
[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Rules and Regulations]
[Pages 10678-10683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04099]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0093; FRL-9906-17]


N-(n-octyl)-2-pyrrolidone; 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 N-(n-octyl)-2-pyrrolidone (CAS Reg. No. 
2687-94-7) when used as an inert ingredient (solvent) in formulations 
of pyraflufen-ethyl herbicide at a maximum concentration of 20% weight. 
Wagner Regulatory Associates on behalf of Nichino America, Inc. 
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 N-(n-octyl)-2-
pyrrolidone.

DATES: This regulation is effective February 26, 2014. Objections and 
requests for hearings must be received on or before April 28, 2014, 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-2013-0093, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2013-0093 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 28, 2014. 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

[[Page 10679]]

objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2013-0093, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.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 27, 2013 (78 FR 13295) (FRL-
9380-2), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (IN-10541) by 
Nichino America, Inc. 4550 New Linden Hill Road, Suite 501, Wilmington, 
DE 19808. The petition requested that 40 CFR 180.1130 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of N-(n-octyl)-2-pyrrolidone (CAS Reg. No. 2687-94-7) when 
used as an inert ingredient (solvent) in formulations of pyraflufen-
ethyl herbicide at a maximum concentration of 20% weight. That document 
referenced a summary of the petition prepared by Wagner Regulatory 
Associates, Inc. 7217 Lancaster Pike, Suite A, P.O. Box 640, Hockessin, 
Delaware 19707, 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 N-(n-octyl)-2-pyrrolidone 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with N-(n-
octyl)-2-pyrrolidone 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 N-(n-octyl)-2-pyrrolidone 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.
    Based on the results of acute toxicity studies in rats, N-(n-
octyl)-2-pyrrolidone is classified as having low acute toxicity via the 
oral and dermal routes of exposure. It is a dermal irritant and a 
dermal sensitizer.
    In mammals, the primary target is the liver. In subchronic feeding 
studies in rats and dogs, N-(n-octyl)-2-pyrrolidone generally caused 
increases in both absolute and relative liver weights along with 
reduction in body weight gain/food consumption and changes in 
hematological and biochemical parameters. No chronic toxicity study is 
available.
    In a developmental toxicity study in rats with N-(n-octyl)-2-
pyrrolidone, there was no evidence of increased susceptibility in 
fetuses as toxic effects were observed only at the highest dose tested, 
800 milligrams/kilograms/day (mg/kg/day), in which dams exhibited 
ruffled fur, ventral recumbency, somnolence, apathy, dyspnea and 
comatose state. Other adverse effects observed were a reduction in food 
consumption and slight body weight loss during the first days of dosing 
and reduced corrected body weight gain. Developmental effects such as 
reduced body weight and delay in skeletal ossification were observed 
only in the presence of maternal toxicity. No reproductive toxicity, 
immunotoxicity or neurotoxicity data are available for N-(n-octyl)-2-
pyrrolidone,
    There were three genotoxicity studies available in the database for 
N-(n-octyl)-2-pyrrolidone. An Ames test, a mouse

[[Page 10680]]

lymphoma assay and a mouse micronucleus test all showed negative 
results for genotoxicity of N-(n-octyl)-2-pyrrolidone.
    No carcinogenicity studies were available in the database for N-(n-
octyl)-2-pyrrolidone. The Agency used a qualitative structure activity 
relationship (SAR) database, DEREK11, to determine if there were 
structural alerts for potential carcinogenicity for N-(n-octyl)-2-
pyrrolidone. No structural alerts for carcinogenicity were identified 
for N-(n-octyl)-2-pyrrolidone. In the absence of any structural alerts 
and lack of mutagenicity concerns, N-(n-octyl)-2-pyrrolidone is not 
expected to be carcinogenic.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for N-(n-octyl)-2-
pyrrolidone used for human risk assessment is given below:
    1. Acute dietary (all populations). There were no adverse effects 
observed attributable to a single dose for the general population 
(including infants and children) or females 13-49 years of age.
    2. Chronic dietary (all populations). The chronic population 
adjusted dose (cPAD) was established based on the NOAEL (30 mg/kg/day) 
from a 90-day oral toxicity study in dogs. The adverse effects seen in 
this study were several statistically significant changes in hematology 
and clinical chemistry parameters and statistically significant dose-
related increases in both absolute and relative liver weights at the 
LOAEL of 90 mg/kg/day. A Food Quality Protection Act (FQPA) safety 
factor/database uncertainty factor of 3X is utilized for dietary risk 
assessment.
    3. Dermal, short-term (1-30 days). The level of concern (LOC) for 
short-term dermal exposure is a Margin of Exposure (MOE) of 300 between 
estimated human exposure and the NOAEL (30 mg/kg/day) from the 90-day 
oral toxicity study in dogs. An FQPA safety factor/database uncertainty 
factor of 3X is utilized for dermal, short-term, assessment.
    4. Inhalation, short-term (1-30 days). The level of concern (LOC) 
for short-term inhalation exposure is a MOE of 300 between estimated 
human exposure and the NOAEL (30 mg/kg/day) from the 90-day oral 
toxicity study in dogs. An FQPA safety factor/database uncertainty 
factor of 3X for the short-term inhalation assessment.
    Quantification of cancer risk is not appropriate since there are no 
concerns for cancer based on SAR analysis of N-(n-octyl)-2-pyrrolidone.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to N-(n-octyl)-2-pyrrolidone, EPA considered exposure under 
the proposed exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from N-(n-octyl)-2-pyrrolidone in food as 
follows:
    In conducting the chronic dietary exposure assessment using the 
Dietary Exposure Evaluation Model/Food Commodity Intake Database (DEEM-
FCID)\TM\, Version 3.16, EPA used 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. As to residue levels in 
food, no residue data were submitted for N-(n-octyl)-2-pyrrolidone. In 
the absence of specific residue data, EPA has developed an approach 
which uses surrogate information to derive upper bound exposure 
estimates for the subject inert ingredient. Upper bound exposure 
estimates are based on the highest tolerance for a given commodity from 
a list of high-use insecticides, herbicides, and fungicides. 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.
    In the case of N-(n-octyl)-2-pyrrolidone, EPA made specific 
adjustments to the dietary exposure assessment to account for the use 
limitations of N-(n-octyl)-2-pyrrolidone as an inert ingredient in 
cotton defoliant formulations containing thidiazuron and diuron as 
active ingredients as well as the proposed use as an inert ingredient 
in formulations of pyraflufen ethyl herbicide at a maximum 
concentration of 20% weight.
    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 N-(n-octyl)-2-
pyrrolidone, 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 proposed use of N-(n-octyl)-2-pyrrolidone is as an inert 
ingredient in pyraflufen ethyl formulations which have uses resulting 
in potential residential exposures. A screening level residential 
exposure and risk assessment was conducted based on the use pattern and 
application rates of pyraflufen ethyl products.
    EPA assessed residential exposure using the following assumptions: 
All residential exposures are considered short-term in duration. The 
residential handler assessment included short-term exposures via the 
dermal and inhalation routes from treating golf courses, ornamental 
turf lawns, road sides, parks and sports fields. In terms of post-
application exposure, there is the potential for dermal post-
application exposure for individuals as result of being in an 
environment that has been previously treated with N-(n-octyl)-2-
pyrrolidone. Short-term dermal exposures were assessed for adults,

[[Page 10681]]

children 1-2 and adult/child golfer. The scenarios used in the 
aggregate assessment were those that resulted in the highest exposures.
    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 N-(n-octyl)-2-pyrrolidone to share a common 
mechanism of toxicity with any other substances, and N-(n-octyl)-2-
pyrrolidone does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that N-(n-octyl)-2-pyrrolidone 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. No evidence of increased 
susceptibility was seen in the developmental toxicity study on N-(n-
octyl)-2-pyrrolidone. The maternal and developmental toxicity NOAEL was 
200 mg/kg bw/day based on reduced body weight gain in dams and mean 
fetal body weight and delay in skeletal ossification at the LOAEL of 
800 mg/kg bw/day. No reproductive toxicity study is available N-(n-
octyl)-2-pyrrolidone.
    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 3X for all scenarios. That decision is based on 
the following findings:
    i. The toxicity database for N-(n-octyl)-2-pyrrolidone consists of 
90-day oral toxicity studies in rats and dogs, several mutagenicity 
studies and a developmental toxicity study. While there are no 
reproductive, neurotoxicity and chronic toxicity studies for N-(n-
octyl)-2-pyrrolidone, there is no evidence of effects on reproductive 
parameters or of any effects suggestive of neurotoxicity from the 
available subchronic studies. Additionally, the most sensitive endpoint 
selected seen in the 90-day dog oral toxicity study is based on 
hematological and clinical chemistry parameters; increases in both 
absolute and relative liver weights; and reduction in body weight gain/
food consumption--effects which are not expected to be progressive and 
for which the resultant exposure assessment is likely to be protective 
of chronic effects and characterize toxicity potential of N-(n-octyl)-
2-pyrrolidone. Although additional data are unlikely to indicate more 
sensitive effects, EPA has retained a FQPA factor of 3X as a database 
uncertainty factor. No inhalation toxicity studies were available in 
the database; however, the only potential inhalation exposure to N-(n-
octyl)-2-pyrrolidone is to pesticide applicators, and, even assuming 
that such exposure has some relevance to decisions on the FQPA safety 
factor, the inhalation exposure to N-(n-octyl)-2-pyrrolidone is 
negligible in comparison to exposure under other pathways. In these 
circumstances, neither retention or removal of the FQPA safety factor 
would have a meaningful impact on assessment of risk from inhalation 
exposure.
    ii. No evidence of immunotoxicity was observed in the available 
database. Slight change in the clinical pathological parameters 
(decreases in albumin/globulin ratio and globulin levels) were not 
considered as an indication of an immunotoxic response since no effects 
on blood lymphocytes and no adverse findings in the spleen and thymus. 
Therefore, an immunotoxicity study is not required.
    iii. There are no residual uncertainties identified in the exposure 
databases. As described earlier, EPA used worst case assumptions for 
the dietary food exposure assessment. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to N-(n-octyl)-2-pyrrolidone in drinking water. EPA 
used similarly conservative assumptions to assess residential post 
application exposure of children as well as incidental oral exposure of 
children 1-2. These assessments will not underestimate the exposure and 
risks posed by N-(n-octyl)-2-pyrrolidone.

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, 
N-(n-octyl)-2-pyrrolidone 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 
N-(n-octyl)-2-pyrrolidone from food and water will utilize 59.37% of 
the cPAD for children 1-2 years old, the population group receiving the 
greatest exposure. The chronic dietary exposure estimates for the total 
U.S. population was 14.31%.
    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). N-(n-octyl)-
2-pyrrolidone is currently 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 N-(n-octyl)-2-pyrrolidone.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1,122 for adults 
and 291 for children 1-2. EPA's level of concern for N-(n-octyl)-2-
pyrrolidone is a MOE of 300 or below, however these MOEs are not of 
concern based on the highly conservative assumptions made regarding 
residential and dietary exposures to N-(n-octyl)-2-pyrrolidone.

[[Page 10682]]

    4. Intermediate-term risk. Intermediate-term residential aggregate 
exposure takes into account intermediate-term residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level). Pyraflufen ethyl is not currently registered for uses 
that could result in intermediate-term residential exposure so an 
intermediate term risk assessment for N-(n-octyl)-2-pyrrolidone was not 
performed. There are also no intermediate-term adverse effects 
identified and therefore N-(n-octyl)-2-pyrrolidone is not expected to 
pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. N-(n-octyl)-2-
pyrolidone is not expected to be carcinogenic.
    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 N-(n-octyl)-2-pyrrolidone 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 N-
(n-octyl)-2-pyrrolidone in or on any food commodities. EPA is 
establishing a limitation on the amount of N-(n-octyl)-2-pyrrolidone 
that may be used in pesticide formulations.
    The 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 for 
sale or distribution containing pyraflufen ethyl as an active 
ingredient with concentrations of N-(n-octyl)-2-pyrrolidone exceeding 
20% by weight of the pesticide formulation.

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 N-(n-octyl)-2-pyrrolidone.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.1130 for N-(n-octyl)-2-pyrrolidone (CAS 
Reg. No. 2687-94-7) when used as an inert ingredient (solvent) in 
formulations of pyraflufen-ethyl herbicide at a maximum concentration 
of 20% by weight.

VII. Statutory and Executive Order Reviews

    This final rule 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 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 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: February 18, 2014.
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. Revise Sec.  180.1130 to read as follows:


Sec.  180.1130  N-(n-octyl)-2-pyrrolidone and N-(n-dodecyl)-2-
pyrrolidone; exemptions from the requirement of a tolerance.

    (a) N-(n-octyl)-2-pyrrolidone and N-(n-dodecyl)-2-pyrrolidone are 
exempt

[[Page 10683]]

from the requirement of a tolerance when used as solvents in cotton 
defoliant formulations containing thidiazuron and diuron as active 
ingredients.
    (b) N-(n-octyl)-2-pyrrolidone is exempt from the requirement of a 
tolerance when used as a solvent in formulations containing pyraflufen-
ethyl as an active ingredient at a concentration not to exceed 20% by 
weight.

[FR Doc. 2014-04099 Filed 2-25-14; 8:45 am]
BILLING CODE 6560-50-P


