By Lynn L. Bergeson and Barbara A. Christianson
On April 22, 2020, Assistant Administrator Alexandra Dapolito Dunn stated, on prerecorded remarks posted by the American Bar Association, that the U.S. Environmental Protection Agency (EPA), after the coronavirus crisis subsides, will review whether some of the current requirements to submit notifications or label amendments are necessary. Some of these requirements have been suspended as part of EPA’s efforts to hasten the process for disinfectants approved for use against SARS-CoV-2, which causes COVID-19.
EPA modified the requirements to submit a notification or label amendment to increase quickly the number of disinfectants available to fight the novel coronavirus that causes COVID-19. These steps include a temporary policy EPA updated on April 14, 2020, describing situations in which manufacturers producing disinfectants for use against SARS-CoV-2 can change certain ingredients or sources of those ingredients without the normal requirement to notify EPA.
On the prerecorded remarks, Assistant Administrator Dunn stated as an example, “if a baker is changing its source of flour, we don’t need to know where it’s coming from as long as it’s the same quality and the company maintains its records.” She also remarked “dropping such ‘administrative hoops’ has helped disinfectant manufacturers get their products to market without putting public health or the environment at risk.”
EPA will proceed with formal rulemaking or another process if EPA decides to modify the requirements to keep the flexibility currently used during the COVID-19 crisis.
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.
By Jason E. Johnston
On August 27, 2019, the U.S. Environmental Protection Agency (EPA) published a proposed rule in the Federal Register that makes several changes to the current “Crop Group 19: Herbs and Spices Group.” This latest proposal, which is the fifth in a series of crop group amendments, was created in response to a petition developed by the International Crop Group Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4 (IR-4). The goals of the crop group amendment program include reducing regulatory burden, coordination with international definitions, and removing barriers to trade. The major components of this proposal are revision of the commodity definition for marjoram; addition of three new commodity definitions for basil, edible flowers, and mint; and replacement of the existing “Crop Group 19: Herbs and Spices Group” with two new crop groups, “Crop Group 25: Herb Group” and “Crop Group 26: Spice Group.” Recognizing that the existing combined Crop Group 19 Herb and Spice Group has limited the establishment of crop group tolerances, EPA has proposed creating the two new separate crop groups to benefit herb and spice growers. The new crop groups are quite large, containing 317 herb commodities in Crop Group 25 and 166 spice commodities in Crop Group 26. The proposal specifies all commodities in the new crop groups (and the subgroups therein, i.e., 25A and 25B for fresh herbs and dried herbs) and provides updated representative commodities for each crop group and subgroup.
The Federal Register notice requests that comments on the proposal be submitted on or before October 28, 2019. The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2006-0766.
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.
By Lisa M. Campbell, Heather F. Collins, M.S., and Margaret R. Graham
On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017. Comments now must be received by EPA on or before December 5, 2017. The notice states that it will “allow stakeholders additional time to submit comments on the proposed guidance.” Eleven comments were filed in the docket, most of which expressed significant concern with changes EPA is proposing, in addition to requesting an extension to the previous deadline which was set to end on October 6, 2017.
EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” A full summary of the changes in the draft guidance is available in our blog item "EPA Releases Draft Guidance for Pesticide Registrants on Notifications, Non-notifications, and Minor Formulation Amendments."
Some of the more substantive comments noted the following issues:
- Several commenters stated objections to the provisions in the draft PR Notice that would eliminate the ability of registrants of formulated products to use notification to add or change sources of either registered technical active ingredients or inert ingredients. Concerns expressed with this proposed change included the effect it would have on the ability of registrants to respond quickly to market changes and conditions, including the availability and price of technical and inert ingredients needed for formulations.
- One commenter had concerns with regard to the proposed changes to the inert ingredient disclosure statement, as EPA is “considering whether the notification method or the non-notification method is an appropriate avenue for industry requested inert disclosure based upon third-party vendor requirements.” The commenter stated that it “believes there is an approach that satisfies third-party vendors while minimizing the burden on the Agency’s resources,” and “a significant delay to this issue could have third-party vendor impacts.”
- Commenters also expressed disappointment with EPA’s notification delivery, stating that EPA “provided very little notice to Stakeholders of this major change in its policies regarding notification” and “as a result, many potentially affected registrants may overlook this change and fail to file comments on it.”
More information on this draft notice and other pesticide registration notice issues is available on our blog under key phrase Pesticide Registration Notice.
By Lisa M. Campbell, Sheryl L. Dolan, and Barbara A. Christianson
On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of and seeking public comment on draft guidance, Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendments. EPA states it is issuing this notice to “align the notification program with the requirements of the Food Quality Protection Act (FQPA) and [the Pesticide Registration Improvement Act (PRIA)] and to clarify the processes for accepting minor, low risk registration amendments to be accomplished through notification, non-notification or as accelerated amendments.” EPA is requesting comments, and specifically information on projected cost implications of this draft updated guidance.
PR Notices are issued by the Office of Pesticide Programs (OPP). EPA states that PR Notice 2017-XX will update and clarify “the scope of changes accepted by notification, non-notification and minor formulation amendments for all pesticide products, and supersedes both PR Notices 95-2 and 98-10 in their entirety.” The PR Notice lists the changes from PRN 98-10 in a table. Those changes include:
In addition to the changes listed on the table, modifications to PR Notice 98-10 consist of the following:
- F. Product Composition: (1) Pesticide Category -- Under PR Notice 98-10, the pesticide categories "disinfectant" and "sanitizer" were two pesticide categories that were allowed to be added to a label by notification. Under the proposed PR Notice, "disinfectant" and "sanitizer" were removed.
- F. Product Composition: (2) Odor -- Under PR Notice 98-10, the terms "fragrance free" and "unscented" were allowed to be added to a label by a notification provided that the product is odorless or nearly odorless and contains odor-masking ingredient such as a perfume. Under the proposed PR Notice, these terms were removed.
Minor Formulation Amendments
- A. Minor Formulation Amendments: (1) Addition, deletion or substitution of one or more colorants in a formulation -- Under PR Notice 98-10, if a product was intended for a use as a seed treatment or rodenticide, it would not be eligible for an accelerated review; that restriction was deleted from the proposed PR Notice.
- A. Minor Formulation Amendments: (2) Addition, deletion or substitution of one or more inert ingredients (other than colorants and fragrances) in a formulation -- Under the proposed PR Notice, if a product is a dog/cat pet spot-on product or if an inert is a bittering agent or a safener, the product would not be eligible for an accelerated review.
- A. Minor Formulation Amendments: (3) Addition, deletion or substitution of one or more fragrances in a formulation -- Under the proposed PR Notice, fragrances will be eligible for an accelerated review if all fragrance component ingredients are included on the Fragrance Ingredient List; individual fragrance component ingredients that exceed 0.1 percent (by weight) of the total pesticide product composition have existing approval for non-food use as an inert ingredient; and new/modified fragrances for antimicrobial products making public health claims are within the certified limits established for fragrances already approved for the product.
- Under the proposed PR Notice, products that are not eligible for accelerated review under minor formulation amendments are:
- Pet spot-on products;
- Change to an active ingredient source;
- Change to nominal concentration of the active ingredient; or
- Addition of new or additional Confidential Statements of Formula (CSF).
EPA Procedures to Review Notifications
Under the proposed PR Notice, EPA outlines changes to the policy for processing notifications by the Registration Division (RD) and the Biopesticides and Pollution Prevention Division (BPPD), but procedures to process notifications by the Antimicrobials Division remain the same.
One item to note under the proposed notification process for RD and BPPD is that a registrant may distribute or sell a product modified by notification once EPA receives the notification but, if EPA determines that a product has been modified through notification inappropriately, EPA may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application to amend the registration.
Registrants Submitting Minor Formulation Amendments
Under the proposed PR Notice, EPA requires that registrants submit with their application for registration a cover letter listing names and dates of all EPA accepted CSFs. EPA will consider any CSFs not listed in the cover letter as superseded/no longer valid.
Comments on this PR notice are due October 6, 2017, and can be submitted online under Docket ID EPA-HQ-OPP-2016-0671.
Registrants should review the draft PR Notice carefully, as it includes important changes. For example, the consequence for submitting a minor formulation amendment and neglecting to include a list of all current CSFs is severe. As another example, EPA signals in its proposal that proceeding to market with a product revised through the notification process may be risky if the submitter has erred in its judgment regarding what is eligible for a notification. Should the PR Notice be issued without change to this provision, submitters may wish to give close consideration to waiting until it has EPA’s written confirmation that a notification has been accepted before introducing the revised product to market. Comments on issues of concern should be considered.