Document ID: EPA-HQ-OPP-2008-0511-0001
Agency: epa
Document Type: Rule
Title: 1-Methylcyclopropene; Pesticide Tolerance; Technical Correction
Posted Date: 2008-07-30T04:00Z

[Federal Register: July 30, 2008 (Volume 73, Number 147)]
[Rules and Regulations]               
[Page 44156-44157]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy08-12]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0511; FRL-8372-9]

 
1-Methylcyclopropene; Pesticide Tolerance; Technical Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION:  Final rule; technical correction.

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SUMMARY: 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).

DATES: This final rule is effective July 30, 2008.

ADDRESSES:  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.

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: benmhend.driss@epa.gov.

SUPPLEMENTARY 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?

    The final rule, identified as FR Doc. E8-7458 that was published in 
the Federal Register of April 9, 2008 (73 FR 19147) (FRL-8357-5) is 
corrected as follows:
    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

[[Page 44157]]

97% 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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting 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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