[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Rules and Regulations]
[Pages 78923-78928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27212]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0655; FRL-9953-82]
2-Pyrrolidinone, 1-butyl-; 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 2-pyrrolidinone, 1-butyl- (CAS Reg. No.
3470-98-2) when used as an inert ingredient (solvent/cosolvent) in
pesticide formulations applied to growing crops only at a concentration
not to exceed 30% by weight under EPA regulations. SciReg. Inc. on
behalf of Taminco U.S., Inc. a subsidiary of Eastman Chemical Company
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 rule eliminates the need to establish
a maximum permissible level for residues of 2-pyrrolidinone, 1-butyl-
when used in accordance with the regulations.
DATES: This regulation is effective November 10, 2016. Objections and
requests for hearings must be received on or before January 9, 2017,
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-2015-0655, 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: [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-2015-0655 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
January 9, 2017. 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-2015-0655, 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 October 21, 2015 (80 FR 63731) (FRL-
9935-29), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10854) by SciReg Inc. (12733 Director's Loop, Woodbridge, VA 22192) on
behalf of Taminco U.S., Inc.
[[Page 78924]]
a subsidiary of Eastman Chemical Company (Two Windsor Plaza, Suite 400,
7540 Windsor Drive, Allentown, PA 18195). The petition requested that
40 CFR 180.920 be amended by establishing an exemption from the
requirement of a tolerance for residues of 2-pyrrolidinone, 1-butyl-
(CAS Reg. No. 3470-98-2), when used as an inert ingredient (solvent/
cosolvent) in pesticide formulations applied to growing crops only.
That document referenced a summary of the petition prepared by SciReg.
Inc. on behalf of Taminco U.S., Inc., the petitioner, which is
available in the docket, http://www.regulations.gov. No relevant
comments were received on the notice of filing.
Based upon review of the data supporting the petition, EPA has
limited the concentration of 2-pyrrolidinone, 1-butyl- in final
pesticide formulation not to exceed 30% w/w. This limitation is based
on the Agency's risk assessment which can be found at http://www.regulations.gov in document Human Health Risk Assessment and
Ecological Effects Assessment to Support Proposed Exemption from the
Requirement of a Tolerance When Used as an Inert Ingredient in
Pesticide Formulations in docket ID number EPA-HQ-OPP-2015-0655.
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 2-pyrrolidinone, 1-butyl-
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with 2-
pyrrolidinone, 1-butyl- 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 2-pyrrolidinone, 1-butyl- 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 oral LD50 for 2-pyrrolidinone, 1-butyl- in the rat
is greater than 300 mg/kg. The dermal LD50 in the rat is >
2,000 mg/kg. It is moderately irritating to the eye of New Zealand
White rabbits. It is slightly irritating to the skin of New Zealand
White rabbits. It is not a skin sensitizer in mice in the local lymph
node assay.
A 90-day subchronic oral toxicity study was conducted with Wistar
rats exposed to 2-pyrrolidinone, 1-butyl- via gavage dose of 0, 10,
100, and 500 mg/kg/day, according to OECD Test Guideline 408. The
following effects were considered to be treatment-related and adaptive
in nature and, therefore, not adverse:
1. The microscopic liver changes in animals of either sex treated
with 500 mg/kg/day and males treated with 100 mg/kg/day; however, these
changes were not associated with blood chemistry changes. Therefore
they were considered as an adaptive response.
2. The microscopic changes in the adrenals of males treated with
500 and 100 mg/kg/day and the microscopic thymus changes were not
associated with any changes in the organ weights, therefore they were
not considered as adverse effects. Minor changes in the kidney weights
were not associated with any clinical chemistry changes or treatment
related histopathological findings; therefore, it was not considered
adverse. The NOAEL is 500 mg/kg/day.
A prenatal development toxicity study was conducted with 2-
pyrrolidinone, 1-butyl-, in accordance with OECD Test Guideline 414
using Pregnant Crl:CD(SD) rats exposed to the test item at
concentrations of 0, 5, 50, or 500 mg/kg/day by oral gavage. Maternal
toxicity was manifested as decreased food consumption and weight loss
on days 6 to 19 of gestation at a dose level of 500 mg/kg/day.
Developmental toxicity was manifested as decreased fetal weight in
female fetuses at the same dose as maternal toxicity, 500 mg/kg/day.
There was no evidence of fetal susceptibility. The NOAEL for
developmental toxicity of 2-pyrrolidinone, 1-butyl- was determined to
be 50 mg/kg/day.
Since there is a wide dose spread in the developmental toxicity
study in rats, a benchmark dose (BMD) modeling was conducted using
decreased fetal weight
[[Page 78925]]
as an adverse effect. The BMD value is 306 mg/kg/day and the average
BMDL is 201 mg/kg/day for a 5% response in decreased fetal body weight.
Carcinogenicity data are not available for 2-pyrrolidinone, 1-
butyl-. In the 90-day toxicity study, the liver, kidney, thymus, and
adrenals were target organs, however, they were considered as adaptive
response at the dose levels tested. Evaluation of the database for N-
methylpyrrolidone (NMP) shows similar target organ toxicity as 2-
pyrrolidinone, 1-butyl- (structurally related chemicals differing only
in carbon chain length (1 vs 4 carbon chain length)) and 1-
ethylpyrrolidin-2-one (NEP) (2 carbon chain length), as both chemicals
are considered suitable surrogates for evaluation. Neither 2-
pyrrolidinone, 1-butyl-, N-methylpyrrolidone, nor 1-ethylpyrrolidin-2-
one was found to be genotoxic or mutagenic in a number of assays. In
carcinogenicity studies, N-methylpyrrolidone was not carcinogenic in
two-year rat studies by the inhalation and dietary routes of exposure.
An increased incidence of liver adenomas and carcinomas was seen in
mice exposed to a dietary level of N-methylpyrrolidone exceeding 1,000
mg/kg/day for 18 months. However, based on the lack of mutagenicity or
genotoxicity and the similarity of 2-pyrrolidinone, 1-butyl- to n-
methylpyrrolidone, it can be concluded that 2-pyrrolidinone, 1-butyl-
should not be considered as potentially carcinogenic at doses below the
limit dose of 1,000 mg/kg/day.
The mutagenic potential of 2-pyrrolidinone, 1-butyl- was assessed
in the Salmonella typhimurium reverse mutation assay, mammalian cell
gene mutation and micronucleus tests. 2-Pyrrolidinone, 1-butyl- was
negative in all assays. Therefore, 2-pyrrolidinone, 1-butyl- is not
considered mutagenic nor clastogenic.
There were no studies/data directly related to the possible
neurotoxicity of 2-pyrrolidinone, 1-butyl. However, evidence of
potential neurotoxicity was not observed in functional observation
battery (FOB) performed in the 90-day oral toxicity study in the rat.
Therefore, pyrrolidinone, 1-butyl is not expected to be neurotoxic.
There were no studies/data directly related to the immunotoxicity
of 2-pyrrolidinone, 1-butyl. Thymic atrophy was observed at >100 mg/kg/
day in rats treated with 2-pyrrolidinone, 1-butyl for 90 days via
gavage. However, microscopic changes in thymus were considered as an
adaptive response and not as an adverse effect.
There were no studies/data directly related to the metabolism, of
2-pyrrolidinone, 1-butyl.
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.
For purposes of risk assessment, the Agency utilizes the toxicity
point of departure identified in the developmental toxicity study in
rats for chronic dietary assessment, residential exposure assessment
and all dermal and inhalation exposure durations. Since there was a
large dose spread, a benchmark dose modeling (BMD) assessment was
conducted. The average benchmark model lower confidence limit (BMDL) is
201 mg/kg/day for a 5% response which was based on a 5% decreased fetal
body weight. The BMDL of 201 mg/kg/day is used as a point departure for
the risk assessment. An uncertainty factor of 10X is applied for
interspecies extrapolation and an uncertainty factor of 10X is applied
for intraspecies variation. The Food Quality Protection Act factor is
reduced to 1X. Therefore, the Agency's level of concern is for Margins
of Exposure (MOE) less than 100. No endpoint of concern was identified
for acute dietary assessment in the database. Although there was a
decrease in body weights in maternal animals on GD7 in the
developmental toxicity study in rats, this effect is not considered
relevant for acute dietary exposure assessment since the body weights
returned to normal on GD8. A cancer risk assessment was not conducted
because the Agency concluded that 2-pyrrolidinone, 1-butyl is unlikely
to be carcinogenic at the anticipated dietary exposure levels. Dermal
and inhalation absorption is assumed 100% of the oral equivalent dose.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 2-pyrrolidinone, 1-butyl-, EPA considered exposure under
the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from 2-pyrrolidinone, 1-butyl- in food as
follows:
Dietary exposure (food and drinking water) to 2-pyrrolidinone, 1-
butyl- can occur following ingestion of foods with residues from
treated crops. Because no adverse effects attributable to a single
exposure of 2-pyrrolidinone, 1-butyl- are seen in the toxicity
databases, an acute dietary risk assessment is not necessary. For the
chronic dietary risk assessment, EPA used the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCIDTM, Version 3.16, and food consumption information
from the U.S. Department of Agriculture's (USDA's) 2003-2008 National
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA). One hundred percent crop treated was assumed, default
processing factors, and tolerance-level residues for all foods and use
limitations of not more than 30% by weight of 2-pyrrolidinone, 1-butyl-
in pesticide formulations applied to food.
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 residues of 2-
pyrrolidinone, 1-butyl- a conservative drinking water concentration
value of 100 ppb based on screening-level modeling was used to assess
the contribution to drinking water for the chronic dietary risk
assessment. This value was 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).
[[Page 78926]]
2-Pyrrolidinone, 1-butyl- may be used as an inert ingredient in
products that are registered for specific uses that may result in
residential exposure, such as pesticides used in and around the home.
The Agency conducted a screening level assessment to represent worst-
case residential exposure by assessing 2-pyrrolidinone, 1-butyl- in
pesticide formulations (Outdoor Scenarios) and in disinfectant-type
uses (Indoor Scenarios).
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 2-pyrrolidinone, 1-butyl- to share a common
mechanism of toxicity with any other substances, and 2-pyrrolidinone,
1-butyl do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that 2-pyrrolidinone, 1-butyl- 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.
2. Prenatal and postnatal sensitivity. A developmental toxicity
study in rats was available with 2-pyrrolidinone, 1-butyl. Fetal
susceptibility was not observed. Maternal and developmental toxicity
were observed at the same dose, 500 mg/kg/day, the highest dose tested.
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. That decision is based on the following
findings:
i. The toxicity database for 2-pyrrolidinone, 1-butyl is adequate
for FQPA assessment. It includes a 90-day rat oral toxicity study with
FOB measurements, a prenatal developmental study in rats, acute
toxicity studies and mutagenicity studies.
ii. There is no evidence of increased susceptibility in the
database. There are no concerns for the lack of 2-generation
reproduction study because the male and female reproductive parameters
were evaluated in the 90-day study and no evidence of fetal
susceptibility was seen in the rat developmental toxicity study in
rats.
iii. There were no studies/data directly related to the possible
neurotoxicity of 2-pyrrolidinone, 1-butyl. However, no evidence of
potential neurotoxicity was observed in the functional observation
battery (FOB) performed in the 90-day oral toxicity study in the rat.
Therefore, pyrrolidinone, 1-butyl is not expected to be neurotoxic.
iv. There were no studies/data directly related to the immunotoxic
potential of 2-pyrrolidinone, 1-butyl. However, no evidence of
potential immunotoxicity was observed in the 90-day oral toxicity study
in rats. EPA concluded that the immunotoxicity study is not required at
this time.
v. The dietary food exposure assessment utilizes proposed tolerance
level or higher residues and 100% crop treated (CT) information for all
commodities. In addition, a conservative drinking water concentration
value of 100 parts per billion (ppb) was used to assess the
contribution to drinking water. By using these screening-level
assessments, chronic exposures/risks will not be underestimated.
Taking into consideration the available information, EPA concludes
the additional 10X FQPA safety factor be reduced to 1X.
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,
2-pyrrolidinone, 1-butyl- 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,
2-pyrrolidinone, 1-butyl- from food and water will utilize 21.1% of the
cPAD for children 1-2 years old, the population group receiving the
greatest exposure.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
2-Pyrrolidinone, 1-butyl- may be used as inert ingredients in
pesticide products that could result in short-term and intermediate-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term and intermediate-term residential exposures to 2-
pyrrolidinone, 1-butyl-. Using the exposure assumptions described
above, EPA has concluded that the combined short-term and intermediate-
term aggregated food, water, and residential exposures result in an MOE
of 350 for both adult males and females respectively. Adult residential
exposure combines high-end dermal and inhalation handler exposure from
indoor hard surface, wiping with a high-end post application dermal
exposure from contact with treated lawns. As the level of concern is
for MOEs that are lower than 100, this MOE is not of concern. EPA has
concluded the combined short-term and intermediate-term aggregated
food, water, and residential exposures result in an aggregate MOE of
218 for children. Children's residential exposure includes total
exposures associated with contact with treated lawns (dermal and hand-
to-mouth exposures). As the level of concern is for MOEs that are lower
than 100, this MOEs is not of concern.
4. Aggregate cancer risk for U.S. population. Based on lack of
carcinogenicity for N-methyl pyrrolidone (a surrogate chemical of 2-
pyrrolidinone, 1-butyl-), 2-
[[Page 78927]]
pyrrolidinone, 1-butyl- is not expected to pose a cancer risk to
humans.
5. 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 2-pyrrolidinone, 1-butyl- residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of 2-
pyrrolidinone, 1-butyl- in or on any food commodities. EPA is
establishing a limitation on the amount of 2-pyrrolidinone, 1-butyl-
that may be used in pesticide formulations applied to growing crops.
That limitation will be enforced through the pesticide registration
process under the Federal Insecticide, Fungicide, and Rodenticide Act
(``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register any pesticide
formulation for use on growing crops for sale or distribution that
exceed 30% of 2-pyrrolidinone, 1-butyl-.
B. Revision to Petitioned-for Tolerances
The submitter requested an unlimited use of 2-pyrrolidinone, 1-
butyl in pesticide formulations under 180.920. However, MOEs for the
aggregate residential exposure exceeded the Agency's level of concern;
therefore the refinement was made using 30% maximum concentration in
the final formulation. At that concentration level, the Agency is able
to support the safety finding for the inert tolerance exemption;
therefore, the Agency is limiting the tolerance exemption to cover
residues of 2-pyrrolidinone, 1-butyl only when used at levels not to
exceed 30% by weight in pesticide formulations.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for residues of 2-pyrrolidinone, 1-
butyl- (CAS Reg. No. 3470-98-2) when used as an inert ingredient
(solvent/cosolvent) in pesticide formulations applied to growing crops
at a concentration not to exceed 30% by weight in the end-use
formulation.
VII. Statutory and Executive Order Reviews
This action establishes an exemption to the requirement for 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 exemption 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: October 20, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.920, add alphabetically the inert ingredient ``2-
Pyrrolidinone, 1-butyl- (CAS Reg. No. 3470-98-2)'' to the table to read
as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
2-Pyrrolidinone, 1-butyl- (CAS Not to exceed 30% by Solvent/
Reg. No. 3470-98-2). weight of pesticide cosolvent.
formulation.
* * * * * * *
------------------------------------------------------------------------
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[FR Doc. 2016-27212 Filed 11-9-16; 8:45 am]
BILLING CODE 6560-50-P