Abstract
The FDA impurities policy embodies a regulatory approach which distinguishes between a food or color additive as a whole and its constituents for the purpose of determining when the Delaney clause is triggered. Under the impurities policy, the Delaney clause does not apply to a carcinogenic impurity in a food or color additive unless there is a finding that the additive as a whole induces cancer. This interpretation of the Delaney clause enables the agency to use risk assessment to determine whether, under the general safety provisions for food and color additives, there is a reasonable certainty that no harm will result from the proposed use of an additive. The use of risk assessment in the implementation of the impurities policy permits the FDA to manage insignificant risk from low-level carcinogens consistent with the anti-cancer prohibitions of the Delaney clause.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Federal Food, Drug, and Cosmetic Act (1938), Pub. L. 717, ch. 675, 52 Stat. 1040, as amended; codified at 21 U.S.C. sec. 301 et seq
Food Additives Amendment of 1958, Pub. L. No. 85–929, 72 Stat. 1784 (1958)
Color Additive Amendments of 1960, Pub. L. No. 86–618, 74 Stat. 397 (1960)
21 U.S.C. sec. 348(c)(3) [food additives]; 21 U.S.C. sec. 376(b)(4) [color additives]
21 U.S.C. sec. 348(c)(3)(A) [food additives]; 21 U.S.C. sec. 376(b)(5)(B) [color additives]
21 U.S.C. sec. 348(c)(3)(A)
21 U.S.C. sec. 376(b)(4)
21 C.F.R. sec. 170.3(i), definition of “safe” with respect to food additives
21 C.F.R. sec. 70.3(i), definition of “safe” with respect to color additives
See supra note 2; Delaney clause applicable to food additives codified at 21 U.S.C. sec. 348(c)(3)(A)
See supra note 3; Delaney clause applicable to color additives codified at 21 U.S.C. sec. 376(b)(5)(B)
Scheuplein, “Risk Assessment and Food Safety: A Scientist’s and Regulator’s View,” Food Drug Cosm. L. J. 42: 237 (1987)
Id
Monsanto Co. v. Kennedy,613 F.2d 947 (D.C. Cir. 1979)
21 U.S.C. sec. 321(s), definition of “food additive”
Fed. Reg. 14, 463 (1982)
Fed. Reg. 14, 138 (1982)
47 Fed. Reg. 24,278 (1982). See also final rule; termination of stay and confirmation of effective date, 47 Fed. Reg. 49, 628 (1982)
Scott v. Food and Drug Administration,728 F.2d 322 (6th Cir. 1984)
See supra note 16
See supra note 12
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1989 Plenum Press, New York
About this chapter
Cite this chapter
Lake, L.R., Smith, K.M. (1989). History of the Impurities Policy: Risk Assessment for Food and Color Additives. In: Bonin, J.J., Stevenson, D.E. (eds) Risk Assessment in Setting National Priorities. Advances in Risk Analysis, vol 7. Springer, Boston, MA. https://doi.org/10.1007/978-1-4684-5682-0_27
Download citation
DOI: https://doi.org/10.1007/978-1-4684-5682-0_27
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4684-5684-4
Online ISBN: 978-1-4684-5682-0
eBook Packages: Springer Book Archive