97-13542. Radiation Exposure Compensation Act: Evidentiary Requirements; Definitions and Number of Claims Filed  

  • [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
    
    
    

Document Information

Published:
05/23/1997
Department:
Justice Department
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
97-13542
Dates:
Written comments must be submitted on or before July 22, 1997.
Pages:
28393-28396 (4 pages)
Docket Numbers:
A.G. Order No. 2084-97
RINs:
1105-AA49: Radiation Exposure Compensation Act: Evidentiary Requirements; Definitions and Number of Times Claims May Be Filed
RIN Links:
https://www.federalregister.gov/regulations/1105-AA49/radiation-exposure-compensation-act-evidentiary-requirements-definitions-and-number-of-times-claims-
PDF File:
97-13542.pdf
CFR: (10)
28 CFR 79.32(c)(1)
28 CFR 79.4
28 CFR 79.5
28 CFR 79.21
28 CFR 79.27
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