By Lynn L. Bergeson, James V. Aidala, and Margaret R. Graham
On February 14, 2017, in the House of Representatives, Rep. Rodney Davis (R-IL) introduced H.R. 1029, the “Pesticide Registration Enhancement Act of 2017,” which reauthorizes the Pesticide Registration Improvement Act (PRIA). H.R. 1029 was immediately referred to the Agriculture Committee and to the Energy and Commerce Committee; it was passed by the Agriculture Committee on February 16, 2017. Per Agriculture Committee Chair Michael Conaway’s opening statement at the Business Meeting markup of H.R. 1029, changes to PRIA include “reasonable increases in registration fees, funding for Good Laboratory Practices, and a seven year reauthorization as opposed to the five-year reauthorizations of the past.” H.R. 1029 would allow the U.S. Environmental Protection Agency (EPA) to collect up to 31 million in registration fees (up from 27.8 million) per year from fiscal years (FY) 2017-2023. It also includes the following registration increases for FY2017 through FY2023:
- The maximum annual fee for registrants holding 50 pesticide registrations or less would be $129,400 (up from $115,500);
- The maximum annual fee for registrants holding over 50 pesticide registrations would be $207,000 (up from $184,800);
- The maximum annual fee payable for a small business registrant holding 50 pesticide registrations or less would be $79,100 (up from $70,600); and
- The maximum annual fee payable for a small business registrant holding over 50 pesticide registrations would be $136,800 (up from $122,100).
PRIA represents a commitment by the pesticide registrants to help with the continued resource issues of the pesticide regulatory program. This has become an issue of increased concern with the arrival of the Trump Administration after campaign rhetoric about eliminating EPA and cutting budgets. Fees are seldom a popular topic, but an essential program component. Without staff and resources to approve pesticide registrations, registrants would be left with new products destined to pile in EPA in-boxes. PRIA is designed to help maintain some certainty and predictability to the review process.
Of some note is that in recent years Congress has appropriated funds at a level below the statutory minimum that originally was a line in the sand which, if breeched, would de-authorize EPA’s authority to charge application fees. The regulated community has reluctantly supported Congressional action to lower this “minimum” level of funding to hold onto the programmatic progress which has been made since the first PRIA authorization. This appears to be an uneasy acceptance of the budget realities surrounding federal spending on discretionary, non-defense expenditures.
By Lynn L. Bergeson, Sheryl Lindros Dolan, and Margaret R. Graham
On February 17, 2017, the U.S. Environmental Protection Agency (EPA) announced that the Centers for Disease Control and Prevention (CDC) issued guidance revising its recommendation regarding controlling Candida auris (C. auris) infections in U.S. healthcare facilities. The CDC guidance now recommends a “thorough daily and terminal cleaning and disinfection” of patient rooms in which C. auris infection or colonization was present … with the use of an [EPA]-registered hospital-grade disinfectant effective against Clostridium difficile [(C. difficile)] spores.” The new guidance updates the CDC’s clinical alert on C. auris issued in June 2016 after receiving reports from international healthcare facilities that C. auris, “an emerging multidrug-resistant (MDR) yeast, [was] causing invasive healthcare-associated infections with high mortality.” Previously, CDC recommended use of an EPA-registered disinfectant with a fungal efficacy claim.
As EPA is responsible for regulating hospital disinfectants and other antimicrobial pesticides used in healthcare facilities, this updated guidance has particular interest and significance for registrants of hospital disinfectant products. EPA maintains a list of registered antimicrobial products effective against C. difficile (List K) and states that “Guidance to the companies that register antimicrobial products and seek label claims against C. auris is under development.”
By Lynn L. Bergeson, James V. Aidala, and Margaret R. Graham
On February 2, 2017, Dominic J. Mancini, Acting Administrator of the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) issued interim guidance in a questions and answers format (Q&A) to implement President Trumps’s recent Executive Order (EO) regarding the costs of agency rulemaking, Memorandum: Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, Titled “Reducing Regulation and Controlling Regulatory Costs.” More information on the EO is available in our blog item EPA Issues Report to Congress on Implementing Amended TSCA Provisions, President Trump Issues Memo and Order on Reducing Federal Regulations.
The OMB memorandum, issued for regulatory policy officers and executive departments and agencies and managing and executive directors of certain agencies and commissions, states that it explains three requirements specified in the EO:
- That every agency must identify two existing regulations to be repealed when they promulgate a new rulemaking;
- That there can be no incremental costs (no greater than zero) for any new regulations or for the repeal of any regulations for fiscal year (FY) 2017, unless otherwise required by law or consistent with advice provided in writing by the OMB Director; and
- In furtherance and in relation to # 1, if there are any new incremental costs, they will be offset by the elimination of the existing costs of at least two prior regulations.
Agencies planning to issue one or more significant regulatory action on or before September 30, 2017 (the end of FY 2017), are directed to provide: (1) “[a] reasonable period of time before the agency issues that action, identify two existing regulatory actions the agency plans to eliminate or propose for elimination on or before September 30, 2017”; and (2) “[f]ully offset the total incremental cost of such new significant regulatory action as of September 30, 2017.”
The memorandum’s Q&As cover 23 questions under three categories: Coverage; Accounting Questions; and Process and Waiver Questions. A few of the stated answers include:
- The requirements only apply to significant regulatory actions issued between noon on January 20, 2017, and September 30, 2017;
- New significant guidance or interpretive documents will be addressed on a case-by-case basis;
- Regulatory actions issued before January 20 that are vacated or remanded by a court after that date will not qualify for savings, but regulatory actions overturned by subsequently enacted laws will qualify, on a general basis;
- Costs should be measured as the opportunity cost to society, and be annualized as defined in and in accordance with OMB Circular A-4, a Memorandum on Regulatory Analysis issued in 2003;
- Regulatory actions should be eliminated before or on the same schedule as the new regulatory action they offset (to the extent feasible);
- Regulatory savings by a component in one agency can be used to offset a regulatory burden by a different component in that same agency; and
- An agency that is not able to generate sufficient savings to account for its regulatory actions may submit a request to the OMB Director to request a transfer of savings from another agency.
This guidance about the meaning and implementation of the EO will provide greater direction to the broad goals of the Trump Administration’s desire to “reduce regulation.” On its face, this “2 for 1” directive is a clear message to the agencies to reduce the regulatory burdens of their work, mostly regardless of the particular mission or underlying legislative requirements of the affected programs.
One obvious target of such effort is the U.S. Environmental Protection Agency (EPA), widely criticized during the Trump campaign and in the party platform as causing harm to the economy and hindering economic growth. Like any broad campaign rhetoric that becomes more substantive as the specifics are rolled out, it is interesting to see what the possible exceptions are or to speculate where implementing the broad rhetorical goal will lead to unpredictable outcomes. An example might be how reductions in record-keeping costs in one EPA program might offset new regulatory costs in another: this ironically may give new internal value to some parts of EPA which have routinely been more heavy-handed in imposing regulatory requirements. “Burdensome and unnecessary” requirements imposed by the enforcement office may be of help in the ability to propose new water program regulations -- or any number of odd fellow combinations may come to the surface.
Other unanticipated consequences will also include those regulations that are actively supported by the affected regulated entity. The pesticide industry is one example where a regulation establishing the allowable amount of a pesticide used on food -- the tolerance -- is essential for completing the registration process allowing the use of a new pesticide. So this kind of regulation fosters innovation and economic return to the industry, and without this regulation, the product will not make it to market. So the new Administration policies must allow for and distinguish between a sort of “good” regulation and a “bad” regulation -- all fitting within the broad rhetorical directive of a “2 for 1” approach to reducing regulatory burdens.
By Lynn L. Bergeson, Lisa R. Burchi, and Margaret R. Graham
A tentative ruling issued January 26, 2017, in Monsanto Company v. Office of Environmental Health Hazard Assessment, et al., Case No. 16 CE CG 00183, by the Superior Court of California, County of Fresno, granted the Office of Environmental Health Hazard Assessment’s (OEHHA or Defendant) motion for judgment on the pleadings as to Monsanto Company’s (Monsanto) petition and complaint, and sustained the demurrers to Monsanto’s petition and complaint (Sierra Club) and California Citrus’ complaint in intervention, for failure to state facts sufficient to constitute a cause of action. The tentative ruling was issued prior to the hearing date of January 27, 2017. If this ruling is made final, Monsanto’s case will be dismissed, but Monsanto has stated it will challenge the tentative ruling.
Monsanto’s complaint alleged various violations committed by OEHHA under the U.S. and California Constitutions in listing glyphosate on the Proposition 65 (Prop 65) list of chemicals that are known to the state to cause cancer. Monsanto argues, for example, that OEHHA engaged in an unconstitutional delegation of its rulemaking authority to the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) when it used the IARC’s classification of glyphosate as “probably carcinogenic to humans” as the basis for the Prop 65 listing. Specifically, Monsanto argued that the Labor Code listing mechanism upon which the glyphosate listing is based is unconstitutional because OEHHA “cedes the basis of its regulatory authority to an unelected and non-transparent foreign body that is not under the oversight or control of any federal or state government entity.” The five constitutional violations that Monsanto claimed are: (1) a violation of the due process clauses of the California and U.S. Constitutions; (2) a violation of free speech under the California and the U.S. Constitutions; (3) a violation of the Guarantee Clause of the U.S. Constitution; (4) a violation of the California Constitution regarding the naming/identifying of IARC (Article II, Section 12); and (5) a violation of the California Constitution through empowering IARC to make laws applicable to California (Article IV, Section 1).
The tentative ruling details the court’s arguments concerning Monsanto’s failure to state facts/insufficiently allege its claims for each of the claims. Concerning the first allegation on the unconstitutional delegation of authority, the court stated “there is no support for Monsanto’s conclusion that the OEHHA has unconstitutionally delegated its rulemaking authority to the IARC,” since, in part, “the voters and the legislature have established the basic legislative scheme and made the fundamental policy decision with regard to listing possible carcinogens under Proposition 65, and then allowed the IARC to make the highly technical fact-finding decisions with regard to which specific chemicals would be added to the list.” The court also found no support for any of Monsanto’s other claims. As of February 1, 2017, the ruling was not yet made final.
By Lisa M. Campbell and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has scheduled a final rule to be published on on January 26, 2017, which will temporarily delay the effective date of certain regulations until March 21, 2017. This final rule is being issued in accordance with the Presidential directive entitled “Regulatory Freeze Pending Review” issued January 20, 2017. Among the 30 regulations that meet those criteria is the final rule Pesticides; Certification of Pesticide Applicators, which revises EPA’s regulations concerning the certification of applicators of restricted use pesticides which was scheduled to be effective as of March 6, 2017. The final rule states that it “may consider delaying the effective dates … beyond March 21, 2017,” but in that event, “the Agency would propose any later effective date for public comment.” More information on this final rule is available in our memorandum Final EPA Rule Requires Stronger Standards for Applying Riskiest Pesticides.
By Lynn L. Bergeson and Margaret R. Graham
On January 19, 2017, the U.S. Environmental Protection Agency (EPA), together with a host of other federal agencies, announced revisions via a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. 82 Fed. Reg. 7151. The Federal Register publication states that this final rule is intended to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators, and “these revisions are an effort to modernize, simplify, and enhance the current system of oversight.” The rule will become effective on January 19, 2018. The compliance date is also January 19, 2018, with some exceptions.
The final rule differs in important ways from the proposed rule issued on September 8, 2015; most significantly, several proposals are not being adopted. Other minor changes have been to improve the rule and for purposes of clarity and accuracy. Some of the changes include:
- It does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.
- To the extent some of the proposals relied on standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance.
- It does not expand the policy to cover clinical trials that are not federally funded.
- It does not adopt the proposed new concept of ‘‘excluded’’ activities. Generally, activities proposed to be excluded are now either described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
- The proposed revisions to the exemption categories have been modified to better align with the longstanding ordering in the final rule. It does not include the proposed requirement that exemption determinations need to be made in specified ways.
- It does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens.
- It does not adopt the most restrictive proposed criteria for obtaining a waiver of the consent requirements relating to research with identifiable biospecimens.
The final rule makes the following significant changes to the Common Rule:
- Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
- Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
- Establishes new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
- Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective three years after publication of the final rule.
- Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.
More information on the Federal Policy for the Protection of Human Subjects is available on the U.S. Department of Health & Human Services’ website.
By Zameer Qureshi
On November 23, 2016, the European Court of Justice (ECJ) issued two landmark judgments in Case C-673/13 P (Commission v Stichting Greenpeace Nederland and Pan Europe) and Case C-442/14 (Bayer CropScience and Stichting De Bijenstichting v College voor de toelating van gewasbeschermingsmiddelen en biociden).
In Case C-673/13 P, the associations Stichting Greenpeace Nederland and Pesticide Action Network Europe (PAN Europe) submitted a request to the European Commission (EC) under Regulation (EC) No 1367/2006 for access to a number of documents relating to the initial marketing authorization for glyphosate, one of the most widely used herbicides in the world for agricultural weeding and the maintenance of urban and industrial areas. The EC granted access to the documents, with the exception of part of the draft assessment report prepared by Germany. The EC justified its refusal by stating that the document in question contained confidential information on the intellectual property rights of the applicants for the glyphosate authorization.
The associations brought an action before the General Court of the European Union (EU) for annulment of the EC’s decision. The General Court upheld that action in its judgment of October 8, 2013. The General Court considered that certain segments of the document in question contained information relating to emissions into the environment. Consequently, the EC was not entitled to invoke the confidentiality of commercial and industrial information, and “should have granted the associations access to those parts.” The EC was not satisfied with the judgment and asked the ECJ to set it aside.
In Case C-442/14, Bijenstichting, a Dutch bee protection association, submitted a request to the Netherlands’ authority responsible for authorizing the marketing of plant protection products and biocidal products (i.e., College voor de toelating van gewasbeschermingsmiddelen en biociden (CTB)) for disclosure of 84 documents concerning marketing authorizations issued by the authority. Bayer, a company holding a large number of these authorizations, objected to the disclosure on the basis that it would “infringe copyright and adversely affect the confidentiality of commercial or industrial information.” CTB authorized disclosure of 35 of the 84 requested documents because they contained information on emissions into the environment, “even though such disclosure could have an adverse effect on the confidentiality of commercial or industrial information.” Under Directive 2003/4/EC, commercial and industrial confidentiality may not be invoked to prevent disclosure of such information.
Bijenstichting and Bayer appealed CTB’s decision before the Netherlands courts, which referred several questions to the ECJ for a preliminary ruling regarding, among other things, whether the information requested by Bijenstichting falls within the concept of “information on emissions into the environment” -- with the consequence that it should be disclosed without Bayer being entitled to object on the grounds that such disclosure could adversely affect the confidentiality of commercial or industrial information.
The ECJ’s judgments clarify what must be understood by “emissions into the environment” and “information on [or which relates to] emissions into the environment” within the meaning of the Regulation applicable in Case C-673/13 P and the Directive applicable in Case C-442/14. In both judgments, the ECJ found that the concept of “emissions into the environment” includes the release into the environment of products or substances (e.g., plant protection products or biocides or active substances contained in those products) to the extent that the release is actual or foreseeable under “normal or realistic conditions of use of the product or substance.”
The ECJ concluded, therefore, that this concept is indistinguishable from the concepts of “release” and “discharge” and cannot be restricted to emissions emanating from industrial installations. The ECJ decided that the concept covers emissions resulting from spraying of a product into the air or its use on plants, in water, or in soil. Such limitations, the ECJ opined, would be “at odds with the objective of the regulation and directive for disclosing environmental information as widely as possible.” Additionally, the ECJ decided that Directive 2003/4/EC and Regulation (EC) No 1367/2006 cover information on actual and foreseeable emissions from a product into the environment. The ECJ concluded that “purely hypothetical emissions” are not covered by the laws.
The ECJ stated that the concept of “emissions into the environment” must be interpreted as covering not only information on emissions, but also information enabling the public to “check whether the assessment of actual or foreseeable emissions,” on the basis of which the Competent Authority authorized the product or substance in question, is correct.
In Case C-673/13 P, the ECJ set aside the judgment of the General Court insofar as the General Court considered that it is sufficient that information relates “in a sufficiently direct manner” to emissions into the environment for it to be covered by Regulation (EC) No 1367/2006. The ECJ referred the case back to the General Court of the EU for determination of whether the information at issue relates to emissions into the environment, and, if necessary, for ruling on the parties’ arguments that were not examined in its judgment. Case C-442/14 has also been referred back to the lower court.
The ECJ’s judgments clarify that public interest in “information on emissions into the environment” is important and oftentimes overrides commercial interests. The ECJ’s rulings have potentially significant and widespread implications for companies seeking to protect trade secrets and other sensitive information. The ECJ’s reasoning in its judgment can be applied to information submitted in relation to chemical products other than pesticides that are intended for uses that involve releases into the environment. The ECJ’s judgments have been criticized for not addressing risks of substantial harm to pesticide industry innovators and their proprietary rights if studies are now deemed subject to the EU’s disclosure mandate -- data developers will need to consider this possibility and take measures to protect their sensitive information.
By James V. Aidala and Margaret R. Graham
On January 12, 2017, the U.S. Environmental Protection Agency (EPA) released its Policy to Mitigate the Acute Risk to Bees from Pesticide Products (Mitigation Policy) which describes methods for addressing acute risks to bees from pesticides. EPA states that this Mitigation Policy is “more flexible and practical than the proposed policy” that was issued on May 29, 2015, and it has “made modifications to its approach with the goal of better targeting compounds that pose an acute risk, and with the goal of reducing potential impact of this effort on growers.” EPA states that it will use its Tier 1 acute risk assessment to, in part, determine the products that trigger concerns about pollinator risk that the label restrictions are intended to address. EPA will begin implementing this Policy in 2017 by sending letters to registrants describing steps that must be taken to incorporate the new labeling. More information on the Mitigation Policy, including its supporting documents, and EPA’s response to comments submitted on the proposed policy, is available on www.regulations.gov under Docket ID EPA-HQ-OPP-2014-0818.
Also on January 12, 2017, EPA published preliminary pollinator-only risk assessments for the neonicotinoid insecticides clothianidin, thiamethoxam, and dinotefuran, and an update to its preliminary risk assessment for imidacloprid, published in January 2016. EPA states that the preliminary assessments for clothianidin, thiamethoxam, and dinotefuran are similar to the preliminary pollinator assessment for imidacloprid, in that they showed that “most approved uses do not pose significant risks to bee colonies,” but “spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.” As for the updated imidacloprid assessment, EPA states that is looked at potential risks to aquatic species, and identified some risks for aquatic insects. Interested parties will have 60 days to comment on the preliminary risk assessments after notice is published in the Federal Register. In terms of comments, EPA states that it is especially interested in getting input from stakeholders “on the new method for assessing potential exposure and risk through pollen and nectar.” Links to risk assessment dockets for each individual insecticide are available on EPA’s website under Schedule for Review of Neonicotinoid Pesticides. EPA states it is hopes to release the final neonicotinoid risk assessments by mid-2018.
The revised Mitigation Policy has been long in coming since it was first released over eighteen months ago. The delay in revising its approach reflects the complexity of the comments submitted, and EPA’s deliberateness in more finely crafting its policies, given the passage of time and other considerations. This revised policy contains more flexibility and explicit discussion of the need for exceptions to blanket requirements in response to some of the comments received on the earlier proposal. There remains significant public and regulator concern about the possible impacts on pollinators from pesticide use, however, there is currently less of a manic tone to EPA’s statements and actions.
For example, when discussing how EPA will approach changing the labels of the affected universe of pesticide products, there is a much less onerous tone and no specific deadlines for registrants to submit revised labels “or else.” (The 2013 directives to registrants included demands for thousands of revised labels to be submitted within six weeks “or else” -- EPA would take “appropriate action” under FIFRA.) EPA reminds us all that it retains authority to impose these new requirements broadly, a statement that will strike some as regulatory overreach, but the tone and approach is more in line with past EPA “guidance” about how it will approach a new or revised regulatory concern.
Similar to what EPA previously concluded about imidacloprid, where that assessment concluded that the most controversial use -- corn seed treatments -- did not indicate a risk concern, EPA did include in its summary about the other three neonicotinoid pesticides that:
- The assessments for clothianidin, thiamethoxam, and dinotefuran, similar to the preliminary pollinator assessment for imidacloprid showed: most approved uses do not pose significant risks to bee colonies. However, spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.
This might unfairly be summarized as: after years of regulatory analysis EPA has concluded that if insecticides come into direct contact with insects, there is likely to be a risk to the exposed insect.
This conclusion would be too simplistic since EPA and other regulatory bodies have expressed concern about what unintended exposures to insecticides might cause, and more generally the possibility of colony level impacts on honeybee and other pollinator populations from pesticide use. Some critics will continue to insist that EPA broaden its regulatory approach to more than just pesticides used for crops under contracted pollinator services. The broader issue of pesticide drift and possible impacts on non-target species will continue to be a concern for all pesticides.
Perhaps the more deliberate consideration of needed data generation and assessment that seems to be the current approach will allow both more refined regulatory controls if needed, and a reduction in the sometimes hot rhetoric which has accompanied the pollinator issues.
Lastly, although this revised Mitigation Policy and the three new preliminary assessments are not unexpected next steps as part of the ongoing registration review program for pesticides, given their very late release -- less than ten days before the arrival of a new Administration -- some might question whether this is part of the “midnight regulations” pushing the political agenda of the outgoing Administration. The new leadership may revise what has been released, and may come to different conclusions about any needed restrictions. That said, the issue of whether certain pesticides are having a dangerous impact on honeybee populations will continue to be a concern for regulators both in the U.S. and globally.
By Lynn L. Bergeson and Carla N. Hutton
On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:
- Graphics that illustrate agency-specific overviews of regulatory roles;
- Case studies that demonstrate how a product developer might navigate the regulatory framework; and
- A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.
In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.” EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities. In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products. When completed, the agencies will consider the study’s findings, as well as the comments. More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology.
By Lynn L. Bergeson, Oscar Hernandez, Ph.D., Lara A. Hall, MS, RQAP-GLP, and Margaret R. Graham
On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, 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 to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA). The notice states that these test guidelines “serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions,” and they “provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA.” The test guidelines will be accessible through EPA Docket ID Numbers EPA-HQ-OPPT-2009-0150 through EPAHQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576 on www.regulations.gov.
The changes to test guidelines are varied. Some of the changes include:
- Simple cosmetic changes, e.g., presentation of test conditions, test validity criteria, and equations for calculating response measurements;
- Housekeeping changes, e.g., the addition of final versions of draft guidelines that had not been prepared in final yet;
- The addition of a limit test option to several acute invertebrate toxicity tests;
- Changes from “cut off” dosages in existing guidelines to limit concentrations and a change in the limit concentration for industrial chemicals from “1,000 milligrams/liter (mg/L)” to “100 mg/L” for acute toxicity tests and “10 mg/L” for chronic tests; and
- Changes to terminology, e.g., to clarify 10-day versus acute exposures for sediment-dwelling invertebrate toxicity tests and saltwater versus marine conditions.
The addition of a limit test option aligns well with the new TSCA mandate to reduce vertebrate testing as a matter of federal policy. EPA notes that certain guidelines were not issued in final, but remain available for reference as draft guidelines. In that certain ecological effects guidelines relate to guidelines already developed for the Endocrine Disruptor Screening Program (EDSP), EPA notes that it will consider test design elements from the relevant EDSP guidelines in the development of OSCPP 850 series guidelines.
By Lynn L. Bergeson, Karin F. Baron, and Margaret R. Graham
On December 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity studies for pesticide formulations.”
For this pilot program, EPA is requesting submission of acute oral and acute inhalation toxicity study data paired with mathematical calculations (GHS Mixtures Equation data) to support the evaluation of pesticide product formulations; instruction for doing so are available on the GHS Equation Pilot Program webpage, and Guidance on the GHS Mixtures Equation is available in the Guidance on the Application of the CLP (Classification, Labeling and Packaging) Criteria.
The program is an interesting approach considering the conceptual differences of risk assessment and hazard determination that exist at the core of EPA risk approaches and GHS fundamentals. Also, the definition of the EPA Categories compared to GHS has been problematic for hazard communication applications.
Mixture calculation tools rely on the availability of data for all components and would only be applicable if the data for each were generated using the same species under similar exposure conditions.
This pilot program is being developed under EPA’s initiative to develop non-animal alternatives for acute toxicity testing, as well as EPA’s Office of Pesticide Programs’ Strategic Vision for Adopting 21st Century Science Methodologies. More information on these initiatives can be found on our Pesticide Law and Policy blog under key phrase “toxicity testing.”
By Margaret R. Graham
On November 29, 2016, the U.S. Environmental Protection Agency (EPA) announced the issuance of its new guidance for testing pesticides designed to reduce animal testing for acute dermal toxicity for pesticides, Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis, in final. This guidance was issued as part of the Office of Pesticide Programs’ (OPP) Strategic Vision for implementing the 2007 National Research Council’s report on Toxicity Testing in the 21st Century.
OPP states that it “receives about 200-300 dermal formulation toxicity tests annually, each of which generally use 10 animals per test,” and “[w]e expect this waiver guidance to save 2,500 or more laboratory animals every year.” Further, as described in OPP Director Jack Housenger’s March 17, 2016, letter to stakeholders, “[t]his new policy represents significant progress toward EPA’s goal of significantly reducing the use of animals in acute effects testing.”
More information on OPP’s Strategic Direction for Adopting 21st Century Science Methodologies is available on EPA’s website and in our blog item EPA’s OPP Releases Guidance Documents Related to Strategic Vision for Adopting 21st Century Science Methodologies.
By Susan M. Kirsch
On November 1, 2016, the U.S. Environmental Protection Agency (EPA) published its Final National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit for Point Source Discharges from the Application of Pesticides in the Federal Register, which regulates discharges to waters of the United States from the application of biological pesticides and chemical pesticides that leave a residue. 81 Fed. Reg. 75816. The 2016 NPDES Pesticide General Permit (PGP) replaces the 2011 PGP, which expired on October 31, 2016. The PGP applies to the following geographic areas where EPA serves as the NPDES permitting authority:
- The States of: Massachusetts, New Hampshire, New Mexico, and Idaho;
- District of Columbia;
- All U.S. territories except the U.S. Virgin Islands;
- Federal facilities in Delaware, Vermont, Colorado, and Washington;
- Discharges in Texas that are not under the authority of the Texas Commission on Environmental Quality, including activities associated with oil and gas exploration (see Appendix A of the Final 2016 PGP for further description); and
- All areas of Indian Country that are not covered by an EPA-approved permitting program (see Appendix A for Indian Country covered within each EPA Region).
Similar to the 2011 PGP, the 2016 PGP contains additional permit conditions and modifications that some states and tribes added through the Clean Water Act (CWA) Section 401 certification process and/or the Coastal Zone Management Act process. Part 9 of the 2016 PGP provides a detailed breakdown of any additional requirements. Forty-six states have delegated authority to administer state versions of the PGP. The majority of states recently revised and reissued their respective state PGPs for another five-year permit cycle.
The 2016 PGP applies to the same pesticide use patterns covered by the 2011 PGP, which are:
- Mosquito and Other Flying Insect Pest Control -- control of public health/nuisance and other flying insect pests (including mosquitoes and black flies) that develop or are present during a portion of their life cycle in or above standing or flowing water.
- Weed and Algae Pest Control -- control of weeds, algae, and pathogens that are pests in water and at water’s edge, including ditches and/or canals.
- Animal Pest Control -- control of animal pests, including fish, lampreys, insets, mollusks, and pathogens, in water and at water’s edge.
- Forest Canopy Pest Control -- application of a pesticide to a forest canopy to control the population of a pest species (e.g., insect or pathogen) where, to target the pests effectively, a portion of the pesticide unavoidably will be applied over and deposited to water.
The 2016 PGP requirements are nearly identical to those in the 2011 PGP, with the exception of the following two updates included in the 2016 PGP:
- Electronic reporting (Part 7.8) -- All reporting under the 2016 PGP (i.e., Notice of Intent (NOI), Annual Report, and Notice of Terminations (NOT) submissions) must be submitted via EPA’s eNOI system to be consistent with EPA’s Electronic Reporting Rule. EPA will make these reports publicly available through a searchable index tool -- eNOI search. More information on electronic reporting, and access to the Central Data Exchange for NOI, Annual Report, and NOT submissions is available here.
- Updated definition of the National Marine Fisheries Service (NMFS) Listed Resources of Concern -- Following consultation between EPA and NMFS, as required under Section 7 of the Endangered Species Act (ESA), EPA expanded the Listed Resources of Concern to include additional species not included in the 2011 PGP definition. Under Part 126.96.36.199, pesticide discharges that overlap with NMFS Listed Resources of Concern trigger additional NOI requirements to certify that the discharges and discharge-related activities are not likely to adversely affect federally listed “endangered” or “threatened” species, or federally-designated “critical habitat.” Permittees may consult EPA’s PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool to determine whether a discharge activity will overlap with these Resources of Concern. Appendix I provides endangered species instructions for affected permittees. EPA states in the corresponding Fact Sheet for the 2016 PGP that it continues to estimate that less than two percent of the total number of Operators in the PGP coverage areas will need to meet additional permit requirements in order to meet ESA-related provisions.
The 2016 PGP permit conditions went into effect on October 31, 2016, and the PGP will expire in five years on October 31, 2021. 2016 PGP coverage is automatic through January 12, 2017, without the submission of an NOI, but pesticide Operators (i.e., pesticide applicators) must comply with all 2016 PGP conditions as of October 31, 2016. For any discharges commencing on or before January 12, 2017, that will continue after this date, a decision-maker must submit an NOI no later than January 2, 2017, to ensure PGP coverage, and for any discharges subsequent to January 12, 2017, an NOI submission is required no later than 10 days before the first discharge. Table 1-1 at Part 1.2.3 outlines which decision-makers must submit NOIs based on the particular pesticide use pattern, location (i.e., if discharging to a designated Outstanding National Resource Water), and acreage thresholds. Table 1-2 at Part 1.2.3 provides applicable NOI submission deadlines, including grace periods for NOI filing for discharges in response to a Declared Pest Emergency.
EPA’s webpage for pesticide NPDES permitting includes links to the final 2016 PGP, a related fact sheet, the permitting decision tool, and information on eNOI and ESA procedures.
Although the 2016 PGP largely mirrors the 2011 version of the permit, it will be important for decision-makers to familiarize themselves with the new electronic reporting requirements (Part 7.8). EPA’s eNOI system is publicly searchable and could subject PGP permit holders to additional scrutiny by citizens and advocacy groups concerned about potential environmental and public health implications of pesticide applications in their areas. Decision-makers should consult EPA’s PGP NMFS Listed Resources of Concern -- Interactive Mapping Tool and the Alternative PGP Sources of Information for NMFS Listed Resources of Concern to determine where discharges may overlap with these areas and trigger additional permit conditions.
By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has recently announced the availability of two proposed test methods and associated testing guidance for evaluating antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa and Staphylococcus aureus, for comments. EPA states that registrants of antimicrobial products with public health claims are “required to submit efficacy data to EPA in support of the product’s registration” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA is soliciting comments on the clarity of the standard operating procedures and the regulatory guidance. The two test methods are:
The Draft Guidance to Assess the Efficacy of Antimicrobial Pesticide Products Intended to Control Public Health Biofilms on Hard, Non-Porous Surfaces describes biofilms and their public health significance; the two test procedures for developing efficacy data supporting biofilm claims; products that may be eligible for biofilm claims; test criteria; data submission procedures for efficacy data; and labeling guidance.
The draft guidance states that the term biofilm “is reserved for claims against biofilm that contain specific bacteria that are directly or indirectly infectious or pathogenic to humans,” and “biofilm claims are considered to be public health claims for which the agency must review and approve appropriate efficacy data.” EPA states: “Examples of use sites that may be supported by the biofilm test methodologies herein, and found acceptable, include restrooms, shower stalls, sink basins or drains (excluding the drain pipe) and nearby hard, non-porous surfaces of walls, countertops, and instrument trays in patient care areas of hospitals. In contrast, claims against non-public health slimicides must also be supported by appropriate efficacy data, however, submission of the data is only required when requested by the EPA.”
The Draft Guidance also sets forth examples of acceptable label claims against public health biofilms and acceptable non-public health claims. The examples of acceptable label claims against public health biofilms are:
- Kills 99.9999% of bacteria* in biofilm on a hard, non-porous surface;
- Kills a minimum of 99.9999% of bacteria* in biofilm;
- Reduces at least 99.9999% of bacteria* growing in biofilm;
- Formulated to kill 99.9999% of bacteria* in biofilm;
- Other related claims:
- Kills biofilm bacteria*; and
- Penetrates biofilm, killing the bacteria* living there.
*[List of bacteria “tested as a biofilm”; at a minimum, Pseudomonas aeruginosa and Staphylococcus aureus].
Examples of acceptable non-public health claims supported by appropriate efficacy data include:
- Cleans away microorganism slime/grunge;
- Maintains control of slime; and
- Controls slime-forming microorganisms.
Comments will be accepted until December 5, 2016.
By Lisa M. Campbell and Lisa R. Burchi
The California Department of Pesticide Regulation (DPR) recently proposed a regulation that it states is intended to “(1) provide minimum statewide standards for all agricultural pesticide applications near public K-12 schools and child day care facilities; (2) provide an extra margin of safety in case of unintended drift or when other problems with applications occur (e.g., equipment failure causes an unintended release of pesticide, or an abrupt change in weather conditions); (3) increase communication between growers and schools/child day care facilities; and (4) provide information to assist schools and child day care facilities in preparing for and responding to pesticide emergencies.”
This proposal has been long anticipated, is far reaching, and of significant concern to many growers and registrants.
In its Initial Statement of Reasons, DPR summarizes the proposed regulations, stating that they will: “require growers to notify public K-12 schools, child day care facilities (except family day care homes), and county agricultural commissioners when certain pesticide applications made for the production of an agricultural commodity near a schoolsite are planned in the coming year and also a few days prior to the applications.” The proposed regulation also would prohibit at certain times certain pesticide applications near these schoolsites. Specifically, the regulation is proposed to do the following:
- Prohibit many pesticide applications for the production of an “agricultural commodity” within a quarter mile of schoolsites from Monday through Friday between 6:00 a.m. and 6:00 p.m. “Schoolsites” are defined by Education Code section 17609(f) as: “‘any facility used as a child day care facility, as defined in Section 1596.750 of the Health and Safety Code, or for kindergarten, elementary, or secondary school purposes. The term includes the buildings or structures, playgrounds, athletic fields, vehicles, or any other area of property visited or used by pupils.” ‘Schoolsite’ does not include any postsecondary educational facility attended by secondary pupils or private kindergarten, elementary, or secondary school facilities.” DPR also proposed to exclude from the definition of schoolsite any family day care homes “because, unlike other schoolsites, the locations of these facilities are not publically available.” DPR states it considered other distances but proposed the one-quarter mile radius based on several factors, including but not limited the fact that this restriction is similar to the restrictions on fumigant labels that prohibit closer applications around schools and other difficult to evacuate sites and based on an analysis of pesticide illnesses due to drift from agricultural applications. The proposed prohibition would apply to applications by aircraft, sprinkler chemigation equipment, air-blast sprayers, and fumigant applications. In addition, dust and/or powder pesticide applications would also be prohibited during this time unless applied as a dust or powder using field soil injection equipment.
- Require California growers and pest control contractors to notify public K-12 schools and child day-care facilities and county agricultural commissioners (CAC) when certain pesticide applications are made within a quarter mile of these schools and facilities.
Under the proposed regulation, California growers would be required to provide two types of notifications to a school or child day-care facility:
An annual notification that lists all the pesticides expected to be used during the upcoming year. This must be provided to the school or child day care facility administrator by April 30 each year. The notice must include, among other things:
The name of pesticide products (and the main active ingredient) to be used;
A map showing the location of the field to be treated;
Contact information for the grower/operator and the County Agricultural Commissioner; and
The web address for the National Pesticide Information Center where additional sources of information or facts on pesticides may be obtained.
An application-specific notification which must be provided to the school or child day-care facility 48 hours before each application is made. This begins January 1, 2018, and must include, among other things:
- Name of pesticide products (and the main active ingredient) to be used;
- Specific location of the application and the number of acres to be treated; and
- Earliest date and time of the application.
Comments on the proposed regulation are due by November 17, 2016. DPR states that a final regulation is expected to become effective in September 2017.
Many have concerns with the proposed regulation, which DPR has been discussing publicly for some time. These concerns include what many believe are significant economic impacts to growers and others that they believe may not have been adequately considered and are not necessary for appropriate use of registered pesticides. Registrants and others should review the proposal carefully.