Does Nitrite Cause Cancer? Concerns About Validity of FDA-Sponsored Study Delay Answer
HRD-80-46: Published: Jan 31, 1980. Publicly Released: Jan 31, 1980.
Additional Materials:
- Full Report:
Contact:
A recent study conducted for the Food and Drug Administration (FDA) indicated that nitrite may cause cancer. Legislation provides that any substance determined to cause cancer in humans or animals may not be used as a food additive. This same legislation also states that a substantial unresolved question about the safety of a food additive is also a basis for its removal from use. For several years, nitrite has been used to preserve, color and flavor meat, poultry, and fish. It also protects against the formation of botulism toxin. FDA and the Department of Agriculture (USDA) are faced with a regulatory dilemma in that the use of nitrate protects consumers against one serious problem, and may cause another. Because nitrite is widely used, is important, and lacks an acceptable chemical substitute, FDA, with USDA concurrence, planned to phase out its use over several years. However, the Department of Justice determined that no authority exists for such a phase out and that removal of a cancer-causing substance may not be delayed.
Questions have been raised about the validity of the nitrite study. Site visits to the researcher's laboratory were to be used to assess contractor performance, but this was not done until a critical phase of the study was nearly completed. When progress reports, the primary tool for monitoring the study, were submitted late or not at all, agency officials did not follow up with the researcher and did not make a prompt written evaluation of the reports received. FDA review of long-term study results did not include a reexamination of animal tissue slides which, along with notes from the physical examination of the animal, are the basis for pathology diagnoses used to assess the cancer-causing potential of a substance. Because the contract for this study did not specify the types of data FDA would need to evaluate study results, some data were submitted late or not recorded. FDA does not have guidelines for design data recording and reporting, and statistical evaluation for long-term toxicity studies such as this one. Statistical procedures used in evaluating test data were criticized by reviewers. Many deviations from acceptable laboratory procedures were revealed in a FDA inspection of the nitrite researcher's laboratory.
Jan 19, 2021
-
Elder Justice:
HHS Could Do More to Encourage State Reporting on the Costs of Financial ExploitationGAO-21-90: Published: Dec 18, 2020. Publicly Released: Jan 19, 2021.
Nov 23, 2020
-
Consumer Privacy:
Better Disclosures Needed on Information Sharing by Banks and Credit UnionsGAO-21-36: Published: Oct 22, 2020. Publicly Released: Nov 23, 2020.
Nov 19, 2020
-
Consumer Product Safety Commission:
Actions Needed to Improve Processes for Addressing Product Defect CasesGAO-21-56: Published: Nov 19, 2020. Publicly Released: Nov 19, 2020.
Oct 30, 2020
-
Small Business Loans:
SBA Generally Incorporated Key Elements for Estimating Subsidy Cost of 7(a) ProgramGAO-20-618: Published: Sep 30, 2020. Publicly Released: Oct 30, 2020.
Oct 13, 2020
-
Aviation Consumer Protection:
Increased Transparency Could Help Build Confidence in DOT's Enforcement ApproachGAO-21-109: Published: Oct 13, 2020. Publicly Released: Oct 13, 2020.
Oct 1, 2020
-
Small Business Administration:
COVID-19 Loans Lack Controls and Are Susceptible to FraudGAO-21-117T: Published: Oct 1, 2020. Publicly Released: Oct 1, 2020.
Sep 30, 2020
-
Small Business Research Programs:
Many Agencies' Award Issuances Are Not Timely; Some Practices May Improve TimelinessGAO-20-693: Published: Sep 30, 2020. Publicly Released: Sep 30, 2020.
Sep 28, 2020
-
Intellectual Property:
Additional Agency Actions Can Improve Assistance to Small Businesses and InventorsGAO-20-556: Published: Aug 27, 2020. Publicly Released: Sep 28, 2020.
Jul 30, 2020
-
Small Business Contracting:
Better Documentation and Reporting Needed on Procurement Center RepresentativesGAO-20-462: Published: Jun 30, 2020. Publicly Released: Jul 30, 2020.
Jun 29, 2020
-
Small Business Subcontracting:
Oversight of Contractor Compliance with Subcontracting Plans Needs ImprovementGAO-20-464: Published: May 28, 2020. Publicly Released: Jun 29, 2020.
Looking for more? Browse all our products here