Thiophanate-methyl; Pesticide Tolerances for Emergency Exemptions, 14551-14556 [05-5720]
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Federal Register / Vol. 70, No. 55 / Wednesday, March 23, 2005 / Rules and Regulations
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 rule.
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
VIII. Congressional Review Act
List of Subjects in 40 CFR Part 180
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 14, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.571 is amended by
alphabetically adding the following
commodities to the table in paragraph (a)
to read as follows:
I
§ 180.571 Mesotrione; tolerances for
residues.
(a) * * *
Commodity
Parts per million
*
*
*
*
Corn, sweet, forage .................................................................................................
Corn, sweet, kernel plus cob with husks removed .................................................
Corn, sweet, stover ..................................................................................................
*
*
*
*
*
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0011; FRL–7699–3]
Thiophanate-methyl; Pesticide
Tolerances for Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
time-limited tolerances for combined
residues of thiophanate-methyl and its
metabolite methyl 2-benzimidazoyl
carbamate (MBC) in or on cotton and
cotton, gin byproducts. This action is in
response to EPA’s granting of an
emergency exemption under section 18
of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA)
authorizing use of the pesticide on
cotton. This regulation establishes a
maximum permissible level for residues
of thiophanate-methyl in these feed
commodities. These tolerances will
expire and are revoked on December 31,
2007.
DATES: This regulation is effective
March 23, 2005. Objections and requests
for hearings must be received on or
before May 23, 2005.
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0.5
0.01
1.5
To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under docket
identification (ID) number OPP–2005–
0011. All documents in the docket are
listed in the EDOCKET index at http:/
/www.epa.gov/edocket. Although listed
in the index, some information is not
publicly available, i.e., 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
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
ADDRESSES:
[FR Doc. 05–5719 Filed 3–22–05; 8:45 am]
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FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6463; e-mail address:
madden.barbara@epa.gov.
SUPPLEMENTARY INFORMATION:
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I. General Information
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 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS
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
discussed above. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
How Can I Access Electronic Copies of
this Document and Other Related
Information?
In addition to using EDOCKET (http:/
/www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
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https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
EPA, on its own initiative, in
accordance with sections 408(e) and 408
(l)(6) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a,
is establishing tolerances for combined
residues of the fungicide thiophanatemethyl, and its metabolite MBC, in or
on cotton at 0.05 parts per million
(ppm) and cotton gin byproducts at 5.0
ppm. These tolerances will expire and
are revoked on December 31, 2007. EPA
will publish a document in theFederal
Register to remove the revoked
tolerance from the Code of Federal
Regulations.
Section 408(l)(6) of the FFDCA
requires EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption granted by
EPA under section 18 of FIFRA. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on section 18 related tolerances
to set binding precedents for the
application of section 408 of the FFDCA
and the new safety standard to other
tolerances and exemptions. Section
408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption
from the requirement of a tolerance on
its own initiative, i.e., without having
received any petition from an outside
party.
Section 408(b)(2)(A)(i) of the FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of the FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of the FFDCA requires EPA
to give special consideration to
exposure of infants and children to the
pesticide chemical residue in
establishing a tolerance and to ‘‘ensure
that there is a reasonable certainty that
no harm will result to infants and
children from aggregate exposure to the
pesticide chemical residue. . . .’’
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Section 18 of the FIFRA authorizes
EPA to exempt any Federal or State
agency from any provision of FIFRA, if
EPA determines that ‘‘emergency
conditions exist which require such
exemption.’’ This provision was not
amended by the Food Quality Protection
Act of 1996 (FQPA). EPA has
established regulations governing such
emergency exemptions in 40 CFR part
166.
III. Emergency Exemption for
Thiophanate-methyl on Cotton and
FFDCA Tolerances
On July 20, 2004, the State of Florida
utilized the crisis exemption authority
as provided under FIFRA section 18 for
use of thiophanate-methyl on cotton.
According to the State, fusarium
hardlock of cotton has been identified as
a severe economic disease during the
last 4 years. This disease has become a
problem since the state began to grow
primarily genetically modified (GMOs)
varieties of cotton. Cotton yields have
been reduced up to 50% as a result of
the disease. To date, thiophanate-methyl
is the only pesticide that has been
identified to control this disease on
cotton. EPA has authorized under
FIFRA section 18 the use of
thiophanate-methyl on cotton for
control of fusarium hardlock in Florida.
After having reviewed the submission,
EPA concurs that emergency conditions
exist for this State.
As part of its assessment of this
emergency exemption, EPA assessed the
potential risks presented by residues of
thiophanate-methyl in or on cotton. In
doing so, EPA considered the safety
standard in section 408(b)(2) of the
FFDCA, and EPA decided that the
necessary tolerance under section
408(l)(6) of the FFDCA would be
consistent with the safety standard and
with FIFRA section 18. Consistent with
the need to move quickly on the
emergency exemption in order to
address an urgent non-routine situation
and to ensure that the resulting food is
safe and lawful, EPA is issuing these
tolerances without notice and
opportunity for public comment as
provided in section 408(l)(6) of the
FFDCA. Although these tolerances will
expire and are revoked on December 31,
2007, under section 408(l)(5) of the
FFDCA, residues of the pesticide not in
excess of the amounts specified in the
tolerance remaining in or on cotton and
cotton gin byproducts after that date
will not be unlawful, provided the
pesticide is applied in a manner that
was lawful under FIFRA, and the
residues do not exceed a level that was
authorized by these tolerances at the
time of that application. EPA will take
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action to revoke these tolerances earlier
if any experience with, scientific data
on, or other relevant information on this
pesticide indicate that the residues are
not safe.
Because these tolerances are being
approved under emergency conditions,
EPA has not made any decisions about
whether thiophanate-methyl meets
EPA’s registration requirements for use
on cotton or whether permanent
tolerances for this use would be
appropriate. Under these circumstances,
EPA does not believe that these
tolerances serve as a basis for
registration of thiophanate-methyl by a
State for special local needs under
FIFRA section 24(c). Nor do these
tolerances serve as the basis for any
State other than Florida to use this
pesticide on this crop under section 18
of FIFRA without following all
provisions of EPA’s regulations
implementing FIFRA section 18 as
identified in 40 CFR part 166. For
additional information regarding the
emergency exemption for thiophanatemethyl, contact the Agency’s
Registration Division at the address
provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and
Determination of Safety
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see the final
rule on Bifenthrin Pesticide Tolerances
November 26, 1997 (62 FR 62961 (FRL–
5754–7).
Consistent with section 408(b)(2)(D)
of the FFDCA , EPA has reviewed the
available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of thiophanate-methyl and
to make a determination on aggregate
exposure, consistent with section
408(b)(2) of the FFDCA, for a timelimited tolerance for combined residues
of thiophanate-methyl in or on cotton at
0.05 ppm and cotton, gin byproducts at
5.0 ppm.
Residue data were submitted for
cotton. Cotton is not consumed by
humans, any inadvertent exposure to
residues of thiophanate-methyl from
this emergency exemption will result
from the consumption of meat or milk
since cotton gin byproducts and
cottonseed (meal, hulls) are animal feed
items. Currently there are tolerances for
residues of thiophanate-methyl in or on
milk and ruminant meat, meat
byproducts, liver, and fat. Since there is
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an established dry apple pomace
tolerance at 40 ppm and peanut forage/
hay tolerances exist at 15 ppm, the
Agency has determined that adding
cotton feed items to the animal diet will
not increase the dietary burden and
therefore, the current tolerances on
animal commodities are adequate.
The Agency conducted dietary
exposure assessments for the cotton use
under section 18 of FIFRA. Using the
Dietary Exposure Evaluation Model
software with the Food Commodity
Intake Database (DEEMTM-FCID version
2.02) an analysis evaluated the
individual food consumption as
reported by respondents in the United
States Department of Agriculture
(USDA) 1994–1996 and 1998
nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and
accumulated exposure to thiophanatemethyl for each commodity. The
addition of cotton did not result in any
increase in dietary exposure compared
to existing uses. Further, there are no
new residential uses being proposed
since the Agency’s previous risk
assessment. Therefore, establishing
tolerances for residues of thiophanatemethyl in or on cotton and cotton gin
byproducts will not increase the most
recent estimated aggregate risks
resulting from use of thiophanatemethyl, as discussed in the Federal
Register of July 23, 2003 (68 FR 43465)
(FRL–7317–5) final rule establishing a
time-limited tolerance for combined
residues of thiophanate methyl and its
metabolite MBC in or on fruiting
vegetables. Refer to the July 23, 2003
Federal Register document for a
detailed discussion of the aggregate risk
assessments and determination of
safety. Additionally, a summary of the
toxicological dose and endpoints for
thiophanate methyl for use in human
risk assessment is discussed in the final
rule published in the Federal Register
of August 28, 2002 (67 FR 55137) (FRL–
7192–1). EPA relies upon these risk
assessments and the findings made in
the July 23, 2003 Federal Register
document in support of this action.
Below is a summary of the aggregate risk
assessments.
The acute and chronic dietary risk
estimates for thiophanate methyl were
less than 100% of the acute and chronic
Population Adjusted Doses (aPAD and
cPAD) at the 99.9th exposure percentile
for the general U.S. population and all
population subgroups. The acute and
chronic dietary risk estimates for MBC
+2-AB were also less than 100% of the
aPAD and cPAD at the 99.9th exposure
percentile for the general U.S.
population and all population
subgroups. EPA generally has no
concern for exposures below 100% of
the PADs, because the PADs represent
the level at or below which daily
aggregate dietary exposure over a
lifetime will not pose appreciable risks
to human health. The most highly
exposed subgroup for all risk estimates
calculated was children 1–2 years. Table
1 summarizes the percentages of aPADs
and cPADs for all scenarios for the
overall U.S. population and for the most
highly exposed population subgroup
(children 1–2 years).
TABLE 1.—ACUTE AND CHRONIC DIETARY RISK ESTIMATES FOR THIOPHANATE METHYL EXISTING AND PROPOSED USE
cPAD Utilized
Population Subgroup
aPAD Utilized
TM
The acute drinking water assessment,
based on simultaneous dietary exposure
to both MBC and thiophanate methyl
(which was converted to MBC
equivalents) resulted in Drinking Water
Levels of Concern (DWLOCs) for the
Overall U.S. Population of 5,833 parts
per billion (ppb), and for children (1–2
years) of 72 ppb (the population
subgroup with the lowest DWLOC). All
acute DWLOCs were well above the
acute Estimated Environmental
Concentrations (EECs) for groundwater
and surfacewater, at 3 and 44 ppb,
respectively.
The chronic drinking water
assessment, based on simultaneous
dietary exposure to both MBC and
thiophanate methyl (which was
converted to MBC equivalents) resulted
in chronic DWLOCs for the Overall U.S.
Population of 870 ppb, and for children
(1–2 years) of 22 ppb (the population
subgroup with the lowest DWLOC). All
chronic DWLOCs were well above the
chronic EEC for groundwater of 3 ppb.
The chronic DWLOCs were also above
the chronic EEC for surfacewater of 23–
24 ppb, except for that of the most
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<1%
<1%
22%
Children (1–2 years old)
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TM
6%
U.S. population
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MBC +2-AB
58%
2%
10%
highly exposed subgroup, children (1–2
years), which is slightly below the EEC
with a chronic DWLOC of 22 ppb.
However, given the conservative nature
of the screening-level approach to
estimated drinking water risks, and the
equivalent levels of the chronic DWLOC
and EEC (22–23–24 ppb), the Agency
does not believe this represents a
significant risk or concern for chronic
aggregate exposures.
Short-term aggregate exposure takes
into account residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Thiophanate methyl
and MBC are currently registered for
uses that could result in short-term
residential exposure and the Agency has
determined that it is appropriate to
aggregate chronic food and water and
short-term exposures for thiophanate
methyl and MBC. All residential
exposures are considered to be shortterm. The Margins of Exposure (MOEs)
(converted to MBC equivalents) for
aggregate short-term exposure to
thiophanate methyl are as follows: oral
exposure of children (1–6 years) is 670;
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dermal exposure of children (1–6 years)
is 1,000; and dermal exposure of
females (13–50 years) is 1,315. The
MOEs for aggregate exposure to MBC
from the use of MBC as an in-can paint
preservative are 670 for dermal
exposure and 770 for exposure via
inhalation. The MOEs (converted to
MBC equivalents) for the total
thiophanate methyl and MBC aggregate
exposure are as follows: 630 for oral and
dermal exposure of children (1–years);
770 for exposure via inhalation for
females (13–50 years); and 620 for oral
and dermal exposure for females (13–50
years). Although the MOEs below 1,000
exceed the Agency’s level of concern,
when considering the conservative
method of exposure estimation and the
negotiated risk mitigation whereby the
registrant has agreed to conduct handpress studies to help refine this
assessment, the risks do not exceed the
Agency’s level of concern.
The total thiophanate methyl and
MBC+2-AB dietary cancer risk is 1.1 x
10-6 for existing and proposed new uses.
The cancer risk from non-occupational
residential exposure is 1.1 x 10-6.
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Therefore, aggregate cancer risk is 2.2 x
10-6. This risk estimate includes cancer
risk from both thiophanate methyl and
MBC+2-AB on food including all
existing uses and section 18 uses,
thiophanate methyl exposure from
treating ornamentals, thiophanate
methyl exposure from performing postapplication lawn activities, and
exposure from applying paint
containing MBC. This is considered to
be a high-end risk scenario since it is
not expected that someone would treat
ornamentals, perform high exposure
post-application activities, and apply
paint containing MBC every year for 70
years. Therefore, this estimate is
considered to be a conservative
estimate. Additionally, the cancer risk
estimate for drinking water is based on
the highest EEC, which is also a very
high-end risk estimate since it is based
on the maximum rate being applied
every season for 70 years. The risk
estimate calculations also assumed that
the modeled surface water EEC is
equivalent to concentrations in finished
drinking water. Thus, food plus water
plus non-occupational residential
cancer risk is 2.2 x 10-6 which is within
the range considered as negligible.
Therefore, the risks do not exceed the
Agency’s level of concern.
Based on these risk assessments, EPA
concludes that there is a reasonable
certainty that no harm will result to the
general population, and to infants and
children from aggregate exposure to
thiophanate-methyl residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(example—gas chromatography) is
available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
Canada, Codex, and Mexico do not
have maximum residue limits for
residues of thiophanate-methyl in or on
cotton or byproducts of cotton.
Therefore, harmonization is not an
issue.
VI. Conclusion
Therefore, tolerances are established
for combined residues of thiophanatemethyl, thiophanate-methyl and its
metabolite (methyl 2-benzimidazoyl
carbamate (MBC), in or on cotton at 0.05
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ppm and cotton, gin byproducts at 5.0
ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
Although the procedures in those
regulations require some modification to
reflect the amendments made to the
FFDCA by the FQPA, EPA will continue
to use those procedures, with
appropriate adjustments, until the
necessary modifications can be made.
The new section 408(g) of the FFDCA
provides essentially the same process
for persons to ‘‘object’’ to a regulation
for an exemption from the requirement
of a tolerance issued by EPA under new
section 408(d) of the FFDCA, as was
provided in the old sections 408 and
409 of the FFDCA. However, the period
for filing objections is now 60 days,
rather than 30 days.
A. What Do I Need to Do to File an
Objection or Request a Hearing?
You must file your objection or
request a hearing on this regulation in
accordance with the instructions
provided in this unit and in 40 CFR part
178. To ensure proper receipt by EPA,
you must identify docket ID number
OPP–2005–0011 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before May 23, 2005.
1. Filing the request. Your objection
must specify the specific provisions in
the regulation that you object to, and the
grounds for the objections (40 CFR
178.25). If a hearing is requested, the
objections must include a statement of
the factual issues(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
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Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2.Copies for the Docket. In addition to
filing an objection or hearing request
with the Hearing Clerk as described in
Unit VII.A., you should also send a copy
of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by the docket ID
number OPP–2005–0011, to: Public
Information and Records Integrity
Branch, Information Resources and
Services Division (7502C), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001. In person or by courier, bring a
copy to the location of the PIRIB
described in ADDRESSES. You may also
send an electronic copy of your request
via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and
avoid the use of special characters and
any form of encryption. Copies of
electronic objections and hearing
requests will also be accepted on disks
in WordPerfect 6.1/8.0 or ASCII file
format. Do not include any CBI in your
electronic copy. You may also submit an
electronic copy of your request at many
Federal Depository Libraries.
B. When Will the Agency Grant a
Request for a Hearing?
A request for a hearing will be granted
if the Administrator determines that the
material submitted shows the following:
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
uncontested claims or facts to the
contrary; and resolution of the factual
issues(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
VIII. Statutory and Executive Order
Reviews
This final rule establishes timelimited tolerances under section 408 of
the FFDCA. The Office of Management
and Budget (OMB) has exempted these
types of actions from review under
Executive Order 12866, entitled
Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this
rule has been exempted from review
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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 final 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 the
FFDCA. For these same reasons, the
Agency has determined that this 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 6, 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
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
under Executive Order 12866 due to its
lack of significance, this rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., 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 under 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 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). Since
tolerances and exemptions that are
established on the basis of a FIFRA
section 18 exemption under section 408
of the FFDCA, such as the tolerances in
this final rule, do not require the
issuance of a proposed rule, the
requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. 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
Commodity
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
IX. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 25, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.371 is amended by
alphabetically adding commodities to
the table in paragraph (b) to read as
follows:
I
§ 180.371 Thiophanate-methyl; tolerances
for residues.
(b) *
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Federal Register / Vol. 70, No. 55 / Wednesday, March 23, 2005 / Rules and Regulations
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[FR Doc. 05–5720 Filed 3–22–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 271
[FRL–7888–3]
North Carolina: Final Authorization of
State Hazardous Waste Management
Program Revision
Environmental Protection
Agency (EPA).
ACTION: Immediate final rule.
AGENCY:
North Carolina has applied to
EPA for Final authorization of the
changes to its hazardous waste program
under the Resource Conservation and
Recovery Act (RCRA). EPA has
determined that these changes satisfy all
requirements needed to qualify for Final
authorization, and is authorizing the
State’s changes through this immediate
final action. EPA is publishing this rule
to authorize the changes without a prior
proposal because we believe this action
is not controversial and do not expect
comments that oppose it. Unless we get
written comments which oppose this
authorization during the comment
period, the decision to authorize North
Carolina’s changes to their hazardous
waste program will take effect. If we get
comments that oppose this action, we
will publish a document in the Federal
Register withdrawing this rule before it
takes effect and a separate document in
the proposed rules section of this
Federal Register will serve as a proposal
to authorize the changes.
DATES: This Final authorization will
become effective on May 23, 2005,
unless EPA receives adverse written
comment by April 22, 2005. If EPA
receives such comment, it will publish
a timely withdrawal of this immediate
final rule in the Federal Register and
inform the public that this authorization
will not take effect.
ADDRESSES: Send written comments to
Thornell Cheeks, North Carolina
Authorizations Coordinator, RCRA
Programs Branch, Waste Management
Division, U.S. Environmental Protection
Agency, Atlanta Federal Center, 61
Forsyth Street, SW., Atlanta, GA 30303–
3104; (404) 562–8479. You may also email your comments to
Cheeks.Thornell@epa.gov or submit
your comments at https://
www.regulation.gov. Copies of North
Carolina’s applications may be viewed
from 9 a.m. to 4 p.m. at the following
addresses: North Carolina Department of
SUMMARY:
VerDate jul<14>2003
14:14 Mar 22, 2005
Jkt 205001
Environment and Natural Resources,
401 Oberlin Rd., Suite 150, Raleigh,
North Carolina 29201, (919)733–2178;
and EPA Region 4, Atlanta Federal
Center, Library, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303; (404) 562–8190,
John Wright, Librarian.
FOR FURTHER INFORMATION CONTACT:
Thornell Cheeks, North Carolina
Authorizations Coordinator, RCRA
Programs Branch, Waste Management
Division, U.S. Environmental Protection
Agency, Atlanta Federal Center, 61
Forsyth Street, SW., Atlanta, GA 30303–
3104; (404) 562–8479.
SUPPLEMENTARY INFORMATION:
A. Why Are Revisions to State
Programs Necessary?
States which have received final
authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must
maintain a hazardous waste program
that is equivalent to, consistent with,
and no less stringent than the Federal
program. As the Federal program
changes, States must change their
programs and ask EPA to authorize the
changes. Changes to State programs may
be necessary when Federal or State
statutory or regulatory authority is
modified or when certain other changes
occur. Most commonly, States must
change their programs because of
changes to EPA’s regulations in 40 Code
of Federal Regulations (CFR) parts 124,
260 through 266, 268, 270, 273 and 279.
B. What Decisions Have We Made in
This Rule?
We conclude that North Carolina’s
applications to revise its authorized
program meets all of the statutory and
regulatory requirements established by
RCRA. Therefore, we grant North
Carolina Final authorization to operate
its hazardous waste program with the
changes described in the authorization
applications. North Carolina has
responsibility for permitting Treatment,
Storage, and Disposal Facilities (TSDFs)
within its borders (except in Indian
Country) and for carrying out the
aspects of the RCRA program described
in its revised program application,
subject to the limitations of the
Hazardous and Solid Waste
Amendments of 1984 (HSWA). New
Federal requirements and prohibitions
imposed by Federal regulations that
EPA promulgates under the authority of
HSWA take effect in authorized States
before they are authorized for the
requirements. Thus, EPA will
implement those requirements and
prohibitions in North Carolina,
including issuing permits, until the
State is granted authorization to do so.
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C. What Is the Effect of Today’s
Authorization Decision?
The effect of this decision is that a
facility in North Carolina subject to
RCRA will now have to comply with the
authorized State requirements instead of
the equivalent Federal requirements in
order to comply with RCRA. North
Carolina has enforcement
responsibilities under its State
hazardous waste program for violations
of such program, but EPA retains its
authority under RCRA sections 3007,
3008, 3013, and 7003, which include,
among others, authority to:
• Do inspections, and require
monitoring, tests, analyses or reports.
• Enforce RCRA requirements and
suspend or revoke permits.
• Take enforcement actions regardless
of whether the State has taken its own
actions.
This action does not impose
additional requirements on the
regulated community because the
regulations for which North Carolina is
being authorized by today’s action are
already effective, and are not changed
by today’s action.
D. Why Wasn’t There a Proposed Rule
Before Today’s Rule?
EPA did not publish a proposal before
today’s rule because we view this as a
routine program change and do not
expect comments that oppose this
approval. We are providing an
opportunity for public comment now. In
addition to this rule, in the proposed
rules section of today’s Federal Register
we are publishing a separate document
that proposes to authorize the State
program changes.
E. What Happens if EPA Receives
Comments That Oppose This Action?
If EPA receives comments that oppose
this authorization, we will withdraw
this rule by publishing a document in
the Federal Register before the rule
becomes effective. EPA will base any
further decision on the authorization of
the State program changes on the
proposal mentioned in the previous
paragraph. We will then address all
public comments in a later final rule.
You may not have another opportunity
to comment. If you want to comment on
this authorization, you must do so at
this time.
If we receive comments that oppose
only the authorization of a particular
change to the State hazardous waste
program, we will withdraw that part of
this rule but the authorization of the
program changes that the comments do
not oppose will become effective on the
date specified above. The Federal
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]]>Agencies
[Federal Register Volume 70, Number 55 (Wednesday, March 23, 2005)]
[Rules and Regulations]
[Pages 14551-14556]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5720]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0011; FRL-7699-3]
Thiophanate-methyl; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
combined residues of thiophanate-methyl and its metabolite methyl 2-
benzimidazoyl carbamate (MBC) in or on cotton and cotton, gin
byproducts. This action is in response to EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on cotton. This regulation establishes a maximum permissible level for
residues of thiophanate-methyl in these feed commodities. These
tolerances will expire and are revoked on December 31, 2007.
DATES: This regulation is effective March 23, 2005. Objections and
requests for hearings must be received on or before May 23, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number OPP-2005-0011. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
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 electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 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 discussed above. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
How Can I Access Electronic Copies of this Document and Other Related
Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at
[[Page 14552]]
https://www.epa.gov/fedrgstr/. A frequently updated electronic version
of 40 CFR part 180 is available at E-CFR Beta Site Two at https://
www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for combined residues of the
fungicide thiophanate-methyl, and its metabolite MBC, in or on cotton
at 0.05 parts per million (ppm) and cotton gin byproducts at 5.0 ppm.
These tolerances will expire and are revoked on December 31, 2007. EPA
will publish a document in theFederal Register to remove the revoked
tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Thiophanate-methyl on Cotton and FFDCA
Tolerances
On July 20, 2004, the State of Florida utilized the crisis
exemption authority as provided under FIFRA section 18 for use of
thiophanate-methyl on cotton. According to the State, fusarium hardlock
of cotton has been identified as a severe economic disease during the
last 4 years. This disease has become a problem since the state began
to grow primarily genetically modified (GMOs) varieties of cotton.
Cotton yields have been reduced up to 50% as a result of the disease.
To date, thiophanate-methyl is the only pesticide that has been
identified to control this disease on cotton. EPA has authorized under
FIFRA section 18 the use of thiophanate-methyl on cotton for control of
fusarium hardlock in Florida. After having reviewed the submission, EPA
concurs that emergency conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of thiophanate-methyl in or
on cotton. In doing so, EPA considered the safety standard in section
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance
under section 408(l)(6) of the FFDCA would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing these tolerances without notice and opportunity
for public comment as provided in section 408(l)(6) of the FFDCA.
Although these tolerances will expire and are revoked on December 31,
2007, under section 408(l)(5) of the FFDCA, residues of the pesticide
not in excess of the amounts specified in the tolerance remaining in or
on cotton and cotton gin byproducts after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by these tolerances at the time of that application. EPA will take
action to revoke these tolerances earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether thiophanate-
methyl meets EPA's registration requirements for use on cotton or
whether permanent tolerances for this use would be appropriate. Under
these circumstances, EPA does not believe that these tolerances serve
as a basis for registration of thiophanate-methyl by a State for
special local needs under FIFRA section 24(c). Nor do these tolerances
serve as the basis for any State other than Florida to use this
pesticide on this crop under section 18 of FIFRA without following all
provisions of EPA's regulations implementing FIFRA section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemption for thiophanate-methyl, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961 (FRL-
5754-7).
Consistent with section 408(b)(2)(D) of the FFDCA , EPA has
reviewed the available scientific data and other relevant information
in support of this action. EPA has sufficient data to assess the
hazards of thiophanate-methyl and to make a determination on aggregate
exposure, consistent with section 408(b)(2) of the FFDCA, for a time-
limited tolerance for combined residues of thiophanate-methyl in or on
cotton at 0.05 ppm and cotton, gin byproducts at 5.0 ppm.
Residue data were submitted for cotton. Cotton is not consumed by
humans, any inadvertent exposure to residues of thiophanate-methyl from
this emergency exemption will result from the consumption of meat or
milk since cotton gin byproducts and cottonseed (meal, hulls) are
animal feed items. Currently there are tolerances for residues of
thiophanate-methyl in or on milk and ruminant meat, meat byproducts,
liver, and fat. Since there is
[[Page 14553]]
an established dry apple pomace tolerance at 40 ppm and peanut forage/
hay tolerances exist at 15 ppm, the Agency has determined that adding
cotton feed items to the animal diet will not increase the dietary
burden and therefore, the current tolerances on animal commodities are
adequate.
The Agency conducted dietary exposure assessments for the cotton
use under section 18 of FIFRA. Using the Dietary Exposure Evaluation
Model software with the Food Commodity Intake Database
(DEEMTM-FCID version 2.02) an analysis evaluated the
individual food consumption as reported by respondents in the United
States Department of Agriculture (USDA) 1994-1996 and 1998 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to thiophanate-methyl for each commodity. The
addition of cotton did not result in any increase in dietary exposure
compared to existing uses. Further, there are no new residential uses
being proposed since the Agency's previous risk assessment. Therefore,
establishing tolerances for residues of thiophanate-methyl in or on
cotton and cotton gin byproducts will not increase the most recent
estimated aggregate risks resulting from use of thiophanate-methyl, as
discussed in the Federal Register of July 23, 2003 (68 FR 43465) (FRL-
7317-5) final rule establishing a time-limited tolerance for combined
residues of thiophanate methyl and its metabolite MBC in or on fruiting
vegetables. Refer to the July 23, 2003 Federal Register document for a
detailed discussion of the aggregate risk assessments and determination
of safety. Additionally, a summary of the toxicological dose and
endpoints for thiophanate methyl for use in human risk assessment is
discussed in the final rule published in the Federal Register of August
28, 2002 (67 FR 55137) (FRL-7192-1). EPA relies upon these risk
assessments and the findings made in the July 23, 2003 Federal Register
document in support of this action. Below is a summary of the aggregate
risk assessments.
The acute and chronic dietary risk estimates for thiophanate methyl
were less than 100% of the acute and chronic Population Adjusted Doses
(aPAD and cPAD) at the 99.9th exposure percentile for the
general U.S. population and all population subgroups. The acute and
chronic dietary risk estimates for MBC +2-AB were also less than 100%
of the aPAD and cPAD at the 99.9th exposure percentile for
the general U.S. population and all population subgroups. EPA generally
has no concern for exposures below 100% of the PADs, because the PADs
represent the level at or below which daily aggregate dietary exposure
over a lifetime will not pose appreciable risks to human health. The
most highly exposed subgroup for all risk estimates calculated was
children 1-2 years. Table 1 summarizes the percentages of aPADs and
cPADs for all scenarios for the overall U.S. population and for the
most highly exposed population subgroup (children 1-2 years).
Table 1.--Acute and chronic dietary risk estimates for Thiophanate Methyl Existing and Proposed Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
cPAD Utilized MBC
Population Subgroup aPAD Utilized -------------------------------------------------------------------------- +2-
TM MBC +2-AB TM
----------------------------------------------------------------------------------------------------------------------------------------------------- -----
U.S. population 6% 2% <1% <1%
-------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 22% 58% 2% 10%
--------------------------------------------------------------------------------------------------------------------------------------------------------
The acute drinking water assessment, based on simultaneous dietary
exposure to both MBC and thiophanate methyl (which was converted to MBC
equivalents) resulted in Drinking Water Levels of Concern (DWLOCs) for
the Overall U.S. Population of 5,833 parts per billion (ppb), and for
children (1-2 years) of 72 ppb (the population subgroup with the lowest
DWLOC). All acute DWLOCs were well above the acute Estimated
Environmental Concentrations (EECs) for groundwater and surfacewater,
at 3 and 44 ppb, respectively.
The chronic drinking water assessment, based on simultaneous
dietary exposure to both MBC and thiophanate methyl (which was
converted to MBC equivalents) resulted in chronic DWLOCs for the
Overall U.S. Population of 870 ppb, and for children (1-2 years) of 22
ppb (the population subgroup with the lowest DWLOC). All chronic DWLOCs
were well above the chronic EEC for groundwater of 3 ppb. The chronic
DWLOCs were also above the chronic EEC for surfacewater of 23-24 ppb,
except for that of the most highly exposed subgroup, children (1-2
years), which is slightly below the EEC with a chronic DWLOC of 22 ppb.
However, given the conservative nature of the screening-level approach
to estimated drinking water risks, and the equivalent levels of the
chronic DWLOC and EEC (22-23-24 ppb), the Agency does not believe this
represents a significant risk or concern for chronic aggregate
exposures.
Short-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Thiophanate methyl and MBC are currently
registered for uses that could result in short-term residential
exposure and the Agency has determined that it is appropriate to
aggregate chronic food and water and short-term exposures for
thiophanate methyl and MBC. All residential exposures are considered to
be short-term. The Margins of Exposure (MOEs) (converted to MBC
equivalents) for aggregate short-term exposure to thiophanate methyl
are as follows: oral exposure of children (1-6 years) is 670; dermal
exposure of children (1-6 years) is 1,000; and dermal exposure of
females (13-50 years) is 1,315. The MOEs for aggregate exposure to MBC
from the use of MBC as an in-can paint preservative are 670 for dermal
exposure and 770 for exposure via inhalation. The MOEs (converted to
MBC equivalents) for the total thiophanate methyl and MBC aggregate
exposure are as follows: 630 for oral and dermal exposure of children
(1-years); 770 for exposure via inhalation for females (13-50 years);
and 620 for oral and dermal exposure for females (13-50 years).
Although the MOEs below 1,000 exceed the Agency's level of concern,
when considering the conservative method of exposure estimation and the
negotiated risk mitigation whereby the registrant has agreed to conduct
hand-press studies to help refine this assessment, the risks do not
exceed the Agency's level of concern.
The total thiophanate methyl and MBC+2-AB dietary cancer risk is
1.1 x 10-6 for existing and proposed new uses. The cancer
risk from non-occupational residential exposure is 1.1 x
10-6.
[[Page 14554]]
Therefore, aggregate cancer risk is 2.2 x 10-6. This risk
estimate includes cancer risk from both thiophanate methyl and MBC+2-AB
on food including all existing uses and section 18 uses, thiophanate
methyl exposure from treating ornamentals, thiophanate methyl exposure
from performing post-application lawn activities, and exposure from
applying paint containing MBC. This is considered to be a high-end risk
scenario since it is not expected that someone would treat ornamentals,
perform high exposure post-application activities, and apply paint
containing MBC every year for 70 years. Therefore, this estimate is
considered to be a conservative estimate. Additionally, the cancer risk
estimate for drinking water is based on the highest EEC, which is also
a very high-end risk estimate since it is based on the maximum rate
being applied every season for 70 years. The risk estimate calculations
also assumed that the modeled surface water EEC is equivalent to
concentrations in finished drinking water. Thus, food plus water plus
non-occupational residential cancer risk is 2.2 x 10-6 which
is within the range considered as negligible. Therefore, the risks do
not exceed the Agency's level of concern.
Based on these risk assessments, EPA concludes that there is a
reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
thiophanate-methyl residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example--gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
Canada, Codex, and Mexico do not have maximum residue limits for
residues of thiophanate-methyl in or on cotton or byproducts of cotton.
Therefore, harmonization is not an issue.
VI. Conclusion
Therefore, tolerances are established for combined residues of
thiophanate-methyl, thiophanate-methyl and its metabolite (methyl 2-
benzimidazoyl carbamate (MBC), in or on cotton at 0.05 ppm and cotton,
gin byproducts at 5.0 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0011 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before May 23,
2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2.Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by the docket ID number OPP-2005-0011, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes time-limited tolerances under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review
[[Page 14555]]
under Executive Order 12866 due to its lack of significance, this rule
is not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., 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 under 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 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). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. 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 final
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 the
FFDCA. For these same reasons, the Agency has determined that this 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 6, 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 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 rule.
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 25, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.371 is amended by alphabetically adding commodities to
the table in paragraph (b) to read as follows:
Sec. 180.371 Thiophanate-methyl; tolerances for residues.
(b) * * *
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
* * * * *
Cotton 0.05 12/31/07
----------------------------------------------------------------------------------------------------------------
Cotton, gin byproducts 5.0 12/31/07
* * * * *
----------------------------------------------------------------------------------------------------------------
[[Page 14556]]
* * * * *
[FR Doc. 05-5720 Filed 3-22-05; 8:45 am]
BILLING CODE 6560-50-S
