Document ID: EPA-HQ-OPP-2015-0018-0003
Agency: epa
Document Type: Rule
Title: Requirement of a Tolerance; Exemptions: 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
Posted Date: 2016-05-18T04:00Z

[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Rules and Regulations]
[Pages 31172-31177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11743]

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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.

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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/text-idx?&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.

[[Page 31173]]

     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-
observed-adverse-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

[[Page 31174]]

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 non-occupational, 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 non-
pesticide 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

[[Page 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.

[[Page 31176]]

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]

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 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:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
         Inert ingredients                   Limits                                 Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Quaternary ammonium compounds,       Not to exceed 1.0% by  Suspending or structuring agent.
 benzylbis(hydrogenated tallow        weight of pesticide
 alkyl)methyl, bis(hydrogenated       formulation.
 tallow alkyl)di-methylammonium
 salts with saponite (CAS Reg. No.
 1588523-05-0).
Quaternary ammonium compounds,       Not to exceed 2.0% by  Suspending or structuring agent.
 benzylbis(hydrogenated tallow        weight of pesticide
 alkyl)methyl, bis(hydrogenated       formulation,
 tallow alkyl)di-methylammonium       asbestos free and
 salts with sepiolite (CAS Reg. No.   containing less than
 1574487-61-8).                       1% crystalline
                                      silica.
 
                                                  * * * * * * *
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[FR Doc. 2016-11743 Filed 5-17-16; 8:45 am]
 BILLING CODE 6560-50-P