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[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Rules and Regulations]
[Pages 54248-54252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22030]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0143; FRL-9932-06]

Propylene Glycol Monomethyl Ether; 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 propylene glycol monomethyl ether (PGME; 
CAS No. 107-98-2) when used as an inert ingredient under 40 CFR 180.910 
as a solvent in pesticide formulations which include pre-and post-
harvest use on crops. Syngenta Crop Protection submitted a petition to 
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
establishment of an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of PGME.

DATES: This regulation is effective September 9, 2015. Objections and 
requests for hearings must be received on or before November 9, 2015, 
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-2015-0143, 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:

     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0143 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 
November 9, 2015. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0143, 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 April 6, 2015 (80 FR 18327) (FRL-9924-
00), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition inert ingredient 
(PP IN-10775) by Syngenta Crop Protection, P.O. Box 18300, Greensboro, 
NC 27409, The petition requested that 40 CFR 180.910 be amended by 
establishing an

[[Page 54249]]

exemption from the requirement of a tolerance for residues of PGME (CAS 
No. 107-98-2) when used as an inert ingredient as a solvent in 
pesticide formulations applied to pre- and post-harvest use on crops. 
That document referenced a summary of the petition prepared by Syngenta 
Crop Protection, 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 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 PGME including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with PGME 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 PGME 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.
    PGME exhibits low acute toxicity by the oral, dermal, and 
inhalation routes. PGME is not a skin sensitizer or skin irritant and 
was only slightly irritating to the eye. In repeat dose inhalation 
studies ranging from 11 days to six months in duration, NOAELs of 300 
parts per million (ppm) and higher were seen in rats, mice, rabbits, 
guinea pigs and monkeys. Effects observed included sedation, hepatic 
changes and a decrease in body weight gain. Oral NOAELs of 459.5 
milligram/kilogram/day (mg/kg/day) and 919 mg/kg/day were observed in 
rat studies lasting 13 and 5 weeks, respectively. Observations included 
central nervous system (CNS) effects at very high doses (above limit 
dose of 1,000 mg/kg/day), enlarged livers and weight loss. In a 
reproduction study conducted via the inhalation route, offspring 
effects seen at 3,000 ppm appear to be related to decreased maternal 
body weight and secondary to general toxicity and nutritional stress. 
Decreased maternal body weight was also noted at the next lower dose. 
NOAELs in this study were 300 ppm for adults and 1,000 ppm for 
offspring. Studies with rats, mice, and rabbits showed that PGME was 
not a developmental toxicant (two inhalation and three gavage studies). 
Weight-of-evidence indicates that PGME is not genotoxic or 
carcinogenic. In a 2-year bioassay, there were no statistically 
significant increases in any tumor type in rats and mice.

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 the NOAEL and the LOAEL are identified. 
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.
    No acute adverse effect level has been selected for PGME. The 
chronic NOAEL of 459.5 mg/kg/day was based on CNS effects at very high 
doses, enlarged livers and weight loss in a 13 week oral study in rats.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to PGME, EPA considered

[[Page 54250]]

exposure under the proposed exemption from the requirement of a 
tolerance. EPA assessed dietary exposures from PGME in food as follows:
    An acute dietary risk assessment was not conducted because no 
endpoint of concern following a single exposure was identified in the 
available studies. A chronic dietary exposure assessment was completed 
and performed using the Dietary Exposure Evaluation Model DEEM-
FCID\TM\, Version 3.16.which includes food consumption information from 
the U.S. Department of Agriculture's National Health and Nutrition 
Examination Survey, ``What We Eat In America'', (NHANES/WWEIA). This 
dietary survey was conducted from 2003 to 2008. In the absence of 
actual residue data, the inert ingredient evaluation is based on a 
highly conservative model that assumes that the residue level of the 
inert ingredient would be no higher than the highest established 
tolerance for an active ingredient on a given commodity. Implicit in 
this assumption is that there would be similar rates of degradation 
between the active and inert ingredient (if any) and that the 
concentration of inert ingredient in the scenarios leading to these 
highest of tolerances would be no higher than the concentration of the 
active ingredient. The model assumes 100 percent crop treated (PCT) for 
all crops and that every food eaten by a person each day has tolerance-
level residues. A complete description of the general approach taken to 
assess inert ingredient risks in the absence of residue data is 
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates 
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) 
Dietary Exposure and Risk Assessments for the Inerts'' (D361707, S. 
Piper, 2/25/09) and can be found at http://www.regulations.gov in 
docket ID number EPA-HQ-OPP-2008-0738.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for PGME, a conservative 
drinking water concentration value of 100 parts per billion (ppb) based 
on screening level modeling was used to assess the contribution to 
drinking water for the chronic dietary risk assessments for parent 
compound. These values were directly entered into the dietary exposure 
model.
    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). The 
highest exposures to consumers are likely to be associated with the use 
of paints and varnishes that contain PGME with some small dermal 
exposures possible. Inhalation exposures to relatively high 
concentrations of PGME are believed to be self-limiting due to the 
irritant effects of the chemical. Based on this residential exposure 
assessment, exposure to PGME would be low (less than 2 mg/kg/day). This 
level of exposure would be two orders of magnitude below that which 
would be of concern for PGME.
    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 PGME to share a common mechanism of toxicity with 
any other substances, and PGME does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that PGME 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 Food Quality 
Protection Act Safety Factor (FQPA 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. Studies in laboratory 
animals indicate that PGME is not a developmental toxicant when 
administered via inhalation or ingestion. Developmental studies 
conducted in rats and rabbits with PGME administered via inhalation 
showed no developmental toxicity in the rabbit and developmental delays 
(delayed sternebral ossification) in the rat but only in the presence 
of maternal toxicity. In oral developmental studies in rats, mice, and 
rabbits, developmental delays were seen only in the rat fetuses at the 
highest dose tested.
    3. Conclusion. Based on this information there is no concern for 
increased sensitivity to infants and children to PGME when used as an 
inert ingredient in pesticide formulations. For the same reason, a 
safety factor analysis has not been used to assess risk to PGME and, 
therefore, the additional safety factor for the protection of infants 
and children is also unnecessary.
    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. That decision is based on the following findings:
    i. The toxicity database for PGME is complete.
    ii. There is a clinical signs of neurotoxicity observed at very 
high oral doses. However, there are no concern at this time because the 
clinical signs were observed at or above limit doses. Therefore there 
is no need for a developmental neurotoxicity study or additional UFs to 
account for neurotoxicity.
    iii. There is no evidence that PGME results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and model estimates from the use of PGME in pesticidal 
formulations resulting in chronic dietary exposure estimates for food 
and drinking water below the Agency's level of concern. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to PGME in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
PGME.

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

[[Page 54251]]

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, 
PGME 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 chronic exposure to 
PGME from food and water will utilize 15.4% of the cPAD for children 1-
2 years old, the population group receiving the greatest exposure. 
Based on the explanation in this unit, regarding residential use 
patterns, chronic residential exposure to residues of PGME is not 
expected.
    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).
    PGME may be used as an inert ingredient in pesticide products that 
are 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 PGME.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures are below EPA's level of concern for PGME 
based on highly conservative assumptions made regarding residential and 
dietary exposures to PGME as described in Unit IV. Section C.
    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).
    PGME may be used as an inert ingredient in pesticide products that 
are 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 
short-term residential exposures to PGME.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined intermediate-term food, 
water, and residential exposures are below EPA's level of concern for 
PGME based on highly conservative assumptions made regarding 
residential and dietary exposures to PGME as described in Unit IV. 
Section C.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, PGME is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to PGME residues.

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 PGME.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for PGME (CAS No. 107-98-2) when used 
as an inert ingredient (as a solvent) in pesticide formulations applied 
to crops, post-harvest.

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

[[Page 54252]]

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 17, 2015.
Susan Lewis,
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, add alphabetically the following inert ingredient 
to 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
------------------------------------------------------------------------
 
                              * * * * * * *
Propylene glycol monomethyl       none...............  solvent.
 ether (CAS No. 107-98-2).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-22030 Filed 9-8-15; 8:45 am]
 BILLING CODE 6560-50-P
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