Fact Sheet on NIOSH Special Exposure Cohort Rulemaking

By Richard Miller, Government Accountability Project (GAP), http://www.whistleblower.org

Name of Rule: Procedures for designating classes of Employees as Members of the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000 (42 CFR Part 83)

Federal Register: March 7, 2003
Comment Period: 30 days
Statutory Authority: Energy Employees Occupational Illness Compensation Program Act
Agency Rule: HHS



Radiation dosimetry in many DOE and vendor facilities are of questionable reliability for making compensation decisions. Dose data has been shown to be grossly  inaccurate, missing, altered, and in some cases failed to even measure for major radiation hazards. This has been confirmed by GAO, DOE and numerous studies and hearings. Congress sought to address this problem in EEOICPA.

Claimants in the "Special Exposure Cohort" under EEOICPA gain an unrebuttable presumption of causation for 22 "radio-sensitive" cancers for specified job categories and time periods.   By statute, workers at 4 locations are in the Special Exposure Cohort (Portsmouth, Paducah, Oak Ridge K-25 and Amchitka Island Test Site), and other classes of workers may petition the Secretary of HHS for inclusion in a Special Exposure Cohort, subject to the conditions in this rulemaking.

The statutory criteria for expanding Special Exposure Cohorts are:

1) It is not feasible to estimate with sufficient accuracy the radiation dose that the class received.

2) There is a reasonable likelihood that such radiation dose may have endangered the health of the members of the class.

Issue #1:
NIOSH proposes that in defining a class:

"if applicable, the identification of a set of one or more types of cancers to which NIOSH's finding that it was not feasible to estimate dose with sufficient accuracy" (Section 83.13)

Critique:
The effect of this language will authorize NIOSH to reduce the number of cancers covered in the SECs from 22 to a number (as few as one) set forth by NIOSH.  Congress did not authorize NIOSH to make any judgment on limiting the list of cancers. This is clearly outside of Congressional intent.  Nothing in history suggested Congress ever intended to reduce the list of covered cancers.

NIOSH is creating "disease cohorts" not exposure cohorts. The law called for exposure cohorts.

NIOSH defends this approach to limiting cancers by saying biokinetic models can predict which organs would get a "significant dose," but NIOSH fails to consider that some probability exists for cancer under the scientifically accepted linear no threshold theory (e.g., that there is no dose beneath which a cancer cannot be caused).   It is incredible and preposterous that NIOSH could say that they know which organs are affected in a situation where they have already admitted they cannot even come up with a worst case dose.

Workers at the 4 facilities in the Special Cohorts set forth by Congress are compensated for all 22 cancers. NIOSH proposes that other groups of workers in Special Cohorts could be included with as few as 1 type of cancer. This creates a gross inequity where workers will ask why do some SECs compensate more cancers than others? This policy is not only inequitable, it appears to lack a legal foundation.

Issue #2:
NIOSH's proposed rule establishes a test for whether it is "feasible" to estimate a dose. The rule says that it is "feasible" to estimate radiation dose (hence people will not be allowed into the Special Cohort) if NIOSH has access to sufficient information to estimate the maximum radiation dose that could have been incurred in plausible circumstances by any member of the class. (e.g., NIOSH has enough data to "cap the dose.")  NIOSH asserts that data from personal dosimetry or area monitoring are not essential to "capping the dose," if there is information on the types and quantities of radioisotopes to which workers were potentially exposed.

Critique:
Health physics experts do not agree that a maximum dose estimate always can be calculated with as little as the type/quantity of radionuclide.  The rule fails to lay out what methods it will use to "cap the dose".  There are no checklists or objective criteria that would set forth a bright line test on whether sufficient information is available to come up with a maximum potential dose.  Working conditions vary widely from plant to plant.  For example, would NIOSH use worst case conditions in a similar type of facility?  And if the answer is yes, would NIOSH then send this dose estimate to DOL for determination of a claim? If not, what are the implications of saying a "worst case" dose can be estimated, but not using it for a claim and simultaneously excluding someone from a special cohort?

Issue #3:
NIOSH states that a dose estimate is "sufficiently accurate" if it is "reasonably certain" to be at least as high as the highest dose that could plausibly have been received.

Critique:
How will someone be able to evaluate whether NIOSH is "reasonably certain?" What test will be applied or methods will be used to determine whether they are reasonably certain? What checklist of items will be followed?

Issue #4:
NIOSH has proposed a 30 day comment period.

Critique:
There needs to be a 60 day comment period. There also needs to be at least one public hearing for the public to learn about the rule and express their views.

Issue #5:
NIOSH's rule fails to provide for an administrative appeal for petitions that are submitted and not evaluated due to a NIOSH staff determination that there is insufficient information provided to the agency. An appeals process needs to be established for this circumstance.