85%
20%
Continuous/no fat added (1.0 log reduction)
45%
5%
70%
Vacuum (no reduction)
5%
5%
5%
Rendering – Contamination of non prohibited MBM by
prohibited MBM in mixed facilities
Probability for a particular prohibited packet
14%
5%
25%
Magnitude of contamination
a
0.1% 0.01% 1.0%
Rendering – Probability that prohibited MBM will be
mislabeled as non-prohibited MBM when produced by
either a mixed or prohibited rendering plant
5% 2% 10%
Feed Production – Contamination of non prohibited MBM
by prohibited MBM in mixed facilities
Probability for a particular prohibited packet
16%
5%
16%
Magnitude of contamination
a
0.1% 0.01% 1.0%
Feed Production – Probability that prohibited feed will be
mislabeled as non-prohibited feed when produced by either a
mixed feed production plant
5% 2% 33%
Probability that correctly labeled prohibited feed will be
incorrectly administered to cattle
1.6% 0.1%  15%
Notes:
a.
Refers to the proportion of the prohibited packet that ends up in the non-prohibited packet when
contamination occurs.

Section 3
-
70 -
3.2.4
Proportion of Tissues Recovered for Human Consumption
Table 3-10 details the base case, best case, and worst case assumptions regarding the
proportion of tissue recovered for human consumption.  Note that none of these sets of
assumptions include a specified risk material (SRM) ban.
Table 3-10
Base Case, Best Case, and Worst Case Values for the Proportion of Tissues Recovered from
Cattle for Human Consumption
Tissue Base Best
Cas
e
Case
Worst
Case
AMR Meat
0.98
0.98
0.98
Blood 0.05 0.025 0.3
Bone (in-bone cuts of meat)
0.98
0.98
0.98
Brain 0.01 0.001 0.02
Dorsal root ganglia
0
0
0
Eyes 0.001 0 0.002
Ileum
0.01 0.001 0.02
Heart 0.5 0.3 0.6
Kidney
0.25 0.15 0.35
Liver 0.6 0.4 0.7
Lung
0 0 0
Muscle 0.98 0.98 0.98
Spinal Cord
0.01
0.001
0.02
Trigeminal ganglia
0
0
0
3.2.5
Proportion of Animals That Die on Farm that Are Rendered
The base case assumes that 85% of the animals that die on the farm (i.e., before they are
sent to slaughter) are rendered.  The best case assumes that this proportion is 60%, while the
worst case assumes that it is 99%.
3.2.6
The Possibility That BSE-Infected Cattle Carry Infectivity in Their Blood
The base case assumes that cattle infected with BSE do not carry infectivity in their blood
(although emboli formation may result in blood contamination).  We consider the possibility that
0.016% of the infectivity in an animal with BSE is carried in the blood, a value that is consistent
with the assumption that its concentration is at the level of detection in an animal with a full-
blown case of BSE (SSC, 2000a).

Section 3
-
71 -
3.2.7
The Possibility that Humans are Exposed to BSE Infectivity in Trigeminal Ganglia
The base case assumes that the trigeminal ganglia harbor no infectivity prior to the
passage of 50% of the period between infection and the manifestation of clinical signs, but that
after that time, they harbor 2.6% of the total infectivity.  It assumes further that no trigeminal
ganglia tissue is recovered for human consumption.  The uncertainty analysis evaluates the
impact of assuming that 0.1% of the infectivity in the trigeminal ganglia (as much as 0.0026% of
the total infectivity) is recovered for human consumption with 1% probability, and that with 99%
probability, none of this infectivity is recovered for human consumption.
3.3
The Base Case:  Impact of Alternative Sources of Infectivity
This section describes how we used the model to evaluate the impact of different sources
of infectivity on the model’s predictions.  For each of the scenarios considered, we adopted the
base case assumptions.  Infectivity sources evaluated include: spontaneous development of
disease (Section 3.3.1), importation of infected cattle (Section 3.3.2), scrapie in sheep (Section
3.3.3), chronic wasting disease (CWD) in deer/elk-derived protein supplements (Section 3.3.4),
CWD from direct contact with infected mule deer, white tail deer and/or elk (Section 3.3.5),
transmissible mink encephalopathy in mink (Section 3.3.6), a TSE in pigs (Section 3.3.7), and a
TSE in chickens (Section 3.3.8).
3.3.1 Spontaneous BSE
Because there are no measurements of an incidence rate for spontaneous BSE in cattle,
we use the observed age-specific sporadic rate for CJD in humans as a proxy, adjusting the ages
to reflect the difference between the natural lifespan for bovines (approximately 20 years)
(Nowak et al., 1983) and the much longer natural lifespan for humans (approximately 75 years).
For example, the CJD incidence rate for 75-year old humans is assumed to represent the BSE
incidence rate for 20-year old bovines.  Making this adjustment and taking into account the
incubation period for BSE yields the age-specific rates that appear in Table 3-11.
Developing age-specific rates is necessary because the often-quoted incidence rate for
sporadic CJD in humans of one per million per year hides substantial variation across age groups.
The disease is virtually never seen before age 30 and has a peak incidence between ages 60 and

Section 3
-
72 -
65 (Collinge and Palmer, 1997).  If this pattern (Figure 3-7) is applicable to sporadic BSE, then
estimated rates in cattle must reflect the age structure of the disease.
Finally, recall that the human CJD rates used to estimate the incidence rate for BSE
represent the rate at which clinical cases appear in the population.  Therefore, the rates in Figure
3-7 cannot be used to estimate the rate at which new pre-clinical cases might develop.  Instead,
the case age-specific clinical incidence rates must be advanced by the duration of the period
between infection and the manifestation of clinical signs.  The median incubation period for BSE
is approximately four years (Section <IP_ADDRESS>).  Table 3-11 lists the sporadic BSE rates inferred
from the human sporadic CJD rates.  Note that the fourth column from the left (the spontaneous
BSE new infection rate) is similar to the third column from the left (the spontaneous CJD new
clinical case rate) but is offset by three rows, representing four years.

Section 3
-
73 -
Table 3-11
Human Age Categories, Equivalent Cattle Age Categories, and Age-Specific Human
Sporadic CJD Rates
a
Human Age
Category
(years)
Equivalent
Cattle Age Category
(years)
Annual Clinical
CJD Incidence Rate
(per million)
Annual Pre-Clinical
BSE Incidence Rate
(per million)
0 to 4
0.0 to 1.0
<0.01
0
<s>b</s>
5 to 9
1.3 to 2.4
0
< 0.01
10 to 14
2.6 to 3.7
0
<0.01
15 to 19
4.0 to 5.0
0
0.04
20 to 24
5.3 to 6.4
<0.01
0.08
25 to 29
6.6 to 7.7
<0.01
0.16
30 to 34
8.0 to 9.07
0.04
0.45
35 to 39
9.3 to 10.4
0.08
0.99
40 to 44
10.6 to11.7
0.16
2.14
45 to 49
12.0 to13.0
0.45
3.55
50 to 54
13.3 to14.4
0.99
5.03
55 to 59
14.6 to15.7
2.14
5.75
60 to 64
16.0 to17.0
3.55
5.6
65 to 69
17.3 to18.4
5.03
3.94
70 to 74
18.6 to19.7
5.75
2.42
75 to 79
20.0 to21.0
5.6
2.42
c
80 to 84
21.3 to22.4
3.94
2.42
c
85 +
22.6 +
2.42
2.42
c
Notes:
a.
Adapted from (Holman et al., 1995, anonymous, 1996)
b.
We assume that the spontaneous CJD case observed in a young child was erroneous.
c.
We assume that the spontaneous rate for BSE remains unchanged at ages beyond what can be
inferred from the corresponding spontaneous CJD data.
3.3.2
Importation of Infected Cattle
Because APHIS has banned the import of cattle from countries in which the presence of
native BSE has been documented (see Section 2.3.2), the import of even a single infected animal
is not likely. Given that even in the UK, the prevalence of BSE is relatively small, it is
implausible that a large number of animals infected with BSE might be imported into the United
States.
Nonetheless, in order to evaluate the robustness of the U.S. cattle population against the
introduction of infected animals, we have simulated the introduction of 1, 5, 20, 50, 200, and 500

Section 3
-
74 -
animals into the U.S. We assume that the imported animals are 12-month old female dairy cattle
that have just become infected.
3.3.3 Domestic Scrapie
The transmission of scrapie from sheep to cattle is one of the primary hypotheses for the
origin of BSE  (Horn et al., 2001).  Moreover, scrapie is present in the United States.  Although
no North American strain of scrapie has been successfully transmitted to cattle exposed orally to
the agent (Cutlip et al., 2001), we evaluate the impact of assuming that such transmission is
possible.  In particular, if such transmission is possible, we estimate that the rendering of scrapie-
infected sheep could expose the U.S. cattle population to 1 cattle oral ID
50
in feed each month.
The derivation of this estimate is based on the assumption that the number of cattle oral ID s
50
administered to cattle is equal to the product of 1) the number of scrapie-infected sheep rendered
each year, 2) the number of sheep oral ID s per infected animal, 3) the inverse of the cattle-sheep
50
species barrier, and 4) the proportion of infectivity sent to rendering that survives rendering and is
ultimately administered to cattle.
Number of scrapie-infected sheep rendered:  We estimate the number of clinical sheep
and the number of pre-clinical sheep separately.  A total of approximately 180,000 federally
inspected mature sheep are slaughtered each year in the U.S. (USDA-FSIS, 1998).  Assuming that
the prevalence of scrapie is the same in the U.S. as it is in the UK (11%) (Simmons et al., 2000),
there are approximately 20,000 sheep with scrapie slaughtered each year.  Although sheep with
clinical signs would ordinarily be detected at AM inspection and directed to incineration, we
assume that they are rendered.  We assume that 1% of the infected sheep fall into this category,
suggesting that approximately 200 sheep with clinical signs are slaughtered each year.  Note that
these estimates are likely to be conservative because the true prevalence of scrapie in the U.S. is
probably less than it is in the UK.
Number of sheep oral ID s per clinical scrapie case:  For sheep with clinical scrapie, we
50
assume that this quantity is 10,000, i.e., the same as the number of cattle oral ID s per clinical
50
case of BSE.  In order to estimate the amount of infectivity in sheep that are not yet showing
clinical signs of disease, we assume that the infectivity load for scrapie follows the same temporal
pattern as BSE does in cattle (see Figure 3-6).  As a result, we estimate the average number of
ID s in a sheep to equal the time-averaged ID
50
50
burden in cattle over the period prior to the

Section 3
-
75 -
development of clinical signs, or approximately 600 ID s.  Note that this estimate is likely to
50
overstate the true average culling and slaughter ensure that the number of older sheep (and hence
the number of sheep that have been infected with scrapie for a long period of time) is less than the
number of sheep that are younger (and hence are likely to have been infected for a shorter period
of time).
The cattle-sheep species barrier:  We assume that the species barrier between sheep and
cattle is 1,000, i.e., 1 sheep oral ID
50
is equivalent to 0.001 cattle oral ID s.  This assumption is
50
based on an evaluation of the relative transmissibilty of BSE from cattle to mice (Bradley, 1999)
and on results from in vitro conversion studies (Raymond et al., 1997).  The true species barrier is
unknown and may be substantially higher.  For example, no North American strain of scrapie has
been successfully transmitted to cattle exposed orally to the agent (Cutlip et al., 2001).
Proportion of infectivity surviving rendering and administered to cattle:  We used the
simulation model, along with the base case assumptions to estimate the proportion of infectivity
in prohibited material that is ultimately administered to cattle.  In particular, we repeatedly
simulated the rendering of a bovine with 1 ID
50
using the base case assumptions.  Based on 1,000
runs of this simulation, we estimate that under the conditions described the base case, the average
number of ID s administered to cattle amounted to 8
50
×
10 , i.e., a little less than 0.1% of the
-4
infectivity in prohibited material survives rendering and is ultimately administered to cattle.
Total infectivity to cattle:  For sheep with clinical scrapie, the product of the four
quantities just described is approximately 2 cattle oral ID s per year.  For sheep not yet showing
50
clinical signs of disease, the product is approximately 10 cattle oral ID s per year.  The total
50
amounts to 12 cattle oral ID s annually, or 1 cattle oral ID
50
50
per month.  Note that this estimate
probably overstates actual cattle exposure for two reasons.  First, it is likely that the true species
barrier is greater than the value of 1,000 used here.  Second, the prevalence of scrapie in the U.S.
is probably less than the UK prevalence rates adopted here.
3.3.4
Chronic Wasting Disease:  Oral Exposure
The FDA feed ban prohibits the use of rendered material derived from cervids in the
production of feed to be administered to cattle.  However, because the ban is not completely
effective, cattle may be exposed to cervid-derived protein and hence to CWD. This section

Section 3
-
76 -
describes our estimate of an upper bound on this exposure.  Annual cattle exposure to CWD
attributable to consumption of cervid-derived protein is the product of the 1) number of diseased
animals harvested, 2) the number of cervid ID s per slaughtered case, 3) the fraction of animals
50
rendered, 4) the inverse of the species barrier, and 5) the proportion of infectivity surviving
rendering and administered to cattle.  As described below, we estimate that present-day exposures
to CWD among the U.S. cattle population could be as high as 2 cattle oral ID s per year,
50
although the true value is likely to be substantially lower and could be zero.
Number of diseased animals harvested:  Table 3-12 details the disease prevalence rate,
population size, and annual harvest rate for the three species suspected of harboring CWD.  In
one respect, these estimates are likely to overstate the true values because they assume the
prevalence rate for the endemic area applies to the entire population.  On the other hand, because
monitoring of CWD is limited to post mortem evaluation of brain tissue, it is possible that
surveillance fails to detect animals with less advanced disease.
Table 3-12
Annual Number of CWD-Infected Animals Harvested
Species Disease
Prevalence
a
Population
Size
b
Annual
Harvest
Rate
b
Infected Animals
Harvested per
Year
c
Mule deer
4.9%
2
×
10
<s>6</s>
20-25% 24,500
White tail deer
2.1%
3.2
×
10
7
25% 168,000
Rocky Mountain Elk
0.5%
1.0
×
10
6
15-20% 1,000
Total
194,000
Notes:
a.
Refers to the estimated prevalence of CWD among animals harvested from the CWD endemic areas
of north central Colorado and southeastern Wyoming (Miller et al., 2000)
b. Source (Rocky Mountain Elk Foundation, 1997); Lloyd Floyd, personal communication; Quality
Deer Management Association's
c.
Computed using the upper bound annual harvest rate in the fourth column from the left.
Number of cervid ID s per case:  Because the prevalence rate has been estimated on the
50
basis of post mortem evaluation of brain tissue, they may reflect only those animals that have
advanced disease.  We assume that there are 10,000 cervid oral ID s per case of disease.
50

Section 3
-
77 -
Fraction of animals rendered:  Only a small portion of cervids harvested for human
consumption are likely to be rendered at all.  Those that are rendered are most often processed by
an independent facility that handles only prohibited rendered material (Don Franco, personal
communication).  We assume that 10% of the harvested cervids are rendered.
The species barrier:  As noted in Section 2.3.4, the species barrier for the transmission of
CWD from cervids to cattle appears to be between 10 and 10 .  We conservatively assume that


[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Notices]
[Page 56812]
[FR Doc No: 2023-17906]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 5596-020]

Town of Bedford, Virginia; Notice of Waiver Period for Water
Quality Certification Application

    On July 31, 2023, the Town of Bedford, Virginia submitted to the
Federal Energy Regulatory Commission (Commission) a copy of its request
for a Clean Water Act section 401(a)(1) water quality certification
filed with the Virginia Department of Environmental Quality (Virginia
DEQ), in conjunction with the above captioned project. Pursuant to 40
CFR 121.6 and section 5.23(b) of the Commission's regulations,\1\ we
hereby notify the Virginia DEQ of the following:
---------------------------------------------------------------------------

    \1\ 18 CFR 5.23(b).
---------------------------------------------------------------------------

    Date of Receipt of the Certification Request: July 28, 2023.
    Reasonable Period of Time to Act on the Certification Request: One
year (July 28, 2024).
    If Virginia DEQ fails or refuses to act on the water quality
certification request on or before the above date, then the agency
certifying authority is deemed waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: August 15, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-17906 Filed 8-18-23; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF CHEMICAL SAFETY AND

                      POLLUTION PREVENTION

  SEQ CHAPTER \h \r 1 MEMORANDUM

  SEQ CHAPTER \h \r 1

DATE: November 15, 2010

SUBJECT:	ChemSAC Review of the USDA IR-4 Crop Grouping Proposal to Amend
the Tree Nut Crop Group 14, and Analysis of the USDA IR-4 Petition to
Amend the Crop Group Regulation 40 CFR § 180.41 (16) and Commodity
Definitions [40 CFR § 180.1 (g)].

FROM:	Bernard A. Schneider, Ph.D., Senior Plant Physiologist

Chemistry and Exposure Branch

Health Effects Division (7509P)

TO:	Michael Doherty, Ph.D. and William Donovan, Ph.D.,

Chairpersons HED Chemistry Science Advisory Council (ChemSAC)

		Jennifer Selwyn, PMRA

		Felix Valera, SAGARPA, Mexico

	Barbara Madden, Minor Use Officer, RD (7505P)

		Laura Nollen, RD (7505P)

cc: 	IR-4 Project, Bill Barney, Jerry Baron, Dan Kunkel, Debbie
Carpenter, Van Starner

BACKGROUND:

	The current Crop Group 14, Tree Nuts group published in 40 CFR 180.41
(14) includes 12 commodity entries in seven botanical families including
Anacardiaceae, Betulaceae, Fagaceae, Juglandaceae, Lecythidaceae,
Proteaceae, and Rosaceae.  Almond and pecan were selected as
representative commodities for this group.  There have been 55 group
tolerances established on tree nut crop group based on the residue data
generated from the representative crops.

	Botanically, a nut is a hard indehiscent (not opening at maturity)
one-seeded fruit.  It is also defined as a hard shelled fruit or seed of
which the kernel is eaten by humans.  A nut is the seed of a tree.
However, a nut in commerce and cuisine has a much less restrictive
definition than a nut in botany.  The term is applied to many seeds that
are not true nuts.  Any large kernel found within a shell and used in
food may be regarded as a nut.  For example, almond is the edible seed
of a drupe, while the Brazil nut is the seed from a capsule.  Candlenut
and cashew nut are seeds.  Pine nut is the seed of several species of
pine, while the pistachio nut is the seed of a thin-shelled drupe.
Peanuts can be disqualified from “nuts” because peanuts include two
or three seeds in the indehiscent pod and are legume crops.

	Since the tree nut crop group is a somewhat artificial crop group and
because the various crops within the group come from diverse families,
they are not expected to be susceptible to the same pests and diseases
requiring the same pesticide treatment.  There are 18 different plant
families represented in this proposed tree nut crop group.  However, in
practice, residues (expressed on the edible portion) in tree nuts from
field use are often low or not detectable irrespective of the pesticide
use, so a tree nut group tolerance can be achieved.  Most are grown in
similar orchard or plantations and maintained with similar cultural
practices.  Comparing U.S., Codex, and the EU Tree nut
MRL’s/tolerances based on residue data generated from the
representative crops range from 0.01 to 0.5 ppm with one Codex tolerance
established at 1 ppm for carbaryl.  Most U.S. tolerances for the Tree
Nuts are < 0.2 ppm.

	Since this crop group was established in 1995, more species and
varieties of tree nuts have become popular in commercial production and
some in international trade.  Tree nuts that were previously considered
as orphan crops include tropical almond, betelnut, coconut, ginkgo,
heartnut, bur oak, pili nut, pine nut and pistachio.

	The Crop Group 14 proposal was generated at the USDA/IR-4 Crop Grouping
Symposium in Washington, DC, October 2002 by the Temperate Tree and
Small Fruit Workgroup Chaired by Van Starner of USDA, IR-4 and
Co-Chaired by Craig Hunter, Canadian Horticultural Center, Rick
Melnicoe, University of California Department of Environmental
Toxicology, Dr. Richard Loranger and Chris Olinger, EPA, HED and John
Wise, Michigan State University.  It was further discussed and developed
within the Tree Nut Workgroup of the International Crop Grouping
Consulting Committee (ICGCC).  This workgroup consists of 200 crop or
regulatory experts from the US, NAFTA, EU, Asia, Middle East, Africa,
and Latin America regions representing 30 countries.  The Workgroup
discussed and validated each of the existing crop group commodities and
representative commodities.  It was proposed that “Filbert
(hazelnut)” be changed to “Hazelnut (filbert)”.  Additional tree
nuts proposed at the Symposium included guana, nut-o-nogal, cajou,
dalison, okari nut, bunya and candlenut.  These additional tree nuts
were also validated at the Symposium, except it was later determined
that dalison should be considered as part of the tropical fruit group.
Also, guana was not included in this submission since it apparently only
grows in eastern Cuba and is a threatened species.  It was determined
that nut-o-nogal is a alternative name for black walnut and will be
included in the EPA Food and Feed Commodity Vocabulary as a lookup term.

The concept of having separate temperate and tropical/subtropical
subgroups was not validated at the Symposium, so no subgroups are
proposed in this submission.  The Symposium also proposed crop
definitions for the representative crops of almond and pecan, but due to
the previously discussed diverse taxonomic nature of tree nuts, no crop
definitions are proposed in this submission.

	Another important aspect is the harmonization with the Codex crop
classification.  The Codex Classification of foods and animal feeds for
Tree nut Group is also undergoing revision.  The IR-4/EPA Crop Grouping
Working Group and the International Crop Grouping Consulting Committee
(ICGCC) are collaborating with the revision of the Codex crop
classification.  The expanded Tree Nut Group and the representative
commodities proposed in this petition would facilitate the harmonization
of the U.S. and the Codex crop classification systems.  Proposed
additions to the Codex Classification including Brazilian pine,
castanha-do-maranhao, Guiana chestnut and monkey-pot were also included
in the petition.

	Other tree nuts presented to the ICGCC but not validated include the
Australian or Moreton Bay chestnut, canarium nut, shea nut, suari nut,
African walnut and tallow tree.  Two proposed crops, purging nut and
karanj were not accepted because of the poisonous nature of the nut or
bean and because development of these crops is primarily for biofuel.
One additional proposed crop kalamungay (Moringa oleifera) will be
considered to be added to a future tropical fruit crop group.  Further
work by the ICGCC also identified four more potential commodities to be
proposed for the Tree nut group.  They are the African nut tree
[Ricinodendron heudelotii (Baill.) Heckel], dika nut [Irvingia
gabonensis (Aubry-Lecomte ex O’Rorke) Baill.], mongongo nut
[Schinziophtyon rautanenii (Schinz) Radcl.-Sm.], and the peach palm nut
(Bactris gasipaes Kunth var gasipaes).

The world total hectares for tree nuts (almond, betelnut, brazil nut,
cashew, chestnut, coconut, hazelnut, pistachio, and walnut) reported by
FAO (FAO 2009, have increased from 17,420,730 hectares (ha) in 1997 to
19,961,492 ha in 2007, and the total production of these nuts has
increased from 57,174,933 metric tons in 1997 to 72,519,897 metric tons
in 2007.

Some “minor” tree nut commodities like the chestnut, pili nut, pine
nut, and okari nut are becoming more popular.  Some of these nuts
don’t have large commercial production, and thus have little chance to
be added to pest control products labels unless they are placed in the
tree nut group.  By being excluded from the crop groups, means that
tolerances requested for these commodities would have to be established
based on separate residue studies.  Without a doubt the inclusion of
these commodities in crop groups will benefit growers, consumers, save
time and tax payer’s money on residue studies, save government
agencies time in reviewing residue data, as well as facilitating the
establishment of import tolerances.  Many of these crops are of economic
importance or have a great potential to be grown in larger scale in the
future due to their nutritional value or medicinal value, or the
increased market demand driven by both the growing ethnic populations
and greater awareness of these crops by the non-ethnic population as a
whole.  The American cuisine has a distinct global nature that includes
many orphan crops not yet in a crop group.

REQUEST:

	William P. Barney, Crop Grouping Project Coordinator and Tracey Switek,
USDA Interregional Research Project No. 4 (IR-4), State Agricultural
Experiment Station, Rutgers University has submitted a petition (May 29,
2008) on behalf of the IR-4 Project, and the Tree Nuts Workgroup of the
International Crop Grouping Consulting Committee (ICGCC) to amend the
Crop Group Regulation 40 CFR § 180.41 (c) (16) Crop Group 14, Tree Nut
Group.

	The above-mentioned Tree nut crop group petition requested the
following four proposals:

IR-4 Proposal 1: “Amend the existing crop group in 40 CFR 180.41 (c)
(14) that consists of following twelve commodity entries:

Almond, Prunus dulcis (Mill.) D.A. Webb (Rosaceae)

Beechnut, Fagus spp. (Fagaceae)

Brazil nut, Bertholletia excelsa Bonpl. (Lecythidaceae)

Butternut, Juglans cinerea L. (Juglandaceae)

Cashew, Anacardium occidentale L. (Anacardiaceae)

Chestnut, Castanea spp. (Fagaceae)

Chinquapin, Castanea pumila (L.) Mill. (Fagaceae)

Filbert (Hazelnut), Corylus spp. (Betulaceae)

Hickory nut, Carya spp. (Juglandaceae)

Macadamia nut, Macadamia integrifolia Maiden & Betche (Proteaceae)

Pecan, Carya illinoinensis (Wangenh.) K.Koch (Juglandaceae)

Walnut, black and English, Juglans spp. (Juglandaceae);

To an expanded crop group that consists of following Thirty-two
commodity entries:

Almond, Prunus dulcis (Mill.) D.A. Webb (Rosaceae)

Beechnut, Fagus spp. (Fagaceae)

Betelnut, Areca catechu L. (Arecaceae (Palmae))

Brazil nut, Bertholletia excelsa Bonpl. (Lecythidaceae)

Brazilian pine, Araucaria angustifolia ((Bertol.) Kuntze (Araucariaceae)

Bunya, Araucaria bidwillii Hook. (Araucariaceae)

Bur oak, Quercus macrocarpa Michx. (Fagaceae)

Butternut, Juglans cinerea L. (Juglandaceae)

Cajou nut, Anacardium giganteum Hancock ex Engl. (Anacardiaceae)

Candlenut, Aleurites moluccanus (L.) Willd. (Euphorbiaceae)

Cashew, Anacardium occidentale L. (Anacardiaceae)

Castanha-do-maranhao, Pachira glabra Pasq. (Malvaceae)

Chestnut (Chinquapin), Castanea spp. (Fagaceae)

Coconut, Cocos nucifera L. (Arecaceae (Palmae))

Ginkgo, Ginkgo biloba L. (Ginkgoaceae)

Guiana chestnut, Pachira aquatic Aubl. (Malvaceae)

Hazelnut (Filbert), Corylus spp. (Betulaceae)

Heartnut, Juglans ailantifolia var. cordiformis (Makino) Rehder
(Juglandaceae)

Hickory nut, Carya spp. (Juglandaceae)

Japanese horse-chestnut, Aesculus turbinata Blume (Sapindaceae)

Macadamia nut, Macadamia integrifolia Maiden & Betche (Proteaceae)

Monkey-pot, Lecythis pisonis Cambess. (Lecythidaceae)

Okari nut, Terminalia kaernbachii Warb. (Combretaceae)

Pachira nut, Pachira insignis (Sw.) Savigny (Malvaceae)

Pecan, Carya illinoinensis (Wangenh.) K.Koch (Juglandaceae)

Pequi, Caryocar spp. (Caryocaraceae)

Pili nut, Canarium ovatum Engl. (Bursraceae)

Pine nut, Pinus edulis Engelm. (Pinaceae)

Pistachio, Pistacia vera L. (Anacardiaceae)

Sapucaia nut, Lecythis zabucaja Aubl. (Lecythidaceae)

Tropical almond, Terminalia catappa L. (Combretaceae)

Walnut, black, Juglans spp. (Juglandaceae) and Walnut, English, Juglans
regia L. (Juglandaceae)

And all edible varieties and/or hybrids of Fagus species, Castanea
species, Corylus species, Carya species, Caryocar species, and Juglans
species.”

IR-4 Proposal 2:  Representative Commodities:

IR-4 recommends that the following commodities,

Almond and pecan remain as representative commodities for the expanded
group.

IR-4 Proposal 3. Crop Subgroups:

No crop subgroups are proposed for the Tree Nuts crop group.

IR-4 Proposal 4. Crop Definitions:

No commodity definitions for the Tree Nuts are proposed or were
recommended at this time.

HED RECOMMENDATIONS:

	Each of the proposals and recommendations will be discussed below,
followed by a series of other recommendations on terminology, database
development, and harmonization with Codex.  The EPA would like to
commend the valuable and high quality input of the ICGCC, all its
members, and the Committee Chairperson Bill Barney, USDA IR-4, as well
as Dr. Yuen-Shaung Ng, Biologist, HED, Doug Dotson, Chemist, Susan
Stanton, Roger Chesser, Andy Ertman, and Laura Nollen, Biologists, RD,
EPA for their input and development of various databases in this report
and Dr. Paul Schwartz, USDA, Office of Minor Use Pesticides for his
advice and peer review of the analysis.

IR-4 Proposal 1:

1. “Amend the existing crop group that consists of twelve commodity
entries 40 CFR 180.41 (c) (14)”

To an expanded crop group that consists of following thirty-eight
commodity entries:

Tree Nut Commodities

African nut tree	Hazelnut (Filbert)

Almond	Heartnut

Beechnut	Hickory Nut

Betelnut	Japanese horse-chestnut

Brazil nut	Macadamia nut

Brazilian pine	Monkey-pot

Bunya	Mongongo nut

Bur oak	Okari nut

Butternut	Pachira nut

Cajou nut	Peach palm nut

Candlenut	Pecan

Cashew	Pequi

Castanha-do-maranhao	Pili nut

Chestnut	Pine nut

Chinquapin	Pistachio

Coconut	Sapucaia nuts

Dika nut	Tropical almond

Ginkgo	Walnut, black

Guiana chestnut	Walnut, English

And all edible varieties and/or hybrids of Fagus species, Castanea
species, Corylus species, Carya species, Caryocar species, and Juglans
species.”

HED Recommendations for Proposal 1:

	Based on similarities of the comparison of tree nuts cultural
practices, edible food and animal feed items, residue levels,
geographical locations, processing, established tolerances, and for
international harmonization purposes, I recommend that ChemSAC concur to
amend the Tree Nut Crop Group 14 from twelve commodities to thirty –
nine commodities (See Table 1).  There are 18 different plant families
represented in this proposed tree nut crop group.  Since the tree nut
crop group is a somewhat artificial crop group and because the various
crops within the group come from diverse families, and they are all not
expected to be susceptible to the same pests and diseases requiring the
same pesticide treatment, but their harvesting, processing (hulling,
drying), marketing, uses, and nutritional value are very similar. Also,
in practice, residues (expressed on the edible portion) in tree nuts
from field use are often low or not detectable irrespective of the
pesticide use, so a tree nut group tolerance can be achieved, and most
are grown in similar orchard or plantations and maintained with similar
cultural practices.   The members of this crop group have similar uses,
and all are consumed after maturity or consumed cooked or roasted in
various recipes including salads, meats, and cookies.  Some of these
tree nuts also have medicinal properties.  Many of the tree nuts from
the same botanical family with similar biological and cultural aspects
suggests they should also encounter similar pest problems and hence have
similar needs for pest control products in similar use patterns.  All of
these commodities except for betelnut were found to have similar
characteristics and uses to become a member of the Tree nut group.

	While USDA IR-4 also recommended adding betelnut to the Tree nut group,
however, after analysis of this crop, I recommend ChemSAC concur not to
add this commodity to this crop group.  Betelnut is used mostly as a
stimulant crop and is chewed during the day, so it does not share the
traditional uses of the tree nut crops.  Also, I recommend deleting
Castanha-do-maranhao (Pachira glabra Pasq), because it is limited to
Brazil, endangered, and appears at this timing to have limited chance of
further expansion.

	There were no crop subgroups proposed by IR-4 for this crop group.  HED
is also recommending adding three other commodities that meet the tree
nut criteria to the group.  The three commodities are: coquito nut,
monkey puzzle nut, and yellowhorn.  These three nuts are available to
grow in the U.S. and coquito nut is already available in the marketplace
and in commercial nursery catalogs.  Therefore, the recommended Tree nut
crop group 14 -10 or 14-11 commodities are listed in Table 1 below and
include their appropriate scientific names.  Table 2 contains a
comparison between the current Tree Nut Crop Group and the recommended
changes to the proposed Tree Nut Crop Group 14-10 or 14-11.

“HED Recommended Tree Nut Crop Group 14 – 10 or 14-11”.

Commodities

African nut tree, Ricinodendron heudelotii (Baill.) Heckel

Almond, Prunus dulcis (Mill.) D.A. Webb

Beechnut, Fagus grandifolia Ehrh., F. sylvatica L., F. sylvatica L.
subsp. sylvatica

Brazil nut, Bertholletia excelsa Humb. & Bonpl.

Brazilian pine, Araucaria angustifolia (Bertol.) Kuntze

Bunya, Araucaria bidwillii Hook.

Bur Oak, Quercus macrocarpa Michx.

Butternut, Juglans cinerea L.

Cajou nut, Anacardium giganteum Hance ex Engl.

Candlenut, Aleurites moluccanus (L.) Willd.

Cashew, Anacardium occidentale L.

Chestnut, Castanea crenata Siebold & Zucc., C. dentata (Marshall)
Borkh., C. mollissima Blume, C. sativa Mill.

Chinquapin, Castanea pumila (L.) Mill., Castanea ozarkensis Ashe

Coconut, Cocos nucifera L.

Coquito nut, Jubaea chilensis (Molina) Baill.

Dika nut, Irvingia gabonensis (Aubry-Lecomte ex O’Rorke) Baill.

Ginkgo, Ginkgo biloba L.

Guiana chestnut, Pachira aquatica Aubl.

Hazelnut (Filbert), Corylus americana Marshall, C. avellana L., C.
californica (A. DC.) Rose, C. chinensis Franch.

Heartnut, Juglans ailantifolia Carrière var. cordiformis (Makino)
Rehder, Juglans ailantifolia Carrière

Hickory nut, Carya cathayensis Sarg., C. glabra (Mill.) Sweet, C.
laciniosa (F. Michx.) W. P. C. Barton, C. myristiciformis (F. Michx.)
Elliott, .C. ovata (Mill.) K. Koch, C. tomentosa (Lam.) Nutt.

Japanese horse-chestnut, Aesculus turbinata Blume

Macadamia nut, Macadamia integrifolia Maiden & Betche, Macadamia
tetraphylla L.A.S. Johnson

Mongongo nut, Schinziophyton rautanenii (Schinz) Radcl.-Sm.

Monkey-pot, Lecythis pisonis Cambess.

Monkey puzzle nut, Araucaria araucana (Molina) K. Koch

Okari nut, Terminalia kaernbachii Warb.

Pachira nut, Pachira insignis (Sw.) Savigny

Peach palm nut, Bactris gasipaes Kunth var. gasipaes

Pecan, Carya illinoinensis (Wangenh.) K.Koch

Pequi, Caryocar brasiliense Cambess., C. villosum (Aubl.) Pers, Caryocar
nuciferum L.

Pili nut, Canarium ovatum Engl., Canarium vulgare Leenh. Canarium
indicum L.

Pine nut, Pinus edulis Engelm., P. koraiensis Siebold & Zucc., P.
sibirica Du Tour, P. pumila (Pall.) Regel, P. gerardiana Wall. ex D.
Don, P.  monophylla Torr. & Frém., P. quadrifolia Parl. ex Sudw. P.
pinea L.

Pistachio, Pistacia vera L.

Sapucaia nut, Lecythis zabucaja Aubl.

Tropical almond, Terminalia catappa L.

Walnut, black, Juglans hindsii Jeps. ex R. E. Sm., J. microcarpa
Berland., J. nigra L.

Walnut, English, Juglans regia L.

Yellowhorn, Xanthoceras sorbifolium Bunge

Cultivars, varieties, and/or hybrids of these commodities

HED Additional Recommendation for Proposal 1:

HED also recommends that in the crop group table the term “all edible
varieties and/or hybrids of Fagus species, Castanea species, Corylus
species, Carya species, Caryocar species, and Juglans species varieties
and/or hybrids of these” should be changed to, “Cultivars,
varieties, and hybrids, of these commodities” will avoid all confusion
with terminology regarding whether they are cultivars, varieties, or
hybrids of the any tree nut commodities.  This is also consistent with
the other revised crop groups completed to date.

HED also recommends changing the preferred commodity name for filbert to
hazelnut, since hazelnut is the commodity term used in international
trade and the U.S. Hazelnut Growers Marketing Board since 1981 has
changed their name from filbert to hazelnut even though filbert is the
correct name for the tree and nut.  The name is of French origin and the
tree was likely first introduced into Oregon by early French settlers.
Hazelnut is the name coined by the English and it was applied to the
native species by early settlers.  The EPA Food and Feed Commodity
Vocabulary (http://www.epa.gov/pesticides/foodfeed) for filbert will be
changed to hazelnut as the preferred commodity term in the next
vocabulary update.

Table 2.  EPA Crop Group Proposals Comparison of the Current Established
EPA Tree Nut Crop Group 14 with the Proposal Recommendations to ChemSAC
to the Amended 2010 Tree Nut Crop Group 14-11.

Regulation	Current Tree Nut Crop Group 14

(May 17, 1995).	2010 Proposed Tree Nut Crop Group 14-10 for ChemSAC
Approval

Name of the Crop Group	Tree Nut Group 14	Tree Nut Group 14-11 hopefully.

Representative Crops	Two:

Almond and

Pecan	Two:

Almond and

Pecan same commodities

Subgroup(s)	None	None

Commodities included	12 (Almond, Beechnut, Brazil nut, Butternut,
Cashew, Chestnut, Chinquapin, Filbert (Hazelnut), Hickory nut ,
Macadamia nut, Pecan, Walnut, black and English)	39 (African tree nut,
Almond, Beechnut, Brazil nut, Brazilian pine, Bunya, Bur oak, Butternut,
Cajou nut, Candlenut, Cashew, Chestnut, Chinquapin, Coconut, Coquito
nut, Dika nut, Ginkgo, Guiana chestnut, Hazelnut (Filbert), Heartnut,
Hickory nut, Japanese horse-chestnut, Macadamia nut, Mongongo nut,
Monkey pot, Monkey puzzle nut, Okari nut, Pachira nut, Peach palm nut,
Pecan, Pequi, Pili nut, Pine nut, Pistachio, Sapucaia nut, Tropical
almond, Walnut, black, Walnut, English, and Yellowhorn, cultivars,
varieties, and/or hybrids of these).

Commodity Definitions 180.1(g).	None were proposed.	None

IR-4 Proposal 2:

“The following commodities, Almond and Pecan, should remain as
representative commodities for the expanded group.

HED Recommendation for Proposal 2:

	I recommend ChemSAC concur to retain almond and pecan, as
representative commodities for the amended Tree Nut Crop Group 14.
These representative commodities account for > 74 % of the harvested
acres for the members of the amended Tree Nut Group, and are the two
most widely grown tree nuts in the U.S. with the largest acreages and
geographical distribution.  The representative commodities are based on
similarities in fruit (nut) and cultural practices and geographical
locations, as well as their high production (both acres and yield) and
consumption.  A comparison of established tolerances on tree nut
commodities also supports that residue levels will be similar between
members of the crop group.

IR-4 Proposal 3: “No subgroups are proposed for the Tree Nuts crop
group.”

HED Recommendation for Proposal 3:

	I agree that the Tree nut crop group will not benefit from establishing
any crop subgroup.

IR-4 Proposal 4: “No Tree Nut crop definitions are proposed.”

HED Recommendation for Proposal 4 Commodity Definition for Tree Nuts:

	I agree that commodity definitions are not needed for the tree nuts.

Additional HED Recommendations/Conclusions:

HED Recommendation 5:

	Another important aspect of crop grouping is the harmonization effort
with the Codex Classification of Foods and Animal Feeds.  The current
EPA crop group for Tree nut group 14 is very similar to the
corresponding Codex Group 022, Tree Nuts, which consists of nineteen
commodities including matches to the all the twenty-four commodities in
the proposed amended EPA crop group 14.  The differences are because
several of the Codex commodities refer to another commodity in a similar
manner to the EPA Food and Feed Commodity Vocabulary Lookup to Preferred
Tolerance Terms, such as “Pignolia”, see Pine nuts.  Several Codex
names are equivalent to lookup terms in the EPA Food and Feed Commodity
Vocabulary like filberts is hazelnuts.  The thirty commodities listed by
Codex are really nineteen individual commodities.  The U.S. is proposing
to add the following commodities: African tree nut, betelnut, Brazilian
pine, bunya, bur oak, cajou, candlenut, castanha–do-maranhao,
chinquapin, dika nut, ginkgo, Guiana chestnut, heartnut, monkey pot,
monkey puzzle nut, okari nut, pachira nut, and pequi, that are not yet
in the Codex system.

	Recently, Codex has been reviewing the list of commodities in a revised
Tree nut group 022 (Secretariat, 2010) derived from the USDA IR-4
proposal.

	Note that the current Codex crop group does not have representative
commodities.  A revision of the Codex Classification is underway with
consideration to include adding new commodities, creating subgroups, and
selecting representative commodities.  The expanded Tree nut group and
the representative commodities proposed in this petition would
facilitate the harmonization of the U.S. and the Codex crop
classification systems.

HED Recommendation 6:

	The Health Effects Division Dry Matter database was updated by Dr’s.
NG and Schneider to include newer tree and presented in the Analysis of
the Tree Nut Crop Group Petition, Table 40 Part I Analysis.

HED Recommendation 7:

Guidance for HED SOP 99.6 -  SEQ CHAPTER \h \r 1  “Classification of
Food Forms with Respect to Level of Blending” issued August 20, 1999,
and HED SOP 2000.1 – “  SEQ CHAPTER \h \r 1 Guidance for Translation
of Field Trial Data from Representative Commodities in the Crop Group
Regulation to Other Commodities in Each Crop Group/Subgroup” issued
September 12, 2000 can be updated to reflect the amendment to the Tree
nut group 14.

HED Recommendation 8:

Guidance on expressing tolerance terminology for the Tree nut crop group
14 is discussed under the “Tolerance expression guidance section of
this analysis.

HED Recommendation 9:

New lookup and preferred EPA terms for the members of the Tree Nut Crop
Group are listed in the EPA Food and Feed Commodity Vocabulary section
of this report and these terms will be to the updated EPA Food and Feed
Commodity Vocabulary website (  HYPERLINK
"http://www.epa.gov/pesticides/foodfeed"
http://www.epa.gov/pesticides/foodfeed ) when it is updated.

 PAGE

 PAGE   8


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on August 16, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2005-21993

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Kuwait Airways Corporation				Date Filed:  July 27, 2005

Relief requested:   Exemption from 49 U.S.C. § 41301 to operate a sixth
roundtrip flight, on a nonstop basis, between Kuwait and New York.

If renewal, date and citation of last action:  New authority

Applicant representatives:  Henry C. Cashen II<PHONE_NUMBER> & Douglas
N. Jacobson<PHONE_NUMBER>

DOT Analyst:  Shelita A. Smith<PHONE_NUMBER>

Responsive pleadings:  None filed

DISPOSITION

Action:  Approved							Action date:  August 16, 2005

Effective dates of exemption authority granted:  August 16, 2005 –
August 16, 2006

Basis for approval (bilateral agreement/reciprocity):  Reciprocity

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

  X   Standard exemption conditions (attached)            X    Foreign
air carrier permit   (Order 2002-9-27)

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied

all requests in the referenced Docket.  We may amend, modify, or revoke
the authority granted in this Notice at any time without hearing at our
discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

 Kuwait Airways holds a foreign air carrier permit, issued by Order
2002-2-27, which includes authority to conduct scheduled foreign air
transportation of persons, property and mail between Kuwait, via the
intermediate points London and Frankfurt, and New York, subject to the
condition that it operate not more than four roundtrip flights per week,
provided that it operate not more than one roundtrip flight per week via
Frankfurt.  Kuwait Airways also holds an exemption, most recently
renewed by Notice of Action Taken issued December 8, 2004 (Docket
OST-2002-14072), authorizing it to operate a fifth weekly roundtrip
flight, on a nonstop basis, between Kuwait and New York.

05/2004


[Federal Register: December 7, 2007 (Volume 72, Number 235)]
[Notices]
[Page 69202-69203]
[DOCID:fr07de07-39]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ES07-66-002]

Allegheny Generating Company; Notice of Compliance Filing

November 30, 2007.
    Take notice that on November 29, 2007, Allegheny Generating Company
tendered for filing a supplement to Exhibit B of its application as
requested by the Commission on November 14, 2007.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public

Reference Room in Washington, DC. There is an ``eSubscription'' link on
the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 10, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-23775 Filed 12-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Rules and Regulations]
[Pages 56610-56611]
[FR Doc No: 2013-22266]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2013-0780]

Drawbridge Operation Regulations; Reynolds Channel, Lawrence, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Atlantic Beach Bridge, mile 0.4, across Reynolds Channel, at Lawrence,
New York. This temporary deviation authorizes the Atlantic Beach Bridge
to operate under an alternate schedule for 92 days, to facilitate
electrical and structural rehabilitation at the bridge.

DATES: This deviation is effective from September 13, 2013 through
December 1, 2013, and has been enforced with actual notice since
September 1, 2013.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2013-0780 and are available online
at www.regulations.gov, inserting USCG-2013-0780 in the ``Keyword'' and
then clicking ``Search''. They are also available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Ms. Judy Leung-Yee, Project Officer, First Coast Guard
District, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Barbara Hairston,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Atlantic Beach Bridge, across Reynolds
Channel, mile 0.4, at Lawrence, New York, has a vertical clearance in
the closed position of 25 feet at mean high water and 30 feet at mean
low water. The existing drawbridge operation regulations are listed at
33 CFR 117.799(e).
    The owner of the bridge, Nassau County Bridge Authority, requested
a temporary deviation to facilitate electrical and structural
rehabilitation at the bridge.
    The waterway has commercial and seasonal recreational vessels of
various sizes.
    Under this temporary deviation the draw of the Atlantic Beach
Bridge at mile 0.4, across Reynolds Channel shall operate as follows:
    (1) From September 1, 2013 through September 30, 2013, Monday
through Friday, the draw may operate a single span on signal, every two
hours, on the even hour, between 6 a.m. and 8 p.m. From 8 p.m. through
6 a.m. the draw may operate a single span on signal. On weekends and
holidays from Friday at 8 p.m. through Monday at 6 a.m. the bridge
shall open both spans every hour on the hour. The draw may remain in
the closed position between 12 a.m. and 5 a.m. on September 12, 13, 24,
and 25, 2013.

    (2) From October 1, 2013 through December 1, 2013, the bridge shall
operate a single span on signal at 6 a.m., 12 p.m., 4 p.m., and 8 p.m.
and at any time between 8 p.m. and 6 a.m. The draw shall open both
spans at all times for commercial vessel traffic after at least a 48
hour advance notice is given by calling the number posted at the
bridge. The draw may remain in the closed position between 12 a.m. and
5 a.m. on October 15, and October 16, 2013.
    The Coast Guard contacted all known commercial waterway users
regarding this deviation and no objections were received.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: August 29, 2013.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2013-22266 Filed 9-12-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Notices]
[Page 3126]
[FR Doc No: 2016-00966]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL11-66-000]

Notice of Filing

    Martha Coakley, Massachusetts Attorney General; Connecticut
Public Utilities Regulatory Authority; Massachusetts Department of
Public Utilities; New Hampshire Public Utilities Commission;
Connecticut Office of Consumer Counsel; Maine Office of the Public
Advocate; George Jepsen, Connecticut Attorney General; New Hampshire
Office of Consumer Advocate; Rhode Island Division of Public
Utilities and Carriers; Vermont Department of Public Service;
Massachusetts Municipal Wholesale Electric Company; Associated
Industries of Massachusetts; The Energy Consortium; Power Options,
Inc.; and the Industrial Energy Consumer Group, v. Bangor Hydro-
Electric Company; Central Maine Power Company; New England Power
Company d/b/a National Grid; New Hampshire Transmission LLC d/b/a
NextEra; NSTAR Electric and Gas Corporation; Northeast Utilities
Service Company; The United Illuminating Company; Unitil Energy
Systems, Inc. and Fitchburg Gas and Electric Light Company; Vermont
Transco, LLC

    Take notice that on January 13, 2016, Vermont Transco LLC submitted
tariff filing per: Refund Report to be effective N/A, pursuant to the
Commission's Opinion No. 531-A, issued on October 16, 2014.\1\
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    \1\ Martha Coakley, Mass. Attorney Gen., et al. v. Bangor Hydro-
Elec. Co., et al., Opinion No. 531, 147 FERC ] 61,234 (2014)
(Opinion No. 531), order on paper hearing, Opinion No. 531-A, 149
FERC ] 61,032 (2014) (Opinion No. 531-A).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on February 3, 2016.

    Dated: January 13, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-00966 Filed 1-19-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Rules and Regulations]
[Pages 67996-68001]
[FR Doc No: 2020-21464]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2019-0614; FRL-10013-53]
RIN 2070-AB27

Modification of Significant New Uses of Certain Chemical
Substances (20-1.M)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending significant new use rules (SNURs) issued under
the Toxic Substances Control Act (TSCA) for certain chemical
substances, which were the subject of premanufacture notices (PMNs) and
significant new use notices (SNUNs). As a result of EPA's review of
SNUNs for these chemical substances and based on new and existing data,
EPA is finalizing amendments to these SNURs. Specifically, this action
amends the identified SNURs to allow certain new uses reported in the
SNUNs without additional notification requirements and modify the
significant new use notification requirements based on the actions and
determinations for the SNUN submissions.

DATES: This rule is effective on December 28, 2020. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
November 10, 2020.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: William Wysong, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email 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 manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers

determine whether this document applies to them. Potentially affected
entities may include:
     Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify that the shipment of the
chemical substance complies with all applicable rules and orders under
TSCA, which would include the SNUR requirements. The EPA policy in
support of import certification appears at 40 CFR part 707, subpart B.
In addition, any persons who export or intend to export a chemical
substance that is the subject of this rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and
40 CFR 721.20, and must comply with the export notification
requirements in 40 CFR part 707, subpart D.

B. How can I access the docket?

    The docket includes information considered by the Agency in
developing the proposed and final rules. The docket for this action,
identified by docket identification (ID) number EPA-HQ-OPPT-2019-0263,
is available at http://www.regulations.gov or at the Office of
Pollution Prevention and Toxics Docket (OPPT Docket), Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    EPA is issuing amendments to the SNURs for certain chemical
substances in 40 CFR part 721, subpart E. A SNUR for a chemical
substance designates certain activities as a significant new use.
Persons who intend to manufacture or process the chemical substance for
the significant new use must notify EPA at least 90 days before
commencing that activity. The required notification (i.e., a SNUN)
initiates EPA's evaluation of the intended use within the applicable
review period. Manufacture and processing for the significant new use
may not commence until EPA has conducted a review of the notice, made
an appropriate determination on the notice, and taken such actions as
are required with that determination.
    Previously, in the Federal Register of April 1, 2020 (85 FR 18173;
FRL-10004-51), EPA proposed amendments to the SNURs for these chemical
substances and established the record for these SNUR amendments in the
docket under docket ID number EPA-HQ-OPPT-2019-0614. That docket
includes information considered by the Agency in developing the
proposed and final rules, including public comments and EPA's responses
to the public comments received.

B. What is the Agency's authority for taking this action?

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule (i.e., a SNUR) after
considering all relevant factors, including those listed in TSCA
section 5(a)(2). EPA may also amend a SNUR promulgated under TSCA
section 5(a)(2). Procedures and criteria for modifying or revoking SNUR
requirements appear at 40 CFR 721.185.

C. How do the general SNUR provisions apply to this action?

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the final rule,
recordkeeping requirements, exemptions to reporting requirements, and
applicability of the rule to uses occurring before the effective date
of the final rule. Provisions relating to user fees appear at 40 CFR
part 700. According to 40 CFR 721.1(c), persons subject to these SNURs
must comply with the same notice requirements and EPA regulatory
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1), the exemptions
authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and
the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must
either determine that the significant new use is not likely to present
an unreasonable risk of injury or take such regulatory action as is
associated with an alternative determination before the manufacture or
processing for the significant new use can commence. If EPA determines
that the significant new use is not likely to present an unreasonable
risk, EPA is required under TSCA section 5(g) to make public, and
submit for publication in the Federal Register, a statement of EPA's
findings.

III. Significant New Use Determination

A. Considerations for Significant New Use Determinations

    TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In determining whether and how to modify the significant new uses
for the chemical substances that are the subject of these SNURs, and as
described in the preamble to the proposed rule, EPA considered relevant
information about the toxicity of the chemical substance, likely human
exposures and environmental releases associated with possible uses, and
the four TSCA section 5(a)(2) factors listed in this unit.

B. Procedures for Significant New Uses Claimed as CBI

    By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a

procedure to deal with the situation where a specific significant new
use is CBI, at 40 CFR 721.1725(b)(1) and has referenced it to apply to
other SNURs.
    Under these procedures a manufacturer or processor may request EPA
to determine whether a specific use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in 40 CFR
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
    If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received three public comments on the proposed amendments. The
Agency's responses to these comments are provided in a separate
Response to Public Comments document that is available in the docket
for this rule. EPA made one change to the final rule amending 40 CFR
721.10663 based on one comment. Specifically, EPA added language used
in previous SNURs for other carbon nanotube chemicals identifying
criteria where SNUR requirements do not apply. EPA agrees with the
commenter that when the chemical substance meets any of these criteria,
there is no unreasonable risk from exposure to the substance.

V. Rationale of the Final Rule

    These amendments are based on EPA's determination under 40 CFR
721.185(a)(3) following review of significant new use notices (SNUNs)
for the chemical substances submitted to EPA. After reviewing the
SNUNs, EPA concluded that there is no need to require additional notice
from persons who propose to engage in identical or similar activities.
In those instances where EPA expanded the scope of the significant new
use, the Agency identified concerns during review of the SNUNs, as
discussed in Unit IV. of the proposed rule, associated with certain
potential new uses. In addition to considering the factors discussed in
Unit IV. of the proposed rule, EPA determined that those uses could
result in changes in the type or form of exposure to the chemical
substance, increased exposures to the chemical substance, and/or
changes in the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of
the chemical substance.

VI. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule

    To establish a significant new use, EPA must determine that the use
is not ongoing. EPA made this determination in issuing the original
final rule for each chemical substance, and solicited additional
comments on the proposed modifications to provide an opportunity for
members of the public to indicate whether any of the uses which are not
significant new uses under the current rules, but which would be
regulated as ``significant new uses'' if the proposed rule is
finalized, are ongoing. EPA received no comments that these uses were
ongoing. Therefore, EPA concludes that the uses are not ongoing and
designated April 1, 2020 (the date of publication of the proposed rule)
as the cutoff date for determining whether the new use is ongoing.
    In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of the cutoff date, that person will have to cease any
such activity upon the effective date of the final rule. To resume
their activities, that person would have to first comply with all
applicable SNUR notification requirements and wait until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 generally does not require
development of any particular new information (e.g., generating test
data) before submission of a SNUN. There is an exception: If a person
is required to submit information for a chemical substance pursuant to
a rule, order or consent agreement under TSCA section 4, then TSCA
section 5(b)(1)(A) requires such information to be submitted to EPA at
the time of submission of the SNUN.
    In the absence of an applicable rule, order or consent agreement
under TSCA section 4, or a TSCA section 5(b)(4) listing covering the
chemical substance, persons are required only to submit information in
their possession or control and to describe any other information known
to or reasonably ascertainable by them (see 40 CFR 720.50). However,
upon review of PMNs and SNUNs, the Agency has the authority to require
appropriate testing.
    Unit IV. of the proposed rule lists potentially useful information
for all SNURs addressed in this final rule. Descriptions are provided
for informational purposes. The information identified in Unit IV. of
the proposed rule will be potentially useful to EPA's evaluation of a
chemical substance in the event that someone submits a SNUN for a
significant new use pursuant to the SNURs addressed in this final rule.
Companies who are considering submitting a SNUN are encouraged, but are
not required, to develop the potentially useful information on the
substance.
    EPA strongly encourages persons, before performing any testing, to
consult with the Agency. Furthermore, pursuant to TSCA section 4(h),
which pertains to reduction of testing on vertebrate animals, EPA
encourages consultation with the Agency on the use of alternative test
methods and strategies (also called New Approach Methodologies, or
NAMs), if available, to generate the recommended test data. EPA
encourages dialogue with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h).
    The potentially useful information identified in Unit IV. of the
proposed rule may not be the only means of addressing the potential
risks of the chemical substance. However, submitting a SNUN without any
test data or other information may increase the likelihood that EPA
will take action under TSCA sections 5(e) or 5(f). EPA recommends that
potential SNUN

submitters contact EPA early enough to provide time for conducting
appropriate tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances; and
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN under 40 CFR part 720, including submission
of test data on health and environmental effects as described in 40 CFR
720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated
using e-PMN software, and submitted to the Agency in accordance with
the procedures set forth in 40 CFR 721.25 and 720.40. E-PMN software is
available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2019-0614.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review

    This action modifies SNURs for several chemical substances that
were the subject of PMNs and SNUNs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011).

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not subject to Executive Order 13771 (82 FR 9339,
February 3, 2017), because this action is not a significant regulatory
action under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA (44 U.S.C. 3501 et seq.). Burden is defined in 5 CFR
1320.3(b). The information collection activities associated with new
chemical SNURs have already been approved under OMB control number
2070-0012 (EPA ICR No. 0574). This action does not impose any burden
requiring additional OMB approval.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information that requires OMB approval
under PRA, unless it has been approved by OMB and displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register, are
listed in 40 CFR part 9, and included on the related collection
instrument or form, if applicable. This listing of the OMB control
numbers and their subsequent codification in the CFR satisfies the
display requirements of PRA and OMB's implementing regulations at 5 CFR
part 1320.
    If an entity were to submit a SNUN to the Agency, the annual burden
is estimated to average between 30 and 170 hours per response. This
burden estimate includes the time needed to review instructions, search
existing data sources, gather and maintain the data needed, and
complete, review, and submit the required SNUN. Send any comments about
the accuracy of the burden estimate, and any suggested methods for
minimizing respondent burden, including through the use of automated
collection techniques, to the Director, Regulatory Support Division,
Office of Mission Support (2822T), Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember
to include the OMB control number in any correspondence, but do not
submit any completed forms to this address.

D. Regulatory Flexibility Act (RFA)

    Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNUR modifications
will not have a significant adverse economic impact on a substantial
number of small entities. The requirement to submit a SNUN applies to
any person (including small or large entities) who intends to engage in
any activity described in the final rule as a ``significant new use.''
Because these uses are ``new'' based on all information currently
available to EPA, EPA has concluded that no small or large entities
presently engage in such activities. A SNUR requires that any person
who intends to engage in such activity in the future must first notify
EPA by submitting a SNUN. Although some small entities may decide to
pursue a significant new use in the future, EPA cannot presently
determine how many, if any, there may be. However, EPA's experience to
date is that, in response to the promulgation of SNURs covering over
1,000 chemicals, the Agency receives only a small number of notices per
year. For example, EPA received 7 SNUNs in Federal fiscal year (FY)
2013, 13 in FY2014, 6 in FY2015, 10 in FY2016, 14 in FY2017, and 11 in
FY2018 and only a fraction of these were from small businesses. In
addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $16,000 to $2,800.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this SNUR
are not expected to be significant or adversely impact a substantial
number of small entities. In a SNUR that published in the Federal
Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.

E. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

F. Executive Order 13132: Federalism

    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).

G. Executive Order 13175: Consultation and Coordination With Indian
Tribe Governments

    This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action does not significantly nor uniquely affect the communities of
Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply
to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children. EPA interprets Executive Order
13045 as applying only to those regulatory actions that concern
environmental health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards and is
therefore not subject to considerations under NTTAA section 12(d) (15
U.S.C. 272 note).

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).

XI. Congressional Review Act (CRA)

    This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: September 14, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, for the reasons stated in the preamble, EPA amends 40
CFR part 721 as follows:

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
2. Amend Sec.  721.5185 by revising paragraphs (a)(1) and (a)(2)(i) and
(iii) to read as follows:

Sec.  721.5185  2-Propen-1-one, 1-(4-morpholinyl)-.

    (a) * * *
    (1) The chemical substance identified as 2-propen-1-one, 1-(4-
morpholinyl)- (PMN P-95-169; SNUN S-08-7; SNUN S-14-1; and SNUN S-17-
10; CAS No. 5117-12-4) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this rule do not apply to quantities of the
chemical substance after it has been completely reacted (cured) because
2-propen-1-one, 1-(4-morpholinyl)- will no longer exist.
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iv), (a)(3)(i) and (ii), (a)(6)(v), (b),
and (c).
    (A) Safety 4/4H EVOH/PE laminate, Ansell Edmont Neoprene number
865, and Solvex Nitrile Rubber number 275 gloves have been tested in
accordance with the American Society for Testing Materials (ASTM) F739
method and found by EPA to satisfy the consent orders and Sec.
721.63(a)(2)(i) requirements for dermal protection to 100 percent PMN
substance. Gloves and other dermal protection may not be used for a
time period longer than they are actually tested and must be replaced
at the end of each work shift. For additional dermal protection
materials, a company must submit all test data to the Agency and must
receive written Agency approval for each type of material tested prior
to use of that material as worker dermal protection. However, for the
purposes of determining the imperviousness of gloves, up to 1 year
after the commencement of commercial manufacture or import, the
employer may use the method described in Sec.  721.63(a)(3)(ii),
thereafter, they must use the method described in Sec.
721.63(a)(3)(i). For purposes of Sec.  721.63(b), the concentration is
set at 1.0%.
    (B) Additional requirements for use as a monomer for
stereolithography: Requirements as specified in Sec.  721.63(a)(4) and
(5), (a)(6)(v), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(4), engineering
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible. For purposes of Sec.
721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health assigned protection factor of at least
50.
* * * * *
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(y)(1). It is a significant new use to use
the chemical substance for any use other than as a monomer for use in
ultraviolet ink jet applications or stereolithography, unless the
chemical substance is processed and used in an enclosed process.
* * * * *

0
3. Amend Sec.  721.10371 by revising paragraphs (a)(1) and (a)(2)(i) to
read as follows:

Sec.  721.10371  Butanoic acid, 3-mercapto-,1,1'-[2-(hydroxymethyl)-2-
(substituted-1-oxoalkoxy)methyl)-1,3-propanediyl] ester (generic).

    (a) * * *
    (1) The chemical substance identified generically as butanoic acid,
3-mercapto-,1,1'-[2-(hydroxymethyl)-2-(substituted-1-oxoalkoxy)methyl)-
1,3-propanediyl] ester (PMN P-10-136 and

S-18-5, Chemical A) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to use the
substance other than as a monomer for acryl-based ultra-violet (UV)-
curing coatings, inks, and adhesives or the confidential use described
in the significant new use notice S-18-5.
* * * * *

0
4. Amend Sec.  721.10372 by revising paragraphs (a)(1) and (a)(2)(i) to
read as follows:

Sec.  721.10372  Butanoic acid, 3-mercapto-,1,1'-[2,2-bis[(substituted-
1-oxoalkoxy)methyl]-1,3-propanediyl] ester (generic).

    (a) * * *
    (1) The chemical substance identified generically as butanoic acid,
3-mercapto-,1,1'-[2,2-bis[(substituted-1-oxoalkoxy)methyl]-1,3-
propanediyl] ester (PMN P-10-136 and SNUN S-18-5, Chemical B) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to use the
substance other than as a monomer for acryl-based ultra-violet (UV)-
curing coatings, inks, and adhesives, or the confidential use described
in the SNUN S-18-5.
* * * * *

0
5. Amend Sec.  721.10663 by revising paragraphs (a)(1), (a)(2)(i) and
(ii), and (b)(1) to read as follows:

Sec.  721.10663  Functionalized multi-walled carbon nanotubes
(generic).

    (a) * * *
    (1) The chemical substance identified generically as functionalized
multi-walled carbon nanotubes (PMN P-12-44; SNUN S-18-4; and SNUN S-19-
5) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the PMN substance that have
been completely reacted (cured); incorporated or embedded into a
polymer matrix that itself has been completely reacted (cured);
embedded in a permanent solid polymer form that is not intended to
undergo further processing except for mechanical process; or
incorporated into an article.
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (6), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. For purposes of Sec.  721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor of at least 50. For purposes of Sec.
721.63(a)(6), the airborne form of the substance includes particulate.
For purposes of Sec.  721.63(b), concentration is set at 1.0%.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(v)(1), (w)(1), and (x)(1). It is a
significant new use to use the substance other than as a chemical
additive for use in epoxy compounds for transportation, marine and
industrial coatings, paints and manufactured goods, for the
confidential use described in PMN P-12-44, or for the confidential use
described in SNUN S-19-5.
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (f), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
* * * * *

0
6. Amend Sec.  721.10928 by revising paragraphs (a)(1) and (a)(2)(iii)
to read as follows:

Sec.  721.10928  Coke (coal), secondary pitch; a carbon-containing
residue from the coking of air blown pitch coke oil and/or pitch
distillate; composed primarily of isotropic carbon, it contains small
amounts of sulfur and ash constituents.

    (a) * * *
    (1) The chemical substance identified as coke (coal), secondary
pitch. Definition: A carbon-containing residue from the coking of air
blown pitch coke oil and/or pitch distillate; composed primarily of
isotropic carbon, it contains small amounts of sulfur and ash
constituents (PMN P-12-292, PMN P-17-217, and SNUN S-19-4; CAS No.
94113-91-4) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (p), and (y)(1) and (2). It is a
significant new use to use the substance other than for the
confidential use permitted by the Order for P-12-292, as a lubricating
agent used in the production of automotive disc brakes, or to process
as an additive for the manufacture of diesel particulate filters to
increase the porosity of the filter. It is a significant new use to use
the substance in an additive formulation to produce diesel particulate
filters within the United States. For purposes of Sec.  721.80, the
aggregate volume is 2,500,000 kilograms.
* * * * *
[FR Doc. 2020-21464 Filed 10-26-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 10, 2010 (Volume 75, Number 27)]
[Notices]
[Page 6790]
[DOCID:fr10fe10-156]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending January 30, 2010

    The following Applications for: Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et. seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2010-0023.
    Date Filed: January 25, 2010.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: February 16, 2010.
    Description: Application of Wings Airways, Inc. requesting a
certificate of public convenience and necessity to transport passenger,
property and mail in interstate air transportation.

    Docket Number: DOT-OST-2010-0028.
    Date Filed: January 29, 2010.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: February 19, 2010.
    Description: Application of Aero Republica S.A. requesting a
foreign air carrier permit and corresponding exemption to enable it to
engage in daily scheduled nonstop flights between Bogota, Colombia and
Miami, Florida.

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2010-2903 Filed 2-9-10; 8:45 am]
BILLING CODE 4910-9X-P