Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 96.
BLOODBORNE PATHOGEN CONTROL
The Executive Commissioner of the Health and Human Services Commission,
on behalf of the Department of State Health Services (department), adopts
amendments to §§96.101, 96.201 - 96.203, 96.301 - 96.304, 96.401,
96.402, 96.501 and the repeal of 96.601, concerning the applicability, minimum
standards, safety recommendations, device registration procedures and fees,
and sharps injury logs of bloodborne pathogen exposure control plans. The
amendments to §§96.301, 96.401, and 96.501 are adopted with changes
to the proposed text as published in the January 6, 2006, issue of the
BACKGROUND AND PURPOSE
The amendments and repeal are necessary to comply with Health and Safety
Code, §§81.301 - 81.307, which require the department to establish
an exposure control plan designed to minimize exposure of employees to bloodborne
pathogens and to implement a registration program for needleless systems and
sharps with engineered sharp injury protections; and House Bill 2292, 78th
Legislature, Regular Session, 2003, §2.42, added Health and Safety Code, §12.0112,
which requires that the term for licenses issued or renewed after January
1, 2005, will be two years.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Sections 96.101,
96.201 - 96.203, 96.301 - 96.304, 96.401, 96.402, 96.501, and 96.601 have
been reviewed, and the department has determined that reasons for adopting
the sections continue to exist because rules on this subject are needed and
required by law. Section 96.601 is repealed because the rule is no longer
necessary.
SECTION-BY-SECTION SUMMARY
Amendments to §96.101 add more components to the definitions of "Governmental
unit" and also provide additional information concerning the contracting of
the Hepatitis B, C, and Human immunodeficiency viruses; §§96.201
- 96.203, 96.301 - 96.304, 96.401, 96.402, and 96.501 update and correct the
department's reference from the "Texas Department of Health" to the "Department
of State Health Services"; §§96.202, 96.303, and 96.401 provide
a new website for information on bloodborne pathogen control; amendments to §96.301
and §96.501 reflect changes in the Department of State Health Services'
organizational unit names and commissioner titles; amendments to §96.302
and §96.304 add a two-year period for registration and renewal fees; §96.301
and §96.501 are amended to delete reference to issuance of waivers.
Section 96.601 is repealed because the reference to the effective date
of the rules is no longer relevant.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared
responses to the comments received regarding the proposed rules during the
comment period, which the commission has reviewed and accepts. The commenter
was an individual representing the Texas AIDS Network. The commenter was not
against the rules in their entirety; however, the commenter asked about the
continuation of rules that had an expiration date.
Comment: Concerning Safety Recommendation Waiver for Undue Burden in §96.301(b),
the commenter asked why the May 1, 2003, prohibition date was extended for
the use of prefilled syringes approved by the Federal Food and Drug Administration.
Response: The commission agrees that the waiver for prohibition of the
use of the prefilled syringe approved by the Federal Food and Drug Administration
shall be continued because certain medications including immunization vaccines
and antibiotics are available only in a prefilled syringe. There was no change
made as a result of this comment.
Comment: Concerning Waiver for Rural Counties in §96.501, the commenter
asked why the 2001 date for the waivers for rural counties was extended.
Response: The commission agrees that waivers should no longer be granted
and this section has been amended to reflect this in the final version of
the rules. The legislation that authorized the granting of waivers has expired
(Chapter 1411, 76th Legislature §26.02).
The department staff, on behalf of the commission, provided comments and
the commission has reviewed and agrees to the following changes.
Change: Concerning §96.301(b), Waiver for Undue Burden, staff noted
that the legislature provision which allowed this waiver expired in 2001 and
this section has been amended to reflect the changes. The legislation that
authorized the granting of waivers has expired (Chapter 1411, 76th Legislature, §26.02).
Change: Concerning §96.401(f), the Internet address was corrected
to "http://www.dshs.state.tx.us/idcu/health/bloodborne_pathogens/reporting/"
instead of "http://www.dshs.state.tx.us/ideas/bloodborne_pathogens/reporting/".
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.