Best Practices for Convening a Generally Recognized as Safe Panel: Draft Guidance for Industry; Availability, 53433-53438 [2017-24845]
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Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Proposed Rules
Camcopter S–100, which has been
placed in the docket. The S–100 would
be considered Risk Class 3.
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Operational Considerations
The following operational
considerations were evaluated during
the development of this document:
1. The S–100 would be used for
power transmission line survey
operations. It operates in a designated
corridor and area within the right-ofway of the power transmission lines and
is operationally limited to 100 feet
above and laterally within 100 feet of
the power line it would be surveying.
2. While there is minimal population
exposure within the power transmission
line right-of-way, the mission path
would cross several public highways
and pass in close proximity to several
neighborhoods with population
densities of less than 950 people per
square mile.
3. The S–100 would operate Beyond
Visual Line of Sight (BVLOS). BVLOS
for this UAS is defined as those
operations that do not conform to the
definition of Visual Line of Sight
(VLOS) in 14 CFR part 107.31 at
amendment 107–1.
4. The radio control uplink and
downlink would operate within
frequencies approved by the Federal
Communications Commission (FCC).
5. This S–100 is designed to operate
both autonomously and manually by the
pilot-in-command (PIC).
6. Minimum crew includes one PIC,
one mission specialist, and one mission
flight director.
7. The minimum crew would operate
only one S–100 at any time.
8. The aircraft would remain within
Radio Line of Sight (RLOS) of the
control station. RLOS refers to the
straight and unobstructed path between
the transmitting and receiving antennas.
9. The control station would be
ground based.
10. All crew would be FAA certified
airmen with current and applicable
medical credentials.
11. All crew would successfully
complete required crew training.
12. Maintenance personnel would
hold appropriate FAA maintenance
certificates.
13. Maintenance personnel would
complete required maintenance
training.
Unresolved Criteria
The FAA’s ongoing development of
operational criteria will necessitate the
incorporation of additional
airworthiness criteria into the S–100
and may also necessitate future clarity
of the airworthiness criteria published
VerDate Sep<11>2014
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in the Airworthiness Criteria for the
FlightScan Camcopter S–100, available
in the docket. These may include but
are not necessarily limited to the
following—
1. Command and Control (*) 3—UAS
control and communications link
security is a key safety and
interoperability requirement in
integrating civil UAS into the National
Airspace System NAS;
2. Sense and Avoid (SAA) Equipage
(*)—SAA systems could serve as a
means of compliance with 14 CFR
91.113 right-of-way rules and others.
Issues associated with the use of SAA
systems to comply with 14 CFR 91
requirements and others, if any, must be
identified; and
3. Noise Act Finding (*)—Noise
standards have not been developed for
UAS.
Proposed Airworthiness Criteria
The FAA has not previously
published airworthiness criteria for
UAS. The FAA proposes new type
certification airworthiness criteria for
the FlightScan Camcopter S–100 as
found in Airworthiness Criteria for the
FlightScan Camcopter S–100, Revision
0, dated November 3, 2017. Locate the
document at https://www.regulations.gov
using docket number FAA–2017–1058.
Issued in Kansas City, Missouri, on
November 8, 2017.
Pat Mullen,
Manager, Small Airplane Standards Branch,
Aircraft Certification Service.
[FR Doc. 2017–24866 Filed 11–15–17; 8:45 am]
BILLING CODE 4910–13–P
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.
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
SUMMARY:
3 Criteria that have not yet been developed are
identified with an asterisk (*).
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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).
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.
DATES:
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
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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
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FR 56469, September 18, 2015, or access
the information at: https://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 selfaddressed 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, 240–402–1192.
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,
240–402–5838. 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, PRAStaff@
fda.hhs.gov.
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
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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
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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
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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,
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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
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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 × 2 = 160).
The publicly available database does
not record documented GRAS
conclusions for substances intended for
use in animal food. However, based on
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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 × 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 nonreporting 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
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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 × 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
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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 × 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 × 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
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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 × 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 × 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
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53437
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 × 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 × 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 × 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.
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Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Proposed Rules
TABLE 1—ESTIMATED ONE-TIME RECORDKEEPING BURDEN 1
Recommendation
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total 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
Recommendation
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total 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
Recommendation
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total hours
Information provided by potential GRAS panel members to
the proponents of GRAS conclusions ..............................
462
1
462
4
1,848
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
https://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.
nshattuck on DSK9F9SC42PROD with PROPOSALS
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/
GenerallyRecognizedas
SafeGRASNotifications/ucm243845.htm.
3. AIBMR Life Sciences, Inc. (2017).
Independent GRAS (Generally
Recognized As Safe) Conclusion
Inventory Database. Available at https://
aibmr.com/natural-products-industrycompliance-consultation/gras-generallyrecognized-as-safe-safety-studies/.
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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-inmedical-research-education-andpractice.
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 https://
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
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DEPARTMENT OF DEFENSE
Department of the Army, Corps of
Engineers
33 CFR Part 334
[COE–2017–0003]
Establishment of a Permanent
Restricted Area for U.S. Coast Guard
Yard, Baltimore, Maryland, in Curtis
Creek and Arundel Cove
AGENCY:
U.S. Army Corps of Engineers,
DoD.
Notice of proposed rulemaking
and request for comments.
ACTION:
The Corps of Engineers is
proposing to establish a permanent
restricted area for the U. S. Coast Guard
in waters of Curtis Creek and Arundel
Cove located in Baltimore, Maryland.
The establishment of the restricted area
is necessary to reflect the current
security needs at U. S. Coast Guard Yard
(CG Yard), Baltimore, Maryland,
including the protection of Coast Guardwide military assets. The CG Yard is the
Coast Guard’s only shipyard and its
largest industrial facility. It performs
major ship, electronics, and heavy
weapons overhaul, repair, and
manufacture. The CG Yard is also the
host command for various Coast Guard
commands supporting local and
nationwide Coast Guard missions.
SUMMARY:
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]]>Agencies
[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Proposed Rules]
[Pages 53433-53438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24845]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 53434]]
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: https://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, 240-402-1192. 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, 240-402-5838. 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, PRAStaff@fda.hhs.gov.
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
[[Page 53435]]
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
[[Page 53436]]
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
[[Page 53437]]
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.
[[Page 53438]]
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 https://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
https://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 https://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
