Substances Generally Recognized as Safe Added to Food for Animals; Notice of Pilot Program, 31800-31803 [2010-13464]
Download as PDF
31800
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Fellowships and Dissertations.
Date: July 13, 2010.
Time: 1 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Serena P. Chu, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6154, MSC 9609,
Bethesda, MD 20892–9609, 301–443–0004,
sechu@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: May 27, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–13414 Filed 6–3–10; 8:45 am]
BILLING CODE 4140–01–P
[Docket No. FDA–2010–N–0215]
Substances Generally Recognized as
Safe Added to Food for Animals;
Notice of Pilot Program
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
AGENCY:
ACTION:
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
Jkt 220001
Food and Drug Administration,
HHS.
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
srobinson on DSKHWCL6B1PROD with NOTICES
Dated: May 27, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
Food and Drug Administration
BILLING CODE 4140–01–P
16:01 Jun 03, 2010
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Race-Based Social
Stress and Health in the MADICS
Longitudinal Study, University of Michigan
at Ann Arbor.
Date: June 25, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Michele C. HindiAlexander, PhD, Division of Scientific
Review, National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 1600
Executive Boulevard, Rm. 5B01, Bethesda,
MD 20892, (301) 435–8382,
hindialm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–13413 Filed 6–3–10; 8:45 am]
VerDate Mar<15>2010
would constitute a clearly unwarranted
invasion of personal privacy.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is seeking
participants for a voluntary pilot
program whereby persons submit to
FDA notices of claims that a particular
use of a substance in food for animals
is exempt from the statutory premarket
approval requirements based on the
notifier’s determination that such use is
generally recognized as safe (GRAS).
FDA intends to evaluate these notices
and will inform each participant
(notifier) in writing either that the
notice provides a sufficient basis for the
GRAS determination or that FDA has
identified questions as to whether the
intended use of the substance is GRAS.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
DATES: Submit written requests to
participate in the pilot program
beginning June 4, 2010.
ADDRESSES: Submit written requests to
participate in the pilot program to the
Division of Animal Feeds (HFV–224),
Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855.
FOR FURTHER INFORMATION CONTACT:
Geoffrey K. Wong, Center for Veterinary
Medicine (HFV–224), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6879,
Geoffrey.wong@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. The 1958 Amendment
In 1958, in response to public concern
about the increased use of chemicals in
foods and food processing, Congress
enacted the Food Additives Amendment
(the 1958 amendment) to the Federal
Food, Drug, and Cosmetic Act (the act).
The 1958 amendment required that,
before a new additive could be used in
food, its producer must demonstrate the
safety of the additive to FDA. The 1958
amendment defined the terms ‘‘food
additive’’ (section 201(s) of the act (21
U.S.C. 321(s))) and ‘‘unsafe food
additive’’ (section 409(a) of the act (21
U.S.C. 348(a))), established a premarket
approval process for food additives
(section 409(b) through (h)), and
amended the food adulteration
provisions of the act to deem
adulterated any food that is, or bears or
contains, any food additive that is
unsafe within the meaning of section
409 (section 402(a)(2)(C) of the act (21
U.S.C. 342(a)(2)(C))).
In enacting the 1958 amendment,
Congress recognized that many
substances intentionally added to food
would not require formal premarket
review by FDA to assure their safety.
Congress thus adopted, in section 201(s)
of the act, a two-step definition of ‘‘food
additive.’’ The first step broadly
includes 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 food. The second step, however,
excludes from the definition of ‘‘food
additive’’ substances that are generally
recognized, among experts qualified by
scientific training and experience to
evaluate their safety (‘‘qualified
experts’’), 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 through
E:\FR\FM\04JNN1.SGM
04JNN1
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
experience based on common use in
food) to be safe under the conditions of
their intended use.
B. Elements of the GRAS Standard
Importantly, under section 201(s) of
the act, it is the use of a substance,
rather than the substance itself, that is
eligible for the GRAS exemption. FDA
has defined ‘‘safe’’ as a reasonable
certainty in the minds of competent
scientists that the substance is not
harmful under its intended conditions
of use (21 CFR 570.3(i)). Current
§ 570.30(b) (21 CFR 570.30(b)) provides
that general recognition of safety based
on scientific procedures requires the
same quantity and quality of scientific
evidence as is required to obtain
approval of a food additive regulation
for the substance. The requirement for
scientific evidence of safety is referred
to in this document as the ‘‘technical
element’’ of safety. While a
determination that a food additive is
safe requires technical evidence of
safety, a determination that a particular
use of a substance is GRAS requires
both technical evidence of safety and a
basis to conclude that this technical
element of safety is generally
recognized. Such general recognition of
safety requires common knowledge
about the substance throughout the
scientific community, so it is referred to
in this document as the ‘‘common
knowledge element’’ of the GRAS
standard.
The common knowledge element of
the GRAS standard includes two facets:
(1) The data and information relied on
to establish the technical element,
which must be of the same kind and
quality as is required to obtain FDA
approval of the use of the substance,
must be generally available and (2) there
must be a basis to conclude that there
is consensus among qualified experts
about the safety of the substance for its
intended use. (See United States v.
Western Serum Co., Inc., 666 F.2d 335,
338 (9th Cir. 1982); United States v.
Articles of Drug * * * Promise
Toothpaste, 624 F.Supp. 776, 778 (N.D.
Ill. 1985), aff’d 826 F.2d 564 (7th Cir.
1987); United States v. Articles of Drug
* * * Hormonin, 498 F.Supp.2d 424,
435 (D.N.J. 1980)). None of the facets by
themselves are sufficient to satisfy the
common knowledge element of the
GRAS standard.
The usual mechanism to establish that
scientific information is generally
available is to show that the information
is published in a peer-reviewed
scientific journal. However,
mechanisms to establish the basis for
concluding that there is expert
consensus about the safety of a
VerDate Mar<15>2010
16:01 Jun 03, 2010
Jkt 220001
substance are more varied. In some
cases, publication in a peer-reviewed
scientific journal of data (such as
toxicity studies) on a substance has been
used to establish expert consensus in
addition to general availability. In other
cases, such publication of data and
information in the primary scientific
literature has been supplemented by: (1)
Publication of data and information in
the secondary scientific literature, such
as scientific review articles, textbooks,
and compendia; (2) documentation of
the opinion of an ‘‘expert panel’’ that is
specifically convened for this purpose;
or (3) the opinion or recommendation of
an authoritative body such as the
National Research Council of the
National Academy of Sciences on a
broad or specific issue that is related to
a GRAS determination.
In this document, FDA is using the
term ‘‘consensus’’ in discussing the
common knowledge element of the
GRAS standard. Such consensus does
not require unanimity among qualified
experts. (See United States v. Articles of
Drug * * * 5,906 Boxes, 745 F.2d 105,
119 n. 22 (1st Cir. 1984); United States
v. An Article of Drug * * * 4,680 Pails,
725 F.2d 976, 990 (5th Cir. 1984); ColiTrol 80, supra, 518 F.2d at 746; Promise
Toothpaste, supra, 624 F.Supp. at 782).
A substance used in food prior to
January 1, 1958, may be shown to be
GRAS for an intended use through
scientific procedures or through
experience based on common use in
food. Current § 570.30(c) (21 CFR
570.30(c)) provides that general
recognition of safety through experience
based on common use in food prior to
January 1, 1958, may be determined
without the quantity or quality of
scientific procedures required for
approval of a food additive regulation.
Current § 570.3(f) defines ‘‘common use
in food’’ as a substantial history of
consumption for food use by a
significant number of animals in the
United States.
C. History of FDA’s Approach to the
GRAS Exemption
Shortly after passage of the 1958
amendment, FDA clarified the
regulatory status of a multitude of food
substances that were used in food prior
to 1958 and amended its regulations to
include a list of food substances that,
when used for the purposes indicated
and in accordance with current good
manufacturing practices, are GRAS.
This GRAS list was incorporated into
the agency’s regulations as § 121.101(d)
(now parts 182 and 582 (21 CFR parts
182 and 582)) (24 FR 9368, November
20, 1959). As part of that rulemaking,
however, FDA acknowledged that it
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
31801
would be impracticable to list all
substances that are GRAS for their
intended use.
In 1970, FDA announced that it was
undertaking a comprehensive agency
review of substances listed as GRAS (35
FR 18623, December 8, 1970). In the
notice announcing this review, FDA
proposed criteria that could be used to
establish whether these substances
should continue to be listed as GRAS,
become the subject of a food additive
regulation, or become the subject of an
interim food additive regulation
pending completion of additional
studies. These criteria were
incorporated into the agency’s
regulations in 21 CFR 121.3 (precursor
of current 21 CFR 570.30) (36 FR 12093,
June 25, 1971). FDA subsequently
codified procedures for the agency to
affirm, on its own, the GRAS status of
substances found to satisfy these criteria
(§ 570.35(a) and (b) (21 CFR 570.35(a)
and (b))). Because the GRAS review did
not cover all GRAS substances (e.g., it
did not cover many substances that
were marketed based on a
manufacturer’s independent GRAS
determination), that rulemaking
included a mechanism (the GRAS
petition process currently codified in
§ 570.35(c)) whereby an individual
could petition FDA to review the GRAS
status of substances (37 FR 25705,
December 2, 1972).
D. The 1997 Proposed Rule
In the Federal Register of April 17,
1997 (62 FR 18938) (the 1997 proposed
rule), FDA published a proposed rule
that would replace this voluntary GRAS
affirmation petition process in
§§ 170.35(c) (21 CFR 170.35(c)) and
570.35(c) with a voluntary notification
procedure whereby any person may
notify FDA of a determination that a
particular use of a substance in human
food (proposed § 170.36) or in animal
food (proposed § 570.36) is GRAS.
FDA tentatively concluded in the
1997 proposed rule that the proposed
notification procedure has advantages
over the current petition process
because the resource-intensive
rulemaking that is associated with a
petition would be eliminated. This
streamlining would allow FDA to
redirect its resources to questions about
GRAS status that are a priority with
respect to public health protection. In
addition, the proposed notice is simpler
than a GRAS affirmation petition and
therefore conceivably would provide an
incentive for manufacturers to inform
FDA of their GRAS determinations. This
would result in increased agency
awareness of the composition of the
nation’s food supply and the cumulative
E:\FR\FM\04JNN1.SGM
04JNN1
31802
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
dietary exposure to GRAS substances.
FDA also tentatively concluded in the
1997 proposed rule that the public
health would be better served if some
resources that are currently directed to
the GRAS petition process were
redirected to the preparation of
documents that would provide the
industry with guidance on certain food
safety issues for complex substances
(e.g., macroingredients or biological
polymers, such as proteins,
carbohydrates, and fats and oils).
Finally, FDA tentatively concluded that
the reduction in resources devoted to
the evaluation of GRAS substances
would allow FDA to shift resources to
its statutorily mandated task of
reviewing food and color additive
petitions (62 FR 18938 at 18941).
As part of the 1997 proposed rule,
FDA announced an ‘‘interim policy’’
whereby interested persons could begin
immediately to submit notifications of
GRAS determinations (GRAS exemption
claims) as described in proposed
§ 170.36(b) and (c) for substances used
in human food. FDA stated that, in
general, FDA would administer the
notices as described in proposed
§ 170.36(d) through (f) (i.e., FDA would
acknowledge receipt of the notice,
respond in writing to the notifier, and
make publicly accessible a copy of all
GRAS determination claims and the
agency’s response). However, although
FDA would make a good faith effort to
respond within the proposed 90-day
timeframe, the agency would not be
bound by such a timeframe (62 FR
18938 at 18954).
As with the human food pilot
program, the animal food pilot program,
which will be administered by FDA’s
Center for Veterinary Medicine (CVM),
will be based on the notification
procedures announced in the 1997
proposed rule. Additionally, CVM has
consulted with the Center for Food
Safety and Applied Nutrition (CFSAN)
and, where applicable, made its
administrative procedures consistent
with CFSAN’s. Information about the
CFSAN/GRAS notification program,
including links to the 1997 proposed
rule and relevant guidance documents,
may be found at CFSAN’s GRAS Web
page: https://www.fda.gov/Food/Food
IngredientsPackaging/Generally
RecognizedasSafeGRAS/default.htm.
II. Description of the CVM Pilot
Program
FDA is implementing a voluntary
pilot program to accept submission of
notices of claims that a particular use of
a substance in food for animals is
exempt from the statutory premarket
approval requirements based on the
VerDate Mar<15>2010
16:01 Jun 03, 2010
Jkt 220001
notifier’s determination that such use is
GRAS (notices of GRAS determination).
FDA will accept notices of GRAS
determination from all interested
persons beginning immediately.
However, FDA strongly encourages
potential participants in the animal food
pilot program to contact the Division of
Animal Feeds (see ADDRESSES) prior to
submitting notices to discuss their
submission plans.
In general, the agency will implement
the pilot program for substances added
to animal food in the same manner as
the interim policy for substances added
to human food and as described in
section VIII of the 1997 proposed rule
(62 FR 18938 at 18954 through 18955).
FDA invites interested persons who
determine that a particular use of a
substance in animal food is GRAS to
notify FDA of such GRAS determination
as described in section III of this
document (see also proposed § 570.36(b)
and (c) of the 1997 proposed rule.)
III. How to Participate in the Pilot
Any person may notify FDA of a
claim that a particular use of a
substance is exempt from the statutory
premarket approval requirements based
on the notifier’s determination that such
use is GRAS. Notifiers should submit
triplicate copies of their notices of
GRAS determination to the Division of
Animal Feeds (HFV–224), Office of
Surveillance and Compliance, Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Notifiers should
submit the following information:
• A claim, dated and signed by the
notifier, or by the notifier’s attorney or
agent, or (if the notifier is a corporation)
by an authorized official, that a
particular use of a substance is exempt
from the premarket approval
requirements of the act because the
notifier has determined that such use is
GRAS. Such a claim should include:
Æ The name and address of the
notifier;
Æ The common or usual name of the
substance that is the subject of the
GRAS determination claim (i.e., the
‘‘notified substance’’);
Æ The applicable conditions of use of
the notified substance, including the
foods in which the substance is to be
used, levels of use in such foods, and
the purposes for which the substance is
used, including, when appropriate, a
description of the population (including
the specific animal species) expected to
consume the substance;
Æ The basis for the GRAS
determination (i.e., through scientific
procedures or through experience based
on common use in food); and
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Æ A statement that the data and
information that are the basis for the
notifier’s GRAS determination are
available for FDA’s review and copying
at reasonable times at a specific address
set out in the notice and will be sent to
FDA upon request.
• Detailed information about the
identity of the notified substance,
including, as applicable, its chemical
name, Chemical Abstracts Service (CAS)
Registry Number, Enzyme Commission
number, empirical formula, structural
formula, quantitative composition,
method of manufacture (excluding any
trade secrets and including, for
substances of natural biological origin,
source information such as genus and
species), characteristic properties, any
content of potential human or animal
toxicants, and specifications for feedgrade material;
• Information on any self-limiting
levels of use; and
• A detailed summary of the basis for
the notifier’s determination that a
particular use of the notified substance
is exempt from the premarket approval
requirements of the act because such
use is GRAS. Such determination may
be based either on scientific procedures
or on common use in food.
Æ For a GRAS determination through
scientific procedures, such summary
should include:
—A comprehensive discussion of, and
citations to, generally available and
accepted scientific data, information,
methods, or principles that the notifier
relies on to establish safety, including a
consideration of the probable
consumption of the substance and the
probable consumption of any substance
formed in or on food because of its use
and the cumulative effect of the
substance in the diet, taking into
account any chemically or
pharmacologically related substances in
such diet. Where a substance is
intended for use in the food of an
animal used to produce human food,
this should include a comprehensive
discussion of, and citations to, generally
accepted scientific data, information,
methods, or principles about both safety
to the target animal and human food
safety. The scientific data, information,
methods, or principles provided should
be sufficient to show that the substance
is generally recognized among qualified
experts to be safe for animals consuming
food containing the substance as well as
to humans consuming food derived
from such animals (i.e., under its
intended conditions of use);
—A comprehensive discussion of any
reports of investigations or other
information that may appear to be
E:\FR\FM\04JNN1.SGM
04JNN1
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
inconsistent with the GRAS
determination; and
—The basis for concluding, in light of
the data and information submitted, that
there is consensus among experts
qualified by scientific training and
experience to evaluate the safety of
substances added to food that there is
reasonable certainty that the substance
is not harmful under the intended
conditions of use.
Æ For a GRAS determination through
experience based on common use in
food, such summary should include:
—A comprehensive discussion of, and
citations to, generally available data and
information that the notifier relies on to
establish safety, including documented
evidence of a substantial history of
consumption of the substance by a
significant number of animals. Where a
substance is intended for use in the food
of an animal used to produce human
food, this should include a
comprehensive discussion of, and
citations to, generally accepted
scientific data, information, methods, or
principles about both safety to the target
animal and human food safety. The
scientific data, information, methods, or
principles provided should be sufficient
to show that the substance is generally
recognized among qualified experts to
be safe for animals consuming food
containing the substance as well as to
humans consuming food derived from
such animals (i.e., under its intended
conditions of use);
—A comprehensive discussion of any
reports of investigations or other
information that may appear to be
inconsistent with the GRAS
determination;
—The basis for concluding, in light of
the data and information submitted, that
there is consensus among experts
qualified by scientific training and
experience to evaluate the safety of
substances added to food that there is
reasonable certainty that the substance
is not harmful under the intended
conditions of use.
IV. How FDA Will Administer Notices
Under the Pilot Program
In general, the agency will administer
the notices under the pilot program as
described in proposed § 570.36(d)
through (f) of the 1997 proposed rule, as
follows:
1. Within 30 days of receipt of the
notice, FDA intends to acknowledge
receipt of the notice by informing the
notifier in writing.
2. Under the 1997 proposed rule, FDA
would respond to the notifier in writing
within 90 days of receipt of the notice
either that the notice provides a
sufficient basis for the GRAS
VerDate Mar<15>2010
16:01 Jun 03, 2010
Jkt 220001
determination or that FDA has
identified questions as to whether the
intended use of the substance is GRAS.
Due to resource limitations in the
animal food program, it is unlikely that
CVM will be able to evaluate and
respond to notices within the 90-day
timeframe contained in the 1997
proposed rule. CVM will therefore
respond to notifications of GRAS
determinations in its pilot program as
quickly as resources permit.
• Any GRAS determination claim
submitted as part of the pilot program
shall be immediately available for
public disclosure on the date the notice
is received. All remaining data and
information in the notice shall be
available for public disclosure, in
accordance with 21 CFR part 20, on the
date the notice is received.
• For each notice of GRAS
determination submitted under the pilot
program, the following information
shall be readily accessible for public
review and copying:
Æ A copy of the submitted GRAS
determination claim,
Æ A copy of any letter issued by the
agency, as described in paragraph 2 of
this section.
Æ A copy of any subsequent letter
issued by the agency regarding such
notice.
V. Paperwork Reduction Act of 1995
The collections of information in this
notice are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520), and
have been previously approved by
OMB. OMB originally approved
Paperwork Reduction Act (PRA)
burdens for GRAS notification under the
1997 proposed rule under OMB control
number 0910–0342. The original OMB
approval covered the collections of
information in both proposed 21 CFR
170.36 and 570.36; however, only
CFSAN operated a GRAS notification
program for human food under the
original OMB PRA approval. Extension
of the original OMB PRA approval for
GRAS notification was granted by OMB
on August 24, 2009, under OMB control
number 0910–0342.
As with the human food GRAS
notification program administered by
CFSAN, which has operated for several
years, the animal food pilot program,
which will be administered by CVM,
will be based on the notification
procedures announced in the 1997
proposed rule. The provisions for GRAS
notification under proposed §§ 170.36
and 570.36 for human and animal food,
respectively, are virtually identical and
therefore the same number of hours per
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
31803
response were estimated for reporting
(150 hours) and recordkeeping (15 hours
per record) burdens for both proposed
sections under the original and
extended OMB PRA approvals. Because
CFSAN’s GRAS program has
successfully operated under these PRA
estimates for several years, FDA believes
these burden estimates remain accurate
for CVM’s GRAS pilot program.
FDA’s estimate of the annual number
of GRAS determination notices that will
be received by CVM in the extended
OMB PRA approval (5) was revised
downward from the original PRA
approval (10). This revision was based
on the actual number of GRAS notices
received by CFSAN from 1998 to 2008,
which was lower than anticipated and
caused CFSAN to also revise downward
its estimate in the extended PRA
approval. The revised estimate in the
extended PRA approval reflects FDA’s
best judgment at this time as to the
number of notices CVM will receive
annually through this pilot program.
CVM believes that the PRA estimates
in the extended PRA approval cover
CVM’s GRAS notice program.
Dated: May 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13464 Filed 6–3–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final
Determination Concerning a Lift Unit
for an Overhead Patient Lift System
AGENCY: U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of final determination.
SUMMARY: This document provides
notice that U.S. Customs and Border
Protection (‘‘CBP’’) has issued a final
determination concerning the country of
origin of a lift unit for an overhead
patient lift system. Based upon the facts
presented, CBP has concluded in the
final determination that Sweden is the
country of origin of the lift unit for
purposes of U.S. government
procurement.
DATES: The final determination was
issued on May 28, 2010. A copy of the
final determination is attached. Any
party-at-interest, as defined in 19 CFR
177.22(d), may seek judicial review of
this final determination within July 6,
2010.
E:\FR\FM\04JNN1.SGM
04JNN1
Agencies
[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Notices]
[Pages 31800-31803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13464]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0215]
Substances Generally Recognized as Safe Added to Food for
Animals; Notice of Pilot Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is seeking participants
for a voluntary pilot program whereby persons submit to FDA notices of
claims that a particular use of a substance in food for animals is
exempt from the statutory premarket approval requirements based on the
notifier's determination that such use is generally recognized as safe
(GRAS). FDA intends to evaluate these notices and will inform each
participant (notifier) in writing either that the notice provides a
sufficient basis for the GRAS determination or that FDA has identified
questions as to whether the intended use of the substance is GRAS.
DATES: Submit written requests to participate in the pilot program
beginning June 4, 2010.
ADDRESSES: Submit written requests to participate in the pilot program
to the Division of Animal Feeds (HFV-224), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855.
FOR FURTHER INFORMATION CONTACT: Geoffrey K. Wong, Center for
Veterinary Medicine (HFV-224), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-453-6879,
Geoffrey.wong@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. The 1958 Amendment
In 1958, in response to public concern about the increased use of
chemicals in foods and food processing, Congress enacted the Food
Additives Amendment (the 1958 amendment) to the Federal Food, Drug, and
Cosmetic Act (the act). The 1958 amendment required that, before a new
additive could be used in food, its producer must demonstrate the
safety of the additive to FDA. The 1958 amendment defined the terms
``food additive'' (section 201(s) of the act (21 U.S.C. 321(s))) and
``unsafe food additive'' (section 409(a) of the act (21 U.S.C.
348(a))), established a premarket approval process for food additives
(section 409(b) through (h)), and amended the food adulteration
provisions of the act to deem adulterated any food that is, or bears or
contains, any food additive that is unsafe within the meaning of
section 409 (section 402(a)(2)(C) of the act (21 U.S.C. 342(a)(2)(C))).
In enacting the 1958 amendment, Congress recognized that many
substances intentionally added to food would not require formal
premarket review by FDA to assure their safety. Congress thus adopted,
in section 201(s) of the act, a two-step definition of ``food
additive.'' The first step broadly includes 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 food. The second step, however, excludes from the
definition of ``food additive'' substances that are generally
recognized, among experts qualified by scientific training and
experience to evaluate their safety (``qualified experts''), 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 through
[[Page 31801]]
experience based on common use in food) to be safe under the conditions
of their intended use.
B. Elements of the GRAS Standard
Importantly, under section 201(s) of the act, it is the use of a
substance, rather than the substance itself, that is eligible for the
GRAS exemption. FDA has defined ``safe'' as a reasonable certainty in
the minds of competent scientists that the substance is not harmful
under its intended conditions of use (21 CFR 570.3(i)). Current Sec.
570.30(b) (21 CFR 570.30(b)) provides that general recognition of
safety based on scientific procedures requires the same quantity and
quality of scientific evidence as is required to obtain approval of a
food additive regulation for the substance. The requirement for
scientific evidence of safety is referred to in this document as the
``technical element'' of safety. While a determination that a food
additive is safe requires technical evidence of safety, a determination
that a particular use of a substance is GRAS requires both technical
evidence of safety and a basis to conclude that this technical element
of safety is generally recognized. Such general recognition of safety
requires common knowledge about the substance throughout the scientific
community, so it is referred to in this document as the ``common
knowledge element'' of the GRAS standard.
The common knowledge element of the GRAS standard includes two
facets: (1) The data and information relied on to establish the
technical element, which must be of the same kind and quality as is
required to obtain FDA approval of the use of the substance, must be
generally available and (2) there must be a basis to conclude that
there is consensus among qualified experts about the safety of the
substance for its intended use. (See United States v. Western Serum
Co., Inc., 666 F.2d 335, 338 (9th Cir. 1982); United States v. Articles
of Drug * * * Promise Toothpaste, 624 F.Supp. 776, 778 (N.D. Ill.
1985), aff'd 826 F.2d 564 (7th Cir. 1987); United States v. Articles of
Drug * * * Hormonin, 498 F.Supp.2d 424, 435 (D.N.J. 1980)). None of the
facets by themselves are sufficient to satisfy the common knowledge
element of the GRAS standard.
The usual mechanism to establish that scientific information is
generally available is to show that the information is published in a
peer-reviewed scientific journal. However, mechanisms to establish the
basis for concluding that there is expert consensus about the safety of
a substance are more varied. In some cases, publication in a peer-
reviewed scientific journal of data (such as toxicity studies) on a
substance has been used to establish expert consensus in addition to
general availability. In other cases, such publication of data and
information in the primary scientific literature has been supplemented
by: (1) Publication of data and information in the secondary scientific
literature, such as scientific review articles, textbooks, and
compendia; (2) documentation of the opinion of an ``expert panel'' that
is specifically convened for this purpose; or (3) the opinion or
recommendation of an authoritative body such as the National Research
Council of the National Academy of Sciences on a broad or specific
issue that is related to a GRAS determination.
In this document, FDA is using the term ``consensus'' in discussing
the common knowledge element of the GRAS standard. Such consensus does
not require unanimity among qualified experts. (See United States v.
Articles of Drug * * * 5,906 Boxes, 745 F.2d 105, 119 n. 22 (1st Cir.
1984); United States v. An Article of Drug * * * 4,680 Pails, 725 F.2d
976, 990 (5th Cir. 1984); Coli-Trol 80, supra, 518 F.2d at 746; Promise
Toothpaste, supra, 624 F.Supp. at 782).
A substance used in food prior to January 1, 1958, may be shown to
be GRAS for an intended use through scientific procedures or through
experience based on common use in food. Current Sec. 570.30(c) (21 CFR
570.30(c)) provides that general recognition of safety through
experience based on common use in food prior to January 1, 1958, may be
determined without the quantity or quality of scientific procedures
required for approval of a food additive regulation. Current Sec.
570.3(f) defines ``common use in food'' as a substantial history of
consumption for food use by a significant number of animals in the
United States.
C. History of FDA's Approach to the GRAS Exemption
Shortly after passage of the 1958 amendment, FDA clarified the
regulatory status of a multitude of food substances that were used in
food prior to 1958 and amended its regulations to include a list of
food substances that, when used for the purposes indicated and in
accordance with current good manufacturing practices, are GRAS. This
GRAS list was incorporated into the agency's regulations as Sec.
121.101(d) (now parts 182 and 582 (21 CFR parts 182 and 582)) (24 FR
9368, November 20, 1959). As part of that rulemaking, however, FDA
acknowledged that it would be impracticable to list all substances that
are GRAS for their intended use.
In 1970, FDA announced that it was undertaking a comprehensive
agency review of substances listed as GRAS (35 FR 18623, December 8,
1970). In the notice announcing this review, FDA proposed criteria that
could be used to establish whether these substances should continue to
be listed as GRAS, become the subject of a food additive regulation, or
become the subject of an interim food additive regulation pending
completion of additional studies. These criteria were incorporated into
the agency's regulations in 21 CFR 121.3 (precursor of current 21 CFR
570.30) (36 FR 12093, June 25, 1971). FDA subsequently codified
procedures for the agency to affirm, on its own, the GRAS status of
substances found to satisfy these criteria (Sec. 570.35(a) and (b) (21
CFR 570.35(a) and (b))). Because the GRAS review did not cover all GRAS
substances (e.g., it did not cover many substances that were marketed
based on a manufacturer's independent GRAS determination), that
rulemaking included a mechanism (the GRAS petition process currently
codified in Sec. 570.35(c)) whereby an individual could petition FDA
to review the GRAS status of substances (37 FR 25705, December 2,
1972).
D. The 1997 Proposed Rule
In the Federal Register of April 17, 1997 (62 FR 18938) (the 1997
proposed rule), FDA published a proposed rule that would replace this
voluntary GRAS affirmation petition process in Sec. Sec. 170.35(c) (21
CFR 170.35(c)) and 570.35(c) with a voluntary notification procedure
whereby any person may notify FDA of a determination that a particular
use of a substance in human food (proposed Sec. 170.36) or in animal
food (proposed Sec. 570.36) is GRAS.
FDA tentatively concluded in the 1997 proposed rule that the
proposed notification procedure has advantages over the current
petition process because the resource-intensive rulemaking that is
associated with a petition would be eliminated. This streamlining would
allow FDA to redirect its resources to questions about GRAS status that
are a priority with respect to public health protection. In addition,
the proposed notice is simpler than a GRAS affirmation petition and
therefore conceivably would provide an incentive for manufacturers to
inform FDA of their GRAS determinations. This would result in increased
agency awareness of the composition of the nation's food supply and the
cumulative
[[Page 31802]]
dietary exposure to GRAS substances. FDA also tentatively concluded in
the 1997 proposed rule that the public health would be better served if
some resources that are currently directed to the GRAS petition process
were redirected to the preparation of documents that would provide the
industry with guidance on certain food safety issues for complex
substances (e.g., macroingredients or biological polymers, such as
proteins, carbohydrates, and fats and oils). Finally, FDA tentatively
concluded that the reduction in resources devoted to the evaluation of
GRAS substances would allow FDA to shift resources to its statutorily
mandated task of reviewing food and color additive petitions (62 FR
18938 at 18941).
As part of the 1997 proposed rule, FDA announced an ``interim
policy'' whereby interested persons could begin immediately to submit
notifications of GRAS determinations (GRAS exemption claims) as
described in proposed Sec. 170.36(b) and (c) for substances used in
human food. FDA stated that, in general, FDA would administer the
notices as described in proposed Sec. 170.36(d) through (f) (i.e., FDA
would acknowledge receipt of the notice, respond in writing to the
notifier, and make publicly accessible a copy of all GRAS determination
claims and the agency's response). However, although FDA would make a
good faith effort to respond within the proposed 90-day timeframe, the
agency would not be bound by such a timeframe (62 FR 18938 at 18954).
As with the human food pilot program, the animal food pilot
program, which will be administered by FDA's Center for Veterinary
Medicine (CVM), will be based on the notification procedures announced
in the 1997 proposed rule. Additionally, CVM has consulted with the
Center for Food Safety and Applied Nutrition (CFSAN) and, where
applicable, made its administrative procedures consistent with CFSAN's.
Information about the CFSAN/GRAS notification program, including links
to the 1997 proposed rule and relevant guidance documents, may be found
at CFSAN's GRAS Web page: https://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/default.htm.
II. Description of the CVM Pilot Program
FDA is implementing a voluntary pilot program to accept submission
of notices of claims that a particular use of a substance in food for
animals is exempt from the statutory premarket approval requirements
based on the notifier's determination that such use is GRAS (notices of
GRAS determination). FDA will accept notices of GRAS determination from
all interested persons beginning immediately. However, FDA strongly
encourages potential participants in the animal food pilot program to
contact the Division of Animal Feeds (see ADDRESSES) prior to
submitting notices to discuss their submission plans.
In general, the agency will implement the pilot program for
substances added to animal food in the same manner as the interim
policy for substances added to human food and as described in section
VIII of the 1997 proposed rule (62 FR 18938 at 18954 through 18955).
FDA invites interested persons who determine that a particular use of a
substance in animal food is GRAS to notify FDA of such GRAS
determination as described in section III of this document (see also
proposed Sec. 570.36(b) and (c) of the 1997 proposed rule.)
III. How to Participate in the Pilot
Any person may notify FDA of a claim that a particular use of a
substance is exempt from the statutory premarket approval requirements
based on the notifier's determination that such use is GRAS. Notifiers
should submit triplicate copies of their notices of GRAS determination
to the Division of Animal Feeds (HFV-224), Office of Surveillance and
Compliance, Center for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855. Notifiers
should submit the following information:
A claim, dated and signed by the notifier, or by the
notifier's attorney or agent, or (if the notifier is a corporation) by
an authorized official, that a particular use of a substance is exempt
from the premarket approval requirements of the act because the
notifier has determined that such use is GRAS. Such a claim should
include:
[cir] The name and address of the notifier;
[cir] The common or usual name of the substance that is the subject
of the GRAS determination claim (i.e., the ``notified substance'');
[cir] The applicable conditions of use of the notified substance,
including the foods in which the substance is to be used, levels of use
in such foods, and the purposes for which the substance is used,
including, when appropriate, a description of the population (including
the specific animal species) expected to consume the substance;
[cir] The basis for the GRAS determination (i.e., through
scientific procedures or through experience based on common use in
food); and
[cir] A statement that the data and information that are the basis
for the notifier's GRAS determination are available for FDA's review
and copying at reasonable times at a specific address set out in the
notice and will be sent to FDA upon request.
Detailed information about the identity of the notified
substance, including, as applicable, its chemical name, Chemical
Abstracts Service (CAS) Registry Number, Enzyme Commission number,
empirical formula, structural formula, quantitative composition, method
of manufacture (excluding any trade secrets and including, for
substances of natural biological origin, source information such as
genus and species), characteristic properties, any content of potential
human or animal toxicants, and specifications for feed-grade material;
Information on any self-limiting levels of use; and
A detailed summary of the basis for the notifier's
determination that a particular use of the notified substance is exempt
from the premarket approval requirements of the act because such use is
GRAS. Such determination may be based either on scientific procedures
or on common use in food.
[cir] For a GRAS determination through scientific procedures, such
summary should include:
--A comprehensive discussion of, and citations to, generally
available and accepted scientific data, information, methods, or
principles that the notifier relies on to establish safety, including a
consideration of the probable consumption of the substance and the
probable consumption of any substance formed in or on food because of
its use and the cumulative effect of the substance in the diet, taking
into account any chemically or pharmacologically related substances in
such diet. Where a substance is intended for use in the food of an
animal used to produce human food, this should include a comprehensive
discussion of, and citations to, generally accepted scientific data,
information, methods, or principles about both safety to the target
animal and human food safety. The scientific data, information,
methods, or principles provided should be sufficient to show that the
substance is generally recognized among qualified experts to be safe
for animals consuming food containing the substance as well as to
humans consuming food derived from such animals (i.e., under its
intended conditions of use);
--A comprehensive discussion of any reports of investigations or
other information that may appear to be
[[Page 31803]]
inconsistent with the GRAS determination; and
--The basis for concluding, in light of the data and information
submitted, that there is consensus among experts qualified by
scientific training and experience to evaluate the safety of substances
added to food that there is reasonable certainty that the substance is
not harmful under the intended conditions of use.
[cir] For a GRAS determination through experience based on common
use in food, such summary should include:
--A comprehensive discussion of, and citations to, generally
available data and information that the notifier relies on to establish
safety, including documented evidence of a substantial history of
consumption of the substance by a significant number of animals. Where
a substance is intended for use in the food of an animal used to
produce human food, this should include a comprehensive discussion of,
and citations to, generally accepted scientific data, information,
methods, or principles about both safety to the target animal and human
food safety. The scientific data, information, methods, or principles
provided should be sufficient to show that the substance is generally
recognized among qualified experts to be safe for animals consuming
food containing the substance as well as to humans consuming food
derived from such animals (i.e., under its intended conditions of use);
--A comprehensive discussion of any reports of investigations or
other information that may appear to be inconsistent with the GRAS
determination;
--The basis for concluding, in light of the data and information
submitted, that there is consensus among experts qualified by
scientific training and experience to evaluate the safety of substances
added to food that there is reasonable certainty that the substance is
not harmful under the intended conditions of use.
IV. How FDA Will Administer Notices Under the Pilot Program
In general, the agency will administer the notices under the pilot
program as described in proposed Sec. 570.36(d) through (f) of the
1997 proposed rule, as follows:
1. Within 30 days of receipt of the notice, FDA intends to
acknowledge receipt of the notice by informing the notifier in writing.
2. Under the 1997 proposed rule, FDA would respond to the notifier
in writing within 90 days of receipt of the notice either that the
notice provides a sufficient basis for the GRAS determination or that
FDA has identified questions as to whether the intended use of the
substance is GRAS. Due to resource limitations in the animal food
program, it is unlikely that CVM will be able to evaluate and respond
to notices within the 90-day timeframe contained in the 1997 proposed
rule. CVM will therefore respond to notifications of GRAS
determinations in its pilot program as quickly as resources permit.
Any GRAS determination claim submitted as part of the
pilot program shall be immediately available for public disclosure on
the date the notice is received. All remaining data and information in
the notice shall be available for public disclosure, in accordance with
21 CFR part 20, on the date the notice is received.
For each notice of GRAS determination submitted under the
pilot program, the following information shall be readily accessible
for public review and copying:
[cir] A copy of the submitted GRAS determination claim,
[cir] A copy of any letter issued by the agency, as described in
paragraph 2 of this section.
[cir] A copy of any subsequent letter issued by the agency
regarding such notice.
V. Paperwork Reduction Act of 1995
The collections of information in this notice are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520), and have been previously
approved by OMB. OMB originally approved Paperwork Reduction Act (PRA)
burdens for GRAS notification under the 1997 proposed rule under OMB
control number 0910-0342. The original OMB approval covered the
collections of information in both proposed 21 CFR 170.36 and 570.36;
however, only CFSAN operated a GRAS notification program for human food
under the original OMB PRA approval. Extension of the original OMB PRA
approval for GRAS notification was granted by OMB on August 24, 2009,
under OMB control number 0910-0342.
As with the human food GRAS notification program administered by
CFSAN, which has operated for several years, the animal food pilot
program, which will be administered by CVM, will be based on the
notification procedures announced in the 1997 proposed rule. The
provisions for GRAS notification under proposed Sec. Sec. 170.36 and
570.36 for human and animal food, respectively, are virtually identical
and therefore the same number of hours per response were estimated for
reporting (150 hours) and recordkeeping (15 hours per record) burdens
for both proposed sections under the original and extended OMB PRA
approvals. Because CFSAN's GRAS program has successfully operated under
these PRA estimates for several years, FDA believes these burden
estimates remain accurate for CVM's GRAS pilot program.
FDA's estimate of the annual number of GRAS determination notices
that will be received by CVM in the extended OMB PRA approval (5) was
revised downward from the original PRA approval (10). This revision was
based on the actual number of GRAS notices received by CFSAN from 1998
to 2008, which was lower than anticipated and caused CFSAN to also
revise downward its estimate in the extended PRA approval. The revised
estimate in the extended PRA approval reflects FDA's best judgment at
this time as to the number of notices CVM will receive annually through
this pilot program.
CVM believes that the PRA estimates in the extended PRA approval
cover CVM's GRAS notice program.
Dated: May 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13464 Filed 6-3-10; 8:45 am]
BILLING CODE 4160-01-S