[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR171.1]
 
[Page 24-28]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                          SERVICES (CONTINUED)
 
PART 171_FOOD ADDITIVE PETITIONS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 171.1  Petitions.
    (a) Petitions to be filed with the Commissioner under the provisions
of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act)
shall be submitted in triplicate (quadruplicate, if intended uses
include use in meat, meat food product, or poultry product). If any part
of the material submitted is in a foreign language, it shall be
accompanied by an accurate and complete English translation. The
petition shall state petitioner's post office address to which published
notices or orders issued or objections filed pursuant to section 409 of
the Act may be sent.
    (b) Pertinent information may be incorporated in, and will be
considered as
 
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part of, a petition on the basis of specific reference to such
information submitted to and retained in the files of the Food and Drug
Administration. However, any reference to unpublished information
furnished by a person other than the applicant will not be considered
unless use of such information is authorized in a written statement
signed by the person who submitted it. Any reference to published
information offered in support of a food additive petition should be
accompanied by reprints or photostatic copies of such references.
    (c) Petitions shall include the following data and be submitted in
the following form:
 
                                                                  (Date)
Name of petitioner______________________________________________________
Post-office address_____________________________________________________
Date____________________________________________________________________
Name of food additive and proposed use__________________________________
________________________________________________________________________
 
Petitions Control Branch
Food and Drug Administration
Department of Health and Human Services
Washington, DC 20204.
 
Dear Sirs:
    The undersigned, ---------- submits this petition pursuant to
section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with
respect to ----------
 
(Name of the food additive and proposed use)
 
    Attached hereto, in triplicate (quadruplicate, if intended uses
include use in meat, meat food product, or poultry product), and
constituting a part of this petition are the following:
    A. The name and all pertinent information concerning the food
additive, including chemical identity and composition of the food
additive, its physical, chemical, and biological properties, and
specifications prescribing the minimum content of the desired
component(s) and identifying and limiting the reaction byproducts and
other impurities. Where such information is not available, a statement
as to the reasons why it is not should be submitted.
    When the chemical identity and composition of the food additive is
not known, the petition shall contain information in sufficient detail
to permit evaluation regarding the method of manufacture and the
analytical controls used during the various stages of manufacturing,
processing, or packing of the food additive which are relied upon to
establish that it is a substance of reproducible composition.
Alternative methods and controls and variations in methods and controls
within reasonable limits that do not affect the characteristics of the
substance or the reliability of the controls may be specified.
    If the food additive is a mixture of chemicals, the petition shall
supply a list of all substances used in the synthesis, extraction, or
other method of preparation, regardless of whether they undergo chemical
change in the process. Each substance should be identified by its common
English name and complete chemical name, using structural formulas when
necessary for specific identification. If any proprietary preparation is
used as a component, the proprietary name should be followed by a
complete quantitative statement of composition. Reasonable alternatives
for any listed substance may be specified.
    If the petitioner does not himself perform all the manufacturing,
processing, and packing operations for a food additive, the petition
shall identify each person who will perform a part of such operations
and designate the part.
    The petition shall include stability data, and, if the data indicate
that it is needed to insure the identity, strength, quality, or purity
of the additive, the expiration date that will be employed.
    B. The amount of the food additive proposed for use and the purposes
for which it is proposed, together with all directions, recommendations,
and suggestions regarding the proposed use, as well as specimens of the
labeling proposed for the food additive and any labeling that will be
required by applicable provisions of the Federal Food, Drug, and
Cosmetic Act on the finished food by reason of the use of the food
additive. If the additive results or may reasonably be expected to
result from the use of packaging material, the petitioner shall show how
this may occur and what residues may reasonably be anticipated.
    (Typewritten or other draft-labeling copy will be accepted for
consideration of the petition, provided a statement is made that final
printed labeling identical in content to the draft copy will be
submitted as soon as available and prior to the marketing of the food
additive.)
    (If the food additive is one for which a tolerance limitation is
required to assure its safety, the level of use proposed should be no
higher than the amount reasonably required to accomplish the intended
physical or other technical effect, even though the safety data may
support a higher tolerance.)
    C. Data establishing that the food additive will have the intended
physical or other technical effect or that it may reasonably be expected
to become a component, or to affect the characteristics, directly or
indirectly, of food and the amount necessary to accomplish this. These
data should include information in sufficient detail to permit
evaluation with control data.
 
[[Page 26]]
 
    D. A description of practicable methods to determine the amount of
the food additive in the raw, processed, and/or finished food and of any
substance formed in or on such food because of its use. The test
proposed shall be one that can be used for food-control purposes and
that can be applied with consistent results by any properly equipped and
trained laboratory personnel.
    E. Full reports of investigations made with respect to the safety of
the food additive.
    (A petition may be regarded as incomplete unless it includes full
reports of adequate tests reasonably applicable to show whether or not
the food additive will be safe for its intended use. The reports
ordinarily should include detailed data derived from appropriate animal
and other biological experiments in which the methods used and the
results obtained are clearly set forth. The petition shall not omit
without explanation any reports of investigations that would bias an
evaluation of the safety of the food additive.)
    F. Proposed tolerances for the food additive, if tolerances are
required in order to insure its safety. A petitioner may include a
proposed regulation.
    G. If submitting petition to modify an existing regulation issued
pursuant to section 409(c)(1)(A) of the Act, full information on each
proposed change that is to be made in the original regulation must be
submitted. The petition may omit statements made in the original
petition concerning which no change is proposed. A supplemental petition
must be submitted for any change beyond the variations provided for in
the original petition and the regulation issued on the basis of the
original petition.
    H. The petitioner is required to submit either a claim for
categorical exclusion under Sec. 25.30 or 25.32 of this chapter or an
environmental assessment under Sec. 25.40 of this chapter.
 
Yours very truly,
Petitioner______________________________________________________________
By______________________________________________________________________
                                                    (Indicate authority)
 
    (d) The petitioner will be notified of the date on which his
petition is filed; and an incomplete petition, or one that has not been
submitted in triplicate, will usually be retained but not filed as a
petition under section 409 of the Act. The petitioner will be notified
in what respects his petition is incomplete.
    (e) The petition must be signed by the petitioner or by his attorney
or agent, or (if a corporation) by an authorized official.
    (f) The data specified under the several lettered headings should be
submitted on separate sheets or sets of sheets, suitably identified. If
such data have already been submitted with an earlier application, the
present petition may incorporate it by specific reference to the
earlier. If part of the data have been submitted by the manufacturer of
the food additive as a master file, the petitioner may refer to the
master file if and to the extent he obtains the manufacturer's written
permission to do so. The manufacturer may authorize specific reference
to the data without disclosure to the petitioner. Nothing herein shall
prevent reference to published data.
    (g) A petition shall be retained but shall not be filed if any of
the data prescribed by section 409(b) of the Act are lacking or are not
set forth so as to be readily understood.
    (h)(1) The following data and information in a food additive
petition are available for public disclosure, unless extraordinary
circumstances are shown, after the notice of filing of the petition is
published in the Federal Register or, if the petition is not promptly
filed because of deficiencies in it, after the petitioner is informed
that it will not be filed because of the deficiencies involved:
    (i) All safety and functionality data and information submitted with
or incorporated by reference in the petition.
    (ii) A protocol for a test or study, unless it is shown to fall
within the exemption established for trade secrets and confidential
commercial information in Sec. 20.61 of this chapter.
    (iii) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information, after deletion of:
    (a) Names and any information that would identify the person using
the product.
    (b) Names and any information that would identify any third party
involved with the report, such as a physician or hospital or other
institution.
    (iv) A list of all ingredients contained in a food additive, whether
or not it is in descending order of predominance. A particular
ingredient or group of ingredients shall be deleted from any such list
prior to public disclosure if it is shown to fall within the exemption
established in Sec. 20.61 of this chapter, and a notation shall be made
that any such ingredient list is incomplete.
 
[[Page 27]]
 
    (v) An assay method or other analytical method, unless it serves no
regulatory or compliance purpose and is shown to fall within the
exemption established in Sec. 20.61 of this chapter.
    (2) The following data and information in a food additive petition
are not available for public disclosure unless they have been previously
disclosed to the public as defined in Sec. 20.81 of this chapter or
they relate to a product or ingredient that has been abandoned and they
no longer represent a trade secret or confidential commercial or
financial information as defined in Sec. 20.61 of this chapter:
    (i) Manufacturing methods or processes, including quality control
procedures.
    (ii) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal data or
information which is not available for public disclosure under this
provision is available for public disclosure.
    (iii) Quantitative or semi quan ti ta tive formulas.
    (3) All correspondence and written summaries of oral discussions
relating to a food additive petition are available for public disclosure
in accordance with the provisions of part 20 of this chapter when the
food additive regulation is published in the Federal Register.
    (4) For purposes of this regulation, safety and functionality data
include all studies and tests of a food additive on animals and humans
and all studies and tests on a food additive for identity, stability,
purity, potency, performance, and usefulness.
    (i)(1)(i) Within 15 days after receipt, the Food and Drug
Administration will notify the petitioner of the acceptance or
nonacceptance of a petition, and if not accepted, the reasons therefor.
If accepted, the petitioner will be sent a letter stating this and the
date of the letter shall become the date of filing for the purposes of
section 409(b)(5) of the act. In cases in which the Food and Drug
Administration agrees that a premarket notification for a food contact
substance (Food Contact Notification (FCN)) submitted under section
409(h) of the act may be converted to a petition, the withdrawal date
for the FCN will be deemed the date of receipt for the petition.
    (ii) If the petitioner desires, he may supplement a deficient
petition after being notified regarding deficiencies. If the
supplementary material or explanation of the petition is deemed
acceptable, the petitioner shall be notified. The date of such
notification becomes the date of filing. If the petitioner does not wish
to supplement or explain the petition and requests in writing that it be
filed as submitted, the petition shall be filed and the petitioner so
notified.
    (iii) Notwithstanding paragraph (i)(1)(ii) of this section, the
petition shall not be filed if the Food and Drug Administration
determines that the use identified in the petition should be the subject
of an FCN under section 409(h) of the act rather than a petition.
    (2) The Commissioner will publish in the Federal Register within 30
days from the date of filing of such petition, a notice of the filing,
the name of the petitioner, and a brief description of the proposal in
general terms. In the case of a food additive which becomes a component
of food by migration from packaging material, the notice shall include
the name of the migratory substance, and where it is different from that
of one of the original components, the name of the parent component, the
maximum quantity of the migratory substance that is proposed for use in
food, and the physical or other technical effect which the migratory
substance or its parent component is intended to have in the packaging
material. A copy of the notice will be mailed to the petitioner when the
original is forwarded to the Federal Register for publication.
    (j) The Commissioner may request a full description of the methods
used in, and the facilities and controls used for, the production of the
food additive, or a sample of the food additive, articles used as
components thereof, or of the food in which the additive is proposed to
be used, at any time while a petition is under consideration. The
Commissioner shall specify in the request for a sample of the food
additive, or articles used as components thereof, or of the
 
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food in or on which the additive is proposed to be used, a quantity
deemed adequate to permit tests of analytical methods to determine
quantities of the food additive present in foods for which it is
intended to be used or adequate for any study or investigation
reasonably required with respect to the safety of the food additive or
the physical or technical effect it produces. The date used for
computing the 90-day limit for the purposes of section 409(c)(2) of the
Act shall be moved forward 1 day for each day after the mailing date of
the request taken by the petitioner to submit the sample. If the
information or sample is requested a reasonable time in advance of the
180 days, but is not submitted within such 180 days after filing of the
petition, the petition will be considered withdrawn without prejudice.
    (k) If nonclinical laboratory studies are involved, petitions filed
with the Commissioner under section 409(b) of the act shall include,
with respect to each nonclinical study contained in the petition, either
a statement that the study has been, or will be, conducted in compliance
with the good laboratory practice regulations as set forth in part 58 of
this chapter, or, if any such study was not conducted in compliance with
such regulations, a brief statement of the reason for the noncompliance.
    (l) [Reserved]
    (m) If clinical investigations involving human subjects are
involved, petitions filed with the Commissioner under section 409(b) of
the Act shall include statements regarding each such clinical
investigation relied upon in the petition that it either was conducted
in compliance with the requirements for institutional review set forth
in part 56 of this chapter, or was not subject to such requirements in
accordance with Sec. 56.104 or Sec. 56.105, and that it was conducted
in compliance with the requirements for informed consent set forth in
part 50 of this chapter.
    (n)(1) If intended uses of the food additive include uses in meat,
meat food product, or poultry product subject to regulation by the U.S.
Department of Agriculture (USDA) under the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition,
forward a copy of the petition or relevant portions thereof to the Food
Safety and Inspection Service, USDA, for simultaneous review under the
PPIA and FMIA.
    (2) FDA will ask USDA to advise whether the proposed meat and
poultry uses comply with the FMIA and PPIA, or if not, whether use of
the substance would be permitted in products under USDA jurisdiction
under specified conditions or restrictions.
 
[42 FR 14489, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977;
46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26,
1985; 62 FR 40599, July 29, 1997; 65 FR 51763, Aug. 25, 2000; 67 FR
35731, May 21, 2002]
 
    Effective Date Note: At 65 FR 51763, Aug. 25, 2000, Sec. 171.1 was
amended in paragraph (a) by revising the first sentence, in paragraph
(c) in the petition by revising the introductory paragraph preceding
paragraph A., and by adding paragraph (n). The revised and added text
contains information collection and recordkeeping requirements and will
not become effective until approval has been given by the Office of
Management and Budget.