Document ID: EPA-HQ-OPP-2016-0639-0009
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Aluminum tris (O-ethylphosphonate)
Posted Date: 2018-03-21T04:00Z

[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Rules and Regulations]
[Pages 12260-12265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05642]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0639; FRL-9974-63]

Aluminum tris (O-ethylphosphonate); Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation amends a tolerance for residues of aluminum 
tris (O-ethylphosphonate) in or on Fruit, citrus, group 10. Fosetyl-al 
is the common name for aluminum tris (O-ethylphosphonate). Tessenderlo 
Kerley, Inc requested the amended tolerance under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 21, 2018. Objections and 
requests for hearings must be received on or before May 21, 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-2016-0639, 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:

[[Page 12261]]

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-2016-0639 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 
May 21, 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-2016-0639, 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 July 26, 2017 (82 FR 34664) (FRL-9963-
50), 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 
6F8517) by Tessenderlo Kerley, Inc, 2255 N. 44th St., Suite 300, 
Phoenix, AZ 85008. The petition requested that 40 CFR 180.415 be 
modified by amending tolerances for residues of the fungicide aluminum 
tris (O-ethylphosphonate), in or on fruit, citrus, group 10 from 5.0 
parts per million (ppm) to 9.0 ppm. That document referenced a summary 
of the petition prepared by Tessenderlo Kerley, Inc, the registrant, 
which is available in the docket, http://www.regulations.gov. No 
comments were received on this notice of filing.
    Because EPA does not issue group tolerances for groups that have 
been updated or superseded, the petitioner submitted a revised 
petition, clarifying that its request was to establish tolerances for 
residues of the fungicide aluminum tris (O-ethylphosphonate) in or on 
the updated crop group fruit, citrus, group 10-10 at 9.0 ppm. EPA 
published notice of this revised petition in the Federal Register on 
December 19, 2017 (82 FR 60167) (FRL-9971-11). That document referenced 
a summary of this updated petition, 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.

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 aluminum tris (O-
ethylphosphonate) including exposure resulting from the tolerances 
established by this action. EPA's assessment of exposures and risks 
associated with aluminum tris (O-ethylphosphonate) 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).
    The prenatal developmental studies in rabbits and rats and the 3-
generation reproduction study in rats showed no indication of increased 
susceptibility following in utero and/or postnatal exposure to fosetyl-
Al. Developmental toxicity was not observed in the rat at the limit 
dose or in the rabbit at the highest dose tested (500 mg/kg/day). 
Reproductive toxicity was not observed

[[Page 12262]]

at the limit dose, and offspring toxicity (decreased pup body weight at 
600 mg/kg/day) was observed at the same dose as maternal toxicity 
(decreased body weight gain and urinary tract changes). The toxicology 
database for fosetyl-Al does not show any evidence of neurotoxicity.
    Fosetyl-Al is classified as not likely to be carcinogenic to humans 
since it was negative for carcinogenicity except at extremely high 
doses (>limit dose) in rats and mice, and it did not show any genotoxic 
potential. Fosetyl-Al is not acutely toxic via the oral, dermal, and 
inhalation routes, is not a skin irritant or dermal sensitizer, but is 
a severe eye irritant.
    Specific information on the studies received and the nature of the 
adverse effects caused by aluminum tris (O-ethylphosphonate) 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 document Fosetyl-Aluminum (Fosetyl-AI): 
Human Health Risk Assessment in Support of the Amended Registration for 
the Proposed 0-day Pre-Harvest Interval (PHI) for Citrus Fruit Group 
10-10 at pages 9-14 in docket ID number EPA-HQ-OPP-2016-0639.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for aluminum tris (O-
ethylphosphonate) used for human risk assessment is shown in Table 1 of 
this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Aluminum tris (O-ethylphosphonate) 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 (All populations)..      No appropriate endpoint was identified. There were no adverse effects
                                     observed in oral toxicity studies that could be attributed to a single-dose
                                                                      exposure.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 250mg/kg/day  Chronic RfD = 2.5    Chronic oral toxicity (dog).
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 500 mg/kg/day based on an
                                   UFH = 10x...........  cPAD = 2.5 mg/kg/     increased incidence of testicular
                                   FQPA SF = 1x........   day.                 degeneration (spermatocytic and/
                                                                               or spermatidic giant cells in the
                                                                               lumen of the seminiferous
                                                                               tubules).
----------------------------------------------------------------------------------------------------------------
Incidental oral (Short- and        NOAEL = 300 mg/kg/    Residential LOC for  3-generation reproduction (rat).
 intermediate-term).                day.                  MOE <100.           LOAEL = 600 mg/kg/day based on
                                    UFA = 10x..........                        decreased body weight gains in
                                   UFH = 10x...........                        the F2b generation and urinary
                                   FQPA SF = 1x........                        tract changes in adults and
                                                                               decreased pup body weights.
----------------------------------------------------------------------------------------------------------------
Dermal (All durations)...........  No potential hazard via the dermal route, based on the lack of systemic
                                    effects following repeat dermal exposure of rabbits at dose levels up to
                                    1,500 mg/kg/day, which is greater than the limit dose.
----------------------------------------------------------------------------------------------------------------
Inhalation (Short- and             NOAEL = 300 mg/kg/    Residential and      3-generation reproduction (rat).
 intermediate -term).               day.                  Occupational LOC    LOAEL = 600 mg/kg/day based on
                                   UFA = 10x...........   for MOE <100.        decreased body weight gains in
                                   UFH = 10x...........                        the F2b generation and urinary
                                   FQPA SF = 1x........                        tract changes in adults.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)                     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 (a = acute, 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 aluminum tris (O-ethylphosphonate), EPA considered exposure 
under the petitioned-for tolerances as well as all existing aluminum 
tris (O-ethylphosphonate) tolerances in 40 CFR 180.415. EPA assessed 
dietary exposures from aluminum tris (O-ethylphosphonate) 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

[[Page 12263]]

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 aluminum tris (O-ethylphosphonate); 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 USDA Nationwide 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, 
the chronic dietary analysis was obtained from the Dietary Exposure 
Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; 
version 3.16). The unrefined chronic analysis is based on tolerance-
level residues and 100% crop treated 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 aluminum tris (O-ethylphosphonate) 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 percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for aluminum tris (O-ethylphosphonate). Tolerance-
level residues and/or 100% CT 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 aluminum tris (O-ethylphosphonate) in drinking water. 
These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of aluminum tris (O-
ethylphosphonate). 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.
    Environmental fate properties suggest that aluminum tris (O-
ethylphosphonate) 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. However, if aluminum tris (O-ethylphosphonate) reached 
groundwater, it could persist. Based on the Screening Concentration in 
Ground Water (SCI-GROW) model, the estimated drinking water 
concentration (EDWC) of aluminum tris (O-ethylphosphonate) for chronic 
exposures for non-cancer assessments is estimated to be 0.006 ppb for 
ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.006 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). Aluminum tris (O-
ethylphosphonate) is currently registered for the following uses that 
could result in residential exposures: Turf and ornamental plants. EPA 
assessed residential exposure using the following assumptions: 
Inhalation exposure from the hose end sprayer for turf applications, 
and incidental oral exposure from post-application exposure to treated 
turf. Because no dermal endpoint was identified, non-occupational 
dermal exposures were not 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 aluminum tris (O-ethylphosphonate) to share a 
common mechanism of toxicity with any other substances, and aluminum 
tris (O-ethylphosphonate) does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that aluminum tris (O-
ethylphosphonate) 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 concern for 
increased quantitative or qualitative susceptibility of the young 
following in utero (rats and rabbits) and post-natal exposure (rats) to 
fosetyl-Al. Also, there is no evidence of developmental toxicity, 
reproductive toxicity, neurotoxicity, or immunotoxicity at dose levels 
that do not exceed 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 aluminum tris (O-ethylphosphonate) is 
complete.
    ii. There is no indication that aluminum tris (O-ethylphosphonate) 
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 aluminum tris (O-ethylphosphonate) 
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 and are not likely to 
underestimate risk. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
aluminum tris (O-ethylphosphonate) in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children as well as incidental oral exposure of toddlers.

[[Page 12264]]

These assessments will not underestimate the exposure and risks posed 
by aluminum tris (O-ethylphosphonate).

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, 
aluminum tris (O-ethylphosphonate) 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 
aluminum tris (O-ethylphosphonate) from food and water will utilize 14% 
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 aluminum tris (O-ethylphosphonate) 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).
    Aluminum tris (O-ethylphosphonate) 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 
aluminum tris (O-ethylphosphonate).
    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 3200 for male 
adults, 3300 for female adults and 480 for children 1-2 years old. 
Because EPA's level of concern for aluminum tris (O-ethylphosphonate) 
is a 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). An intermediate-term adverse effect was identified; however, 
aluminum tris (O-ethylphosphonate) 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 aluminum tris (O-ethylphosphonate).
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, aluminum tris (O-ethylphosphonate) 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 aluminum tris (O-ethylphosphonate) residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Pesticide Analytical Manual (PAM) 
II method, which uses diazomethane as the methylating agent and 
quantitation of aluminum tris (O-ethylphosphonate) by Gas 
Chromatography with Flame Photometric Detector (GC/FPD)) is available 
to enforce the tolerance expression.

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 aluminum tris (O-ethylphosphonate) on citrus 
fruit.

C. Response to Comments

    EPA received five comments on the second notice of filing. Two 
comments pertained to the general concern over addition of more 
chemicals to the daily diet and onset of autoimmune diseases but did 
not contain any specific information relevant to the potential risks 
from aluminum tris (O-ethylphosphonate). In response, the Agency 
explains that it has complied with the requirements of the FFDCA, which 
allow the Agency to establish or modify tolerances if the Agency 
determines they are safe. When new or amended tolerances are requested 
for the presence of the residues of a pesticide and its toxicologically 
significant metabolite(s) in food or feed, the EPA, as is required by 
section 408 of the FFDCA, estimates the risk of the potential exposure 
to these residues by performing an aggregate risk assessment. Such a 
risk assessment integrates the individual assessments that are 
conducted for food, drinking water, and residential exposures. 
Additionally, the Agency, as is further required by section 408 of the 
FFDCA, considers available information concerning what are termed the 
cumulative toxicological effects of the residues of that pesticide and 
of other substances having a common mechanism of toxicity with it. The 
Agency has concluded after this assessment that there is a reasonable 
certainty that no harm will result from exposure to the residues of 
interest. Therefore, the Agency may establish the tolerances requested 
in this petition.
    Another citizen was concerned about the risk to pollinators. The 
commenter stated this use should be denied due to toxicity to 
pollinators and that keeping them healthy should be our top priority. 
The comment primarily appears directed to the registration of the 
pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) and are not relevant to the underlying safety finding made 
under the FFDCA; therefore, the EPA will consider impacts to the 
environment and non-target species under the authority of FIFRA. The 
remaining two comments were not

[[Page 12265]]

germane to this action; therefore, no further response from the Agency 
is required.

V. Conclusion

    Therefore, tolerances are amended for residues of aluminum tris (O-
ethylphosphonate), in or on fruit, citrus, group 10-10 at 9.0 ppm.

VI. Statutory and Executive Order Reviews

    This action amends and expands an existing crop group tolerance 
under FFDCA section 408(d) in response to a petition submitted to the 
Agency. The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). 
Because this action has been exempted from review under Executive Order 
12866, this action is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive 
Order 13045, entitled ``Protection of Children from Environmental 
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This 
action does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et 
seq.), nor does it require any special considerations under Executive 
Order 12898, entitled ``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations'' (59 FR 
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as 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: March 7, 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.  180.415,
0
a. Remove the entry for ``Fruit, citrus, group 10'' from the table in 
paragraph (a).
0
b. Add alphabetically an entry to the table in paragraph (a) for 
``Fruit, citrus, group 10-10''.
    The addition reads as follows:

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

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, citrus, group 10-10...................................        9.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-05642 Filed 3-20-18; 8:45 am]
BILLING CODE 6560-50-P