[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46260-46265]
From the Federal Register Online via the Government Publishing 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: [email protected].
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