Document ykmDVYqqD6Dm04LyEx66E0YDr

JOSEPH E. KELLER JEROME H- HECKMAN CHARLES M. MEEHAN william h. borqhesani. JR ROBERT H TIEHNAN WAYNE V. BLACK DAVID L- HILL MARTIN W, BERCOVICI LELAND J- BLAIR PETER M. NEMKOV I*AW OFFICES Relieb and Heckman 1130 ITT* STREET, N. W. SUITE lOOO WASHINGTON, D.C- 20036 January 10, 1973 JAN 15 1973 1, /? 3> * a- '/ l TELEPHONE 02 296-etQO CABLE ADDRESS"KELMAN" TO: All Members of the SPI-Food, Drug and Cosmetic Packaging Materials Committee RE: Proposed Rulemaking for Bottled Water Gentlemen: The Federal Register for Monday, January 8, 1973, contains a proposed quality standard for bottled water. Because of the obvious importance of this proposed action to our interests, we are enclosing a copy of this proposed rulemaking (38 F.R. 1019, 1020). It is of interest to note that the first sentence in this proposal asserts the Food and Drug Administration's jurisdiction over bottled water for human consumption. Con sistent with our present understanding, the regulation of water that is piped into homes is not being contemplated. As we reviewed this proposed regula tion there does not seem to us to be any need for comments on behalf of the Society. However, if any of you feel that comments should be made, please let us know before February 15 so that there will be sufficient time to prepare a suitable submission before March 9, 1973, the last day for filing comments. We shall, of course, keep you informed about any further activity in this area. In the meantime if you have any questions or com ments, please do not hesitate to contact us. Enclosure ASI-PR 0001699 Proposed Rule Making 1019 DEPARTMENT OE HEALTH, coliform organism. Standard plate counts 1047 and 1055-1056, as amended by 70 ranged from zero to "too numerous to Stat. 919 and 72 Stat. 948; 21 UJS.C. 341, EDUCATION, AND WELFARE count". Gross changes in the standard 343(h), 371) and under authority dele plate counts were noted in the 25 samples gated to him (21 CFR 2.120) the Com Food and Drug Adminisfrah'on that were examined during a 63-day stor missioner proposes to amend Part 11 (37 age test. While six samples remained at FR 20038) of Chapter I, of Title 21 of I 21 CFR Part 11 ] or near zero for the entire test period, the Code of Federal Regulations by add four rose to levels that became too ing a new section to Subpart B as fol BOTTLED WATER numerous to count, while the remainder lows : Proposed Qualify Standards fluctuated widely with no definite dis cernible pattern. Chemical analyses by 11.7 Bottled waiei*. Bottled water for human consumption EPA revealed that three samples ex is a food within the meaning of the Fed eral Food, Drug, and Cosmetic Act. ceeded the PHS Standards for total dis solved solids and that one sample ex Bottled water is increasingly being ceeded the PHS Standard for copper used as a source of drinking water. Fac while another sample exceeded the PHS tors that have influenced this increase include consumer reaction to publicity of the potential pollution of some public water supplies, abnormal taste and odor of tap water in some areas, and increas ing consumer affluence. The consumer ex Standard for lead. The criteria of the TJ.S. Public Health Service Drinking Water Standards (1962) can be applied to bottled water with two notable exceptions: (1) The sampling plans of the PHS Standards are pects bottled water to meet the minimum designed for the repetitive examination criteria established for public drinking of public water supplies and are not ap water supplies. propriate for bottled water, and (2) the The Food and Drug Administration bacteriological limits set by the stand has evaluated bottled water for human, ards are based on. repetitive examinations consumption using essentially the same and also are not appropriate for bottled criteria used in determining the accepta water. bility of public water supplies. The cri The Environmental Protection Agency teria for evaluation of public water sup now has the responsibility for establish plies are those of the U.S, Public Health ing drinking water standards. Extensive ervice Drinking Water Standards revisions of the -drinking water stand fI 3), promulgated as regulations for ards are currently being developed by ring water and water supply systems EPA. It is FDA's intention to revise the used by interstate common carriers and bottled water quality standards to keep others subject to the Federal interstate them compatible with revisions of the quarantine regulations. These standards EPA drinking water standards. set microbiological, physical, chemical, On the basis of the TJ.S. Public Health and radioactivity limits in drinking water Service Drinking Water Standards based on health or esthetic factors. (1962), survey data, and other available The standards are considered the mini information, the Commissioner of Food mum for public water supplies by the and Drugs is of the opinion that reason American Water Works Association and able grounds exist for proposing stand are the bases of State and local regula ards of quality for bottled water. Ac tions pertaining to the control of public cordingly, in order to promote honesty water supplies. and fair dealing in the interest of con Analyses by the FDA and the Envi sumers the Commissioner proposes to ronmental Protection Agency (EPA) establish quality standards for bottled have shown that some bottled water fails water. (a) For purposes of this section, the following definitions shall apply: (1) "Bottled water" is water that is sealed in bottles or other containers and intended for human consumption. Bot tled water does not include mineral wa ter or any food defined in 31.1 of this chapter. (2) A "sample" is 10 containers of water which are representative of the lot. (3) An "analytical unit" is that por tion of water taken from a container for purposes of analysis. (b) Microbiological quality. Bottled water shall, when a sample is examined by the methods described in Part 400, of "Standard Methods for the Examination of Wafer and Wastewater," 13th Ed.. 1971, American Public Health Associa tion,1 meet standards of microbiological quality as follows: (1) (i) Multiple-tube fermentation method. Not more than one of the analyt ical units in the sample shall have a most probable number (MPN) of 2.2 or more coliform organisms per 100 milli liters and no analytical unit shall have a MPN of 9.2 or more coliform organisms per 100 milliliters, or: (ii) Membrane filter method. Not more than one of the analytical units in the sample shall have 4.0 or more coliform organisms per 100 milliliters and the arithmetic mean of the coliform density of the sample shall not exceed 500 per milliliter. (2) The geometric average of the bac terial density (Standard Plate Count) of to meet the criteria of the US. Public Health Service Drinking Water Stand ards (1962), A survey of bottled water in 1971, conducted by the FDA, revealed that 8 out of 85 samples tested contained The Commissioner proposed in the Federal Register for September 23, 1972 (37 FR 20038), a new Part 11 for micro biological standards for foods for which there are no standards of identity. Al the 10 analytical units comprising the sample shall not exceed 500 per milliliter. (c) Physical quality. Bottled water shall, when a composite of analytical units of equal volume from a sample is coliform bacteria at levels in excess of the PHS Standards. In addition, the range of the geometric mean of the aerobic total plate count was 0 to 5.4 by 107 for the samples. Results of chemical tests on 86 samples revealed that none of the sam ples contained concentrations of heavy metals or pesticides that exceeded the though the proposal to establish quality standards for bottled water includes physical and chemical aspects as well as microbiological aspects, it is logical to include this proposal within that new part. The heading of the new part will be changed when the final order promul gating the regulations proposed in the examined by the methods described in Part 100 of the 13th Ed., 1971, of "Stand ard Methods for the Examination of Wa ter and Wastewater," American Public Health Association,1 meet standards of physical quality as follows: (1) The turbidity shall not exceed 5 units. PHS drinking water standards. As part September 23. 1972, Federal Register is (2) The color shall not exceed 15 units. of the EPA survey of the bottled water In Issued, to reflect that quality standards (3) The odor shall not exceed thresh dustry, bacteriological and chemical ex may include provisions relating other old odor No. 3. aminations were made of about 50 bottled than to mlcroblollgical aspects of a food. (d) Chemical quality. Bottled water water products from 25 bottling Arms. Therefore, pursuant to the provisions shall, when a composite of analytical Eight percent of the bottled water ex of the Federal Food, Drug, and Cosmetic units of equal volume from a sample Is amined evidenced the presence of the Act (secs. 491, 403(h), 701, 52 Stat. 1046, examined by the methods described In No. 4--Pt. I-- -40 FEDERAL REGISTER, VOL. 38, NO. 4--MONDAY, JANUARY 8, 1973 ASI-PR 0001700 1020 PROPOSED RULE MAKING Part 100 of the 13th Ed., 1971, of "Stand label shall bear the statement of sub ard Methods of Examination of Water standard quality specified in $ 11.1(b). and Wastewater." American Public (2) When the physical, chemical, Health Association,1 meet standards of and/or radiological quality of bottled chemical quality as follows: (1) The bottled water shall not contain chemical substances In excess of the fol lowing concentrations: Substance Concentration (a milligrams per liter water is below that prescribed by para graphs (c) through (e) respectively of this section, the label shall bear the state ment of substandard quality specified in 111.1(b) except that, as appropriate, in stead of or in addition to the words Arsenic ------------------------------------------ - 0. 05 Barium 1.0 Cadmium . 0.01 Chloride ........... ------------- ------------------- 250.0 Chromium (Hexavalent)------------ 0. 05 Copper 1.0 Cyanide------- ----------------------------- ... 0. 2 Iron 0,3 Lead.................. ....................... ...... ............ 0.05 Manganese. 0.05 Nitrate------------------------------------------------ 45. 0 Phenols____ .....-_____ 0.001 Selenium 0.01 Sliver............... 0.05 Sulfate 250.0 Total Dissolved Solids ______________ 600.0 Zinc______ ________ __________________ _ 5.0 (2) The bottled water shall not contain fluoride in excess of the levels in Table I and these levels shall be based on the an nual average of maximum daily air tem peratures at the location where the bot tled water was filled. - "Contains Excessive Bacteria" the fol lowing statement(s) shall be used: (1) "Excessively Turbid", "Abnormal Color", and/or "Abnormal Odor" if the bottled water fails to meet the require ments of paragraph (c)(1), (2), and/or (3), respectively, of this section. (il) "Contains Excessive Chemical Substances", if the bottled water fails to meet any of the requirements of para graph (d) of this section. The specific chemical(s) may be declared in lieu of the words "Chemical Substances" In the statement "Contains Excessive Chemical Substances". When a specific chemical is declared, that name by which the chemical(s) is designated in paragraph (d) of this section shall be used. Example: "Contains Excessive Copper". (ill) "Excessively Radioactive" if the bottled water fails to meet the require ments of paragraph (e) of this section. Table I Annual average of Ftouridc concentration maximum dally in milligrams per liter air temperatures: 50.0-53.7 .......... 2.4 53.8-58.3 2.2 58.4-63.8 _________________ 2,0 (g) Bottled water containing a sub stance at a level considered injurious to health under section 402(a) (1) of the act is deemed to be adulterated, regardless of whether or not the bottled water bears a label statement of substandard quality prescribed by paragraph (f) of this 63.9-70.61.8 70.7-79.2 1.6 79.3-90.3 ..................... 1.4 (e) Radiological quality. Bottled water shall, when a composite of analytical units of equal volume from a sample is examined by the methods described in Part 300 of the 13th Ed., 1971. of "Stand ard Methods for the Examination of Water and Wastewater," American Pub lic Health Association,1 meet standards of radiological quality as follows: (1> The bottled water shall not contain radioactivity in excess of the following section. Interested persons may, on or before March 9, 1973, file with the Hearing Clerk, Department of Health, Education, and Welfare, Room 6-88, 5600 Fishers Lane, Rockville, MD 20 852, written com ments (preferably in qulntuplicate) re garding this proposal. Comments may be accompanied by a memorandum or brief in support thereof. Received comments may be seen in the above office during working hours, Monday through Friday. Dated: December 22.1972. concentrations: Charles C. Edwards, Substance Concentration in Commissioner of Food and Drugs. micromicrocuries per liter Radium-226 3 [FR Doc.73-318 Filed 1-6-73:8:45 am] Stroritlum-9010 (2) When it Is known that the stron-. National Institute of Education Mum-90 and alpha emitters are absent, the composite shall not contain a gross beta concentration In excess of 1,000 micromicrocuries per liter, 145 CFR Ch. 141 EDUCATIONAL RESEARCH AND DEVELOPMENT GRANTS (f) Label statements. Bottled water, the quality of which is below that pre scribed by this section, shall be labeled General Provisions of National Institute of Education with a statement of substandard quality as follows: (1) When the microbiological quality of bottled water is below that prescribed by paragraph (b) of this section, the Pursuant to the authority contained in section 405 of the General Education Provisions Act, the Director of the Na tional Institute of Education, with the approval of the Secretary of Health, 1 "Standard Methods for the Examination of Water and Wastewater," 13th Ed. 1971, can be obtained from the American Pnbllo Health Association, 1015 18th Street HW, Washing ton, DC 20036. Education, and Welfare, hereby proposes to amend Title 45 of the Code of Fed eral Regulations by adding a new Chap ter XTV, Subchapter A, as set forth below. In section 301(a) of the Education Amendments of 1972 (Public Law 92318). Congress enunciated policies of the U.S. Government: (1) To provide to every person an equal opportunity to re ceive an education of high quality re gardless of bis race, color, religion, sex, national origin, or social class; (2) to provide leadership in the conduct and support of scientific inquiry into the edu cational process to achieve such equality of opportunity; and (3) to improve American education through its reform and renewal and through the strength ening of the scientific and technological foundations of education and the build ing of an effective educational research and development system, (section 405(a) of the General Education Provisions Act). To carry out these policies. Congress established, within the Education Divi sion of the Department of Health, Edu cation, and Welfare, the National Insti tute of Education, to conduct educational research, collect and disseminate the findings of educational research, train individuals in educational research; to assist and foster such research, collec tion, dissemination, or training through grants, contracts, technical assistance to, or jointly financed cooperative arrange ments with, public or private organizaMons, institutions, agencies, or individ uals; and to promote the coordination of such research and research support with in the Federal Government. An interim statement of organization for the Insti tute was published at 37 FR 19158 (Sep tember 19, 1972). This proposed subchapter establishes general rules and requirements, both sub stantive and procedural, for the award of assistance to eligible parties to support "educational research," which is broadly defined in the statute to include basic and applied research, planning, surveys, evaluations, investigations, experiments, developments, and demonstrations in the field of education (including career education). Sections 1400.2 and 1400.4 of this pro posed subchapter indicate that the award and administration of contracts by the Institute are not subject to this sub chapter, but are instead covered by Chapters 1 and 3 of Title 41 of the Code of Federal Regulations. However, SS 1400.2 and 1400.4 bear upon prospec tive contractors by providing that De partment standards for the selection between contract and grant procedures and instruments (published at 41 CFR 3-1.53) shall govern such selection by the Institute, both with respect to solicita tion of grant proposals or contract pro posals and awards based upon unsolicited proposals. In addition, 5 1400.4(e) pro vides that the provisions on eligible applicants in this subchapter (5 1403.2) shall govern contracts, as well as grant awards, except that profitmaking insti tutions may also be eligible for contracts with the Institute. The body of this subchapter applies only to the award and administration of grants by the Institute. The provisions of this proposed subpart would establish general rules and FEDERAL REGISTER, VOl. 3B, NO. A--MONDAY, JANUARY 8, 1973 ASI-PR 0001701