A Practical Approach, Second Edition=Ronald D. Ho.pdf

PRINCIPLES OF RISK ASSESSMENT — FDA PERSPECTIVE 879requiring the preclearance of safety studies for chemicals added to food and granted the FDAauthority to set tolerances for pesticides in foods (Section 408).In 1958, Congress enacted the Food Additives Amendment (Section 409) to the FFDCA. Thisamendment requires that a food additive be shown to be safe under its intended conditions of usebefore it is allowed in food. The amendment requires premarket safety evaluation of food additivesand provides the FDA with authority to issue tolerances and regulations approving the use of foodadditives. In establishing the standard for demonstrating the safety of a food additive, Congressrecognized that it is not possible to determine with absolute certainty that no harm will result fromthe intended use of an additive. Specifically, therefore, the legislation requires that the petitionerprovide proof of reasonable certainty that no harm will result from the intended use of the additive.Prior to 1958, upon request of the industry, FDA periodically would review the safety of variouschemicals and render letters of advisory opinion on their acceptability, under certain conditions,as safe additives in food. 1 These written FDA Advisory opinions were recognized by Congress inthe 1958 Food Additives Amendment as “prior sanctions.” In the food additives regulations, theseare categorized in 21 CFR Part 181.Under Section 409 of the act as originally established, food additives require a food additivepetition, premarket approval by FDA, and publication of a regulation authorizing their intendeduse. The Food Additives Amendment applies to both “direct” and “indirect” food additives. Directadditives (21 CFR Part 172) are substances added deliberately in finite amounts, for whatevertechnical purpose served, and remain in the food as consumed. Secondary food additives (21 CFRPart 173) represent substances added to food or food components during manufacture or processingbut removed before the final product is consumed. Indirect food additives (21 CFR Parts 175 and179) are not intentionally added to food; they are substances used as articles or components ofarticles that are intended for use in packaging, transporting, or holding food. Because indirect foodadditives are not intended to become components of the food, their presence in food may be theresult of migration or inadvertent extraction from the food contact surface. 1Section 309 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) amendsSection 409 of the FFDCA (21 USC 348) to establish a notification procedure as the primarymethod by which the FDA regulates food additives that are food contact substances (FCS). Foodcontact substances include all substances that are intended for use as components of materials usedin manufacturing, packaging, transporting, or holding food if the use is not intended to have anytechnical effect in the food.The Delaney Clause, part of the 1958 Food Additives Amendment (Section 409) to the FFDCA,sets a zero-tolerance cancer-risk standard for substances added directly or indirectly to food. Thisfar-reaching standard is still the priority test for food additives, and any other risks or risk assessmentsare based on knowledge of the noncarcinogenic properties of the additive.In 1960, Congress passed the Color Additive Amendments (Section 721) of the FFDCA, whichrequired that color additives be shown to be safe for use in or on food, drugs, or cosmetics priorto approval. The amendments created an analogous premarket approval process for color additivesused in foods, drugs, and cosmetics, or medical devices. Approved color additives are listed in 21CFR Parts 73 and 74.The act also recognizes GRAS (Generally Recognized as Safe) status for certain food ingredients.GRAS substances are generally recognized by experts as safe, based either on their extensivehistory of use in food before 1958 or on generally available and accepted scientific evidence. 1 Theavailable data and information must establish that the intended use of the substance is safe.B. The Statutory Safety Standard for AdditivesThe Food Additives Amendment of the 1938 Act requires that a food additive be shown to be safeunder the intended conditions of use before it is allowed in food. This safety requirement is oftenreferred to as the general safety clause for food additives. Although what is meant by “safe” is not© 2006 by Taylor & Francis Group, LLC