Title 21—Food and Drugs--Volume 1
PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
§ 2.5   Imminent hazard to the public health.
(a) Within the meaning of the Federal Food, Drug, and Cosmetic Act an imminent hazard to the public health is considered to exist when the evidence is sufficient to show that a product or practice, posing a significant threat of danger to health, creates a public health situation (1) that should be corrected immediately to prevent injury and (2) that should not be permitted to continue while a hearing or other formal proceeding is being held. The imminent hazard may be declared at any point in the chain of events which may ultimately result in harm to the public health. The occurrence of the final anticipated injury is not essential to establish that an imminent hazard of such occurrence exists.
(b) In exercising his judgment on whether an imminent hazard exists, the Commissioner will consider the number of injuries anticipated and the nature, severity, and duration of the anticipated injury.
§ 2.10   Examination and investigation samples.
(a)(1) When any officer or employee of the Department collects a sample of a food, drug, or cosmetic for analysis under the act, the sample shall be designated as an official sample if records or other evidence is obtained by him or any other officer or employee of the Department indicating that the shipment or other lot of the article from which such sample was collected was introduced or delivered for introduction into interstate commerce, or was in or was received in interstate commerce, or was manufactured within a Territory. Only samples so designated by an officer or employee of the Department shall be considered to be official samples.
(2) For the purpose of determining whether or not a sample is collected for analysis, the term analysis includes examinations and tests.
(3) The owner of a food, drug, or cosmetic of which an official sample is collected is the person who owns the shipment or other lot of the article from which the sample is collected.
(b) When an officer or employee of the Department collects an official sample of a food, drug, or cosmetic for analysis under the act, he shall collect at least twice the quantity estimated by him to be sufficient for analysis, unless:
(1) The amount of the article available and reasonably accessible for sampling is less than twice the quantity so estimated, in which case he shall collect as much as is available and reasonably accessible.
(2) The cost of twice the quantity so estimated exceeds $150.
(3) The sample cannot by diligent use of practicable preservation techniques available to the Food and Drug Administration be kept in a state in which it could be readily and meaningfully analyzed in the same manner and for the same purposes as the Food and Drug Administration's analysis.
(4) The sample is collected from a shipment or other lot which is being imported or offered for import into the United States.
(5) The sample is collected from a person named on the label of the article or his agent, and such person is also the owner of the article.
(6) The sample is collected from the owner of the article, or his agent, and such article bears no label or, if it bears a label, no person is named thereon.
(c) After the Food and Drug Administration has completed such analysis of an official sample of a food, drug, or cosmetic as it determines, in the course of analysis and interpretation of analytical results, to be adequate to establish the respects, if any, in which the article is adulterated or misbranded within the meaning of the act, or otherwise subject to the prohibitions of the act, and has reserved an amount of the article it estimates to be adequate for use as exhibits in the trial of any case that may arise under the act based on the sample, a part of the sample, if any remains available, shall be provided for analysis, upon written request, by any person named on the label of the article, or the owner thereof, or the attorney or agent of such person or owner, except when:
(1) After collection, the sample or remaining part thereof has become decomposed or otherwise unfit for analysis, or
(2) The request is not made within a reasonable time before the trial of any case under the act, based on the sample to which such person or owner is a party. The person, owner, attorney, or agent who requests the part of sample shall specify the amount desired. A request from an owner shall be accompanied by a showing of ownership, and a request from an attorney or agent by a showing of authority from such person or owner to receive the part of sample. When two or more requests for parts of the same sample are received the requests shall be complied with in the order in which they were received so long as any part of the sample remains available therefor.
(d) When an official sample of food, drug, or cosmetic is the basis of a notice given under section 305 of the act, or of a case under the act, and the person to whom the notice was given, or any person who is a party to the case, has no right under paragraph (c) of this section to a part of the sample, such person or his attorney or agent may obtain a part of the sample upon request accompanied by a written waiver of right under such paragraph (c) from each person named on the label of the article and owner thereof, who has not exercised his right under such paragraph (c). The operation of this paragraph shall be subject to the exceptions, terms, and conditions prescribed in paragraph (c) of this section.
(e) The Food and Drug Administration is authorized to destroy:
(1) Any official sample when it determines that no analysis of such sample will be made;
(2) Any official sample or part thereof when it determines that no notice under section 305 of the act, and no case under the act, is or will be based on such sample;
(3) Any official sample or part thereof when the sample was the basis of a notice under section 305 of the act, and when, after opportunity for presentation of views following such notice, it determines that no other such notice, and no case under the act, is or will be based on such sample;
(4) Any official sample or part thereof when the sample was the basis of a case under the act which has gone to final judgment, and when it determines that no other such case is or will be based on such sample;
(5) Any official sample or part thereof if the article is perishable;
(6) Any official sample or part thereof when, after collection, such sample or part has become decomposed or otherwise unfit for analysis;
(7) That part of any official sample which is in excess of three times the quantity it estimates to be sufficient for analysis.
§ 2.19   Methods of analysis.
Where the method of analysis is not prescribed in a regulation, it is the policy of the Food and Drug Administration in its enforcement programs to utilize the methods of analysis of the AOAC INTERNATIONAL (AOAC) as published in the latest edition (13th Ed., 1980) of their publication “Official Methods of Analysis of the Association of Official Analytical Chemists,” and the supplements thereto (“Changes in Methods” as published in the March issues of the “Journal of the Association of Official Analytical Chemists”), which are incorporated by reference, when available and applicable. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. In the absence of an AOAC method, the Commissioner will furnish a copy of the particular method, or a reference to the published method, that the Food and Drug Administration will use in its enforcement program. Other methods may be used for quality control, specifications, contracts, surveys, and similar nonregulatory functions, but it is expected that they will be calibrated in terms of the method which the Food and Drug Administration uses in its enforcement program. Use of an AOAC method does not relieve the practioner of the responsibility to demonstrate that he can perform the method properly through the use of positive and negative controls and recovery and reproducibility studies.
§ 2.25   Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.
(a) In recent years there has developed increasing use of poisonous treatments on seed for fungicidal and other purposes. Such treated seed, if consumed, presents a hazard to humans and livestock. It is not unusual for stocks of such treated food seeds to remain on hand after the planting season has passed. Despite the cautions required by the Federal Seed Act (53 Stat. 1275, as amended 72 Stat. 476, 7 U.S.C. 1551 et seq. ) in the labeling of the treated seed, the Food and Drug Administration has encountered many cases where such surplus stocks of treated wheat, corn, oats, rye, barley, and sorghum seed had been mixed with untreated seed and sent to market for food or feed use. This has resulted in livestock injury and in legal actions under the Federal Food, Drug, and Cosmetic Act against large quantities of food adulterated through such admixture of poisonous treated seeds with good food. Criminal cases were brought against some firms and individuals. Where the treated seeds are prominently colored, buyers and users or processors of agricultural food seed for food purposes are able to detect the admixture of the poisonous seed and thus reject the lots; but most such buyers, users, and processors do not have the facilities or scientific equipment to determine the presence of the poisonous chemical at the time crops are delivered, in cases where the treated seeds have not been so colored. A suitable color for this use is one that is in sufficient contrast to the natural color of the food seed as to make admixture of treated, denatured seeds with good food easily apparent, and is so applied that it is not readily removed.
(b) On and after December 31, 1964, the Food and Drug Administration will regard as adulterated any interstate shipment of the food seeds wheat, corn, oats, rye, barley, and sorghum bearing a poisonous treatment in excess of a recognized tolerance or treatment for which no tolerance or exemption from tolerance is recognized in regulations promulgated pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act, unless such seeds have been adequately denatured by a suitable color to prevent their subsequent inadvertent use as food for man or feed for animals.
(c) Attention is called to the labeling requirements of the Federal Hazardous Substances Act, where applicable to denatured seeds in packages suitable for household use.
§ 2.35   Use of secondhand containers for the shipment or storage of food and animal feed.
(a) Investigations by the Food and Drug Administration, the National Communicable Disease Center of the U.S. Public Health Service, the Consumer and Marketing Service of the U.S. Department of Agriculture, and by various State public health agencies have revealed practices whereby food and animal feed stored or shipped in secondhand containers have been rendered dangerous to health. Such contamination has been the result of the original use of these containers for the storage and shipment of articles containing or bearing disease organisms or poisonous or deleterious substances.
(b) The Commissioner concludes that such dangerous or potentially dangerous practices include, but are not limited to, the following:
(1) Some vegetable growers and packers employ used poultry crates for shipment of fresh vegetables, including cabbage and celery. Salmonella organisms are commonly present on dressed poultry and in excreta and fluid exudates from dressed birds. Thus wooden crates in which dressed poultry has been iced and packed are potential sources of Salmonella or other enteropathogenic microorganisms that may contaminate fresh vegetables which are frequently consumed without heat treatment.
(2) Some potato growers and producers of animal feeds use secondhand bags for shipment of these articles. Such bags may have originally been used for shipping or storing pesticide-treated seed or other articles bearing or containing poisonous substances. Thus these secondhand bags are potential sources of contamination of the food or animal feed stored or shipped therein.
(c) In a policy statement issued April 11, 1968, the Food and Drug Administration declared adulterated within the meaning of section 402(a) of the Federal Food, Drug, and Cosmetic Act shipments of vegetables or other edible food in used crates or containers that may render the contents injurious to health. This policy statement is extended so that the Food and Drug Administration will regard as adulterated within the meaning of section 402(a) of the act shipments of vegetables, other edible food, or animal feed in used crates, bags, or other containers that may render the contents injurious to health.
§ 2.110   Definition of ammonia under Federal Caustic Poison Act.
For the purpose of determining whether an article containing ammonia is subject to the Federal Caustic Poison Act, the ammonia content is to be calculated as NH 3 .
§ 2.125   Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.
(a) As used in this section, ozone-depleting substance (ODS) means any class I substance as defined in 40 CFR part 82, appendix A to subpart A, or class II substance as defined in 40 CFR part 82, appendix B to subpart A.
(b) Except as provided in paragraph (c) of this section, any food, drug, device, or cosmetic that is, consists in part of, or is contained in an aerosol product or other pressurized dispenser that releases an ODS is not an essential use of the ODS under the Clean Air Act.
(c) A food, drug, device, or cosmetic that is, consists in part of, or is contained in an aerosol product or other pressurized dispenser that releases an ODS is an essential use of the ODS under the Clean Air Act if paragraph (e) of this section specifies the use of that product as essential. For drugs, including biologics and animal drugs, and for devices, an investigational application or an approved marketing application must be in effect, as applicable.
(d) [Reserved]
(e) The use of ODSs in the following products is essential:
(1) Metered-dose corticosteroid human drugs for oral inhalation. Oral pressurized metered-dose inhalers containing the following active moieties:
(i)-(v) [Reserved]
(2) Metered-dose short-acting adrenergic bronchodilator human drugs for oral inhalation. Oral pressurized metered-dose inhalers containing the following active moieties:
(i)-(v) [Reserved]
(3) [Reserved]
(4) Other essential uses. (i)-(ii) [Reserved]
(iii) Anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application.
(iv)-(ix) [Reserved]
(f) Any person may file a petition under part 10 of this chapter to request that FDA initiate rulemaking to amend paragraph (e) of this section to add an essential use. FDA may initiate notice-and-comment rulemaking to add an essential use on its own initiative or in response to a petition, if granted.
(1) If the petition is to add use of a noninvestigational product, the petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the product without ODSs;
(ii) The product will provide an unavailable important public health benefit; and
(iii) Use of the product does not release cumulatively significant amounts of ODSs into the atmosphere or the release is warranted in view of the unavailable important public health benefit.
(2) If the petition is to add use of an investigational product, the petitioner must submit compelling evidence that:
(i) Substantial technical barriers exist to formulating the investigational product without ODSs;
(ii) A high probability exists that the investigational product will provide an unavailable important public health benefit; and
(iii) Use of the investigational product does not release cumulatively significant amounts of ODSs into the atmosphere or the release is warranted in view of the high probability of an unavailable important public health benefit.
(g) Any person may file a petition under part 10 of this chapter to request that FDA initiate rulemaking to amend paragraph (e) of this section to remove an essential use. FDA may initiate notice-and-comment rulemaking to remove an essential use on its own initiative or in response to a petition, if granted. If the petition is to remove an essential use from paragraph (e) of this section, the petitioner must submit compelling evidence of any one of the following criteria:
(1) The product using an ODS is no longer being marketed; or
(2) After January 1, 2005, FDA determines that the product using an ODS no longer meets the criteria in paragraph (f) of this section after consultation with a relevant advisory committee(s) and after an open public meeting; or
(3) For individual active moieties marketed as ODS products and represented by one new drug application (NDA):
(i) At least one non-ODS product with the same active moiety is marketed with the same route of administration, for the same indication, and with approximately the same level of convenience of use as the ODS product containing that active moiety;
(ii) Supplies and production capacity for the non-ODS product(s) exist or will exist at levels sufficient to meet patient need;
(iii) Adequate U.S. postmarketing use data is available for the non-ODS product(s); and
(iv) Patients who medically required the ODS product are adequately served by the non-ODS product(s) containing that active moiety and other available products; or
(4) For individual active moieties marketed as ODS products and represented by two or more NDAs:
(i) At least two non-ODS products that contain the same active moiety are being marketed with the same route of delivery, for the same indication, and with approximately the same level of convenience of use as the ODS products; and
(ii) The requirements of paragraphs (g)(3)(ii), (g)(3)(iii), and (g)(3)(iv) of this section are met.