Radiation Exposure Compensation Act: Evidentiary Requirements; Definitions and Number of Claims Filed

DEPARTMENT OF JUSTICE

Civil Division

28 CFR Part 79

RIN 1105-AA49

[A.G. Order No. 2084-97]

Radiation Exposure Compensation Act: Evidentiary Requirements;

Definitions and Number of Claims Filed

AGENCY: Civil Division, Department of Justice.

ACTION: Proposed rule.

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SUMMARY: The Department of Justice (``the Department'') proposes to

amend its existing regulations implementing the Radiation Exposure

Compensation Act (``RECA'' or ``Act''). The proposed rule would: Allow

claimants to submit affidavits or declarations in support of a claim

under certain circumstances; allow the use of high resolution computed

tomography reports and pathology reports of tissue biopsies as

additional means by which claimants can present evidence of a

compensable non-malignant respiratory disease; amend the definitions of

``smoker'' and ``non-smoker;'' include in situ lung cancers under the

definition of primary cancers of the lung; and allow claimants who have

filed claims prior to the implementation of these proposed regulations

and have been denied compensation to file another three times.

DATES: Written comments must be submitted on or before July 22, 1997.

ADDRESSES: Please submit written comments to Gerard W. Fischer,

Assistant Director, U.S. Department of Justice, Civil Division, P.O.

Box 146, Ben Franklin Station, Washington, D.C. 20044-0146.

FOR FURTHER INFORMATION CONTACT: Gerard W. Fischer (Assistant

Director), (202) 616-4090 and Lori Beg (Attorney), (202) 616-4377.

SUPPLEMENTARY INFORMATION: At the recommendation of the President's

Advisory Committee on Human Radiation Experiments, the Administration

empaneled the Radiation Exposure Compensation Act Committee (the

``Radiation Committee'') to re-evaluate the provisions in the Radiation

Exposure Compensation Act, 42 U.S.C. Sec. 2210 note (1994), and the

Department's implementing regulations relating to uranium miners. In

July 1996, after extensive investigation, the Radiation Committee

submitted a Final Report detailing its findings and recommendations. In

addition to recommending changes to the eligibility criteria in the

Act, the Radiation Committee recommended that the Department modify

some of the regulations governing proof of medical, smoking, and

exposure criteria. Based upon this report and the Department's own

evaluation of the regulations, this rule is proposed.

This proposed rule would expand the set of circumstances in which

claimants are allowed to submit affidavits or declarations in support

of a claim. Sworn statements are presently permitted to establish

identity of family members, prior receipt of other compensation, coffee

consumption and employment information. As modified by this rule,

claimants will now be allowed to submit sworn statements to establish

smoking and alcohol consumption histories where no other records exist.

This action is needed because relevant records are not available to

some claimants due to the passage of time. Therefore, this modification

represents only a minor expansion of an existing regulation.

The rule would also allow the use of high resolution computed

tomography (``HRCT'') reports and pathology reports of tissue biopsies

as additional means by which claimants can present evidence of a

compensable non-malignant respiratory disease. HRCT is increasingly

being used by physicians to diagnose pneumoconioses because it is often

a more sensitive diagnostic tool than standard chest x-rays. Accepting

HRCT findings will assist many claimants who cannot prove they have

developed a compensable non-malignant respiratory disease through

standard chest x-rays. Additionally, pathology reports of tissue

biopsies are considered a highly reliable basis for diagnosis of

disease by the medical community.

The rule would also allow the use of high resolution computed

tomography (``HRCT'') reports and pathology reports of tissue biopsies

as additional means by which claimants can present evidence of a

compensable non-malignant respiratory disease. HRCT is increasingly

being used by physicians to diagnose pneumoconioses because it is often

a more sensitive diagnostic tool than standard chest x-rays. Accepting

HRCT findings will assist many claimants who cannot prove they have

developed a compensable non-malignant respiratory disease through

standard chest x-rays. Additionally, pathology reports of tissue

biopsies are considered a highly reliably basis for diagnosis of

disease by the medical community.

The rule would amend the definitions of ``heavy smoker'' and

``smoker'' to exclude, and the definition of ``non-smoker'' to include,

claimants who stopped smoking for at least fifteen years prior to the

date of diagnoses of specific diseases. It is now accepted by experts

in the medical community that smoking cessation leads to a significant

reduction in relative risk of developing certain cancers. Another

proposed change would include in situ long cancers under the definition

of primary cancers of the lung, based upon expert opinion from the

National Cancer Institute.

Finally, the rule would allow claimants who have filed claims prior

to the implementation of these proposed regulations and have been

denied compensation to file another three times. This action would

allow denied claimants to take advantage of changes in the regulations

that liberalize documentation requirements. The Department anticipates

that much of the information in refiled claims will have been

previously verified. Accordingly, the internal administrative

processing costs of refiled cases will be minimal. Presently, the

regulations permit three attempts at establishing eligibility, so

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this proposal simply continues that process.

Although the practical effect of the proposed rule will likely be

to increase the number of claimants eligible for compensation, the

extent of that increase is not entirely clear. Presently, RECA has been

appropriated $30 million for FY 1997. In addition, because the proposed

rule expands the type of evidence that will be considered, it is not

anticipated that the proposed rule will generate any significant

controversy.

In accordance with 5 U.S.C. 605(b), the Attorney General has

reviewed this regulation and certifies that this rule affects only

individuals filing claims under RECA. Therefore, this rule does not

have a significant economic impact on a substantial number of small

entities. This rule, however, is a significant regulatory action under

Executive Order 12866 and, accordingly, has been reviewed by the Office

of Management and Budget. The rule is not a major rule as defined by 5

U.S.C. 804(2) nor is it a rule having federalism implications

warranting assessment in accordance with section 6 of Executive Order

12612. In addition, this rule is in full compliance with the Paperwork

Reduction Act.

List of Subjects in 28 CFR Part 79

Administrative practice and procedure, Authority delegations

(Government agencies), Cancer, Claims, Radiation Exposure Compensation

Act, Radioactive materials, Reporting and recordkeeping requirements,

Underground mining, Uranium.

Accordingly, part 79 of chapter I of title 28 of the Code of

Federal Regulations is proposed to be amended as follows:

PART 79--CLAIMS UNDER THE RADIATION EXPOSURE COMPENSATION ACT

1. The authority citation for part 79 continues to read as follows:

Authority: Secs. 6 (b) and (j), Pub. L. 101-426, 104 Stat. 920

(42 U.S.C. 2210 note).

2. Section 79.4(c) is amended by redesignating paragraphs (c)(3)

and (c)(4) as paragraphs (c)(4) and (c)(5), adding a new paragraph

(c)(3) and revising paragraphs (c)(1) and (c)(2) and new paragraphs

(c)(4) and (c)(5) as follows:

Sec. 79.4 Burden of proof, production of documents, presumptions, and

affidavits.

* * * * *

(c) * * *

(1) Eligibility of family members as set forth in Sec. 79.51 (e),

(f), (g), (h) or (i);

(2) Other compensation received as set forth in Sec. 79.55 (c) or

(d);

(3) Smoking and/or drinking history and/or age at diagnosis as set

forth in Sec. 79.27(d) and Sec. 79.37(d);

(4) The amount of coffee consumed as set forth in Sec. 79.27(d); or

(5) Mining information as set forth in Sec. 79.33(b)(2).

3. Section 79.5 is amended by adding paragraph (c) to read as

follows:

Sec. 79.5 Requirements for written medical documentation,

contemporaneous records, and other records or documents.

* * * * *

(c) To establish eligibility the claimant or eligible surviving

beneficiary may be required to provide, where appropriate, additional

contemporaneous records to the extent they exist or an authorization to

release additional contemporaneous records or a statement by the

custodian(s) of the records certifying that the requested record(s) no

longer exist. Nothing in these regulations shall be construed to limit

the Assistant Director's ability to require additional documentation.

4. In Sec. 79.21, paragraph (d) is amended by adding one new

sentence after the second sentence to read as follows:

Sec. 79.21 Definitions.

* * * * *

(d) * * * The term excludes an individual who smoked more than 20

pack years, but who can establish in accordance with Sec. 79.27 that he

or she stopped smoking at least fifteen (15) years prior to the

diagnosis of primary cancer of the esophagus, pharynx, or pancreas, and

did not resume smoking at any time thereafter.

* * * * *

5. Section 79.27 is amended by revising the heading, redesignating

paragraph (c) as new paragraph (e), adding new paragraphs (c) and (d),

and revising paragraphs (a) and (b), to read as follows:

Sec. 79.27 Proof of no heavy smoking, no heavy drinking, no heavy

coffee drinking and no indication of the presence of hepatitis B and

cirrhosis.

(a)(1) If the claimant or eligible surviving beneficiary is

claiming eligibility under this Subpart for primary cancer of the

esophagus, pharynx, pancreas or liver, the claimant or eligible

surviving beneficiary must submit, in addition to proof of the disease,

all medical records listed below from any hospital, medical facility,

or health care provider that were created within the period six (6)

months before and six (6) months after the date of diagnosis of primary

cancer of the esophagus, pharynx, pancreas or liver:

(i) All history and physical examination reports;

(ii) All operative and consultation reports;

(iii) All pathology reports; and

(iv) All physician, hospital and health care facility admission and

discharge summaries.

(2) In the event that any of the above records no longer exist, the

claimant or eligible surviving beneficiary must submit a certified

statement by the custodian(s) of those records to that effect.

(b) If the medical records listed in paragraph (a) of this section,

or information possessed by the state cancer or tumor registries

reflects that the claimant was a heavy smoker or a heavy drinker or

indicates the presence of hepatitis B and/or cirrhosis, the Radiation

Exposure Compensation Unit will notify the claimant or eligible

surviving beneficiary and afford that individual the opportunity to

submit other written medical documentation or contemporaneous records

in accordance with Sec. 79.52(b) to establish that the claimant was not

a heavy smoker or heavy drinker or that there was no indication of

hepatitis B and/or cirrhosis.

(c) The Unit may also require that the claimant or eligible

surviving beneficiary provide additional medical records or other

contemporaneous records and/or an authorization to release such

additional medical and contemporaneous records as may be needed to make

a determination regarding the indication of the presence of hepatitis B

and/or cirrhosis and the claimant's history of smoking and alcohol-

consumption.

(d) If the custodian(s) of the records listed in paragraph (a) of

this section and records requested in accordance with paragraph (c) of

this section certifies that a claimant's records no longer exist, and

if the state cancer or tumor registries do not contain information

concerning the claimant's history of smoking or alcohol-consumption,

the Assistant Director may require that the claimant or eligible

surviving beneficiary submit an affidavit (or declaration) made under

penalty of perjury detailing the histories or lack thereof and the

basis for such knowledge (if the eligible surviving beneficiary). This

affidavit (or declaration) will be considered by the Assistant Director

in making a determination concerning the claimant's history of smoking

and alcohol-consumption.

* * * * *

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6. Section 79.31 is amended by revising paragraphs (e) and (f) and

the second sentence of paragraph (h), and adding paragraphs (s) and (t)

to read as follows:

Sec. 79.31 Definitions

* * * * *

(e) Non-smoker means an individual who never smoked tobacco

cigarette products or smoked less than the amount defined in paragraph

(f) of this section and includes an individual who smoked at least one

(1) pack year but whose acceptable documentation as set forth in

Sec. 79.37 establishes that he or she stopped smoking at least fifteen

(15) years prior to the diagnosis of primary cancer of the lung and did

not resume smoking at any time thereafter.

(f) Smoker means an individual who has smoked at least one (1) pack

year of cigarette products, and who is not deemed a non-smoker by

virtue of paragraph (e) of this section.

* * * * *

(h) * * * The term includes cancers in situ.

* * * * *

(s) High resolution computed tomography (HRCT) means a computed

tomograph (CT) of the chest that utilizes thin collimation, image

reconstruction with a high-spatial frequency algorithm, increased kVp

or mA technique, and the use of a large matrix size.

(t) HRCT Reader means a physician who is board-certified in

radiology and who devotes at least thirty (30) percent of his or her

practice to thoracic radiology or is a member of the Society of

Thoracic Radiology. An affidavit (or declaration) made under penalty of

perjury must be submitted by the HRCT reader to establish the above

qualifications.

8. Section 79.36, is amended by revising the first sentence of

paragraph (a), revising paragraph (d)(1)(ii), and adding new paragraph

(e) to read as follows:

Sec. 79.36 Proof of non-malignant respiratory disease.

(a) Written medical documentation is required in all cases to prove

that the claimant developed a non-malignant respiratory disease. * * *

* * * * *

(d) * * *

(1) * * *

(i) * * *

(ii) If the claimant is alive, (A) One of the following:

(1) Chest x-rays and two ``B'' reader interpretations. A chest x-

ray administered in accordance with standard techniques on full size

film at quality 1 or 2, and interpretative reports of the x-ray by two

certified ``B'' readers classifying the existence of fibrosis of

category 1/0 or higher according to the ILO 1980, or subsequent

revisions;

(2) High resolution computed tomography scans and interpretation.

An HRCT scan administered in accordance with Tables 5a and 5b in

Appendix D of this part, and an interpretative reading by one HRCT

reader showing:

(i) Honeycombing, bilaterally at two or more levels; or

(ii) Any two of the findings listed below, visible bilaterally at

two or more HRCT levels in a non-dependent lung:

(A) Intralobular interstitial thickening;

(B) Irregular interlobular septal thickening;

(C) Parenchymal bands unassociated with pleural thickening;

(D) Subpleural lines or subpleural nodules (1 to 5 mm in diameter);

(E) Architectural distortion;

(F) Pulmonary nodules (1 to 10 mm. in diameter); or

(G) Cicatricial emphysema; or

(3) Pathology reports of tissue biopsies. A pathology report of a

tissue biopsy, but only if performed for medically-justified reasons;

and

(B) One or more of the following:

(1) Pulmonary function tests. Pulmonary function tests consisting

of three tracings recording the results of the forced expiratory volume

in one second (FEV1) and the forced vital capacity (FVC) administered

and reported in accordance with the Standardization of Spirometry--1987

Update by the American Thoracic Society, and reflecting values for FEV1

or FVC that are equal to or less than 80% of the predicted value for an

individual of the claimant's age, sex, and height, as set forth in the

Tables in Appendix A; or

(2) Arterial blood-gas studies. An arterial blood-gas study

administered at rest in a sitting position, or an exercise arterial

blood-gas test, reflecting values equal to or less than the values set

forth in the Tables in Appendix B.

* * * * *

(e) The Radiation Exposure Compensation Unit may seek qualified

medical review of HRCT, ``B'' reader interpretations, and pathology

reports of tissue biopsies submitted by a claimant or eligible

surviving beneficiary or obtain additional HRCT and ``B'' reader

interpretations or pathology reports of tissue biopsies at any time to

ensure that appropriate weight is given to this evidence and to

guarantee uniformity and reliability. This review may include obtaining

additional HRCT and chest x-ray interpretations and additional

pathology reports of tissue biopsies.

9. Section 79.37 is amended by revising the section heading,

revising paragraphs (a) and (b), and adding new paragraphs (c) and (d)

to read as follows:

Sec. 79.37 Proof of non-smoker and diagnosis prior to age 45.

(a) (1) In order to prove a history of non-smoking for purposes of

Sec. 79.32(c)(1), and/or diagnosis of a compensable disease prior to

age 45 for purposes of Sec. 79.32(c)(2)(i), the claimant or eligible

surviving beneficiary must submit all medical records listed below from

any hospital, medical facility, or health care provider that were

created within the period six (6) months before and six (6) months

after the date of diagnosis of primary lung cancer or a compensable

nonmalignant respiratory disease:

(i) All history and physical examination reports;

(ii) All operative and consultation reports;

(iii) All pathology reports;

(iv) All physician, hospital and health care facility admission and

discharge summaries.

(2) In the event that any of the above records no longer exist, the

claims or eligible surviving beneficiary must submit a certified

statement by the custodian(s) of those records to that effect.

(b) If, after a review of the records listed in paragraph (a)

above, and/or the information possessed by the PHS, NIOSH, state cancer

or tumor registries, state authorities, or the custodian of a federally

supported health-related study, the Assistant Director finds that the

claimant was a smoker, and/or that the claimant was diagnosed with a

compensable disease after age 45, the Unit will notify the claimant or

eligible surviving beneficiary and afford that individual the

opportunity to submit other written medical documentation in accordance

with Sec. 79.52(b) to establish that the claimant was a non-smoker and/

or was diagnosed with a compensable disease prior to age 45.

(c) The Unit may also require that the claimant or eligible

surviving beneficiary provide additional medical records or other

contemporaneous records and/or an authorization to release such

additional medical and contemporaneous records as may be needed to make

a determination regarding the claimant's smoking history and/or age at

diagnosis with a compensable disease.

(d) If the custodian(s) of the records listed in paragraph (a) of

this section and the records requested in accordance with paragraph (c)

of this section certifies that a claimant's records no

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longer exist, and information possessed by the PHS, NIOSH, state

cancer or tumor registries, state authorities, or the custodian of a

federally supported health-related study do not contain information

pertaining to the claimant's smoking history, the Assistant Director

may require that the claimant or eligible surviving beneficiary submit

an affidavit (or declaration) made under penalty of perjury detailing

the claimant's smoking history or lack thereof and, if the affiant is

the eligible surviving beneficiary, the basis for such knowledge. This

affidavit (or declaration) will be considered by the Assistant Director

in making a determination concerning the claimant's history of smoking.

10. In Sec. 79.51, paragraph (j) is amended by revising paragraphs

(j)(3) and (j)(4), adding paragraph (j)(5) and adding a sentence at the

end of the concluding text to read as follows:

Sec. 79.51 Filing of claims.

* * * * *

(j) * * *

(3) Onsite participation in a nuclear test,

(4) Exposure to a defined minimum level or radiation in a uranium

mine or mines during a designated time period, or

(5) The identity of the claimant and/or surviving beneficiary.

* * * Claims filed prior to the date of implementation of these

amending regulations will not be included in determining the number of

claims filed.

11. In Sec. 79.55, paragraphs (d)(1)(i) and (d)(1)(ii) are revised

to read as follows:

Sec. 79.55 Procedures for payment of claims.

* * * * *

(d) * * *

(1) * * *

(i) Any disability payments or compensation benefits paid to the

claimant and his/her dependents while the claimant is alive; and

(ii) Any Dependency and Indemnity Compensation payments made to

survivors due to death related to the illness for which the claim under

the Act is submitted.

* * * * *

11. Appendix D to Part 79 is added to read as follows:

Appendix D to Part 79--HRCT Technique

Table A: Summary of HRCT Technique; Essential Scanner Settings

1. Collimation: Thinnest available collimation (1-1.5 mm).

2. Reconstruction algorithm: High-spatial frequency or ``sharp''

algorithm

3. Scan time: 1-2 seconds

4. kVp; mA; mAs: Routine settings for chest CT

5. Matrix size: Largest available (512 x 512).

6. Window level: -600 to -700 HU Window width: 1000 HU to 1500 HU

7. Photography: 12 on 1.

8. Field of view: As small as possible to incorporate both lungs

(30-40 cm.)

Table B: Scanning Protocol and Procedure; HRCT Technique: Scan Protocol

for Suspected Silicosis or Fibrotic Lung disease

Chest radiograph normal or minimally abnormal:

Full inspiration with prone and supine scans using 2-cm spacing from

lung apices to bases.

Dated: May 16, 1997.

Janet Reno,

Attorney General.

[FR Doc. 97-13542 Filed 5-22-97; 8:45 am]

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