[Federal Register: November 29, 2006 (Volume 71, Number 229)]
[Rules and Regulations]
[Page 69028-69033]
[DOCID:fr29no06-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0181; FRL-8103-8]

Diflubenzuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of diflubenzuron and its metabolites 4-chlorophenylurea and 4-
chloroaniline in or on brassica, leafy greens subgroup 5B, turnip
greens, peanut, peanut hay, peanut oil, barley grain, barley hay,
barley straw, oat grain, oat forage, oat hay, oat straw, wheat grain,
wheat forage, wheat hay, wheat straw, aspirated grain fractions, and
pummelo. The Interregional Research Project 4 requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective November 29, 2006. Objections and
requests for hearings must be received on or before January 29, 2007,
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:  EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0181. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    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 in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.epa.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0181 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before January 29, 2007.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0181, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of April 12, 2006 (71 FR 18742) (FRL-7773-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
5E6965, PP 5E6966, and PP 5E6967) by Interregional Project Number 4,
681 Highway 1 South, North Brunswick, NJ 08902-3390. The petitions
requested that 40 CFR 180.377 be amended by establishing tolerances for
residues of diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide and metabolites convertible to p-chloroaniline
expressed as diflubenzuron in or on the raw agricultural commodities
barley grain, oat grain, wheat grain at 0.06 ppm; forage of barley, oat
and wheat at 5.0 ppm; hay of barley, oat and wheat at 2.0 ppm; straw of
barley, oat and wheat at 2.0 ppm; aspirated grain fractions of barley,
oat and wheat at 3.0 ppm; and pummelo at 0.5 ppm (PP 5E6965), brassica,
leafy greens subgroup 5B and turnip greens at 8.0 ppm, eggplant and
okra at 1.0 ppm (PP 5E6966), and peanut at 0.2 ppm (PP 5E6967). That
notice included a summary of the petition prepared by IR-4. There were
no comments received in response to the notice of filing.
    Tolerances were later amended by IR-4 as follows: Barley, hay at
3.0 ppm; barley, straw at 1.8 ppm; oat forage at 7.0 ppm; oat hay at
6.0 ppm; oat straw at 3.5 ppm; wheat, forage at 7.0 ppm, wheat, hay at
6.0 ppm, wheat, straw at 3.5 ppm; grain, aspirated fractions at 11 ppm
(PP 5E6965); brassica, leafy greens, subgroup 5B and turnip greens at
9.0 ppm (PP 5E6966); peanut at 0.10 ppm; peanut, hay at 55 ppm; peanut,
refined oil at 0.20 ppm (PP 5E6967).
    In addition, the proposed tolerance for barley, forage (PP 5E6965)
was deleted by IR-4 because this is not a raw agricultural commodity
(RAC) of barley. Also, the proposed tolerances for eggplant and okra
(PP 5E6966) were withdrawn by IR-4 because the Agency concluded that
there are insufficient data to establish tolerances for

diflubenzuron residues in or on these commodities at this time.
    EPA is also deleting several established tolerances in Sec.
180.377 (b) that are no longer needed as a result of this action. The
tolerance deletions under Sec.  180.377 (b) are time-limited tolerances
established under section 18 emergency exemptions that are superceded
by the establishment of general tolerances for diflubenzuron and its
metabolites under Sec.  180.377 (a)(2).
    The revisions to Sec.  180.377 (b) are as follows:
    1. Delete the time-limited tolerance for barley, grain at 0.05 ppm.
A tolerance for barley, grain at 0.06 ppm is established by this action
under Sec.  180.377(a)(2).
    2. Delete the time-limited tolerance for barley, hay at 1.0 ppm. A
tolerance for barley, hay at 3.0 ppm is established by this action
under Sec.  180.377(a)(2).
    3. Delete the time-limited tolerance for barley, straw at 0.50 ppm.
A tolerance for barley, straw at 1.8 ppm is established by this action
under Sec.  180.377 (a)(2).
    4. Delete the time-limited tolerance for wheat, grain at 0.05 ppm.
A tolerance for wheat, grain at 0.06 ppm is established by this action
under Sec.  180.377(a)(2).
    5. Delete the time-limited tolerance for wheat, hay at 1.0 ppm. A
tolerance for wheat, hay at 6.0 ppm is established by this action under
Sec.  180.377(a)(2).
    6. Delete the time-limited tolerance for wheat, straw at 0.50 ppm.
A tolerance for wheat, straw at 3.5 ppm is established by this action
under Sec.  180.377 (a)(2).
    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. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section
408(a)(2) of FFDCA, for tolerances for combined residues of
diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide and its metabolites 4-chlorophenylurea and 4-
chloroaniline in or on the raw agricultural commodities barley, grain
at 0.06 ppm; barley, hay at 3.0 ppm; barley, straw at 1.8 ppm; oat,
grain at 0.06 ppm; oat forage at 7.0 ppm; oat hay at 6.0 ppm; oat straw
at 3.5 ppm; wheat, grain at 0.06 ppm; wheat, forage at 7.0 ppm, wheat,
hay at 6.0 ppm, wheat, straw at 3.5 ppm; grain, aspirated fractions at
11 ppm; pummelo at 0.50 ppm; brassica, leafy greens, subgroup 5B at 9.0
ppm; turnip greens at 9.0 ppm; peanut at 0.10 ppm; peanut, hay at 55
ppm; peanut, refined oil at 0.20 ppm. EPA's assessment of exposures and
risks associated with establishing the tolerance 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. Specific information on the studies received and the nature
of the toxic effects caused by diflubenzuron 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.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm
 (67 FR

59006).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for diflubenzuron used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of September 19, 2002 (67 FR 59006)
(FRL-7200-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances for
residues of diflubenzuron are established under 40 CFR 180.377.
Tolerances listed in 40 CFR 180.377(a)(1) are expressed in terms of
diflubenzuron per se. Under this section, tolerances of 0.05-6.0 ppm
are established for residues in/on eggs; milk; fat and meat of cattle,
goat, hog, horse, poultry, and sheep; poultry meat byproducts;
cottonseed; mushroom; grapefruit, orange (sweet); tangerine; soybean
hulls; and globe artichoke. Tolerances listed in 40 CFR 180.377(a)(2)
are expressed in terms of the combined residues of diflubenzuron and
its metabolites 4-chlorophenylurea (CPU) and 4-chloroaniline (PCA).
Under this section, tolerances of 0.02-6.0 ppm are established for
residues in/on rice grain; tree nuts (group 14); pistachios; fruit,
stone (group 12) except cherry; meat byproducts of cattle, goat, hog,
horse, and sheep; pear; rice straw; pepper; and almond hulls. Time-
limited tolerances listed in 40 CFR 180.377(b) are expressed in terms
of the combined residues of diflubenzuron and its metabolites CPU and
PCA, expressed as the parent diflubenzuron, in connection with use of
the pesticide under Section 18 Emergency Exemptions granted by EPA.
Risk assessments were conducted by EPA to assess dietary exposures from
diflubenzuron 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. The diflubenzuron toxicology
studies indicated no possibility of such an effect for either the
general U.S. population (including infants and children) or the females
13-50 years old population subgroup for diflubenzuron; therefore, an
acute dietary exposure analysis was not performed.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM-FCID\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the chronic exposure assessments: For the chronic analysis a Tier 1
chronic dietary-exposure assessment was conducted using the
established/recommended tolerances for all food commodities, 100% CT
information for all proposed and existing uses, and DEEM(\TM\) Version
7.81 default processing factors for some processed commodities.
    iii. Cancer. The Agency has classified diflubenzuron as ``Group
E,'' evidence of non-carcinogenicity for humans, based on lack of
evidence of carcinogenicity in rats and mice. There are also two
metabolites of diflubenzuron; PCA and CPU. PCA tested positive for
splenic tumors in male rats and hepatocellular adenomas/carcinomas in
male mice in a National Toxicology Program (NTP) study. Therefore, EPA
classified PCA as a ``Group B2'' probable human carcinogen. The Agency
determined for those commodities that contained PCA and CPU, the Q1* of
PCA should be used to calculate the cancer risk from the sum of these
two metabolites.
    Based on the submitted metabolism studies, there are two possible
sources for dietary exposure to PCA and CPU: residues in mushrooms and
residues in milk and liver. Because human exposure to PCA and CPU will
not be affected by the proposed new uses, and EPA has previously
concluded that exposure to these compounds is safe, therefore, the
cancer dietary risk from PCA and CPU will not be addressed in this
document. For a detailed discussion on the exposure and risks to PCA
and CPU, please refer to the September, 2002 Federal Register document
titled Diflubenzuron; Pesticide Tolerances (September 19, 2002, FR 67
59006); http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm
.

    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for diflubenzuron in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of diflubenzuron. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
diflubenzuron and the major degradate CPU for chronic exposures are
estimated to be 2.76 ppb for surface water and 0.208 ppb for ground
water.Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\, Version 2.03).
For chronic dietary risk assessment, the annual average concentration
of 2.76 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).
    Although there are no registered homeowner uses, there are
registered uses for professional applications to outdoor residential
and recreational areas to control mosquitoes, moths, and other insects.
However, the potential for post-application residential exposure is
expected to be limited, due to the low dermal absorption rate (0.5%) of
diflubenzuron, and since it is only applied to the tree canopy, minimal
bystander contact is expected.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to diflubenzuron and any
other substances and diflubenzuron does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that diflubenzuron has
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 the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Based on the developmental
and reproductive toxicity studies, there is no indication of increased
susceptibility of rats or rabbits to in utero or postnatal exposure.
    3. Conclusion. Based on the reliable data available on
diflubenzuron, EPA determined that the additional FQPA 10X safety
factor to protect infants and children was not needed. This decision
was based on the following:
    i. There is a complete toxicity data base for diflubenzuron

    ii. There is no indication of increased susceptibility of rats or
rabbits to in utero or postnatal exposure;
    iii. A developmental neurotoxicity study (DNT) with diflubenzuron
is not required;
    iv. Food and drinking water exposure assessments will not
underestimate the potential exposure for infants and children; and
    v. There are currently no registered or proposed residential (non-
occupational) uses of diflubenzuron for homeowners. Although there are
no registered homeowner uses, there is potential for professional
applications to outdoor residential and recreational areas to control
mosquitoes, moths, and other insects. However, the potential for post-
application residential exposures are expected to be limited. Due to
the low dermal absorption rate (0.5%) of diflubenzuron, and since it is
only applied to the tree canopy to control gypsy moths and mosquitoes,
minimal bystander contact is expected.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and residential uses. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf
.

    More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EDWCs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs. The
risk assessment for diflubenzuron used in this tolerance document uses
this approach of incorporating water exposure directly into the dietary
exposure analysis.
    1. Acute risk. Because there were no toxic effects attributable to
a single dose of diflubenzuron, it 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 exposure to
diflubenzuron from food and water will utilize 11% of the cPAD for the
U.S. population, 12% of the cPAD for all infants less than 1 year old,
and 37% of the cPAD for children 1-2 years old. There are no
residential uses for diflubenzuron that result in chronic residential
exposure to diflubenzuron. EPA does not expect the aggregate exposure
to exceed 100% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Diflubenzuron is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Diflubenzuron is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    5. Aggregate cancer risk for U.S. population. Based on the
available evidence, which included adequate carcinogenicity studies in
rats and mice, and battery of negative mutagenicity studies,
diflubenzuron has been classified as ``Group E,'' evidence of non-
carcinogenicity for humans, by the Agency.
    As noted in Unit III.C.1.iii. of this document, the Agency has
concluded that human exposure to PCA and CPU (metabolites of
diflubenzuron) will not be affected by the proposed new uses. EPA has
previously found aggregate exposure to these compounds to be safe.
(September 19, 2002, 67 FR 59006); http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm
    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, and to infants and children from aggregate
exposure to diflubenzuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There are adequate enforcement methods, published in the Pesticide
Analytical Manual (PAM, Vol. II), for determining diflubenzuron
residues of concern. In addition, a new analytical methodology for
plant commodities was successfully validated by an independent
laboratory as well as by Agency chemists at the Analytical Chemistry
Branch (ACB)/Biological and Economics Analysis Division (BEAD) in
conjunction with the approved rice petition (PP8F4925). The
new methods were forwarded to the Food and Drug Administration (FDA)
for publication in PAM Vol. II as Roman Numeral Methods. These methods
can separately determine residues of diflubenzuron by gas
chromatography/electron-capture detection (GC/ECD), CPU by GC/ECD, and
PCA by GC/mass spectrometry (MS). The reported limit of quantitation
(LOQ) for diflubenzuron in/on rice grain, straw, and bran is 0.01 ppm,
and is 0.05 ppm in/on rice hull. In rice straw, the LOQ for CPU is 0.01
ppm and 0.005 ppm for PCA.

B. International Residue Limits

    The Codex Alimentarius has established maximum residue limits
(MRL), expressed in terms of diflubenzuron per se, for many commodities
including: apple (5 ppm), citrus fruits (0.5 ppm), edible offal
(mammalian) (0.1 ppm), eggs (0.05 ppm), meat (from mammals other than
marine mammals) (0.1 ppm), milks (0.02 ppm), mushrooms (0.3 ppm), pear
(5 ppm), pome fruits (5 ppm), poultry meat (0.05 ppm), rice (0.01 ppm),
and rice straw and fodder (dry) 0.7 ppm). As the U.S. residue
definition includes CPU and PCA, compatibility is not possible with the
proposed tolerances.

V. Conclusion

    Therefore, tolerances are established for combined residues of
diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide and its metabolites 4-chlorophenylurea and 4-
chloroaniline in or on the raw agricultural commodities barley, grain
at 0.06 ppm; barley, hay at 3.0 ppm; barley, straw at 1.8 ppm; oat,
grain at 0.06 ppm; oat forage at 7.0 ppm; oat hay at 6.0 ppm; oat straw
at 3.5 ppm; wheat, grain at 0.06 ppm; wheat, forage at 7.0 ppm, wheat,
hay at 6.0 ppm, wheat, straw at 3.5 ppm; grain, aspirated fractions at
11 ppm; pummelo at 0.50 ppm; brassica, leafy greens, subgroup 5B

at 9.0 ppm; turnip greens at 9.0 ppm; peanut at 0.10 ppm; peanut, hay
at 55 ppm; peanut, refined oil at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on 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, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 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'' is 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 final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. 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 this final rule in the Federal Register. This final
rule 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: November 16, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.377 is amended by alphabetically adding commodities to
the table in paragraph (a)(2) and removing from the table in paragraph
(b), the commodities ``barley, grain''; ``barley, hay''; barley,
straw''; ``wheat, grain''; ``wheat, hay''; and ``wheat, straw'' to read
as follows:

Sec.  180.377  Diflubenzuron; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Barley, grain...........................................            0.06
Barley, hay.............................................             3.0
Barley, straw...........................................             1.8
Brassica, leafy greens, subgroup 5B.....................             9.0
                                * * * * *
Grain, aspirated fractions..............................              11
                                * * * * *
Oat, forage.............................................             7.0
Oat, grain..............................................            0.06
Oat, hay................................................             6.0
Oat, straw..............................................             3.5
Peanut..................................................            0.10
Peanut, hay.............................................              55
Peanut, refined oil.....................................            0.20
                                * * * * *
Pummelo.................................................            0.50
                                * * * * *
Turnip greens...........................................             9.0
Wheat, forage...........................................             7.0
Wheat, grain............................................            0.06
Wheat, hay..............................................             6.0
Wheat, straw............................................             3.5
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-20147 Filed 11-28-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Proposed Rules]
[Pages 17892-17894]
[FR Doc No: 2010-8020]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0299 Airspace Docket No. 10-AAL-9]

Proposed Revision of Class E Airspace; Galena, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to revise Class E airspace at Galena, AK.
The amendment of three Standard Instrument Approach Procedures (SIAPs),
and the development of one Obstacle Departure Procedure (ODP) at the
Edward G. Pitka Sr. Airport have made this action necessary to enhance
safety and management of Instrument Flight Rules (IFR) operations.

DATES: Comments must be received on or before May 24, 2010.

ADDRESSES: Send comments on the proposal to the Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001. You must identify the docket number FAA-2010-0299/Airspace Docket
No. 10-AAL-9 at the beginning of your comments. You may also submit
comments on the Internet at http://www.regulations.gov. You may review
the public docket containing the proposal, any comments received, and
any final disposition in person in the Dockets Office between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527) is on the plaza level of the
Department of Transportation NASSIF Building at the above address.
    An informal docket may also be examined during normal business
hours at the office of the Manager, Safety, Alaska Flight Service
Operations, Federal Aviation Administration, 222 West 7th Avenue, Box
14, Anchorage, AK 99513-7587.

FOR FURTHER INFORMATION CONTACT: Gary Rolf, Federal Aviation
Administration,

222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587; telephone number
(907) 271-5898; fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet address: http://www.faa.gov/about/office_org/headquarters_offices/ato/service_units/systemops/fs/alaskan/rulemaking/.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2010-0299/
Airspace Docket No. 10-AAL-9.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this notice may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition, in person in the Federal
Docket Management System Office (see ADDRESSES section for address and
phone number) between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. An informal docket may also be examined during normal
business hours at the office of the Alaska Flight Services Information
Area Group. Persons interested in being placed on a mailing list for
future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-
9677, to request a copy of Advisory Circular No. 11-2A, Notice of
Proposed Rulemaking Distribution System, which describes the
application procedure.

The Proposal

    This action proposes to amend Title 14 Code of Federal Regulations
(14 CFR) part 71 by revising Class E airspace at Galena, AK, to
accommodate a new departure procedure and amended SIAPs at Edward G.
Pitka Sr. Airport. This Class E airspace would provide adequate
controlled airspace upward from the surface, and from 700 feet above
the surface, for the safety and management of IFR operations at Edward
G. Pitka Sr. Airport.
    The Class E2 surface areas are published in paragraph 6002 in FAA
Order 7400.9T, Airspace Designations and Reporting Points, signed
August 27, 2009, and effective September 15, 2009, which is
incorporated by reference in 14 CFR 71.1. The Class E airspace areas
designated as 700/1200 foot transition areas are published in paragraph
6005 in FAA Order 7400.9T, Airspace Designations and Reporting Points,
signed August 27, 2009, and effective September 15, 2009, which is
incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document would be subsequently published in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Because this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle 1, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it proposes to revise airspace at Galena, Alaska, and represents the
FAA's continuing effort to safely and efficiently use the navigable
airspace.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING
POINTS

    1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009, is to be amended as follows:

* * * * *

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

AAL AK E2 Galena, AK [Revised]

Edward G. Pitka Sr. Airport, AK
    (Lat. 64[deg]44'10'' N., long. 156[deg]56'15'' W.)

    Within a 4.2 mile radius of the Edward G. Pitka Sr. Airport, AK.
* * * * *

Paragraph 6005 Class E Airspace Extending Upward From 700 Feet or
More Above the Surface of the Earth.

* * * * *

AAL AK E5 Galena, AK [Revised]

Edward G. Pitka Sr. Airport, AK
    (Lat. 64[deg]44'10'' N., long. 156[deg]56'15'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.2-mile radius of the Edward G. Pitka Sr. Airport, AK, and
within 3.8 miles either side of the 239 bearing from the Edward G.
Pitka Sr. Airport, extending from the 7.2-mile radius to 12.9 miles
west of the Edward G. Pitka Sr. Airport, and within 2.9 miles either
side of the 110 bearing from the Edward G. Pitka Sr. Airport,
extending from the 7.2-mile radius to 14.5 miles east of the Edward
G. Pitka Sr. Airport; and that airspace extending upward from 1,200
feet above the surface within a 73-mile radius of the Edward G.
Pitka Sr. Airport, AK.

    Issued in Anchorage, AK, on March 25, 2010.
Anthony M. Wylie,
Manager, Alaska Flight Services Information Area Group.
[FR Doc. 2010-8020 Filed 4-7-10; 8:45 am]
BILLING CODE 4910-13-P


Public Hearing

17th Floor Conference Room

L & C Tower

 401 Church Street

 Nashville, TN 37243-1531

1:00 p.m.

March 20, 2006

Hearing Officer:		Ron Culberson       TDEC   APC

Division of Air Pollution Control Representatives:
         (Recording Secretary) APC

Lida Galbreath       TDEC   APC

Other Divisions: Resources Management Bureau	None

Public	W. C. Markham, Jr. P.E.    (TVA)

Comment Summary

Chapter 1200-3-9

Construction and Operating Permits

Amendments

Chapter 1200-3-9 Construction and Operating Permits is amended in the
following four (4) respects:

1.	Item (III) of subpart (i) of part 45. of subparagraph (b) of
paragraph (4) of rule 1200-3-9-.01 CONSTRUCTION PERMITS  is amended by
substituting for the present item a different item.

Item (IV) of subpart (ii) of part 45. of subparagraph ((b) of paragraph
(4) of rule 1200-3-9-.01 CONSTRUCTION PERMITS  is amended by
substituting for the present item a different item.

Subitem III. of item (I) of subpart (xlvii) of part 1. of subparagraph
(b) of paragraph (5) of rule  1200-3-9-.01 CONSTRUCTION PERMITS  is
amended by substituting for the present subitem a different subitem.

4.	Subitem IV. of item  (II) of subpart (xlvii) of part 1. of
subparagraph (b) of paragraph (5) of rule  1200-3-9-.01 CONSTRUCTION
PERMITS  is amended by substituting for the present subitem a different
subitem.

There were no comments received concerning these amendments at the
public hearing.

D:/mb/phc/901c1.doc


[Federal Register: February 14, 2008 (Volume 73, Number 31)]
[Proposed Rules]
[Page 8640-8641]
[DOCID:fr14fe08-25]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 271 and 272

[EPA-R08-RCRA-2006-0501 FRL-8524-6]

North Dakota: Final Authorization of State Hazardous Waste
Management Program Revisions and Incorporation by Reference of Approved
Hazardous Waste Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: North Dakota has applied to EPA for final authorization of the
changes to its hazardous waste program under the Resource Conservation
and Recovery Act (RCRA). The EPA proposes to grant final authorization
to the hazardous waste program changes submitted by North Dakota. In
addition, EPA is proposing to codify in the regulations entitled
``Approved State Hazardous Waste Management Programs'', North Dakota's
authorized hazardous waste program. EPA will incorporate by reference
into the Code of Federal Regulations (CFR) those provisions of the
State statutes and regulations that are authorized and that EPA will
enforce under the Solid Waste Disposal Act, as amended and commonly
referred to as RCRA. In the ``Rules and Regulations'' section of this
Federal Register, we are authorizing the State's program changes and
codifying and incorporating by reference the authorized hazardous waste
program as an immediate final rule. EPA did not make a proposal prior
to the immediate final rule because we believe these actions are not
controversial and do not expect comments to oppose them. We have
explained the reasons for this authorization and incorporation-by-
reference in the preamble to the immediate final rule. Unless we get
written comments opposing this authorization and incorporation by
reference during the comment period, the immediate final rule will
become

effective and the Agency will not take further action on this proposal.
If we receive comments that oppose these actions, we will publish a
document in the Federal Register withdrawing this rule before it takes
effect. EPA will then address public comments in a later final rule
based on this proposal. Any parties interested in commenting on these
actions must do so at this time. EPA may not provide further
opportunity for comment.

DATES: Comments must be received on or before March 17, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
RCRA-2006-0501, by one of the following methods:
     Federal eRulemaking Portal: http://
www.regulations.gov.Follow the on-line instructions for submitting
comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Send written comments to Carl Daly, Solid and
Hazardous Waste Program, EPA Region 8, Mailcode 8P-HW, 1595 Wynkoop
Street, Denver, Colorado 80202-1129.
     Hand Delivery or Courier: Deliver your comments to Carl
Daly, Solid and Hazardous Waste Program, EPA Region 8, Mailcode 8P-HW,
1595 Wynkoop Street, Denver, CO 80202-1129. Such deliveries are only
accepted during the Regional Office's normal hours of operation. The
public is advised to call in advance to verify the business hours.
Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-RCRA-
2006-0501. EPA's policy is that all comments received will be included
in the public docket without change, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov, or e-mail. The federal web site, http://
www.regulations.gov, is an ``anonymous access'' system, which means EPA
will not know your identity or contact information unless you provide
it in the body of your comment. If you send an e-mail comment directly
to EPA without going through http://www.regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties, and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters or any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
through www.regulations.gov or in hard copy at: EPA Region 8, from 9
a.m. to 4 p.m., 1595 Wynkoop Street, Denver, Colorado, contact: Carl
Daly, phone number<PHONE_NUMBER>, or the North Dakota Department of
Health (NDDH) from 9 a.m. to 4 p.m., 1200 Missouri Ave, Bismarck, ND
58504-5264, contact: Curt Erickson, phone number<PHONE_NUMBER>. The
public is advised to call in advance to verify the business hours.

FOR FURTHER INFORMATION CONTACT: Carl Daly, Solid and Hazardous Waste
Program, U.S. Environmental Protection Agency, Region 8, 1595 Wynkoop
Street, Denver, CO 80202,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For additional information, please see the
immediate final rule published in the ``Rules and Regulations'' section
of this Federal Register.

    Dated: January 22, 2008.
Carol Rushin,
Acting Regional Administrator, Region 8.
 [FR Doc. E8-2158 Filed 2-13-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56282-56286]
[FR Doc No: 2017-25607]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82139; File No. SR-NYSEAMER-2017-33]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Rule 7.35E Relating to Auction Collars and To Add Temporary Rules

November 21, 2017.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on November 17, 2017, NYSE American LLC (``Exchange'' or ``NYSE
American'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to (1) amend Rule 7.35E(a)(10) to allow
auctions to be conducted at a price equal to the Auction Collars and to
change the rounding methodology for determining Auction Collars; (2)
add Commentary .02 to Rule 7.35E to describe rules that would be in
effect on a temporary basis pending the implementation of the auction
logic changes; and (3) make clarifying amendments to Rules 7.35E(c)(1)
and (d)(1). The proposed rule change is available on the Exchange's Web
site at www.nyse.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 7.35E(a)(10) to allow auctions
to be conducted at a price equal to the Auction Collars and to change
the rounding methodology for determining Auction Collars.\4\ The
Exchange also proposes Commentary .02 to Rule 7.35E to provide that
until the Exchange implements the amendments to Rule 7.35E(a)(10) (but
no later than February 26, 2018): (1) The Re-Opening Time for a Trading
Halt Auction will be extended if the unadjusted Indicative Match Price
is equal to the Auction Collars; and (2) the Trading Halt Auction
processing described in Rules 7.35E(e)(5), (6), (7)(C), (8), and (10)
would not be applicable to a Trading Halt Auction following a trading
halt due to extraordinary market volatility under Rule 7.12-E (``MWCB
Halt'') or a regulatory halt (together, ``Temporary Rules''). Finally,
the Exchange proposes clarifying amendments to Rules 7.35E(c)(1) and
(d)(1).
---------------------------------------------------------------------------

    \4\ Capitalized terms used in this rule filing have the same
meaning as the capitalized terms in Rule 7.35E.
---------------------------------------------------------------------------

    The Exchange proposes that the Temporary Rules would become
operative on the same date the Exchange implements recent amendments to
Rule 7.35E, which the Exchange anticipates implementing at the same
time that the changes described in the twelfth amendment to the
Regulation NMS Plan to Address Extraordinary Market Volatility
(``Plan'') are implemented.\5\ As described in greater detail in the
Reopening Filing, the Exchange amended its rules relating to the
reopening of trading in conjunction with LULD Amendment 12. The
Exchange and the participants to the Plan have announced that the
changes described in the Reopening Filing and LULD Amendment 12 will be
implemented on November 20, 2017.\6\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 81968 (October 27,
2017), 82 FR 50898 (November 2, 2017) (SR-NYSEAmer-2017-30) (Notice
of filing and immediate effectiveness of proposed rule change)
(``Reopening Filing''). See also Securities Exchange Act Release
Nos. 79107 (October 18, 2016), 81 FR 73159 (October 24, 2016)
(Notice) and 79846 (January 19, 2017), 82 FR 8548 (January 26, 2017)
(Approval Order) (SR-NYSEArca-2016-130) (the ``NYSE Arca Reopening
Filing''), and Securities Exchange Act Release No. 79845 (January
19, 2017), 82 FR 8551 (January 26, 2017) (File No. 4-631) (Order
approving twelfth amendment to the Plan) (``LULD Amendment 12'').
    \6\ See Trader Update available here: https://www.nyse.com/publicdocs/nyse/markets/nyse/NYSE_Group_LULD_12_testing.pdf.
---------------------------------------------------------------------------

Proposed Amendment to Rule 7.35E(a)(10)
    Rule 7.35E(a)(10)(B) provides that an Indicative Match Price that
is equal to or higher (lower) than the upper (lower) boundary of the
Auction Collar will be adjusted to one minimum price variation below
(above) the upper (lower) boundary of the Auction Collar. In other
words, the Exchange does not conduct an auction at the Auction Collar
price.
    By contrast, Rule 7.35E(e)(5) currently defines the term
``Impermissible Price,'' i.e., when a Trading Halt Auction would not be
conducted, to mean when the Indicative Match Price, before being
adjusted based on Auction Collars, is below (above) the Lower (Upper)
Auction Collar or if there is a sell (buy) Market Imbalance. In other
words, the Exchange extends the Re-Opening Time for a Trading Halt
Auction only if the unadjusted Indicative Match Price is outside the
Auction Collar price.
    As currently approved, because the Exchange does not operate an
auction at the Auction Collar price, but also does not extend an
auction if the unadjusted Indicative Match Price is at the Auction
Collar Price, these two rules together would allow for a Trading Halt
Auction where not all auction interest (including Market Orders) would
be satisfied. For example, if the lower Auction Collar is 10.10 for a
security, and at 10.10 there are 200 shares to buy, at 10.11 there are
100 shares to buy, and the Exchange receives a sell Limit Order for 300
shares priced at 10.10, the Indicative Match Price, before being
adjusted for Auction Collars, would be 10.10, which would be equal to
the lower Auction Collar. Pursuant to Rule 7.35E(e)(5), an unadjusted
Indicative Match Price of 10.10 would not be an Impermissible Price and
therefore the auction would be conducted and would not be extended.
However, pursuant to Rule 7.35E(a)(10)(B), the collared Indicative
Match Price for that security would be 10.11, which would be where the
auction would be priced. Because the auction would be conducted at
10.11, the buy Limit Order priced at 10.10 would not participate.
Accordingly, in this scenario, 200 shares of the sell order would not
be executed and would be available to participate in continuous trading
after the auction. Similarly, if the sell order were a 300 share Market
Order, in this scenario, only 100 shares

of the Market Order would be executed, leaving 200 shares of the sell
Market Order unexecuted.
    The Exchange proposes to resolve the conflict between these two
rules by adjusting the price at which its auctions would be eligible to
trade. As proposed, the Exchange would permit auctions to be conducted
at prices equal to the Auction Collar price threshold. This proposed
rule change to allow for auctions to be priced equal to the Auction
Collar price thresholds is consistent with how another exchange prices
its auctions.\7\ To effect this change, the Exchange proposes to amend
Rule 7.35E(a)(10)(B) as follows (deletions in brackets):
---------------------------------------------------------------------------

    \7\ See Cboe BZX Exchange, Inc. (``BZX Equities'') Rule
11.23(a)(6) and (d)(2)(C).

    (B) An Indicative Match Price that is [equal to or] higher
(lower) than the upper (lower) boundary of the Auction Collar will
be adjusted to [one MPV below (above)] the upper (lower) boundary of
the Auction Collar and orders eligible to participate in the
applicable auction will trade at the collared Indicative Match
---------------------------------------------------------------------------
Price.

    The Exchange similarly proposes to amend Rule 7.35E(a)(10)(C) to
delete the phrase ``at or'' so that Limit Orders priced equal to the
Auction Collars would be eligible to participate in the Auction without
being collared, as follows (deletions in brackets):

    (C) Limit Orders to buy (sell) with a limit price [at or] above
(below) the upper (lower) Auction Collar will be included in the
Auction Imbalance Information at the collared Indicative Match Price
and will be eligible to trade at the Indicative Match Price.

    Rule 7.35E(a)(10)(A) provides that the Auction Collar for the Core
Open Auction and the Closing Auction (except as provided for in Rule
7.35E(e)(10)(B)) will be based on a price that is the greater of $0.50
or 10% away from the Auction Reference Price for the applicable
Auction. The rule further provides that the upper (lower) boundary of
the Auction Collar is the Auction Reference Price increased (decreased)
by either $0.50 or 10%, as applicable, rounded down to the MPV.
Finally, the rule provides that the Auction Collar for the Trading Halt
Auction is specified in Rule 7.35E(e)(7). Rule 7.35E(e)(7)(B)(i) and
(ii) similarly provide that Auction Collars for Trading Halt Auctions
are rounded down to the nearest MPV.
    The Exchange proposes to change its rounding methodology for
determining Auction Collars for all auctions. To effect this change,
the Exchange proposes to move the last sentence of Rule 7.35E(a)(10)(A)
to after the first sentence of that paragraph and make a non-
substantive amendment to change ``Rule 7.35E(e)(7)'' to ``paragraph
(e)(7) of this Rule.'' Next, the Exchange proposes to amend what was
formerly the second sentence of this paragraph, and what would now be
the last sentence, to replace the term ``10%'' with the term
``specified percentage,'' so that this sentence, which addresses how
Auction Collars are determined, would include how Auction Collars are
determined for Trading Halt Auctions. Finally, the Exchange proposes to
amend Rule 7.35E(a)(10)(A) to provide that the upper (lower) boundary
of the Auction Collar is the Auction Reference Price increased
(decreased) by either $0.50 or the specified percentage, as applicable,
rounded to the nearest MPV.\8\ The Exchange proposes to similarly amend
Rule 7.35-E(e)(7)(B)(i) and (ii) to provide that Auction Collars would
be rounded to the nearest MPV. Both Nasdaq Stock Market LLC
(``Nasdaq'') and BZX Equities use this rounding methodology when
determining auction collar prices for reopenings following a Trading
Pause.\9\ The Exchange would apply this same rounding methodology when
determining the Auction Collars for all auctions on the Exchange.
---------------------------------------------------------------------------

    \8\ If adding or subtracting the specified percentage of the
Auction Reference price to the Auction Collar would result in a
tenth of a penny, the Exchange would round down to the nearest penny
when the calculation results in one to four tenths of a penny and
the Exchange would round up to the nearest penny when the
calculation results in five to nine tenths of a penny.
    \9\ See Nasdaq Rule 4120(c)(10)(A)(ii)a. and b. and BZX Equities
Rule 11.23(d)(2)(C)(i) and (ii). The Nasdaq and BZX Equities rules
are silent on the rounding methodology they use when applying
percentages to auction collars for opening or closing auctions.
---------------------------------------------------------------------------

    The Exchange further proposes to amend Rules 7.35E(a)(10)(A) and
(e)(7)(B)(i) and (ii) to provide that the lowest Auction Collar would
be one MPV above $0.00. For example, if the Reference Price for a
security is $0.10, subtracting $0.15 from this Reference Price would
equal a negative number. In such case, the lower boundary of the
Auction Collar would be $0.0001. Because, as described above, the
Exchange would allow an auction to run at a price equal to an Auction
Collar, this proposed rule change would make clear that an auction
could run even if the Auction Collar would mathematically be equal to
or below $0.00.
    Because of technology changes associated with the proposed changes
to Rules 7.35E(a)(10)(A), (B), and (C), the Exchange proposes to
announce the implementation date of these changes by Trader Update,
which will be no later than February 26, 2018. Between the effective
date of these proposed rule changes and the implementation date, the
Exchange proposes to keep the deleted rule text in its rule book, but
will keep the deleted text in brackets and new text underlined to
indicate that the Exchange has an effective proposed rule change
amending that text. To reduce confusion and promote transparency, the
Exchange proposes to describe how the text will be marked in proposed
paragraph (c) to new Commentary .02 as follows:

    Paragraphs (a)(10)(A), (B), and (C) of this Rule will have text
in brackets indicating which text will be deleted and underlined
text indicating which text will be new when the Exchange implements
the amendments to those paragraphs.

Temporary Rule for Extending an Auction When Indicative Match Price Is
Equal to Auction Collar
    Pending the implementation of the technology changes described
above, the Exchange proposes a temporary rule that would provide that
the Exchange would extend the Re-Opening Time for a Trading Halt
Auction if the unadjusted Indicative Match Price is equal to an Auction
Collar. As proposed, for the period beginning November 20, 2017, when
the changes described in the Reopening Filing are implemented, and
ending when the Exchange's technology changes are implemented or
February 26, 2018, whichever is earlier, an Impermissible Price would
include a price equal to the Auction Collar and thus a Trading Halt
Auction would be extended when the unadjusted Indicative Match Price is
equal to the Upper or Lower Auction Collar. This temporary rule would
align the extension of an auction under Rule 7.35E(e)(5) with the price
at which an auction would be conducted pursuant to Rule
7.35E(a)(10)(B). The Exchange believes that amending its rules on a
temporary basis would be consistent with the purpose of the extension
logic for Trading Halt Auctions, which is, in part, to ensure that all
interest (including Market Orders) eligible to participate in the
Trading Halt Auction is satisfied and not carried over to continuous
trading.\10\
---------------------------------------------------------------------------

    \10\ See Reopening Filing, supra note 5.
---------------------------------------------------------------------------

    To effect this temporary change, the Exchange proposes to add
Commentary .02 to Rule 7.35E that would describe the Temporary Rules
that would be in effect until the earlier of February 26, 2018 or when
the Exchange implements amendments to Rules 7.35E(a)(10)(A), (B), and
(C), described above, which would be announced by Trader Update.

Proposed paragraph (a) to new Commentary .02 to Rule 7.35E would
describe the Temporary Rule relating to determining when a Trading Halt
Auction would be extended and would provide that Rule 7.35E(e)(5) would
not be in effect and a Trading Halt Auction would not be conducted if
the Indicative Match Price, before being adjusted based on Auction
Collars, would be equal to or below (above) the Lower (Upper) Auction
Collar or if there is a sell (buy) Market Imbalance (an ``Impermissible
Price'').
    The Exchange believes that including temporary rule text that
describes how the Exchange will be determining the Impermissible Price
beginning on November 20, 2017 will promote the protection of investors
and the public interest because it will provide transparency in
Exchange rules regarding how the Exchange is operating. The proposed
amendment would further promote transparency by including the end date
for the temporary rule. Once the temporary rule is no longer in effect,
the Exchange will file a proposed rule change to delete the proposed
Commentary .02(a) to Rule 7.35E.
Temporary Rule for MWCB and Regulatory Halts
    In the Reopening Filing, the Exchange amended Rule 7.35E(e) to
provide for a standardized methodology regarding how a primary listing
exchange that conducts automated reopenings following a Trading Pause
would reopen if Market Orders cannot be satisfied in the Trading Halt
Auction. The amendments provide for a standardized Auction Reference
Price and Auction Collar values, as well as for a standardized process
for extending the Trading Pause if there is an Impermissible Price at
the Re-Opening Time. The rule also implements the requirement set forth
in LULD Amendment 12 that if an NMS Stock is in a Trading Pause during
the last ten minutes of trading before the end of Regular Trading
Hours, the Primary Listing Exchange shall not reopen trading and shall
attempt to execute a closing transaction using its established closing
procedures.\11\
---------------------------------------------------------------------------

    \11\ See LULD Amendment 12, supra note 5.
---------------------------------------------------------------------------

    As described in the Reopening Filing, the Exchange chose to make
the changes described in the Reopening Filing available for Trading
Halt Auctions following a MWCB Halt or regulatory halt.\12\ However,
because of the different technology supporting Trading Halt Auctions
following MWCB Halts and regulatory halts, the changes described in the
Reopening Filing as applicable for a Trading Halt Auction following a
MWCB Halt or regulatory halt will not be available on the
implementation date for the LULD Amendment 12 changes.\13\
---------------------------------------------------------------------------

    \12\ See Reopening Filing, supra note 5.
    \13\ The changes described in the Reopening Filing as applicable
for Trading Halt Auctions following a Trading Pause will be
implemented at the same time as the LULD Amendment 12 changes.
---------------------------------------------------------------------------

    The Exchange will adjust its technology to align the treatment of
Trading Halt Auctions following a MWCB Halt or regulatory halt with
current Rules 7.35E(e)(5)-(8) and (e)(10). However, because these
technology changes will not be ready by November 20, 2017, which is
when the rules described in the Reopening Filing will be implemented,
the Exchange proposes paragraph (b) to Commentary .02 to Rule 7.35E to
provide for the Temporary Rule that the Trading Halt Auction processing
described in Rules 7.35E(e)(5), (6), (7)(C), (8) and (10) would not be
applicable to a Trading Halt Auction following a MWCB Halt or a
regulatory halt. Rule 7.35E(e)(7) and sub-paragraphs (A) and (B) of
that Rule, which specify the Auction Collar Reference Price and Auction
Collars for Trading Halt Auctions, including for Trading Halt Auctions
following a MWCB Halt or regulatory halt, would be applicable beginning
November 20, 2017 for all Trading Halt Auctions. The Exchange intends
to make the technology changes relating to Trading Halt Auctions
following a MWCB Halt or regulatory halt at the same time that it
implements the technology changes relating to the amendments to Rules
7.35E(a)(10)(A), (B), and (C), described above.
    The Exchange believes that including temporary rule text that
describes how the Exchange will be processing Trading Halt Auctions
following a MWCB Halt or regulatory halt beginning on November 20, 2017
will promote the protection of investors and the public interest
because it will provide transparency in Exchange rules regarding how
the Exchange is operating. The proposed amendment would further promote
transparency by including the end date for the temporary rule. Once the
temporary rule is no longer in effect, the Exchange will file a
proposed rule change to delete proposed Commentary .02(b) to Rule
7.35E.\14\
---------------------------------------------------------------------------

    \14\ The Exchange also proposes to amend Rule 7.35E(e)(10) to
add the phrase ``halted or'' to the second sentence of that rule so
that it would provide: ``Instead, the Exchange will remain halted or
paused and will conduct a Closing Auction in such security as
provided for in paragraph (d) of this Rule.'' The Exchange believes
that because current Rule 7.35E(e)(10) applies to both halts and
pauses, this proposed rule change clarifies the existing rule text.
This proposed rule change would be in effect once the Temporary Rule
described in Commentary .02(b) to Rule 7.35E has ended.
---------------------------------------------------------------------------

Clarifying Amendments to Rule 7.35E(c)(1) and (d)(1)
    Rules 7.35E(c)(1) provides that the Exchange will begin publishing
Core Open Auction Imbalance Information at 8:00 a.m. Eastern Time. Rule
7.35E(d)(1) provides that the Exchange will begin publishing Closing
Auction Imbalance Information one hour before the scheduled time for
the Closing Auction. Because regularly scheduled auctions are not
overlapping, the Exchange does not publish auction imbalance
information for more than one auction at a time. However, if there is a
Trading Halt Auction during the period when the Exchange would
otherwise be publishing either Core Open or Closing Auction Imbalance
Information, the Exchange stops publishing the Core Open or Closing
Auction information and begins publishing Trading Halt Auction
Imbalance Information. The proprietary data feeds that carry the
Auction Imbalance Information specify for which auction the auction
imbalance information is for (e.g., Trading Halt Auction or Core Open
Auction).
    The Exchange proposes to amend Rules 7.35E(c)(1) and (d)(1) to
clarify what auction information is published if there is a halt (or
pause) in the period when either Core Open Auction or Closing Auction
Imbalance Information would otherwise be published.\15\
---------------------------------------------------------------------------

    \15\ A halt before Core Trading Hours would be a regulatory halt
because a Trading Pause will occur only during Core Trading Hours,
and therefore a security would not be paused before the Core Open
Auction, and a MWCB Halt can be triggered only during Core Trading
Hours.
---------------------------------------------------------------------------

    As proposed, Rule 7.35E(c)(1) would be amended to add that ``unless
a security is halted,'' the Exchange will begin publishing Core Open
Auction Imbalance Information at 8:00 a.m. Eastern Time. The Exchange
further proposes to add two new sentences to the rule that would
provide:

    If a security is halted after 8:00 a.m. Eastern Time but before
the Core Open Auction, the Exchange will stop publishing Core Open
Auction Imbalance Information and will begin publishing Trading Halt
Auction Imbalance Information. The Exchange will resume publishing
Core Open Auction Imbalance Information if the security reopens
trading before Core Trading Hours begin.

    Similarly, as proposed, Rule 7.35E(d)(1) would be amended to add
that ``unless a security is halted or paused,'' the Exchange will begin
publishing Closing Auction Imbalance Information one hour before the

scheduled time for the Closing Auction. The Exchange further proposes
to add two new sentences to that rule that would provide:

    If a security is halted or paused less than one hour before the
scheduled time for the Closing Auction, the Exchange will stop
publishing Closing Auction Imbalance Information and will begin
publishing Trading Halt Auction Imbalance Information. The Exchange
will resume publishing Closing Auction Imbalance Information the
earlier of when the security reopens trading or ten minutes before
the scheduled time for the Closing Auction.\16\
---------------------------------------------------------------------------

    \16\ The reference in this proposed rule to resuming publishing
Closing Auction Imbalance Information ten minutes before the
scheduled time for the Closing Auction refers to Rule 7.35-E(e)(10),
which will be implemented for Trading Pauses on November 20, 2017,
and will be implemented for MWCB Halts and regulatory halts the
earlier of February 26, 2018 or when the technology changes
described above are implemented.

    Because the proposed amendments to Rules 7.35E(c)(1) and (d)(1)
describe current functionality, the Exchange proposes that these rule
changes would be implemented on the operative date of this filing.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Exchange Act,\17\ in general, and with Section
6(b)(5),\18\ in particular, because it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, to
remove impediments to, and perfect the mechanism of, a free and open
market and a national market system and, in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed amendment to Rules
7.35E(a)(10)(B) and (C) to allow auctions to be conducted at a price
equal to the Auction Collars would remove impediments to and perfect
the mechanism of a free and open market and a national market system
because it would align how auctions are priced with the rules of
another exchange.\19\ Specifically, the application of auction collars
on BZX Equities allow for an auction to be priced equal to the auction
collars on that market. The proposed amendments to Rule 7.35E(a)(10)
would similarly allow for the Exchange to price auctions equal to the
Auction Collar. More specifically, for Trading Halt Auctions, the
Exchange believes that this proposed rule change would remove
impediments to and perfect the mechanism of a free and open market and
a national market system because it would align how reopening auctions
are priced, which is consistent with the goal of the Reopening Filing
to have standardized processes for re-opening a security following a
Trading Pause across the primary listing exchange.
---------------------------------------------------------------------------

    \19\ See supra note 7.
---------------------------------------------------------------------------

    The Exchange believes that the proposed amendment to Rules
7.35E(a)(10)(A) and 7.35-E(e)(7)(B)(i) and (ii) to apply the same
rounding methodology as Nasdaq and BZX Equities when determining the
Auction Collars following a Trading Halt Auction would remove
impediments to and perfect the mechanism of a free and open market and
a national market system because it would align the Exchange's rules
regarding how Auction Collars would be determined for a Trading Halt
Auction with the rules of Nasdaq and BZX Equities. The Exchange further
believes that it would remove impediments to and perfect the mechanism
of a free and open market to apply the proposed rounding methodology to
determining Auction Collars for all auctions on the Exchange because it
would promote consistency in the application of rounding when
determining Auction Collars, thereby promoting consistency across
Exchange rules and reducing potential confusion. The Exchange further
believes that amending Exchange rules to provide that the lowest
Auction Collar would be one MPV above $0.00 would remove impediments to
and perfect the mechanism of a free and open market and a national
market system because it would clarify that an auction could run even
if the Auction Collar would mathematically be equal to or below $0.00,
thereby promoting transparency in Exchange rules.
    The Exchange believes that the Temporary Rules would remove
impediments to and perfect the mechanism of a free and open market and
a national market system because these proposed rule changes would
provide transparency regarding how the Exchange will function when the
changes described in LULD Amendment 12 and the Reopening Filing are
implemented, which is scheduled for November 20, 2017. The Exchange
fully intends to implement the rules as approved in the Reopening
Filing. However, the Exchange will not be able to implement Rule
7.35E(e)(5), as described in the Exchange's current rules, or apply the
processing describing in Rules 7.35E(e)(5), (6), (7)(C), (8), and (10)
to Trading Halt Auctions following a MWCB Halt or regulatory halt,
until the changes described for the proposed amendments to Rule
7.35E(a)(10) are implemented. The Exchange believes that adding the
Temporary Rules for the interim period pending such implementation will
promote the protection of investors and the public interest because it
will provide transparency in Exchange rules regarding how the Exchange
is operating. The proposed amendment would further promote transparency
by including the end date for the temporary rule.
    Finally, the Exchange believes that the proposed amendments to
Rules 7.35E(c)(1) and (d)(1) will remove impediments to and perfect the
mechanism of a free and open market and a national market system
because these proposed amendments would clarify in Exchange rules which
imbalance information would be published if there is a trading halt or
pause during a period when either Core Open Auction or Closing Auction
Imbalance Information is being published. The Exchange believes that
the proposed clarifications will promote the protection of investors
and the public interest because they will provide transparency
regarding which imbalance information would be published at specific
times prior to the Core Open and Closing Auctions.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change to
Rules 7.35E(a)(10) and (e)(7) would remove a potential burden on
competition by aligning the Exchange's rules regarding how auctions
would be priced and Auction Collars would be determined with the rules
of other exchanges. The proposed Temporary Rules and clarifying
amendment to Rules 7.35E(c)(1) and (d)(1) are not designed to address
any competitive issues but rather to promote transparency in Exchange
rules regarding how the Exchange will function.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
\20\ and Rule 19b-4(f)(6) thereunder.\21\
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and the text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \22\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \23\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. According to
the Exchange, the implementation date of November 20, 2017 for the
changes described in the Reopening Filing and LULD Amendment 12 is an
industry-wide implementation date. The Exchange states that it fully
intends to implement the rules as approved in the Reopening Filing, but
it will not be able to implement Rule 7.35E(e)(5) or apply the
processing described in Rules 7.35E(e)(5), (6), (7)(C), (8), and (10)
to Trading Halt Auctions following a MWCB Halt or regulatory halt until
the proposed amendments to Rule 7.35E(a)(10) are implemented.\24\
According to the Exchange, until it makes the changes in the proposed
amendments to Rule 7.35E(a)(10), it will have functionality in
production that does not match its current rules.
---------------------------------------------------------------------------

    \22\ 17 CFR 240.19b-4(f)(6).
    \23\ 17 CFR 240.19b-4(f)(6)(iii).
    \24\ According to the Exchange, the proposed amendments to Rules
7.35E(a)(10) and (e)(7) are consistent with the goal of having
standardized processes across primary listing exchanges for re-
opening a security following a Trading Pause, will promote
consistency when determining Auction Collars across the Exchange's
auctions, and will make clear that an auction could run even if the
Auction Collar would mathematically be equal to or below $0.00.
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
The Commission believes that implementing the Temporary Rules without
delay will promote transparency in the Exchange's rules regarding how
the Exchange will function during this interim period.\25\ The
Commission notes that the Temporary Rules will be in effect until the
Exchange implements its technology changes or until February 26, 2018,
whichever is earlier. Accordingly, the Commission hereby waives the 30-
day operative delay and designates the proposal operative upon
filing.\26\
---------------------------------------------------------------------------

    \25\ In addition, according to the Exchange, the proposed
amendments to Rule 7.35E(c)(1) and (d)(1) will provide transparency
regarding which imbalance information would be published at specific
times prior to the Core Open and Closing Auctions.
    \26\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEAMER-2017-33 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEAMER-2017-33. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEAMER-2017-33 and should
be submitted on or before December 19, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-25607 Filed 11-27-17; 8:45 am]
 BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C., 20460
                                   OFFICE OF
                              CHEMICAL SAFETY AND
                             POLLUTION PREVENTION
                                   OFFICE OF
                              CHEMICAL SAFETY AND
                             POLLUTION PREVENTION

                                                                PC Code: 053001
                                                            DP Barcodes: 428697

MEMORANDUM	February 17, 2016

SUBJECT:	Metaldehyde: Drinking Water Exposure Assessment for New Use on Garden Beets, Hops, Rutabaga, Turnips, and Wheat in the Pacific Northwest for Interregional Research Project No.4 (IR-4).

TO:			Barbara Madden, Team Leader
            Sidney Jackson, Reviewer
         Minor Use, and Emergency Response Branch
         Registration Division

FROM:	James Hetrick, Ph.D., Senior Science Advisor
                              Rosanna Louie-Juzwiak, Risk Assessment Process Leader
               Environmental Fate and Effects Division

THROUGH:	Dana Spatz, Branch Chief
               Environmental Risk Branch 3
         Environmental Fate and Effects Division (7507P)\

The Interregional Research Project #4 (IR-4) has proposed new uses of metaldehyde (2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane) on garden beets, hops, rutabaga, turnips, and wheat in the Pacific Northwest. The proposed maximum metaldehyde application rates are 2 lb a.i./A/year for garden beets, 4 lb a.i./A/year for hops, rutabaga, turnip, and 6 lb ai/A/year for wheat.

Previous drinking water assessments for metaldehyde were conducted to support the APHIS exotic mollusk eradication use on to grass (seed crop), forage and hay (DP Barcode 404861, 7/17/13).  The application rate used in the assessment was 2 lb a.i./acre applied in 6 broadcast (ground) applications for a total maximum annual application of 12 lb a.i./acre.  The estimated drinking water concentrations (EDWCs) are shown in Table 1. The highest estimated 1-in-10-year annual peak (acute), annual average (chronic) and 30-year annual average (cancer) concentrations of metaldehyde in surface water sources of drinking water are 205, 136, and 83 μg/L, respectively.  For groundwater sources of drinking water, the estimated peak and post-breakthrough average concentrations were 1,740 μg/L and 635 μg/L, respectively (Error! Reference source not found.).

Table 1. Maximum Tier II estimated drinking water concentrations (EDWCs) in parts per     billion (μg/L) resulting from applications of metaldehyde at an annual application rate of 12 lb a.i./acre.
Drinking water source (model)
                                 1-in-10 year
                              30-year simulation

                                     Acute
                                    Chronic
                                     Acute
                                    Chronic
Surface water
(PRZM-EXAMS)
                                      205
                                      136
                                       -
                                      83
Groundwater
(PRZM-GW)
                                       -
                                       -
                                     1740
                                      635

Because the proposed new metaldehyde uses on the US-LON-A label (EPA Reg. No. 6836-350) have application rates lower than assessed in previous drinking water assessments (DP Barcode 404861, 7/17/13), the EDWCs reported in the previous drinking water assessment for metaldehyde continue to be the recommended values for use in the human health assessment. These EDWCs provide the most conservative concentrations in surface and ground source drinking water for current metaldehyde uses.