[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Proposed Rules]
[Pages 51944-51946]
[FR Doc No: 2022-18199]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2021-0569; FRL-10136-01-R4]

Air Plan Approval; TN; Updates to References to Appendix W
Modeling Guideline

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by
Tennessee, on April 9, 2021. Specifically, EPA is proposing to approve
updates to the incorporation by reference of federal guidelines on air
quality modeling in the Tennessee SIP. Based on its proposal to approve
this revision, EPA is also proposing to convert the previous
conditional approval regarding infrastructure SIP prevention of
significant deterioration (PSD) elements for the 2015 Ozone National
Ambient Air Quality Standard (NAAQS) for Tennessee to a full approval.
EPA is proposing to approve this revision pursuant to the Clean Air Act
(CAA or Act).

DATES: Comments must be received on or before September 23, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2021-0569 at www.regulations.gov. Follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. EPA may publish any comment received to
its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Josue Ortiz Borrero, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-8085. Mr. Ortiz Borrero can also be reached via electronic
mail at staff email [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On October 1, 2015, EPA promulgated a revised primary and secondary
NAAQS for ozone, revising the 8-hour ozone standards from 0.075 parts
per million (ppm) to a new more protective level of 0.070 ppm. See 80
FR 65292 (October 26, 2015). Pursuant to section 110(a)(1) of the CAA,
states are required to submit SIP revisions meeting the applicable
requirements of section 110(a)(2) within three years after promulgation
of a new or revised NAAQS or within such shorter period as EPA may
prescribe. Section 110(a)(2) requires states to address basic SIP
elements such as requirements for monitoring, basic program
requirements, and legal authority that are designed to assure
attainment and maintenance of the NAAQS. This particular type of SIP is
commonly referred to as an ``infrastructure SIP'' or ``iSIP.'' States
were required to submit such SIP revisions for the 2015 8-hour ozone
NAAQS to EPA no later than October 1, 2018.\1\
---------------------------------------------------------------------------

    \1\ In infrastructure SIP submissions, states generally certify
evidence of compliance with sections 110(a)(1) and (2) of the CAA
through a combination of state regulations and statutes, some of
which have been incorporated into the SIP. In addition, certain
federally-approved, non-SIP regulations may also be appropriate for
demonstrating compliance with sections 110(a)(1) and (2).
---------------------------------------------------------------------------

    On September 13, 2018, Tennessee met the requirement to submit an
iSIP for the 2015 8-hour ozone NAAQS by the October 1, 2018, deadline.
Through previous rulemakings, EPA approved most of the infrastructure
SIP elements for the 2015 Ozone NAAQS for Tennessee.2 3
However, regarding the PSD elements of section 110(a)(2)(C), (D)(i)(II)
(prong 3), and (J) (herein referred to as element C, Prong 3, and
element J, respectively), EPA conditionally approved \4\ these portions

of Tennessee's iSIP submission because of outdated references to the
federal guideline on air quality modeling found in Appendix W of 40 CFR
part 51.\5\ As previously mentioned, all other applicable iSIP
requirements for Tennessee for the 2015 8-hour ozone NAAQS were
addressed or will be addressed in separate rulemakings.
---------------------------------------------------------------------------

    \2\ EPA approved most elements for Tennessee, except for the
Interstate Transport provisions (Prongs 1 & 2), and the PSD
provisions (element C, Prong 3, and J), on December 26, 2019. See 84
FR 70895.
    \3\ The Interstate Transport provisions (Prongs 1 & 2) for
Tennessee have been proposed for disapproval but that action has not
been finalized at this time. See 87 FR 9545 (February 22, 2022).
    \4\ Under CAA section 110(k)(4), EPA may conditionally approve a
SIP revision based on a commitment from a state to adopt specific
enforceable measures by a date certain, but not later than one year
from the date of approval. If the state fails to meet the commitment
within one year of the final conditional approval, the conditional
approval will be treated as a disapproval and EPA will issue a
finding of disapproval.
    \5\ For the state of Tennessee, EPA conditionally approved the
PSD provisions of element C, Prong 3, and element J, on April 9,
2020. See 85 FR 19888.
---------------------------------------------------------------------------

    For elements C and J to be approved for PSD, a state needs to
demonstrate that its SIP meets the PSD-related infrastructure
requirements of these sections. These requirements are met if the
state's implementation plan includes a PSD program that meets current
federal requirements. Prong 3 is also approvable when a state's
implementation plan contains a fully approved, up-to-date PSD program.
EPA's PSD regulations at 40 CFR 51.166(l) require that modeling be
conducted in accordance with Appendix W, Guideline on Air Quality
Models. EPA promulgated the most current version of Appendix W on
January 17, 2017 (82 FR 5182). Therefore, in order to approve the iSIP
PSD elements for the 2015 8-hour ozone NAAQS, PSD regulations in SIPs
are required to reference the most current version of Appendix W.
    As discussed in the conditional approval for the 2015 ozone iSIP
PSD elements, Tennessee's SIP contained outdated references to Appendix
W and the State committed to update the outdated references and submit
a SIP revision within one year of EPA's final rule conditionally
approving these PSD elements. Accordingly, Tennessee was required to
submit a SIP revision by April 9, 2021. Tennessee met its commitment by
submitting a SIP revision to correct the deficiencies on or before the
deadline. Through this Notice of Proposed Rulemaking (NPRM), EPA is now
proposing to approve changes to the Tennessee SIP and to convert the
conditional approval to a full approval for Tennessee regarding element
C, Prong 3, and element J, for the 2015 8-hour ozone NAAQS
infrastructure SIP.

II. What is EPA's approach to the review of infrastructure SIP
submissions?

    As discussed above, whenever EPA promulgates a new or revised
NAAQS, CAA section 110(a)(1) requires states to submit infrastructure
SIPs that meet the various requirements of CAA section 110(a)(2), as
applicable. Due to ambiguity in some of the language of CAA section
110(a)(2), EPA believes that it is appropriate to interpret these
provisions in the specific context of acting on infrastructure SIP
submissions. EPA has previously provided comprehensive guidance on the
application of these provisions through a guidance document for
infrastructure SIP submissions and through regional actions on
infrastructure submissions.\6\ Unless otherwise noted below, EPA is
following that existing approach in acting on this submission. In
addition, in the context of acting on such infrastructure submissions,
EPA evaluates the submitting state's implementation plan for facial
compliance with statutory and regulatory requirements, not for the
state's implementation of its SIP.\7\ EPA has other authority to
address any issues concerning a state's implementation of the rules,
regulations, consent orders, etc. that comprise its SIP.
---------------------------------------------------------------------------

    \6\ EPA explains and elaborates on these ambiguities and its
approach to address them in its September 13, 2013 Infrastructure
SIP Guidance (available at https://www3.epa.gov/airquality/urbanair/sipstatus/docs/Guidance_on_Infrastructure_SIP_Elements_Multipollutant_FINAL_Sept_2013.pdf), as well as in numerous agency actions, including EPA's prior
action on the Tennessee infrastructure SIP to address the 2010
Sulfur Dioxide NAAQS. See 81 FR 8540 (November 28, 2016).
    \7\ See Mont. Envtl. Info. Ctr. v. Thomas, 902 F.3d 971 (9th
Cir. 2018).
---------------------------------------------------------------------------

III. EPA's Analysis of Tennessee's April 9, 2021, Submittal

    On April 9, 2021, Tennessee submitted a SIP revision to address
outdated references to EPA's modeling guidelines in order to meet the
PSD iSIP requirements for the 2015 8-hour ozone NAAQS. The SIP revision
includes changes to two SIP-approved rules to update the incorporation
by reference date for Appendix W and a request to convert the April 9,
2020, Conditional Approval of element C, Prong 3, and element J of
Tennessee's 2015 8-hour ozone NAAQS infrastructure SIP to a full
approval. Specifically, the April 9, 2021, SIP revision makes changes
to Tennessee Rules 1200-03-09-.01, Construction Permits, and 1200-03-
21-.01, General Alternate Emission Standard.
    Paragraph 1200-03-09-.01(1) is a set of general construction
permitting requirements that apply to new or modified sources,
including sources subject to PSD, and subparagraph (f) requires
estimates of ambient concentration to be based on air quality models.
Previously, this provision referenced EPA publication No. 450/2-78-
027R, ``Guidelines on Air Quality Models (revised)'' (1986), and
certain specified supplements for modeling. However, the April 9, 2021,
SIP revision deletes this reference to EPA publication No. 450/2-78-
027R and replaces it with a specific incorporation by reference of 40
CFR part 51 Appendix W, as published in the July 1, 2019, edition of
the Code of Federal Regulations (CFR). This provision currently allows
the Technical Secretary to approve the use of a modified or substitute
model on a case-by-case basis after consultation with and written
approval by EPA, and is revised to limit the use of a modified or
substitute model to incidences where the air quality model in Appendix
W is inappropriate, which is consistent with 40 CFR 51.166(l)(2) for
PSD. Tennessee also changed the word ``another'' to ``substituted'' in
the model substitution provision. The changes to Paragraph 1200-03-
09-.01(1)(f) align with federal requirements to make use of the most
current version of Appendix W.
    In addition, modeling requirements under the State's PSD rule at
Paragraph 1200-03-09-.01(4)(k) are revised to similarly include an
incorporation by reference date for Appendix W of the July 1, 2019, CFR
publication edition, and includes the same minor edit to change
``another'' to ``substituted''.
    Lastly, Paragraph 1200-03-21-.01(2)(c), which provides procedures
for alternative emission standards, is also revised to delete a
reference to EPA publication No. 450/2-78-027R and replace it with a
specific incorporation by reference of 40 CFR part 51 Appendix W, as
published in the July 1, 2019, edition of the CFR, as in Rule 1200-03-
09-.01 described above.
    As explained in the April 9, 2020, conditional approval, Tennessee
committed to update its PSD regulations to reference the most current
version of Appendix W. EPA approved the most current version of
Appendix W on January 17, 2017 (82 FR 5182), so by incorporating by
reference the July 1, 2019, version of Appendix W into the SIP,
Tennessee is meeting the commitment of the conditional approval, as
well as the requirements of the PSD elements for the 2015 8-hour ozone
infrastructure SIP.
    For the reasons stated above, EPA is proposing to approve the
changes into the Tennessee SIP and convert the April 9, 2020,
conditional approval of element C, Prong 3, and element J, of
Tennessee's 2015 8-hour ozone NAAQS infrastructure SIP to a full
approval.

IV. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference Tennessee Rules 1200-03-09-.01, Construction Permits,\8\ and
1200-03-21-.01, General Alternate Emission Standard, state effective on
April 22, 2021. EPA has made, and will continue to make, these
materials generally available through www.regulations.gov and at the
EPA Region 4 office (please contact the person identified in the For
Further Information Contact section of this preamble for more
information).
---------------------------------------------------------------------------

    \8\ EPA is not proposing to incorporate the April 22, 2021,
state effective version of: 1200-03-09-.01(1)(a); 1200-03-
09-.01(1)(d); 1200-03-09-.01(1)(h); 1200-03-09-.01(1)(j); 1200-03-
09-.01(4)(a)7(vi); 1200-03-09-.01(4)(b)24(XVII); 1200-03-
09-.01(4)(b)29; 1200-03-09-.01(4)(b)47(i)(IV); 1200-03-
09-.01(4)(j)3; 1200-03-09-.01(4)(l)2(iii); 1200-03-
09-.01(5)(b)1(x)(VII); the PM2.5 annual and 24-hour
averaging time as part of subparagraph 1200-03-09-.01(5)(b)(1)(xix);
1200-03-09-.01(5)(b)2(viii)(III); 1200-03-09-.01(5)2(iii)(II); and
1200-03-09-.01(5)(b)3(i)(III). These provisions are either not
approved into the SIP or the April 22, 2021, version of the rule
contains language changes that are not before EPA for approval into
the SIP. If EPA finalizes this action, the Agency will update the
SIP table at 40 CFR 52.2220(c) to reflect these exceptions.
---------------------------------------------------------------------------

V. Proposed Action

    EPA is proposing to approve changes to the Tennessee SIP, and
convert the conditional approval for element C, Prong 3, and element J,
for the 2015 8-hour ozone Infrastructure SIP to a full approval.
Specifically, EPA is proposing to approve changes to Tennessee Rules
1200-03-09-.01, Construction and Operating Permits, and 1200-03-21-.01,
General Alternate Emission Standard.

VI. 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. See 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. This action merely
proposes to approve 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the proposed
rule does not have tribal implications as specified by Executive Order
13175 (65 FR 67249, November 9, 2000), nor will it impose substantial
direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

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

    Dated: August 18, 2022.
Daniel Blackman,
Regional Administrator, Region 4.
[FR Doc. 2022-18199 Filed 8-23-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65081-65085]
[FR Doc No: 2022-23378]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0085]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substances Generally
Recognized as Safe: Best Practices for Convening a Generally Recognized
as Safe Panel

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by November 28, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Substances Generally Recognized as Safe:
Best Practices for Convening a GRAS Panel.'' Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

I. Background

Best Practices for Convening a Generally Recognized as Safe Panel

OMB Control Number 0910-NEW
    This information collection supports FDA's implementation of Agency
guidance. In 2017, FDA developed and published for comment a draft
guidance entitled ``Best Practices for Convening a Generally Recognized
as Safe Panel,'' (https://www.fda.gov/media/109006/download) which,
once finalized, would assist persons who choose to convene a panel of
experts in support of a conclusion that the use of a substance in food
is generally recognized as safe (GRAS).
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that
all food additives (as defined by section 201(s) (21 U.S.C. 321(s)) be
approved by FDA for their intended use in food before they are
marketed. Section 409 of the FD&C Act (21 U.S.C. 348) establishes a
premarket approval requirement for ``food additives.'' Section 201(s)
of the

FD&C Act provides an exclusion to the definition of ``food additive,''
and thus from the premarket approval requirement, for uses of
substances that are generally GRAS by qualified experts.
    The GRAS provision of section 201(s) of the FD&C Act is implemented
in 21 CFR part 170 for human food and 21 CFR part 570 for animal food.
The regulations provide the criteria for when the use of a substance in
food for humans or animals is GRAS. Part 170, subpart E and part 570,
subpart E provide the procedure under which a person (also referred to
as the ``proponent'' of a GRAS conclusion) may notify FDA about a
conclusion that a substance is GRAS under the conditions of its
intended use in human and/or animal food. This includes a standard
format for the submission of a GRAS notice. The information submitted
to us in a GRAS notice is necessary to allow us to administer
efficiently the FD&C Act's various provisions that apply to the use of
substances added to food; specifically, whether a substance is GRAS
under the conditions of its intended use or whether it is a food
additive subject to premarket review and approval by FDA. To support a
GRAS conclusion, a proponent may convene a panel of qualified experts
to provide evidence that generally available safety data and
information about the intended use of the substance in food are
generally accepted among experts, which is one of the criteria for
eligibility for GRAS status (81 FR 54959 at 54975; August 17, 2016).
    From 2008 to 2010, the Government Accountability Office (GAO)
conducted a study related to ingredients used in human food on the
basis of the GRAS provision in section 201(s) of the FD&C Act. In 2010,
GAO issued a report (the GAO report \1\) that included recommendations
for FDA. Of relevance here, the GAO report recommended that FDA develop
a strategy to minimize the potential for conflicts of interest among
GRAS panel members, including issuing guidance for companies on
conflict of interest, and we requested comment on issuing such a
guidance in our reopening notice (75 FR 81536 at 81542; December 28,
2010). In the GRAS final rule, we stated our intent to issue such
guidance (see Response 125, 81 FR 54959 at 55026). This guidance
recommends an assessment for conflict of interest and the appearance of
conflict of interest as part of the best practices for convening a GRAS
panel and would address the final outstanding GAO recommendation for
FDA from the 2010 report.
---------------------------------------------------------------------------

    \1\ United States Government Accountability Office (2010).
``Report to Congressional Requestors on Food Safety: FDA Should
Strengthen Its Oversight of Food Ingredients Determined to Be
Generally Recognized as Safe (GRAS),'' Report No. GAO-10-246.
Available at https://www.gao.gov/assets/gao-10-246.pdf.
---------------------------------------------------------------------------

    The guidance document recommends specific content elements
pertaining to recordkeeping and third-party disclosure. The guidance
explains a recordkeeping recommendation for proponents to develop a
one-time, written GRAS panel policy record describing how it will
convene a panel. The proponent creates the written policy to fit its
needs. The guidance document discusses a third-party disclosure
recommendation for prospective panel members to provide vetting
information to proponents, to ascertain expertise and reduce risk of
bias. The guidance document also explains a recordkeeping
recommendation for proponents to document the application of the GRAS
panel policy to each GRAS panel member as part of the vetting process.
Respondents do not submit to FDA the recordkeeping or third-party
disclosure information.
    The guidance will assist respondents convening a GRAS panel. The
information collection recommendations (establishment of a written GRAS
panel policy, solicitation of information from prospective GRAS panel
members about potential conflicts of interest and other sources of
bias, and documentation of the application of the GRAS panel policy to
each GRAS panel member) would help the respondent to identify GRAS
panel members who have appropriate and balanced expertise and reduce
the risk that bias (or the appearance of bias) will affect the
credibility of the GRAS panel's output.
    Description of Respondents: Respondents to this collection of
information are persons (``proponents'') who are responsible for a
conclusion that a substance may be used in food on the basis of the
GRAS provision of the FD&C Act when such persons convene a GRAS panel
to independently evaluate whether the available scientific data,
information, and methods establish that the substance is safe under the
conditions of its intended use in human food or animal food.
Respondents would also include members and prospective members of GRAS
panels. We estimate that there are 1,260 such respondents as discussed
more fully below. The term ``GRAS panel'' is defined as a panel of
individuals convened for the purpose of evaluating whether the
available scientific data, information, and methods establish that a
substance is safe under the conditions of its intended use in food.
    In the Federal Register of November 16, 2017 (82 FR 53433), we
published a draft guidance requesting public comment on the proposed
collection of information. We received 13 comments with almost half
being responsive to PRA topics. All comments were considered even if
they were not fully captured by our paraphrasing in this document. Most
comments communicated general support for the information collection.
Comments articulated that the guidance would promote uniformity of
practices for industry and mitigate potential conflicts and biases. One
comment expressed that the recommendations for preparing a GRAS panel
policy are not unusual or burdensome to proponents, although another
comment believed that establishment and implementation of a written
GRAS panel policy would be burdensome. However, the comment recognized
that the proponent drafts the written policy, which allows the
proponent to tailor the policy to itself and make the policy broad
enough to cover the wide range of issues it may encounter. The comment
further stated that many in industry already employ policies and
procedures recommended in the guidance. Another comment believed that
the time estimates to perform the information collections are
reasonable. No other comments were received disputing the need for the
information, the accuracy of our burden estimate, or ways to minimize
burden. Although we are preparing to finalize the guidance document to
clarify discussions around evaluating and managing conflicts of
interest and appearance issues, to emphasize that a GRAS panel is not
necessary, and providing additional background information regarding
the value of a GRAS panel in providing evidence to support the
``general acceptance'' aspect of the criteria for eligibility for GRAS
status through scientific procedures, none of the revisions pertain to
the information collection recommendations discussed in our 60-day
notice.
    Since the publication of the 60-day notice, we have further
considered the burden estimate and adjusted it based on updated
information available to us from FDA's GRAS Notices Inventory and the
Independent GRAS Conclusion Inventory Database (Refs. 1, 2, and 3).
    The records recommended in the guidance to be maintained by a
proponent include a one-time information collection burden pertaining
to a written GRAS panel policy to govern the assembly and

conduct of a GRAS panel. The records recommended in the guidance also
include annual information collection burdens pertaining to documenting
the application of the written GRAS panel policy to each member of a
GRAS panel convened in a given year and collecting information from
prospective members of the GRAS panel to conduct the vetting process as
detailed in the written GRAS panel policy. Finally, the guidance
recommends that a GRAS panel provides a written report of its findings;
however, we consider a written GRAS panel report as customary business
practice that is already being created by GRAS panels and, thus, we do
not estimate an annual information collection burden for the creation
of a GRAS panel report.
    We estimate the burden of this collection of information as
follows:

Burden Estimate for Written GRAS Panel Policy Recommendation

                                                  Table 1--Estimated One-Time Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden per
                           Activity                                Number of       records per      Total annual     recordkeeping (in     Total hours
                                                                 recordkeepers     recordkeeper       records             hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishing written GRAS panel policy.......................              696                1              696                    40           27,840
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    For the purpose of this analysis, we make the conservative
assumption that all proponents who document a GRAS conclusion will
create a written GRAS panel policy that would apply to GRAS panels
convened in the first year that the final guidance would be in effect,
as well as to GRAS panels convened in subsequent years. We also assume
that these proponents will create a written GRAS panel policy
regardless of whether they report the panel's documented GRAS
conclusion to FDA in the form of a GRAS notice. Therefore, for the
purpose of this analysis we: (1) calculated the number of proponents
who have submitted at least one GRAS notice to FDA and (2) estimated
the number of proponents who have documented at least one GRAS
conclusion without reporting that documented GRAS conclusion to FDA in
the form of a GRAS notice.
    Using the data in our inventories of GRAS notices submitted for
substances intended for use in human food (Ref. 1) and animal food
(Ref. 2) during the time period of April 17, 1997, through October 2,
2020, we calculate that 466 proponents submitted at least one GRAS
notice for a substance intended for use in human food, and 20
proponents submitted at least one GRAS notice for a substance intended
for use in animal food. For the purpose of this analysis, we make the
conservative assumption that there will be no overlap between
proponents who submit GRAS notices for substances intended for use in
human food and proponents who submit GRAS notices for substances
intended for use in animal food. Therefore, the total number of
proponents who have submitted at least one GRAS notice to FDA is 486
(466 human food proponents + 20 animal food proponents).
    We have very little information about the number of proponents who
have documented a GRAS conclusion without reporting that GRAS
conclusion to FDA in the form of a GRAS notice. To estimate the number
of such proponents, we used a publicly available database entitled
``Independent GRAS (Generally Recognized As Safe) Conclusion Inventory
Database'' (Ref. 3), which is a compilation of the results of a
consulting company's search of publicly available information in
industry trade journals about documented GRAS conclusions for
substances intended for use in human food. The oldest entry is for the
year 1995. We received the first GRAS notice for substances intended
for use in human food in 1998 and, thus, the database covers the entire
timeframe during which FDA has been receiving GRAS notices for
substances intended for use in human food. As of October 2, 2020, that
database recorded that there had been a total of 213 documented GRAS
conclusions, with 41 of those documented GRAS conclusions reported to
FDA as a GRAS notice and 172 of those documented GRAS conclusions not
reported to FDA as a GRAS notice. In contrast, as of October 2, 2020,
FDA's inventory of GRAS notices shows that the number of GRAS
conclusions reported to FDA during this timeframe was 937, not 41 (Ref.
1). We assume that the reduced number of documented GRAS conclusions
that the database recorded as being reported to FDA is due to the
mechanism by which the database searches for documented GRAS
conclusions (i.e., publications in industry trade journals). For
example, there could be less incentive for a business that reports its
documented GRAS conclusion to FDA to publicize that GRAS conclusion
through industry trade journals, because the business can publicize
FDA's response to the GRAS notice in other ways.
    The database attributes the 172 documented GRAS conclusions not
reported to FDA to 146 different proponents. However, 62 of these
proponents have also submitted a GRAS notice to FDA and, thus, we
calculate that the database attributes documented GRAS conclusions to
84 proponents who have not submitted a GRAS notice to FDA (146
proponents listed in the database--62 proponents whom we already
counted because they submitted a GRAS notice to FDA). We also make the
conservative assumption that the number of proponents who have
documented GRAS conclusions without reporting them to FDA since FDA
began receiving GRAS notices is twice as high as recorded in the
database--i.e., 168 proponents (84 proponents listed in the database x
2).
    The publicly available database does not record documented GRAS
conclusions for substances intended for use in animal food. In the
burden estimate for the approved information collection ``Substances
Generally Recognized as Safe: Notification Procedure'' (OMB control
number 0910-0342), we estimated that 100 GRAS notices would be
submitted to FDA for substances intended for use in human food and that
25 GRAS notices will be submitted to FDA for substances intended for
use in animal food (86 FR 64943; November 19, 2021). For the purpose of
our current analysis, we use that 25 percent ratio to estimate that the
number of proponents who have documented GRAS conclusions for
substances intended for use in animal food without reporting those GRAS
conclusions to FDA is 25 percent of the number of proponents who
documented GRAS conclusions for substances intended for use in human
food without reporting those GRAS conclusions to FDA--i.e., 42
proponents (168 estimated proponents who have documented GRAS
conclusions without reporting those GRAS conclusions to FDA x 0.25). We
estimate that the total number of proponents who documented GRAS
conclusions without reporting those

GRAS conclusions to FDA is 210 proponents (168 estimated proponents who
have documented GRAS conclusions for substances intended for use in
human food + 42 estimated proponents who have documented GRAS
conclusions for substances intended for use in animal food).
    To estimate the total number of proponents, we are adding 210
estimated proponents who have not reported their documented GRAS
conclusions to FDA to the 486 proponents who have already submitted at
least one GRAS notice to FDA for a total of 696 proponents who will
document a GRAS conclusion (210 non-reporting proponents + 486
reporting proponents). As already stated, for the purpose of this
analysis we make the conservative assumption that all of these
proponents who document GRAS conclusions (i.e., 696 proponents) will
create a written GRAS panel policy. We estimate that it will take 40
hours to create a written GRAS panel policy, including 8 hours to
review relevant, publicly available policies that address conflict of
interest and 32 hours to tailor a GRAS panel policy specific to the
proponent, using relevant information from such existing policies as
appropriate to the needs of the proponent. As shown in table 1, the
total one-time burden to create a written GRAS panel policy is 40 hours
per proponent x 696 proponents = 27,840 hours.

Burden Estimate for Records Documenting the Application of the GRAS
Panel Policy to GRAS Panel Members

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden per
                           Activity                                Number of       records per      Total annual     recordkeeping (in     Total hours
                                                                 recordkeepers     recordkeeper       records             hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application of written GRAS panel policy to GRAS panel                      94                6              564                    16            9,024
 members.....................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
 \1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on the number of annual GRAS notices submitted to FDA in
recent years, we previously estimated that 100 GRAS notices will be
submitted to FDA for substances intended for use in human food and that
25 GRAS notices will be submitted to FDA for substances intended for
use in animal food (OMB control number 0910-0342; 86 FR 64943), for a
total number of 125 GRAS notices submitted to FDA each year. We count
each GRAS notice as a single GRAS conclusion, and, for the purpose of
our analysis, we assume that a different proponent submits each of
these GRAS notices. Therefore, we estimate that the total number of
documented GRAS conclusions submitted to FDA on an annual basis is 125
GRAS conclusions and that these GRAS conclusions are submitted by 125
proponents.
    We have not previously estimated the annual number of documented
GRAS conclusions that are not reported to FDA as a GRAS notice. To
estimate such GRAS conclusions, we used the same database (Ref. 3) that
we used to estimate the total number of proponents who document GRAS
conclusions without reporting the GRAS conclusions to FDA in the form
of a GRAS notice. As already stated, the oldest recorded entry in the
database is for the year 1995. However, with the exception of that
single entry for 1995, the remaining entries are for the years 2001 and
beyond. Therefore, we use 20 years (i.e., from 2001 through 2020) as
the number of years covering those documented GRAS conclusions that are
not reported to FDA. For the purpose of calculating the annual number
of documented GRAS conclusions that are for substances intended for use
in human food and are not reported to FDA, we estimate that there are
171 such GRAS conclusions (172 documented, unreported GRAS conclusions
for substances intended for use in human food minus 1 GRAS conclusion
reported before 2001). We calculate that, on average, the annual number
of documented, unreported GRAS conclusions for substances intended for
use in human food and recorded in the database is 9 (171 documented,
unreported GRAS conclusions/20 years = 8.55 documented, unreported GRAS
conclusions per year recorded in the database, rounded up to 9). As
with our analysis of the total number of proponents, we conservatively
assume that the annual number of documented, unreported GRAS
conclusions for substances intended for use in human food could be
twice as high as the annual number of documented, unreported GRAS
conclusions recorded in the database--i.e., 18 documented, unreported
GRAS conclusions for substances intended for use in human food each
year (9 documented, unreported GRAS conclusions recorded in the
database on an annual basis x 2). As with documented GRAS conclusions
that are reported to FDA, we assume that a different proponent is
responsible for each documented GRAS conclusion not reported to FDA
and, thus, on an annual basis there are 18 proponents who do not report
their documented GRAS conclusions for substances intended for use in
human food to FDA. We previously estimated that 100 GRAS notices will
be submitted to FDA for substances intended for use in human food and
that 25 GRAS notices will be submitted to FDA for substances intended
for use in animal food (OMB control number 0910-0342; 84 FR 29216).
Using that ratio, we conservatively assume that the annual number of
documented, unreported GRAS conclusions for substances intended for use
in animal food is 25 percent of the annual number of documented,
unreported GRAS conclusions for substances intended for use in human
food--i.e., 5 documented, unreported GRAS conclusions for substances
intended for use in animal food on an annual basis (18 documented,
unreported GRAS conclusions for substances intended for use in human
food x 0.25 = 4.5, rounded up to 5). We also calculate that there are a
total of 23 documented, unreported GRAS conclusions each year (18
documented, unreported GRAS conclusions for substances intended for use
in human food + 5 documented, unreported GRAS conclusions for
substances intended for use in animal food). We therefore calculate
that there are 148 proponents who document a GRAS conclusion on an
annual basis (125 proponents who submit their documented GRAS
conclusions to FDA in a GRAS notice + 23 proponents who do not submit
their documented GRAS conclusions to FDA in a GRAS notice).
    We have information about the percentage of proponents who convene
a GRAS panel for a documented GRAS conclusion and also submit a GRAS
notice to FDA. During the time period April 17, 1997, through October
2, 2020, on average, 57 percent of proponents who submitted a GRAS
notice for a substance intended for use in human food, and 55 percent
of proponents who

submitted a GRAS notice for a substance intended for use in animal
food, convened a GRAS panel. We therefore estimate that, on an annual
basis, 57 proponents will convene a GRAS panel and submit a GRAS notice
to FDA for substances intended for use in human food (57 percent x 100
proponents), and 14 proponents will convene a GRAS panel and submit a
GRAS notice to FDA for substances intended for use in animal food (55
percent x 25 proponents). We calculate that the total number of
proponents who will convene a GRAS panel and submit a GRAS notice to
FDA is 71 proponents (57 human food proponents + 14 animal food
proponents). We also assume that all proponents will document the
application of a written GRAS panel policy to each member of the GRAS
panel.
    We have very little information about the percentage of proponents
who convene a GRAS panel for a documented GRAS conclusion but do not
report their documented GRAS conclusions to FDA in a GRAS notice. For
the purpose of this analysis, we make the conservative assumption that
all 23 proponents who annually document GRAS conclusions without
reporting them to FDA will convene a GRAS panel. Taking into account
the estimated number of proponents who convene a GRAS panel and submit
a GRAS notice to FDA, and the estimated number of proponents who
convene a GRAS panel but do not submit a GRAS notice to FDA, we
calculate that the total number of proponents who will convene a GRAS
panel and document the application of the written GRAS panel policy to
each member of a GRAS panel on an annual basis is 94 proponents (71
proponents who submit GRAS notices to FDA + 23 proponents who do not
submit GRAS notices).
    Based on the recommendations in the guidance, we assume that all
GRAS panels will include at least 3 panel members and that some GRAS
panels will include as many as 6 panel members. We assume that a GRAS
panel will include 5 panel members on average. We also assume that the
proponent will reject at least one individual with applicable expertise
due to a conflict of interest and, thus, that 94 proponents will
document the application of the written GRAS panel policy to 6
individual GRAS panel members, for a total of 564 documentations of the
application of the written GRAS panel policy (94 proponents x 6 panel
members). As shown in table 2, we estimate that it will take the
proponent 16 hours to document the application of the written GRAS
policy to each panel member, for a total of 9,024 hours (564
documentations x 16 hours).

Burden Estimate for Disclosures by GRAS Panel Members to Proponents of
GRAS Conclusions

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                         Average burden
                            Activity                                Number of      disclosures per     Total annual     per disclosure     Total hours
                                                                   respondents        respondent       disclosures        (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
GRAS panel members provide information to the proponents of                 564                  1              564                  4            2,256
 GRAS conclusions..............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As shown in table 3, we assume that all 564 individuals who are
being considered as members of a GRAS panel will each need 4 hours to
provide information related to the panel selection and vetting process
to the proponent, as detailed in the written GRAS panel policy, for a
total of 2,256 hours (564 individuals x 4 hours).
    FDA plans to consolidate this collection with OMB control number
0910-0342, ``Substances Generally Recognized as Safe: Notification
Procedure'' which contains the regulatory procedures under which a
person may notify FDA about a conclusion that a substance is GRAS under
the conditions of its intended use in human and/or animal food and
includes a standard format for the submission of a GRAS notice. The
revision will add 39,120 burden hours and 1,260 respondents.
    This guidance also refers to previously approved FDA collections of
information. The collections of information in 21 CFR parts 170 and 570
have been approved under OMB control number 0910-0342.

II. References

    The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. FDA (2020). GRAS Notices. Available at https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices.
2. FDA (2020). Current Animal Food GRAS Notices Inventory. Available
at https://www.fda.gov/animal-veterinary/generally-recognized-safe-gras-notification-program/current-animal-food-gras-notices-inventory.
3. AIBMR Life Sciences, Inc. (2020). Independent GRAS (Generally
Recognized As Safe) Conclusion Inventory Database. Available at
http://aibmr.com/natural-products-industry-compliance-consultation/gras-generally-recognized-as-safe-safety-studies/.

    Dated: October 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23378 Filed 10-26-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 4, 2008 (Volume 73, Number 66)]
[Notices]
[Page 18604]
[DOCID:fr04ap08-132]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Nineteenth Meeting: RTCA Special Committee 207/Airport Security
Access Control Systems

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 207 Meeting, Airport Security
Access Control Systems.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 207, Airport Security Access Control
Systems.

DATES: The meeting will be held April 29, 2008, from 9:30 a.m.-4 p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1828 L Street, NW.,
Suite 805, Colson Board Room, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 207 meeting. The agenda will
include:

April 29

     Opening Plenary Session (Welcome, Introductions, and
Administrative Remarks).
     Review of Meeting Summary, RTCA Paper No. 078-081SC207-
047.
     Martime TWIC Report.
     ACTS Report.
     Comment review by section.
    [cir] Workgroup 1: Introduction.
    [cir] Workgroup 2: Requirements and System Design.
    [cir] Workgroup 3: Local Identity Management System.
    [cir] Workgroup 4: Physical Access Control.
    [cir] Workgroup 5: Intrusion Detection Systems.
    [cir] Workgroup 6: Video Systems.
    [cir] Workgroup 7: Security Operating Center.
    [cir] Workgroup 8: Communications Infrastructure.
    [cir] Workgroup 9: General Considerations.
    [cir] Workgroup 10: Appendices.
     Consider for Approval--Revised DO-230A--Standards for
Airport Security Access Control Systems, RICA Paper No. 070-081SC207-
046.
     Closing Plenary Session (Other Business. Establish Agenda,
Date and Place of Following Meetings).
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section.
    Members of the public may present a written statement to the
committee at any time.

    Issued in Washington, DC, on March 27, 2008.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. E8-6945 Filed 4-3-08; 8:45 am]

BILLING CODE 4910-13-M