Food additives (animal feed) (21 CFR 570.3-570.38)

520 21 CFR Ch. I (4–1–11 Edition) Pt. 570 Zoalene in grams/ton Combination in grams/ton Indications for use Limitations ........................................... 2. Broiler chicken; as an aid in the prevention of infectious co ryza; prevention and control of coccidiosis.. Feed for 7 to 14 d; withdraw 24 h before slaughter; as erythro mycin thiocyanate. Erythromycin 185. ............. Broiler chickens; as an aid in the prevention and reduction of le sions and in lowering severity of chronic respiratory disease; prevention and control of coc cidiosis.. Feed for 5 to 8 d; do not use in birds producing eggs for food purposes; withdraw 48 h be fore slaughter; as erythromycin thiocyanate. Hygromycin B 8 to 12. ...... Broiler chickens; prevention and control of coccidiosis; control of infestation of large round worms (Ascaris galli) cecal worms (Heterakis gallinae) and capillary worms (Capillaria obsignate) .. Lincomycin 2. .................... Broiler chickens; increase in rate of weight gain; improved feed efficiency; as an aid in the pre vention and control of coccidi osis.. Do not feed to laying chickens; to be fed as the sole ration; as lincomycin hydrochloride monohydrate provided by No. 000009 in § 510.600(c) of this chapter. Penicillin 2.4 to 50. ........... Broiler chickens; growth pro motion and feed efficiency; prevention and control of coc cidiosis.. As procaine penicillin. Penicillin 2.4 to 50 plus roxarsone 22.7 to 45.4 (0.0025 to 0.005%).. Broiler chickens; prevention and control of coccidiosis; growth promotion and feed efficiency; improving pigmentation.. Withdraw 5 d before slaughter; as sole source of organic ar senic; as procaine penicillin. Roxarsone 22.7 to 45.4 (0.0025 to 0.005%).. Broiler chickens; prevention and control of coccidiosis; growth promotion and feed efficiency; improving pigmentation.. Withdraw 5 d before slaugher; as sole source of organic arsenic. (iii) 113.5 to 170.3 (0.0125 to 0.01875%).. ........................................... Turkeys; prevention and control of coccidiosis.. For turkeys grown for meat pur poses only. Arsanilic acid 90(0.01%). .. do. ........................................ Do. Bacitracin methylene disa licylate 4–50.. Turkeys; prevention and control of coccidiosis, and increased rate of weight gain and im proved feed efficiency.. For turkeys grown for meat pur poses only, not to be fed to laying birds, feed continuously as sole ration until 14 to 16 weeks of age. Carbarsone (not U.S.P.) 277 to 340.5 (0.025% to 0.0375%).. Turkeys; prevention and control of coccidiosis; aid in the pre vention of blackhead.. For turkeys grown for meat pur poses only; feed continuously beginning 2 weeks before blackhead and coccidiosis are expected and continue as long as prevention of blackhead and prevention and control of coccidiosis is needed; with draw 5 d before slaughter; as sole source of organic arsenic. Roxarsone 22.7 to 45.4 (0.0025% to 0.005%).. Turkeys; growth promotion and feed efficiency; improving pig mentation.. Withdraw 5 d before slaughter; as sole source of organic ar senic. (2) Zoalene may also be used in com bination with roxarsone as in § 558.530. [41 FR 11005, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 FR 20817, Apr. 22, 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8461, Mar. 8, 1990; 57 FR 8403, Mar. 10, 1992; 57 FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, 1996; 63 FR 38750, July 20, 1998; 67 FR 6868, Feb. 14, 2002; 71 FR 16223, Mar. 31, 2006; 71 FR 27958, May 15, 2006; 76 FR 17027, Mar. 28, 2011] PART 564 [RESERVED] PART 570—FOOD ADDITIVES Subpart A—General Provisions Sec. 570.3 Definitions. 570.6 Opinion letters on food additive sta tus. VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00530 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 521 Food and Drug Administration, HHS § 570.3 570.13 Indirect food additives resulting from packaging materials prior sanctioned for animal feed and pet food. 570.14 Indirect food additives resulting from packaging materials for animal feed and pet food. 570.15 Adoption of regulation on initiative of Commissioner. 570.17 Exemption for investigational use and procedure for obtaining authoriza tion to market edible products from ex perimental animals. 570.18 Tolerances for related food additives. 570.19 Pesticide chemicals in processed foods. Subpart B—Food Additive Safety 570.20 General principles for evaluating the safety of food additives. 570.30 Eligibility for classification as gen erally recognized as safe (GRAS). 570.35 Affirmation of generally recognized as safe (GRAS) status. 570.38 Determination of food additive sta tus. AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, 371. SOURCE: 41 FR 38644, Sept. 10, 1976, unless otherwise noted. Subpart A—General Provisions § 570.3 Definitions. (a) Secretary means the Secretary of Health and Human Services. (b) Department means the Department of Health and Human Services. (c) Commissioner means the Commis sioner of Food and Drugs. (d) As used in this part, the term act means the Federal Food, Drug, and Cosmetic Act approved June 25, 1936 (52 Stat. 1040 et seq., as amended; 21 U.S.C. 301–392). (e) Food additives includes all sub stances not exempted by section 201(s) of the act, the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteris tics of food. A material used in the pro duction of containers and packages is subject to the definition if it may rea sonably be expected to become a com ponent, or to affect the characteristics, directly or indirectly, of food packed in the container. Affecting the characteris tics of food does not include such phys ical effects, as protecting contents of packages, preserving shape, and pre venting moisture loss. If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive. A sub stance that does not become a compo nent of food, but that is used, for exam ple, in preparing an ingredient of the food to give a different flavor, texture, or other characteristic in the food, may be a food additive. (f) Common use in food means a sub stantial history of consumption of a substance by a significant number of animals in the United States. (g) The word substance in the defini tion of the term food additive includes a food or feed or a component of a food or feed consisting of one or more ingredi ents. (h) Scientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance. (i) Safe or safety means that there is a reasonable certainty in the minds of competent scientists that the sub stance is not harmful under the in tended conditions of use. It is impos sible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Safety may be determined by scientific procedures or by general recognition of safety. In determining safety, the following fac tors shall be considered: (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) The cumulative effect of the sub stance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; (3) Safety factors which, in the opin ion of experts qualified by scientific training and experience to evaluate the safety of food and food ingredients, are generally recognized as appropriate. (j) The term nonperishable processed food means any processed food not sub ject to rapid decay or deterioration that would render it unfit for consump tion. Not included are hermetically sealed foods and other processed foods requiring refrigeration. VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00531 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 522 21 CFR Ch. I (4–1–11 Edition) § 570.6 (k) General recognition of safety shall be determined in accordance with § 570.30. (l) Prior sanction means an explicit approval granted with respect to use of a substance in food prior to September 6, 1958, by the Food Drug and Adminis tration or the United States Depart ment of Agriculture pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry Products Inspection Act, or the Meat Inspection Act. (m) Food includes human food, sub stances migrating to food from food contact articles, pet food, and animal feed. [41 FR 38644, Sept. 10, 1976, as amended at 42 FR 55206, Oct. 14, 1977] § 570.6 Opinion letters on food addi tive status. (a) Over the years the Food and Drug Administration has given informal written opinions to inquirers as to the safety of articles intended for use as components of, or in contact with, food. Prior to the enactment of the Food Additives Amendment of 1958 (Pub. L. 85–929, Sept. 6, 1958), these opinions were given pursuant to sec tion 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, which reads in part: ‘‘A food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health’’. (b) Since enactment of the Food Ad ditives Amendment, the Food and Drug Administration has advised such in quirers that an article: (1) Is a food additive within the meaning of section 201(s) of the act; or (2) Is generally recognized as safe (GRAS); or (3) Has prior sanction or approval under that amendment; or (4) Is not a food additive under the conditions of intended use. (c) In the interest of the public health, such articles which have been considered in the past by the Food and Drug Administration to be safe under the provisions of section 402(a)(1), or to be generally recognized as safe for their intended use, or to have prior sanction or approval, or not to be food additives under the conditions of in tended use, must be reexamined in the light of current scientific information and current principles for evaluating the safety of food additives if their use is to be continued. (d) Because of the time span in volved, copies of many of the letters in which the Food and Drug Administra tion has expressed an informal opinion concerning the status of such articles may no longer be in the file of the Food and Drug Administration. In the ab sence of information concerning the names and uses made of all the articles referred to in such letters, their safety of use cannot be reexamined. For this reason all food additive status opinions of the kind described in paragraph (c) of this section given by the Food and Drug Administration are hereby re voked. (e) The prior opinions of the kind de scribed in paragraph (c) of this section will be replaced by qualified and cur rent opinions if the recipient of each such letter forwards a copy of each to the Department of Health and Human Services, Food and Drug Administra tion, Center for Veterinary Medicine, Office of Surveillance and Compliance (HFV–200), 7500 Standish Pl., Rockville, MD 20855, along with a copy of his let ter of inquiry, on or before July 23, 1970. (f) This section does not apply to food additive status opinion letters per taining to articles that were considered by the Food and Drug Administration to be food additives nor to articles in cluded in regulations in this Sub chapter E if the articles are used in ac cordance with the requirements of such regulations. [41 FR 38644, Sept. 10, 1976, as amended at 54 FR 18281, Apr. 28, 1989; 57 FR 6476, Feb. 25, 1992] § 570.13 Indirect food additives result ing from packaging materials prior sanctioned for animal feed and pet food. Regulations providing for the use of food packaging materials as prior sanc tioned in part 181 of this chapter are incorporated in Subchapter E as appli cable to packaging materials used for animal feed and pet food. [42 FR 14091, Mar. 15, 1977] VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00532 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 523 Food and Drug Administration, HHS § 570.18 § 570.14 Indirect food additives result ing from packaging materials for animal feed and pet food. Regulations providing for the use of food packaging materials in parts 174 through 179 of this chapter are incor porated in Subchapter E as applicable to packaging materials used for animal feed and pet food. [42 FR 14091, Mar. 15, 1977] § 570.15 Adoption of regulation on ini tiative of Commissioner. (a) The Commissioner upon his own initiative may propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions under which such addi tive may be safely used. Notice of such proposal shall be published in the FED ERAL REGISTER and shall state the rea sons for the proposal. (b) Action upon a proposal made by the Commissioner shall proceed as pro vided in part 10 of this chapter. [41 FR 38644, Sept. 10, 1976, as amended at 42 FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, 1977] § 570.17 Exemption for investigational use and procedure for obtaining au thorization to market edible prod ucts from experimental animals. A food additive or food containing a food additive intended for investiga tional use by qualified experts shall be exempt from the requirements of sec tion 409 of the act under the following conditions: (a) If intended for investigational use in vitro or in laboratory research ani mals, it bears a label which states prominently, in addition to the other information required by the act, the warning: Caution. Contains a new food additive for investigational use only in laboratory re search animals or for tests in vitro. Not for use in humans. (b) If intended for use in animals other than laboratory research animals and if the edible products of the ani mals are to be marketed as food, per mission for the marketing of the edible products as food has been requested by the sponsor, and authorization has been granted by the Food and Drug Ad ministration in accordance with § 511.1 of this chapter or by the Department of Agriculture in accordance with 9 CFR 309.17, and it bears a label which states prominently, in addition to the other information required by the act, the warning: Caution. Contains a new food additive for use only in investigational animals. Not for use in humans. Edible products of investigational animals are not to be used for food unless authoriza tion has been granted by the U.S. Food and Drug Administration or by the U.S. Depart ment of Agriculture. (c) If intended for nonclinical labora tory studies in food-producing animals, the study is conducted in compliance with the regulations set forth in part 58 of this chapter. [41 FR 38644, Sept. 10, 1976, as amended at 43 FR 60023, Dec. 22, 1978] § 570.18 Tolerances for related food ad ditives. (a) Food additives that cause similar or related pharmacological effects will be regarded as a class, and in the ab sence of evidence to the contrary, as having additive toxic effects and will be considered as related food additives. (b) Tolerances established for such related food additives may limit the amount of a common component that may be present, or may limit the amount of biological activity (such as cholinesterase inhibition) that may be present or may limit the total amount of related food additives that may be present. (c) Where food additives from two or more chemicals in the same class are present in or on a food, the tolerance for the total of such additives shall be the same as that for the additive hav ing the lowest numerical tolerance in this class, unless there are available methods that permit quantitative de termination of the amount of each food additive present or unless it is shown that a higher tolerance is reasonably required for the combined additives to accomplish the physical or technical effect for which such combined addi tives are intended and that the higher tolerance will be safe. (d) Where residues from two or more additives in the same class are present in or on a food and there are available VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00533 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 524 21 CFR Ch. I (4–1–11 Edition) § 570.19 methods that permit quantitative de termination of each residue, the quan tity of combined residues that are within the tolerance may be deter mined as follows: (1) Determine the quantity of each residue present. (2) Divide the quantity of each res idue by the tolerance that would apply if it occurred alone, and multiply by 100 to determine the percentage of the permitted amount of residue present. (3) Add the percentages so obtained for all residues present. (4) The sum of the percentages shall not exceed 100 percent. § 570.19 Pesticide chemicals in proc essed foods. When pesticide chemical residues occur in processed foods due to the use of raw agricultural commodities that bore or contained a pesticide chemical in conformity with an exemption granted or a tolerance prescribed under section 408 of the act, the processed food will not be regarded as adulter ated so long as good manufacturing practice has been followed in removing any residue from the raw agricultural commodity in the processing (such as by peeling or washing) and so long as the concentration of the residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity. But when the concentration of residue in the processed food when ready to eat is higher than the tolerance prescribed for the raw agricultural commodity, the processed food is adulterated unless the higher concentration is permitted by a tolerance obtained under section 409 of the act. For example, if fruit bearing a residue of 7 parts per million of DDT permitted on the raw agricul tural commodity is dried and a residue in excess of 7 parts per million of DDT results on the dried fruit, the dehy drated fruit is adulterated unless the higher tolerance for DDT is authorized by the regulations in this part. Food that is itself ready to eat, and which contains a higher residue than allowed for the raw agricultural commodity, may not be legalized by blending or mixing with other foods to reduce the residue in the mixed food below the tol erance prescribed for the raw agricul tural commodity. Subpart B—Food Additive Safety § 570.20 General principles for evalu ating the safety of food additives. (a) In reaching a decision on any pe tition filed under section 409 of the act, the Commissioner will give full consid eration to the specific biological prop erties of the compound and the ade quacy of the methods employed to demonstrate safety for the proposed use, and the Commissioner will be guided by the principles and procedures for establishing the safety of food addi tives stated in current publications of the National Academy of Sciences-Na tional Research Council. A petition will not be denied, however, by reason of the petitioner’s having followed pro cedures other than those outlined in the publications of the National Acad emy of Sciences-National Research Council if, from available evidence, the Commissioner finds that the proce dures used give results as reliable as, or more reliable than, those reasonably to be expected from the use of the out lined procedures. In reaching a deci sion, the Commissioner will give due weight to the anticipated levels and patterns of consumption of the additive specified or reasonably inferable. For the purposes of this section, the prin ciples for evaluating safety of additives set forth in the above-mentioned publi cations will apply to any substance that may properly be classified as a food additive as defined in section 201(s) of the act. (b) Upon written request describing the proposed use of an additive and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he be lieves the experiments planned will yield data adequate for an evaluation of the safety of the additive. § 570.30 Eligibility for classification as generally recognized as safe (GRAS). (a) General recognition of safety may be based only on the views of experts VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00534 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 525 Food and Drug Administration, HHS § 570.30 qualified by scientific training and ex perience to evaluate the safety of sub stances directly or indirectly added to food. The basis of such views may be ei ther (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through expe rience based on common use in food. General recognition of safety requires common knowledge about the sub stance throughout the scientific com munity knowledgeable about the safety of substances directly or indirectly added to food. (b) General recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regu lation for the ingredient. General rec ognition of safety through scientific procedures shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data and information. (c) General recognition of safety through experience based on common use in food prior to January 1, 1958, may be determined without the quan tity or quality of scientific procedures required for approval of a food additive regulation. General recognition of safe ty through experience based on com mon use in food prior to January 1, 1958, shall ordinarily be based upon generally available data and informa tion. An ingredient not in common use in food prior to January 1, 1958, may achieve general recognition of safety only through scientific procedures. (d) The food ingredients listed as GRAS in part 582 of this chapter do not include all substances that are gen erally recognized as safe for their in tended use in food. Because of the large number of substances the intended use of which results or may reasonably be expected to result, directly or indi rectly, in their becoming a component or otherwise affecting the characteris tics of food, it is impracticable to list all such substances that are GRAS. A food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the United States prior to January 1, 1958, without known detrimental effects, which is subject only to conventional processing as practiced prior to Janu ary 1, 1958, and for which no known safety hazard exists, will ordinarily be regarded as GRAS without specific in clusion in part 582 of this chapter. (e) A food ingredient that is not GRAS or subject to a prior sanction re quires a food additive regulation pro mulgated under section 409 of the act before it may be directly or indirectly added to food. (f) A food ingredient that is listed as GRAS in part 582 of this chapter shall be regarded as GRAS only if, in addi tion to all the requirements in the ap plicable regulation, it also meets all of the following requirements: (1) It complies with any applicable specifications, or in the absence of such specifications, shall be of a purity suit able for its intended use. (2) It performs an appropriate func tion in the food or food-contact article in which it is used. (3) It is used at a level no higher than necessary to achieve its intended pur pose in that food or, if used as a compo nent of a food-contact article, at a level no higher than necessary to achieve its intended purpose in that ar ticle. (g) New information may at any time require reconsideration of the GRAS status of a food ingredient. Any change in status shall be accomplished pursu ant to § 570.38. (h) If a substance is affirmed as GRAS pursuant to § 570.35 and listed in a regulation with no limitation other than good manufacturing practice, it shall be regarded as GRAS if its condi tions of use are not significantly dif ferent from those reported in the regu lation as the basis on which the GRAS status of the substance was affirmed. If the conditions of use are significantly different, such use of the substance may not be GRAS. In such case a man ufacturer may not rely on the regula tion as authorizing the use but must independently establish that the use is GRAS or must use the substance in ac cordance with a food additive regula tion. (i) If an ingredient is affirmed as GRAS pursuant to § 570.35 and listed in a regulation with specific limitation(s), it may be used in food only within such limitation(s) (including the category of VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00535 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 526 21 CFR Ch. I (4–1–11 Edition) § 570.35 food(s), the functional use(s) of the in gredient, and the level(s) of use). Any use of such and ingredient not in full compliance with each such established limitation shall require a food additive regulation. (j) Pursuant to § 570.35, a food ingre dient may be affirmed as GRAS and listed in a regulation for a specific use(s) without a general evaluation of use of the ingredient. In addition to the use(s) specified in the regulation, other uses of such an ingredient may also be GRAS. Any affirmation of GRAS status for a specific use(s), without a general evaluation of use of the ingredient, is subject to reconsideration upon such evaluation. [42 FR 55206, Oct. 14, 1977] § 570.35 Affirmation of generally recog nized as safe (GRAS) status. (a) The Commissioner, either on his initiative or on the petition of an in terested person, may affirm the GRAS status of substances that directly or indirectly become components of food. (b)(1) If the Commissioner proposes on his own initiative that a substance is entitled to affirmation as GRAS, he will place all of the data and informa tion on which he relies on public file in the office of the Division of Dockets Management and will publish in the FEDERAL REGISTER a notice giving the name of the substance, its proposed uses, and any limitations proposed for purposes other than safety. (2) The FEDERAL REGISTER notice will allow a period of 60 days during which any interested person may review the data and information and/or file com ments with the Division of Dockets Management. Copies of all comments received shall be made available for ex amination in the Division of Dockets Management’s office. (3) The Commissioner will evaluate all comments received. If he concludes that there is convincing evidence that the substance is GRAS as defined in § 570.3(k), he will publish a notice in the FEDERAL REGISTER listing the sub stance in this subchapter E as GRAS. (4) If, after evaluation of the com ments, the Commissioner concludes that there is a lack of convincing evi dence that the substance is GRAS and that it should be considered a food ad ditive subject to section 409 of the act, he shall publish a notice thereof in the FEDERAL REGISTER in accordance with § 570.38. (c)(1) Persons seeking the affirmation of GRAS status of substances as pro vided for in § 570.30(e), except those sub ject to the NAS-NRC GRAS list survey (36 FR 20546), shall submit a petition for GRAS affirmation pursuant to part 10 of this chapter. Such petition shall contain information to establish that the GRAS criteria as set forth in § 570.30(b) have been met, in the fol lowing form: (i) Description of the substance, in cluding: (a) Common or usual name. (b) Chemical name. (c) Chemical Abstract Service (CAS) registry number. (d) Empirical formula. (e) Structural formula. (f) Specifications for food grade ma terial, including arsenic and heavy metals. (Recommendation for any change in the Food Chemicals Codex monograph should be included where applicable.) (g) Quantitative compositions. (h) Manufacturing process (excluding any trade secrets). (ii) Use of the substance, including: (a) Date when use began. (b) Information and reports or other data on past uses in food. (c) Foods in which used, and levels of use in such foods, and for what pur poses. (iii) Methods for detecting the sub stance in food, including: (a) References to qualitative and quantitative methods for determining the substance(s) in food, including the type of analytical procedures used. (b) Sensitivity and reproducibility of such method(s). (iv) Information to establish the safe ty and functionality of the substance in food. Published scientific literature, evidence that the substance is identical to a GRAS counterpart of natural bio logical origin, and other data may be submitted to support safety. Any ad verse information or consumer com plaints shall be included. Complete bib liographic references shall be provided where a copy of the article is not pro vided. VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00536 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 527 Food and Drug Administration, HHS § 570.38 (v) A statement signed by the person responsible for the petition that to the best of his knowledge it is a represent ative and balanced submission that in cludes unfavorable information, as well as favorable information, known to him pertinent to the evaluation of the safety and functionality of the sub stance. (vi) If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each nonclinical study, either a state ment that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compli ance with such regulations, a brief statement of the reason for the non compliance. (vii) [Reserved] (viii) A claim for categorical exclu sion under § 25.30 or 25.32 of this chapter or an environmental assessment under § 25.40 of this chapter. (2) Within 30 days after the date of filing the petition, the Commissioner will place the petition on public file in the Division of Dockets Management and will publish a notice of filing in the FEDERAL REGISTER giving the name of the petitioner and a brief description of the petition including the name of the substance, its proposed use, and any limitations proposed for reasons other than safety. A copy of the notice will be mailed to the petitioner at the time the original is sent to the FEDERAL REGISTER. (3) The notice of filing in the FED ERAL REGISTER will allow a period of 60 days during which any interested per son may review the petition and/or file comments with the Division of Dockets Management. Copies of all comments received shall be made available for ex amination in the Division of Dockets Management. (4) The Commissioner will evaluate the petition and all available informa tion including all comments received. If the petition and such information provide convincing evidence that the substance is GRAS as defined in § 570.3, he will publish an order in the FEDERAL REGISTER listing the substance in this subchapter E as GRAS. (5) If, after evaluation of the petition and all available information, the Com missioner concludes that there is a lack of convincing evidence that the substance is GRAS and that it should be considered a food additive subject to section 409 of the act, he shall publish a notice thereof in the FEDERAL REG ISTER in accordance with § 570.38. (6) The notice of filing in the FED ERAL REGISTER will request submission of proof of any applicable prior sanc tion for use of the ingredient under conditions different from those pro posed to be determined to be GRAS. The failure of any person to come for ward with proof of such an applicable prior sanction in response to the notice of filing will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice of filing will also constitute a proposal to estab lish a regulation under this subchapter E, incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a re sult of submission of proof of such an applicable prior sanction in response to the notice of filing. [41 FR 38644, Sept. 10, 1976, as amended at 42 FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, 1977; 42 FR 55207, Oct. 10, 1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR 18281, Apr. 28, 1989; 62 FR 40600, July 29, 1997] § 570.38 Determination of food addi tive status. (a) The Commissioner may, in ac cordance with § 570.35 (b)(4) or (c)(5), publish a notice in the FEDERAL REG ISTER determining that a substance is not GRAS and is a food additive sub ject to section 409 of the act. (b)(1) The Commissioner, on his own initiative or on the petition of any in terested person, pursuant to part 10 of this chapter, may issue a notice in the FEDERAL REGISTER proposing to deter mine that a substance is not GRAS and is a food additive subject to section 409 of the act. Any petition shall include all relevant data and information of the type described in § 571.130(b) of this chapter. The Commissioner will place all of the data and information on which he relies on public file in the Di vision of Dockets Management and will include in the FEDERAL REGISTER no tice the name of the substance, its VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00537 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 528 21 CFR Ch. I (4–1–11 Edition) Pt. 571 known uses, and a summary of the basis for the determination. (2) The FEDERAL REGISTER notice will allow a period of 60 days during which any interested person may review the data and information and/or file com ments with the Division of Dockets Management. Copies of all comments shall be made available for examina tion in the Division of Dockets Man agement. (3) The Commissioner will evaluate all comments received. If he concludes that there is a lack of convincing evi dence that the substance is GRAS or is otherwise exempt from the definition of a food additive in section 201(s) of the act, he will publish a notice thereof in the FEDERAL REGISTER. If he con cludes that there is convincing evi dence that the substance is GRAS, he will publish an order in the FEDERAL REGISTER listing the substance in this subchapter E as GRAS. (c) A FEDERAL REGISTER notice deter mining that a substance is a food addi tive shall provide for the use of the ad ditive in food or food-contact surfaces as follows: (1) It may promulgate a food additive regulation governing use of the addi tive. (2) It may promulgate an interim food additive regulation governing use of the additive. (3) It may require discontinuation of the use of the additive. (4) It may adopt any combination of the above three approaches for dif ferent uses or levels of use of the addi tive. (d) If the Commissioner of Food and Drugs is aware of any prior sanction for use of the substance, he will con currently propose a separate regulation covering such use of the ingredient under this subchapter E. If the Com missioner is unaware of any such appli cable prior sanction, the proposed regu lation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its ex istence. Any regulation promulgated pursuant to this section constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the act, and the failure of any person to come forward with proof of such an applica ble prior sanction in response to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under this subchapter E., in corporating the same provisions, in the event that such a regulation is deter mined to be appropriate as a result of submission of proof of such an applica ble prior sanction in response to the proposal. [41 FR 38644, Sept. 10, 1976, as amended at 42 FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, 1977; 42 FR 55207, Oct. 14, 1977; 54 FR 18281, Apr. 28, 1989] PART 571—FOOD ADDITIVE PETITIONS Subpart A—General Provisions Sec. 571.1 Petitions. 571.6 Amendment of petition. 571.7 Withdrawal of petition without preju dice. Subpart B—Administrative Actions on Applications 571.100 Regulation based on petition. 571.102 Effective date of regulation. 571.110 Procedure for objections and hear ings. 571.115 Application of the cancer clause of section 409 of the act. 571.130 Procedure for amending and repeal ing tolerances or exemptions from toler ances. AUTHORITY: 21 U.S.C. 321, 342, 348, 371; 42 U.S.C. 241. SOURCE: 41 FR 38647, Sept. 10, 1976, unless otherwise noted. Subpart A—General Provisions § 571.1 Petitions. (a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the act shall be sub mitted in triplicate. If any part of the material submitted is in a foreign lan guage, it shall be accompanied by an accurate and complete English trans lation. The petition shall state peti tioner’s post office address to which published notices or orders issued or objections filed pursuant to section 409 of the act may be sent. VerDate Mar<15>2010 10:42 May 17, 2011 Jkt 223070 PO 00000 Frm 00538 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150