Common or usual names for non-standardized animal foods (21 CFR 502.5-502.19)

32 21 CFR Ch. I (4–1–16 Edition) Pt. 502 label bearing the common or usual names of the animal feed ingredients listed in paragraph (b) of this section under the following prescribed condi tions: (1) The animal feed is intended solely for livestock and poultry. (2) The label of the animal feed bears the collective name(s) prescribed in paragraph (b) of this section in lieu of the corresponding common or usual names of the individual feed ingredi ents contained therein. (3) The label of the animal feed oth erwise conforms to the requirements of section 403(i)(2) of the act. (4) The ingredients of any feed listed in paragraph (b) of this section neither contain nor are food additives as de fined in section 201(s) of the act unless provided for by and in conformity with applicable regulations established pur suant to section 409 of the act. (b) Each collective name referred to in this paragraph may be used for the purpose of labeling where one or more of the ingredients listed for that collec tive name are present. The animal feed ingredients listed under each of the collective names are the products de fined by the Association of American Feed Control Officials. The collective names are as follows: (1) Animal protein products include one or more of the following: Animal prod ucts, marine products, and milk prod ucts. (2) Forage products include one or more of the following: Alfalfa meals, entire plant meals, hays, and stem meals. (3) Grain products include one or more of the following: Barley, grain sor ghums, maize (corn), oats, rice, rye, and wheat. (4) Plant protein products include one or more of the following: Algae meals, coconut meals (copra), cottonseed meals, guar meal, linseed meals, pea nut meals, safflower meals, soybean meals, sunflower meals, and yeasts. (5) Processed grain byproducts include one or more of the following: Brans, brewers dried grains, distillers grains, distillers solubles, flours, germ meals, gluten feeds, gluten meals, grits, groats, hominy feeds, malt sprouts, middlings, pearled, polishings, shorts, and wheat mill run. (6) Roughage products include one or more of the following: Cobs, hulls, husks, pulps, and straws. PART 502—COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS Sec. 502.5 General principles. 502.19 Petitions. AUTHORITY: 21 U.S.C. 321, 343, 371. § 502.5 General principles. (a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its charac terizing properties or ingredients. The name shall be uniform among all iden tical or similar products and may not be confusingly similar to the name of any other food that is not reasonably encompassed within the same name. Each class or subclass of food shall be given its own common or usual name that states, in clear terms, what it is in a way that distinguishes it from dif ferent foods. (b) The common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or component(s) when the proportion of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erro neous impression that such ingre dient(s) or component(s) is present in an amount greater than is actually the case. The following requirements shall apply unless modified by a specific reg ulation in this part. (1) The percentage of a characterizing ingredient or component shall be de clared on the basis of its quantity in the finished product (i.e., weight/ weight in the case of solids, or volume/ volume in the case of liquids). (2) The percentage of a characterizing ingredient or component shall be de clared by the words ‘‘containing (or contains) ll percent (or %) ll’’ or ‘‘ll percent (or %) ll’’ with the first blank filled in with the percentage ex pressed as a whole number not greater VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00042 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 33 Food and Drug Administration, HHS § 502.19 than the actual percentage of the in gredient or component named and the second blank filled in with the common or usual name of the ingredient or component. The word ‘‘containing’’ (or ‘‘contains’’), when used, shall appear on a line immediately below the part of the common or usual name of the food required by paragraph (a) of this sec tion. For each characterizing ingre dient or component, the words ‘‘ll percent (or %) ll’’shall appear fol lowing or directly below the word ‘‘containing’’ (or ‘‘contains’’), or di rectly below the part of the common or usual name of the food required by paragraph (a) of this section when the word ‘‘containing’’ (or ‘‘contains’’) is not used, in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives: (i) Not less than one-sixteenth inch in height on packages having a prin cipal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or (ii) Not less than one-half the height of the largest type appearing in the part of the common or usual name of the food required by paragraph (a) of this section. (c) The common or usual name of a food shall include a statement of the presence or absence of any character izing ingredient(s) or component(s) and/or the need for the user to add any characterizing ingredient(s) or compo nent(s) when the presence or absence of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erro neous impression that such ingre dient(s) or component(s) is present when it is not, and consumers may oth erwise be misled about the presence or absence of the ingredient(s) or compo nent(s) in the food. The following re quirements shall apply unless modified by a specific regulation in this part. (1) The presence or absence of a char acterizing ingredient or component shall be declared by the words ‘‘con taining (or contains) llll’’ or ‘‘con taining (or contains) lllll’’ or ‘‘no lllll’’ or ‘‘does not contain lllll’’, with the blank being filled in with the common or usual name of the ingredient or component. (2) The need for the user of a food to add any characterizing ingredient(s) or component(s) shall be declared by an appropriate informative statement. (3) The statement(s) required under paragraph (c) (1) and/or (2) of this sec tion shall appear following or directly below the part of the common or usual name of the food required by para graphs (a) and (b) of this section, in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the alternatives established under paragraph (b)(2) (i) and (ii) of this section. (d) A common or usual name of a food may be established by common usage or by establishment of a regula tion in this part, in a standard of iden tity, or in other regulations in this chapter. [41 FR 38627, Sept. 10, 1976. Redesignated at 42 FR 14091, Mar. 15, 1977] § 502.19 Petitions. (a) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to issue, amend, or revoke, under this part, a regulation pre scribing a common or usual name for a food, pursuant to part 10 of this chap ter. (b) If the principal display panel of a food for which a common or usual name regulation is established is too small to accommodate all mandatory requirements, the Commissioner may establish by regulation an acceptable alternative, e.g., a smaller type size. A petition requesting such a regulation, which would amend the applicable reg ulation, shall be submitted pursuant to part 10 of this chapter. [42 FR 4716, Jan. 25, 1977; 42 FR 10980, Feb. 25, 1977. Redesignated at 42 FR 14091, Mar. 15, 1977, and amended at 42 FR 15675, Mar. 22, 1977; 42 FR 24254, May 13, 1977] VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00043 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 34 21 CFR Ch. I (4–1–16 Edition) Pt. 507 PART 507—CURRENT GOOD MAN UFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK–BASED PRE VENTIVE CONTROLS FOR FOOD FOR ANIMALS Subpart A—General Provisions Sec. 507.1 Applicability and status. 507.3 Definitions. 507.4 Qualifications of individuals who man ufacture, process, pack, or hold animal food. 507.5 Exemptions. 507.7 Requirements that apply to a qualified facility. 507.10 Applicability of subparts C and E of this part to a facility solely engaged in the storage of unexposed packaged ani mal food. 507.12 Applicability of this part to the hold ing and distribution of human food by products for use as animal food. Subpart B—Current Good Manufacturing Practice 507.14 Personnel. 507.17 Plant and grounds. 507.19 Sanitation. 507.20 Water supply and plumbing. 507.22 Equipment and utensils. 507.25 Plant operations. 507.27 Holding and distribution. 507.28 Holding and distribution of human food by-products for use as animal food. Subpart C—Hazard Analysis and Risk Based Preventive Controls 507.31 Food safety plan. 507.33 Hazard analysis. 507.34 Preventive controls. 507.36 Circumstances in which the owner, operator, or agent in charge of a manu facturing/processing facility is not re quired to implement a preventive con trol. 507.37 Provision of assurances required under § 507.36(a)(2), (3), and (4). 507.38 Recall plan. 507.39 Preventive control management com ponents. 507.40 Monitoring. 507.42 Corrective actions and corrections. 507.45 Verification. 507.47 Validation. 507.49 Verification of implementation and effectiveness. 507.50 Reanalysis. 507.51 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged animal food. 507.53 Requirements applicable to a preven tive controls qualified individual and a qualified auditor. 507.55 Implementation records required for this subpart. Subpart D—Withdrawal of a Qualified Facility Exemption 507.60 Circumstances that may lead FDA to withdraw a qualified facility exemption. 507.62 Issuance of an order to withdraw a qualified facility exemption. 507.65 Contents of an order to withdraw a qualified facility exemption. 507.67 Compliance with, or appeal of, an order to withdraw a qualified facility ex emption. 507.69 Procedure for submitting an appeal. 507.71 Procedure for requesting an informal hearing. 507.73 Requirements applicable to an infor mal hearing. 507.75 Presiding officer for an appeal and for an informal hearing. 507.77 Timeframe for issuing a decision on an appeal. 507.80 Revocation of an order to withdraw a qualified facility exemption. 507.83 Final agency action. 507.85 Reinstatement of a qualified facility exemption that was withdrawn. Subpart E—Supply-Chain Program 507.105 Requirement to establish and imple ment a supply-chain program. 507.110 General requirements applicable to a supply-chain program. 507.115 Responsibilities of the receiving fa cility. 507.120 Using approved suppliers. 507.125 Determining appropriate supplier verification activities (including deter mining the frequency of conducting the activity). 507.130 Conducting supplier verification ac tivities for raw materials and other in gredients. 507.135 Onsite audit. 507.175 Records documenting the supply chain program. Subpart F—Requirements Applying to Records That Must Be Established and Maintained 507.200 Records subject to the requirements of this subpart. 507.202 General requirements applying to records. 507.206 Additional requirements applying to the food safety plan. 507.208 Requirements for record retention. 507.212 Use of existing records. 507.215 Special requirements applicable to a written assurance. VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00044 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B