[Federal Register: April 25, 2007 (Volume 72, Number 79)]
[Rules and Regulations]
[Page 20436-20439]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap07-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0224; FRL-8121-2]
Propiconazole; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of propiconazole and its metabolites containing the
dichlorobenzoic acid (DCBA) moiety expressed as parent compound, in or
on peach and nectarine. This action is in response to EPA's granting of
emergency exemptions under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on peach and nectarine as a post-harvest treatment. This regulation
establishes maximum permissible levels for residues of propiconazole in
these food commodities. The tolerances expire and are revoked on
December 31, 2010.
DATES: This regulation is effective April 25, 2007. Objections and
requests for hearings must be received on or before June 25, 2007, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0224. 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 web site 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., 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 telephone number
is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9356; e-mail address: conrath.andrea@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.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. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2007-0224 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before June 25, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0224, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted
during the Docket's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday,
[[Page 20437]]
excluding legal holidays). Special arrangements should be made for
deliveries of boxed information. The Docket telephone number is (703)
305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for combined residues of the
fungicide propiconazole, and its metabolites containing the
dichlorobenzoic acid (2,4-DCBA) moiety expressed as parent compound, in
or on peach and nectarine at 2.0 parts per million (ppm). These
tolerances expire and are revoked on December 31, 2010. EPA will
publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations (CFR).
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Propiconazole as a Post-Harvest Treatment
on Peach and Nectarine and FFDCA Tolerances
The applicant states that market demands have required producers to
change storage practices for peaches and nectarines, and allow a pre-
ripening time of 48 hours at 68[deg]F to enhance fruit quality, prior
to placing the fruit in cold storage at 32[deg]F. This extra step has
inadvertently fostered increased incidence of sour rot which has caused
significant losses to growers. The current storage conditions used were
developed to improve fruit quality and satisfy customer demands;
returning to previous storage conditions would not result in acceptable
fruit quality for the industry or consumer. Without the ability to
adequately manage sour rot, economic data provided indicates that
significant economic losses will occur. EPA has authorized under FIFRA
section 18 the use of propiconazole on peach and nectarine as a post-
harvest treatment, for control of sour rot in California. After having
reviewed the submission, EPA concurs that emergency conditions exist
for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of propiconazole in or on
peach and nectarine. In doing so, EPA considered the safety standard in
section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of the FFDCA would be consistent with
the safety standard and with FIFRA section 18. Consistent with the need
to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment as provided in section 408(l)(6) of the
FFDCA. Although these tolerances expire and are revoked on December 31,
2010, under section 408(l)(5) of the FFDCA, residues of the pesticide
not in excess of the amounts specified in the tolerances remaining in
or on peach and nectarine after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
these tolerances at the time of that application. EPA will take action
to revoke these tolerances earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether propiconazole
meets EPA's registration requirements for use on peach and nectarine as
a post-harvest treatment or whether permanent tolerance for these uses
would be appropriate. Under these circumstances, EPA does not believe
that these tolerances serve as bases for registration of propiconazole
by a State for special local needs under section 24(c) of FIFRA. Nor do
these tolerances serve as the basis for any State other than California
to use this pesticide on these crops under section 18 of FIFRA without
following all provisions of EPA's regulations implementing FIFRA
section 18 as identified in 40 CFR part 166. For additional information
regarding the emergency exemption for propiconazole, contact the
Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
Consistent with section 408(b)(2)(D) of the FFDCA , EPA has
reviewed the available scientific data and other relevant information
in support of this action. EPA has sufficient data to assess the
hazards of propiconazole and to make a determination on aggregate
exposure, consistent with section 408(b)(2) of the FFDCA, for time-
limited tolerances for combined residues or residues of propiconazole
in or on peach and nectarine at 2.0 ppm. While this post-harvest use
under section 18 is not expected to result in residues exceeding 1.0
ppm, there is a pre-harvest use registered for use on stone fruit
(includes peach and nectarine) for which a permanent tolerance is
[[Page 20438]]
established at 1.0 ppm. Therefore, EPA does not expect total residues
from both of these uses to exceed 2.0 ppm in or on peach and nectarine.
On September 22, 2006 the Agency published a Final Rule (71 FR
55300, FRL-8092-1) establishing tolerances for combined residues of
propiconazole and its metabolites containing the dichlorobenzoic acid
(2,4-DCBA) moiety expressed as parent compound, in or on various
commodities; and inadvertent residues in or on alfalfa, forage, and
alfalfa, hay. When the Agency conducted the risk assessments in support
of these tolerance actions it assumed that propiconazole residues would
be present on peach and nectarine at 2.0 ppm, in association with this
section 18 post-harvest use and the already registered pre-harvest use
(for which there is a permanent tolerance established at 1.0 ppm), as
well as on all foods covered by the proposed and established
tolerances. Residues on peach and nectarine were included because there
was a pending emergency exemption application under the Federal
Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq., for
emergency post-harvest use on these commodities. Therefore,
establishing the peach and nectarine tolerances will not change the
most recent estimated aggregate risks resulting from use of
propiconazole, as discussed in the September 22, 2006 Federal Register.
Refer to the September 22, 2006 Federal Register document, and its
associated docket EPA-HQ-OPP-2006-0347, for a detailed discussion of
the aggregate risk assessments and determination of safety. EPA relies
upon those risk assessments and the findings made in the Federal
Register document in support of this action.
Based on the risk assessments discussed in the final rule published
in the Federal Register of September 22, 2006, EPA concludes that there
is a reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
propiconazole residues. The September 22, 2006 final rule contains a
docket that has a risk assessment that describes the exposure and
safety findings in detail.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (a gas chromatography (GC) method
using electron capture detection (Method AG-454) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
The Codex Alimentarious Commission has established a maximum
residue limit (MRL) for propiconazole in/on stone fruit, which includes
peach and nectarine, at 1.0 ppm, expressed in terms of propiconazole
per se. In addition, Canada has established MRLs on peach and nectarine
of 1.0 ppm, expressed as propiconazole and its metabolites including
the 2,4-DCBA moiety. As discussed above, there is a permanent U.S.
tolerance set at 1.0 ppm for the stone fruit crop group, in association
with a registered pre-harvest use. Therefore, to the extent possible,
the U.S. tolerances are numerically harmonized with Codex and Canada.
However, this section 18 emergency use represents a difference in the
use pattern and the supporting residue data indicates a tolerance of
2.0 ppm will be necessary to cover total residues which may occur as a
result of both the registered pre-harvest use, as well as this section
18 post-harvest use. A summary of Codex MRLs, Canadian MRLs, and
Mexican tolerances and the corresponding U.S. tolerances for
propiconazole is discussed at http://www.regulations.gov Docket No.
EPA-HQ-OPP-2006-0347-0004; pages 53-54.
VI. Conclusion
Therefore, the tolerances are established for combined residues of
propiconazole, and its metabolites containing the dichlorobenzoic acid
(DCBA) moiety expressed as parent compound in or on peach and nectarine
at 2.0 ppm.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000) do not apply to this rule. In addition, This rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. 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
[[Page 20439]]
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: April 12, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.434 is amended by adding text and table to paragraph (b)
to read as follows:
Sec. 180.434 Propiconazole; tolerances for residue.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of propiconazole (1-[[2-(2,4-dichlorophenyl)-
4-propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole) and its
metabolites determined as 2,4-dichlorobenzoic acid and expressed as
parent compound, in connection with use of the pesticide under section
18 emergency exemptions granted by EPA. The tolerances will expire and
are revoked on the dates specified in the following table:
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Expiration/revocation
Commodity Parts per million date
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Nectarine................... 2.0 12/31/2010
Peach....................... 2.0 12/31/2010
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[FR Doc. E7-7678 Filed 4-24-07; 8:45 am]
BILLING CODE 6560-50-S