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 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The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015.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.


 

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.


 

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.


 

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.

 


 

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. 


 

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.

 


 

By Lisa M. Campbell and Lisa R. Burchi

On July 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice extending the public comment period regarding its proposed Antimicrobial Pesticides Use Site Index (USI) from July 31, 2015 to August 31, 2015.  The initial Federal Register notice announcing the availability of EPA’s guidance on the USI was issued on July 1, 2015.

By way of background, in 2014, EPA issued a final rule on Data Requirements for Antimicrobial Pesticides amending the regulations setting forth the data requirements that support an application to register a pesticide product.  The final rule contains the data requirements specifically applicable to antimicrobial pesticides that were codified in 40 C.F.R. Part 158, subpart W.  The final rule lists 12 antimicrobial use patterns in 40 C.F.R. § 158.2201.  The data requirements applicable to a pesticide product depend in part on the product’s use pattern.  The general use patterns are broad designations, and are used as columns in the antimicrobial data requirements tables to identify which data requirements might be pertinent to the particular pesticide use site.

EPA has developed the USI to assist antimicrobial pesticide applicants and registrants and to assist EPA staff to identify the use pattern that applies to a pesticide product, and thus the data requirements that must be met to register the product.  EPA states that the USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels and links these commonly listed use sites with the twelve general use patterns.

The posting of this proposed guidance document for public comment is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that followed ACC’s July 2013 initiation of a legal challenge to the data requirements regulation in the U.S. Court of Appeals for the District of Columbia Circuit. 

In addition to extending the comments, EPA also published in the docket a Question and Answer document on the USI Webinar for questions submitted to EPA prior to the July 14, 2015, webinar.  Additional information regarding the USI is available in EPA Docket EPA-HQ-OPP-2015-0302.

 


 

By Lisa M. Campbell and Margaret R. Graham

On June 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a notification that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the United States Department of Health and Human Services (HHS) a draft regulatory document concerning the draft final rule entitled ''Pesticides; Revisions to Minimum Risk Exemption.'' This notice states that the draft final rule will not be available to the public until after it has been signed and made available to EPA. Sections 25(a)(2)(B) and 21(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires the EPA Administrator to provide to the Secretary of USDA and the Secretary of HHS a copy of any draft final rule at least 30 days before signing it in final form for publication in the Federal Register; EPA must only provide any draft final rules pertaining to public health pesticides, however, to HHS.

The Spring 2015 Regulatory Agenda stated that EPA is developing the final rule related to revisions it proposed in December 2012: "Specifically, EPA proposed to more clearly describe the active and inert ingredients permitted in products eligible for the exemption from regulation for minimum risk pesticides. These lists would be reorganized by adding specific chemical identifiers that would make it clearer which ingredients are permitted in minimum risk pesticide products. No ingredients would be added or removed from the exemption. The label requirements in the exemption would also be modified to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, and to require producer contact information on the label. These changes are intended to maintain the availability of minimum risk pesticide products while providing more consistent information for consumers, clearer regulations for producers, and easier identification by states, tribes and EPA as to whether a product is in compliance with the exemption."  Further information regarding the proposed rule is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum entitled EPA Proposes Revisions to Minimum Risk Exemption for Pesticides.

 


 

By Lynn L. Bergeson and Carla N. Hutton

In a bit of a surprise announcement, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality released a memorandum on July 2, 2015, directing three federal agencies with jurisdiction over products of biotechnology, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. The Memorandum for Heads of Food and Drug Administration, Environmental Protection Agency, and Department of Agriculture, is short, but clear as to timetable and deliverables.

 

Last updated in 1992, and first rolled out in 1986, the Coordinated Framework is the blueprint for federal regulatory policy for ensuring the safety of products of biotechnology.  The Coordinated Framework is of significant interest to the agribusiness community as USDA and EPA regulate genetically modified crops and plant pests.  According to the New York Times, more than 90 percent of the corn, soybeans, and cotton grown in the U.S. have foreign genes inserted into the DNA to make the crops resistant to herbicides, insects, or both.  While acknowledging the Coordinated Framework is working as intended in ensuring the safety of biotechnology products, the OSTP was quick to note in their blog item “Improving Transparency and Ensuring Continued Safety in Biotechnology,” that “the complexity of the array of regulations and guidance documents developed by the three federal agencies with jurisdiction over biotechnology products can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies.”

 

The goal of the update effort, according to the memorandum, is to ensure public confidence in the regulatory system, improve transparency, predictability, coordination, and efficiency in the regulatory system, and encourage and support innovation in the area of biotechnology and products of biotechnology.  According to the OSTP blog item:

 

  • “First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process.  This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.

 

  • Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology.  This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making.
  • Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology.  The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.”

 

According to the memorandum, the following elements will support the process to achieve these objectives:

 

  • Biotechnology Working Group Under the Emerging Technologies Interagency Policy Coordination Committee:  The Biotechnology Working Group will include representatives from the Executive Office of the President, EPA, FDA, and USDA.

 

  • Mission and Function of the Biotechnology Working Group:  Within one year of the date of the memorandum, the Biotechnology Working Group shall take steps detailed below and others, as appropriate, to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology.  The Working Group will:
    1. Update the Coordinated Framework to clarify the current roles and responsibilities of the agencies that regulate the products of biotechnology, after input from the public; and
    2. Develop a long-term strategy to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology 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.

 

  • Independent Assessment:  EPA, FDA, and USDA shall commission an external, independent analysis of the future landscape of biotechnology products that will identify (1) potential new risks and frameworks for risk assessment, and (2) areas in which the risks or lack of risks relating to the products of biotechnology are well understood.  The review will help inform future policy making.  Due to the rapid pace of change in this arena, an external analysis should be completed at least every five years.

 

  • Budgeting for Efficiency:  EPA, FDA, and USDA shall work with OSTP and OMB, within the annual President’s budget formulation process, to develop a plan for supporting the implementation of this memo in agency fiscal year (FY) 2017 budget requests and, as appropriate, in future budget submissions.

 

  • Annual Reporting:  For at least five years, starting one year after the release of the strategy described above, the Biotechnology Working Group will produce an annual report on specific steps that agencies are taking to implement that strategy and any other steps that the agencies are taking to improve the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products.  This report will be made available to the public by the Executive Office of the President.

 

A number of reports have .issued in the recent past calling for exactly what the Administration announced on July 2.  Last year, the Venter Institute issued a landmark analysis of the domestic biotechnology regulatory system in which it highlighted the critical need for modernizing the Coordinated Framework.  J. Craig Venter Institute.  Synthetic Biology and the U.S. Biotechnology Regulatory System:  Challenges and Options (May 2014).

 

More recently, the National Research Council of the National Academies issued, on March 13, 2015, Industrialization of Biology:  A Roadmap to Accelerate the Advance Manufacturing of Chemicals.  The report, prepared by the Board on Chemical Sciences and Technology, Board on Life Sciences, Division on Earth and Life Studies, identified the challenges and opportunities posed by the current regulatory system relating to biotechnology and synthetic biology.  

 

The Woodrow Wilson International Center for Scholars Synthetic Biology Project issued a statement praising the Administration’s decision:  “The Synthetic Biology Project supports the effort by the White House Office of Science and Technology Policy (OSTP) to update the Coordinated Framework for the Regulation of Biotechnology to address emerging technologies like synthetic biology.”  The statement goes on to say:  “We see this as a positive development and one that is long overdue considering the rapid advancement of biotech-related fields like synthetic biology.”

 

A forthcoming report from the Synthetic Biology Project examines the regulatory pathways of new applications that are close to entering the market.  That report finds confusion about the regulatory jurisdiction of different agencies in the framework and questions which statutes apply to the applications.  Earlier this year, the Project released an interactive, crowdsourced inventory to track applications and products that utilize synthetic biology techniques.

 

The memorandum is welcome news as the Coordinated Framework needs updating for all the reasons outlined in the reports noted above.  Despite the Framework’s inherent elasticity and nimbleness, the pace of innovation and complexity of new biotechnology products require a modernized, forward-focused framework.  


 

By Lisa R. Burchi and Lisa M. Campbell

 

On June 16, 2015, the California Superior Court for the County of Almeda denied the petition of the Pesticide Action Network North America, et al. (PANNA) for a writ of mandate to direct the California Department of Pesticide Regulation (DPR) to set aside and vacate its final decisions approving amended registrations of Dinotefuran 20SG manufactured by Mitsui Chemicals Agro and Venom manufactured by Valent USA. 

 

The active ingredient in both products at issue, dinotefuran, is a neonicotinoid pesticide that has been subject to additional reviews and labeling requirements with regard to its impact on pollinating bees on the federal and state level.  PANNA argued, in part, that under the California Environmental Quality Act (CEQA), DPR should not have approved the amended labels because it had not developed an Environmental Impact Report (EIR) describing the potential environmental impacts, analyzing direct, indirect, and cumulative impacts, and analyzing alternatives. 

 

The court held as a matter of law that “to give effect to CEQA’s current policy goals as developed since 1979 in the Public Resources Code, in the CEQA Guidelines and in case law, that the court must read the DPR’s regulations as requiring that the DPR apply current CEQA analysis in deciding whether to register pesticides.”  That does not, however, require DPR to comply with all of CEQA’s documentation requirements; instead, DPR’s environmental documentation is required to “address only those significant adverse environmental effects that can reasonably be expected to occur, directly or indirectly, from implementing the proposal.”

 

With regard to the standard of review, the court found that DPR’s decision is in the nature of an EIR, which required the court to review the adequacy of the decision for substantial evidence, and not, as PANNA had argued, the functional equivalent of a negative declaration that would have triggered a “fair argument” review standard.  The court then found there was substantial evidence in the administrative record supporting DPR’s decision that the proposed mitigation measures will eliminate any significant environmental impact.  The court held that the record supported DPR’s assertion that the product labels provide necessary environmental protections, noting, for example, that EPA’s conclusion that the federal labeling is adequate to protect bees is substantial evidence to support DPR’s “identical conclusion.”  The court further held that DPR was not required to consider the feasibility of alternatives. 

 

Since the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) preempts a state from imposing label requirements that are different from the U.S. Environmental Protection Agency (EPA)-approved label, the court noted that DPR’s decision was either to register the products consistent with EPA’s approved labels or not register the products for use in California.  Although DPR’s failure to conduct a risk-benefit analysis was not argued before the court, the decision, by way of dicta, noted that the “record suggests that the DPR conducted a de facto risk-benefit analysis and did not actually conclude that the labeling on the Insecticides would mitigate all adverse affect on bees.”  Instead, the court suggests DPR’s risk-benefit analysis was based on the fact that under FIFRA, the only alternative would be to deny the registrations and that would be infeasible considering economic, social, or other considerations. 

 

The decision is a significant judgment regarding DPR’s ability to make decisions regarding label amendments and the court’s ability to review such decisions.  It appears likely an appeal will be filed.  It is also important to note that DPR’s reevaluation of neonicotinoids is still pending -- DPR is required under AB 1789 (codified at Food and Agricultural Code Section 12838(a)) to issue a determination before July 1, 2018, regarding the neonicotinoid registrations and to adopt any control measures determined to be necessary to protect pollinator health.  


 
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