View source for Food Additives Amendment of 1958

{{Infobox U.S. legislation
| shorttitle        = Food Additives Amendment of 1958
| othershorttitles  =
| longtitle         = An Act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety.
| colloquialacronym = 
| nickname          = Delaney clause (referring to part of the amendment)
| enacted by        = 85th
| effective date    = September 6, 1958
| public law url    = http://www.gpo.gov/fdsys/pkg/STATUTE-72/pdf/STATUTE-72-Pg1784.pdf
| cite public law   = 85-929
| cite statutes at large = {{usstat|72|1784}} ''aka'' 72 Stat. 1786
| acts amended    = 
| acts repealed   = 
| title amended   = [[Title 21 of the United States Code|21 U.S.C.: Food and Drugs]]
| sections created = <!--{{USC}} can be used-->
| sections amended = {{unbulleted list|{{Usc-title-chap|21|9|II}} § 321|{{Usc-title-chap|21|9|IV}} § 341 et seq.}}
| leghisturl      = 
| introducedin    = House
| introducedbill  = {{USBill|85|H.R.|13254}}
| introducedby    = <!--sponsor(s)-->
| introduceddate  = 
| committees      = 
| passedbody1     = 
| passeddate1     = 
| passedvote1     = 
| passedbody2     = 
| passedas2       = <!-- used if the second body changes the name of the legislation -->
| passeddate2     = 
| passedvote2     = 
| conferencedate  = 
| passedbody3     = 
| passeddate3     = 
| passedvote3     = 
| agreedbody3     = <!-- used when the other body agrees without going into committee -->
| agreeddate3     = <!-- used when the other body agrees without going into committee -->
| agreedvote3     = <!-- used when the other body agrees without going into committee -->
| agreedbody4     = <!-- used if agreedbody3 further amends legislation -->
| agreeddate4     = <!-- used if agreedbody3 further amends legislation -->
| agreedvote4     = <!-- used if agreedbody3 further amends legislation -->
| passedbody4     = 
| passeddate4     = 
| passedvote4     = 
| signedpresident = [[Dwight Eisenhower]]
| signeddate      = September 6, 1958
| unsignedpresident = <!-- used when passed without presidential signing -->
| unsigneddate    = <!-- used when passed without presidential signing -->
| vetoedpresident = <!-- used when passed by overriding presidential veto -->
| vetoeddate      = <!-- used when passed by overriding presidential veto -->
| overriddenbody1 = <!-- used when passed by overriding presidential veto -->
| overriddendate1 = <!-- used when passed by overriding presidential veto -->
| overriddenvote1 = <!-- used when passed by overriding presidential veto -->
| overriddenbody2 = <!-- used when passed by overriding presidential veto -->
| overriddendate2 = <!-- used when passed by overriding presidential veto -->
| overriddenvote2 = <!-- used when passed by overriding presidential veto -->
| amendments      = 
| SCOTUS cases    = 
}}
The '''Food Additives Amendment of 1958''' is a 1958 amendment to the [[Federal Food, Drug, and Cosmetic Act|Food, Drugs, and Cosmetic Act of 1938]]. It was a response to concerns about the safety of new food additives. The amendment established the designation of "[[generally recognized as safe]]", which refers to chemicals or substances which can be used as food additives without further evaluation or testing just because they have been long used and there is broad acceptance of their use. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a [[food additive]].

=="Generally recognized as safe"==
{{main|Generally recognized as safe}}
Generally recognized as safe (GRAS) is a [[Food and Drug Administration (United States)|Food and Drug Administration]] (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual [[Federal Food, Drug, and Cosmetic Act]] (FFDCA) food additive tolerance requirements.<ref name="GRASfda">{{cite web|url=http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm2006850.htm|title=Generally Recognized as Safe (GRAS) |publisher=Fda.gov |date= |accessdate=2013-03-17}}</ref> The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards.

==Delaney Clause==
The Delaney Clause is a [[Provision (contracting)|provision]] in the amendment named after Congressman [[James J. Delaney|James Delaney]] of New York. 
It said:

:"the Secretary of the [[Food and Drug Administration]] shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals."<ref name=Merrill>Merrill, Richard A. "Food Safety Regulation: Reforming the Delaney Clause" in ''Annual Review of Public Health'', 1997, 18:313-40.[http://aseh.net/teaching-research/teaching-unit-better-living-through-chemistry/historical-sources/lesson-2/Merrill-Food%20Safety%20Regulation-1997.pdf] This source includes a useful historical survey of prior food safety regulation.</ref>

The Delaney Clause applied to [[pesticide]]s in processed foods, but only when the concentration of a residue of a cancer-causing pesticide increased during processing; for example when more of a pesticide was present in [[ketchup]] than in the raw tomatoes used to make it. (It never applied to pesticides in raw foods.)   When the law was passed, "neither advocates nor opponents of the policy, including FDA ofﬁcials, believed it would have broad application, for only a handful of chemicals had then been shown to be animal [[carcinogen]]s."<ref name=Merrill />  

The Delaney Clause was invoked in 1959 when [[Arthur Sherwood Flemming]], the Secretary of the [[Department of Health, Education and Welfare]] issued a statement advising the public about the possible contamination of substantial quantities of cranberries in [[Oregon]] and [[Washington (U.S. state)|Washington]] with the [[herbicide]] [[aminotriazole]], which the FDA had recently determined was a carcinogen (see [[Arthur Sherwood Flemming#Cranberry scare of 1959|Cranberry scare of 1959]]).  Taking place the week of [[Thanksgiving]], the announcement was referred to by many in the cranberry industry as "Black Monday" − sales plummeted, even though many government officials attempted to defuse the [[health scare|scare]] by declaring their intention to eat cranberries anyway.  This episode is regarded as one of the first modern food scares based on a chemical additive.

As [[analytical chemistry]] became more powerful and able to detect smaller quantities of chemicals, and as chemicals became more widely used, regulatory agencies had an increasingly difficult time administering the Delaney Clause as it "recognizes no distinctions based on carcinogenic [[Potency (pharmacology)|potency]] and, at least in theory, it applies equally to additives used in large amounts and to those present at barely detectable levels. It thus takes no account of the actual risk a carcinogenic additive might pose."<ref name=Merrill />

The FDA was the first agency to have to confront this problem, with respect to the use of [[diethylstilbestrol]] to promote the growth of livestock used in meat production, which remained present in the meat. It addressed the issue by using quantitative [[risk assessment]], declaring that if a carcinogenic food additive was present at a concentration of less than 1 part in 1,000,000, the risk was negligible.  This standard became known as the "de minimis" exception to the Delaney Rule and was used throughout the FDA and other agencies.<ref name=Merrill />

In 1988 the [[United States Environmental Protection Agency]] eased restrictions on several pesticides which posed a "de minimis" risk to humans.  This change was challenged by the [[Natural Resources Defense Council]], and overturned in 1992 by the [[Ninth Circuit Court of Appeals]].

Pesticide use was removed from the Delaney Clause in 1996 by an amendment to Title IV of the [[Food Quality Protection Act of 1996]] (P.L. 104-170, Sec. 404).

The Delaney prohibition appears in three separate parts of the FDCA: Section 409 on food additives; Section 512, relating to animal drugs in meat and poultry; and Section 721 on color additives.  The Section 409 prohibition applied to many pesticide residues until enactment of the Food Quality Protection Act of 1996.  This legislation removed pesticide residue tolerances from Delaney Clause constraints. 

Many foods contain natural substances which are carcinogenic, for example [[safrole]], which occurs in [[sassafras]] and sweet [[basil]].  Even these substances are covered by the Delaney clause, so that, for example, safrole may not be added to [[root beer]] in the USA.<ref>{{cite book |author=Fennema, Owen R. |title=Food chemistry |publisher=Marcel Dekker |location=New York, N.Y |year=1996 |page=827 |isbn=0-8247-9691-8 |oclc= |doi= |accessdate=}}</ref>

== References ==

{{Reflist}}

== See also ==
*[[Precautionary principle]]

{{Pesticide regulation in the United States}}

[[Category:Food additives]]
[[Category:Oncology]]
[[Category:United States federal health legislation]]
[[Category:Food and Drug Administration]]