Dicloran and Formetanate; Proposed Tolerance Actions, 18748-18752 [2012-7445]
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Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules
VI. Technical Amendments
The Office will adopt technical
amendments as needed to conform
existing regulations to the changes
proposed in this notice.
VII. Request for Comments
The Copyright Office is publishing the
proposed new fee schedule to provide
the public with an opportunity to
comment. The Office anticipates
implementation of the new fees with the
beginning of the new fiscal year,
October 1, 2012.
Dated: March 21, 2012.
Maria A. Pallante,
Register of Copyrights.
[FR Doc. 2012–7428 Filed 3–27–12; 8:45 am]
BILLING CODE P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0507; FRL–9340–9]
RIN 2070–ZA16
Dicloran and Formetanate; Proposed
Tolerance Actions
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to revoke
certain tolerances for the fungicide
dicloran and the insecticide formetanate
hydrochloride because, in follow-up to
voluntary requests from registrants,
domestic registrations were voluntarily
amended to delete specific uses, leaving
no dicloran and formetanate
hydrochloride registrations for those
uses. Also, in accordance with current
Agency practice, EPA is proposing to
make minor revisions to the tolerance
expressions for dicloran and
formetanate hydrochloride and to
specific tolerance nomenclatures for
dicloran.
SUMMARY:
Comments must be received on
or before May 29, 2012.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2011–0507, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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
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DATES:
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Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2011–
0507. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
email. The regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
regulations.gov, your email address will
be automatically captured and included
as part of the comment that is placed in
the docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., 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 https://
www.regulations.gov, or, if only
available in hard copy, at the 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
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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:
Joseph Nevola, Pesticide Re-evaluation
Division (7508P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (703) 308–8037; email address:
nevola.joseph@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. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit II.A. 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. 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
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will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
C. What can I do if I wish the Agency
to maintain a tolerance that the Agency
proposes to revoke?
This proposed rule provides a
comment period of 60 days for any
person to state an interest in retaining
a tolerance proposed for revocation. If
EPA receives a comment within the 60day period to that effect, EPA will not
proceed to revoke the tolerance
immediately. However, EPA will take
steps to ensure the submission of any
needed supporting data and will issue
an order in the Federal Register under
the Federal Food, Drug, and Cosmetic
Act (FFDCA) section 408(f), if needed.
The order would specify data needed
and the timeframes for its submission,
and would require that within 90 days
some person or persons notify EPA that
they will submit the data. If the data are
not submitted as required in the order,
EPA will take appropriate action under
FFDCA.
EPA issues a final rule after
considering comments that are
submitted in response to this proposed
rule. In addition to submitting
comments in response to this proposed
rule, you may also submit an objection
at the time of the final rule. If you fail
to file an objection to the final rule
within the time period specified, you
will have waived the right to raise any
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issues resolved in the final rule. After
the specified time, issues resolved in the
final rule cannot be raised again in any
subsequent proceedings.
II. Background
A. What action is the Agency taking?
EPA is proposing to revoke the potato
tolerance for the fungicide dicloran and
the apple, peach, and pear tolerances for
the insecticide formetanate
hydrochloride.
EPA is proposing the tolerance
revocations in follow-up to the Agency’s
approval (as described in Unit II.A.) of
voluntary requests from registrants to
amend dicloran and formetanate
product labels to delete uses for specific
food commodities. Also, in accordance
with current Agency practice, EPA is
proposing to make minor revisions to
the tolerance expression for dicloran
and to specific tolerance nomenclatures
for dicloran. In addition, in accordance
with current Agency practice to describe
more clearly the measurement and
scope or coverage of the tolerances,
including applicable metabolites and
degradates, EPA is proposing minor
revisions to the tolerance expression for
formetanate hydrochloride. The
revisions do not substantively change
the tolerance or, in any way, modify the
permissible level of residues permitted
by the tolerance. It is EPA’s general
practice to propose revocation of those
tolerances for residues of pesticide
active ingredients on crop uses for
which there are no active registrations
under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), unless someone submits
comments on the proposed rule
indicating a need for the tolerance to
cover residues in or on imported
commodities or legally treated domestic
commodities. The following discussion
explains the specific changes and the
reasons for the changes.
1. Dicloran. Because it is no longer
Agency practice to distinguish between
preharvest and postharvest applications
in the tolerance expression, in 40 CFR
180.200, EPA is proposing to remove
paragraph (a)(2), redesignate paragraph
(a)(1) as paragraph (a), and revise the
introductory text containing the
tolerance expression in newly
designated paragraph (a) by removing
the reference concerning preharvest and
postharvest applications, to read as set
out in the proposed regulatory text at
the end of this document.
Also, in the Federal Register of
December 1, 2010 (75 FR 74714) (FRL–
8854–3), EPA published a notice of
receipt of requests to voluntarily amend
certain dicloran (DCNA) registrations to
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delete the use for potato, and therefore
terminate the last registrations for use of
dicloran in or on potato. In the Federal
Register of November 16, 2011 (76 FR
71022) (FRL–8883–8), EPA approved
the cancellation order for amendments
to terminate product uses and allowed
registrants to sell and distribute existing
stocks of the affected products until
November 16, 2012. The Agency
allowed persons other than the
registrant to sell, distribute, or use
existing stocks of the affected products
until they are exhausted, provided that
it complies with the EPA approved
labeling. Recently, the registrant has
been in further communication with the
Agency, and based on the information
provided, EPA believes that existing
stocks are likely to be exhausted by
December 31, 2014. Therefore, EPA is
proposing to revoke the tolerance in
newly designated 40 CFR 180.200(a) on
potato with an expiration/revocation
date of December 31, 2014.
In addition, because it is no longer
Agency practice to distinguish between
preharvest and postharvest applications
in the tolerance definitions, EPA is
proposing to revise the commodity
terminology in newly designated 40
CFR 180.200(a) from ‘‘apricot,
postharvest’’ to ‘‘apricot,’’ ‘‘carrot, roots,
postharvest’’ to ‘‘carrot, roots,’’ ‘‘cherry,
sweet, postharvest,’’ to ‘‘cherry, sweet,’’
‘‘nectarine, postharvest’’ to ‘‘nectarine,’’
‘‘peach, postharvest,’’ to ‘‘peach,’’
‘‘plum, prune, fresh, postharvest’’ to
‘‘plum, prune, fresh,’’ and ‘‘sweet
potato, postharvest,’’ to ‘‘sweet potato,
roots.’’
2. Formetanate hydrochloride. In the
Federal Register of July 13, 2011 (76 FR
41250) (FRL–8879–7), EPA published a
notice of receipt of requests to
voluntarily amend certain formetanate
registrations to delete uses for apple,
peach, and pear, and therefore terminate
the last registrations for use of
formetanate hydrochloride in or on
those commodities. In the Federal
Registers of September 14, 2011 (76 FR
56753) (FRL–8888–2) and November 16,
2011 (76 FR 71021) (FRL–9327–1), EPA
approved the cancellation order for
amendments to terminate product uses
and amended the order to allow
registrants to sell and distribute existing
stocks of the affected products until
January 31, 2012 (which extended the
deadline by 60 days beyond that
previously allowed in the September 14,
2011 cancellation order). The Agency
allowed persons other than the
registrant to sell, distribute, or use
existing stocks of the affected products
until December 31, 2013. Therefore,
EPA is proposing to revoke the
tolerances in 40 CFR 180.276(a) on
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apple; apple, wet pomace; peach; and
pear with expiration/revocation dates of
December 31, 2013.
In order to describe more clearly the
measurement and scope or coverage of
the tolerances, EPA is proposing to
revise the introductory text containing
the tolerance expression in 40 CFR
180.276(a) to read as set out in the
proposed regulatory text at the end of
this document.
B. What is the agency’s authority for
taking this action?
A ‘‘tolerance’’ represents the
maximum level for residues of pesticide
chemicals legally allowed in or on raw
agricultural commodities and processed
foods. Section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA of 1996,
Public Law 104–170, authorizes the
establishment of tolerances, exemptions
from tolerance requirements,
modifications in tolerances, and
revocation of tolerances for residues of
pesticide chemicals in or on raw
agricultural commodities and processed
foods. Without a tolerance or
exemption, food containing pesticide
residues is considered to be unsafe and
therefore ‘‘adulterated’’ under FFDCA
section 402(a), 21 U.S.C. 342(a). Such
food may not be distributed in interstate
commerce (21 U.S.C. 331(a)). For a fooduse pesticide to be sold and distributed,
the pesticide must not only have
appropriate tolerances under the
FFDCA, but also must be registered
under FIFRA (7 U.S.C. 136 et seq.).
Food-use pesticides not registered in the
United States must have tolerances in
order for commodities treated with
those pesticides to be imported into the
United States.
EPA’s general practice is to propose
revocation of tolerances for residues of
pesticide active ingredients on crops for
which FIFRA registrations no longer
exist and on which the pesticide may
therefore no longer be used in the
United States. EPA has historically been
concerned that retention of tolerances
that are not necessary to cover residues
in or on legally treated foods may
encourage misuse of pesticides within
the United States. Nonetheless, EPA
will establish and maintain tolerances
even when corresponding domestic uses
are canceled if the tolerances, which
EPA refers to as ‘‘import tolerances,’’ are
necessary to allow importation into the
United States of food containing such
pesticide residues. However, where
there are no imported commodities that
require these import tolerances, the
Agency believes it is appropriate to
revoke tolerances for unregistered
pesticides in order to prevent potential
misuse.
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Furthermore, as a general matter, the
Agency believes that retention of import
tolerances not needed to cover any
imported food may result in
unnecessary restriction on trade of
pesticides and foods. Under FFDCA
section 408, a tolerance may only be
established or maintained if EPA
determines that the tolerance is safe
based on a number of factors, including
an assessment of the aggregate exposure
to the pesticide and an assessment of
the cumulative effects of such pesticide
and other substances that have a
common mechanism of toxicity. In
doing so, EPA must consider potential
contributions to such exposure from all
tolerances. If the cumulative risk is such
that the tolerances in aggregate are not
safe, then every one of these tolerances
is potentially vulnerable to revocation.
Furthermore, if unneeded tolerances are
included in the aggregate and
cumulative risk assessments, the
estimated exposure to the pesticide
would be inflated. Consequently, it may
be more difficult for others to obtain
needed tolerances or to register needed
new uses. To avoid potential trade
restrictions, the Agency is proposing to
revoke tolerances for residues on crops
for which FIFRA registrations no longer
exist, unless someone expresses a need
for such tolerances. Through this
proposed rule, the Agency is inviting
individuals who need these import
tolerances to identify themselves and
the tolerances that are needed to cover
imported commodities.
Parties interested in retention of the
tolerances should be aware that
additional data may be needed to
support retention. These parties should
be aware that, under FFDCA section
408(f), if EPA determines that additional
information is reasonably required to
support the continuation of a tolerance,
EPA may require that parties interested
in maintaining the tolerances provide
the necessary information. If the
requisite information is not submitted,
EPA may issue an order revoking the
tolerance at issue.
C. When do these actions become
effective?
EPA is proposing that the actions
proposed in this document will become
effective on the date of publication of
the final rule in the Federal Register.
EPA is proposing an expiration/
revocation date of December 31, 2014
for revocation of the dicloran tolerance
on potato and December 31, 2013 for
revocation of the formetanate
hydrochloride tolerances on apple;
apple, wet pomace; peach; and pear.
The Agency believes that these
revocation dates allow users to exhaust
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stocks and allow sufficient time for
passage of treated commodities through
the channels of trade. However, if EPA
is presented with information that
existing stocks would still be available
and that information is verified, the
Agency will consider extending the
expiration date of the tolerance. If you
have comments regarding existing
stocks and whether the effective date
allows sufficient time for treated
commodities to clear the channels of
trade, please submit comments as
described under SUPPLEMENTARY
INFORMATION.
Any commodities listed in this
proposed rule treated with the
pesticides subject to this proposed rule,
and in the channels of trade following
the tolerance revocations, shall be
subject to FFDCA section 408(1)(5), as
established by FQPA. Under this unit,
any residues of these pesticides in or on
such food shall not render the food
adulterated so long as it is shown to the
satisfaction of the Food and Drug
Administration that:
1. The residue is present as the result
of an application or use of the pesticide
at a time and in a manner that was
lawful under FIFRA, and
2. The residue does not exceed the
level that was authorized at the time of
the application or use to be present on
the food under a tolerance or exemption
from tolerance. Evidence to show that
food was lawfully treated may include
records that verify the dates when the
pesticide was applied to such food.
III. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for formetanate hydrochloride or MRL
for dicloran in or on potatoes.
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Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules
IV. Statutory and Executive Order
Reviews
In this proposed rule, EPA is
proposing to revoke specific tolerances
established under FFDCA section 408.
The Office of Management and Budget
(OMB) has exempted this type of action
(e.g., tolerance revocation for which
extraordinary circumstances do not
exist) from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this proposed
rule has been exempted from review
under Executive Order 12866 due to its
lack of significance, this proposed rule
is not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001). This proposed
rule does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.
104–4). Nor does it require any special
considerations as required by Executive
Order 12898, entitled ‘‘Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994); or OMB review or any other
Agency action under Executive Order
13045, entitled ‘‘Protection of Children
from Environmental Health Risks and
Safety Risks’’ (62 FR 19885, April 23,
1997). 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). Pursuant to
the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency
previously assessed whether revocations
of tolerances might significantly impact
a substantial number of small entities
and concluded that, as a general matter,
these actions do not impose a significant
economic impact on a substantial
number of small entities. This analysis
was published on December 17, 1997
(62 FR 66020) (FRL–5753–1), and was
provided to the Chief Counsel for
Advocacy of the Small Business
Administration. Taking into account
this analysis, and available information
concerning the pesticides listed in this
proposed rule, the Agency hereby
certifies that this proposed rule will not
have a significant negative economic
impact on a substantial number of small
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entities. In a memorandum dated May
25, 2001, EPA determined that eight
conditions must all be satisfied in order
for an import tolerance or tolerance
exemption revocation to adversely affect
a significant number of small entity
importers, and that there is a negligible
joint probability of all eight conditions
holding simultaneously with respect to
any particular revocation. This Agency
document is available in the docket of
this proposed rule. Furthermore, for the
pesticides named in this proposed rule,
the Agency knows of no extraordinary
circumstances that exist as to the
present proposed rule that would
change the EPA’s previous analysis.
Any comments about the Agency’s
determination should be submitted to
the EPA along with comments on the
proposed rule, and will be addressed
prior to issuing a final rule. In addition,
the Agency has determined that this
action will not have a substantial direct
effect on States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government, as
specified in Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999). Executive Order
13132 requires EPA to develop an
accountable process to ensure
‘‘meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications.’’ ‘‘Policies that have
federalism implications’’ is defined in
the Executive order to include
regulations that have ‘‘substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’ This
proposed rule directly regulates
growers, food processors, food handlers,
and food retailers, not States. This
action does not alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). For these same
reasons, the Agency has determined that
this proposed rule does not have any
‘‘tribal implications’’ as described in
Executive Order 13175, entitled
‘‘Consultation and Coordination with
Indian Tribal Governments’’ (65 FR
67249, November 9, 2000). Executive
Order 13175 requires EPA to develop an
accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
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Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
proposed rule will not have substantial
direct effects on tribal governments, on
the relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 19, 2012.
Steve Bradbury,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise § 180.200 to read as follows:
§ 180.200 Dicloran; tolerances for
residues.
(a) General. Tolerances are
established for residues of the fungicide
dicloran, including its metabolites and
degradates, in or on the commodities in
the table in this paragraph. Compliance
with the tolerance levels specified in
this paragraph is to be determined by
measuring only dicloran, 2,6-dichloro-4nitroaniline, in or on the commodity.
Commodity
Apricot .............
Bean, snap,
succulent.
Carrot, roots ....
Celery ..............
Cherry, sweet ..
Cucumber .......
Endive .............
Garlic ...............
Grape ..............
Lettuce ............
Nectarine .........
Onion ..............
Peach ..............
Plum, prune,
fresh.
E:\FR\FM\28MRP1.SGM
28MRP1
Parts per
million
Expiration/
revocation
date
20
20
None.
None.
10
15
20
5
10
5
10
10
20
10
20
15
11/2/11.
None.
None.
None.
None.
None.
None.
None.
None.
None.
None.
None.
18752
Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Proposed Rules
Expiration/
revocation
date
Parts per
million
Commodity
Potato ..............
Rhubarb ..........
Sweet potato,
roots.
Tomato ............
0.25
10
10
5
40 CFR Part 721
12/31/14.
None.
None.
[EPA–HQ–OPPT–2010–0573; FRL–8865–2]
RIN 2070–AJ73
None.
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
3. Revise § 180.276 to read as follows:
§ 180.276 Formetanate hydrochloride;
tolerances for residues.
(a) General. Tolerances are
established for residues of the
insecticide formetanate hydrochloride,
including its metabolites and
degradates, in or on the commodities in
the table in this paragraph. Compliance
with the tolerance levels specified in
this paragraph is to be determined by
measuring only formetanate
hydrochloride, N,N-dimethyl-N ′-[3[[(methylamino)carbonyl]oxy]phenyl]
methanimidamide hydrochloride, in or
on the commodity.
Parts per
million
Commodity
Apple ...............
Apple, wet
pomace.
Grapefruit ........
Lemon .............
Lime ................
Nectarine .........
Orange ............
Peach ..............
Pear ................
Tangelo ...........
Tangerine ........
Expiration/
revocation
date
0.50
1.5
12/31/13.
12/31/13.
1.5
0.60
0.03
0.40
1.5
0.40
0.50
0.03
0.03
None.
None.
None.
None.
None.
12/31/13.
12/31/13.
None.
None.
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
tkelley on DSK3SPTVN1PROD with PROPOSALS
[FR Doc. 2012–7445 Filed 3–27–12; 8:45 am]
BILLING CODE 6560–50–P
VerDate Mar<15>2010
17:42 Mar 27, 2012
Jkt 226001
ENVIRONMENTAL PROTECTION
AGENCY
Benzidine-Based Chemical
Substances; Di-n-pentyl phthalate
(DnPP); and Alkanes, C12–13, Chloro;
Proposed Significant New Use Rules
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
Under the Toxic Substances
Control Act (TSCA), EPA is proposing:
To add nine benzidine-based chemical
substances to the Significant New Use
Rule (SNUR) on benzidine-based
chemical substances; a SNUR for di-npentyl phthalate (DnPP) (1,2benzenedicarboxylic acid, 1,2-dipentyl
ester) (CAS No. 131–18–0); and a SNUR
for alkanes, C12–13, chloro (CAS No.
71011–12–6). In the case of the
benzidine-based chemical substances,
EPA is also proposing to make
inapplicable the exemption relating to
persons that import or process
substances as part of an article. If
finalized, this rule would require
persons who intend to manufacture,
import, or process these chemical
substances for an activity that is
designated as a significant new use to
notify EPA at least 90 days before
commencing that activity. The required
notification would provide EPA with
the opportunity to evaluate activities
associated with a significant new use
and an opportunity to protect against
potential unreasonable risks, if any,
from exposure to the chemical
substance.
DATES: Comments must be received on
or before June 26, 2012.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2010–0573, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave. NW.,
Washington, DC. Attention: Docket ID
number EPA–HQ–OPPT–2010–0573.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
SUMMARY:
PO 00000
Frm 00035
Fmt 4702
Sfmt 4702
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
• Instructions: Direct your comments
to docket ID number EPA–HQ–OPPT–
2010–0573. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
email. The regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
regulations.gov, your email address will
be automatically captured and included
as part of the comment that is placed in
the docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
• Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave. NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number of
the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
E:\FR\FM\28MRP1.SGM
28MRP1
]]>Agencies
[Federal Register Volume 77, Number 60 (Wednesday, March 28, 2012)]
[Proposed Rules]
[Pages 18748-18752]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7445]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0507; FRL-9340-9]
RIN 2070-ZA16
Dicloran and Formetanate; Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to revoke certain tolerances for the
fungicide dicloran and the insecticide formetanate hydrochloride
because, in follow-up to voluntary requests from registrants, domestic
registrations were voluntarily amended to delete specific uses, leaving
no dicloran and formetanate hydrochloride registrations for those uses.
Also, in accordance with current Agency practice, EPA is proposing to
make minor revisions to the tolerance expressions for dicloran and
formetanate hydrochloride and to specific tolerance nomenclatures for
dicloran.
DATES: Comments must be received on or before May 29, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-0507, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online 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 Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0507. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at https://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., 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 https://www.regulations.gov, or, if only available in hard
copy, at the 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: Joseph Nevola, Pesticide Re-evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 308-8037; email address:
nevola.joseph@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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II.A. 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. 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
[[Page 18749]]
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
C. What can I do if I wish the Agency to maintain a tolerance that the
Agency proposes to revoke?
This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(f), if
needed. The order would specify data needed and the timeframes for its
submission, and would require that within 90 days some person or
persons notify EPA that they will submit the data. If the data are not
submitted as required in the order, EPA will take appropriate action
under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposed rule, you may also submit an
objection at the time of the final rule. If you fail to file an
objection to the final rule within the time period specified, you will
have waived the right to raise any issues resolved in the final rule.
After the specified time, issues resolved in the final rule cannot be
raised again in any subsequent proceedings.
II. Background
A. What action is the Agency taking?
EPA is proposing to revoke the potato tolerance for the fungicide
dicloran and the apple, peach, and pear tolerances for the insecticide
formetanate hydrochloride.
EPA is proposing the tolerance revocations in follow-up to the
Agency's approval (as described in Unit II.A.) of voluntary requests
from registrants to amend dicloran and formetanate product labels to
delete uses for specific food commodities. Also, in accordance with
current Agency practice, EPA is proposing to make minor revisions to
the tolerance expression for dicloran and to specific tolerance
nomenclatures for dicloran. In addition, in accordance with current
Agency practice to describe more clearly the measurement and scope or
coverage of the tolerances, including applicable metabolites and
degradates, EPA is proposing minor revisions to the tolerance
expression for formetanate hydrochloride. The revisions do not
substantively change the tolerance or, in any way, modify the
permissible level of residues permitted by the tolerance. It is EPA's
general practice to propose revocation of those tolerances for residues
of pesticide active ingredients on crop uses for which there are no
active registrations under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), unless someone submits comments on the
proposed rule indicating a need for the tolerance to cover residues in
or on imported commodities or legally treated domestic commodities. The
following discussion explains the specific changes and the reasons for
the changes.
1. Dicloran. Because it is no longer Agency practice to distinguish
between preharvest and postharvest applications in the tolerance
expression, in 40 CFR 180.200, EPA is proposing to remove paragraph
(a)(2), redesignate paragraph (a)(1) as paragraph (a), and revise the
introductory text containing the tolerance expression in newly
designated paragraph (a) by removing the reference concerning
preharvest and postharvest applications, to read as set out in the
proposed regulatory text at the end of this document.
Also, in the Federal Register of December 1, 2010 (75 FR 74714)
(FRL-8854-3), EPA published a notice of receipt of requests to
voluntarily amend certain dicloran (DCNA) registrations to delete the
use for potato, and therefore terminate the last registrations for use
of dicloran in or on potato. In the Federal Register of November 16,
2011 (76 FR 71022) (FRL-8883-8), EPA approved the cancellation order
for amendments to terminate product uses and allowed registrants to
sell and distribute existing stocks of the affected products until
November 16, 2012. The Agency allowed persons other than the registrant
to sell, distribute, or use existing stocks of the affected products
until they are exhausted, provided that it complies with the EPA
approved labeling. Recently, the registrant has been in further
communication with the Agency, and based on the information provided,
EPA believes that existing stocks are likely to be exhausted by
December 31, 2014. Therefore, EPA is proposing to revoke the tolerance
in newly designated 40 CFR 180.200(a) on potato with an expiration/
revocation date of December 31, 2014.
In addition, because it is no longer Agency practice to distinguish
between preharvest and postharvest applications in the tolerance
definitions, EPA is proposing to revise the commodity terminology in
newly designated 40 CFR 180.200(a) from ``apricot, postharvest'' to
``apricot,'' ``carrot, roots, postharvest'' to ``carrot, roots,''
``cherry, sweet, postharvest,'' to ``cherry, sweet,'' ``nectarine,
postharvest'' to ``nectarine,'' ``peach, postharvest,'' to ``peach,''
``plum, prune, fresh, postharvest'' to ``plum, prune, fresh,'' and
``sweet potato, postharvest,'' to ``sweet potato, roots.''
2. Formetanate hydrochloride. In the Federal Register of July 13,
2011 (76 FR 41250) (FRL-8879-7), EPA published a notice of receipt of
requests to voluntarily amend certain formetanate registrations to
delete uses for apple, peach, and pear, and therefore terminate the
last registrations for use of formetanate hydrochloride in or on those
commodities. In the Federal Registers of September 14, 2011 (76 FR
56753) (FRL-8888-2) and November 16, 2011 (76 FR 71021) (FRL-9327-1),
EPA approved the cancellation order for amendments to terminate product
uses and amended the order to allow registrants to sell and distribute
existing stocks of the affected products until January 31, 2012 (which
extended the deadline by 60 days beyond that previously allowed in the
September 14, 2011 cancellation order). The Agency allowed persons
other than the registrant to sell, distribute, or use existing stocks
of the affected products until December 31, 2013. Therefore, EPA is
proposing to revoke the tolerances in 40 CFR 180.276(a) on
[[Page 18750]]
apple; apple, wet pomace; peach; and pear with expiration/revocation
dates of December 31, 2013.
In order to describe more clearly the measurement and scope or
coverage of the tolerances, EPA is proposing to revise the introductory
text containing the tolerance expression in 40 CFR 180.276(a) to read
as set out in the proposed regulatory text at the end of this document.
B. What is the agency's authority for taking this action?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA of 1996, Public Law 104-170, authorizes the
establishment of tolerances, exemptions from tolerance requirements,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore
``adulterated'' under FFDCA section 402(a), 21 U.S.C. 342(a). Such food
may not be distributed in interstate commerce (21 U.S.C. 331(a)). For a
food-use pesticide to be sold and distributed, the pesticide must not
only have appropriate tolerances under the FFDCA, but also must be
registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not
registered in the United States must have tolerances in order for
commodities treated with those pesticides to be imported into the
United States.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where there are no
imported commodities that require these import tolerances, the Agency
believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under FFDCA section 408, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may be more difficult for others to obtain needed
tolerances or to register needed new uses. To avoid potential trade
restrictions, the Agency is proposing to revoke tolerances for residues
on crops for which FIFRA registrations no longer exist, unless someone
expresses a need for such tolerances. Through this proposed rule, the
Agency is inviting individuals who need these import tolerances to
identify themselves and the tolerances that are needed to cover
imported commodities.
Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if EPA determines
that additional information is reasonably required to support the
continuation of a tolerance, EPA may require that parties interested in
maintaining the tolerances provide the necessary information. If the
requisite information is not submitted, EPA may issue an order revoking
the tolerance at issue.
C. When do these actions become effective?
EPA is proposing that the actions proposed in this document will
become effective on the date of publication of the final rule in the
Federal Register. EPA is proposing an expiration/revocation date of
December 31, 2014 for revocation of the dicloran tolerance on potato
and December 31, 2013 for revocation of the formetanate hydrochloride
tolerances on apple; apple, wet pomace; peach; and pear. The Agency
believes that these revocation dates allow users to exhaust stocks and
allow sufficient time for passage of treated commodities through the
channels of trade. However, if EPA is presented with information that
existing stocks would still be available and that information is
verified, the Agency will consider extending the expiration date of the
tolerance. If you have comments regarding existing stocks and whether
the effective date allows sufficient time for treated commodities to
clear the channels of trade, please submit comments as described under
SUPPLEMENTARY INFORMATION.
Any commodities listed in this proposed rule treated with the
pesticides subject to this proposed rule, and in the channels of trade
following the tolerance revocations, shall be subject to FFDCA section
408(1)(5), as established by FQPA. Under this unit, any residues of
these pesticides in or on such food shall not render the food
adulterated so long as it is shown to the satisfaction of the Food and
Drug Administration that:
1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA,
and
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates when the
pesticide was applied to such food.
III. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for formetanate hydrochloride
or MRL for dicloran in or on potatoes.
[[Page 18751]]
IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to revoke specific
tolerances established under FFDCA section 408. The Office of
Management and Budget (OMB) has exempted this type of action (e.g.,
tolerance revocation for which extraordinary circumstances do not
exist) from review under Executive Order 12866, entitled ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993). Because this
proposed rule has been exempted from review under Executive Order 12866
due to its lack of significance, this proposed rule is not subject to
Executive Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001). This proposed rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any special considerations as required by Executive Order
12898, entitled ``Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994); or OMB review or any other Agency action under Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). 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). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), the Agency previously assessed whether revocations of
tolerances might significantly impact a substantial number of small
entities and concluded that, as a general matter, these actions do not
impose a significant economic impact on a substantial number of small
entities. This analysis was published on December 17, 1997 (62 FR
66020) (FRL-5753-1), and was provided to the Chief Counsel for Advocacy
of the Small Business Administration. Taking into account this
analysis, and available information concerning the pesticides listed in
this proposed rule, the Agency hereby certifies that this proposed rule
will not have a significant negative economic impact on a substantial
number of small entities. In a memorandum dated May 25, 2001, EPA
determined that eight conditions must all be satisfied in order for an
import tolerance or tolerance exemption revocation to adversely affect
a significant number of small entity importers, and that there is a
negligible joint probability of all eight conditions holding
simultaneously with respect to any particular revocation. This Agency
document is available in the docket of this proposed rule. Furthermore,
for the pesticides named in this proposed rule, the Agency knows of no
extraordinary circumstances that exist as to the present proposed rule
that would change the EPA's previous analysis. Any comments about the
Agency's determination should be submitted to the EPA along with
comments on the proposed rule, and will be addressed prior to issuing a
final rule. In addition, the Agency has determined that this action
will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This proposed rule directly regulates
growers, food processors, food handlers, and food retailers, not
States. This action does not alter the relationships or distribution of
power and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this proposed rule does not have any
``tribal implications'' as described in Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000). Executive Order 13175 requires EPA to develop
an accountable process to ensure ``meaningful and timely input by
tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 19, 2012.
Steve Bradbury,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise Sec. 180.200 to read as follows:
Sec. 180.200 Dicloran; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide dicloran, including its metabolites and degradates, in or on
the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only dicloran, 2,6-dichloro-4-nitroaniline, in or on the
commodity.
------------------------------------------------------------------------
Parts per Expiration/revocation
Commodity million date
------------------------------------------------------------------------
Apricot............................ 20 None.
Bean, snap, succulent.............. 20 None.
Carrot, roots...................... 10 11/2/11.
Celery............................. 15 None.
Cherry, sweet...................... 20 None.
Cucumber........................... 5 None.
Endive............................. 10 None.
Garlic............................. 5 None.
Grape.............................. 10 None.
Lettuce............................ 10 None.
Nectarine.......................... 20 None.
Onion.............................. 10 None.
Peach.............................. 20 None.
Plum, prune, fresh................. 15 None.
[[Page 18752]]
Potato............................. 0.25 12/31/14.
Rhubarb............................ 10 None.
Sweet potato, roots................ 10 None.
Tomato............................. 5 None.
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
3. Revise Sec. 180.276 to read as follows:
Sec. 180.276 Formetanate hydrochloride; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide formetanate hydrochloride, including its metabolites and
degradates, in or on the commodities in the table in this paragraph.
Compliance with the tolerance levels specified in this paragraph is to
be determined by measuring only formetanate hydrochloride, N,N-
dimethyl-N '-[3-[[(methylamino)carbonyl]oxy]phenyl]methanimidamide
hydrochloride, in or on the commodity.
------------------------------------------------------------------------
Parts per Expiration/revocation
Commodity million date
------------------------------------------------------------------------
Apple.............................. 0.50 12/31/13.
Apple, wet pomace.................. 1.5 12/31/13.
Grapefruit......................... 1.5 None.
Lemon.............................. 0.60 None.
Lime............................... 0.03 None.
Nectarine.......................... 0.40 None.
Orange............................. 1.5 None.
Peach.............................. 0.40 12/31/13.
Pear............................... 0.50 12/31/13.
Tangelo............................ 0.03 None.
Tangerine.......................... 0.03 None.
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2012-7445 Filed 3-27-12; 8:45 am]
BILLING CODE 6560-50-P
