31172 Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Rules and Regulations 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: May 13, 2016, 

C.J. Bisignano, 

Supervisory Bridge Management Specialist, 

First Coast Guard District. 

[FR Doc. 2016–11713 Filed 5–17–16; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0018, EPA–HQ–OPP– 

2015–0020; FRL–9945–76] 

Quaternary Ammonium Compounds, 

Benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium Salts With 

Sepiolite; and Quaternary Ammonium 

Compounds, Benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium Salts 

With Saponite; Exemptions From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite (CAS Reg. No. 1574487–61–8) 

when used as an inert ingredient 

(suspending or structuring agent) in 

pesticide formulations applied to 

growing crops at a concentration not to 

exceed 2.0% by weight in the 

formulation, asbestos free and 

containing less than 1% crystalline 

silica. This regulation also establishes 

an exemption from the requirement of a 

tolerance for residues of quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

saponite (CAS Reg. No. 1588523–05–0) 

when used as an inert ingredient 

(suspending or structuring agent) in 

pesticide formulations applied to 

growing crops at a concentration not to 

exceed 1.0% by weight in the 

formulation. Technology Sciences 

Group on behalf of BYK Additives Inc. 

submitted petitions to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with saponite. 

DATES: This regulation is effective May 

18, 2016. Objections and requests for 

hearings must be received on or before 

July 18, 2016, 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 dockets for these 

actions, identified by docket 

identification (ID) number EPA–HQ– 

OPP–2015–0018, EPA–HQ–OPP–2015– 

0020 are 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). 

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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2015–0018 (CAS Reg. No. 

1574487–61–8), EPA–HQ–OPP–2015– 

0020 (CAS Reg. No. 1588523–05–0) 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 July 18, 2016. 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– 

2015–0018, EPA–HQ–OPP–2015–0020 

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. 


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• 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 April 6, 

2015 (80 FR 18327) (FRL–9924–00), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the filing of pesticide 

petitions (PP IN–10780) and (PP IN– 

10781) by Technology Sciences Group 

on behalf of BYK Additives Inc., 1600 

West Hill Street, Louisville, KY 40210. 

The petitions requested that 40 CFR 

180.920 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite (CAS Reg. No. 1574487–61–8) 

when used as an inert ingredient 

suspending or structuring agent in 

pesticide formulations applied to 

growing crops with a limitation of 2.0% 

in formulation, asbestos free and 

containing less than 1% crystalline 

silica; and quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with saponite (CAS Reg. No. 1588523– 

05–0) when used as an inert ingredient 

suspending or structuring agent in 

pesticide formulations applied to 

growing crops with a limitation of 1.0% 

in formulation. 

That document referenced a summary 

of the petitions prepared by Technology 

Science Group, the petitioner, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notices of filing. 

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 quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite, and quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with saponite including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with sepiolite and with quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

saponite follows. 

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 both quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in this 

unit. 

Based on data in structurally similar 

quaternary ammonium clay substances, 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite have low 

acute toxicity via the oral, dermal and 

inhalation routes in rats. The substances 

are expected to be a slight skin and eye 

irritant. A structurally similar 

quaternary ammonium clay substance 

did not cause skin sensitization in 

guinea pigs. 

Multiple 28-day repeat-dose studies 

consistently showed high No Observed 


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Adverse Effect Levels (NOAELs), 

typically the highest dose tested, which 

was 1,000 milligrams/kilogram/day (mg/ 

kg/day) in rats. There was an absence of 

test substance-related toxicologically 

significant effects at any of the doses 

administered, including for neurological 

and immunological endpoints. 

Similarly, there were no effects on 

reproductive or developmental 

endpoints and no evidence for 

genotoxicity in multiple in vitro and in 

vivo assays (OECD 471, 474 and 476 on 

multiple quaternary ammonium 

compounds). 

Clays treated with quaternary 

ammonium compounds have low water 

solubility, a high hydrophobic partition 

coefficient and relatively high molecular 

weight. All three factors indicate likely 

limited absorption following ingestion, 

dermal exposure or inhalation. Based on 

similarities to other quaternary 

ammonium clays (high molecular 

weights, low water solubility, high 

hydrophobicity), both 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite would also 

be almost completely eliminated from 

the body shortly after oral dosing. 

Therefore, the biological availability is 

expected to be low. 

B. Toxicological Points of Departure/ 

Levels of Concern 

1. The available toxicity studies 

indicate that both quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite have very 

low overall toxicity. The NOAELs were 

>1,000 mg/kg/day (limit dose). Since 

signs of toxicity were not observed at 

the limit dose an endpoint of concern 

for risk assessment purposes were not 

identified. Therefore, since no endpoint 

of concern was identified for the acute 

and chronic dietary exposure 

assessment and short and intermediate 

dermal and inhalation exposure, 

quantitative risk assessments for both 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite are not 

necessary. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to both quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with sepiolite and with saponite, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from both 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite in food as 

follows: 

Under this exemption from the 

requirement of a tolerance, residues of 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite may be 

found on foods from crops that were 

treated with pesticide formulations 

containing both quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with sepiolite and with saponite. 

However, quantitative dietary exposure 

assessments were not conducted since 

endpoints for risk assessment were not 

identified. 

2. Dietary exposure from drinking 

water. Since hazard endpoints of 

concern were not identified for the 

acute and chronic dietary assessments, 

quantitative dietary exposure risk 

assessments for drinking water were not 

conducted, although exposures may be 

expected from use on food crops. 

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). Both quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with sepiolite and with saponite may be 

used in pesticide products and nonpesticide products that may be used 

around the home. Based on the 

discussion in Unit IV.B., quantitative 

residential exposure assessments for 

both quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with sepiolite and with saponite was 

not conducted. 

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 either quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with sepiolite or with saponite to share 

a common mechanism of toxicity with 

any other substances, and both 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that both 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite do 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 

As part of its qualitative assessment, 

the Agency did not use safety factors for 

assessing risk, and no additional safety 

factor is needed for assessing risk to 

infants and children. Based on the lack 

of toxicity of ammonium acetate in the 

available studies and its chemical 

properties, EPA has concluded that 

there are no toxicological endpoints of 

concern for the U.S. population, 

including infants and children. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information both quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with sepiolite when used as an inert 

ingredient (suspending or structuring 

agent) with a limitation of 2.0% in 

formulation, asbestos free and 

containing less than 1% crystalline 

silica and quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with saponite when used as an inert 

ingredient (suspending or structuring 

agent) with a limitation of 1.0% in 

formulation, EPA has determined that 

there is a reasonable certainty that no 

harm to any population subgroup will 

result from aggregate exposure to both 


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Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Rules and Regulations 31175 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite under 

reasonable foreseeable circumstances. 

Therefore, the establishment of an 

exemption from tolerance under 40 CFR 

180.920 for residues of both quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite when used as an inert 

ingredient in pesticide formulations 

applied to growing crops with a 

limitation of 2.0% in formulation, 

asbestos free and containing less than 

1% crystalline silica and quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

saponite when used as an inert 

ingredient (suspending or structuring 

agent) with a limitation of 1.0% in 

formulation, is safe under FFDCA 

section 408. 

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, both quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite are not 

expected to pose an acute risk. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

subchronic and chronic exposure 

estimates from dietary consumption of 

food and drinking water. No adverse 

effect resulting from a subchronic or 

chronic oral exposure were identified 

and no chronic dietary endpoints were 

selected. Therefore, quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl) dimethylammonium salts with 

sepiolite is not expected to pose a 

chronic risk. 

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, both 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite were not 

expected to pose short-term risks. 

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, both quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite and with saponite were not 

expected to pose intermediate-term 

risks. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit IV.A., 

EPA does not expect either quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite or with saponite 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 either 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite or with saponite residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Although EPA is establishing a 

limitation on the amount of quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite; and quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with saponite that may be used in 

pesticide formulations, an analytical 

enforcement methodology is not 

necessary for this exemption from the 

requirement of tolerance. The limitation 

will be enforced through the pesticide 

registration process under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), 7 U.S.C. 136 et seq. EPA 

will not register any pesticide for sale or 

distribution for use on growing crops 

with concentrations of quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite exceeding 2.0% by weight of 

the formulation, asbestos free and 

containing less than 1% crystalline 

silica; and quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with saponite exceeding 1.0% by weight 

of the formulation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nation Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite, and quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with saponite. 

VI. Conclusions 

Therefore, exemptions from the 

requirement of a tolerance are 

established under 40 CFR 180. 920 for 

quaternary ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

sepiolite (CAS Reg. No. 1574487–61–8) 

when used as an inert ingredient 

(suspending or structuring agent) in 

pesticide formulations applied to 

growing crops with a limitation of 2.0% 

in formulation, asbestos free and 

containing less than 1% crystalline 

silica; and for quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with saponite (CAS Reg. No. 1588523– 

05–0) when used as an inert ingredient 

(suspending or structuring agent) in 

pesticide formulations applied to 

growing crops with a limitation of 1.0% 

in formulation. 


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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 

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: May 10, 2016. 

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 ingredients ‘‘Quaternary 

ammonium compounds, 

benzylbis(hydrogenated tallow 

alkyl)methyl, bis(hydrogenated tallow 

alkyl)dimethylammonium salts with 

saponite’’ and ‘‘Quaternary ammonium 

compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated 

tallow alkyl)dimethylammonium salts 

with sepiolite’’ to the table to read as 

follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Quaternary ammonium compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with saponite (CAS Reg. No. 

1588523–05–0).

Not to exceed 1.0% by weight of pesticide formulation.Suspending or structuring agent. 

Quaternary ammonium compounds, benzylbis(hydrogenated 

tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salts with sepiolite (CAS Reg. No. 

1574487–61–8).

Not to exceed 2.0% by weight of pesticide formulation, asbestos free 

and containing less than 1% crystalline silica.

Suspending or structuring agent. 

*******

[FR Doc. 2016–11743 Filed 5–17–16; 8:45 am] 

BILLING CODE 6560–50–P 


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Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Rules and Regulations 31177 

ENVIRONMENTAL PROTECTION 

AGENCY 

48 CFR Parts 1503 and 1552 

[EPA–HQ–OARM–2015–0662; FRL 9943–61– 

OARM] 

Environmental Protection Agency 

Acquisition Regulation; Improper 

Business Practices and Personal 

Conflicts of Interest, Solicitation 

Provisions and Contract Clauses 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is issuing a final rule to 

make administrative changes to the 

Environmental Protection Agency 

Acquisition Regulation (EPAAR). EPA 

does not anticipate any adverse 

comments. 

DATES: This rule is effective on July 18, 

2016 without further action, unless EPA 

receives adverse comment by June 17, 

2016. If EPA receives adverse comment, 

a timely withdrawal will be published 

in the Federal Register informing the 

public that the rule will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OARM–2015–0662, at http://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or removed from Regulations.gov. 

The EPA may publish any comment 

received to its public docket. Do not 

submit electronically any information 

you consider to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e. on the web, cloud, or 

other file sharing system). For 

additional submission methods, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/dockets/

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Julianne Odend’hal, Policy, Training, 

and Oversight Division, Acquisition 

Policy and Training Service Center 

(3802R), Environmental Protection 

Agency, 1200 Pennsylvania Avenue 

NW., Washington, DC 20460; telephone 

number: (202) 564–5218; email address: 

odend’hal.julianne@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Why is EPA using a direct final rule? 

EPA is publishing this rule without a 

prior proposed rule because EPA views 

this as a noncontroversial action and 

anticipates no adverse comment. 

EPAAR parts 1503 and 1552 are 

amended to conform to the format of the 

Federal Acquisition Regulation (FAR) 

and to correct, clarify and update 

information. If EPA receives adverse 

comment, a timely withdrawal will be 

published in the Federal Register 

informing the public that the rule will 

not take effect. Any parties interested in 

commenting must do so at this time. 

II. Does this action apply to me? 

The EPAAR applies to contractors 

who have a contract with the EPA. 

III. What should I consider as I prepare 

my comments for EPA? 

A. Submitting CBI. Do not submit this 

information to EPA through http://

www.regulations.gov or email. Clearly 

mark the part or all of the information 

that you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI, and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

B. Tips for Preparing Your Comments. 

When submitting comments, remember 

to: 

• Identify the rulemaking by docket 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

• Follow directions—The agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

• Explain why you agree or disagree, 

suggest alternatives, and substitute 

language for your requested changes. 

• Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

• If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

• Provide specific examples to 

illustrate your concerns, and suggest 

alternatives. 

• Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

• Make sure to submit your 

comments by the comment period 

deadline identified. 

IV. Background 

EPAAR parts 1503 and 1552 are 

amended to conform to the format of the 

Federal Acquisition Regulation (FAR) 

and to correct, clarify and update 

information. 

V. Final Rule 

This direct final rule makes the 

following changes: (1) Updates the title 

and clarifies the information in section 

1503.101–370 including correcting 

statute citations; (2) corrects section 

number ‘‘1503.104–5’’ to read 

‘‘1503.104–4’’ and corrects the reference 

to ‘‘FAR 3.104–5’’ to read ‘‘FAR 3.104– 

4’’; (3) removes section 1503.408, 

Evaluation of the SF 119, because the 

form no longer exists; (4) updates the 

subpart number and title of ‘‘1503.5’’ 

including ‘‘1503.500–70’’, ‘‘1503.500– 

71’’ and ‘‘1503.500–72’’ to read 

‘‘1503.10 Contractor Code of Business 

Ethics and Conduct’’, ‘‘1503.1002 

Policy’’, ‘‘1503.1003 Requirements’’, 

and ‘‘1503.1004 Contract clause’’ to 

conform to the FAR, updates the 

reference to ‘‘EPAAR 1503.500–71(b)’’ 

to read ‘‘EPAAR 1503.1003(b)’’; (5) 

replaces the term ‘‘regular employee’’ 

with ‘‘employee’’ which is defined at 5 

U.S.C. 2505, and replaces the term 

‘‘special employee’’ with ‘‘special 

government employee’’ which is 

defined at 18 U.S.C. 202 in sections 

1503.600–71, 1503.601, and 1552.203– 

70; and (6) updates the EPA OIG contact 

information in section 1552.203–71. 

VI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is not a significant 

regulatory action and was therefore not 

submitted to the Office of Management 

and Budget (OMB) for review. 

B. Paperwork Reduction Act 

This action does not impose an 

information collection burden under the 

PRA because it does not contain any 

information collection activities. 


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