[Federal Register Volume 80, Number 11 (Friday, January 16, 2015)]
[Rules and Regulations]
[Pages 2315-2320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00491]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0540; FRL-9920-54]


Fosetyl-Al; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
Aluminum tris (O-ethylphosphonate) (fosetyl-Al) in or

[[Page 2316]]

on pepper/eggplant, subgroup 8-10B. Bayer CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 16, 2015. Objections and 
requests for hearings must be received on or before March 17, 2015, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0540, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2014-0540 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 
March 17, 2015. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0540, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of November 7, 2014 (79 FR 66347) (FRL-
9918-69), 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 
3E8182) by Bayer CropScience, 2 T.W. Alexander Dr., P.O. Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.415 be amended by establishing tolerances for residues of the 
fungicide fosetyl-Al, aluminum tris (O-ethylphosphonate), in or on 
pepper/eggplant, subgroup 8-10B at 0.01 parts per million (ppm) and 
non-bell (chili) pepper, dried fruit at 0.01 ppm. That document 
referenced a summary of the petition prepared by Bayer CropScience, the 
registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is not 
establishing a separate tolerance for residues of fosetyl-Al on pepper, 
non-bell (chili), dry fruit. The reason for this is explained in Unit 
IV.D.

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 fosetyl-Al

[[Page 2317]]

including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
fosetyl-Al 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 major target organs following repeated oral exposure to 
fosetyl-Al are the reproductive system in the dog (testicular 
degeneration: Spermatocytic and/or spermatidic giant cells in the lumen 
of the seminiferous tubules) and the urinary system in the rat 
(histopathological changes in the kidney, impairment of calcium/
phosphorus metabolism, calculi and hyperplasia in the urinary tract, 
bladder tumors). There is no concern for increased quantitative or 
qualitative susceptibility of the young following in utero (rats and 
rabbits) and pre-and postnatal exposure (rats) to fosetyl-Al. Also, 
there is no evidence of developmental toxicity, reproductive toxicity 
in the rat, neurotoxicity, or immunotoxicity at dose levels that do not 
exceed the limit dose. The microscopic finding in the dog testes may be 
considered an isolated finding in light of the lack of any functional 
deficits in the rat 2-generation reproductive toxicity study and the 
lack of effects on the rat reproductive organs following chronic 
exposure. Additionally, a clear no-observed-adverse-effect level 
(NOAEL) was established for the effect observed in the dog and was 
selected as a suitable point of departure (POD) for the chronic dietary 
(all populations) exposure scenario. Fosetyl-Al is negative for 
carcinogenicity except at extremely high doses (>limit dose) in rats 
and mice, and it did not show any genotoxic potential (classified as 
not likely to be carcinogenic to humans). Fosetyl-Al is not acutely 
toxic via the oral, dermal, and inhalation routes. It produces severe 
eye irritation, is not a dermal irritant, and is negative for dermal 
sensitization.
    Specific information on the studies received and the nature of the 
adverse effects caused by fosetyl-Al as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document ``Fosetyl-
Aluminum [Fosetyl-Al]: Human Health Risk Assessment for the 
Establishment of Tolerances with No U.S. Registration in/on Pepper/
eggplant, Subgroup 8-10B and Pepper, Non-bell (Chili), Dry Fruit'' in 
docket ID number EPA-HQ-OPP-2014-0540.

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 fosetyl-Al used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Fosetyl-Al for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  No hazard or appropriate acute endpoint was identified in the database.
 including infants and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 250 mg/kg/    Chronic RfD = 2.5    Chronic oral toxicity (dog).
                                    day.                  mg/kg/day.          LOAEL = 500 mg/kg/day based on
                                   UFA = 10x...........  cPAD = 2.5 mg/kg/     increased incidence of testicular
                                   UFH = 10x...........   day.                 degeneration (spermatocytic and/
                                   FQPA SF = 1x........                        or spermatidic giant cells in the
                                                                               lumen of the seminiferous
                                                                               tubules).
Incidental oral short-term (1 to   NOAEL = 300 mg/kg/    Residential LOC for  3-generation reproduction (rat).
 30 days) and intermediate-term     day.                  MOE <100.           LOAEL = 600 mg/kg/day based on
 (1 to 6 months).                  UFA = 10x...........                        decreased body weight gains in
                                   UFH = 10x...........                        the F2b generation and urinary
                                   FQPA SF = 1x........                        tract changes in adults.
Inhalation short-term (1 to 30     Inhalation (or oral)  Residential LOC for  3-generation reproduction (rat).
 days) and intermediate-term (1     study NOAEL = 300     MOE <100.           LOAEL = 600 mg/kg/day based on
 to 6 months).                      mg/kg/day                                  decreased body weight gains in
                                    (inhalation                                the F2b generation and urinary
                                    absorption rate =                          tract changes in adults.
                                    100%).
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------

[[Page 2318]]

 
Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (c = chronic). RfD = reference dose. UF = uncertainty factor. UFA =
  extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of
  the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fosetyl-Al, EPA considered exposure under the petitioned-
for tolerances as well as all existing fosetyl-Al tolerances in 40 CFR 
180.415. EPA assessed dietary exposures from fosetyl-Al 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 fosetyl-Al; 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 (USDA's) 2003-2008 National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA's unrefined chronic analysis is based on 
tolerance-level residues and 100% crop treated (PCT) assumptions. 
Default processing factors were used for all crops except for citrus 
where processing studies showed no residue concentration; thus, the 
processing factor was set to one for processed citrus commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fosetyl-Al is not carcinogenic 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 and/or PCT information in the dietary assessment 
for fosetyl-Al. Tolerance level residues and/or 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 fosetyl-Al in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fosetyl-Al. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Environmental fate properties suggest that fosetyl-Al is not likely 
to reach ground or surface water under most conditions, and if it does 
reach surface water, it is expected to degrade rapidly. Using the 
Screening Concentration in Ground Water (SCI-GROW) model, the estimated 
drinking water concentration (EDWC) of fosetyl-Al for chronic exposures 
for non-cancer assessments is estimated to be 0.006 parts per billion 
(ppb) for ground water. Thus, the ground water EDWC of 0.006 ppb was 
directly incorporating into the chronic dietary risk assessment.
    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). Fosetyl-Al is 
currently registered for the following use that could result in 
residential exposure: Turf. EPA assessed residential exposure using the 
following assumptions: Residential handler and residential post-
application exposures. The residential handler assessment 
quantitatively evaluated inhalation exposure from hose end sprayer for 
turf applications but not dermal exposure as no dermal point of 
departure was identified. There is the potential for short-term post-
application exposure for individuals exposed as a result of being in an 
environment that has been previously treated with fosetyl-Al (based on 
contact with treated turf at the maximum turf application rate of 17.6 
pounds (lbs) active ingredient/Acre (ai/A)). Incidental oral post-
application exposure is quantitatively assessed for children 1 to <2 
years old for exposure to treated turf. Dermal post-application 
exposure was not assessed because no dermal hazard was identified. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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.''
    Although fosetyl-Al shares a similar chemical structure with many 
organophosphates (OPs), there is no evidence of neurotoxicity or 
evidence of cholinesterase inhibition following exposure to fosetyl-Al 
at dose levels at and greater than the limit dose. EPA has concluded 
that fosetyl-Al is a not member of the OP cumulative group. EPA has not 
found fosetyl-Al to share a common mechanism of toxicity with any other 
substances either, and fosetyl-Al does not appear to produce a toxic 
metabolite produced by any other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that fosetyl-Al 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

[[Page 2319]]

and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility following in utero exposure to fosetyl-Al in 
either the rat (at dose levels that do not exceed the limit dose) or 
rabbit developmental toxicity study, and there is no evidence of 
increased susceptibility following in utero and/or pre-/postnatal 
exposure in the 3-generation reproduction study in rats.
    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 fosetyl-Al is complete.
    ii. There is no indication that fosetyl-Al is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that fosetyl-Al results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 3-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the water modeling used to assess exposure 
to fosetyl-Al 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 fosetyl-Al.

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, 
fosetyl-Al 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 
fosetyl-Al from food and water will utilize 12% of the cPAD for 
children 1-2 years 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 
fosetyl-Al is not expected.
    3. Short-term risk. Fosetyl-Al 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 
fosetyl-Al.
    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 3,200 for adult 
residential handlers applying liquid concentrates to turf via hose-end 
sprayer and for children, 540 for children's incidental oral post-
application exposure from contacting treated lawns. Because EPA's level 
of concern for fosetyl-Al is an MOE of 100 or below, these MOEs are 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).
    Because no intermediate-term non-occupational exposures are 
expected, fosetyl-Al is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A, fosetyl-Al 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 fosetyl-Al residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Rhone-Poulenc Method No. AR 154-97 underwent successfully 
independent laboratory validation for use as an enforcement analytical 
method. Although the tolerance expression includes only parent fosetyl-
Al, Method AR 154-97 was validated for both fosetyl-Al and its 
metabolite, phosphorous acid.
    In support of the pepper trials, the registrant made use of a data 
collection method, Method No. 00861/M001, which achieved a lower Limit 
of Quantitation (LOQ) than Method AR 154-97. Method No. 00861/M001 is 
an HPLC-MS/MS (high performance liquid chromatography-tandem mass 
spectrometry) method that uses the same extraction solvent as Method AR 
154-97. Sufficient method validation data were submitted with the field 
trial data to support a LOQ of 0.01 ppm for fosetyl-Al residues in 
pepper (bell and non-bell). As EPA encourages the development of 
improved analytical methods and because both methods use the same 
extraction solvent, EPA considers Method No. 00861/M001 to also be a 
suitable enforcement method for peppers. Thus, both methods 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 fosetyl-Al.

[[Page 2320]]

C. Response to Comments

    The Agency received a comment expressing concerns about allowing 
residues of pesticides on eggplant and peppers. The Agency understands 
the commenter's concerns and recognizes that some individuals believe 
that no residue of pesticides should be allowed because of potential 
effects. However, under the existing legal framework provided by FFDCA 
section 408, EPA is authorized to establish pesticide tolerances where 
persons seeking such tolerances have demonstrated that the pesticide 
meets the safety standard imposed by the statute. Based on its 
assessment of the available data, the Agency has concluded there is a 
reasonable certainty that no harm will result from aggregate exposure 
to residues of fosetyl-Al.

D. Revisions to Petitioned-For Tolerances

    EPA is not establishing a separate tolerance for residues of 
fosetyl-Al in or on pepper, non-bell (chili), dry fruit. The residues 
found on the dried commodity will be covered by the tolerance for 
residues of fosetyl-Al in or on pepper/eggplant, subgroup 8-10B; 
therefore, no separate tolerance is needed.

 V. Conclusion

    Therefore, tolerances are established for residues of fosetyl-Al, 
aluminum tris (O-ethylphosphonate), in or on pepper/eggplant, subgroup 
8-10B at 0.01 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 of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this 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).

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: December 23, 2014.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.415, add alphabetically ``Pepper/eggplant, subgroup 8-
10'' to the table in paragraph (a) to read as follows:


Sec.  180.415  Aluminum tris (O-ethylphosphonate); tolerances for 
residues.

    (a) * * *

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Pepper/eggplant, subgroup 8-10B \1\....................            0.01
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of December 23, 2014.

* * * * *
[FR Doc. 2015-00491 Filed 1-15-15; 8:45 am]
BILLING CODE 6560-50-P