NOTICE OF FILING FOR PESTICIDE PETITION (PP#0F7744) PUBLISHED IN THE
FEDERAL REGISTER

<EPA Registration Division contact: Kathryn Montague, Herbicide Branch,
Product Manager, Team 23,<PHONE_NUMBER>>

<BASF Corporation>

<Pesticide Petition #0F7744>

<	EPA has received a pesticide petition (0F7744) from BASF Corporation,
26 Davis Drive, P.O. Box 13528, Research Triangle Park, North Carolina
27709-3528 proposing, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180.649 by establishing a tolerance for combined residues of
Saflufenacil
(2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-py
rimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide)
and its metabolites
N-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidin
yl)-4-fluorobenzoyl]-N'-isopropylsulfamide and
N-[4-chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino}
carbonyl)phenyl]urea, calculated as the stoichiometric equivalent of
Saflufenacil in or on the raw agricultural commodity oilseeds,
cottonseed subgroup 20C, gin by products at 3.5 parts per million (ppm)
and commodity oilseeds, cottonseed subgroup 20C, undelinted seed at 0.2
parts per million (ppm) and commodity oilseeds, sunflower subgroup 20B,
seed at 1.0 parts per million (ppm) and commodity pea, vines at 8.0
parts per million (ppm) and commodity soybean, aspirated grain fractions
at 4.52 parts per million (ppm) and commodity soybean, hulls at 0.42
parts per million (ppm) and commodity soybean, seed at 0.1 parts per
million (ppm) and commodity vegetable, legume, subgroup 6C, beans, dry
at 0.5 parts per million (ppm) and commodity vegetable, legume, subgroup
6C, peas, dry at 0.1 parts per million (ppm).  EPA has determined that
the petition contains data or information regarding the elements set
forth in section 408 (d)(2) of  FDDCA; 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.>

<A. Residue Chemistry>

<	1. Plant metabolism. Previously submitted metabolism data for corn,
soybean, and tomato and a confined rotational crop study are adequate to
elucidate the nature of the residue in plants resulting from
preplant/preemergence application. The residues of concern for the
tolerance expression and risk assessment consist of Saflufenacil,
M800H11, and M800H35. An additional nature of residue study was
conducted on soybean with a postemergence application in support of the
proposed uses as harvest aid / desiccation. The metabolism of
Saflufenacil in plants following a postemergence application is similar
to the metabolism of Saflufenacil in plants following a
preplant/preemergence application.>

<	2. Analytical method. Adequate enforcement methodology (liquid
chromatography/mass spectrometry/mass spectrometry (LCMS/MS) methods
D0603/02 (plants) and L0073/01 (livestock)) is available to enforce the
tolerance expression.>

<	3. Magnitude of residues. Field trials were carried out to determine
the magnitude of the residue following a postemergence application of
Saflufenacil made for harvest aid / desiccation uses in/on legumes
vegetables (crop subgroup 6C dry beans and dry peas), soybean, and
cotton. The number and locations of field trials are in accordance with
OPPTS Guideline 860.1500. Field trials were carried out using the
maximum label rates, the maximum number of applications, and the minimum
pre-harvest interval (PHI) for all the crops. Detected combined residues
of Saflufenacil plus metabolites in all crops support the proposed
tolerances.>

<B. Toxicological Profile>

<	1. Acute toxicity.  Saflufenacil has low acute toxicity via >the oral,
dermal, and inhalation routes of exposure. It is slightly irritating to
the eye but is neither a dermal irritant nor sensitizer.

<	2. Genotoxicty.  Saflufenacil is weakly clastogenic in the >in vitro
chromosomal aberration assay in V79 cells in the presence of S9
activation; however, the response was not evident in the absence of S9
activation. It is neither mutagenic in bacterial cells nor clastogenic
in rodents in vivo.

<	3. Reproductive and developmental toxicity. Increased fetal and
offspring >susceptibility to Saflufenacil were observed in the
developmental toxicity studies in the rat and rabbit and in the
2–generation reproduction study in the rat. Developmental effects such
as decreased fetal body weights and increased skeletal variations
occurred at doses that were not maternally toxic in the developmental
study in rats, indicating increased quantitative susceptibility. In
rabbits, developmental effects such as increased liver porphyrins were
observed at doses that were not maternally toxic, indicating increased
quantitative susceptibility. In the 2–generation reproduction study in
rats, offspring effects such as increased number of stillborn pups,
decreased viability and lactation indices, decreased pre-weaning body
weight and/or body-weight gain, and changes in hematological parameters
were observed at a dose resulting in less severe maternal toxicity
(decreased food intake, body weight/weight gain and changes in
hematological parameters and organ weights indicative of anemia),
indicating increased qualitative susceptibility.

<	4. Subchronic toxicity. Short-term, subchronic, and chronic toxicity
studies in rats, mice, and dogs identified the hematopoietic system as
the target organ of saflufenacil. Protoporphyrinogen oxidase inhibition
in the mammalian species may result in disruption of heme synthesis
which in turn causes anemia. In these studies, decreased hematological
parameters (red blood cells (RBC), hematocrit (Ht), mean corpuscular
volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular
hemoglobin concentration (MCHC)) were seen at about the same dose level
across species, except in the case of the dog, where the effects were
seen at a slightly higher dose. These effects occurred around the same
dose level from the short-term through long-term exposures without
increasing in severity. Effects were also seen in the liver (increased
weight, centrilobular fatty change, and lymphoid infiltrate) in mice,
the spleen (increased spleen weight and extramedullary hematopoiesis) in
rats, and in both these organs (increased iron storage in the liver and
extramedullary hematopoiesis in the spleen) in dogs. These effects also
occurred around the same dose level from the short-term through
long-term exposures without increasing in severity. No dermal toxicity
was seen at the limit dose in a 28–day dermal toxicity study in rats.

There was no evidence of neurotoxicity or neuropathology in the toxicity
database for Saflufenacil. In the acute neurotoxicity study, a decrease
in motor activity was observed on the first day of dosing at the limit
dose in males only. The finding was not accompanied by any other
neuropathological changes and was considered a reflection of a mild and
transient general systemic toxicity and not a substance-specific
neurotoxic effect. In the subchronic neurotoxicity study, systemic
toxicity (anemia), but no evidence of neurotoxicity, was seen in males
and females.

There is no evidence of immunotoxity in the Saflufenacil database. The
increase in spleen weight seen only in rats in the 90–day oral
toxicity study is attributable to an increased clearance of defective
RBCs (i.e., defective hemoglobin synthesis) and is thus an indication of
toxicity to the hematopoietic system rather than to the immune system.>

<	5. Chronic toxicity. Carcinogenicity studies in rats and mice showed
no evidence of increased incidence of tumors at the tested doses.
Saflufenacil is classified as ‘‘not likely to be carcinogenic to
humans.>

<	6. Animal metabolism. Rat metabolism data indicate that Saflufenacil
is well absorbed and rapidly excreted.  The maximum concentration of
Saflufenacil in blood and plasma was reached within 1 hour (h) of dosing
and declined rapidly after 24 h.  Excretion of orally dosed Saflufenacil
was essentially complete within 96 h, with the majority eliminated
within the first 24 to 48 h.  There was a sex-dependent difference in
the excretion of orally administered Saflufenacil.  The main route of
elimination in male rats was via the feces, while urinary excretion was
the major route of elimination in females.  The sex-dependent excretion
was more pronounced at the low-dose level than at the high-dose level.
Also, males had significantly higher biliary excretion of Saflufenacil
residues than females.  Exhalation was not a relevant excretion pathway
of Saflufenacil.  At 168 h after dosing, Saflufenacil residues remaining
in tissues were very low and occurred mainly in carcass, liver, skin,
and gut contents.

The parent molecule and 3 major metabolites were identified and isolated
from urine and feces. There were no significant gender differences in
metabolic profiles.  Saflufenacil was metabolized by three major
transformation steps, which were demethylation of the uracil ring
system, degradation of the N-methyl-N-isopropyl group to NH2, and
cleavage of the uracil ring, forming a sulfonylamide group. The
metabolism of Saflufenacil in the animals is well understood.>

<	7. Metabolite toxicology. No metabolites of toxicological concern are
identified.>

<	8. Endocrine disruption. No specific tests have been conducted with
Saflufenacil to determine whether the chemical may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen or other endocrine effects.  However, there were no significant
findings in other relevant toxicity studies (e.g., sub-chronic and
chronic toxicity, developmental toxicity and multi-generation
reproductive studies) which would suggest that Saflufenacil produces any
endocrine disruption.>

<C. Aggregate Exposure>

<	1. Dietary exposure. Exposure assessments were conducted to evaluate
the potential risk due to acute and chronic dietary exposure of the U.S.
population to combined residues of Saflufenacil and metabolites M800H11
and M800H35. The current tolerance values are listed in the U.S. 40 CFR
§ 180.649. This analysis includes all the crops with established
tolerances values as of June 2010 plus the proposed tolerance values for
legumes vegetables (crop subgroup 6C beans and peas), soybean, and
cotton.>

<	i. Food.

Acute Dietary Exposure Assessment

Acute dietary exposure estimates were conducted using the currently
established tolerances for Saflufenacil (40 CFR 180.649) and currently
proposed tolerances for soybean, soybean hulls, legume vegetables crop
subgroup 6C dried shelled pea and bean (except soybean), cotton
undelinted seed, cotton gin byproducts, crop group 7 foliage of legume
vegetables group (based on pea vine data), and higher residue levels in
meat-by-products (except liver) from goat, hog, sheep, horse, cattle,
and liver from cattle, goat, hog, sheep, and horse based on the
re-calculation of the feed burden containing feedstuffs with proposed
tolerances.  The assessment was conducted using tolerance values,
default process factors, and 100% crop treatment factors.  The
consumption data was from the USDA Continuing Survey of Food Intake by
Individuals (CSFII 1994 - 1996, 1998) and the EPA Food Commodity
Ingredient Database (FCID) using Exponent's Dietary Exposure Evaluation
Module (DEEM-FCID) software.

The resulting exposure estimates were compared against the Saflufenacil
acute Population Adjusted Dose (aPAD) of 5 mg/kg b.w./day for all
populations.  This endpoint is based on the NOAEL of 500 mg/kg/day with
the standard inter- and intra-species uncertainity factors of 100X and
an FQPA safety factor of 1.  The exposure for all sub-population was
less than 1.0% utilization of the aPAD.  The results of the acute
dietary assessment are presented in Table 1.

Table 1.	Results for Saflufenacil Acute Dietary Exposure Analysis
Considering all Proposed Tolerances using DEEM-FCID at the 95th
Percentile, food only

Population	Exposure Estimate	%aPAD

Subgroups	(mg/kg b.w./day)

U.S. Population	0.001322	0.03

All Infants (< 1 year old)	0.002475	0.05

Children (1-2 years old)	0.002974	0.06

Children (3-5 years old)	0.002383	0.05

Children (6-12 years old)	0.001457	0.03

Youth (13-19 years old)	0.000949	0.02

Adults (20-49 years old)	0.000759	0.02

Adults (50+ years old)	0.000702	0.01

Females (13 – 49 years old)	0.000744	0.01

The results of the analysis show that for all populations, the estimated
exposures are well below the Agency's level of concern (< 100% aPAD).
Additional refinements in the dietary risk assessment (i.e. utilizing
anticipated residue values, percent crop treated values) would further
reduce the estimated exposure values.

Chronic Dietary Exposure Assessment

Chronic dietary exposure were conducted using the currently established
tolerances for Saflufenacil (40 CFR 180.649) and currently proposed
tolerances for soybean, soybean hulls, legume vegetables crop subgroup
6C dried shelled pea and bean (except soybean), cotton undelinted seed,
cotton gin byproducts, crop group 7 foliage of legume vegetables group
(based on pea vine data), and higher residue levels in meat-by-products
(except liver) from goat, hog, sheep, horse, cattle, and liver from
cattle, goat, hog, sheep, and horse based on the re-calculation of the
feed burden containing feedstuffs with proposed tolerances.  The
assessment was conducted using tolerance values, default process
factors, and 100% crop treatment factors.  The consumption data was from
the USDA Continuing Survey of Food Intake by Individuals (CSFII 1994 -
1996, 1998) and the EPA Food Commodity Ingredient Database (FCID) using
Exponent's Dietary Exposure Evaluation Module (DEEM-FCID) software.

The chronic Population Adjusted Dose (cPAD) used for U.S. population and
all sub-populations is 0.046 mg/kg bw/day. This endpoint is based on the
NOAEL value of 4.6 using the standard inter- and intra-species
uncertainity factors of 100X and with a FQPA safety factor of 1.  The
most highly exposed population sub-group was children 1-2 years of age
which utilized 3.2 % cPAD.  The results of the chronic dietary
assessment are presented in Table 2.

Table 2. Results for Saflufenacil Chronic Dietary Exposure Analysis
Considering all Proposed Tolerances using DEEM-FCID, food only

Population	Exposure Estimate	%cPAD

Subgroups	(mg/kg b.w./day)

U.S. Population	0.000448	1.0

All Infants (< 1 year old)	0.001039	2.3

Children (1-2 years old)	0.001472	3.2

Children (3-5 years old)	0.001171	2.5

Children (6-12 years old)	0.000698	1.5

Youth (13-19 years old)	0.000398	0.9

Adults (20-49 years old)	0.000319	0.7

Adults (50+ years old)	0.000302	0.7

Females (13-49 years old)	0.000315	0.7

The results of the analysis show that for all populations, the exposures
are far below a level of concern (< 100% cPAD).  Additional refinements
in the chronic dietary risk assessment (i.e. utilizing anticipated
residue values and percent crop treated values) would further reduce the
estimated exposure values.>

<	ii. Drinking water. All Saflufenacil uses were examined at maximum use
rates, maximum number of applications, and all proposed application
methods to determine which use would result in the highest water
concentrations.  The highest water concentrations occurred from the
Mississippi corn scenario (model) from an aerial application at 0.134 lb
ai/A.  Based on results from the PRZM/EXAMS and SCI-GROW models
estimates, the highest acute Estimated Drinking Water Concentrations
(EDWC) for Saflufenacil were estimated to be 8.1 ug/L (ppb) in surface
water and 0.36 ug/L in ground water.  The highest chronic EDWC’s for
Saflufenacil were estimated to be 2.5 ug/L in surface water and 0.36
ug/L in ground water.

Drinking water exposure contributions were assessed based on the maximum
estimated Saflufenacil water concentrations (acute 8.1 ug/L, chronic 2.5
ug/L), and water consumption and body weights reported in CSFII, using
DEEM-FCID software.  The acute and chronic estimated water exposure
values are summarized in Tables 3 and 4, respectively.  Drinking water
exposure accounts for less than 1% of the aPAD and 1 % of the cPAD for
all populations.

Table 3. Results for Saflufenacil Acute Water Exposure Analysis
Considering the Maximum Estimated Acute Drinking Water Concentration
using DEEM-FCID

Population	Water Exposure Estimate	% aPAD

Subgroups	(mg/kg b.w./day)

U.S. Population	0.000423	0.01

All Infants (< 1 year old)	0.001535	0.03

Children (1-2 years old)	0.000664	0.01

Children (3-5 years old)	0.000607	0.01

Children (6-12 years old)	0.000422	0.01

Youth (13-19 years old)	0.000343	0.01

Adults (20-49 years old)	0.000392	0.01

Adults (50+ years old)	0.000354	0.01

Females (13-49 years old)	0.000394	0.01

Table 4. Results for Saflufenacil Chronic Water Exposure Analysis
Considering the Maximum Estimated Chronic Drinking Water Concentration
using DEEM-FCID

Population	Water Exposure Estimate	%cPAD

Subgroups	(mg/kg b.w./day)

U.S. Population	0.000053	0.1

All Infants (< 1 year old)	0.000173	0.4

Children (1-2 years old)	0.000078	0.2

Children (3-5 years old)	0.000073	0.2

Children (6-12 years old)	0.000051	0.1

Youth (13-19 years old)	0.000038	0.1

Adults (20-49 years old)	0.000049	0.1

Adults (50+ years old)	0.000052	0.1

Females (13-49 years old)	0.000049	0.1

Acute Aggregate Exposure and Risk (food and water)

The aggregate acute risk includes exposure of Saflufenacil from food and
water (Table 5). The results demonstrate that there are no safety
concerns for any subpopulation based on the proposed uses and the
results meet the FQPA standard of reasonable certainty of no harm.

Table 5. 	Estimated Acute Aggregate Exposure and Risk of Saflufenacil.

Population Subgroup	aPAD (mg/kg/day)	Food Exposure (mg/kg/day)	Water
Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	% aPAD

U.S. Population	5	0.001322	0.000423	0.00175	0.03

All Infants (< 1 yr old)	5	0.002475	0.001535	0.00401	0.08

Children 1-2 years	5	0.002974	0.000664	0.00364	0.07

Children 3-5 years	5	0.002383	0.000607	0.00299	0.06

Children 6 – 12 years	5	0.001457	0.000422	0.00188	0.04

Youth 13-19 years	5	0.000949	0.000343	0.00129	0.03

Adults 20-49 years	5	0.000759	0.000392	0.00115	0.02

Adults + 50	5	0.000702	0.000354	0.00106	0.02

Females 13-49 years	5	0.000744	0.000394	0.00114	0.02

Short- and Intermediate-Term Aggregate Exposure and Risk (food, water,
and residential)

Short- and intermediate-term aggregate risk assessments include exposure
from food, water, and residential uses.  There are no residential uses
for Saflufenacil, therefore, a short- and intermediate-term aggregate
risk assessment is not required.

Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes exposure of Saflufenacil from food
and water (Table 6). The results demonstrate there are no safety
concerns for any subpopulation based on the proposed uses and the
results meet the FQPA standard of reasonable certainty of no harm.

Table 6. 	Estimated Chronic Aggregate Exposure and Risk of Saflufenacil

Population Subgroup	cPAD (mg/kg/day)	Food Exposure (mg/kg/day)	Water
Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	% cPAD

U.S. Population	0.046	0.000448	0.000053	0.00050	1.1

All Infants (< 1 yr old)	0.046	0.001039	0.000173	0.00121	2.6

Children 1-2 years	0.046	0.001472	0.000078	0.00155	3.4

Children 3-5 years	0.046	0.001171	0.000073	0.00124	2.7

Children 6 – 12 years	0.046	0.000698	0.000051	0.00075	1.6

Youth 13-19 years	0.046	0.000398	0.000038	0.00044	0.9

Adults 20-49 years	0.046	0.000319	0.000049	0.00037	0.8

Adults + 50	0.046	0.000302	0.000052	0.00035	0.8

Females 13-49 years	0.046	0.000315	0.000049	0.00036	0.8

>

<	2. Non-dietary exposure. The term ‘‘residential exposure’’ is
used to refer to non-occupational, non-dietary exposure (e.g., for lawn
and garden pest control, indoor pest control, termiticides, and flea and
tick control on pets). Saflufenacil is not registered for any specific
use patterns that would result in residential exposure.  Therefore, a
non-dietary exposure and risk evaluation was not conducted.>

<D. Cumulative Effects>

<	Section 408(b)(2)(D)(v) 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 Saflufenacil to share a
common mechanism of toxicity with any other substances, and Saflufenacil
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance petition, therefore, EPA
will assume that Saflufenacil does not have a common mechanism of
toxicity with other substances.>

<E. Safety Determination>

<	1. U.S. population. Based on the current risk assessments, EPA may
conclude that there is a reasonable certainty that no harm will result
to the general population from aggregate exposure to Saflufenacil
residues from the proposed uses.>

<	2. Infants and children. Based on the current risk assessments, EPA
may conclude that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to Saflufenacil
residues from the proposed uses.>

<F. International Tolerances>

<	There are no Codex maximum residue limits (MRLs) established for
residues of Saflufenacil and its metabolites in crops or livestock
commodities. The residue definition and harmonized MRLs are established
for residues of Saflufenacil and its metabolites in similar crops and
livestock commodities in Canada.>

 PAGE

 PAGE   9


[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Proposed Rules]
[Pages 37255-37258]
[FR Doc No: 2014-15399]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2013-0746; FRL-9912-95-Region 4]

Approval and Promulgation of Implementation Plans; Florida:
Removal of Sulfur Storage and Handling Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Environmental Protection Agency (EPA) is proposing to approve
a revision to the Florida State Implementation Plan (SIP), submitted by
the Florida Department of Environmental Protection (FDEP), on April 5,
2012. The revision modifies Florida's SIP to remove two state rules
relating to new and existing sulfur storage and handling facilities
because they are no longer necessary. EPA has preliminarily determined
that Florida's April 5, 2012, SIP revision regarding sulfur storage and
handling facilities is approvable because it is consistent with the
Clean Air Act (CAA or Act).

DATES: Written comments must be received on or before July 31, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2013-0746, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2013-0746''--Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2013-0746. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Joel Huey, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and

Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The
telephone number is<PHONE_NUMBER>. Mr. Huey can also be reached via
electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The proposed revision requests that EPA remove two state rules--
Rule 62-212.600, F.A.C., ``Sulfur Storage and Handling Facilities'' and
Rule 62-296.411, F.A.C., ``Sulfur Storage and Handling Facilities''--
from Florida's SIP. Florida repealed these rules on February 16, 2012.
    The requirements of Rule 62-212.600, F.A.C., apply to proposed new
or modified sulfur storage and handling facilities. The rule states
that the owner or operator of any proposed new or modified sulfur
storage and handling facility that is to be located within five
kilometers of either a particulate matter (PM) air quality maintenance
area or a prevention of significant deterioration (PSD) Class I area
shall provide FDEP with an analysis of the probable particulate matter
ambient air quality impacts that could result from the operation of the
facility. Additionally, the owner or operator shall provide FDEP with
an analysis of the probable annual and maximum monthly sulfur
deposition rates that could occur as a result of the operation of the
facility. The owner or operator shall conduct post-construction air
quality and deposition monitoring of sulfur particulate emissions from
the facility for two years from the date of issuance of the initial air
operation permit for the facility, and, through the permitting process,
shall determine the period of time, if any, such monitoring must be
continued. The data collected would then be provided to FDEP as
specified in the permit. Florida states that the ``General
Preconstruction Review Requirements'' and ``Prevention of Significant
Deterioration (PSD)'' provisions of the Rules 62-212.300 and 62-
212.400, F.A.C., respectively, can be used instead of Rule 62-212.600,
F.A.C to prevent PM emissions that would interfere with attainment and
maintenance of national ambient air quality standards (NAAQS),
prevention of significant deterioration of air quality, or protection
of visibility.
    Rule 62-296.411, F.A.C., states that no person shall cause, suffer,
or allow elemental sulfur to be stored, handled, or transported within
the State in crushed bulk or slate form or in any form other than
standard sulfur pellets or in molten form, except that sulfur may be
transferred within the boundaries of a single facility in other forms.
Facilities using standard sulfur pellets or molten sulfur, or sulfur
vatting facilities, may be permitted only in conformance with the
practices identified in the rule. Florida states that the ``General
Pollutant Emission Limiting Standards'' of Rule 62-296.320, F.A.C., can
be applied instead of Rule 62-296.411, F.A.C. to adequately control PM
emissions from dry material handling operations such as those
associated with sulfur storage and handling facilities.
    With removal of the above two rules from the SIP, Florida's PM
requirements under the SIP for new and existing sulfur storage and
handling facilities would align with the PM requirements for other,
similar dry material handling sources in the State. At the time that
Florida promulgated its sulfur storage and handling rules, the State
was concerned that total suspended particulate matter levels in Florida
would be negatively impacted by increased sulfur handling and storage
operations to such an extent as to warrant additional facility-specific
work practices and monitoring. However, the anticipated increase in
sulfur handling and storage operations did not occur, and only 11
facilities are subject to Rule 62-212.300, F.A.C. and Rule 62-212.400,
F.A.C. EPA approved these two state rules into the SIP on December 24,
1985, at 50 FR 52460.\1\
---------------------------------------------------------------------------

    \1\ EPA's December 24, 1985, action incorporated the state
sulfur storage and handling rules at 17-2.540, F.A.C. and 17-2.600,
F.A.C. into Florida's SIP. Florida later reorganized its
administrative code and renumbered these rules as 62-212.600, F.A.C.
and 62-296.411, F.A.C., respectively. EPA updated the Florida SIP on
June 16, 1999 (64 FR 32346), to make it consistent with the revised
numbering system.
---------------------------------------------------------------------------

II. Analysis of the State's Submittal

    EPA's primary consideration for determining the approvability of
Florida's request to remove the existing sulfur storage and handling
facilities rules, 62-212.600, F.A.C. and 62-296.411, F.A.C., from the
SIP is whether these requested actions comply with section 110(l) of
the CAA. Under Section 110(l), EPA cannot approve a SIP revision if
that revision would interfere with any applicable requirement regarding
attainment, reasonable further progress (RFP), or any other applicable
requirement established in the CAA. EPA will approve a SIP revision
that removes or modifies control measures in the SIP only after the
state makes a ``noninterference'' demonstration that such a removal or
modification will not interfere with RFP, attainment or maintenance of
any NAAQS, or any other CAA requirement. As such, Florida must make a
demonstration of noninterference in order to remove the sulfur storage
and handling facilities requirements from its SIP.
    Because actual emissions are not expected to change, there will be
no impact on PSD increments, RFP, visibility, attainment or maintenance
of any NAAQS, or any other applicable CAA requirement. Particulate
matter, in the form of coarse (PM10) and fine
(PM2.5) PM, is the pollutant related to the SIP revision. On
January 15, 2013 (78 FR 3086), EPA established an annual primary
PM2.5 NAAQS at 12.0 micrograms per cubic meter ([mu]g/m\3\)
based on a 3-year average of annual mean PM2.5
concentrations. At that time, EPA retained the 2006 24-hour
PM2.5 NAAQS at 35 [mu]g/m\3\ based on a 3-year average of
the 98th percentile of 24-hour concentrations.
    All areas in the State are currently designated as attainment for
the PM10 and PM2.5 NAAQS. For example, Table 1
identifies the PM2.5 annual and 24-hour design values for
the counties where facilities subject to the repealed sulfur storage
and handling rules are located and demonstrates that these design
values are well below the respective NAAQS.

                                          Table 1--PM2.5 Design Values
----------------------------------------------------------------------------------------------------------------
                     County                          2008-2010       2009-2011       2010-2012       2011-2013
----------------------------------------------------------------------------------------------------------------
                                               Annual Design Value
----------------------------------------------------------------------------------------------------------------
Hillsborough....................................             8.0             7.8             7.6             7.1
Polk............................................             7.7             7.5             7.4             7.0
----------------------------------------------------------------------------------------------------------------

                                              24-hour Design Value
----------------------------------------------------------------------------------------------------------------
Hillsborough....................................              16              17              16              16
Polk............................................              15              15              16              15
----------------------------------------------------------------------------------------------------------------

    There are no emissions reductions of carbon monoxide (CO), lead,
nitrogen oxides, ozone, or sulfur dioxide (SO2) attributable
to the sulfur storage and handling facilities requirements. As a
result, the removal of these requirements will not interfere with
attainment of these NAAQS.
    A comparison of PM emissions from sulfur handling and storage
emission units at each subject facility with PM emissions from the
entire facility demonstrates that sulfur PM emissions from the subject
units account for approximately zero to nine percent of total PM
emissions at most facilities. Of the four facilities at which all
facility PM emissions are entirely due to sulfur PM emissions from
sulfur handling and storage emissions units, the amount of sulfur PM
emitted ranges from approximately one to six tons per year per
facility. See Table 2.

Table 2--Comparison of PM Emissions From Sulfur Handling and Storage Emission Units (EU) at Each Facility Versus
                                    PM Emissions From the Entire Facility \2\
----------------------------------------------------------------------------------------------------------------
                                                                All facility   Sulfur EU PM %   Potential (P) or
           Facility              Facility ID    Sulfur EU PM    EU PM  (tons/      of all      2010  actual  (A)
                                                 (tons/year)        year)      facility EU PM    PM  emissions
----------------------------------------------------------------------------------------------------------------
WHITE SPRS AG CHEM--SR/SC              470002             5.6          2084.8             0.3  P
 CMPLX.
CF INDUSTRIES--PLANT CITY              570005             0.6            59.4             1.0  A
 PHOSP COMPLEX.
MOSAIC FERTILIZER--RIVERVIEW           570008             0.6            27.9             2.2  A
 FACILITY.
GULF SULPHUR SERVICES,                 570082             1.0             1.0           100.0  P
 HOOKER'S PT SITE.
GULF SULPHUR SERVICES, PORT            570100             6.0             6.0           100.0  P
 SUTTON SITE.
PASCO TERMINALS, INC.........          570455             4.5             4.5           100.0  P
MARTIN GAS SALES, INC........          570477             1.5             1.5           100.0  P
MOSAIC FERTILIZER, LLC--              1050046             4.4            57.0             7.7  A
 BARTOW FACILITY.
MOSAIC FERTILIZER--SOUTH              1050055             0.4            99.6             0.4  P
 PIERCE FACILITY.
MOSAIC FERTILIZER--NEW WALES          1050059            12.0           141.3             8.5  A
 FACILITY.
QUANTUM ST REGIS TREATING &           1130005             0.0            14.7             0.0  A
 JAY GAS.
                                              ------------------------------------------------------------------
    Total....................  ..............            36.6          2497.7             1.5
----------------------------------------------------------------------------------------------------------------

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

    \2\ These data can be accessed at www.regulations.gov using
Docket ID No. EPA-R04-OAR-2013-0746.
---------------------------------------------------------------------------

    Of the 11 facilities that are subject to the sulfur handling and
storage emission rules, four will experience a relaxation in the
opacity limit from 10 or 15 percent to 20 percent if 62-212.600, F.A.C.
and 62-296.411, F.A.C. are removed from the SIP, but emissions are not
expected to increase because the underlying work practices will remain
unchanged. The sulfur particulate emitting emissions units at these
four facilities are approximately less than one ton per year, and a
majority of the visible emissions tests conducted in 2010-11 for sulfur
storage and handling units showed no visible emissions (i.e., zero
percent opacity).
    Furthermore, several existing state rules incorporated into
Florida's SIP can be applied in lieu of Rules 62-212.600, F.A.C. and
62-296.411, F.A.C. to address sulfur PM emissions from sulfur storage
and handling emissions units at these facilities. Rules 62-212.300 and
62-212.400, F.A.C., respectively, can be applied instead of the sulfur-
specific requirements of paragraph 62-212.600(2)(a), F.A.C., to
evaluate potential particulate matter ambient air quality impacts. The
sulfur deposition analysis required by paragraph 62-212.600(2)(b),
F.A.C., is unnecessary because there is no standard to compare the
results with to demonstrate compliance. Rule 62-296.411, F.A.C., the
``General Pollutant Emission Limiting Standards'' of Rule 62-296.320,
F.A.C., and, for some emissions units, the PM Reasonably Available
Control Technology requirements of Rule 62-296.711, F.A.C., can be
applied to control the sulfur PM emissions from sulfur storage and
handling emissions units at these facilities. Rule 62-296.711, F.A.C.
generally imposes a five percent opacity limit for existing sulfur
handling, sizing, screening, crushing, and grinding operations in
former total suspended particulate non-attainment areas or within 50
kilometers of such former areas except where an emissions unit has
received a Best Available Retrofit Technology (BACT) determination or
the emissions are insignificant enough to be exempted under Rule 62-
296.700(2), F.A.C. The control techniques and work practice standards
found in Rule 62-296.411, F.A.C., to control unconfined emissions of
particulate matter can also be required by paragraph 62-296.320(4)(c),
F.A.C., which prohibits the emission of unconfined particulate matter
without taking reasonable precautions to prevent such emissions.
    For the reasons discussed above, EPA has determined that removal of
the sulfur storage and handling facilities rules will not interfere
with attainment or maintenance of the NAAQS in surrounding states or
interfere with any other requirement identified in section 110(l).

III. Proposed Action

    EPA is proposing to approve Florida's April 5, 2012, SIP revision
to remove state Rule 62-212.600, F.A.C. and Rule 62-296.411, F.A.C.,
related to sulfur

storage and handling facilities, from the Florida SIP because the
Agency has preliminarily determined that this revision is consistent
with section 110(l) of the CAA.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves State law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, and
Reporting and recordkeeping requirements.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: June 16, 2014.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2014-15399 Filed 6-30-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3419-3422]
[FR Doc No: 2023-00973]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3657]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Accreditation Scheme for Conformity Assessment Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with the Accreditation Scheme for Conformity Assessment
(ASCA) Program.

DATES: Either electronic or written comments on the collection of
information must be submitted by March 20, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 20, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3657 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Accreditation Scheme for
Conformity Assessment Program.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites

comments on these topics: (1) whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Accreditation Scheme for Conformity Assessment Program

OMB Control Number 0910-0889--Extension

    The FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52)
amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360d(d)) by adding a new subsection (d) entitled
``Accreditation Scheme for Conformity Assessment.''
    Section 514(d) of the FD&C Act required FDA to establish a pilot
program under which testing laboratories may be accredited by
accreditation bodies meeting criteria specified by FDA to assess the
conformance of a device within certain FDA-recognized standards.
Determinations by accredited testing laboratories that a device
conforms with an eligible standard included as part of the ASCA Program
shall be accepted by FDA for the purposes of demonstrating such
conformity unless FDA finds that a particular such determination shall
not be so accepted.
    The statute provides that FDA may review determinations by
accredited testing laboratories, including by conducting periodic
audits of such determinations or processes of accreditation bodies or
testing laboratories.
    Following such a review, or if FDA becomes aware of information
materially bearing on safety or effectiveness of a device assessed by
an accredited testing laboratory, FDA may take additional measures as
determined appropriate, including suspension or withdrawal of
accreditation of a testing laboratory or a request for additional
information regarding a specific device.
    FDA issued the final guidance ``The Accreditation Scheme for
Conformity Assessment (ASCA) Pilot Program'' (https://www.fda.gov/media/130901/download) to discuss the goals and implementation of the
voluntary ASCA Pilot Program (hereafter referred to as the ASCA Program
in accordance with amendments made to section 514 of the FD&C Act by
FDARA, and as part of the enactment of the Medical Device User Fee
Amendments of 2017 (MDUFA IV)).
    The establishment of the goals, scope, procedures, and a suitable
framework for the voluntary ASCA Program supports the Agency's
continued efforts to use its scientific resources effectively and
efficiently to protect and promote public health. FDA believes the
voluntary ASCA Program may further encourage international
harmonization of medical device regulation because it incorporates
elements, where appropriate, from a well-established set of
international conformity assessment practices and standards (e.g., ISO/
IEC 17000 series). The voluntary ASCA Program does not supplant or
alter any other existing statutory or regulatory requirements governing
the decision-making process for premarket submissions.
    Under the ASCA Program's conformity assessment scheme, recognized
accreditation bodies accredit testing laboratories using ASCA program
specifications associated with each eligible standard and ISO/IEC
17025:2017: General requirements for the competence of testing and
calibration laboratories. ASCA-accredited testing laboratories may
conduct testing to determine conformance of a device with at least one
of the standards eligible for inclusion in the ASCA Program. When an
ASCA-accredited testing laboratory conducts such testing, it may
provide a complete test report to the device manufacturer. A device
manufacturer who utilizes an ASCA-accredited testing laboratory to
perform testing in accordance with the provisions of the ASCA Program
can then include a declaration of conformity with supplemental
documentation (including a summary test report) as part of a premarket
submission to FDA. Testing performed by an ASCA-accredited testing
laboratory can be used to support a premarket submission for any device
if the testing was conducted using a standard eligible for inclusion in
the ASCA Program and in accordance with the ASCA program specifications
for that standard.
    The ASCA Program includes participation from accreditation bodies,
testing laboratories, device manufacturers, and FDA staff. Each of
these entities plays a critical role in the ASCA Program to ensure that
patients and healthcare providers have timely and continued access to
safe, effective, and high-quality medical devices.
    To participate in the ASCA Program, accreditation bodies and
testing laboratories apply to FDA to demonstrate that they have the
qualifications for their respective roles within the program. An
application includes agreement to terms of participation. For example,
a participating accreditation body or testing laboratory agrees to
attend training, regularly communicate with FDA, and support periodic
FDA audits. FDA recognizes qualified applicants as participants. In its
recognition, FDA will identify the scope of recognition of specific
standards and test methods to which each participant may accredit or
test as part of the ASCA Program.
    After recognizing a testing laboratory as a participant in the ASCA
Program, FDA will generally grant the testing laboratory ASCA
Accreditation. During the ASCA Program, FDA generally will accept
determinations from ASCA-accredited testing laboratories that a medical
device is in conformity with the specified testing to a particular
standard and does not intend to review complete test reports from ASCA-
accredited testing laboratories in support of a declaration of
conformity submitted with a premarket submission except in certain
circumstances.
    Note that ASCA Accreditation is separate from any accreditation
that an accreditation body may provide to a testing laboratory for
purposes other than the ASCA Program. FDA's decision to recognize the
accreditation for purposes of the ASCA Program is separate and distinct
from any independent decision by the accreditation body with respect to
a testing laboratory for purposes outside of the ASCA Program.
    The ASCA Program does not address specific content for a particular
premarket submission. Information collections associated with premarket
submissions have been previously approved.
    FDA plans to issue draft guidance updates to the three published
ASCA Pilot guidance documents \1\ to improve

and streamline the ASCA Program. The guidance updates are being issued
to discuss the lessons learned during ASCA's pilot phase and to also
facilitate the transition from a pilot to a permanent program. As a
result of these guidance updates, there is minimal adjustment to the
burden estimate.
---------------------------------------------------------------------------

    \1\ The Accreditation Scheme for Conformity Assessment (ASCA)
Pilot Program [verbar] FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program). Basic Safety and
Essential Performance of Medical Electrical Equipment, Medical
Electrical Systems, and Laboratory Medical Equipment--Standards
Specific Information for the Accreditation Scheme for Conformity
Assessment (ASCA) Pilot Program [verbar] FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-and). Biocompatibility Testing of Medical
Devices--Standards Specific Information for the Accreditation Scheme
for Conformity Assessment (ASCA) Pilot Program [verbar] FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testing-medical-devices-standards-specific-information-accreditation-scheme).
---------------------------------------------------------------------------

    Respondents are accreditation bodies (ABs) and testing laboratories
(TLs). In tables 1 through 3, these abbreviations are used.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                   Activity                        Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses                                                    \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application by AB for ASCA Recognition........               8               1               8  6.......................................              48
Request by AB to continue ASCA Recognition....               2               1               2  6.......................................              12
Request by AB for ASCA Recognition (subsequent               1               1               1  6.......................................               6
 to withdrawal).
Request by AB to expand scope of ASCA                        1               1               1  6.......................................               6
 Recognition.
AB annual status report.......................               8               1               8  3.......................................              24
AB notification of change.....................               8               1               8  1.......................................               8
Application by TL for ASCA Accreditation......             150               1             150  4.......................................             600
Request by TL to continue ASCA Accreditation..              75               1              75  4.......................................             300
Request by TL for ASCA Accreditation                         5               1               5  4.......................................              20
 (subsequent to withdrawal or suspension).
Request by TL to expand scope of ASCA                       75               1              75  4.......................................             300
 Accreditation.
TL annual status report.......................             150               1             150  1.5.....................................             225
TL notification of change.....................               5               1               5  1.......................................               5
Request for withdrawal or suspension of ASCA                 6               1               6  0.08 (5 minutes)........................               1
 Accreditation (TLs) or request for withdrawal
 of ASCA Recognition (ABs).
Pilot feedback questionnaire (ABs and TLs)....             158               1             158  0.5 (30 minutes)........................              79
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................           1,634
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Totals have been rounded to the nearest hour.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Activity                 Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
AB setup documentation standard                3               1               3              25              75
 operating procedures (SOPs) &
 training (one-time burden).....
TL setup documentation SOPs &                 20               1              20              25             500
 training (one-time burden).....
AB record maintenance...........               8               1               8               1               8
TL record maintenance...........             150               1             150               1             150
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             733
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of    disclosures per   Total annual         Average burden per disclosure         Total hours
                                                 respondents      respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for Accreditation (TLs requesting                 150                1             150  0.5 (30 minutes)........................              75
 accreditation from ABs).
Review/Acknowledgement of accreditation                     8               22             176  40......................................           7,040
 request (ABs).
Test Reports (TLs)...........................             880                1             880  1.......................................             880
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ...............  ..............  ........................................           7,995
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate of eight ABs is based on the number of International
Laboratory Accreditation Cooperation signatories in the U.S. economy.
We estimate that approximately 150 testing labs will seek
accreditation. Our estimate of Test Reports is based on the number of
premarket submissions we expect per year with testing from an ASCA-
accredited testing laboratory.
    Our estimates for the average burden per response, recordkeeping,
and disclosure are based on our experience with the pilot program.
    Our estimated burden for the information collection reflects an
overall decrease of 3,129 hours and an increase of 94 responses/
records. We attribute this adjustment to a decrease in the one-time
burden for accreditation bodies and testing laboratories training and
SOPs because much of this activity was completed during the pilot. In
addition, there is an increase in the annual responses/records because
there is an increase in renewal requests (Request by AB to continue
ASCA Recognition and Request by TL to continue ASCA Accreditation)
since the pilot program was initiated.

    Dated: January 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00973 Filed 1-18-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 7, 2010 (Volume 75, Number 194)]
[Rules and Regulations]
[Page 61985-61987]
[DOCID:fr07oc10-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0950; Directorate Identifier 2009-NM-194-AD;
Amendment 39-16460; AD 2009-19-06]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 747-100, 747-100B, 747-
100B SUD, 747-200B, 747-200F, 747-300, 747-400, 747-400D, 747SP, and
747SR Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: This document publishes in the Federal Register an amendment
adopting airworthiness directive (AD) 2009-19-06 that was sent
previously by individual notices to the known U.S. owners and operators
of affected airplanes identified above. This AD requires installing
certain equipment on the flight deck door. This AD was prompted by
reports that the current design of the flight deck door is defective.
We are issuing this AD to prevent failure of this equipment, which
could jeopardize flight safety.

DATES: This AD becomes effective October 12, 2010 to all persons except
those persons to whom it was made immediately effective by AD 2009-19-
06, which contained the requirements of this amendment.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of October 12,
2010.
    We must receive comments on this AD by November 22, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, 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 service information identified in this AD, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, P.O. Box
3707, MC 2H-65, Seattle, Washington 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; e-mail

<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Robert Kaufman, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
ACO, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6433; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On September 9, 2009, we issued AD 2009-19-
06, which applies to certain Boeing Model 747-100, 747-100B, 747-100B
SUD, 747-200B, 747-200F, 747-300, 747-400, 747-400D, 747SP, and 747SR
series airplanes.

Background

    We have received a report indicating that the current design of the
flight deck door is defective. This condition, if not corrected, could
jeopardize flight safety.

Relevant Service Information

    We reviewed Boeing Service Bulletin 747-52-2293, dated September 4,
2009. The service bulletin describes procedures for installing certain
equipment associated with the flight deck door.

FAA's Determination and Requirements of This AD

    Since the unsafe condition described is likely to exist or develop
on other airplanes of the same type design, we issued AD 2009-19-06 to
prevent failure of the flight deck door, which could jeopardize flight
safety. The AD requires accomplishing the actions specified in the
service information previously described.
    We have determined that notice and opportunity for prior public
comment on AD 2009-19-06 were contrary to the public interest, and good
cause existed to make the AD effective immediately by individual
notices issued on September 9, 2009, to the known U.S. owners and
operators of certain Boeing Model 747-100, 747-100B, 747-100B SUD, 747-
200B, 747-200F, 747-300, 747-400, 747-400D, 747SP, and 747SR series
airplanes. These conditions still exist, and the AD is hereby published
in the Federal Register as an amendment to section 39.13 of the Federal
Aviation Regulations (14 CFR 39.13) to make it effective to all
persons.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2010-0950; Directorate Identifier 2009-NM-194-AD'' at
the beginning of your comments. We specifically invite comments on the
overall regulatory, economic, environmental, and energy aspects of this
AD. We will consider all comments received by the closing date and may
amend this AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2009-19-06 The Boeing Company: Amendment 39-16460. Docket No. FAA-
2010-0950; Directorate Identifier 2009-NM-194-AD.

Effective Date

    (a) This AD becomes effective October 12, 2010, to all persons
except those persons to whom it was made immediately effective by AD
2009-19-06, issued on September 9, 2009, which contained the
requirements of this amendment.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 747-100, 747-100B, 747-100B
SUD, 747-200B, 747-200F, 747-300, 747-400, 747-400D, 747SP, and
747SR series airplanes, certificated in any category; as identified
in Boeing Service Bulletin 747-52-2293, dated September 4, 2009.

Subject

    (d) Air Transport Association (ATA) of America Code 52: Doors.

Unsafe Condition

    (e) This AD was prompted by reports that the current design of
the flight deck door is

defective. We are issuing this AD to prevent failure of this
equipment, which could jeopardize flight safety.

Compliance

    (f) Comply with this AD within the compliance times specified,
unless already done.

Door Equipment Installation

    (g) Within 30 days after the effective date of this AD, install
certain equipment associated with the flight deck door, in
accordance with Boeing Service Bulletin 747-52-2293, dated September
4, 2009.

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Seattle Aircraft Certification Office, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to Robert
Kaufman, Aerospace Engineer, Cabin Safety and Environmental Systems
Branch, ANM-150S, FAA, Seattle Aircraft Certification Office, 1601
Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6433; fax<PHONE_NUMBER>. Or e-mail information to 9-ANM-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically refer to this AD.

Incorporation by Reference

    (i) You must use Boeing Service Bulletin 747-52-2293, dated
September 4, 2009, to do the actions required by this AD, unless the
AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on September 23, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-25194 Filed 10-6-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Page 64958]
[FR Doc No: 2011-27058]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4017-DR; Docket ID FEMA-2011-0001]

Puerto Rico; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Puerto Rico (FEMA-4017-DR), dated August 27,
2011, and related determinations.

DATES: Effective Date: October 4, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Puerto Rico is hereby amended to include the
following area among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of August 27, 2011.

    Patillas Municipality for Public Assistance (already designated
for Individual Assistance).

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

    Dated: October 13, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-27058 Filed 10-18-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50031-50032]
[FR Doc No: 2019-20677]

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

[FRL-10000-24-OA]

Notification of a Public Meeting of the Science Advisory Board
All-Ages Lead Model Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Announcement of meeting.

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SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office announces a public meeting of the SAB's All-
Ages Lead Model (AALM) Panel. The Panel will meet to conduct a peer
review the EPA's AALM External Review Draft Version 2.0, comprising the
model's software, technical documentation, and user manual (hereafter
referred to collectively as AALM 2.0). The AALM 2.0 was developed by
EPA's Office of Research and Development.

DATES: The two-day public meeting will be held October 17-18, 2019,
from 9 a.m. until 5:30 p.m. the first day and from 8:30 a.m. until 3:30
p.m. the second day (Eastern Time).

ADDRESSES: The meeting will be held at the Crystal Gateway Marriott,
1700 Jefferson Davis Highway, Arlington, VA 20002.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this public meeting may contact Iris
Goodman, Designated Federal Officer (DFO), EPA Science Advisory Board
Staff (SAB) Office, by telephone at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>The SAB mailing address is U.S. EPA Science
Advisory Board (1400R), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue NW, Washington, DC 20460. General information about
the SAB, including information concerning the SAB meeting announced in
this notice, can be found at the SAB web page at http://epa.gov/sab.
    Technical Contact for EPA's Draft Reports: For information
concerning the EPA materials to be reviewed, please contact James
Brown, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Background: The SAB was established pursuant to the Environmental
Research, Development, and Demonstration Authorization Act (ERDAA)
codified at 42 U.S.C. 4365, to provide independent scientific and
technical peer review, advice, consultation, and recommendations to the
EPA Administrator on the technical basis for Agency positions and
regulations. The SAB is a Federal Advisory Committee chartered under
the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. Pursuant
to FACA and EPA policy, notice is hereby given that the SAB AALM Review
Panel will hold a public meeting for its peer review of the AALM 2.0,
which was developed by EPA's Office of Research and Development (ORD).
    EPA's ORD requested that the SAB conduct a peer review of the AALM
2.0. The EPA SAB Staff Office formed a Panel of subject matter experts
to provide advice to the Administrator through the chartered board
regarding the AALM 2.0. The AALM Panel will provide advice to the
Administrator through the chartered SAB. The public meeting on October
17-18, 2019, will be a two-day review of the AALM 2.0. All draft
reports developed by SAB panels, committees, or workgroups are reviewed
and approved by the Chartered SAB through a quality review process
before being finalized and transmitted to the EPA Administrator. The
AALM Review Panel will comply with the provisions

of FACA and all appropriate SAB Staff Office procedural policies.
    Availability of the Meeting Materials: Prior to the meeting, the
following materials will be posted on the SAB website (http://www.epa.gov/sab): The meeting agenda, charge questions, EPA
presentations, the link to the AALM 2.0 software, technical
documentation, and user manual. To locate meeting materials, go to
www.epa.gov/sab and click on ``Upcoming and Recent Meetings'' to get to
the SAB calendar. From the calendar, click on October 17, 2019. For
questions concerning EPA's AALM materials to be reviewed, please
contact Dr. James Brown, EPA Office of Research and Development, at
<EMAIL_ADDRESS>    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to the EPA program
offices. The process for submitting comments to a federal advisory
committee is thus different from the process used to submit comments to
an EPA program office. Federal advisory committees and panels,
including scientific advisory panels, provide independent advice to the
EPA. Members of the public can submit relevant comments pertaining to
the EPA's charge, meeting materials, or the group providing the advice.
Input from the public to the SAB will have the most impact if it
provides specific scientific or technical information or analysis for
the SAB to consider or if it relates to the clarity or accuracy of the
technical information. Members of the pubic wishing to provide comment
should follow the instructions below to submit comments.
    Oral Statements: In general, individuals or groups requesting to
make an oral presentation at the meeting will be limited to five
minutes during a public comment period. Interested parties wishing to
provide comments should contact Iris Goodman, DFO, in writing
(preferably via email), at the contact information noted above by
October 10, 2019, to be placed on the list of public speakers.
    Written Statements: Written statements will be accepted throughout
the advisory process; however, for timely consideration by the AALM
Review Panel, statements should be supplied to the DFO (preferably via
email) at the contact information above by October 10, 2019 (7 days
prior to meeting). It is the SAB Staff Office general policy to post
written comments on the web page for the advisory meeting or
teleconference. Submitters are requested to provide a signed and
unsigned version of each document because the SAB Staff Office does not
publish documents with signatures on its websites. Members of the
public should be aware that their personal contact information, if
included in any written comments, may be posted to the SAB website.
Copyrighted material will not be posted without explicit permission of
the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Iris Goodman at 202-564-
2164, or<EMAIL_ADDRESS>preferably at least ten days prior to
the meeting to give the EPA as much time as possible to process your
request.

    Dated: September 16, 2019.
Khanna Johnston,
 Deputy Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2019-20677 Filed 9-23-19; 8:45 am]
BILLING CODE 6560-50-P