[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Rules and Regulations]
[Pages 56262-56269]
[FR Doc No: 2018-24379]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0694; FRL-9985-32]

Cyantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
cyantraniliprole in or on multiple commodities which are identified and
discussed later in this document. The Interregional Research Project
No. 4 (IR-4) and DuPont Crop Protection requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 13, 2018. Objections and
requests for hearings must be received on or before January 14, 2019,
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-2017-0694, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0694 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
January 14, 2019. 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-2017-0694, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 21, 2018 (83 FR 12311) (FRL-9974-
76), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8631) by The Interregional Research Project No. 4 (IR-4), Rutgers,
The State University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.672 be
amended by establishing tolerances for residues of the insecticide,
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on
Berry, low growing, except strawberry, subgroup 13-07H, except
blueberry, lowbush and lingonberry at 0.08 parts per million (ppm)
(proposal to replace an existing tolerance at the same level that is
only for imported Berry, low growing, except strawberry, subgroup 13-
07H, with a tolerance supporting both domestic production and imported
low growing berries, except strawberries); Brassica, leafy greens,
subgroup 4-16B at 30 ppm; Caneberry subgroup 13-07A at 4.0 ppm; Celtuce
at 20 ppm; Coffee, green bean at 0.05 ppm (proposal to replace an
existing tolerance at the same level that is only for imported Coffee,
green bean with a tolerance supporting both domestic production and
imported coffee); Florence fennel at 20 ppm; Kohlrabi at 3.0 ppm; Leafy
greens subgroup 4-16A at 20 ppm; Leaf petiole vegetable subgroup 22B at
20 ppm; and Vegetable,

Brassica, head and stem, group 5-16 at 3.0 ppm. Upon the establishment
of the above tolerances, IR-4 proposed to remove existing tolerances in
40 CFR part 180.672 in or on the following commodities: Brassica head
and stem, subgroup 5A at 3.0 ppm; Brassica leafy vegetables, subgroup
5B at 30 ppm; and Vegetable, leafy, except Brassica, group 4 at 20 ppm.
    In the Federal Register of April 11, 2018 (83 FR 15528) (FRL-9975-
57), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F8622) by DuPont Crop Protection, Stine-Haskell Research Center, P.O.
Box 30, Newark, DE 19714-0030. The petition requested that 40 CFR
180.672 be amended by establishing tolerances for residues of the
insecticide cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-
cyano-2-methyl-6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-
carboxamide, in or on Rice, hulls at 0.05 ppm; Rice, straw at 0.015
ppm; Soybean, forage at 15 ppm; Soybean, hay at 50 ppm; Soybean, hulls
at 1 ppm; Soybean, seed at 0.4 ppm; and Aspirated grain fractions at
200 ppm. Upon the approval of the proposed tolerances in soybean forage
and hay, it is proposed that the existing tolerances for indirect or
inadvertent residues in soybean forage and hay be cancelled. In
addition, DuPont Crop Protection requests to amend the tolerances in 40
CFR 180.672, in or on rice, grain at 0.02 ppm by replacing an existing
tolerance at the same level that is only for imported grain with a
tolerance supporting both domestic production and imported grain.
    These documents referenced summaries of the petitions prepared by
DuPont Crop Protection, the registrant, which are available in the
docket, http://www.regulations.gov. Three comments were received on the
notices of filing. EPA's response to these comments is discussed in
Unit IV.C.
    Based upon review of the data supporting the petition, EPA modified
some of the tolerance levels to conform to EPA's rounding classes and
revised the commodity terminology for two tolerances. These changes are
explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for cyantraniliprole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with
cyantraniliprole follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    In general, cyantraniliprole administration in mammalian test
species produces both adverse and adaptive changes in the liver,
thyroid gland, and adrenal cortex. With repeated dosing, consistent
findings of mild to moderate increases in liver weights across multiple
species (rats, mice and dogs) are observed. Dogs appear to be more
sensitive than rats and mice; cyantraniliprole produces adverse liver
effects (increases in alkaline phosphatase, decreases in cholesterol,
and decreases in albumin) in dogs at lower dose levels than in rats. In
addition, the liver effects in the dog show progressive severity with
increased duration of exposure. The available data also show thyroid
hormone homeostasis is altered in rats following exposure to
cyantraniliprole after 28 or 90 days; however, cyantraniliprole is not
a direct thyroid toxicant.
    Cyantraniliprole is classified as ``not likely to be carcinogenic
to humans'' based on the absence of increased tumor incidence in
acceptable/guideline carcinogenicity studies in rats and mice, and
there are no mutagenicity concerns. There are also no developmental or
reproductive toxicity concerns and no offspring susceptibility
concerns. Cyantraniliprole does not produce developmental toxicity in
either rats or rabbits. The 2-generation reproduction study in rats
shows that cyantraniliprole has no adverse effect on any reproductive
parameters.
    Acute and subchronic neurotoxicity studies reveal no evidence of
neurotoxicity. Similarly, cyantraniliprole does not adversely impact
the immune system in rats and mice. Based on the results of a 28-day
dermal study in rats (as well as the dermal LD50 study),
cyantraniliprole does not demonstrate any appreciable toxicity via
dermal exposure. The 28-day inhalation toxicity study in rats does not
show any adverse systemic or portal of entry effect at the highest
concentration tested (100 mg/m\3\, equivalent to 18 mg/kg/day).
    Cyantraniliprole has no significant acute toxicity via the oral,
dermal, and inhalation routes of exposure. Cyantraniliprole is not an
eye or skin irritant and does not cause skin sensitization.
    Specific information on the studies received and the nature of the
adverse effects caused by cyantraniliprole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Cyantraniliprole. Human Health Risk
Assessment for Proposed Uses and Tolerance Requests on Coffee;
Caneberry Subgroup 13-07A; Low Growing Berry Subgroup 13-07H, Except
Strawberry, Lowbush Blueberry and Lingonberry; Brassica Leafy Greens
Subgroup 4-16A; Leafy Greens Subgroup 4-16B; Brassica Head and Stem
Vegetable Group 5-16; Leaf Petiole Vegetable Subgroup 22B; Celtuce;
Florence Fennel; Kohlrabi; Rice; Soybean; and Aspirated Grain
Fractions'' on pages 36-45 in docket ID number EPA-HQ-OPP-2017-0694.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there

is no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for cyantraniliprole used
for human risk assessment is discussed in Unit III.B of the final rule
published in the Federal Register of February 5, 2014 (79 FR 6826)
(FRL-9388-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyantraniliprole, EPA considered exposure under the
petitioned-for tolerances as well as all existing cyantraniliprole
tolerances in 40 CFR 180.672. EPA assessed dietary exposures from
cyantraniliprole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for cyantraniliprole;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the 2003-2008 United
States Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, a refined chronic (food and drinking
water) dietary assessment was conducted assuming average field trial
residues for all crops (except crop subgroup 1A, for which tolerance
level residues were assumed); percent crop treated (PCT) data;
empirical processing factors; and default processing factors were used
as appropriate.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that cyantraniliprole does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on
the actual percent of food treated for assessing chronic dietary risk
only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: If data are available on pesticide use and
food consumption in a particular area, the exposure estimate does not
understate exposure for the population in such areas.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the average PCT for existing uses as follows:
Citrus: oranges 62%, grapefruit 87%, and lemons 46%; pome fruit: apples
61% and pears 76%; stone fruits: apricots 53%, cherries 48%, peaches
41%, and plums/prunes 59%; tree nuts: almonds 72%, hazelnuts 65%,
pecans 22%, pistachios 49%, and walnuts 53%; bushberries (subgroup 13-
07B): blueberries 45%; fruiting vegetables: peppers 45% and tomatoes
54%; cucurbits: cantaloupes 50%, cucumbers 23%, pumpkins 18%, squash
24%, and watermelons 29%; leafy vegetables: celery 70%, lettuce 78%,
and spinach 53%; Brassica (cole) leafy vegetables: broccoli 81%,
cabbage 50%, and cauliflower 83%; onion 58%; potato 50%; oilseeds:
canola 15% and sunflower 35%; corn 56%, cotton 41%; peanuts 41%;
carrots 23%; soybeans 21%; strawberries 59%; vegetable crop group 7:
dry beans/peas 6%, soybeans 21%, beans (snap, bush, etc.) 49%, and peas
fresh/green/sweet) 38%; vegetable crop group 2: sugar beets 40%;
vegetable crop group 6A: soybeans 21%, beans (snap, bush, etc., string)
49%; peas fresh/green/sweet) 38%; and vegetable crop group 6C: dried
bean and peas 6%. 100 PCT was assumed for all other crops, including
all proposed new use crops. For imported grapes (wine grapes), a 50%
import estimate was used in the chronic dietary risk assessment.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and California Department of
Pesticide Regulation (CDPR) Pesticide Use Reporting (PUR) for the
chemical/crop combination for the most recent 10 years. EPA uses an
average PCT for chronic dietary risk analysis and a maximum PCT for
acute dietary risk analysis. The average PCT figures for each existing
use are derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding up
to the nearest 5%, except for those situations in which the average PCT
is less than 1% or less than 2.5%. In those cases, the Agency would use
less than 1% or less than 2.5% as the average PCT value, respectively.
The maximum PCT figure is the highest observed maximum value reported
within the most recent 10 years of available public and private market
survey data for the existing use and rounded up to the nearest multiple
of 5%, except where the maximum PCT is less than 2.5%, in which case,
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to

which cyantraniliprole may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cyantraniliprole in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of cyantraniliprole. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticides in Water Calculator (PWC; version 1.52) and
Pesticide Root Zone Model Ground Water (PRZM GW) for ground water and
FQPA Index Reservoir Screening Tool (FIRST) for surface water, the
estimated drinking water concentrations (EDWCs) of cyantraniliprole for
chronic exposures for non-cancer assessments are estimated to be 24 ppb
for surface water and 64 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 64 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Cyantraniliprole is currently registered for the following uses
that could result in residential exposures: Turf grass (including
residential, recreational, and golf course turf), ornamentals, and
structural buildings (including indoor crack/crevice and outdoor
broadcast). EPA assessed residential exposure using the following
assumptions: EPA determined that residential exposures may occur by the
dermal, oral, and inhalation routes of exposures. However, since dermal
hazard has not been identified for cyantraniliprole, the only exposures
of concern are handler inhalation (for adults), and post-application
incidental oral (for children). Residential handler exposure is
expected to be short-term in duration. The turf and ornamental labels
indicate that a maximum of two applications are allowed per season.
Thus, intermediate-term handler exposures are not likely because of the
intermittent nature of applications by homeowners. Post-application
incidental oral exposures for children may occur for short- and
intermediate-term durations due to the persistence of cyantraniliprole.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
cyantraniliprole to share a common mechanism of toxicity with any other
substances, and cyantraniliprole does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that cyantraniliprole does
not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
susceptibility in developmental toxicity studies in rats and rabbits.
The developmental toxicity study in rats is tested up to the limit dose
(1,000 mg/kg/day). In the rabbit developmental toxicity study,
decreases in fetal body weight are seen at a dose higher than that
resulting in maternal effects. In the reproductive toxicity study,
increased incidence of thyroid follicular epithelium hypertrophy/
hyperplasia occurs in F1 parental animals at a dose lower
than that for the parental (P) generation. A clear NOAEL (1.4 mg/kg/
day) is established for F1 parental animals, and the PODs
selected for risk assessment from the dog studies (1 or 3 mg/kg/day)
are protective of the effect (thyroid effect) seen in the F1
parental animals. In addition, the submitted data support the
conclusion that the effects on the thyroid are secondary to effects on
the liver. As such, a comparative thyroid study is not required at this
time.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for cyantraniliprole is complete.
    ii. There is no indication that cyantraniliprole 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 cyantraniliprole results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The exposure databases are complete or are estimated based
on data that reasonably account for potential exposures. The chronic
dietary food exposure assessment was a refined assessment which assumed
average field trial residues for all crops (except crop subgroup 1A);
PCT when available; empirical processing factors, if available, or
default processing factors, as appropriate. The 2012 Residential
standard operating procedures (SOPs) were previously used to assess
post-application exposure to children including incidental oral
exposure, and the residential post-application assessment assumed that
maximum application rates are applied and that hand-to-mouth activities
occur on the day of application. All of the exposure estimates are
based on conservative, health-protective assumptions and are not likely
to underestimate risk. EPA made conservative (protective) assumptions
in the ground and surface water modeling used to assess exposure to
cyantraniliprole in drinking water. EPA used similarly conservative
assumptions to assess post application exposure of children as well as

incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by cyantraniliprole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cyantraniliprole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyantraniliprole from food and water will utilize 99% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
cyantraniliprole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Cyantraniliprole is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to cyantraniliprole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 149 for
children 1 to 2 years old. For adults, the oral and inhalation routes
of exposure are not appropriate to be aggregated since the endpoints of
concern are not common. Because EPA's level of concern for
cyantraniliprole is a MOE of 100 or below, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Cyantraniliprole is currently registered for uses that could
result in intermediate-term residential exposure, however, the short-
term aggregate risk estimate described above is protective of potential
intermediate-term exposures and risks in children.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, cyantraniliprole 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 cyantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem
mass spectroscopy (LC/MS/MS)) is available to enforce the tolerance
expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no established Codex MRLs on the caneberry subgroup 13-
07A, soybean, aspirated grain fractions, celtuce, Florence fennel and
rice. The U.S. tolerances being established for coffee and Brassica,
leafy greens subgroup 4-16A are harmonized with Codex. The U.S.
tolerances being established for the low growing berry subgroup 13-07H;
leaf petiole vegetable subgroup 22B; Brassica head and stem vegetable
group 5-16; leafy greens subgroup 4-16B; and kohlrabi are not
harmonized with Codex MRLs. The Codex MRLs established for residues of
cyantraniliprole on these commodities are lower than the recommended
U.S. tolerances. The U.S. tolerances cannot be harmonized because
following the label use directions could result in residues above the
established Codex MRLs.

C. Response to Comments

    EPA received three comments in response to the Notices of Filing.
The first comment indicated IR-4 and Rutgers University are
profiteering by registering pesticides. The content of this comment is
not material to the safety of the tolerances that are the subject of
this action; pesticide registration occurs under the provisions of the
Federal Insecticide, Fungicide, and Rodenticide Act. The FFDCA allows
any person to file a petition proposing the establishment of a
tolerance, and financial benefit from associated registration of
pesticides is not a factor EPA considers when determining whether a
tolerance is safe.
    The second comment stated, in part, that no residues should be
allowed. The Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops. However, the
existing legal framework provided by section 408 of the Federal Food,
Drug and Cosmetic Act (FFDCA) states that tolerances may be set when
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. This
citizen's comment appears to be directed at the underlying statute and
not EPA's implementation of it; the citizen has made no contention that
EPA has acted in violation of the statutory framework.
    The last comment expressed concern about pollutant loadings and
relatively high costs of regulations. The commenter also mentioned the
Shelby Amendment, the Freedom of Information Act and the
Intergovernmental Panel on Climate Change. The comment did not raise
any issue related to the Agency's safety determination for
cyantraniliprole tolerances. The receipt of this comment

is acknowledged; however, this comment is not relevant to this action.

D. Revisions to Petitioned-For Tolerances

    EPA modified the proposed tolerance levels for soybean, hulls and
soybean, seed to conform to the Agency's rounding classes. The Agency
also revised the commodity terminology to use the correct commodity
definitions for Florence fennel (Fennel, Florence, fresh leaves and
stalk) and Aspirated grain fractions (Grain, aspirated grain
fractions).

V. Conclusion

    Therefore, tolerances are established for residues of
cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-
6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on
Berry, low growing, except strawberry, subgroup 13-07H, except
blueberry, lowbush and lingonberry at 0.08 parts per million (ppm);
Brassica, leafy greens, subgroup 4-16B at 30 ppm; Caneberry subgroup
13-07A at 4.0 ppm; Celtuce at 20 ppm; Fennel, Florence, fresh leaves
and stalk at 20 ppm; Grain, aspirated grain fractions at 200 ppm;
Kohlrabi at 3.0 ppm; Leaf petiole vegetable subgroup 22B at 20 ppm;
Leafy greens subgroup 4-16A at 20 ppm; Rice hulls at 0.05 ppm; Rice,
straw at 0.015 ppm; Soybean, forage at 15 ppm; Soybean, hay at 50 ppm;
Soybean, hulls at 1.0 ppm; Soybean, seed at 0.40 ppm; and Vegetable,
Brassica, head and stem, group 5-16 at 3.0 ppm. In addition, EPA is
removing the following tolerances as they are superseded by the new
tolerances being established in this rulemaking: from paragraph (a)
(Berry, low growing, except strawberry, subgroup 13-07H at 0.08 ppm;
Brassica head and stem, subgroup 5A at 3.0 ppm; Brassica leafy
vegetables, subgroup 5B at 30 ppm; and Vegetable, leafy, except
Brassica, group 4 at 20 ppm) and from paragraph (d) (soybean, forage at
0.70 ppm and soybean, hay at 0.70 ppm). Finally, EPA is removing the
footnote noting the lack of US registrations for the tolerances for
coffee, green bean and rice, grain.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: October 24, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.672:
0
a. In the table to paragraph (a):
0
i. Remove the entry ``Berry, low growing, except strawberry, subgroup
13-07H\1\''.
0
ii. Add alphabetically the entry ``Berry, low growing, except
strawberry, subgroup 13-07H, except blueberry, lowbush and
lingonberry''.
0
iii. Remove the entry ``Brassica head and stem, subgroup 5A''.
0
iv. Add alphabetically the entry ``Brassica, leafy greens, subgroup 4-
16B.
0
v. Remove the entry ``Brassica leafy vegetables, subgroup 5B''.
0
vi. Add alphabetically the entries: ``Caneberry subgroup 13-07A'' and
``Celtuce''.
0
vii. Revise the entry ``Coffee, green bean''.
0
viii. Add alphabetically the entries: ``Fennel, Florence, fresh leaves
and stalk''; ``Grain, aspirated grain fractions''; ``Kohlrabi''; ``Leaf
petiole vegetable subgroup 22B''; ``Leafy greens subgroup 4-16A'';
0
ix. Revise the entry ``Rice, grain''.
0
x. Add alphabetically the entries: ``Rice hulls''; ``Rice, straw'';
``Soybean, forage''; ``Soybean, hay''; ``Soybean, hulls''; ``Soybean,
seed''; and ``Vegetable, Brassica, head and stem, group 5-16''.
0
xi. Remove the entry ``Vegetable, leafy, except Brassica, group 4''.

0
b. Remove from the table in paragraph (d) the entries: ``Soybean,
forage''; and ``Soybean, hay''.
    The additions and revisions read as follows:

Sec.  180.672   Cyantraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Berry, low growing, except strawberry, subgroup 13-07H,             0.08
 except blueberry, lowbush and lingonberry..............
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Brassica, leafy greens, subgroup 4-16B..................              30
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Caneberry subgroup 13-07A...............................             4.0
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Celtuce.................................................              20
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Coffee, green bean......................................            0.05
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Fennel, Florence, fresh leaves and stalk................              20
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Grain, aspirated grain fractions........................             200
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Kohlrabi................................................             3.0
------------------------------------------------------------------------
Leaf petiole vegetable subgroup 22B.....................              20
Leafy greens subgroup 4-16A.............................              20

------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
Rice, grain.............................................            0.02
------------------------------------------------------------------------
Rice, hulls.............................................            0.05
Rice, straw.............................................           0.015

------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
Soybean, forage.........................................              15
Soybean, hay............................................              50
Soybean, hulls..........................................             1.0
Soybean, seed...........................................            0.40
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
Vegetable, Brassica, head and stem, group 5-16..........             3.0
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-24379 Filed 11-9-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 31 (Friday, February 14, 2014)]
[Notices]
[Pages 8977-8978]
[FR Doc No: 2014-03276]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0393]

Questions and Answers About Electronic Medical Device Reporting;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Questions and Answers About
eMDR--Electronic Medical Device Reporting.'' FDA has published a final
rule that requires device manufacturers and importers to submit
mandatory reports of individual medical device adverse events, also
known as medical device reports (MDRs), to the Agency in an electronic
format that FDA can process, review and archive. This guidance provides
general information regarding how to prepare and send an electronic
postmarket medical device report to the Center for Devices and
Radiological Health (CDRH) in FDA. The guidance also identifies where
to find more detailed information on the preparation and transmission
of the reports.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on agency guidance documents are welcome at
any time.

ADDRESSES:  Submit written requests for single copies of the guidance
document entitled ``Questions and Answers About eMDR--Electronic
Medical Device Reporting'' to the Division of Small Manufacturers,
International, and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Tahseen Mirza, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2312, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 519 of the Federal Food, Drug and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360i) is FDA's authorization to issue a regulation to
require mandatory reporting of device-related adverse events. The
Medical Device Reporting (MDR) regulation, 21 CFR part 803, effective
December 13, 1984, contained reporting requirements for device
manufacturers and importers. Amendments to the FD&C Act under the Safe
Medical Devices Act of 1990 and the Medical Device Amendments of 1992
introduced mandatory reporting by device user facilities and changed
the requirements for device manufacturers, importers and distributors.
FDA revised the MDR regulation (part 803) effective July 31, 1996, to
address the reporting changes. On February 28, 2005, FDA revised the
MDR regulation into plain language.
    On August 21, 2009, FDA published a proposed rule (74 FR 42203) to
amend part 803 to require manufacturers, importers, and user facilities
to submit MDRs to the Agency in an electronic format. Because of
concerns over the cost of implementation for user facilities, and the
relatively low volume of reports FDA receives from such facilities, the
final rule does not require user facilities to adopt electronic
reporting. Although FDA encourages user facilities to file reports
electronically, they may continue to use only paper forms for MDR
reporting. The final rule for electronic submission of MDRs to FDA
anticipates that there will be a reduction in costs and time associated
with the submission of MDR reports, elimination of transcription errors
associated with paper reports, and both expedited access to safety
information and enhanced ability to communicate information about
suspected problems. This question and answer guidance provides general
information on how to prepare and send an electronic postmarket medical
device report to FDA and identifies where to find more detailed
information on how to prepare and transmit eMDRs.
    The draft eMDR guidance document was published in the Federal
Register of August 21, 2009. No significant comments were received.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on electronic MDR reporting. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Questions and Answers about eMDR--
Electronic Medical Device Reporting,'' you may either send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document number 1679 to identify the guidance you are
requesting. A search capability for all CDRH guidance documents is
available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 803 have been approved under
OMB control numbers 0910-0291 and 0910-0437.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03276 Filed 2-13-14; 8:45 am]
BILLING CODE 4160-01-P


Wednesday,

November 1, 2000 Part VIII Environmental Protection Agency 40 CFR Part 761 Polychlorinated Biphenyls (PCB's); Return of PCB Waste From U. S. Territories Outside the Customs Territory of the United States; Proposed Rule VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65654 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 761 [OPPTS± 66020; FRL± 6750± 6]

Polychlorinated Biphenyls (PCB's); Return of PCB Waste from U. S. Territories Outside the Customs Territory of the United States AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed Rule.

SUMMARY: EPA is proposing to clarify that PCB waste in United States' territories and possessions outside the customs territory of the United States may be returned to the U. S. Customs Territory for proper disposal. This proposed rule interprets the prohibition on the manufacture of PCBs at Section 6( e) of the Toxic Substances Control Act (TSCA) to allow the movement of PCB waste among any States of the United States for the purpose of disposal, and that such movement is not considered `` import. '' This interpretation will allow U. S. territories and possessions which fall outside of the definition of `` customs territory of the United States'' to dispose of their PCB waste in the mainland of the United States where facilities are available that can properly dispose of PCB waste. Thus, this rule would ensure that a safe and viable mechanism exists for the protection of health and the environment for those citizens in areas of the United States where facilities are not available for the proper management and disposal of PCB waste. Because disposal of these wastes may occur only at approved facilities, no unreasonable risks to health or the environment on the mainland United States will be created by this rule.

DATES: Comments, identified by the docket number OPPTS± 66020, must be received by EPA on or before December 1, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION section. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS± 66020 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics (7408), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone numbers: 202± 554± 1404; e mail address: TSCA Hotline@ epa. gov. For technical information contact: Peggy Reynolds, OPPT/ NPCD, 7404, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202± 260± 3965; fax number: 202± 260± 1724; e mail address: reynolds. peggy@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are in a United States territory or possession outside of the customs territory of the United States, and you manufacture, process, distribute in commerce, or use PCBs. Examples of such territories and possessions are Guam, American Samoa, the Commonwealth of the Northern Mariana Islands (CNMI) including Saipan, and the United States Virgin Islands. Potentially affected entities may include, but are not limited to:

Types of entities NAICS codes Examples of potentially affected entities Crude Petroleum and Natural Gas Extraction 211111 Facilities that own electrical equipment containing PCBs Electric Power Generation; Transmission and Distribution 2211 Facilities that own electrical equipment containing PCBs Food Manufacturing 311 Facilities that own electrical equipment containing PCBs Petroleum and Coal Products Manufacturing 324 Facilities that own electrical equipment containing PCBs Chemical Manufacturing 325 Facilities that own electrical equipment containing PCBs Primary Metal Manufacturing 331 Facilities that own electrical equipment containing PCBs Waste Treatment and Disposal 5622 Facilities that own electrical equipment containing PCBs. Entities that process and distribute PCB waste Materials Recovery Facilities 56292 Facilities that own electrical equipment containing PCBs. Entities that process and distribute PCB waste Public Administration 92 Agencies that own electrical equipment containing PCBs This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed above could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR part 761. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed in the FOR FURTHER INFORMATION CONTACT section.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain copies of this document and certain other available documents from the EPA Internet Home Page at http// :www. epa. gov/. On the Home Page select `` Laws and Regulations'' and then look up the entry for this document under Federal RegisterÐ Environmental Documents. You can also go directly to the Federal Register listings at http// :www. epa. gov/ fedrgstr/. Information about the Office of Prevention, Pesticides and Toxic Substances (OPPTS) and OPPTS related programs is available from http// :www. epa. gov/ internet/ oppts/. If you want additional information about EPA's PCB regulations at 40 CFR part 761, go to http//: www. epa. gov/ pcb. 2. In person. The Agency has established an official record for this action under docket control number OPPTS± 66020. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65655 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, Northeast Mall, Rm. B± 607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from 12 noon to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number of the Center is (202) 260± 7099.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS± 66020 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: the OPPT Document Control Office (DCO) in East Tower Rm. G± 099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is 202± 260± 7093. 3. Electronically. You may submit your comments electronically by E mail to: oppt. ncic@ epa. gov, or mail or deliver your computer disk to the addresses identified above. Do not submit any information electronically that you consider to be CBI. E mailed comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments will also be accepted on standard computer disks in WordPerfect 689 or ASCII file format. All comments in electronic form must be identified by the docket control number OPPTS± 66020. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person identified in the FOR FURTHER INFORMATION CONTACT section.

II. Background A. What Action is the Agency Taking? EPA proposes to amend the disposal regulations at 40 CFR 761.99 to allow certain PCB waste located anywhere in the United States, including the territories and possessions of the United States that are not inside the customs territory of the United States (hereafter `` territories and possessions''), to be moved to any area within the United States for disposal. The proposed rule would clarify that such movement is not considered `` import'' for purposes of the ban on manufacturing PCBs under TSCA section 6( e)( 3).

B. What is the Agency's Authority for Taking this Action? EPA is taking this action to clarify its interpretation of the TSCA provisions relating to the manufacture of PCBs as an exercise of the agency's inherent authority to issue regulations interpreting the statutes it administers. This proposed regulation would codify EPA's interpretation of an undefined term, `` import'' in the definition of `` manufacture'' under section 3( 7) of TSCA, for purposes of section 6( e)( 3) of TSCA. EPA's definition of the term `` import'' for all other purposes under TSCA is not affected.

III. Summary of the Proposed Action A. What Risks do PCBs Present and How are PCBs Regulated? PCBs cause significant ecological and human health effects, including cancer, neurotoxicity, reproductive and developmental toxicity, immune system suppression, liver damage, skin irritation, and endocrine disruption (Ref. 1). EPA has found that any exposure of humans or the environment to PCBs may be significant, depending on such factors as the quantity of PCBs involved in the exposure, the likelihood of exposure to humans and the environment, and the effect of exposure (40 CFR 761.20). PCBs are readily absorbed through the skin and at even faster rates when inhaled. Because PCBs are stored in animal fatty tissue, humans are also exposed to PCBs through ingestion of animal products. Significantly, bioaccumulated PCBs appear to be even more toxic than those found in the ambient environment, since the more toxic PCB congeners are more persistent and thus more likely to be retained (Ref. 1). Under section 6( e) of the Toxic Substances Control Act (TSCA), 15 U. S. C. 2605( e), and implementing regulations at 40 CFR part 761, the manufacture, processing, and distribution in commerce of PCBs are banned unless EPA issues a regulatory exemption to the ban. The ban on manufacture of PCBs was designed to prevent the creation or introduction to the United States of new PCBs, and it has been largely successful. Use of PCBs is banned except in a totally enclosed manner or as authorized by rule based on a finding that the use will not pose an unreasonable risk to human health or the environment. Disposal of PCBs is strictly controlled to minimize release to the environment. By enacting TSCA section 6( e), Congress established a presumption that PCBs pose an unreasonable risk of injury to health and the environment. See, Central and Southwest Services, et al. v. EPA, 220 F. 3d 683, 688 (5th Cir. 2000). Before the statutory ban was enacted in 1976, PCBs were widely used in industrial applications, particularly as insulating fluids in electrical equipment. Utilities and other industries lawfully manufactured and sold items such as PCB electrical equipment and hydraulic or heat transfer equipment. After TSCA's general bans on manufacture, processing, distribution in commerce, and use of such items went into effect, EPA authorized the continued use of much of this equipment subject to conditions that protect against an unreasonable risk to health or the environment from the PCBs in the equipment. As these items reach the end of their useful lives, the owners are responsible for disposing of them following the stringent requirements of 40 CFR part 761. Any PCBs that are released from the equipment also must VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65656 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules be disposed of following these requirements. TSCA was enacted to protect all of the citizens of the United States from unreasonable risk of injury to health or the environment from exposure to chemical substances. TSCA sections 3( 13) and 3( 14) define `` United States'' to include `` any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States. '' Thus, the prohibitions and restrictions on PCBs under TSCA section 6( e) and its implementing regulations protect not only United States citizens in the 50 States, but United States citizens in all the territories and possessions of the United States. PCBs in the 50 States and in the territories and possessions must be managed and disposed of in a manner that does not present an unreasonable risk to health or the environment.

B. What Special Problems Do PCBs Present in the Territories and Possessions? PCBs and PCB waste in the territories and possessions pose an especially great environmental threat. The territories and possessions have no permitted commercial PCB disposal facilities, so PCB waste is accumulated in long term storage. Many of the territories and possessions are subject to frequent typhoons and earthquakes, which can severely damage storage areas and other buildings. PCBs and PCB waste in storage therefore may present a greater risk to human health and the environment than PCBs stored in the mainland United States (Ref. 8). Between 1945 and 1990, within 180 nautical miles of Guam, there were 118 tropical storms (wind speed 40 to 72 mph), 36 typhoons (wind speed 75 to 149 mph), and 8 super typhoons (wind speed 150 mph or more). Between 1973 and 2000, Guam has seen an average of 18 earthquakes a year within a 100 kilometer radius. During the last 10 years, 12 earthquakes of magnitude 5 or higher have occurred within a 50 kilometer radius of Guam. The Commonwealth of the Northern Marianas Islands is 120 miles from Guam and shares similar geologic characteristics, so the risks would be similar (Ref. 8). The Samoas lie squarely within the South Pacific's notorious cyclone belt. In American Samoa, Cyclone Tusi caused extensive damage to property, vegetation, and wildlife in 1987. Cyclones occur, on average, every 10 to 15 years, but in the early 1990s, the Samoas were devastated by two of the strongest and most destructive storms on record. Cyclone Ofa struck in February, 1990, bringing winds of up to 250 kilometers per hour, killing 16 people and leveling much of the island of Savai'i. In 1991, Cyclone Val pummeled the islands for 5 days with winds up to 260 kilometers per hour and waves of up to 25 meters in height. Although the storm destroyed nearly three times as much as its predecessor, the death toll was the same. Total damage was estimated at $380 million (Ref. 8). PCBs that are released to the environment in the territories and possessions, through natural disasters or other events, can present significant exposure risks to residents of these areas. Many island residents consume fish for subsistence, and PCBs bioaccumulate in fish. In addition, island natural resources are severely limited and therefore vulnerable. Even a small quantity of PCBs seeping into the groundwater system could permanently eliminate an island's only source of clean drinking water (Ref. 8). Disposal of PCBs in the territories and possessions presents a special challenge. Most PCBs that are regulated for disposal must be disposed of in a TSCA approved facility, such as an incinerator or a chemical waste landfill (40 CFR part 761, subpart D). However, as noted above, there are no TSCAapproved commercial PCB disposal facilities in any of the territories or possessions of the United States (Ref. 6), so disposal in the territory or possession where the waste is generated is not possible in most cases. A recent survey of the status of PCB waste in the territories and possessions shows that, because of the lack of disposal options, PCB wastes have been placed in storage awaiting disposal in facilities that are not approved commercial storage facilities under TSCA. In some cases, spills or releases from these facilities are inadequately controlled, presenting risks to health and the environment (Ref. 8). The territories and possessions cannot dispose of their waste at facilities outside the United States if the PCB concentration is ³50 ppm because EPA regulations prohibit the export for disposal of such waste (see 40 CFR 761.97). Moreover, it is a violation of the PCB regulations to dilute PCB wastes to lower concentrations to avoid these restrictions on export (40 CFR 761.1( b)( 5)). Even if such export were not prohibited, it is not clear that export would be a viable option. Even assuming that foreign countries would be willing to accept PCB waste from the United States, there is some uncertainty about the disposal capacity at foreign disposal sites capable of managing PCBs (Ref. 17). Furthermore, EPA disfavors disposing of PCB wastes generated in the United States in other countries. The only remaining disposal option for most TSCA regulated PCB waste in the territories and possessions is disposal in one of the TSCA approved facilities in the mainland United States. However, EPA has historically interpreted TSCA in a way that made this option unavailable. Since 1979, TSCA section 6( e) has banned the manufacture of PCBs except under an exemption issued by rulemaking. TSCA section 3( 7) defines `` manufacture'' to include `` import into the customs territory of the United States (as defined in general note 2 of the Harmonized Tariff Schedule of the United States). '' General note 2 defines the `` customs territory of the United States'' as `` any State of the United States, the District of Columbia, and Puerto Rico. '' Thus, any movement of PCBs from a location outside the customs territory of the United States to a location inside the customs territory could be considered to be an import of PCBs into the customs territory of the United States. Since most of the territories and possessions, such as Guam and American Samoa, are not included within the definition of `` customs territory of the United States'' as found in the Harmonized Tariff Schedule, EPA has historically interpreted a movement of PCBs from one of these areas to a mainland State to be an `` import'' within the meaning of `` manufacture'' as it is used in TSCA section 6( e)( 3). EPA has in the past exercised limited discretion to allow the movement of PCB waste from U. S. territories and possessions to the mainland United States (Ref. 15).

C. How Would This Proposed Rule Address Disposal of PCBs in the Territories and Possessions?

EPA proposes to amend its regulations to allow the movement of PCB waste for disposal among any States of the United States, as defined in TSCA sections 3( 13) and 3( 14), regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCBs [or the PCB waste] were present in the United States on January 1, 1979, when the ban on manufacturing took effect, and have remained within the United States since that date. EPA would not consider these movements to be imports subject to the ban on manufacturing under TSCA sections 3( 7) and 6( e)( 3)

VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65657 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules As noted above, the territories and possessions are subject to all of TSCA's requirements. EPA is charged with implementing section 6( e) to protect the health and environment of all United States citizens, including the residents of the territories and possessions. To interpret the statute as prohibiting the movement of PCB waste from the territories and possessions to disposal facilities in the United States mainland puts the residents of the territories and possessions at a serious disadvantage compared to residents of areas that fall within the definition of the customs territory. Because there are no EPAapproved commercial PCB storage or disposal facilities outside the customs territory, and because of the unique environmental conditions in the territories and possessions, the Unites States citizens of these areas are subject to a higher likelihood of exposure to PCBs, and thus a higher risk of injury. Moreover, EPA is particularly concerned about the risks from improper disposal of PCBs wherever it may occur. PCBs are persistent in the environment and can become dispersed world wide. Research supporting EPA's report to Congress, Deposition of Air Pollutants to the Great Waters (Refs. 2, 3, 4 and 5), indicates that up to 89% of the PCB loading for Lake Superior occurs through air deposition, much of it from distant sources. Figures for the other Great Lakes range from 6% to 63%. Based on the persistence of PCBs in the global environment and EPA's finding that any exposure to human beings or the environment may be significant, EPA believes that the safe disposal of PCBs in approved United States facilities poses less risk of injury to health or the environment in the United States than the continued presence of PCBs in the territories and possessions, since proper disposal in this country provides protection against possible hazards from improper disposal elsewhere. EPA is also concerned that the only options currently available for handling PCBs in the territories and possessions may violate the requirements of TSCA and its implementing regulations. Indefinite storage of PCB waste is not lawful under EPA's regulations at 40 CFR 761.65. Disposal in a facility that is not EPA approved would also violate the regulations. As noted above, shipment of any wastes containing PCBs ³50 ppm to a foreign country for disposal would violate the export prohibition. In contrast, residents of areas inside the customs territory that do not have EPA approved PCB disposal facilities can simply ship their PCB wastes to an approved facility in another State. For example, the residents of Alaska and Hawaii, States in which no TSCA approved disposal facilities are located, can ship their PCBs to facilities in the mainland United States for disposal (Ref. 13), in spite of the fact that it is impossible to move wastes from those States to the mainland without either entering Canada or crossing international waters (40 CFR 761.99). EPA has determined that its previous interpretation of the definition of `` manufacture'' is not mandated by the language of TSCA, results in inequitable treatment among different areas within the United States, does not adequately protect health and the environment throughout the United States, and therefore is not in the public interest. EPA believes that the term `` import, '' as commonly understood, was not intended to include the movement of PCB waste that has never been outside the United States or outside the regulatory control of TSCA (after enactment) from one area of the United States (the territories and possessions) to another area of the United States (the mainland) for disposal. There is an obvious distinction between that type of movement and the introduction of a chemical into the United States from a foreign country, which is clearly an import. This latter category is much more analogous to the manufacture of a new chemical substance in the United States. Therefore, EPA proposes to interpret the movement of PCB waste from the territories and possessions into the customs territory of the United States for disposal not to be an import, and therefore not within the ban on manufacture under TSCA section 6( e). This proposed interpretive rule would allow the movement of PCB waste for disposal among any States of the United States, as defined in TSCA sections 3( 13) and 3( 14), regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCBs in the waste were present in the United States on January 1, 1979, when the ban on manufacturing took effect, and has remained within the United States since that date. This would allow PCB waste that was present in the territories and possessions at the time TSCA's ban on manufacturing took effect, and that remained within the territories and possessions since that date, to be stored and disposed of in any facility in the United States that meets the requirements of 40 CFR part 761, subpart D. It would also allow PCBs that were present in the territories and possessions at the time TSCA's bans took effect, but were not designated as waste until after that date, to be stored and disposed of in any subpart D facility in the United States, as long as the PCBs and PCB waste had remained in the United States. Finally, it would allow PCBs or PCB wastes that were transferred from an area in the United States that is outside the territories and possessions, but that was moved to a territory or possession after January 1, 1979, and that has never left the United States, to be stored and disposed of in any subpart D facility in the United States. EPA would not consider movement of any of these wastes to the customs territory of the United States to be an import subject to the ban on manufacturing under TSCA section 6( e). This proposed rule would apply to PCB waste that is present in the territories and possessions as the result of conduct that was legal at the time it occurred (for example, PCB materials that were brought to the territories before TSCA's ban on distribution in commerce became effective), and that has been subject to regulation under TSCA throughout its lifespan; or PCB equipment that was lawfully in use in one of the States, that was transferred to a territory or possession for continued lawful use, and that reached the end of its useful life and became subject to disposal while in the territory or possession. This proposed amendment would also be consistent with EPA's longstanding policy that it does not interpret movement of PCBs purchased or procured in the United States by the Federal Government, taken overseas for use in United States Government facilities, remained under the control and jurisdiction of the United States Government, and subsequently returned to the United States for disposal in an approved facility as either exports or imports for purposes of TSCA section 6( e) (Refs. 14 and 16). EPA established this policy because the wastes had always been the property of the United States and disposal facilities for these wastes might not be readily available overseas. This proposed rule would not allow disposal in the United States of PCBs transported to the territories and possessions from foreign countries after the effective date of the ban on manufacture in TSCA section 6( e)( 3). The purpose of this proposal is to ensure that all United States PCB waste can be disposed of in compliance with the requirements of TSCA section 6( e) and its implementing regulations. This proposal is not intended to allow the territories and possessions to become a conduit to the United States for PCB waste generated in other countries.

VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65658 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules Finally, EPA has not made a formal finding of `` no unreasonable risk'' for this proposed regulation. This regulation is not being proposed under TSCA section 6( e), but rather as an exercise of EPA's inherent authority to interpret the statutes it administers.

IV. References and Documents in the Record As indicated in Unit I. B. 2., the official record for this rulemaking has been established under docket control number OPPTS± 66020, the public version of which is available for inspection as specified in Unit I. B. 2. The following is a listing of the documents that have already been placed in the official record for this rulemaking:

A. Federal Register Notices 1. U. S. Environmental Protection Agency (USEPA). 44 FR 31514, May 31, 1979, `` Polychlorinated Biphenyls (PCBs); Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions: Final Rule. '' 2. USEPA. 45 FR 29115, May 1, 1980, `` Polychlorinated Biphenyls (PCBs); Expiration of the Open Border Policy for PCB Disposal: Notice. '' OPTS 62008. 3. USEPA. 59 FR 62788, December 6, 1994, `` Disposal of Polychorinated Biphenyls: Proposed Rule. '' OPPTS± 66009A. 4. USEPA. 61 FR 11096, March 18, 1996, `` Disposal of Polychlorinated Biphenyls; Import for Disposal: Final Rule. '' OPPTS± 66009B. 5. USEPA. 63 FR 35384, June 29, 1998, `` Disposal of Polychlorinated Biphenyls (PCBs): Final Rule. '' OPPTS± 66009C.

B. Reference Documents 1. USEPA, Office of Research and Development (ORD). PCBs Cancer DoseResponse Assessment and Application to Environmental Mixtures. EPA600P± 96001F (September 1996): 75pp. OPPTS± 66009C. 2. USEPA, Office of Air Quality Planning and Standards (OAQPS). Deposition of Air Pollutants to the Great Waters, First Report to Congress. EPA± 453R± 93± 055 (May 1994): 136pp. OPPTS± 66009B. 3. USEPA, OAQPS. Identification of Sources Contributing to the Contamination of the Great Waters by Toxic Compounds. EPA± 453R± 94± 087 (March 17, 1993): 145pp. OPPTS± 66009B. 4. USEPA, OAQPS. Relative Atmospheric Loadings of Toxic Contaminants and Nitrogen to the Great Waters. EPA± 453R± 94± 086 (March 15, 1993): 142pp. OPPTS± 66009B. 5. USEPA. Chapter 2.2, Exposure and Effects of Airborne Contamination for the Great Waters Program Report. EPA± 453R± 94± 085 (December 22, 1992): 201pp. OPPTS± 66009B. 6. USEPA, Office of Prevention, Pesticides, and Toxic Substances (OPPTS). Commercially Permitted PCB Disposal Companies (April 2000): 3pp. 7. USEPA, Office of Pollution Prevention and Toxics (OPPT). Excerpt from the PCB Waste Handler Database; Facility Information for U. S. Territories and Possessions (September 27, 2000): 12pp. 8. USEPA, Region IX. Memo from Lily Lee, Guam Program Manager, to Enrique Manzanilla, Director, Cross Media Division, Re: Summary of PCB Waste Quantities and Concentrations in the US Territories (July 19, 2000): 5pp. 9. Unitek Environmental Guam. Letter from LeRoy Moore, President, to John Malone [sic], Director, National Program Chemicals Division, Re: PCB Shipments from Guam and Possessions of the United States for Disposal in the Mainland United States (May 11, 2000): 2pp. 10. USEPA, OPPT. Note from Peter Gimlin to the File, Re: Unitek Environmental Guam (UEG) Meeting (September 27, 2000): 1p. 11. U. S. Congress. Letter from Robert A. Underwood, House of Representatives, to Carol M. Browner, Administrator, EPA, Re: Disposal of Polychlorinated Biphenyls (PCBs) from Guam and the Other U. S. Territories (April 12, 2000): 2pp. 12. USEPA, Region IX. Letter from Felicia Marcus, Regional Administrator, to Robert A. Underwood, U. S. House of Representatives, Re: Disposal of Polychlorinated Biphenyl Waste (February 4, 2000): 2pp. 13. USEPA, OPPT. Memo from John W. Melone, Director, Chemical Management Division, to George Abel, Chief, Pesticides and Toxic Substances Branch, USEPA Region X, Re: Transit of PCB Waste Generated in the United States Through a Foreign Country (January 19, 1995): 2pp. 14. USEPA, OPPT. Letter from John W. Melone, Director, Chemical Management Division, to Arthur J. Brown, National Science Foundation, Re: Request to Return PCBs in Antarctica to the United States for Disposal (March 11, 1994): 3pp. 15. USEPA, OCM and OE. Letter from Michael F. Wood, Director, Compliance Division, and Michael J. Walker, Enforcement Counsel for the Toxics Litigation Division, to Marion P. Herrington, General Electric Company, Re: Transfer of PCB Waste Generated in A U. S. Territory to An Approved Disposal Facility in the Continental United States (August 14, 1992): 2pp. 16. USEPA, Office of Toxic Substances (OTS). Letter from Don R. Clay, Director to Colonel Joseph T. Cuccaro, Defense Logistics Agency, Re: USEPA Position on DOD Owned PCB Fluid Located Abroad and Returned to the U. S. for Disposal (February 7, 1984): 3pp. 17. United Nations Environment Programme (UNEP). Inventory of World wide PCB Destruction Capacity, First Issue (December 1998): 85pp. 18. U. S. Congress. Congressional Record from the House of Representatives, H8598, Guam's Environmental Problems (October 2, 2000): 1p. 19. U. S. Congress. Letter from Robert A. Underwood, House of Representatives, to Carol Browner, Administrator, EPA, Re: Inability of Guam to Import PCBs into the U. S. Mainland for Proper Disposal (December 10, 1999): 2 pp. 20. USEPA, OPPTS. Letter from Susan H. Wayland, Acting Assistant Administrator, to Robert A. Underwood, U. S. House of Representatives, Re: Disposal of PCB Waste in Guam (June 14, 2000): 2 pp. 21. USEPA, OPPTS. Letter from Susan H. Wayland, Acting Assistant Administrator, to Robert A. Underwood, U. S. House of Representatives, Re: Meeting on PCB Waste in Guam (September 29, 2000): 2 pp.

V. Regulatory Assessment Requirements A. Executive Order 12866 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that this action is not a `` significant regulatory action'' subject to review by OMB, because this action is not likely to result in a rule that meets any of the criteria for a `` significant regulatory action'' provided in section 3( f) of the Executive Order. This proposed rule simply clarifies EPA's interpretation of the TSCA section 6( e) provisions relating to the manufacture of PCBs.

B. Regulatory Flexibility Act (RFA)

Pursuant to section 605( b) of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U. S. C. 601 et seq., the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is that this action is not expected to result in any direct adverse impact for small entities. This rule interprets the prohibition on the `` manufacture of PCBs'' in a manner which affords U. S. citizens (including small entities) residing in U. S. territories and possessions located outside the `` customs territory of the United States'' an opportunity to dispose of PCB waste when facilities that require EPA approval to manage PCB waste are not readily available. This rule is being promulgated in the public interest to ensure equitable treatment among different areas within the United States and adequate protection of health and the environment throughout the United States. This rule provides a mechanism for the disposal of PCB waste resulting from natural disasters (e. g., tropical storms, cyclones, typhoons and hurricanes), former use of U. S. territories and possessions for defense purposes, spills of PCBs and when PCB equipment has reached the end of its natural life span.

VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65659 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules C. Paperwork Reduction Act (PRA)

This regulatory action does not contain any information collection requirements that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U. S. C. 3501 et seq.

D. Unfunded Mandates Reform Act (UMRA)

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104± 4, EPA has determined that this action does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local or tribal governments, in the aggregate, or on the private sector in any one year. The UMRA requirements in sections 202, 204, and 205 do not apply to this rule, because this action does not contain any `` Federal mandates'' or impose any `` enforceable duty'' as defined by UMRA on StateTribal, or local governments or on the private sector. The requirements in section 203 do not apply because this rule does not contain any regulatory requirements that might significantly or uniquely affect small governments.

E. Executive Order 13132 Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. '' `` Policies that have federalism implications'' are defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. '' This proposed rule does not have federalism implications, because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action interprets the TSCA prohibition on the manufacture of PCBs in a manner which allows PCB waste in U. S. territories and possessions located outside of the customs territory of the U. S. to be disposed of in EPA approved facilities on the mainland of the United States. Thus, the requirements of section 6 of the Executive Order do not apply to this rule. F. Executive Order 13084 Under Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments `` to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities. '' This rule does not significantly or uniquely affect the communities of Indian tribal governments, nor does it impose substantial direct compliance costs on such communities. It interprets the TSCA prohibition on the manufacture of PCBs in a manner which allows PCB waste in U. S. territories and possessions located outside of the customs territory of the U. S. to be disposed of in EPA approved facilities on the mainland of the United States. Accordingly, the requirements of section 3( b) of Executive Order 13084 do not apply to this rule.

G. Executive Order 12898 Pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations (59 FR 7629, February 16, 1994), the Agency has considered environmental justice related issues with regard to the potential impacts of this action on the environmental and health conditions in low income and minority communities. EPA finds that the amendments in this proposed rule will reduce the risk to human health and the environment from exposure to PCBs, particularly in low income and minority communities. This proposed rule would allow PCB waste found in U. S. territories and possessions located outside of the customs territory of the U. S. to be disposed of in EPA approved facilities on the mainland of the United States.

H. Executive Order 13045 Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), does not apply to this rule, because it is not `` economically significant'' as defined under Executive Order 12866, and does not involve decisions on environmental health risks or safety risks that may disproportionately affect children. This proposed regulation would allow PCB waste in U. S. territories and possessions located outside of the customs territory of the U. S. to be disposed of in EPA approved facilities on the mainland of the United States. Therefore, the disposal of PCB waste will occur where children are either not present or not permitted, and the disposal activity will pose no special risks to children. Also, the rule will prevent exposure of children in U. S. territories and possessions to PCBs that might result from improper storage or disposal of PCB waste.

I. National Technology Transfer and Advancement Act (NTTAA)

This regulatory action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104± 113, section 12( d) (15 U. S. C. 272 note).

J. Executive Order 12630 EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the `` Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the Executive Order.

K. Executive Order 12778 In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65660 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules List of Subjects in 40 CFR Part 761 Environmental protection, Hazardous substances, Labeling, Polychlorinated Biphenyls (PCBs), Recordkeeping and reporting requirements.

Dated: October 24, 2000.

Carol M. Browner,

Administrator.

Therefore, 40 CFR chapter I, part 761 is proposed to be amended as follows: PART 761Ð[ AMENDED]

1. The authority citation for part 761 will continue to read as follows:

Authority: 15 U. S. C. 2605, 2607, 2611, 2614, and 2616.

2. Section 761.99 is amended by adding paragraph (c) to read as follows:

§761.99 Other transboundary shipments.

* * * * * (c) PCB waste transported from any State to any other State for disposal, regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCB waste or the PCBs from which the waste was derived were present in the United States on January 1, 1979, and have remained within the United States since that date.

[FR Doc 00± 27971 Filed 10± 26± 00; 4: 34 p. m.]

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