Risk Assessment in the Federal Government Managing the Process Working Papers (1983) / Chapter Skim
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Nitrite
Nitrite
Pages 39-54
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From page 39... ...
Nitrite inhibits the growth of various microorganisms found in foods, including Clostridium botulinum. It also helps to maintain the typical reddish color of cured meats, inhibits the development of rancidity in meat and fish, and may contribute to the flavor of cured products.
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From page 40... ...
In September 1974, the Panel provided a prel imaginary report which prompted USDA to propose several regulations that reduced the levels of nitrite permitted in various meat products ~ In 197S, the Panel issued its final report recommending levels of nitrite in a variety of products. USOA published a final regulation on the use of nitrite in bacons Further action on the rules proposed by USI)
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From page 41... ...
The requirements for revoking approval of a food additive are not as demanding under the general safety clause as under the Delaney Clause. Instead of proof that a substance causes cancer, FDA is required only to present new evidence raising a substantial unres o tved que s t ion about the s a fe ty ~ f an ap proved s ubs tance .
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From page 42... ...
2 pathologists on the IAW(; reported that patllolog~cal assessment of tumors in MIT study may be faulty. FDA contracted the UAREP, a nonprofit Consortium representing pathology departments of 15 universities to review pathological s 1 ides of MIT ~ tuty .
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From page 43... ...
A number of bills are introduced in Congress to prevent the agencies from banning or phasing out nitrite. UAREP report fail s to confirm carcinogenic)
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From page 44... ...
a commercial chow diet was substituted, and sodium nitrite concentrations of 0, 1, 000 or 2, 000 mg/Icg diet were fed to the animals. Groups 13 and 14 were given a refined casein diet containing nitrite at O or 1,000 mg/Icg, while another two groups, 15 and 16, were fed the original semisynthet~c diet containing nitrite at ~ or I, 000 mg/kg.
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From page 45... ...
'The FDA commissioner appointed a special ~ntra-agency Ad Hoc Working Group to review the data and to make recormnendationse The Chief Counsel was responsible for overall development of the regulatory policy and the Acting Director, Bureau of Foods was responsible for directing the scientific review of the study. The other members of the Ad Hoc Working Group were the Commissioner, Deputy Commi so loner, Execut ive Ass is tent to the Commiss toner, Associate Director of Regulatory Affairs, Director of Health Affairs, and two staff scientists from the Bureau of Foods .
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From page 46... ...
The numbers in parentheses are the estimated lifetime cancer risks per 10,000 population.
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From page 47... ...
7. Mat qualitative factors affected the weighting of data?
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From page 48... ...
UAREP pathologic ts did report a greater than 1: incidence of other types of tumors, including his tiocytic sarcomas, angiosarcomas, liver neoplasms, ear duct tumors, pancreatic tumors ~ pituitary tumor, and mammary tumors. However, after statistical analysis and careful review by the IAWG, no demonstration could be found that the increased incidences of these tumors were induced by the inges tion of sodium nitrite.
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From page 49... ...
by the USDA. In the case of the planned phaseout of nitrite, FDA informed USDA of its activities-the original announcement was to 'nave been made jointly by the Secretaries o f HEW ant {JSDA.
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From page 50... ...
Yes. Despite the fact that the major Elaw in the interpretation of the study stemmed from differences in pathologic diagnoses that cannot be addressed by inference guidelines, there were many other scientific issues that were not appropriately cons idered in the initial assessment of risks done by IDA.
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From page 51... ...
PERFORMANCE CONST DERATIONS 1 Ability to obtain relevant scientific information . FDA contracted for this study.
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From page 52... ...
Subsequent review of the study revealed many flaws in tie data, casting further doubt on the conclusions drawn in the original assessment. The credibility of the second review was not a major issue as this was an internal document looking at the broader issues of nitrosamine formation as well as nitrite carcinogenicity.
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From page 53... ...
e., it reflected an agency awareness o f public concerns and the importance to consider alternative regulatory actions. The subsequent appointment of an Interagency Working Group resulted from questions raised by F1)
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From page 54... ...
Some observers of the nitri te decision would sugges t that policy considerations were weighted more heavily than scientific con: siderations in the initial as se~sment done by the Ad Hoc Forking Group. Certainly, the makeup of the Group would indicate that the "policy-~ypes" out numbered (and outranked)
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