§ 102.49 Fried clams made from minced clams. (a) The common or usual name of the food product that resembles and is of the same composition as fried clams, except that it is composed of comminuted clams, shall be "fried clams made from minced clams." (b) The words "made from minced clams" shall immediately follow or appear on a line(s) immediately below the words "fried clams" and in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives: (1) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and not less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or (2) Not less than one-half the height of the largest type used in the words "fried clams." (a) When the cocktail contains only one seafood ingredient, the name of the seafood ingredient followed by the word "cocktail" (e.g., shrimp cocktail, crabmeat cocktail) and a statement of the percentage by weight of that seafood ingredient in the product in the manner set forth in § 102.5(b). (b) When the cocktail contains more than one seafood ingredient, the term "seafood cocktail" and a statement of the percentage by weight of each seafood ingredient in the product in the manner set forth in § 102.5(b). (a) The common on usual name of the food product that conforms to the definition and standard of identity described by § 161.175(c)(6) of this chapter, except that the food is made from comminuted shrimp and is not in raw frozen form, shall be made from minced shrimp," the blank to be filled in with the words "breaded shrimp sticks" or "breaded shrimp cutlets" depending upon the shape of the product, or if prepared in a shape other than that of sticks or cutlets "breaded shrimp made from minced shrimp," the blank to be filled by a word or phrase that accurately describes the shape and that is not misleading. (b) The words "made from minced shrimp" shall immediately follow or appear on a line(s) immediately below the other words required by this section in easily legible boldface print or type in distinct contrast to other printed or graphic matter, and in a height not less than the larger of the following alternatives: (1) Not less than one-sixteenth inch in height on packages having a principal display panel with an area of 5 square inches or less and no less than one-eighth inch in height if the area of the principal display panel is greater than 5 square inches; or (2) Not less than one-half the height of the largest type used in the words "breaded shrimp sticks" or the other comparable words required by this section. (1) For purposes of determining quality factors related to manufacture, processing, or packing, a collection of primary containers or units of the same size, type, and style produced under conditions as nearly uniform as possible and usually designated by a common container code or marking, or in the absence of any common container code or marking, a day's production. (2) For purposes of determining quality factors related to distribution and storage, a collection of primary containers or units transported, stored, or held under conditions as nearly uniform as possible. (b) A sample consists of 10 subsamples (consumer units), taken one from each of 10 different randomly chosen shipping cases to be representative of a given lot, unless otherwise specified in a specific quality standard in this part. (c) An analytical unit is the portion(s) of food taken from a subsample of a sample for the purpose of analysis. [42 FR 14325, Mar. 15, 1977] § 103.5 General principles. (a) The quality of a food depends upon numerous characteristics including but not limited to the levels of microorganisms and such physical factors as turbidity, color, flavor, and odor. Such characteristics are indicative of the quality of the raw materials and ingredients, the degree of quality control used in manufacture, processing, and packing, and the conditions of distribution and storage. The diversity of raw materials, food processing, and distribution practices, as well as the variation in quality factors important to consumers, requires that individual standards of quality be established for different types of food. (b)(1) The label of a food that fails to meet the requirements of an applicable standard of quality promulgated pursuant to this part shall bear the general statement of substandard quality specified in § 130.14(a) of this chapter in the manner and form therein specified; but in lieu of such general statement of substandard quality, the label may bear the alternative statement, "Below Standard in Quality-the blank to be filled in with whichever of the following are applicable: (i) "Contains Excessive Bacteria". (iv) The phrase specified in the applicable standard of quality to describe any other quality deviation. (2) The statement of substandard quality shall appear on the principal display panel or panels and shall immediately and conspicuously precede or follow, without intervening written, printed or graphic matter, the name of the food. (c) Product descriptions included in a standard of quality promulgated pursuant to this part are intended only to designate the class of foods to which the standards apply, and are not standards of identity for the products involved. Should a standard of identity later be established for any of these foods, the standard of quality will be recodified to appear in the same part of the regulations. (d) The food characteristics included in a standard of quality published in this part relate only to the quality of the food and not to compliance with any of the adulteration provision of section 402 of the act. Compliance with a standard of quality promulgated pursuant to this part does not excuse failure to observe either the requirement of section 402(a)(4) of the act that food may not be prepared, packed, or held under insanitary conditions, or the provisions of parts 110 and 129 of this chapter requiring that food manufacturers must observe current food manufacturing practices. For example, evidence obtained through factory inspection indicating such a violation renders the food unlawful, even though the food contains levels of microorganisms lower than those prescribed by an applicable standard. (e) The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may establish, amend, or repeal, under subpart B of this part, a regulation prescribing a standard of quality for a food pursuant to part 10 of this chapter. [42 FR 14325, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 44 FR 12172, Mar. 6, 1979] Subpart B-Standards of Quality §103.35 Bottled water. (a) Definitions. (1) Bottled water is defined as water that is sealed in bottles or other containers and intended for human consumption. Bottled water does not include mineral water or any type of soft drink commonly known as soda water, which is made by absorbing carbon dioxide in potable water. (2) Trihalomethane (THM) means one of the family of organic compounds, named as derivatives of methane, wherein three of the four hydrogen atoms in methane are each substituted by a halogen atom in the molecular structure. rounded to two significant figures. (b) Microbiological quality. Bottled water shall, when a sample consisting of analytical units of equal volume is examined by the methods described in applicable sections of "Standard Methods for the Examination of Water and Wastewater," 15th Ed. (1980), American Public Health Association, which is incorporated by reference (copies may be obtained from the Division of Food Chemistry and Technology, Center for Food Safety and Applied Nutrition (HFF-410), 200 C St., SW., Washington, DC 20204, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20001), meet the following standards of microbiological quality: (1) Multiple-tube fermentation method. Not more than one of the analytical units in the sample shall have a most probable number (MPN) of 2.2 or more coliform organisms per 100 milliliters and no analytical unit shall have an MPN of 9.2 or more coliform organisms per 100 milliliters; or (2) 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 one coliform organism per 100 milliliters. (c) Physical quality. Bottled water shall, when a composite of analytical units of equal volume from a sample is examined by the method described in applicable sections of "Standard Methods for the Examination of Water and Wastewater," 15th Ed. (1980), which is incorporated by reference (the availability of this incorporation by reference is given in paragraph (b) of this section), meet the following standards of physical quality: (1) The turbidity shall not exceed 5 units. (2) The color shall not exceed 15 units. for Chlorinated Phenoxy Acid Herbicides in Industrial Effluents," November 28, 1973, which are incorporated by reference, and "Part I: The Analysis of Trihalomethanes in Finished Waters by the Purge and Trap Method," Method 501.1 and "Part II: The Analysis of Trihalomethanes in Drinking Water by Liquid/Liquid Extraction," Method 501.2 in 40 CFR part 141, appendix C (45 FR 68672; November 29, 1979). The availability of these incorporations by reference are given in paragraph (b) of this section. (2)(i) Bottled water packaged in the United States to which no fluoride is added shall not contain fluoride in excess of the levels in Table 1 and these levels shall be based on the annual average of maximum daily air temperatures at the location where the bottled water is sold at retail. TABLE 1 Fluoride concen Endrin (1,2,3,4,10,10-hexachloro-6,7-epoxy1,4,4a,5,6,7,8,8a-Octa-hydro-1,4-endo, endo-5,8-dimethano naphthalene)..... Methaoxychlor (1,1,1-trichloro-2,2-bis[pmethoxy-phenyl] ethane. 0.0002 milli Lindane (1,2,3,4,5,6-hexachloro-cyclohexane, gamma isomer).. 2.4 2.2 2.0 1.8 1.6 1.4 0.01 (ii) Analyses conducted to determine compliance with paragraph (d)(1)(i) of this section shall be made in accordance with the methods described in the applicable sections of "Standard Methods for the Examination of Water and Wastewater," 15th Ed. (1980), or "Methods for Chemical Analysis of Water and Wastes," Environmental Monitoring and Support Laboratory, EPA-600/4-82-055, March 1983, U.S. Environmental Protection Agency, both of which are incorporated by reference. Analyses for organic substances shall be determined by appropriate methods described in "Methods for Organochlorine Pesticides in Industrial Effluents" and "Methods (ii) Imported bottled water to which no fluoride is added shall not contain fluoride in excess of 1.4 milligrams per liter. (iii) Bottled water packaged in the United States to which fluoride is added shall not contain fluoride in excess of levels in Table 2 and these levels shall be based on the annual average of maximum daily air temperatures at the location where the bottled water is sold at retail. (iv) Imported bottled water to which fluoride is added shall not contain fluoride in excess of 0.8 milligram per liter. (3) Having consulted with the U.S. Environmental Protection Agency (EPA) as required by section 410 of the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration has determined that bottled water, when a composite of analytical units of equal volume from a sample is examined by the methods listed in paragraph (d)(3)(vi) of this section, shall not contain the following chemical contaminants in excess of the conspecified in paragraph (d)(3)(ii) of this section. centrations listed separately in paragraphs (d)(3)(vi)(A) through (d)(3)(vi)(E) of this section, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Except as otherwise indicated below, copies are available from the National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, or available for inspection at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (A) Method 502.1-"Volatile Halogenated Organic Compounds in Water by Purge and Trap Gas Chromatography" (applicable to VOC's). (B) Method 502.2-"Volatile Organic Compounds in Water by Purge and Trap Capillary Column Gas Chromatography with Photoionization and Electrolytic Conductivity Detectors in Series" (applicable to VOC's). (C) Method 503.1-"Volatile Aromatic and Unsaturated Organic Compounds in Water by Purge and Trap Gas Chromatography" (applicable to VOC's). (D) Method 524.1-"Measurement of Purgeable Organic Compounds in Water by Purged Column Gas Chromatography/Mass Spectrometry" (applicable to VOC's). (E) Method 524.2-"Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry" (applicable to VOC's). (vii) [Reserved] (e) Radiological quality. (1) Bottled water shall, when a composite of analytical units of equal volume from a sample is examined by the methods described in paragraph (e)(2) of this section, meet standards of radiological quality as follows: (i) The bottled water shall not contain a combined radium-226 and radium-228 activity in excess of 5 picocuries per liter of water. (ii) The bottled water shall not contain a gross alpha particle activity (including radium-226, but excluding radon and uranium) in excess of 15 picocuries per liter of water. (iii) The bottled water shall not contain beta particle and photon radioactivity from manmade radionuclides in excess of that which would produce an |