nies per standard sample shall not exceed %0 ml, 100 ml, 200 ml, or 100 ml in: (i) Two consecutive samples; (ii) More than one standard sample when less than 20 are examined per month; or (iii) More than five percent of the standard samples when 20 or more are examined per month. When coliform colonies in a single standard sample exceed the above values, daily samples from the same sampling point shall be collected promptly and examined until the results obtained from at least two consecutive samples show the water to be of satisfactory quality. § 72.204 Physical characteristics. (a) Sampling. The frequency and manner of sampling shall be determined by the reporting agency and the certifying authority. Under normal circumstances samples should be collected one or more times per week from representative points in the distribution system and examined for turbidity, color, threshold odor, and taste. (b) Limits. Drinking water should contain no impurity which would cause offense to the sense of sight, taste, or smell. Under general use, the following limits should not be exceeded: Turbidity-5 units. Threshold odor number-3. § 72.205 Chemical characteristics. (a) Sampling. (1) The frequency and manner of sampling shall be determined by the reporting agency and the certifying authority. Under normal circumstances, analyses for substances listed below need be made only semiannually. If, however, there is some presumption of unfitness because of the presence of undesirable elements, compounds, or materials, periodic determinations for the suspected toxicant or material should be made more frequently and an exhaustive sanitary survey should be made to determine the source of the pollution. Where the concentration of a substance is not expected to increase in processing and distribution, available and acceptable source water analyses performed in accordance with standard methods may be used as evidence of compliance with these Standards. (2) Where experience, examination, and available evidence indicate that particular substances are consistently absent from a water supply or below levels of concern, semi-annual examinations for those substances may be omitted when approved by the reporting agency and the certifying authority. (3) The burden of analysis may be reduced in many cases by using data from acceptable sources. Judgment concerning the quality of water supply and the need for performing specific local analyses may depend in part on information produced by such agencies as (i) the U.S. Geological Survey, which determines chemical quality of surface and ground waters of the United States and publishes these data in "Water Supply Papers" and other reports, and (ii) the U.S. Public Health Service which determines water quality related to pollution (or the absence of pollution) in the principal rivers of the Nation and publishes these data annually in "National Water Quality Network." Data on pollution of waters as measured by carbon chloroform extracts (CCE) may be found in the latter publication. (b) Limits. Drinking water shall not contain impurities in concentrations which may be hazardous to the health of the consumers. It should not be excessively corrosive to the water supply system. Substances used in its treatment shall not remain in the water in concentrations greater than required by good practice. Substances which may have deleterious physiological effect, or for which physiological effects are not known, shall not be introduced into the system in a manner which would permit them to reach the consumer. (1) The following chemical substances should not be present in a water supply in excess of the listed concentrations where, in the judgment of the reporting agency and the certifying authority, other more suitable supplies are or can be made available. Based on temperature data obtained for a minimum of five years. (iii) In addition to the sampling required by paragraph (a) of this section, fluoridated and defluoridated supplies shall be sampled with sufficient frequency to determine that the desired fluoride concentration is maintained. (a) Sampling. (1) The frequency of sampling and analysis for radioactivity shall be determined by the reporting agency and the certifying authority after consideration of the likelihood of significant amounts being present. Where concentrations of Ra-226 or Sr-90 may vary considerably, quarterly samples composited over a period of three months are recommended. Samples for determination of gross activity should be taken and analyzed more frequently. (2) As indicated in § 72.205(a), data from acceptable sources may be used to indicate compliance with these requirements. (b) Limits. (1) The effects of human radiation exposure are viewed as harmful and any unnecessary exposure to ionizing radiation should be avoided. Approval of water supplies containing radioactive materials shall be based upon the judgment that the radioactivity intake from such water supplies when added to that from all other sources is not likely to result in an intake greater than the radiation protection guidance1 recommended by Annual average of maximum daily air temperatures Lower Optimum 50.0-53.7 0.9 1.2 The Federal Radiation Council, in its Memorandum for the President, September 13, 1961, recommended that "Routine control of useful applications of radiation and atomic energy should be such that expected average exposures of suitable samples of an exposed population group will not exceed the upper value of Range II (20 μμс/day of Radium-226 and 200 μμc/day of Strontium90)." the Federal Radiation Council and approved by the President. Water supplies shall be approved without further consideration of other sources of radioactivity intake of Radium-226 and Strontium-90 when the water contains these substances in amounts not exceeding 3 and 10 μμc/liter, respectively. When these concentrations are exceeded, a water supply shall be approved by the certifying authority if surveillance of total intakes of radioactivity from all sources indicates that such intakes are within the limits recommended by the Federal Radiation Council for control action. (2) In the known absence of Strontium-90 and alpha emitters, the water supply is acceptable when the gross beta concentrations do not exceed 1,000 μμc/liter. Gross beta concentrations in excess of 1,000 μμc/liter shall be grounds for rejection of supply except when more complete analyses indicate that concentrations of nuclides are not likely to cause exposures greater than the Radiation Protection Guides as approved by the President on recommendation of the Federal Radiation Council. § 72.207 Recommended analytical methods. (a) Analytical methods to determine compliance with the requirements of these Standards shall be those specified in Standard Methods for the Examination of Water and Wastewater, Am. Pub. Health Assoc., current edition and those specified as follows: (1) Barium: Methods for the Collection and Analyses of Water Samples, Water Supply Paper No. 1454, Rainwater, F. H. & Thatcher, L. L., U.S. Geological Survey, Washington, D.C. (2) Carbon Chloroform Extract (CCE): Manual for Recovery and Identification of Organic Chemicals in Water, Middletown, F. M., Rosen, A. A., and Burttschell, R. H., Robert A. Taft Sanitary Engineering Center, PHS, Cincinnati, Ohio. 2Absence is taken here to mean a negligibly small fraction of the above specific limits, where the limit for unidentified alpha emitters is taken as the listed limit for Radium-226. Radioactivity: Laboratory (3) Manual of Methodology, Radionuclide Analyses of Environmental Samples, Technical Report R59-6. Robert A. Taft Sanitary Engineering Center, PHS, Cincinnati, Ohio, and Methods of Radiochemical Analysis, Technical Report No. 173, Report of the Joint WHO-FAO Committee, 1959, World Health Organization. (4) Selenium: Suggested Modified Method for Colorimetric Determination of Selenium in Natural Water, Magin, G. B., Thatcher, L. L., Rettig, S., and Levine, H., J. Am. Water Works Assoc. 52, 1199 (1960). (b) Organisms of the coliform group. All of the details of techniques in the determination of bacteria of this group, including the selection and preparation of apparatus and media, the collection and handling of samples and the intervals and conditions of storage allowable between collection and examination of the water sample, shall be in accordance with Standard Methods for the Examination of Water and Wastewater, current edition, and the procedures shall be those specified therein for: (1) The Membrane Filter Technique, Standard Test, or (2) The Completed Test, or (3) The Confirmed Test, procedure with brilliant green lactose bile broth, 3 "The Confirmed Test is allowed, provided the value of this test to determine the sanitary quality of the specific water supply being examined is established beyond reasonable doubt by comparisons with Completed Tests performed on the same water supply. "The Federal Radiation Council, in its Memorandum for the President, September 13, 1961, recommended that "Routine control of useful applications of radiation and atomic energy should be such that expected average exposures of suitable samples of an exposed population group will not exceed the upper value of Range II (20 μμс/day of Radium-226 and 200 μμc/day of Strontium90)." Subpart H-Revocation, Suspension, and Limitation of Licenses and Letters of Exemption; Notice Sec. 74.60 Revocation, suspension, and limitation of licenses and letters of exemption. 74.61 Contents of notice. Subpart I-Hearings [Reserved] AUTHORITY: Sec. 215, 58 Stat. 690; 42 U.S.C. 216. SOURCE: 33 FR 20043, Dec. 31, 1968, unless otherwise noted. Subpart A-Definitions and § 74.1 Definitions. (a) As used in this part, all terms not defined herein shall have the meaning given them in the Act. (b) "Accredited institution" means an institution accredited by an agency or organization recognized for such purpose by the U.S. Commissioner of Education. (c) "Accredited laboratory" means a laboratory, or a laboratory in a hospital, accredited by an approved accreditation body. (d) "Act" means the Public Health Service Act, as amended, 42 U.S.C. 201, et seq. (e) "Approved accreditation body" means, with respect to hospitals, Joint Commission on the Accreditation of Hospitals, or American Osteopathic Association, and with respect to laboratories, Commission on Inspection and Accreditation of the College of American Pathologists; or any other national accreditation body which has been approved by the Secretary as provided in section 353 of the Act. (f) "Director" means the Director of the National Communicable Disease Center, Health Services and Mental Health Administration, Department of Health, Education, and Welfare. (g) "Health insurance program" means the program created under Title XVIII of the Social Security Act, pursuant to which individuals are entitled to have payments made on their behalf for services performed by independent laboratories as provided in Title 20, Code of Federal Regulations, Part 405, Subpart M. 'Redesignated as 42 CFR Part 405. (h) A "physician" is a person licensed to practice medicine or osteopathy in any state or possession of the United States. (i) "Radiobioassay" includes (1) an examination to identify radionuclides or determine and quantitate body levels of radionuclides which are taken in by chronic or acute absorption, ingestion, or inhalation and (2) following the administration of a radioactive material to a patient, the subsequent analysis of a body fluid or excreta in order to evaluate body function. (j) A “referee laboratory" is a laboratory designated by the Secretary to examine specimens or other materials for purposes of proficiency testing using the same time schedule allowed for licensed laboratories and under conditions similar to those under which licensed laboratories examine materials. (k) A "reference laboratory" is a laboratory designated by the Secretary to authenticate the identification, content, and titer of samples and other materials used or to be used in proficiency testing. (1) "Secretary" means the Secretary of Health, Education, and Welfare or his designee. (m) "Specimen" means any material derived from the human body for examination or other procedure for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, man. [33 FR 20043, Dec. 31, 1968, as amended at 38 FR 10721, May 1, 1973) § 74.2 Applicability. (a) Except as otherwise provided herein, the regulations in this part apply to laboratories engaged in the laboratory examination of, or other laboratory procedures relating to, specimens solicited or accepted in interstate commerce directly or indirectly, for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment, or the assessment of the health, of man. (b) The regulations in this part do not apply to the following:1 (1) Any laboratory with respect to any category in which it accepts no more than 100 specimens during any calendar year: Provided, That the laboratory holds an unrevoked and unsuspended letter of exemption for such category issued upon application submitted by such laboratory to the Director, National Communicable Disease Center, 1600 Clifton Road NE., Atlanta, Ga. 30333, and upon its agreement to maintain and make available such accession and other records, submit such information and reports, and comply with such provisions of this part as the Secretary may reasonably find necessary to determine its initial and continuing eligibility for exemption under this paragraph. For purposes of this paragraph, a category shall be one of the following: (i) Microbiology and serology; (ii) clinical chemistry; (iii) immunohematology; (iv) hematology; (v) pathology; (vi) radiobioassay. (2) Pursuant to section 353(i), any clinical laboratory operated by a licensed physician, osteopath, dentist, or podiatrist, or group thereof, who performs or perform laboratory tests or procedures solely as an adjunct to the treatment of his or their patients. (3) Pursuant to section 353(i), any laboratory with respect to tests or other procedures made by it for any person engaged in the business of insurance if made solely for the purposes of determining whether to write an insurance contract or of determining eligibility or continued eligibility for payments thereunder. (4) Clinical laboratories exempted by the Secretary pursuant to section 353(1) of the Act. (c) The requirements of this part for the issuance and renewal of licenses do not apply to an accredited laboratory: |