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

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). 

XI. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 1, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.960, add alphabetically the 

following polymer to the table to read as 

follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

* * * * * 

Cellulose carboxymethyl ether, 

potassium salt, minimum 

number average molecular 

weight 9587 Daltons ............. 54848–04–3 

* * * * * 

[FR Doc. 2015–25689 Filed 10–8–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0630; FRL–9934–17] 

Dimethyl Sulfoxide; Exemption From 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

exemption from the requirement of a 

tolerance for residues of dimethyl 

sulfoxide (CAS Reg. No. 67–68–5) when 

used as an inert ingredient (solvent, cosolvent) in pesticide formulations 

applied to growing crops (pre-emergent 

use only) to include use after the crop 

emerges from the soil but before harvest 

provided that the potential for increased 

residues of the formulation’s active 

ingredient(s) in or on food commodities 

has been assessed. ISK BioSciences 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(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: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 


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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/textidx?&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. 


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Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations 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 noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

Dimethyl sulfoxide has low acute 

toxicity via the oral and dermal in rats 

and mice and inhalation route in rats. 

The acute oral lethal dose (LD)50 ≥ 

7,920 milligrams/kilograms (mg/kg) in 

rats and mice. The acute dermal LD50 

≥ 40,000 mg/kg in rats and mice. The 

acute inhalation lethal concentration 

(LC)50 ≥ 1,600 milligram/meter3 (mg/

m3) (∼277 mg/kg) in rats. It is a dermal, 

eye and gastric irritant in rats and 

rabbits. It is a sensitizer in guinea pigs. 

Overall systemic toxicity with regard 

to oral and dermal exposure to dimethyl 

sulfoxide is low. The target organ of 

toxicity is the eye. Changes in the eyes, 

such as refractile changes in the lens 

and lens composition are seen in 

various animals at doses above the limit 

dose (1,000 mg/kg/day). 

Systemic toxicity is not observed 

following exposure to dimethyl 

sulfoxide at dose levels up to 1,000 mg/ 

kg/day (the limit dose) in subchronic, 

chronic or reproduction/developmental 

toxicity studies via oral, dermal or 

inhalation exposures in rats, dogs and 

rabbits. Dimethyl sulfoxide is not 

expected to be carcinogenic based on 

the lack of mutagenicity and the lack of 

tumor formation in cancer initiation/

promotion studies. It is not neurotoxic 

nor immunotoxic. 

Toxicity of dimethyl sulfoxide via the 

inhalation route of exposure is limited 

to portal of entry effects at 2.783 mg/1 

(equivalent to 722 mg/kg/day). 

In the rat and monkey, dimethyl 

sulfoxide administered via the oral and/ 

or dermal route is rapidly absorbed, 

metabolized and excreted. Excretion is 

primarily via urine, feces was a minor 

route in the rat only. The major 

metabolite was dimethyl sulfone. 

Dimethyl sulfide, another metabolite, is 

eliminated through the breath. There is 

no bioaccumulation. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by Dimethyl sulfoxide as 

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 ≥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 nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Dimethyl sulfoxide may be used in 

consumer products that may be used 

around the home. However, based on 

the lack of toxicity, a quantitative 

exposure assessment from ‘‘residential 

exposures’’ was not performed. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found dimethyl sulfoxide 

to share a common mechanism of 

toxicity with any other substances, and 

dimethyl sulfoxide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that dimethyl sulfoxide does 

not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at 

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 


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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 

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 intermediateterm risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

increased tumor formation in initiation/ 

promotion toxicity studies and the lack 

of mutagenicity, dimethyl sulfoxide is 

not expected to pose a cancer risk to 

humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to dimethyl 

sulfoxide residues. 

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 


rmajette on DSK7SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations 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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.920, add alphabetically the 

inert ingredient ‘‘Dimethyl Sulfoxide 

(CAS No. 67–68–5)’’ to the table to read 

as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Dimethyl Sulfoxide (CAS No. 

67–68–5).

For 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.

Solvent or co-solvent. 

* * * * * * * 

[FR Doc. 2015–25589 Filed 10–8–15; 8:45 a.m.] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[CG Docket No. 02–278; WC Docket No. 

07–35; FCC 15–72] 

Rules and Regulations Implementing 

the Telephone Consumer Protection 

Act of 1991; et al. 

AGENCY: Federal Communications 

Commission. 

ACTION: Petitions for Rulemaking, denial 

and dismissal; declaratory ruling; timelimited waivers; exemptions. 

SUMMARY: The Commission affirms and 

further clarifies the requirements of the 

Telephone Consumer Protection Act 

(TCPA), focusing on consumers’ rights 

to stop unwanted robocalls, including 

both voice calls and text messages. The 

Commission acted in an Omnibus 

Declaratory Ruling and Order (Omnibus 

Order) in response to 21 petitions for 

rulemaking, clarification, or other action 

regarding the TCPA or the 

Commission’s rules and orders. In 

addition to denying one petition for 

rulemaking and dismissing another 

petition for rulemaking, the Omnibus 

Order took a number of actions, 

including clarifying when certain 

conduct violates the TCPA and 

providing guidance intended to assist 

callers in avoiding violations and 

consequent litigation. 

DATES: The Omnibus Order was issued 

on July 10, 2015. 

ADDRESSES: The full text of the Omnibus 

Order is available at https://

www.fcc.gov/document/tcpa-omnibusdeclaratory-ruling-and-order. 

FOR FURTHER INFORMATION CONTACT: 

Kristi Lemoine, Consumer Policy 

Division, Consumer and Governmental 

Affairs Bureau, Federal 

Communications Commission, 445 12th 

Street SW., Washington, DC 20554. 

(202) 418–2467. 

SUPPLEMENTARY INFORMATION: 

1. The Omnibus Order denied one 

petition for rulemaking and dismisses 

another petition for rulemaking as both 

requests were subsumed in the 

declaratory ruling portion of that 

document. The Omnibus Order also 

addressed a number of requests for 

clarification or other relief. 

2. Petitions for Rulemaking. The 

Professional Association for Customer 

Engagement (PACE) filed a Petition for 

Expedited Declaratory Ruling and/or 

Expedited Rulemaking, and ACA 

International filed a Petition for 

Rulemaking. PACE’s petition was 

addressed on its merits as a Petition for 

Declaratory Ruling and its Petition for 

Expedited Rulemaking was therefore 

dismissed. In the Omnibus Order the 

Commission provided clarification 

regarding the issues raised by ACA and 

therefore its petition was denied. 

3. Requests for Clarification or Other 

Action. The Omnibus Order also 

addressed separate requests for 

clarification or other action regarding 

the TCPA or the Commission’s rules and 

orders implementing the TCPA. The full 

text of the Omnibus Order is available 

at https://www.fcc.gov/document/tcpaomnibus-declaratory-ruling-and-order. 

4. The Commission strengthened the 

core protections of the TCPA by 

confirming that: 

Æ Callers cannot avoid obtaining 

consumer consent for a robocall simply 

because they are not ‘‘currently’’ or 

‘‘presently’’ dialing random or 

sequential phone numbers; 

Æ Simply being on an acquaintance’s 

phone contact list does not amount to 

consent to receive robocalls from thirdparty applications downloaded by the 

acquaintance; 

Æ Callers are liable for robocalls to 

reassigned wireless numbers when the 

current subscriber to or customary user 

of the number has not consented, 

subject to a limited, one-call exception 

for cases in which the caller does not 

have actual or constructive knowledge 

of the reassignment; 

Æ Internet-to-phone text messages 

require consumer consent; and 

Æ Text messages are ‘‘calls’’ subject to 

the TCPA, as previously determined by 

the Commission. 

Æ The Commission also empowered 

consumers to stop unwanted calls by 

confirming that: 

Æ Consumers may revoke consent at 

any time and through any reasonable 

means; and 

Æ Nothing in the Communications 

Act or the Commission’s implementing 

rules prohibits carriers or Voice over 

Internet Protocol providers from 

implementing consumer-initiated callblocking technology that can help 

consumers stop unwanted robocalls. 

5. Finally, the Commission recognized 

the legitimate interests of callers by: 

Æ Clarifying that application 

providers that play a minimal role in 

sending text messages are not per se 

liable for unwanted robocalls; 


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