Aquashade, Nithiazine, d-limonene, and 2H-Cyclopent(d)isothiazol-3(4H)-one, 5,6-dihydro-2-methyl- (MTI) Registration Review Interim Decisions; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's interim registration review decisions for the pesticides aquashade, nithiazine, d-limonene, and 2H-Cyclopent(d)isothiazol-3(4H)-one, 5,6-dihydro-2-methyl- (MTI). 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, that the pesticide can perform its intended function without causing unreasonable adverse effects on human health or the environment. 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.

FOR FURTHER INFORMATION CONTACT:

For pesticide specific information, contact: The Chemical Review Manager for the pesticide of interest identified in the Table in Unit II. For general information 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 workers, 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 pesticide specific contact person listed in the Table in Unit II.

FOR FURTHER INFORMATION CONTACT:

B. How can I get copies of this document and other related information?

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0393 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

Pursuant to 40 CFR 155.58(c), this notice announces the availability of EPA's interim registration review decision for the pesticides found in the Table in this unit.

Aquashade (Interim Decision). Aquashade is as an aquatic herbicide whose mode of action is light filtration. It is primarily used in small water bodies like ornamental ponds and small lakes, fountains and other landscaping water features, swimming holes, aquaculture ponds, and animal watering holes. The Ecological Risk Assessment found no level of concern risk exceedances to all taxa. The Human Health Risk Assessment also indicated no risk (dietary, residential, and occupational). Aquashade 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. No mitigation is proposed at this time. The Agency's final registration review decision is dependent upon the assessment of risks to threatened and endangered species and after an EDSP Federal Food, Drug and Cosmetic Act (FFDCA) Section 408(p) determination has been made.

Nithiazine (Interim Decision). The Nithiazine Summary Document was published on March 18, 2009. Nithiazine is used as part of a bait station to control flies in animal housing facilities and other industrial operations. The structure of the bait station makes contact between nithiazine and humans unlikely; therefore, there are no human health risk concerns for nithiazine. Since the active ingredient is contained in a bait station, no ecological exposure is expected. Therefore, there are no ecological risk concerns for nithiazine. Nithiazine does not pose a threat to pollinators and the Agency has determined that it will cause No Effect to listed species. The Agency has determined that no additional data are required at this time to support the continuing registrations of nithiazine products. The final decision on the registration review for nithiazine will occur after an EDSP FFDCA section 408(p) determination has been made.

d-Limonene (Interim Decision). The registration review docket for d-limonene opened in September 2010. d-Limonene is a naturally occurring chemical obtained from the rind of citrus fruits. It is registered for use as an acaricide, insecticide, herbicide, insect repellent, and is used as an inert ingredient for scent and flavoring in other non-pesticide products. d-Limonene is currently registered for use in/on food crops (citrus, pome fruits, grapes), feed crops, non-food crops (ornamentals, Christmas trees, fencerows, recreational areas, wood protection) and for residential uses. EPA published the draft human health and ecological risk assessments in December 2014. A qualitative human health assessment was conducted, and the Agency concluded that d-limonene does not pose a risk to human health. A quantitative ecological risk assessment was conducted and levels of concern were exceeded for terrestrial plants and mammals (risks to birds and terrestrial invertebrates could not be precluded). The Agency is requiring modifications to several labels to reduce potential risks of d-limonene to terrestrial birds and mammals. In addition, the Agency will make several modifications to 40 CFR part 180. The Agency will establish an exemption for the herbicidal uses of d-limonene from a tolerance under subpart D, and existing exemption from tolerances from the repellant uses of d-limonene under 180.539 subpart C will be moved to subpart D for insecticidal uses. This Interim Decision does not cover the EDSP component of this registration review case, nor does it include a complete endangered species assessment or pollinator risk assessment. The Agency's final registration review decision is dependent upon the assessment of risks to threatened and endangered species and pollinators as well as a determination under FFDCA Section 408(p) regarding endocrine disruption.

2H-Cyclopent(d)isothiazol- 3(4H)-one, 5,6-dihydro-2- methyl- (Interim Decision). There is one EPA registered product containing active ingredient 2H-Cyclopent(d)isothiazol-3(4H)-one, 5,6- dihydro-2- methyl-, also known as MTI. MTI is a materials preservative for use in the manufacture of aqueous compositions used in the manufacture of imaging products. The Agency did not require any additional data in support of MTI's registration review or need to conduct human health or environmental risk assessments due to the lack of exposure concerns for MTI's registered use. Based on the lack of potential exposure, the Agency made a “no effect” determination for listed species under the Endangered Species Act (ESA). Except for the EDSP component of the MTI registration review case, the Agency is not requiring additional data and is not proposing any risk reduction measures for this case. The final decision on the registration review for MTI will occur after the EDSP FFDCA section 408(p) determination is made.

Pursuant to 40 CFR 155.57, a registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA has considered the pesticides found in the Table in this unit in light of the FIFRA standard for registration. The Interim Decision document in the dockets describes the Agency's rationale for issuing a registration review interim decision for these pesticides.

In addition to the interim registration review decision documents, the registration review dockets for the pesticides listed in the Table in this unit also includes other relevant documents related to the registration review of these cases. The proposed interim registration review decisions were posted to the docket and the public was invited to submit any comments or new information.

EPA addresses the comments or information received during the 60-day comment period in the discussion for each pesticide listed in this document. During the 60-day comment period, no public comments were received for aquashade, nithiazine, or 2H-Cyclopent(d)isothiazol- 3(4H)-one, 5,6-dihydro-2- methyl (MTI). Comments were received for d-limonene however the public comments received were not substantive and did not affect the Agency's interim decision.

Pursuant to 40 CFR 155.58(c), the registration review case docket for the pesticides listed in the Table in Unit II will remain open until all actions required in the interim decisions have been completed.

Background on the registration review program is provided at: https://www.epa.gov/pesticide-reevaluation/registration-review-process. Links to earlier documents related to the registration review of these pesticides are provided in the pesticide chemical search data base accessible at https://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1.

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