ftrnald ~tu.JTmin: irades & lahar {ounriI

AFL . CIO Metal Trades Affiliated

~ P.O. Box 126, Ross, Ohio 45051

Comments of the Fernald Atomic Trades & Labor Council (FAT &LC)

reg:arding: the HHS Notice ofProoosed RulemakinQ:

for Desig:natinQ: Classes of Emolovees as Members of the Soecial Exoosure

Cohort under the EnerQ:V Emolovees Occuoational Illness Comoensation

Proe:ram Act of2000 (42 CFR Part 83)

Federal Reg:ister Vol. 68. No. 45.00.11294-11310 (March 7.2003)

Outlined below are FAT &LC' s comments on the March 7, 2003 NIOSH Notice of

Proposed Rulemaking Procedure for Designating Classes of Employees as Members of the

Special Exposure Cohort under EEOICPA., 68 FR 11294-11310, March 7, 2003 (hereinafter

NPRM #2). FAT&LC also filed comments on the previous m-IS Notice of Proposed Rul~making

related to Special Exposure Cohorts, 67 FR 42962-42973, (published on June 25, 2002).

FAT&LC represents approximately 575 hourly employees of the prime contractor and

certain subcontractors at the Department of Energy's Fernald, OH site. FAT&LC has represented

production, maintenance, environmental restoration and support service workers at the Fernald

site since 1952. Fernald produced uranium metal, processed thorium and uranium compounds,

and conducted uranium rolling and machining operations for the ABC and DOE. Recycled

uranium was used at Fernald which was contaminated with transuranics. FAT&LC believe this

dose will be impossible to estimate and thus many workers may be candidates for a Special Exposure Cohort. .,.

FAT&LC has 13 affiliated unions from industrial and craft based unions, including the

International Chemical Workers Union Council, International Association of Machinists,

Operating Engineers, Carpenters, Masons, Painters, International Brotherhood of Electrical

Workers, Ironworkers, Pipefitters, Oilers, Sheetmetal Workers, Teamsters and Service Employees (SEIU). .: .

Questions on these comments should be directed to Gene Branham or Robert Tabor, 513-648-

5079.

Section 83.S-Definitions

There are three (3) sets of comments on the "definitions" section of the rule:

1) Class of Employees--In §83.5(c), the proposed rule defines a "class of employees" as "a

group of employees who work or worked at the same DOE or AWE m~ and for whom the

availability of information and recorded data is comparable with respect to the informational
Comments ofFAT&LC on BBS Special Cohort Rule Page 2 of 12

May 5, 2003

needs of dose reconstructions conducted under 42 CFR Part 82." (Emphasis added)

(a) the definition of "class of emPloyees" should be modified so that employees who

work or worked at one or more DOE and/or AWE facility may be included in a "class of

employees" if they are similarly situated with respect employment (time and place) and

insufficient radiation monitoring. Radiation technicians, "bum and turn" workers, and

construction workers are groups that could conceivably fall into a class of employees

who were employed in multiple facilities. NIOSH has an unquestionable legal right to

interpret the term "facility" to allow more than one facility in defining a class of

employees, pursuant to §3626. Section 3626 states, in part:

"...the members of a class of employees at a Department of Energy facility, or at

an atomic weapons employer _facility. may be treated as members of the Special

Exposure Cohort for purposes of the compensation program... " (emphasis add~d)

Whenever the interpretation of a legislative enactment becomes an issue in a case, the

courts will commonly resort to the Rules oj Statutory Construction to determine the proper

application of the statutory language to the facts at hand.

In reviewing the question of whether the singular includes the plural, five different texts

dealing with the rules of statutory construction all make the same point: the singular includes the

plural (and none were found that contradict this principle). For example:

"The singular includes the plural, and the plural, the singular.

Thus, unless the result of such an interpretation were to defeat clear legislative intent, the

rules of statutory construction allow the singular to include the plural. In this case, legislative

intent is enhanced, not defeated, by construing the term "facility" to include "facilities," because

the object of the Special Exposure Cohorts is to define a class of employees where radiation

doses cannot be estimated, and this may include groups of workers employed in similar jobs at

multiple facilities with similar limitations on the quantity or quality of radiation exposure

information.

DOL allows the use of multiple facilities for members .of the SECs in its EEOICP A

regulations at 20 ~ 30.214. DOL's rules allow members of the class to accumulate of days of

employment at multiple gaseous diffiJsion plants in up to 3 different states to meet the 250

workday threshold for members of that Special Exposure Cohort. There is no logical reason for

NIOSH to impose a cramped reading of the law.

Recommendation: The NIOSH rule at §83.5(c) should be amended to allow for

employment in either "one or more DOE and/or AWE facilities" to be used in defining both a

"class", and in accumulating days of potential radiation exposure to meet the 250 day

employment threshold under §83.13).

(b) a "class" is also defined in the proposed rule by the requirement that "availability of
Comments ofFAT&LC on BBS Special Cohort Rule Page 3 of 12

May 5, 2003

information and recorded data is comparable with respect to the informational needs of dose

reconstructions conducted under 42 CFR PaT! 82." It unclear why the rule imposes a requirement

for specific "information and recorded data" be "available" for purposes of ' 'class definition"

when the point of a Special Exposure Cohort is that the information and recorded data needed for

a dose reconstruction is not available. This section must be redrafted to establish that the class is

defined by what information is NOT available.

2) Section 83.5 should define "facility" as a term.

Employees from two categories of facilities covered under EEOICP A can file petitions:

an Atomic Weapons Employer Facilities (as defined in EEOICPA §3621(5» and a Department

of Energy facility (as defined in EEOICPA §3621(12».

The definition of , 'facility" in this rule should include all buildings. structures. premises.

production processes, and the grounds upon which such buildings, structures, premises and

production processes are or were located at an Atomic Weapons Employer facility or a

Department of Energy facility.

The reason for making the definition offacility as broad and inclusive as possible is that

it will reduce the number of classes to be established for a given group of workers. It makes

more sense to group classes based on exposure histories within a DOE site or an AWE site"

Common exposure histories can crossover from process-to-process, building-to-buildi"ng and site-to-site. The law doesn't call for "facility cohorts, " rather it calls for exposure cohorts. A

narrowly defined facility (e.g., a production line) would frustrate the establishment of exposure

cohorts, or result in the unnecessary proliferation of exposure cohorts. Instead, the classes should

be defined by whether there was insufficient data to estimate doses for employees who meet the

employment duration threshold.

Section 83. '-Who can submit a petition on behalf of a class of employees?

NIOSH has developed a well considered approach to who can file a petition, and assures

that petitioners are adequately authorized. One commentor on this rule suggested that only the

union representing employees at a site would have the right to file a petition. At Fernald that

could mean that there would have to be 13 different petitions, one for each of the on-site

production and maintenance unions in the Fernald Atomic Trades & Labor Council. In addition,

the 14 unions that make up the Grealer Cincinnati Building an4,Construction Trades Council

might have to file another 14 petitions for their members. We could forsee 27 petitions for a

single time period at Fernald. The proposal made by a consultant who prepared PACE's

comments to limit the petitioners to the "exclusive representative" is simply unworkable.

The proposed rule at §83.7 has come up with the right formula for assuring that unions

can file petitions, and that petitions by others are adequately authorized. NIOSH should not

tamper with this sect.ion in this rulemaking.

Section 83.9-What information must a Detition include?

Section 83.9(c)(iv) only authorizes report(s) published by a "scientific" government

agency to meet the infonnational requirements regarding deficient infonnation in this subsection
Comments of FA T&LC on HDS Special Cohol1 Rule Page 4 of 12

May S, 2003

(emphasis added). The word "scientific" should be deleted in §83. 9( c )(iv), in order to allow

government agency reports from any agency .or branch. For example, the U.S. General

Accounting Office (GAO) is not a "scientific~ agency, but it has done extensive auditing on the

inadequacy of DOE dosimetry practices and provided this information to Congress. Likewise,

Congress has published reports (such as Committee reports and hearing records) which describe

inadequate radiation monitoring and/or destruction or dose records~ Although these are not

"scientific" agencies, their reports are credible and should not be rejected when evaluating an

SEC petition. In fact "scientific"agencies, such as the Department of Energy (and its

predecessors), have issued reports declaring their contractor's radiation measurement programs

credible, only to be contradicted by subsequent reviews by non-scientific agencies or declassified

documents. Recommendation: the word "scientific" should be removed as a limitation on the

source of government agency assessmentshat can be used by petitioners; rather, any authentic

government report should be allowable as a source of information.

Section 83.9(c)(iv) also contains a limitation that government agencies reports or peer

review articles of deficient radiation dosimetry programs must "also find that such information

might be essential to produce such estimates." It is over-burdensome for a petitioner to produce

an article which finds that both radiation dosimetry is unavailable In.4 also make a finding that

such information might be essential to produce such estimates. Although such conclusions would

be helpful, NIOSH has reduced the universe of information commonly available to petitioners,

such as the DOE Tiger Team Reports, Occurrence Reports, Inspector General Reports, or

Oversight and Investigation Team Reports. These reports typically identify deficiencies in

radiation dosimetry, but may not make a formal finding that "such information might be essential

to produce such [dose] estimates;" indeed, that kind of conclusion depends upon NIOSH using

its professional judgement in consultation with the Advisory Board. We urge the deletion of the

requirement in §83.9(c)(iv) that the report must explicitly "find that such information might be essential to produce such estimates." ...

FAT&LC supports the reduced information requirements for submitting a SEC petition in

this rule, compared with what had been proposed

Section 83.II-What haooens to oetitions that do not satisfy all relevant reauirements under

§§ 83.7 throu2h 83.9?

The rule should provide an ind.ependent administrative appeals process within IrnS for

petitioners after NIOSH makes a determination under §83.11 (b) that the petition has failed to

meet the requirements for evaluation. Absent an administrative review process, claimants will

have no choice but to seek judicial review in federal court after NIOSH renders a final agency

action. While we expect NIOSH will act in good faith, people are occasionally fallible. An

independent review within HHS is a way to help conserve judicial resources and reduce the

agency's burden on its legal department. The rule should specify with whom the request for an

appeal must be filed, the address, the procedural requirements, and the regulations that will

govern these appeals proceedings.
Comments of FAT &LC on HHS Special Cohort Rule Page 5 of 12

May 5, 2003

Section 83.13-How will NIOSH evaluate netitions. other than netitions for claimants

covered under &83.14? ,

1) Definition and Application of the "Sf}fficient Accuracy" Test--

Section 83. 13(b)(1)(i) states that NIOSH will determine that "radiation doses can be

estimated with sufficient accuracy ifNIOSH has established that it has access to sufficient

information to estimate the maximum radiation dose that could have been incurred in ~Iausible

circumstances by any member of the class" (called a "worst case" or "capping the dose").

First, the rule should define what the term "plausible circumstances" means. And what it

doesn't mean. Simply saying that this term will be applied on a case-by-case basis is not

adequate. Substituting one vague term ("sufficient accuracy") in the statute with another vague

term ("plausible circumstances") in the rule, does not meet the minimal requirements of a rule

giving effect to a statute and offers no clear basis for assuring NIOSH will achieve con~istency

from case-to-case.

Second, the rule should define what "sufficient infonnation" means. (a) What is the

minimum amount and type of information needed to "cap the dose." (b) Is there a checklist or

some other methods that can provide a basis for qualitative judgment that there is not "sufficient

data" "cap the dose"? For example, if workers moved between multiple process buildings, such as

maintenance workers or security guards, and there is no valid personal monitoring data, how will

NIOSH know whether or not it can cap the dose for this class of workers? (c) What methods will

be allowed or disallowed in determining whether NIOSH fairly "capped the dose," (d) What test

will be applied to determine whether NIOSH improperly underestimated maximum potential

dose? Simply saying that NIOSH will decide these questions on a case-by-case basis is not

adequate, and offers no clear basis for assuring that NIOSH will achieve consistency from caseto-case.

Third, we are concerned that claimants could fall into a regulatory void between NIOSH's

proposed Special Exposure Cohort rule and NIOSH's existing dose reconstruction rule (42 CFR

82). Under the proposed rule, SEC petitions would be dismissed if there is enough data for "to

estimate maximum potential dose." However, these claims could also be dismissed under the

dose reconstruction rule because "worst case" estimates are only allowable at 42 CFR 82.10(k) as

part of an "efficiency" mechanism if the dose falls ~ the 50 percent probability of causation.

What is not clear is what happens to ~aimants where the worst ~se estimates exceed 50 percent probability of causation? Do they fall into a void? :

According to the record ora discussion between NIaSH"s Ted Katz and Advisory Board

Member Mark Griffon at the March 7, 2003 Advisory Board meeting, maximum dose estimates

would be used in determining claims under 42 CFR Part 82:

Mr. Griffon: And just to clarify that ifyou can calculate a maximum dose, then those

maximum doses will be used in their detennination ofMr. Katz: Yes.

Mr. Griffon: --probability of causation?
Comments ofFAT&LC on BBS Special Cohort Rule

May 5, 2003

Page 6 of 12

Mr. Katz: Then they {the claimant} w9uld have dose reconstructions based on those

maximum doses versus something mor~ accurate and lower. (See: transcript, pp. 45-46)

The policy to use "worst case" estimates

causation (CCP of C") is > 50010, has not been spel

reconstruction rule. Rather than providing clear

rule at 67 FR 22325 suggests that using a worst

ofNIOSH to complete dose reconstruction depe to substitute for monitoring data. t,It states:

"Simplifying assumptions (e.g., worst case) become more difficzllt to apply, however,

when "the potential level of radiation for individual ranges greatly, particularly when

they range from low levels to potentially compensable levels... In these

circumstances, the ability of N/OSH to complete dose reconstruction depends on

extent and quality of information available to substitute for monitoring data.. "

As noted above, the Preamble is equivocal, at best, and there is no other explicit support in

42 CFR 82 for the argument that worst case estimate could be used when P ofC >50%...

IfNIOSH wants to introduce the use of ' 'worst case" dose estimates to limit who can be

placed in new Special Exposure Cohorts, it should do so in an even-handed way. Indeed, it would

be contradictory (and unfair) for NIOSH to take the position that claimants cannot be

compensated ifdata only permits a worst-case dose estimate which ends up ~ the 50 percent

probability of causation threshold.

NIOSH should-coincident with the current SEC rulemakin2-amend its dose

reconstruction rule to nrovide absolute claritY that worst case estimates will be used to

"comulete" a dose reconstruction (if it wants to retain the "worst case" threshold for

determinin2 an SEC).

Fourth, NIOSH must spell out how it will use a "maximum potential dose" in a

compensation case. The Health Physics Society, in their comments on the SEC Rule, recommends

that "[a] "maximum realistic" dose e~timate should be estimated,and used as a point estimate of

dose for the remainder of the probability of causation determination." (HPS Comments, pp. 10,

Section B3). Assuming that the "maximum realistic dose" is the same as the "maximum

potential" dose or "worst case" estimate, will NIOSH include this maximum potential dose as a

point estimate? Or is NlOSH going to use a "worst case" estimate as part of a dose distribution

where the maximum is at the upper tail end or a distribution where it will receive lesser weight in

a P orc determination. (A" triangular mode distribution was compared with a single point estimate

to confirm this conclusion using NlOSH-IREP). Clearly, using the worst case as a point estimate

would generate a more claimant friendly outcome than including it in the tail of a distribution.

At the March 7 Advisory Board meeting, NIOSH's health physics director (Jim Neton)

indicated that the maximum potential dose would DQ.t be used as a point estimate, rather it would

be used as Dart of a distribution:

, when data is limited and the probability of

led out in clear language within the dose

authority, the Preamble to the dose reconstruction

case estimate will be "difficult" and "the ability

nds on extent and quality of information available
Comments ofFAT&LC on HHS Special Cohort Rule

May 5, 2003

Page 7 of 12

Dr. Neton: I'd like to maybe clarify w~at Ted said. Not necessarily the maximum

dose, if we could develop some sort of~istribution. but the maximum credible dose

would be used in the analysis. It would not always be the maximum dose.

Mr. Katz: But it could be.

Dr. Neton: It could be, sure.

Mr Katz: Yes, which isDr. Neton: But if one generated distribution, a theoretical distribution of doses, that

would be the sampling that would be done to that dose reconstruction.

(See: March 7, 2003 Transcript, pp.46)

We agree with using the "worst case" as a point estimate (e.g.,!REP provide for a

"constant value"). maSH needs to justify why it would not use the maximum potential dose as a

point estimate and make its methodology clear in the rule.

Fifth, NPRM #1 set the threshold for "sufficient accuracy" at the level at which a dose

could be "completed." When "completing" a dose estimate, NIOSH is making a "reasonable

estimate of dose received." In NPRM #1, when a reasonable estimate cannot be developed,

NIOSH concludes it cannot estimate dose with "sufficient accuracy."

In NPRM#2, NIaSH appears to have raised the bar for evaluating whether doses can be

estimated with "sufficient accuracy" to only those cases (or classes) for whom NIOSH cannot

"cap the dose." NIOSH haS not explained why it chose to raise the bar on eligibility for SECs.

If statements by senior NIOSH personnel can be credited that they can "cap AnI dose,"

NIOSH's decision to raise the bar may have intentionally precluded virtually anyone ftom ever

qualifying for the SEC. Is this the intent ofNIOSH? If not, what NIOSH should do is provide

some examples in the Preamble of the kinds of cases where it believe it will not be able to

estimate dose with sufficient accuracy under the new thresholds set forth in NPRM #2. If there are

no conceivable cases, NIOSH should .state this as well, so that claimants will understand the futility of petitioning for a Special Exposure Cohort. :

2) Limiting the List of22 Specified Cancers-In §83.12(b)(I)(iv), NIOSH says that when it

finds it is not feasible to estimate dose with sufficient accuracy, NIOSH will then "determine"

whether such finding "is limited to radiation doses incurred at certain tissue-specific cancer sites."

Likewise, in §83.13(b)(2)(iii), NIOSH proposes to identify tissue specific cancers for which it

was not feasible to estimate dose with sufficient accuracy. Further, in §83.13(c)(4), NIOSH may,

in its report to the petitioner and Board, limit specified cancers to "a set of one or more types of

cancers specified by NIOSH."

First. maSH's orooosal to limit the number of soecified cancers in a 2iven"'Suecial
Page 8 of 12

. .

Exposure Cohort directly contradicts Con2ressional intent.

NIOSH has no legal authority to redu~ or limit the 22 specified cancers designated by

EEOICP A for any members of any Special Exposure Cohort, including both those designated by

Congress or those designated by the Secretary offlliS pursuant to EEOICPA §3626.

The legislative history for EEOICPA delineates Congressional intent that a "fixed list" of

specified cancers would serve as the basis for compensation for members of a Special Exposure

Cohort, and not a variable list drawn up on a case-by-case basis at the discretion of the agency.

The Congressional Record (page 10377) for October 12, 2000 states (attached):

"There are a few groups of workers that we know, today, belong in this category~

They are specifically mentioned in the definition of Special Exposure Cohort. For

other workers to be placed in this special category, the decision that it was infeasible

to reconstructheir dose would have to be made both by the President (or his

designee) and by an independent external advisory committee of radiation, health,

and workplace safety experts. We allow groups of workers to petition to be

considered by the advisory committee for inclusion in this group. Once a group of

workers was placed in the category [i.e., the Special Exposure Cohort], it would

be eligible for compensation for a!1!£!! list of radiation-related cancers."

(Emphasis added)

NIOSH should delete the provisions authorizing it to select organ specific cancers in

§§83.13(b)(2), 83.13(b)(3) and 83.13(c)(4).

~econd.bY ~etermininf! that certain cancers are not at risk in a f!iyen SEC class~

infeasible to Quantify cancer risk when there is insufficient data to "can the dose."

NlaSH states in the Preamble to the §83.13 of the proposed rule at 68 FR 11297

...

I:ack}n~ a I.act~al basis for establishing such a cap or upper bound to the possible

By authorizing a process to determine which organs will be significantly affected (e.g"

"endangered"), NIOSH has positioned itself at odds with its clearly stated declaration (above) that

"MOSH cannot quantitatively evaluate health endangerment" for those classes of workers where

it admittedly lacks sufficient data to even come up with a maximum potential dose.

Furthermore, by authorizing risk estimation to determine which specified cancers should

be included or excluded in a class. the proposed rule positions itself at odds with the previous

recommendations of the NIaSH Advisory Board and public-which NIaSH had properly

accepted-- to remove risk quantification from the SEC rule precisely because it is impossible to

assign risk where a maximum potential dose cannot even be estimated. This double standard on

Comments ofFAT&LC on HHS Special Cohort Rule

May 5. 2003

level of radiation exposure, mOSH cannot quantitatively evaluate health

endangennent. \ . :
~

May Comments ofFAT&LC on HHS Special Cohort Rule Page 9 of 12 5, 2003 .

the use of risk estimation should be soundly rejected.

Congress resolved the question of scientific uncertainty in favor of claimants precisely

because risk cannot be quantified when exposures are not known and it is the right thing to do for

those put at risk. NIOSH should not be second guessing or otherwise undermining this sound

policy decision.

At 68 FR 11296 NIaSH takes the position that there is adequate infonnation about

"where the radioactive compounds concentrate and significantly irradiate certain organs and

tissues" that could allow NIaSH to estimate which cancers could be excluded from a class where

the dose c~ot be "capped". The proposed rule does not define the tenn "significantly," leaving

completely open to speculation what risk level is actually indicated. NIaSH concedes, properly,

that some amount of radiation that is inhaled or ingested will find its way into every organ in

some quantity (March 7, 2003 hearing transcript). Thus, every organ will incur some unquantified

risk from radiation dose, but the amount is unknown, because NIaSH concedes that in these

instances the dose cannot even be capped.

The rule doesn't explain whether NIOSH will adopt the Health Physics Society~ (HPS)

recommendations when it comes to defining threshold exposure levels where certain tissues

would be deemed "significantly" irradiated. HPS opines that 10 rem is the threshold level

beneath which no adverse health effects occur. HPS's March 2001 position paper states: "there

should be no compensation for persons whose lifetimes doses are less than approximately 0.1 Sv

(10 rem)." The scientific validity of the HPS contention that a threshold compensation model

should be adopted at the 10 rem level is completely at odds with the premises underlaying maSH

IREP. Indeed, the NIOSH-IREP model compensates certain cancers below 5 rem exposure (e.g.,

leukemia).' If the HPS recommended threshold is adopted, maSH will be presented with highly

visible inconsistencies in its application of the NIOSH-IREP model on the one hand, and risk

estimations used to include or exclude certain cancers from SECs on the other hand.

3) Is it "feasible" to estimate dose?- The proposed rule takes the position that dose

reconstruction is feasible "iffffiS 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." This standard is inconsistent with clearly expressed Congressional intent. The pertinent

discussion in the legislative history (qctober 12,2000 Congressi.onal Record, S10377) states:

"There are several reasons why reconstructing a dose might be infeasib[le]. First,

relevant records of dose may be lacking, or might not exist altogether. Second, there

might be a way to reconstruct the dose, but it would be prohibitively expensive to do

so. Finally, it might take so long to reconstruct a dose for a group of workers that

they will be all dead before we have an answer that can be used to determine their

eligibility.-

This passage evidences a much broader test of feasibility than the one proposed in the

rule. Congress consciously used the word feasible in EEOICP A §3626 because it was motivated

by a concern that the dose reconstruction process could become so complicated that the essential
Comments ofFAT&LC on HHS Special Cohort Rule Page 10 of

12

l\M~~ statute (i.e.. timely compensation) would be frustrated. The standard proposed in the

rule will result in dose reconstructions being attempted in many of the circumstances that

Congress sought to exclude when crafting the~tatute. The final rule should specify parameters

related to time and cost to serve as a means or considering the issues of excessive lengtlt of time

and prohibitive cost in dose reconstruction. This should include time limits on dose

reconstruction.

4) May have endangered the health of the members of the class--In §83.13(b)(3), the

proposed rule, NIaSH establishes endangerment by two basic tests:

a) employment information that indicated the potential for radiation exposure

b) 250 days of employment, or less in the event of discrete exposure event(s).

This basic framework is a major improvement compared with the approach used in

NPRM#l for determining "endangerment". However, added refinements are needed.

Employment information- What employment information is needed to establish

potential for radiation exposure?

Duration of employment - NIOSH sets forth duration of employment as exposure to

"discrete events" (such as criticality), or in the absence of a "discrete event", having been

employed for 250 work days within the employment parameters set forth for the class.

First, the rule itself(and not just the Preamble) should provide added flexibility"in

abbreviating the 250 days requirement when appropriate. Thus we recommend that the rule

explicitly state in §83.13(b)(3)(ii):

'WaSH will use the 250 day employment criterion only when it lacks sufficient

basis to establish a lower minimum duration."

Second, the 250 day employment requirement should allow for workers to accumulate this

time at multiple facilities, if their employment at one site totals less than 250 days, and the class

includes employment at more than one facility.

Third, the rule should allow clarify that "discrete events'"covered under §83.13(b)(3)(i)

could include short duration operations where radiation controls were largely non-existent. For

example, would a "discrete event" include AWE vendors where production operations (rolling of

uranium or thorium) from start to finish took several weeks or months, but didn't take 250 work

days, and for which maximum potential exposures were unquantifiable? The 250 day limit would

be unfair to impose in this instance, because there were not 250 days in the discrete event.

Would those fighting a plutonium fife or conducting related rescue operations count as a

"discrete event," even though the class of individuals involved in fighting the fire may not have

received the same dose as a person would have received in a criticality event, but nonetheless

received an unknowable potential uptake of high fired oxides of plutonium (which cannot be
Comments ofFAT&LC on HBS Special Cohort Rule Page 11 of

12

l\fnmAit~ through bioassay)? This potential class was discussed by Dr. Robert Bistline at the

July 1,2002 NIOSH Advisory Board meeting,in Denver (pp. 203-212). Unless the workers were

deemed to have been included in a "discrete event", they would be disqualified as a class under

the 250 day employment rule, because the employment in firefighting and cleanup operations

took less than 250 work days.

The rule should be modified. as recommended above. to provide additional flexibility in

setting forth shorter durations of employment (outside of criticality or equ,ivalent events).

Section 83.16-How will the Secretary decide the outcome ora oetition? ..

1) Timelines for Initial Secretarial Decision - The rule should stipulate that the Secretary

shall review recommended decisions from NIOSH and the Advisory Board and issue a final

written determination in not more than 21 days after receipt of such materials from NIOSH and

the Advisory Board. Inasmuch as all of the evaluations and reviews have been undertaken by

NIOSH staff, its contractors and the Advisory Board, the Secretary's review appears to be more

ofa formality, unless there is an appeal taken.

2) Type of Appeals, Hearings - The proposed rule does not indicate which Office or branch

ofInlS will hear appeals of adverse determinations by the Secretary (or his/her designee). Will

the same individuals who rendered an adverse determination on an SEC petition be the same

individuals who evaluate the appeals of their initial finding? Or will there be an independent

review within InIS? We recommend that an independent review be provided. What rules of

procedure be used? Will such appeals allow for oral presentations by petitioners? Will hearings

allow for presentations by experts in support of a petition? Will the entire administrative record

involved in the NIOSH SEC evaluation be made available to petitioners for use during the appeals

process?

3) Notification - FAT&LC applauds the addition ofa notification in the Federal Register

immediately after the Secretary makes a determination to add a class to the SEC and forwards

such recommendation to Congress for its 180 day review. ...

Other issues

1) Time lines-We believe NIOSH should establish a time frame of 180 days to complete a

dose reconstruction, after which NIOSH should establish that "it.is not feasible to estimate dose with sufficient accuracy." . . ..

NIOSH should establish a time frame for completing SEC petitions and sending them to

the Secretary within 180 days. If it cannot meet this time line, NIOSH should provide written

notice to Congressional Committees and the House and Senate Members who have petitioners in

their district or state with an estimate of when such petitions will be completed.

2) Technical Assistance--NIOSH should provide small technical assistance grants to assist

in the development of SEC petitions. Grants would be used to hire health physicists or other

qualified professionals to assist in the development of a technically sound petition. NIOSH should

also hold several training workshops to address the information requirements of a petition.
Comments ofFAT&LC on HHS Special Cohort Rule

May 5, 2003

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3) Coordination Between SEC and Dos,e Reconstruction Rule - maSH should have

proposed necessary changes to its dose reconstruction rule at 42 CFR Part 82 in conjunction with

this rulemaking proceeding, rather than dealing with the two rules in a piecemeal fashion. NIOSH

should refrain from finalizing any adverse SEC determination until it implements revisions to its

dose reconstruction rule due to need to align thresholds for eligibility in both rules.

Fernald Atomic Trades & Labor Council