Environmental Protection Agency (EPA).
Final rule; technical correction.
EPA issued a final rule in the Federal Register of April 9, 2008 (73 FR 19147) (FRL-8357-5), concerning 1-methylcyclopropene (1-MCP); amendment to an exemption from the requirement of a tolerance. This document is being issued to correct a technical error, specifically the omission of addressing the comments received after the publication of the notice of filing on August 8, 2007 (72 FR 44520) (FRL-8138-9).
This final rule is effective July 30, 2008.
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0511. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Driss Benmhend, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9525; e-mail address: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
I. General Information
A. Does this Action Apply to Me?
The Agency included in the final rule a list of those who may be potentially affected by the action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under the FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document and Other Related Information?
In addition to using regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr.
II. What Does this Correction Do?
On page 19148, under “II. Background and Statutory Findings”, the last sentence of paragraph one, “There were no comments received in response to the notice of filing”, is corrected to read as follows:
After the publication of the notice of filling, the following comments were received and reviewed by the Agency:
The first set of comments raised concerns that the Agency may not have completely assessed the safety of the active ingredient for its new outdoor use, especially with regard to its fate and behavior in the outdoor environment. The second set of comments addressed the potential negative effects on human health as a result of the new use of 1-MCP for pre-harvest treatments on fruits and vegetables.
The active ingredient, 1-methylcyclopropene, has been completely assessed by the Agency for its potential for adverse environmental effects, particularly in regard to non-target organisms, including threatened and endangered species. Its effects on the environment (if any) are directly related to its mode of action as an ethylene inhibitor in plants. Animals have no ethylene receptors and, therefore, it is highly unlikely that 1-MCP would have any adverse effects on animals. Furthermore, the product is applied at extremely low rates. The maximum use rate permitted on the product label is approximately 0.28 lbs (121.4 g) of 1-MCP/acre.
1-MCP is a volatile gas. When dissolved in water and applied to field crops and orchards, 1-MCP will rapidly volatilize from plant and soil surfaces and its effects will be confined to the plant tissues to which it has been directly applied. Once in the atmosphere, it will be rapidly diluted and degraded by sunlight and reaction with hydroxyl molecules within approximately 6.4 hours master record identification number ((MRIDs) 471082-06 & 471082-07). A study by the European Food and Safety Authority concurs with EPA's conclusion, and has estimated an atmospheric half-life of 1-MCP to be about 4.4 hours (EFSA, 2005).
A study on soil leaching (MRID 47108204) demonstrated that more than Start Printed Page 4415797% of applied 1-MCP was bound rapidly and tightly to the surfaces of four different soil types, and that no 1-MCP was detected in the soil leachates. This study indicates that 1-MCP has extremely low mobility in the soil and that it is highly unlikely that it will move into ground water. Modeling of potential runoff into surface waters using the generic expected environmental concentration (GENEEC) 2, shows that the maximum potential concentration of 1-MCP in surface waters following runoff would not exceed approximately 25 ppb.
With regard to the potential exposure and effects on human health as a result of the newly approved usage of 1-MCP in pre-harvest treatments, the applicant submitted extensive guideline animal studies. These studies were conducted using doses much greater than any measured or estimated environmental concentration of 1-MCP following applications at the maximum allowable label rate. EPA reviews of these studies concluded that 1-MCP has no adverse effects on any animal organism tested. These reviews are discussed in detail in the April 9, 2008 Federal Register document (73 FR 19147).
Furthermore, based on the nature of residue studies (D339988, MRIDs 47088611-12 & 47108203, field residue studies demonstrate that environmental concentrations of 1-MCP will be extremely low following applications at the maximum allowable product label use rate. When the product was applied to apple trees at the maximum product label use rate 0.28 lbs (121.4 g) 1-MCP/acre, 1-MCP residues ranged from 3 to 4 parts per billion (ppb) on apple fruits, at 3 to 7 days post-treatment; 212 to 379 ppb on apple leaves at 3 to 30 days post-treatment; and 17 ppb in the upper 2 centimeter of soil below the tree at 1 day post-treatment
The Agency does not expect any human health concerns or negative effect on non-target organisms including endangered species, from exposure to residues of 1-MCP when applied or used as directed on the label and in accordance with good agricultural practices.
III. Why is this Correction Issued as a Final Rule?
Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's technical correction final without prior proposal and opportunity for comment, because EPA is merely responding to comments that were not addressed in the previously published final rule. The comments received and reviewed do not affect EPA's decision for establishing an amendment to the tolerance exemption for the use 1-MCP for pre-harvest treatment. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).
IV. Do Any of the Statutory and Executive Order Reviews Apply to this Action?
No. The applicable statutory and Executive order reviews were included in the April 8, 2008 Federal Register document. This document is a technical correction and as such no new reviews are applicable.
V. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).Start List of Subjects
List of Subjects in 40 CFR Part 180
- Environmental protection
- Administrative practice and procedure
- Agricultural commodities
- Pesticides and pests
- R eporting and Recordkeeping Requirements
Dated: July 23, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.
[FR Doc. E8-17478 Filed 7-29-08; 8:45 am]
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