Dimethyl Sulfoxide; Exemption From the Requirement of a Tolerance, 61125-61129 [2015-25589]
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Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations
approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
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
(NTTAA) (15 U.S.C. 272 note).
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XI. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
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List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
This regulation is effective
October 9, 2015. Objections and
requests for hearings must be received
on or before December 8, 2015, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, add alphabetically the
following polymer to the table to read as
follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
*
*
Polymer
CAS No.
*
*
*
*
*
Cellulose carboxymethyl ether,
potassium salt, minimum
number average molecular
weight 9587 Daltons ............. 54848–04–3
*
*
*
*
*
[FR Doc. 2015–25689 Filed 10–8–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
Dimethyl Sulfoxide; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends the
exemption from the requirement of a
tolerance for residues of dimethyl
sulfoxide (CAS Reg. No. 67–68–5) when
used as an inert ingredient (solvent, cosolvent) in pesticide formulations
applied to growing crops (pre-emergent
use only) to include use after the crop
emerges from the soil but before harvest
provided that the potential for increased
residues of the formulation’s active
ingredient(s) in or on food commodities
has been assessed. ISK BioSciences
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
SUMMARY:
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0630, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
[EPA–HQ–OPP–2014–0630; FRL–9934–17]
PO 00000
(FFDCA), requesting an amendment to
an existing exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of dimethyl sulfoxide.
DATES:
Dated: October 1, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
*
61125
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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. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations
II. Petition for Exemption
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2014–0630 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before December 8, 2015. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2014–0630, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
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In the Federal Register of March 4,
2015 (80 FR 11611) (FRL–9922–68),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (IN–10713) by ISK BioSciences,
7470 Auburn Rd., Suite A, Concorde,
OH 44077. The petition requested that
40 CFR 180.920 be amended by
modifying an exemption from the
requirement of a tolerance for residues
of dimethyl sulfoxide (CAS Reg. No. 67–
68–5) when used as an inert ingredient
(diluent) at levels not to exceed 62% in
pesticide formulations containing
cyclaniliprole. That document
referenced a summary of the petition
prepared by ISK BioSciences, the
petitioner, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA has
modified the request for a tolerance
exemption due to the concern regarding
the chemical properties of dimethyl
sulfoxide that may result in increased
active ingredient residues. Therefore,
the tolerance exemption under 40 CFR
180.920 was modified. This limitation is
based on the Agency’s risk assessment
which can be found at https://
www.regulations.gov in document
Dimethyl sulfoxide; Human Health Risk
Assessment and Ecological Effects
Assessment to Support Proposed
Exemption from the Requirement of a
Tolerance When Used as Inert
Ingredients in Pesticide Formulations in
docket ID number EPA–HQ–OPP–2014–
0630.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
PO 00000
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IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for 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 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 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. . . .’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
inert ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with FFDCA section
408(c)(2)(A), and the factors specified in
FFDCA section 408(c)(2)(B), 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
and to make a determination on
aggregate exposure for dimethyl
sulfoxide including exposure resulting
from the exemption established by this
action. EPA’s assessment of exposures
and risks associated with dimethyl
sulfoxide follows.
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A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by dimethyl sulfoxide as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
are discussed in this unit.
Dimethyl sulfoxide has low acute
toxicity via the oral and dermal in rats
and mice and inhalation route in rats.
The acute oral lethal dose (LD)50 ≥
7,920 milligrams/kilograms (mg/kg) in
rats and mice. The acute dermal LD50
≥ 40,000 mg/kg in rats and mice. The
acute inhalation lethal concentration
(LC)50 ≥ 1,600 milligram/meter3 (mg/
m3) (∼277 mg/kg) in rats. It is a dermal,
eye and gastric irritant in rats and
rabbits. It is a sensitizer in guinea pigs.
Overall systemic toxicity with regard
to oral and dermal exposure to dimethyl
sulfoxide is low. The target organ of
toxicity is the eye. Changes in the eyes,
such as refractile changes in the lens
and lens composition are seen in
various animals at doses above the limit
dose (1,000 mg/kg/day).
Systemic toxicity is not observed
following exposure to dimethyl
sulfoxide at dose levels up to 1,000 mg/
kg/day (the limit dose) in subchronic,
chronic or reproduction/developmental
toxicity studies via oral, dermal or
inhalation exposures in rats, dogs and
rabbits. Dimethyl sulfoxide is not
expected to be carcinogenic based on
the lack of mutagenicity and the lack of
tumor formation in cancer initiation/
promotion studies. It is not neurotoxic
nor immunotoxic.
Toxicity of dimethyl sulfoxide via the
inhalation route of exposure is limited
to portal of entry effects at 2.783 mg/1
(equivalent to 722 mg/kg/day).
In the rat and monkey, dimethyl
sulfoxide administered via the oral and/
or dermal route is rapidly absorbed,
metabolized and excreted. Excretion is
primarily via urine, feces was a minor
route in the rat only. The major
metabolite was dimethyl sulfone.
Dimethyl sulfide, another metabolite, is
eliminated through the breath. There is
no bioaccumulation.
Specific information on the studies
received and the nature of the adverse
effects caused by Dimethyl sulfoxide as
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well as the NOAEL and the LOAEL from
the toxicity studies can be found at
https://www.regulations.gov in the
document ‘‘Dimethyl sulfoxide; Human
Health Risk Assessment and Ecological
Effects Assessment to Support Proposed
Exemption from the Requirement of a
Tolerance When Used as Inert
Ingredients in Pesticide Formulations’’
in docket ID number EPA–HQ–OPP–
2014–0630.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
The available toxicity studies indicate
that dimethyl sulfoxide has low toxicity.
These data demonstrated adverse effects
only at doses ≥1100 mg/kg/day (above
the limit dose). Therefore, since no
endpoint of concern was identified for
dimethyl sulfoxide, a qualitative risk
assessment is appropriate.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to dimethyl sulfoxide, EPA
considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
dimethyl sulfoxide in food as follows:
Dietary exposure can occur from
eating foods containing residues of
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61127
dimethyl sulfoxide. Because no hazard
endpoint of concern was identified for
the acute and chronic dietary
assessment (food and feed uses, a
quantitative dietary exposure risk
assessment was not conducted.
2. Dietary exposure from drinking
water. Since a hazard endpoint of
concern was not identified for the acute
and chronic dietary assessment, a
quantitative dietary exposure risk
assessment for drinking water was not
conducted.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
Dimethyl sulfoxide may be used in
consumer products that may be used
around the home. However, based on
the lack of toxicity, a quantitative
exposure assessment from ‘‘residential
exposures’’ was not performed.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found dimethyl sulfoxide
to share a common mechanism of
toxicity with any other substances, and
dimethyl sulfoxide does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that dimethyl sulfoxide does
not have a common mechanism of
toxicity with other substances. For
information regarding EPA’s efforts to
determine which chemicals have a
common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see EPA’s Web site at
https://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
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safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
At this time, there is no concern for
potential sensitivity to infants and
children resulting from exposures to
dimethyl sulfoxide. There is no reported
quantitative or qualitative evidence of
increased susceptibility of rat or rabbit
fetuses to in utero exposure to dimethyl
sulfoxide in developmental toxicity
studies in rats and rabbits. No
quantitative or qualitative evidence of
increased susceptibility has been
reported following the pre/postnatal
exposure to rats and rabbits in 2generation reproduction toxicity studies
in rats and rabbits. Given the lack of
adverse toxicological effects at limit
dose levels, a safety factor analysis has
not been used to assess the risk. For
these reasons the additional tenfold
safety factor is unnecessary.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Because no intermediate-term adverse
effect was identified, dimethyl sulfoxide
is not expected to pose an intermediateterm risk.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
increased tumor formation in initiation/
promotion toxicity studies and the lack
of mutagenicity, dimethyl sulfoxide is
not expected to pose a cancer risk to
humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to dimethyl
sulfoxide residues.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, dimethyl sulfoxide
is not expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that based on the low toxicity of
dimethyl sulfoxide and since no chronic
endpoint was identified, chronic risk is
not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Because no short-term
adverse effect was identified, dimethyl
sulfoxide is not expected to pose a
short-term risk.
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance.
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V. Other Considerations
A. Analytical Enforcement Methodology
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.920 for dimethyl
sulfoxide (CAS Reg. No. 67–68–5) when
used as an inert ingredient solvent,
cosolvent in pesticide formulations used
before crop emerges from soil or prior to
formation of edible parts of food plants;
for pesticide formulations used after
crop emerges but before harvest,
provided that the potential for increased
residues of the formulation’s active
ingredient(s) in or on food commodities
has been assessed.
VII. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action 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) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
PO 00000
Frm 00042
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Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
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
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal
E:\FR\FM\09OCR1.SGM
09OCR1
61129
Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations
Dated: September 14, 2015.
G. Jeffery Herndon,
Acting Director, Registration Division, Office
of Pesticide Programs.
Register. This action 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.
Therefore, 40 CFR chapter I is
amended as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, add alphabetically the
inert ingredient ‘‘Dimethyl Sulfoxide
(CAS No. 67–68–5)’’ to the table to read
as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
■
Inert ingredients
*
*
*
Limits
Uses
*
*
*
*
*
*
Dimethyl Sulfoxide (CAS No. For pesticide formulations used before crop emerges from soil or prior to formation of
67–68–5).
edible parts of food plants; for pesticide formulations used after crop emerges but before harvest, provided that the potential for increased residues of the formulation’s active ingredient(s) in or on food commodities has been assessed.
*
*
*
FOR FURTHER INFORMATION CONTACT:
FEDERAL COMMUNICATIONS
COMMISSION
Kristi Lemoine, Consumer Policy
Division, Consumer and Governmental
Affairs Bureau, Federal
Communications Commission, 445 12th
Street SW., Washington, DC 20554.
(202) 418–2467.
47 CFR Part 64
[CG Docket No. 02–278; WC Docket No.
07–35; FCC 15–72]
Rules and Regulations Implementing
the Telephone Consumer Protection
Act of 1991; et al.
Federal Communications
Commission.
ACTION: Petitions for Rulemaking, denial
and dismissal; declaratory ruling; timelimited waivers; exemptions.
AGENCY:
The Commission affirms and
further clarifies the requirements of the
Telephone Consumer Protection Act
(TCPA), focusing on consumers’ rights
to stop unwanted robocalls, including
both voice calls and text messages. The
Commission acted in an Omnibus
Declaratory Ruling and Order (Omnibus
Order) in response to 21 petitions for
rulemaking, clarification, or other action
regarding the TCPA or the
Commission’s rules and orders. In
addition to denying one petition for
rulemaking and dismissing another
petition for rulemaking, the Omnibus
Order took a number of actions,
including clarifying when certain
conduct violates the TCPA and
providing guidance intended to assist
callers in avoiding violations and
consequent litigation.
DATES: The Omnibus Order was issued
on July 10, 2015.
rmajette on DSK7SPTVN1PROD with RULES
VerDate Sep<11>2014
15:01 Oct 08, 2015
Jkt 238001
*
The full text of the Omnibus
Order is available at https://
www.fcc.gov/document/tcpa-omnibusdeclaratory-ruling-and-order.
BILLING CODE 6560–50–P
SUMMARY:
*
ADDRESSES:
[FR Doc. 2015–25589 Filed 10–8–15; 8:45 a.m.]
SUPPLEMENTARY INFORMATION:
1. The Omnibus Order denied one
petition for rulemaking and dismisses
another petition for rulemaking as both
requests were subsumed in the
declaratory ruling portion of that
document. The Omnibus Order also
addressed a number of requests for
clarification or other relief.
2. Petitions for Rulemaking. The
Professional Association for Customer
Engagement (PACE) filed a Petition for
Expedited Declaratory Ruling and/or
Expedited Rulemaking, and ACA
International filed a Petition for
Rulemaking. PACE’s petition was
addressed on its merits as a Petition for
Declaratory Ruling and its Petition for
Expedited Rulemaking was therefore
dismissed. In the Omnibus Order the
Commission provided clarification
regarding the issues raised by ACA and
therefore its petition was denied.
3. Requests for Clarification or Other
Action. The Omnibus Order also
addressed separate requests for
clarification or other action regarding
the TCPA or the Commission’s rules and
orders implementing the TCPA. The full
text of the Omnibus Order is available
at https://www.fcc.gov/document/tcpaomnibus-declaratory-ruling-and-order.
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
*
*
*
Solvent or co-solvent.
*
4. The Commission strengthened the
core protections of the TCPA by
confirming that:
Æ Callers cannot avoid obtaining
consumer consent for a robocall simply
because they are not ‘‘currently’’ or
‘‘presently’’ dialing random or
sequential phone numbers;
Æ Simply being on an acquaintance’s
phone contact list does not amount to
consent to receive robocalls from thirdparty applications downloaded by the
acquaintance;
Æ Callers are liable for robocalls to
reassigned wireless numbers when the
current subscriber to or customary user
of the number has not consented,
subject to a limited, one-call exception
for cases in which the caller does not
have actual or constructive knowledge
of the reassignment;
Æ Internet-to-phone text messages
require consumer consent; and
Æ Text messages are ‘‘calls’’ subject to
the TCPA, as previously determined by
the Commission.
Æ The Commission also empowered
consumers to stop unwanted calls by
confirming that:
Æ Consumers may revoke consent at
any time and through any reasonable
means; and
Æ Nothing in the Communications
Act or the Commission’s implementing
rules prohibits carriers or Voice over
Internet Protocol providers from
implementing consumer-initiated callblocking technology that can help
consumers stop unwanted robocalls.
5. Finally, the Commission recognized
the legitimate interests of callers by:
Æ Clarifying that application
providers that play a minimal role in
sending text messages are not per se
liable for unwanted robocalls;
E:\FR\FM\09OCR1.SGM
09OCR1
]]>Agencies
[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Rules and Regulations]
[Pages 61125-61129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25589]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0630; FRL-9934-17]
Dimethyl Sulfoxide; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the exemption from the requirement of a
tolerance for residues of dimethyl sulfoxide (CAS Reg. No. 67-68-5)
when used as an inert ingredient (solvent, co-solvent) in pesticide
formulations applied to growing crops (pre-emergent use only) to
include use after the crop emerges from the soil but before harvest
provided that the potential for increased residues of the formulation's
active ingredient(s) in or on food commodities has been assessed. ISK
BioSciences submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting an amendment to an existing
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of dimethyl sulfoxide.
DATES: This regulation is effective October 9, 2015. Objections and
requests for hearings must be received on or before December 8, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0630, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
[[Page 61126]]
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0630 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 8, 2015. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0630, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922-
68), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (IN-10713) by ISK
BioSciences, 7470 Auburn Rd., Suite A, Concorde, OH 44077. The petition
requested that 40 CFR 180.920 be amended by modifying an exemption from
the requirement of a tolerance for residues of dimethyl sulfoxide (CAS
Reg. No. 67-68-5) when used as an inert ingredient (diluent) at levels
not to exceed 62% in pesticide formulations containing cyclaniliprole.
That document referenced a summary of the petition prepared by ISK
BioSciences, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the request for a tolerance exemption due to the concern
regarding the chemical properties of dimethyl sulfoxide that may result
in increased active ingredient residues. Therefore, the tolerance
exemption under 40 CFR 180.920 was modified. This limitation is based
on the Agency's risk assessment which can be found at https://www.regulations.gov in document Dimethyl sulfoxide; Human Health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations in docket ID number EPA-HQ-OPP-
2014-0630.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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 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 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. . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 and to make a
determination on aggregate exposure for dimethyl sulfoxide including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with dimethyl sulfoxide
follows.
[[Page 61127]]
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by dimethyl sulfoxide as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
Dimethyl sulfoxide has low acute toxicity via the oral and dermal
in rats and mice and inhalation route in rats. The acute oral lethal
dose (LD)50 = 7,920 milligrams/kilograms (mg/kg) in rats and
mice. The acute dermal LD50 = 40,000 mg/kg in rats and mice.
The acute inhalation lethal concentration (LC)50 = 1,600
milligram/meter\3\ (mg/m\3\) (~277 mg/kg) in rats. It is a dermal, eye
and gastric irritant in rats and rabbits. It is a sensitizer in guinea
pigs.
Overall systemic toxicity with regard to oral and dermal exposure
to dimethyl sulfoxide is low. The target organ of toxicity is the eye.
Changes in the eyes, such as refractile changes in the lens and lens
composition are seen in various animals at doses above the limit dose
(1,000 mg/kg/day).
Systemic toxicity is not observed following exposure to dimethyl
sulfoxide at dose levels up to 1,000 mg/kg/day (the limit dose) in
subchronic, chronic or reproduction/developmental toxicity studies via
oral, dermal or inhalation exposures in rats, dogs and rabbits.
Dimethyl sulfoxide is not expected to be carcinogenic based on the lack
of mutagenicity and the lack of tumor formation in cancer initiation/
promotion studies. It is not neurotoxic nor immunotoxic.
Toxicity of dimethyl sulfoxide via the inhalation route of exposure
is limited to portal of entry effects at 2.783 mg/1 (equivalent to 722
mg/kg/day).
In the rat and monkey, dimethyl sulfoxide administered via the oral
and/or dermal route is rapidly absorbed, metabolized and excreted.
Excretion is primarily via urine, feces was a minor route in the rat
only. The major metabolite was dimethyl sulfone. Dimethyl sulfide,
another metabolite, is eliminated through the breath. There is no
bioaccumulation.
Specific information on the studies received and the nature of the
adverse effects caused by Dimethyl sulfoxide as well as the NOAEL and
the LOAEL from the toxicity studies can be found at https://www.regulations.gov in the document ``Dimethyl sulfoxide; Human Health
Risk Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2014-0630.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
The available toxicity studies indicate that dimethyl sulfoxide has
low toxicity. These data demonstrated adverse effects only at doses
[gteqt]1100 mg/kg/day (above the limit dose). Therefore, since no
endpoint of concern was identified for dimethyl sulfoxide, a
qualitative risk assessment is appropriate.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dimethyl sulfoxide, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from dimethyl sulfoxide in food as follows:
Dietary exposure can occur from eating foods containing residues of
dimethyl sulfoxide. Because no hazard endpoint of concern was
identified for the acute and chronic dietary assessment (food and feed
uses, a quantitative dietary exposure risk assessment was not
conducted.
2. Dietary exposure from drinking water. Since a hazard endpoint of
concern was not identified for the acute and chronic dietary
assessment, a quantitative dietary exposure risk assessment for
drinking water was not conducted.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
Dimethyl sulfoxide may be used in consumer products that may be
used around the home. However, based on the lack of toxicity, a
quantitative exposure assessment from ``residential exposures'' was not
performed.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found dimethyl sulfoxide to share a common mechanism of
toxicity with any other substances, and dimethyl sulfoxide does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
dimethyl sulfoxide does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of
[[Page 61128]]
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
At this time, there is no concern for potential sensitivity to
infants and children resulting from exposures to dimethyl sulfoxide.
There is no reported quantitative or qualitative evidence of increased
susceptibility of rat or rabbit fetuses to in utero exposure to
dimethyl sulfoxide in developmental toxicity studies in rats and
rabbits. No quantitative or qualitative evidence of increased
susceptibility has been reported following the pre/postnatal exposure
to rats and rabbits in 2-generation reproduction toxicity studies in
rats and rabbits. Given the lack of adverse toxicological effects at
limit dose levels, a safety factor analysis has not been used to assess
the risk. For these reasons the additional tenfold safety factor is
unnecessary.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
dimethyl sulfoxide is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that based on the low
toxicity of dimethyl sulfoxide and since no chronic endpoint was
identified, chronic risk is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Because no
short-term adverse effect was identified, dimethyl sulfoxide is not
expected to pose a short-term risk.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term adverse effect was identified,
dimethyl sulfoxide is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
increased tumor formation in initiation/promotion toxicity studies and
the lack of mutagenicity, dimethyl sulfoxide is not expected to pose a
cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to dimethyl sulfoxide residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for dimethyl sulfoxide (CAS Reg. No.
67-68-5) when used as an inert ingredient solvent, cosolvent in
pesticide formulations used before crop emerges from soil or prior to
formation of edible parts of food plants; for pesticide formulations
used after crop emerges but before harvest, provided that the potential
for increased residues of the formulation's active ingredient(s) in or
on food commodities has been assessed.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action 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) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
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 (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal
[[Page 61129]]
Register. This action 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: September 14, 2015.
G. Jeffery Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
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. In Sec. 180.920, add alphabetically the inert ingredient ``Dimethyl
Sulfoxide (CAS No. 67-68-5)'' to the table to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Dimethyl Sulfoxide (CAS No. 67-68-5) For pesticide formulations used before Solvent or co-solvent.
crop emerges from soil or prior to
formation of edible parts of food
plants; for pesticide formulations
used after crop emerges but before
harvest, provided that the potential
for increased residues of the
formulation's active ingredient(s) in
or on food commodities has been
assessed.
* * * * * * *
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[FR Doc. 2015-25589 Filed 10-8-15; 8:45 a.m.]
BILLING CODE 6560-50-P
