24142 Federal Register / Vol. 51, No. 127 / Wednesday, July 2, 1986 / Rules and Regulations change of sponsor for a new animal drug ACTION: Final rule; Treasury decision. viticultural area with boundaries application (NADA) from Parke-Davis, generally as stated in the petition. The Division of Warner-Lambert Co., to SUMMARY: The Bureau of Alcohol, notice also solicited public comment A.H. Robins Co. Tobacco and Firearms (ATF) has concerning the proposed viticultural decided to establish a viticultural area area. EFFECTIVE DATE: July 2, 1986. in Arkansas, Missouri, and Oklahoma to FOR FURTHER INFORMATION CONTACT: be known as "Ozark Mountain." This Comments David L. Gordon, Center for Veterinary decision is the result of a petition Medicine (HFV-238), Food and Drug submitted by Mr. Al Wiederkehr, a The principal commenter was Mr. Administration, 5600 Fishers Lane, grape grower and winery proprietor in Robert G. Cowie, Secretary-Treasurer of Rockville, MD 20857, 301-443-6243. the area. The establishment of the Arkansas Wine Producers Association and proprietor of a winery SUPPLEMENTARY INFORMATION: AH. viticultural areas and the subsequent Robins Co., 1407 Cummings Dr., P.O. use of viticultural area names in wine located just outside the boundaries Box 26609, Richmond, VA 23261-6609, labeling and advertising enables proposed in Notice No. 569. Mr. Cowie filed a supplement to NADA 106-111 winemakers to label wines more requested extension of the boundaries in (TelazolO injection, tiletamine precisely and helps consumers to better order to include an area south of the hydrochloride and zolazepam identify the wines they purchase. Arkansas River, in which his winery is located. This area is generally located hydrochloride, for dogs and cats) EFFECTIVE DATE: August 1, 1986. for a change of sponsor from between the Arkansas and Petit Jean providing FOR FURTHER INFORMATION CONTACT: Parke-Davis, Division of Warner- Rivers and includes Mt. Magazine, the Steve Simon, FAA, Wine and Beer highest mountain in Arkansas. Mr. Lambert Co. Parke-Davis confirmed the Branch, Bureau of Alcohol, Tobacco and change. FDA is amending the Cowie presented evidence to show that Firearms, 1200 Pennsylvania Avenue, this area is locally known as being part regulations to reflect the sponsor NW., Washington, DC 20226 (202-566- of the "Ozark Mountain" region and change. 7626). contains the same distinguishing List of Subjects in 21 CFR Part 522 SUPPLEMENTARY INFORMATION: geographical features as the "Ozark Animal drugs. Background Mountain" area proposed by the under the Federal Food, petitioner. Comments supportive of Mr. Therefore, ATF regulations in 27 CFR Part 4 Drug, and Cosmetic Act and under provide for the establishment of definite Cowie's request were received from two authority delegated to the Commissioner viticultural areas. The regulations also members of the Arkansas legislature, a of Food and Drugs and redelegated to allow the name of an approved geologist from the Arkansas Geological the Center for Veterinary Medicine, Part viticultural area to be used as an Commission, a geography professor at 522 is amended to read as follows: appellation of origin on wine labels and Arkansas Tech University, and eight in wine advertisements. others who are residents of Mr. Cowie's PART 522-IMPLANTATION OR local area. The additional area proposed INJECTABLE DOSAGE FORM NEW Part 9 of 27 CFR provides for the listing of approved American viticultural by Mr. Cowie contains about 800 square ANIMAL DRUGS NOT SUBJECT TO miles, of which about 60 acres are CERTIFICATION areas, the names of which may be used as appellations of origin. planted to grapes. At one time, as many 1. The authority citation for 21 CFR Section 4.25a(e)(1), Title 27 CFR, as seven wineries were operating in that Part 522 continues to read as follows: defines an American viticultural area as area, but at present the Cowie Wine Authority: Sec. 512(i), 82 Stat. 347 (21 U.S.C. a delimited grape-growing region Cellars is the only one left. 360b(i)); 21 CFR 5.10 and 5.83. distinguishable by geographical After considering the evidence features. Section 4.25(e)(2) outlines the presented by the commenters, ATF has § 522.2470 [Amended] procedures for proposing an American determined that it would be proper to 2. § 522.2470 Tiletamine hydrochloride viticultural area. Any interested person extend the boundaries of the "Ozark and zolazepam hydrochloridefor may petition ATF to establish a grape- Mountain" area. Accordingly, this injection is amended in paragraph (b) by growing region as a viticultural area. document prescribes boundaries for the removing the sponsor number "000071" Petition "Ozark Mountain" viticultural area that and inserting in its place "000031." include the area advocated by Mr. Dated: June 26, 1986. ATF received a petition from Mr. Al Cowie. Wiederkehr of Altus, Arkansas, Marvin A. Norcross, southern Missouri, Name Associate Directorfor New Animal Drug proposing an area in Evaluation. northern Arkansas, and northeastern The following evidence demonstrates as a viticultural area to be [FR Doc. 86-14880 Filed 7-1-86; 8:45 am] Oklahoma that the viticultural area established by known as "Ozark Mountain." The area is known by the BILLING CODE 4160-01-M that was proposed contains about 55,000 this Treasu'y decision square miles. There are about 4,280 name of "Ozark Mountain": acres of grapes planted in the area (a) Wine labels from Wiederkehr TREASURY DEPARTMENT OF THE proposed by Mr. Wiederkehr, and Wine Cellars and others have borne the approximately 35 wineries are operating appellation "Ozark Mountain" since as Bureau of Alcohol, Tobacco and far back as 1959. Firearms within that area. (b) This area has been referred to as Notice of Proposed Rulemaking 27 CFR Part 9 the "Ozark Mountain" region in many In response to the petition, ATF geographical books, including Natural [T.D. ATF-231; Ref. Notice No. 569] published a notice of proposed Regions of the United States and rulemaking, Notice No. 569, in the Canada by C.B. Hunt (W.H. Freeman & Ozark Mountain Viticultural Area Federal Register on Tuesday, September Co., San Francisco, 1974) and The AGENCY: Bureau of Alcohol, Tobacco 17, 1985. That notice proposed Ozarks by Richard Rhodes (Time-Life and Firearms, Treasury. establishment of the "Ozark Mountain" Books, New York, 1974). Federal Register / Vol. 51, No. 127 / Wednesday, July 2, 1986 / Rules and Regulations 24143

(c) The Ozark Mountain area is well- temperature zones. This is demonstrated establishing a large viticultural area known as a winE making region, as is by the following quote from Milton D. based on geographical features which shown by this quote: "Like all of the Rafferty in The Ozarks, Land and Life affect viticultural features, ATF other American wine regions, the (University of Oklahoma Press, Norman, recognizes that the distinctions between Ozarks [Mountains] are quietly seething 1980), p. 29; a small area and its surroundings are with new ideas, new personalities, new Within the Ozarks, temperatures will vary more refined than the differences grape varieties and a new sense of widely with the orientation of slope, nature of between a large area and its direction." (Restaurateurs'Guide to surface materials, relief, and presence of surroundings. It is possible for a large American Wines, PartIV: The Wines water. South and west-facing slopes receive viticultural area to contain approved and Wineries of the Ozarks. "Dining," the greatest amount of sunlight and are viticultural areas, if each area fulfills the April-May 1973, p. 58.) subject to higher rates of evaporation... In requirements for establishment of a winter, perhaps the most noticeable effect of Geography temperature differences within a small area viticultural area. is the duration of snow and icicles on the Miscellaneous The following evidence demonstrates north-facing slopes. that the viticultural area is distinguished Air drainage creates the most readily ATF does not want to give the geographically from the surrounding observed temperature differences in summer. impression by approving "Ozark areas: Nights are notable for the cool breeze that Mountain" as a viticultural area that it (a) In his book, The Ozarks, Richard drains down the slopes, beginning an hour or is approving or endorsing the quality of Rhodes states (pp. 19, 22), as quoted by two before sunset... the wine from this area. ATF is the petitioner: ... As a rule, frosts occur in the valleys several weeks earlier in fall and later in approving this area as being distinct but Stretching from the forests of southern spring than they do on the uplands, especially not better than other areas. By Missouri outside St. Louis through northern in the case of the larger valleys lying in the approving this area, ATF allows wine Arkansas to the Oklahoma plains near Tulsa, hill regions. The margins of the uplands have producers to claim a distinction on the 55,000 square miles of the Ozarks are the best air drainage and are least subject to labels and advertisements as to the bounded by five major rivers: the Mississippi, frosts. the Missouri, the Osage, the Neosho, and the origin of the grapes. Any commercial Arkansas. The Ozark highlands, the only Ozark viticulturists rely on their advantage can only come from extensive elevated area in the United States knowledge of local microclimatic consumer acceptance of "Ozark between the Appalachians and the Rocky conditions to select the best sites for Mountain" wines. Mountains, consist of low mountains and their vineyards. Such sites possess Regulatory Flexibility Act hills shaped by springfed streams and rivers generally similar conditions of soil and ...cutting their way thorugh the elevated The provisions of the Regulatory bed rock... climate, thus giving Ozark viticulture a ... These boundaries do not merely locate distinctive character. Favorable Flexibility Act relating to a final the Ozarks on the map, but also serve to conditions for viticulture can be found at regulatory flexibility analysis (5 U.S.C. isolate some of the region's plant and animal locations throughout the Ozarks, from 604) are not applicable to this final rule, life ... Hermann in the north to Altus and Paris because it will not have a significant The Ozarks mark the farthest western in the south. The reason for this is economic impact on a substantial extension of the great deciduous forest that summarized succinctly by Milton D. number of small entities. The final rule once covered the eastern United States. Their Rafferty in the book mentioned above is not expected to have significant western border is the beginning of the prairie (p. 160): "The growing of grapes is well secondary or incidental effects on a that runs from Western Missouri to the Rockies and from Texas to Canada. Their suited to the climate and soils of the substantial number of small entities. northern border, the Missouri River, is about Ozarks." Further, the final rule will not impose, or otherwise cause, a significant increase as far south as the glacier of the ice age came Boundaries • . . And the hot, lush alluvial lands of the in the reporting, recordkeeping, or other Mississippi begin at the Ozarks' abrupt The boundaries of the viticultural area compliance burdens on s substantial southeastern edge, in the Missouri bootheel. were proposed by the petitioner to number of small entitites. With four different climatic regions largely follow the five major rivers Accordingly, it is hereby certified pressing against them, the Ozarks serve as a mentioned above in the quote from under the provisions of section 3 of the sanctuary for a selection of plants and Richard Rhodes (the Mississippi, animals from all sides... Regulatory Flexibility Act (5 U.S.C. Missouri, Osage, Neosho, and 605(b)) that this final rule will not have a (b) Geologically, the Ozarks are Arkansas). However, for reasons significant economic impact on a regarded as an upland plateau, in which previously stated (under substantial number of small entities. mountains and valleys have been "COMMENTS"), these boundaries have carved out by numerous streams and been slightly modified, so that the Executive Order 12291 rivers. The land is hilly to mountainous, southern boundary of the area In compliance with Executive Order and the soils are characteristically stony established by this Treasury decision 12291 of Feb. 17, 1981, the Bureau has and well-drained. The distinctive soil of follows the Petit Jean River as well as determined that this final rule is not a the Ozark region is "Clay from deeply the Arkansas River. These boundaries major rule since it will not result in: weathered, well consolidated may be found on 11 U.S.G.S. maps in the sedimentary and deeply weathered scale of 1:250,000 titles St. Louis, (a) An annual effect on the economy of $100 million or more; volcanic rocks." (Hunt, op. cit., pp. 122- Jefferson City, Springfield, Joplin, Tulsa, 123.) Most of the land remains forested, Fort Smith, Russellville, Memphis, (b) A major increase in costs or prices as it was before the arrival of Poplar Bluff, Paducah, and Rolla. The for consumers, individual industries, civilization, in contrast to the boundaries are as described in § 9.108, Federal, State, or local government neighboring plains country. as added by this Treasury decision. agencies, or geographical regions; or (c) The primary effect which the The following approved viticultural (c) Significant adverse effects on mountainous terrain has on the climate areas are entirely enclosed within the competition, employment, investment, of the Ozarks is to divide the region into Ozark Mountain boundaries: Altus productivity, or on the ability of United innumerable small microclimatic (§ 9.77) and Hermann (§ 9.71). In States-based enterprises to compete 24144 Federal Register / Vol. 51,No. 127 / Wednesday, July 2, 1986 / Rules and Regulations with foreign-based enterprises in (5) Tulsa, Oklahoma; Arkansas; (ix) Then southeastward and domestic or export markets. Missouri; Kansas (1958, revised 1973); southwestward following Vache Grasse (6) Fort Smith, Arkansas-Oklahoma Creek to the place where it is crossed by Paperwork Reduction Act (1978); Arkansas Highway 10, near Greenwood, The provisions of the Paperwork (7) Russellville, Arkansas (compiled in Arkansas; Reduction Act of 1980, Pub. L. 96-511, 44 1954); (x) Then westward along Highway 10 to U.S. Highway 71 U.S.C. Chapter 35, and its implementing (8) Memphis, Tennessee; Arkansas; Missouri (1953, revised 1978); regulations, 5 CFR Part 1320 do not (Note: Highway 10 is the primary highway apply to this final rule, because no (9) Poplar Bluff, Missouri; Arkansas (1957, revised 1978]; leading from Greenwood to Hackett, requirement to collect information is Arkansas): imposed. (10) Paducah, Kentucky; Illinois; Missouri; Indiana (1949, revised 1969); (xi) Then southward and eastward List of Subjects in 27 CFR Part 9 and along Highway 71 until it crosses Rock (11) Rolla, Missouri; Illinois (1954, Creek; Administrative practice and revised 1969]. (xii) Then northeastward along Rock procedures, Consumer protection, (c) Boundary-(1) General.The Ozark Viticultural areas, Wine. Mountain viticultural area is located in Creek to Petit Jean Creek; Drafting information Missouri, Oklahoma, and Arkansas. The (xiii) Then generally northeastward starting point of the following boundary and eastward along Petit Jean Creek The principal author of this document description is the point at which the until it becomes the Petit Jean River (on is Steve Simon, FAA Wine and Beer Missouri River joins the Mississippi the Russellville map); Branch, Bureau of Alcohol, Tobacco and River north of St. Louis, Missouri (on the (xiv) Then generally eastward along Firearms. St. Louis map). the Petit lean River, flowing through Issuance (2) Boundary Description-(i)The Blue Mountain Lake, until the Petit Jean boundary proceeds from the starting Accordingly, 27 CFR Part 9 is River joins the Arkansas River; point westward along the Missouri River amended as follows: (xv] Then generally eastward along until it meets the Osage River; the Arkansas River to Cadron Creek; (ii) Then further westward along the PART 9-AMERICAN VITICULTURAL Osage River (flowing through Lake of (xvi) Then northeastward and AREAS the Ozarks and the Harry S. Truman eastward along Cadron Creek, for about 21/2 miles, until it pases under U.S. Paragraph A. The authority citation Reservoir) until it passes adjacent to 64, approximately 31/2 miles for Part 9 continues to read as follows: Missouri Highway 82 in Osceola, Highway Missouri (on the Jefferson City map); west of Conway, Arkansas; Authority: 27 U.S.C. 205 (iii) Then southwestward along (xvii) Then eastward along U.S. Par. B. The table of sections in 27 CFR Missouri Highway 82 until it intersects Highway 64 until it intersects U.S. Part 9, Subpart C, is amended to add the U.S. Highway 54 in Eldorado Springs, Highway 67, near Beebe, Arkansas (on title of § 9.108, to read as follows: Missouri (on the Joplin map); the Memphis map); (iv) Then westward along U.S. (xviii) Then northeastward along U.S. Highway 54 until it intersects U.S. Highway 67 into the state of Missouri, Subpart C-Approved American Viticultural Highway 71 near Nevada, Missouri; Areas (v] Then southward along U.S. then northward until U.S. Highway 67 Sec. Highway 71 until it intersects Interstate intersects U.S. Highway 60, in Poplar Highway 44, approximately 5 miles Bluff, Missouri (on the Poplar Bluff map); 9.108 Ozark Mountain. south of Carthage, Missouri; (xix) Then eastward along U.S. (vi) Then westward and Highway 60 until it crosses the western boundary of Stoddard County Par. C. Subpart C of 27 CFR Part 9 is southwestward along Interstate amended by adding § 9.108, which reads Highway 44 into the State of Oklahoma, (Note: Here that boundary is the St. Francis as follows: and continuing southwestward until Interstate Highway 44 crosses the River); § 9.108 Ozark Mountain. Neosho River near Miami, Oklahoma (a) Name. The name of the viticultural (on the Tulsa map); (xxx] Then northward, northeastward, area described in this section is "Ozark (vii) Then southward along the and eastward along the boundary of Mountain." Neosho River (flowing through the Lake Stoddard County until it joins the (b) Approved maps. The appropriate of the Cherokees, Lake Hudson, and Fort southern boundary of Cape Girardeau maps for determining the boundaries of Gibson Lake) until it flows into the County (on the Cape Girardeau map); Ozark Mountain viticultural area are 11 Arkansas River, approximately 2 miles U.S.G.S. maps in the scale of 1:250,000. west of Fort Gibson, Oklahoma (on the (xxxi) Then northeastward along the They are titled- Fort Smith map); Cape Girardeau County boundary until (1) St. Louis, Missouri (1963, revised (viii) Then southward and eastward it meets the Mississippi River south of 1969); along the Arkansas River (flowing Cape Girardeau, Missouri; (2) Jefferson City, Missouri (1955, through the Robert S. Kerr Lake) into the (xxxii] Then northward along the revised 1970]; State of Arkansas, and continuing Mississippi River to the starting point. (3) Springfield, Missouri (1954, revised eastward until the Arkansas River is June 10, 1986. 1969]; joined by Vache Grasse Creek, Signed: (4) Joplin, Missouri; Kansas (1954, approximately 4 miles east of Barling, Stephen E. Higgins, revised 1974); Arkansas; Director.