Methyl Bromide; Pesticide Tolerances for Emergency Exemptions, 8758-8764 [2018-04193]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Rules and Regulations]
[Pages 8758-8764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04193]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0447; FRL-9971-19]


Methyl Bromide; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of the fumigant methyl bromide, including its metabolites and 
degradates in or on post-harvest imported/domestic agricultural 
commodities. This action is in response to EPA's granting quarantine 
exemptions under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizing use of the pesticide on specified agricultural 
commodities. This regulation establishes a maximum permissible level 
for residues of methyl bromide in or on these commodities. The time-
limited tolerances expire on December 31, 2020.

DATES: This regulation is effective March 1, 2018. Objections and 
requests for hearings must be received on or before April 30, 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-2017-0447, is available at https://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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Director, 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:
    [emsp14]Crop production (NAICS code 111).

[[Page 8759]]

    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://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 section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2017-0447 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before April 30, 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-2017-0447, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for residues of methyl bromide, in 
or on the following agricultural commodities: Avocado at 5.0 parts per 
million (ppm); Banana at 5.0 ppm; Cactus at 3.0 ppm; Coconut, copra at 
8.0 ppm; Coffee, green bean at 150 ppm; Cola at 150 ppm; Cucurbit, seed 
at 150 ppm; Fig at 10 ppm; Fruit, berry and small fruit, group 13-07 at 
5.0 ppm; Fruit, stone, group 12-12 at 5.0 ppm; Herbs and spices, group 
19 at 35 ppm; Hibiscus, seed at 150 ppm; Ivy gourd at 5.0 ppm; Kaffir 
lime, leaves at 0.50 ppm; Kenaf, seed at 150 ppm; Longan at 5.0 ppm; 
Lychee at 5.0 ppm; Oilseed group 20 at 150 ppm; Peppermint, tops at 35 
ppm; Pointed gourd at 5.0 ppm; Pomegranate at 5.0 ppm; Rambutan at 5.0 
ppm; Spanish Lime 5.0 ppm; Spearmint, tops at 35 ppm; Stalk, stem and 
leaf petiole vegetable group 22 at 0.50 ppm; Tropical and subtropical 
fruits, edible peel, group 23 at 10.0 ppm; Tropical and subtropical 
fruits, inedible peel, group 24 at 5.0 ppm; Vegetable, Head and Stem 
Brassica, group 5-16 at 1.0 ppm; Vegetable, bulb, group 3-07 at 2.0 
ppm; Vegetable, cucurbit, group 9 at 5.0 ppm; Vegetable, foliage of 
legume, group 7 at 0.50 ppm; Vegetable fruiting, group 8-10 at 7.0 ppm; 
Vegetable, leafy, group 4-16 at 0.50 ppm; Vegetable leaves of root and 
tuber, group 2 at 0.50 ppm; Vegetable, legume, group 6 at 3.0 ppm; 
Vegetable, root and tuber, group 1 at 3.0 ppm. These time-limited 
tolerances expire on December 31, 2020.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Methyl Bromide on Various Commodities and 
FFDCA Tolerances

    Quarantine exemptions were issued to the Plant Protection and 
Quarantine (PPQ) division of the United States Department of 
Agriculture, Animal and Plant Health Inspection Service (USDA/APHIS), 
for the post-harvest use of the fumigant methyl bromide on imported and 
domestic commodities to target invasive, non-indigenous quarantine 
plant pests and to prevent the introduction and/or spread of any new or 
recently introduced foreign pest(s) to any U.S. geographical location.
    After having reviewed the submissions, EPA determined that 
emergency conditions existed for the PPQ division of the USDA/APHIS, 
and that the criteria for approval of these quarantine exemptions were 
met. EPA authorized quarantine exemptions under FIFRA section 18 for 
the post-harvest use of methyl bromide in or on specified imported and 
domestic agricultural commodities to eliminate the threat of invasive 
plant pests.
    As part of its evaluation of the proposed quarantine emergency 
uses, EPA assessed the potential risks presented by residues of methyl 
bromide in or on specified imported and

[[Page 8760]]

domestic agricultural commodities. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary time-limited tolerances under FFDCA section 408(l)(6) would 
be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the quarantine exemption 
actions in order to address urgent non-routine situations and to ensure 
that the resulting food is safe and lawful, EPA issued these time-
limited tolerances without notice and opportunity for public comment as 
provided in FFDCA section 408(l)(6). Although these time-limited 
tolerances expire on December 31, 2020, under FFDCA section 408(l)(5), 
residues of the pesticide not in excess of the amounts specified in the 
tolerances remaining in or on the specified agricultural commodities 
after that date will not be unlawful, provided the pesticide was 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed levels that were authorized by these time-limited tolerances 
at the time of the applications. EPA will take action to revoke these 
time-limited tolerances earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
methyl bromide meets FIFRA's registration requirements for use on the 
specified agricultural commodities or whether permanent tolerances for 
these uses would be appropriate. Under these circumstances, EPA does 
not believe that these time-limited tolerance decisions serve as a 
basis for registration of methyl bromide by a State for special local 
needs under FIFRA section 24(c). Nor do these tolerances by themselves 
serve as the authority for persons other than certified fumigators to 
use this pesticide on the applicable crops under FIFRA section 18 
absent the authorization of the quarantine exemption issued to the 
Plant Protection and Quarantine division of the United States 
Department of Agriculture, Animal and Plant Health Inspection Service. 
For additional information regarding the quarantine exemptions for 
methyl bromide, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. 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 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 expected as a result of these quarantine exemption requests 
and the time-limited tolerances for residues of methyl bromide on the 
specified agricultural commodities. EPA's assessment of exposures and 
risks associated with establishing these time-limited tolerances 
follows.

A. 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. Further, the Agency's exposure and risk assessment for 
the emergency use of methyl bromide on various agricultural commodities 
is discussed in greater detail in the following documents: Methyl 
Bromide. Section 18 Emergency Quarantine Exemption Use on commodities 
Requested by the U.S. Department of Agriculture/Animal and Plant Health 
Inspection Service/Plant Protection and Quarantine (USDA/APHIS/PPQ) 
Division, May 02, 2017 and Methyl Bromide: Human Health Risk Assessment 
for the Section 18 Emergency Exemption Use on USDA APHIS PPQ 
Commodities, September 13, 2013 are available in the docket at the 
address provided under ADDRESSES. A summary of the toxicological 
endpoints for methyl bromide used for human risk assessment is shown 
below in Table 1 of this unit.

Table 1--Summary of Toxicological Doses and Endpoints for Methyl Bromide for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-50       Dev. NOAEL = 14 mg/   Acute RfD = 0.14 mg/ Developmental Toxicity--Rabbit
 years of age).                     kg/day.               kg/day.              (Inhalation).
                                   UF = 100x...........  aPAD = 0.14 mg/kg/   LOAEL = 28 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 agenesis of the gall bladder and
                                                                               increased incidence of fused
                                                                               sternebrae.
----------------------------------------------------------------------------------------------------------------

[[Page 8761]]

 
Acute dietary (General population  NOAEL = 90 mg/kg/day  Acute RfD = 0.9 mg/  Acute neurotoxicity study--rat
 including infants and children).  UF = 100x...........   kg/day.              (Inhalation).
                                   FQPA SF = 1x........  aPAD = 0.9 mg/kg/    LOAEL = 314 mg/kg/day based on
                                                          day.                 decreased activity, increase in
                                                                               number of animals with drooping/
                                                                               half-closed eyelids and alertness
                                                                               as measured in the Functional
                                                                               Observational Battery (FOB),
                                                                               decreased rears, decreased motor
                                                                               activity, increased piloerection
                                                                               and decreased body temperature.
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Chronic dietary (All populations)  NOAEL = 2.2 mg/kg/    Chronic RfD = 0.022  Chronic/carcinogenicity study--
                                    day.                  mg/kg/day.           rats.
                                   UF = 100x...........  cPAD = 0.022 mg/kg/  LOAEL = 11.1 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 based on decreased body weight,
                                                                               body weight gain and food
                                                                               consumption.
----------------------------------------------------------------------------------------------------------------
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. NOAEL = no-
  observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.
  UF =uncertainty factor.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to methyl bromide, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing 
methyl bromide tolerances in 40 CFR 180.124.
    EPA assessed dietary exposures from methyl bromide in food as 
follows:
    i. Acute exposure. Acute effects were identified for methyl 
bromide. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). For purposes of this 
acute exposure assessment, EPA calculated residue levels based on 
dissipation and time-to-market data, assumed 100 percent crop treated 
(PCT) and assumed that no residues were present in any processed 
commodity where heating was involved.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. To estimate chronic exposure from residues in food, EPA 
calculated residue levels based on dissipation and time-to-market data, 
assumed 100% crop treated, and assumed that no residues were present in 
any processed commodity where heating was involved. For the chronic 
exposure assessment, consumption data were averaged for the entire U.S. 
population and within population subgroups.
    iii. Cancer. Based on the data summarized in Unit IV.A., Table 1, 
EPA has concluded that methyl bromide does not pose a cancer risk to 
humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk in unnecessary.
    EPA reviewed numerous residue trials submitted by industry 
(controlled fumigation trials) in support of the reregistration of 
methyl bromide. Residue levels were calculated using residue decline 
curves for each commodity assuming first order kinetics and taking into 
account minimum predicted time intervals between fumigation and market 
availability. USDA APHIS requested uses on additional crops, providing 
detailed use pattern data. For these crops, residue levels were 
translated from similar commodities having residue trial data, 
considering use patterns and taking into account time intervals between 
fumigation and market availability.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for methyl bromide in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of methyl bromide. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
    The methyl bromide Estimated Drinking Water Concentration was 
derived from groundwater estimates. Based on data from the database of 
pesticides in groundwater (U.S. EPA, 1992), two wells in California 
(out of 20,429 wells monitored in Florida, California, and Hawaii) had 
methyl bromide levels of 2.5 and 6.4 microgram/Liter ([mu]g/L). The 
highest groundwater monitoring value of 6.4 parts per billion (ppb) was 
used for both the acute and chronic (non-cancer) assessments. 
Concentrations of methyl bromide in surface water are considered 
negligible due to the rapid dissipation of methyl bromide from water to 
the air (half-life of 73 minutes).
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Methyl bromide is a restricted use pesticide and is not registered 
for any specific residential use patterns; however, there is potential 
for residential bystander inhalation exposure in and around port areas 
where post-harvest commodity fumigation treatments takes place. Buffers 
have been implemented on all methyl bromide labels, which reduce 
bystander exposures to levels that do not exceed the Agency's level of 
concern.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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

[[Page 8762]]

substances that have a common mechanism of toxicity.''
    EPA has not found methyl bromide to share a common mechanism of 
toxicity with any other substances, and methyl bromide does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
methyl bromide 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 https://www.epa.gov/pesticides/cumulative.

C. 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 SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased 
quantitative or qualitative susceptibility was observed in 
developmental toxicity studies in rats or rabbits. The rabbit 
inhalation developmental study also did not indicate susceptibility to 
the young as the dams and the offspring had identical NOAEL and LOAEL 
values.
    Therefore, toxicity studies on adults will not underestimate the 
risks methyl bromide poses to children.
    3. Conclusion. EPA has determined that reliable data show that 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 methyl bromide is complete.
    ii. There is no indication that methyl bromide 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 methyl bromide results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies. In the rat developmental inhalation study there 
was no indication of susceptibility to the young, at doses up to 70 
ppm. The rabbit inhalation developmental study also did not indicate 
susceptibility to the young, as the dams and the offspring had 
identical NOAEL and LOAEL values.
    iv. There are no residual uncertainties identified in the exposure 
databases. The use of inhalation studies to assess dietary risks is a 
conservative (protective) approach since inhalation exposure is 
expected to lead to a higher internal dose than dietary exposure since 
chemicals will enter the circulatory system before many of the 
detoxification processes associated with oral exposure (e.g. first pass 
effect) occur. Therefore, these assessments will not underestimate the 
exposure and risks posed by methyl bromide.

D. 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) presented in Unit IV.A. Table 
1. Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs in Table 1 to ensure that an adequate MOE 
exists.
    1. Acute risk. Using the exposure assumptions discussed in Unit 
IV.B. for acute exposure, the acute dietary exposure from food and 
water to methyl bromide will occupy 3.5% of the aPAD for children 1-2 
years old, the population group receiving the greatest exposure. The 
Agency has determined that dietary risk estimates for aggregate acute 
exposure through food and water to methyl bromide are below the 
Agency's level of concern for the U.S. population and all population 
subgroups. There is also potential for inhalation exposure to 
residential bystanders. However, since the dietary contribution to 
acute aggregate risk is negligible, EPA has determined that the 
mitigation measures EPA required in the 2006 Tolerance Reassessment and 
Risk Management Decision (TRED) for Methyl Bromide, and Reregistration 
Eligibility Decision (RED) for Methyl Bromide's Commodity Uses to 
protect residential bystanders will ensure that acute aggregate risks 
do not exceed EPA's level of concern.
    2. Chronic risk. Using the exposure assumptions described in Unit 
IV.B. for chronic exposure, EPA has concluded that chronic exposure to 
methyl bromide from food and water will utilize 43% of the cPAD for 
(children 1-2 years old) the population group receiving the greatest 
exposure. Based on the explanation in the unit regarding residential 
use patterns, chronic residential exposure to residues of methyl 
bromide is not expected. Although there is potential for inhalation 
exposure to residential bystanders, EPA did not aggregate short-, 
intermediate-term, or chronic dietary and inhalation exposures to 
methyl bromide because endpoints for dietary and inhalation exposures 
for these durations are not based on common toxicological effects. 
Methyl bromide is not registered for use in residential settings; 
therefore, residential exposures from the direct use of methyl bromide 
in residential areas is not expected.
    3. Short-term risk. Short-term risk is assessed based on short-term 
residential exposure plus chronic dietary exposure. Methyl bromide is 
not registered for use in residential settings; therefore, residential 
handler exposures from the direct use of methyl bromide in residential 
areas is not expected. EPA did not aggregate short-, intermediate-term, 
or chronic dietary and inhalation exposures to methyl bromide because 
endpoints for dietary and inhalation exposures for these durations are 
not based on common toxicological effects.
    4. Intermediate-term risk. Intermediate-term risk is assessed based 
on intermediate-term residential exposure plus chronic dietary 
exposure. Methyl bromide is not registered for use in residential 
settings; therefore, residential handler exposures from the direct use 
of methyl bromide in residential areas is not expected. EPA did not 
aggregate short-, intermediate-term, or chronic dietary and inhalation 
exposures to methyl bromide because endpoints for dietary and 
inhalation exposures for these durations are not based on common 
toxicological effects.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, methyl bromide 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 methyl bromide residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (King headspace method, J. 
Agricultural Food Chemistry, Vol 29, No. 5, pp 1003-1005) is available 
to enforce the tolerance expression. This

[[Page 8763]]

method is a gas chromatography/electron capture (GC/EC) method that was 
validated in 1987 in the EPA Environmental Chemistry Laboratory 
(D168869, L. Cheng, 27-OCT-1992). The headspace procedure for 
determining methyl bromide has been forwarded to FDA for inclusion in 
PAM Vol. II. This method is adequate for data collection and for 
tolerance enforcement on plant and processed food commodities.

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.
    Methyl bromide Codex MRLs have been established for several 
commodities; however, there are no Codex MRLs for any of the 
commodities that are the subject of this quarantine action. Therefore, 
at this time, there are no harmonization issues.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
the fumigant methyl bromide, including its metabolites and degradates, 
in or on specified agricultural imported/domestic commodities. These 
tolerances expire on December 31, 2020.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 13, 2018.
Donna S. Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.124, revise paragraph (b) to read as follows:


Sec.  [emsp14]180.124   Methyl bromide; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances as 
listed in the following table are established for residues of the 
fumigant methyl bromide, including its metabolites and degradates, in 
or on the specified agricultural commodities, resulting from use of the 
pesticide pursuant to FIFRA section 18 emergency exemptions. Compliance 
with the tolerance levels specified below is to be determined by 
measuring only methyl bromide. These tolerances expire and are revoked 
on the date indicated in the table.

------------------------------------------------------------------------
                                 Parts per
          Commodity               million           Expiration date
------------------------------------------------------------------------
Avocado.....................             5.0  December 31, 2020.
Banana......................             5.0  December 31, 2020.
Cactus......................             3.0  December 31, 2020.
Coconut, copra..............             8.0  December 31, 2020.

[[Page 8764]]

 
Coffee, green bean..........             150  December 31, 2020.
Cola........................             150  December 31, 2020.
Cucurbit, seed..............             150  December 31, 2020.
Fig.........................              10  December 31, 2020.
Fruit, berry and small                   5.0  December 31, 2020.
 fruit, group 13-07.
Fruit, stone, group 12-12...             5.0  December 31, 2020.
Herb and spice, group 19....              35  December 31, 2020.
Hibiscus, seed..............             150  December 31, 2020.
Ivy gourd...................             5.0  December 31, 2020.
Kaffir lime, leaves.........            0.50  December 31, 2020.
Kenaf, seed.................             150  December 31, 2020.
Longan......................             5.0  December 31, 2020.
Lychee......................             5.0  December 31, 2020.
Oilseed group 20............             150  December 31, 2020.
Peppermint, tops............              35  December 31, 2020.
Pointed gourd...............             5.0  December 31, 2020.
Pomegranate.................             5.0  December 31, 2020.
Rambutan....................             5.0  December 31, 2020.
Spanish lime................             5.0  December 31, 2020.
Spearmint, tops.............              35  December 31, 2020.
Stalk, stem and leaf petiole            0.50  December 31, 2020.
 vegetable group 22.
Tropical and subtropical                  10  December 31, 2020.
 fruits, edible peel, group
 23.
Tropical and subtropical                 5.0  December 31, 2020.
 fruits, inedible peel,
 group 24.
Vegetable, bulb, group 3-07.             2.0  December 31, 2020.
Vegetable, cucurbit, group 9             5.0  December 31, 2020.
Vegetable, foliage of                   0.50  December 31, 2020.
 legume, group 7.
Vegetable, fruiting, group 8-            7.0  December 31, 2020.
 10.
Vegetable, Head and Stem                 1.0  December 31, 2020.
 Brassica, group 5-16.
Vegetable, leafy, group 4-16            0.50  December 31, 2020.
Vegetable, leaves of root               0.50  December 31, 2020.
 and tuber, group 2.
Vegetable, legume, group 6..             3.0  December 31, 2020.
Vegetable, root and tuber,               3.0  December 31, 2020.
 group 1.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-04193 Filed 2-28-18; 8:45 am]
 BILLING CODE 6560-50-P