[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66673-66678]
[FR Doc No: 2019-26234]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0731]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based
Products: Establishment Registration and Listing; Eligibility
Determination for Donors; and Current Good Tissue Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) 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 the information collection requirements for
FDA regulations related to human cells, tissues, and cellular and
tissue-based products (HCT/Ps) involving establishment registration and
listing; eligibility determination for donors; and current good tissue
practice (CGTP).

DATES: Submit either electronic or written comments on the collection
of information by February 3, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 3, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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-2013-N-0731 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Cells, Tissues, and
Cellular and Tissue-Based Products: Establishment Registration and
Listing; Eligibility Determination for Donors; and Current Good Tissue
Practice.'' 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Human Cells, Tissues, and Cellular and Tissue-Based Products:
Establishment Registration and Listing; Eligibility Determination for
Donors; and Current Good Tissue Practice

OMB Control Number 0910-0543--Extension

    Under section 361 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to
prevent the introduction, transmission, or spread of communicable
diseases between the States or possessions or from foreign countries
into the States. As derivatives of the human body, all HCT/Ps pose some
risk of carrying pathogens that could potentially infect recipients or
handlers. FDA has issued regulations related to HCT/Ps involving
electronic establishment registration and listing using an electronic
system, eligibility determination for donors, and CGTP.

I. Electronic Establishment Registration and Listing

    The regulations in part 1271 (21 CFR part 1271) require domestic
and foreign establishments that recover, process, store, label,
package, or distribute an HCT/P regulated solely under section 361 of
the PHS Act and described in Sec.  1271.10(a) (21 CFR 1271.10(a)), or
that perform screening or testing of the cell or tissue donor, to
register electronically with FDA (Sec. Sec.  1271.1(a) (21 CFR
1271.1(a)) and 1271.10(b)(1)) and submit a list electronically of each
HCT/P manufactured (Sec. Sec.  1271.1(a) and 1271.10(b)(2)). Section
1271.21(a) (21 CFR 1271.21(a)) requires an establishment to follow
certain procedures for initial registration and listing of HCT/Ps, and
Sec.  1271.25(a) and (b) (21 CFR 1271.25(a) and (b)) identifies the
required initial registration and HCT/P listing information. Section
1271.21(b), in brief, requires an annual update of the establishment
registration. Section 1271.21(c)(ii) requires establishments to submit
HCT/P listing updates if a change as described in Sec.  1271.25(c) has
occurred. Section 1271.25(c) identifies the required HCT/P listing
update information. Section 1271.26 (21 CFR 1271.26) requires
establishments to submit an amendment if ownership or location of the
establishment changes, or if there is a change in the U.S. agent's
name, address, telephone number, or email address. FDA requires the use
of an electronic registration and listing system entitled ``eHCTERs''
(Electronic Human Cell and Tissue Establishment Registration System) to
submit the required information (Sec. Sec.  1271.10, 1271.21, 1271.25,
and 1271.26)). Under Sec.  1271.23 (21 CFR 1271.23), manufacturers may
request a waiver from the requirements in 21 CFR 1271.22 that
information must be provided to FDA in electronic format.

II. Eligibility Determination for Donors

    In brief, FDA requires certain HCT/P establishments described in
Sec.  1271.1(b) to determine donor eligibility based on donor screening
and testing for relevant communicable disease agents and diseases
except as provided under 21 CFR 1271.90. The documented determination
of a donor's eligibility is made by a responsible person as defined in
Sec.  1271.3(t) (21 CFR 1271.3(t)) and is based on the results of
required donor screening, which includes a donor medical history
interview (defined in Sec.  1271.3(n)), and testing (Sec.  1271.50(a)
(21 CFR 1271.50(a)). Certain records must accompany an HCT/P once the
donor-eligibility determination has been made (Sec.  1271.55(a) (21 CFR
1271.55(a))). This requirement applies both to an HCT/P from a donor
who is determined to be eligible as well as to an HCT/P from a donor
who is determined to be ineligible or where the donor-eligibility
determination is not complete if there is a documented urgent medical
need, as defined in Sec.  1271.3(u) (Sec. Sec.  1271.60 and 1271.65 (21
CFR 1271.60 and 1271.65)). Once the donor-eligibility determination has
been made, the HCT/P must be accompanied by a summary of records used
to make the donor-eligibility determination (Sec.  1271.55(b)), and a
statement whether, based on the results

of the screening and testing of the donor, the donor is determined to
be eligible or ineligible (Sec.  1271.55(a)(2)). Records used in
determining the eligibility of a donor, i.e., results and
interpretations of testing for relevant communicable disease agents,
the donor-eligibility determination, the name and address of the
testing laboratory or laboratories, and the name of the responsible
person (defined in Sec.  1271.3(t)) who made the donor-eligibility
determination and the date of the determination, must be maintained
(Sec.  1271.55(d)(1)). If any information on the donor is not in
English, the original record must be maintained and translated to
English and accompanied by a statement of authenticity by the
translator (Sec.  1271.55(d)(2)). HCT/P establishments must retain the
records pertaining to a particular HCT/P at least 10 years after the
date of its administration, or, if the date of administration is not
known, then at least 10 years after the date of the HCT/P's
distribution, disposition, or expiration, whichever is latest (Sec.
1271.55(d)(4)).
    When a product is shipped in quarantine, as defined in Sec.
1271.3(q), before completion of screening and testing, the HCT/P must
be accompanied by records identifying the donor (e.g., by a distinct
identification code affixed to the HCT/P container) stating that the
donor-eligibility determination has not been completed and stating that
the product must not be implanted, transplanted, infused, or
transferred until completion of the donor-eligibility determination,
except in cases of urgent medical need, as defined in Sec.  1271.3(u)
(Sec.  1271.60(c)). When an HCT/P is used in cases of documented urgent
medical need, the results of any completed donor screening and testing,
and a list of any required screening and testing that has not yet been
completed also must accompany the HCT/P (Sec.  1271.60(d)(2)). When a
HCT/P is used in cases of urgent medical need or from a donor who has
been determined to be ineligible (as permitted under Sec.  1271.65),
documentation by the HCT/P establishment is required, showing that the
recipient's physician received notification that the testing and
screening were not complete (in cases of urgent medical need), and upon
the completion of the donor-eligibility determination, of the results
of the determination (Sec. Sec.  1271.60(d)(3) and (4), and
1271.65(b)(3)).
    An HCT/P establishment is also required to establish and maintain
procedures for all steps that are performed in determining eligibility
(Sec.  1271.47(a) (21 CFR 1271.47(a)), including the use of a product
from a donor of viable, leukocyte-rich cells or tissue testing reactive
for cytomegalovirus (Sec.  1271.85(b)(2) (21 CFR 1271.85(b)(2))). The
HCT/P establishment must record and justify any departure from a
procedure relevant to preventing risks of communicable disease
transmission at the time of its occurrence (Sec.  1271.47(d)).

III. Current Good Tissue Practice (CGTP)

    FDA requires HCT/P establishments that manufacture HCT/Ps that are
regulated solely under section 361 of the PHS Act to follow CGTP (Sec.
1271.1(b)). Section 1271.155(a) (21 CFR 1271.155(a)) permits the
submission of a request for FDA approval of an exemption from or an
alternative to any requirement in subpart C or D of part 1271. Section
1271.290(c) (21 CFR 1271.290(c)) requires establishments to affix a
distinct identification code to each HCT/P that they manufacture that
relates the HCT/P to the donor and to all records pertaining to the
HCT/P. Whenever an establishment distributes an HCT/P to a consignee,
Sec.  1271.290(f) requires the establishment to inform the consignee,
in writing, of the product tracking requirements and the methods the
establishment uses to fulfill these requirements. Non-reproductive HCT/
P establishments described in Sec.  1271.10 are required under Sec.
1271.350(a)(1) and (3) (21 CFR 1271.350(a)(1) and (3)) to investigate
and report to FDA adverse reactions (defined in Sec.  1271.3(y)) using
Form FDA-3500A (Sec.  1271.350(a)(2)). Form FDA-3500A is approved under
OMB control number 0910-0291. Section 1271.370(b) and (c) (21 CFR
1271.370(b) and (c)) requires establishments to include specific
information either on the HCT/P label or with the HCT/P.
    The standard operating procedures (SOP) provisions under part 1271
include the following: (1) Section 1271.160(b)(2) (21 CFR
1271.160(b)(2)) (receiving, investigating, evaluating, and documenting
information relating to core CGTP requirements, including complaints,
and for sharing information with consignees and other establishments);
(2) Sec.  1271.180(a) (21 CFR 1271.180(a)) (to meet core CGTP
requirements for all steps performed in the manufacture of HCT/Ps); (3)
Sec.  1271.190(d)(1) (21 CFR 1271.190(d)(1)) (facility cleaning and
sanitization); (4) Sec.  1271.200(b) (21 CFR 1271.200(b)) (cleaning,
sanitizing, and maintenance of equipment); (5) Sec.  1271.200(c)
(calibration of equipment); (6) Sec.  1271.230(a) and (c) (21 CFR
1271.230(a) and (c)) (validation of a process and review and evaluation
of changes to a validated process); (7) Sec.  1271.250(a) (21 CFR
1271.250(a)) (controls for labeling HCT/Ps); (8) Sec.  1271.265(e) (21
CFR 1271.265(e)) (receipt, predistribution shipment, availability for
distribution, and packaging and shipping of HCT/Ps); (9) Sec.
1271.265(f) (suitable for return to inventory); (10) Sec.  1271.270(b)
(21 CFR 1271.270(b)) (records management system); (11) Sec.
1271.290(b)(1) (21 CFR 1271.290(b)(1)) (system of HCT/P tracking); and
(12) Sec.  1271.320(a) (21 CFR 1271.320(a)) (review, evaluation, and
documentation of complaints as defined in Sec.  1271.3(aa)).
    Section 1271.155(f) requires an establishment operating under the
terms of an exemption or alternative to maintain documentation of FDA's
grant of the exemption or approval and the date on which it began
operating under the terms of the exemption or alternative. Section
1271.160(b)(3) requires the quality program of an establishment that
performs any step in the manufacture of HCT/Ps to document corrective
actions relating to core CGTP requirements. Section 1271.160(b)(6)
requires documentation of HCT/P deviations. Section 1271.160(d)
requires, in brief, documentation of validation of computer software if
the establishment relies upon it to comply with core CGTP requirements.
Section 1271.190(d)(2) requires documentation of all cleaning and
sanitation activities performed to prevent contamination of HCT/Ps.
Section 1271.195(d) requires documentation of environmental control and
monitoring activities. Section 1271.200(e) requires documentation of
all equipment maintenance, cleaning, sanitizing, calibration, and other
activities. Section 1271.210(d) (21 CFR 1271.210(d)) requires, in
brief, documentation of the receipt, verification, and use of each
supply or reagent. Section 1271.230(a) requires documentation of
validation activities and results when the results of processing
described in 21 CFR 1271.220 cannot be fully verified by subsequent
inspection and tests. Section 1271.230(c) requires that when changes to
a validated process subject to Sec.  1271.230(a) occur, documentation
of the review and evaluation of the process and revalidation, if
necessary, must occur. Section 1271.260(d) and (e) (21 CFR 1271.260(d)
and (e)) requires documentation of any corrective action taken when
proper storage conditions are not met and documentation of the storage
temperature for HCT/Ps. Section 1271.265(c)(1) requires documentation

that all release criteria have been met before distribution of an HCT/
P. Section 1271.265(c)(3) requires documentation of any departure from
a procedure relevant to preventing risks of communicable disease
transmission at the time of occurrence. Section 1271.265(e) requires
documentation of the activities in paragraphs (a) through (d) of that
section, which must include identification of the HCT/P and the
establishment that supplied the HCT/P, activities performed and the
results of each activity, date(s) of activity, quantity of HCT/P
subject to the activity, and disposition of the HCT/P. Section
1271.270(a) requires documentation of each step in manufacturing
required in part 1271, subparts C and D. Section 1271.270(e) requires
documentation of the name and address, and a list of responsibilities
of any establishment that performs a manufacturing step for the
establishment. Section 1271.290(d) and (e) require documentation of a
method for recording the distinct identification code and type of each
HCT/P distributed to a consignee to enable tracking from the consignee
to the donor and to enable tracking from the donor to the consignee or
final disposition. Section 1271.320(b) requires an establishment to
maintain a record of each complaint that it receives. The complaint
file must contain sufficient information about each complaint for
proper review and evaluation of the complaint and for determining
whether the complaint is an isolated event or represents a trend.
    Section 1271.420(a) (21 CFR 1271.420(a)) requires importers of HCT/
Ps to notify the FDA District Director having jurisdiction over the
port of entry through which the HCT/Ps are offered for import. The HCT/
Ps must be held intact or transported under quarantine until they are
inspected and released by FDA.
    Respondents to this information collection are establishments that
recover, process, store, label, package or distribute any HCT/P that is
regulated solely under section 361 of the PHS Act or perform donor
screening or testing. The estimates provided below are based on most
recent available information from FDA's database system and trade
organizations. The hours per response and hours per record are based on
data provided by the Eastern Research Group, or FDA experience with
similar recordkeeping or reporting requirements.
    There are an estimated 2,736 HCT/P establishments (conventional
tissue, eye tissue, peripheral blood stem cell, stem cell products from
cord blood, reproductive tissue, and sperm banks), including 1,004
manufacturers of HCT/Ps regulated under the Federal Food, Drug, and
Cosmetic Act and section 351 of the PHS Act (42 U.S.C 262), that have
registered and listed with FDA. In addition, we estimate that 193 new
establishments have registered with FDA (Sec. Sec.  1271.10(b)(1) and
(2) and 1271.25(a) and (b)). There are an estimated 1,062 listing
updates (Sec. Sec.  1271.10(b)(2), 1271.21(c)(ii), and 1271.25(c)) and
358 location/ownership amendments (Sec.  1271.26).
    Under Sec.  1271.23, FDA estimates an average of one waiver request
annually.
    Under Sec.  1271.55(a), an estimated total of 2,594,415 HCT/Ps
(which include conventional tissues, eye tissues, hematopoietic stem
cells/progenitor cells, and reproductive cells and tissues), and an
estimated total of 2,454,415 non-reproductive cells and tissues (total
HCT/Ps minus reproductive cells and tissues) are distributed per year
by an estimated 1,632 establishments (2,736-1,104 = 1,632).
    Under Sec.  1271.60(c) and (d)(2), FDA estimates that 1,611
establishments shipped an estimated 572,000 HCT/P under quarantine, and
that an estimated 15 establishments requested 64 exemptions from or
alternative to any requirement under part 1271, subpart C or D,
specifically under Sec.  1271.155(a).
    Under Sec. Sec.  1271.290(c) and 1271.370(b) and (c), the estimated
2,109 non-reproductive HCT/P establishments label each of their
2,441,644 HCT/Ps with certain information. These establishments are
also required to inform their consignees in writing of the requirements
for tracking and of their established tracking system under Sec.
1271.290(f).
    FDA estimates 13 HCT/P establishments submitted 188 adverse
reaction reports with 162 involving a communicable disease (Sec.
1271.350(a)(1)).
    FDA estimates that 193 new establishments will create SOPs, and
that 2,736 establishments will review and revise existing SOPs
annually.
    FDA estimates that 1,368 HCT/P establishments (2,736 x 50 percent =
1,368) and 1,055 non-reproductive HCT/P establishments (2,109 x 50
percent = 1,055) record and justify a departure from the procedures
(Sec. Sec.  1271.47(d) and 1271.265(c)(3)).
    Under Sec.  1271.50(a), HCT/P establishments are required to have a
documented medical history interview about the donor's medical history
and relevant social behavior as part of the donor's relevant medical
records for each of the estimated total of 109,019 donors (which
include conventional tissue donors, eye tissue donors, peripheral and
cord blood stem cell donors, and reproductive cell and tissue donors),
and the estimated total of 103,419 non-reproductive cells and tissue
donors (total donors minus reproductive cell and tissue donors).
    FDA estimates that 821 HCT/P establishments (2,736 x 30 percent =
821) document an urgent medical need of the product to notify the
physician using the HCT/P (Sec. Sec.  1271.60(d)(3) and 1271.65(b)(3)).
    FDA also estimates that 2,189 HCT/P establishments (2,736 x 80
percent = 2,189) have to maintain records for an average of 2 contract
establishments to perform their manufacturing process (Sec.
1271.270(e) and 1,687 HCT/P establishments (2,109 x 80 percent = 1,687)
maintain an average of 5 complaint records annually (Sec.
1271.320(b)).
    FDA estimates that under Sec.  1271.420(a), 200 establishments will
submit 560 reports of HCT/Ps offered for imports.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR part 1271; human cells,                     Number of
   tissues, and cellular and       Number of     responses per   Total annual    Average burden     Total hours
     tissue-based products        respondents     respondent       responses      per response          \3\
----------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b)             2,736               1           2,736  0.5 (30 minutes)           1,368
 \2\.
1271.10(b)(1) and (2),                     193               1             193  0.75 (45                     145
 1271.21(a), and 1271.25(a)                                                      minutes).
 and (b) \2\.
1271.10(b)(2),                           1,062               1           1,062  0.5 (30 minutes)             531
 1271.21(c)(2)(ii) and
 1271.25(c) \2\.
1271.23.......................               1               1               1  1...............               1
1271.26 \2\...................             358               1             358  0.25 (15                      90
                                                                                minutes).

1271.155(a)...................              15            4.27              64  3...............             192
1271.350(a)(1) and (3)........              13           14.46             188  1...............             188
1271.420(a)...................             200             2.8             560  0.25 (15                     140
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           2,655
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Using eHCTERS.
\3\ Rounded to the nearest whole number.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR part 1271; human cells,                     Number of                     Average burden
   tissues, and cellular and       Number of      records per    Total annual          per          Total hours
     tissue-based products       recordkeepers   recordkeeper       records       recordkeeping         \3\
----------------------------------------------------------------------------------------------------------------
New SOPs \2\..................             193               1             193  48..............           9,264
SOP Update \2\................           2,736               1           2,736  24..............          65,664
1271.47(d)....................           1,368               1           1,368  1...............           1,368
1271.50(a)....................           2,736          39.846         109,019  5...............         545,095
1271.55(d)(1).................           2,736          39.846         109,019  1...............         109,019
1271.55(d)(2).................           2,736               1           2,736  1...............           2,736
1271.55(d)(4).................           2,736               1           2,736  120.............         328,320
1271.60(d)(3) and (4)                      821               1             821  2...............           1,642
 1271.65(b)(3)(iii).
1271.155(f)...................              15            4.27              64  0.25 (15                      16
                                                                                minutes).
1271.160(b)(3) and (6)........           2,109              12          25,308  1...............          25,308
1271.160(d)...................           2,109              12          25,308  1...............          25,308
1271.190(d)(2)................           2,109              12          25,308  1...............          25,308
1271.195(d)...................           2,109              12          25,308  1...............          25,308
1271.200(e)...................           2,109              12          25,308  1...............          25,308
1271.210(d)...................           2,109              12          25,308  1...............          25,308
1271.230(a)...................           2,109              12          25,308  1...............          25,308
1271.230(c)...................           2,109               1           2,109  1...............           2,109
1271.260(d)...................           2,109              12          25,308  0.25 (15                   6,327
                                                                                minutes).
1271.260(e)...................           2,109             365         769,785  0.083 (5                  63,892
                                                                                minutes).
1271.265(c)(1)................           2,109       1,163.781       2,454,415  0.083 (5                 203,716
                                                                                minutes).
1271.265(c)(3)................           1,055               1           1,055  1...............           1,055
1271.265(e)...................           2,109       1,163.781       2,454,415  0.083 (5                 203,716
                                                                                minutes).
1271.270(a)...................           2,109       1,163.781       2,454,415  0.25 (15                 613,604
                                                                                minutes).
1271.270(e)...................           2,189               2           4,378  0.5 (30 minutes)           2,189
1271.290(d) and (e)...........           2,109          49.037         103,419  0.25 (15                  25,855
                                                                                minutes).
1271.320(b)...................           1,687               5           8,435  1...............           8,435
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................       2,371,178
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b),
  1271.200(c), 1271.230(a), 1271.250(a), and 1271.265(e).
\3\ Rounded to the nearest whole number.

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
   21 CFR part 1271; human                         Number of
 cells, tissues, and cellular     Number of     disclosures per   Total annual    Average burden    Total hours
  and tissue-based products      respondents      respondent       disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
1271.55(a)...................           1,632         1,589.715       2,594,415  0.5 (30               1,297,208
                                                                                minutes).
1271.60(c) and (d)(2)........           1,611            355.06         572,000  0.5 (30                 286,000
                                                                                minutes).
1271.290(c)..................           2,109         1,163.781       2,454,415  0.083 (5                203,716
                                                                                minutes).
1271.290(f)..................           2,109                 1           2,109  1..............           2,109
1271.370(b) and (c)..........           2,109         1,163.781       2,454,415  0.25 (15                613,604
                                                                                minutes).
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ................  ..............  ...............       2,402,637
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Rounded to the nearest whole number.

    Our estimated burden for the information collection reflects an
overall increase of 628,585 hours (111 reporting burden hours; 305,118
recordkeeping hours; and 323,356 disclosure burden hours) and a
corresponding increase of annual responses, annual records, and annual
disclosures. We attribute this

adjustment to an increase in the number HCT/P establishments and an
increase in the number HCT/Ps distributed over the past few years.

    Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26234 Filed 12-4-19; 8:45 am]
 BILLING CODE 4164-01-P


11330 Federal Register / Vol. 68, No. 46 / Monday, March 10, 2003 / Rules and Regulations ( 8) For any storm water discharge associated with small construction activity identified in paragraph ( b)( 15)( i) of this section, see § 122.21( c)( 1). Discharges from these sources, other than discharges associated with small construction activity at oil and gas exploration, production, processing, and treatment operations or transmission facilities, require permit authorization by March 10, 2003, unless designated for coverage before then. Discharges associated with small construction activity at such oil and gas sites require permit authorization by March 10, 2005. * * * * * [ FR Doc. 03   5708 Filed 3   7   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0348; FRL   7292   6]

Aluminum tris ( O ethylphosphonate); Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for residues of the fungicide aluminum tris ( O ethylphosphonate) ( fosetyl Al) in or on onion, green. The Interregional Research Project # 4 ( IR 4), Center for Minor Crop Management, Rutgers, The State University of New Jersey, 681 U. S. Highway # 1 South, North Brunswick, NJ 08902   3390 requested this tolerance under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective March 10, 2003. Objections and requests for hearings, identified by docket ID number OPP   2002   0348, must be received on or before May 9, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   7610; e mail address: jackson. sidney@ epa. gov.

SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. Potentially affected entities may include, but are not limited to:   Crop production ( NAIC code 111)   Animal production ( NAIC code 112)   Food manufacturing ( NAIC code 311)   Pesticide manufacturing ( NAIC code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in OPP   2002   0348. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2002   0348. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of January 2, 2003 ( 68 FR 103) ( FRL   7282   5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide petition ( PP 2E6366) by IR 4, Center for Minor Crop Management, Rutgers, The State University of New Jersey, 681 U. S. Highway # 1 South, North Brunswick, NJ 08902   3390. That notice included a summary of the petition prepared by Bayer CropScience, the registrant. The petition requested that 40 CFR 180.415 be amended by establishing a tolerance for residues of the fungicide fosetyl Al, aluminum tris ( Oethylphosphonate in or on onion, green at 10 parts per million ( ppm). There were no comments received in response to the notice of filing. Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....''

VerDate Dec< 13> 2002 14: 08 Mar 07, 2003 Jkt 200001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10MRR1. SGM 10MRR1 11331 Federal Register / Vol. 68, No. 46 / Monday, March 10, 2003 / Rules and Regulations EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997) ( FRL   5754   7).

III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for a tolerance for residues of fosetyl Al on onion, green at 10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile EPA has evaluated the available toxicity data on fosetyl Al and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by fosetyl Al are discussed in the Federal Register of August 18, 2000 ( 65 FR 50431) ( FRL   6599   4) as well as the noobserved adverse effect level ( NOAEL) and the lowest observed adverse effectlevel ( LOAEL) from the toxicity studies reviewed. Please refer to this document should you desire detailed toxicological information on fosetyl Al.

B. Toxicological Endpoints The dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified ( the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factors ( SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10   6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for fosetyl Al used for human risk assessment is discussed in Unit III. B. of the final rule on fosetyl Al tolerances published in the Federal Register on August 29, 2002 ( 67 FR 55339) ( FRL   7195   1).

C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.415) for the residues of fosetyl Al, in or on a variety of raw agricultural commodities. Residues of fosetyl Al are currently regulated under 40 CFR 180.415( a) in bushberry subgroup, and juneberry, lingonberry, and salal, at 40 ppm; caneberries, fresh ginseng root, pineapple, pineapple fodder and forage at 0.1 ppm; onions ( dry bulb) at 0.5 ppm, macadamia nuts at 0.2 ppm; cranberry at 0.5 ppm; fruit, citrus, group at 5.0 ppm; pea, succulent at 0.3 ppm; tomatoes and bananas at 3.0 ppm; pome fruit at 10 ppm; cucurbit vegetables group at 15 ppm; avocados at 25 ppm; hops, dried at 45 ppm; brassica ( cole) leafy vegetables group at 60 ppm; strawberries at 75 ppm; turnip, roots at 15 ppm; turnip, tops at 40 ppm; and leafy vegetables ( except brassica vegetables) group at 100 ppm. Timelimited tolerances associated with a section 18 request for the residues of fosetyl Al have been granted in/ on peas, succulent at 1.0 ppm under 40 CFR 180.415( b) which expired September 31, 2000. Additionally, tolerances are established in 40 CFR 180.415( c) for residues of fosetyl Al in/ on asparagus at 0.1 ppm and grapes at 10 ppm in conjunction with regional registrations. Risk assessments were conducted by EPA to assess dietary exposures from fosetyl Al in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1   day or single exposure. No appropriate endpoint attributable to a single exposure ( dose) of fosetyl Al was identified from the oral toxicity studies including developmental toxicity studies in rats and rabbits. Therefore, fosetyl Al is not expected to pose an acute risk. ii. Chronic exposure. In conducting this chronic dietary risk assessment, the Dietary Exposure Evaluation Model ( DEEM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989   1992 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The Tier 1 ( assuming tolerance level residues and 100% crops treated for all commodities) chronic dietary exposure assessment was conducted for all supported fosetyl Al food uses. Chronic dietary exposure estimates were provided for the general U. S. population and various population subgroups. iii. Cancer. The Agency concludes that pesticidal use of fosetyl Al is unlikely to pose a carcinogenic hazard to humans. Therefore, a cancer dietary exposure analysis for fosetyl Al was not performed. 2. Dietary exposure from drinking water. Fosetyl Al is not expected to reach ground water or surface water under most conditions.

VerDate Dec< 13> 2002 14: 08 Mar 07, 2003 Jkt 200001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10MRR1. SGM 10MRR1 11332 Federal Register / Vol. 68, No. 46 / Monday, March 10, 2003 / Rules and Regulations Based on screening models, FQPA Index Reservoir Screening Tool ( FIRST) and Screening Concentrations in Ground Water ( SCI GROW), the estimated environmental concentrations ( EECs) of fosetyl Al for acute exposures are estimated to be 0.0086 parts per billion ( ppb) for surface water and 0.006 ppb for ground water. The EECs for chronic exposures are estimated to be 0.00003 ppb for surface water and 0.006 ppb for ground water. 3. From non dietary exposure. Fosetyl Al is currently registered for use on the following residential non dietary sites: Lawn, turf, and ornamental plants under the brand names CHIPO   Aliette WDG and Aliette   HG. CHIPO   Aliette WDG is sold to professional applicators only, which includes lawn care operators ( LCO). Because all residential uses of CHIPO   Aliette WDG are applied by the LCO, a residential applicator exposure assessment for this product was not performed. Short and intermediate term dermal, inhalation, and oral exposures to fosetyl Al may occur from residential handling/ postapplication activities. For a detailed discussion of fosetyl Al risk assessment, see Unit III. C. 3. of the final rule on fosetyl Al tolerances published in the Federal Register on August 29, 2002 ( 67 FR 55339). 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) of the 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 does not have, at this time, available data to determine whether fosetyl Al has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, fosetyl Al does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that fosetyl Al has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997). D. Safety Factor for Infants and Children 1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. The developmental and reproductive toxicity data did not indicate increased quantitative or qualitative susceptibility of rats or rabbits to in utero and/ or postnatal exposure. 3. Conclusion. There is a complete toxicity data base for fosetyl Al and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be reduced to 1X. The FQPA factor was reduced because the toxicology data base is complete; the developmental and reproductive toxicity data did not indicate increased quantitative or qualitative susceptibility of rats or rabbits to in utero and/ or postnatal exposure; a developmental neurotoxicity study is not required by the Agency; and the exposure assessment, which assumes the theoretical maximum residue contribution will not underestimate the potential dietary ( food and water) and non dietary exposures for infants and children resulting from the use of fosetyl Al.

E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates drinking water level of concerns ( DWLOC) which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water [ e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD  ( average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA are used to calculate DWLOCs: 2 liter ( L)/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. The acute aggregate risk assessment takes into account exposure estimates from dietary consumption of fosetyl Al ( food and drinking water). However, no appropriate endpoint attributable to a single dose ( exposure) was identified in oral toxicity studies for fosetyl Al. Therefore, fosetyl Al is not expected to pose an acute risk. 2. Chronic risk. The chronic aggregate risk assessment takes into account average exposure estimates from food, drinking water, and residential uses. However, based on the use pattern, no chronic residential exposures are expected. Therefore, the chronic aggregate risk assessment will consider exposure from food and drinking water only. Chronic risk estimates resulting from aggregate exposure to fosetyl Al in food and water are below Agency's LOC. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fosetyl Al from food will utilize 4% of the cPAD for the U. S.

VerDate Dec< 13> 2002 14: 08 Mar 07, 2003 Jkt 200001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10MRR1. SGM 10MRR1 11333 Federal Register / Vol. 68, No. 46 / Monday, March 10, 2003 / Rules and Regulations population, 5% of the cPAD for infants and 8% of the cPAD for children 1   6 years old, subpopulation at greatest exposure. Based the use pattern, chronic residential exposure to residues of fosetyl Al is not expected. In addition, there is potential for chronic dietary exposure to fosetyl Al in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 1 of this unit:

TABLE 1.   DWLOCS FOR CHRONIC ( NON CANCER) EXPOSURE TO FOSETYL AL Population Subgroup1 cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) 2 Ground Water EEC ( ppb) 2 Chronic DWLOC ( ppb) 3 U. S. Population ........................................................................................ 2.5 4 0.00003 0.006 84,000 Children ( 1   6 years old) .......................................................................... 2.5 8 0.00003 0.006 23,000 All infants (< 1 year old) .......................................................................... 2.5 5 0.00003 0.006 24,000 Female ( 13   50 years old) ........................................................................ 2.5 3 0.00003 0.006 73,000 1 Within each of these subgroups, the subpopulation with the highest food exposurehaving an adequately representative number of samples was selected. Default body weights are: General U. S. population, 70 kg; females ( 13 plus years old), 60 kg; and, All Infants/ Children, 10 kg. 2 Estimate for the highest use rate was chosen. 3 DWLOC ( µ g/ L) = [ Maximum water exposure ( mg/ kg/ day) X body wt ( kg) divided by ( 10   3 mg/ µ g) X water consumed daily ( L/ day)]. µ g/ L = parts per billion. Default daily drinking rates are 2 L/ day for Adults and 1 L/ day for Infants/ Children.

3. Short term risk. Short term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). The short term aggregate risk assessment estimates risks likely to result from 1 to 30 day exposure to fosetyl Al residues from food, drinking water, and residential pesticide uses. High end estimates of residential exposure are used in the short term assessment, while average values are used for food and drinking water exposure ( i. e. chronic exposures). A short term risk assessment is required for adults because there is a residential handler inhalation exposure scenario. In addition, a short term risk assessment is required for infants and children because there is a residential post application oral exposure scenario. As no short or intermediate term dermal endpoint was established, there is no dermal component to these aggregate risk assessments. Fosetyl Al is currently registered for use that could result in short term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short term exposures for fosetyl Al. Using the exposure assumptions described in this unit for short term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 3,300 for adults, 570 for children ages 1   6 years old, and 650 for all infants < 1 year old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short term DWLOCs were calculated and compared to the EECs for chronic exposure of fosetyl Al in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect short term aggregate exposure to exceed the Agency's level of concern, as shown in Table 2 of this unit:

TABLE 2.   AGGREGATE RISK ASSESSMENT FOR SHORT TERM EXPOSURE TO FOSETYL AL Population Subgroup Aggregate MOE ( Food + Residential 1 Aggregate Level of Concern ( LOC) 2 Surface Water EEC ( ppb) 3 Ground Water EEC ( ppb) 3 Short Term DWLOC ( ppb) 4 Adults ....................................................................................................... 3,300 100 0.00003 0.006 102,000 Children ( 1   6 years old) .......................................................................... 570 100 0.00003 0.006 25,000 All infants (< 1 year old) ............................................................................ 650 100 0.00003 0.006 25,000 1 Aggregate MOE = [ NOAEL ( 300 mg/ kg/ day)   ( Avg Food Exposure + Residential Exposure)] 2 The LOC is 100, based on interspecies and intraspecies safety factors totaling 100. 3 The crop producing the highest level was used. 4 DWLOC( µ g/ L) = [ Maximum water exposure ( mg/ kg/ day) x body weight ( kg)   water consumption ( L) x 10   3 mg/ µ g] For adults, a 70 kg body weight was used, for children, 10 kg.

4. Intermediate term risk. Intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). An intermediate term risk assessment was not performed since adult residential handler scenarios are not expected to occur for longer than a short term timeframe ( more than 30 days of continuous exposure) and intermediate term exposure is not likely to occur for infants and children ( residential post application oral exposure scenario) because fosetyl Al has a very short half life ( less than 3 hours in aerobic soil). 5. Aggregate cancer risk for U. S. population. The Agency concludes that pesticidal uses of fosetyl Al are not likely to pose a carcinogenic hazard to humans. Therefore, an aggregate cancer risk assessment was not performed. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to fosetyl Al residues.

IV. Other Considerations A. Analytical Enforcement Methodology An adequate analytical method is available for enforcement of the proposed tolerances in/ on onion, green. The method is Method I in PAM II, which uses diazomethane as the VerDate Dec< 13> 2002 14: 08 Mar 07, 2003 Jkt 200001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10MRR1. SGM 10MRR1 11334 Federal Register / Vol. 68, No. 46 / Monday, March 10, 2003 / Rules and Regulations methylating agent and quantitation of fosetyl Al by GC/ FPD. The method may be requested from: Francis Griffith, Analytical Chemistry Branch, Environmental Science Center, Environmental Protection Agency, 701 Mapes Road, Fort George G. Mead, MD 20755   5350; telephone number: ( 410) 305   20905; e mail address: griffith. francis@ epa. gov.

B. International Residue Limits There is no established or proposed maximum residue limit ( MRL) or tolerance for fosetyl Al in or on onion, green for Canada, Mexico, or Codex.

V. Conclusion Therefore, the tolerance is established for residues of fosetyl Al, aluminum tris ( O ethylphosphonate), in or on onion, green at 10 ppm.

VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2002   0348 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before May 9, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2002   0348, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

VII. Statuatory and Executive Order Reviews This final rule establishes a tolerance under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any VerDate Dec< 13> 2002 14: 08 Mar 07, 2003 Jkt 200001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10MRR1. SGM 10MRR1 11335 Federal Register / Vol. 68, No. 46 / Monday, March 10, 2003 / Rules and Regulations unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: February 28, 2003. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

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

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

2. Section 180.415 is amended by alphabetically adding an entry for `` Onion, green'' to the table in paragraph ( a) to read as follows:

§ 180.415 Aluminum tris ( Oethylphosphonate tolerance for residues.

( a) * * *

Commodity Parts per million Expiration/ Revocation Date * * * * * Onion, green ................................................................................................................................................ 10.0 None * * * * *

* * * * * [ FR Doc. 03   5616 Filed 3   7   03; 8: 45 am]

BILLING CODE 6560   50   S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [ DA 03   431; MM Docket No. 01   254; RM   10264; RM   10375; RM   10376]

Radio Broadcasting Services; Atoka, Haileyville and Clayton, OK AGENCY: Federal Communications Commission. ACTION: Final rule.

SUMMARY: This document dismisses a petition for rule making filed at the request of Maurice Salsa (`` Salsa'') proposing the allotment of FM Channel 290A at Atoka, Oklahoma, as that community's second local FM transmission service ( RM   10264). See 66 FR 52733, October 17, 2001. In response to a counterproposal filed on behalf of Keystone Broadcasting, this VerDate Dec< 13> 2002 14: 08 Mar 07, 2003 Jkt 200001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10MRR1. SGM 10MRR1