Infant food formula (quality control procedures) (21 CFR 106.1-106.120)

185 Food and Drug Administration, HHS § 106.1 nonnutritive sweetener(s) is added, the statement shall indicate the presence of both types of sweetener, e.g., ‘‘Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s).’’ (c) ‘‘Low calorie’’ foods. A food pur porting to be ‘‘low calorie’’ must com ply with the criteria set forth for such foods in § 101.60(b)(2) and (b)(3) of this chapter. (d) ‘‘Reduced calorie’’ foods and other comparative calorie claims. A food pur porting to be ‘‘reduced calorie’’ or oth erwise containing fewer calories than a reference food must comply with the criteria set forth for such food in § 101.60(b)(4) and (b)(5) of this chapter. (e) Label terms suggesting usefulness as low calorie or reduced calorie foods. (1) Except as provided in paragraphs (e)(2) and (e)(3) of this section, and in § 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as ‘‘diet,’’ ‘‘dietetic,’’ ‘‘ar tificially sweetened,’’ or ‘‘sweetened with nonnutritive sweetener’’ only if the claim is not false and misleading, and the food is labeled ‘‘low calorie’’ or ‘‘reduced calorie’’ or bears another comparative calorie claim in compli ance with part 101 of this chapter and this section. (2) Paragraph (e)(1) of this section shall not apply to any use of such terms that is specifically authorized by regulation governing a particular food, or, unless otherwise restricted by regu lation, to any use of the term ‘‘diet’’ that clearly shows that the food is of fered solely for a dietary use other than regulating body weight, e.g., ‘‘for low-sodium diets.’’ (3) Paragraph (e)(1) of this section shall not apply to any use of such terms on a formulated meal replace ment or other food that is represented to be of special dietary use as a whole meal, pending the issuance of a regula tion governing the use of such terms on foods. (f) ‘‘Sugar free,’’ and ‘‘no added sugar.’’ Criteria for the use of the terms ‘‘sugar free’’ and ‘‘no added sugar’’ are provided for in § 101.60(c) of this chapter. [58 FR 2430, Jan. 6, 1993] Subpart C [Reserved] Subpart D—Standards of Identity [Reserved] PART 106—INFANT FORMULA QUALITY CONTROL PROCEDURES Subpart A—General Provisions Sec. 106.1 Status and applicability of the quality control procedures regulation. 106.3 Definitions. Subpart B—Quality Control Procedures for Assuring Nutrient Content of Infant For mulas 106.20 Ingredient control. 106.25 In-process control. 106.30 Finished product evaluation. 106.90 Coding. Subpart C—Records and Reports 106.100 Records. Subpart D—Notification Requirements 106.120 New formulations and reformula tions. AUTHORITY: 21 U.S.C. 321, 350a, 371. SOURCE: 47 FR 17025, Apr. 20, 1982, unless otherwise noted. Subpart A—General Provisions § 106.1 Status and applicability of the quality control procedures regula tion. (a) The criteria set forth in §§ 106.20, 106.25, 106.30, 106.90, and 106.100 shall apply in determining whether an infant formula meets the safety, quality, and nutrient requirements of section 412 of the act and the requirements of regula tions promulgated under section 412(a)(2) of the act. (b) The failure to comply with any regulation set forth in §§ 106.20, 106.25, 106.30, 106.90, and 106.100 applicable to the manufacturing, processing, and packaging of an infant formula shall render such formula adulterated under section 412(a)(1)(C) of the act. (c) References in this part to regu latory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00195 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 186 21 CFR Ch. I (4–1–11 Edition) § 106.3 § 106.3 Definitions. The definitions and interpretations contained in section 201 of the act are applicable to such terms when used in this part. The following definitions shall also apply: (a) Indicator nutrient. An indicator nutrient is a nutrient whose concentra tion is measured during the manufac ture of an infant formula to confirm complete addition and/or uniform dis tribution of a premix or other sub stance of which the indicator nutrient is a part. (b) In-process batch. An in-process batch is a combination of ingredients at any point in the manufacturing process before packaging. (c) Manufacturer. A manufacturer is a person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula and/or packages the product in a container for distribution. (d) Nutrient. A nutrient is any vita min, mineral, or other substance re quired in accordance with the table set out in section 412(g) of the act or by regulations promulgated under section 412(a)(2)(A) of the act. (e) Nutrient premix. A nutrient premix is a combination of ingredients con taining two or more nutrients. A nutri ent premix either may be received from a supplier or be prepared by an infant formula manufacturer. Subpart B—Quality Control Proce dures for Assuring Nutrient Content of Infant Formulas § 106.20 Ingredient control. (a) Except as provided in § 106.20(b), no analysis before use in manufac turing is needed for ingredients that are generally stable in shipping and storage, and that either are received under a supplier’s guarantee or certifi cation that the mixture has been ana lyzed as to nutrient composition or are labeled as having nutrient composi tions complying with specifications in the U.S. Pharmacopeia, the National Formulary, the Food Chemicals Codex, or other similar recognized standards. (b) Unless each batch of finished product is analyzed as specified in § 106.30(b)(1) before release of product for commercial or charitable distribu tion, the following shall apply: (1) When an ingredient is relied upon as a source of a nutrient(s) and when evidence indicates that such nutri ent(s) in that ingredient is likely to be affected adversely by shipping or stor age conditions, the manufacturer shall analyze that ingredient for each relied upon nutrient that may be affected, using validated analytical methods. (2) Ingredients, including nutrient premixes, that are either without a supplier’s guarantee or certification, or not labeled as complying with pre scribed standards, shall be sampled and analyzed for each relied-upon nutrient by the manufacturer, except that in gredients used as a major source of pro tein or fat need not be analyzed for each relied-upon nutrient if the manu facturer has records to show that each relied-upon nutrient is present at a reasonably constant level. Nutrient premixes prepared by the infant for mula manufacturer shall be sampled and analyzed for each relied-upon nu trient. Nutrient premixes which are re ceived from suppliers shall be sampled and analyzed for each relied-upon nu trient unless the supplier has sampled and analyzed each batch of premix for each relied-upon nutrient and has so certified in writing. § 106.25 In-process control. (a) For each infant formula, a master manufacturing order shall be prepared and approved by a responsible official of the manufacturer. The manufacturer shall establish a quality control sys tem that assures and verifies the addi tion of each ingredient specified in the manufacturing order. (b) Unless each batch of finished product is analyzed as specified in § 106.30(b)(1), the manufacturer shall analyze each in-process batch for: (1) Solids; (2) Protein, fat, and carbohydrates (carbohydrates either by analysis or by mathematical difference); (3) The indicator nutrient(s) in each nutrient premix; (4) Each nutrient added independ ently of nutrient premixes during for mulation of the product, except for lin oleic acid, vitamin D, vitamin K, choline, inositol, and biotin; and VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00196 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 187 Food and Drug Administration, HHS § 106.30 (5) Solids or an appropriate nutrient to confirm proper dilution when final dilution is made after performance of the analyses in paragraph (b) (1) through (4) of this section. § 106.30 Finished product evaluation. (a) The manufacturer shall establish criteria for sampling and testing to en sure that each batch of infant formula meets the nutrient requirements of section 412(g) of the act or of regula tions promulgated under section 412(a)(2) of the act before release of product for commercial or charitable distribution. (b)(1) Immediate analysis. Before re lease of product for commercial or charitable distribution, the manufac turer shall analyze representative sam ples of each batch of finished product for: (i) Specific nutrient(s) to assess proc ess degradation; and (ii) All nutrients not previously ana lyzed for by the manufacturers, unless each in-process batch is analyzed for nutrients as specified in § 106.25(b) and the ingredients are analyzed as speci fied in § 106.20(b). No analyses are need ed for linoleic acid, vitamin D, vitamin K, choline, inositol, and biotin; and for nutrients that are added as a part of a nutrient premix analyzed by the manu facturer or having a supplier’s guar antee or certification and for which an indicator nutrient(s) was analyzed by the manufacturer. (2) Periodic analysis. The manufac turer shall sample at least one newly processed finished product batch every 3 months and shall analyze representa tive samples for all nutrients except those that the manufacturers measured in the immediate analysis of that prod uct batch. (3) Stability analysis. Using represent ative samples collected from finished product batches, the manufacturer shall conduct stability analysis for se lected nutrients with sufficient fre quency to substantiate the mainte nance of nutrient content throughout the shelf life of the product. (c) The manufacturer shall evaluate new formulations and the effect of changes in ingredients or processing conditions that could affect the level of nutrients by means of a testing pro gram designed to confirm uniformity of batches and to determine the effects of such changes. The following shall apply: (1) A minor change is a minor reduc tion in nutrient levels, a minor in crease in levels of nutrients that are subject to maximum limits established under section 412(g) of the act or in regulations established under section 412(a)(2) of the act, or any other change where experience or theory would not predict a possible significant adverse impact on nutrient levels or nutrient availability. After a minor change the manufacturer shall analyze representa tive samples for all nutrients so changed and those possibly affected by the change. (2) A major change is any new formu lation, or any change of ingredients or processes where experience or theory would predict a possible significant ad verse impact on levels of nutrients or availability of nutrients. After a major change the manufacturer shall analyze representative samples for osmolality, all nutrients, and the biological qual ity of the protein. A protein biological quality analysis is not necessary for a formulation change that is not ex pected to have an adverse effect on the biological quality of the protein. Vita min D shall be determined by the rat bioassay method as prescribed in ‘‘Of ficial Methods of Analysis of the Asso ciation of Official Analytical Chem ists’’ (AOAC), 13th Ed. (1980), sections 43.195–43.208, ‘‘Vitamin D (30)—Official Final Action,’’ which is incorporated by reference. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at the National Archives and Records Ad ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.Before release of the product for commercial or charitable distribution, the manufacturer shall have completed all appropriate anal yses except that shipment of the prod uct need not be delayed until results of VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00197 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 188 21 CFR Ch. I (4–1–11 Edition) § 106.90 the vitamin D bioassay and, if re quired, a protein biological quality bio assay are complete, provided such bio assays have been initiated, and if an other analysis for the vitamin D has been run and the protein content has been determined by a suitable method. The biological quality of the protein shall be determined by an appropriate modification of the AOAC bioassay method of analysis. The manufacturer shall analyze additional samples from the same batch for vitamin D, by any suitable method, and for the biological quality of the protein. The manufac turer shall perform such analyses at least annually for a period not to ex ceed the expected shelf life of the prod uct. (d) A simple adjustment in the level of an ingredient to accommodate in consistencies in processing is consid ered to be neither a minor nor a major change. [47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 63 FR 14035, Mar. 24, 1998] § 106.90 Coding. The manufacturer shall code all in fant formulas in conformity with the coding requirements that are applica ble to thermally processed low-acid foods packaged in hermetically sealed containers as prescribed in § 113.60(c). Subpart C—Records and Reports § 106.100 Records. (a) Every manufacturer of infant for mula shall maintain the records speci fied in this regulation in order to per mit the Food and Drug Administration to determine whether each manufac turer is in compliance with section 412 of the Federal Food, Drug, and Cos metic Act (the act). (b) The manufacturer shall maintain all records that pertain to food-pack aging materials subject to § 174.5 of this chapter and that bear on whether such materials would cause an infant for mula to be adulterated within the meaning of section 402(a)(2)(C) of the act. (c) The manufacturer shall maintain all records that pertain to nutrient premix testing that it generates or re ceives. Such records shall include, but are not limited to: (1) Any results of testing conducted to ensure that each nutrient premix is in compliance with the premix certifi cate and guarantee and specifications that have been provided to the manu facturer by the premix supplier, includ ing tests conducted when nutrients ex ceed their expiration date or shelf life (retest date). (2) All certificates and guarantees given by premix suppliers concerning the nutrients required by section 412(i) of the act and § 107.100 of this chapter. (d) The premix supplier shall main tain the results of all testing con ducted to provide all certificates and guarantees concerning nutrient pre mixes for infant formulas. Such records shall include but are not limited to: (1) The results of tests conducted to determine the purity of each nutrient required by section 412(i) of the act or § 107.100 of this chapter and any other nutrient listed in the certificate and guarantee; (2) The weight of each nutrient added; (3) The results of any quantitative tests conducted to determine the amount of each nutrient certified or guaranteed; and (4) The results of any quantitative tests conducted to identify the nutri ent levels present when nutrient pre mixes exceed their expiration date or shelf life (retest date). (e) The manufacturer shall maintain all records necessary to ensure proper nutrient quality control in the manu facture of infant formula products. Such records shall include the results of any testing conducted to verify that each nutrient required by section 412(i) of the act or § 107.100 of this chapter is present in each batch of infant formula at the appropriate concentration. This requirement pertains to ingredients, in process batch and finished product from the time of manufacture through its expiration date. (f) The manufacturer shall maintain all records necessary to ensure re quired nutrient content at the final product stage. Such records shall in clude, but are not limited to, testing results for vitamins A, B1 (thiamine), VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00198 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 189 Food and Drug Administration, HHS § 106.100 C, and E for each batch of infant for mula. ‘‘Final product stage’’ means the point in the manufacturing process prior to distribution at which the in fant formula is homogenous and not subject to further degradation from the manufacturing process. (g) The manufacturer shall maintain all records pertaining to distribution of the infant formula. Such records shall include, but not be limited to, all infor mation and data necessary to effect and monitor recalls of the manufactur er’s infant formula products in accord ance with subpart E of part 107 of this chapter. (h) The manufacturer shall maintain all records pertaining to the micro biological quality and purity of raw materials and finished powdered infant formula. (i) [Reserved] (j) The manufacturer shall maintain all records pertaining to regularly scheduled audits, including audit plans and procedures. Audit plans identify the specific manufacturing and quality control procedures to be reviewed. Audit procedures are the methods used to review the manufacturing and qual ity control procedures. Records of au dits shall include the information and data necessary for a determination as to whether the manufacturer complies with the current good manufacturing practices and quality procedures iden tified in parts 106, 107, 109, 110, and 113 of this chapter. The records shall in clude written assurances from the manufacturer that regularly scheduled audits are being conducted by appro priately trained individuals who do not have any direct responsibility for the manufacture or production of infant formula, and that the complete audit plans and procedures for the firm have been followed. The actual written re ports of the audits need not be made available. (k) The manufacturer shall maintain procedures describing how all written and oral complaints regarding infant formula will be handled. The manufac turer shall follow these procedures and shall include in them provisions for the review of any complaint involving an infant formula and for determining the need for an investigation of the pos sible existence of a hazard to health. (1) For purposes of this section, every manufacturer shall interpret a ‘‘com plaint’’ as any communication that contains any allegation, written or oral, expressing dissatisfaction with a product for any reason, including con cerns about the possible existence of a hazard to health and about appearance, taste, odor, and quality. Correspond ence about prices, package size or shape, or other matters that could not possibly reveal the existence of a haz ard to health shall not, for compliance purposes, be considered a complaint and therefore need not be made avail able to an FDA investigator. (2) When a complaint shows that a hazard to health possibly exists, the manufacturer shall conduct an inves tigation into the validity of the com plaint. Where such an investigation is conducted, the manufacturer shall in clude in its file on the complaint the determination as to whether a hazard to health exists and the basis for that determination. No investigation is nec essary when the manufacturer deter mines that there is no possibility of a hazard to health. When no investiga tion is necessary, the manufacturer shall include in the record the reason that an investigation was found to be unnecessary and the name of the re sponsible person making that deter mination. (3) When there is a reasonable possi bility of a causal relationship between the consumption of an infant formula and an infant’s death, the manufac turer shall, within 15 days of receiving such information, conduct an inves tigation and notify the agency as re quired in § 106.120(b). (4) The manufacturer shall maintain in designated files all records per taining to the complaints it receives. The manufacturer shall separate the files into two classes: (i) Those complaints that allege that the infant became ill from consuming the product or required treatment by a physician or health-care provider. (ii) Those complaints that may in volve a possible existence of a hazard to health but do not refer to an infant becoming ill or the need for treatment by physician or a health care provider. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00199 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 190 21 CFR Ch. I (4–1–11 Edition) § 106.120 (5) The manufacturer shall include in a complaint file the following informa tion concerning the complaint: (i) The name of the infant formula; (ii) The batch number; (iii) The name of complainant; (iv) A copy of the complaint or a memo of the telephone conversation or meeting and all correspondence with the complainant; (v) By reference or copy, all the asso ciated manufacturing records and com plaint investigation records needed to evaluate the complaint. When copies of such records are not maintained in the complaint file, they must be available within 24 hours when requested by an FDA official. (vi) All actions taken to follow up on the complaint; and (vii) All findings and evaluations of the complaint. (6) The manufacturer should main tain the files regarding infant formula complaints at the establishment where the infant formula was manufactured, processed, or packed. When the manu facturer wishes to maintain all con sumer complaints for the entire firm at one location other than at the facility where an infant formula was manufac tured, processed, or packed, the manu facturer may do so as long as all records required by this section are available within 24 hours of request for inspection at that facility. However, all records of consumer complaints, in cluding summaries, any reports, and any files, maintained at the manufac turing facility or at any other facility shall be made available to investiga tors for review and copying upon re quest. (l) The manufacturer shall make readily available for authorized inspec tion all records required under this part or copies of such records. Records shall be available at any reasonable time at the establishment where the activities described in such records oc curred. (Infant formula complaint files may be maintained at one facility, as provided in § 106.100(k)(6), if all required records are readily available at that fa cility.) These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another lo cation by electronic means shall be considered as meeting the require ments of this paragraph. (m) Records required under this part may be retained either as original records or as true copies such as photo copies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques, such as microfilming are used, suitable reader and photocopying equipment shall be readily available. (n) Production control, product test ing, testing results, complaints, and distribution records necessary to verify compliance with parts 106, 107, 109, 110, and 113 of this chapter, or with other appropriate regulations, shall be re tained for 1 year after the expiration of the shelf life of the infant formula or 3 years from the date of manufacture, whichever is greater. (o) The manufacturer shall maintain quality control records that contain sufficient information to permit a pub lic health evaluation of any batch of infant formula. [56 FR 66571, Dec. 24, 1991; 57 FR 7435, Mar. 2, 1992] Subpart D—Notification Requirements § 106.120 New formulations and refor mulations. (a) Information required by section 412(b)(2) and (3) of the act shall be sub mitted to Center for Food Safety and Applied Nutrition (HFS–830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. (b) The manufacturer shall promptly notify the Food and Drug Administra tion when the manufacturer has knowl edge (as defined in section 412(c)(2) of the act) that reasonably supports the conclusion that an infant formula that has been processed by the manufac turer and that has left an establish ment subject to the control of the man ufacturer may not provide the nutri ents required by section 412(g) of the act and by regulations promulgated under section 412(a)(2) of the act, or when there is an infant formula that is otherwise adulterated or misbranded and that may present risk to human health. This notification shall be made, VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00200 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 191 Food and Drug Administration, HHS § 107.10 by telephone, to the Director of the ap propriate Food and Drug Administra tion district office specified in part 5, subpart M of this chapter. After nor mal business hours (8 a.m. to 4:30 p.m.), contact the FDA Emergency Call Cen ter at 866–300–4374. The manufacturer shall send a followup written confirma tion to the Center for Food Safety and Applied Nutrition (HFS–605), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to the appropriate Food and Drug Administration district office specified in part 5, subpart M of this chapter. [47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 61 FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 75 FR 32658, June 9, 2010] PART 107—INFANT FORMULA Subpart A—General Provisions Sec. 107.3 Definitions. Subpart B—Labeling 107.10 Nutrient information. 107.20 Directions for use. 107.30 Exemptions. Subpart C—Exempt Infant Formulas 107.50 Terms and conditions. Subpart D—Nutrient Requirements 107.100 Nutrient specifications. Subpart E—Infant Formula Recalls 107.200 Food and Drug Administration-re quired recall. 107.210 Firm-initiated product removals. 107.220 Scope and effect of infant formula recalls. 107.230 Elements of an infant formula re call. 107.240 Notification requirements. 107.250 Termination of an infant formula re call. 107.260 Revision of an infant formula recall. 107.270 Compliance with this subpart. 107.280 Records retention. AUTHORITY: 21 U.S.C. 321, 343, 350a, 371. SOURCE: 50 FR 1840, Jan. 14, 1985, unless otherwise noted. Subpart A—General Provisions § 107.3 Definitions. The following definitions shall apply, in addition to the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act): Exempt formula. An exempt infant for mula is an infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or die tary problems. Manufacturer. A manufacturer is a person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages the infant formula in containers for distribution. References. References in this part to regulatory sections of the Code of Fed eral Regulations are to chapter I of title 21, unless otherwise noted. [50 FR 48186, Nov. 22, 1985] Subpart B—Labeling § 107.10 Nutrient information. (a) The labeling of infant formulas, as defined in section 201(aa) of the Fed eral Food, Drug, and Cosmetic Act, shall bear in the order given, in the units specified, and in tabular format, the following information regarding the product as prepared in accordance with label directions for infant con sumption: (1) A statement of the number of fluid ounces supplying 100 kilocalories (in case of food label statements, a kilocalorie is represented by the word ‘‘Calorie’’); and (2) A statement of the amount of each of the following nutrients sup plied by 100 kilocalories: Nutrients Unit of measurement Protein ............................................. Grams. Fat ................................................... Do. Carbohydrate ................................... Do. Water ............................................... Do. Linoleic acid .................................... Milligrams. Vitamins: Vitamin A .................................. International units. Vitamin D ................................. Do. Vitamin E .................................. Do. Vitamin K .................................. Micrograms. Thiamine (Vitamin B 1) ............. Do. Riboflavin (Vitamin B 2 ............. Do. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00201 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R