21 C.F.R. § 180.1 General.
(a) Substances having a history of use in food for human consumption or in food contact surfaces may at any time have their safety or functionality brought into question by new information that in itself is not conclusive. An interim food additive regulation for the use of any such substance may be promulgated in this subpart when new information raises a substantial question about the safety or functionality of the substance but there is a reasonable certainty that the substance is not harmful and that no harm to the public health will result from the continued use of the substance for a limited period of time while the question raised is being resolved by further study.
(b) No interim food additive regulation may be promulgated if the new information is conclusive with respect to the question raised or if there is a reasonable likelihood that the substance is harmful or that continued use of the substance will result in harm to the public health.
(c) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may propose an interim food additive regulation. A final order promulgating an interim food additive regulation shall provide that continued use of the substance in food is subject to each of the following conditions:
(1) Use of the substance in food or food contact surfaces must comply with whatever limitations the Commissioner deems to be appropriate under the circumstances.
(2) Within 60 days following the effective date of the regulation, an interested person shall satisfy the Commissioner in writing that studies adequate and appropriate to resolve the questions raised about the substance have been undertaken, or the Food and Drug Administration may undertake the studies. The Commissioner may extend this 60-day period if necessary to review and act on proposed protocols. If no such commitment is made, or adequate and appropriate studies are not undertaken, an order shall immediately be published in the Federal Register revoking the interim food additive regulation effective upon publication.
(3) A progress report shall be filed on the studies every January 1 and July 1 until completion. If the progress report is inadequate or if the Commissioner concludes that the studies are not being pursued promptly and diligently or if interim results indicate a reasonable likelihood that a health hazard exists, an order will promptly be published in the Federal Register revoking the interim food additive regulation effective upon publication.
(4) If nonclinical laboratory studies are involved, studies filed with the Commissioner shall include, with respect to each study, 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.
(5) [Reserved]
(6) If clinical investigations involving human subjects are involved, such investigations filed with the Commissioner shall include, with respect to each investigation, a statement that the investigation 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 §§ 56.104 or 56.105, and that it has been or will be conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.
(d) Promptly upon completion of the studies undertaken on the substance, the Commissioner will review all available data, will terminate the interim food additive regulation, and will either issue a food additive regulation or will require elimination of the substance from the food supply.
(e) The Commissioner may consult with advisory committees, professional organizations, or other experts in the field, in evaluating:
(1) Whether an interim food additive regulation is justified,
(2) The type of studies necessary and appropriate to resolve questions raised about a substance,
(3) Whether interim results indicate the reasonable likelihood that a health hazard exists, or
(4) Whether the data available at the conclusion of those studies justify a food additive regulation.
(f) Where appropriate, an emergency action level may be issued for a substance subject to paragraph (a) of this section that is not an approved food additive, pending the issuance of a final interim food additive regulation. Such an action level shall be issued pursuant to sections 306 and 402(a) of the act to identify, based upon available data, a safe level of use for the substance. Such an action level shall be issued in a notice published in the Federal Register and shall be followed as soon as practicable by a proposed interim food additive regulation. Where the available data do not permit establishing an action level for the safe use of a substance, use of the substance may be prohibited. The identification of a prohibited substance may be made in part 189 of this chapter when appropriate.