the labeling proposed for the color additive. If the color effect results or may reasonably be expected to result from use of the color additive in 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 final printed labeling identical in content to the draft copy is submitted as soon as available, and prior to the marketing of the color additive. The printed labeling shall conform in prominence and conspicuousness with the requirements of the act.

If the color 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. If the safety data will not support the use of the amount of the color additive reasonably needed to accomplish the desired color effect, the requested tolerance will not be established. Petitioners are expected to propose the use of color additives in accordance with sound color chemistry.

C-1. A description of practicable methods to determine the pure color and all intermediates, subsidiary colors, and other components of the color additive.

2. A description of practicable methods to determine the amount of the color additive in any raw, processed, and/or finished food, drug, or cosmetic in which use of the color additive is proposed. (The tests proposed shall be those that can be used for food, drug, or cosmetic control purposes and can be applied with consistent results by any properly equipped laboratory and trained personnel.)

8. A description of methods for identification and determination of any substance formed in or on such food, drug, or cosmetic because of the use of the color additive.

(If it is the petitioner's view that any such method would not be needed, under the terms of the section 706(b)(5)(A)(iv), a statement shall be submitted in lieu of methods as to the basis for such view.)

D. Full reports of investigations made with respect to the safety of the color additive.

(A petition will be regarded as incomplete unless it includes full reports of adequate tests reasonably applicable to show whether or not the color 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 data that would influence the evaluation of the safety of the color additive).

E. Complete data which will allow the Commissioner to consider, among other things, the probable consumption of, and/or

other relevant exposure from the additive and of any substance formed in or on food, drugs, or cosmetics because of such additive; and the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in the diet including, but not limited to food additives and pesticide chemicals for which tolerances or exemptions from tolerances have been established.

F. Proposed tolerances and other limitations on the use of the color additive, if tolerances and limitations are required in order to insure its safety. A petitioner may include a proposed regulation.

G. If exemption from batch certification is requested, the reasons why it is believed such certification is not necessary (including supporting data to establish the safety of the intended use).

H. If submitting a petition to alter an existing regulation issued pursuant to section 706(b) 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.

(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 be retained but not filed. A petition shall be retained but shall not be filed if any of the data listed in the above form are lacking or are not set forth so as to be readily understood or if the prescribed fee has not been submitted. 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 authorized agent, who is a resident of the United States.

(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 petition.

§ 8.5

Notification of filing of petition.

(a) Except where the petition involves a new drug, the Commissioner, within 15 days after receipt, will notify the petitioner of acceptance or nonacceptance of petition, and if not accepted the reasons therefor. If accepted, the date of the notification letter sent to petitioner becomes the date of filling for the purposes of section 706(d) (1) of the act. 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, 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. The date of such notification becomes the date of filing. Where the petition involves a new drug or certifiable antibiotic, notification to the petitioner will be made in accordance with § 8.3(b) (3).

(b) The Commissioner will cause to be published 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. A copy of the notice will be mailed to the petitioner when the original document is signed.

§ 8.6 Publication of regulation.

The Commissioner will forward for publication in the FEDERAL REGISTER, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 706(d) (1) of the act):

(a) A regulation listing in Subpart C, D, E, F, G, or H of this part the color additive on the appropriate list or lists as provided under section 706(b) (1).

(1) Such a regulation may list the color additive for use generally in or on foods, drugs, or cosmetics or for use in coloring the human body, as the case may be, or may prescribe the conditions under which the color additive may be safely used (including, but not limited to, specifications as to the particular food, drug, or cosmetic or classes of food, drugs, or cosmetics in or on which such color additive may be used, or for the material intended for coloring the human

body; the maximum quantity of any straight color or diluent that may be used or permitted to remain in or on such food, drug, or cosmetic or article intended for coloring the human body; the manner in which such color additive may be added to or used in or on such food, drug, or cosmetic or for coloring the human body; and any directions or other labeling or packaging requirements for such color additives deemed necessary to assure the safety of such use).

(2) Such regulations shall list the color additive only for the use or uses for which it has been found suitable and for which it may safely be employed. Alternatively, the Commissioner shall by order deny the petition, and notify the petitioner of such order and the reasons therefor.

(b) Whenever the Commissioner finds that batch certification is not necessary for the protection of the public health he will, by order, exempt the color additive from the certification procedure. In determining whether certification of a color additive is necessary, the Commissioner will consider the composition of the additive, its manufacturing process, possible impurities, its toxic potential, control and analytical procedures necessary to assure compliance with the listing specifications, and the variability of its composition.

§ 8.7 Samples; additional information.

The Commissioner may request samples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, and any additional information needed to clarify a submitted method or other aspect of a petition at any time while a petition is under consideration. The Commissioner shall specify in the request for a sample of the color additive, or articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, a quantity deemed adequate to permit tests of analytical methods to determine quantities of the color additive present in products for which it is intended to be used or adequate for any study or investigation reasonably required with respect to the safety of the color additive or the physical or technical effect it produces. The date used for computing the

90-day limit for the purposes of section 706(d) (1) of the act shall be moved forward 1 day for each day, after mailing date of the request, taken by the petitioner to submit the information and/or 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.

[28 F.R. 6439, June 22, 1963, as amended at 33 FR. 8812, June 18, 1968]

§ 8.8 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice.

(a) Extension of time for studying petitions. If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the 90-day period for not more than 180 days after the filing of the petition.

(b) Substantive amendments. After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amounts to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew.

(c) Withdrawal of petitions without prejudice. (1) In some cases the Commissioner may notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal will be without prejudice to a future filling. Upon refiling, the time limitation will begin to run anew from the date of refiling.

(2) At any time before the order provided for in § 8.6 has been forwarded to the FEDERAL REGISTER for publication the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew.

§ 8.9 Confidentiality of petition.

Data in a petition regarding any method or process entitled to protection

as a trade secret will be held confidential and not revealed, unless it is necessary to do so in the record of an administrative hearing preliminary to possible judicial proceedings under section 706 of the act. Data in the petition will not be revealed to persons other than the petitioner and persons engaged in the enforcement of the act beyond that which is necessary to comply with section 706(d) (1) (notice of the regulation proposed) and 706(b) (1) (order acting on the petition). § 8.10 Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued.

The Commissioner shall refuse to issue a regulation listing a color additive, if in his judgement the data before him show that such proposed use would promote deception of the consumer or would result in misbranding or adulteration within the meaning of the act. Such a finding shall be by order published in the FEDERAL REGISTER Subject to the filing of objections and a request for a hearing by adversely affected parties. The issuance of a regulation for a color additive authorizing its use generally in or on a food, drug, or cosmetic shall not be construed as authorization to use the color additive in a manner that may promote deception or conceal damage or inferiority. The use of a color additive to promote deception or conceal damage or inferiority shall be considered as the use of a color additive for which no regulation has issued pursuant to section 706(b) of the act, even though the regulation is effective for other uses.

§ 8.11 Allocation of color additives.

Whenever, in the consideration of a petition or a proposal to list a color additive or to alter an existing listing, the data before the Commissioner fail to show that it would be safe to list the color additive for all the uses proposed or at the levels proposed, the Commissioner will notify the petitioner and other interested persons by publication in the FEDERAL REGISTER that it is necessary to allocate the safe tolerance for the straight color in the color additive among the competing needs. This notice shall call for the presentation of data by all interested persons on which the allocation can be made in accordance with section 706 (b) (8) of the act. The time for acting upon the petition shall be stayed until such data are presented, whereupon the time limits shall begin to run anew. As

promptly as possible after presentation of the data, the Commissioner will, by order, announce the allocation and the tolerance limitations.

§ 8.12 Advisory committee on the application of the cancer clause.

(a) Any person who will be adversely affected by any action or proposed action applying the cancer clause may at any time, before or within 30 days after the publication of the Commissioner's order taking such action, request the referral of the matter to an advisory committee for a report and recommendations. Such request shall be made in writing to the Commissioner and shall be accompanied by an advance deposit for fees prescribed by § 8.50.

(b) The Commissioner may, at any time, upon his own initiative refer any such matter to an advisory committee for a report and recommendations. In case the Commissioner on his own initiative deems it necessary to refer a proposal to an advisory committee, he shall, in writing, so inform the person filing the petition, if any there be.

§ 8.13 Appointment of advisory com

mittee.

(a) Whenever the referral of a petition or proposal to an advisory committee is requested, or the Commissioner otherwise deems such referral necessary, the Commissioner will request the National Academy of Sciences to select qualified experts willing to serve on the advisory committee. All such experts shall have had sufficient training and experience in biology, medicine, physiology, toxicology, pharmacology, veterinary medicine, or other appropriate science to qualify them on the subject matter to be referred to them. The Commissioner will request the National Academy of Sciences, when it furnishes the names of such experts, to supply a biographical sketch showing the background of their experience and their connection, if any, with academic and commercial institutions.

(b) Each advisory committee shall consist of not less than three experts qualified in the subject matter to be referred to the committee and of adequately diversified professional background. The Commissioner may specify a larger number to serve. He shall appoint one member of the committee as chairman, and the chairman shall be the spokesman of the committee for re

ceiving and forwarding reports and other functions of the committee.

(c) The Commissioner shall appoint the experts so selected and fix their compensation at not to exceed $75.00 a day for each day or part thereof spent in committee meetings and in traveling to and from committee meetings held outside the city of their residence, plus necessary traveling and subsistence expenses while the experts are serving away from their places of residence. Subsistence expenses shall not exceed $25.00 per day.

§ 8.14 Procedure for advisory com

mittee.

(a) The Commissioner shall submit to the chairman of the committee the petition, if any there be; all pertinent data on which he based the issuance, amendment, or repeal of any regulation in question; and other such relevant information as is available. When the Commissioner submits a proposal to an advisory committee, he shall inform the petitioner, if any there be, and furnish him with copies of material other than the petition that is furnished the committee. The chairman of the committee shall acknowledge receipt of the information and readiness of the committee to act. The date of receipt of such information shall be considered the beginning of the period allowed for consideration by the committee. Copy of this acknowledgment shall be forwarded to the petitioner, if any there be, by the chairman of the committee.

(b) A secretariat to the advisory committees will be established by the Commissioner. The secretariat shall furnish members of the committee with copies of the proposal or petition and any data received by the chairman. If the chairman of the committee believes that a meeting of the committee is necessary before making a recommendation, he shall so advise the Commissioner. meetings shall be held in Washington, D.C., or at such other place as the Commissioner shall furnish a suitable meeting place for the committee. If a meeting is held, the secretariat shall keep the minutes and provide clerical assistance.

Such

(c) As soon as practicable, the advisory committee shall make an independent study of the data, and not later than 60 days after receipt of the proposal or petition (unless the time has been extended as provided in paragraph

(d) of this section), the chairman shall certify to the Commissioner the report and recommendations of the committee, including any minority report, together with all underlying data and a statement of the reasons or basis for the recommendations, and shall return the petition or proposal. The report will include copies of all material considered by the committee, except that in the case of scientific literature readily available in scientific libraries proper reference may be made to it instead of furnishing actual copies. A copy of the report of the advisory committee will be supplied to any person who has filed a petition or requested the referral to the advisory committee.

(d) If at any time within 60 days the chairman believes that the advisory committee needs more time, he shall so inform the Commissioner in writing, in which case he shall make the certification contemplated by section 706(b) (5) (C)(ii) of the act within the additional 30 days. The Commissioner shall in turn notify the petitioner.

(e) Within 30 days after receipt of the committee report, the Commissioner shall confirm or modify any order theretofore issued by him or shall issue an order acting on the proposal if no order has been issued.

(f) The chairman of the committee, after consultation with the committee members, will inform the National Academy of Sciences of the committee's opinion as to the member who may best represent the committee at a hearing, if one

occurs.

(g) More than one petition or proposal may be handled by a committee concurrently.

(h) A person who has filed a petition or who has requested the referral of a proposal to the advisory committee in accordance with the provisions of this section, as well as representatives of the Department of Health, Education, and Welfare, shall have a right to consult with the committee in connection with the petition or proposal. Such persons shall notify the chairman and if practicable make appointments through him. The report of the committee shall show the names of persons other than committee members discussing proposals or petitions with the committee. Except

for discussions with authorized persons the committee shall not disclose data originating with a petitioner prior to publication of a regulation.

§ 8.15

Condition for certification.

(a) When the Commissioner cannot conclude from the information before him that there is a basis for exempting a color additive from the requirement of batch certification, he will so order by appropriate listing in Subpart C, E, or G of this part. The Commissioner's order shall state in detail the specifications that shall be met by the color additive.

(b) Each order shall state a period of time after which use of a color additive subject to batch certification but not from a batch certified by procedure prescribed in this section would result in adulteration of the product in which it is used.

§ 8.16 Revocation of exemption from certification.

If information becomes available to the Commissioner that a color additive that has been granted exemption from certification should not, for the protection of the public health, be so exempted, such exemption will be canceled by a notice published in the FEDERAL REGISTER. § 8.17 Listing and exemption from certification on the Commissioner's initiative.

Where a petition for a regulation to list a color additive has not been received and the Commissioner has available facts which demonstrate that a color additive should be listed and/or that certification procedure is not necessary in order to protect the public health, he may list such color additive by appropriate regulation and listing in Subpart C, D, E, F, G, or H of this part.

§ 8.18 Request for exemption from certification.

A manufacturer, packer, or distributor of a color additive or color additive mixture that has not been exempted from the certification procedure by order of the Commissioner may make formal objections and request an order providing such exemption. Such a request shall be accompanied by full facts on which such a request is based. The request shall furnish reasonable grounds for the desired finding including specifically why such certification is not necessary for the protection of the public health.

§ 8.19 Procedure for filing objections to regulations.

(a) Objections under section 706 (d) of the act and section 203 (d) (2) (C) of