21 U.S.C. § 348 : US Code - Section 348: Food additives

Search 21 U.S.C. § 348 : US Code - Section 348: Food additives

(a) Unsafe food additives; exception for conformity with exemption
or regulation
A food additive shall, with respect to any particular use or
intended use of such additives, be deemed to be unsafe for the
purposes of the application of clause (2)(C) of section 342(a) of
this title, unless -
(1) it and its use or intended use conform to the terms of an
exemption which is in effect pursuant to subsection (j) of this
section;
(2) there is in effect, and it and its use or intended use are
in conformity with, a regulation issued under this section
prescribing the conditions under which such additive may be
safely used; or
(3) in the case of a food additive as defined in this chapter
that is a food contact substance, there is -
(A) in effect, and such substance and the use of such
substance are in conformity with, a regulation issued under
this section prescribing the conditions under which such
additive may be safely used; or
(B) a notification submitted under subsection (h) of this
section that is effective.
While such a regulation relating to a food additive, or such a
notification under subsection (h)(1) of this section relating to a
food additive that is a food contact substance, is in effect, and
has not been revoked pursuant to subsection (i) of this section, a
food shall not, by reason of bearing or containing such a food
additive in accordance with the regulation or notification, be
considered adulterated under section 342(a)(1) of this title.
(b) Petition for regulation prescribing conditions of safe use;
contents; description of production methods and controls;
samples; notice of regulation
(1) Any person may, with respect to any intended use of a food
additive, file with the Secretary a petition proposing the issuance
of a regulation prescribing the conditions under which such
additive may be safely used.
(2) Such petition shall, in addition to any explanatory or
supporting data, contain -
(A) the name and all pertinent information concerning such food
additive, including, where available, its chemical identity and
composition;
(B) a statement of the conditions of the proposed use of such
additive, including all directions, recommendations, and
suggestions proposed for the use of such additive, and including
specimens of its proposed labeling;
(C) all relevant data bearing on the physical or other
technical effect such additive is intended to produce, and the
quantity of such additive required to produce such effect;
(D) a description of practicable methods for determining the
quantity of such additive in or on food, and any substance formed
in or on food, because of its use; and
(E) full reports of investigations made with respect to the
safety for use of such additive, including full information as to
the methods and controls used in conducting such investigations.
(3) Upon request of the Secretary, the petitioner shall furnish
(or, if the petitioner is not the manufacturer of such additive,
the petitioner shall have the manufacturer of such additive
furnish, without disclosure to the petitioner) a full description
of the methods used in, and the facilities and controls used for,
the production of such additive.
(4) Upon request of the Secretary, the petitioner shall furnish
samples of the food additive involved, or articles used as
components thereof, and of the food in or on which the additive is
proposed to be used.
(5) Notice of the regulation proposed by the petitioner shall be
published in general terms by the Secretary within thirty days
after filing.
(c) Approval or denial of petition; time for issuance of order;
evaluation of data; factors
(1) The Secretary shall -
(A) by order establish a regulation (whether or not in accord
with that proposed by the petitioner) prescribing, with respect
to one or more proposed uses of the food additive involved, the
conditions under which such additive may be safely used
(including, but not limited to, specifications as to the
particular food or classes of food in or in which such additive
may be used, the maximum quantity which may be used or permitted
to remain in or on such food, the manner in which such additive
may be added to or used in or on such food, and any directions or
other labeling or packaging requirements for such additive deemed
necessary by him to assure the safety of such use), and shall
notify the petitioner of such order and the reasons for such
action; or
(B) by order deny the petition, and shall notify the petitioner
of such order and of the reasons for such action.
(2) The order required by paragraph (1)(A) or (B) of this
subsection shall be issued within ninety days after the date of
filing of the petition, except that the Secretary may (prior to
such ninetieth day), by written notice to the petitioner, extend
such ninety-day period to such time (not more than one hundred and
eighty days after the date of filing of the petition) as the
Secretary deems necessary to enable him to study and investigate
the petition.
(3) No such regulation shall issue if a fair evaluation of the
data before the Secretary -
(A) fails to establish that the proposed use of the food
additive, under the conditions of use to be specified in the
regulation, will be safe: Provided, That no additive shall be
deemed to be safe if it is found to induce cancer when ingested
by man or animal, or if it is found, after tests which are
appropriate for the evaluation of the safety of food additives,
to induce cancer in man or animal, except that this proviso shall
not apply with respect to the use of a substance as an ingredient
of feed for animals which are raised for food production, if the
Secretary finds (i) that, under the conditions of use and feeding
specified in proposed labeling and reasonably certain to be
followed in practice, such additive will not adversely affect the
animals for which such feed is intended, and (ii) that no residue
of the additive will be found (by methods of examination
prescribed or approved by the Secretary by regulations, which
regulations shall not be subject to subsections (f) and (g) of
this section) in any edible portion of such animal after
slaughter or in any food yielded by or derived from the living
animal; or
(B) shows that the proposed use of the additive would promote
deception of the consumer in violation of this chapter or would
otherwise result in adulteration or in misbranding of food within
the meaning of this chapter.
(4) If, in the judgment of the Secretary, based upon a fair
evaluation of the data before him, a tolerance limitation is
required in order to assure that the proposed use of an additive
will be safe, the Secretary -
(A) shall not fix such tolerance limitation at a level higher
than he finds to be reasonably required to accomplish the
physical or other technical effect for which such additive is
intended; and
(B) shall not establish a regulation for such proposed use if
he finds upon a fair evaluation of the data before him that such
data do not establish that such use would accomplish the intended
physical or other technical effect.
(5) In determining, for the purposes of this section, whether a
proposed use of a food additive is safe, the Secretary shall
consider among other relevant factors -
(A) the probable consumption of the additive and of any
substance formed in or on food because of the use of the
additive;
(B) the cumulative effect of such additive in the diet of man
or animals, taking into account any chemically or
pharmacologically related substance or substances in such diet;
and
(C) safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of
animal experimentation data.
(d) Regulation issued on Secretary's initiative
The Secretary may at any time, upon his own initiative, propose
the issuance of a regulation prescribing, with respect to any
particular use of a food additive, the conditions under which such
additive may be safely used, and the reasons therefor. After the
thirtieth day following publication of such a proposal, the
Secretary may by order establish a regulation based upon the
proposal.
(e) Publication and effective date of orders
Any order, including any regulation established by such order,
issued under subsection (c) or (d) of this section, shall be
published and shall be effective upon publication, but the
Secretary may stay such effectiveness if, after issuance of such
order, a hearing is sought with respect to such order pursuant to
subsection (f) of this section.
(f) Objections and public hearing; basis and contents of order;
statement
(1) Within thirty days after publication of an order made
pursuant to subsection (c) or (d) of this section, any person
adversely affected by such an order may file objections thereto
with the Secretary, specifying with particularity the provisions of
the order deemed objectionable, stating reasonable grounds
therefor, and requesting a public hearing upon such objections. The
Secretary shall, after due notice, as promptly as possible hold
such public hearing for the purpose of receiving evidence relevant
and material to the issues raised by such objections. As soon as
practicable after completion of the hearing, the Secretary shall by
order act upon such objections and make such order public.
(2) Such order shall be based upon a fair evaluation of the
entire record at such hearing, and shall include a statement
setting forth in detail the findings and conclusions upon which the
order is based.
(3) The Secretary shall specify in the order the date on which it
shall take effect, except that it shall not be made to take effect
prior to the ninetieth day after its publication, unless the
Secretary finds that emergency conditions exist necessitating an
earlier effective date, in which event the Secretary shall specify
in the order his findings as to such conditions.
(g) Judicial review
(1) In a case of actual controversy as to the validity of any
order issued under subsection (f) of this section, including any
order thereunder with respect to amendment or repeal of a
regulation issued under this section, any person who will be
adversely affected by such order may obtain judicial review by
filing in the United States Court of Appeals for the circuit
wherein such person resides or has his principal place of business,
or in the United States Court of Appeals for the District of
Columbia Circuit, within sixty days after the entry of such order,
a petition praying that the order be set aside in whole or in part.
(2) A copy of such petition shall be forthwith transmitted by the
clerk of the court to the Secretary, or any officer designated by
him for that purpose, and thereupon the Secretary shall file in the
court the record of the proceedings on which he based his order, as
provided in section 2112 of title 28. Upon the filing of such
petition the court shall have jurisdiction, which upon the filing
of the record with it shall be exclusive, to affirm or set aside
the order complained of in whole or in part. Until the filing of
the record the Secretary may modify or set aside his order. The
findings of the Secretary with respect to questions of fact shall
be sustained if based upon a fair evaluation of the entire record
at such hearing.
(3) The court, on such judicial review, shall not sustain the
order of the Secretary if he failed to comply with any requirement
imposed on him by subsection (f)(2) of this section.
(4) If application is made to the court for leave to adduce
additional evidence, the court may order such additional evidence
to be taken before the Secretary and to be adduced upon the hearing
in such manner and upon such terms and conditions as to the court
may seem proper, if such evidence is material and there were
reasonable grounds for failure to adduce such evidence in the
proceedings below. The Secretary may modify his findings as to the
facts and order by reason of the additional evidence so taken, and
shall file with the court such modified findings and order.
(5) The judgment of the court affirming or setting aside, in
whole or in part, any order under this section shall be final,
subject to review by the Supreme Court of the United States upon
certiorari or certification as provided in section 1254 of title
28. The commencement of proceedings under this section shall not,
unless specifically ordered by the court to the contrary, operate
as a stay of an order.
(h) Notification relating to food contact substance
(1) Subject to such regulations as may be promulgated under
paragraph (3), a manufacturer or supplier of a food contact
substance may, at least 120 days prior to the introduction or
delivery for introduction into interstate commerce of the food
contact substance, notify the Secretary of the identity and
intended use of the food contact substance, and of the
determination of the manufacturer or supplier that the intended use
of such food contact substance is safe under the standard described
in subsection (c)(3)(A) of this section. The notification shall
contain the information that forms the basis of the determination
and all information required to be submitted by regulations
promulgated by the Secretary.
(2)(A) A notification submitted under paragraph (1) shall become
effective 120 days after the date of receipt by the Secretary and
the food contact substance may be introduced or delivered for
introduction into interstate commerce, unless the Secretary makes a
determination within the 120-day period that, based on the data and
information before the Secretary, such use of the food contact
substance has not been shown to be safe under the standard
described in subsection (c)(3)(A) of this section, and informs the
manufacturer or supplier of such determination.
(B) A decision by the Secretary to object to a notification shall
constitute final agency action subject to judicial review.
(C) In this paragraph, the term "food contact substance" means
the substance that is the subject of a notification submitted under
paragraph (1), and does not include a similar or identical
substance manufactured or prepared by a person other than the
manufacturer identified in the notification.
(3)(A) The process in this subsection shall be utilized for
authorizing the marketing of a food contact substance except where
the Secretary determines that submission and review of a petition
under subsection (b) of this section is necessary to provide
adequate assurance of safety, or where the Secretary and any
manufacturer or supplier agree that such manufacturer or supplier
may submit a petition under subsection (b) of this section.
(B) The Secretary is authorized to promulgate regulations to
identify the circumstances in which a petition shall be filed under
subsection (b) of this section, and shall consider criteria such as
the probable consumption of such food contact substance and
potential toxicity of the food contact substance in determining the
circumstances in which a petition shall be filed under subsection
(b) of this section.
(4) The Secretary shall keep confidential any information
provided in a notification under paragraph (1) for 120 days after
receipt by the Secretary of the notification. After the expiration
of such 120 days, the information shall be available to any
interested party except for any matter in the notification that is
a trade secret or confidential commercial information.
(5)(A)(i) Except as provided in clause (ii), the notification
program established under this subsection shall not operate in any
fiscal year unless -
(I) an appropriation equal to or exceeding the applicable
amount under clause (iv) is made for such fiscal year for
carrying out such program in such fiscal year; and
(II) the Secretary certifies that the amount appropriated for
such fiscal year for the Center for Food Safety and Applied
Nutrition of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds the
amount appropriated for the Center for fiscal year 1997,
excluding any amount appropriated for new programs.
(ii) The Secretary shall, not later than April 1, 1999, begin
accepting and reviewing notifications submitted under the
notification program established under this subsection if -
(I) an appropriation equal to or exceeding the applicable
amount under clause (iii) is made for the last six months of
fiscal year 1999 for carrying out such program during such
period; and
(II) the Secretary certifies that the amount appropriated for
such period for the Center for Food Safety and Applied Nutrition
of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds an
amount equivalent to one-half the amount appropriated for the
Center for fiscal year 1997, excluding any amount appropriated
for new programs.
(iii) For the last six months of fiscal year 1999, the applicable
amount under this clause is $1,500,000, or the amount specified in
the budget request of the President for the six-month period
involved for carrying out the notification program in fiscal year
1999, whichever is less.
(iv) For fiscal year 2000 and subsequent fiscal years, the
applicable amount under this clause is $3,000,000, or the amount
specified in the budget request of the President for the fiscal
year involved for carrying out the notification program under this
subsection, whichever is less.
(B) For purposes of carrying out the notification program under
this subsection, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 1999 through
fiscal year 2003, except that such authorization of appropriations
is not effective for a fiscal year for any amount that is less than
the applicable amount under clause (iii) or (iv) of subparagraph
(A), whichever is applicable.
(C) Not later than April 1 of fiscal year 1998 and February 1 of
each subsequent fiscal year, the Secretary shall submit a report to
the Committees on Appropriations of the House of Representatives
and the Senate, the Committee on Commerce of the House of
Representatives, and the Committee on Labor and Human Resources of
the Senate that provides an estimate of the Secretary of the costs
of carrying out the notification program established under this
subsection for the next fiscal year.
(6) In this section, the term "food contact substance" means any
substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food.
(i) Amendment or repeal of regulations
The Secretary shall by regulation prescribe the procedure by
which regulations under the foregoing provisions of this section
may be amended or repealed, and such procedure shall conform to the
procedure provided in this section for the promulgation of such
regulations. The Secretary shall by regulation prescribe the
procedure by which the Secretary may deem a notification under
subsection (h) of this section to no longer be effective.
(j) Exemptions for investigational use
Without regard to subsections (b) to (i), inclusive, of this
section, the Secretary shall by regulation provide for exempting
from the requirements of this section any food additive, and any
food bearing or containing such additive, intended solely for
investigational use by qualified experts when in his opinion such
exemption is consistent with the public health.