, electronic submissions should increase efficiencies and reduce the opportunity for error during EPA’s front-end processing -- always a good thing.


 
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By Susan Hunter Youngren, Ph.D., James V. Aidala and Lisa M. Campbell

The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015.  EPA’s draft framework provides guidance on how the EPA will screen groups of pesticides for cumulative evaluation.  EPA proposes using a two-step approach, beginning with the evaluation of available toxicological information and, if necessary, followed by a risk-based screening approach.  This framework supplements the existing guidance documents for establishing common mechanism groups (CMG) and conducting cumulative risk assessments (CRA).  Additionally, EPA is also seeking comments on a draft copy of the human health risk assessment where the cumulative assessment was conducted in conjunction with pending actions for abamectin.

EPA has described a process that is data intensive and that requires sophisticated knowledge and modeling.  EPA acknowledges that “the level of refinement provided by this approach is not necessary or even feasible for all existing pesticide classes.”  The policy documents for conducting the first step in the process, “developing CMGs,” are still being refined.

This document provides the guidance for screening information to identify candidate CMGs and does not outline how actually to conduct CRAs.  Rather, this document relies on policies and principles provided in other documents found on the EPA cumulative risk assessment website.  These additional policies and principles were developed during the conduct of five CRAs for chemical groups such as the organophosphates and carbamates.

One of the major questions raised by the issuance of this document is the extent of the information that EPA will require for each chemical to determine if there are CMGs.  The five CMGs currently assessed have relatively well defined mechanisms of action.  It is not clear, however, what EPA will consider to be adequate justification that there are no other chemicals with the same mechanism of action for other chemicals of concern.

Requirements for EPA to determine and assess the risks of possible common mechanism of action among groups of similar pesticides was one of the most far-reaching new requirements imposed by the Food Quality Protection Act.  Some observers expected a larger impact on pesticide use than what has occurred to date; whether EPA’s new approach results in more groupings or otherwise leads to restrictions on more groups of pesticides remains to be seen.

Comments on the draft guidance are due September 28, 2015.  More information regarding EPA’s assessment of pesticide cumulative risk is available online.


 
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By Lara A. Hall, MS, RQAP-GLP, Jane S. Vergnes, Ph.D., DABT®, and Lisa M. Campbell
 
On Tuesday, August 25, 2015, in a Federal Register notice, the U.S. Environmental Protection Agency (EPA) announced the addition of three Office of Chemical Safety and Pollution Prevention (OCSPP) final test guidelines to its 890 Series, entitled “Endocrine Disruptor Screening Program Test Guidelines,” as follows:

These test guidelines are part of a series of test guidelines established by OCSPP for use in developing data on potentially adverse effects of pesticides and chemical substances on the endocrine system for submission to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C. 346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.).  These final guidelines have been revised based on public comments received following the release of draft test guidelines in January 2015, existing EPA test guidelines, and concurrent Organisation for Economic Co-operation and Development (OECD) test guidelines
 
EPA worked with OECD to harmonize test guidelines for MEOGRT and LAGDA.  The specific OECD Guidelines for the Testing of Chemicals, Section 2, that apply to MEOGRT and LAGDA, are available here.  Substantive changes reflected in the final OCSPP MEOGRT and LAGDA test guidelines include:
 
1.         The test will end following hatching of the second generation (F2) offspring.  The option for extending the MEOGRT through reproduction by the F2 generation has been removed from the final test guideline pending additional data. This is consistent with the decision made in the draft OECD test guideline for MEOGRT. This test guideline may be updated as new information and data are considered. For example, guidance on extending the F2 generation through reproduction may be potentially useful under certain circumstances (e.g., chemicals with high bioconcentration potential or indications of trans-generational effects in other taxa).
 
2.         The mean water temperature over the duration of the MEOGRT has been changed to 25 ± 2 °C to be consistent with the analogous OECD test guideline.
 
3.         The LAGDA developmental stage terminology has been clarified to avoid confusion with what is meant by complete metamorphosis.
 
4.         An effort was made to clarify and provide more explicit guidance as to what specific histopathology is appropriate based on the results of the study, e.g., the conduct of liver and kidney histopathology in the MEOGRT and LAGDA test guidelines with respect to overt toxicity.
 
5.         The rationale for use of solvent control only, dilution water control only, or pooled controls in the statistical analyses for the MEOGRT and LAGDA was clarified.
 
6.         The guidelines have been modified to address commenters' concerns that they be more flexible and less prescriptive. Examples have been provided as appropriate to add clarity. 
 
The JQTT draft test guideline (OCSPP 890.2100) was revised to address comments provided by the public, the draft OECD test guideline for the avian two-generation toxicity test in the Japanese quail, as well as the existing EPA test guidelines and OECD test guidelines for avian one-generation toxicity tests.
 
EPA revised the terminology, procedures, endpoints measured, figures, tables, and appendices in the JQTT test guideline to clarify specific points raised by public commenters, and to address commenters' concerns that they be more flexible and less prescriptive, as follows:

1.         The revised test guideline includes fewer endpoints.  For example, the revisions eliminated behavioral endpoints to reduce the overall numbers of birds required for the study; eliminated endpoints that are difficult to obtain (i.e., hormone levels measured in embryo blood samples); and eliminated redundant endpoints and statistical analyses.
 
2.         For clarity, the test terminates with measurement of the 14-day survival of the F2 generation chicks.  This is the minimum length of the study necessary to evaluate and measure a chemical's effect on the first generation’s (F1) reproductive performance.  If delayed reproduction is observed in F1 birds, a decision to extend the F2 generation may be made.  If extended, the test should be terminated when F2 birds are approximately 6 weeks old, when 90 percent of control animals have reached sexual maturity.  The decision to limit the length of the JQTT is consistent with EPA's efforts to move to extended one-generation reproduction test protocols for Tier 2 testing rather than require multigenerational studies.  Extended one-generation reproduction tests are scientifically justified in many cases, reduce the use of animals in testing, and reduce costs.

Electronic access to OCSPP test methods and guidelines is available here.
 
The release of these final testing guidelines marks another significant step in the overall Endocrine Disruptor Screening Program (EDSP), making way for the anticipated Tier 2 testing phase with the List 1 chemicals.  EPA recently released Tier 1 weight-of-evidence assessments for List 1 substances in the EDSP and registrants are now receiving the associated data evaluation records (DER) for the Tier 1 screening studies.  The purpose of the Tier 1 screening was to identify potential interactions with three hormonal pathways (estrogen, androgen and thyroid) in the endocrine system.  As a result of the  potential interactions with one or more of these pathways observed, EPA has recommended Tier 2, multigenerational studies across various species for 18 of the 52 List 1 chemicals, including the MEOGRTS (13 chemicals) and LAGDA (5 chemicals).  Test Orders for Tier 2 studies will be issued following completion of the Information Collection Request (ICR) process within the Office of Management and Budget (OMB).  The public review and comment period for this ICR concludes on September 2, 2015, with a response from OMB to follow in early October 2015.  In the interim, registrants are closely reviewing their respective assessments and DERs, and industry groups are assessing the approach employed by EPA in these Tier 1 assessments, including but not limited to, the statistical reanalysis of study data and conclusions drawn by EPA.


 
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By Lisa M. Campbell, Susan Hunter Youngren, Ph.D., and James V. Aidala

On August 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a proposal to revise the Certification of Pesticide Applicators rule.  EPA is proposing stricter standards for people certified to use “restricted use” pesticides (certified applicators).  Restricted use pesticides are not available for purchase by the general public, require special handling, and may only be applied by a certified applicator or someone working under the direct supervision of a certified applicator.

The proposed stricter standards include:

  • Certified applicators must be at least 18 years old;
  • Those working under the supervision of certified applicators would now need training on using pesticides safely and protecting their families from take-home pesticide exposure;
  • Certifications would have to be renewed every 3 years;
  • Additional specialized licensing for certain methods of application that can pose greater risks if not conducted properly, such as fumigation and aerial application; and
  • Updates to the requirements for States, Tribes, and Federal agencies that administer their own certification programs to incorporate the strengthened standards. 

Currently, the majority of certification programs have no renewal requirements.  Thus, this requirement will put additional burdens on States and Tribes administering certification programs to not only strengthen their standards under this new proposal but to incorporate a time-keeping process to ensure applicators’ renewals are kept up to date, and sufficient certification programs are available for re-certifying purposes.  In addition, for some certification programs, the specialized licensing programs will need to be developed, tested, and instituted.

EPA’s proposal to update certification and training requirements comes along with the parallel effort to revise the worker protection standards (WPS), where a final rule updating those requirements are expected sometime in September.  Like the revised WPS, revising the training requirements has been on EPA’s agenda for many years, and this part of the updated requirements for worker protection is expected to be less controversial than some of the changes to the WPS.  In particular, since EPA has emphasized the protection of children as part of its pesticide regulatory program, making the minimum age 18 for pesticide applicators is part of that agenda.

EPA encourages public comment on the proposed improvements.  Comments on the proposal are due November 23, 2015.

More information about certification for pesticide applicators is available here.


 
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By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

On August 11, 2015, the U.S. Court of Appeals for the Ninth Circuit denied a motion for a stay pending review filed on December 18, 2014, by the Natural Resources Defense Council (NRDC), as well as a subsequent stay motion filed on February 6, 2015, by the Center for Food Safety and other petitioners (Case Nos. 14-73353 and 14-73359, consolidated).  Both motions requested that the court stay an October 15, 2014, decision by the U.S. Environmental Protection Agency (EPA) to register Enlist Duo herbicide (a combination of glyphosate and 2,4,-D) for use on corn and soybeans in six Midwestern states.

NRDC and CFS, et al. (Petitioners), filed these stay motions in a case consolidating petitions for review challenging EPA’s decision to register Enlist Duo.  The registrant of Enlist Duo (Dow AgroSciences) has intervened in the consolidated case.  The Petitioners argue that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D.  In response, both EPA and Dow AgroSciences argue that approval of Enlist Duo will not lead to increased use of glyphosate, and that EPA fully considered all of the human health effects of 2,4-D before granting the registration.

The motions for a stay filed by the Petitioners were effectively motions for preliminary injunctive relief, an extraordinary remedy requiring that those seeking such relief show that they are likely to succeed on the merits, that there is likely to be irreparable harm, that the balance of equities tips sharply in their favor, and that an injunction is in the public interest.  In denying the stay motions, the court cited Winter v. NRDC, 555 U.S. 7 (2008).  In the Winter case, the Supreme Court held that irreparable injury must be likely and that a mere possibility of irreparable injury will not suffice in awarding injunctive relief.  Although the court did not opine further on its rationale for denying the Petitioners’ stay motions, it may be inferred that the court determined that the Petitioners had not satisfied the rigorous prerequisites for injunctive relief.

While this decision avoids an immediate disruption in the marketing of pesticides, the potential for disruption to the registration remains until the court challenge has been resolved.  As Enlist is a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D, any disruption now would be especially impactful to the registrant and customers of the product.  Further, it could also have a chilling effect on efforts to introduce similar new or pending products if growers perceive too great a risk of uncertainty for this or similar pesticides.

 


 
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By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala

In an opinion issued on August 10, 2015, the U.S. Court of Appeals for the Ninth Circuit granted a writ of mandamus requested by Pesticide Action Network North America and the Natural Resources Defense Council (Petitioners) to require that the U.S. Environmental Protection Agency (EPA) act in response to a 2007 administrative petition to cancel the registrations of all pesticides containing chlorpyrifos.  A writ of mandamus to compel administrative action is an extraordinary remedy and is generally reserved for instances of egregious delay.  The same court had previously declined to grant mandamus to the same Petitioners in 2013, but has now concluded that mandamus is the only way to end a “cycle of incomplete responses, missed deadlines, and unreasonable delay.”

After the Petitioners commenced the current case, EPA issued a preliminary decision indicating that it intended to deny the petition to cancel chlorpyrifos, and told the court that it would take final action after reviewing public comments by the summer of 2015.  In a status report subsequently filed in response to a June 10, 2015, order by the court, EPA changed course and stated that unresolved concerns about the risk associated with chlorpyrifos levels in some drinking water might warrant a rulemaking to revoke all existing chlorpyrifos tolerances.  EPA stated that it intended to commence such a rulemaking in April, 2016, unless the registrants of chlorpyrifos products agree to make labeling changes to mitigate the risk from residues in drinking water.  The Petitioners were not satisfied with this amorphous response by EPA, and the court has now agreed.

The writ of mandamus directs EPA to issue a proposed or final rule to revoke chlorpyrifos tolerances, or a full and final response to the administrative petition to cancel chlorpyrifos, no later than October 31, 2015.  If EPA elects to issue a proposed revocation rule, EPA must inform the court by October 31, 2015, of the timeline for finalizing the proposed rule.  Meeting this specific directive from the court will be very challenging.  EPA must determine quickly whether the registrants of chlorpyrifos products will agree to label changes that EPA considers sufficient to mitigate drinking water risks.  Such label changes could hypothetically obviate the need for a tolerance revocation rule and provide a basis for a final decision by EPA to deny the petition to ban chlorpyrifos.  Otherwise, EPA will need to substantially accelerate its stated timetable for issuing a proposed rule to revoke chlorpyrifos tolerances.

In brief, this commitment by EPA will accelerate discussions with the registrant and user groups in an attempt to resolve the issues identified in EPA’s assessment.  It appears that this will compress a process which has typically taken many months into a much tighter time frame, to comply with the court’s order.  That obviously was among the goals of the plaintiffs in the case; it remains to be seen how doing so will affect the EPA’s ability to evaluate the risks and benefits of the pesticide as fully as it typically has done in the past. 


 
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By Lisa M. Campbell, Lisa R. Burchi, and Timothy D. Backstrom

On June 24, 2015, in the United States District Court for the Northern District of California, the Center for Environmental Health, Beyond Pesticides, and Physicians for Social Responsibility (Plaintiffs) sued the U.S. Environmental Protection Agency (EPA) and its Administrator Gina McCarthy regarding a 2014 decision by EPA not to proceed with a rulemaking to require disclosure of hazardous inert ingredients on pesticide product labels under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  This decision was characterized by EPA as a denial of a petition previously filed by the Plaintiffs. 

Specifically, Plaintiffs and others previously petitioned EPA in 2006 to require label disclosure of some 370 substances used as inert ingredients in pesticide products that Plaintiffs claim are known to be hazardous to human health and the environment.  In 2009, EPA decided to partially grant the 2006 petition and issued an advance notice of proposed rulemaking to require disclosure of hazardous inert ingredients on pesticide labels.  When EPA did not pursue the rulemaking, the Plaintiffs filed a suit on March 5, 2014, alleging unreasonable delay.  On May 22, 2014, EPA issued a letter explaining that EPA had decided not to proceed with a proposed rule and stating that “this amended response constitutes a denial of the [2006] petitions.”

In the May 22, 2014, letter, EPA cited some legal arguments by registrants in opposition to the proposed rule, including a contention that inert ingredients are entitled to confidential treatment as a class, and that EPA cannot compel disclosure of inert ingredients based solely on hazard without considering exposure.  In the letter, EPA stated that it has concluded that it “can achieve greater reduction in the risks from use of pesticides containing potentially hazardous inert ingredients through a series of non-rule actions designed to reduce the presence of hazardous inert ingredients in specific pesticide products.”  EPA also set forth its plan to prioritize pesticide inert ingredients for increased scrutiny, as well as a list of voluntary and regulatory actions that could be used, as appropriate, to address potential risks from inert ingredients.

In the Complaint, Plaintiffs request that the court:  (1) declare that EPA’s May 22, 2014, decision violates FIFRA and is arbitrary, capricious, and runs counter to the evidence in the record; (2) remand the case to EPA with instructions to consider the evidence weighing in favor of disclosure of inert pesticide ingredients, including the abundance of documentation regarding toxicity and potential risks of exposure to inert pesticide ingredients; (3) retain jurisdiction over this matter until such time as EPA complies with its duties to control unreasonable risk as set forth under FIFRA, including the risks posed by hazardous inert ingredients, and completes its rulemaking to increase disclosure of inert ingredients contained in pesticide products; and (4) award Plaintiffs their costs of litigation.

 


 
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