83_FR_8799 83 FR 8758 - Methyl Bromide; Pesticide Tolerances for Emergency Exemptions

83 FR 8758 - Methyl Bromide; Pesticide Tolerances for Emergency Exemptions

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 41 (March 1, 2018)

Page Range8758-8764
FR Document2018-04193

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.

Federal Register, Volume 83 Issue 41 (Thursday, March 1, 2018)
[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Rules and Regulations]
[Pages 8758-8764]
From the Federal Register Online  [www.thefederalregister.org]
[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 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, 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 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 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: 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. 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
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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 http://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: http://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 http://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



                                           8758                   Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Rules and Regulations

                                                                          EPA-APPROVED ILLINOIS NONREGULATORY AND QUASI-REGULATORY PROVISIONS
                                                                                                      Applicable                   State
                                                                                                      geographic
                                                        Name of SIP provision                                                    submittal                    EPA approval date                          Comments
                                                                                                   or nonattainment                date
                                                                                                         area

                                                                                                                 Attainment and Maintenance Plans


                                                   *                   *                                  *                         *                         *                  *                              *
                                           Ozone (8-hour, 2008) redesignation and                 St. Louis area ........           5/8/2017        3/1/2018 [insert Federal Register cita-
                                            maintenance plan.                                                                                         tion].

                                                        *                        *                           *                      *                         *                         *                       *



                                           PART 81—DESIGNATION OF AREAS                                      Authority: 42 U.S.C. 7401, et seq.                    NAAQS (Primary and secondary)’’ to
                                           FOR AIR QUALITY PLANNING                                                                                                read as follows:
                                                                                                         ■ 4. Section 81.314 is amended by
                                           PURPOSES
                                                                                                         revising the entry ‘‘St. Louis-St. Charles-               § 81.314      Illinois.
                                           ■ 3. The authority citation for part 81                       Farmington, MO-IL:’’ in the table                         *       *       *         *    *
                                           continues to read as follows:                                 entitled ‘‘Illinois—2008 8-Hour Ozone

                                                                                                       ILLINOIS—2008 8-HOUR OZONE NAAQS
                                                                                                                       [Primary and secondary]

                                                                                                                                             Designation                                     Classification
                                                                        Designated area
                                                                                                                                Date 1                     Type                   Date 1                      Type


                                                     *                   *                  *                                       *                         *                         *                       *
                                           St. Louis-St. Charles-Farmington, MO-IL: 2
                                                Madison County, Monroe County, St. Clair County                                   3/1/2018      Attainment.

                                                        *                        *                           *                      *                         *                         *                       *
                                               1 This date is July 20, 2012, unless otherwise noted.
                                               2 Excludes Indian country located in each area, unless otherwise noted.




                                           *       *        *       *      *                             regulation establishes a maximum                          Docket is (703) 305–5805. Please review
                                           [FR Doc. 2018–04094 Filed 2–28–18; 8:45 am]                   permissible level for residues of methyl                  the visitor instructions and additional
                                           BILLING CODE 6560–50–P                                        bromide in or on these commodities.                       information about the docket available
                                                                                                         The time-limited tolerances expire on                     at http://www.epa.gov/dockets.
                                                                                                         December 31, 2020.
                                           ENVIRONMENTAL PROTECTION                                                                                                FOR FURTHER INFORMATION CONTACT:
                                                                                                         DATES: This regulation is effective                       Michael Goodis, Director, Registration
                                           AGENCY
                                                                                                         March 1, 2018. Objections and requests                    Division (7505P), Office of Pesticide
                                           40 CFR Part 180                                               for hearings must be received on or                       Programs, Environmental Protection
                                                                                                         before April 30, 2018, and must be filed                  Agency, 1200 Pennsylvania Ave. NW,
                                           [EPA–HQ–OPP–2017–0447; FRL–9971–19]                           in accordance with the instructions                       Washington, DC 20460–0001; main
                                                                                                         provided in 40 CFR part 178 (see also                     telephone number: (703) 305–7090;
                                           Methyl Bromide; Pesticide Tolerances                          Unit I.C. of the SUPPLEMENTARY                            email address: RDFRNotices@epa.gov.
                                           for Emergency Exemptions                                      INFORMATION).
                                                                                                                                                                   SUPPLEMENTARY INFORMATION:
                                           AGENCY:  Environmental Protection                             ADDRESSES:   The docket for this action,
                                                                                                         identified by docket identification (ID)                  I. General Information
                                           Agency (EPA).
                                           ACTION: Final rule.                                           number EPA–HQ–OPP–2017–0447, is                           A. Does this action apply to me?
                                                                                                         available at http://www.regulations.gov
                                           SUMMARY:   This regulation establishes                        or at the Office of Pesticide Programs                       You may be potentially affected by
                                           time-limited tolerances for residues of                       Regulatory Public Docket (OPP Docket)                     this action if you are an agricultural
                                           the fumigant methyl bromide, including                        in the Environmental Protection Agency                    producer, food manufacturer, or
                                           its metabolites and degradates in or on                       Docket Center (EPA/DC), West William                      pesticide manufacturer. The following
                                           post-harvest imported/domestic                                Jefferson Clinton Bldg., Rm. 3334, 1301                   list of North American Industrial
                                           agricultural commodities. This action is                      Constitution Ave. NW, Washington, DC                      Classification System (NAICS) codes is
amozie on DSK30RV082PROD with RULES




                                           in response to EPA’s granting                                 20460–0001. The Public Reading Room                       not intended to be exhaustive, but rather
                                           quarantine exemptions under the                               is open from 8:30 a.m. to 4:30 p.m.,                      provides a guide to help readers
                                           Federal Insecticide, Fungicide, and                           Monday through Friday, excluding legal                    determine whether this document
                                           Rodenticide Act (FIFRA) authorizing                           holidays. The telephone number for the                    applies to them. Potentially affected
                                           use of the pesticide on specified                             Public Reading Room is (202) 566–1744,                    entities may include:
                                           agricultural commodities. This                                and the telephone number for the OPP                         • Crop production (NAICS code 111).


                                      VerDate Sep<11>2014       17:58 Feb 28, 2018   Jkt 244001   PO 00000       Frm 00016   Fmt 4700   Sfmt 4700    E:\FR\FM\01MRR1.SGM       01MRR1


                                                              Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Rules and Regulations                                          8759

                                             • Animal production (NAICS code                         Additional instructions on                          received any petition from an outside
                                           112).                                                   commenting or visiting the docket,                    party.
                                             • Food manufacturing (NAICS code                      along with more information about                        Section 408(b)(2)(A)(i) of FFDCA
                                           311).                                                   dockets generally, is available at http://            allows EPA to establish a tolerance (the
                                             • Pesticide manufacturing (NAICS                      www.epa.gov/dockets.                                  legal limit for a pesticide chemical
                                           code 32532).                                                                                                  residue in or on a food) only if EPA
                                                                                                   II. Background and Statutory Findings                 determines that the tolerance is ‘‘safe.’’
                                           B. How can I get electronic access to                      EPA, on its own initiative, in                     Section 408(b)(2)(A)(ii) of FFDCA
                                           other related information?                              accordance with FFDCA sections 408(e)                 defines ‘‘safe’’ to mean that ‘‘there is a
                                             You may access a frequently updated                   and 408(l)(6) of, 21 U.S.C. 346a(e) and               reasonable certainty that no harm will
                                           electronic version of 40 CFR part 180                   346a(1)(6), is establishing time-limited              result from aggregate exposure to the
                                           through the Government Printing                         tolerances for residues of methyl                     pesticide chemical residue, including
                                           Office’s e-CFR site at http://                          bromide, in or on the following                       all anticipated dietary exposures and all
                                           www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&                  agricultural commodities: Avocado at                  other exposures for which there is
                                           tpl=/ecfrbrowse/Title40/40tab_02.tpl.                   5.0 parts per million (ppm); Banana at                reliable information.’’ This includes
                                                                                                   5.0 ppm; Cactus at 3.0 ppm; Coconut,                  exposure through drinking water and in
                                           C. How can I file an objection or hearing               copra at 8.0 ppm; Coffee, green bean at               residential settings, but does not include
                                           request?                                                150 ppm; Cola at 150 ppm; Cucurbit,                   occupational exposure. Section
                                             Under section 408(g) of the Federal                   seed at 150 ppm; Fig at 10 ppm; Fruit,                408(b)(2)(C) of FFDCA requires EPA to
                                           Food, Drug, and Cosmetic Act (FFDCA),                   berry and small fruit, group 13–07 at 5.0             give special consideration to exposure
                                           21 U.S.C. 346a, any person may file an                  ppm; Fruit, stone, group 12–12 at 5.0                 of infants and children to the pesticide
                                           objection to any aspect of this regulation              ppm; Herbs and spices, group 19 at 35                 chemical residue in establishing a
                                           and may also request a hearing on those                 ppm; Hibiscus, seed at 150 ppm; Ivy                   tolerance and to ‘‘ensure that there is a
                                           objections. You must file your objection                gourd at 5.0 ppm; Kaffir lime, leaves at              reasonable certainty that no harm will
                                           or request a hearing on this regulation                 0.50 ppm; Kenaf, seed at 150 ppm;                     result to infants and children from
                                           in accordance with the instructions                     Longan at 5.0 ppm; Lychee at 5.0 ppm;                 aggregate exposure to the pesticide
                                           provided in 40 CFR part 178. To ensure                  Oilseed group 20 at 150 ppm;                          chemical residue. . . .’’
                                           proper receipt by EPA, you must                         Peppermint, tops at 35 ppm; Pointed                      Section 18 of FIFRA authorizes EPA
                                                                                                   gourd at 5.0 ppm; Pomegranate at 5.0                  to exempt any Federal or State agency
                                           identify docket ID number EPA–HQ–
                                                                                                   ppm; Rambutan at 5.0 ppm; Spanish                     from any provision of FIFRA, if EPA
                                           OPP–2017–0447 in the subject line on
                                                                                                   Lime 5.0 ppm; Spearmint, tops at 35                   determines that ‘‘emergency conditions
                                           the first page of your submission. All
                                                                                                   ppm; Stalk, stem and leaf petiole                     exist which require such exemption.’’
                                           objections and requests for a hearing
                                                                                                   vegetable group 22 at 0.50 ppm;                       EPA has established regulations
                                           must be in writing, and must be
                                                                                                   Tropical and subtropical fruits, edible               governing such emergency exemptions
                                           received by the Hearing Clerk on or
                                                                                                   peel, group 23 at 10.0 ppm; Tropical                  in 40 CFR part 166.
                                           before April 30, 2018. Addresses for
                                                                                                   and subtropical fruits, inedible peel,
                                           mail and hand delivery of objections                                                                          III. Emergency Exemptions for Methyl
                                                                                                   group 24 at 5.0 ppm; Vegetable, Head
                                           and hearing requests are provided in 40                                                                       Bromide on Various Commodities and
                                                                                                   and Stem Brassica, group 5–16 at 1.0
                                           CFR 178.25(b).                                          ppm; Vegetable, bulb, group 3–07 at 2.0               FFDCA Tolerances
                                             In addition to filing an objection or                 ppm; Vegetable, cucurbit, group 9 at 5.0                 Quarantine exemptions were issued to
                                           hearing request with the Hearing Clerk                  ppm; Vegetable, foliage of legume,                    the Plant Protection and Quarantine
                                           as described in 40 CFR part 178, please                 group 7 at 0.50 ppm; Vegetable fruiting,              (PPQ) division of the United States
                                           submit a copy of the filing (excluding                  group 8–10 at 7.0 ppm; Vegetable, leafy,              Department of Agriculture, Animal and
                                           any Confidential Business Information                   group 4–16 at 0.50 ppm; Vegetable                     Plant Health Inspection Service (USDA/
                                           (CBI)) for inclusion in the public docket.              leaves of root and tuber, group 2 at 0.50             APHIS), for the post-harvest use of the
                                           Information not marked confidential                     ppm; Vegetable, legume, group 6 at 3.0                fumigant methyl bromide on imported
                                           pursuant to 40 CFR part 2 may be                        ppm; Vegetable, root and tuber, group 1               and domestic commodities to target
                                           disclosed publicly by EPA without prior                 at 3.0 ppm. These time-limited                        invasive, non-indigenous quarantine
                                           notice. Submit the non-CBI copy of your                 tolerances expire on December 31, 2020.               plant pests and to prevent the
                                           objection or hearing request, identified                   Section 408(l)(6) of FFDCA requires                introduction and/or spread of any new
                                           by docket ID number EPA–HQ–OPP–                         EPA to establish a time-limited                       or recently introduced foreign pest(s) to
                                           2017–0447, by one of the following                      tolerance or exemption from the                       any U.S. geographical location.
                                           methods:                                                requirement for a tolerance for pesticide                After having reviewed the
                                             • Federal eRulemaking Portal: http://                 chemical residues in food that will                   submissions, EPA determined that
                                           www.regulations.gov. Follow the online                  result from the use of a pesticide under              emergency conditions existed for the
                                           instructions for submitting comments.                   an emergency exemption granted by                     PPQ division of the USDA/APHIS, and
                                           Do not submit electronically any                        EPA under FIFRA section 18. Such                      that the criteria for approval of these
                                           information you consider to be CBI or                   tolerances can be established without                 quarantine exemptions were met. EPA
                                           other information whose disclosure is                   providing notice or period for public                 authorized quarantine exemptions
                                           restricted by statute.                                  comment. EPA does not intend for its                  under FIFRA section 18 for the post-
                                             • Mail: OPP Docket, Environmental                     actions on FIFRA section 18 related                   harvest use of methyl bromide in or on
                                           Protection Agency Docket Center (EPA/                   time-limited tolerances to set binding                specified imported and domestic
                                           DC), (28221T), 1200 Pennsylvania Ave.                   precedents for the application of FFDCA               agricultural commodities to eliminate
amozie on DSK30RV082PROD with RULES




                                           NW, Washington, DC 20460–0001.                          section 408 and the safety standard to                the threat of invasive plant pests.
                                             • Hand Delivery: To make special                      other tolerances and exemptions.                         As part of its evaluation of the
                                           arrangements for hand delivery or                       Section 408(e) of FFDCA allows EPA to                 proposed quarantine emergency uses,
                                           delivery of boxed information, please                   establish a tolerance or an exemption                 EPA assessed the potential risks
                                           follow the instructions at http://                      from the requirement of a tolerance on                presented by residues of methyl
                                           www.epa.gov/dockets/contacts.html.                      its own initiative, i.e., without having              bromide in or on specified imported and


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                                           8760               Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Rules and Regulations

                                           domestic agricultural commodities. In                   States Department of Agriculture,                     and levels of concern to use in
                                           doing so, EPA considered the safety                     Animal and Plant Health Inspection                    evaluating the risk posed by human
                                           standard in FFDCA section 408(b)(2),                    Service. For additional information                   exposure to the pesticide. For hazards
                                           and EPA decided that the necessary                      regarding the quarantine exemptions for               that have a threshold below which there
                                           time-limited tolerances under FFDCA                     methyl bromide, contact the Agency’s                  is no appreciable risk, the toxicological
                                           section 408(l)(6) would be consistent                   Registration Division at the address                  POD is used as the basis for derivation
                                           with the safety standard and with                       provided under FOR FURTHER                            of reference values for risk assessment.
                                           FIFRA section 18. Consistent with the                   INFORMATION CONTACT.                                  PODs are developed based on a careful
                                           need to move quickly on the quarantine                  IV. Aggregate Risk Assessment and                     analysis of the doses in each
                                           exemption actions in order to address                   Determination of Safety                               toxicological study to determine the
                                           urgent non-routine situations and to                                                                          dose at which no adverse effects are
                                           ensure that the resulting food is safe and                 Section 408(b)(2)(A)(i) of FFDCA
                                                                                                                                                         observed (the NOAEL) and the lowest
                                           lawful, EPA issued these time-limited                   allows EPA to establish a tolerance (the
                                                                                                                                                         dose at which adverse effects of concern
                                           tolerances without notice and                           legal limit for a pesticide chemical
                                                                                                   residue in or on a food) only if EPA                  are identified (the LOAEL). Uncertainty/
                                           opportunity for public comment as                                                                             safety factors are used in conjunction
                                           provided in FFDCA section 408(l)(6).                    determines that the tolerance is ‘‘safe.’’
                                                                                                   Section 408(b)(2)(A)(ii) of FFDCA                     with the POD to calculate a safe
                                           Although these time-limited tolerances                                                                        exposure level—generally referred to as
                                           expire on December 31, 2020, under                      defines ‘‘safe’’ to mean that ‘‘there is a
                                                                                                   reasonable certainty that no harm will                a population-adjusted dose (PAD) or a
                                           FFDCA section 408(l)(5), residues of the                                                                      reference dose (RfD)—and a safe margin
                                           pesticide not in excess of the amounts                  result from aggregate exposure to the
                                                                                                   pesticide chemical residue, including                 of exposure (MOE). For non-threshold
                                           specified in the tolerances remaining in                                                                      risks, the Agency assumes that any
                                           or on the specified agricultural                        all anticipated dietary exposures and all
                                                                                                   other exposures for which there is                    amount of exposure will lead to some
                                           commodities after that date will not be                                                                       degree of risk. Thus, the Agency
                                           unlawful, provided the pesticide was                    reliable information.’’ This includes
                                                                                                   exposure through drinking water and in                estimates risk in terms of the probability
                                           applied in a manner that was lawful
                                                                                                   residential settings, but does not include            of an occurrence of the adverse effect
                                           under FIFRA, and the residues do not
                                                                                                   occupational exposure. Section                        expected in a lifetime. For more
                                           exceed levels that were authorized by
                                                                                                   408(b)(2)(C) of FFDCA requires EPA to                 information on the general principles
                                           these time-limited tolerances at the time
                                                                                                   give special consideration to exposure                EPA uses in risk characterization and a
                                           of the applications. EPA will take action
                                                                                                   of infants and children to the pesticide              complete description of the risk
                                           to revoke these time-limited tolerances
                                                                                                   chemical residue in establishing a                    assessment process, see https://
                                           earlier if any experience with, scientific
                                                                                                   tolerance and to ‘‘ensure that there is a             www.epa.gov/pesticide-science-and-
                                           data on, or other relevant information
                                                                                                   reasonable certainty that no harm will                assessing-pesticide-risks/assessing-
                                           on this pesticide indicate that the
                                                                                                   result to infants and children from                   human-health-risk-pesticides. Further,
                                           residues are not safe.
                                                                                                   aggregate exposure to the pesticide                   the Agency’s exposure and risk
                                             Because these time-limited tolerances
                                                                                                   chemical residue. * * *’’                             assessment for the emergency use of
                                           are being approved under emergency                         Consistent with the factors specified
                                           conditions, EPA has not made any                                                                              methyl bromide on various agricultural
                                                                                                   in FFDCA section 408(b)(2)(D), EPA has                commodities is discussed in greater
                                           decisions about whether methyl                          reviewed the available scientific data
                                           bromide meets FIFRA’s registration                                                                            detail in the following documents:
                                                                                                   and other relevant information in                     Methyl Bromide. Section 18 Emergency
                                           requirements for use on the specified                   support of this action. EPA has
                                           agricultural commodities or whether                                                                           Quarantine Exemption Use on
                                                                                                   sufficient data to assess the hazards of              commodities Requested by the U.S.
                                           permanent tolerances for these uses                     and to make a determination on
                                           would be appropriate. Under these                                                                             Department of Agriculture/Animal and
                                                                                                   aggregate exposure expected as a result
                                           circumstances, EPA does not believe                                                                           Plant Health Inspection Service/Plant
                                                                                                   of these quarantine exemption requests
                                           that these time-limited tolerance                                                                             Protection and Quarantine (USDA/
                                                                                                   and the time-limited tolerances for
                                           decisions serve as a basis for registration             residues of methyl bromide on the                     APHIS/PPQ) Division, May 02, 2017 and
                                           of methyl bromide by a State for special                specified agricultural commodities.                   Methyl Bromide: Human Health Risk
                                           local needs under FIFRA section 24(c).                  EPA’s assessment of exposures and risks               Assessment for the Section 18
                                           Nor do these tolerances by themselves                   associated with establishing these time-              Emergency Exemption Use on USDA
                                           serve as the authority for persons other                limited tolerances follows.                           APHIS PPQ Commodities, September
                                           than certified fumigators to use this                                                                         13, 2013 are available in the docket at
                                           pesticide on the applicable crops under                 A. Toxicological Points of Departure/                 the address provided under ADDRESSES.
                                           FIFRA section 18 absent the                             Levels of Concern                                     A summary of the toxicological
                                           authorization of the quarantine                           Once a pesticide’s toxicological                    endpoints for methyl bromide used for
                                           exemption issued to the Plant Protection                profile is determined, EPA identifies                 human risk assessment is shown below
                                           and Quarantine division of the United                   toxicological points of departure (POD)               in Table 1 of this unit.

                                              TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METHYL BROMIDE FOR USE IN HUMAN HEALTH
                                                                                     RISK ASSESSMENT
                                                                                    Point of departure        RfD, PAD, LOC for
                                                  Exposure/scenario                  and uncertainty/                                                    Study and toxicological effects
                                                                                                               risk assessment
amozie on DSK30RV082PROD with RULES




                                                                                      safety factors

                                           Acute dietary (Females 13–50           Dev. NOAEL = 14            Acute RfD = 0.14           Developmental Toxicity—Rabbit (Inhalation).
                                             years of age).                         mg/kg/day.                 mg/kg/day.               LOAEL = 28 mg/kg/day based on agenesis of the gall bladder
                                                                                  UF = 100x                  aPAD = 0.14 mg/kg/           and increased incidence of fused sternebrae.
                                                                                  FQPA SF = 1x                 day




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                                                              Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Rules and Regulations                                           8761

                                              TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METHYL BROMIDE FOR USE IN HUMAN HEALTH
                                                                                RISK ASSESSMENT—Continued
                                                                                    Point of departure        RfD, PAD, LOC for
                                                  Exposure/scenario                  and uncertainty/                                                    Study and toxicological effects
                                                                                                               risk assessment
                                                                                      safety factors

                                           Acute dietary (General popu-           NOAEL = 90 mg/kg/          Acute RfD = 0.9 mg/        Acute neurotoxicity study—rat (Inhalation).
                                             lation including infants and           day.                       kg/day.                  LOAEL = 314 mg/kg/day based on decreased activity, increase
                                             children).                           UF = 100x                  aPAD = 0.9 mg/kg/            in number of animals with drooping/half-closed eyelids and
                                                                                  FQPA SF = 1x                 day                        alertness as measured in the Functional Observational Bat-
                                                                                                                                          tery (FOB), decreased rears, decreased motor activity, in-
                                                                                                                                          creased piloerection and decreased body temperature.

                                           Chronic dietary (All populations)      NOAEL = 2.2 mg/kg/         Chronic RfD = 0.022        Chronic/carcinogenicity study—rats.
                                                                                    day.                       mg/kg/day.               LOAEL = 11.1 mg/kg/day based on based on decreased body
                                                                                  UF = 100x                  cPAD = 0.022 mg/             weight, body weight gain and food consumption.
                                                                                  FQPA SF = 1x                 kg/day

                                           Cancer (Oral, dermal, inhala-                                         Classification: Not likely to be carcinogenic to humans.
                                             tion).
                                             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                                  Therefore, a dietary exposure                         parts per billion (ppb) was used for both
                                              1. Dietary exposure from food and                    assessment for the purpose of assessing               the acute and chronic (non-cancer)
                                           feed uses. In evaluating dietary                        cancer risk in unnecessary.                           assessments. Concentrations of methyl
                                           exposure to methyl bromide, EPA                           EPA reviewed numerous residue trials                bromide in surface water are considered
                                           considered exposure under the time-                     submitted by industry (controlled                     negligible due to the rapid dissipation of
                                           limited tolerances established by this                  fumigation trials) in support of the                  methyl bromide from water to the air
                                           action as well as all existing methyl                   reregistration of methyl bromide.                     (half-life of 73 minutes).
                                           bromide tolerances in 40 CFR 180.124.                   Residue levels were calculated using                     Modeled estimates of drinking water
                                              EPA assessed dietary exposures from                  residue decline curves for each                       concentrations were directly entered
                                           methyl bromide in food as follows:                      commodity assuming first order kinetics               into the dietary exposure model.
                                              i. Acute exposure. Acute effects were                and taking into account minimum                          3. From non-dietary exposure. The
                                           identified for methyl bromide. In                       predicted time intervals between                      term ‘‘residential exposure’’ is used in
                                           estimating acute dietary exposure, EPA                  fumigation and market availability.                   this document to refer to non-
                                           used food consumption information                       USDA APHIS requested uses on                          occupational, non-dietary exposure
                                           from the United States Department of                    additional crops, providing detailed use              (e.g., for lawn and garden pest control,
                                           Agriculture (USDA) 2003–2008 National                   pattern data. For these crops, residue                indoor pest control, termiticides, and
                                           Health and Nutrition Examination                        levels were translated from similar                   flea and tick control on pets).
                                           Survey, What We Eat in America                          commodities having residue trial data,
                                                                                                   considering use patterns and taking into                 Methyl bromide is a restricted use
                                           (NHANES/WWEIA). For purposes of
                                                                                                   account time intervals between                        pesticide and is not registered for any
                                           this acute exposure assessment, EPA
                                                                                                   fumigation and market availability.                   specific residential use patterns;
                                           calculated residue levels based on
                                                                                                     2. Dietary exposure from drinking                   however, there is potential for
                                           dissipation and time-to-market data,
                                                                                                   water. The Agency used screening level                residential bystander inhalation
                                           assumed 100 percent crop treated (PCT)
                                                                                                   water exposure models in the dietary                  exposure in and around port areas
                                           and assumed that no residues were
                                                                                                   exposure analysis and risk assessment                 where post-harvest commodity
                                           present in any processed commodity
                                                                                                   for methyl bromide in drinking water.                 fumigation treatments takes place.
                                           where heating was involved.
                                                                                                   These simulation models take into                     Buffers have been implemented on all
                                              ii. Chronic exposure. In conducting
                                                                                                   account data on the physical, chemical,               methyl bromide labels, which reduce
                                           the chronic dietary exposure assessment
                                                                                                   and fate/transport characteristics of                 bystander exposures to levels that do
                                           EPA used the food consumption data
                                                                                                   methyl bromide. Further information                   not exceed the Agency’s level of
                                           from the USDA 2003–2008 NHANES/
                                                                                                   regarding EPA drinking water models                   concern.
                                           WWEIA. To estimate chronic exposure
                                           from residues in food, EPA calculated                   used in pesticide exposure assessment                    Further information regarding EPA
                                           residue levels based on dissipation and                 can be found at http://www.epa.gov/                   standard assumptions and generic
                                           time-to-market data, assumed 100%                       oppefed1/models/water/index.htm.                      inputs for residential exposures may be
                                           crop treated, and assumed that no                         The methyl bromide Estimated                        found at: http://www.epa.gov/
                                           residues were present in any processed                  Drinking Water Concentration was                      pesticides/trac/science/trac6a05.pdf.
                                           commodity where heating was involved.                   derived from groundwater estimates.                      4. Cumulative effects from substances
                                           For the chronic exposure assessment,                    Based on data from the database of                    with a common mechanism of toxicity.
                                           consumption data were averaged for the                  pesticides in groundwater (U.S. EPA,                  Section 408(b)(2)(D)(v) of FFDCA
amozie on DSK30RV082PROD with RULES




                                           entire U.S. population and within                       1992), two wells in California (out of                requires that, when considering whether
                                           population subgroups.                                   20,429 wells monitored in Florida,                    to establish, modify, or revoke a
                                              iii. Cancer. Based on the data                       California, and Hawaii) had methyl                    tolerance, the Agency consider
                                           summarized in Unit IV.A., Table 1, EPA                  bromide levels of 2.5 and 6.4                         ‘‘available information’’ concerning the
                                           has concluded that methyl bromide                       microgram/Liter (mg/L). The highest                   cumulative effects of a particular
                                           does not pose a cancer risk to humans.                  groundwater monitoring value of 6.4                   pesticide’s residues and ‘‘other


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                                           8762               Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Rules and Regulations

                                           substances that have a common                           susceptibility to the young, at doses up              on the explanation in the unit regarding
                                           mechanism of toxicity.’’                                to 70 ppm. The rabbit inhalation                      residential use patterns, chronic
                                             EPA has not found methyl bromide to                   developmental study also did not                      residential exposure to residues of
                                           share a common mechanism of toxicity                    indicate susceptibility to the young, as              methyl bromide is not expected.
                                           with any other substances, and methyl                   the dams and the offspring had identical              Although there is potential for
                                           bromide does not appear to produce a                    NOAEL and LOAEL values.                               inhalation exposure to residential
                                           toxic metabolite produced by other                         iv. There are no residual uncertainties            bystanders, EPA did not aggregate
                                           substances. For the purposes of this                    identified in the exposure databases.                 short-, intermediate-term, or chronic
                                           tolerance action, therefore, EPA has                    The use of inhalation studies to assess               dietary and inhalation exposures to
                                           assumed that methyl bromide does not                    dietary risks is a conservative                       methyl bromide because endpoints for
                                           have a common mechanism of toxicity                     (protective) approach since inhalation                dietary and inhalation exposures for
                                           with other substances. For information                  exposure is expected to lead to a higher              these durations are not based on
                                           regarding EPA’s efforts to determine                    internal dose than dietary exposure                   common toxicological effects. Methyl
                                           which chemicals have a common                           since chemicals will enter the                        bromide is not registered for use in
                                           mechanism of toxicity and to evaluate                   circulatory system before many of the                 residential settings; therefore,
                                           the cumulative effects of such                          detoxification processes associated with              residential exposures from the direct
                                           chemicals, see EPA’s website at http://                 oral exposure (e.g. first pass effect)                use of methyl bromide in residential
                                           www.epa.gov/pesticides/cumulative.                      occur. Therefore, these assessments will              areas is not expected.
                                                                                                   not underestimate the exposure and                       3. Short-term risk. Short-term risk is
                                           C. Safety Factor for Infants and Children               risks posed by methyl bromide.                        assessed based on short-term residential
                                             1. In general. Section 408(b)(2)(C) of                                                                      exposure plus chronic dietary exposure.
                                                                                                   D. Aggregate Risks and Determination of
                                           FFDCA provides that EPA shall apply                                                                           Methyl bromide is not registered for use
                                                                                                   Safety
                                           an additional tenfold (10X) margin of                                                                         in residential settings; therefore,
                                           safety for infants and children in the                    EPA determines whether acute and                    residential handler exposures from the
                                           case of threshold effects to account for                chronic dietary pesticide exposures are               direct use of methyl bromide in
                                           prenatal and postnatal toxicity and the                 safe by comparing aggregate exposure                  residential areas is not expected. EPA
                                           completeness of the database on toxicity                estimates to the acute PAD (aPAD) and
                                                                                                                                                         did not aggregate short-, intermediate-
                                           and exposure unless EPA determines                      chronic PAD (cPAD) presented in Unit
                                                                                                                                                         term, or chronic dietary and inhalation
                                           based on reliable data that a different                 IV.A. Table 1. Short-, intermediate-, and
                                                                                                                                                         exposures to methyl bromide because
                                           margin of safety will be safe for infants               chronic-term risks are evaluated by
                                                                                                                                                         endpoints for dietary and inhalation
                                           and children. This additional margin of                 comparing the estimated aggregate food,
                                                                                                                                                         exposures for these durations are not
                                           safety is commonly referred to as the                   water, and residential exposure to the
                                                                                                                                                         based on common toxicological effects.
                                           FQPA Safety Factor (SF). In applying                    appropriate PODs in Table 1 to ensure
                                                                                                                                                            4. Intermediate-term risk.
                                           this provision, EPA either retains the                  that an adequate MOE exists.
                                                                                                     1. Acute risk. Using the exposure                   Intermediate-term risk is assessed based
                                           default value of 10X, or uses a different                                                                     on intermediate-term residential
                                           additional SF when reliable data                        assumptions discussed in Unit IV.B. for
                                                                                                   acute exposure, the acute dietary                     exposure plus chronic dietary exposure.
                                           available to EPA support the choice of                                                                        Methyl bromide is not registered for use
                                           a different factor.                                     exposure from food and water to methyl
                                                                                                   bromide will occupy 3.5% of the aPAD                  in residential settings; therefore,
                                             2. Prenatal and postnatal sensitivity.                                                                      residential handler exposures from the
                                           No evidence of increased quantitative or                for children 1–2 years old, the
                                                                                                   population group receiving the greatest               direct use of methyl bromide in
                                           qualitative susceptibility was observed                                                                       residential areas is not expected. EPA
                                           in developmental toxicity studies in rats               exposure. The Agency has determined
                                                                                                   that dietary risk estimates for aggregate             did not aggregate short-, intermediate-
                                           or rabbits. The rabbit inhalation                                                                             term, or chronic dietary and inhalation
                                           developmental study also did not                        acute exposure through food and water
                                                                                                   to methyl bromide are below the                       exposures to methyl bromide because
                                           indicate susceptibility to the young as                                                                       endpoints for dietary and inhalation
                                           the dams and the offspring had identical                Agency’s level of concern for the U.S.
                                                                                                   population and all population                         exposures for these durations are not
                                           NOAEL and LOAEL values.                                                                                       based on common toxicological effects.
                                             Therefore, toxicity studies on adults                 subgroups. There is also potential for
                                                                                                   inhalation exposure to residential                       5. Aggregate cancer risk for U.S.
                                           will not underestimate the risks methyl                                                                       population. Based on the lack of
                                           bromide poses to children.                              bystanders. However, since the dietary
                                                                                                   contribution to acute aggregate risk is               evidence of carcinogenicity in two
                                             3. Conclusion. EPA has determined                                                                           adequate rodent carcinogenicity studies,
                                           that reliable data show that the safety of              negligible, EPA has determined that the
                                                                                                   mitigation measures EPA required in the               methyl bromide is not expected to pose
                                           infants and children would be                                                                                 a cancer risk to humans.
                                           adequately protected if the FQPA SF                     2006 Tolerance Reassessment and Risk
                                                                                                   Management Decision (TRED) for                           6. Determination of safety. Based on
                                           were reduced to 1X. That decision is                                                                          these risk assessments, EPA concludes
                                           based on the following findings:                        Methyl Bromide, and Reregistration
                                                                                                   Eligibility Decision (RED) for Methyl                 that there is a reasonable certainty that
                                             i. The toxicity database for methyl
                                                                                                   Bromide’s Commodity Uses to protect                   no harm will result to the general
                                           bromide is complete.
                                             ii. There is no indication that methyl                residential bystanders will ensure that               population, or to infants and children,
                                           bromide is a neurotoxic chemical and                    acute aggregate risks do not exceed                   from aggregate exposure to methyl
                                           there is no need for a developmental                    EPA’s level of concern.                               bromide residues.
                                           neurotoxicity study or additional UFs to                  2. Chronic risk. Using the exposure                 V. Other Considerations
                                           account for neurotoxicity.                              assumptions described in Unit IV.B. for
amozie on DSK30RV082PROD with RULES




                                             iii. There is no evidence that methyl                 chronic exposure, EPA has concluded                   A. Analytical Enforcement Methodology
                                           bromide results in increased                            that chronic exposure to methyl                          An adequate enforcement
                                           susceptibility in in utero rats or rabbits              bromide from food and water will                      methodology (King headspace method,
                                           in the prenatal developmental studies.                  utilize 43% of the cPAD for (children 1–              J. Agricultural Food Chemistry, Vol 29,
                                           In the rat developmental inhalation                     2 years old) the population group                     No. 5, pp 1003–1005) is available to
                                           study there was no indication of                        receiving the greatest exposure. Based                enforce the tolerance expression. This


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                                                                      Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Rules and Regulations                                                                                       8763

                                           method is a gas chromatography/                                             Order 12866, entitled ‘‘Regulatory                                           Mandates Reform Act (UMRA) (2 U.S.C.
                                           electron capture (GC/EC) method that                                        Planning and Review’’ (58 FR 51735,                                          1501 et seq.).
                                           was validated in 1987 in the EPA                                            October 4, 1993). Because this action                                          This action does not involve any
                                           Environmental Chemistry Laboratory                                          has been exempted from review under                                          technical standards that would require
                                           (D168869, L. Cheng, 27–OCT–1992).                                           Executive Order 12866, this action is                                        Agency consideration of voluntary
                                           The headspace procedure for                                                 not subject to Executive Order 13211,                                        consensus standards pursuant to section
                                           determining methyl bromide has been                                         entitled ‘‘Actions Concerning                                                12(d) of the National Technology
                                           forwarded to FDA for inclusion in PAM                                       Regulations That Significantly Affect                                        Transfer and Advancement Act
                                           Vol. II. This method is adequate for data                                   Energy Supply, Distribution, or Use’’ (66                                    (NTTAA) (15 U.S.C. 272 note).
                                           collection and for tolerance enforcement                                    FR 28355, May 22, 2001) or Executive
                                                                                                                       Order 13045, entitled ‘‘Protection of                                        VIII. Congressional Review Act
                                           on plant and processed food
                                           commodities.                                                                Children from Environmental Health                                             Pursuant to the Congressional Review
                                                                                                                       Risks and Safety Risks’’ (62 FR 19885,                                       Act (5 U.S.C. 801 et seq.), EPA will
                                           B. International Residue Limits                                             April 23, 1997). This action does not                                        submit a report containing this rule and
                                              In making its tolerance decisions, EPA                                   contain any information collections                                          other required information to the U.S.
                                           seeks to harmonize U.S. tolerances with                                     subject to OMB approval under the                                            Senate, the U.S. House of
                                           international standards whenever                                            Paperwork Reduction Act (PRA), 44                                            Representatives, and the Comptroller
                                           possible, consistent with U.S. food                                         U.S.C. 3501 et seq., nor does it require                                     General of the United States prior to
                                           safety standards and agricultural                                           any special considerations under                                             publication of the rule in the Federal
                                           practices. EPA considers the                                                Executive Order 12898, entitled                                              Register. This action is not a ‘‘major
                                           international maximum residue limits                                        ‘‘Federal Actions to Address                                                 rule’’ as defined by 5 U.S.C. 804(2).
                                           (MRLs) established by the Codex                                             Environmental Justice in Minority
                                           Alimentarius Commission (Codex), as                                         Populations and Low-Income                                                   List of Subjects in 40 CFR Part 180
                                           required by FFDCA section 408(b)(4).                                        Populations’’ (59 FR 7629, February 16,                                        Environmental protection,
                                           The Codex Alimentarius is a joint                                           1994).                                                                       Administrative practice and procedure,
                                           United Nations Food and Agriculture                                            Since tolerances and exemptions that                                      Agricultural commodities, Pesticides
                                           Organization/World Health                                                   are established in accordance with                                           and pests, Reporting and recordkeeping
                                           Organization food standards program,                                        FFDCA sections 408(e) and 408(l)(6),                                         requirements.
                                           and it is recognized as an international                                    such as the tolerances in this final rule,
                                                                                                                                                                                                       Dated: February 13, 2018.
                                           food safety standards-setting                                               do not require the issuance of a
                                                                                                                                                                                                    Donna S. Davis,
                                           organization in trade agreements to                                         proposed rule, the requirements of the
                                                                                                                       Regulatory Flexibility Act (RFA) (5                                          Acting Director, Registration Division, Office
                                           which the United States is a party. EPA                                                                                                                  of Pesticide Programs.
                                           may establish a tolerance that is                                           U.S.C. 601 et seq.) do not apply.
                                           different from a Codex MRL; however,                                           This action directly regulates growers,                                     Therefore, 40 CFR chapter I is
                                           FFDCA section 408(b)(4) requires that                                       food processors, food handlers, and food                                     amended as follows:
                                           EPA explain the reasons for departing                                       retailers, not States or tribes, nor does
                                           from the Codex level.                                                       this action alter the relationships or                                       PART 180—[AMENDED]
                                              Methyl bromide Codex MRLs have                                           distribution of power and
                                                                                                                       responsibilities established by Congress                                     ■ 1. The authority citation for part 180
                                           been established for several
                                                                                                                       in the preemption provisions of FFDCA                                        continues to read as follows:
                                           commodities; however, there are no
                                           Codex MRLs for any of the commodities                                       section 408(n)(4). As such, the Agency                                           Authority: 21 U.S.C. 321(q), 346a and 371.
                                           that are the subject of this quarantine                                     has determined that this action will not                                     ■ 2. In § 180.124, revise paragraph (b) to
                                           action. Therefore, at this time, there are                                  have a substantial direct effect on States                                   read as follows:
                                           no harmonization issues.                                                    or tribal governments, on the
                                                                                                                       relationship between the national                                            § 180.124      Methyl bromide; tolerances for
                                           VI. Conclusion                                                              government and the States or tribal                                          residues.
                                             Therefore, time-limited tolerances are                                    governments, or on the distribution of                                       *     *     *     *    *
                                           established for residues of the fumigant                                    power and responsibilities among the                                           (b) Section 18 emergency exemptions.
                                           methyl bromide, including its                                               various levels of government or between                                      Time-limited tolerances as listed in the
                                           metabolites and degradates, in or on                                        the Federal Government and Indian                                            following table are established for
                                           specified agricultural imported/                                            tribes. Thus, the Agency has determined                                      residues of the fumigant methyl
                                           domestic commodities. These tolerances                                      that Executive Order 13132, entitled                                         bromide, including its metabolites and
                                           expire on December 31, 2020.                                                ‘‘Federalism’’ (64 FR 43255, August 10,                                      degradates, in or on the specified
                                                                                                                       1999) and Executive Order 13175,                                             agricultural commodities, resulting from
                                           VII. Statutory and Executive Order                                          entitled ‘‘Consultation and Coordination                                     use of the pesticide pursuant to FIFRA
                                           Reviews                                                                     with Indian Tribal Governments’’ (65 FR                                      section 18 emergency exemptions.
                                             This action establishes tolerances                                        67249, November 9, 2000) do not apply                                        Compliance with the tolerance levels
                                           under FFDCA sections 408(e) and                                             to this action. In addition, this action                                     specified below is to be determined by
                                           408(l)(6). The Office of Management and                                     does not impose any enforceable duty or                                      measuring only methyl bromide. These
                                           Budget (OMB) has exempted these types                                       contain any unfunded mandate as                                              tolerances expire and are revoked on the
                                           of actions from review under Executive                                      described under Title II of the Unfunded                                     date indicated in the table.
amozie on DSK30RV082PROD with RULES




                                                                                                                                                                                                                  Parts per
                                                                                                                   Commodity                                                                                                      Expiration date
                                                                                                                                                                                                                   million

                                           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.



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                                           8764                       Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Rules and Regulations

                                                                                                                                                                                                                     Parts per
                                                                                                                    Commodity                                                                                                         Expiration date
                                                                                                                                                                                                                      million

                                           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 fruit, group 13–07 ......................................................................................................                                   5.0   December   31,   2020.
                                           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 vegetable group 22 ..........................................................................................                                       0.50    December   31,   2020.
                                           Tropical and subtropical fruits, edible peel, group 23 ..................................................................................                                           10   December   31,   2020.
                                           Tropical and subtropical fruits, inedible peel, group 24 ...............................................................................                                           5.0   December   31,   2020.
                                           Vegetable, bulb, group 3–07 ........................................................................................................................                               2.0   December   31,   2020.
                                           Vegetable, cucurbit, group 9 ........................................................................................................................                              5.0   December   31,   2020.
                                           Vegetable, foliage of legume, group 7 .........................................................................................................                                  0.50    December   31,   2020.
                                           Vegetable, fruiting, group 8–10 ....................................................................................................................                               7.0   December   31,   2020.
                                           Vegetable, Head and Stem Brassica, group 5–16 .......................................................................................                                              1.0   December   31,   2020.
                                           Vegetable, leafy, group 4–16 .......................................................................................................................                             0.50    December   31,   2020.
                                           Vegetable, leaves of root and tuber, group 2 ..............................................................................................                                      0.50    December   31,   2020.
                                           Vegetable, legume, group 6 .........................................................................................................................                               3.0   December   31,   2020.
                                           Vegetable, root and tuber, group 1 ..............................................................................................................                                  3.0   December   31,   2020.



                                           *        *          *         *         *                                     and conservation of the squid and                                             Fishery Management Plan (FMP) require
                                           [FR Doc. 2018–04193 Filed 2–28–18; 8:45 am]                                   butterfish resources.                                                         the Mid-Atlantic Council’s Atlantic
                                           BILLING CODE 6560–50–P                                                        DATES: Effective April 2, 2018.                                               Mackerel, Squid, and Butterfish
                                                                                                                         ADDRESSES: Copies of supporting                                               Monitoring Committee to develop
                                                                                                                         documents used by the Mid-Atlantic                                            specification recommendations for each
                                           DEPARTMENT OF COMMERCE                                                        Fishery Management Council, including                                         species based upon the ABC advice of
                                                                                                                         the Environmental Assessment (EA), the                                        the Council’s SSC. The FMP regulations
                                           National Oceanic and Atmospheric                                              Regulatory Impact Review (RIR), and the                                       also require the specification of annual
                                           Administration                                                                Regulatory Flexibility Act (RFA)                                              catch limits (ACLs) and accountability
                                                                                                                         analysis are available from: Dr.                                              measure (AM) provisions for butterfish.
                                           50 CFR Part 648                                                               Christopher M. Moore, Executive                                               Both squid species are exempt from the
                                                                                                                         Director, Mid-Atlantic Fishery                                                ACL/AM requirements because they
                                           [Docket No. 170713663–8176–02]
                                                                                                                         Management Council, 800 North State                                           have a life cycle of less than one year.
                                           RIN 0648–BH04                                                                 Street, Suite 201, Dover, DE 19901,                                           In addition, the regulations require the
                                                                                                                         telephone (302) 674–2331. The EA/RIR/                                         specification of domestic annual harvest
                                           Fisheries of the Northeastern United                                                                                                                        (DAH), domestic annual processing
                                                                                                                         RFA analysis is also accessible via the
                                           States; Atlantic Mackerel, Squid, and                                                                                                                       (DAP), total allowable level of foreign
                                                                                                                         internet at www.regulations.gov/
                                           Butterfish Fisheries; Specifications                                                                                                                        fishing (TALFF), joint venture
                                                                                                                         #!docketDetail;D=NOAA-NMFS-2017-
                                           AGENCY:  National Marine Fisheries                                            0089. Stock assessment reports and                                            processing (JVP), commercial and
                                           Service (NMFS), National Oceanic and                                          assessment update reports for all species                                     recreational annual catch targets (ACT),
                                           Atmospheric Administration (NOAA),                                            are available online at:                                                      the butterfish mortality cap in the
                                           Commerce.                                                                     www.nefsc.noaa.gov/saw/reviews_                                               longfin squid fishery, and initial
                                                                                                                         report_options.php. Performance reports                                       optimum yield (IOY) for both squid
                                           ACTION: Final rule.
                                                                                                                         for the Atlantic mackerel, squid, and                                         species.
                                           SUMMARY:   NMFS implements longfin                                            butterfish fisheries are available online                                        On December 13, 2017, NMFS
                                           squid, Illex squid, and butterfish                                            at: http://www.mafmc.org/msb.                                                 published a proposed rule (82 FR
                                           specifications for the 2018 fishing year                                      FOR FURTHER INFORMATION CONTACT:                                              58583) for the 2018–2020 squid and
                                           and projected specifications for fishing                                      Douglas Christel, Fishery Policy                                              butterfish specifications recommended
amozie on DSK30RV082PROD with RULES




                                           years 2019 and 2020. This action is                                           Analyst, (978) 281–9141.                                                      by the Council. The proposed rule for
                                           necessary to specify catch levels for the                                     SUPPLEMENTARY INFORMATION:                                                    this action included additional
                                           squid and butterfish fisheries based                                                                                                                        background on specifications and the
                                           upon updated information on stock                                             Background                                                                    details of how the Council derived its
                                           status. These specifications are intended                                       The regulations implementing the                                            recommended specifications for longfin
                                           to promote the sustainable utilization                                        Atlantic Mackerel, Squid, and Butterfish                                      and Illex squid and butterfish. Those


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Document Created: 2018-02-28 23:57:53
Document Modified: 2018-02-28 23:57:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation83 FR 8758 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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