By Lynn L. Bergeson and Margaret R. Graham
On October 25, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that the U.S. Food and Drug Administration (FDA), in coordination with the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and OPP, will be holding two public meetings to discuss FDA’s Agricultural Biotechnology Education and Outreach Initiative. The meetings will be held in Charlotte, North Carolina on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST). EPA states that this initiative, which Congress appropriated three million dollars to fund, “calls for FDA to work with EPA and USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology, and the purpose of the meetings is “to provide the public an opportunity to share information, experiences, and suggestions to help inform the development of this education and outreach initiative.” FDA issued a notice on these public meetings in the Federal Register on October 13, 2017. 82 Fed. Reg. 47750. More information on the initiative and how to register for the meetings is available on FDA’s website. Participation is available in person or by webcast.
In the notice, FDA also invites comments and responses to the following questions specifically regarding agricultural biotechnology and biotechnology-derived food products and animal feed:
- What are the specific topics, questions, or other information that consumers would find most useful, and why?
- Currently, how and from where do consumers most often receive information on this subject?
- How can FDA (in coordination with USDA) best reach consumers with science-based educational information on this subject?
Comments can be filed in Docket No. FDA-2017-N-5991 on www.regulations.gov; comments are due by November 17, 2017.
By Lynn L. Bergeson and Sheryl Lindros Dolan
On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology. The notice was published in the Federal Register on October 5, 2017. 82 Fed. Reg. 46500. Guidance for Industry #236, “Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products” (Guidance), provides information for industry and other stakeholders regarding the regulatory oversight of articles, including substances, for use in or on mosquitoes (mosquito-related products). FDA states that it is providing the Guidance to clarify circumstances under which such products are regulated by FDA as new animal drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) and other circumstances under which such products are regulated by EPA as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Scope of Guidance
FDA notes that the Guidance is important in light of the public health urgency of countering the spread of mosquito-borne disease such as that caused by the Zika virus. While novel mosquito control technologies have gained greater attention, there has been confusion regarding FDA and EPA jurisdiction over such products. FDA, working collaboratively with EPA, is providing the Guidance to clarify the regulatory oversight of mosquito-related products. This includes, but is not limited to, those produced through biotechnology.
The Guidance includes the following examples of new animal drugs regulated by FDA:
- Products intended to reduce the virus/pathogen load within a mosquito, including reduction in virus/pathogen replication and spread within the mosquito and/or reduction in virus/pathogen transmissibility from mosquitoes to humans; and
- Products intended to prevent mosquito-borne disease in humans or animals.
Examples of pesticide products regulated by EPA are “[p]roducts intended to reduce the population of mosquitoes (for example, by killing them at some point in their life cycle, or by interfering with their reproduction or development).”
Guidance for Sponsors/Manufacturers of Products Intended for use on Mosquitoes
In the Guidance, FDA encourages sponsors of mosquito-related products, other than those that are “intended to prevent, destroy, repel, or mitigate mosquitoes by controlling a mosquito population,” to contact FDA early in the development process. FDA states that if a developer has a jurisdictional question, such as which agency or agencies would have oversight of a mosquito-related product that is expressly intended for both mosquito population control and human disease suppression, the developer may contact either or both agencies via the contacts listed. FDA and EPA will consult with each other on the jurisdictional question, “as is already common practice.” The agencies may suggest a joint meeting among EPA, FDA, and the sponsor to discuss appropriate pathways to market.
The guidance notes that FDA, EPA, and the U.S. Department of Agriculture (USDA) have committed to clarifying how the federal government intends to regulate genetically engineered insects as described in the September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products. More information on the National Strategy is available in our September 21, 2016, memorandum White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products.
The new FDA guidance states that products intended to prevent mosquito-borne disease in humans or animals are regulated as new animal drugs subject to FDA jurisdiction, but products intended to control mosquito populations would be regulated by EPA as pesticides. That FDA and EPA are attempting to clarify their respective jurisdictions is appreciated. Potential commenters may wish to consider whether the guidance offers sufficient clarity for product development planning purposes. If “products intended to prevent mosquito-borne disease in humans or animals” are under FDA jurisdiction, the status of mosquito repellents currently registered by EPA that make claims about repelling mosquitoes that carry the Zika virus, the West Nile virus, or other viruses is unclear. Additionally, it would seem that the Oxitec mosquito is intended to reduce the mosquito population, among other goals. The Guidance is a good start, but further clarification likely will be needed to support emerging technologies.
More information is available in our memorandum FDA Guidance Addresses FDA and EPA Jurisdiction over Mosquito-Related Products.
By Margaret R. Graham
On September 22, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register (82 Fed. Reg. 44406) announcing the availability of two final Pesticide Registration Notices (PRN):
- PRN 2017-1: Guidance for Pesticide Registrants on Pesticide Resistance Management Labeling, which updates PRN 2001-5 and provides guidance for registrants to follow when developing resistance management information to include on their pesticide labels. It addresses “end-use herbicide, fungicide/bactericide, or insecticide/acaricide products that are intended mainly for agricultural and certain non-crop land areas under commercial or government-sponsored pest management,” and applies in particular to “all field use agricultural pesticide products, as well as pesticides which are labeled for greenhouse production, sod farms, ornamental crops, aquatic vegetation, rights-of way, and pest management along roadways.”
- PRN 2017-2: Guidance for Herbicide Resistance Management Labeling, Education, Training, and Stewardship, which “communicates the agency's approach to address herbicide-resistant weeds.” It is “germane to end-use herbicide products used in agriculture, including commercial turf and sod farms, ornamental production in the open.” It also applies to “non-agricultural use sites such as golf courses, aquatic vegetation, rights-of-way and vegetation management along roadways.”
These final PRNs reflect consideration of public comments submitted on the draft PRNs. Also available in the dockets are EPA’s responses to comments on the draft PRNs: Response to Comments on PRN 2017-1; and Response to Comments on PRN 2017-2. EPA states that “PRNs are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration-related decisions, and to provide guidance to pesticide registrants and OPP personnel.”
More information on PRNs is available on our blog under key phrase pesticide registration notice.
By Heather F. Collins
On August 28, 2017, the U.S. Environmental Protection Agency (EPA) announced the first of three feature and functionality updates to the Pesticide Submission Portal (PSP) expected this year. The portal is a web-based application allowing registrants to submit pesticide application packages to EPA electronically. The PSP application is accessed through EPA’s Central Data Exchange (CDX) Network which requires user registration.
This new PSP, version 1.4, release expands the feature to allow users to submit voluntary data related to specific registration review cases. Users can submit study citations, data matrices (Form 8570-35), cover letters and studies (protocols, study profiles, supplemental study data) using the new "Voluntary Submission" link on the PSP home page. This new release also allows users to resubmit previously submitted 90-day responses. Once a 90-day response or data submission has been successfully transmitted to the Office of Pesticide Programs (OPP), users may now modify responses to data requirements, cite additional studies, upload additional documents, and change how the product registration is supported. EPA states: “This action is another step in a phased approach that will ultimately lead to EPA’s ability to accept all pesticide applications electronically, a move that will help modernize the pesticide registration process, increase operational efficiencies and reduce paper waste.” EPA indicates that in addition to these changes, this update introduces enhancements and bug fixes.
EPA also released the OPP Pesticide Submission Portal (PSP) User Guide Version 1.4 which provides detailed instructions on how to use the PSP application and guidance on how to prepare a package for electronic submission.
Applicants using PSP need not submit multiple electronic copies of any pieces of their applications; EPA states that the requirement to submit multiple copies of data in Pesticide Registration Notice 2011-3 is applicable only to paper submissions. Pesticide registrants who previously submitted information via paper, CD, or DVD may instead use the portal and forego the courier costs of sending to EPA.
More information about the Electronic Submissions of Pesticide Applications is available on EPA’s website.
By Lara A. Hall
On August 3, 2017, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing revised comment period dates for the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) meeting regarding the “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways.” This SAP meeting will be held on November 28-30, 2017, from 9:00 a.m.-5:00 p.m. (EST) at the EPA Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202. Updated details regarding commenting periods are provided below:
- Supporting documents for the FIFRA SAP meeting will be posted online on or before September 1, 2017. Written comments will be accepted on or before October 16, 2017.
The original Federal Register notice announcing the meeting was published on June 6, 2017.
This important meeting, and materials issued in connection with it, will have potentially significant consequences for registrants and should be monitored closely.
By Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala
On June 22, 2017, a complaint was filed against the U.S. Environmental Protection Agency (EPA) by American Oversight, a nonprofit organization (Plaintiff), in the United States District Court for the District of Columbia. The complaint asks the court to compel EPA to provide information in response to a Freedom of Information Act (FOIA) request submitted by the Plaintiff on April 11, 2017, “seeking communications between certain individuals at each agency and certain outside entities related to chlorpyrifos or other pesticides.” The records requested included: (1) a copy of any decision memoranda and attachments associated with the decision to deny the petition to ban chlorpyrifos; and (2) all communications between certain individuals involved with EPA’s Administration as well as certain transition team members, and the following listed entities:
- Any agricultural or other trade group with an interest in pesticides, including but not limited to CropLife, the American Farm Bureau, the National Corn Growers, or the Oklahoma Farm Bureau;
- Any pesticide manufacturer or anyone acting on behalf of a pesticide manufacturer, including but not limited to Dow Chemical or Dow AgroSciences;
- Any member of Congress or anyone acting on behalf of a member of Congress (including both personal and committee staff) regarding agricultural issues or pesticides; and
- Any think tanks, including but not limited to the Heritage Foundation, regarding agricultural issues or pesticides.
The complaint asserts that although EPA responded to the FOIA request by stating that it was “proceeding with the search,” EPA “has not taken any additional actions,” and as of June 14, 2017, had not provided any of the requested records. Plaintiff claims that EPA has failed to comply with the applicable time-limit provisions of FOIA and the complaint contains two Counts: Count I: Failure to Conduct Adequate Search for Responsive Records; and Count II: Wrongful Witholding of Non-Exempt Records. Based on these alleged violations, Plaintiff asks the court to order EPA to conduct a search reasonably calculated to uncover all records responsive to the FOIA request; order EPA to produce any and all non-exempt records responsive to the FOIA request and indexes justifying the withholding of any responsive records withheld under claim of exemption; and enjoin EPA from continuing to withhold any and all non-exempt records responsive to the FOIA request.
This Plaintiff appears to be seeking the responsive records to demonstrate that some kind of untoward or inappropriate communication occurred between the incoming Administration and outside groups leading to the chlorpyrifos petition response that allowed continued use of chlorpyrifos products, pending the completion of the registration review process. Given the record that the Obama Administration constructed to propose the revocation of the chlorpyrifos tolerances, environmental advocates were disappointed that the new EPA leadership decided to postpone a decision. EPA in its petition response articulated its rationale for its decision, but the Plaintiff may believe that these documents would likely show the “politics” behind the decision. This is somewhat ironic since many stakeholders in the agricultural user community are convinced that the initial proposal to revoke chlorpyrifos tolerances issued during the prior Administration was itself an example of “politics over science.”
In this instance, it does not appear that EPA has made any determination yet whether any of the requested records are exempt from disclosure. Moreover, the Plaintiff appears to be seeking decision memoranda and communications between EPA employees and other parties outside of EPA; this fact could affect EPA’s consideration of the applicability of the “deliberative process” privilege set forth in FOIA Exemption 5 to try to withhold any of the requested records, an issue that could be controversial.
The Plaintiffs contend that EPA has not met the mandatory time limits applicable to a FOIA request. This is a common problem, particularly when multiple individuals must participate in the search for responsive records, the records requested are voluminous, or exempt material like confidential commercial information must be redacted from otherwise responsive records. Unless EPA ultimately determines that some records can and should be withheld, and Plaintiff disagrees, this suit may become moot in the event that EPA produces the requested documents before the case can be adjudicated. Regardless of the outcome, Plaintiff has succeeded in keeping EPA’s controversial chlorpyrifos decision in the spotlight.
By Susan M. Kirsch and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) has announced that it will be hosting several events to gather input on regulatory actions that could be repealed, replaced or modified as part of EPA’s regulatory reform efforts under Executive Order (EO) 13777.
The Office of Pesticide Programs (OPP) will host a public meeting on the Pesticide Program Dialogue Committee (PPDC) on May 3, 2017, from 9:00 a.m. to 4:45 p.m. (EDT), and on May 4, 2017, from 8:30 a.m. to 12:00 p.m. (EDT). The session on May 4, 2017, will focus on receiving public feedback on pesticide regulatory reform issues. Registration will be required to attend the May 4, 2017, meeting only. Interested participants may register here. The deadline for registration is April 27, 2017.
The Office of Water (OW) will also host a listening session on May 2, 2017, from 11:00 a.m. to 2:00 p.m. (EDT) and participants may either pre-register here to join by phone (space limited) or join via web conference here. Pre-registration is not required for web participation. The deadline for registration is April 27, 2017.
In the pesticide space, EPA-OW is responsible for the National Pollutant Discharge Elimination System (NPDES) Pesticide General Permit (PGP), which requires NPDES permitting for pesticide applications into, over and near “Waters of the United States,” including mosquito abatement activities. The U.S. Court of Appeals for the Sixth Circuit issued a 2009 decision requiring EPA to regulate pesticides under the NPDES program. Both industry and state co-regulators have criticized PGP requirements as duplicative, burdensome, and unnecessary for pesticides applied in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Attempts to pass legislation that would eliminate NPDES permitting for FIFRA-compliant pesticides applications have not been successful to date. EPA’s actions under EO 13777 may offer an administrative mechanism to repeal the PGP. It is unclear, however, if a repeal would be legally defensible in light of the Sixth Circuit ruling. Alternatively, EPA could modify the PGP to eliminate the reporting and recordkeeping requirements that opponents find overly burdensome. Pesticide stakeholders may wish to join the May 2, 2017, OW listening session to provide recommendations.
Written comments on regulatory reforms on all regulatory reforms, including OW and OPP issues, will also be accepted in docket EPA-HQ-OA-2017-0190, Evaluation of Existing Regulations, currently open through May 15, 2017. More details on the NPDES permit for pesticides are available in our blog item EPA Issues Final 2016 NPDES Pesticide General Permit.
By Susan M. Kirsch and Lisa M. Campbell
On February 21, 2017, the Northwest Environmental Advocates (NWEA) filed a Clean Water Act (CWA) lawsuit in the U.S. District Court for the Western District that involves a number of pesticide active ingredients in addition to other chemicals. The lawsuit seeks to compel the U.S. Environmental Protection Agency’s (EPA) response to NWEA’s 2013 Petition for Rulemaking to Update the Water Quality Criteria for Toxics in the State of the Washington (NWEA v. EPA, No.: 2:17-cv-00263). NWEA asserts that Washington’s aquatic life water quality criteria (ALC) and human health water quality criteria (HHC) for many chemicals that are classified as “toxic pollutants” are outdated and inadequate. The chemicals at issue include the pesticide active ingredients acrolein, carbaryl, copper, diazinon, demeton, malathion, and methoxychlor. NWEA alleges that Washington’s continued use of outdated criteria violates the CWA and poses a risk to species listed as threatened or endangered under the Endangered Species Act (Act), specifically Chinook Salmon and Southern Resident orca whales.
Under the CWA, states develop and adopt water quality criteria and are required on a triennial basis to review and revise or develop new criteria if appropriate to protect designated uses (e.g., recreation, wildlife protection). As part of this triennial review process, states are required to consider any recommended new or revised quality criteria published by EPA. States may adopt the criteria that EPA publishes, modify EPA’s criteria to reflect site-specific conditions, or adopt different criteria based on other scientifically-defensible methods. Criteria are a component of water quality standards that inform the development of total maximum daily load (TMDL) calculations, discharge limits in permits, and management of nonpoint sources of pollution, including agricultural run-off. If state criteria are inadequate for the protection of designated uses, EPA may step-in to issue updated criteria, and can be compelled to promulgate criteria by citizen suit action.
NWEA alleges that Washington has failed to adopt HHC or ALC for several toxic pollutants since 1992. In November 2016, EPA published a final rule updating Washington’s HHC for toxics. 81 Fed. Reg. 85417. NWEA asserts that the revised HHC do not address the full spectrum of HHC, as updates for arsenic, dioxin, and thallium were not included. NWEA also argues that updated HHC do not alleviate the ongoing risk to aquatic life from Washington’s inadequate ALC. EPA has not responded to NWEA’s complaint.
It is unclear how EPA will respond to NWEA’s suit. Often a state will work simultaneously to develop its own criteria that will meet EPA approval. Registrants associated with the pesticides at issue should prepare for potentially forthcoming proposals of more stringent criteria. The proposal and promulgation of new criteria is a lengthy process and requires public notice and comment. It may well be at least two years before either EPA or Washington issues proposed updates for ALC. A compilation of the latest EPA recommended ALC is accessible here. The criteria values in the table provide some indication of the direction that may be taken in future updates.
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.