21 CFR - § 589.1-589.2001 - Substances prohibited from use in animal food or feed

634 21 CFR Ch. I (4–1–23 Edition) § 584.700 § 584.700 Hydrophobic silicas. (a) Product. Amorphous fumed hydro phobic silica or precipitated hydro phobic silica (CAS Reg. No. 68611–0944– 099, silane, dichlorodimethyl-, reaction products with silica). (b) Conditions of use. An anticaking/ free-flow agent in vitamin preparations for animal feed. (c) Limitations. Not to exceed 5 per cent in the vitamin preparation. It shall be used in accordance with good manufacturing or feeding practices. It must be of purity suitable for intended use, and it must comply with the fol lowing specifications: (i) Amorphous fumed hydrophobic silica: Not less than 99.0 percent silicon dioxide after ignition. Not more than 3 ppm arsenic. Not more than 0.003 per cent heavy metals (as lead). Not more than 10 ppm lead. Not more than 2.5 percent loss on drying. Not more than 2 percent loss on ignition after drying. Not more than 1 percent insoluble sub stances. Not more than 50 parts per million dichlorodimethylsilane. (ii) Precipated hydrophobic silica: Not less than 94.0 percent silicon diox ide after ignition. Not more than 3 ppm arsenic. Not more than 0.003 percent heavy metals (as lead). Not more than 10 ppm lead. Not more than 7 percent loss on drying. Not more than 8.5 per cent loss on ignition after drying. Not more than 5 percent soluble ionizable salts (as sodium sulfate). Not more than 1 percent insoluble substances. Not more than 50 parts per million dichlorodimethylsilane. [61 FR 43453, Aug. 23, 1996] § 584.725 25-Hydroxyvitamin D3. (a) Product. 25–Hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene-3b, 25-diol). (b) Conditions of use. This substance is generally recognized as safe as a source of vitamin D3 activity in feed or drinking water of broiler chickens when used in accordance with the limi tations in paragraph (c) of this section. (c) Limitations. (1) Not to exceed 69 parts per billion (ppb) in feed or 34.5 ppb in drinking water. It shall be used in accordance with good manufacturing and feeding practices. (2) The product must comply with the following specifications: (i) Not less than 94.0 percent 25 hydroxyvitamin D3. (ii) Not more than 1 percent of any individual sterol. (iii) Not more than 5 percent water. (iv) Not more than 20 parts per mil lion (ppm) lead. (v) Not more than 20 ppm aluminum. (vi) Not more than 1.0 percent sol vents and non-detectable levels of 2′. 4′. 5′. 7′-tetraiodofluorescin. (3) Product labeling shall bear the following: (i) A statement to indicate that the maximum use level of 25 hydroxyvitamin D3 must not exceed 69 ppb in feed or 34.5 ppb in drinking water. (ii) Adequate use directions to ensure that 25-hydroxyvitamin D3 (and all pre mixes) is uniformly blended through out the feed or drinking water. (iii) An expiration date on all premix labeling. (iv) A statement on all premix label ing (feed and drinking water forms) that 25-hydroxyvitamin D3 should not be used simultaneously in both feed and water. [72 FR 12564, Mar. 16, 2007] PART 589—SUBSTANCES PROHIB ITED FROM USE IN ANIMAL FOOD OR FEED Subpart A—General Provisions Sec. 589.1 Substances prohibited from use in ani mal 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 rumi nant feed. 589.2001 Cattle materials prohibited in ani mal food or feed to prevent the trans mission of bovine spongiform encephalopathy. AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00644 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 635 Food and Drug Administration, HHS § 589.2000 Subpart A—General Provisions § 589.1 Substances prohibited from use in animal food or feed. (a) The substances listed in this part have been prohibited from use in ani mal food or feed by the Food and Drug Administration because of a deter mination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe for use in such food or feed. Use of any of these substances in viola tion of this part causes the animal food or feed involved to be adulterated and in violation of the Act. (b) This part includes only a partial list of substances prohibited from use in animal food or feed; it is for easy reference purposes and is not a com plete list of substances that may not lawfully be used in such animal food or feed. No substance may be used in ani mal food or feed unless it meets all ap plicable requirements of the Act. (c) The Food and Drug Administra tion either on its own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to establish, amend, or repeal a regulation under this part on the basis of new scientific evaluation or in formation. Any such petition shall in clude an adequate scientific basis to support the petition, shall be the form set forth in § 571.1 of this chapter, and will be published in the FEDERAL REG ISTER for comment if it contains rea sonable ground. [45 FR 28319, Apr. 29, 1980] Subpart B—Listing of Specific Sub stances Prohibited From Use in Animal Food or Feed § 589.1000 Gentian violet. 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 ab sence of a regulation providing for its safe use as a food additive under sec tion 409 of the act, unless it is subject to an effective notice of claimed inves tigational exemption for a food addi tive 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 ex emption for a new animal drug under part 511 of this chapter or § 516.125 of this chapter. [72 FR 69131, Dec. 6, 2007] § 589.1001 Propylene glycol in or on cat food. 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 adulter ated and in violation of the Federal Food, Drug, and Cosmetic Act (the act), in the absence of a regulation pro viding 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 in tended for use as a new animal drug and is subject to an approved applica tion under section 512 of the act or an effective notice of claimed investiga tional exemption for a new animal drug under part 511 of this chapter. [61 FR 19544, May 2, 1996] § 589.2000 Animal proteins prohibited in ruminant feed. (a) Definitions—(1) Protein derived from mammalian tissues means any protein containing portion of mammalian ani mals, excluding: Blood and blood prod ucts; gelatin; tallow containing no more than 0.15 percent insoluble impu rities and tallow derivatives as speci fied in § 589.2001; inspected meat prod ucts which have been cooked and of fered 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. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00645 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 636 21 CFR Ch. I (4–1–23 Edition) § 589.2000 (2) Renderer means any firm or indi vidual that processes slaughter byprod ucts, animals unfit for human con sumption, or meat scraps. The term in cludes persons who collect such mate rials 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 in cludes renderers that also blend animal protein products. (3) Blender means any firm or indi vidual which obtains processed animal protein from more than one source or from more than one species, and subse quently mixes (blends) or redistributes an animal protein product. (4) Feed manufacturer includes manu facturers of complete and intermediate feeds intended for animals, and in cludes on-farm in addition to off-farm feed manufacturing and mixing oper ations. (5) Nonmammalian protein includes proteins from nonmammalian animals. (6) Distributor includes persons who distribute or transport feeds or feed in gredients intended for animals. (7) Ruminant includes any member of the order of animals which has a stom ach with four chambers (rumen, reticu lum, 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 mamma lian tissues causes the feed to be adul terated and in violation of the act, un less it is the subject of an effective no tice of claimed investigational exemp tion for a food additive under § 570.17 of this chapter. (c) Requirements for renderers that are not included in paragraph (e) of this sec tion. (1) Renderers that manufacture products that contain or may contain protein derived from mammalian tis sues and that are intended for use in animal feed shall take the following measures to ensure that materials identified in paragraph (b) of this sec tion are not used in the feed of ruminants: (i) Label the materials as follows: ‘‘Do not feed to cattle or other ruminants’’; and (ii) Maintain records sufficient to track the materials throughout their receipt, processing, and distribution, and make the copies available for in spection and copying by the Food and Drug Administration. (2) Renderers described in paragraph (c)(1) of this section will be exempted from the requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this section if they: (i) Use exclusively a manufacturing method that has been validated by the Food and Drug Administration to de activate the agent that causes trans missible spongiform encephalopathy (TSE) and whose design has been made available to the public; (ii) Use routinely a test method that has been validated by the Food and Drug Administration to detect the presence of the agent that causes TSE’s and whose design has been made available to the public. Renderers whose products test positive for agents that cause TSE’s must comply with paragraphs (c)(1)(i) and (c)(1)(ii) of this section. Records of the test results shall be made available for inspection by the Food and Drug Administration; or (iii) Use exclusively a method for controlling the manufacturing process that minimizes the risk of the TSE agent entering the product and whose design has been made available to the public and validated by the Food and Drug Administration. (3) Renderers described in paragraph (c)(1) of this section will be exempted from the requirements of paragraph (c)(1)(ii) of this section if they use a permanent method, approved by FDA, to make a mark indicating that the product contains or may contain pro tein derived from mammalian tissue. If the marking is by the use of an agent that cannot be detected on visual in spection, the renderer must use an agent whose presence can be detected by a method that has been validated by the Food and Drug Administration and VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00646 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 637 Food and Drug Administration, HHS ยง 589.2000 whose design has been made available to the public. (4) Renderers shall comply with all applicable requirements under ยง 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 manu facturers, and distributors that manu facture, blend, process, and distribute products that contain or may contain protein derived from mammalian tis sues shall comply with paragraph (c)(1) of this section. (2) Protein blenders, feed manufac turers, and distributors, shall be ex empt from paragraphs (d)(1) of this sec tion if they: (i) Purchase animal products from renderers that certified compliance with paragraph (c)(2) of this section or purchase such materials from parties that certify that the materials were purchased from renderers that certified compliance with paragraph (c)(2) of this section; or (ii) Comply with the requirements of paragraph (c)(2) of this section where appropriate. (3) Protein blenders, feed manufac turers, and distributors, shall be ex empt from paragraph (c)(1)(ii) of this section if they: (i) Purchase animal protein products that are marked in accordance with paragraph (c)(3) of this section or pur chase such materials from renderers that certified compliance with para graph (c)(3) of this section, or purchase such materials from parties that cer tify that the materials were purchased from renderers that certified compli ance with paragraph (c)(3) of this sec tion; or (ii) Comply with the requirements of paragraph (c)(3) of this section where appropriate. (4) Pet food products that are sold or are intended for sale at retail and feeds for nonruminant laboratory animals are exempt from the labeling require ments in paragraphs (c) and (d) of this section. However, if the pet food prod ucts or feeds for nonruminant labora tory animals are sold or are intended for sale as distressed or salvage items, then such products shall be labeled in accordance with paragraph (c) or (d) of this section, as appropriate. (5) Copies of certifications as de scribed in paragraphs (d)(2) and (d)(3) of this section, shall be made available for inspection and copying by the Food and Drug Administration. (e) Requirements for persons that intend to separate mammalian and nonmamma lian materials. (1) Renderers, protein blenders, feed manufacturers, distribu tors, and others that manufacture, process, blend and distribute both prod ucts that contain or may contain pro tein derived from mammalian tissues or feeds containing such products, and protein products from other animal tis sues or feeds containing such products, and that intend to keep those products separate shall: (i) Comply with paragraphs (c)(1) or (d)(1) of this section as appropriate ex cept that the labeling requirement shall apply only to products that con tain or may contain protein derived from mammalian tissues or feeds con taining such products; (ii) In the case of a renderer, obtain nonmammalian or pure porcine or pure equine materials only from single-spe cies slaughter facilities; (iii) Provide for measures to avoid commingling or cross-contamination; (A) Maintain separate equipment or facilities for the manufacture, proc essing, or blending of such materials; or (B) Use clean-out procedures or other means adequate to prevent carry-over of products that contain or may con tain protein derived from mammalian tissues into animal protein or feeds that may be used for ruminants; and (iv) Maintain written procedures specifying the clean-out procedures or other means, and specifying the proce dures for separating products that con tain or may contain protein derived from mammalian tissue from all other protein products from the time of re ceipt until the time of shipment. (2) Renderers, blenders, feed manu facturers, and distributors will be ex empted from applicable requirements of paragraph (e)(1) of this section, if they meet the criteria for exemption under paragraphs (c)(2) or (c)(3) of this section, and (d)(2) or (d)(3) of this sec tion. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00647 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 638 21 CFR Ch. I (4–1–23 Edition) § 589.2001 (3) Renderers shall comply with all applicable requirements under § 589.2001. (f) Requirements for establishments and individuals that are responsible for feed ing ruminant animals. Establishments and individuals that are responsible for feeding ruminant animals shall main tain copies of purchase invoices and la beling for all feeds containing animal protein products received, and make the copies available for inspection and copying by the Food and Drug Admin istration. (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. (2) Animal protein products, and feeds containing such products, that are not in compliance with the labeling requirements of paragraphs (c) through (f) of this section will be deemed mis branded under section 403(a)(1) or 403(f) 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 min imum of 1 year. (2) Written procedures required by this section shall be made available for inspection and copying by the Food and Drug Administration. [62 FR 30976, June 5, 1997, as amended at 73 FR 22756, Apr. 25, 2008] 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. § 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy. (a) Purpose. The purpose of this sec tion 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 pro hibited in animal feed include: (i) The entire carcass of BSE-positive cattle; (ii) The brains and spinal cords of cattle 30 months of age and older; (iii) The entire carcass of cattle not inspected and passed for human con sumption as defined in paragraph (b)(2) of this section that are 30 months of age or older from which brains and spi nal cords were not effectively removed or otherwise effectively excluded from animal feed; (iv) Mechanically separated beef as defined in paragraph (b)(3) of this sec tion that is derived from materials specified in paragraphs (b)(1)(i), (b)(1)(ii), and (b)(1)(iii) of this section; and (v) Tallow as defined in paragraph (b)(5) of this section that is derived from materials specified in paragraphs (b)(1)(i), (b)(1)(ii), and (b)(1)(iii) of this section. (vi) Cattle materials prohibited in animal feed do not include: (A) Tallow derivatives as defined in paragraph (b)(6) of this section; (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 ac cordance 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 Li brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar chives and Records Administration (NARA). For information on the avail ability 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. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00648 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 639 Food and Drug Administration, HHS § 589.2001 (C) Materials as defined in para graphs (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. (2) Cattle not inspected and passed for human consumption means cattle that did not pass antemortem inspection by the appropriate regulatory authority. This term includes nonambulatory dis abled cattle. Nonambulatory disabled cattle are cattle that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or meta bolic conditions. (3) Mechanically separated beef means a finely comminuted meat food prod uct, resulting from the mechanical sep aration and removal of most of the bone from attached skeletal muscle of cattle carcasses and parts of carcasses. (4) Renderer means any firm or indi vidual that processes slaughter byprod ucts, animals unfit for human con sumption, or meat scraps. The term in cludes persons who collect such mate rials and subject them to minimal processing, or distribute them to firms other than renderers (as defined in this paragraph) whose intended use for the products may include animal feed, in dustrial use, or other uses. The term includes renderers that also blend ani mal protein products. (5) Tallow means the rendered fat of cattle obtained by pressing or by ap plying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other car cass parts and tissues. (6) Tallow derivative means any prod uct obtained through initial hydrol ysis, saponification, or trans esterification of tallow; chemical con version of material obtained by hydrol ysis, saponification, or trans esterification may be applied to obtain the desired product. (c) Requirements. (1) No animal feed or feed ingredient shall be manufactured from, processed with, or otherwise con tain, cattle materials prohibited in animal feed as defined in paragraph (b)(1) of this section. (2) Renderers that receive, manufac ture, process, blend, or distribute cat tle materials prohibited in animal feed as defined in paragraph (b)(1) of this section, or products that contain or may contain cattle materials prohib ited in animal feed, shall take the fol lowing measures to ensure that mate rials prohibited as defined in paragraph (b)(1) of this section are not introduced into animal feed: (i) Exclude from use in animal feed the entire carcass of cattle not in spected and passed for human con sumption as defined in paragraph (b)(2) of this section if: (A) The brain and spinal cord are not effectively removed from such cattle or the brain and spinal cord from such cattle are not otherwise effectively ex cluded from animal feed; and (B) Such cattle are 30 months of age or older. (ii) If renderers remove brain and spi nal cord from cattle not inspected and passed for human consumption, or sep arate such animals based on whether or not they are 30 months of age or older, renderers must maintain adequate written procedures specifying how these processes are carried out. (iii) Once cattle materials prohibited in animal feed have been separated from other cattle materials, provide for measures to avoid cross-contamina tion; (A) Use separate equipment while handling cattle materials prohibited in animal feed; or (B) Use separate containers that ade quately prevent contact with animal feed, animal feed ingredients, or equip ment surfaces; (iv) Label the cattle materials pro hibited in animal feed and products that contain or may contain cattle ma terials prohibited in animal feed in a conspicuous manner as follows: ‘‘Do not feed to animals’’; (v) Mark the cattle materials prohib ited in animal feed and products that contain or may contain cattle mate rials prohibited in animal feed with an agent that can be readily detected on visual inspection; and (vi) Establish and maintain records sufficient to track cattle materials VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00649 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 640 21 CFR Ch. I (4–1–23 Edition) § 589.2001 prohibited in animal feed to ensure such material is not introduced into animal feed, and make the records available for inspection and copying by the Food and Drug Administration. (3) Renderers that receive, manufac ture, process, blend, or distribute any cattle materials shall take the fol lowing measures to ensure that mate rials prohibited as defined in paragraph (b)(1) of this section are not used in animal feed: (i) Establish and maintain records sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with, or does not otherwise contain, cattle ma terials prohibited in animal feed and make copies of all records available for inspection and copying by the Food and Drug Administration. With respect to cattle materials obtained from es tablishments which have segregated cattle materials prohibited in animal feed, such records must demonstrate that establishments supplying cattle materials to the renderers have ade quate procedures in place to effectively exclude cattle materials prohibited in animal feed; and these records shall be considered sufficient to meet this re quirement if they include either: (A) Certification or other documenta tion from the supplier that material supplied to the renderer does not in clude cattle materials prohibited in animal feed; such certification or docu mentation is acceptable, provided that it includes a description of the segrega tion procedures used, documentation that the supplier confirms that its seg regation procedures are in place prior to supplying any cattle material to the renderer, and records of the renderer’s periodic review of the suppliers’ certifi cation or other documentation; or (B) Documentation of another meth od acceptable to FDA, such as third party certification, for verifying that suppliers have effectively excluded cat tle materials prohibited in animal feed. (ii) Comply with all applicable re quirements under § 589.2000 regarding animal proteins prohibited in ruminant feed. (d) Adulteration and misbranding. (1) Failure of a renderer to comply with the requirements in paragraphs (c)(2)(i) through (c)(2)(iii), (c)(2)(v) and (c)(2)(vi), or (c)(3)(i) of this section will render the animal feed or feed ingredi ents adulterated under section 402(a)(4) of the Federal Food, Drug, and Cos metic Act (the act). (2) Animal feed or feed ingredients that are not in compliance with para graph (c)(1) of this section are adulter ated under section 402(a)(2), 402(a)(3), or 402(a)(5) of the act. (3) Animal feed or feed ingredients that are not in compliance with the la beling requirements of paragraph (c)(2)(iv) of this section are misbranded under section 403(a)(1) or 403(f) of the act. (4) Failure of a renderer to comply with the requirements in paragraph (e) of this section will render the animal feed or feed ingredients adulterated under section 402(a)(4) of the act. (e) Inspection; records retention. Records required to be made available for inspection and copying by the Food and Drug Administration, as required by this section, shall be kept for a min imum of 1 year. (f) Process for designating countries. A country seeking designation must send a written request to the Director, Of fice 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 mate rials 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 re quest 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 re view by FDA and may be revoked if FDA determines that the granted re quest is no longer appropriate. [73 FR 22756, Apr. 25, 2008, as amended at 81 FR 5596, Feb. 3, 2016] PARTS 590–599 [RESERVED] VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00650 Fmt 8010 Sfmt 8006 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B