83 FR 29702 - Fluroxypyr; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 123 (June 26, 2018)

Page Range		29702-29706
FR Document		2018-13724
This regulation establishes tolerances for residues of fluroxypyr in or on teff forage, teff grain, teff hay, and teff straw. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Federal Register, Volume 83 Issue 123 (Tuesday, June 26, 2018)
[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Rules and Regulations]
[Pages 29702-29706]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13724]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0225; FRL-9978-70]


Fluroxypyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
fluroxypyr in or on teff forage, teff grain, teff hay, and teff straw. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 26, 2018. Objections and 
requests for hearings must be received on or before August 27, 2018, 
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-2017-0225, 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 EPA's 
tolerance regulations at 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-2017-0225 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 
August 27, 2018. 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-2017-0225, 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

[[Page 29703]]

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. Summary of Petitioned-for Tolerance

    In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-
9967-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7E8550) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR part 180 be amended by establishing tolerances 
for residues of herbicide fluroxypyr 1-methylheptyl ester [1-
methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetate] 
and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy)acetic acid] in or on teff, forage at 12.0 ppm; teff, 
grain at 0.5 ppm; teff, straw at 12.0 ppm; and teff, hay at 20.0 ppm. 
That document referenced a summary of the petition prepared by Dow 
AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
changed the numerical expression of the proposed tolerance values in 
order to conform to current Agency policy on significant figures.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 fluroxypyr including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluroxypyr follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
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.
    The active ingredient used in formulating end-use herbicide 
products is fluroxypyr 1-methylheptyl ester. However, since the ester 
form has been shown to rapidly hydrolyze to the acid form, the residues 
of fluroxypyr 1-methylheptyl ester along with its fluroxypyr acid 
metabolite (free and conjugated), are collectively expressed as 
``fluroxypyr'' and are therefore regulated together for tolerance 
enforcement. In terms of toxicity, the ester and acid forms are 
considered the same.
    Fluroxypyr has low acute toxicity by the oral and dermal routes of 
exposure and moderate to mild acute toxicity by the inhalation route of 
exposure, based on lethality studies. Fluroxypyr is not a dermal 
sensitizer, nor is it irritating to the skin; however, it is a mild eye 
irritant.
    The kidney is the target organ for fluroxypyr following oral 
exposure to rats, mice, and dogs. In the rat, increased kidney weight, 
nephrotoxicity, and death were observed in both sexes in the 90-day 
feeding study, and increased kidney weight and microscopic kidney 
lesions were observed in both sexes in the chronic study. Increased 
kidney weight was also observed in maternal rats in the developmental 
toxicity study, and kidney effects (deaths due to renal failure; 
increased kidney weight, and microscopic kidney lesions) were observed 
in both sexes in the 2-generation reproduction study in rats. Although 
microscopic kidney lesions were observed in dogs in the 28-day feeding 
study, no kidney effects or other treatment related toxicity were seen 
in the chronic feeding study in dogs at the same doses used in the 28-
day study. Microscopic kidney lesions were observed in mice following 
long-term exposure.
    There was no evidence of increased susceptibility (quantitative/
qualitative) following in utero exposure in rats and rabbits, or 
following pre and/or postnatal exposure in rats. Neither developmental 
toxicity nor reproductive toxicity was observed in rats. In rabbits, 
developmental toxicity was not observed following exposure to dose 
levels that resulted in maternal death; however, abortions were 
observed in rabbits following exposure to fluroxypyr at the limit dose. 
There was no evidence of neurotoxicity or neuropathology in any of the 
studies. An immunotoxicity study in rats found no indication of 
immunotoxicity. Fluroxypyr is classified ``not likely to be 
carcinogenic to humans'' due to lack of evidence to suggest 
carcinogenicity in the database, and there is no concern for its 
mutagenicity potential.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluroxypyr as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Fluroxypyr: Human Health 
Risk Assessment to Support Proposed New Use on Teff'' on pages 13-16 in 
docket ID number EPA-HQ-OPP-2017-0225.

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

[[Page 29704]]

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for fluroxypyr used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of January 16, 2013 (78 FR 3328) 
(FRL-9371-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluroxypyr, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluroxypyr tolerances in 40 CFR 
180.535. EPA assessed dietary exposures from fluroxypyr in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for fluroxypyr; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture's National Health and Nutrition Examination Survey, 
``What We Eat in America'' (NHANES/WWEIA) dietary survey conducted in 
2003-2008. As to residue levels in food, EPA assumed tolerance-level 
residues with 100 percent crop treated (PCT) for all existing and 
proposed crop uses and default processing factors for processed 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluroxypyr does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
fluroxypyr. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fluroxypyr in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluroxypyr. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier 1 Rice Model and Screening Concentration in 
Ground Water (SCI-GROW) models, the estimated drinking water 
concentrations (EDWCs) of fluroxypyr for chronic exposures are 
estimated to be 540 parts per billion (ppb) for surface water and 0.055 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration value of 540 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Fluroxypyr is currently registered for the following uses that 
could result in residential exposures: Residential turfgrass, golf 
courses, parks and sports fields. Residential handler exposure was not 
assessed because all the labels require the use of personal-protective 
equipment (PPE) and are not intended for application by homeowners.
    For post-application exposure, although adults and children 
performing physical activities on treated turf (e.g., golfing, mowing) 
may receive dermal exposure to fluroxypyr residues, a quantitative risk 
assessment for the dermal route of exposure was not conducted since 
there are no toxicity findings for the short-term dermal route of 
exposure up to the limit dose. In addition, a quantitative post-
application inhalation exposure assessment was not conducted because of 
the low acute inhalation toxicity, low vapor pressure, and the 
relatively low use rate.
    Young children 1 to <2 years old may receive incidental oral post-
application exposure to fluroxypyr from treated turf. The post-
application exposures for children playing on treated turf resulting in 
incidental oral exposure as a result of mouthing behaviors were 
assessed.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 fluroxypyr to share a common mechanism of 
toxicity with any other substances, and fluroxypyr does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fluroxypyr 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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. There is no evidence of 
increased qualitative or quantitative susceptibility following in utero 
exposure in rats and rabbits or following pre and/or postnatal exposure 
in rats.
    Fluroxypyr is neither a developmental nor a reproductive toxicant 
in rats. Fluroxypyr has been evaluated for potential developmental 
effects in the

[[Page 29705]]

rat and rabbit (gavage administration). Maternal toxicity included 
death in rats and rabbits. There were no developmental effects in the 
rat, and while abortions were observed in the rabbit, they occurred 
only at the limit dose.
    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 fluroxypyr is complete.
    ii. There is no indication that fluroxypyr is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluroxypyr 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 chronic dietary food exposure assessment utilizes 
tolerance-level residue estimates and assumes 100 PCT for all 
commodities. This assessment will not underestimate exposure/risk. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to fluroxypyr in drinking water. 
EPA used similarly conservative assumptions to assess post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by fluroxypyr.

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, 
fluroxypyr 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 
fluroxypyr from food and water will utilize 3.5% of the cPAD for all 
infants less than 1-year-old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
fluroxypyr 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).
    Fluroxypyr is currently 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 fluroxypyr.
    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 an aggregate MOE of 2,500 for 
children 1-2 years old. Because EPA's level of concern for fluroxypyr 
is a MOE of 100 or below, this MOE is not of concern.
    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).
    An intermediate-term adverse effect was identified; however, 
fluroxypyr is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
fluroxypyr.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluroxypyr 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 fluroxypyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate GC/ECD (gas chromatography/electron-capture detection) 
analytical methods are available to enforce the proposed plant 
tolerances. The available methods for plant commodities involve 
extraction of fluroxypyr residues with acetone, partitioning with 
hexane, purification using a florisil column, and analysis of residues 
by GC/ECD. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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 Nations 
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 fluroxypyr on teff.

V. Conclusion

    Therefore, tolerances are established for the combined residues of 
fluroxypyr 1-methylheptyl ester [1-methylheptyl ((4-amino-3,5-dichloro-
6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-
amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] in or on teff, 
forage at 12 ppm; teff, grain at 0.50 ppm; teff, hay at 20 ppm; and 
teff, straw at 12 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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

[[Page 29706]]

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), nor is 
it considered a regulatory action under Executive Order 13771, entitled 
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, 
February 3, 2017). 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 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).

VII. 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: June 8, 2018.
Michael Goodis,
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.  180.535, add alphabetically the entries ``Teff, forage''; 
``Teff, grain''; ``Teff, hay''; and ``Teff, straw'' to the table in 
paragraph (a) to read as follows:


Sec.  180.535  Fluroxypyr 1-methylheptyl ester; tolerances for 
residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Teff, forage................................................          12
Teff, grain.................................................        0.50
Teff, hay...................................................          20
Teff, straw.................................................          12
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-13724 Filed 6-25-18; 8:45 am]
BILLING CODE 6560-50-P
29702 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Rules and Regulations

State EPA
Rule No. Rule title effective effective Final rule citation, date Comments
date date

* * * * * * *

74:36:21 Regional Haze Program

* * * * * * *
74:36:21:02 .................... Definitions ...................... 9/13/2017 7/26/2018 [Insert Federal Register
citation], 6/26/2018.

* * * * * * *
74:36:21:04 .................... Visibility impact analysis 9/13/2017 7/26/2018 [Insert Federal Register
citation], 6/26/2018.
74:36:21:05 .................... BART determination ...... 9/13/2017 7/26/2018 [Insert Federal Register
citation], 6/26/2018.

* * * * * * *
74:36:21:09 .................... Monitoring, record- 9/13/2017 7/26/2018 [Insert Federal Register
keeping, and reporting. citation], 6/26/2018.

* * * * * * *

* * * * * holidays. The telephone number for the site at http://www.ecfr.gov/cgi-bin/text-
[FR Doc. 2018–13598 Filed 6–25–18; 8:45 am] Public Reading Room is (202) 566–1744, idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
BILLING CODE 6560–50–P and the telephone number for the OPP 40tab_02.tpl.
Docket is (703) 305–5805. Please review
C. How can I file an objection or hearing
the visitor instructions and additional
ENVIRONMENTAL PROTECTION request?
information about the docket available
AGENCY at http://www.epa.gov/dockets. Under FFDCA section 408(g), 21
FOR FURTHER INFORMATION CONTACT: U.S.C. 346a, any person may file an
40 CFR Part 180
Michael Goodis, Registration Division objection to any aspect of this regulation
[EPA–HQ–OPP–2017–0225; FRL–9978–70] (7505P), Office of Pesticide Programs, and may also request a hearing on those
Environmental Protection Agency, 1200 objections. You must file your objection
Fluroxypyr; Pesticide Tolerances Pennsylvania Ave. NW, Washington, DC or request a hearing on this regulation
AGENCY: Environmental Protection 20460–0001; main telephone number: in accordance with the instructions
Agency (EPA). (703) 305–7090; email address: provided in 40 CFR part 178. To ensure
ACTION: Final rule. RDFRNotices@epa.gov. proper receipt by EPA, you must
SUPPLEMENTARY INFORMATION: identify docket ID number EPA–HQ–
SUMMARY: This regulation establishes OPP–2017–0225 in the subject line on
tolerances for residues of fluroxypyr in I. General Information the first page of your submission. All
or on teff forage, teff grain, teff hay, and A. Does this action apply to me? objections and requests for a hearing
teff straw. Interregional Research Project must be in writing, and must be
Number 4 (IR–4) requested these You may be potentially affected by received by the Hearing Clerk on or
tolerances under the Federal Food, this action if you are an agricultural before August 27, 2018. Addresses for
Drug, and Cosmetic Act (FFDCA). producer, food manufacturer, or mail and hand delivery of objections
DATES: This regulation is effective June
pesticide manufacturer. The following and hearing requests are provided in 40
26, 2018. Objections and requests for list of North American Industrial CFR 178.25(b).
hearings must be received on or before Classification System (NAICS) codes is
not intended to be exhaustive, but rather In addition to filing an objection or
August 27, 2018, and must be filed in hearing request with the Hearing Clerk
accordance with the instructions provides a guide to help readers
determine whether this document as described in 40 CFR part 178, please
provided in 40 CFR part 178 (see also submit a copy of the filing (excluding
Unit I.C. of the SUPPLEMENTARY applies to them. Potentially affected
entities may include: any Confidential Business Information
INFORMATION). (CBI)) for inclusion in the public docket.
• Crop production (NAICS code 111).
ADDRESSES: The docket for this action, • Animal production (NAICS code Information not marked confidential
identified by docket identification (ID) 112). pursuant to 40 CFR part 2 may be
number EPA–HQ–OPP–2017–0225, is • Food manufacturing (NAICS code disclosed publicly by EPA without prior
available at http://www.regulations.gov 311). notice. Submit the non-CBI copy of your
or at the Office of Pesticide Programs • Pesticide manufacturing (NAICS objection or hearing request, identified
Regulatory Public Docket (OPP Docket) code 32532). by docket ID number EPA–HQ–OPP–
sradovich on DSK3GMQ082PROD with RULES

in the Environmental Protection Agency 2017–0225, by one of the following
Docket Center (EPA/DC), West William B. How can I get electronic access to methods:
Jefferson Clinton Bldg., Rm. 3334, 1301 other related information? • Federal eRulemaking Portal: http://
Constitution Ave. NW, Washington, DC You may access a frequently updated www.regulations.gov. Follow the online
20460–0001. The Public Reading Room electronic version of EPA’s tolerance instructions for submitting comments.
is open from 8:30 a.m. to 4:30 p.m., regulations at 40 CFR part 180 through Do not submit electronically any
Monday through Friday, excluding legal the Government Printing Office’s e-CFR information you consider to be CBI or

VerDate Sep<11>2014 16:05 Jun 25, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\FR\FM\26JNR1.SGM 26JNR1
Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Rules and Regulations 29705

rat and rabbit (gavage administration). 2. Chronic risk. Using the exposure population, or to infants and children
Maternal toxicity included death in rats assumptions described in this unit for from aggregate exposure to fluroxypyr
and rabbits. There were no chronic exposure, EPA has concluded residues.
developmental effects in the rat, and that chronic exposure to fluroxypyr
IV. Other Considerations
while abortions were observed in the from food and water will utilize 3.5% of
rabbit, they occurred only at the limit the cPAD for all infants less than 1-year- A. Analytical Enforcement Methodology
dose. old, the population group receiving the Adequate GC/ECD (gas
3. Conclusion. EPA has determined greatest exposure. Based on the chromatography/electron-capture
that reliable data show the safety of explanation in Unit III.C.3., regarding detection) analytical methods are
infants and children would be residential use patterns, chronic available to enforce the proposed plant
adequately protected if the FQPA SF residential exposure to residues of tolerances. The available methods for
were reduced to 1X. That decision is fluroxypyr is not expected. plant commodities involve extraction of
based on the following findings: 3. Short-term risk. Short-term fluroxypyr residues with acetone,
i. The toxicity database for fluroxypyr aggregate exposure takes into account partitioning with hexane, purification
is complete. short-term residential exposure plus using a florisil column, and analysis of
ii. There is no indication that chronic exposure to food and water residues by GC/ECD. The method may
fluroxypyr is a neurotoxic chemical and (considered to be a background be requested from: Chief, Analytical
there is no need for a developmental exposure level). Chemistry Branch, Environmental
neurotoxicity study or additional UFs to Fluroxypyr is currently registered for
Science Center, 701 Mapes Rd., Ft.
account for neurotoxicity. uses that could result in short-term
iii. There is no evidence that Meade, MD 20755–5350; telephone
residential exposure, and the Agency
number: (410) 305–2905; email address:
fluroxypyr results in increased has determined that it is appropriate to
residuemethods@epa.gov.
susceptibility in in utero rats or rabbits aggregate chronic exposure through food
in the prenatal developmental studies or and water with short-term residential B. International Residue Limits
in young rats in the 2-generation exposures to fluroxypyr. In making its tolerance decisions, EPA
reproduction study. Using the exposure assumptions seeks to harmonize U.S. tolerances with
iv. There are no residual uncertainties described in this unit for short-term international standards whenever
identified in the exposure databases. exposures, EPA has concluded the possible, consistent with U.S. food
The chronic dietary food exposure combined short-term food, water, and safety standards and agricultural
assessment utilizes tolerance-level residential exposures result in an practices. EPA considers the
residue estimates and assumes 100 PCT aggregate MOE of 2,500 for children 1– international maximum residue limits
for all commodities. This assessment 2 years old. Because EPA’s level of (MRLs) established by the Codex
will not underestimate exposure/risk. concern for fluroxypyr is a MOE of 100 Alimentarius Commission (Codex), as
EPA made conservative (protective) or below, this MOE is not of concern. required by FFDCA section 408(b)(4).
assumptions in the ground and surface 4. Intermediate-term risk. The Codex Alimentarius is a joint
water modeling used to assess exposure Intermediate-term aggregate exposure United Nations Food and Agriculture
to fluroxypyr in drinking water. EPA takes into account intermediate-term Organization/World Health
used similarly conservative assumptions residential exposure plus chronic Organization food standards program,
to assess post-application exposure of exposure to food and water (considered and it is recognized as an international
children as well as incidental oral to be a background exposure level). food safety standards-setting
exposure of toddlers. These assessments An intermediate-term adverse effect organization in trade agreements to
will not underestimate the exposure and was identified; however, fluroxypyr is which the United States is a party. EPA
risks posed by fluroxypyr. not registered for any use patterns that may establish a tolerance that is
would result in intermediate-term different from a Codex MRL; however,
E. Aggregate Risks and Determination of residential exposure. Intermediate-term
Safety FFDCA section 408(b)(4) requires that
risk is assessed based on intermediate- EPA explain the reasons for departing
EPA determines whether acute and term residential exposure plus chronic from the Codex level.
chronic dietary pesticide exposures are dietary exposure. Because there is no The Codex has not established a MRL
safe by comparing aggregate exposure intermediate-term residential exposure for fluroxypyr on teff.
estimates to the acute PAD (aPAD) and and chronic dietary exposure has
chronic PAD (cPAD). For linear cancer already been assessed under the V. Conclusion
risks, EPA calculates the lifetime appropriately protective cPAD (which is Therefore, tolerances are established
probability of acquiring cancer given the at least as protective as the POD used to for the combined residues of fluroxypyr
estimated aggregate exposure. Short-, assess intermediate-term risk), no 1-methylheptyl ester [1-methylheptyl
intermediate-, and chronic-term risks further assessment of intermediate-term ((4-amino-3,5-dichloro-6-fluoro-2-
are evaluated by comparing the risk is necessary, and EPA relies on the pyridinyl)oxy)acetate] and its metabolite
estimated aggregate food, water, and chronic dietary risk assessment for fluroxypyr [((4-amino-3,5-dichloro-6-
residential exposure to the appropriate evaluating intermediate-term risk for fluoro-2-pyridinyl)oxy)acetic acid] in or
PODs to ensure that an adequate MOE fluroxypyr. on teff, forage at 12 ppm; teff, grain at
exists. 5. Aggregate cancer risk for U.S. 0.50 ppm; teff, hay at 20 ppm; and teff,
1. Acute risk. An acute aggregate risk population. Based on the lack of straw at 12 ppm.
assessment takes into account acute evidence of carcinogenicity in two
sradovich on DSK3GMQ082PROD with RULES

exposure estimates from dietary adequate rodent carcinogenicity studies, VI. Statutory and Executive Order
consumption of food and drinking fluroxypyr is not expected to pose a Reviews
water. No adverse effect resulting from cancer risk to humans. This action establishes tolerances
a single oral exposure was identified 6. Determination of safety. Based on under FFDCA section 408(d) in
and no acute dietary endpoint was these risk assessments, EPA concludes response to a petition submitted to the
selected. Therefore, fluroxypyr is not that there is a reasonable certainty that Agency. The Office of Management and
expected to pose an acute risk. no harm will result to the general Budget (OMB) has exempted these types

VerDate Sep<11>2014 16:05 Jun 25, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\26JNR1.SGM 26JNR1
Document Created: 2018-06-26 00:51:32
Document Modified: 2018-06-26 00:51:32
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective June 26, 2018. Objections and requests for hearings must be received on or before August 27, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
FR Citation		83 FR 29702
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements