Federal Register / Vol. 54, No. 17 / Friday, January 27, 1989 / Rules and Regulations 4009 by regulations promulgated under § 107.250 Termination of an Infant formula Part 7 of this chapter specify procedures section 412(i)(2) of the act; or recall. that may be useful to a recalling firm in (2) May be otherwise adulterated or The recalling firm may submit a determining how to comply with these misbranded. recommendation for termination of the regulations. (b) Method of notification.The recall to the appropriate Food and Drug notification made pursuant to Administration district office listed in § 107.280 Records retention. § 107.240(a) shall be made, by telephone. § 5.115 of this chapter for transmittal to Each manufacturer of an infant to the Director of the appropriate Food the Division of Regulatory Guidance, formula shall make and retain such and Drug Administration district office Center for Food Safety and Applied records respecting the distribution of the specified in § 5.115 of this chapter. After Nutrition, for action. Any such infant formula through any normal business hours (8 a.m. to 4:30 recommendation shall contain establishment owned or operated by p.m.), FDA's emergency number, 202- information supporting a conclusion that such manufacturer as may be necessary 857-8400, shall be used. The the recall strategy has been effective. to effect and monitor recalls of the manufacturer shall send written The agency will respond within 15 days formula. Such records shall be retained confirmation of the notification to the of receipt by the Division of Regulatory for at least I year after the expiration of Division of Regulatory Guidance (HFF- Guidance, Center for Food Safety and the shelf life of the infant formula. 310), Center for Food Safety and Applied Nutrition, of the request for Applied Nutrition, Food and Drug (Collection of information requirements in termination. The recalling firm shall this section were approved by the Office of Administration, 200 C St. SW., continue to implement the recall Washington, DC 20204, and to the Management and Budget under OMB control strategy until it receives final written number 0910-0188.) appropriate Food and Drug notification from the agency that the Administration district office specified recall has been terminated. The agency Dated: December 22, 1988. in § 5.115 of this chapter. will send such a notification unless it Frank E. Young, (c) Reports about an infant formula has information, from FDA's own audits Commissioner of Foodand Drugs. recall--(1) Telephone report. When a or from other sources, demonstrating [FR Doc. 89-1719 Filed 1-26-89; 8:45 am] determination is made that an infant that the recall has not been effective. BILUNG CODE 4160-01 formula is to be recalled, the recalling The agency may conclude that a recall firm shall telephone within 24 hours the has not been effective if: appropriate Food and Drug (a) The recalling firm's distributors Administration district office listed in have failed to retrieve the recalled DEPARTMENT OF THE TREASURY § 5.115 of this chapter and shall provide infant formula; or Bureau of Alcohol, Tobacco and relevant information about the infant (b) Stocks of the recalled infant formula that is to be recalled. formula remain in distribution channels Firearms (2) Initialwritten report. Within 14 that are not in direct control of the days after the recall has begun, the recalling firm. 27 CFR Part 9 recalling firm shall provide a written § 107.260 Revision of an Infant formula report to the appropriate Food and Drug [T.D. ATF-281; Ref: Notice Nos. 620,644, recall. Administration district office. The report 6471 shall contain relevant information, If after a review of the recalling firm's including the following cumulative recall strategy or periodic reports or Stags Leap District Viticultural Area information concerning the infant other monitoring of the recall, the Food formula that is being recalled: and Drug Administration concludes that AGENCY: (i) Number of consignees notified of the actions of the recalling firm are Bureau of Alcohol, Tobacco and Firearms (ATF), Department of the the recall, and date and method of deficient, the agency shall notify the Treasury. notification, including, for a recall recalling firm of any serious deficiency. pursuant to § 107.200 information about The agency may require the firm to: ACTION: Final rule, Treasury decision. the notice provided for retail display (a) Change the extent of the recall, if and the request for its display. the agency concludes on the basis of SUMMARY: This final rule establishes a (ii) Number of consignees responding available data that the depth of the viticultural area in Napa County, to the recall communication and recall is not adequate in light of the risk California, to be known as "Stags Leap quantity of recalled infant formula on to human health presented by the infant District." The northern boundary alone hand at the time it was received. formula. has been modified from that originally (iii) Quantity of recalled infant (b) Carry out additional effectiveness proposed, to the Yountville Cross Road. formula returned or corrected by each checks, if the agency's audits, or other The establishment of viticultural areas consignee contacted and the quantity of information, demonstrate that the recall and the subsequent use of viticultural recalled infant formula accounted for. has not been effective. area names as appellations of origin in (iv) Number and results of (c) Issue additional notifications to the wine labeling and advertising will help effectiveness checks that were made. firm's direct accounts, if the agency's consumers better identify the wines they (v) Estimated timeframes for audits, or other information demonstrate may purchase, and will help completion of the recall. that the original notifications were not winemakers distinguish their products (3) Status reports. The recalling firm received, or were disregarded in a from wines made in other areas. shall submit to the appropriate Food and significant number of cases. EFFECTIVE DATE: February 27, 1989. Drug Administration district office a written status report on the recall at § 107.270 Compliance with this subparL FOR FURTHER INFORMATION CONTACT: least every 14 days until the recall is A recalling firm may satisfy the James P. Ficaretta, Wine and Beer terminated. The status report shall requirements of this subpart by any Branch, Bureau of Alcohol, Tobacco and describe the steps taken by the recalling means reasonable calculated to meet the Firearms, Ariel Rios Federal Building, firm to carry out the recall since the last obligations set forth in this Subpart E. 1200 Pennsylvania Avenue NW., repnrt and the results of these steps. The recall guidelines in Subpart C of Washington, DC 20226 (202-566-7626). 4010 Federal Register / Vol. 54, No. 17 / Friday, January 27, 1989 / Rules and Regulations SUPPLEMENTARY INFORMATION: 1,350 acres of grapes, and is entirely boundaries as proposed in the Second I. Background within the Napa Valley viticultural area. Amendment, and requested comments. A. History Ill. Rulemaking Proceeding Written comments were to be received On August 23, 1978, ATF published on or before April 13, 1987. A. Petition Treasury Decision ATF-53 (43 FR 37672, C. Comments 54624) revising regulations in 27 CFR On August 22, 1985, the Stags Leap Part 4. These regulations allow the Appellation Committee (hereinafter ATF received two comments in establishment of definite viticultural referred to as Group A), petitioned ATF response to the notice of proposed areas. The regulations also allow the for establishment of a viticultural area rulemaking. One comment in particular, name of an approved viticultural area to in Napa Valley, California, to be known dated April 10, 1987. was submitted by be used as an appellation of origin on as "Stags Leap." The area proposed by Mr. Stanley Anderson of S. Anderson wine labels and in wine advertisements. the petitioners consisted of Vineyard. Mr. Anderson, who owns a On October 2, 1979, ATF published approximately 2,200 acres (including winery and vineyards located just north Treasury Decision ATF-60 (44 FR 56692) approximately 1,100 acres of vineyards), of the proposed northern boundary, which added a new Part 9 to 27 CFR, situated east of the city of Yountville, requested that the northern boundary be providing for the listing of approved and five to eight miles north of the City extended approximately 500 yards. He American viticultural areas, the names of Napa. The proposed area was suggested that the Yountville Cross of which may be used as appellations of surrounded by hills to the north, east, Road would be a more appropriate origin. and west, and was configured like a boundary than the peaks of hills as B. Regulatory Criteria funnel. proposed in Notice No. 620. The Group A then submitted Section 4.25a(e)(1), Title 27, CFR, an proposed revision would add 150 acres amendment defines an American viticultural area as to its petition, dated to the proposed Stags Leap District, for a December a delimited grape-growing region 18, 1985 (hereinafter referred total size of approximately 2,700 acres. distinguishable by geographical to as the First Amendment) and With the exception of the northern requested, features, the boundaries of which have among other things, that the boundary, Mr. Anderson supported the name of the proposed viticultural area been delineated in Subpart C of Part 9. other boundaries as proposed in the be Section 4.25a(e)(2) outlines the