Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=sp21.6.589.b&rgn=div6
Timestamp: 2020-07-02 08:14:51
Document Index: 52806950

Matched Legal Cases: ['art 589', 'ART 589', '§589', '§589', '§589', '§589', '§570', 'art 511', '§516', '§570', 'art 511', '§589', '§570', '§589', '§589', '§589', 'art 51', '§589', '§5']

Title 21 → Chapter I → Subchapter E → Part 589 → Subpart B
PART 589—SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
Subpart B—Listing of Specific Substances Prohibited From Use in Animal Food or Feed
§589.1000 Gentian violet.
§589.1001 Propylene glycol in or on cat food.
§589.2000 Animal proteins prohibited in ruminant feed.
§589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy.
The Food and Drug Administration has determined that gentian violet has not been shown by adequate scientific data to be safe for use in animal feed. Use of gentian violet in animal feed causes the feed to be adulterated and in violation of the Federal Food, Drug, and Cosmetic Act (the act), in the absence of a regulation providing for its safe use as a food additive under section 409 of the act, unless it is subject to an effective notice of claimed investigational exemption for a food additive under §570.17 of this chapter, or unless the substance is intended for use as a new animal drug and is subject to an approved application under section 512 of the act, or an index listing under section 572 of the act, or an effective notice of claimed investigational exemption for a new animal drug under part 511 of this chapter or §516.125 of this chapter.
[72 FR 69131, Dec. 6, 2007]
The Food and Drug Administration has determined that propylene glycol in or on cat food has not been shown by adequate scientific data to be safe for use. Use of propylene glycol in or on cat food causes the feed to be adulterated and in violation of the Federal Food, Drug, and Cosmetic Act (the act), in the absence of a regulation providing for its safe use as a food additive under section 409 of the act, unless it is subject to an effective notice of claimed investigational exemption for a food additive under §570.17 of this chapter, or unless the substance is intended for use as a new animal drug and is subject to an approved application under section 512 of the act or an effective notice of claimed investigational exemption for a new animal drug under part 511 of this chapter.
(a) Definitions—(1) Protein derived from mammalian tissues means any protein-containing portion of mammalian animals, excluding: Blood and blood products; gelatin; tallow containing no more than 0.15 percent insoluble impurities and tallow derivatives as specified in §589.2001; inspected meat products which have been cooked and offered for human food and further heat processed for feed (such as plate waste and used cellulosic food casings); milk products (milk and milk proteins); and any product whose only mammalian protein consists entirely of porcine or equine protein.
(2) Renderer means any firm or individual that processes slaughter byproducts, animals unfit for human consumption, or meat scraps. The term includes persons who collect such materials and subject them to minimal processing, or distribute them to firms other than renderers (as defined here) whose intended use for the products may include animal feed. The term includes renderers that also blend animal protein products.
(3) Blender means any firm or individual which obtains processed animal protein from more than one source or from more than one species, and subsequently mixes (blends) or redistributes an animal protein product.
(4) Feed manufacturer includes manufacturers of complete and intermediate feeds intended for animals, and includes on-farm in addition to off-farm feed manufacturing and mixing operations.
(5) Nonmammalian protein includes proteins from nonmammalian animals.
(6) Distributor includes persons who distribute or transport feeds or feed ingredients intended for animals.
(7) Ruminant includes any member of the order of animals which has a stomach with four chambers (rumen, reticulum, omasum, and abomasum) through which feed passes in digestion. The order includes, but is not limited to, cattle, buffalo, sheep, goats, deer, elk, and antelopes.
(b) Food additive status. The Food and Drug Administration has determined that protein derived from mammalian tissues for use in ruminant feed is a food additive subject to section 409 of the Federal Food, Drug, and Cosmetic Act (the act). The use or intended use in ruminant feed of any material that contains protein derived from mammalian tissues causes the feed to be adulterated and in violation of the act, unless it is the subject of an effective notice of claimed investigational exemption for a food additive under §570.17 of this chapter.
(c) Requirements for renderers that are not included in paragraph (e) of this section. (1) Renderers that manufacture products that contain or may contain protein derived from mammalian tissues and that are intended for use in animal feed shall take the following measures to ensure that materials identified in paragraph (b) of this section are not used in the feed of ruminants:
(i) Label the materials as follows: “Do not feed to cattle or other ruminants”; and
(4) Renderers shall comply with all applicable requirements under §589.2001.
(d) Requirements for protein blenders, feed manufacturers, and distributors that are not included in paragraph (e) of this section. (1) Protein blenders, feed manufacturers, and distributors that manufacture, blend, process, and distribute products that contain or may contain protein derived from mammalian tissues shall comply with paragraph (c)(1) of this section.
(e) Requirements for persons that intend to separate mammalian and nonmammalian materials. (1) Renderers, protein blenders, feed manufacturers, distributors, and others that manufacture, process, blend and distribute both products that contain or may contain protein derived from mammalian tissues or feeds containing such products, and protein products from other animal tissues or feeds containing such products, and that intend to keep those products separate shall:
(3) Renderers shall comply with all applicable requirements under §589.2001.
(f) Requirements for establishments and individuals that are responsible for feeding ruminant animals. Establishments and individuals that are responsible for feeding ruminant animals shall maintain copies of purchase invoices and labeling for all feeds containing animal protein products received, and make the copies available for inspection and copying by the Food and Drug Administration.
(g) Adulteration and misbranding. (1) Animal protein products, and feeds containing such products, that are not in compliance with paragraphs (c) through (f) of this section, excluding labeling requirements, will be deemed adulterated under section 402(a)(2)(C) or 402(a)(4) of the act.
(h) Inspection; records retention. (1) Records that are to be made available for inspection and copying, as required by this section, shall be kept for a minimum of 1 year.
Effective Date Note: At 62 FR 30976, June 5, 1997, §589.2000 was added. Paragraph (e)(1)(iv) of this section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
(a) Purpose. The purpose of this section is to prohibit the use of certain cattle origin materials in the food or feed of all animals to further reduce the risk of the spread of bovine spongiform encephalopathy (BSE) within the United States.
(b) Definitions—(1) Cattle materials prohibited in animal feed include:
(B) Tallow as defined in paragraph (b)(5) of this section that is derived from materials specified in paragraphs (b)(1)(ii) and (b)(1)(iii) of this section and that contains no more than 0.15 percent insoluble impurities. Insoluble impurities must be measured by the method entitled “Insoluble Impurities” (AOCS Method Ca 3a-46), American Oil Chemists' Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from the AOCS (http://www.aocs.org), 2211 W. Bradley Ave., Champaign, IL 61821. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html.
(C) Materials as defined in paragraphs (b)(1)(ii), (b)(1)(iii), (b)(1)(iv) (other than mechanically separated beef from the carcass of a BSE-positive cattle), and (b)(1)(v) of this section from cattle from a country that has been designated under paragraph (f) of this section.
(iv) Label the cattle materials prohibited in animal feed and products that contain or may contain cattle materials prohibited in animal feed in a conspicuous manner as follows: “Do not feed to animals”;
(ii) Comply with all applicable requirements under §589.2000 regarding animal proteins prohibited in ruminant feed.
(f) Process for designating countries. A country seeking designation must send a written request to the Director, Office of the Center Director, Center for Veterinary Medicine, at the address designated in §5.1100 of this chapter. The request shall include information about that country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether the cattle materials from the requesting country do or do not meet the definitions set forth in paragraph (b)(1) of this section. FDA shall respond in writing to any such request and may impose conditions in granting any such request. Any grant by FDA of such a request under this paragraph will be subject to future review by FDA and may be revoked if FDA determines that the granted request is no longer appropriate.
[73 FR 22756, Apr. 25, 2008, as amended at 81 FR 5596, Feb. 3, 2016]