FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

NOTICE OF FILING

EPA Registration Division Contact: Mary Waller (PM#21),<PHONE_NUMBER>

Sipcam Agro USA, Inc.

[PP#9F6023 and PP#6F7084]

	In 1999 the U.S. EPA received pesticide petitions (PP#9F6023 and
PP#6F7084) from Sipcam Agro USA, Inc., 300 Colonial Center Parkway,
#230, Roswell, GA  30076, proposing, pursuant to section 408(d) of the
Federal Code, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180.557 by establishing tolerances for residues of
tetraconazole in or on the raw agricultural commodities:

peanut, nutmeat at 0.03 [subsequently amended to 0.05]; and

peanut, refined oil at 0.1 [subsequently amended to 0.15]; and

pecan at 0.05 parts per million (ppm).

A separate but related petition (PP#5F6971) has proposed tolerances for
residues of tetraconazole in/on poultry (eggs/fat/liver/meat/meat
byproducts) resulting from the feeding of peanut and soybean meal.  EPA
has determined that the petitions contain data or information regarding
the elements set forth in section 408(d)(2) of the FFDCA; however, EPA
has not fully evaluated the sufficiency of the submitted data at this
time or whether the data supports granting of the petition.  Additional
data may be needed before EPA rules on the petition.

Residue Chemistry

	1. Plant and animal metabolism.  In plants and animals, the metabolism
of tetraconazole is adequately understood for the purposes of
establishing the proposed tolerances.  Tetraconazole metabolites include
1,2,4-triazole, and two conjugates, triazolylalanine and triazolyl
acetic acid, which are common to the triazole derivative fungicides.
Based on the available metabolism and toxicology data, parent
tetraconazole is proposed to be considered as the residue of concern in
plant and animal matrices.

	2. Analytical method. In plants and animals, the residue of concern,
parent tetraconazole, can be determined using High Pressure Liquid
Chromatography (HPLC) with a Mass Spectrometer (MS) detector.  The
proposed limit of quantitation (LOQ) for the method is 0.01 ppm for
pecan and peanut raw and processed commodities.  The poultry petition
(PP#5F6971) has defined LOQs for tetraconazole at 0.02 ppm for poultry
meat, fat, byproducts, liver, and 0.01 ppm for egg, which are likewise
relevant to the peanut tolerance proposal.

	3. Magnitude of the residues. A magnitude of study was conducted at a
total of twelve field sites to evaluate the magnitude of the residues of
tetraconazole on peanut raw agricultural commodities following seven
applications of Eminent 125SL at 0.107 lbs of active ingredient (ai) per
acre, with treatments throughout the growing season until 14 days prior
to digging.  Residues of tetraconazole on peanut nutmeats ranged from
nondetectable (<0.010) to 0.0344 ppm [HAFT] among thirty-four samples
taken from the twelve field sites. A subset of dissipation samples taken
from one of the field sites demonstrated that the magnitude of
tetraconazole residues remained unchanged in peanut nutmeats as the
preharvest interval ranged from zero (0) to sixty (60) days.  A
processing study conducted upon bulked peanut nutmeats taken from one of
the field sites determined that residues of tetraconazole concentrated
in peanut refined oil by a factor of 3.3.

A magnitude of residue study was conducted among a total of five field
sites to evaluate the magnitude of the residue of tetraconazole on
pecans following eight applications of Eminent 125SL at 0.133 lbs active
ingredient per acre, with treatments throughout the growing season until
30 days prior to harvest.  Residues of tetraconazole on pecans ranged
from non-detectable (<0.010) to 0.02 ppm [HAFT] among twelve samples
taken from the field sites.  A subset of dissipation samples taken from
one of the field sites demonstrated that the magnitude of tetraconazole
residues remained unchanged and non-detectable in pecans as the
preharvest interval ranged from zero (0) to sixty (60) days.

Toxicological Profile

The toxicological database for tetraconazole is complete.  The EPA’s
assessments of potential exposure and risks associated with the proposed
tolerances are categorized as follows:

1. Acute toxicity. Acute oral lethal dose (LD)50 = 1,031
milligrams/kilogram (mg/kg) (toxicity category III); acute dermal LD50 <
2,000 mg/kg (toxicity category III); acute inhalation lethal
concentration (LC)50 = 3.66 mg/liter (toxicity category IV); primary eye
irritation - clear by 72 hours (toxicity category III); primary skin
irritation - slight irritation (toxicity category IV); and dermal
sensitization - negative.

2. Genotoxicity. A battery of mutagenicity studies yielded negative
results in Salmonella typhimurium, cultured Chinese hamster ovary (CHO)
cells, and mouse lymphoma cells. There was no evidence of clastogenicity
in vitro or in vivo and tetraconazole did not induce unscheduled DNA
synthesis in human HeLa cells.

	3. Reproductive and developmental toxicity. A two-generation
reproduction study was conducted in rats at dietary concentrations of 0,
10, 70 or 490 ppm.  The LOAEL for parental toxicity was 70 ppm,
equivalent to 4.9/5.9 (male/female) mg/kg/day based on increased
mortality in P generation females. The NOAEL was 10 ppm, equivalent to
0.7/0.8 (M/F) mg/kg/day. The LOAEL for off spring toxicity was 490 ppm
(40.6 mg/kg/day from the P generation female intake) based on decreased
litter weight and mean pup weight in litters of all generations before
weaning and increased relative liver weights at weaning in both sexes of
all litters. The NOAEL was 70 ppm (5.9 mg/kg/day). The LOAEL for
reproductive toxicity was 70 ppm, equivalent to 4.9/5.9 (M/F) mg/kg/day
based on increased mean gestation duration in P generation parental
females and related evidence of compound toxicity in the parturition
process.  The NOAEL was 10 ppm (0.7 mg/kg/day for males and 0.8 for
females).

A developmental toxicity study was conducted using rats gavaged with
doses of 0, 5, 22.5, and 100 mg/kg/day from days 2 through 15 of
gestation. The maternal toxicity LOAEL wa100 mg/kg/day based on
decreased body weight gain, and food consumption and increased liver and
kidney weights. The maternal toxicity NOAEL was 22.5 mg/kg/day.
Developmental toxicity was noted at 100 mg/kg/day and consisted of an
increased incidence of small fetuses, and supernumerary ribs. The LOAEL
and NOAEL for developmental toxicity were 100 and 22.5 mg/kg/day,
respectively.

A developmental toxicity study was conducted using rabbits gavaged with
doses of 0, 7.5, 15, or 30 mg/kg/day.  The maternal toxicity NOAEL was
13 mg/kg/day, and LOAEL was 30 mg/kg/day, based upon decreased body
weight gain.  The developmental toxicity NOAEL was 30 mg/kg/day and the
LOAEL was not established.

4. Subchronic toxicity. Ninety-day feeding studies were conducted in
rats and mice.  The rat study was conduced at dietary concentrations of
0, 10, 60, or 360 ppm.  The NOAEL was 4.1/5.5 (M/F) mg/kg/day.  The
LOAEL was 23.9/28.7 (M/F) mg/kg/day, based on single liver cell
degeneration in males, and increased SGPT and SGOT, decreased BUN
levels, increased absolute and relative liver weights and presence of
hepatocellular single cell necrosis in females.  The mouse study was
conducted at dietary concentrations of 0, 5, 25, 125, or 625 ppm.  The
NOAEL was 4 (M/F) mg/kg/day.  The LOAEL was 16/20 (M/F) mg/kg/day, based
on single liver cell degeneration in males, and increased SGPT and SGOT,
decreased BUN levels, increased absolute and relative liver weights and
presence of hepatocellular single cell necrosis in females.

5. Chronic toxicity. A two year combined chronic
toxicity/carcinogenicity study was conducted in rats at dietary
concentrations of 0, 10, 80, 640 or 1280 ppm.  The NOAEL was 3.4/4.4
(M/F) mg/kg/day.  The LOAEL was 27.7/39.4 (M/F) mg/kg/day, based upon
histopathology of the bone (osseous hypertrophy of the cranium/parietal
bone), pale and thickened incisors, and decreased absolute and relative
adrenal and pituitary weights in males; decreased body weight (at
terminal sacrifice) in females.  No treatment-related increases in tumor
incidence were observed.

A 52-week chronic toxicity study was conducted in dogs at dietary
concentrations of 0, 22.5, 90 or 360 ppm.  The NOAEL was 0.73/0.82 (M/F)
mg/kg/day.  The LOAEL was 27.7/39.4 (M/F) mg/kg/day, based upon
increased absolute and relative kidney weights and histopathological
changes in the male kidney.

6. Carcinogenicity.  An 80 week mouse oncogenicity study was conducted
at dietary concentrations of 0, 10, 90, 800, or 1250 ppm.  The NOAEL was
1.4/1.5 (M/F) mg/kg/day.  The LOAEL was 12/14.5 (M/F) mg/kg/day, based
upon increased liver weights and hepatocellular vacuolation in both
sexes and increased kidney weights in males.  Treatment-related
increased incidences of combined benign and malignant liver tumors in
both sexes were observed.

7. Animal metabolism. The nature of tetraconazole residues is adequately
understood.  Tetraconazole is extensively metabolized very quickly and
eliminated from the body by fecal and urinary routes.

8. Metabolite toxicology.  1,2-4-Triazole is the major metabolite
identified in urine and feces with minor amounts of triazole acid and
alcohol.  The most conservative toxicology endpoint for 1,2,4-triazole
is 15 mg/kg/day, based on body weight decreases in male rats in the
reproduction study.

9. Endocrine disruption. Tetraconazole did not affect endocrine organs
or tissues, nor were there any indications of effects on fetal
development in either rats or rabbits, or on reproductive performance in
rats.  Therefore, at doses likely to be encountered, tetraconazole in
not likely to be an endocrine disruptor.

C. Aggregate Exposure

	1. Dietary exposure.  Using 100% crop treated scenarios and existing
sugar beet, milk, cattle, horse, goat, and sheep tolerances, plus the
proposed peanut, pecan, soybean and poultry tolerances, acute dietary
exposure to tetraconazole from food occupies only 0.5% of the aPAD
(0.225 mg/kg at UF = 100) for females 13 to 49 years old, the only
population subgroup for which an acute toxicity endpoint was determined.
 Using the same exposure assumptions, chronic dietary exposure from food
to tetraconazole occupies 3.9% and 11.1% of the cPAD (0.0073 mg/kg/day
at UF = 100) for the U.S. population and the most sensitive
subpopulation, non-nursing infants, respectively.  The estimated
aggregate cancer risk from dietary exposure from the proposed use on
peanuts would not change the previously calculated oncogenic risk of
0.21 x 10-6, a value that falls within the Agency's acceptable risk
standard for cancer in the range of <1 x 10-6.

	i. Food. The cRfD and aRfD values of 0.0073 mg/kg bw and 0.225 mg/kg
bw, respectively, were used to assess risk from dietary exposure.  Tier
1 dietary risk assessments indicate that the highest chronic and acute
exposures never exceed 11.1% and 0.5% (at the 99.9th percentile of
exposure) for the cRfD and aRfD, respectively.

	ii. Drinking water. The standard EPA Mississippi soybean PRZM/EXAMS
modeling scenario with index reservoir (IR) was used to conservatively
estimate concentrations of tetraconazole in drinking water resulting
from a proposed use on soybeans, which also applies to the presently
proposed use on peanuts.  The drinking water estimated concentrations
(DWECs) from the Mississippi soybean scenario model were 2.19 ppb
(acute), 0.578 ppb (chronic) and 0.441ppb (30 year lifetime average).
These are 6 to 28 times greater than the highest level of tetraconazole
“detected” in Minnesota surface water, which was 0.075 ppb (1/2
limit of quantitation).  Thus, the Mississippi DWECs were used to assess
dietary risks from exposure to drinking water for uses on soybeans and
peanuts.  The DWECs are lower than the lowest drinking water level of
comparison (DWLOC) values of 6,720 ppb (acute), 69 to 249 ppb (chronic),
and 1.516 ppb (cancer).  When DWLOC values are not exceed by DWEC values
it can be concluded that dietary risks from exposure to drinking water
are acceptable.

	2. Non-dietary exposure. Tetraconazole is currently not registered or
proposed for use on any residential non-food site.  Therefore,
residential exposure to tetraconazole residues would be through dietary
exposure only.

D. Cumulative Effects

	EPA has not determined that a common mechanism of toxicity pertains to
tetraconazole as compared with any other substance.

E. Safety Determination

	1. U.S. population. Based on the exposure assumptions described above
and on the completeness of the toxicology database, it can be concluded
that total aggregate exposure from food and water to the U.S. population
and all evaluated population subgroups from tetraconazole exposure from
all proposed uses will be below 100% of the RfDs.  EPA generally has no
concerns for estimated exposures below 100% of the RfD, since the RfD
represents the level at or below which daily aggregate exposure will not
pose an appreciable risk to human health.  Thus it can be concluded that
there is reasonable certainty that no harm will result from aggregate
exposure to tetraconazole residues for registered and proposed uses,
including the presently proposed use on peanuts.

	2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of tetraconazole, the
data from developmental toxicity studies in both the rat and rabbit and
a two generation reproduction study in rats have been considered.  These
toxicity studies indicate the offspring are not more sensitive and all
developmental and reproductive effects were secondary to maternal
toxicity. Thus infants and children are protected, and an additional
uncertainty factor pertaining to infants and children is not warranted.

F. International Tolerances

Maximum residue levels (MRL) have been established for tetraconazole in
the following countries (in ppm).

Belgium: sugar beet root, 0.05; wheat grain, 0.05; wheat straw, 2.0.

France: apple, 0.2; barley grain, 0.02; grape, 0.2; wine, 0.01; sugar
beet root, 0.05; wheat grain, 0.02.

Italy: apple, 0.5; artichoke, 0.2; barley grain, 0.1; courgette, 0.2;
cucumber, 0.2; grape, 0.5; melon, 0.05; peach, 0.2; pear, 0.2; pepper,
0.2; tomato, 0.2, watermelon, 0.05; wheat grain, 0.05

Portugal: apple, 0.3; grape, 0.2; melon, 0.1; peach, 0.2; pear, 0.3;
strawberry, 0.2; sugar beet root, 0.05.

Spain: apple, 0.2; artichoke, 0.05; cucurbit fruit & edible peel, 0.2;
nectarine, 0.2; peach, 0.2; pear, 0.2; sugar beet leaves, 0.3; sugar
beet root; 0.05; tomato, 0.1.

United Kingdom: barley grain, 0.2; barley straw, 10; oat grain, 0.1; oat
straw, 2; wheat grain, 0.05; wheat straw, 5.

Czech Republic: apple, 0.5; grape, 0.05

Hungary: apple, 0.2; grape, 0.5; sugar beet root & leaves, 0.5; sugar
beet root, 0.1; wheat grain, 0.05; wheat straw, 3.

Poland: apple, 0.5; cereal grain, 0.05; cereal straw, 3; cucumber edible
peel, 0.2.

Japan: wheat, 0.05; barley; 0.2 other cereal grain, 0.1; sugar beet,
0.5; artichoke, 0.2; tomato, 1; cucumber, 0.5; pumpkin (including
squash), 1; oriental cucurbitaceous vegetables, 0.2; apple, 0.5,
Japanese pear, 0.5, pear, 0.5 quince, 0.5 peach, 0.3, nectarine, 0.2;
apricot, 0.2; Japanese plum (including prune); 0.2; cherry, 0.2;
strawberry, 2; watermelon, 0.2, melon, 0.2; makuwauri, 0.2; grape, 0.5;
tea, 20.

Page   PAGE  1  of   NUMPAGES  6


From:
"Jones, DonnaLee"<EMAIL_ADDRESS>Sent:
Wed, 31 Aug 2022 22:13:16
To:
"Aron H. Schnur"<EMAIL_ADDRESS>Subject:
RE: SunCoke Energy 35-day response to ICR
Hi. Could you please send me a copy of the item referred to as "Letter from P. Brooks to R. Brager (July 28, 2016)." I don't recognize these names as being involved with EPA or the coke oven RTR project. Thanks.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711
Tele:<PHONE_NUMBER>
--------------------------------------------------------------------------------
Fax<PHONE_NUMBER>
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Aron H. Schnur<EMAIL_ADDRESS>Sent: Wednesday, August 31, 2022 2:45 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Cc: BATTEN, KATIE M<EMAIL_ADDRESS>Subject: SunCoke Energy 35-day response to ICR

Dear Dr. Jones:

Attached please find SunCoke Energy's 35-day response to EPA's July 27, 2022 Information Collection Request to the company.  Please let us know if you have any questions.

Thanks,
Aron

Aron H. Schnur
Principal

201 North Charles Street, Suite 2210 ~ Baltimore, MD 21201 ~ bdlaw.com
O +1.410.230.1334 ~ M +1.443.875.6377 ~<EMAIL_ADDRESS>


[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Page 14106]
[FR Doc No: 2015-06129]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-1178-000]

South Jersey Energy ISO8, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of South Jersey Energy ISO8, LLC's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is March 30, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also 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 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>.

    Dated: March 10, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-06129 Filed 3-17-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 246 (Tuesday, December 28, 2021)]
[Rules and Regulations]
[Pages 73677-73678]
[FR Doc No: 2021-28166]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2021-N-0917]

Medical Devices; Anesthesiology Devices; Classification of the
Retrograde Intubation Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the retrograde intubation device into class II (special controls). The
special controls that apply to the device type are identified in this
order and will be part of the codified language for the retrograde
intubation device's classification. We are taking this action because
we have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective December 28, 2021. The classification
was applicable on December 12, 2018.

FOR FURTHER INFORMATION CONTACT: Todd Courtney, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1216, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the retrograde intubation device
as class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, by placing the device into a lower device class than the
automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On September 25, 2017, FDA received Cook Incorporated's request for
De Novo classification of the Retrograde Intubation Set. FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on December 12, 2018, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
868.5095.\1\ We have named the generic type of device retrograde
intubation device, and it is identified as a prescription device used
to perform retrograde intubation via the cricothyroid membrane. The
device may contain or be labeled for use with guidewires and intubating
catheters, in addition to needles (21 CFR 868.5090), syringe (21 CFR
880.5860), and hemostats (21 CFR 878.4800).
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures

required to mitigate these risks in table 1.

   Table 1--Retrograde Intubation Device Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Failure to intubate and ventilate        Non-clinical performance
 (continued hypoxia).                     testing, and Labeling
Tissue damage/trauma resulting in, for   Non-clinical performance
 example:                                 testing, and Labeling
     Bleeding, hematoma........  ...............................
     Subcutaneous emphysema....  ...............................
      Pneumomediastinum  ...............................
     or pneumothorax.
      Damage to          ...............................
     trachea, esophagus, and vocal
     cords.
Infection..............................  Sterilization validation, and
                                          Shelf-life testing
Adverse tissue reaction................  Biocompatibility evaluation
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
    At the time of classification, retrograde intubation devices are
for prescription use only. Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR
801.5, if the conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    While this final order contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this final order. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 868

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
868 is amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

0
1. The authority citation for part 868 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  868.5095 to subpart F to read as follows:

Sec.  868.5095  Retrograde intubation device.

    (a) Identification. A retrograde intubation device is a
prescription device used to perform retrograde intubation via the
cricothyroid membrane. The device may contain or be labeled for use
with guidewires and intubating catheters, in addition to needles (Sec.
868.5090), syringe (Sec.  880.5860 of this chapter), and hemostats
(Sec.  878.4800 of this chapter).
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use,
including the following:
    (i) Wire guide tensile, flex, fracture, and corrosion testing;
    (ii) Catheter tensile strength testing at likely points of failure;
    (iii) Catheter kink radius testing;
    (iv) Compatibility of device components that interact, including
compatibility in connection, disconnection, and ability to transfer
fluids;
    (v) Dimensional validation;
    (vi) Accuracy testing of markings; and
    (vii) Validation of the maximum airway pressure.
    (2) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
    (3) The device must be demonstrated to be biocompatible.
    (4) Labeling must include:
    (i) Instructions for use; and
    (ii) Package labels that clearly identify the minimum compatible
size of endotracheal tube.

    Dated: December 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28166 Filed 12-27-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Rules and Regulations]
[Pages 70697-70700]
[FR Doc No: 2015-29169]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0421; FRL-9936-25]

Tamarind Seed Gum, 2-Hydroxypropyl Ether Polymer; Tolerance
Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of tamarind seed gum, 2-hydroxypropyl ether
polymer (CAS Reg. No. 68551-04-2) when used as an inert ingredient in a
pesticide chemical formulation. Lamberti USA, Incorporated submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of tamarind seed gum, 2-hydroxypropyl ether polymer on
food or feed commodities.

DATES: This regulation is effective November 16, 2015. Objections and
requests for hearings must be received on or before January 15, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0421, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0421 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
January 15, 2016. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0421, by one of
the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-10807)
filed by Lamberti USA, Incorporated, 161 Washington Street Eight Tower
Bridge, Suite 1000 Conshohocken, PA 19428. The petition requested that
40 CFR 180.960 be amended by establishing an exemption from the
requirement of a tolerance for residues of tamarind seed gum, 2-
hydroxypropyl ether polymers (CAS Reg. No. 68551-04-2). That document
included a summary of the petition prepared by the petitioner and
solicited comments on the petitioner's request. The Agency did not
receive any comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . .'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this

action and considered its validity, completeness and reliability and
the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Tamarind seed gum, 2-hydroxypropyl
ether polymers conforms to the definition of a polymer given in 40 CFR
723.250(b) and meets the following criteria that are used to identify
low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as specified in 40 CFR
723.250(d)(6).
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    8. The polymer's minimum number average MW is greater than or equal
to 10,000 daltons. The polymer contains less than 2% oligomeric
material below MW 500 and less than 5% oligomeric material below MW
1,000.
    Thus, tamarind seed gum, 2-hydroxypropyl ether polymer meets the
criteria for a polymer to be considered low risk under 40 CFR 723.250.
Based on its conformance to the criteria in this unit, no mammalian
toxicity is anticipated from dietary, inhalation, or dermal exposure to
tamarind seed gum, 2-hydroxypropyl ether polymer.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that tamarind seed gum, 2-hydroxypropyl ether
polymer could be present in all raw and processed agricultural
commodities and drinking water, and that non-occupational non-dietary
exposure was possible. The number average MW of tamarind seed gum, 2-
hydroxypropyl ether polymer is 10,000 daltons. Generally, a polymer of
this size would be poorly absorbed through the intact gastrointestinal
tract or through intact human skin. Since tamarind seed gum, 2-
hydroxypropyl ether polymer conform to the criteria that identify a
low-risk polymer, there are no concerns for risks associated with any
potential exposure scenarios that are reasonably foreseeable. The
Agency has determined that a tolerance is not necessary to protect the
public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found tamarind seed gum, 2-hydroxypropyl ether polymer
to share a common mechanism of toxicity with any other substances, and
tamarind seed gum, 2-hydroxypropyl ether polymer does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
tamarind seed gum, 2-hydroxypropyl ether polymer does not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of tamarind seed gum, 2-
hydroxypropyl ether polymer, EPA has not used a safety factor analysis
to assess the risk. For the same reasons the additional tenfold safety
factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of tamarind seed gum, 2-hydroxypropyl
ether polymer.

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

    There are no existing tolerance exemptions for tamarind seed gum,
2-hydroxypropyl ether polymer.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

C. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for tamarind seed gum, 2-
hydroxypropyl ether polymer.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of tamarind seed
gum, 2-hydroxypropyl ether polymer from the requirement of a tolerance
will be safe.

X. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: November 5, 2015.
G. Jeffrey Herndon,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.960, add alphabetically the polymer in the table to
read as follows:

Sec.  [emsp14]180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                        Polymer                              CAS No.
------------------------------------------------------------------------

                                * * * * *
Tamarind seed gum, 2-hydroxypropyl ether polymer,            68551-04-2
 minimum number average molecular weight (in amu),
 10,000................................................

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

[FR Doc. 2015-29169 Filed 11-13-15; 8:45 am]
 BILLING CODE 6560-50-P