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List of Subjects in 14 CFR Part 39 Section, Transport Standards Branch, FAA, Issued in Des Moines, Washington, on July has the authority to approve AMOCs for this 3, 2019. Air transportation, Aircraft, Aviation AD, if requested using the procedures found Dionne Palermo, safety, Incorporation by reference, in 14 CFR 39.19. In accordance with 14 CFR Safety. Acting Director, System Oversight Division, 39.19, send your request to your principal Aircraft Certification Service. Adoption of the Amendment inspector or local Flight Standards District Office, as appropriate. If sending information [FR Doc. 2019–14726 Filed 7–10–19; 8:45 am] Accordingly, under the authority directly to the International Section, send it BILLING CODE 4910–13–P delegated to me by the Administrator, to the attention of the person identified in the FAA amends 14 CFR part 39 as paragraph (i)(2) of this AD. Information may follows: be emailed to: 9-ANM-116-AMOC- DEPARTMENT OF HEALTH AND [email protected]. Before using any HUMAN SERVICES PART 39—AIRWORTHINESS approved AMOC, notify your appropriate DIRECTIVES principal inspector, or lacking a principal Food and Drug Administration inspector, the manager of the local flight ■ 1. The authority citation for part 39 standards district office/certificate holding 21 CFR Parts 500, 520, 522, 524, 526, continues to read as follows: district office. 529, 556, and 558 Authority: 49 U.S.C. 106(g), 40113, 44701. (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective [Docket No. FDA–2012–N–1067] actions from a manufacturer, the action must § 39.13 [Amended] RIN 0910–AG17 be accomplished using a method approved ■ 2. The FAA amends § 39.13 by adding by the Manager, International Section, New Animal Drugs; Updating the following new airworthiness Transport Standards Branch, FAA; or the directive (AD): European Aviation Safety Agency (EASA); or Tolerances for Residues of New Animal Drugs in Food 2019–10–02 Saab AB, Saab Aeronautics Saab AB, Saab Aeronautics’ EASA Design Organization Approval (DOA). If approved by (Formerly Known as Saab AB, Saab AGENCY: Food and Drug Administration, the DOA, the approval must include the Aerosystems): Amendment 39–19641; HHS. Docket No. FAA–2018–1067; Product DOA-authorized signature. Identifier 2018–NM–158–AD. ACTION: Final rule; technical (i) Related Information amendments. (a) Effective Date (1) Refer to Mandatory Continuing This AD is effective August 15, 2019. Airworthiness Information (MCAI) EASA AD SUMMARY: The Food and Drug 2018–0240, dated November 7, 2018, for Administration (FDA, the Agency, or (b) Affected ADs related information. This MCAI may be we) is issuing a final rule to revise the None. found in the AD docket on the internet at animal drug regulations for tolerances (c) Applicability http://www.regulations.gov by searching for for residues of approved new animal and locating Docket No. FAA–2018–1067. drugs. This final rule is necessary to This AD applies to Saab AB, Saab (2) For more information about this AD, standardize, simplify, and clarify the Aeronautics Model SAAB 2000 airplanes, contact Shahram Daneshmandi, Aerospace certificated in any category, all serial Engineer, International Section, Transport determination standards of tolerances numbers. Standards Branch, FAA, 2200 South 216th and provide definitions for key terms. (d) Subject St., Des Moines, WA 98198; telephone and This final rule will enhance Air Transport Association (ATA) of fax: 206–231–3220. understanding of tolerance determination and improve the overall America Code 22, Auto flight. (j) Material Incorporated by Reference readability of the relevant regulations. (e) Reason (1) The Director of the Federal Register DATES: This rule is effective September approved the incorporation by reference This AD was prompted by an event where 9, 2019. the airplane did not respond to the (IBR) of the service information listed in this flightcrew’s flight control inputs because the paragraph under 5 U.S.C. 552(a) and 1 CFR ADDRESSES: For access to the docket to pitch trim switches did not disconnect the part 51. read background documents or autopilot. We are issuing this AD to address (2) You must use this service information comments received, go to https:// events where the airplane does not respond as applicable to do the actions required by www.regulations.gov and insert the to the flightcrew’s flight control inputs this AD, unless this AD specifies otherwise. docket number found in brackets in the because the autopilot remains engaged, (i) Saab Service Bulletin 2000–22–008, heading of this final rule into the possibly resulting in loss of control of the dated June 15, 2018. ‘‘Search’’ box and follow the prompts, airplane. (ii) [Reserved] (3) For service information identified in and/or go to the Dockets Management (f) Compliance this AD, contact Saab AB, Saab Aeronautics, Staff, 5630 Fishers Lane, Rm. 1061, Comply with this AD within the SE–581 88, Linko¨ping, Sweden; telephone Rockville, MD 20852. compliance times specified, unless already +46 13 18 5591; fax +46 13 18 4874; email FOR FURTHER INFORMATION CONTACT: done. [email protected]; Dong Yan, Center for Veterinary (g) Modification internet http://www.saabgroup.com. Medicine (HFV–151), Food and Drug (4) You may view this service information Within 3,000 flight hours or 24 months Administration, 7500 Standish Pl., at the FAA, Transport Standards Branch, after the effective date of this AD, whichever Rockville, MD 20855, 240–402–0825, 2200 South 216th St., Des Moines, WA. For occurs first: Modify the wiring for the email: [email protected]. autopilot disconnect logic, in accordance information on the availability of this SUPPLEMENTARY INFORMATION: with the Accomplishment Instructions of material at the FAA, call 206–231–3195. (5) You may view this service information Saab Service Bulletin 2000–22–008, dated Table of Contents June 15, 2018. that is incorporated by reference at the National Archives and Records I. Executive Summary (h) Other FAA AD Provisions Administration (NARA). For information on A. Purpose and Coverage of the Final Rule The following provisions also apply to this the availability of this material at NARA, call B. Summary of the Major Provisions of the AD: 202–741–6030, or go to: http:// Final Rule (1) Alternative Methods of Compliance www.archives.gov/federal-register/cfr/ibr- C. Legal Authority (AMOCs): The Manager, International locations.html. D. Costs and Benefits

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II. Table of Abbreviations/Commonly Used listings and to add cross references to (77 FR 72254) (2012 proposed rule) to Acronyms in This Document part 520, 522, 524, 526, 529, or 558 (21 revise part 556 by standardizing and III. Background CFR part 520, 522, 524, 526, 529, or 558) simplifying the codification style, A. History and Scope of This Rulemaking that contain the approved or revising the general considerations B. General Overview of the Final Rule IV. Legal Authority conditionally approved conditions of section, adding a scope section, and V. Comments on the 2012 Proposed Rule and use of the drug. adding a definition section to define key terms used in the part. The definition 2016 Supplemental Proposed Rule and C. Legal Authority FDA Response section was proposed to include the A. Introduction Our authority for issuing this final terms used by FDA in the determination B. Comments on Scope rule is provided by sections 512(b)(1)(G) of tolerances. We proposed a definition C. Comments on Definition Section and (H), (d)(1)(F), (d)(2), and (i), and section because some of the terms that D. Comments on Analytical Method 571(a)(2)(A) and (b)(1) of the Federal had been used previously in part 556, E. Comments on Subpart B, Listing of Food, Drug, and Cosmetic Act (FD&C Tolerances for Residues of Approved and subpart B were never defined, and some Conditionally Approved New Animal Act) (21 U.S.C. 360b(b)(1)(G) and (H), terminology that had been used was Drugs (d)(1)(F), (d)(2), and (i), and outdated or resulted in confusion to F. Other Comments 360ccc(a)(2)(A) and (b)(1)). These users of the part. We added a new scope VI. Effective/Compliance Date provisions relate to the information new section and proposed a revision to the VII. Economic Analysis of Impacts animal drug and conditional new general considerations section to VIII. Analysis of Environmental Impact animal drug applicants provide with provide additional information and IX. Paperwork Reduction Act of 1995 respect to proposed tolerances, clarification with respect to the X. Federalism withdrawal periods, and practicable tolerances listed in proposed subpart B. XI. Consultation and Coordination With methods, and the process by which FDA Indian Tribal Governments We issued a supplemental notice of XII. References establishes and publishes regulations proposed rulemaking in the Federal setting tolerances for residues of Register of October 28, 2016 (81 FR I. Executive Summary approved and conditionally approved 74962) (2016 supplemental proposed A. Purpose and Coverage of the Final new animal drugs. In addition, section rule) to revise the proposed changes to Rule 701(a) of the FD&C Act (21 U.S.C. part 556 to align with and clarify our 371(a)) gives FDA general rulemaking This final rule revises the animal drug current thinking. We explained our authority to issue regulations for the current thinking about analytical regulations regarding tolerances for efficient enforcement of the FD&C Act. residues of approved and conditionally methods used to determine residue approved new animal drugs in food. D. Costs and Benefits levels in tissues for new animal drugs intended for use in food-producing Specifically, we provide a revised scope This final rule will not impose animals. We also explained that and new section for definitions of key compliance costs, other than reading methods other than the ‘‘regulatory terms FDA uses in the regulations. and understanding the final rule, on method’’ derived from the practicable Additionally, we explain the general current or future sponsors of any method submitted by a sponsor as part considerations for using the tolerance approved and conditionally approved of the new animal drug application can information to ensure the safety of new animal drugs. We estimate those be used to determine the quantity of veterinary drug use in food-producing annualized costs to range from about residue in edible tissues for surveillance animals. Finally, we provide a uniform $1,000 to about $1,500. format for listing tolerances in part 556 By providing a uniform format for and enforcement purposes. We removed (21 CFR part 556), subpart B, by listing tolerances, and removing the definition previously proposed in removing obsolete or confusing terms obsolete and confusing terms, this final 2012 for ‘‘regulatory method’’ and an and cross-referencing tolerances to the rule may provide more clarity to the additional reference to the term to approved conditions of use for that new listing of tolerances. reserve the term for use with animal drug. carcinogenic compounds. We also II. Table of Abbreviations/Commonly revised the previously proposed B. Summary of the Major Provisions of Used Acronyms in This Document definitions for ‘‘marker residue,’’ the Final Rule ‘‘tolerance,’’ ‘‘not required,’’ and ‘‘zero.’’ Abbreviation What it means This final rule standardizes and We also removed the previously clarifies the standards for determining, ARfD ...... Acute reference dose. proposed definition for ‘‘acceptable codifying, and updating tolerances, and ASDI ...... Acceptable single-dose intake. single-dose intake’’ and added a CFR ...... Code of Federal Regulations. provides a definition section. Major CVM ...... Center for Veterinary Medicine. proposed definition for ‘‘acute reference provisions include: FDA ...... U.S. Food and Drug Administration. dose’’ to be consistent with existing • Establishing a new definitions FD&C Act ...... Federal Food, Drug, and Cosmetic international guidance. section with the following definitions in Act. FSIS ...... Food Safety and Inspection Service, B. General Overview of the Final Rule § 556.3 (21 CFR 556.3): United States Department of Agri- Æ Acceptable daily intake; This final rule revises the animal drug Æ culture. Acute reference dose; GFI ...... Guidance for Industry. regulations regarding tolerances for Æ Edible tissues; VICH ...... International Cooperation on residues of approved and conditionally Æ Marker residue; Harmonisation of Technical Re- Æ quirements for Registration of approved new animal drugs in food. We Not required; are finalizing most of the provisions Æ Residue; Veterinary Medicinal Products. Æ Target tissue; proposed in the 2012 proposed rule as Æ Tolerance; III. Background revised by the 2016 supplemental Æ proposed rule. This final rule also Total residue; A. History and Scope of This Æ mg/kg; and reflects revisions FDA made after Æ Zero. Rulemaking considering all comments received. We • Revising the tolerance listings in We issued a proposed rule in the have also made nonsubstantive wording subpart B to standardize the format of Federal Register of December 5, 2012 changes for clarity.

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This final rule amends part 556 by B. Comments on Scope considered to be safe or an adequate standardizing and simplifying the (Comment 1) One comment to the withdrawal period was inherent in the codification style and adding definitions 2012 proposed rule asks FDA to clarify proposed drug use, and there was no for key terms. Specifically, we provide whether the proposed regulations would concern about residues resulting from a revised scope and new section for apply to drug residues in all foods misuse or overdosing; or (2) the drug definitions of key terms FDA uses in the (human and animal food), or only to qualified for a zero withdrawal period regulations. Additionally, we explain human foods. because it was poorly absorbed or the general considerations for using the (Response 1) The regulations apply metabolized rapidly to such an extent as tolerance information to ensure the only to foods intended for human to make selection of an analyte impractical or impossible. The comment safety of veterinary drug use in food- consumption. New § 556.5(c) (21 CFR proposes that conditions (1) and (2) be producing animals. Finally, we provide 556.5(c)) states in part ‘‘. . . the finding replaced with: ‘‘(1) no withdrawal a uniform format for listing tolerances in that the concentration of the marker period (i.e., zero withdrawal) was subpart B, by removing obsolete or residue in the target tissue from a tested necessary for residues of the drug to confusing terms and cross-referencing animal is at or below the tolerance deplete to or below the concentrations tolerances to the approved conditions of indicates that all edible tissues considered to be safe, or (2) an adequate use for that new animal drug. (excluding milk and eggs unless withdrawal period was inherent in the otherwise indicated) from that tested IV. Legal Authority proposed drug use, or (3) there was no animal are safe for human We are issuing this final rule under concern about residues resulting from consumption.’’ sections 512(b)(1)(G) and (H), (d)(1)(F), misuse or overdosing, or (4) the drug (d)(2), and (i), and 571(a)(2)(A) and C. Comments on Definition Section was poorly absorbed or metabolized rapidly to such an extent as to make (b)(1) of the FD&C Act. These provisions We received several comments selection of an analyte impractical or relate to the information new animal regarding proposed definitions. impossible.’’ drug and conditional new animal drug (Comment 2) One comment to the Additionally, a comment to the 2016 applicants provide with respect to 2012 proposed rule expresses concern supplemental proposed rule asks FDA proposed tolerances, withdrawal that the term ‘‘edible tissues’’ as defined periods, and practicable methods, and to explain what revisions were made to in the proposed rule does not include the definition for ‘‘not required’’ in the process by which FDA establishes all parts of animals currently consumed and publishes regulations establishing reference to tolerance in the 2016 as foods in the United States, and thus, supplemental proposed rule (81 FR tolerances for residues of approved and residues of drugs in these foods are not conditionally approved new animal 74962 at 74964), and FDA’s current included in the toxicological evaluation practice with regard to the tolerance drugs. In addition, section 701(a) of the of new animal drugs. The comment FD&C Act gives FDA general rulemaking ‘‘not required.’’ expresses the opinion that many other (Response 3) We disagree with the authority to issue regulations for the tissues are eaten by humans and should efficient enforcement of the FD&C Act. comment to the 2012 proposed rule be included in the toxicology evaluation suggesting revisions because the V. Comments on the 2012 Proposed and tolerance assignments. The revisions do not accurately reflect the Rule and 2016 Supplemental Proposed comment suggests that to ensure safety criteria we used in the past to determine Rule and FDA Response of food for humans, the definition of that a tolerance is ‘‘not required.’’ edible tissue be equivalent to, and broad In the past, we did not assign a A. Introduction enough to cover, any tissue that will tolerance for some drugs when either of We received comments on the 2012 become a component of the food and the conditions described under (1) or (2) proposed rule and 2016 supplemental not be limited to any specific set of in the 2012 proposed rule were met. proposed rule, each containing one or tissues. However, currently and going forward, more comments on one or more issues. (Response 2) We typically request FDA generally assigns and will assign a We received comments from consumers, residue data for muscle, which is a tolerance if a tolerance can be public health organizations, and the highly consumed tissue; liver, kidney, established. There are some situations, pharmaceutical industry. and fat (skin with fat for poultry), which however, under which it is not possible We describe and respond to the are tissues where residues have a to establish a tolerance. For example, a comments in section V.B through E of tendency to accumulate; and milk, eggs, tolerance cannot be established when this document. We have numbered each and honey, if applicable. The edible FDA has determined that an Acceptable comment to help distinguish between tissue definition, which includes all the Daily Intake (ADI) is not needed for the different comments. We have grouped aforementioned edible products, reflects approval after considering the physical, similar comments together under the our current thinking on how to address chemical, toxicological, and exposure same number, and, in some cases, we safety of residues in food products characteristics of the drug residues, or have separated different issues derived from animals treated with new when the drug is poorly absorbed or discussed in the same comment letter animal drugs. metabolized rapidly so as to make and designated them as distinct (Comment 3) One comment to the selection of an analyte impractical or comments for purposes of our 2012 proposed rule suggests changes to impossible. responses. The number assigned to each the proposed definition of ‘‘not In the 2016 supplemental proposed comment or comment topic is purely for required’’ with respect to tolerances. In rule (81 FR 74962 at 74964), FDA organizational purposes and does not the 2012 proposed rule, we proposed proposed to revise and clarify the signify the comment’s value or that ‘‘not required,’’ in reference to definition for ‘‘not required’’ in importance or the order in which tolerances, means that at the time of reference to tolerance by separately comments were received. approval, the drug met one of the listing the conditions described under Some comments address issues that following conditions: (1) No withdrawal (1) and (2) into two paragraphs, to make are outside of the scope of this rule. We period (i.e., zero withdrawal) was it clearer that if either the described do not discuss such comments in this necessary for residues of the drug to conditions under (1) or (2) were met at document. deplete to or below the concentrations the time of approval, a tolerance was

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‘‘not required.’’ In addition, under (1), We received no further comment on states the context of the proposed rule the phrase ‘‘and there was a rapid these proposed revisions and are appears to be the method(s) used to depletion of residues’’ was added before finalizing as proposed in the 2016 collect data to support the setting of the the phrase ‘‘so there was no concern supplemental proposed rule. tolerances preapproval. The comment about residues resulting from misuse or (Comment 5) One comment to the asks if the proposed rule implies that overdosing’’ to explain the reason (i.e., 2012 proposed rule recommends that tolerances may be established using rapid depletion of residues) for no FDA use the term ‘‘point of departure’’ analytical procedures other than the concern about residues resulting from (POD) instead of ‘‘no observed effect determinative procedure. In addition, misuse or overdosing. level (NOEL)’’ for calculation of the the comment states it should be clarified We received no further comment on ADI. if regulatory method is referring to the revised proposed definition and are (Response 5) The ADI definition in method(s) used preapproval for setting finalizing as proposed in the 2016 the 2012 proposed rule stated that an the tolerance versus a finite method(s) supplemental proposed rule. ADI is calculated by dividing the NOEL used for determining post- (Comment 4) A few comments to the (from the most appropriate toxicological commercialization residue to compare 2012 proposed rule recommend that study) by a safety factor. We agree with to the tolerance. Additionally, another FDA be consistent with the terms and the comment that the term ‘‘POD,’’ or comment to the 2016 supplemental definitions used by international threshold, is more appropriate than the proposed rule suggests that, instead of organizations, such as the International term ‘‘NOEL’’ for calculation of the ADI, removing the term ‘‘regulatory method’’ Cooperation on Harmonisation of because the term ‘‘POD’’ is more from the definitions listed in part 556, Technical Requirements for Registration inclusive and reflects FDA’s current and FDA keep this term and add the term of Veterinary Medicinal Products past practice for the derivation of an ‘‘carcinogenic compounds’’ to the (VICH). Specifically, they recommend ADI. definitions and specify that a regulatory that FDA use the VICH definition for However, since the publication of the method is only required for Acute Reference Dose (ARfD) to replace 2012 proposed rule, GFI #232 (VICH carcinogenic compounds. the FDA-proposed definition for GL54) has been published, which Acceptable Single-Dose Intake (ASDI). includes a different definition for ADI (Response 6) We realized that, in the One comment states that FDA should than the one included in the 2012 2012 proposed rule, the term use the VICH term to avoid the proposed rule. There are no ‘‘regulatory method’’ proposed in confusion of having two terms that fundamental scientific differences § 556.3 and used in proposed § 556.5(d) mean virtually the same thing, while between the ADI definition from the caused some confusion; thus, the 2016 another comment also recommends that 2012 proposed rule and the ADI supplemental proposed rule explains we include the phrase ‘‘microgram (mg) definition found in GFI #232 (VICH our current thinking about the term and or milligram (mg)/kg of body weight’’ in GL54). As a result, we are amending the its use (81 FR 74962 at 74963). We the definition for ARfD, as defined in ADI definition and using the ADI explained in the 2016 supplemental the relevant VICH guideline background definition from GFI #232 (VICH GL54) proposed rule that an analytical method information for the definition of ARfD. in this final rule, to be consistent with other than the practicable method, (Response 4) We agree with the the VICH definition for ADI. which is described in § 514.1(b)(7) (21 comment suggesting FDA replace the Unlike the ADI definition in the 2012 CFR 514.1(b)(7)), can be used for proposed definition of ASDI with the proposed rule, the ADI definition found surveillance and enforcement purposes VICH definition of ARfD. In the 2016 in GFI #232 (VICH GL54) and adopted for non-carcinogenic compounds, as supplemental proposed rule (81 FR here does not include a calculation for long as the performance criteria of that 74962 at 74964 and 74965), we an ADI and therefore does not use the method are comparable to those of the proposed to harmonize with the VICH term NOEL or POD. We note, however, practicable method submitted by the by removing the definition of that we use the term POD in the sponsor as part of the new animal drug ‘‘acceptable single-dose intake (ASDI)’’ description for calculation of an ADI in application. Such an analytical method and adding the definition of ‘‘acute the revision of guidance GFI #3 entitled other than the practicable method can reference dose (ARfD),’’ referenced in ‘‘General Principles for Evaluating the be used for surveillance and our draft guidance for industry ((GFI) Human Food Safety of New Animal enforcement purposes for non- #232 (VICH GL54)) entitled ‘‘Studies to Drugs Used in Food-Producing carcinogenic compounds, so long as the Evaluate the Safety of Residues of Animals’’ (Ref. 2 and 83 FR 27333, June performance criteria (e.g., sensitivity, Veterinary Drugs in Human Food: 12, 2018). specificity, accuracy, and precision) of General Approach to Establish an Acute (Comment 6) One comment to the that method are comparable to those of Reference Dose (ARfD)’’ (80 FR 31041, 2012 proposed rule requests the practicable method submitted by the June 1, 2015), which has since been clarification on the proposed definition sponsor as part of the new animal drug finalized (Ref. 1 and 82 FR 40010, for ‘‘regulatory method’’ and on the use application. In addition, we proposed a August 23, 2017). We proposed ARfD to of the term in proposed § 556.5(d), revision to the definition of ‘‘zero’’ in be defined as ‘‘an estimate of the which stated that FDA requires that a proposed § 556.3, in reference to amount of residues expressed on a body drug sponsor develop a regulatory tolerances, by deleting ‘‘when using a weight basis that can be ingested in a method to measure drug residues in method of detection prescribed or period of 24 hours or less without edible tissues of approved target approved by FDA’’ from the definition, adverse effects or harm to the health of species. This comment notes that a because an analytical method other than the human consumer.’’ We disagree that regulatory method has historically been the practicable method can be used for the phrase ‘‘microgram (mg) or milligram used to refer to the ‘‘required surveillance and enforcement purposes (mg)/kg of body weight’’ should be determinative and confirmatory for non-carcinogenic compounds. In the included in the definition for ARfD, procedures for regulatory surveillance of 2016 supplemental proposed rule we because the VICH definition for ARfD is residue concentrations in meat products proposed to revise § 556.5(d) to align not limited to being reported as entering the food supply for comparison with our current thinking and to remove ‘‘microgram (mg) or milligram (mg)/kg of to the tolerance post-commercialization the term ‘‘regulatory method’’ from this body weight’’ (GFI #232 (VICH GL54)). of the product.’’ The comment also provision because we are reserving this

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term for use with carcinogenic residues could be detected using the (Response 10) The regulations under compounds (part 500, subpart E (21 CFR ‘‘approved analytical method.’’ Often, part 500, including those terms listed part 500, subpart E)). Further, the the analytical method chosen to under 21 CFR 500.82, implement the regulations under part 556 are dedicated determine ‘‘zero’’ represented the limit Diethylstilbestrol (DES) Proviso to the to tolerances for non-carcinogenic of analytical method technology at the Delaney Clause in section 512(d)(1)(I) of compounds approved for use in food- time of the evaluation. However, we the FD&C Act (21 U.S.C. 360b(d)(1)(I)), producing animals, while those under recognize that equipment, reagents, and which allows cancer-causing part 500, subpart E, entitled ‘‘Regulation methodology change over time and the compounds to be used in food- of Carcinogenic Compounds Used in analytical method (practicable method) producing animals if, among other Food-Producing Animals,’’ are submitted by the sponsor in support of conditions, no residue of such drug will dedicated to carcinogenic compounds drug approval may become obsolete. be found in any edible portion of such for use in food-producing animals. Therefore, we explained in the 2016 animal after slaughter or in any food FDA’s intention is to clearly separate supplemental proposed rule (81 FR yielded by or derived from the living the purpose of these two parts in Title 74962 at 74964) that an analytical animals. Because there are different 21 of the Code of Federal Regulations method other than the practicable requirements for approving a new and, therefore, does not agree with the method can be used for surveillance and animal drug under these provisions than recommendation. We are finalizing as enforcement purposes for non- those for approving non-carcinogenic proposed in the 2016 supplemental carcinogenic compounds. Such an new animal drugs for use in food- proposed rule and removing the term analytical method should have the same producing animals, a different ‘‘regulatory method’’ from part 556. capability as the practicable method to definition is needed for the term (Comment 7) We received two determine the quantity of the drug ‘‘marker residue’’ depending on whether comments to the 2016 supplemental residues such that the tolerance, the new animal drug is a carcinogenic proposed rule regarding the proposed withdrawal period, or other use compound or a non-carcinogenic changes in the tolerance definition. The restrictions continue to ensure that the compound. The definitions of ‘‘residue’’ comments express concern that by use of the drug will be safe. Therefore, and ‘‘target tissue,’’ although slightly replacing the term ‘‘target tissue’’ with the assigned withdrawal periods will different in wording, have the same ‘‘edible tissue’’ in the definition, the not need to be changed. meaning in both parts 500 and 556, and focus about using target tissue to In response to the last part of the we do not believe this will lead to indicate safety of other edible tissues comment that we replace ‘‘tissue’’ with confusion. from treated animals is likely to be lost. ‘‘edible tissue’’ in the definitions (Comment 11) One comment to the (Response 7) FDA’s revised definition section, we agree and finalize the 2016 supplemental proposed rule asks reflects the fact that we can establish codified as the comment suggested. FDA to explain the differentiation of tolerances for both target and non-target (Comment 9) A comment to the 2016 residue method requirements for tissue. We intend to continue to use the supplemental proposed rule observes carcinogenic and non-carcinogenic target tissue tolerance to indicate safety that new terms such as ‘‘practicable compounds. of all of the edible tissue (excluding method,’’ ‘‘analytical method,’’ ‘‘edible (Response 11) Section 512(d)(1)(I) of milk and eggs, unless otherwise tissue,’’ and ‘‘acute reference dose’’ the FD&C Act provides that an animal specified) from treated animals. were used to replace ‘‘regulatory drug will not be approved if, among (Comment 8) One comment to the method,’’ ‘‘target tissue,’’ and ‘‘acute other reasons, the drug is a carcinogen, 2016 supplemental proposed rule asks single dose intake’’; however, these new unless the Secretary of Health and us to explain how FDA will interpret terms are not present in FDA’s draft Human Services finds that, under the the revised definition for ‘‘zero’’ in revised GFI #3 (81 FR 47397, July 21, conditions of use specified in proposed proposed § 556.3, which reads, ‘‘zero, in 2016) (since finalized), and the labeling and reasonably certain to be reference to tolerances in this part, inconsistency will lead to confusion followed in practice, that no residue of means any residues detected in the between the regulation and guidance. such drug will be found (by methods of tissue renders it unsafe.’’ The comment (Response 9) We interpret the term, examination prescribed or approved by states that ‘‘zero’’ is defined by the ‘‘acute single dose intake,’’ in the the Secretary by regulations) in any sensitivity of the testing methodology comment to mean ‘‘acceptable single- edible portion of such animals after and asks what would happen if the dose intake.’’ We disagree with the slaughter or in any food yielded by or ‘‘testing method increases their comment that the terms, ‘‘practicable derived from the living animals. Thus, sensitivity level that it will be chasing method,’’ ‘‘analytical method,’’ ‘‘edible the FD&C Act requires the use of the zero?’’ The comment asks FDA to tissue,’’ and ‘‘acute reference dose’’ are approved regulatory method as explain how this will influence zero not present in the guidance. Although promulgated in regulation to show ‘‘no tolerance and ‘‘updating new revised GFI #3 does not have a residues’’ of carcinogens; however, there withdrawal times’’ and how this new definition section or glossary, all of is no such requirement to use an information will be communicated to these terms are used in the guidance. approved regulatory method for the industry. The comment also We do not believe there is any measuring residues of non-carcinogenic recommends that in the proposed inconsistency in how these terms are compounds for post-approval residue definition for ‘‘zero,’’ the word ‘‘tissue’’ used and therefore do not believe that surveillance and enforcement. be replaced with ‘‘edible tissue,’’ to be will lead to confusion between the Therefore, an analytical method other consistent throughout the document. regulation and the guidance. than the practicable method (Response 8) We agree with the (Comment 10) One comment to the (§ 514.1(b)(7)) can be used for residue comment that ‘‘zero’’ is defined by the 2016 supplemental proposed rule surveillance and enforcement purpose sensitivity of the testing methodology. observes that many of the revised terms for non-carcinogenic compounds. As explained in the preamble of the proposed for part 556 remain as 2012 proposed rule (77 FR 72254 at currently defined in 21 CFR 500.80. The D. Comments on Analytical Method 72256), in approving certain animal comment expresses concern that the We received eight comments drugs in the past, FDA assigned a ‘‘zero’’ existence of different definitions will regarding the statement in the 2016 tolerance, with ‘‘zero’’ meaning that no lead to confusion. supplemental proposed rule that an

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analytical method other than the original marker residue to total residue for non-carcinogenic compounds, as practicable method can be used for post- ratio is achieved with the analytical long as the performance criteria (e.g., approval residue surveillance and method. sensitivity, specificity, accuracy, and enforcement (81 FR 74962 at 74964). (Response 13) FDA establishes precision) of that method are (Comment 12) One comment tolerances using the practicable method comparable to those of the practicable recommends that FDA modify the (defined at § 514.1(b)(7)) submitted by a method submitted by the sponsor as proposed revision to § 556.5 General sponsor as part of the new animal drug part of the new animal drug application. Considerations by removing the phrase application. The practicable method is (Comment 15) One comment suggests ‘‘FDA uses the practicable method to used to collect data for tolerance that ‘‘the availability of advanced determine the quantity of the drug assignment. After the drug product is methods that improve upon the residues that can safely remain in edible approved, FDA makes the practicable practicable method necessarily means tissue (i.e., the tolerance) . . .’’ from the method available for monitoring drug that the tolerance, withdrawal period, provision. The comment states that the residues in the food supply. In the 2016 and the need for use restrictions of quantity of drug residues that can safely supplemental proposed rule, we stated many drugs must be reassessed using remain in the edible tissues is based on that as technologies have evolved, many the best available technologies.’’ the safe concentration derived from the of the older methods have become (Response 15) The 2016 supplemental ADI. In addition, the comment states obsolete. In addition, there is an proposed rule stated that an analytical that ‘‘while the practicable method may increased reliance on multiresidue method other than the practicable be utilized to determine the ratio of the methods in the monitoring of the food method can be used for post-approval marker residue to the total drug supply. We also stated that an analytical residue surveillance and enforcement, residues, the work typically precedes method other than the practicable which allows the use of evolving the finalization of the official marker method can be used for residue analytical technologies while residue method.’’ surveillance and enforcement purposes maintaining the tolerance, withdrawal (Response 12) FDA does not agree that for non-carcinogenic compounds, as period, and other restrictions as part of the phrase should be removed from the long as the performance criteria (e.g., the conditions of the approval. The sentence under § 556.5 General sensitivity, specificity, accuracy, and practicable method is used to collect Considerations and is finalizing as precision) of the analytical method are data for tolerance assignment. A proposed. In proposed § 556.5(d) of the comparable to those of the practicable different method may be used for 2016 supplemental proposed rule, we method. FDA considers the performance surveillance and enforcement purposes said that we require a drug sponsor to criteria of the two methods to be as long as it has the same capability as submit a practicable method as part of ‘‘comparable’’ if the analytical method the practicable method to measure their new animal drug application. We has been shown, through appropriate residues to ensure the established use the practicable method to determine validation, to have the same capability tolerance is not exceeded. If an the quantity of the drug residues that as the practicable method to determine analytical method has the same can safely remain in edible tissues (i.e., the quantity of the drug residues capability as the practicable method to the tolerance), the withdrawal period, remaining in edible tissues of treated determine the quantity of the same and any other use restrictions necessary animals so that the tolerance, marker residue in the same tissue, then to ensure that the proposed use of the withdrawal period, or other use the tolerance, withdrawal period, or drug will be safe. We think that it is restrictions continue to ensure that the other use restrictions for the approved clear that the phrase refers to use of the drug will be safe. The drug will continue to ensure that the use establishment of a tolerance, which is proposal included sensitivity, of the drug will be safe. based not only on the safe concentration specificity, accuracy, and precision as (Comment 16) One comment suggests derived from the ADI, but also on the examples of the performance criteria. As that, in the cases where the performance marker residue or other residues a result, we do not believe additional criteria of a new analytical method and measured by the practicable method. definitions are necessary. a practicable method are not (Comment 13) Two comments to the (Comment 14) One comment to the comparable, FDA consider 2016 proposed rule express concerns 2016 supplemental proposed rule asks implementing a strategy to correct the that, with the implementation of the FDA to clarify how the Food Safety and tolerance based on the recovery of the rule, an analytical method other than Inspection Service, United States marker residue observed when the new the practicable method may be used for Department of Agriculture (FSIS) analytical method is used, with the goal post-approval residue surveillance and (USDA) methods will be viewed by FDA of ensuring that the use of the approved compliance when that other analytical and whether this supplemental drug is safe while avoiding the need for method is not actually equivalent to the proposed rule is ‘‘intended to indicate new studies to update the marker to practicable method. The comments that any multi-residue method (MRM), total residue ratio. advocate for proper validation of the independent of version, can be used, (Response 16) FDA does not think analytical method before its use for and the version changes have no impact that it is necessary to change the residue surveillance and compliance. on the data.’’ tolerance based on the recovery of the One of the comments asks FDA to (Response 14) We interpret that the marker residue observed with a new clarify the terms ‘‘performance criteria’’ comment is asking whether the analytical method. The point of using an and ‘‘comparable’’ used in the 2016 supplemental proposed rule is intended analytical method with comparable supplemental proposed rule as they to indicate that any multiresidue performance criteria as the practicable relate to the requirements that an method (MRM), independent of version, method is to allow newer more useful analytical method other than the can be used for surveillance and methods to be used for surveillance and practicable method must meet before it enforcement purposes. The enforcement purposes, as long as the can be used for residue surveillance and supplemental proposed rule is intended newer method has the same capability enforcement. It recommends that FDA to indicate, as explained above, that an as the practicable method to determine add a definition for the term analytical method other than the the quantity of the drug residues so that ‘‘performance criteria’’ and provisions practicable method can be used for the tolerance, withdrawal period, or in the final rule to ensure that the surveillance and enforcement purposes other use restrictions continue to ensure

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that the use of the drug will be safe. GFI documents for the method the ADI in part 556 using the formula Such a policy ensures a safe food supply performance recommendations. We described above. and allows regulatory agencies to take further encourage drug sponsors to use (Comment 20) One comment to the advantages of scientific advances in a method that is in line with the 2012 proposed rule questions why analytical methodology. recommendations in the relevant GFIs, FDA’s ‘‘safe level of residue’’ for the (Comment 17) One comment to the regardless of the method’s origin. same drug is different in different food 2016 supplemental proposed rule asks products. The commenter is concerned that, if FSIS MRMs are used prior to an E. Comments on Subpart B, Listing of that FDA’s decision is not based on active pharmaceutical ingredient (API) Tolerances for Residues of Approved science, but ‘‘on rule of law.’’ The being approved, can the FSIS methods and Conditionally Approved New comment uses carbendazim in orange be used [to support a new animal drug Animal Drugs juice as an example. approval] with or without modification (Comment 19) We received two (Response 20) The comment uses the [vis-a`-vis version changes]; if the data comments to the 2012 proposed rule example of carbendazim in orange juice; FSIS generated for validation can be about the removal of safe concentrations however, because the proposed rule submitted to Center for Veterinary from part 556. One comment agrees addresses tolerances for residues of Medicine (CVM); and if a sponsor can with our decision and states this will drugs in edible tissues of treated submit a request for FSIS to provide all reduce the potential for confusion. A animals, we assume the commenter is data on their API. second comment expresses concern asking why the tolerance for the same (Response 17) FDA encourages drug that, for some drugs for which FDA drug may be different in different edible sponsors to take advantage of available historically listed only ADI and safe tissues from a treated animal. information from government concentrations, removing the listing of FDA assigns one ADI to reflect the laboratories and industry for the safe concentrations will lead to the loss quantity of the drug residues that development of an analytical method to of valuable toxicological information humans can safely consume on a daily support a new animal drug approval. about the drugs. The comment cites basis. The ADI is based on the The modification of a method already fenprostalene as an example. The toxicological, microbiological, or validated in a government laboratory comment asks that FDA keep pertinent pharmacological properties of the drug may allow for a scaled down toxicological information for these drugs and represents the total amount of interlaboratory method trial process for which tolerances are not required. residues that humans can safely during the drug application review (Response 19) We agree with the consume on a daily basis from the period. Although FDA does not object to comment that removing safe different food sources of the residue a sponsor requesting information from concentrations from part 556 will (i.e., food derived from the food- FSIS, we defer to USDA on whether, reduce the potential for confusion. We producing animal species for which the how, and under what conditions such disagree with the comment that drug is approved). information is made available. toxicological information about a drug is FDA assigns a tolerance based on not (Comment 18) A comment asks FDA lost when listings of safe concentrations only the ADI, but also the ratio of the to encourage sponsors to utilize the for that drug are removed, so long as the marker residue to total residue in the same analytical methods as those used ADI for that drug is listed. Toxicological specific edible tissue, which can by USDA FSIS for creation of the information for the residue of a drug is potentially differ as a function of approved analytical method, because of determined through toxicological pharmacokinetic properties of the drug the many associated benefits. evaluations and reflected by the in the food-producing animal species for (Response 18) Although, in theory, we assigned ADI. Safe concentrations for an which the drug is approved. The marker agree that submitting a practicable edible tissue are calculated from the residue is the residue whose method that is in use by USDA FSIS ADI using a formula in which the only concentration is in a known relationship may be beneficial, we note that variable is the ADI (safe concentration = to the concentration of total residue in continued use of such a method by ADI × Human Body Weight/Food an edible tissue. In addition, the USDA FSIS is not guaranteed, and as Consumption Value) (see GFI #3 tolerance also takes into account the newer technologies become available ‘‘General Principles for Evaluating the amount of the edible tissue that is and relied on, the same need to use an Human Food Safety of New Animal consumed. Therefore, different analytical method other than the Drugs Used in Food-Producing tolerances, rather than a single practicable method for monitoring the Animals’’ Ref. 2 and 83 FR 27333). tolerance, are often needed and assigned food supply may appear after approval When there is an ADI assigned for the for different edible tissues of the same of the new animal drug application. We residue of a drug, the ADI is listed food-producing animal species, or for also note that the USDA FSIS MRMs, under that drug’s name in part 556, the same edible tissue from different which are used for screening purposes, together with any tolerances (if food-producing animal species, to may or may not be appropriate to use to tolerances are established). Therefore, ensure that daily human consumption establish a tolerance, withdrawal after removing safe concentrations from of the total drug residue in the edible period, and other conditions of safe use, the listings, toxicological information tissues will not exceed the ADI. which is the purpose behind requiring about the drug is still reflected by the (Comment 21) One comment to the submission of a practicable method as ADI. Listing of the ADI alone in part 556 2016 supplemental proposed rule asks part of the new animal drug application. provides sufficient toxicological FDA to clarify the regulatory/ Therefore, as long as a method meets the information for the drug. We note that enforcement use of available requirements of § 514.1(b)(7) for the the safe concentrations remain available surveillance residue methods for non- sponsor of a new animal drug through the Freedom of Information target tissues in a species of livestock application to submit a practicable Drug Summaries, available on the CVM where a tolerance has not been method, FDA declines the commenter’s website at https://www.fda.gov/ established for that tissue but has been request to encourage sponsors to use AnimalVeterinary/Products/ established for another tissue. USDA FSIS methods to meet those ApprovedAnimalDrugProducts/ (Response 21) When CVM establishes requirements. We encourage drug ucm2006466.htm. Additionally, safe a tolerance for a specific edible tissue as sponsors to reference FDA’s relevant concentrations can be calculated with part of a new animal drug approval,

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CVM provides, for surveillance and characteristics of the drug residues, or ‘‘uncooked’’ from the individual listings enforcement purpose, an analytical when the drug is poorly absorbed or for tolerances in subpart B. method that has been evaluated in an metabolized rapidly so as to make (Response 24) Section 556.5, General interlaboratory study for assay of the selection of an analyte impractical or Considerations clarifies that, ‘‘All residue in the specific edible tissue. A impossible. Under both circumstances, tolerances refer to the concentrations of tolerance assigned for a residue in a FDA requires that drug sponsors the marker residue, or other residue specific edible tissue or tissues as listed provide toxicology and residue indicated for monitoring, permitted in in part 556, subpart B applies only to information to ensure that the approved uncooked tissues.’’ Therefore, the word the specific tissue or tissues. use is safe even though a tolerance is ‘‘uncooked’’ is not necessary in the (Comment 22) A comment to the 2012 not assigned. listing of tolerances, so we are finalizing proposed rule expresses concern that, as (Comment 23) A comment to the 2012 as proposed. testing abilities improve over time, proposed rule recommends that the ‘‘smaller and smaller’’ levels of regulation should also include F. Other Comments detection are attained. The end result tolerances for residues of ‘‘new as well could be ‘‘that there will be no food as old drugs,’’ as old and/or forgotten (Comment 25) One comment to the naturally produced that will be totally drugs may have new or undiscovered 2012 proposed rule expresses concern free of detectable residues.’’ The impacts in human health, especially that an unintended consequence of this comment also observes that the those drugs used in different countries rule is that it would have the effect of proposed rule establishes that approved from which the United States receives acting as a ‘‘non-tariff trade barrier as it drugs meet established tolerance levels, imported animal-derived food. does not conform and is contradictory to but that there are drugs that are (Response 23) ‘‘New animal drug’’ is the practices of our trading partners.’’ approved for use in food-producing a term defined by section 201(v) of the (Response 25) We recognize the animals that have no published FD&C Act (21 U.S.C. 321(v)). With very importance of harmonizing tolerance levels. The comment asks limited exceptions, drugs intended for international food safety standards to where FDA stands on this, i.e., when a use for animals meet the definition of facilitate trade. We also recognize that drug is approved, but no tolerance exists ‘‘new animal drug.’’ Since 1968, FDA sometimes, because of our requirement for a particular tissue. The comment has had a specific statutory requirement to meet applicable U.S. statutes and also questions why some new animal under section 512(i) of the FD&C Act to regulations governing food safety, our drugs for use in food-producing animals codify any tolerance established as a tolerances are sometimes not have been approved without a tolerance consequence of the approval of a new harmonized with international food even though residues are able to be animal drug application (NADA). safety standards. detected at very low concentrations as Subpart B in part 556 was created to analytical methods improve. satisfy this requirement; it is a listing of FDA participates in the trilateral (Response 22) The detection limit for tolerances assigned for ‘‘new animal (European Union, Japan, United States) the analytical methods is not a basis to drugs’’ approved or conditionally VICH to harmonize the technical determine if a tolerance needs to be approved for use in food-producing requirements for veterinary product assigned or if a tolerance is not required animals in the United States. Tolerances registration. This harmonization for approval of a new animal drug. for substances administered to food- develops common guidelines, including However, in the past, during the new producing animals as food additives the development of data to support an animal drug approval process FDA prior to 1968 were added to this listing ADI and tolerance for a particular drug. determined that a tolerance was not as appropriate if these substances FDA also participates in The Codex required for some drugs. As we became the subject of an approved Committee on Residues of Veterinary explained in the 2016 supplemental NADA. Drugs in Foods, which determines proposed rule, ‘‘not required’’ means: When approval of an NADA is priorities for the consideration of (1) No withdrawal period was necessary withdrawn, section 512(i) of the FD&C residues of veterinary drugs in foods for residues of the drug to deplete to or Act requires that the Agency revoke the and recommends maximum residue below the concentrations considered to regulations that were published limits (MRLs) for veterinary drugs to be safe, or an adequate withdrawal following the approval. That revocation The Codex Alimentarius Commission of period was inherent in the proposed includes the regulation for any tolerance the Food and Agriculture Organization drug use, and there was a rapid listed in part 556; thus, the tolerance is and the World Health Organization of depletion of residues, so there was no removed for any drug for which the United Nations.1 The Codex concern about residues resulting from approval has been withdrawn. Alimentarius Commission develops misuse or overdosing; or (2) No Regarding importation of animal- harmonized international food withdrawal period was necessary derived food, in addition to establishing standards, guidelines, and codes of because the drug was poorly absorbed or tolerances for approved new animal practice to protect the health of the metabolized rapidly so as to make drugs, FDA also has authority to consumers and ensure fair practices in selection of an analyte impractical (81 establish import tolerances for new the food trade. Again, although FDA FR 74962 at 74966). Currently, FDA’s animal drugs not approved in the recognizes the value in harmonizing general practice is to establish a United States, but used lawfully in requirements and standards, we are tolerance for all new animal drugs we another country, to ensure that food required to follow U.S. law with respect approve. However, as discussed earlier, imported into the United States is safe to our standard setting activities. FDA recognizes that there are some (section 512(a)(6) of the FD&C Act). VI. Effective/Compliance Date situations for which it is not possible to (Comment 24) A comment to the 2012 establish a tolerance. For example, a proposed rule agrees with FDA’s The rule is effective September 9, tolerance cannot be established when proposal to delete salt designations and 2019. FDA has determined that an ADI is not safe concentrations from the tolerance needed for the approval after listings in part 556, subpart B. However, 1 See http://www.fao.org/fao-who- considering the physical, chemical, the comment suggests that it is not codexalimentarius/committees/committee/en/ toxicological, and exposure necessary to delete the word ?committee=CCRVDF.

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VII. Economic Analysis of Impacts rule will not have a significant use in food-producing animals that will We have examined the impacts of the economic impact on a substantial read the final rule. We also estimate that final rule under Executive Order 12866, number of small entities. approximately one sponsor per year will Executive Order 13563, Executive Order The Unfunded Mandates Reform Act submit a first-time application for 13771, the Regulatory Flexibility Act (5 of 1995 (section 202(a)) requires us to approval of a new animal drug for use U.S.C. 601–612), and the Unfunded prepare a written statement, which in a food-producing animal. Thus, we Mandates Reform Act of 1995 (Pub. L. includes an assessment of anticipated estimate that about 51 firms would need 104–4). Executive Orders 12866 and costs and benefits, before issuing ‘‘any to read and understand this rule over 13563 direct us to assess all costs and rule that includes any Federal mandate the next 10 years. benefits of available regulatory that may result in the expenditure by To value the time for complying with alternatives and, when regulation is State, local, and tribal governments, in reading and understanding the rule, we the aggregate, or by the private sector, of necessary, to select regulatory use wages calculated from the Bureau of $100,000,000 or more (adjusted approaches that maximize net benefits Labor Statistics’ national industry- annually for inflation) in any one year.’’ (including potential economic, specific occupational employment and The current threshold after adjustment environmental, public health and safety, wage estimates for the pharmaceutical for inflation is $150 million, using the and other advantages; distributive and medical manufacturing industry most current (2017) Implicit Price impacts; and equity). Executive Order (Ref. 3).23 We use the average of the Deflator for the Gross Domestic Product. 13771 requires that the costs associated $71.06 hourly wage of management This final rule would not result in an with significant new regulations ‘‘shall, occupations (occupation code 11–0000) expenditure in any year that meets or to the extent permitted by law, be offset and the $79.52 hourly wage of legal by the elimination of existing costs exceeds this amount. All entities affected by this final rule occupations. We double this average associated with at least two prior hourly wage to account for benefits and regulations.’’ We believe that this final will incur the one-time cost for reading and understanding this rule. We use the overhead, yielding an average hourly rule is not a significant regulatory action labor cost of $150.58. We estimate the as defined by Executive Order 12866. time required to complete this activity cost for the one person to read and The Regulatory Flexibility Act to estimate the burden of this activity. requires us to analyze regulatory options To understand this rule, affected entities understand the rule ranges from $169 to that would minimize any significant will read the preamble and codified, $211. The total costs for reading and impact of a rule on small entities. which together contain almost 16,800 understanding the rule over 10 years Because this final rule would not words. If those reviewing the rule read range from around $8,600 to around impose compliance costs on current or at the average adult reading speed of $10,800. future sponsors of any approved or approximately 200 words to 250 words In table 1, FDA provides the conditionally approved new animal per minute, the time to read and Regulatory Information Service Center drugs, and because we did not receive understand the regulation is about 67 to and Office of Information and any comments pertaining to this same 84 minutes per person. There are Regulatory Affairs Consolidated assertion in the 2016 supplemental currently 41 sponsors with approved Information Center accounting proposed rule, we certify that the final applications for new animal drugs for information. TABLE 1—ECONOMIC DATA: COSTS AND BENEFITS STATEMENT

Units Category Primary Low High Discount Period Notes estimate estimate estimate Year dollars rate covered (%) (years)

Benefits: Annualized Monetized $millions/year ...... 7 3

Annualized Quantified ...... 7 3

Qualitative ...... Standardizing and simplifying the determination standards and codification style regarding tolerances should provide more clarity for industry members.

Costs: Annualized Monetized $millions/year ...... $0.0011 $0.0010 $0.0013 2017 7 10 $0.0010 $0.0009 $0.0011 2017 3 10

Annualized Quantified ...... 7 3

Qualitative.

Transfers:

2 May 2017 National Industry-Specific 325400 because detailed estimates for NAICS General Medical and Surgical Hospitals, but this Occupational Employment and Wage Estimates for 325412 are not available. Please see http:// difference does not significantly impact of the cost the North American Industry Classification System www.bls.gov/oes/. of the final rule. (NAICS) 325400—Pharmaceutical and Medicine 3 This wage is slightly higher than that of Manufacturing. We use estimates from NAICS management occupations for NAICS 622110—

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TABLE 1—ECONOMIC DATA: COSTS AND BENEFITS STATEMENT—Continued

Units Category Primary Low High Discount Period Notes estimate estimate estimate Year dollars rate covered (%) (years)

Federal Annualized Monetized $millions/year ...... 7 3

From/To ...... From: To:

Other Annualized Monetized $millions/year ...... 7 3

From/To ...... From: To:

Effects: State, Local or Tribal Government: No Effect. Small Business: The final rule will not have a significant impact on a substantial number of small entities that manufacture new animal drugs for use in food-pro- ducing animals. Wages: No effect. Growth: No effect.

Table 2 presents a summary of the has net costs with present values that well below the de minimis cost costs, cost savings, and net costs of the range from about $11,000 to $17,000, threshold for Executive Order 13771. final rule. We estimate that the final rule

TABLE 2—EXECUTIVE ORDER 13771 SUMMARY TABLE [In $ millions 2016 dollars, over a perpetual time horizon]

Primary Lower bound Upper bound Primary Lower bound Upper bound (7%) (7%) (7%) (3%) (3%) (3%)

Present Value of Costs ...... $.011 $.009 $.012 $.014 $.013 $.016 Present Value of Cost Savings ...... 0 0 0 0 0 0 Present Value of Net Costs ...... 011 .009 .012 .014 .013 .016 Annualized Costs...... 0.0007 0.0007 0.0008 0.0004 0.0004 0.0005 Annualized Cost Savings ...... 0 0 0 0 0 0 Annualized Net Costs...... 0.0007 0.0007 0.0008 0.0004 0.0004 0.0005

VIII. Analysis of Environmental Impact policies that have federalism viewing by interested persons between We have determined under 21 CFR implications as defined in the Executive 9 a.m. and 4 p.m., Monday through 25.30(i) that this action is of a type that Order and, consequently, a federalism Friday; they are also available does not individually or cumulatively summary impact statement is not electronically at https:// have a significant effect on the human required. www.regulations.gov. FDA has verified the website addresses, as of the date this environment. Therefore, neither an XI. Consultation and Coordination With document publishes in the Federal environmental assessment nor an Indian Tribal Governments environmental impact statement is Register, but websites are subject to required. We have analyzed this rule in change over time. accordance with the principles set forth IX. Paperwork Reduction Act of 1995 1. FDA, Guidance for Industry #232, in Executive Order 13175. We have ‘‘Studies to Evaluate the Safety of Residues This final rule contains no collection determined that the rule does not of Veterinary Drugs in Human Food: General of information. Therefore, clearance by contain policies that have substantial Approach to Establish an Acute Reference the Office of Management and Budget direct effects on one or more Indian Dose (ARfD), VICH GL54,’’ http:// under the Paperwork Reduction Act of Tribes, on the relationship between the www.fda.gov/downloads/AnimalVeterinary/ 1995 is not required. Federal Government and Indian Tribes, GuidanceComplianceEnforcement/ or on the distribution of power and GuidanceforIndustry/UCM448430.pdf, X. Federalism August 2017. responsibilities between the Federal 2. FDA, Guidance for Industry #3, ‘‘General We have analyzed this final rule in Government and Indian Tribes. Principles for Evaluating the Human Food accordance with the principles set forth Accordingly, we conclude that the rule Safety of New Animal Drugs Used In Food- in Executive Order 13132. We have does not contain policies that have Producing Animals,’’ https://www.fda.gov/ determined that the rule does not tribal implications as defined in the downloads/AnimalVeterinary/ contain policies that have substantial Executive Order and, consequently, a GuidanceComplianceEnforcement/ direct effects on the States, on the tribal summary impact statement is not GuidanceforIndustry/UCM052180.pdf, June relationship between the National required. 2018. Government and the States, or on the 3. Bureau of Labor Statistics, United States XII. References Department of Labor, May 2017 National distribution of power and Industry-Specific Occupational Employment responsibilities among the various The following references are on and Wage Estimates for the North American levels of government. Accordingly, we display at the Dockets Management Staff Industry Classification System (NAICS) conclude that the rule does not contain (see ADDRESSES) and are available for 325400—Pharmaceutical and Medicine

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Manufacturing. Available at http:// ■ 6. In § 520.2325b, redesignate (c) Related tolerances. See § 556.304 www.bls.gov/oes/. paragraph (c) as paragraph (d) and add of this chapter. List of Subjects new paragraph (c) to read as follows: * * * * * 21 CFR Part 500 § 520.2325b Sulfaquinoxaline drench. ■ 14. In § 522.1079, redesignate * * * * * paragraph (c) as paragraph (d) and add Animal drugs, Animal feeds, Cancer, (c) Related tolerances. See § 556.685 new paragraph (c) to read as follows: Labeling, Packaging and containers, of this chapter. Polychlorinated biphenyls (PCBs). § 522.1079 Serum gonadotropin and * * * * * chorionic gonadotropin. 21 CFR Parts 520, 522, 524, 526, and ■ 7. In § 520.2640, revise paragraph (c) * * * * * 529 to read as follows: (c) Related tolerances. See § 556.304 Animal drugs. § 520.2640 Tylosin. of this chapter. 21 CFR Part 556 * * * * * * * * * * ■ Animal drugs, Foods. (c) Related tolerances. See § 556.746 15. In § 522.1192, add paragraph (c) to of this chapter. read as follows: 21 CFR Part 558 * * * * * § 522.1192 Ivermectin. Animal drugs, Animal feeds. PART 522—IMPLANTATION OR * * * * * Therefore, under the Federal Food, INJECTABLE DOSAGE FORM NEW (c) Related tolerances. See § 556.344 Drug, and Cosmetic Act and under ANIMAL DRUGS of this chapter. authority delegated to the Commissioner * * * * * of Food and Drugs, 21 CFR chapter I, ■ 8. The authority citation for part 522 ■ 16. In § 522.1242, redesignate subchapter E, is amended as follows: continues to read as follows: paragraph (c) as paragraph (d) and add PART 500—GENERAL Authority: 21 U.S.C. 360b. new paragraph (c) to read as follows: ■ 9. In § 522.150, redesignate paragraph ■ 1. The authority citation for part 500 (c) as paragraph (d) and add new § 522.1242 Levamisole. continues to read as follows: paragraph (c) to read as follows: * * * * * (c) Related tolerances. See § 556.350 Authority: 21 U.S.C. 321, 331, 342, 343, § 522.150 Azaperone. 348, 351, 352, 353, 360b, 371, 379e. of this chapter. * * * * * * * * * * ■ 2. Amend § 500.82, in paragraph (b), (c) Related tolerances. See § 556.68 of ■ by alphabetically adding a definition for this chapter. 17. In § 522.1662a, add paragraph (l) to read as follows: ‘‘No residue’’ to read as follows: * * * * * § 500.82 Definitions. ■ 10. In § 522.468, add paragraph (c) to § 522.1662a Oxytetracycline hydrochloride * * * * * read as follows: injection. * * * * * (b) * * * § 522.468 Colistimethate sodium powder No residue means the marker residue for injection. (l) For related tolerances see § 556.500 of this chapter. is below the limit of detection using the * * * * * approved regulatory method. The ‘‘no (c) Related tolerances. See § 556.167 ■ 18. In § 522.2120, redesignate residue’’ designation applies only to of this chapter. paragraphs (c) and (d) as paragraphs (d) compounds of carcinogenic concern. and (e) and add new paragraph (c) to * * * * * * * * * * read as follows: ■ 11. In § 522.770, revise paragraph (c) PART 520—ORAL DOSAGE FORM to read as follows: § 522.2120 Spectinomycin dihydrochloride injection. NEW ANIMAL DRUGS § 522.770 Doramectin. * * * * * ■ 3. The authority citation for part 520 * * * * * (c) Related tolerances. See § 556.600 continues to read as follows: (c) Related tolerances. See § 556.222 of this chapter. of this chapter. Authority: 21 U.S.C. 360b. * * * * * * * * * * ■ 4. In § 520.462, redesignate paragraph ■ 19. In § 522.2477, add paragraph (c) to ■ 12. In § 522.850, redesignate (c) as paragraph (d) and add new read as follows: paragraph (c) as paragraph (d) and add paragraph (c) to read as follows: new paragraph (c) to read as follows: § 522.2477 Trenbolone acetate and § 520.462 Clorsulon drench. estradiol. § 522.850 Estradiol valerate and * * * * * norgestomet in combination. * * * * * (c) Related tolerances. See § 556.163 * * * * * (c) Related tolerances. See §§ 556.240 of this chapter. (c) Related tolerances. See § 556.240 and 556.739 of this chapter. * * * * * of this chapter. * * * * * ■ 5. In § 520.1840, add paragraph (c) to * * * * * ■ 20. In § 522.2640, revise paragraph (c) read as follows: ■ 13. In § 522.1077, redesignate to read as follows: § 520.1840 Poloxalene. paragraphs (c) and (d) as paragraphs (d) § 522.2640 Tylosin. and (e) and add new paragraph (c) to * * * * * * * * * * read as follows: (c) Related tolerances. See § 556.517 (c) Related tolerances. See § 556.746 of this chapter. § 522.1077 Gonadorelin. of this chapter. * * * * * * * * * * * * * * *

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PART 524—OPHTHALMIC AND PART 529—CERTAIN OTHER DOSAGE 556.300 Gentamicin. TOPICAL DOSAGE FORM NEW FORM NEW ANIMAL DRUGS 556.304 Gonadotropin. ANIMAL DRUGS 556.308 Halofuginone. ■ 29. The authority citation for part 529 556.310 Haloxon. 556.330 Hygromycin B. ■ continues to read as follows: 21. The authority citation for part 524 556.344 Ivermectin. continues to read as follows: Authority: 21 U.S.C. 360b. 556.346 Laidlomycin. Authority: 21 U.S.C. 360b. ■ 30. In § 529.400, redesignate 556.347 Lasalocid. 556.350 Levamisole. § 524.770 [Amended] paragraph (c) as paragraph (d) and add 556.360 Lincomycin. new paragraph (c) to read as follows: 556.370 Lubabegron. ■ 22. In § 524.770, in paragraph (c), 556.375 Maduramicin. § 529.400 Chlorhexidine tablets and remove ‘‘§ 556.225’’ and in its place add 556.380 Melengestrol. suspension. ‘‘§ 556.222’’. 556.410 Metoserpate. * * * * * ■ 23. In § 524.920, revise paragraph (c) 556.420 Monensin. (c) Related tolerances. See § 556.120 556.425 Morantel. to read as follows: of this chapter. 556.426 Moxidectin. § 524.920 Fenthion. * * * * * 556.428 Narasin. 556.430 Neomycin. * * * * * ■ 31. Revise part 556 to read as follows: 556.445 Nicarbazin. (c) Related tolerances. See § 556.280 556.460 Novobiocin. of this chapter. PART 556—TOLERANCES FOR 556.470 Nystatin. * * * * * RESIDUES OF NEW ANIMAL DRUGS 556.490 Ormetoprim. IN FOOD 556.495 Oxfendazole. ■ 24. In § 524.1044e, redesignate 556.500 Oxytetracycline. paragraph (c) as paragraph (d) and add Subpart A—General Provisions 556.510 Penicillin. new paragraph (c) to read as follows: Sec. 556.513 Piperazine. 556.1 Scope. 556.515 Pirlimycin. § 524.1044e Gentamicin spray. 556.3 Definitions. 556.517 Poloxalene. * * * * * 556.5 General considerations. 556.540 Progesterone. (c) Related tolerances. See § 556.300 556.560 Pyrantel. Subpart B—Specific Tolerances for 556.570 Ractopamine. of this chapter. Residues of Approved and Conditionally 556.580 Robenidine. * * * * * Approved New Animal Drugs 556.592 Salinomycin. ■ 25. In § 524.1600b, redesignate Sec. 556.597 Semduramicin. paragraph (c) as paragraph (d) and add 556.34 Albendazole. 556.600 Spectinomycin. 556.610 Streptomycin. new paragraph (c) to read as follows: 556.36 Altrenogest. 556.38 Amoxicillin. 556.620 Sulfabromomethazine. § 524.1600b Nystatin, neomycin, 556.40 Ampicillin. 556.625 Sulfachloropyrazine. thiostrepton, and triamcinolone ophthalmic 556.50 Amprolium. 556.630 Sulfachlorpyridazine. ointment. 556.52 Apramycin. 556.640 Sulfadimethoxine. 556.650 Sulfaethoxypyridazine. * * * * * 556.60 Avilamycin. 556.68 Azaperone. 556.660 Sulfamerazine. (c) Related tolerances. See §§ 556.430 556.70 Bacitracin. 556.670 Sulfamethazine. and 556.470 of this chapter. 556.75 Bambermycins. 556.685 Sulfaquinoxaline. * * * * * 556.100 Carbadox. 556.700 Sulfomyxin. 556.110 Carbomycin. 556.710 Testosterone. PART 526—INTRAMAMMARY DOSAGE 556.113 Ceftiofur. 556.720 Tetracycline. 556.730 Thiabendazole. FORM NEW ANIMAL DRUGS 556.115 Cephapirin. 556.118 Chloramine-T. 556.732 Tiamulin. 556.120 Chlorhexidine. 556.733 Tildipirosin. ■ 26. The authority citation for part 526 556.735 Tilmicosin. continues to read as follows: 556.150 Chlortetracycline. 556.160 Clopidol. 556.739 Trenbolone. Authority: 21 U.S.C. 360b. 556.163 Clorsulon. 556.741 Tripelennamine. 556.745 Tulathromycin. ■ 556.165 Cloxacillin. 27. In § 526.820, redesignate 556.167 Colistimethate. 556.746 Tylosin. paragraph (c) as paragraph (d) and add 556.168 Coumaphos. 556.748 Tylvalosin. new paragraph (c) to read as follows: 556.169 Danofloxacin. 556.750 Virginiamycin. 556.170 Decoquinate. 556.760 Zeranol. § 526.820 Erythromycin. 556.180 Dichlorvos. 556.765 Zilpaterol. * * * * * 556.185 Diclazuril. 556.770 Zoalene. (c) Related tolerances. See § 556.230 556.200 Dihydrostreptomycin. Authority: 21 U.S.C. 342, 360b, 371. of this chapter. 556.222 Doramectin. 556.224 Efrotomycin. Subpart A—General Provisions * * * * * 556.226 Enrofloxacin. ■ 28. In § 526.1696d, redesignate 556.227 Eprinomectin. § 556.1 Scope. paragraph (c) as paragraph (d) and add 556.230 Erythromycin. (a) The Federal Food, Drug, and new paragraph (c) to read as follows: 556.240 Estradiol and related esters. Cosmetic Act requires an applicant 556.260 Ethopabate. seeking approval or conditional § 526.1696d Penicillin G procaine- 556.273 Famphur. approval of a new animal drug to submit novobiocin for intramammary infusion. 556.275 Fenbendazole. a proposed tolerance as part of its new * * * * * 556.277 Fenprostalene. 556.280 Fenthion. animal drug application when such a (c) Related tolerances. See §§ 556.460 556.283 Florfenicol. tolerance is needed to assure that the and 556.510 of this chapter. 556.286 Flunixin. proposed use of the new animal drug * * * * * 556.292 Gamithromycin. will be safe (see sections 512(b)(1)(H)

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and 571(a)(2)(A) of the Federal Food, from the use of a drug, and includes the Subpart B—Specific Tolerances for Drug, and Cosmetic Act). FDA assigns drug, its metabolites, and any other Residues of Approved and tolerances for animal drugs used in substance formed in or on food because Conditionally Approved New Animal food-producing animals as part of the of the drug’s use. Drugs application approval process. Target tissue means the edible tissue § 556.34 Albendazole. Tolerances for approved and selected to monitor for residues in the conditionally approved new animal (a) Acceptable daily intake (ADI). The target animals. drugs are codified in subpart B of this ADI for total residue of albendazole is part. Tolerance means the maximum 5 mg/kg of body weight per day. (b) Compounds that have been found concentration of a marker residue, or (b) Tolerances. The tolerances for to be carcinogenic are regulated under other residue indicated for monitoring, albendazole 2-aminosulfone (marker subpart E of part 500 of this chapter. that can legally remain in a specific residue) are: edible tissue of a treated animal. (1) Cattle. (i) Liver (target tissue): 0.2 § 556.3 Definitions. Total residue means the aggregate of ppm. As used in this part: (ii) Muscle: 0.05 ppm. all compounds that results from the use Acceptable daily intake (ADI) means (2) Sheep. (i) Liver (target tissue): 0.25 of an animal drug, including the drug, the daily intake which, during up to an ppm. entire life of a human, appears to be its metabolites, and any other (ii) Muscle: 0.05 ppm. without adverse effects or harm to the substances formed in or on food because (3) Goat. (i) Liver (target tissue): 0.25 health of the consumer. The ADI most of such drug use. ppm. often will be set on the basis of the mg/kg means microgram per kilogram. (ii) [Reserved] drug’s toxicological, microbiological, or Zero, in reference to tolerances in this (c) Related conditions of use. See pharmacological properties. It is usually part, means any residues detected in the §§ 520.38a and 520.38b of this chapter. expressed in micrograms or milligrams edible tissue renders it unsafe. of the chemical per kilogram of body § 556.36 Altrenogest. weight per day. § 556.5 General considerations. (a) Acceptable daily intake (ADI). The Acute reference dose (ARfD) means an ADI for total residue of altrenogest is estimate of the amount of residues (a) The tolerances listed in subpart B 0.04 mg/kg of body weight per day. expressed on a body weight basis that of this part pertain only to the species (b) Tolerances. The tolerances for can be ingested in a period of 24 hours and production classes of the animal for altrenogest (marker residue) are: or less without adverse effects or harm which the drug use has been approved (1) Swine. (i) Liver (target tissue): 4 to the health of the human consumer. or conditionally approved. Approved ppb. Edible tissues means muscle, liver, and conditionally approved conditions (ii) Muscle: 1 ppb. kidney, fat, skin with fat in natural of use in parts 516, 520, 522, 524, 526, (2) [Reserved] proportions, whole eggs, whole milk, 529, and 558 of this chapter, including (c) Related conditions of use. See and honey. the species and production classes of § 520.48 of this chapter. Marker residue means the residue animals, are referenced in each § 556.38 Amoxicillin. whose concentration is in a known tolerance section in subpart B of this (a) [Reserved] relationship to the concentration of total part. (b) Tolerances. The tolerance for residue in an edible tissue. (b) All tolerances refer to the amoxicillin is: mg/kg means milligrams per kilogram. concentrations of a marker residue, or (1) Cattle. Edible tissues: 0.01 ppm. Not required, in reference to other residue indicated for monitoring, (2) [Reserved] tolerances in this part, means that at the (c) Related conditions of use. See time of approval: permitted in uncooked tissues. §§ 520.88d, 522.88, and 526.88 of this (1) No withdrawal period was (c) After a tolerance is listed, the chapter. necessary for residues of the drug to finding that the concentration of the deplete to or below the concentrations marker residue in the target tissue from § 556.40 Ampicillin. considered to be safe, or an adequate a tested animal is at or below the (a) [Reserved] withdrawal period was inherent in the tolerance indicates that all edible tissues (b) Tolerances. The tolerances for proposed drug use, and there was a (excluding milk and eggs unless ampicillin are: rapid depletion of residues, so there was otherwise indicated) from that tested (1) Cattle. Edible tissues: 0.01 ppm. no concern about residues resulting animal are safe for human consumption. (2) Swine. Edible tissues: 0.01 ppm. from misuse or overdosing; or If a listed tolerance is not expressly (c) Related conditions of use. See (2) No withdrawal period was linked to a target tissue, then the §§ 520.90e, 520.90f, 522.90a, and necessary because the drug was poorly tolerance is specific only for the named 522.90b of this chapter. absorbed or metabolized rapidly so as to edible tissue and inferences cannot be § 556.50 Amprolium. make selection of an analyte impractical made about the safety of the other edible or impossible. tissues from the tested animal. (a) [Reserved] ppb means parts per billion (b) Tolerances. The tolerances for (equivalent to nanograms per gram (ng/ (d) FDA requires that a drug sponsor amprolium are: g) or mg/kg). submit a practicable method as part of (1) Cattle. (i) Liver, kidney, and ppm means parts per million their new animal drug application. FDA muscle: 0.5 ppm. (equivalent to micrograms per gram (mg/ uses the practicable method to (ii) Fat: 2.0 ppm. g) or mg/kg). determine the quantity of the drug (2) Chickens and turkeys. (i) Liver and ppt means parts per trillion residues that can safely remain in edible kidney: 1 ppm. (equivalent to picograms per gram (pg/ tissues (i.e., the tolerance), the (ii) Muscle: 0.5 ppm. g) or nanograms per kilogram (ng/kg)). withdrawal period, and any other use (iii) Eggs: Residue means any compound restrictions necessary to ensure that the (A) Egg yolks: 8 ppm. present in edible tissues that results proposed use of the drug will be safe. (B) Whole eggs: 4 ppm.

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(3) Pheasants. (i) Liver: 1 ppm. (b) Tolerances. The tolerance for (2) [Reserved] (ii) Muscle: 0.5 ppm. quinoxaline-2-carboxylic acid (marker (c) Related conditions of use. See (c) Related conditions of use. See residue) is: § 529.382 of this chapter. §§ 520.100, 558.55, and 558.58 of this (1) Swine. Liver (target tissue): 30 ppb. chapter. (2) [Reserved] § 556.120 Chlorhexidine. (c) Related conditions of use. See (a) [Reserved] § 556.52 Apramycin. § 558.115 of this chapter. (b) Tolerances. The tolerance for (a) Acceptable daily intake (ADI). The chlorhexidine is: ADI for total residue of apramycin is 25 § 556.110 Carbomycin. (1) Cattle. Edible tissues (excluding mg/kg of body weight per day. (a) [Reserved] milk): Zero. (b) Tolerances. The tolerance for (b) Tolerances. The tolerance for (2) [Reserved] apramycin (marker residue) is: carbomycin is: (c) Related conditions of use. See (1) Swine. Kidney (target tissue): 0.1 (1) Chickens. Edible tissues § 529.400 of this chapter. ppm. (excluding eggs): Zero. (2) [Reserved] (2) [Reserved] § 556.150 Chlortetracycline. (c) Related conditions of use. See (c) Related conditions of use. See (a) Acceptable daily intake (ADI). The §§ 520.110 and 558.59 of this chapter. § 520.1660a of this chapter. ADI for total residue of tetracyclines § 556.60 Avilamycin. including chlortetracycline, § 556.113 Ceftiofur. oxytetracycline, and tetracycline is 25 (a) Acceptable daily intake (ADI). The (a) Acceptable daily intake and acute m ADI for total residue of avilamycin is 1.1 g/kg of body weight per day. reference dose—(1) Acceptable daily (b) Tolerances. The tolerances for the mg/kg of body weight per day. (b) Tolerances. The tolerances for intake (ADI). The ADI for total residue sum of tetracycline residues are: m avilamycin are: of ceftiofur is 30 g/kg of body weight (1) Cattle. (i) Liver: 6 ppm. (1) Chickens. Edible tissues per day. (ii) Kidney and fat: 12 ppm. (excluding eggs): Not required. (2) Acute reference dose (ARfD). The (iii) Muscle: 2 ppm. (2) Swine. Edible tissues: Not ARfD for total residue of ceftiofur is (2) Chickens, turkeys, and ducks. (i) required. 0.830 mg/kg of body weight. Liver: 6 ppm. (c) Related conditions of use. See (b) Tolerances. The tolerances for (ii) Kidney and fat: 12 ppm. § 558.68 of this chapter. desfuroylceftiofur (marker residue) are: (iii) Muscle: 2 ppm. (1) Cattle. (i) Kidney (target tissue): (iv) Eggs: 0.4 ppm for § 556.68 Azaperone. 0.4 ppm. chlortetracycline only. (a) Acceptable daily intake (ADI). The (ii) Liver: 2 ppm. (3) Sheep. (i) Liver: 6 ppm. ADI for total residue of azaperone is (iii) Muscle: 1 ppm. (ii) Kidney and fat: 12 ppm. 0.63 mg/kg of body weight per day. (iv) Milk: 0.1 ppm. (iii) Muscle: 2 ppm. (b) Tolerances. The tolerance for (2) Chickens and turkeys. Edible (4) Swine. (i) Liver: 6 ppm. azaperone is: tissues (excluding eggs): Not required. (ii) Kidney and fat: 12 ppm. (1) Swine. Edible tissues: Not (3) Goats. (i) Kidney (target tissue): 8 (iii) Muscle: 2 ppm. required. ppm. (c) Related conditions of use. See (2) [Reserved] (ii) Liver: 2 ppm. §§ 520.441, 520.443, 520.445, 558.128, (c) Related conditions of use. See (iii) Muscle: 1 ppm. and 558.140 of this chapter. § 522.150 of this chapter. (iv) Milk: 0.1 ppm. (4) Sheep. Edible tissues (excluding § 556.160 Clopidol. § 556.70 Bacitracin. milk): Not required. (a) [Reserved] (a) Acceptable daily intake (ADI). The (5) Swine. (i) Kidney (target tissue): (b) Tolerances. The tolerances for ADI for total residue of bacitracin is 0.05 0.25 ppm. clopidol are: mg/kg of body weight per day. (ii) Liver: 3 ppm. (1) Chickens and turkeys. (i) Liver and (b) Tolerances. The tolerances for (iii) Muscle: 2 ppm. kidney: 15 ppm. bacitracin are: (c) Related conditions of use. See (ii) Muscle: 5 ppm. (1) Cattle. Edible tissues: 0.5 ppm. §§ 522.313a, 522.313b, 522.313c, and (2) [Reserved] (2) Chickens, turkeys, pheasants, 526.313 of this chapter. (c) Related conditions of use. See quail. Edible tissues: 0.5 ppm. § 558.175 of this chapter. (3) Swine. Edible tissues: 0.5 ppm. § 556.115 Cephapirin. (c) Related conditions of use. See (a) [Reserved] § 556.163 Clorsulon. §§ 520.154a, 520.154c, 558.76, and (b) Tolerances. The tolerances for (a) Acceptable daily intake (ADI). The 558.78 of this chapter. cephapirin are: ADI for total residue of clorsulon is 8 § 556.75 Bambermycins. (1) Cattle. (i) Edible tissues (excluding mg/kg of body weight per day. (a) [Reserved] milk): 0.1 ppm. (b) Tolerances. The tolerances for (b) Tolerances. The tolerances for (ii) Milk: 0.02 ppm. clorsulon (marker residue) are: bambermycins are: (2) [Reserved] (1) Cattle. (i) Kidney (target tissue): (1) Cattle. Edible tissues (excluding (c) Related conditions of use. See 1.0 ppm. milk): Not required. §§ 526.363 and 526.365 of this chapter. (ii) Muscle: 0.1 ppm. (2) [Reserved] (2) Chickens and turkeys. Edible § 556.118 Chloramine-T. tissues (excluding eggs): Not required. (c) Related conditions of use. See (3) Swine. Edible tissues: Not (a) Acceptable daily intake (ADI). The §§ 520.462 and 522.1193 of this chapter. required. ADI for total residue of chloramine-T is (c) Related conditions of use. See 5 mg/kg of body weight per day. § 556.165 Cloxacillin. § 558.95 of this chapter. (b) Tolerances. The tolerance for para- (a) [Reserved] toluenesulfonamide (marker residue) is: (b) Tolerances. The tolerance for § 556.100 Carbadox. (1) Fish. Muscle/skin (target tissue): cloxacillin is: (a) [Reserved] 0.9 ppm. (1) Cattle. Edible tissues: 0.01 ppm.

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(2) [Reserved] § 556.185 Diclazuril. (b) Tolerances. The tolerances for (c) Related conditions of use. See (a) Acceptable daily intake (ADI). The eprinomectin B1a (marker residue) are: §§ 526.464a, 526.464b, and 526.464c of ADI for total residue of diclazuril is 25 (1) Cattle. (i) Liver (target tissue): 1.5 this chapter. mg/kg of body weight per day. ppm. (b) Tolerances. The tolerances for (ii) Muscle: 100 ppb. § 556.167 Colistimethate. diclazuril are: (iii) Milk: 12 ppb. (a) [Reserved] (1) Chickens and turkeys. (i) Liver: 3 (2) [Reserved] (b) Tolerances. The tolerance for ppm. (c) Related conditions of use. See colistimethate is: (ii) Muscle: 0.5 ppm. §§ 522.814 and 524.814 of this chapter. (1) Chickens. Edible tissues (iii) Skin/fat: 1 ppm. (excluding eggs): Not required. (2) [Reserved] § 556.230 Erythromycin. (2) [Reserved] (c) Related conditions of use. See (a) [Reserved] (c) Related conditions of use. See § 558.198 of this chapter. (b) Tolerances. The tolerances for erythromycin are: § 522.468 of this chapter. § 556.200 Dihydrostreptomycin. (1) Cattle. (i) Edible tissues (excluding § 556.168 Coumaphos. (a) [Reserved] milk): 0.1 ppm. (a) [Reserved] (b) Tolerances. The tolerances for (ii) Milk: Zero. (b) Tolerances. The tolerances for dihydrostreptomycin are: (2) Chickens and turkeys. (i) Edible coumaphos (measured as coumaphos (1) Cattle. (i) Kidney: 2.0 ppm. (ii) Other edible tissues (excluding tissues (excluding eggs): 0.125 ppm. and its oxygen analog, O,O-diethyl O-3- (ii) Eggs: 0.025 ppm. chloro-4-methyl-2-oxo-2 H-1- milk): 0.5 ppm. (iii) Milk: 0.125 ppm. (3) Swine. Edible tissues: 0.1 ppm. benzopyran-7-yl phosphate) are: (2) Swine. (i) Kidney: 2.0 ppm. (c) Related conditions of use. See (1) Cattle. (i) Edible tissues (excluding (ii) Other edible tissues: 0.5 ppm. §§ 520.823, 522.820, 526.820, and milk): 1 ppm. (c) Related conditions of use. See 558.248 of this chapter. (ii) Milk fat: 0.5 ppm. §§ 522.650, 526.1696b, and 526.1696c of § 556.240 Estradiol and related esters. (2) Chickens. (i) Edible tissues this chapter. (excluding eggs): 1 ppm. (a) [Reserved] (ii) Eggs: 0.1 ppm. § 556.222 Doramectin. (b) Residues. Residues of estradiol are (c) Related conditions of use. See (a) Acceptable daily intake (ADI). The not permitted in excess of the following § 558.185 of this chapter. ADI for total residue of doramectin is increments above the concentrations of 0.75 mg/kg of body weight per day. estradiol naturally present in untreated § 556.169 Danofloxacin. (b) Tolerances. The tolerances for animals: (a) Acceptable daily intake (ADI). The doramectin (marker residue) are: (1) Cattle. (i) Muscle: 120 ppt. ADI for total residue of danofloxacin is (1) Cattle. (i) Liver (target tissue): 100 (ii) Fat: 480 ppt. 2.4 mg/kg of body weight per day. ppb. (iii) Kidney: 360 ppt. (b) Tolerances. The tolerances for (ii) Muscle: 30 ppb. (iv) Liver: 240 ppt. danofloxacin (marker residue) are: (2) Swine. Liver (target tissue): 160 (2) [Reserved] (1) Cattle. (i) Liver (target tissue): 0.2 ppb. (c) Related conditions of use. See ppm. (c) Related conditions of use. See §§ 522.840, 522.842, 522.850, 522.1940, (ii) Muscle: 0.2 ppm. §§ 522.770 and 524.770 of this chapter. 522.2477, and 522.2478 of this chapter. (2) [Reserved] § 556.224 Efrotomycin. (c) Related conditions of use. See § 556.260 Ethopabate. § 522.522 of this chapter. (a) Acceptable daily intake (ADI). The (a) [Reserved] ADI for total residue of efrotomycin is (b) Tolerances. The tolerances for § 556.170 Decoquinate. 10 mg/kg of body weight per day. ethopabate, measured as (a) Acceptable daily intake (ADI). The (b) Tolerances. The tolerance for metaphenetidine, are: ADI for total residue of decoquinate is efrotomycin is: (1) Chickens. (i) Liver: 1.5 ppm. (1) Swine. Edible tissues: Not 75 mg/kg of body weight per day. (ii) Kidney: 1.5 ppm. required. (b) Tolerances. The tolerances for (iii) Muscle: 0.5 ppm. decoquinate are: (2) [Reserved] (c) Related conditions of use. See (2) [Reserved] (1) Cattle. (i) Muscle: 1 ppm. § 558.235 of this chapter. (c) Related conditions of use. See (ii) Other edible tissues (excluding § 558.58 of this chapter. milk): 2 ppm. § 556.226 Enrofloxacin. § 556.273 Famphur. (2) Chickens. (i) Muscle: 1 ppm. (a) Acceptable daily intake (ADI). The (ii) Other edible tissues (excluding ADI for total residue of enrofloxacin is (a) [Reserved] eggs): 2 ppm. 3 mg/kg of body weight per day. (b) Tolerances. The tolerance for (3) Goats. (i) Muscle: 1 ppm. (b) Tolerances. The tolerances for famphur including its oxygen analog is: (ii) Other edible tissues (excluding enrofloxacin are: (1) Cattle. Edible tissues (excluding milk): 2 ppm. (1) Cattle. Liver (target tissue): 0.1 milk): 0.1 ppm. (c) Related conditions of use. See ppm desethylene ciprofloxacin (marker (2) [Reserved] §§ 520.543 and 558.195 of this chapter. residue). (c) Related conditions of use. See (2) Swine. Liver (target tissue): 0.5 §§ 520.1242g, 524.900, and 558.254 of § 556.180 Dichlorvos. ppm enrofloxacin (marker residue). this chapter. (a) [Reserved] (c) Related conditions of use. See § 556.275 Fenbendazole. (b) Tolerances. The tolerance for § 522.812 of this chapter. dichlorvos is: (a) Acceptable daily intake (ADI). The (1) Swine. Edible tissues: 0.1 ppm. § 556.227 Eprinomectin. ADI for total residue of fenbendazole is (2) [Reserved] (a) Acceptable daily intake (ADI). The 40 mg/kg of body weight per day. (c) Related conditions of use. See ADI for total residue of eprinomectin is (b) Tolerances. The tolerances for §§ 520.596 and 558.205 of this chapter. 10 mg/kg of body weight per day. fenbendazole are:

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(1) Cattle. (i) Liver (target tissue): 0.8 § 556.286 Flunixin. hydrobromide is 0.7 mg/kg of body ppm fenbendazole (marker residue). (a) Acceptable daily intake (ADI). The weight per day. (ii) Muscle: 0.4 ppm fenbendazole. ADI for total residue of flunixin is 0.72 (b) Tolerances. The tolerances for (iii) Milk: 0.6 ppm fenbendazole mg/kg of body weight per day. halofuginone (marker residue) are: sulfoxide. (b) Tolerances. The tolerances for (1) Chickens. Liver (target tissue): 0.16 (2) Chickens. (i) Liver (target tissue): flunixin are: ppm. 5.2 ppm fenbendazole sulfone (marker (1) Cattle. (i) Liver (target tissue): 125 (2) Turkeys. Liver (target tissue): 0.13 residue). ppb flunixin free acid (marker residue). ppm. (ii) Eggs: 1.8 ppm fenbendazole (ii) Muscle: 25 ppb flunixin free acid. (c) Related conditions of use. See sulfone (marker residue). (iii) Milk: 2 ppb 5-hydroxy flunixin § 558.265 of this chapter. (3) Goats. (i) Liver (target tissue): 0.8 (marker residue). § 556.310 Haloxon. ppm fenbendazole (marker residue). (2) Swine. (i) Liver (target tissue): 30 (ii) Muscle: 0.4 ppm fenbendazole. (a) [Reserved] ppb flunixin free acid (marker residue). (b) Tolerances. The tolerance for (4) Swine. (i) Liver (target tissue): 3.2 (ii) Muscle: 25 ppb flunixin free acid. haloxon is: ppm fenbendazole (marker residue). (c) Related conditions of use. See (1) Cattle. Edible tissues (excluding (ii) Muscle: 2 ppm fenbendazole. §§ 522.956, 522.970, 522.1664, and milk): 0.1 ppm. (5) Turkeys. (i) Liver (target tissue): 6 524.970 of this chapter. (2) [Reserved] ppm fenbendazole sulfone (marker § 556.292 Gamithromycin. (c) Related conditions of use. See residue). §§ 520.1120a and 520.1120b of this (ii) Muscle: 2 ppm fenbendazole (a) Acceptable daily intake (ADI). The chapter. sulfone. ADI for total residue of gamithromycin (c) Related conditions of use. See is 10 mg/kg of body weight per day. § 556.330 Hygromycin B. §§ 520.905a, 520.905c, 520.905d, (b) Tolerances. The tolerances for (a) [Reserved] 520.905e, and 558.258 of this chapter. gamithromycin (marker residue) are: (b) Tolerances. The tolerances for (1) Cattle. (i) Liver (target tissue): 500 hygromycin B are: § 556.277 Fenprostalene. ppb. (1) Chickens. Edible tissues: Zero. (a) Acceptable daily intake (ADI). The (ii) Muscle: 150 ppb. (2) Swine. Edible tissues: Zero. ADI for total residue of fenprostalene is (2) [Reserved] (c) Related conditions of use. See 0.08 mg/kg of body weight per day. (c) Related conditions of use. See § 558.274 of this chapter. (b) Tolerances. The tolerances for § 522.1014 of this chapter. fenprostalene are: § 556.344 Ivermectin. (1) Cattle. Edible tissues (excluding § 556.300 Gentamicin. (a) Acceptable daily intake (ADI). The milk): Not required. (a) Acceptable daily intake (ADI). The ADI for total residue of ivermectin is 1 (2) Swine. Edible tissues: Not ADI for total residue of gentamicin is 60 mg/kg of body weight per day. required. mg/kg of body weight per day. (b) Tolerances. The tolerances for (c) Related conditions of use. See (b) Tolerances. The tolerances for 22,23-dihydroavermectin B1a (marker § 522.914 of this chapter. gentamicin are: residue) are: (1) Chickens and turkeys. Edible (1) American bison. Liver (target § 556.280 Fenthion. tissues (excluding eggs): 0.1 ppm. tissue): 15 ppb. (a) [Reserved] (2) Swine. (i) Liver: 0.3 ppm. (2) Cattle. (i) Liver (target tissue): 100 (b) Tolerances. The tolerance for (ii) Kidney (target tissue): 0.4 ppm ppb. fenthion is: gentamicin (marker residue). (ii) Muscle: 10 ppb. (1) Cattle. Edible tissues (excluding (iii) Fat: 0.4 ppm. (3) Reindeer. Liver (target tissue): 15 milk): 0.1 ppm. (iv) Muscle: 0.1 ppm. ppb. (4) Sheep. Liver (target tissue): 30 (2) [Reserved] (c) Related conditions of use. See ppb. (c) Related conditions of use. See §§ 522.1044a, 520.1044b, 520.1044c, (5) Swine. (i) Liver (target tissue): 20 § 524.920 of this chapter. and 524.1044e of this chapter. ppb. § 556.283 Florfenicol. § 556.304 Gonadotropin. (ii) Muscle: 20 ppb. (a) Acceptable daily intake (ADI). The (a) Acceptable daily intake (ADI). The (c) Related conditions of use. See ADI for total residue of florfenicol is 10 ADI for residues of total gonadotropins §§ 520.1192, 520.1195, 520.1197, mg/kg of body weight per day. (human chorionic gonadotropin and 522.1192, 522.1193, 524.1193, and (b) Tolerances. The tolerances for pregnant mare serum gonadotropin) is 558.300 of this chapter. florfenicol amine (marker residue) are: 42.25 International Units per kilogram § 556.346 Laidlomycin. (1) Cattle. (i) Liver (target tissue): 3.7 of body weight per day. (a) Acceptable daily intake (ADI). The ppm. (b) Tolerances. The tolerances for ADI for total residue of laidlomycin is (ii) Muscle: 0.3 ppm. gonadotropin are: 7.5 mg/kg of body weight per day. (2) Swine. (i) Liver (target tissue): 2.5 (1) Cattle. Edible tissues (excluding (b) Tolerances. The tolerance for ppm. milk): Not required. laidlomycin (marker residue) is: (ii) Muscle: 0.2 ppm. (2) Fish. Edible tissues: Not required. (1) Cattle. Liver (target tissue): 0.2 (3) Catfish. Muscle (target tissue): 1 (3) Swine. Edible tissues: Not ppm. ppm. required. (2) [Reserved] (4) Freshwater-reared warmwater (c) Related conditions of use. See (c) Related conditions of use. See finfish (other than catfish) and §§ 522.1077, 522.1079, and 522.1081 of § 558.305 of this chapter. salmonids. Muscle/skin (target tissue): 1 this chapter. ppm. § 556.347 Lasalocid. (c) Related conditions of use. See § 556.308 Halofuginone. (a) Acceptable daily intake (ADI). The §§ 520.955, 522.955, 522.956, and (a) Acceptable daily intake (ADI). The ADI for total residue of lasalocid is 10 558.261 of this chapter. ADI for total residue of halofuginone mg/kg of body weight per day.

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(b) Tolerances. The tolerances for (1) Cattle. Fat: 25 ppb. § 556.428 Narasin. lasalocid (marker residue) are: (2) [Reserved] (a) Acceptable daily intake (ADI). The (1) Cattle. Liver (target tissue): 0.7 (c) Related conditions of use. See ADI for total residue of narasin is 5 mg/ ppm. § 558.342 of this chapter. kg of body weight per day. (2) Chickens. (i) Skin with adhering (b) Tolerances. The tolerance for fat (target tissue): 1.2 ppm. § 556.410 Metoserpate. narasin (marker residue) is: (ii) Liver: 0.4 ppm. (a) [Reserved] (1) Chickens. Abdominal fat (target (3) Rabbits. Liver (target tissue): 0.7 (b) Tolerances. The tolerance for tissue): 480 ppb. ppm. metoserpate is: (2) [Reserved] (4) Sheep. Liver (target tissue): 1.0 (1) Chickens. Edible tissues (c) Related conditions of use. See ppm. (excluding eggs): 0.02 ppm. §§ 558.363 and 558.364 of this chapter. (5) Turkeys. (i) Liver (target tissue): (2) [Reserved] 0.4 ppm. (c) Related conditions of use. See § 556.430 Neomycin. (ii) Skin with adhering fat: 0.4 ppm. § 520.1422 of this chapter. (a) Acceptable daily intake (ADI). The (c) Related conditions of use. See ADI for total residue of neomycin is 6 § 558.311 of this chapter. § 556.420 Monensin. mg/kg of body weight per day. § 556.350 Levamisole. (a) Acceptable daily intake (ADI). The (b) Tolerances. The tolerances for (a) [Reserved] ADI for total residue of monensin is 12.5 neomycin are: (b) Tolerances. The tolerances for mg/kg of body weight per day. (1) Cattle. (i) Kidney (target tissue): levamisole are: (b) Tolerances. The tolerances for 7.2 ppm. (1) Cattle. Edible tissues (excluding monensin are: (ii) Liver: 3.6 ppm. milk): 0.1 ppm. (1) Cattle. (i) Liver: 0.10 ppm. (iii) Muscle: 1.2 ppm. (2) Sheep. Edible tissues (excluding (ii) Muscle, kidney, and fat: 0.05 ppm. (iv) Fat: 7.2 ppm. milk): 0.1 ppm. (iii) Milk: Not required. (v) Milk: 0.15 ppm. (3) Swine. Edible tissues: 0.1 ppm. (2) Chickens and turkeys. Edible (2) Sheep and goats. (i) Kidney (target (c) Related conditions of use. See tissues (excluding eggs): Not required. tissue): 7.2 ppm. §§ 520.1242a, 520.1242b, 520.1242d, (3) Goats. Edible tissues (excluding (ii) Liver: 3.6 ppm. 520.1242e, 520.1242f, 520.1242g, milk): 0.05 ppm. (iii) Muscle: 1.2 ppm. 522.1242, and 524.1240 of this chapter. (4) Quail. Edible tissues (excluding (iv) Fat: 7.2 ppm. eggs): Not required. (v) Milk: 0.15 ppm. § 556.360 Lincomycin. (c) Related conditions of use. See (3) Swine. (i) Kidney (target tissue): (a) Acceptable daily intake (ADI). The § 558.355 of this chapter. 7.2 ppm. ADI for total residue of lincomycin is 25 (ii) Liver: 3.6 ppm. mg/kg of body weight per day. § 556.425 Morantel. (iii) Muscle: 1.2 ppm. (b) Tolerances. The tolerances for (a) Acceptable daily intake (ADI). The (iv) Fat: 7.2 ppm. lincomycin are: ADI for total residue of morantel tartrate (4) Turkeys. (i) Skin with adhering fat: (1) Chickens. Edible tissues is 10 mg/kg of body weight per day. 7.2 ppm. (excluding eggs): Not required. (b) Tolerances. The tolerances for N- (ii) Liver: 3.6 ppm. (2) Swine. (i) Liver: 0.6 ppm. methyl-1,3-propanediamine (marker (iii) Muscle: 1.2 ppm. (ii) Muscle: 0.1 ppm. (c) Related conditions of use. See (c) Related conditions of use. See residue) are: (1) Cattle. (i) Liver (target tissue): 0.7 §§ 520.1484, 524.1600b, 558.365, and §§ 520.1263c, 522.1260, and 558.325 of 558.455 of this chapter. this chapter. ppm. (ii) Milk: Not required. § 556.445 Nicarbazin. § 556.370 Lubabegron. (2) Goats. (i) Liver (target tissue): 0.7 (a) Acceptable daily intake (ADI). The (a) Acceptable daily intake (ADI). The ppm. ADI for total residues of nicarbazin (4,4′- ADI for total residues of lubabegron is (ii) Milk: Not required. dinitrocarbanilide and 2-hydroxy-4,6- 3 micrograms per kilogram of body (c) Related conditions of use. See dimethylpyrimidine) is 200 mg/kg of weight per day. §§ 520.1450a, 520.1450b, 520.1450c, body weight per day. (b) Tolerances. The tolerance for and 558.360 of this chapter. (b) Tolerances. The tolerance for 4,4′- lubabegron (marker residue) is: § 556.426 Moxidectin. dinitrocarbanilide (marker residue) is: (1) Cattle. Liver (target tissue): 10 ppb. (1) Chickens. Liver (target tissue): 52 (a) Acceptable daily intake (ADI). The (2) [Reserved] ppm. (c) Related conditions of use. See ADI for total residue of moxidectin is 4 (2) [Reserved] mg/kg of body weight per day. § 558.330 of this chapter. (c) Related conditions of use. See (b) Tolerances. The tolerances for §§ 558.364 and 558.366 of this chapter. § 556.375 Maduramicin. moxidectin (marker residue) are: (a) [Reserved] (1) Cattle. (i) Fat (target tissue): 900 § 556.460 Novobiocin. (b) Tolerances. The tolerance for ppb. (a) [Reserved] maduramicin (marker residue) is: (ii) Liver: 200 ppb. (b) Tolerances. The tolerances for (1) Chickens. Fat (target tissue): 0.38 (iii) Muscle: 50 ppb. ppm. novobiocin are: (iv) Milk: 40 ppb. (2) [Reserved] (1) Cattle. (i) Edible tissues (excluding (c) Related conditions of use. See (2) Sheep. (i) Fat (target tissue): 900 milk): 1 ppm. § 558.340 of this chapter. ppb. (ii) Milk: 0.1 ppm. (ii) Liver: 200 ppb. (2) Chickens, turkeys, and ducks. § 556.380 Melengestrol. (iii) Muscle: 50 ppb. Edible tissues (excluding eggs): 1 ppm. (a) [Reserved] (c) Related conditions of use. See (c) Related conditions of use. See (b) Tolerances. The tolerance for §§ 520.1454, 522.1450, and 524.1450 of §§ 526.1590, 526.1696d, and 558.415 of melengestrol is: this chapter. this chapter.

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§ 556.470 Nystatin. (1) Cattle. (i) Edible tissues (excluding (1) Swine. (i) Liver and kidney: 10 (a) [Reserved] milk): 0.05 ppm. ppm. (b) Tolerances. The tolerances for (ii) Milk: Zero. (ii) Muscle: 1 ppm. nystatin are: (2) Chickens. Edible tissues: Zero. (2) [Reserved] (1) Cattle. Edible tissues (excluding (3) Pheasants and quail. Edible (c) Related conditions of use. See milk): Zero. tissues: Zero. §§ 520.2045 and 558.485 of this chapter. (2) Chickens and turkeys. Edible (4) Sheep and swine. Edible tissues: tissues: Zero. Zero. § 556.570 Ractopamine. (c) Related conditions of use. See (5) Turkeys. Edible tissues (excluding (a) Acceptable daily intake (ADI). The §§ 524.1600b and 558.430 of this eggs): 0.01 ppm. ADI for total residue of ractopamine chapter. (c) Related conditions of use. See hydrochloride is 1.25 mg/kg of body §§ 520.1696b, 522.1696a, 522.1696b, weight per day. § 556.490 Ormetoprim. 526.1696a, 526.1696b, 526.1696c, and (b) Tolerances. The tolerances for (a) [Reserved] 526.1696d of this chapter. ractopamine (marker residue) are: (b) Tolerances. The tolerances for (1) Cattle. (i) Liver (target tissue): 0.09 ormetoprim are: § 556.513 Piperazine. ppm. (1) Chickens, turkeys, ducks, and (a) [Reserved] (ii) Muscle: 0.03 ppm. chukar partridges. Edible tissues (b) Tolerances. The tolerances for (2) Swine. (i) Liver (target tissue): 0.15 (excluding eggs): 0.1 ppm. piperazine are: ppm. (2) Salmonids and catfish. Edible (1) Chickens and turkeys. Edible (ii) Muscle: 0.05 ppm. tissues: 0.1 ppm. tissues (excluding eggs): 0.1 ppm. (3) Turkeys. (i) Liver (target tissue): (c) Related conditions of use. See (2) Swine. Edible tissues: 0.1 ppm. 0.45 ppm. § 558.575 of this chapter. (c) Related conditions of use. See (ii) Muscle: 0.1 ppm. § 520.1807 of this chapter. (c) Related conditions of use. See § 556.495 Oxfendazole. § 556.515 Pirlimycin. § 558.500 of this chapter. (a) Acceptable daily intake (ADI). The ADI for total residue of oxfendazole is (a) Acceptable daily intake (ADI). The § 556.580 Robenidine. 7 mg/kg of body weight per day. ADI for total residue of pirlimycin is (a) [Reserved] (b) Tolerances. The tolerance for 0.01 mg/kg of body weight per day. (b) Tolerances. The tolerances for fenbendazole (marker residue) is: (b) Tolerances. The tolerances for robenidine are: (1) Cattle. Liver (target tissue): 0.8 pirlimycin (marker residue) are: (1) Chickens. (i) Skin and fat: 0.2 ppm. ppm. (1) Cattle. (i) Liver (target tissue): 0.5 (ii) Other edible tissues (excluding (2) [Reserved] ppm. eggs): 0.1 ppm. (c) Related conditions of use. See (ii) Muscle: 0.3 ppm. (2) [Reserved] (iii) Milk: 0.4 ppm. §§ 520.1629 and 520.1630 of this (c) Related conditions of use. See (2) [Reserved] § 558.515 of this chapter. chapter. (c) Related conditions of use. See § 556.500 Oxytetracycline. § 526.1810 of this chapter. § 556.592 Salinomycin. (a) Acceptable daily intake (ADI). The § 556.517 Poloxalene. (a) Acceptable daily intake (ADI). The ADI for total tetracycline residues (a) [Reserved] ADI for total residue of salinomycin is (chlortetracycline, oxytetracycline, and (b) Tolerances. The tolerance for 5 mg/kg of body weight per day. tetracycline) is 25 mg/kg of body weight poloxalene is: (b) Tolerances. The tolerances for per day. (1) Cattle. Edible tissues (excluding salinomycin are: (b) Tolerances. The tolerances for the milk): Not required. (1) Chickens. Edible tissues sum of tetracycline residues are: (2) [Reserved] (excluding eggs): Not required. (1) Cattle. (i) Muscle: 2 ppm. (c) Related conditions of use. See (2) Quail. Edible tissues (excluding (ii) Liver: 6 ppm. §§ 520.1840, 558.464, and 558.465 of eggs): Not required. (iii) Fat and kidney: 12 ppm. this chapter. (c) Related conditions of use. See (iv) Milk: 0.3 ppm. § 558.550 of this chapter. (2) Chickens and turkeys. (i) Muscle: § 556.540 Progesterone. § 556.597 Semduramicin. 2 ppm. (a) [Reserved] (ii) Liver: 6 ppm. (b) Residues. Residues of progesterone (a) Acceptable daily intake (ADI). The (iii) Fat and kidney: 12 ppm. are not permitted in excess of the ADI for total residue of semduramicin is (3) Finfish. Muscle (with adhering following increments above the 3 mg/kg of body weight per day. skin when edible): 2 ppm. concentrations of progesterone naturally (b) Tolerances. The tolerances for (4) Lobster. Muscle: 2 ppm. present in untreated animals: semduramicin are: (5) Swine and sheep. (i) Muscle: 2 (1) Cattle and sheep. (i) Muscle: 5 (1) Chickens. (i) Liver: 400 ppb. ppm. ppb. (ii) Muscle: 130 ppb. (ii) Liver: 6 ppm. (ii) Liver: 15 ppb. (2) [Reserved] (iii) Fat and kidney: 12 ppm. (iii) Kidney: 30 ppb. (c) Related conditions of use. See (c) Related conditions of use. See (iv) Fat: 30 ppb. § 558.555 of this chapter. §§ 520.1660a, 520.1660c, 520.1660d, (2) [Reserved] § 556.600 Spectinomycin. 522.1660a, 522.1660b, 522.1662a, (c) Related conditions of use. See 522.1664, 529.1660, 558.450, and §§ 522.1940 and 529.1940 of this (a) Acceptable daily intake (ADI). The 558.455 of this chapter. chapter. ADI for total residue of spectinomycin is 25 mg/kg of body weight per day. § 556.510 Penicillin. § 556.560 Pyrantel. (b) Tolerances. The tolerances for (a) [Reserved] (a) [Reserved] spectinomycin are: (b) Tolerances. The tolerances for (b) Tolerances. The tolerances for (1) Cattle. (i) Kidney (target tissue): 4 penicillin are: pyrantel are: ppm spectinomycin (marker residue).

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(ii) Muscle: 0.25 ppm. § 556.650 Sulfaethoxypyridazine. § 556.720 Tetracycline. (2) Chickens and turkeys. Edible (a) [Reserved] (a) Acceptable daily intake (ADI). The tissues (excluding eggs): 0.1 ppm. (b) Tolerances. The tolerances for ADI for total tetracycline residues (3) Swine. Edible tissues: Not sulfaethoxypyridazine are: (chlortetracycline, oxytetracycline, and required. (1) Cattle. (i) Edible tissues (excluding tetracycline) is 25 mg/kg of body weight (c) Related conditions of use. See milk): 0.1 ppm. per day. §§ 520.1265, 520.2123b, 520.2123c, (ii) Milk: Zero. (b) Tolerances. The tolerances for the 522.2120, and 522.2121 of this chapter. (2) Swine. Edible tissues: Zero. sum of tetracycline residues are: (c) Related conditions of use. See (1) Cattle and sheep. (i) Kidney and § 556.610 Streptomycin. §§ 520.2240a, 520.2240b, and 522.2240 fat: 12 ppm. (a) [Reserved] of this chapter. (ii) Liver: 6 ppm. (b) Tolerances. The tolerances for § 556.660 Sulfamerazine. (iii) Muscle: 2 ppm. streptomycin are: (2) Chickens and turkeys. (i) Kidney (1) Cattle and swine. (i) Kidney: 2.0 (a) [Reserved] and fat: 12 ppm. ppm. (b) Tolerances. The tolerance for (ii) Liver: 6 ppm. (ii) Other edible tissues (excluding sulfamerazine is: (iii) Muscle: 2 ppm. milk): 0.5 ppm. (1) Trout. Edible tissues: Zero. (3) Swine. (i) Kidney and fat: 12 ppm. (2) Chickens. (i) Kidney: 2.0 ppm. (2) [Reserved] (ii) Liver: 6 ppm. (ii) Other edible tissues (excluding (c) Related conditions of use. See (iii) Muscle: 2 ppm. eggs): 0.5 ppm. § 558.582 of this chapter. (c) Related conditions of use. See (c) Related conditions of use. See § 556.670 Sulfamethazine. §§ 520.2345c and 520.2345d of this § 520.2158 of this chapter. (a) [Reserved] chapter. § 556.620 Sulfabromomethazine. (b) Tolerances. The tolerances for § 556.730 Thiabendazole. sulfamethazine are: (a) [Reserved] (a) [Reserved] (1) Cattle. Edible tissues (excluding (b) Tolerances. The tolerances for (b) Tolerances. The tolerances for sulfabromomethazine are: milk): 0.1 ppm. (2) Chickens and turkeys. Edible thiabendazole are: (1) Cattle. (i) Edible tissues (excluding (1) Cattle. (i) Edible tissues (excluding tissues (excluding eggs): 0.1 ppm. milk): 0.1 ppm. milk): 0.1 ppm. (ii) Milk: 0.01 ppm. (3) Swine. Edible tissues: 0.1 ppm. (c) Related conditions of use. See (ii) Milk: 0.05 ppm. (2) [Reserved] §§ 520.2260a, 520.2260b, 520.2260c, (2) Swine. Edible tissues: 0.1 ppm. (c) Related conditions of use. See (3) Sheep and goats. (i) Edible tissues § 520.2170 of this chapter. 520.2261a, 520.2261b, 522.2260, 558.140, and 558.630 of this chapter. (excluding milk): 0.1 ppm. (ii) Milk: 0.05 ppm. § 556.625 Sulfachloropyrazine. § 556.685 Sulfaquinoxaline. (4) Pheasants. Edible tissues (a) [Reserved] (a) [Reserved] (excluding eggs): 0.1 ppm. (b) Tolerances. The tolerance for (b) Tolerances. The tolerances for (c) Related conditions of use. See sulfachloropyrazine is: sulfaquinoxaline are: §§ 520.2380a, 520.2380b, 520.2380c, (1) Chickens. Edible tissues (1) Cattle. Edible tissues (excluding and 558.600 of this chapter. (excluding eggs): Zero. milk): 0.1 ppm. § 556.732 Tiamulin. (2) [Reserved] (2) Chickens and turkeys. Edible (c) Related conditions of use. See tissues (excluding eggs): 0.1 ppm. (a) Acceptable daily intake (ADI). The § 520.2184 of this chapter. (c) Related conditions of use. See ADI for total residue of tiamulin is 25 mg/kg of body weight per day. § 556.630 Sulfachlorpyridazine. §§ 520.2325a, 520.2325b, and 558.586 of this chapter. (b) Tolerances. The tolerance for 8- (a) [Reserved] alpha-hydroxymutilin (marker residue) (b) Tolerances. The tolerances for § 556.700 Sulfomyxin. is: sulfachlorpyridazine are: (a) [Reserved] (1) Swine. Liver (target tissue): 0.6 (1) Cattle and swine. Edible tissues (b) Tolerances. The tolerances for ppm. (excluding milk): 0.1 ppm. sulfomyxin are: (2) [Reserved] (2) [Reserved] (1) Chickens and turkeys. Edible (c) Related conditions of use. See (c) Related conditions of use. See tissues (excluding eggs): Zero. §§ 520.2455 and 558.612 of this chapter. §§ 520.2200 and 522.2200 of this (2) [Reserved] chapter. (c) Related conditions of use. See § 556.733 Tildipirosin. (a) Acceptable daily intake (ADI). The § 556.640 Sulfadimethoxine. § 522.2340 of this chapter. ADI for total residue of tildipirosin is 10 (a) [Reserved] § 556.710 Testosterone. mg/kg of body weight per day. (b) Tolerances. The tolerances for (a) [Reserved] (b) Tolerances. The tolerance for sulfadimethoxine are: (b) Residues. Residues of testosterone tildipirosin (the marker residue) is: (1) Catfish and salmonids. Edible are not permitted in excess of the (1) Cattle. (i) Liver (the target tissue): tissues: 0.1 ppm. following increments above the 10 ppm. (2) Cattle. (i) Edible tissues (excluding concentrations of testosterone naturally (ii) [Reserved] milk): 0.1 ppm. present in untreated animals: (2) [Reserved] (ii) Milk: 0.01 ppm. (1) Cattle. (i) Fat: 2.6 ppb. (c) Related conditions of use. See (3) Chickens, turkeys, ducks, and (ii) Kidney: 1.9 ppb. § 522.2460 of this chapter. chukar partridges. Edible tissues (iii) Liver: 1.3 ppb. (excluding eggs): 0.1 ppm. (iv) Muscle: 0.64 ppb. § 556.735 Tilmicosin. (c) Related conditions of use. See (2) [Reserved] (a) Acceptable daily intake (ADI). The §§ 520.2220a, 520.2220d, 520.2220e, (c) Related conditions of use. See ADI for total residue of tilmicosin is 25 522.2220, and 558.575 of this chapter. § 522.842 of this chapter. mg/kg of body weight per day.

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(b) Tolerances. The tolerances for (b) Tolerances. A tolerance for § 558.68 [Amended] tilmicosin (marker residue) are: tylvalosin in edible tissues of swine is ■ 33. In § 558.68, in paragraph (c), (1) Cattle. (i) Liver (target tissue): 1.2 not required. remove ‘‘556.68’’ and in its place add ppm. (c) Related conditions of use. See ‘‘556.60’’. (ii) Muscle: 0.1 ppm. §§ 520.2645 and 558.633 of this chapter. (2) Sheep. (i) Liver (target tissue): 1.2 ■ 34. In § 558.95, add paragraph (c) to ppm. § 556.750 Virginiamycin. read as follows: (ii) Muscle: 0.1 ppm. (a) Acceptable daily intake (ADI). The § 558.95 Bambermycins. (3) Swine. (i) Liver (target tissue): 7.5 ADI for total residue of virginiamycin is ppm. 250 mg/kg of body weight per day. * * * * * (ii) Muscle: 0.1 ppm. (b) Tolerances. The tolerances for (c) Related tolerances. See § 556.75 of (c) Related conditions of use. See virginiamycin are: this chapter. §§ 520.2471, 522.2471, and 558.618 of (1) Cattle. Edible tissues (excluding * * * * * this chapter. milk): Not required. ■ 35. In § 558.185, revise paragraph (c) § 556.739 Trenbolone. (2) Chickens. Edible tissues to read as follows: (a) Acceptable daily intake (ADI). The (excluding eggs): Not required. ADI for total residue of trenbolone is 0.4 (3) Swine. (i) Kidney, skin, and fat: 0.4 § 558.185 Coumaphos. mg/kg of body weight per day. ppm. * * * * * (b) Tolerances. The tolerance for (ii) Liver: 0.3 ppm. (c) Related tolerances. See § 556.168 trenbolone is: (iii) Muscle: 0.1 ppm. of this chapter. (1) Cattle. Edible tissues (excluding (4) Turkeys. Edible tissues (excluding * * * * * milk): Not required. eggs): Not required. (2) [Reserved] (c) Related conditions of use. See ■ 36. In § 558.235, revise paragraph (a), (c) Related conditions of use. See § 558.635 of this chapter. redesignate paragraph (b) as paragraph §§ 522.2476, 522.2477, and 522.2478 of (d), and add new paragraphs (b) and (c) this chapter. § 556.760 Zeranol. to read as follows: (a) Acceptable daily intake (ADI). The § 558.235 Efrotomycin. § 556.741 Tripelennamine. ADI for total residue of zeranol is 1.25 (a) [Reserved] mg/kg of body weight per day. (a) Specifications. Type A medicated (b) Tolerances. The tolerances for (b) Tolerances. The tolerances for articles containing 14.5 grams tripelennamine are: zeranol are: efrotomycin per pound. (1) Cattle. (i) Edible tissues (excluding (1) Cattle. Edible tissues (excluding (b) Sponsor. See No. 050604 in milk): 200 ppb. § 510.600(c) of this chapter. (ii) Milk: 20 ppb. milk): Not required. (2) [Reserved] (2) Sheep. Edible tissues (excluding (c) Related tolerances. See § 556.224 (c) Related conditions of use. See milk): 20 ppb. of this chapter. § 522.2615 of this chapter. (c) Related conditions of use. See * * * * * § 522.2680 of this chapter. § 556.745 Tulathromycin. ■ 37. In § 558.464, revise paragraph (a), (a) Acceptable daily intake (ADI). The § 556.765 Zilpaterol. redesignate paragraph (b) as paragraph ADI for total residue of tulathromycin is (a) Acceptable daily intake (ADI). The (d), and add new paragraphs (b) and (c) 15 mg/kg of body weight per day. ADI for total residue of zilpaterol is to read as follows: (b) Tolerances. The tolerances for CP– 0.083 mg/kg of body weight per day. § 558.464 Poloxalene. 60,300 (marker residue) are: (b) Tolerances. The tolerance for (1) Cattle. Liver (target tissue): 5.5 zilpaterol freebase (marker residue) is: (a) Specifications. Dry Type A ppm. (1) Cattle. Liver (target tissue): 12 ppb. medicated articles containing 53 percent (2) Swine. Kidney (target tissue): 15 (2) [Reserved] poloxalene or liquid Type A medicated ppm. (c) Related conditions of use. See articles containing 99.5 percent (c) Related conditions of use. See § 558.665 of this chapter. poloxalene. § 522.2630 of this chapter. (b) Sponsor. See No. 054771 in § 556.770 Zoalene. § 510.600(c) of this chapter. § 556.746 Tylosin. (a) [Reserved] (c) Related tolerances. See § 556.517 (a) [Reserved] (b) Tolerances. The tolerances for of this chapter. (b) Tolerances. The tolerances for zoalene and its metabolite 3-amino-5- * * * * * tylosin are: nitro-o-toluamide are: (1) Cattle. (i) Liver, kidney, fat, and ■ (1) Chickens. (i) Liver and kidney: 6 38. In § 558.465, revise paragraph (a), muscle: 0.2 ppm. redesignate paragraph (b) as paragraph (ii) Milk: 0.05 ppm. ppm. (ii) Muscle: 3 ppm. (d), and add new paragraphs (b) and (c) (2) Chickens and turkeys. (i) Liver, to read as follows: kidney, fat, and muscle: 0.2 ppm. (iii) Fat: 2 ppm. (ii) Eggs: 0.2 ppm. (2) Turkeys. Liver and muscle: 3 ppm. § 558.465 Poloxalene free-choice liquid (3) Swine. Liver, kidney, fat, and (c) Related conditions of use. See Type C feed. muscle: 0.2 ppm. § 558.680 of this chapter. (a) Specifications. Type A medicated (c) Related conditions of use. See articles containing 99.5 percent §§ 520.2640, 522.2640, 558.625, and PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS poloxalene. 558.630 of this chapter. (b) Sponsor. See No. 066104 in § 556.748 Tylvalosin. ■ 32. The authority citation for part 558 § 510.600(c) of this chapter. (a) Acceptable daily intake (ADI). The continues to read as follows: (c) Related tolerances. See § 556.517 ADI for total residues of tylvalosin is Authority: 21 U.S.C. 354, 360b, 360ccc, of this chapter. 47.7 mg/kg of body weight per day. 360ccc–1, 371. * * * * *

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§ 558.625 [Amended] the correction into the Code of Federal DEPARTMENT OF THE TREASURY ■ 39. In § 558.625, in paragraph (c), Regulations at that time. Office of Foreign Assets Control remove ‘‘556.740’’ and in its place add Need for Correction ‘‘556.746’’. 31 CFR Part 510 As published March 2, 1988 (53 FR § 558.630 [Amended] 6603), the final regulations (TD 8179; FR Technical Amendments to North Korea ■ 40. In § 558.630, in paragraph (c), Doc. 88–4451) contain an error that Sanctions Regulations remove ‘‘556.740’’ and in its place add needed to be corrected. Treasury ‘‘556.746’’. Decision 8179 was corrected at 53 FR Correction Dated: June 20, 2019. 16408, May 9, 1988; however, the Office In rule document 2019–13652, Norman E. Sharpless, of the Federal Register did not properly appearing on pages 30868 through Acting Commissioner of Food and Drugs. incorporate the correction into the Code 30870, in the issue of Friday, June 28, of Federal Regulations. Dated: June 25, 2019. 2019 make the following correction: On page 30869, in the first column, in Eric D. Hargan, Applicability of Correction the second paragraph, on the twelfth Deputy Secretary, Department of Health and line, ‘‘§§ ’’ should read ‘‘sections’’. Human Services. Generally, the amendments to the [FR Doc. C1–2019–13652 Filed 7–10–19; 8:45 am] [FR Doc. 2019–14098 Filed 7–10–19; 8:45 am] regulations under section 52 of the Code BILLING CODE 1300–00–D BILLING CODE 4164–01–P (relating to tax credits for employees) apply to taxable years beginning after December 31, 1976. However, because the May 9, 1988 correction was not ENVIRONMENTAL PROTECTION DEPARTMENT OF THE TREASURY properly incorporated into the Code of AGENCY Internal Revenue Service Federal Regulations at the time of publication, with respect to taxable 40 CFR Part 52 26 CFR Part 1 years that began prior to the Effective [EPA–R09–OAR–2018–0761; FRL–9996–38– date, the Internal Revenue Service will Region 9] [TD 8179] not challenge the application of either published version of the regulation. Air Plan Approval; Arizona; Regional Organizations Under Common Control; Haze Progress Report Eighty Percent Control Test for a List of Subjects in 26 CFR Part 1 Brother-Sister Controlled Group; AGENCY: Environmental Protection Correcting Amendment Income taxes, Reporting and Agency (EPA). recordkeeping requirements. ACTION: Final rule. AGENCY: Internal Revenue Service. ACTION: Correcting amendment. Correction of Publication SUMMARY: The Environmental Protection Agency (EPA) is approving Arizona’s Accordingly, 26 CFR part 1 is SUMMARY: This document contains a Regional Haze Progress Report corrected by making the following correction to Treasury Decision 8179, (‘‘Progress Report’’ or ‘‘Report’’), which was published in the Federal correcting amendment: submitted on November 12, 2015, as a Register for Wednesday, March 2, 1988. PART 1—INCOME TAXES revision to its state implementation plan Treasury Decision 8179 issued final (SIP). This SIP revision addresses regulations and withdrew temporary ■ requirements of the Clean Air Act (CAA) regulations relating to organizations Paragraph 1. The authority citation and the EPA’s rules that require states under common control for purposes of for part 1 continues to read in part as to submit periodic reports describing certain rules relating to pension, profit- follows: progress toward reasonable progress sharing, and stock bonus plans. Authority: 26 U.S.C. 7805 * * * goals (RPGs) established for regional Treasury Decision 8179 was corrected haze and a determination of adequacy of on May 9, 1988; however, the § 1.52–1 [Amended] the state’s existing regional haze plan. corrections were not properly ■ Par. 2. In § 1.52–1, paragraph (d)(1)(i) The EPA is approving the Report on the incorporated into the Code of Federal basis that it addresses the progress is amended by removing the language Regulations. report and adequacy determination ‘‘§ 1.414(c)–4(b)(1))’’ and adding requirements for the first DATES: ‘‘§ 1.414(c)–4’’ in its place. Effective date. This correction is implementation period for regional effective on July 11, 2019. Martin V. Franks, haze. Applicability date: March 2, 1988. Chief, Publications and Regulations Branch, DATES: This rule is effective on August FOR FURTHER INFORMATION CONTACT: Dara Legal Processing Division, Associate Chief 12, 2019. Counsel (Procedure and Administration). Alderman at (202) 317–5500. ADDRESSES: The EPA has established a [FR Doc. 2019–14424 Filed 7–10–19; 8:45 am] SUPPLEMENTARY INFORMATION: docket for this action under Docket ID BILLING CODE 4830–01–P No. EPA–R09–OAR–2018–0761. All Background documents in the docket are listed on The final regulations (TD 8179) that the https://www.regulations.gov are the subject of this correction are website. Although listed in the index, under section 52 of the Internal Revenue some information is not publicly Code. Treasury Decision 8179 was available, i.e., Confidential Business corrected at 53 FR 16408, May 9, 1988; Information (CBI) or other information however, the Office of the Federal whose disclosure is restricted by statute. Register did not properly incorporate Certain other material, such as

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