Posted on July 20, 2022 by Lisa M. Campbell
By Lisa M. Campbell, James V. Aidala, and Lisa R. Burchi
On July 12, 2022, the U.S. Court of Appeals for the Eleventh Circuit (Court) issued an opinion in Carson v. Monsanto that reverses a ruling by the U.S. District Court for the Southern District of Georgia (District Court) that the Plaintiff’s failure to warn claim under Georgia law was preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Plaintiff alleged that Monsanto’s label for its product Roundup®, which contains the active ingredient glyphosate, did not have adequate warning of the “harmful nature of glyphosate under Georgia law.” The District Court ruled that FIFRA preempts Georgia law and Plaintiff’s failure to warn claim because the U.S. Environmental Protection Agency (EPA) classified glyphosate as not likely to be carcinogenic to humans and approved the Roundup label. Plaintiff appealed.
The Court found that the District Court erred in concluding that the Plaintiff’s failure to warn claim was preempted under FIFRA. In its Opinion, the Court stated that a common-law cause of action, such as the failure to warn claim under Georgia law, would be preempted “if two conditions are met: 1) the state requirement must be for ‘labeling or packaging’ under the language of the statute; and 2) the state requirement is ‘in addition to or different from’ requirements derived from FIFRA.” The Court found that EPA’s registration process “is not sufficiently formal to carry with it the force of law” and instead “at most creates a rebuttable presumption of compliance with FIFRA’s registration process and nothing more.” In addition, with regard to FIFRA’s labeling provisions, the Court found that the Georgia law failure to warn claim is not in addition to or different from FFIRA requirements. Instead, the Court states that the Georgia failure to warn claim “simply enforces the FIFRA cause of action, so it is not expressly preempted.”
The Court also responded to Monsanto’s argument providing several EPA documents indicating that it could not label Roundup as carcinogenic. These included various registration reviews and reregistration eligibility decisions regarding glyphosate products, an EPA paper written about the EPA Scientific Advisory Panel’s independent review of the effects of glyphosate, and “[v]arious papers involving scientific analysis where the EPA concluded that glyphosate did not cause cancer.” Monsanto additionally provided evidence regarding the August 2019 letter from EPA to glyphosate registrants that it would not permit label amendments to include warnings under California’s Proposition 65 that glyphosate is known to the State of California to cause cancer. In that letter, EPA stated that it would consider such language to be “false or misleading,” and thus would not approve of such language on any label and further that registrants were to remove such statements from any approved labels.
The Court found, however, that none of these documents had the “indicia of formality” necessary to meet their standard of review. The Court noted that none of the documents identified were the product of notice and comment rulemaking or formal adjudication, and they did not “‘bespeak the legislative type of activity that would naturally bind’ Monsanto.” The Court thus remanded this case back to the District Court for further proceedings on the failure to warn claim.
This case potentially places glyphosate registrants in the position of defending themselves for not warning about the potential carcinogenicity of glyphosate despite past EPA statements that any such warning would be considered a violation of FIFRA. Registrants should pay attention to the potential implications of this case, and others like it, particularly with regard to label claims that EPA has approved. More information on other glyphosate issues is available on our blog.
Regardless of the outcome of this decision, the long and tortured history of the FIFRA preemption issue was expected to, and certainly will, continue. For many years, the debate over the implications of the FIFRA requirement that the EPA label cannot have conflicting (“different from”) language that would be needed, as the argument goes, to comply with state requirements to provide adequately warnings. To a casual observer, the FIFRA label and EPA review should take care of imposing the necessary conditions to avoid harms since it is axiomatic that “the label is the law,” and, if label directions are followed, EPA expects there would be no “unreasonable adverse effects” caused by the pesticide application. But the case law has evolved over the years not only about the confines of FIFRA but also regarding other “failure to warn” cases involving label instructions and warnings approved by other federal agencies (e.g., the U.S. Food and Drug Administration). The result has been a continued series of cases where the courts, state and federal, have to determine where federal requirements end and freedom for state requirements are allowed.
In this case, the outcome was a disappointment to the registrant community but is unlikely to stop the flow of litigation on both sides of the preemption arguments. And the recent announcement in April 2022 by the Biden Administration EPA to reverse effectively the 2019 letter to California about FIFRA labels and California’s Proposition 65 requirements (Letter from California’s Office of Environmental Health Hazard Assessment on California Proposition 65 |to EPA) might further muddy the water of what a FIFRA label really does imply regarding state warnings, “right-to-know” requirements, and the like.
Posted on October 12, 2021 by Lisa M. Campbell
By Lisa R. Burchi
On October 7, 2021, U.S. Environmental Protection Agency (EPA) Region 2 announced a settlement with Reckitt Benckiser, LLC (Reckitt Benckiser) regarding alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The specific alleged violations relate to 239 sales and distributions of two rodenticide products in the United States that EPA asserts had misleading advertising claims on the packaging. Reckitt Benckiser has agreed to pay a civil penalty of $458,000 under the settlement to resolve these violations.
Reckitt Benckiser is a supplemental distributor of two rodenticide products that are bait stations registered under FIFRA to kill mice. EPA states that in 2019, it conducted inspections of a Home Depot in South Plainfield, New Jersey, and Reckitt Benckiser’s offices in Parsippany, New Jersey. EPA thereafter determined that Reckitt Benckiser was selling these two rodenticide products in packaging or labeling that made comparative claims as to the effectiveness of the product. Specifically, the packaging stated that the products were “10x Tastier Than Lead Competitor.” The labels EPA approved for the two products did not contain this comparative claim language, and at the time of registration, data associated with the products’ claims were never provided. EPA’s regulations at 40 C.F.R. Section 156.10(a)(5)(iv) provide that statements or representations in the labeling which constitute misbranding include a “false or misleading comparison with other pesticides or devices.” EPA states that because "the comparative claims were not subject to verification, they were ‘false and misleading comparisons’ prohibited under [FIFRA].”
This case serves as another reminder to registrants and supplemental distributors to review all labeling and advertising claims to ensure conformity with EPA-approved labels and avoidance of claims that EPA identifies as false or misleading.
Posted on May 14, 2021 by Lisa M. Campbell
By Heather F. Collins, M.S. and Barbara A. Christianson
On May 10, 2021, the U.S. Environmental Protection Agency (EPA) announced the launch of an electronic Confidential Statement of Formula application (eCSF builder) to support pesticide registration applications. The new electronic tool is part of EPA’s interest in improving and modernizing the internal processes and digital workflows for pesticide registration submissions.
As part of the registration process for new pesticide products, EPA requires the submission of a Confidential Statement of Formula (CSF). The form lists all the product’s components and percent by weight, along with various additional information.
Currently, CSF applications must be submitted to EPA in hard copy. The new eCSF builder will automatically validate certain data in a CSF application prior to submission to EPA. EPA states this functionality, along with real-time validation of chemical ingredients through EPA’s Substance Registry Services, will make the pesticide registration process more efficient, saving EPA and registrants time and resources. While paper CSF forms remain available, EPA encourages submitting applications electronically, as the review of paper applications could be a longer process.
Users can access the eCSF builder on the Central Data Exchange (CDX) under Pre-Submission Tools, Form Builders, by clicking the Create eCSF button. Users can provide feedback to EPA through the CDX.
Additional information is available on our blog.
Posted on May 13, 2021 by Lisa M. Campbell
By Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on May 6, 2021, that Bear River Supply Inc., based in Rio Oso, California, has agreed to pay a $50,578 penalty to resolve EPA’s findings that the Company produced pesticides in an unregistered establishment, distributed and sold misbranded pesticides, and failed to maintain equipment properly. According to EPA, the California Department of Pesticide Regulation (CDPR) and EPA discovered the violations during a series of inspections conducted at two separate facilities in Rio Oso. Inspectors found that “Vistaspray 440 Spray Oil” and “Roundup PowerMax” were being repackaged and distributed with improper labeling. In addition, EPA states, inspectors determined that Bear River Supply was producing pesticides in a facility that was not registered with EPA. While at the facilities, inspectors also found that a secondary containment unit and loading pad, both used to contain potential spills, were inadequate. The Company has since corrected the violations.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), pesticide manufacturers must register their facilities with EPA and annually report their pesticide production. EPA states that production records provide information on the quantities of pesticides produced and distributed. EPA notes that in addition, the number assigned to the establishment must appear on the label. FIFRA’s reporting and labeling requirements allow EPA and state agencies to track pesticide products back to the companies that produced them and “are necessary to ensure safe management and distribution” of pesticides.
Posted on April 26, 2021 by Lisa M. Campbell
By Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on April 19, 2021, that Univar Solutions USA, Inc. of Portland, Oregon, will pay a $165,000 penalty for violating the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) when it failed to label properly its “Woodlife 111” pesticide, which is used as a wood preservative. EPA notes that under FIFRA, “a pesticide is misbranded if, ‘the labeling accompanying it does not contain directions for use which are necessary … to protect health and the environment’ and if ‘…the label does not contain a warning or caution statement which may be necessary … to protect health and the environment.’” According to the press release, EPA alleged that between approximately January 1, 2017, and December 31, 2018, Woodlife 111 labels “omitted several required sections important for the protection of the handler and for the environment, including user safety requirements, first aid directions, use of personal protective equipment, and portions of the storage and disposal section.” EPA states that it cited the company for 33 FIFRA violations when Univar sold and distributed the misbranded pesticide via bulk shipments. According to the press release, the case resulted from a March 5, 2019, inspection of the Univar facility by the Oregon Department of Agriculture’s EPA-credentialed inspectors.
Posted on December 18, 2020 by Lisa M. Campbell
By Lisa M. Campbell, Heather F. Collins, M.S., and Barbara A. Christianson
On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced a new policy that will allow registrants of antimicrobial pesticide products voluntarily to disclose all inert ingredients more efficiently in response to the request of retailers, states, and industry.
Registrants who wish to disclose all inert ingredient can choose to do so in three ways under the new policy:
- On the product label as part of the full ingredient statement or on the product’s back or side panel with a referral to the full ingredient statement;
- On a website referenced on the product label; or
- On a website that is not directly linked to the product label.
EPA states that it will allow registrants to use alternate nomenclature to disclose inert ingredients. This policy is effective as of January 16, 2021.
EPA states that there is no statutory or regulatory requirement to identify inert ingredients in the ingredient statement, except when EPA determines that such inert ingredients may pose a hazard to humans or the environment. EPA states that if EPA determines an inert ingredient may pose a hazard, EPA may determine that the name of the inert ingredient must be listed in the ingredient statement on a case-by-case basis for either risk-based or hazard-based reasons. Examples include the following ingredients:
- Petroleum distillates, xylene, or xylene range aromatic solvents > 10%;
- Sodium nitrate > 0.1%; or
- Inert ingredients of toxicological concern (formerly known as “List 1 Inerts”).
EPA’s long-standing policy, as stated in its Label Review Manual, has been that “if a registrant wants to list a particular inert ingredient in the ingredient statement, the registrant should list all inert ingredients directly below the ingredient statement in descending order by weight. A partial listing on the label could be misleading.” EPA’s new policy applies to voluntary identification of inert ingredients using alternate nomenclature and not to cases where EPA directs registrants to list particular inert ingredients because of risk-based or hazard-based reasons.
EPA states that beginning December 15, 2020, the Office of Pesticide Programs (OPP) will review antimicrobial pesticide applications for voluntary inert ingredient disclosure. Under this new process, EPA states that if a registrant chooses to utilize alternate chemical nomenclature on its product labeling, the registrant must resubmit the Confidential Statement of Formula (CSF) containing the inert ingredient as approved on the existing formulation as well as the alternate chemical nomenclature. EPA requires that a “crosswalk” between the approved nomenclature of the CSF and the alternate nomenclature be provided with the registrants’ non-Pesticide Registration Improvement Extension Act (PRIA 4) application, which will fall under a 90-day review.
If registrants choose to use alternate nomenclature, EPA encourages using the following sources:
If a registrant chooses to disclose voluntarily inert ingredients on the label, the registrant should list all of the inert ingredients directly below the ingredient statement in descending order by weight, so that the list does not interfere with the required labeling information. If space is limited, however, to avoid crowding of required labeling information, a referral statement may be used directing the reader to the back or side panel for the full list of inert ingredients in descending order by weight. The referral statement should be placed directly below the ingredient statement with an asterisk or some other equivalent symbol connecting the “Inert Ingredients” or “Other Ingredients” heading in the ingredient statement with the full list of inert ingredients placed on the back or side panel of the label. For example, an acceptable referral statement is “*See back panel for complete inert ingredient statement,” and acceptable corresponding text on the back panel is “*Inert Ingredients: Inert A, Inert B., etc.”
When registrants choose to add a website address or quick response (QR) code to their labeling that leads to inert ingredient information, EPA asks that registrants, in a cover letter transmitting the labeling amendment application, self-certify that the inert ingredient information provided on the registrant’s website(s) and in other marketing materials is consistent with the information provided on the latest approved CSF.
EPA states that registrants do not need to amend its their master label or notify EPA before adding an inert ingredient statement to a website, provided that the site is not referenced on the product label. In such cases, the application process outlined below does not apply.
EPA states that no other actions should be included with inert ingredient disclosure applications. The following information is required to be included in the application:
- Applications to add alternate nomenclature to the label must:
- Crosswalk link the current CSF nomenclature to any alternate nomenclature as confirmation that the current CSF nomenclature and alternate nomenclature are synonyms of each other (the exact same inert ingredient). EPA provides a template spreadsheet for the alternate nomenclature crosswalk to link the current CSF nomenclature to any alternate inert ingredient nomenclature.
- Identify in the cover letter the proposed changes to the alternate nomenclature on product labels and CSFs, the revised CSF (which includes the current and alternate nomenclature) and master label with changes highlighted.
- For applications to add currently approved nomenclature to the label registrants should include with the application a cover letter identifying the proposed change(s) on product labels and master label with changes highlighted, including the following self-certification statement: “The inert ingredients voluntarily disclosed in the labeling for EPA Registration No. [add registration number], are accurate for the EPA-registered product listed above. No changes to the product formulation have been made. I certify that no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. 1001 to willfully make any false statement to EPA. I further understand that if the information I have provided is misbranded as defined in section 2(q) of FIFRA, 7 U.S.C. 136(q), this product may be in violation of FIFRA and EPA may pursue enforcement actions under sections 12 and 14 of FIFRA, 7 U.S.C. 136(j) and 136(l).”
- For applications to add or change a website or QR code to include inert information, applicants must include a cover letter that identifies the proposed change(s) on product labels and master label with changes highlighted, including the following self-certification statement: “The inert ingredients voluntarily disclosed in the labeling for EPA Registration No. [add registration number], are accurate for the EPA-registered product listed above. No changes to the product formulation have been made. I certify that no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. 1001 to willfully make any false statement to EPA. I further understand that if the information I have provided is misbranded as defined in section 2(q) of FIFRA, 7 U.S.C. 136(q), this product may be in violation of FIFRA and EPA may pursue enforcement actions under sections 12 and 14 of FIFRA, 7 U.S.C. 136(j) and 136(l).”
According to EPA, the scope of this policy is currently limited to antimicrobial pesticide products. EPA states that it may consider expanding to conventional pesticide and biopesticide products in the future.
Additional information is available here.
Posted on June 30, 2020 by Lisa M. Campbell
By Lisa M. Campbell, Timothy D. Backstrom, and Lisa R. Burchi
On June 22, 2020, the U.S. District Court for the Eastern District of California granted summary judgment for the Plaintiffs in National Association of Wheat Growers et. al. v. Becerra, and entered a permanent injunction against enforcement of a Proposition 65 (Prop 65) warning label for pesticide products containing glyphosate. The court found that requiring the registrants of glyphosate products to include such a warning could not be justified as a valid restriction on commercial speech and therefore is contrary to the First Amendment of the Constitution. The same District Court had previously entered a preliminary injunction against the Prop 65 warning in 2018, and the required warning has consequently never been in effect. (See our February 28, 2018, blog entitled “Eastern District of California Rules on Motion to Enjoin Prop 65 Listing and Warning on Glyphosate Products.”) The U.S. Environmental Protection Agency (EPA) also has stated that it would not allow a Prop 65 warning to be added to the labeling for any registered glyphosate product because such a warning is misleading and would cause the product to be “misbranded” under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(q)(1)(A). (See our August 15, 2019, blog entitled “EPA Issues Guidance Regarding Prop 65 Labeling Requirements for Glyphosate Products and OEHHA Responds.”)
A Prop 65 warning is required when the California Office of Environmental Health Hazard Assessment (OEHHA) determines that a product contains a substance that has been classified as a human carcinogen by certain authoritative bodies, including the International Agency for Research on Cancer (IARC). Based on an IARC determination that glyphosate is “probably carcinogenic” in humans, OEHHA listed glyphosate in July 2017 as a chemical known to the State of California to cause cancer, thereby triggering Prop 65 warning requirements. Despite the IARC determination, every other authoritative body that has considered the matter (including EPA, the European Commission, and the World Health Organization) has reached a contrary determination that glyphosate is not likely to be carcinogenic in humans. California’s imposition of a Prop 65 warning for glyphosate was challenged in 2018 by the registrant Bayer and a coalition of farming groups and industry stakeholders, who obtained a preliminary injunction against enforcement of the warning.
Before entering the new permanent injunction, the District Court considered whether California’s regulation of commercial speech should be scrutinized under the lower standard set by the Supreme Court in Zauderer v. Office of Disciplinary Counsel or the intermediate standard set by Central Hudson Gas & Electric v. Public Service Commission. The Zauderer standard only applies to mandatory disclosure of “purely factual and uncontroversial information,” and the Court found that the Prop 65 warning for glyphosate is “misleading” and therefore neither factual nor uncontroversial. Under the Central Hudson level of scrutiny, a governmental agency may only restrict commercial speech when the restriction directly advances an important governmental interest and where the restriction is not more extensive than necessary to serve that interest. The Court found that the Prop 65 warning for glyphosate is misleading, and therefore does not directly advance the interest of the state in informing consumers regarding potential cancer hazards, and that the asserted state interest could be effectively advanced by other measures that do not burden freedom of speech in the same manner.
California argued that no Prop 65 warning would actually be required for glyphosate in practice because OEHHA has set a quantitative “safe harbor” level for glyphosate exposure, but the court found that this would not prevent parties other than California from bringing separate enforcement actions to enforce the listing. Since a Prop 65 warning only needs to be “clear and reasonable,” California also proposed several alternative forms for a warning that would meet state requirements, but the court found these alternate warnings to all be misleading as well. Based on all of these factors, the court decided to enjoin permanently the enforcement of Prop 65 warning requirements for glyphosate as an unconstitutional burden on commercial speech.
Under FIFRA Section 24(b), no state may impose any labeling for a registered pesticide that differs from the labeling approved by EPA. Although EPA has sometimes been willing to accommodate state labeling requirements or preferences within the labeling approved under FIFRA, there are necessary limits to this practice. When label language sought by a state becomes misleading, approving it would also be expressly contrary to FIFRA. How much precedential effect this decision may have with respect to other state requirements for labeling in the future is an issue that registrants should monitor closely.
Posted on December 09, 2019 by editor
By Timothy D. Backstrom
On December 5, 2019, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced the availability of a revised interim registration review decision for use of sodium cyanide in the M-44 predator control device. The M-44 device is a restricted use pesticide (RUP) and may be used only by certified applicators in compliance with specific mandatory restrictions set forth on the label. Although the registration review process for sodium cyanide remains pending, EPA has decided to issue an interim decision for the M-44 device now to adopt new label restrictions intended to mitigate potential risks. The revised interim decision adopts two new restrictions and also modifies certain existing restrictions, which EPA states "will reduce the potential for unintended impacts on humans, pets, and other non-target animals.”
The M-44 predator control device uses a spring-loaded ejector to fire a capsule containing a single lethal capsule of sodium cyanide. The M-44 is used by livestock producers to control predators (primarily coyotes) that kill sheep, goats, and cattle. Registrations for the M-44 device are currently held by the U.S. Department of Agriculture, and by five individual States (South Dakota, Texas, Montana, Wyoming, and New Mexico) where livestock predation has been a particular problem.
New or revised restrictions that will be incorporated in the approved labeling for the M-44 device include:
- Requiring a 600-foot buffer zone around residences where an M-44 cannot be used (except for a cooperating landowner who has given written permission).
- Requiring that the applicator notify occupants of all residences within a 0.5 mile radius (by face-to-face communication, person-to-person telephone communication, door hanger, or certified mail) prior to an M-44 placement.
- Increasing from 50 feet to 300 feet the distance from designated public paths and roads where M-44 use is prohibited.
- Requiring two elevated warning signs placed 15 feet from the M-44 device and facing the most likely directions of approach, instead of one elevated sign placed 25 feet from the device.
Livestock producers and State departments of agriculture contend that the M-44 device is essential to limit economic losses resulting from predation, which reportedly amount to hundreds of millions of dollars annually. In contrast, wildlife advocates have strongly opposed any continued use of the M-44 device. In 2017, WildEarth Guardians and the Center for Biological Diversity petitioned EPA to suspend and cancel all registrations for M-44 capsules, but EPA concluded that the petition did not contain substantial new information and denied the petition in 2018. Although the new and modified label restrictions adopted by EPA in the interim decision for the M-44 device are not likely to satisfy opponents, these changes should nonetheless reduce the likelihood that humans, pets, or other non-target species will be exposed to the M-44 capsules or the toxin they contain.
Posted on October 21, 2019 by editor
By Heather F. Collins, M.S.
On October 17, 2019, the U.S. Environmental Protection Agency (EPA) released the Spanish Translation Guide for Pesticide Labeling resource for use by all, including pesticide registrants that choose to display parts of their pesticide product label in Spanish. The purpose of the guide is to be a resource for the translation of the health and safety sections on pesticide labeling from English to Spanish. EPA states that the “guide is written in a universal form of Spanish to reach as many Spanish speakers as possible.”
While translating pesticide labels is not a requirement, EPA generally allows pesticide registrants to translate their product labels into any language so long as there is an EPA-accepted English version of the label and the translation is true and accurate. The guide is not intended to substitute for or eliminate the pesticide labels in English. An English version of all required labeling text is needed for all pesticide products in accordance with 40 C.F.R. Section 156.10(a)(3).
The guide provides translations for standard language typically used in the health and safety sections of pesticide product labels such as the:
- First aid and precautionary statement label language;
- Signal words;
- Misuse statements;
- Storage and pesticide container disposal instructions;
- Personal protection equipment label statements; and
- Worker Protection Standard agricultural use requirements.
EPA states that it “developed the Spanish translation guide in response to feedback from stakeholders who believe that having bilingual pesticide labeling is critical to the well-being of pesticide handlers, applicators, and farmworkers, many of whom do not speak English as a first language.”
The English statement appears in the left-hand column and the corresponding Spanish translation is available in the right-hand column of the guide. EPA states that the “guide will help registrants maintain accurate, consistent translations on product labels and ease their burden when adding Spanish translations.”
Posted on August 23, 2019 by editor
By Lisa M. Campbell and Timothy D. Backstrom
On August 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the receipt of 10 applications to amend currently registered pesticide products to add hemp as a new use site. The 10 application amendments are the result of the 2018 Farm Bill, signed in to law on December 20, 2018, that removed hemp from the Controlled Substances Act and legalized commercial use and production of hemp that contains less than 0.3% tetrahydrocannabinol (THC).
EPA states in the notice that Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(4) does not require EPA to provide notice and opportunity to comment concerning these 10 applications because hemp falls within the terrestrial outdoor and residential outdoor use pattern previously approved for the pesticidal active ingredients in question, and approval of the applications would therefore not involve "a changed use pattern." Instead, EPA states that it has decided to provide an opportunity to comment in this instance "because of the potential significant interest from the public" and to be "completely transparent about these applications." EPA also states that it does not intend to provide notice or opportunity to comment for similar applications to add hemp that are likely to be submitted in the future.
EPA also states that the products with requested label amendments contain active ingredients for which EPA "has previously determined the residues will be safe under any reasonably foreseeable circumstances." Each active ingredient has an established tolerance exemption for residues on all raw agricultural or food commodities.
The 10 products for which EPA has received an application to add hemp are:
- Debug Turbo, EPA Registration No. 70310-5, active ingredients: azadirachtin and neem oil;
- Debug Optimo, EPA Registration No. 70310-7, active ingredients: azadirachtin and neem oil;
- Debug Trés, EPA Registration No. 70310-8, active ingredients: azadirachtin and neem oil;
- Debug-ON, EPA Registration No. 70310-11, active ingredient: neem oil;
- REGALIA Bioprotectant Concentrate, EPA Registration No. 84059-3, active ingredient: extract of Reynoutria sachalinensis;
- MBI-110 EP, EPA Registration No. 84059-28, active ingredient: Bacillus amyloliquefaciens strain F727;
- GH CMT, EPA Registration No. 91865-1, active ingredients: soybean oil, garlic, oil, and capsicum oleoresin extract;
- GH MPMT, EPA Registration No. 91865-2, active ingredient: potassium salts of fatty acids;
- GH DNMT, EPA Registration No. 91865-3, active ingredient: Bacillus amyloliquefaciens strain D747; and
- GH NAMT, EPA Registration No. 91865-4, active ingredient: azadirachtin.
Once public comments are received, EPA anticipates making its decision on adding hemp as a new use site on the specific products before the end of 2019, so that these products may be available for the 2020 growing season.
Although the Federal government has legalized commercial production and use of hemp (as opposed to marijuana that contains higher levels of THC), not every State has changed its laws to conform to the new classification. EPA took the unusual step of announcing receipt of the new amendment applications at Hemp Production Field Day at the University of Kentucky. Senator Rand Paul of Kentucky has long been a proponent of commercial hemp production, and about 1,000 growers in Kentucky now have licenses to grow hemp for commercial use.
As hemp production increases, there will also be increased demand for pesticides to combat weeds, insects, and plant diseases that pose a potential threat to this crop. Although hemp fiber and oil have many potential industrial uses, hemp also has potential medicinal uses because extracts containing cannabidiol (CBD) are now being widely marketed for their purported health benefits. This use of hemp means that EPA will have to consider whether new tolerances may be required for some active ingredients before they can applied to hemp. As EPA has noted, the active ingredients in the 10 products for which EPA announced that applications are pending to add labeling for hemp already have tolerance exemptions, and therefore do not present this issue.
Comments are due on or before September 23, 2019. The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2019-0369.