Document ID: EPA-HQ-OPP-2012-0908-0003
Agency: epa
Document Type: Rule
Title: Sorbitan Monooleate Ethylene OxideAdduct; Exemption From theRequirement of a Tolerance
Posted Date: 2013-07-31T04:00Z

[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46260-46265]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18188]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0908; FRL-9389-8]

Sorbitan Monooleate Ethylene Oxide Adduct; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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[[Page 46261]]

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of sorbitan, mono-9-octadecenoate, 
poly(oxy-1,2-ethanediyl) derivs., (Z)- (CAS Reg. No 9005-65-6) (also 
known as ``sorbitan monooleate ethylene oxide adduct'' and as 
``polysorbate 80'') when used as an inert ingredient in antimicrobial 
formulations for use on food-contact surfaces in public eating places, 
dairy-processing equipment, and food-processing equipment and utensils. 
Exponent, on behalf of Ecolab, Inc. submitted a petition to EPA under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the 
establishment of an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of sorbitan monooleate ethylene oxide adduct.

DATES: This regulation is effective July 31, 2013. Objections and 
requests for hearings must be received on or before September 30, 2013, 
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-2012-0908, 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), EPA West 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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.

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-2012-0908 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 
September 30, 2013. 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-2012-0908, 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.htm. 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 February 15, 2013 (78 FR 11129) (FRL-
9378-4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10524) by 
Exponent, on behalf of Ecolab, Inc., 370 Wabasha St., St. Paul MN 
55102. The petition requested that 40 CFR 180.940(a) be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of sorbitan monooleate ethylene oxide adduct when used as an 
inert ingredient in antimicrobial formulations applied to food-contact 
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. 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.

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

[[Page 46262]]

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 sorbitan monooleate ethylene 
oxide adduct including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with sorbitan monooleate ethylene oxide adduct 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 sorbitan monooleate ethylene oxide 
adduct 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.
    The acute oral toxicity of sorbitan monooleate ethylene oxide 
adduct is low; the LD50 was >25,000 mg/kg in the rat and 
mouse. Also, no systemic or adverse effects were observed in rats 
following a single oral dose of 22,000 mg/kg/day. Sorbitan monooleate 
ethylene oxide adduct did not cause eye irritation in rabbits. It was 
not a dermal sensitizer in guinea pigs. Acute dermal toxicity was not 
observed in rabbits exposed to sorbitan sesquioleate ethoxylate, a 
substance that is closely related to sorbitan monooleate ethylene oxide 
adduct.
    Sorbitan monooleate ethylene oxide adduct was administered via the 
diet to rats in a subchronic toxicity study. Systemic toxicity was not 
observed in rats following exposure to 2,500 mg/kg/day of sorbitan 
monooleate ethylene oxide adduct in the diet for 13 weeks.
    In developmental and reproduction toxicity studies, rats and mice 
administered sorbitan monooleate ethylene oxide adduct at doses >10,000 
mg/kg/day exhibited toxicity. These doses well exceed the limit dose of 
1,000 mg/kg/day.
    Available mutagenicity studies included the rec-assay, reverse 
mutation assay, chromosome aberration test, a mouse micronucleus assay, 
and a dominant lethal test. Sorbitan monooleate ethylene oxide adduct 
was negative for inducing mutations and aberrations in all of the 
studies. Therefore, sorbitan monooleate ethylene oxide adduct is 
considered nonmutagenic.
    Evidence of carcinogenicity was not observed in mice. In rats, the 
incidence of adrenal medulla malignant and benign pheochromocytoma is 
4% and 58%, respectively, in high dose males. The historical control 
ranges for malignant and total benign pheochromocytoma are 0-20% and 
22-48%, respectively. The incidence of total benign adrenal medulla 
pheochromocytoma (29/50, 58%) was marginally increased though not 
significantly in high dose (50,000 ppm) males only when compared to 
control male rats (21/50, 42%). Nevertheless, the Agency concluded that 
the concern for carcinogenicity is low based on the following:
    1. The adrenal medulla pheochromocytomas were observed in only one 
sex and species at an extremely high dose, 2,500 mg/kg/day, which is in 
excess of 2.5 times the limit dose;
    2. The increased incidence was observed in benign tumors,
    3. The lack of mutagenicity of sorbitan monoleate ethylene oxide 
adduct; and
    4. General low toxicity of the substance. Therefore, a cancer risk 
assessment was not conducted.
    Neurotoxicity parameters were evaluated in a reproduction toxicity 
study in rats with sorbitan monooleate ethylene oxide adduct. Evidence 
of neurotoxicity was not observed.
    Although no immunotoxicity studies were available for review, none 
of the submitted studies indicated any evidence of immunotoxicity.
    A metabolism study in rats showed that sorbitan monooleate ethylene 
oxide adduct administered orally is hydrolyzed, poorly absorbed, and 
excreted mainly in the feces. Bioaccumulation was not observed.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that sorbitan monooleate 
ethylene oxide adduct has very low toxicity. The toxicity database is 
consists of toxicity data on subchronic and chronic exposures; 
carcinogenicity, developmental, reproduction, mutagenicity and 
metabolism. Although a developmental study in rabbits and a dermal 
toxicity study are not available, there is no concern for the lack of 
these studies. There is no concern for the lack of a developmental 
study in rabbits because fetal susceptibility was not observed in the 
available developmental and reproduction studies in rats and mice. 
Also, toxicity was only observed at doses (>10,000 mg/kg/day) well 
above the limit dose.
    In regard to the sorbitan monooleate ethylene oxide adduct toxicity 
database, the lowest NOAEL (100 mg/kg/day) was observed in a 
developmental study in rats where 100 mg/kg/day was the only tested 
dose. However, the results in this study were considered unreliable 
because the effects were not reproducible in other studies conducted 
with the same species, at higher doses and longer exposure. In these 
remaining studies, toxicity was observed only at doses >2,500 mg/kg/
day, well above the limit dose of 1,000 mg/kg/day. Therefore, since no 
endpoint of concern was identified for the acute and chronic dietary 
exposure assessment and short and intermediate dermal and inhalation 
exposure, a quantitative risk assessment

[[Page 46263]]

for sorbitan monooleate ethylene oxide adduct is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sorbitan monooleate ethylene oxide adduct, EPA considered 
exposure under the proposed exemption from the requirement of a 
tolerance (40 CFR 180.940(a)) and as an inert ingredient used in 
pesticide formulations applied to growing crops and animals under the 
existing exemptions from the requirement of a tolerance given at 40 CFR 
180.910 and 180.930. EPA assessed dietary exposures from sorbitan 
monooleate ethylene oxide adduct in food as follows:
    Sorbitan monooleate ethylene oxide adducts are used as surfactants, 
related adjuvants of surfactants, emulsifiers, buffering agents, and 
corrosion inhibitors in a variety of residential pesticide products 
including yard, garden, and turf products, as well as in agricultural 
crop products, applied to growing crops, raw agricultural commodities 
after harvest, and/or to animals. Additionally, they are used 
extensively as emulsifiers, stabilizers and thickeners in food, 
cosmetics, personal care and medical products, and lubricants.
    For the general population, the majority of exposure to sorbitan 
monooleate ethylene oxide adduct occurs from the extensive use in 
consumer products and as FDA-approved direct and indirect food 
additives. Under this exemption from the requirement of a tolerance, 
residues of this chemical also may be found on food-contact surfaces, 
such as tableware and utensils, and in dairies and beverage- and food-
processing plants. Because no hazard endpoint of concern was identified 
for the acute and chronic dietary assessment (food and drinking water), 
a quantitative dietary exposure risk assessment was not conducted.
    2. Dietary exposure from drinking water. Sorbitan monooleate 
ethylene oxide adduct is not expected to be present in drinking water 
based on its physical/chemical properties. Further, a hazard endpoint 
of concern was not identified for the acute and chronic dietary 
assessment; therefore, a quantitative dietary exposure risk assessment 
was not conducted.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables). In the 
case of sorbitan monooleate ethylene oxide adduct, the request is for 
use as an inert ingredient in antimicrobial formulations for use on 
food contact surfaces. Sorbitan monooleate ethylene oxide adduct may 
also be used in personal care products and in products that are 
registered for specific uses that may result in residential exposure. 
However, based on the lack of toxicity, a quantitative exposure 
assessment from ``residential exposures'' was not performed.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found sorbitan monooleate ethylene oxide adduct to 
share a common mechanism of toxicity with any other substances, and 
sorbitan monooleate ethylene oxide adduct does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that sorbitan monooleate 
ethylene oxide adduct does not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of 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.
    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. The toxicity 
database contains several acute and subchronic, carcinogenicity, 
development toxicity, reproductive toxicity, and mutagenicity studies. 
The available toxicity studies indicate that sorbitan monooleate 
ethylene oxide adduct has very low toxicity. The lowest NOAEL (100 mg/
kg/day) was observed in a developmental study where 100 mg/kg/day was 
the only tested dose. However, in the remaining studies where more than 
one dose was tested, toxicity was observed only at doses >2,500 mg/kg/
day, well above the limit dose of 1,000 mg/kg/day. Further, fetal 
toxicity was only observed at doses >10,000 mg/kg/day. Although no 
neurotoxicity studies are available for sorbitan monooleate ethylene 
oxide adduct, EPA is not concerned for neurotoxic effects because 
neurotoxicity was not observed in a developmental study in rats where 
neurotoxic parameters were evaluated. Also, although no immunotoxicity 
studies are available for sorbitan monooleate ethylene oxide adduct, 
none of the submitted studies showed any indications of immunotoxicity. 
Thus, there is no residual uncertainty with regard to pre- and post-
natal toxicity of sorbitan monooleate ethylene oxide adduct.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
sorbitan monooleate ethylene oxide adduct is not expected to pose an 
acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that based on the lack of 
toxicity of sorbitan monooleate ethylene oxide adduct and since no 
chronic endpoint was identified, chronic risk is not expected.

[[Page 46264]]

    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, sorbitan monooleate ethylene 
oxide adduct is not expected to pose a short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term adverse effect was identified, 
sorbitan monooleate ethylene oxide adduct is not expected to pose an 
intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion of the potential carcinogenicity of sorbitan monooleate 
ethylene oxide adduct in Unit IV.A., sorbitan monooleate ethylene oxide 
adduct is not expected to pose a cancer risk.
    6. Determination of safety. Based on the lack of concern for hazard 
posed by sorbitan monooleate ethylene oxide adduct, 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 
sorbitan monooleate ethylene oxide adduct.

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 sorbitan monooleate 
ethylene oxide adduct.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for sorbitan, mono-9-octadecenoate, 
poly(oxy-1,2-ethanediyl) derivs., (Z)- (also known as sorbitan 
monooleate ethylene oxide adduct) (CAS Reg. No. 9005-65-6) when used as 
an inert ingredient (in antimicrobial formulations) applied to food-
contact surfaces in public eating places, dairy-processing equipment, 
and food-processing equipment and utensils.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of 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 final rule has been exempted from review 
under Executive Order 12866, this final rule 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 final rule 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 exemption to the 
requirement of a 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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: July 22, 2013.
Lois Rossi,
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.  180.940, in paragraph (a), alphabetically add the following 
inert ingredient to the table to read as follows:

[[Page 46265]]

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

* * * * *
    (a) * * *

------------------------------------------------------------------------
                                          CAS Reg.
          Pesticide chemical                No.             Limits
------------------------------------------------------------------------
 
                                * * * * *
Sorbitan, mono-9-octadecenoate,           9005-65-6  None.
 poly(oxy-1,2-ethanediyl) derivs., (Z)-
 .
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-18188 Filed 7-30-13; 8:45 am]
BILLING CODE 6560-50-P