Aldicarb, Bensulide, Coumaphos, Ethalfluralin, and Pirimiphos-methyl Registration Review; Draft Human Health and Ecological Risk Assessments; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's draft human health risk and draft ecological risk assessments for aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl and opens a public comment period on these documents. 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 draft human health and ecological risk assessments for all aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl uses. After reviewing comments received during the public comment period, EPA will 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 aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl. Through this program, EPA is ensuring that each pesticide's registration 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 June 27, 2016.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0794, 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 1of 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: (703) 308-8015; email address: dumas.richard@epa.gov.

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 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 its registration review of aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA 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 pesticide registration for aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl to ensure that it continues to satisfy the FIFRA standard for registration—that is, that aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl can still be used without unreasonable adverse effects on human health or the environment.

Aldicarb. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2012-0161). Aldicarb is a systemic carbamate insecticide, acaricide, and nematicide registered for use on cotton, dry beans, peanuts, soybeans, sugar beets, and sweet potatoes. It is not registered for non-agricultural/residential use. EPA conducted a comprehensive human health risk assessment including a highly refined acute dietary exposure assessment for all existing food uses of aldicarb. Acute dietary exposure estimates for drinking water as well as food and drinking water combined are of concern. A commodity specific analysis (CSA) was conducted to obtain estimates of acute exposure and risk following a single consumption of a single commodity. Exposure estimates were above the level of concern for children following consumption of sweet potatoes or potatoes. Additionally, there are short- and intermediate-term occupational handler risk estimates of concern for the registered uses of aldicarb with label-specified personal protective equipment. EPA also conducted a screening level ecological risk assessment and identified potential risks to both aquatic and terrestrial non-target organisms. The assessments did not cover the EDSP component of this registration review case, nor does it include a full pollinator assessment or a complete endangered species assessment.

Bensulide. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2008-0022). Bensulide is a systemic organophosphate herbicide registered to control grasses and broadleaf weeds in a variety of agricultural (e.g., lettuce, cantaloupe, broccoli) and non-agricultural (golf course, turf farm, residential lawn, rights-of-way, and landscaping) settings, and is usually applied to bare ground before crops are planted. EPA conducted a comprehensive human health risk assessment and identified risks of concern for dietary, residential, occupational, and spray drift exposures. The bensulide risk assessment retained the FQPA 10x safety factor due to the uncertainty in the human dose-response relationship for neuro-developmental effects. EPA also conducted an ecological risk assessment for bensulide, which identified risks of concern for non-listed species for birds, reptiles, and terrestrial-phase amphibians; mammals; freshwater fish and aquatic-phase amphibians; marine/estuarine fish; freshwater invertebrates; and aquatic vascular plants. Neither an endangered species assessment nor a pollinator assessment been completed for bensulide at this time. Bensulide is on the second list of chemicals for tier one screening under the Endocrine Disruptor Screening Program (EDSP).

Coumaphos. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2008-0023). Coumaphos is an organophosphate acaricide. It is used to control ticks and mites on livestock, as well as to control varroa mites and small hive beetles in beehives. The human health risk assessment for coumaphos found dietary risks of concern, with food (beef meat) being the driver in the steady state risk estimates. In addition, almost all of the occupational exposure scenarios show risks of concern for both dermal and inhalation routes of exposure at varying levels of personal protection equipment and all formulations with the exception of liquid. The coumaphos risk assessment retained the FQPA 10x safety factor due to the uncertainty in human dose-response relationship for neuro-developmental effects. Coumaphos is expected to pose an acute risk to birds. Coumaphos is not expected to pose a risk to endangered or non-endangered mammals because of its limited use pattern. Coumaphos usage on cattle may pose a high acute risk to aquatic invertebrates. Coumaphos is not expected to pose chronic or acute risks to listed or non-listed fish. Neither a comprehensive endangered species assessment nor a pollinator assessment has been completed for coumaphos at this time. Coumaphos is on the second list of chemicals for Tier 1 screening under EDSP.

Ethalfluralin. Draft Human Health and Ecological Risk Assessments (EPA-HQ-OPP-2011-0094). Ethalfluralin is a preemergence herbicide used to control a variety of annual grasses and broadleaf weeds on agricultural sites. Ethalfluralin has multiple end-use products that are registered for use on various agricultural crops. EPA conducted a comprehensive human health risk assessment and did not identify any risks of concern. EPA also conducted an ecological risk assessment. Potential risks to aquatic animals, aquatic and terrestrial plants, and mammals were identified. The assessments did not cover the EDSP component of this registration review case, nor does it include either a full pollinator assessment or a complete endangered species assessment.

Pirimiphos-methyl. Draft Human Health Risk and Ecological Assessments (EPA-HQ-OPP-2009-0056). Pirimiphos-methyl is a member of the organophosphate class of pesticides. Currently, it is registered for use as an insecticide in cattle ear tags, and on post-harvest stored grain/seeds (sorghum and corn). There are two special local need FIFRA section 24(c) registrations: A fogger treatment on iris bulbs in Washington, and a fogger and drench treatment on gladiola bulbs in Michigan. EPA conducted a human health risk assessment, and did not identify any risks of concern for dietary or residential exposures. However, risks of concern were identified for occupational exposure and for all handler scenarios. The pirimiphos-methyl risk assessment retained the FQPA 10x safety factor due to the uncertainty in human dose-response relationship for neuro-developmental effects. EPA also conducted a quantitative ecological risk assessment and identified potential risks to terrestrial and aquatic invertebrates. A complete endangered species assessment nor a pollinator assessment has been completed for pirimiphos-methyl. The assessments did not cover the EDSP component of this registration review case.

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 aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl. 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 assessments. 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 aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl.

1. Other related information. Additional information on aldicarb, bensulide, coumaphos, ethalfluralin, and pirimiphos-methyl is available on the Agency's registration review program and its implementing regulation is available at https://www.epa.gov/pesticide-reevaluation.

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.