[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Proposed Rules]
[Pages 53433-53438]
[FR Doc No: 2017-24845]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 170 and 570

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

Best Practices for Convening a Generally Recognized as Safe
Panel: Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a draft guidance for industry entitled
``Best Practices for Convening a GRAS Panel.'' This draft guidance
document is intended for any person who is responsible for a conclusion
that a substance may be used in food on the basis of the generally
recognized as safe (GRAS) provision of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) when that person convenes a panel of
experts (``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. This draft guidance provides our current thinking
on best practices to identify GRAS panel members who have appropriate
and balanced expertise; to take steps to reduce the risk that bias (or
the appearance of bias) will affect the credibility of the GRAS panel's
output (often called a ``GRAS panel report''), including the assessment
of potential GRAS panel members for conflict of interest and the
appearance of conflict of interest; and to limit the data and
information provided to a GRAS panel to public information (e.g., by
not providing the GRAS panel with information such as trade secret
information).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on this draft
guidance before we issue the final version of the guidance, submit
either electronic or written comments by May 15, 2018. For comments
related to the collection of information provisions in this draft
guidance, submit either electronic or written comments by January 16,
2018.

ADDRESSES: You may submit comments as follows:

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-2017-D-0085 for ``Best Practices for Convening a GRAS Panel.''
Received comments 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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.
    Submit written requests for single copies of the draft guidance to
Office of Food Additive Safety, Center for Food Safety and Applied
Nutrition, Food and Drug Administration (HFS-200), 5001 Campus Dr.,
College Park, MD 20740 or to the Office of Surveillance and Compliance
(HFV-200), 7519 Standish Pl., Rockville, MD 20855. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Regarding substances that would be
used in human food: Paulette M. Gaynor, Center for Food Safety and
Applied Nutrition (HFS-255), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>. Regarding substances that
would be used in animal food: Geoffrey K. Wong, Center for Veterinary
Medicine (HFV-224), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>. Regarding the information collection
issues: FDA PRA Staff, Office of Operations, Food and Drug
Administration, Three White Flint North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) defines a ``food
additive'' as any substance the intended use of which results or may
reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristics of any
food if such substance is not generally recognized, among experts
qualified by scientific training and experience to evaluate its safety,
as having been adequately shown through scientific procedures (or, in
the case of a substance used in food prior to January 1, 1958, through
either scientific procedures or experience based on common use in food)
to be safe under the conditions of its intended use. Under this
definition, a substance that is GRAS under the conditions of its
intended use is not a ``food additive'' and is therefore not subject to
mandatory premarket review by FDA under section 409 of the FD&C Act (21
U.S.C. 348). In this document, we refer to a person who is responsible
for a conclusion that a substance may be used in human food or animal
food on the basis of the GRAS provision of the FD&C Act, without
premarket review by FDA under section 409 of the FD&C Act, as the
``proponent'' of that substance.
    We have established regulations implementing the GRAS provision of
section 201(s) of the FD&C Act in part 170 (21 CFR part 170) for human
food and in part 570 (21 CFR part 570) for animal food. Those
regulations include a voluntary procedure (``GRAS notification
procedure'') through which a proponent may notify us of a conclusion
that a substance is GRAS under the conditions of its intended use in
human food (part 170, subpart E) or animal food (part 570, subpart E).
Under the interim pilot program, we have filed and responded to more
than 600 GRAS notices for substances intended for use in human food and
18 GRAS notices for substances intended for use in animal food (80 FR
54960 at 54964, August 17, 2016).
    In some cases, the process whereby the proponent evaluates whether
the available data and information support a conclusion that a
substance is GRAS under the conditions of its intended use includes
considering the opinion of a ``GRAS panel'' of qualified experts who
independently evaluate whether the available scientific data,
information, and methods establish that a substance is safe under the
conditions of its intended use in human food or animal food. Depending
on the outcome of the GRAS panel's analysis, the proponent could either
reach a conclusion regarding the safety of the substance under the
conditions of its intended use, or be advised of one or more issues
(such as gaps in the data and information, or alternative
interpretations of the available data and information) that warrant
investigation before a conclusion can be drawn about whether the
substance is safe under the conditions of its intended use. When the
outcome of the GRAS panel's analysis supports the proponent's
conclusion that a substance is safe under the conditions of its
intended use, in essence the proponent then relies on the members of
the GRAS panel to act as a proxy for the larger scientific community
knowledgeable about the safety of substances directly or

indirectly added to food and, in so doing, relies on the outcome of the
GRAS panel's analysis to support the proponent's conclusion that the
safety of the intended use is ``generally recognized'' by qualified
experts. Whether a GRAS panel is a sufficient proxy for the larger
scientific community depends on a number of factors, such as the
subject matter expertise of the members of the GRAS panel and whether
the members of the GRAS panel would be considered representative of
experts qualified by scientific training and experience to evaluate the
safety of the substance under the conditions of its intended use.
    A GRAS panel is one mechanism that proponents have used to
demonstrate that the safety of a substance under the conditions of its
intended use is generally recognized by qualified experts. However, the
use of a GRAS panel is not the only mechanism for doing so and the use
of a GRAS panel does not necessarily mean that the GRAS criteria have
been met (81 FR 54960 at 54974-54975, August 17, 2016).
    We are announcing the availability of a draft guidance for industry
entitled ``Best Practices for Convening a GRAS Panel.'' We are issuing
the draft guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The draft guidance, when finalized, will
represent the current thinking of FDA on this topic. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations. This is not a
significant regulatory action subject to Executive Order 12866.
    This draft guidance document is intended for any proponent who
convenes a GRAS panel and provides our current thinking on best
practices to identify GRAS panel members who have appropriate and
balanced expertise; to take steps to reduce the risk that bias (or the
appearance of bias) will affect the credibility of a GRAS panel report,
including the assessment of potential GRAS panel members for conflict
of interest and the appearance of conflict of interest; and to limit
the data and information provided to a GRAS panel to public information
(e.g., by not providing the GRAS panel with information such as trade
secret information).

II. Paperwork Reduction Act of 1995

    This draft guidance contains proposed information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520). ``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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, we invite 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 collected; and (4)
ways to minimize the burden of the information collected on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    Title: Best Practices for Convening a GRAS Panel (OMB control
number 0910--NEW).
    Description of respondents: This new collection of information
would be performed by those 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. The records recommended in this draft guidance would
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 this draft guidance also would
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. Finally, the draft guidance
recommends that a GRAS panel provide a written report of its findings;
however, we consider that a written GRAS panel report is 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.
    Analysis of Burden Estimates Resulting from the Recommendation for
a Written GRAS Panel Policy: 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 draft guidance, if
finalized, 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
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 September 5,
2017, we calculate that 396 proponents submitted at least one GRAS
notice for a substance intended for use in human food, and 15
proponents submitted at least one GRAS notice for a substance intended
for use in animal food. During that time period, there were three
proponents who had submitted at least one GRAS notice for a substance
intended for use in human food and at least one GRAS notice for a
substance intended for use in animal food. However, 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 411 (396 proponents + 15 proponents = 411 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. FDA 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 September 5, 2017, that database recorded that there had been a
total of 199 documented GRAS conclusions, with 41 of those documented
GRAS conclusions reported to FDA as a GRAS notice and 158 of those
documented GRAS conclusions not reported to FDA as a GRAS notice. In
contrast, as of September 5, 2017, FDA's inventory of GRAS notices
shows that the number of GRAS conclusions reported to FDA during this
timeframe was 720, 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 158 documented GRAS conclusions not
reported to FDA to 142 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
80 proponents who have not submitted a GRAS notice to FDA (142
proponents listed in the database--62 proponents who 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., 160 proponents (80 proponents listed in the database x
2 = 160).
    The publicly available database does not record documented GRAS
conclusions for substances intended for use in animal food. However,
based on the number of annual GRAS notices submitted to FDA in recent
years, we previously estimated that the number of annual GRAS notices
submitted to FDA for substances intended for use in animal food would
be 50 percent of the number of annual GRAS notices submitted to FDA for
substances intended for use in human food (i.e., we estimated 50 GRAS
notices will be submitted to FDA annually for substances intended for
use in human food and that 25 GRAS notices will be submitted to FDA
annually for substances intended for use in animal food (OMB control
number 0910-0342; 81 FR 54960)). Therefore, for the purpose of this
analysis we assume 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 50 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., 80 proponents (160 estimated proponents who have documented GRAS
conclusions without reporting those GRAS conclusions to FDA x 0.5 = 80
proponents). We calculate that the total number of proponents who
documented GRAS conclusions without reporting those GRAS conclusions to
FDA is 240 proponents (160 estimated proponents who have documented
GRAS conclusions for substances intended for use in human food + 80
estimated proponents who have documented GRAS conclusions for
substances intended for use in animal food = 240 proponents).
    To estimate the total number of proponents, we are adding 240
estimated proponents who have not reported their documented GRAS
conclusions to FDA to the 411 proponents who have already submitted at
least one GRAS notice to FDA for a total of 651 proponents who will
document a GRAS conclusion (240 non-reporting proponents + 411
reporting proponents = 651 total 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., 651
proponents) will create a written GRAS panel policy. We estimate that
it would take 40 hours to create a written GRAS panel policy, including
8 hours to review relevant, publicly available policies (e.g., Refs. 4
and 5) 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 651 proponents = 26,040 hours.
We request comment on our estimate of the total number of proponents
and on the hourly burden to create a written GRAS panel policy. There
are no estimated capital costs or operating and maintenance costs
associated with the information collection for a written GRAS panel
policy.
    Analysis of Burden Estimates Resulting From the Recommendation for
Application of a Written GRAS Panel Policy to GRAS Panel Members: Based
on the number of annual GRAS notices submitted to FDA in recent years,
we previously estimated that 50 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; 81 FR 54960), for a total number of 75
GRAS notices submitted to FDA each year. We count each GRAS notice as a
single GRAS conclusion, and, for the purpose of this 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 75 GRAS conclusions
and that these GRAS conclusions are submitted by 75 proponents.
    We have not previously estimated the annual number of documented
GRAS conclusions that are not reported to FDA as a GRAS notice. For the
purpose of this analysis, 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. In addition, the current year (2017)
has not reached its end. Therefore, we use 16 years (i.e., from 2001
through 2016) 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 but not reported to FDA,
we estimate that there are 157 such GRAS conclusions (158 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 10 (157 documented,
unreported GRAS conclusions/16 years = 9.8 documented, unreported GRAS
conclusions per year recorded in the database, rounded up to 10). 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, unrecorded GRAS
conclusions recorded in the database--i.e., 20 documented, unreported
GRAS conclusions for substances intended for use in human food each
year (10 documented, unreported GRAS conclusions recorded in the
database on an annual basis x 2 = 20 documented, unreported GRAS
conclusions on an annual basis). 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 20 proponents who do not report
their documented GRAS conclusions for substances intended for use in
human food to FDA. 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 animal food is 50 percent of the annual number of documented,
unreported GRAS conclusions for substances intended for use in human
food--i.e., 10 documented, unreported GRAS conclusions for substances
intended for use in animal food on an annual basis (20 documented,
unreported GRAS conclusions for substances intended for use in human
food x 0.5). We therefore calculate that there is a total of 30
documented, unreported GRAS conclusions each year (20 documented,
unreported GRAS conclusions for substances intended for use in human
food + 10 documented, unreported GRAS conclusions for substances
intended for use in animal food). We also calculate that there are 105
proponents who document a GRAS conclusion on an annual basis (75
proponents who report their documented GRAS conclusions to FDA as a
GRAS notice + 30 proponents who do not report their documented GRAS
conclusions to FDA as a GRAS notice = 105 total proponents).
    We have information about the percent 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 September
5, 2017, on average, 63 percent of proponents who submitted a GRAS
notice for a substance intended for use in human food, and 60 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, 32 proponents will convene a GRAS panel and submit
a GRAS notice to FDA for substances intended for use in human food (63
percent x 50 proponents = 31.5 proponents; rounded up to 32
proponents), and 15 proponents will convene a GRAS panel and submit a
GRAS notice to FDA for substances intended for use in animal food (60
percent x 25 proponents = 15 proponents). We calculate that the total
number of proponents who will convene a GRAS panel and submit a GRAS
notice to FDA is 47 proponents (32 proponents who submit GRAS notices
for substances intended for use in human food + 15 proponents who
submit GRAS notices for substances intended for use in animal food = 47
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 percent of proponents who
convene a GRAS panel for a documented GRAS conclusion but do not report
their documented GRAS conclusions to FDA as a GRAS notice. For the
purpose of this analysis, we make the conservative assumption that all
30 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 77 proponents (47
proponents who submit GRAS notices to FDA+ 30 proponents who do not
submit GRAS notices = 77 proponents).
    Based on the recommendations in the draft guidance, if finalized,
we assume that all GRAS panels will include at least 3 panel members
(with expertise in chemistry or biochemistry, toxicology, and exposure
assessment) and that some GRAS panels will include as many as 6 panel
members with expertise that reflects the physical, chemical, and
biological properties of the substance and the scientific questions
that arise in relation to the conditions of its intended use. 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 financial conflict of interest or the
appearance of a financial or non-financial conflict of interest and,
thus, that 77 proponents will document the application of the written
GRAS panel policy to 6 individual GRAS panel members, for a total of
462 documentations by proponents of the application of the written GRAS
panel policy (77 proponents x 6 individual panel members = 462
documentations). As shown in table 2, we estimate that it will take 16
hours to document the application of the written GRAS policy to each
panel member, for a total of 7,392 hours (462 documentations x 16 hours
per documentation = 7,392 hours). As shown in table 3, we assume that
all 462 individuals who are being considered as members of a GRAS panel
will each need 4 hours to provide applicable information to the
proponent, for a total of 1,848 hours (462 individuals x 4 hours per
individual = 1,848 hours).
    There are no estimated capital costs or operating and maintenance
costs associated with this information collection for the application
of a written GRAS panel policy to individuals being considered as
members of a GRAS panel.

                                                  Table 1--Estimated One-Time Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                                                        Number of        Number of       Total annual         per
                           Recommendation                             recordkeepers     records per        records       recordkeeping     Total hours
                                                                                recordkeeper                       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written GRAS panel policy..........................................             651                1              651               40           26,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                                                        Number of        Number of       Total annual         per
                           Recommendation                             recordkeepers     records per        records       recordkeeping     Total hours
                                                                                recordkeeper                       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application of written GRAS panel policy to GRAS panel members.....              77                6              462               16            7,392
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                                                        Number of        Number of       Total annual         per
                           Recommendation                             recordkeepers     records per        records       recordkeeping     Total hours
                                                                                recordkeeper                       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information provided by potential GRAS panel members to the                     462                1              462                4            1,848
 proponents of GRAS conclusions....................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

IV. 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 Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. FDA (2017). GRAS Notices. Available at https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices.
2. FDA (2017). Current Animal Food GRAS Notices Inventory. Available
at https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/GenerallyRecognizedasSafeGRASNotifications/ucm243845.htm.
3. AIBMR Life Sciences, Inc. (2017). 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/.
4. Institute of Medicine (2009). Full Report. Conflict of Interest
in Medical Research, Education, and Practice. National Academies
Press, 500 5th Street NW., Lockbox 285, Washington, DC 20055.
Available at https://www.nap.edu/catalog/12598/conflict-of-interest-in-medical-research-education-and-practice.
5. The National Academies of Sciences, Engineering, and Medicine
(2003). Conflicts of Interest Policy for Committees Used in the
Development of Reports. The National Academies Press, 500 5th Street
NW., Washington, DC 20001. Available at http://www.nationalacademies.org/coi/.

    Dated: November 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24845 Filed 11-15-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 150 (Monday, August 5, 2019)]
[Notices]
[Pages 38087-38091]
[FR Doc No: 2019-16693]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0177]

Crash Preventability Determination Program

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: On July 27, 2017, FMCSA announced a crash preventability
demonstration program to evaluate the preventability of eight
categories of crashes through submissions of Requests for Data Review
to its national data correction system known as DataQs. After 18 months
of operating the program, FMCSA has decided to operate a crash
preventability determination program, using a streamlined process, and
proposes to modify the Safety Measurement System to remove crashes
found to be not preventable from the prioritization algorithm and
noting the not preventable determinations in the Pre-Employment
Screening Program. In addition, FMCSA proposes to consolidate two of
the original crash types in the demonstration program and start
reviewing additional crash types to determine if crashes in the
additional categories are predominantly not preventable. FMCSA seeks
comments on its implementation of these changes and on the new crash
types.

DATES: Comments must be received on or before October 4, 2019.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2014-0177 using any of the
following methods:
    Federal eRulemaking Portal: Go to www.regulations.gov. Follow the
on-line instructions for submitting comments.
    Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 0590-0001.
    Hand Delivery or Courier: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The on-line Federal document management system
is available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its processes. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Mr. Catterson Oh, Compliance Division,
Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE,
Washington, DC 20590, Telephone<PHONE_NUMBER> or by email:
<EMAIL_ADDRESS>If you have questions regarding viewing or
submitting material to the docket, contact Docket Services, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice FMCSA-2014-0177, indicate the specific section of this document
to which each comment applies, and provide a reason for each suggestion
or recommendation. You may submit your comments and material online or
by fax, mail, or hand delivery, but please use only one of these means.
FMCSA recommends that you include your name and a mailing address, an
email address, or a phone number in the body of your document so the
Agency can contact you if it has questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
put the docket number, ``FMCSA-2014-0177'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope.
    FMCSA will consider all comments and material received during the
comment period and may change this notice based on your comments.

II. Background

History

    The Agency's Crash Indicator Behavior Analysis Safety Improvement
Category (BASIC) in FMCSA's Safety Measurement System (SMS) includes
all crashes, without regard to the preventability of the crash. On
January 23, 2015, FMCSA announced the results of the Agency's study on
the feasibility of using a motor carrier's role in crashes in the
assessment of the company's safety (80 FR 3719). In response to the
January 2015 Federal Register notice,

the American Trucking Associations (ATA) provided a list of certain
types of crashes it considered not preventable and suggested that FMCSA
establish a process by which documents could be submitted on these
crashes and they could be removed from the motor carriers' records.
    In a Federal Register notice dated July 12, 2016, FMCSA proposed a
demonstration program to determine the efficacy of preventability
determinations on certain types of crashes that are generally less
complex (81 FR 45210). The Agency proposed to accept Requests for Data
Review (RDRs) to evaluate the preventability of certain categories of
crashes through its national data correction system known as DataQs. It
proposed that a crash challenged through an RDR would be found not
preventable when evidence submitted with the RDR established that the
crash could not have been averted by an act, or failure to act, by the
motor carrier or the driver.
    On July 27, 2017, FMCSA published a subsequent Federal Register
notice announcing the start of the demonstration program to test eight
specific crash types and explaining the details of the program (82 FR
35045). On February 7, 2018, FMCSA published a Federal Register notice
to clarify how crash types were being defined and to provide other
information to help submitters (83 FR 5506).

First Set of Crash Types

    To date, FMCSA has reviewed RDRs submitted under one of the
following eight crash types:
    1. When the commercial motor vehicle (CMV) was struck by a motorist
driving under the influence (or related offense);
    2. When the CMV was struck by a motorist driving the wrong
direction;
    3. When the CMV was struck in the rear;
    4. When the CMV was struck while it was legally stopped or parked,
including when the vehicle was unattended;
    5. When the CMV struck an individual committing or attempting to
commit suicide by stepping or driving in front of the CMV;
    6. When the CMV sustained disabling damage after striking an animal
in the roadway;
    7. When the crash was the result of an infrastructure failure,
falling trees, rocks, or other debris; or
    8. When the CMV was struck by cargo or equipment from another
vehicle.
Statistics
    Between August 1, 2017 and May 31, 2019, 12,249 RDRs were submitted
to FMCSA. Approximately 56 percent of the submitted RDRs were eligible,
meaning they were one of the eight crash types. After reviewing the
eligible crashes, approximately 93 percent were found to have been not
preventable.
    FMCSA maintains statistics on the program on its website at
www.fmcsa.dot.gov/crash-preventability-demonstration-program. As of May
31, 2019, information from the program is as follows:

                       Table 1--Crash Preventability Program Determinations by Crash Type
----------------------------------------------------------------------------------------------------------------
                  Crash type                      Total RDRs     Not preventable    Preventable      Undecided
----------------------------------------------------------------------------------------------------------------
1. When the commercial motor vehicle (CMV) was             417               386              12              19
 struck by a motorist driving under the
 influence (or related offense)...............
2. When the CMV was struck by a motorist                   365               334               6              25
 driving the wrong direction..................
3. When the CMV was struck in the rear........           3,927             3,675              49             203
4. When the CMV was struck while legally                   444               413               8              23
 stopped or parked, including when the vehicle
 was unattended...............................
5. When the CMV was struck by an individual                 17                16               0               1
 committing or attempting to commit suicide by
 stepping or driving in front of the CMV......
6. When the CMV sustained disabling damage                 218               206               2              10
 after striking an animal in the roadway......
7. When the crash was a result of an                        82                79               2               1
 infrastructure failure, falling trees, rocks,
 or other debris..............................
8. When the CMV was struck by cargo or                     149               138               4               7
 equipment from another vehicle...............
                                               -----------------------------------------------------------------
    Total.....................................           5,619             5,247              83             289
----------------------------------------------------------------------------------------------------------------

    As of May 31, 2019, 3,558 unique carriers had submitted RDRs. Of
these, 1,750 carriers submitted 1 RDR, 1,618 carriers submitted between
2 and 9 RDRs, and 190 carriers submitted 10 or more RDRs. The highest
number of RDRs submitted by 1 carrier was 254 RDRs.
    For the majority of crashes that were determined to be preventable,
the driver was operating with an out of service (OOS) condition under
the North American Standard OOS Criteria, including that the driver was
not properly licensed on the day of the crash. The Agency was clear in
its July 2017 Federal Register notice that in these circumstances,
crashes would be found to be preventable.
    The undecided determinations were largely due to the submitter's
failure to provide, after FMCSA's request, documentation confirming the
validity of the driver's commercial driver's license (CDL) or medical
certification on the date of the crash, or would found to be undecided
because the documentation provided contained conflicting information
about the submitter's actions in the crash.

Review Processes

    FMCSA has used contract resources to complete two stages of review
within the DataQs system. In stage 1, the reviewer collects all
documents related to the crash from the submitter and FMCSA systems
including the Motor Carrier Management Information System (MCMIS) crash
report, the Commercial Driver's License Information System (CDLIS)
driver history record, any post-crash inspection report, the Driver
Information Resource, any recent enforcement information for the motor
carrier, and any media reports about the crash.
    If the CDLIS record has been updated since the date of the crash,
the reviewer requests documentation of the CDL or medical certificate
on the date of the crash. In the cases of fatal crashes, the reviewer
requests the CMV driver's post-crash drug and alcohol test results.
    In stage 2, an experienced crash report reviewer evaluates all of
the documents from the submitter and stage 1. Based on

the evidence reviewed, the stage 2 reviewer makes a recommendation to
FMCSA as to whether the submitter demonstrated, through compelling
evidence, that the crash was not preventable.
    An FMCSA employee reviews the evidence collected and considered by
the stage 2 reviewer and the recommendation and makes the
determination. If FMCSA agrees with the recommendation of not
preventable, the crash is posted for public input on the DataQs system
for 30 days. Any new documents or data will be reviewed and considered
before FMCSA makes a final determination. At this time, the DataQs
public input functionality has been used only two times, to provide
additional information from the submitter and to make a general comment
about not preventable crashes that was not crash specific.
    In addition, as announced in the Agency's February 2018 Federal
Register notice, the Agency recognized that some parties involved in
the crash might not be able to provide input within 30 days. The Agency
is maintaining a list of not preventable final determinations on its
website at https://www.fmcsa.dot.gov/safety/crash-preventability-demonstration-program. This list is updated monthly. If at any time a
party has information and documentation to counter a determination,
FMCSA will accept that information at<EMAIL_ADDRESS>and
may change the determination. To date, no emails have been received
with information contrary to a determination.
    Final determinations (i.e., not preventable, preventable,
undecided) made through this demonstration program are noted on the
Agency's public SMS website within 60 days. No crashes are removed from
the SMS Crash Indicator BASIC. However, a logged-in motor carrier
viewing its own data in SMS sees an alternative percentile and measure
with the crashes with not preventable determinations removed. The Crash
Indicator BASIC percentiles have never been publicly available and
remain available only to motor carriers who log in to view their own
data, as well as to FMCSA and law enforcement users.

Submitted Documents

    FMCSA has not required submitters to provide any specific
documentation. The burden is on the submitter to show, by compelling
evidence, that the crash was not preventable. FMCSA estimates that 99
percent of submitters of eligible crashes provided Police Accident
Reports (PARs). In the limited situations where a PAR was not submitted
and the crash was found to be eligible, another official law
enforcement-issued document with sufficient information was provided,
such as a State-issued driver information exchange report with
sufficient details of the crash.
    FMCSA notes that other evidence such as photos and videos
significantly improved the Agency's ability to determine: (1) If the
crash met one of the eligible crash types or not; and, if eligible, (2)
preventability. Internal company documents and insurance reports were
provided by some submitters but, when reviewed on their own, did not
generally provide compelling evidence.

Effectiveness Analysis

    FMCSA conducted a preliminary analysis of the 2-year demonstration
program. A copy of the Agency's analysis using 18 months of safety data
is included in the docket for this notice. This analysis quantified the
program's impacts in terms of: (1) Number of carriers impacted; (2)
size of SMS percentile changes; and (3) future crash rate of identified
carriers like is calculated in the Agency's SMS effectiveness analysis.
    In summary, the carriers that have Not Preventable crashes removed
through the demonstration program see a reduction in their Crash
Indicator BASIC percentiles. The analysis team found a negligible
impact on SMS effectiveness after removing Not Preventable crashes.
Regardless of whether Not Preventable crashes are removed, carriers
identified in SMS, when considering all BASICs, have a crash rate 97%
higher than those not identified. The lack of an impact is mainly a
result of the small number of carriers affected by the removal of Not
Preventable crashes. Only 169 and 208 carriers are expected to gain and
lose alert in the Crash Indicator BASIC, respectively, which is a small
fraction (2%) of the 8,634 carriers identified in the Crash Indicator
BASIC.
    Small carriers that have Not Preventable crashes removed through
the demonstration program have the largest reductions in their Crash
Indicator BASIC percentiles, mainly by dropping below the data
sufficiency threshold. However, most of the small carrier population,
did not participate. To improve representation, small carriers could be
encouraged participate in the Agency's future program.
Implementation Proposal

Changes to Eligible Crash Types

    FMCSA proposes two changes to the original eight crash types.
First, FMCSA would combine the crash type involving infrastructure
failures and debris with the crash type for CMVs struck by cargo and
equipment. The distinction between these two crash types did not result
in different determinations and, in some cases, required submitters to
resubmit their RDRs under the other crash type. In addition, FMCSA is
changing the ``Motorist Under the Influence'' crash type to
``Individual Under the Influence'' to include pedestrians and
bicyclists. As a result, the revised crash types are:
    1. Struck in rear--Crashes would qualify when the striking vehicle
was directly behind the submitter's vehicle prior to the crash and
strikes the CMV on the back plane. This crash type does not include
side swipes or when the point of impact was on the side toward the rear
of the truck/trailer.
    2. Legally stopped or parked--Crashes would qualify if the CMV was
stopped at a light, stop sign or other traffic control device, stopped
for railroad crossings or school buses, or was parked. This crash type
does not include crashes that occurred when the CMV was stopped in
traffic.
    3. Suicides or Suicide Attempts--Crashes would qualify if the
submitter provided evidence that the CMV struck an individual
committing or attempting to commit suicide. This crash type does not
include action where a vehicle or pedestrian enters the CMV's path with
no documented reason.
    4. Wrong Direction--Crashes would qualify only if the CMV was
struck after the other vehicle fully crossed the center line or median,
or the other driver was driving in the wrong direction (e.g., driving
southbound in the northbound lanes of an interstate or opposite on a
one-way road). To qualify for this crash type the other vehicle was
operating in the opposing direction before the crash. This crash type
does not include when the vehicle partially crosses the center line or
when the involved vehicles were traveling in the same direction. This
crash type also does not include when the CMV crossed into the other
lane.
    5. Animal Strikes--Crashes would qualify only if the CMV struck the
animal. This would not include crashes where the CMV crashed avoiding
the animal.
    6. Individuals Under the Influence--This crash type would require
evidence that the CMV was struck by an individual who was operating
``under

the influence'' (or related violation such as operating while
intoxicated), according to the legal standard of the jurisdiction in
which the crash occurred, to include either alcohol or drug test
results, an arrest, a citation/violation, or a refusal.
    7. Infrastructure failure or struck by cargo, equipment or debris--
This crash type would be changed to include any cargo and equipment,
not just fallen cargo and equipment. This would include crashes when
the cargo or equipment on a vehicle shifts or extends into the path of
travel. This crash type would not include when the CMV was struck by
another vehicle that was not being transported as cargo.
    In addition, FMCSA proposes to test the following additional crash
types. These crashes were frequently submitted during the demonstration
program, but did not qualify for one of the original crash types.
However, the PARs provided sufficient information to reach a
preventability determination.
    8. When the CMV is struck on the side in the rear--These crashes
would include when the CMV is struck on the side at the rear of the CMV
when the other driver was in another lane before the crash and strikes
the CMV at the side. For example, this would include when the PAR
indicates that the CMV was struck at the 5:00 or 7:00 point of impact;
    9. When the CMV is struck by a vehicle that did not stop or slow in
traffic--These crashes are when the CMV is stopped in a traffic lane
due to traffic. This would include when the CMV is struck on the side;
    10. When the CMV is struck by a vehicle that failed to stop at a
traffic control device (e.g., stop sign, red light or yield);
    11. When the CMV is struck by a vehicle that was making a U-turn or
illegal turn;
    12. When the CMV is struck by a driver who experiences a medical
issue which causes the crash;
    13. When the CMV is struck by a driver who admits falling asleep or
admits distracted driving (e.g., cellphone, GPS, passengers, other);
    14. When the crash involved an individual ``under the influence''
(or related violation such as operating while intoxicated), according
to the legal standard of the jurisdiction in which the crash occurred,
even if the CMV was struck by another vehicle involved in the crash and
not by the individual under the influence. The standards for test
results, arrest or a citation would continue to apply; or
    15. When the crash involved a driver operating in the wrong
direction, even if the CMV was struck by another vehicle involved in
the crash and not by the driver operating in the wrong direction. The
standard for the other wrong direction vehicle to be completely
operating in the wrong lane (e.g., completely across the center line or
over a median) or the other driver was driving in the wrong direction
(e.g., driving southbound in the northbound lanes of an interstate or
opposite on a one-way road.) to qualify for this crash type.
    FMCSA expects to analyze these additional crash types for 24 months
but may announce changes earlier if: (1) Certain crash types cannot be
consistently reviewed; (2) these crash types result largely in
preventable or undecided determinations; or (3) there is sufficient
information to make recommendations for future implementation.

SMS and PSP Changes

    Effective for crashes on or after August 1, 2019, for any of the 15
types noted above, FMCSA would continue to display the crashes in SMS
with notations of not preventable, preventable or undecided but would
remove crashes with not preventable determinations from the SMS Crash
Indicator BASIC calculation. FMCSA will also note the not preventable
determinations in PSP. FMCSA proposes that preventable determinations
would not be noted in PSP because the driver may not be aware when the
motor carrier submits a crash that results in a preventable
determination. The Agency is specifically interested in receiving
comments on this issue.
    As crashes in SMS are only displayed for 2 years, notations in SMS
for crashes reviewed during the demonstration program will remain for 2
years from the date of the crash. Crashes reviewed during the
demonstration program will not be removed from calculation of the SMS
Crash Indicator BASIC but motor carriers will still have access to the
alternative measures and percentiles.
    The Agency has an interest in maintaining transparent and accurate
safety performance data. The Agency also believes that removing not
preventable crashes from the SMS may provide additional safety
incentives to carriers that are not reflected in the effectiveness
study, but requests comments on this issue.
    The proposed changes to SMS would go into effect only after
comments to this notice are fully reviewed and any needed changes
addressed. In addition, FMCSA needs to implement information technology
system changes, specifically in the DataQs system, to sustain longer
term operations and reduce costs and improve efficiencies.
    As a result, the changes proposed in this notice would not go into
effect until these steps, and other needed implementation actions, are
completed and the Agency publishes a follow up Federal Register notice.

Impact of SMS Changes

    Once FMCSA begins removing crashes from the Crash Indicator BASIC,
and because SMS is a relative system, the calculation may increase the
Crash Indicator BASIC percentiles of other carriers. As a result, a
motor carrier that does not have any additional crashes may see its
Crash Indicator BASIC percentile increase because its peers submitted
RDRs and crashes were found to be not preventable and were removed from
the calculations.
    Although removing not preventable crashes from the calculation of
the Crash Indicator BASIC may identify a different set of carriers for
intervention, the Crash Indicator BASIC percentiles have never been
publicly available and will remain available only to motor carriers who
log in to view their own data, as well as to FMCSA and law enforcement
users. This change would not change any carrier's safety fitness rating
or ability to operate, nor would it establish any obligations or impose
legal requirements on any motor carrier. This change also would not
change how the Agency makes enforcement decisions.

End of Demonstration Program and Start of New Program

    FMCSA proposes to continue accepting crashes occurring on or after
June 1, 2017, and through July 31, 2019, until September 30, 2019. This
will allow RDRs for crashes occurring in July 2019 to be submitted,
reviewed and preventability determinations noted in SMS.
    FMCSA is preparing to be able to accept the 15 crash types noted
above in DataQs on or about October 1, 2019. Submitters will be able to
submit crashes occurring on or after August 1, 2019, for all 15 crash
types. As a result, there is no gap in time for submissions of RDRs.

Public Input Changes

    As previously noted, FMCSA has not received public input on any of
the crashes. As a result, FMCSA proposes to cease the 30-day public
input period and cease the practice of publishing preliminary not
preventable determinations. This will allow RDRs to be closed with not
preventable determinations without the 30-day

delay and will reduce resources to take additional action on the RDR.
In addition, FMCSA proposes to stop publishing a list of not
preventable determinations on the Agency's website. Instead, the Agency
would accept information about any crash by email to the
<EMAIL_ADDRESS>email address for any crash in SMS with a
not preventable notation. Any information received would be fully
considered and could result in a change in the determination. The
Agency is specifically interested in receiving comments on this issue.

Document Requirement

    FMCSA also proposes requiring submitters to provide the complete
PAR to participate in the program. In nearly all qualified submissions,
a PAR was needed to reach a determination, and most submitters provided
the PAR as the required compelling evidence. The submitter may provide
other documentation as well, as the burden will remain on the submitter
to provide compelling evidence showing that the crash was not
preventable. Therefore, if only the PAR is submitted and it contains
conflicting information about the crash (i.e., the narrative is
different than the diagram or point of impact information) and FMCSA
cannot determine eligibility for one of the 15 crash types, the crash
will be deemed Not Eligible. If the crash is found to be eligible, the
PAR information conflicts, this may result in an undecided
determination.

Process Information

    The demonstration program required submitters to resubmit the RDR
for it to be considered under another crash type. In the future, FMCSA
proposes to develop the functionality in DataQs to allow FMCSA to
change the crash type on behalf of the submitter to another eligible
crash type, when appropriate.
    FMCSA will streamline the review process and use only one stage of
contract reviewers to provide a recommendation. In addition, FMCSA may
allow the contract reviewers to close RDRs for crashes that are not one
of the 15 eligible crash types.
    To date, the stage 1 reviewer has pulled the MCMIS crash record and
a current CDLIS report for the submitter's driver. For many RDRs, the
driver had a license change such as a renewal or new medical
certificate after the date of the crash, and FMCSA requested
confirmation of the CDL or medical certificate on the date of the
crash. On only a few RDRs did this result in a determination that the
driver was not qualified on the date of the crash. In most RDRs, the
MCMIS crash report accurately reflected the driver's proper licensing
status at the time of the crash. As a result, FMCSA proposes to rely
solely on the MCMIS report to confirm the driver's license and medical
certification status as part of implementation.
    FMCSA proposes to continue reviewing any post-crash inspection
reports and if the inspection shows that the CMV was in violation of an
OOS regulation under the North American Standard OOS Criteria prior to
the crash or that the driver was not properly licensed, the crash would
be deemed preventable. In addition, FMCSA will continue to request
post-crash drug and alcohol test results when the crash results in a
fatality.

Crash Preventability Determinations During Investigations and Safety
Audits

    It should be noted that the crash preventability determination
program does not change FMCSA's processes for reviewing crashes during
an investigation or safety audit. In the event an investigation or
audit results in a different determination than was made through this
program, FMCSA will review all information provided and the
determination made through this program may change.

National Academy of Sciences' Correlation Study

    FMCSA proposes to make these changes to SMS separately from the
ongoing work that FMCSA is undertaking in response to the June 27,
2017, report of the National Academy of Sciences (NAS), ``Improving
Motor Carrier Safety Measurement.'' In its report, the NAS noted that
the demonstration program was of interest but did not issue a
recommendation directly relating to the program.
Comments Sought
    FMCSA seeks comments generally on the proposals described above.
FMCSA also seeks comments specifically on the following questions.
    1. If you participated in the demonstration program, did you
realize any new safety incentives to your operations? If so, how were
they quantified?
    2. Would the ability to have not preventable crashes removed from
the calculation of your Crash Indicator BASIC measure and percentile
provide any new safety incentives to your operations?
    3. If you have not submitted a crash for a preventability
determination, what were your reasons for not participating?

    Dated: July 31, 2019.
Raymond P. Martinez,
Administrator.
[FR Doc. 2019-16693 Filed 8-2-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 71 (Monday, April 13, 2020)]
[Rules and Regulations]
[Pages 20424-20426]
[FR Doc No: 2020-07142]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2020-0033; FRL-10007-60-Region 7]

Air Plan Approval; Missouri; Control of Emissions From the
Manufacturing of Paints, Varnishes, Lacquers, Enamels, and Other Allied
Surface Coating Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a revision to the State Implementation Plan (SIP) for
the State of Missouri for a regulation that controls emissions from
facilities that manufacture paints, varnishes, enamels, and other
allied surface coating products. This final action will amend the SIP
to include adding incorporations by reference, including definitions
specific to the rule, revising unnecessarily restrictive language, and
making other administrative wording changes. The EPA's approval of
these rule revisions is being done in accordance with the requirements
of the Clean Air Act (CAA).

DATES: This final rule is effective on May 13, 2020.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R07-OAR-2020-0033. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available through https://www.regulations.gov or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional information.

FOR FURTHER INFORMATION CONTACT: Will Stone, Environmental Protection
Agency, Region 7 Office, Air Quality Planning Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219; telephone number<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA.

Table of Contents

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. The EPA's Response to Comments
IV. What action is the EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    The EPA is approving revisions to 10 Code of State Regulation (CSR)
10-2.300, Control of Emissions from the Manufacturing of Paints,
Varnishes, Lacquers, Enamels and Other Allied Surface Coating Products
in the Missouri SIP. Missouri made several revisions to the rule. These
revisions are described in detail in the technical support document
(TSD) included in the docket for this action. The EPA is finalizing
this action because the revisions to these rules will not have a
negative impact on air quality.

II. Have the requirements for approval of a SIP revision been met?

    The State submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice on this SIP revision from June 15, 2018,
to September 6, 2018, and received four comments. The State revised the
rule based on the comments submitted. In addition, as explained in more
detail in the TSD included in the docket for this action, the revision
meets the substantive SIP requirements of the CAA, including section
110 and implementing regulations.

III. The EPA's Response to Comments

    The public comment period on the EPA's proposed rule opened
February 13, 2020, the date of its publication in the Federal Register,
and closed on March 16, 2020 (85 FR 8229). During this period, EPA
received one comment. The comment was not substantive or adverse and
can be found in the docket for this action.

IV. What action is the EPA taking?

    The EPA is taking final action to approve revisions to 10 CSR 10-
2.300, Control of Emissions from the Manufacturing of Paints,
Varnishes, Lacquers, Enamels and Other Allied Surface Coating Products
in the Missouri SIP. Approval of these revisions will ensure
consistency between State and federally approved rules. The EPA has
determined that these changes will not adversely impact air quality.

V. Incorporation by Reference

    In this document, the EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with requirements of
1 CFR 51.5, the EPA is finalizing the incorporation by reference of the
Missouri Regulations described in the amendments to 40 CFR part 52 set
forth below. The EPA has made, and will continue to make, these
materials generally available through www.regulations.gov and at the
EPA Region 7 Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).
    Therefore, these materials have been approved by the EPA for
inclusion in the State Implementation Plan, have been incorporated by
reference by EPA into that plan, are fully federally enforceable under
sections 110 and 113 of the CAA as of the effective date of the final
rulemaking of the EPA's approval, and will be incorporated by reference
in the next update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).

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

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. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this 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);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     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 the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    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 action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 12, 2020. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: March 31, 2020.
James Gulliford,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart AA--Missouri

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by revising
the entry ``10-2.300'' to read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
----------------------------------------------------------------------------------------------------------------
                                                         State
     Missouri citation               Title          effective date    EPA approval date         Explanation
----------------------------------------------------------------------------------------------------------------
                                    Missouri Department of Natural Resources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
  Chapter 2--Air Quality Standards and Air Pollution Control Regulations for the Kansas City Metropolitan Area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
10-2.300...................  Control of Emissions        2/28/2019  4/13/2020, [insert     .....................
                              from Manufacturing                     Federal Register
                              of Paints,                             citation].
                              Varnishes, Lacquers,
                              Enamels and Other
                              Allied Surface
                              Coating Products.

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

* * * * *
[FR Doc. 2020-07142 Filed 4-10-20; 8:45 am]
 BILLING CODE 6560-50-P