[Federal Register Volume 73, Number 147 (Wednesday, July 30, 2008)]
[Rules and Regulations]
[Pages 44156-44157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17478]
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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: [email protected].
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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