Statement of
Denise Brock and Patricia Ehlman
Advisory Board
on Radiation and Worker Health
NIOSH Petition
Review SEC-0012 (Mallinckrodt Downtown Site (MCW))
February 8,
2005
I thank the Advisory Board for meeting in St. Louis and affording us time on your busy agenda. We also thank Dr. John Howard, Lew Wade and the OCAS staff, Senator Kit Bond, and the members of the Missouri Congressional delegation who have been so helpful in this SEC process. Welcome to the many claimants and members of the public who are here today.
For those who are not familiar, my father was a MCW employee from 1945-58 and died at age 52. My mother received benefits as a survivor under this program.
The co-petitioner, Patricia Ehlman, is also a survivor and has received benefits under this program. UAW was advised that, as a successor union, they did not qualify as a petitioner and withdrew.
We are not here beseeching you for compensation for ourselves, but are here on behalf of those workers and survivors who need an advocate, and cannot fathom the complexity of this program. However, we are simple working people, without degrees, cannot be called “Doctor” when addressed by others in this formal forum. We do not have science advisors, consultants, or technical qualifications, but we do know how to read documents, file Freedom of Information Act requests, and interview workers. Our case today would be immeasurably strengthened, if we had resources for technical advisors. We would urge NIOSH to consider small technical assistance grants to universities or non profits which could help petitioners to level the playing field.
As many of you know, Mallinckrodt downtown facility was not designed for manufacturing and processing uranium. One uranium facility was a sash and door plant, the other was a chemical processing plant. None were expected to operate for more than a few months. It ran from 42-57 instead.
This was a highly secretive operation, according to a memo by a Mallinckrodt health and safety director. He wrote:
“In 1949 the Mallinckrodt operations were still highly classified, before 1947 only a few technical and management employees knew officially the identity of the materials being processed.”
The Uranium Division processed African pitchblende ore, which had 65% uranium, and with it came high levels of radium, and U 235 and U 238 decay chain progeny, including thorium 230, actinium 227, and protactinium 231. This plant, as Jim Neton and others have described, was a sloppy operation.
A 1950 memo by Merrill Eisnbud, the Director of the AEC's Health and Safety Laboratory regarding Mallinckrodt employees during the period July 1942 to October 1949 stated:
“Early in 1947, the NYOO evaluated the potential hazards in these plants and, after finding them to be considerable, recommend the necessary corrective actions”
Eisenbud continued:
“It was recognized that pending the elimination of excessive exposures, here was a unique opportunity to conduct clinical studies on a fairly large size population whose radiation exposure for several years had been considerably in excess of any group for which data are available.”
The AEC allowed this operation to continue with unacceptably high levels, and it seems as though the Atomic Energy Commission saw the high levels of workforce exposure as an opportunity for a human experiment, rather than a moral outrage.
AEC and Mallinckrodt management both saw this as a liability of significant concern. “A memo of January 31, 1951 from Eisenbud to WE Kelley states:
“About a year ago you asked if it would be possible for us estimate our potential liability among the long term Mallinckrodt employees.” As I explained at that time, you presented a rather knotty problem, one which, in the present state of knowledge, would probably not be answered to a first approximation.”
Merrill Eisenbud’s memo reveals that 17 workers had dose rates of 1000 rem to the lung. Eisenbud reported that body parts from Mallinckrodt workers were exploited a resource for study, including two cadavers and a worker’s knee. Bone and cartilage was analyzed for uranium uptakes.
Mallinckrodt’s safety manager, Mont Mason, revealed some of the liability concerns that confronted his management in a 10/3/72 memo to Dr. Thomas Mancuso.
A dust evaluation was done in 1949 by Mallinckrodt, and which resulted in the removal of 34 employees from further exposure. Mason noted that this was “a potentially explosive issue” in light of growing employee awareness of the presence of radioactive materials. He wrote:
“Carefully drafted explanations and responses were prepared in advance of announcing the transfer of people. Managers, supervisors, medical staff and health department staff were all coached in coordinated.”
Mont Mason reported that there was a significant liability concern which affected how Mallinckrodt recorded its data on dust studies: Mason’s memo states:
“As part of the caution and upon advice of attorney, a
formal report was never prepared on this [1949 dust] study. Thus, there was no document to subpoena,
only lists of names with numbers, and work sheets. There was no lengthy description of the basis for calculations to
be pulled apart by the scientific community, with the possibility that such
controversy would undermine employee confidence in the company safety measure.”
In this liability averse environment, the company’s own Health and Safety Director casts serious doubt on the reliability of Mallinckrodt’s dust study. This undermines the very basis for the use of MCW records in dose reconstruction.
Today, we are responding to NIOSH slicing and dicing our SEC petition into three parts. One class for 1942-1945, one class for 1946-1948, and a third class from 1949-1957. It’s division is questionable and the politics are unworkable. This SEC package looks like a compromise between those who believe there is no dose that cannot be reconstructed (as we hear too often from NIOSH), and those who recognize the limited amount and questionable validity of the data, the inexcusable circumstances under which workers labored, and have read carefully Congressional intent.
By breaking up the petition into subclasses as proposed by NIOSH, there are inequities created. For example, workers first employed during an SEC (with fewer than 250 days) and then their employment rolls over into the period when NIOSH says it can reconstruct dose, how do you estimate the dose rates for a claimant in the SEC period? We already know that a maximum plausible dose cannot be reconstructed, so how does NIOSH make this calculation? Splitting workers between cohorts and non-cohorts as proposed here is unworkable.
There are equity questions as well. For a worker first employed in mid 1948, for example, for 180 days, and then keeps working for another 5 years won’t be in the SEC, but someone employed 250 days and another 5 years with the same work history and job exposure will meet the SEC criteria.
As you can see, breaking up this SEC petition into subclasses creates brand new problems. I welcome NIOSH back to St. Louis to explain to a roomful of claimants who is in and who is out of the SEC once its subparts get Congressional review. I hope they can explain how they will reconstruct dose for time periods when workers were employed in SEC time frames.
What follows is our best effort to work with the SEC Rule and its implementing procedures,
1942-1945
With respect to Petition Number 00012-1 covering 1942-1945, NIOSH recommends approval of SEC:
We agree with the NIOSH Report that it is infeasible to estimate dose for 1942-1945.
NIOSH states on pp 15 of its report: “Workers were not individually monitored for external dose prior to December 1945, except for a limited pilot program, starting in June 1945. NIOSH has not obtained any monitoring results from the pilot program.”
We are puzzled how NIOSH will be able to reconstruct external dose without personal dosimetry badges in the period from 1942-1945, although NIOSH’s SEC report suggests that it can somehow come up with a “maximum dose.” We don’t know if the term “maximum dose” in this SEC Report is the same as the term as “maximum plausible dose” in the dose reconstruction rule, since the NIOSH SEC Report does not use precisely the same language that is applied in the dose reconstruction rule for maximizing dose. Moreover, it is unclear if the “maximum dose” that NIOSH asserts can be estimated will, in fact, ever be used for actually compensating non-SEC cases, such as skin cancer. If NIOSH is unprepared to use the “maximum dose” for compensating workers in the absence of adequate dose information, what is the value in being able to say that you can estimate a “maximum dose”? I have been at several meetings of this Board where we get different answers to this question. We hope the Board will probe this issue to get clarity.
With respect to the heath endangerment section, first, let us recall a few facts about this site.
Workers were exposed to alpha dust concentrations between 1943-1947 at 50-100 times Maximum Allowable Concentration also called MAC, and some short term concentrations of 1000 times MAC. This morning, we heard from SCA that these numbers could be even higher.
The class definition is based on the finding of health endangerment tied to a recommended 250 days of employment.
Given that:
1) some workers inhaled uranium dust in level of 1000 MAC (or higher during events, such as the common explosions during the magnesium reduction process),
2) Eisenbud documented lung doses of 1000 rem, and
3) we know large number of workers received radiation dose in excess of the maximum permissible body burden,
it is reasonable for NIOSH to look at a shorter time frame than 250 days, because workers were exposed during discrete exceptionally high exposure events where there was a complete loss of containment or controls.
NIOSH regulations permit shorter durations than 250 days, if there are discrete events with exceptionally high levels of exposure. We would recommend 60-125 days, and ask the Board to consider this.
As a minor technical matter, NIOSH doesn’t allow for days worked in another SEC to be aggregated as part of this class to meet the minimum employment duration. This is at odds with NIOSH OCAS Procedure PR–004, Section 4.12.4.1.1, which requires that time worked can be aggregated into multiple special cohorts. (We do note that NIOSH did comply with this requirement in the SEC Petition 12-02 for the 1946-1948 time period)
1946-1948
We agree with NIOSH that internal radiation dose cannot be estimated with sufficient accuracy for the period 1946-1948.
We note that there is no breath radon monitoring 1946 to 1947, and scant data in 1948.
There is no internal dose data for 1946 and 1947, and internal monitoring did commence in 1948. Only half the claimants report internal dose measurements, and SCA’s review raises questions about the viability of back extrapolation in this case.
There is no isotope specific monitoring for key radionuclides which were present in the raffinates and pack a big punch, including Ac-227, Pa-231 and Th-230. Absent this monitoring data, we are dubious that a credible dose can be reconstructed.
We attended a workshop held by SC&A in 2004 with site experts, which revealed that many workers had received severe acid burns from nitric acid and HF. Some severe chemical burns required hospital treatment, and many sought assistance from dispensary. In one case, an HF release resulted in damage to employees’ cars, and a massive repainting campaign was undertaken, even to Mr. Mallinckrodt’s personal car.
We arranged for this workshop with SCA to be taped (over the objections, we are told, by NIOSH), and I would be pleased to make this tape available to the Board or NIOSH, because you will see from this session that open wounds were prevalent enough at the Downtown plant to be investigated as a common pathway for radiation uptakes. I have interviewed numerous workers who have described excruciatingly painful acid burns from HF. This is not an isolated problem, the failure to address this should be addressed in the SEC Report, and I hope the Board will consider this factor.
On the issue of extrapolation, the 1950 Eisenbud study of cumulative exposures from 1942-1949 indicated that exposures prior to when dust data first became available “may have been moderately more severe” than in the later time periods. We are unclear how one can credibly quantify the term “moderately more severe” in a back extrapolation. It defies common sense. We are also concerned that back extrapolation will not yield reliable internal dose estimates for the 1946-1947 time periods, because of spotty data on job changes, according to a memo reviewing the Mallinckrodt records issued by Al Becker, and knowing job changes after initial employment is so important to using surrogate data.
Finally, as NIOSH notes, and Mont Mason’s memo indicates, there is substantial reason to question the validity of the Mallinckrodt 1949 dust study data due the company’s deep concerns about liability. On Monday, Senator Bond underscored this point very effectively and I will not restate his arguments. This is such an important consideration, and one which takes this SEC decision well over the top.
However, in our view, a conclusion on the reconstructability of dose can be made even without making a finding on the dubious credibility of the Mallinckrodt data.
For these reasons, we concur with the NIOSH finding that it is not feasible to estimate dose with sufficient accuracy.
With respect to the definition of the class, the SEC for 42-45 time period and the SEC for 46-48 time period, at a minimum, should be combined into a single cohort, if the Board concurs with NIOSH’s evaluation reports. This will simplify the process of determining covered time periods, and simplify claimant understanding. Due to the discrete high exposure events, and for the same reasons as stated above, we believe the time period should be less than 250 days, instead 60-125 days would be appropriate.
1949-1957
We respectfully disagree with the NIOSH conclusion that it is feasible to estimate dose with sufficient accuracy in the 1949-1957 time period.
First, the credibility of the data needs to be assessed for the post-1948 time period. NIOSH’s position is that HASL did its own monitoring, and this means that there is verification on the Mallinckrodt data that was not in place prior to 1949. We are unpersuaded that the post 1948 data is necessarily more credible than Mallinckrodt’s. SCA’s audit report notes that there were dramatically different results from monitoring by MCW and HASL of the same exposures. The HASL data is higher than MCWs in 15 cases and lower than MCWs in 12 cases, according to a chart in the SCA audit report. So we cannot answer the question of who has reliable data, or whether it is possible that neither Mallinckrodt nor HASL are reliable to reconstruct dose. This does not change the fact that there is evidence to doubt the credibility of MCW’s data due their liability concerns.
Second, there is no isotope specific monitoring for raffinates. There was frequent exposure in Plant 6 to raffinates whose pathways for uptake are not well understood. The raffinates were dewatered in a Sperry Press and contained Ac-227, Pa-231, Thorium 230, plus radium. The raffinates apparently were acidic and were neutralized with lime, and a cake was created. This mixture likely created an exothermic reaction, and the temperature of the raffinates is unknown. However, possible inhalation pathways could include aerosolized vapors, mists, liquids oozing from the filterpress, and dusts from loading caked materials off the filter press cloth into drums. Skin dose is also likely. Durations of raffinate exposure are not well quantified, although NIOSH seems to think these were of relatively short duration. There is no isotope specific urinalysis to quantify any raffinate uptakes, and the burden of proof on NIOSH is very high to establish internal dose, and it is circumstances like this that are why Congress created the SEC.
Congress reemphasized this point in the FY 2005 Omnibus Appropriations Report: when it urged NIOSH to grant SECs when individual monitoring was not performed.
Dose consequences from exposure to raffinates are significant. Routine inhalation of even milligram quantities of Sperry cake (1 milligram per month over a few years) has the potential for significant internal radiation doses, notably to the bone surfaces and lungs. Thorium 227, the main decay product of Ac-227 is a potential concern for the lung dose as well. Dose from the radionuclides has not been evaluated in any documents we have seen, and NIOSH has nothing in its Rev.0 TBD to help answer this question, according to Section 5.2.6 of the SCA site profile review.
As noted above neither the TBD nor the SEC Evaluation Report address internal and external radiation dose from open wound and burns, which, workers have testified, were prevalent. Thus, this is not a trivial or nitpicking issue.
NIOSH concludes that there is sufficient information from various monitoring activities –coupled with information on radiological sources and processes to estimate dose. They support this conclusion in the SEC Report (page 32) by stating:
“Since the release of Rev. 0 of the site TBD, new information and data have been retrieved, that provides additional site information to support dose reconstruction. The TBD is under revision to include this information. This evaluation report is the result of the formal review of the Mallinckrodt Destrehan Street Site.”
This revised TBD is not available to the petitioners, nor has it been issued. How can NIOSH issue its SEC Report without having a revised TBD? We understand it is still under review in NIOSH.
We learned just today that this revised TBD has not been presented to the Board or reviewed its audit contractor. We also learned today that the revised TBD, when presented, won’t even address all of the issues.
Is there a rush to judgment to deny the 1949-1957 time period in this SEC petition?
Does NIOSH think it can sell this decision when the factual basis for its conclusions remain undisclosed? This program was created to overcome the secrecy and mistrust created by the government’s conduct during the Cold War era.
We can’t respond to something we haven’t seen. I hope you won’t be offended, but this feels a bit like a “gotcha.”
In conclusion--
We urge the Board to consider the following actions:
1) approve the cohort from 1942-1957, based on the inability of NIOSH to reconstruct dose with sufficient accuracy. We concur with the views of Senator Bond.
2) In the alternative, we would urge the board to approve 1942-1948 as a single cohort with a 60-125 day time frame for determining health endangerment today;
and
3) evaluate the merits of an SEC in the 1949-57 time frame including the apparent justifications contained in the Revised TBD. If this is the path you choose, we would respectfully ask that the Board and its audit contractor undertake a review to determine whether this SEC Report for the 1949-1957 time period is technically sound. After this has been concluded, the Board can then deliberate on the weight of evidence issues that NIOSH wants the Board to evaluate.
We have great confidence in the work of SC&A, and we would like the Board to bring their technical skills to bear on this 1949-1957 time period.
Thank you for listening.