Source: https://www.federalregister.gov/documents/2012/12/05/2012-29322/new-animal-drugs-updating-tolerances-for-residues-of-new-animal-drugs-in-food
Timestamp: 2016-10-01 07:13:07
Document Index: 409770183

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:: New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
A Proposed Rule by the Food and Drug Administration on 12/05/2012
72254-72268
1. Scope (Proposed § 556.1)
2. Definitions (Proposed § 556.3)
3. General Considerations (Proposed § 556.5)
https://www.federalregister.gov/d/2012-29322
12/04/2012 at 08:45 am.
Dong Yan, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8117, email: dong.yan@fda.hhs.gov.
Sections 512(b)(1)(H), 512(i), and 571(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(b)(1)(H), 360b(i), and 360ccc(a)(2)(A)) provide the authority for the Secretary of Health and Human Services (the Secretary) to establish and publish regulations setting tolerances for residues of approved and conditionally approved new animal drugs. The Secretary delegated this authority to the Commissioner of Food and Drugs. FDA's regulations setting forth the tolerances for residues of new animal drugs in food are codified in part 556 of Title 21 of the Code of Federal Regulations (21 CFR part 556) (40 FR 13802 at 13942, March 27, 1975). The part 556 regulations describe general considerations regarding tolerances for residues of new animal drugs in food in subpart A and specific tolerances for residues of new animal drugs in subpart B. Subpart B has been amended frequently as new animal drugs have been approved for use in food-producing animals. Food from treated animals with new animal drug residues that exceed established tolerances is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act (21 U.S.C. 342(a)(2)(C)(ii)).
From the mid-1970s to the present, FDA's human food safety evaluation of animal drug residues has evolved with advancements in science. As a result, the procedures described in the existing § 556.1 for setting drug tolerances no longer accurately reflect current regulatory science. In addition, current part 556 employs a patchwork of various styles for listing tolerances that have evolved over the past 40 years. As a result, the listings in part 556 are not uniform in format, and, in some instances, do not provide all relevant information in a consistent manner. For example, the regulations provide the ADI and safe concentrations for some, but not all, drugs. In addition, the regulations list some tolerances as being for “negligible” residue, and others as “no residue,” “zero,” or “not required,” but they do not explain what these important terms mean. The proposed rule addresses these inconsistencies by simplifying and standardizing the determination standards and codification style and by adding definitions for key terms.
FDA proposes to revise part 556 by standardizing and simplifying the codification style and adding definitions for key terms. First, proposed § 556.1 provides a revised scope for part 556. Second, proposed § 556.3 provides definitions of key terms FDA uses in the regulations. Third, proposed § 556.5 explains the general considerations for using the tolerance information for veterinary drug residues. Finally, FDA proposes a uniform format for listing tolerances in subpart B, by, among other things, removing obsolete or confusing terms and cross-referencing tolerances to the approved conditions of use for that new animal drug.
FDA proposes to delete existing § 556.1 (“General considerations; tolerances for residues of new animal drugs in food”) and replace it with a description of the scope. FDA proposes to discuss general considerations for setting tolerances in new § 556.5.
Proposed § 556.1 reiterates the requirement in sections 512(b)(1)(H) and 571(a)(2)(A) of the FD&C Act that applicants seeking approval or conditional approval of new animal drugs must submit a proposed tolerance as part of new animal drug applications when necessary to assure that the proposed use of the new animal drug will be safe. The proposed section states that FDA assigns tolerances for animal drugs used in food-producing animals as part of the application approval process and then codifies them in subpart B of part 556. Proposed § 556.1 also clarifies that compounds that have been found to be carcinogenic are regulated under subpart E of part 500 (21 CFR part 500).
FDA proposes to define in § 556.3 certain key terms used in animal drug residue chemistry and some terms frequently used in part 556. In the proposed rule, the definitions appear in alphabetical order. In this preamble, the definitions are discussed in an order that facilitates the explanation of the interrelated concepts the terms represent.
First, over the years, many people have mistakenly believed the term “zero” with respect to tolerances to mean there could be no residue remaining in an edible tissue. However, FDA acknowledges that some residue will remain in the animal, even if below a detectable level, and that a complete lack of drug residue is not achievable. In approving certain animal drugs, FDA assigned a “zero” tolerance, with “zero” meaning that no residues could be detected using the approved analytical method to detect residues of that drug. Often, the analytical method chosen to determine “zero” represented the limit of technology at the time. FDA no longer assigns “zero” tolerances for new approvals, but instead assigns a tolerance for a drug based on a toxicological and residue chemistry evaluation (see proposed § 556.5). However, FDA is not proposing to remove the previously assigned “zero” tolerances from the regulations at this time.
Second, FDA uses the term “no residue” to apply specifically to compounds of carcinogenic concern. Under section 512(d)(1)(I) of the FD&C Act, “no residue” of any drug that induces cancer when ingested by man or animal is allowed in any edible tissue of a food-producing animal, when tested using methods of examination prescribed or approved by FDA. FDA historically has interpreted the term “no residue” to mean that any residue in the target tissue must be non-detectable or below the limit of detection of the approved regulatory method (67 FR 78172, December 23, 2002). Consistent with this interpretation, FDA is proposing to define “no residue” to mean that the marker residue is below the limit of detection using the approved regulatory method. FDA is proposing to add this definition to § 500.82 under subpart E entitled “Regulation of Carcinogenic Compounds Used in Food-Producing Animals.”
Proposed § 556.5(a) states that tolerances published in subpart B of part 556 pertain only to the species and production classes of the animal for which the drug use has been approved or conditionally approved. The proposed rule provides the approved use and conditionally approved use conditions, including species and production classes, in each tolerance listing under “(c) Related conditions of use.” Tolerances are not provided for extralabel (e.g., use in species or production classes in which the drug is not approved for use.) Extralabel use resulting in any residue above an established safe level or tolerance is unlawful and renders the drug product adulterated under section 501(a)(5) of the FD&C Act (21 U.S.C. 351(a)(5)), in that it is unsafe within the meaning of section 512 of the FD&C Act.
Proposed § 556.5(b) states that all tolerances refer to the concentrations of a marker residue, or other residue indicated for monitoring, permitted in uncooked tissues.
Proposed § 556.5(c) states that a finding that the concentration of a marker residue is at or below the tolerance in the target tissue from a tested animal indicates that all edible tissues (excluding milk and eggs unless otherwise specified) from that animal are safe. In the proposed listing format, if a listed tolerance is linked to a target tissue, the phrase “target tissue” will appear in parentheses immediately after the identified tissue. If a listed tolerance is not expressly linked to a target tissue, then the tolerance is meant to apply only to the named edible tissue, and inferences cannot be made about the safety of the other edible tissues from the target animal.
Proposed § 556.5(d) states that FDA requires that a drug sponsor develop a regulatory method to measure drug residues in edible tissues of approved target species at concentrations around the tolerance as provided in § 514.1(b)(7) of this chapter. The tolerance is directly tied to the approved regulatory method because FDA determines the tolerance using data collected with that method.
FDA proposes to revise subpart B by deleting tolerances for certain drugs (or species of animals) whose approvals have been withdrawn, but the corresponding tolerances were not removed from the part 556 listing; and adding tolerances for approved drugs not previously listed in this subpart. Specifically, FDA proposes to delete the tolerances for clopidol for all species other than chickens and turkeys (§ 556.160) and nystatin for swine (§ 556.470). FDA proposes to add tolerance listings for: Azaperone, bambermycins, coumaphos, efrotomycin, fenprostalene (swine), fenthion, flurogestone, and poloxalene.
Note that some listings provide more than one tolerance. For example, tilmicosin in cattle (§ 556.735(b)(1)) includes the following information: A marker residue (tilmicosin), a target tissue (liver), a tolerance of 1.2 ppm for tilmicosin in liver of cattle, and a tolerance of 0.1 ppm for tilmicosin in muscle of cattle.
2. Amend § 500.82, in paragraph (b), by alphabetically adding a definition for “no residue” to read as follows:
§ 500.82 Definitions.
4. In § 520.1840, revise paragraph (c) to read as follows:
§ 520.1840 Poloxalene.
(c) Related tolerances. See § 556.517 of this chapter.
5. In § 520.2640, revise paragraph (c) to read as follows:
§ 520.2640 Tylosin.
(c) Related tolerances. See § 556.746 of this chapter.
7. In § 522.770, revise paragraph (c) to read as follows:
§ 522.770 Doramectin.
(c) Related tolerances. See § 556.222 of this chapter.
8. In § 522.2640, revise paragraph (d) to read as follows:
§ 522.2640 Tylosin.
(d) Related tolerances. See § 556.746 of this chapter.
10. In § 524.920, revise paragraph (c)(4) to read as follows:
§ 524.920 Fenthion.
(4) Related tolerances. See § 556.280 of this chapter.
12. In § 529.1003, add paragraph (d) to read as follows:
§ 529.1003 Flurogestone acetate-impregnated vaginal sponge.
(d) Related tolerances. See § 556.290 of this chapter.
§ 556.1 Scope.
§ 556.3 Definitions.
§ 556.5 General considerations.
(d) FDA requires that a drug sponsor develop a regulatory method to measure drug residues in edible tissues of approved target species at concentrations around the tolerance as provided in § 514.1(b)(7) of this chapter. Because FDA determines the tolerance for the marker residue using data collected with the approved regulatory method, the tolerance is directly tied to that method. Approved regulatory methods are available from the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
§ 556.34 Albendazole.
§ 556.36 Altrenogest.
(c) Related conditions of use. See § 520.48 of this chapter.
§ 556.38 Amoxicillin.
(c) Related conditions of use. See §§ 520.88, 522.88, and 526.88 of this chapter.
§ 556.40 Ampicillin.
(c) Related conditions of use. See §§ 520.90e, 520.90f, and 522.90 of this chapter.
§ 556.50 Amprolium.
(c) Related conditions of use. See §§ 520.100, 558.55, and 558.58 of this chapter.
§ 556.52 Apramycin.
(c) Related conditions of use. See §§ 520.110 and 558.59 of this chapter.
§ 556.60 Arsenic.
(c) Related conditions of use. See §§ 520.2087, 520.2088, 520.2089, 558.62, 558.120, 558.369, and 558.530 of this chapter.
§ 556.68 Azaperone.
(c) Related conditions of use. See § 522.150 of this chapter.
§ 556.70 Bacitracin.
(c) Related conditions of use. See §§ 520.154, 558.76, and 558.78 of this chapter.
§ 556.75 Bambermycins.
(c) Related conditions of use. See § 558.95 of this chapter.
§ 556.100 Carbadox.
(c) Related conditions of use. See § 558.115 of this chapter.
§ 556.110 Carbomycin.
(c) Related conditions of use. See § 520.1660a of this chapter.
§ 556.113 Ceftiofur.
(c) Related conditions of use. See §§ 522.313 and 526.313 of this chapter.
§ 556.115 Cephapirin.
(c) Related conditions of use. See §§ 526.363 and 526.365 of this chapter.
§ 556.120 Chlorhexidine.
(c) Related conditions of use. See § 529.400 of this chapter.
§ 556.150 Chlortetracycline.
(iii) Muscle: 2 ppm. (c) Related conditions of use. See §§ 520.445, 558.128, 558.145, and 558.155 of this chapter.
§ 556.160 Clopidol.
(c) Related conditions of use. See § 558.175 of this chapter.
§ 556.163 Clorsulon.
(c) Related conditions of use. See §§ 520.462 and 522.1193 of this chapter.
§ 556.165 Cloxacillin.
(c) Related conditions of use. See § 526.464 of this chapter.
§ 556.167 Colistimethate.
(c) Related conditions of use. See § 522.468 of this chapter.
§ 556.168 Coumaphos.
(c) Related conditions of use. See § 558.185 of this chapter.
§ 556.169 Danofloxacin.
(c) Related conditions of use. See § 522.522 of this chapter.
§ 556.170 Decoquinate.
(c) Related conditions of use. See § 558.195 of this chapter.
§ 556.180 Dichlorvos.
(c) Related conditions of use. See § 558.205 of this chapter.
§ 556.185 Diclazuril.
(c) Related conditions of use. See § 558.198 of this chapter.
§ 556.200 Dihydrostreptomycin.
(c) Related conditions of use. See §§ 520.2158b, 520.2158c, 522.650, and 526.1696b of this chapter.
§ 556.222 Doramectin.
(c) Related conditions of use. See §§ 522.770 and 524.770 of this chapter.
§ 556.224 Efrotomycin.
(c) Related conditions of use. See § 558.235 of this chapter.
§ 556.226 Enrofloxacin.
(c) Related conditions of use. See § 522.812 of this chapter.
§ 556.227 Eprinomectin.
(b) Tolerances. The tolerances for eprinomectin B1a (marker residue) are:
(c) Related conditions of use. See §§ 522.814 and 524.814 of this chapter.
§ 556.230 Erythromycin.
(c) Related conditions of use. See §§ 520.823, 522.820, 526.820, and 558.248 of this chapter.
§ 556.240 Estradiol and related esters.
(2) [Reserved] (c) Related conditions of use. See §§ 522.840, 522.842, 522.850, 522.1940, 522.2477, and 522.2478 of this chapter.
§ 556.260 Ethopabate.
(c) Related conditions of use. See § 558.58 of this chapter.
§ 556.273 Famphur.
(c) Related conditions of use. See §§ 520.1242g, 524.900, and 558.254 of this chapter.
§ 556.275 Fenbendazole.
(c) Related conditions of use. See §§ 520.905 and 558.258 of this chapter.
§ 556.277 Fenprostalene.
(c) Related conditions of use. See § 522.914 of this chapter.
§ 556.280 Fenthion.
(c) Related conditions of use. See § 524.920 of this chapter.
§ 556.283 Florfenicol.
(c) Related conditions of use. See §§ 520.955, 522.955, 522.956, and 558.261 of this chapter.
§ 556.286 Flunixin.
(c) Related conditions of use. See §§ 522.956 and 522.970 of this chapter.
§ 556.290 Flurogestone.
(c) Related conditions of use. See § 529.1003 of this chapter.
§ 556.292 Gamithromycin.
(c) Related conditions of use. See § 522.1014 of this chapter.
§ 556.300 Gentamicin.
(c) Related conditions of use. See §§ 522.1044, 524.1044e, and 529.1044b of this chapter.
§ 556.304 Gonadotropin.
(c) Related conditions of use. See §§ 522.1077, 522.1078, 522.1079, and 522.1081 of this chapter.
§ 556.308 Halofuginone.
(c) Related conditions of use. See § 558.265 of this chapter.
§ 556.310 Haloxon.
(c) Related conditions of use. See § 520.1120 of this chapter.
§ 556.330 Hygromycin B.
(c) Related conditions of use. See § 558.274 of this chapter.
§ 556.344 Ivermectin.
(b) Tolerances. The tolerances for 22,23-dihydroavermectin B1 a (marker residue) are: (1) American bison—Liver (target tissue): 15 ppb.
(4) Sheep— Liver (target tissue): 30 ppb.
§ 556.346 Laidlomycin.
(c) Related conditions of use. See § 558.305 of this chapter.
§ 556.347 Lasalocid.
(c) Related conditions of use. See § 558.311 of this chapter.
§ 556.350 Levamisole.
(c) Related conditions of use. See §§ 520.1242, 522.1244, and 524.1240 of this chapter.
§ 556.360 Lincomycin.
(c) Related conditions of use. See §§ 520.1263b, 520.1263c, 522.1260, and 558.325 of this chapter.
§ 556.375 Maduramicin.
(c) Related conditions of use. See § 558.340 of this chapter.
§ 556.380 Melengestrol.
(c) Related conditions of use. See § 558.342 of this chapter.
§ 556.410 Metoserpate.
(c) Related conditions of use. See § 520.1422 of this chapter.
§ 556.420 Monensin.
(c) Related conditions of use. See § 558.355 of this chapter.
§ 556.425 Morantel.
(c) Related conditions of use. See §§ 520.1450 and 558.360 of this chapter.
§ 556.426 Moxidectin.
(c) Related conditions of use. See §§ 520.1454, 522.1450, and 524.1450 of this chapter.
§ 556.428 Narasin.
(c) Related conditions of use. See § 558.363 of this chapter.
§ 556.430 Neomycin.
(c) Related conditions of use. See §§ 520.1484, 524.1600b, and 558.364 of this chapter.
§ 556.440 Nequinate.
(2) [Reserved] (c) Related conditions of use. See § 558.365 of this chapter.
§ 556.445 Nicarbazin.
(c) Related conditions of use. See § 558.366 of this chapter.
§ 556.460 Novobiocin.
(c) Related conditions of use. See §§ 526.1590, 526.1696d, and 558.415 of this chapter.
§ 556.470 Nystatin.
(c) Related conditions of use. See §§ 524.1600b and 558.430 of this chapter.
§ 556.480 Oleandomycin.
(c) Related conditions of use. See § 558.435 of this chapter.
§ 556.490 Ormetoprim.
(c) Related conditions of use. See § 558.575 of this chapter.
§ 556.495 Oxfendazole.
(c) Related conditions of use. See §§ 520.1629 and 520.1630 of this chapter.
§ 556.500 Oxytetracycline.
(c) Related conditions of use. See §§ 520.1660, 522.1660, 522.1662, 524.1662b, 529.1660, and 558.450 of this chapter.
§ 556.510 Penicillin.
(c) Related conditions of use. See §§ 520.1696, 522.1696, 526.1696, and 558.460 of this chapter.
§ 556.513 Piperazine.
(c) Related conditions of use. See § 520.1807 of this chapter.
§ 556.515 Pirlimycin.
(c) Related conditions of use. See § 526.1810 of this chapter.
§ 556.517 Poloxalene.
(c) Related conditions of use. See §§ 520.1840, 558.464, and 558.465 of this chapter.
§ 556.540 Progesterone.
(c) Related conditions of use. See §§ 522.1940 and 529.1940 of this chapter.
§ 556.560 Pyrantel.
(c) Related conditions of use. See §§ 520.2045 and 558.485 of this chapter.
§ 556.570 Ractopamine.
(c) Related conditions of use. See § 558.500 of this chapter.
§ 556.580 Robenidine.
(c) Related conditions of use. See § 558.515 of this chapter.
§ 556.592 Salinomycin.
(c) Related conditions of use. See § 558.550 of this chapter.
§ 556.597 Semduramicin.
(c) Related conditions of use. See § 558.555 of this chapter.
§ 556.600 Spectinomycin.
(c) Related conditions of use. See §§ 520.1265, 520.2123b, 520.2123c, 522.2120, and 522.2121 of this chapter.
§ 556.610 Streptomycin.
(c) Related conditions of use. See § 520.2158 of this chapter.
§ 556.620 Sulfabromomethazine.
(c) Related conditions of use. See § 520.2170 of this chapter.
§ 556.625 Sulfachloropyrazine.
(c) Related conditions of use. See § 520.2184 of this chapter.
§ 556.630 Sulfachlorpyridazine.
(c) Related conditions of use. See §§ 520.2200 and 522.2200 of this chapter.
§ 556.640 Sulfadimethoxine.
(c) Related conditions of use. See §§ 520.2220, 522.2220, and 558.575 of this chapter.
§ 556.650 Sulfaethoxypyridazine.
(c) Related conditions of use. See §§ 520.2240 and 522.2240 of this chapter.
§ 556.660 Sulfamerazine.
(c) Related conditions of use. See § 558.582 of this chapter.
§ 556.670 Sulfamethazine.
(c) Related conditions of use. See §§ 520.2260, 520.2261, 522.2260, 558.145, and 558.630 of this chapter.
§ 556.685 Sulfaquinoxaline.
(c) Related conditions of use. See §§ 520.2325 and 558.586 of this chapter.
§ 556.690 Sulfathiazole.
(c) Related conditions of use. See § 558.155 of this chapter.
§ 556.700 Sulfomyxin.
(c) Related conditions of use. See § 522.2340 of this chapter.
§ 556.710 Testosterone.
(c) Related conditions of use. See § 522.842 of this chapter.
§ 556.720 Tetracycline.
(c) Related conditions of use. See §§ 520.2345c and 520.2345d of this chapter.
§ 556.730 Thiabendazole.
(c) Related conditions of use. See §§ 520.2380a, 520.2380b, 520.2380c, and 558.615 of this chapter.
§ 556.733 Tildipirosin.
(c) Related conditions of use. See § 522.2460 of this chapter.
§ 556.735 Tilmicosin.
(c) Related conditions of use. See §§ 522.2471 and 558.618 of this chapter.
§ 556.738 Tiamulin.
(c) Related conditions of use. See §§ 520.2455 and 558.600 of this chapter.
§ 556.739 Trenbolone.
(c) Related conditions of use. See §§ 522.2476, 522.2477, and 522.2478 of this chapter.
§ 556.741 Tripelennamine.
(c) Related conditions of use. See § 522.2615 of this chapter.
§ 556.745 Tulathromycin.
§ 556.746 Tylosin.
(c) Related conditions of use. See §§ 520.2640, 522.2640, 558.625, and 558.630 of this chapter.
§ 556.748 Tylvalosin.
(c) Related conditions of use. See § 520.2645 of this chapter.
§ 556.750 Virginiamycin.
(c) Related conditions of use. See § 558.635 of this chapter.
§ 556.760 Zeranol.
(c) Related conditions of use. See § 522.2680 of this chapter.
§ 556.765 Zilpaterol.
(c) Related conditions of use. See § 558.665 of this chapter.
§ 556.770 Zoalene.
(c) Related conditions of use. See § 558.680 of this chapter.
16. In § 558.95, add paragraph (c) to read as follows:
§ 558.95 Bambermycins.
(c) Related tolerances. See § 556.75 of this chapter.
17. In § 558.185, revise paragraph (c) to read as follows:
§ 558.185 Coumaphos.
(c) Related tolerances. See § 556.168 of this chapter.
18. In § 558.235, add paragraph (c) to read as follows:
§ 558.235 Efrotomycin.
(c) Related tolerances. See § 556.224 of this chapter.
19. In § 558.464, add paragraph (c) to read as follows:
§ 558.464 Poloxalene.
20. In § 558.465, add paragraph (c) to read as follows:
§ 558.465 Poloxalene free-choice liquid Type C feed.
21. In § 558.625, revise paragraph (e) to read as follows:
§ 558.625 Tylosin.
(e) Related tolerances. See § 556.746 of this chapter.
22. In § 558.630, revise paragraph (d) to read as follows:
§ 558.630 Tylosin and sulfamethazine.
(d) Related tolerances. See §§ 556.670 and 556.746 of this chapter.