2015-24452. Pesticide Registration Review; Draft Human Health and Ecological Risk Assessments for Sulfonylureas and Certain Other Pesticides; Notice of Availability and Request for Comment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of and opens a public comment period on EPA's draft human health and ecological risk assessments for the registration review of a group of pesticides known collectively as sulfonylureas (SUs) that are identified individually in this document in Table 1 of Unit III, as well as additional chemicals identified in Table 2 of Unit III. This notice also announces both the opening of the registration review docket and the availability of the registration review human health and ecological risk assessments for antimycin A and imazosulfuron. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration that is the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed a comprehensive preliminary human health and ecological risk assessment for the pesticide uses of the identified pesticides. After reviewing comments received during the public comment period, EPA may issue a revised risk assessment, explain any changes to the draft risk assessment, and respond to comments and may request public input on risk mitigation before completing a proposed registration review decision for the identified pesticides. Through this program, EPA is ensuring that the registration of each pesticide is based on current scientific and other knowledge, including its effects on human health and the environment.

DATES:

Comments must be received on or before November 24, 2015.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0386, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

For pesticide specific information, contact: The Chemical Review Manager listed in Table 1 and Table 2 of Unit III.

For general questions on the registration review program, contact: Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager listed in Table 1 and Table 2 of Unit III.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/​dockets/​comments.html.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

II. Authority

EPA is conducting the registration review of the pesticides identified in this document pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. FIFRA section 3(g) provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.

III. Registration Reviews

As directed by FIFRA section 3(g), EPA is reviewing the registrations for the pesticides listed in Tables 1 and 2 to ensure that each pesticide on the list continues to satisfy the FIFRA standard for registration—that is, that these pesticides can still be used without unreasonable adverse effects on human health or the environment.

Table 1—Draft Risk Assessments Being Made Available for Public Comment—Sulfonylureas

Registration review case name and No.	Docket ID No.	Chemical review manager and contact information
Bensulfuron-methyl 7216	EPA-HQ-OPP-2011-0663	Moana Appleyard, [e-mail], [phone].
Chlorimuron-ethyl 7403	EPA-HQ-OPP-2010-0478	Wilhelmena Livingston, [e-mail], [phone].
Chlorsulfuron 0631	EPA-HQ-OPP-2012-0878	Miguel Zavala, [e-mail], [phone].
Flazasulfuron 7271	EPA-HQ-OPP-2011-0994	Ricardo Jones, [e-mail], [phone].
Foramsulfuron 7252	EPA-HQ-OPP-2012-0387	Jose Gayoso, [e-mail], [phone].
Halosulfuron-methyl 7233	EPA-HQ-OPP-2011-0745	Brittany Pruitt, [e-mail], [phone].
Imazosulfuron 7285-1	EPA-HQ-OPP-2015-0625	Caitlin Newcamp, [e-mail], [phone].
Iodosulfuron-methyl-sodium 7253	EPA-HQ-OPP-2012-0717	Katherine St. Clair, [e-mail], [phone].
Mesosulfuron-methyl 7277	EPA-HQ-OPP-2012-0833	Jolene Trujillo, [e-mail], [phone].
Metsulfuron-methyl 7205	EPA-HQ-OPP-2011-0375	Katherine St. Clair, [e-mail], [phone].
Nicosulfuron 7227	EPA-HQ-OPP-2012-0372	Miguel Zavala, [e-mail], [phone].
Orthosulfamuron 7270	EPA-HQ-OPP-2011-0438	Khue Nguyen, [e-mail], [phone].
Primisulfuron-methyl 7220	EPA-HQ-OPP-2011-0844	Christina Scheltema, [e-mail], [phone].
Prosulfuron 7235	EPA-HQ-OPP-2011-1010	Wilhelmena Livingston, [e-mail], [phone].
Rimsulfuron 7218	EPA-HQ-OPP-2012-0178	Jose Gayoso, [e-mail], [phone].
Sulfometuron-methyl 3136	EPA-HQ-OPP-2012-0433	Caitlin Newcamp, [e-mail], [phone].
Sulfosulfuron 7247	EPA-HQ-OPP-2011-0434	Kelly Ballard, [e-mail], [phone].
Thifensulfuron-methyl 7206	EPA-HQ-OPP-2011-0171	Brittany Pruitt, [e-mail], [phone].
Triasulfuron 7221	EPA-HQ-OPP-2012-0115	Margaret Hathaway, [e-mail], [phone].
Tribenuron-methyl 7217	EPA-HQ-OPP-2010-0626	Brittany Pruitt, [e-mail], [phone].
Trifloxysulfuron-Sodium 7208	EPA-HQ-OPP-2013-0409	Kelly Ballard, [e-mail], [phone].
Triflusulfuron-methyl 7236	EPA-HQ-OPP-2012-0605	Matthew Manupella, [e-mail], [phone].

A single, streamlined ecological risk assessment document covering the 22 sulfonylurea chemicals listed in Table 1, as well as 22 chemical-specific human health risk assessments separately addressing the same 22 active ingredients are being made available for public review and comment. The sulfonylureas (SUs) are an established and widely used class of agricultural pesticides in the United States. They are used to control broadleaf and grassy weeds and are registered for many agricultural and non-agricultural uses. The ecological risk assessment examines risks from the SUs simultaneously but not cumulatively. The streamlined assessment for SUs will focus on the risks to plants. This single document approach is intended to increase efficiency and consistency in assessing potential risks from this class of compounds. Separate human health risk assessment documents have been generated for each of the SUs because of differences in toxicity endpoints and points of departure.

Table 2—Draft Risk Assessments Being Made Available for Public Comment—Additional Chemicals

Registration review case name and No.	Docket ID No.	Chemical review manager and contact information
Antimycin A 4121	EPA-HQ-OPP-2015-0480	Christina Scheltema, [e-mail], [phone].
Chlorpyrifos-methyl 8011	EPA-HQ-OPP-2010-0119	Joel Wolf, [e-mail], [phone].
Dicrotophos Case 0145	EPA-HQ-OPP-2008-0440	Khue Nguyen, [e-mail], [phone].
Dimethoate 0088	EPA-HQ-OPP-2009-0059	Kelly Ballard, [e-mail], [phone].
Diquat Dibromide 0288	EPA-HQ-OPP-2009-0846	Bonnie Adler, [e-mail], [phone].
Ethoprop 0106	EPA-HQ-OPP-2008-0560	Tracy Perry, [e-mail], [phone].
Fosamine ammonium 2355	EPA-HQ-OPP-2010-0215	James Parker, [e-mail], [phone].
Hexazinone 0266	EPA-HQ-OPP-2009-0755	Dana L. Friedman, [e-mail], [phone].
Methoxyfenozide 7431	EPA-HQ-OPP-2012-0663	Bonnie Adler, [e-mail], [phone].
Profenofos 2540	EPA-HQ-OPP-2008-0345	Christina Scheltema, [e-mail], [phone].
Tebufenozide 7416	EPA-HQ-OPP-2008-0824	Christina Scheltema, [e-mail], [phone].
Terbufos 0109	EPA-HQ-OPP-2008-0119	Matthew Manupella, [e-mail], [phone].
Tribufos 2145	EPA-HQ-OPP-2008-0883	Marianne Mannix, [e-mail], [phone].

Antimycin A. Draft Human Health and Ecological Risk Assessments, Preliminary Work Plan (EPA-HQ-OPP-2015-0480). Antimycin A (Fintrol®) is a restricted use pesticide registered for limited aquatic use by the U.S. National Park Service to control invasive species and restore native fish populations. EPA has completed combined scoping and preliminary human health and ecological risk assessments for Antimycin A. These assessments are limited to the current registered uses of Antimycin A in accordance with the Federal label and do not consider endangered species or endocrine effects.

Chlorpyrifos-methyl. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2010-0119). Chlorpyrifos-methyl is registered as an insecticide used to target and kill a variety of stored grain insects including beetles, weevils, moths, and grain borers. The registered uses of chlorpyrifos-methyl are limited to indoor applications made to the interior of empty grain storage bins or warehouses. EPA conducted a preliminary ecological risk assessment and effects determination and a human health risk assessment. An endangered species assessment was completed and a No Effect determination was made for all listed species, as well as a No Habitat Modification determination for all designated critical habitats for the currently registered uses of chlorpyrifos-methyl. Chlorpyrifos-methyl was not on either initial list of chemicals to be screened under the EDSP, and an endangered species assessment has not been conducted at this time.

Dicrotophos. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2008-0440). Dicrotophos is an organophosphate insecticide mainly used on cotton and ornamental trees. Dicrotophos is primarily used to target stinkbugs and tarnished plant bugs in cotton growing states. EPA published preliminary human health and ecological risk assessments in 2014 for public comment. EPA has revised its human health risk assessment by revising the Food Quality Protection Act (FQPA) safety factor and its dietary analysis. EPA has identified possible dietary risk for both adults and children, possible spray drift risks, and possible occupational handler risk from both aerial and ground application. EPA has revised its ecological risk assessment by providing additional characterization of potential ecological risk from typical application rates and average foliar residue (i.e., Kenaga) values for mammalian and bird dietary exposure. EPA identified possible ecological risks for the following taxa: Aquatic invertebrates, mammals, birds, and terrestrial invertebrates. An endangered species assessment has not been completed for dicrotophos at this time. Dicrotophos was not on the first list of chemicals for endocrine disruption screening.

Dimethoate. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2009-0059). Dimethoate is a wide spectrum systemic organophosphate insecticide. It is registered for use on a wide variety of agricultural crops, tree crops, ornamentals, and non-cropland adjacent to agricultural fields. There are no residential uses. EPA conducted a comprehensive human health risk assessment and identified potential risks of concern for dietary and occupational exposures. EPA also conducted a screening level ecological risk assessment that addressed all registered use of dimethoate. Potential risks were identified for freshwater, estuarine/marine, and terrestrial invertebrates, birds, and mammals. An endangered species assessment has not been completed for dimethoate at this time. Dimethoate was evaluated for its potential to affect endocrine systems in mammals and wildlife and the results of the agency's review are found in the Weight of Evidence review in this registration review docket.

Diquat Dibromide. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2009-0846). Diquat dibromide is a non-selective contact algicide, defoliant, desiccant, and herbicide. As an herbicide/algicide it is registered for use to control weeds in non-crop (including residential) and aquatic areas. As a desiccant/defoliant, it is registered for use on seed crops and potatoes. The Agency issued a FWP for diquat dibromide in March 2011, and data were called in. The reviews of those data are incorporated into the draft risk assessments. The ecological risk assessment identifies risk of concern for both terrestrial and aquatic organisms. The human health risk assessment identifies risks of concerns for residential and occupations handlers via inhalation, and dermal concerns for workers after application. Diquat dibromide was not on either initial list of chemicals to be screened under the Endocrine Disruptor Screening Program (EDSP), and an endangered species assessment has not been conducted at this time.

Ethoprop. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2008-0560). Ethoprop is an organophosphate, restricted use insecticide-nematicide registered for use on a variety of crops, including potatoes and sugarcane. The Agency has completed draft risk assessments for ethoprop, which identified both human health and ecological risks of concern. These assessments do not consider endangered species. Ethoprop was evaluated for its potential to affect endocrine systems in mammals and wildlife and the results of the agency's review are found in the Weight of Evidence review in this registration review docket.

Fosamine Ammonium. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2010-0215). Fosamine ammonium is an herbicide which is applied to prevent growth of undesirable seedlings and saplings of brush and vines. Fosamine ammonium is registered for use on non-agricultural rights-of way, industrial sites, fencerows, and pine plantations. It is used for general weed control in uncultivated nonagricultural areas (e.g., airports, highway, railroad and utility rights-of-way, and sewage disposal areas), uncultivated agricultural areas (e.g., non-crop producing farmyards, fuel storage areas, fencerows) and industrial sites (e.g., lumberyards, pipeline and tank farms). The Agency has conducted a human health risk assessment for fosamine ammonium. The Agency has also conducted a quantitative ecological risk assessment, which includes a screening-level listed species assessment. Fosamine ammonium was not on either initial list of chemicals to be screened under the EDSP, and an endangered species assessment has not been conducted at this time.

Hexazinone. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2009-0755). Hexazinone is a broad spectrum herbicide registered for use on food and feed crops (including alfalfa, blueberry, pineapple, sugarcane), non-food crops (including Christmas tree plantations, industrial areas, recreational areas), drainage systems, and in forestry (including conifer release, reforestation, forest trees). EPA conducted a comprehensive human health risk assessment and did not identify any risks of concern for dietary or residential exposure. Most occupational risks identified may be addressed with additional levels of personal protective equipment, though some scenarios still pose concerns considering engineering controls. EPA also conducted a preliminary ecological risk assessment that identified potential risks, mainly to terrestrial and aquatic plants. Hexazinone was not on either initial list of chemicals to be screened under the EDSP, and an endangered species assessment has not been conducted at this time.

Methoxyfenozide. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2013-0606). Methoxyfenozide is a diacylhydrazine insecticide and insect growth regulator registered for use on a variety of agricultural and non-agricultural sites. The ecological assessment indicates that methoxyfenozide has the potential for direct acute and chronic effects on listed and non-listed freshwater and estuarine/marine invertebrates. The likelihood of direct adverse effects on birds, terrestrial-phase amphibians, reptiles, mammals, fish, aquatic-phase amphibians, and terrestrial and aquatic plants as a result of registered methoxyfenozide use is expected to be low. However, taxa that depend on aquatic invertebrate species may be indirectly affected. The endangered species protection bulletin for methoxyfenozide can be found by following the links at http://www.epa.gov/​oppfead1/​endanger/​bulletins.htm). The human health risk assessment considered both current and pending proposed uses of methoxyfenozide, and the Agency concluded there were no risks of concern identified for any route or duration of exposure. Methoxyfenozide was not included in either the first or second list of chemicals to be screened for endocrine disruptor potential.

Profenofos. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2008-0345). Profenofos (Curacron®) is an organophosphate, restricted use insecticide registered for use on cotton. However, use has declined significantly since 2000, and EPA has not found any reports of use since 2011. The Agency has completed preliminary human health and ecological risk assessments for profenofos. Profenofos was not on either initial list of chemicals to be screened under the EDSP, and an endangered species assessment has not been conducted at this time.

Tebufenozide. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2008-0824). Tebufenozide (Confirm®) is an insect growth regulator registered for use on a variety of crops, mint, ornamentals, tree and nut fruit and in forestry. EPA has completed preliminary human health and ecological risk assessments for tebufenozide. Tebufenozide was not on either initial list of chemicals to be screened under the EDSP, and an endangered species assessment has not been conducted at this time.

Terbufos. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2008-0119). Terbufos is a systemic organophosphate insecticide-nematicide used to control a variety of pests on corn (field and sweet corn), grain sorghum, and sugar beets. EPA conducted a dietary and occupational human health risk assessment. The agency identified dietary and occupational risks. EPA also conducted a comprehensive ecological risk assessment and found risks to both aquatic and terrestrial animals. Endangered species, EDSP and pollinator assessments have not been completed for terbufos at this time.

Tribufos. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2008-0883). Tribufos is an organophospate chemical used as a pre-harvest desiccant on cotton. The Environmental Protection Agency conducted comprehensive human health and ecological risk assessments, which identified human health and ecological risks. Tribufos was not on either initial list of chemicals to be screened under the EDSP, and an endangered species assessment has not been conducted at this time.

Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, through this notice of availability, for interested parties to provide comments and input concerning the Agency's draft human health and ecological risk assessments for the pesticides identified in this document. Such comments and input could address, among other things, the Agency's risk assessment methodologies and assumptions, as applied to this draft risk assessment. The Agency will consider all comments received during the public comment period and make changes, as appropriate, to the draft human health and ecological risk assessment. EPA will then issue a revised risk assessment, explain any changes to the draft risk assessment, and respond to comments. In the Federal Register notice announcing the availability of the revised risk assessment, if the revised risk assessment indicates risks of concern, the Agency may provide a comment period for the public to submit suggestions for mitigating the risk identified in the revised risk assessment before developing a proposed registration review decision on the pesticides identified in this document.

1. Other related information. Additional information on the pesticides identified in this document is available on the Pesticide Registration Review Status Web page. Information on the Agency's registration review program and its implementing regulation is available at http://www.epa.gov/​oppsrrd1/​registration_​review.

2. Information submission requirements. Anyone may submit data or information in response to this document. To be considered during a pesticide's registration review, the submitted data or information must meet the following requirements:

• To ensure that EPA will consider data or information submitted, interested persons must submit the data or information during the comment period. The Agency may, at its discretion, consider data or information submitted at a later date.
• The data or information submitted must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.
• Submitters must clearly identify the source of any submitted data or information.
• Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.

As provided in 40 CFR 155.58, the registration review docket for each pesticide case will remain publicly accessible through the duration of the registration review process; that is, until all actions required in the final decision on the registration review case have been completed.

Authority: 7 U.S.C. 136 et seq.

Dated: September 21, 2015.

Richard P. Keigwin, Jr.,

Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs.