DEFINITIONS AND STANDARDS FOR ANIMAL FOOD

[Title 21 CFR 564]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)]
[Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS]
[Part 564 - DEFINITIONS AND STANDARDS FOR ANIMAL FOOD]
[From the U.S. Government Publishing Office]

21
FOOD AND DRUGS
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1996-04-01
1996-04-01
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DEFINITIONS AND STANDARDS FOR ANIMAL FOOD
564
PART 564

FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 564--DEFINITIONS AND STANDARDS FOR ANIMAL FOOD--Table of Contents

Subpart A--General Provisions

Sec.
564.3 Definitions and interpretations.
564.5 Procedure for establishing a food standard.
564.6 Review of Codex Alimentarius Food Standards.
564.8 Conformity to definitions and standards of identity.
564.12 General methods for water capacity and fill of container.
564.14 General statements of substandard quality and substandard fill
of container.
564.17 Temporary permits for interstate shipment of experimental packs
of food varying from the requirements of definitions and
standards of identity.

Subpart B--Food Additives in Standardized Animal Food

564.20 Food additives proposed for use in animal foods for which
definitions and standards of identity are established.

Authority: Secs. 401, 403, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341, 343, 371).

Source: 41 FR 38641, Sept. 10, 1976, unless otherwise noted.

Subpart A--General Provisions

Sec. 564.3 Definitions and interpretations.

(a) The definitions and interpretations of terms contained in
section 201 of the Federal Food, Drug, and Cosmetic Act shall be
applicable also to such terms when used in regulations promulgated under
the act.
(b) If a regulation prescribing a definition and standard of
identity for a food has been promulgated under section 401 of the act
and the name therein specified for the food is used in any other
regulation under section 401 or any other provision of the act, such
name means the food which conforms to such definition and standard,
except as otherwise specifically provided in such other regulation.
(c) No provision of any regulation prescribing a definition and
standard of identity or standard of quality or fill of container under
section 401 of the act shall be construed as in any way affecting the
concurrent applicability of the general provisions of the act and the
regulations thereunder relating to adulteration and misbranding. For
example, all regulations under section 401 of the act contemplate that
the food and all articles used as components or ingredients thereof
shall not be poisonous or deleterious and shall be clean, sound, and fit
for food. A provision in such regulations for the use of coloring or
flavoring does not authorize such use under circumstances or in a manner
whereby damage or inferiority is concealed or whereby the food is made
to appear better or of greater value than it is.
(d) Safe and suitable means that the ingredient:
(1) Performs an appropriate function in the food in which it is
used.
(2) Is used at a level no higher than necessary to achieve its
intended purpose in that food.
(3) Is not a food additive or color additive as defined in section
201 (s) or (t) of the act as used in that food, or is a food additive or
color additive as so defined and is used in conformity with regulations
established pursuant to section 409 or 721 of the act.

Sec. 564.5 Procedure for establishing a food standard.

(a) The procedure for establishing a food standard under section 401
of the act shall be governed by part 10 of this chapter.
(b) Any petition for a food standard shall show that the proposal,
if adopted, would promote honesty and fair dealing in the interest of
consumers.
(c) Any petition for a food standard shall assert that the
petitioner commits himself to substantiate the information in the
petition by evidence in a public hearing, if such a hearing becomes
necessary.
(d) If a petitioner fails to appear, or to substantiate the
information in his petition, at a public hearing on the matter, the
Commissioner may either (1) withdraw the regulation and terminate the
proceeding or (2) if he concludes that it is in accordance with the
requirements of section 401 of the act, continue the proceeding and
introduce evidence to substantiate such information.

[42 FR 4717, Jan. 25, 1977, as amended at 42 FR 15675, Mar. 22, 1977]

[[Page 485]]

Sec. 564.6 Review of Codex Alimentarius Food Standards.

(a) All food standards adopted by the Codex Alimentarius Commission
will be reviewed by the Food and Drug Administration and will be
accepted without change, accepted with change, or not accepted.
(b) Review of Codex standards will be accomplished in one of the
following three ways:
(1) Any interested person may petition the Commissioner to adopt a
Codex standard, with or without change, by proposing a new standard or
an appropriate amendment of an existing standard, pursuant to section
401 of the act. Any such petition shall specify any deviations from the
Codex standard, and the reasons for any such deviations. The
Commissioner shall publish such a petition in the Federal Register as a
proposal, with an opportunity for comment, if reasonable grounds are
provided in the petition. Any published proposal shall state any
deviations from the Codex standard and the stated reasons therefor.
(2) The Commissioner may on his own initiative propose by
publication in the Federal Register the adoption of a Codex standard,
with or without change, through a new standard or an appropriate
amendment to an existing standard, pursuant to section 401 of the act.
Any such proposal shall specify any deviations from the Codex standard,
and the reasons for any such deviations.
(3) Any Codex standard not handled under paragraph (b) (1) or (2) of
this section may be published in the Federal Register for review and
informal comment. Interested persons shall be requested to comment on
the desirability and need for the standard, on the specific provisions
of the standard, on additional or different provisions that should be
included in the standard, and on any other pertinent points. After
reviewing all such comments, the Commissioner either shall publish a
proposal to establish a food standard pursuant to section 401 of the act
covering the food involved, or shall publish a notice terminating
consideration of such a standard.
(c) All interested persons are encouraged to confer with different
interest groups (consumers, industry, the academic community,
professional organizations, and others) in formulating petitions or
comments pursuant to paragraph (b) of this section. All such petitions
or comments are requested to include a statement of any meetings and
discussions that have been held with other interest groups. Appropriate
weight will be given by the Commissioner to petitions or comments that
reflect a consensus of different interest groups.

Sec. 564.8 Conformity to definitions and standards of identity.

In the following conditions, among others, a food does not conform
to the definition and standard of identity therefor:
(a) If it contains an ingredient for which no provision is made in
such definition and standard, unless such ingredient is an incidental
additive introduced at a nonfunctional and insignificant level as a
result of its deliberate and purposeful addition to another ingredient
permitted by the terms of the applicable standard and the presence of
such incidental additive in unstandardized foods has been exempted from
label declaration as provided in Sec. 501.100 of this chapter.
(b) If it fails to contain any one or more ingredients required by
such definition and standard;
(c) If the quantity of any ingredient or component fails to conform
to the limitation, if any, prescribed therefor by such definition and
standard.

Sec. 564.12 General methods for water capacity and fill of container.

For the purposes of regulations promulgated under section 401 of the
act:
(a) The term general method for water capacity of containers means
the following method:
(1) In the case of a container with lid attached by double seam, cut
out the lid without removing or altering the height of the double seam.
(2) Wash, dry, and weigh the empty container.
(3) Fill the container with distilled water at 68 deg. F to \3/16\
inch vertical distance below the top level of the container, and weigh
the container thus filled.

[[Page 486]]

(4) Subtract the weight found in paragraph (a)(2) of this section
from the weight found in paragraph (a)(3) of this section. The
difference shall be considered to be the weight of water required to
fill the container.

In the case of a container with lid attached otherwise than by double
seam, remove the lid and proceed as directed in paragraph (a)(2) to (4)
of this section, except that under paragraph (a)(3) of this section,
fill the container to the level of the top thereof.
(b) The term general method for fill of containers means the
following method:
(1) In the case of a container with lid attached by double seam, cut
out the lid without removing or altering the height of the double seam.
(2) Measure the vertical distance from the top level of the
container to the top level of the food.
(3) Remove the food from the container; wash, dry, and weigh the
container.
(4) Fill the container with water to \3/16\ inch vertical distance
below the top level of the container. Record the temperature of the
water, weigh the container thus filled, and determine the weight of the
water by subtracting the weight of the container found in paragraph
(b)(3) of this section.
(5) Maintaining the water at the temperature recorded in paragraph
(b)(4) of this section, draw off water from the container as filled in
paragraph (b)(4) of this section to the level of the food found in
paragraph (b)(2) of this section, weigh the container with remaining
water, and determine the weight of the remaining water by subtracting
the weight of the container found in paragraph (b)(3) of this section.
(6) Divide the weight of water found in paragraph (b)(5) of this
section by the weight of water found in paragraph (b)(4) of this
section, and multiply by 100. The result shall be considered to be the
percent of the total capacity of the container occupied by the food.

In the case of a container with lid attached otherwise than by double
seam, remove the lid and proceed as directed in paragraph (b)(2) to (6)
of this section, except that under paragraph (b)(4) of this section,
fill the container to the level of the top thereof.

Sec. 564.14 General statements of substandard quality and substandard fill of container.

For the purposes of regulations promulgated under section 401 of the
act:
(a) The term general statement of substandard quality means the
statement ``Below Standard in Quality Good Food--Not High Grade''
printed in two lines of Cheltenham bold condensed caps. The words
``Below Standard in Quality'' constitute the first line, and the second
immediately follows. If the quantity of the contents of the container is
less than 1 pound, the type of the first line is 12-point and of the
second, 8-point. If such quantity is 1 pound or more, the type of the
first line is 14-point, and of the second, 10-point. Such statement is
enclosed within lines, not less than 6 points in width, forming a
rectangle. Such statement, with enclosing lines, is on a strongly
contrasting, uniform background, and is so placed as to be easily seen
when the name of the food or any pictorial representation thereof is
viewed, wherever such name or representation appears so conspicuously as
to be easily seen under customary conditions of purchase.
(b) The term general statement of substandard fill means the
statement ``Below Standard in Fill'' printed in Cheltenham bold
condensed caps. If the quantity of the contents of the container is less
than 1 pound, the statement is in 12-point type; if such quantity is 1
pound or more, the statement is in 14-point type. Such statement is
enclosed within lines, not less than 6 points in width, forming a
rectangle; but if the statement specified in paragraph (a) of this
section is also used, both statements (one following the other) may be
enclosed within the same rectangle. Such statement or statements, with
enclosing lines, are on a strongly contrasting, uniform background, and
are so placed as to be easily seen when the name of the food or any
pictorial representation thereof is viewed, wherever such name or
representation appears so conspicuously as to be easily seen under
customary conditions of purchase.

[[Page 487]]

Sec. 564.17 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity.

(a) The Food and Drug Administration recognizes that before
petitions to amend food standards can be submitted, appropriate
investigations of potential advances in food technology sometimes
require tests in interstate markets of the advantages to and acceptance
by consumers of experimental packs of food varying from applicable
definitions and standards of identity prescribed under section 401 of
the act.
(b) It is the purpose of the Administration to permit such tests
when it can be ascertained that the sole purpose of the tests is to
obtain data necessary for reasonable grounds in support of a petition to
amend food standards, that the tests are necessary to the completion or
conclusiveness of an otherwise adequate investigation, and that the
interests of consumers are adequately safeguarded; permits for such
tests shall normally be for a period not to exceed 15 months. The
Commissioner, for good cause shown by the applicant, may provide for a
longer test market period. The Administration will therefore refrain
from recommending regulatory proceedings under the act on the charge
that a food does not conform to an applicable standard, if the person
who introduces or causes the introduction of the food into interstate
commerce holds an effective permit from the Commissioner providing
specifically for those variations in respect to which the food fails to
conform to the applicable definition and standard of identity. The test
period will begin on the date the person holding an effective permit
from the Commissioner introduces or causes the introduction of the food
covered by the permit into interstate commerce but no later than 3
months after notice of the issuance of the permit is published in the
Federal Register. The Commissioner shall be notified in writing of the
date on which the test period begins as soon as it is determined.
(c) Any person desiring a permit may file with the Commissioner a
written application in triplicate containing as part thereof the
following:
(1) Name and address of the applicant.
(2) A statement of whether or not the applicant is regularly engaged
in producing the food involved.
(3) A reference to the applicable definition and standard of
identity (citing applicable section of regulations).
(4) A full description of the proposed variation from the standard.
(5) The basis upon which the food so varying is believed to be
wholesome and nondeleterious.
(6) The amount of any new ingredient to be added; the amount of any
ingredient, required by the standard, to be eliminated; any change of
concentration not contemplated by the standard; or any change in name
that would more appropriately describe the new product under test. If
such new ingredient is not a commonly known food ingredient, a
description of its properties and basis for concluding that it is not a
deleterious substance.
(7) The purpose of effecting the variation.
(8) A statement of how the variation is of potential advantage to
consumers. The statement shall include the reasons why the applicant
does not consider the data obtained in any prior investigations which
may have been conducted sufficient to support a petition to amend the
standard.
(9) The proposed label (or an accurate draft) to be used on the food
to be market tested. The label shall conform in all respects to the
general requirements of the act and shall provide a means whereby the
consumer can distinguish between the food being tested and such food
complying with the standard.
(10) The period during which the applicant desires to introduce such
food into interstate commerce, with a statement of the reasons
supporting the need for such period. If a period longer than 15 months
is requested, a detailed explanation of why a 15-month period is
inadequate shall be provided.
(11) The probable amount of such food that will be distributed. The
amount distributed should be limited to the smallest number of units
reasonably required for a bona fide market test. Justification for the
amount requested shall be included.

[[Page 488]]

(12) The areas of distribution.
(13) The address at which such food will be manufactured.
(14) A statement of whether or not such food has been or is to be
distributed in the State in which it was manufactured.
(15) If it has not been or is not to be so distributed, a statement
showing why.
(16) If it has been or is to be so distributed, a statement of why
it is deemed necessary to distribute such food in other States.
(d) The Commissioner may require the applicant to furnish samples of
the food varying from the standard and to furnish such additional
information as may be deemed necessary for action on the application.
(e) If the Commissioner concludes that the variation may be
advantageous to consumers and will not result in failure of the food to
conform to any provision of the act except section 403(g), a permit
shall be issued to the applicant for interstate shipment of such food.
The terms and conditions of the permit shall be those set forth in the
application with such modifications, restrictions, or qualifications as
the Commissioner may deem necessary and state in the permit.
(f) The terms and conditions of the permit may be modified at the
discretion of the Commissioner or upon application of the permittee
during the effective period of the permit.
(g) The Commissioner may revoke a permit for cause, which shall
include but not be limited to the following:
(1) That the permittee has introduced a food into interstate
commerce contrary to the terms and conditions of the permit.
(2) That the application for a permit contains an untrue statement
of a material fact.
(3) That the need therefor no longer exists.
(h) During the period within which any permit is effective, it shall
be deemed to be included within the terms of any guaranty or undertaking
otherwise effective pursuant to the provisions of section 303(c) of the
act.
(i) If an application is made for an extension of the permit, it
shall be accompanied by a description of experiments conducted under the
permit, tentative conclusions reached, and reasons why further
experimental shipments are considered necessary. The application for an
extension shall be filed not later than 3 months prior to the expiration
date of the permit and shall be accompanied by a petition to amend the
affected food standard. If the Commissioner concludes that it will be in
the interest of consumers to issue an extension of the time period for
the market test, a notice will be published in the Federal Register
stating that fact. The notice will include an invitation to all
interested persons to participate in the market test under the same
conditions that applied to the initial permit holder, including labeling
and the amount to be distributed, except that the designated area of
distribution shall not apply. The extended market test period shall not
begin prior to the publication of a notice in the Federal Register
granting the extension and shall terminate either on the effective date
of an affirmative order ruling on the proposal or 30 days after a
negative order ruling on the proposal, whichever the case may be. Any
interested person who accepts the invitation to participate in the
extended market test shall notify the Commissioner in writing of that
fact, the amount to be distributed, and the area of distribution; and
along with such notification, he shall submit the labeling under which
the food is to be distributed.
(j) Notice of the granting or revocation of any permit shall be
published in the Federal Register.
(k) All applications for a temporary permit, applications for an
extension of a temporary permit, and related records are available for
public disclosure when the notice of a permit or extension thereof is
published in the Federal Register. Such disclosure shall be in
accordance with the rules established in part 20 of this chapter.
(l) Any person who contests denial, modification, or revocation of a
temporary permit shall have an opportunity for a regulatory hearing
before

[[Page 489]]

the Food and Drug Administration pursuant to part 16 of this chapter.

[41 FR 38641, Sept. 10, 1976, as amended at 42 FR 4717, Jan. 25, 1977;
42 FR 15675, Mar. 22, 1977; 54 FR 18281, Apr. 28, 1989]

Subpart B--Food Additives in Standardized Animal Food

Sec. 564.20 Food additives proposed for use in animal foods for which definitions and standards of identity are established.

(a) Where a petition is received for the issuance or amendment of a
regulation establishing a definition and standard of identity for a food
under section 401 of the act, which proposes the inclusion of a food
additive in such definition and standard of identity, the provisions of
the regulations in this subchapter E shall apply with respect to the
information that must be submitted with respect to the food additive.
Since section 409(b)(5) of the act requires that the Commissioner
publish notice of a petition for the establishment of a food-additive
regulation within 30 days after filing, notice of a petition relating to
a definition and standard of identity shall also be published within
that time limitation if it includes a request, so designated, for the
establishment of a regulation pertaining to a food additive.
(b) If a petition for a definition and standard of identity contains
a proposal for a food-additive regulation, and the petitioner fails to
designate it as such, the Commissioner, upon determining that the
petition includes a proposal for a food-additive regulation, shall so
notify the petitioner and shall thereafter proceed in accordance with
the regulations in this Subchapter E.