[Federal Register Volume 70, Number 97 (Friday, May 20, 2005)]
[Rules and Regulations]
[Pages 29191-29194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10042]


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DEPARTMENT OF JUSTICE

Bureau of Prisons

28 CFR Part 549

[BOP-1104-F]
RIN 1120-AB03


Infectious Disease Management: Voluntary and Involuntary Testing

AGENCY: Bureau of Prisons, Justice.

ACTION: Final rule.

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SUMMARY: In this document, the Bureau of Prisons (Bureau) finalizes 
regulations on the management of infectious diseases. The changes 
address the circumstances under which the Bureau conducts voluntary and 
involuntary testing for HIV, tuberculosis, and other infectious 
diseases. We intend this amendment to provide for the health and safety 
of staff and inmates.

DATES: This rule is effective on June 20, 2005.

FOR FURTHER INFORMATION CONTACT: Sarah Qureshi, Office of General 
Counsel, Bureau of Prisons, phone (202) 307-2105.

SUPPLEMENTARY INFORMATION: The Bureau finalizes its regulations on the 
infectious disease management program (28 CFR part 549, subpart A).
    These regulations were first published in the Federal Register on 
October 5, 1995 (60 FR 52278) as interim final rules. We received no 
public comment on that interim rule. We had published an entry in the 
Unified Regulatory Agenda describing the finalization of that interim 
final rule (BOP-1017-F, RIN 1120-AA23). To clarify that this rulemaking 
is a change to the same interim rules, we merged that action into a 
proposed rule which we published on July 12, 2002 (67 FR 46136).
    Why we are making this rule: The Correction Officers Health and 
Safety Act of 1998 gave the Bureau new statutory authority for 
conducting HIV tests. Additionally, the Centers for Disease Control 
(CDC) has issued a variety of recommendations on prevention and control 
of HIV, tuberculosis, and other infectious diseases. Consequently, the 
Bureau revises its regulations in accordance with the new statutory 
authority and in consideration of CDC recommendations.
    Previously, Bureau regulations on the management of infectious 
diseases provided for mandatory HIV testing of a yearly random sample, 
yearly new commitment sample, new commitment re-test sample, pre-
release testing, and clinically indicated testing. Any inmate refusing 
an order for one of these mandatory HIV testing programs is subject to 
an incident report for refusing to obey an order. Previous regulations 
did not allow for involuntary HIV testing of an inmate following any 
intentional or unintentional exposure, when there is a risk of 
transmission of HIV infection to Bureau employees or other persons in a 
Bureau institution.
    The Correction Officers Health and Safety Act of 1998 provides that 
each individual convicted of a Federal offense who is sentenced to a 
period of six months or more is to be tested for HIV, if such 
individual is determined to be at risk for HIV infection in accordance 
with the guidelines issued by the Bureau. The act also provides for 
involuntary HIV testing following any intentional or unintentional 
exposure when there is a risk of transmission of HIV infection to 
Bureau employees or other persons in a Bureau institution. Because of 
this new statutory authority, the Bureau amends its regulations to 
allow involuntary testing in those instances where an inmate refuses to 
be tested following any intentional or unintentional exposure. The 
inmate may also be subject to an incident report for refusing to obey 
an order.
    The Bureau will continue to allow an inmate to request to be tested 
for HIV. Such testing is limited to no more than once per 12-month 
period, unless the Bureau determines that additional testing is 
warranted. The Bureau will also continue to provide pre- and post-test 
counseling, regardless of the test results.
    The Bureau also amends its regulations on infectious disease 
management to address testing requirements for tuberculosis (TB). The 
Bureau's general authority to protect and provide for the safekeeping 
and care of inmates in Bureau custody (18 U.S.C. 4042(a)) allows us to 
conduct medical tests as necessary to protect the health of the inmate 
population. Currently, testing of inmates for TB is conducted in 
accordance with the recommendations and guidelines published by the 
Centers for Disease Control (CDC) in 1992. In response to the increased 
transmission of TB in correctional facilities, the CDC updated and 
expanded previously published recommendations for preventing and 
controlling TB in correctional facilities.
    Based on these updated recommendations, the Bureau will screen each 
inmate for TB within two calendar days of initial incarceration. We 
intend to appropriately treat, isolate and/or protect inmates as a 
result of exposure in the two-day interim before testing. The Bureau 
will also conduct

[[Page 29192]]

follow-up testing for each inmate annually. In addition, the Bureau 
will screen an inmate for TB when health services staff determine that 
the inmate may be at risk for infection. An inmate who refuses TB 
screening may be subject to an incident report for refusing to obey an 
order. If an inmate refuses tuberculin skin testing, and there is no 
contraindication to tuberculin skin testing, institution medical staff 
will educate and counsel the inmate regarding the need for such testing 
in an institutional setting (for example, the need to identify HIV+ 
inmates who have not received a course of prophylaxis and are at high 
risk for the development of active tuberculous disease). If an inmate 
still refuses tuberculin testing despite education and counseling, 
institution medical staff will test the inmate involuntarily. The 
intent of this amendment is to control TB among staff and inmates in 
correctional facilities.
    To provide for the protection, safekeeping, and care of inmates in 
our custody (as required by 18 U.S.C. 4042(a)), we retain, revised for 
clarity, regulations on diagnostics (549.12(c)); Programming, Duty and 
Housing Restrictions (549.13); Confidentiality of Information (549.14); 
and Infectious Disease Training and Preventive Measures (549.15).
    Finally, the Bureau removes provisions dealing with medical 
isolation and quarantining as these are governed by normal medical 
protocols and do not need to appear in the regulations. Removing these 
provisions from regulation and retaining them in Bureau policy allows 
us the flexibility to adhere to ever-changing medical standards and 
Federal medical guidelines.
    Public Comments and Bureau Responses: We received three comments to 
the proposed rule. One supported the rule, stating that it would ``help 
control the epidemic of AIDS and other diseases in prison.''
    The second commenter expressed concern that using mandatory ``PPD 
skin testing'' to detect tuberculosis would contravene his Buddhist 
religious beliefs. The ``PPD skin test'' is a medical term of art 
referring to a test that, in earlier years, involved injecting purified 
pork derivative liquid under the skin. The commenter and other inmates 
were concerned that this would amount to consuming a pork product, 
which would contravene several religious beliefs, including Buddhism 
and Islam. The commenter further expressed concerns that there would be 
unnecessary follow-up testing after initial TB screening, thereby 
subjecting inmates to further violation of religious beliefs.
    Although the use of PPD as a screening test is routine, questions 
frequently arise about the required tuberculin skin test. The current 
version of the PPD uses a Purified Protein Derivative instead of a pork 
derivative. Inmates who object to the ``PPD skin test'' frequently cite 
religious reasons based on a mistaken belief that the liquid solution 
injected under the skin is a fat and/or animal derivative. The solution 
is not a fat or animal derivative, but is instead synthetic. However, 
the guiding principle with medical issues and religion is weighing the 
individual interest and the compelling government interest. TB is a 
highly communicable disease. The tuberculin skin test is used as an 
early diagnostic tool because it is highly effective in determining TB 
infection. Some cite that the x-ray is a least restrictive alternative 
because it can detect TB. However, x-rays do not provide early 
diagnostic information. Therefore, the safety of the institution's 
population, staff and inmate, is put at risk if the x-ray is used as an 
alternative. The compelling government interest outweighs the sincerely 
held religious belief and motivation of the inmate.
    In response to the comment, however, we recognize that the term 
``PPD test'' may be misleading and therefore will change the name of 
the test to more accurately reflect what it is: The Tuberculin Skin 
Test. We also eliminate references to the term ``PPD'' in the rule 
text.
    Also, our previous TB testing provision had stated that after the 
initial screening, we would conduct follow-up testing annually. To 
allay the commenter's apparent concern that inmates will be tested 
unnecessarily every year, we clarify that we will conduct TB screening 
for each inmate annually only as medically indicated.
    Finally, the third commenter complained that he had been subjected 
to seven HIV tests as part of ``random'' testing. This inmate had filed 
an administrative remedy complaint with the Bureau requesting to be 
removed from the HIV testing program.
    Before May 2000, the Bureau conducted random HIV testing. In May 
2000, the Bureau began testing a new commitment sample and, new 
recommitment re-test sample in addition to voluntary, pre-release, and 
as clinically indicated as set forth in then-current regulation (28 CFR 
549.13(b)). All new commitments between October 1, 1999, and March 31, 
2000, with release dates projected at 3 years or more qualified 
initially for the new commitment testing. If baseline testing showed an 
inmate was HIV negative, new commitment re-testing was to be completed 
every year thereafter, until further notice.
    The new commitment, new recommitment re-test sample was not a 
random sample. Unfortunately, when this system became effective, 
initial guidance referenced the testing incorrectly as a ``subset of 
randomly selected inmates''. This may have resulted in the use of the 
term ``random'' in discussing the seroconversion testing and subsequent 
misconceptions by staff and inmates.

Changes to Sec.  549.14, Confidentiality of Information

    After internal agency deliberation, we made changes to this part of 
the proposed rule for clarity and to more accurately reflect the intent 
of the Correction Officers Health and Safety Act (Pub. L. 105-370, 
codified at 18 U.S.C. 4014).
    In our proposed rule, this section stated that any disclosure of 
test results or medical information would be made in accordance with 
the Privacy Act of 1974 and the HHS Standards for Privacy of 
Individually Identifiable Health Information promulgated pursuant to 
the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).
    The Bureau of Prisons is not a ``covered entity'' under subsequent 
regulations promulgated by the Department of Health and Human Services 
to implement HIPAA. We therefore exclude references to the Health 
Insurance Portability and Accountability Act of 1996.
    Also, when we proposed this regulation, we described four types of 
routine uses of such information maintained by the Bureau in its 
Privacy Act systems of records.
    In our revised rule, instead of singling out four routine uses of 
such information, we merely state that a more thorough description of 
routine uses allowable for inmate health records may be found in the 
Department of Justice Privacy Act System of Records Notice entitled 
``Inmate Physical and Mental Health Record System, JUSTICE/BOP-007.''
    In addition, we clarify that test results may be disclosed in 
accordance with The Correction Officers Health and Safety Act of 1998 
(codified at 18 U.S.C. 4014), which authorizes the Bureau to 
communicate test results to a person requesting the test, the person 
tested, and, if the results of the test indicate the presence of HIV, 
to correctional facility personnel consistent with Bureau policy on 
this issue.

[[Page 29193]]

Executive Order 12866

    This rule has been reviewed as a ``significant regulatory action'' 
under section 3(f) of Executive Order 12866 by the Office of Management 
and Budget (OMB). This rule will not impose a substantial cost on the 
public, the government or regulated entities. This rule change, 
mandated by statute and required to conform to CDC guidelines, will 
benefit inmates by allowing us to detect and treat infectious diseases 
more efficiently, thereby decreasing further infection.

Executive Order 13212

    This regulation will not have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on distribution of power and responsibilities among the 
various levels of government. Therefore, in accordance with Executive 
Order 13132, it is determined that this rule does not have sufficient 
federalism implications to warrant the preparation of a Federalism 
Assessment.

Regulatory Flexibility Act

    The Director of the Bureau of Prisons, in accordance with the 
Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this 
regulation and by approving it certifies that this regulation will not 
have a significant economic impact upon a substantial number of small 
entities for the following reasons: This rule pertains to the 
correctional management of offenders committed to the custody of the 
Attorney General or the Director of the Bureau of Prisons, and its 
economic impact is limited to the Bureau's appropriated funds.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and it will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by Sec.  804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996. This rule will 
not result in an annual effect on the economy of $100,000,000 or more; 
a major increase in costs or prices; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of United States-based companies to compete with foreign-
based companies in domestic and export markets.

List of Subjects in 28 CFR Part 549

    Prisoners.

Harley G. Lappin,
Director, Bureau of Prisons.

0
Under rulemaking authority vested in the Attorney General in 5 U.S.C. 
552(a) and delegated to the Director, Bureau of Prisons, we amend 28 
CFR part 549 as follows.

SUBCHAPTER C--INSTITUTIONAL MANAGEMENT

PART 549--MEDICAL SERVICES

0
1. Revise the authority citation for 28 CFR part 549 to read as 
follows:

    Authority: 5 U.S.C. 301; 18 U.S.C. 3621, 3622, 3624, 4001, 4005, 
4014, 4042, 4045, 4081, 4082 (Repealed in part as to offenses 
committed on or after November 1, 1987), 4241-4247, 5006-5024 
(Repealed October 12, 1984, as to offenses committed after that 
date), 5039; 28 U.S.C. 509, 510.


0
2. Revise Subpart A to read as follows:
Subpart A--Infectious Disease Management
Sec.
549.10 Purpose and scope.
549.11 Program responsibility.
549.12 Testing.
549.13 Programming, duty, and housing restrictions.
549.14 Confidentiality of information.
549.15 Infectious disease training and preventive measures.

Subpart A--Infectious Disease Management


Sec.  549.10  Purpose and scope.

    The Bureau will manage infectious diseases in the confined 
environment of a correctional setting through a comprehensive approach 
which includes testing, appropriate treatment, prevention, education, 
and infection control measures.


Sec.  549.11  Program responsibility.

    Each institution's Health Services Administrator (HSA) and Clinical 
Director (CD) are responsible for the operation of the institution's 
infectious disease program in accordance with applicable laws and 
regulations.


Sec.  549.12  Testing.

    (a) Human Immunodeficiency Virus (HIV).
    (1) Clinically indicated. The Bureau tests inmates who have 
sentences of six months or more if health services staff determine, 
taking into consideration the risk as defined by the Centers for 
Disease Control guidelines, that the inmate is at risk for HIV 
infection. If the inmate refuses testing, staff may initiate an 
incident report for refusing to obey an order.
    (2) Exposure incidents. The Bureau tests an inmate, regardless of 
the length of sentence or pretrial status, when there is a well-founded 
reason to believe that the inmate may have transmitted the HIV 
infection, whether intentionally or unintentionally, to Bureau 
employees or other non-inmates who are lawfully present in a Bureau 
institution. Exposure incident testing does not require the inmate's 
consent.
    (3) Surveillance Testing. The Bureau conducts HIV testing for 
surveillance purposes as needed. If the inmate refuses testing, staff 
may initiate an incident report for refusing to obey an order.
    (4) Inmate request. An inmate may request to be tested. The Bureau 
limits such testing to no more than one per 12-month period unless the 
Bureau determines that additional testing is warranted.
    (5) Counseling. Inmates being tested for HIV will receive pre- and 
post-test counseling, regardless of the test results.
    (b) Tuberculosis (TB).
    (1) The Bureau screens each inmate for TB within two calendar days 
of initial incarceration.
    (2) The Bureau conducts screening for each inmate annually as 
medically indicated.
    (3) The Bureau will screen an inmate for TB when health services 
staff determine that the inmate may be at risk for infection.
    (4) An inmate who refuses TB screening may be subject to an 
incident report for refusing to obey an order. If an inmate refuses 
skin testing, and there is no contraindication to tuberculin skin 
testing, then, institution medical staff will test the inmate 
involuntarily.
    (5) The Bureau conducts TB contact investigations following any 
incident in which inmates or staff may have been exposed to 
tuberculosis. Inmates will be tested according to paragraph (b)(4) of 
this section.
    (c) Diagnostics. The Bureau tests an inmate for an infectious or 
communicable disease when the test is necessary to verify transmission 
following exposure to bloodborne pathogens or to infectious body fluid. 
An inmate who refuses diagnostic testing is subject to an incident 
report for refusing to obey an order.


Sec.  549.13  Programming, duty, and housing restrictions.

    (a) The CD will assess any inmate with an infectious disease for 
appropriateness for programming, duty,

[[Page 29194]]

and housing. Inmates with infectious diseases that are transmitted 
through casual contact will be prohibited from work assignments in any 
area, until fully evaluated by a health care provider.
    (b) Inmates may be limited in programming, duty, and housing when 
their infectious disease is transmitted through casual contact. The 
Warden, in consultation with the CD, may exclude inmates, on a case-by-
case basis, from work assignments based upon the security and good 
order of the institution.
    (c) If an inmate tests positive for an infectious disease, that 
test alone does not constitute sole grounds for disciplinary action. 
Disciplinary action may be considered when coupled with a secondary 
action that could lead to transmission of an infectious agent. Inmates 
testing positive for infectious disease are subject to the same 
disciplinary policy that applies to all inmates (see 28 CFR part 541, 
subpart B). Except as provided for in our disciplinary policy, no 
special or separate housing units may be established for HIV-positive 
inmates.


Sec.  549.14  Confidentiality of information.

    Any disclosure of test results or medical information is made in 
accordance with:
    (a) The Privacy Act of 1974, under which the Bureau publishes 
routine uses of such information in the Department of Justice Privacy 
Act System of Records Notice entitled ``Inmate Physical and Mental 
Health Record System, JUSTICE/BOP-007''; and
    (b) The Correction Officers Health and Safety Act of 1998 (codified 
at 18 U.S.C. 4014), which provides that test results must be 
communicated to a person requesting the test, the person tested, and, 
if the results of the test indicate the presence of HIV, to 
correctional facility personnel consistent with Bureau policy.


Sec.  549.15  Infectious disease training and preventive measures.

    (a) The HSA will ensure that a qualified health care professional 
provides training, incorporating a question-and-answer session, about 
infectious diseases to all newly committed inmates, during Admission 
and Orientation.
    (b) Inmates in work assignments which staff determine to present 
the potential for occupational exposure to blood or infectious body 
fluids will receive annual training on prevention of work-related 
exposures and will be offered vaccination for Hepatitis B.

[FR Doc. 05-10042 Filed 5-19-05; 8:45 am]
BILLING CODE 4410-05-P