[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
