[Federal Register Volume 62, Number 100 (Friday, May 23, 1997)]
[Proposed Rules]
[Pages 28393-28396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13542]


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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

[[Page 28394]]

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.
* * * * *

[[Page 28395]]

    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

[[Page 28396]]

 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]
BILLING CODE 4410-12-M