80_FR_61321 80 FR 61125 - Dimethyl Sulfoxide; Exemption From the Requirement of a Tolerance

80 FR 61125 - Dimethyl Sulfoxide; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 196 (October 9, 2015)

Page Range61125-61129
FR Document2015-25589

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.

Federal Register, Volume 80 Issue 196 (Friday, October 9, 2015)
[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Rules and Regulations]
[Pages 61125-61129]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25589]


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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.

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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 http://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 http://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: [email protected].

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 http://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: http://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 http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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, http://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 http://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 http://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 http://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  http://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.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-25589 Filed 10-8-15; 8:45 a.m.]
 BILLING CODE 6560-50-P



                                                                Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations                                                     61125

                                             approval under the Paperwork                            List of Subjects in 40 CFR Part 180                               (FFDCA), requesting an amendment to
                                             Reduction Act (PRA) (44 U.S.C. 3501 et                    Environmental protection,                                       an existing exemption from the
                                             seq.), nor does it require any special                  Administrative practice and procedure,                            requirement of a tolerance. This
                                             considerations under Executive Order                    Agricultural commodities, Pesticides                              regulation eliminates the need to
                                             12898, entitled ‘‘Federal Actions to                    and pests, Reporting and recordkeeping                            establish a maximum permissible level
                                             Address Environmental Justice in                        requirements.                                                     for residues of dimethyl sulfoxide.
                                             Minority Populations and Low-Income                                                                                       DATES: This regulation is effective
                                                                                                       Dated: October 1, 2015.
                                             Populations’’ (59 FR 7629, February 16,                                                                                   October 9, 2015. Objections and
                                             1994).                                                  Susan Lewis,
                                                                                                     Director, Registration Division, Office of                        requests for hearings must be received
                                                Since tolerances and exemptions that                 Pesticide Programs.                                               on or before December 8, 2015, and
                                             are established on the basis of a petition                                                                                must be filed in accordance with the
                                                                                                       Therefore, 40 CFR chapter I is
                                             under FFDCA section 408(d), such as                                                                                       instructions provided in 40 CFR part
                                                                                                     amended as follows:
                                             the tolerance in this final rule, do not                                                                                  178 (see also Unit I.C. of the
                                             require the issuance of a proposed rule,                PART 180—[AMENDED]                                                SUPPLEMENTARY INFORMATION).
                                             the requirements of the Regulatory
                                                                                                                                                                       ADDRESSES:    The docket for this action,
                                             Flexibility Act (RFA) (5 U.S.C. 601 et                  ■ 1. The authority citation for part 180                          identified by docket identification (ID)
                                             seq.), do not apply.                                    continues to read as follows:                                     number EPA–HQ–OPP–2014–0630, is
                                                This action directly regulates growers,                  Authority: 21 U.S.C. 321(q), 346a and 371.                    available at http://www.regulations.gov
                                             food processors, food handlers, and food                ■ 2. In § 180.960, add alphabetically the                         or at the Office of Pesticide Programs
                                             retailers, not States or tribes, nor does               following polymer to the table to read as                         Regulatory Public Docket (OPP Docket)
                                             this action alter the relationships or                  follows:                                                          in the Environmental Protection Agency
                                             distribution of power and                                                                                                 Docket Center (EPA/DC), West William
                                             responsibilities established by Congress                § 180.960 Polymers; exemptions from the                           Jefferson Clinton Bldg., Rm. 3334, 1301
                                             in the preemption provisions of FFDCA                   requirement of a tolerance.                                       Constitution Ave. NW., Washington, DC
                                             section 408(n)(4). As such, the Agency                  *           *     *           *          *                        20460–0001. The Public Reading Room
                                             has determined that this action will not                                                                                  is open from 8:30 a.m. to 4:30 p.m.,
                                             have a substantial direct effect on States                               Polymer                              CAS No.     Monday through Friday, excluding legal
                                             or tribal governments, on the                                                                                             holidays. The telephone number for the
                                             relationship between the national                                                                                         Public Reading Room is (202) 566–1744,
                                                                                                        *         *        *            *       *
                                             government and the States or tribal                     Cellulose carboxymethyl ether,
                                                                                                                                                                       and the telephone number for the OPP
                                             governments, or on the distribution of                    potassium salt, minimum                                         Docket is (703) 305–5805. Please review
                                             power and responsibilities among the                      number average molecular                                        the visitor instructions and additional
                                             various levels of government or between                   weight 9587 Daltons ............. 54848–04–3                    information about the docket available
                                             the Federal Government and Indian                                                                                         at http://www.epa.gov/dockets.
                                             tribes. Thus, the Agency has determined                       *               *              *           *          *
                                                                                                                                                                       FOR FURTHER INFORMATION CONTACT:
                                             that Executive Order 13132, entitled                    [FR Doc. 2015–25689 Filed 10–8–15; 8:45 am]                       Susan Lewis, Registration Division
                                             ‘‘Federalism’’ (64 FR 43255, August 10,                                                                                   (7505P), Office of Pesticide Programs,
                                                                                                     BILLING CODE 6560–50–P
                                             1999) and Executive Order 13175,                                                                                          Environmental Protection Agency, 1200
                                             entitled ‘‘Consultation and Coordination                                                                                  Pennsylvania Ave. NW., Washington,
                                             with Indian Tribal Governments’’ (65 FR                 ENVIRONMENTAL PROTECTION                                          DC 20460–0001; main telephone
                                             67249, November 9, 2000) do not apply                   AGENCY                                                            number: (703) 305–7090; email address:
                                             to this action. In addition, this action                                                                                  RDFRNotices@epa.gov.
                                             does not impose any enforceable duty or                 40 CFR Part 180
                                             contain any unfunded mandate as                                                                                           SUPPLEMENTARY INFORMATION:
                                                                                                     [EPA–HQ–OPP–2014–0630; FRL–9934–17]
                                             described under Title II of the Unfunded                                                                                  I. General Information
                                             Mandates Reform Act (UMRA) (2 U.S.C.                    Dimethyl Sulfoxide; Exemption From
                                             1501 et seq.).                                                                                                            A. Does this action apply to me?
                                                                                                     the Requirement of a Tolerance
                                                This action does not involve any                                                                                          You may be potentially affected by
                                                                                                     AGENCY:  Environmental Protection
                                             technical standards that would require                                                                                    this action if you are an agricultural
                                                                                                     Agency (EPA).
                                             Agency consideration of voluntary                                                                                         producer, food manufacturer, or
                                             consensus standards pursuant to section                 ACTION: Final rule.
                                                                                                                                                                       pesticide manufacturer. The following
                                             12(d) of the National Technology                        SUMMARY:   This regulation amends the                             list of North American Industrial
                                             Transfer and Advancement Act                            exemption from the requirement of a                               Classification System (NAICS) codes is
                                             (NTTAA) (15 U.S.C. 272 note).                           tolerance for residues of dimethyl                                not intended to be exhaustive, but rather
                                                                                                     sulfoxide (CAS Reg. No. 67–68–5) when                             provides a guide to help readers
                                             XI. Congressional Review Act
                                                                                                     used as an inert ingredient (solvent, co-                         determine whether this document
                                               Pursuant to the Congressional Review                  solvent) in pesticide formulations                                applies to them. Potentially affected
                                             Act (5 U.S.C. 801 et seq.), EPA will                    applied to growing crops (pre-emergent                            entities may include:
                                             submit a report containing this rule and                use only) to include use after the crop                              • Crop production (NAICS code 111).
                                             other required information to the U.S.                  emerges from the soil but before harvest
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                                                                                                                                                                          • Animal production (NAICS code
                                             Senate, the U.S. House of                               provided that the potential for increased                         112).
                                             Representatives, and the Comptroller                    residues of the formulation’s active
                                             General of the United States prior to                   ingredient(s) in or on food commodities                              • Food manufacturing (NAICS code
                                             publication of the rule in the Federal                  has been assessed. ISK BioSciences                                311).
                                             Register. This action is not a ‘‘major                  submitted a petition to EPA under the                                • Pesticide manufacturing (NAICS
                                             rule’’ as defined by 5 U.S.C. 804(2).                   Federal Food, Drug, and Cosmetic Act                              code 32532).


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                                             61126              Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations

                                             B. How can I get electronic access to                   II. Petition for Exemption                            IV. Aggregate Risk Assessment and
                                             other related information?                                In the Federal Register of March 4,                 Determination of Safety
                                               You may access a frequently updated                   2015 (80 FR 11611) (FRL–9922–68),                        Section 408(c)(2)(A)(i) of FFDCA
                                             electronic version of 40 CFR part 180                   EPA issued a document pursuant to                     allows EPA to establish an exemption
                                             through the Government Printing                         FFDCA section 408, 21 U.S.C. 346a,                    from the requirement for a tolerance (the
                                             Office’s e-CFR site at http://                          announcing the filing of a pesticide                  legal limit for a pesticide chemical
                                             www.ecfr.gov/cgi-bin/text-                              petition (IN–10713) by ISK BioSciences,
                                                                                                                                                           residue in or on a food) only if EPA
                                             idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    7470 Auburn Rd., Suite A, Concorde,
                                                                                                                                                           determines that the tolerance is ‘‘safe.’’
                                             40tab_02.tpl.                                           OH 44077. The petition requested that
                                                                                                                                                           Section 408(b)(2)(A)(ii) of FFDCA
                                                                                                     40 CFR 180.920 be amended by
                                             C. How can I file an objection or hearing                                                                     defines ‘‘safe’’ to mean that ‘‘there is a
                                                                                                     modifying an exemption from the
                                             request?                                                                                                      reasonable certainty that no harm will
                                                                                                     requirement of a tolerance for residues
                                                                                                     of dimethyl sulfoxide (CAS Reg. No. 67–               result from aggregate exposure to the
                                               Under FFDCA section 408(g), 21                                                                              pesticide chemical residue, including
                                             U.S.C. 346a, any person may file an                     68–5) when used as an inert ingredient
                                                                                                     (diluent) at levels not to exceed 62% in              all anticipated dietary exposures and all
                                             objection to any aspect of this regulation                                                                    other exposures for which there is
                                             and may also request a hearing on those                 pesticide formulations containing
                                                                                                     cyclaniliprole. That document                         reliable information.’’ This includes
                                             objections. You must file your objection                                                                      exposure through drinking water and in
                                             or request a hearing on this regulation                 referenced a summary of the petition
                                                                                                     prepared by ISK BioSciences, the                      residential settings, but does not include
                                             in accordance with the instructions                                                                           occupational exposure. Section
                                             provided in 40 CFR part 178. To ensure                  petitioner, which is available in the
                                                                                                     docket, http://www.regulations.gov.                   408(b)(2)(C) of FFDCA requires EPA to
                                             proper receipt by EPA, you must                                                                               give special consideration to exposure
                                             identify docket ID number EPA–HQ–                       There were no comments received in
                                                                                                     response to the notice of filing.                     of infants and children to the pesticide
                                             OPP–2014–0630 in the subject line on                                                                          chemical residue in establishing a
                                                                                                       Based upon review of the data
                                             the first page of your submission. All                                                                        tolerance and to ‘‘ensure that there is a
                                                                                                     supporting the petition, EPA has
                                             objections and requests for a hearing                                                                         reasonable certainty that no harm will
                                                                                                     modified the request for a tolerance
                                             must be in writing, and must be                                                                               result to infants and children from
                                                                                                     exemption due to the concern regarding
                                             received by the Hearing Clerk on or                                                                           aggregate exposure to the pesticide
                                                                                                     the chemical properties of dimethyl
                                             before December 8, 2015. Addresses for                                                                        chemical residue. . . .’’
                                                                                                     sulfoxide that may result in increased
                                             mail and hand delivery of objections
                                                                                                     active ingredient residues. Therefore,                   EPA establishes exemptions from the
                                             and hearing requests are provided in 40
                                                                                                     the tolerance exemption under 40 CFR                  requirement of a tolerance only in those
                                             CFR 178.25(b).
                                                                                                     180.920 was modified. This limitation is              cases where it can be clearly
                                               In addition to filing an objection or                 based on the Agency’s risk assessment                 demonstrated that the risks from
                                             hearing request with the Hearing Clerk                  which can be found at http://                         aggregate exposure to pesticide
                                             as described in 40 CFR part 178, please                 www.regulations.gov in document                       chemical residues under reasonably
                                             submit a copy of the filing (excluding                  Dimethyl sulfoxide; Human Health Risk                 foreseeable circumstances will pose no
                                             any Confidential Business Information                   Assessment and Ecological Effects                     appreciable risks to human health. In
                                             (CBI)) for inclusion in the public docket.              Assessment to Support Proposed                        order to determine the risks from
                                             Information not marked confidential                     Exemption from the Requirement of a
                                             pursuant to 40 CFR part 2 may be                                                                              aggregate exposure to pesticide inert
                                                                                                     Tolerance When Used as Inert                          ingredients, the Agency considers the
                                             disclosed publicly by EPA without prior                 Ingredients in Pesticide Formulations in
                                             notice. Submit the non-CBI copy of your                                                                       toxicity of the inert in conjunction with
                                                                                                     docket ID number EPA–HQ–OPP–2014–                     possible exposure to residues of the
                                             objection or hearing request, identified                0630.
                                             by docket ID number EPA–HQ–OPP–                                                                               inert ingredient through food, drinking
                                             2014–0630, by one of the following                      III. Inert Ingredient Definition                      water, and through other exposures that
                                             methods:                                                                                                      occur as a result of pesticide use in
                                                                                                       Inert ingredients are all ingredients
                                                                                                                                                           residential settings. If EPA is able to
                                               • Federal eRulemaking Portal: http://                 that are not active ingredients as defined
                                                                                                                                                           determine that a finite tolerance is not
                                             www.regulations.gov. Follow the online                  in 40 CFR 153.125 and include, but are
                                                                                                                                                           necessary to ensure that there is a
                                             instructions for submitting comments.                   not limited to, the following types of
                                                                                                                                                           reasonable certainty that no harm will
                                             Do not submit electronically any                        ingredients (except when they have a
                                                                                                                                                           result from aggregate exposure to the
                                             information you consider to be CBI or                   pesticidal efficacy of their own):
                                                                                                                                                           inert ingredient, an exemption from the
                                             other information whose disclosure is                   Solvents such as alcohols and
                                                                                                                                                           requirement of a tolerance may be
                                             restricted by statute.                                  hydrocarbons; surfactants such as
                                                                                                                                                           established.
                                               • Mail: OPP Docket, Environmental                     polyoxyethylene polymers and fatty
                                                                                                     acids; carriers such as clay and                         Consistent with FFDCA section
                                             Protection Agency Docket Center (EPA/
                                                                                                     diatomaceous earth; thickeners such as                408(c)(2)(A), and the factors specified in
                                             DC), (28221T), 1200 Pennsylvania Ave.
                                             NW., Washington, DC 20460–0001.                         carrageenan and modified cellulose;                   FFDCA section 408(c)(2)(B), EPA has
                                                                                                     wetting, spreading, and dispersing                    reviewed the available scientific data
                                               • Hand Delivery: To make special                      agents; propellants in aerosol                        and other relevant information in
                                             arrangements for hand delivery or                       dispensers; microencapsulating agents;                support of this action. EPA has
                                             delivery of boxed information, please                   and emulsifiers. The term ‘‘inert’’ is not            sufficient data to assess the hazards of
                                             follow the instructions at http://                      intended to imply nontoxicity; the                    and to make a determination on
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                                             www.epa.gov/dockets/contacts.html.                      ingredient may or may not be                          aggregate exposure for dimethyl
                                             Additional instructions on commenting                   chemically active. Generally, EPA has                 sulfoxide including exposure resulting
                                             or visiting the docket, along with more                 exempted inert ingredients from the                   from the exemption established by this
                                             information about dockets generally, is                 requirement of a tolerance based on the               action. EPA’s assessment of exposures
                                             available at http://www.epa.gov/                        low toxicity of the individual inert                  and risks associated with dimethyl
                                             dockets.                                                ingredients.                                          sulfoxide follows.


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                                                                Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations                                       61127

                                             A. Toxicological Profile                                well as the NOAEL and the LOAEL from                  dimethyl sulfoxide. Because no hazard
                                               EPA has evaluated the available                       the toxicity studies can be found at                  endpoint of concern was identified for
                                             toxicity data and considered their                      http://www.regulations.gov in the                     the acute and chronic dietary
                                             validity, completeness, and reliability as              document ‘‘Dimethyl sulfoxide; Human                  assessment (food and feed uses, a
                                             well as the relationship of the results of              Health Risk Assessment and Ecological                 quantitative dietary exposure risk
                                             the studies to human risk. EPA has also                 Effects Assessment to Support Proposed                assessment was not conducted.
                                                                                                     Exemption from the Requirement of a                      2. Dietary exposure from drinking
                                             considered available information
                                                                                                     Tolerance When Used as Inert                          water. Since a hazard endpoint of
                                             concerning the variability of the
                                                                                                     Ingredients in Pesticide Formulations’’               concern was not identified for the acute
                                             sensitivities of major identifiable
                                                                                                     in docket ID number EPA–HQ–OPP–                       and chronic dietary assessment, a
                                             subgroups of consumers, including
                                                                                                     2014–0630.                                            quantitative dietary exposure risk
                                             infants and children. Specific                                                                                assessment for drinking water was not
                                             information on the studies received and                 B. Toxicological Points of Departure/                 conducted.
                                             the nature of the adverse effects caused                Levels of Concern                                        3. From non-dietary exposure. The
                                             by dimethyl sulfoxide as well as the no-                   Once a pesticide’s toxicological                   term ‘‘residential exposure’’ is used in
                                             observed-adverse-effect-level (NOAEL)                   profile is determined, EPA identifies                 this document to refer to non-
                                             and the lowest-observed-adverse-effect-                 toxicological points of departure (POD)               occupational, non-dietary exposure
                                             level (LOAEL) from the toxicity studies                 and levels of concern to use in                       (e.g., textiles (clothing and diapers),
                                             are discussed in this unit.                             evaluating the risk posed by human                    carpets, swimming pools, and hard
                                               Dimethyl sulfoxide has low acute                      exposure to the pesticide. For hazards                surface disinfection on walls, floors,
                                             toxicity via the oral and dermal in rats                that have a threshold below which there               tables).
                                             and mice and inhalation route in rats.                  is no appreciable risk, the toxicological                Dimethyl sulfoxide may be used in
                                             The acute oral lethal dose (LD)50 ≥                     POD is used as the basis for derivation               consumer products that may be used
                                             7,920 milligrams/kilograms (mg/kg) in                   of reference values for risk assessment.              around the home. However, based on
                                             rats and mice. The acute dermal LD50                    PODs are developed based on a careful                 the lack of toxicity, a quantitative
                                             ≥ 40,000 mg/kg in rats and mice. The                    analysis of the doses in each                         exposure assessment from ‘‘residential
                                             acute inhalation lethal concentration                   toxicological study to determine the                  exposures’’ was not performed.
                                             (LC)50 ≥ 1,600 milligram/meter3 (mg/                    dose at which no adverse effects are                     4. Cumulative effects from substances
                                             m3) (∼277 mg/kg) in rats. It is a dermal,               observed (the NOAEL) and the lowest                   with a common mechanism of toxicity.
                                             eye and gastric irritant in rats and                    dose at which adverse effects of concern              Section 408(b)(2)(D)(v) of FFDCA
                                             rabbits. It is a sensitizer in guinea pigs.             are identified (the LOAEL). Uncertainty/              requires that, when considering whether
                                                Overall systemic toxicity with regard                safety factors are used in conjunction                to establish, modify, or revoke a
                                             to oral and dermal exposure to dimethyl                 with the POD to calculate a safe                      tolerance, the Agency consider
                                             sulfoxide is low. The target organ of                   exposure level—generally referred to as               ‘‘available information’’ concerning the
                                             toxicity is the eye. Changes in the eyes,               a population-adjusted dose (PAD) or a                 cumulative effects of a particular
                                             such as refractile changes in the lens                  reference dose (RfD)—and a safe margin                pesticide’s residues and ‘‘other
                                             and lens composition are seen in                        of exposure (MOE). For non-threshold                  substances that have a common
                                             various animals at doses above the limit                risks, the Agency assumes that any                    mechanism of toxicity.’’
                                             dose (1,000 mg/kg/day).                                 amount of exposure will lead to some                     EPA has not found dimethyl sulfoxide
                                                Systemic toxicity is not observed                    degree of risk. Thus, the Agency                      to share a common mechanism of
                                             following exposure to dimethyl                          estimates risk in terms of the probability            toxicity with any other substances, and
                                             sulfoxide at dose levels up to 1,000 mg/                of an occurrence of the adverse effect                dimethyl sulfoxide does not appear to
                                             kg/day (the limit dose) in subchronic,                  expected in a lifetime. For more                      produce a toxic metabolite produced by
                                             chronic or reproduction/developmental                   information on the general principles                 other substances. For the purposes of
                                             toxicity studies via oral, dermal or                    EPA uses in risk characterization and a               this tolerance action, therefore, EPA has
                                             inhalation exposures in rats, dogs and                  complete description of the risk                      assumed that dimethyl sulfoxide does
                                             rabbits. Dimethyl sulfoxide is not                      assessment process, see http://                       not have a common mechanism of
                                             expected to be carcinogenic based on                    www.epa.gov/pesticides/factsheets/                    toxicity with other substances. For
                                             the lack of mutagenicity and the lack of                riskassess.htm.                                       information regarding EPA’s efforts to
                                             tumor formation in cancer initiation/                      The available toxicity studies indicate            determine which chemicals have a
                                             promotion studies. It is not neurotoxic                 that dimethyl sulfoxide has low toxicity.             common mechanism of toxicity and to
                                             nor immunotoxic.                                        These data demonstrated adverse effects               evaluate the cumulative effects of such
                                                Toxicity of dimethyl sulfoxide via the               only at doses ≥1100 mg/kg/day (above                  chemicals, see EPA’s Web site at
                                             inhalation route of exposure is limited                 the limit dose). Therefore, since no                  http://www.epa.gov/pesticides/
                                             to portal of entry effects at 2.783 mg/1                endpoint of concern was identified for                cumulative.
                                             (equivalent to 722 mg/kg/day).                          dimethyl sulfoxide, a qualitative risk
                                                In the rat and monkey, dimethyl                                                                            D. Safety Factor for Infants and
                                                                                                     assessment is appropriate.                            Children
                                             sulfoxide administered via the oral and/
                                             or dermal route is rapidly absorbed,                    C. Exposure Assessment                                  1. In general. Section 408(b)(2)(C) of
                                             metabolized and excreted. Excretion is                    1. Dietary exposure from food and                   FFDCA provides that EPA shall apply
                                             primarily via urine, feces was a minor                  feed uses. In evaluating dietary                      an additional tenfold (10X) margin of
                                             route in the rat only. The major                        exposure to dimethyl sulfoxide, EPA                   safety for infants and children in the
                                                                                                                                                           case of threshold effects to account for
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                                             metabolite was dimethyl sulfone.                        considered exposure under the
                                             Dimethyl sulfide, another metabolite, is                proposed exemption from the                           prenatal and postnatal toxicity and the
                                             eliminated through the breath. There is                 requirement of a tolerance. EPA                       completeness of the database on toxicity
                                             no bioaccumulation.                                     assessed dietary exposures from                       and exposure unless EPA determines
                                                Specific information on the studies                  dimethyl sulfoxide in food as follows:                based on reliable data that a different
                                             received and the nature of the adverse                    Dietary exposure can occur from                     margin of safety will be safe for infants
                                             effects caused by Dimethyl sulfoxide as                 eating foods containing residues of                   and children. This additional margin of


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                                             61128              Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations

                                             safety is commonly referred to as the                      4. Intermediate-term risk.                         Risks and Safety Risks’’ (62 FR 19885,
                                             FQPA Safety Factor (SF). In applying                    Intermediate-term aggregate exposure                  April 23, 1997). This action does not
                                             this provision, EPA either retains the                  takes into account intermediate-term                  contain any information collections
                                             default value of 10X, or uses a different               residential exposure plus chronic                     subject to OMB approval under the
                                             additional safety factor when reliable                  exposure to food and water (considered                Paperwork Reduction Act (PRA) (44
                                             data available to EPA support the choice                to be a background exposure level).                   U.S.C. 3501 et seq.), nor does it require
                                             of a different factor.                                  Because no intermediate-term adverse                  any special considerations under
                                                At this time, there is no concern for                effect was identified, dimethyl sulfoxide             Executive Order 12898, entitled
                                             potential sensitivity to infants and                    is not expected to pose an intermediate-              ‘‘Federal Actions to Address
                                             children resulting from exposures to                    term risk.                                            Environmental Justice in Minority
                                             dimethyl sulfoxide. There is no reported                   5. Aggregate cancer risk for U.S.                  Populations and Low-Income
                                             quantitative or qualitative evidence of                 population. Based on the lack of                      Populations’’ (59 FR 7629, February 16,
                                             increased susceptibility of rat or rabbit               increased tumor formation in initiation/              1994).
                                             fetuses to in utero exposure to dimethyl                promotion toxicity studies and the lack                  Since tolerances and exemptions that
                                             sulfoxide in developmental toxicity                     of mutagenicity, dimethyl sulfoxide is                are established on the basis of a petition
                                             studies in rats and rabbits. No                         not expected to pose a cancer risk to                 under FFDCA section 408(d), such as
                                             quantitative or qualitative evidence of                 humans.                                               the tolerance in this final rule, do not
                                             increased susceptibility has been                          6. Determination of safety. Based on               require the issuance of a proposed rule,
                                             reported following the pre/postnatal                    these risk assessments, EPA concludes                 the requirements of the Regulatory
                                             exposure to rats and rabbits in 2-                      that there is a reasonable certainty that             Flexibility Act (RFA) (5 U.S.C. 601 et
                                             generation reproduction toxicity studies                no harm will result to the general                    seq.), do not apply.
                                             in rats and rabbits. Given the lack of                  population, or to infants and children                   This action directly regulates growers,
                                             adverse toxicological effects at limit                  from aggregate exposure to dimethyl                   food processors, food handlers, and food
                                             dose levels, a safety factor analysis has               sulfoxide residues.                                   retailers, not States or tribes, nor does
                                             not been used to assess the risk. For
                                                                                                     V. Other Considerations                               this action alter the relationships or
                                             these reasons the additional tenfold
                                                                                                                                                           distribution of power and
                                             safety factor is unnecessary.                           A. Analytical Enforcement Methodology                 responsibilities established by Congress
                                             E. Aggregate Risks and Determination of                   An analytical method is not required                in the preemption provisions of FFDCA
                                             Safety                                                  for enforcement purposes since the                    section 408(n)(4). As such, the Agency
                                                EPA determines whether acute and                     Agency is establishing an exemption                   has determined that this action will not
                                             chronic dietary pesticide exposures are                 from the requirement of a tolerance.                  have a substantial direct effect on States
                                             safe by comparing aggregate exposure                                                                          or tribal governments, on the
                                                                                                     VI. Conclusions                                       relationship between the national
                                             estimates to the acute PAD (aPAD) and
                                             chronic PAD (cPAD). For linear cancer                     Therefore, an exemption from the                    government and the States or tribal
                                             risks, EPA calculates the lifetime                      requirement of a tolerance is established             governments, or on the distribution of
                                             probability of acquiring cancer given the               under 40 CFR 180.920 for dimethyl                     power and responsibilities among the
                                             estimated aggregate exposure. Short-,                   sulfoxide (CAS Reg. No. 67–68–5) when                 various levels of government or between
                                             intermediate-, and chronic-term risks                   used as an inert ingredient solvent,                  the Federal Government and Indian
                                             are evaluated by comparing the                          cosolvent in pesticide formulations used              tribes. Thus, the Agency has determined
                                             estimated aggregate food, water, and                    before crop emerges from soil or prior to             that Executive Order 13132, entitled
                                             residential exposure to the appropriate                 formation of edible parts of food plants;             ‘‘Federalism’’ (64 FR 43255, August 10,
                                             PODs to ensure that an adequate MOE                     for pesticide formulations used after                 1999) and Executive Order 13175,
                                             exists.                                                 crop emerges but before harvest,                      entitled ‘‘Consultation and Coordination
                                                1. Acute risk. An acute aggregate risk               provided that the potential for increased             with Indian Tribal Governments’’ (65 FR
                                             assessment takes into account acute                     residues of the formulation’s active                  67249, November 9, 2000) do not apply
                                             exposure estimates from dietary                         ingredient(s) in or on food commodities               to this action. In addition, this action
                                             consumption of food and drinking                        has been assessed.                                    does not impose any enforceable duty or
                                             water. No adverse effect resulting from                                                                       contain any unfunded mandate as
                                                                                                     VII. Statutory and Executive Order                    described under Title II of the Unfunded
                                             a single oral exposure was identified                   Reviews
                                             and no acute dietary endpoint was                                                                             Mandates Reform Act (UMRA) (2 U.S.C.
                                             selected. Therefore, dimethyl sulfoxide                   This action establishes a tolerance                 1501 et seq.).
                                             is not expected to pose an acute risk.                  under FFDCA section 408(d) in                            This action does not involve any
                                                2. Chronic risk. Using the exposure                  response to a petition submitted to the               technical standards that would require
                                             assumptions described in this unit for                  Agency. The Office of Management and                  Agency consideration of voluntary
                                             chronic exposure, EPA has concluded                     Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                             that based on the low toxicity of                       of actions from review under Executive                12(d) of the National Technology
                                             dimethyl sulfoxide and since no chronic                 Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                             endpoint was identified, chronic risk is                Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                             not expected.                                           October 4, 1993). Because this action
                                                                                                                                                           VIII. Congressional Review Act
                                                3. Short-term risk. Short-term                       has been exempted from review under
                                             aggregate exposure takes into account                   Executive Order 12866, this action is                   Pursuant to the Congressional Review
                                             short-term residential exposure plus                    not subject to Executive Order 13211,                 Act (5 U.S.C. 801 et seq.), EPA will
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                                             chronic exposure to food and water                      entitled ‘‘Actions Concerning                         submit a report containing this rule and
                                             (considered to be a background                          Regulations That Significantly Affect                 other required information to the U.S.
                                             exposure level). Because no short-term                  Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
                                             adverse effect was identified, dimethyl                 FR 28355, May 22, 2001) or Executive                  Representatives, and the Comptroller
                                             sulfoxide is not expected to pose a                     Order 13045, entitled ‘‘Protection of                 General of the United States prior to
                                             short-term risk.                                        Children from Environmental Health                    publication of the rule in the Federal


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                                                                Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations                                                      61129

                                             Register. This action is not a ‘‘major                     Dated: September 14, 2015.                                   Authority: 21 U.S.C. 321(q), 346a and 371.
                                             rule’’ as defined by 5 U.S.C. 804(2).                   G. Jeffery Herndon,
                                                                                                                                                                 ■ 2. In § 180.920, add alphabetically the
                                                                                                     Acting Director, Registration Division, Office
                                             List of Subjects in 40 CFR Part 180                     of Pesticide Programs.                                      inert ingredient ‘‘Dimethyl Sulfoxide
                                                                                                                                                                 (CAS No. 67–68–5)’’ to the table to read
                                               Environmental protection,                               Therefore, 40 CFR chapter I is
                                                                                                                                                                 as follows:
                                             Administrative practice and procedure,                  amended as follows:
                                             Agricultural commodities, Pesticides                                                                                § 180.920 Inert ingredients used pre-
                                                                                                     PART 180—[AMENDED]                                          harvest; exemptions from the requirement
                                             and pests, Reporting and recordkeeping
                                             requirements.                                                                                                       of a tolerance.
                                                                                                     ■ 1. The authority citation for part 180
                                                                                                     continues to read as follows:                               *        *    *       *   *

                                                    Inert ingredients                                                                   Limits                                                     Uses


                                                      *                 *                     *                    *                    *                    *                                         *
                                             Dimethyl Sulfoxide (CAS No. For pesticide formulations used before crop emerges from soil or prior to formation of                            Solvent or co-solvent.
                                               67–68–5).                   edible parts of food plants; for pesticide formulations used after crop emerges but be-
                                                                           fore harvest, provided that the potential for increased residues of the formulation’s ac-
                                                                           tive ingredient(s) in or on food commodities has been assessed.

                                                       *                       *                         *                          *                       *                      *                   *



                                             [FR Doc. 2015–25589 Filed 10–8–15; 8:45 a.m.]           ADDRESSES:  The full text of the Omnibus                       4. The Commission strengthened the
                                             BILLING CODE 6560–50–P                                  Order is available at https://                              core protections of the TCPA by
                                                                                                     www.fcc.gov/document/tcpa-omnibus-                          confirming that:
                                                                                                     declaratory-ruling-and-order.                                  Æ Callers cannot avoid obtaining
                                                                                                                                                                 consumer consent for a robocall simply
                                             FEDERAL COMMUNICATIONS                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                 because they are not ‘‘currently’’ or
                                             COMMISSION                                              Kristi Lemoine, Consumer Policy
                                                                                                                                                                 ‘‘presently’’ dialing random or
                                                                                                     Division, Consumer and Governmental
                                                                                                                                                                 sequential phone numbers;
                                             47 CFR Part 64                                          Affairs Bureau, Federal
                                                                                                                                                                    Æ Simply being on an acquaintance’s
                                                                                                     Communications Commission, 445 12th
                                                                                                                                                                 phone contact list does not amount to
                                             [CG Docket No. 02–278; WC Docket No.                    Street SW., Washington, DC 20554.
                                                                                                                                                                 consent to receive robocalls from third-
                                             07–35; FCC 15–72]                                       (202) 418–2467.                                             party applications downloaded by the
                                                                                                     SUPPLEMENTARY INFORMATION:                                  acquaintance;
                                             Rules and Regulations Implementing
                                             the Telephone Consumer Protection                          1. The Omnibus Order denied one                             Æ Callers are liable for robocalls to
                                             Act of 1991; et al.                                     petition for rulemaking and dismisses                       reassigned wireless numbers when the
                                                                                                     another petition for rulemaking as both                     current subscriber to or customary user
                                             AGENCY:  Federal Communications                         requests were subsumed in the                               of the number has not consented,
                                             Commission.                                             declaratory ruling portion of that                          subject to a limited, one-call exception
                                             ACTION: Petitions for Rulemaking, denial                document. The Omnibus Order also                            for cases in which the caller does not
                                             and dismissal; declaratory ruling; time-                addressed a number of requests for                          have actual or constructive knowledge
                                             limited waivers; exemptions.                            clarification or other relief.                              of the reassignment;
                                                                                                                                                                    Æ Internet-to-phone text messages
                                             SUMMARY:   The Commission affirms and                      2. Petitions for Rulemaking. The                         require consumer consent; and
                                             further clarifies the requirements of the               Professional Association for Customer                          Æ Text messages are ‘‘calls’’ subject to
                                             Telephone Consumer Protection Act                       Engagement (PACE) filed a Petition for                      the TCPA, as previously determined by
                                             (TCPA), focusing on consumers’ rights                   Expedited Declaratory Ruling and/or                         the Commission.
                                             to stop unwanted robocalls, including                   Expedited Rulemaking, and ACA                                  Æ The Commission also empowered
                                             both voice calls and text messages. The                 International filed a Petition for                          consumers to stop unwanted calls by
                                             Commission acted in an Omnibus                          Rulemaking. PACE’s petition was                             confirming that:
                                             Declaratory Ruling and Order (Omnibus                   addressed on its merits as a Petition for                      Æ Consumers may revoke consent at
                                             Order) in response to 21 petitions for                  Declaratory Ruling and its Petition for                     any time and through any reasonable
                                             rulemaking, clarification, or other action              Expedited Rulemaking was therefore                          means; and
                                             regarding the TCPA or the                               dismissed. In the Omnibus Order the                            Æ Nothing in the Communications
                                             Commission’s rules and orders. In                       Commission provided clarification                           Act or the Commission’s implementing
                                             addition to denying one petition for                    regarding the issues raised by ACA and                      rules prohibits carriers or Voice over
                                             rulemaking and dismissing another                       therefore its petition was denied.                          Internet Protocol providers from
                                             petition for rulemaking, the Omnibus                       3. Requests for Clarification or Other                   implementing consumer-initiated call-
                                             Order took a number of actions,                         Action. The Omnibus Order also                              blocking technology that can help
                                             including clarifying when certain                       addressed separate requests for                             consumers stop unwanted robocalls.
rmajette on DSK7SPTVN1PROD with RULES




                                             conduct violates the TCPA and                           clarification or other action regarding                        5. Finally, the Commission recognized
                                             providing guidance intended to assist                   the TCPA or the Commission’s rules and                      the legitimate interests of callers by:
                                             callers in avoiding violations and                      orders implementing the TCPA. The full                         Æ Clarifying that application
                                             consequent litigation.                                  text of the Omnibus Order is available                      providers that play a minimal role in
                                             DATES: The Omnibus Order was issued                     at https://www.fcc.gov/document/tcpa-                       sending text messages are not per se
                                             on July 10, 2015.                                       omnibus-declaratory-ruling-and-order.                       liable for unwanted robocalls;


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Document Created: 2015-12-15 08:33:19
Document Modified: 2015-12-15 08:33:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 61125 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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