Paraquat Dichloride; Proposed Interim Mitigation Decision; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's proposed interim mitigation decision for paraquat dichloride (paraquat) and opens a public comment period on this proposed interim mitigation decision. 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 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. EPA may pursue mitigation at any time during the registration review process if it finds that a pesticide poses unreasonable adverse effects to human health or the environment. Based on the number and severity of paraquat human health incidents, the EPA believes that the mitigation measures outlined in this proposed interim mitigation decision are necessary to address identified human health risk concerns.

DATES:

Comments must be received on or before May 9, 2016.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2011-0855, 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: Marianne Mannix, Chemical Review Manager, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 703-347-0275; email address: Mannix.marianne@epa.gov.

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 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 under FOR FURTHER INFORMATION CONTACT.

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.

II. What action is the agency taking?

Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's proposed interim mitigation decision for paraquat, and opens a 60-day public comment period on the proposed interim mitigation decision. Paraquat is a widely used broad spectrum herbicide for the control of weeds in many agricultural and non-agricultural settings, and is also used as a defoliant on crops, prior to harvest. It is classified as restricted use due to high toxicity. An estimated 1.5 tsp can be lethal if ingested and there is no known antidote. Paraquat dichloride is associated with a disproportionately high number of incidents including accidental ingestions typically leading to fatalities as well as occupational spills, splashes, and leaks resulting in severe and often damaging dermal or ocular contact. Paraquat is known to be corrosive to skin and eyes. EPA recently reviewed all available incident information and determined that mitigation measures to address these human health risk concerns are necessary. EPA has had some discussions with the paraquat technical registrants that suggest that the mitigation measures could be adopted voluntarily by pesticide manufacturers.

The registration review docket for a pesticide includes earlier documents related to the registration review of the case along with supporting materials for this proposed interim mitigation decision. Following public comment, the Agency will issue a final interim mitigation decision for products containing paraquat. Notwithstanding this action, paraquat is still undergoing registration review. Within the next several years, EPA anticipates conducting comprehensive draft human health and ecological risk assessments for paraquat, followed by a proposed registration review decision, all of which will be posted for public comment.

The registration review program is being conducted under congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public. Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136a(g)) required EPA to establish by regulation procedures for reviewing pesticide registrations, originally with a goal of reviewing each pesticide's registration every 15 years to ensure that a pesticide continues to meet the FIFRA standard for registration. The Agency's final rule to implement this program was issued in August 2006 and became effective in October 2006, and appears at 40 CFR part 155, subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA) was amended and extended in September 2007. FIFRA, as amended by PRIA in 2007, requires EPA to complete registration review decisions by October 1, 2022, for all pesticides registered as of October 1, 2007.

The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed interim mitigation decision. All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. These comments will become part of the docket for paraquat. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

The Agency will carefully consider all comments received by the closing date and will provide a “Response to Comments Memorandum” in the docket. The final interim mitigation decision will explain the effect that any comments had on the final decision and provide the Agency's response to significant comments.

Background on the registration review program is provided at: http://www2.epa.gov/pesticide-reevaluation. Links to earlier documents related to the registration review of paraquat are provided at: http://www.epa.gov/ingredients-used-pesticide-products/paraquat.

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