EPA Announces Registration of Ten Pesticides for Use on Hemp; Still No Products Registered for Use on Cannabis

            On December 19, 2019, the U.S. Environmental Protection Agency announced the addition of hemp as a registered use for ten registered pesticides held by three registrants: Agro Logistic Systems, Marrone Bio Innovations and Hawthorne Hydroponics. These ten products, which include nine biopesticides and one conventional product, join several others already registered for use on hemp.

            The ten include the Registered biopesticides are:

Agro Logistic Systems:

 EPA registration number: 70310-5; active ingredients: azadirachtin and neem oil. Product type: Insecticide, miticide, fungicide and nematicide.

EPA registration number: 70310-7; active ingredients: Azadirachtin and neem oil. Product type: Insecticide, miticide, fungicide and nematicide.

EPA registration number: 70310-8; active ingredients: Azadirachtin and neem oil. Product type: Insecticide, miticide, fungicide and nematicide.

EPA registration number: 70310-11; active ingredient: Neem oil. Product type: Insecticide, miticide and fungicide.

Marrone Bio Innovations:

EPA registration number: 84059-3; active ingredient: Extract of Reynoutria           sachalinensis. Product type: Fungicide and fungistat.

EPA registration number: 84059-28; active ingredient: Bacillus amyloliquefaciens strain F727. Product type: Fungicide.

Hawthorne Hydroponics, dba General Hydroponics.

EPA registration number: 91865-1; active ingredients: Soybean oil, garlic oil, and Capsicum Oleoresin extract. Product type: Insecticide and repellent.

EPA registration number: 91865-3; active ingredient: Bacillus amyloliquefaciens strain D747. Product type: Fungicide and bactericide.

EPA registration number: 91865-4; active ingredient: Azadirachtin. Product type: Insect growth regulator and repellent.

The registered conventional pesticide product is:

Hawthorne Hydroponics, dba General Hydroponics:

            EPA registration number: 91865-2; active ingredient: Potassium salts of fatty acids. Product type: Insecticide, fungicide and miticide.

            When the hemp amendments were being considered, EPA had undertaken the unusual step of inviting public comment, which is not normally required for amendments such as these. The Notice prompted a number of supportive comments from a range of interests, including the U.S. Department of Agriculture, the National Association of State Departments of Agriculture, the American Farm Bureau Federation, the Bio Pesticides Industry Association and the California Department of Pesticide Regulation. With the rapidly growing number of acres planted in hemp as a result of the 2018 Farm Bill, additional registrants can be expected to seek to add hemp as a target crop, although such future amendments are not likely to be the subject of public notice.

         Despite the increased attention too hemp. EPA continues to assert that no pesticides are allowed to be used on cannabis grown for medical or adult uses.  In this regard it is interesting to note that Hawthorne Gardening  is a subsidiary of the Scotts Miracle-Gro Company, which has been quite public about its interest in expanding in the cannabis space. 

COVID-19 Poses Potential Threat to 2020 United States Agricultural Chemical Supply

 

The COVID-19 epidemic which originated in the Chinese city of Wuhan and surrounding Hubei Province poses a threat to the 2020 agricultural chemical supply for the United States. Having been spreading for over a month as of this writing, there are now over 73,000 cases and at least 1,868 deaths reported.

The epidemic poses at least a short term if not longer term threat to agricultural chemical production, which could have a world-wide impact on agriculture. Exports account for two thirds of Chinese agricultural chemical production, and such exports constitute a significant portion of the supply for the US. In addition to the indigenous companies, many major international agricultural chemical companies produce in China. Of some 15,000 pesticide producing establishments registered with the U.S. Environmental Protection Agency, over 1,100, or some 7%, are located in China. That compares with 15% of FDA-registered pharmaceutical production facilities located in China. While only approximately thirty to forty pesticide establishments are in Hubei, the epidemic is presenting a nationwide threat to the industry supply chain.

The China Crop Protection Industry Association (“CCPIA”) recently released results of a member survey assessing the impact of the epidemic. The short term was uniformly pessimistic, and while holding to the hope that the interruption will not be long term, respondents were united in their belief that annual exports will decrease for 2020. Several major industry international trade shows, including the CAC Exhibition in Shanghai in late February, have already been cancelled.

Production has largely ceased nationwide, with only halting efforts at restarting production. While the Lunar New Year holiday is over, many Chinese citizens who did travel for the holiday are being impeded in their efforts to return home, many cities are confining residents to their homes. Some companies did anticipate this problem, and ramped up production prior to the onset of the virus.  However respondents stated that logistical obstacles are rampant and at present even if there is product on hand, none is able to be exported. Both inbound and outbound trans-ocean shipping has been significantly disrupted. While not directly relevant to agricultural chemicals, a major backlog of refrigerated containers requiring electricity has caused shippers to unload containers at other than the intended ports in order to find available power supplies. Further delays are anticipated as facilities seeking to restart operations must first secure local government approval.

As of this writing the rate of expansion of cases has slowed, but the course of the epidemic remains uncertain.  It is likely that the next weeks will reveal whether a pandemic erupts, which will likely further impair production and exports.    

February 17, 2020

New York Announces Administrative Elimination of Chlorpyrifos [Updated]

Despite its registration having been upheld by the U.S. Environmental Protection Agency (“EPA”), the insecticide chlorpyrifos continues to face multiple challenges to its continued use. The continued EPA registration continues to be challenged in Court by a collection of states, while California has secured the agreement of major registrants to administratively cancel all registration. Now the New York Governor has directed the Department of Environmental Conservation (“NYSDEC”) to administratively phase out most uses of the ingredient.

In New York, the legislature passed a bill which would in three stages eliminate all uses of chlorpyrifos by December 1, 2021. See S. 5343; A-2477B. Aerial application would be prohibited as of January 1, 2020, following which all uses except applications to apple tree trunks would end as of January 1, 2021. The apple tree use would then end December 1, 2021. In a somewhat contradictory move, rather than signing the legislation, the Governor vetoed it but has directed the NYSDEC to promulgate rules largely mirroring the vetoed legislation. The Governor’s Veto Message stated that pesticides should not be regulated by legislative mandate, but instead by NYSDEC on the basis of science. The Veto Message stated that NYSDEC will act to immediately ban aerial application; most remaining uses are to be eliminated by July 1, 2021.

New York has a procedurally complex rulemaking process. To propose a rule, the moving agency must first secure approval of the State Division of the Budget. A proposed rule is then published, which must be accompanied by a series of documents assessing the impacts of the proposed rule, including a Regulatory Flexibility Analysis, a Rural Area Flexibility Analysis and a Job Impact Statement. If not finalized within a year of publication, a proposed rule expires. In fact, it often consumes most of that year to arrive and publish a final rule.  To achieve the objective of immediately eliminating aerial application, NYSDEC will need to promulgate an emergency regulation, followed by a proposed permanent rule.  The emergency rule will need to be supported by a statement justifying the need for an emergency rule.

Section 24(a) of the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7 USC §136v(a), expressly authorizes states to regulate pesticides more strictly than EPA. That said, a state must still follow its own procedures and meet its own legal standards to support a rulemaking. Although EPA has concluded that chlorpyrifos does not present an unacceptable risk, that decision was arrived at in part by excluding epidemiological data developed by the Columbia University’s Center for Children’s Environmental Health and Mt. Sinai Hospital.  EPA asserts that the data is not valid, complete and reliable data unless EPA is granted access to the underlying raw data.  The study sponsors have refused to supply such information, claiming that to do so would violated subject confidentiality. New York will be free to include that study as a basis for its action without demanding the underlying data and is likely to do so.  Bottom line: even if challenged, done correctly New York’s anticipated rule is likely to be upheld.

With chlorpyrifos on its way out in two major states, it remains to be seen whether chlorpyrifos remains on the market, regardless of the outcome of the litigation.

 

EPA Seeks Public Comment on Pending Applications to Amend Existing Registrations to Add Hemp as a Target Site  

On August 23, 2019, the U.S, Environmental Protection Agency (“EPA”) published a notice seeking public comment on ten pending applications to amend existing registrations of agricultural pesticides to add hemp as an approved target site. See 84 Federal Register 44296 (August 23, 2019)

Interest in hemp has grown enormously since the enactment of the Agriculture Improvement Act of 2018, colloquially known as the Farm Bill. Hemp is simply another term for the cannabis plant, also known as marijuana. The Farm Bill legalized the cultivation of and interstate commerce in hemp, defined as the cannabis plant containing less than 0.03 % THC [delta-9-tetrahydrocannabinol; the psychoactive constituent of cannabis]. Plants containing above 0.3% THC remain classified as an illegal Schedule 1 drug under the Controlled Substances Act.

The legalization of what is also known as industrial hemp has been greeted with great interest by the agricultural community. In some areas, such as upstate New York, hemp is seen as an alternative crop that might help save failing dairy farms. It is also seen as a natural corollary to increased cultivation of hops to meet the demands of the burgeoning craft brewery industry.

EPA has received applications to amend the registrations of ten products from three registrants:  Agro Logistic Systems, Inc. of Diamond Bar, California; Marrone Bio Innovations of Davis, California; and Hawthorne Hydroponics of Santa Rosa California. Hawthorne Hydroponics is a subsidiary of Hawthorne Gardening, itself a subsidiary of Scotts Miracle-Gro. Hawthorne is Scott’s vehicle for creating a space servicing the cannabis industry.

The ingredients in question are mostly biologic pesticides, and all hold exemptions from the requirement for a food tolerance. The proposed use patterns are within those already approved for the products in question.

EPA acknowledged that these proposed amendments do not meet the minimum standards of the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) for required public notice of pending applications. Nonetheless it stated that sufficient public interest in hemp justified seeking public comment at this initial stage, but would not continue to publicize the increasing number of applications which it expects to receive.

Comments are due September 23, 2019, and can be filed at www.regulations.gov

 

 

 

U.S. Supreme Court Grants Review of Emerging Clean Water Act Liability Theory

As anticipated, on February 19, 2019 the U.S. Supreme Court acted as recommended by the U.S. Solicitor General (“SG”) and granted certiorari in one of two Clean Water Act (“CWA”) citizen suits for which Petitions for Certiorari were pending, Hawaii Wildlife Fund v County of Maui, 886 F 3d 737[9th Cir.; March 30, 2018].

The CWA requires a permit under the National Pollutant Discharge Elimination System (“NPDES”) or a state counterpart program for any discharge of a pollutant from a point source into the waters of the United States. A typical NPDES permit circumstance involves a pipe discharging pollutants directly into the waters of the U.S. The emerging theory is that pollutant discharges from a point source that travel through the ground to reach the waters of the U.S., rather than being discharged directly into U.S. waters, also violate the CWA.  This application of the CWA is termed the “conduit” theory. EPA’s position has been that CWA jurisdiction does extend to pollutants traveling through the ground only if a direct hydrologically connection to the waters of the U.S. can be demonstrated.

The County of Maui operates injection wells into which it discharges treated wastewater.  It is undisputed that the treated water constitutes a pollutant and that it can be traced and shown to be reaching the Pacific Ocean. In Hawaii Wildlife Fund v County of Maui, 886 F 3d 737[9thCir.; March 30, 2018] the Court upheld a District Court decision finding a violation of the CWA on the theory that a discharge into the waters of the U.S. that was first injected into the ground and then migrated into the Pacific Ocean can still be characterized as originating from a point source, notwithstanding the lack of a direct discharge from the point source to the waters of the U.S. The County then filed a Petition for Certiorari.

Although in submitting the recommendation to grant certiorari the Solicitor General did not take position on the merits of the case, it is anticipated that the U.S. will support the County and oppose the conduit theory.  In its amicus brief the Solicitor’s office stated that EPA would soon be issuing guidance on this topic, but so far no guidance has been issued.

Given the timing of the grant within the 2018-2019 term, this matter will not be heard until the 2019-2020 term. Extensive amicus participation is anticipated.

 

Congress Allows Pesticide Registration Improvement Act to Expire

Despite both EPA and industry support, Congress failed to include a renewal of the Pesticide Registration Improvement Act (“PRIA”) in the budget adopted for EPA for the remainder of fiscal year 2019, ending September 30, 2019. PRIA is the pesticide fee for service program, under which applicants for pesticide registrations or amendments pay a specified fee for the type of action and in return are given a firm date by which the action can be expected to be completed.  Originally enacted in 2004, this enactment would have been the fourth iteration of the program.  It provided reasonable certainty to a system that previously was chaotic.

In its absence, EPA has advised industry participants that as of February 16, 2019, fees will be reduced by 70%, but no deadlines will apply to actions in question.  All applications submitted prior to February 16 will still be subject to the PRIA decision times.

The Senate has passed a stand-alone re-enactment of PRIA, but is future remains uncertain.  Until the picture becomes clearer, it might be the wiser course to refrain at the moment from filing any applications.  If PRIA is re-enacted, it may retroactively cover filings during the lapse of the Act, but that is by no means a certainty.

EPA Pesticide Program Reopens to Challenging Workloads

Now that EPA is again operating, some signals are coming from the Agency as to how the pesticide work backlog will be addressed. Points of interest are:

>As to actions subject to the Pesticide Registration Improvement Act (“PRIA”) for which the decisions deadline fell during the shutdown, EPA intends to renegotiate the deadline with the applicant;

>the budget extender that runs through February 15 was retroactive to December 21 so actions submitted during the shutdown that fall within PRIA are subject to the full PRIA fee and the PRIA timeframes.

>Since reopening EPA has experienced a significantly increased volume of pesticide submissions and expects high submission volumes over the next two weeks because of the uncertainty around another shutdown.

Given the strained circumstances within pesticide program, one certainty is that acknowledgements of pesticide notifications are likely to be very long in coming. Given that certain states require require EPA confirmation of notifications, this logjam is likely to cause certain product changes to take months to implement.

Confirmation of EPA Assistant Administrator Prompts Announcement of Pesticide-Related Policy Developments, Including the Worker Protection Standard and Applicator Certification Rule

The U.S. Senate recently confirmed the appointment of Alexandra Dunn as Assistant Administrator for Office of Chemical Safety and Pollution Prevention (“OCSPP”) at the U.S. Environmental Protection Agency (“EPA”). Ms. Dunn had most recently been a Trump appointee as EPA Regional Administrator for Region 1, based in Boston.

During Ms. Dunn’s confirmation process Senator Thomas Carper of Delaware raised issues related to the Agency’s regulation of chemicals, including the approach to the use of science in regulation. Most of the emphasis was on the Toxic Substances Control Act (“TSCA”) and the implementation of the related Frank Lautenberg Chemical Safety Act for the 21st Century. However, several significant pesticide policy issues were also raised, including use of science in reviews of pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), as well as regulatory issues related to worker protection and applicator certification. The Agency set forth its position on these issues in a letter from Acting Administrator Wheeler to Senator Carper.

On the science front, at issue was the science policy regulation proposed by OCSPP last April. See 83 Federal Register 18768 (April 30, 2018). The proposal, entitled “Strengthening Transparency in Regulatory Science” The stated overall aim of the proposal was to “ensure that the data and models underlying scientific studies that are pivotal to regulatory action are available to the public.” This change was proposed notwithstanding the fact that multiple Courts have found EPA’s existing practices in relying science to be legally acceptable. See American Trucking Associations v EPA, 283 F.3d 355 (2002.)

In fact the proposal raised significant alarm in the scientific community. Concern was expressed that rather than promoting sound science, the proposal would undermine EPA’s reliance on science because it would rule out otherwise valid studies whose underlying data was confidential. See for example a letter from the editors of four major journals, who objected to the proposed policy and EPA’s assertion that the policy was in line with the policies of the journals in question. http://science.sciencemag.org/content/360/6388/eaau0116 Acting Administrator Wheeler has now committed to having the proposed policy reviewed by the National Academy of Science. Although the outcome of such a process will be somewhat influenced by the charge which is given to the NAS in referring the issue, many critics are likely pleased by this outcome.

In the same exchange policy changes were also announced with respect to pesticide Worker Protection Standards and applicator certification rules. EPA had spent several years developing a new certified applicator rule, which was promulgated on January 4, 2017. See 82 Fed. Reg. 952.
The most controversial aspect of the rule changes was the imposition of a nationwide requirement that person applying restricted use pesticide must be at least 18 years of age. Notwithstanding an exemption for family members under 18 applying pesticides under the supervision of a family member, agricultural interests still pushed back on the age restriction. As a result EPA had proposed extending the effective date of the rule and reconsidering the age restriction. See 82 Fed. Reg.60196 (December 19, 2017). Mr. Wheeler has now announced that EPA will withdraw its proposed revisions from the Office of Management and Budget, and will not lower the age restriction nor designated representative provisions, another controversial aspect of the worker protection rule. Wheeler did state that there may reconsideration of the application exclusion zone (AEZ”) aspect of the worker protection rule, but if so would do so through a public notice and comment process.

U.S. Environmental Protection Agency’s Office of Pesticide Programs Issues Guidance on Impacts of Agency Closure on Pesticide Regulatory Actions

The U.S. Environmental Protection Agency’s Office of Pesticide Programs has issued the following guidance to the registrants and producers of pesticides describing the impacts of the partial closing of the U.S. government, which includes EPA:

Due to the government shutdown, any submissions to EPA after December 28, 2018, will not be considered received or processed until after a change in EPA’s operational status for work to resume. Please note that the Pesticide Registration Improvement Renewal Act (PRIA 3) expired on December 21, 2018. Per phase out provisions described in FIFRA sec. 33(m)(2)(B), registration service fees for new applications received after that date will be reduced by 70% from the fiscal year 2017 levels. In addition, such applications will not be subject to the decision review time frames specified in PRIA 3. Pending a change in EPA’s operational status, applications received after December 21, 2018 will be subject to these new provisions, and applications received on or prior to December 21, 2018, will continue to be reviewed under the decision time frames specified in PRIA 3.

Aside from the obvious impact that work will not be performed while OPP employees are furloughed, the major impact will be on parties seeking new registrations or amendments to existing registrations. PRIA is a fee-for-service statute governing all major pesticide regulatory actions by EPA. Each covered action is assigned a review period and a processing fee. PRIA has added certainty to regulatory process, providing applicants with a firm decision date that facilitates regulatory and business planning. With PRIA now suspended, no deadline will apply to any applications filed during the closure, although a reduced fee will still apply. It is highly unlikely that many parties will continue with filings during this period, as there can be no estimate of when EPA might complete processing of the application.

A resolution of the closure will likely include the enactment of a new PRIA. Once PRIA is again operative, EPA will likely see a wave of applications filed, putting any application not subject to PRIA in further uncertainty. Depending upon EPA’s position on these applications once business resumes, parties who filed during this period of ambiguity may want to consider refiling in order to become subject to the new PRIA.

Budget Bill Continues Protection of State Medical Marijuana Programs

The budget bill which passed the House on March 22 contains the Rohrabacher (R-CA)-Blumenauer (D-OR) amendment, which prohibits the expenditure of Federal funds to take any enforcement action against anyone acting in compliance with a state medical marijuana program. Enactment by the Senate and signing by the President is anticipated. Assuming enactment the protection will continue until September 30, 2018, the end of the Federal fiscal year. Efforts by the Colorado delegation to extend protection to state recreational marijuana programs failed.