[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR109.3] [Page 208] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 109_UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL--Table of Contents Subpart A_General Provisions Sec. 109.3 Definitions and interpretations. Subpart A_General Provisions Sec. 109.3 Definitions and interpretations. 109.4 Establishment of tolerances, regulatory limits, and action levels. 109.6 Added poisonous or deleterious substances. 109.7 Unavoidability. 109.15 Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials. 109.16 Ornamental and decorative ceramicware. Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances 109.30 Tolerances for polychlorinated biphenyls (PCB's). Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances [Reserved] Subpart D--Naturally Occurring Poisonous or Deleterious Substances [Reserved] Authority: 21 U.S.C. 321, 336, 342, 346, 346a, 348, 371. Source: 42 FR 52819, Sept. 30, 1977, unless otherwise noted. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) The definitions of terms contained in section 201 of the act are applicable to such terms when used in this part unless modified in this section. (c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination. (d) An added poisonous or deleterious substance is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase. (e) Food includes human food and substances migrating to food from food-contact articles.