[Federal Register Volume 59, Number 194 (Friday, October 7, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-24902] [[Page Unknown]] [Federal Register: October 7, 1994] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 210 Alternate Foods for Meals: Enriched Macaroni Products With Fortified Protein; National School Lunch Program AGENCY: Food and Nutrition Service, USDA. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule requires the use of the Protein Digestibility- Corrected Amino Acid Score (PDCAAS) instead of the Protein Efficiency Ratio (PER) for evaluating the biological quality of proteins in enriched macaroni products with fortified protein. This action is necessary for consistency with the Food and Drug Administration's (FDA) Nutrition Labeling Education Act regulations. The PDCAAS is a more accurate, efficient and less costly method for measuring protein quality of this food product used in the National School Lunch Program (NSLP). This rule also makes clear that enriched macaroni products may not be used for infants under one year of age. In addition, this rule deletes reference in the NSLP regulations to the FDA Standard of Identity (21 CFR 139.117) for enriched macaroni products with fortified protein which has been stayed by FDA and clarifies that protein quality is to be determined on the dry basis not on the cooked food. This rule also makes a typographical correction and in accordance with the Metric Conversion Act of 1975 adds the metric equivalent for all weights and measurements. This final rule further clarifies that manufacturers of enriched macaroni with fortified protein must notify the Food and Nutrition Service (FNS) if there is a change in the protein content of their product after the original testing. FNS will assume the protein content of the product remains the same as that submitted for the original testing unless otherwise notified. DATES: This final rule is effective on October 7, 1994. The incorporation by reference of the ``Official Methods of Analysis of the AOAC International'' (formerly the Association of Analytical Chemists) 15th Ed. (1990) and the ``Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,'' as published by the Food and Agriculture Organization of the United Nations/World Health Organization, listed in this regulation is approved by the Director of the Federal Register as of October 7, 1994. FOR FURTHER INFORMATION CONTACT: Ms. Marion Hinners, Section Head, Food Science and Nutrition Section, Nutrition and Technical Services Division, USDA, (703) 305-2556. SUPPLEMENTARY INFORMATION: This rule has been determined to be not significant for purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. This rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 through 612). The Administrator of FNS has certified that this rule will not have a significant economic impact on a substantial number of small entities. There are currently fewer than ten companies participating in the Child Nutrition Programs (CNPs) under this regulation. In addition, the changes contained in this regulation are expected to reduce costs for the manufacturer. The Administrator of FNS has determined pursuant to 5 U.S.C. 553 (b) and (d) that notice and comment on this rule prior to implementation is unnecessary and contrary to public interest. The public interest would be better served by allowing a more accurate and efficient method for measuring the protein quality of foods used in the NSLP. This change will allow food companies to minimize costs, thereby allowing them to provide quality products at the lowest cost possible. Moreover, receiving prior comment would be unnecessary and impracticable in this case for the following reasons. First, requiring prior notice and comment would waste valuable government resources. The Food Safety and Inspection Service of the Department of Agriculture (USDA) and FDA already have received and reviewed comments on this issue in response to proposed rules governing nutrition labeling of all regulated products, including products covered by this FNS regulation, and have published final regulations which accept the PDCAAS method. Second, FNS, with FDA concurrence, has already recognized the merits of the PDCAAS method in permitting its use for vegetable protein products (VPPs). Third, this rule provides affected parties an implementation period of 30 days during which either protein quality test may be used for enriched macaroni products. Executive Order 12778 This final rule has been reviewed under Executive Order 12778, Civil Justice Reform. This rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would otherwise impede its full implementation. This rule is not intended to have retroactive effect unless so specified in the ``Date'' section of this preamble. Prior to any judicial challenge to the provisions of this rule or the application of the provisions, all applicable administrative procedures must be exhausted. In the NSLP, the administrative procedures are set forth under the following regulations: (1) school food authority appeals of State agency findings as a result of a Coordinated Review must follow State agency hearing procedures as established pursuant to 7 CFR 210.18(q); (2) school food authority appeals of FNS findings as a result of a Coordinated Review must follow FNS hearing procedures as established pursuant to 7 CFR 210.30(d)(3); AND (3) State agency appeals of State Administrative Expense fund sanctions (7 CFR 235.11(b)) must follow the FNS Administrative Review Process as established pursuant to 7 CFR 235.11(f). The NSLP is listed in the Catalog of Federal Domestic Assistance under No. 10.555 and is subject to the provisions of Executive Order 12372 which requires intergovernmental consultation with State and local officials. (7 CFR Part 3015, Subpart V and final rule-related notice at 48 FR 29114, June 24, 1983). No new data collection or recordkeeping requiring Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 through 3502) are included in this rule. Background: On March 27, 1974, the Department published final regulations (39 FR 11248) which defined enriched macaroni products with fortified protein as a food item meeting the NSLP meal pattern requirements specified in 7 CFR 210.10 under specified terms and conditions. At that time, the PER was the only recognized test for determining the biological quality of protein in foods. At present, there is another recognized method for determining the biological quality of protein in foods, the PDCAAS method. Several international bodies, including a Joint Expert Consultation on Protein Evaluation of the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) (1989), have concluded that PDCAAS, in which a score of 1.0 equals 100 percent of the 1985 WHO essential amino acid requirement patterns for 2 to 5 year olds, is an appropriate method for evaluating food protein quality. The 2 to 5 year old requirement is the most inclusive of those recommended and thus may be used for all age groups, except infants. PER is based on the assumption that proteins which are equivalent to casein meet the amino acid and protein requirements for the various age groups consuming a particular food. The specification of this methodology, which is based upon rodent nutrition requirements, was assumed to correlate to human requirements when PER was adopted as the sole regulatory method for determining protein quality. Extensive studies have since been conducted on human amino acid requirements which demonstrate that the essential amino acid requirements of humans are significantly different from those of rodents. This was recognized as early as 1980 by a conference of protein scientists and nutritionists held to assess protein quality in humans. A report of this working conference indicated a dissatisfaction with the PER method. The report further recognized that an amino acid scoring system, corrected for digestibility, is an appropriate alternative for measuring protein value. In 1985, WHO published its revised Energy and Protein Requirement Report prepared by a Joint Expert Consultation of the FAO/WHO and United Nations University (UNU). This consultation revised amino acid pattern requirements for humans into age groups of 2 to 5 years, 6 to 12 years, and adult, and extensively reviewed the requirements based on amino acid scoring and digestibility. Of the three amino acid patterns established, the 2 to 5 year old child pattern has the highest individual and total requirements. The report stated that protein and diets containing essential amino acids that met the greater needs of young children were also adequate for older children and adults, whereas the reverse may not be true. On this basis, the Joint FAO/WHO Expert Consultation on Protein Evaluation (1989) concluded that no adequate basis existed for using different scoring patterns for different age groups, with the exception of infants, who have a much greater need for essential amino acids. They recommended that the FAO/ WHO/UNU amino acid scoring pattern for preschool children should be used to evaluate protein quality for all age groups, except infants. PDCAAS was recommended for calculating dietary protein intakes. Thus, precise human amino acid requirement patterns are available for all age groups. Both FNS and the FDA have recognized the applicability and usefulness of the PDCAAS method of measuring protein quality. The regulation governing the use of VPP in the Child Nutrition Programs, 7 CFR Parts 210, 225 and 226, Appendix A - Alternate Foods for Meals; Vegetable Protein Products, published January 7, 1983, allowed FNS to approve an alternate test for measuring the biological quality of protein for VPP. This provision was included in the regulation in anticipation of recognition by the scientific community and FDA of the PDCAAS. FNS has since accepted the PDCAAS method in addition to the PER method for determining protein quality of VPP. This acceptance was based on the Joint FAO/WHO Expert Consultation on Protein Evaluation (1989) and with FDA's concurrence. On July 19, 1990 (55 FR 29487 at 29499), FDA stated that their regulatory requirements to use PER ``inhibit(ed) flexibility in determining protein quality by alternative methodologies.'' At that time, FDA proposed to continue the use of the PER, while also allowing use of alternative acceptable validated procedures as they become available. Subsequently, in response to a petition from Protein Technologies International, Inc., FDA stated in the preamble to the nutrition labeling proposal published on November 27, 1991 (56 FR 60366 at 60369), that permitting PDCAAS to be used as an alternative to PER had merit. In commenting on that petition FDA quoted its earlier comments on the need for a flexible approach to determining protein quality: As new methodologies and new information on amino acid requirements of various age groups become available, the agency believes it must become more flexible in regard to permitted protein quality methodologies. Therefore, while the PER method described in the Official Methods of Analysis of the Association of Official Analytical Chemists may continue to be used as one of the methods for assessing the protein quality of foods, alternative acceptable validated procedures may be used as they become available. (55 FR 29487 at 29499). However, FDA later proposed to require the PDCAAS, stating in the preamble (56 FR 60366 at 60370) that: The agency has reviewed the FAO/WHO report and tentatively accepts its conclusion that the protein digestibility-corrected amino acid score method is more appropriate for assessing protein quality of foods than animal assays and is preferable for regulatory purposes. In October, 1989, the Subcommittee on the 10th Edition of the Recommended Dietary Allowances published the revised Recommended Dietary Allowances. These new allowances confirm and accept the amino acid requirement pattern as published by the WHO, 1985, and recognize PDCAAS as an appropriate method of assessing protein quality of human diets. The amino acid requirements for the 2 to 5 year old suggested by both of these scientific bodies are identical. The Codex Alimentarius Vegetable Protein Committee as well as the Codex Committee on Special Dietary Foods have also recommended amino acid scoring for evaluation of vegetable proteins and special dietary foods. The PDCAAS was considered and accepted by the Joint FAO/WHO Codex Alimentarius Commission which convened in Geneva, Switzerland during July 1989. An Expert Consultation convened at the request of the Codex Alimentarius Commission reviewed the amino acid scoring methodologies and recommended the implementation of the PDCAAS for measuring protein quality. After extensive deliberation, resulting in a comprehensive report, it was reported that, ``. . . the Consultation agreed that the Protein Digestibility-Corrected Amino Acid Score method was the most suitable approach for routine evaluation of protein quality for humans, and recommended the adoption of this method as an official method at the international level.'' (Joint FAO/WHO Expert Consultation on Protein Evaluation, Codex Alimentarius, Washington, D.C., 1989). The Expert Consultation's report and recommendations were transmitted to the FAO Secretariat in Rome for final review and dissemination to the Codex Alimentarius Commission membership. The report of the Expert Consultation contains many findings and conclusions, most supportive of the PDCAAS. No conclusions adverse to this method were reported. On January 6, 1993, FDA published final rules (58 FR 2079) requiring use of the PDCAAS method as the method for determining protein quality for food intended for children over 1 year of age and adults. While this method is recommended for all children above 1 year of age, it is not recommended for infants, and therefore FDA's final rule (58 FR 2079 at 2102) retained the PER method for assessing protein quality and retained casein as the standard in expressing the percentage of the Reference Daily Intake (RDI) for protein in foods represented and purported to be for use by infants. This rule became effective on May 8, 1994. In recognition of these scientific advances and the adoption by FDA of PDCAAS as the only method for determining protein quality for children above one year of age, this rule amends the NSLP regulations at appendix A of Part 210 to require PDCAAS as the only method for determining protein quality for enriched macaroni. However, in order to provide affected parties an implementation period, the amended paragraph 2 further provides that for 30 days after publication of the rule either the PER or the PDCAAS may be used. Finally, a new paragraph 1(c) is added to Appendix A to make clear that enriched macaroni may not be used for infants under 1 year of age in the NSLP. Accordingly, FNS will no longer approve enriched macaroni products purported for use by infants regardless of what method their protein quality has been tested. It was never the Department's intention that enriched macaroni products be served to infants and this amendment is meant to make clear that policy. Manufacturers of enriched macaroni with fortified protein, currently approved by FNS, will not be affected by the change to an alternate method unless the nutritional composition of their approved product changes. Should the nutritional composition of an approved product previously tested under PER method change after the 30 day implementation period, data obtained by the PDCAAS method will be required for re-approval. The FDA Standard of Identity (21 CFR 139.117), referenced and quoted in Appendix A and upon which the FNS final regulation was based, was stayed on March 21, 1978, pending a determination of whether a public hearing was necessary to resolve issues raised by objections (43 FR 11695). At that time, FDA stated that ``during the period of the stay, the (enriched macaroni products with fortified protein) may be introduced into interstate commerce with appropriate labeling as a nonstandardized food.'' (43 FR 11695). Therefore, this rule deletes all references to that Standard in Appendix A. However, the requirements for processing and labeling of enriched macaroni products with fortified protein prescribed by FDA in the stayed Standard of Identity were previously incorporated in the FNS final rule and will remain the same, with some technical changes. In addition, this final rule amends the current regulation to correct a statement which has caused confusion and which was recently brought to our attention by analytical laboratories. The current regulation states that the protein quality is to be determined on the cooked food. However, determining protein quality on the cooked food is not feasible in practice, because when utilizing the PER method the moisture content prevents laboratory rodents from eating test foods in sufficient quantities to accurately determine protein quality. Likewise, the moisture content in the cooked food may affect the test results under the PDCAAS method. Therefore, FAO/WHO suggests a moisture content in the cooked food of less than ten percent for viable testing. Determinations made on a dry basis has been the procedure commonly employed by commercial laboratories in the past. Thus, this rule requires determination of protein quality on a dry basis. This final rule makes a typographical correction and, in accordance with the Metric Conversion Act of 1975, adds, side by side, the metric equivalent for all weights and measurements contained in the rule. This final rule also includes a clarification that all manufacturers, including those with currently accepted macaroni products, must notify FNS if there is a change in the protein portion of their product since the original data submission and product approval. FNS will assume the protein content remains the same unless otherwise notified. List of Subjects in 7 CFR Part 210 Children, Commodity school program, Food assistance programs, Grants programs--Social programs, Incorporation by reference, National School Lunch Program, Nutrition, Reporting and recordkeeping requirements, Surplus agricultural commodities. Accordingly, 7 CFR part 210 is amended as follows: PART 210--NATIONAL SCHOOL LUNCH PROGRAM 1. The authority citation for 7 CFR part 210 continues to read as follows: Authority: 42 U.S.C. 1751-1760, 1779. 2. In Appendix A--Alternate Foods for Meals; Enriched Macaroni Products with Fortified Protein: (a) The heading of Appendix A is revised. (b) A new subheading is added under the heading of Appendix A. (c) Paragraphs 1(a) and 1(b) are amended by adding ``(28.35 grams)'' after the words ``ounce'' or ``ounces'' wherever they appear. (d) A new paragraph 1(c) is added. (e) Paragraphs 2 and 3 are revised. Appendix A to Part 210--Alternate Foods for Meals Enriched Macaroni Products With Fortified Protein 1. * * * (c) Enriched macaroni product may not be used for infants under 1 year of age. 2. Only enriched macaroni products with fortified protein that have been accepted by FNS for use in the USDA Child Nutrition Programs may be labeled as provided in paragraph 1(b) of this appendix. Manufacturers seeking acceptance of their product shall furnish FNS a chemical analysis, the Protein Digestibility-Corrected Amino Acid Score (PDCAAS), and such other pertinent data as may be requested by FNS, except that prior to November 7, 1994, manufacturers may submit protein efficiency ratio analysis in lieu of the PDCAAS. This information is to be forwarded to: Director, Nutrition and Technical Services Division, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, room 607, Alexandria, VA 22302. All laboratory analyses are to be performed by independent or other laboratories acceptable to FNS. (FNS prefers an independent laboratory.) All laboratories shall retain the ``raw'' laboratory data for a period of 1 year. Such information shall be made available to FNS upon request. Manufacturers must notify FNS if there is a change in the protein portion of their product after the original testing. Manufacturers who report such a change in protein in a previously approved product must submit protein data in accordance with the method specified in this paragraph. 3. The product should not be designed in such a manner that would require it to be classified as a Dietary Supplement as described by the Food and Drug Administration (FDA) in 21 CFR part 105. To be accepted by FNS, enriched macaroni products with fortified protein must conform to the following requirements: (a)(1) Each of these foods is produced by drying formed units of dough made with one or more of the milled wheat ingredients designated in 21 CFR 139.110(a) and 139.138(a), and other ingredients to enable the finished food to meet the protein requirements set out in paragraph 3.(a)(2)(i) under Enriched Macaroni Products with Fortified Protein in this Appendix. Edible protein sources, including food grade flours or meals made from nonwheat cereals or from oilseeds, may be used. Vitamin and mineral enrichment nutrients are added to bring the food into conformity with the requirements of paragraph (b) under Enriched Macaroni Products with Fortified Protein in this Appendix. Safe and suitable ingredients, as provided for in paragraph (c) under Enriched Macaroni Products with Fortified Protein in this Appendix, may be added. The proportion of the milled wheat ingredient is larger than the proportion of any other ingredient used. (2) Each such finished food, when tested by the methods described in the pertinent sections of ``Official Methods of Analysis of the AOAC International,'' (formerly the Association of Official Analytical Chemists), 15th Ed. (1990) meets the following specifications. This publication is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the AOAC International, 2200 Wilson Blvd., suite 400, Arlington, VA 22201-3301. This publication may be examined at the Food and Nutrition Service, Nutrition and Technical Services Division, 3101 Park Center Drive, room 607, Alexandria, Virginia 22302 or the Office of the Federal Register, 800 North Capital Street, NW., suite 700, Washington, DC. (i) The protein content (N x 6.25) is not less than 20 percent by weight (on a 13 percent moisture basis) as determined by the appropriate method of analysis in the AOAC manual cited in (a)(2) under Enriched Macaroni Products with Fortified Protein in this Appendix. The protein quality is not less than 95 percent that of casein as determined on a dry basis by the PDCAAS method as described below: (A) The PDCAAS shall be determined by the methods given in sections 5.4.1, 7.2.1. and 8.0 as described in ``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,'' Rome, 1990, as published by the Food and Agriculture Organization (FAO) of the United Nations/World Health Organization (WHO). This report is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this report may be obtained from the Nutrition and Technical Services Division, Food and Nutrition Service, 3101 Park Center Drive, room 607, Alexandria, Virginia 22302. This report may also be inspected at the Office of the Federal Register 800 North Capitol St., NW., suite 700, Washington, DC. (B) The standard used for assessing protein quality in the PDCAAS method is the amino acid scoring pattern established by FAO/ WHO and United Nations University (UNU) in 1985 for preschool children 2 to 5 years of age which has been adopted by the National Academy of Sciences, Recommended Dietary Allowances (RDA), 1989. (C) To calculate the PDCAAS for an individual food, the test food must be analyzed for proximate analysis and amino acid composition according to AOAC methods. (D) The PDCAAS may be calculated using FDA's limited data base of published true digestibility values (determined using humans and rats). The true digestibility values contained in the WHO/FAO report referenced in paragraph 3.(a)(2)(i)(A) under Enriched Macaroni Products with Fortified Protein in this Appendix may also be used. If the digestibility of the protein is not available from these sources it must be determined by a laboratory according to methods in the FAO/WHO report (sections 7.2.1 and 8.0). (E) The most limiting essential amino acid (that is, the amino acid that is present at the lowest level in the test food compared to the standard) is identified in the test food by comparing the levels of individual amino acids in the test food with the 1985 FAO/ WHO/UNU pattern of essential amino acids established as a standard for children 2 to 5 years of age. (F) The value of the most limiting amino acid (the ratio of the amino acid in the test food over the amino acid value from the pattern) is multiplied by the percent of digestibility of the protein. The resulting number is the PDCAAS. (G) The PDCAAS of food mixtures must be calculated from data for the amino acid composition and digestibility of the individual components by means of a weighted average procedure. An example for calculating a PDCAAS for a food mixture of varying protein sources is shown in section 8.0 of the FAO/WHO report cited in paragraph 3.(a)(2)(i)(A) under Enriched Macaroni Products with Fortified Protein in this Appendix. (H) For the purpose of this regulation, each 100 grams of the product (on a 13 percent moisture basis) must contain protein in amounts which is equivalent to that provided by 20 grams of protein with a quality of not less than 95 percent casein. The equivalent grams of protein required per 100 grams of product (on a 13 percent moisture basis) would be determined by the following equation:![]()
TR07OC94.022 X=grams of protein required per 100 grams of product a=20 grams (amount of protein if casein) b=.95 [95% x 1 (PDCAAS of casein)] c=PDCAAS for protein used in formulation (ii) The total solids content is not less than 87 percent by weight as determined by the methods described in the ``Official Methods of Analysis of the AOAC International'' cited in paragraph (a)(2) under Enriched Macaroni Products with Fortified Protein in this Appendix. (b)(1) Each pound of food covered by this section shall contain 5 milligrams of thiamine, 2.2 milligrams of riboflavin, 34 milligrams of niacin or niacinamide, and 16.5 milligrams of iron. (2) Each pound of such food may also contain 625 milligrams of calcium. (3) Only harmless and assimilable forms of iron and calcium may be added. The enrichment nutrients may be added in a harmless carrier used only in a quantity necessary to effect a uniform distribution of the nutrients in the finished food. Reasonable overages, within the limits of good manufacturing practice, may be used to assure that the prescribed levels of the vitamins and mineral(s) in paragraphs (b)(1) and (2) under Enriched Macaroni Products with Fortified Protein in this Appendix are maintained throughout the expected shelf life of the food under customary conditions of distribution. (c) Ingredients that serve a useful purpose such as to fortify the protein or facilitate production of the food are the safe and suitable ingredients referred to in paragraph (a) under Enriched Macaroni Products with Fortified Protein in this Appendix. This does not include color additives, artificial flavorings, artificial sweeteners, chemical preservatives, or starches. Ingredients deemed suitable for use by this paragraph are added in amounts that are not in excess of those reasonably required to achieve their intended purposes. Ingredients are deemed to be safe if they are not food additives within the meaning of section 201(s) of the Federal Food, Drug and Cosmetic Act, or in case they are food additives if they are used in conformity with regulations established pursuant to section 409 of the act. (d)(1) The name of any food covered by this section is ``Enriched Wheat ________________ Macaroni Product with Fortified Protein'', the blank being filled in with appropriate word(s) such as ``Soy'' to show the source of any flours or meals used that were made from non-wheat cereals or from oilseeds. In lieu of the words ``Macaroni Product'' the words ``Macaroni'', ``Spaghetti'', or ``Vermicelli'' as appropriate, may be used if the units conform in shape and size to the requirements of 21 CFR 139.110 (b), (c), or (d). (2) When any ingredient not designated in the part of the name prescribed in paragraph (d)(1) under Enriched Macaroni Products with Fortified Protein in this Appendix, is added in such proportion as to contribute 10 percent or more of the quantity of protein contained in the finished food, the name shall include the statement ``Made with ________________'', the blank being filled in with the name of each such ingredient, e.g. ``Made with nonfat milk''. (3) When, in conformity with paragraph (d)(1) or (d)(2) under Enriched Macaroni Products with Fortified Protein in this Appendix, two or more ingredients are listed in the name, their designations shall be arranged in descending order of predominance by weight. (4) If a food is made to comply with a section of 21 CFR 139, but also meets the compositional requirements of the Enriched Macaroni with Fortified Protein Appendix, it may alternatively bear the name set out in the other section. (e) Each ingredient used shall declare its common name as required by the applicable section of 21 CFR 101. In addition, the ingredients statement shall appear in letters not less than one half the size of that required by 21 CFR 101.105 for the declaration of net quantity of contents, and in no case less than one-sixteenth of an inch in height. * * * * * Dated: September 22, 1994. Ellen Haas, Assistant Secretary for Food and Consumer Services. [FR Doc. 94-24902 Filed 10-6-94; 8:45 am] Billing Code 3410-30-U