Maneb; Proposed Tolerance Actions, 29475-29479 [2010-12376]
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Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0327; FRL–8826–2]
Maneb; Proposed Tolerance Actions
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke all
the tolerances for the fungicide maneb
because the Agency has approved
requests for voluntary cancellation by
registrants of the last registrations for
the food uses of maneb in the United
States.
DATES: Comments must be received on
or before July 26, 2010.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2010–0327, by
one of the following methods:
• Federal eRulemaking Portal: https://
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
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–2010–
0327. 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 website 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 e-mail comment directly
to EPA without going through
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regulations.gov, your e-mail 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; e-mail 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
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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 e-mail. 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
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.
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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
section 408(f) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 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 proposal,
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
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A. What Action is the Agency Taking?
EPA is proposing to revoke all the
tolerances for residues of the fungicide
maneb, manganous
ethylenebisdithiocarbamate, because the
Agency has approved requests for
voluntary cancellation by registrants of
the last registrations for food uses of
maneb in the United States. These
tolerances are associated with food uses
that are no longer registered under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and therefore
are no longer needed. It is EPA’s general
practice to propose revocation of those
tolerances/tolerance exemptions for
residues of pesticide active ingredients
on crop uses for which there are no
active registrations under FIFRA, unless
any person submits comments on the
proposal that indicate a need for the
tolerance to cover residues in or on
imported commodities or legally treated
domestic commodities.
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EPA completed a Reregistration
Eligibility Decision (RED) for maneb in
2005, which included a tolerance
reassessment summary for maneb. As
part of the tolerance reassessment, the
Agency recommended specific changes
to the tolerance definition for maneb,
changes to tolerance values, tolerances
to be revoked, and new tolerances to be
proposed to be established. EPA also
reviewed any Codex Alimentarius
maximum residue limits (MRLs) for
maneb. Because Codex has no
established MRLs for maneb per se, but
groups MRLs for maneb with MRLs for
dithiocarbamate pesticides expressed in
terms of parts per million (ppm) carbon
disulfide, EPA recommended
harmonizing with Codex by changing
the tolerance definition for maneb, so
that it is expressed in terms of carbon
disulfide.
In the maneb RED, the Agency
recommended revocation of certain
maneb tolerances which still exist in 40
CFR 180.110(a). Maneb use on certain
crops was disallowed by EPA, as
announced in a notice published in the
Federal Register of March 2, 1992 (57
FR 7484) (FRL–4045–8). In that notice,
the Agency announced its conclusion of
Special Review (PD4) regarding
ethylene bisdithiocarbamate (EBDC)
fungicides, including maneb, and its
intent to cancel any EBDC product
registrations bearing food uses that
included, among others, apricots,
succulent beans, carrots, celery,
nectarines, and peaches. There have
been no U.S. registrations for maneb use
on apricots, succulent beans, nectarines,
and peaches since 1992, and no U.S.
registrations for maneb use on carrots
and celery since 1994. Therefore, the
maneb tolerances on these commodities
are no longer needed and should be
revoked. Consequently, EPA is
proposing to revoke the tolerances in 40
CFR 180.110(a) for maneb residues of
concern in or on apricot; bean,
succulent; carrot, roots; celery;
nectarine; and peach.
Subsequent to the RED, all maneb
technical and end-use registrants chose
to request voluntary cancellation of all
U.S. registrations for maneb technical
grade active ingredient and end-use
maneb products. Registrants submitted
their voluntary requests for cancellation
of their maneb technical and product
registrations to EPA in accordance with
section 6(f) of FIFRA, and the Agency
published notices of their receipt and
subsequent cancellation orders in the
Federal Register, which are summarized
herein.
In a Federal Register notice of
September 12, 2008 (73 FR 53007)
(FRL–8380–7), EPA announced receipt
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of a request from United Phosphorous
Inc. to voluntarily cancel all of its
maneb registrations. EPA accepted this
request and published a cancellation
order, for all United Phosphorous
maneb products, in a Federal Register
notice of August 26, 2009 (74 FR
43124)(FRL–8429–6), effective on
August 26, 2009. Under conditions of
the cancellation order, United
Phosphorous Inc. was permitted to sell
and distribute existing stocks of the
canceled maneb products until
December 31, 2009. Also, this order
permitted persons other than the
registrant to sell and distribute existing
stocks of the canceled maneb products
until supplies were exhausted and
formulate end use products until March
2010.
In a Federal Register notice of January
6, 2010 (75 FR 860) (FRL–8806–3), EPA
announced the Agency’s receipt of a
request from Drexel Chemical Company
to voluntarily cancel its technical
registration for maneb and thereby
terminate the last maneb technical
product registered in the United States
(EPA Reg. No. 19713–377). After the
close of the 30–day comment period,
EPA approved cancellation of this last
maneb technical product, and issued a
cancellation order in the Federal
Register notice of February 24, 2010 (75
FR 8340) (FRL–8813–9), effective on
February 24, 2010. Under conditions of
the cancellation order, Drexel Chemical
Company was permitted to sell and
distribute existing stocks of the canceled
maneb technical product until February
26, 2010 and formulate end-use
products until March 10, 2010. Also,
this order permitted persons other than
the registrants to use the maneb end-use
products until supplies are exhausted.
In another Federal Register notice of
January 6, 2010 (75 FR 869) (FRL–8806–
2), EPA announced the Agency’s receipt
of request from Drexel Chemical
Company to voluntarily cancel its last
maneb registrations. After the close of
the 30–day comment period, EPA
approved cancellation of the
registrations, and issued a cancellation
order in a Federal Register notice of
February 26, 2010 (75 FR 8942) (FRL–
8813–6), effective February 26, 2010.
Under conditions of the cancellation
order, Drexel Chemical Company was
permitted to sell and distribute existing
stocks of the canceled maneb products
until supplies are exhausted. Also, this
order permitted persons other than the
registrants to sell, distribute, and use
existing stocks of the canceled maneb
products until supplies are exhausted.
Also, in a Federal Register notice of
March 4, 2010 (75 FR 9896) (FRL–8813–
5), EPA announced the Agency’s receipt
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of requests from DuPont Crop Protection
to voluntarily cancel their maneb
product registration (EPA Reg. No. 352–
655), the last maneb product registered
for use in the United States, thereby
terminating the last maneb food uses in
the United States. After the close of the
30–day comment period, EPA approved
cancellation of this product registration
and issued a cancellation order in the
Federal Register of April 16, 2010 (75
FR 19967) (FRL–8822–2), effective on
April 16, 2010. Under conditions of the
cancellation order, DuPont Crop
Protection was permitted to sell and
distribute existing stocks of the canceled
maneb product until supplies are
exhausted. Also, this order permitted
persons other than the registrants to sell,
distribute, and use existing stocks of the
canceled maneb product until supplies
are exhausted.
In the time since the last cancellation
order, the Agency has received
information from the registrants that
significant levels of existing stocks of
the canceled maneb products are
unlikely. Therefore, the Agency believes
that end users have had sufficient time
to exhaust those existing stocks and for
maneb treated commodities to have
cleared the channels of trade. The
termination of the last food uses means
that the tolerances will no longer be
needed and should be revoked.
Consequently, EPA is proposing to
revoke the tolerances in 40 CFR
180.110(a) on almond; apple; banana
(not more than 0.5 part per million shall
be in the pulp after peel is removed and
discarded (preharvest application
only)); bean, dry, seed; beet, sugar, tops;
broccoli; Brussels sprouts; cabbage;
cabbage, Chinese, bok choy; cabbage,
Chinese, napa; cauliflower; collards;
corn, sweet, kernel plus cob with husks
removed; cranberry; cucumber;
eggplant; endive; fig; grape; kale;
kohlrabi; lettuce; melon; mustard
greens; onion; papaya; pepper; potato;
pumpkin; squash, summer; squash,
winter; tomato; turnip, greens; and
turnip, roots. EPA is proposing that
these revocations become effective on
the date of publication of the final rule
for maneb in the Federal Register.
Because the time-limited tolerance
associated with the use of maneb under
a FIFRA section 18 emergency
exemption for combined maneb
residues of concern in or on walnut
expired on December 31, 2009, it should
be removed. Therefore, EPA is
proposing to remove the expired
tolerance in 40 CFR 180.110(b) on
walnut.
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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 Food Quality
Protection Act (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 section
402(a) of FFDCA, 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/tolerance
exemptions 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 section 408
of FFDCA, a tolerance/tolerance
exemption may only be established or
maintained if EPA determines that the
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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/
tolerance exemptions for residues on
crops uses for which FIFRA
registrations no longer exist, unless
someone expresses a need for such
tolerances/tolerance exemptions.
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/tolerance exemptions should
be aware that additional data may be
needed to support retention. These
parties should be aware that, under
section 408(f) of FFDCA, if the Agency
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/
tolerance exemption at issue.
C. When Do These Actions Become
Effective?
EPA is proposing that revocation of
these maneb tolerances and removal of
the expired maneb tolerance become
effective on the date of publication of
the final rule in the Federal Register.
Most of the maneb tolerances proposed
for revocation in this document are
associated with uses that have been
canceled in 2010. However, the
available information on recently
canceled maneb products indicates that
significant levels of existing stocks are
unlikely. Therefore, the Agency believes
that existing stocks of maneb products
labeled for uses associated with
tolerances proposed for revocation have
been completely exhausted and that
maneb treated commodities have had
sufficient time for passage through the
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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 that information prior to
moving forward with tolerance
revocation. 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
proposal treated with the pesticides
subject to this proposal, and in the
channels of trade following the
tolerance revocations, shall be subject to
section 408(l)(5) of FFDCA, 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 section 408(b)(4) of FFDCA.
The Codex Alimentarius is a joint U.N.
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, section 408(b)(4) of FFDCA
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established a MRL
for maneb per se.
IV. Statutory and Executive Order
Reviews
In this proposed rule, EPA is
proposing to revoke specific tolerances
established under section 408 of
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FFDCA. 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) (Public
Law 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
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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
pesticide named in this proposed rule,
the Agency knows of no extraordinary
circumstances that exist as to the
present proposal 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 proposal, 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 section 408(n)(4) of
FFDCA. 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
E:\FR\FM\26MYP1.SGM
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Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Proposed Rules
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: May 14, 2010.
Steven Bradbury,
Acting 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.
§ 180.110
[Removed]
2. Section 180.110 is removed.
[FR Doc. 2010–12376 Filed 5–25–10; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 482 and 485
[CMS–3227–P]
RIN 0938–AQ05
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Medicare and Medicaid Programs:
Proposed Changes Affecting Hospital
and Critical Access Hospital (CAH)
Conditions of Participation (CoPs):
Credentialing and Privileging of
Telemedicine Physicians and
Practitioners
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
SUMMARY: This proposed rule would
revise the conditions of participation
(CoPs) for both hospitals and critical
access hospitals (CAHs). These revisions
would allow for a new credentialing and
privileging process for physicians and
practitioners providing telemedicine
services.
VerDate Mar<15>2010
15:16 May 25, 2010
Jkt 220001
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on July 26, 2010.
ADDRESSES: In commenting, please refer
to file code CMS–3227–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the instructions under the ‘‘More Search
Options’’ tab.
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–3227–
P, P.O. Box 8010, Baltimore, MD 21244–
1850.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3227–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201. (Because
access to the interior of the Hubert H.
Humphrey Building is not readily
available to persons without Federal
government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is
available for persons wishing to retain
a proof of filing by stamping in and
retaining an extra copy of the
comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–
1850.
If you intend to deliver your
comments to the Baltimore address,
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
29479
please call telephone number (410) 786–
9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
Submission of comments on
paperwork requirements. You may
submit comments on this document’s
paperwork requirements by following
the instructions at the end of the
‘‘Collection of Information
Requirements’’ section in this document.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: CDR
Scott Cooper, USPHS (410) 786–9465.
Marcia Newton, (410) 786–5265. Jeannie
Miller, (410) 786–3164.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244, on Monday
through Friday of each week from 8:30
a.m. to 4 p.m. EST. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
Electronic Access
This Federal Register document is
also available from the Federal Register
online database through GPO Access, a
service of the U.S. Government Printing
Office. Free public access is available on
a Wide Area Information Server (WAIS)
through the Internet and via
asynchronous dial-in. Internet users can
access the database by using the World
Wide Web (the Superintendent of
Documents’ home page address is
https://www.gpoaccess.gov/),
by using local WAIS client software, or
by telnet to swais.access.gpo.gov, then
login as guest (no password required).
Dial-in users should use
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to call (202) 512–1661; type swais, then
login as a guest (no password required).
E:\FR\FM\26MYP1.SGM
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Agencies
[Federal Register Volume 75, Number 101 (Wednesday, May 26, 2010)]
[Proposed Rules]
[Pages 29475-29479]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-12376]
[[Page 29475]]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0327; FRL-8826-2]
Maneb; Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to revoke all the tolerances for the
fungicide maneb because the Agency has approved requests for voluntary
cancellation by registrants of the last registrations for the food uses
of maneb in the United States.
DATES: Comments must be received on or before July 26, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0327, by one of the following methods:
Federal eRulemaking Portal: https://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 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-
2010-0327. 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 e-
mail. The regulations.gov website 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 e-
mail comment directly to EPA without going through regulations.gov,
your e-mail 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; e-mail 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 e-mail. 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 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.
[[Page 29476]]
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
section 408(f) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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 proposal, 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 all the tolerances for residues of the
fungicide maneb, manganous ethylenebisdithiocarbamate, because the
Agency has approved requests for voluntary cancellation by registrants
of the last registrations for food uses of maneb in the United States.
These tolerances are associated with food uses that are no longer
registered under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), and therefore are no longer needed. It is EPA's general
practice to propose revocation of those tolerances/tolerance exemptions
for residues of pesticide active ingredients on crop uses for which
there are no active registrations under FIFRA, unless any person
submits comments on the proposal that indicate a need for the tolerance
to cover residues in or on imported commodities or legally treated
domestic commodities.
EPA completed a Reregistration Eligibility Decision (RED) for maneb
in 2005, which included a tolerance reassessment summary for maneb. As
part of the tolerance reassessment, the Agency recommended specific
changes to the tolerance definition for maneb, changes to tolerance
values, tolerances to be revoked, and new tolerances to be proposed to
be established. EPA also reviewed any Codex Alimentarius maximum
residue limits (MRLs) for maneb. Because Codex has no established MRLs
for maneb per se, but groups MRLs for maneb with MRLs for
dithiocarbamate pesticides expressed in terms of parts per million
(ppm) carbon disulfide, EPA recommended harmonizing with Codex by
changing the tolerance definition for maneb, so that it is expressed in
terms of carbon disulfide.
In the maneb RED, the Agency recommended revocation of certain
maneb tolerances which still exist in 40 CFR 180.110(a). Maneb use on
certain crops was disallowed by EPA, as announced in a notice published
in the Federal Register of March 2, 1992 (57 FR 7484) (FRL-4045-8). In
that notice, the Agency announced its conclusion of Special Review
(PD4) regarding ethylene bisdithiocarbamate (EBDC) fungicides,
including maneb, and its intent to cancel any EBDC product
registrations bearing food uses that included, among others, apricots,
succulent beans, carrots, celery, nectarines, and peaches. There have
been no U.S. registrations for maneb use on apricots, succulent beans,
nectarines, and peaches since 1992, and no U.S. registrations for maneb
use on carrots and celery since 1994. Therefore, the maneb tolerances
on these commodities are no longer needed and should be revoked.
Consequently, EPA is proposing to revoke the tolerances in 40 CFR
180.110(a) for maneb residues of concern in or on apricot; bean,
succulent; carrot, roots; celery; nectarine; and peach.
Subsequent to the RED, all maneb technical and end-use registrants
chose to request voluntary cancellation of all U.S. registrations for
maneb technical grade active ingredient and end-use maneb products.
Registrants submitted their voluntary requests for cancellation of
their maneb technical and product registrations to EPA in accordance
with section 6(f) of FIFRA, and the Agency published notices of their
receipt and subsequent cancellation orders in the Federal Register,
which are summarized herein.
In a Federal Register notice of September 12, 2008 (73 FR 53007)
(FRL-8380-7), EPA announced receipt of a request from United
Phosphorous Inc. to voluntarily cancel all of its maneb registrations.
EPA accepted this request and published a cancellation order, for all
United Phosphorous maneb products, in a Federal Register notice of
August 26, 2009 (74 FR 43124)(FRL-8429-6), effective on August 26,
2009. Under conditions of the cancellation order, United Phosphorous
Inc. was permitted to sell and distribute existing stocks of the
canceled maneb products until December 31, 2009. Also, this order
permitted persons other than the registrant to sell and distribute
existing stocks of the canceled maneb products until supplies were
exhausted and formulate end use products until March 2010.
In a Federal Register notice of January 6, 2010 (75 FR 860) (FRL-
8806-3), EPA announced the Agency's receipt of a request from Drexel
Chemical Company to voluntarily cancel its technical registration for
maneb and thereby terminate the last maneb technical product registered
in the United States (EPA Reg. No. 19713-377). After the close of the
30-day comment period, EPA approved cancellation of this last maneb
technical product, and issued a cancellation order in the Federal
Register notice of February 24, 2010 (75 FR 8340) (FRL-8813-9),
effective on February 24, 2010. Under conditions of the cancellation
order, Drexel Chemical Company was permitted to sell and distribute
existing stocks of the canceled maneb technical product until February
26, 2010 and formulate end-use products until March 10, 2010. Also,
this order permitted persons other than the registrants to use the
maneb end-use products until supplies are exhausted.
In another Federal Register notice of January 6, 2010 (75 FR 869)
(FRL-8806-2), EPA announced the Agency's receipt of request from Drexel
Chemical Company to voluntarily cancel its last maneb registrations.
After the close of the 30-day comment period, EPA approved cancellation
of the registrations, and issued a cancellation order in a Federal
Register notice of February 26, 2010 (75 FR 8942) (FRL-8813-6),
effective February 26, 2010. Under conditions of the cancellation
order, Drexel Chemical Company was permitted to sell and distribute
existing stocks of the canceled maneb products until supplies are
exhausted. Also, this order permitted persons other than the
registrants to sell, distribute, and use existing stocks of the
canceled maneb products until supplies are exhausted.
Also, in a Federal Register notice of March 4, 2010 (75 FR 9896)
(FRL-8813-5), EPA announced the Agency's receipt
[[Page 29477]]
of requests from DuPont Crop Protection to voluntarily cancel their
maneb product registration (EPA Reg. No. 352-655), the last maneb
product registered for use in the United States, thereby terminating
the last maneb food uses in the United States. After the close of the
30-day comment period, EPA approved cancellation of this product
registration and issued a cancellation order in the Federal Register of
April 16, 2010 (75 FR 19967) (FRL-8822-2), effective on April 16, 2010.
Under conditions of the cancellation order, DuPont Crop Protection was
permitted to sell and distribute existing stocks of the canceled maneb
product until supplies are exhausted. Also, this order permitted
persons other than the registrants to sell, distribute, and use
existing stocks of the canceled maneb product until supplies are
exhausted.
In the time since the last cancellation order, the Agency has
received information from the registrants that significant levels of
existing stocks of the canceled maneb products are unlikely. Therefore,
the Agency believes that end users have had sufficient time to exhaust
those existing stocks and for maneb treated commodities to have cleared
the channels of trade. The termination of the last food uses means that
the tolerances will no longer be needed and should be revoked.
Consequently, EPA is proposing to revoke the tolerances in 40 CFR
180.110(a) on almond; apple; banana (not more than 0.5 part per million
shall be in the pulp after peel is removed and discarded (preharvest
application only)); bean, dry, seed; beet, sugar, tops; broccoli;
Brussels sprouts; cabbage; cabbage, Chinese, bok choy; cabbage,
Chinese, napa; cauliflower; collards; corn, sweet, kernel plus cob with
husks removed; cranberry; cucumber; eggplant; endive; fig; grape; kale;
kohlrabi; lettuce; melon; mustard greens; onion; papaya; pepper;
potato; pumpkin; squash, summer; squash, winter; tomato; turnip,
greens; and turnip, roots. EPA is proposing that these revocations
become effective on the date of publication of the final rule for maneb
in the Federal Register.
Because the time-limited tolerance associated with the use of maneb
under a FIFRA section 18 emergency exemption for combined maneb
residues of concern in or on walnut expired on December 31, 2009, it
should be removed. Therefore, EPA is proposing to remove the expired
tolerance in 40 CFR 180.110(b) on walnut.
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 Food Quality Protection Act (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 section 402(a) of FFDCA, 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/
tolerance exemptions 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 section 408 of FFDCA, a tolerance/tolerance exemption 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/tolerance
exemptions for residues on crops uses for which FIFRA registrations no
longer exist, unless someone expresses a need for such tolerances/
tolerance exemptions. 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/tolerance
exemptions should be aware that additional data may be needed to
support retention. These parties should be aware that, under section
408(f) of FFDCA, if the Agency 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/tolerance
exemption at issue.
C. When Do These Actions Become Effective?
EPA is proposing that revocation of these maneb tolerances and
removal of the expired maneb tolerance become effective on the date of
publication of the final rule in the Federal Register. Most of the
maneb tolerances proposed for revocation in this document are
associated with uses that have been canceled in 2010. However, the
available information on recently canceled maneb products indicates
that significant levels of existing stocks are unlikely. Therefore, the
Agency believes that existing stocks of maneb products labeled for uses
associated with tolerances proposed for revocation have been completely
exhausted and that maneb treated commodities have had sufficient time
for passage through the
[[Page 29478]]
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 that information prior to moving
forward with tolerance revocation. 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 proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to section 408(l)(5) of FFDCA,
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 section
408(b)(4) of FFDCA. The Codex Alimentarius is a joint U.N. 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, section 408(b)(4) of FFDCA requires that EPA
explain the reasons for departing from the Codex level.
The Codex has not established a MRL for maneb per se.
IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to revoke specific
tolerances established under section 408 of FFDCA. 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) (Public Law 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 pesticide named in this proposed rule, the Agency
knows of no extraordinary circumstances that exist as to the present
proposal 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 proposal, 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 section 408(n)(4) of FFDCA. 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
[[Page 29479]]
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: May 14, 2010.
Steven Bradbury,
Acting 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.
Sec. 180.110 [Removed]
2. Section 180.110 is removed.
[FR Doc. 2010-12376 Filed 5-25-10; 8:45 am]
BILLING CODE 6560-50-S