Document ID: EPA-HQ-OPP-2019-0093-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Oxirane, 2-methyl-, Polymer with Oxirane, Monoundecyl Ether, Branched and Linear
Posted Date: 2019-08-27T04:00Z

[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Rules and Regulations]
[Pages 44712-44718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18362]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0093; FRL-9996-95]

Oxirane, 2-methyl-, Polymer With Oxirane, Monoundecyl Ether, 
Branched and Linear; Exemption 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 oxirane, 2-methyl-, polymer with 
oxirane, monoundecyl ether, branched and linear (CAS Reg. No. 2222805-
23-2) when used as an inert ingredient in a pesticide chemical 
formulation. Exponent, Inc. on behalf of Clariant Corporation submitted 
a petition to EPA under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), requesting an amendment to an existing requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of oxirane, 2-methyl-, polymer with 
oxirane, monoundecyl ether, branched and linear.

DATES: This regulation is effective August 27, 2019. Objections and 
requests for hearings must be received on or before October 28, 2019, 
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-2019-0093, 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: Michael Goodis, 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).

[[Page 44713]]

     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 Publishing Office's e-CFR site at 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2019-0093 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 
October 28, 2019. 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-2019-0093, 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 August 5, 2009 (74 FR 38935) (FRL-8430-
1), EPA issued a final rule, announcing the establishment of a 
tolerance exemption pursuant to a pesticide petition (PP 9E7534) by The 
Joint Inerts Task Force, Cluster Support Team 1 (CST 1), c/o CropLife 
America, 1156 15th Street NW, Suite 400, Washington, DC 20005. The 
petition requested that 40 CFR 180.910, 180.930, 180.940(a) and 180.960 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of a group of substances known as [alpha]-alkyl-
[omega]-hydroxypoly(oxypropylene) and/or poly (oxyethylene) polymers 
where the alkyl chain contains a minimum of 6 carbons, herein referred 
to in this document as AAA.
    The current petition seeks to expand the exemptions for AAA by 
adding additional CAS Reg. Nos. In the Federal Register of May 13, 2019 
(84 FR 20843) (FRL-9991-91), EPA issued a document pursuant to FFDCA 
section 408, 21 U.S.C. 346a, announcing the filing of a pesticide 
petition (PP IN-11254) by Exponent Inc. on behalf of Clariant 
Corporation, Suite 1100, 1150 Connecticut Avenue NW, Washington DC 
20036. The petition requested that 40 CFR 180.910, 180.930, 180.940(a) 
and 180.960 be amended by establishing an exemption from the 
requirement of a tolerance for residues of oxirane, 2-methyl-, polymer 
with oxirane, monoundecyl ether, branched and linear (CAS Reg. No. 
2222805-23-2). That document referenced a summary of the petition 
prepared by Exponent, 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 
confirmed that the requested CAS Reg. No. is acceptable for 
consideration under the currently approved descriptor. This 
determination is based on the Agency's risk assessment which can be 
found at http://www.regulations.gov in document ``Alkyl Alcohol 
Alkoxylates (AAA-JITF CST 1 Inert Ingredient), Human Health Risk 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance under 40 CFR 180.960 when used as an Inert Ingredient in 
Pesticide Formulations'' in docket ID number EPA-HQ-OPP-2009-0145.

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

[[Page 44714]]

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 oxirane, 2-methyl-, polymer 
with oxirane, monoundecyl ether, branched and linear including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with oxirane, 2-methyl-, 
polymer with oxirane, monoundecyl ether, branched and linear 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 AAA 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 the final rule 
published in the Federal Register of August 5, 2009 (74 FR 38935) (FRL-
8430-1).

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.
    A summary of the toxicological endpoints for AAA used for human 
risk assessment is discussed in Unit IV of the final rule published in 
the Federal Register of August 5, 2009 (74 FR 38938) (FRL-8430-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to AAA, EPA considered exposure under the proposed exemption 
from the requirement of a tolerance. EPA assessed dietary exposures 
from AAA in food as follows:
    i. Acute exposure. No adverse effects attributable to a single 
exposure of the AAAs was seen in the toxicity databases. Therefore, 
acute dietary risk assessments for the AAAs are not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) 1994 -1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII).
    iii. Cancer. The Agency used a qualitative structure activity 
relationship (SAR) database, DEREK11, to determine if there were 
structural alerts suggestive of carcinogenicity. No structural alerts 
for carcinogenicity were identified. The AAAs are not expected to be 
carcinogenic. Therefore, a cancer dietary exposure assessment is not 
necessary to assess cancer risk.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for the AAAs in drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to nonoccupational, non-dietary exposure 
(e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). The AAAs may be used 
in inert ingredients in pesticide products that are registered for 
specific uses that may result in both indoor and outdoor residential 
exposures. A screening level residential exposure and risk assessment 
was completed for products containing the AAAs as inert ingredients.
    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 AAA to share a common mechanism of toxicity with 
any other substances, and AAA does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that AAA 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 website 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 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.
    2. Prenatal and postnatal sensitivity. In the case of the lower 
weight AAA surfactants, there was no evidence of increased 
susceptibility to the offspring of rats following prenatal and 
postnatal exposure in the reproductive/developmental screening studies 
on several representative AAA surfactants. Decreased litter size and 
increased post-implantation loss were observed in one OPPTS Harmonized 
Guideline 870.3550 reproduction/developmental toxicity screening study 
at 470 mg/kg/day where maternal/paternal toxicity was manifested as one 
maternal death (GD

[[Page 44715]]

22), decreased body weight, bodyweight gain and food consumption and 
clinical signs (ptosis and hypoactivity) and microscopic changes in the 
testes (atrophy) and epididymides (increased intraluminal exfoliated 
spermatogenic cells) and dilated seminiferous tubules at the same dose 
(470 mg/kg/day). The maternal and offspring toxicity NOAEL was 168 mg/
kg/day. The offspring toxicity in the OPPTS Harmonized Test Guideline 
870.3650 study was manifested in the presence of more severe maternal 
toxicity (deaths), therefore, EPA concluded that there is no evidence 
of increased susceptibility in this study. In addition, there was no 
evidence of increased susceptibility in other submitted studies.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for the lower weight AAAs. (As discussed 
earlier, given the low toxicological concerns with the high weight 
AAAs, a safety factor analysis is unnecessary).

E. Aggregate Risks and Determination of Safety Determination of Safety 
Section

    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, 
AAA is not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account exposure estimates from chronic dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for chronic exposure the chronic dietary exposure from food and water 
to the AAAs is 11% of the cPAD for the U.S. population and 37% of the 
cPAD for children 1 to 2 years old, the most highly exposed population 
subgroup.
    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).
    AAAs are used as inert ingredients in pesticide products that are 
currently registered for uses that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to the AAAs. EPA has concluded that 
the combined short-term aggregated food, water, and residential 
exposures result in aggregate MOEs of 110 for both adult males and 
females. Adult residential exposure combines high end indoor inhalation 
handler exposure with a high-end post application to pet exposures. EPA 
has concluded the combined short-term aggregated food, water, and 
residential exposures result in an aggregate MOE of 110 for children. 
Children's residential exposure includes total combined pet exposures. 
As the level of concern is for MOEs that are lower than 100, these MOEs 
are not of concern.
    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).
    The AAAs are used as inert ingredients in pesticide products that 
are currently registered for uses that could result in intermediate-
term residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
intermediate-term residential exposures to the AAAs. EPA has concluded 
that the combined intermediate-term aggregated food, water, and 
residential exposures result in aggregate MOEs of 230 for both adult 
males and females, respectively. Adult residential exposure includes 
high-end post application dermal exposure from contact with treated 
pets. EPA has concluded that the combined intermediate-term aggregated 
food, water, and residential exposures result in an aggregate MOE of 
110 for children. Children's residential exposure includes total 
combined pet exposure. As the level of concern is for MOEs that are 
lower than 100, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to the AAAs.
    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 residues of the lower weight AAAs. For the high molecular 
weight AAAs under 40 CFR 180.960. Since AAA conforms to the criteria 
that identify a low-risk polymer, there are no concerns for risks 
associated with any potential exposure scenarios that are reasonably 
foreseeable. Therefore, 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 residues of the high 
molecular weight AAAs.

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 without any numerical limitation.

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 AAAs.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of the lower molecular weight [alpha]-alkyl-
[omega]-hydroxypoly(oxypropylene) and/or poly (oxyethylene) polymers 
where the alkyl chain contains a minimum of 6 carbons, including 
oxirane, 2-methyl-, polymer with oxirane, monoundecyl ether, branched 
and linear (CAS Reg. No. 2222805-23-2) when used as an inert ingredient 
in pesticide formulations applied to pre- and post-harvest, applied to 
livestock, and used in antimicrobial formulations under 40 CFR 180.910, 
40 CFR 180.930, and 40 CFR 180.940(a). In addition, an

[[Page 44716]]

exemption from the requirement of a tolerance is established for 
residues of the larger molecular weight compounds of a-alkyl-w-
hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the 
alkyl chain contains a minimum of 6 carbons, including oxirane, 2-
methyl-, polymer with oxirane, monoundecyl ether, branched and linear 
(CAS Reg. No. 2222805-23-2) under 40 CFR 180.960.

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: August 16, 2019.
Daniel Rosenblatt,
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.  180.910, revise the inert ingredients ``[alpha]-Alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers 
where the alkyl chain contains a minimum of six carbons'' in the table 
to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
            Inert ingredients                 Limits          Uses
------------------------------------------------------------------------
 
                              * * * * * * *
[alpha]-Alkyl-[omega]-hydroxypoly          ...........  Surfactants,
 (oxypropylene) and/or poly (oxyethylene)                related
 polymers where the alkyl chain contains                 adjuvants of
 a minimum of six carbons (CAS Reg. Nos.:                surfactants
 9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
 9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
 05-5; 9043-30-5; 9087-53-0; 25190-05-0;
 24938-91-8; 25231-21-4; 251553-55-6;
 26183-52-8; 26468-86-0; 26636-39-5;
 27252-75-1; 27306-79-2; 31726-34-8;
 34398-01-1; 34398-05-5; 37251-67-5;
 37311-00-5; 37311-01-6; 37311-02-7;
 37311-04-9; 39587-22-9; 50861-66-0;
 52232-09-4; 52292-17-8; 52609-19-5;
 57679-21-7; 59112-62-8; 60828-78-6;
 61702-78-1; 61723-78-2; 61725-89-1;
 61791-13-7; 61791-20-6; 61791-28-4;
 61804-34-0; 61827-42-7; 61827-84-7;
 62648-50-4; 63303-01-5; 63658-45-7;
 63793-60-2; 64366-70-7; 64415-24-3;
 64415-25-4; 64425-86-1; 65104-72-5;
 65150-81-4; 66455-14-9: 66455-15-0;
 67254-71-1; 67763-08-0; 68002-96-0;
 68002-97-1; 68131-39-5; 68131-40-8;
 68154-96-1; 68154-97-2; 68154-98-3;
 68155-01-1; 68213-23-0; 68213-24-1;
 68238-81-3; 68238-82-4; 68409-58-5;
 68409-59-6; 68439-30-5; 68439-45-2;
 68439-46-3; 68439-48-5; 68439-49-6;
 68439-50-9; 68439-51-0; 68439-53-2;
 68439-54-3; 68458-88-8; 68526-94-3;
 68526-95-4; 68551-12-2; 68551-13-3;
 68551-14-4; 68603-20-3; 68603-25-8;
 68920-66-1; 68920-69-4; 68937-66-6;
 68951-67-7; 68954-94-9; 68987-81-5;
 68991-48-0; 69011-36-5; 69013-18-9;
 69013-19-0; 69227-20-9; 69227-21-0;
 69227-22-1; 69364-63-2; 70750-27-5;
 70879-83-3; 70955-07-6; 71011-10-4;
 71060-57-6; 71243-46-4; 72066-65-0;
 72108-90-8; 72484-69-6; 72854-13-8;
 72905-87-4; 73018-31-2; 73049-34-0;
 74432-13-6; 74499-34-6; 78330-19-5;
 78330-20-8; 78330-21-9; 78330-23-1;
 79771-03-2; 84133-50-6; 85422-93-1;
 97043-91-9; 97953-22-5; 102782-43-4;
 103331-86-8; 103657-84-7; 103657-85-8;
 103818-93-5; 103819-03-0; 106232-83-1;
 111905-54-5; 116810-31-2; 116810-32-3;
 116810-33-4; 120313-48-6; 120944-68-5;
 121617-09-2; 126646-02-4; 126950-62-7;
 127036-24-2; 139626-71-4; 152231-44-2;
 154518-36-2; 157627-86-6; 157627-88-8;
 157707-41-0; 157707-43-2; 159653-49-3;
 160875-66-1; 160901-20-2; 160901-09-7;
 160901-19-9; 161025-21-4; 161025-22-5;
 166736-08-9; 169107-21-5; 172588-43-1;
 176022-76-7; 196823-11-7; 287935-46-0;
 288260-45-7; 303176-75-2; 954108-36-2;
 2222805-23-2).
 
                              * * * * * * *
------------------------------------------------------------------------

[[Page 44717]]

0
3. In Sec.  180.930, revise the inert ingredients ``[alpha]-Alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers 
where the alkyl chain contains a minimum of six carbons'' in the table 
to read as follows:

Sec.  180.930   Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
            Inert ingredients                 Limits          Uses
------------------------------------------------------------------------
 
                              * * * * * * *
[alpha]-Alkyl-[omega]-hydroxypoly          ...........  Surfactants,
 (oxypropylene) and/or poly (oxyethylene)                related
 polymers where the alkyl chain contains                 adjuvants of
 a minimum of six carbons (CAS Reg. Nos.:                surfactants
 9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
 9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
 05-5; 9043-30-5; 9087-53-0; 25190-05-0;
 24938-91-8; 25231-21-4; 251553-55-6;
 26183-52-8; 26468-86-0; 26636-39-5;
 27252-75-1; 27306-79-2; 31726-34-8;
 34398-01-1; 34398-05-5; 37251-67-5;
 37311-00-5; 37311-01-6; 37311-02-7;
 37311-04-9; 39587-22-9; 50861-66-0;
 52232-09-4; 52292-17-8; 52609-19-5;
 57679-21-7; 59112-62-8; 60828-78-6;
 61702-78-1; 61723-78-2; 61725-89-1;
 61791-13-7; 61791-20-6; 61791-28-4;
 61804-34-0; 61827-42-7; 61827-84-7;
 62648-50-4; 63303-01-5; 63658-45-7;
 63793-60-2; 64366-70-7; 64415-24-3;
 64415-25-4; 64425-86-1; 65104-72-5;
 65150-81-4; 66455-14-9: 66455-15-0;
 67254-71-1; 67763-08-0; 68002-96-0;
 68002-97-1; 68131-39-5; 68131-40-8;
 68154-96-1; 68154-97-2; 68154-98-3;
 68155-01-1; 68213-23-0; 68213-24-1;
 68238-81-3; 68238-82-4; 68409-58-5;
 68409-59-6; 68439-30-5; 68439-45-2;
 68439-46-3; 68439-48-5; 68439-49-6;
 68439-50-9; 68439-51-0; 68439-53-2;
 68439-54-3; 68458-88-8; 68526-94-3;
 68526-95-4; 68551-12-2; 68551-13-3;
 68551-14-4; 68603-20-3; 68603-25-8;
 68920-66-1; 68920-69-4; 68937-66-6;
 68951-67-7; 68954-94-9; 68987-81-5;
 68991-48-0; 69011-36-5; 69013-18-9;
 69013-19-0; 69227-20-9; 69227-21-0;
 69227-22-1; 69364-63-2; 70750-27-5;
 70879-83-3; 70955-07-6; 71011-10-4;
 71060-57-6; 71243-46-4; 72066-65-0;
 72108-90-8; 72484-69-6; 72854-13-8;
 72905-87-4; 73018-31-2; 73049-34-0;
 74432-13-6; 74499-34-6; 78330-19-5;
 78330-20-8; 78330-21-9; 78330-23-1;
 79771-03-2; 84133-50-6; 85422-93-1;
 97043-91-9; 97953-22-5; 102782-43-4;
 103331-86-8; 103657-84-7; 103657-85-8;
 103818-93-5; 103819-03-0; 106232-83-1;
 111905-54-5; 116810-31-2; 116810-32-3;
 116810-33-4; 120313-48-6; 120944-68-5;
 121617-09-2; 126646-02-4; 126950-62-7;
 127036-24-2; 139626-71-4; 152231-44-2;
 154518-36-2; 157627-86-6; 157627-88-8;
 157707-41-0; 157707-43-2; 159653-49-3;
 160875-66-1; 160901-20-2; 160901-09-7;
 160901-19-9; 161025-21-4; 161025-22-5;
 166736-08-9; 169107-21-5; 172588-43-1;
 176022-76-7; 196823-11-7; 287935-46-0;
 288260-45-7; 303176-75-2; 954108-36-2;
 2222805-23-2).
 
                              * * * * * * *
------------------------------------------------------------------------

0
4. In Sec.  180.940, revise the inert ingredients ``[alpha]-Alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers 
where the alkyl chain contains a minimum of six carbons'' in the table 
in paragraph (a) to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

----------------------------------------------------------------------------------------------------------------
          Pesticide chemical                             CAS Reg. No.                             Limits
----------------------------------------------------------------------------------------------------------------
 
                                                 * * * * * * **
[alpha]-Alkyl-[omega]-hydroxypoly      9002-92-0; 9004-95-9; 9004-98-2; 9005-00-9; 9035- None
 (oxypropylene) and/or poly             85-2; 9038-29-3; 9038-43-1; 9040-05-5; 9043-30-
 (oxyethylene) polymers where the       5; 9087-53-0; 25190-05-0; 24938-91-8; 25231-21-
 alkyl chain contains a minimum of      4; 251553-55-6; 26183-52-8; 26468-86-0; 26636-
 six carbons.                           39-5; 27252-75-1; 27306-79-2; 31726-34-8; 34398-
                                        01-1; 34398-05-5; 37251-67-5; 37311-00-5; 37311-
                                        01-6; 37311-02-7; 37311-04-9; 39587-22-9; 50861-
                                        66-0; 52232-09-4; 52292-17-8; 52609-19-5; 57679-
                                        21-7; 59112-62-8; 60828-78-6; 61702-78-1; 61723-
                                        78-2; 61725-89-1; 61791-13-7; 61791-20-6; 61791-
                                        28-4; 61804-34-0; 61827-42-7; 61827-84-7; 62648-
                                        50-4; 63303-01-5; 63658-45-7; 63793-60-2; 64366-
                                        70-7; 64415-24-3; 64415-25-4; 64425-86-1; 65104-
                                        72-5; 65150-81-4; 66455-14-9: 66455-15-0; 67254-
                                        71-1; 67763-08-0; 68002-96-0; 68002-97-1; 68131-
                                        39-5; 68131-40-8; 68154-96-1; 68154-97-2; 68154-
                                        98-3; 68155-01-1; 68213-23-0; 68213-24-1; 68238-
                                        81-3; 68238-82-4; 68409-58-5; 68409-59-6; 68439-
                                        30-5; 68439-45-2; 68439-46-3; 68439-48-5; 68439-
                                        49-6; 68439-50-9; 68439-51-0; 68439-53-2; 68439-
                                        54-3; 68458-88-8; 68526-94-3; 68526-95-4; 68551-
                                        12-2; 68551-13-3; 68551-14-4; 68603-20-3; 68603-
                                        25-8; 68920-66-1; 68920-69-4; 68937-66-6; 68951-
                                        67-7; 68954-94-9; 68987-81-5; 68991-48-0; 69011-
                                        36-5; 69013-18-9; 69013-19-0; 69227-20-9; 69227-
                                        21-0; 69227-22-1; 69364-63-2; 70750-27-5; 70879-
                                        83-3; 70955-07-6; 71011-10-4; 71060-57-6; 71243-
                                        46-4; 72066-65-0; 72108-90-8; 72484-69-6; 72854-
                                        13-8; 72905-87-4; 73018-31-2; 73049-34-0; 74432-
                                        13-6; 74499-34-6; 78330-19-5; 78330-20-8; 78330-
                                        21-9; 78330-23-1; 79771-03-2; 84133-50-6; 85422-
                                        93-1; 97043-91-9; 97953-22-5; 102782-43-4;
                                        103331-86-8; 103657-84-7; 103657-85-8; 103818-
                                        93-5; 103819-03-0; 106232-83-1; 111905-54-5;
                                        116810-31-2; 116810-32-3; 116810-33-4; 120313-
                                        48-6; 120944-68-5; 121617-09-2; 126646-02-4;
                                        126950-62-7; 127036-24-2; 139626-71-4; 152231-
                                        44-2; 154518-36-2; 157627-86-6; 157627-88-8;
                                        157707-41-0; 157707-43-2; 159653-49-3; 160875-
                                        66-1; 160901-20-2; 160901-09-7; 160901-19-9;
                                        161025-21-4; 161025-22-5; 166736-08-9; 169107-
                                        21-5; 172588-43-1; 176022-76-7; 196823-11-7;
                                        287935-46-0; 288260-45-7; 303176-75-2; 954108-
                                        36-2; 2222805-23-2.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[[Page 44718]]

* * * * *

0
5. In Sec.  180.960, revise the inert ingredients ``[alpha]-Alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers 
where the alkyl chain contains a minimum of six carbons and a minimum 
number average molecular weight (in amu) 1,100'' in the table to read 
as follows:

Sec.  180.960   Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

------------------------------------------------------------------------
           Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
[alpha]-Alkyl-[omega]-         9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
 hydroxypoly (oxypropylene)     9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
 and/or poly (oxyethylene)      05-5; 9043-30-5; 9087-53-0; 25190-05-0;
 polymers where the alkyl       24938-91-8; 25231-21-4; 251553-55-6;
 chain contains a minimum of    26183-52-8; 26468-86-0; 26636-39-5;
 six carbons and a minimum      27252-75-1; 27306-79-2; 31726-34-8;
 number average molecular       34398-01-1; 34398-05-5; 37251-67-5;
 weight (in amu) 1,100.         37311-00-5; 37311-01-6; 37311-02-7;
                                37311-04-9; 39587-22-9; 50861-66-0;
                                52232-09-4; 52292-17-8; 52609-19-5;
                                57679-21-7; 59112-62-8; 60828-78-6;
                                61702-78-1; 61723-78-2; 61725-89-1;
                                61791-13-7; 61791-20-6; 61791-28-4;
                                61804-34-0; 61827-42-7; 61827-84-7;
                                62648-50-4; 63303-01-5; 63658-45-7;
                                63793-60-2; 64366-70-7; 64415-24-3;
                                64415-25-4; 64425-86-1; 65104-72-5;
                                65150-81-4; 66455-14-9: 66455-15-0;
                                67254-71-1; 67763-08-0; 68002-96-0;
                                68002-97-1; 68131-39-5; 68131-40-8;
                                68154-96-1; 68154-97-2; 68154-98-3;
                                68155-01-1; 68213-23-0; 68213-24-1;
                                68238-81-3; 68238-82-4; 68409-58-5;
                                68409-59-6; 68439-30-5; 68439-45-2;
                                68439-46-3; 68439-48-5; 68439-49-6;
                                68439-50-9; 68439-51-0; 68439-53-2;
                                68439-54-3; 68458-88-8; 68526-94-3;
                                68526-95-4; 68551-12-2; 68551-13-3;
                                68551-14-4; 68603-20-3; 68603-25-8;
                                68920-66-1; 68920-69-4; 68937-66-6;
                                68951-67-7; 68954-94-9; 68987-81-5;
                                68991-48-0; 69011-36-5; 69013-18-9;
                                69013-19-0; 69227-20-9; 69227-21-0;
                                69227-22-1; 69364-63-2; 70750-27-5;
                                70879-83-3; 70955-07-6; 71011-10-4;
                                71060-57-6; 71243-46-4; 72066-65-0;
                                72108-90-8; 72484-69-6; 72854-13-8;
                                72905-87-4; 73018-31-2; 73049-34-0;
                                74432-13-6; 74499-34-6; 78330-19-5;
                                78330-20-8; 78330-21-9; 78330-23-1;
                                79771-03-2; 84133-50-6; 85422-93-1;
                                97043-91-9; 97953-22-5; 102782-43-4;
                                103331-86-8; 103657-84-7; 103657-85-8;
                                103818-93-5; 103819-03-0; 106232-83-1;
                                111905-54-5; 116810-31-2; 116810-32-3;
                                116810-33-4; 120313-48-6; 120944-68-5;
                                121617-09-2; 126646-02-4; 126950-62-7;
                                127036-24-2; 139626-71-4; 152231-44-2;
                                154518-36-2; 157627-86-6; 157627-88-8;
                                157707-41-0; 157707-43-2; 159653-49-3;
                                160875-66-1; 160901-20-2; 160901-09-7;
                                160901-19-9; 161025-21-4; 161025-22-5;
                                166736-08-9; 169107-21-5; 172588-43-1;
                                176022-76-7; 196823-11-7; 287935-46-0;
                                288260-45-7; 303176-75-2; 954108-36-2;
                                2222805-23-2
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2019-18362 Filed 8-26-19; 8:45 am]
BILLING CODE 6560-50-P