BLOODBORNE PATHOGENS REGULATORY UPDATE
Last reviewed: 6/21/1999
Last revised: 6/21/1999
(Latest revisions shown in bold italics)
Current status of the emergency regulation
Current status of the permanent rulemaking
Summary of emergency and proposed revisions
Cal/OSHA Consultation Service
Regulatory and legislative background
On Thursday, December 17, 1998, the Cal/OSHA Standards Board adopted, as an emergency regulation, revisions to Title 8, California Code of Regulations, Section 5193 (Bloodborne Pathogens) to meet the mandates of Assembly Bill 1208 (1998), which places a new section, Section 144.7, in the California Labor Code. (AB 1208 1998 can be viewed at www.leginfo.ca.gov) The Cal/OSHA Standards Board is also conducting permanent rulemaking as described below.
Current status of the emergency regulation
Emergency revisions to the Cal/OSHA bloodborne pathogens regulation took effect January 22, 1999. This came about as a result of approval by the Office of Administrative Law (OAL) on January 22 of the final version of the regulation adopted by the Cal/OSHA Standards Board on January 14, 1999. The final version of the regulation adopted on January 14 contained revisions necessary to address a concern raised by OAL.
The January 14 version contains only one substantive change from the version adopted by the Standards Board on December 17, 1998: The start-up date for provisions which were originally proposed to take effect on August 1, 1999 was changed to July 1, 1999. For a summary of the provisions which have delayed start-up dates please refer to items 1, 3 & 4 of the "Summary of emergency and proposed permanent revisions" included in this regulatory update.
Press http://www.dir.ca.gov/DIR/OS&H/OSHSB/bloodborne.html to view a copy of the emergency regulation as approved by the Office of Administrative Law which went into effect January 22, 1999.
Current status of the permanent rulemaking process
In addition to the emergency regulation, the Standards Board is conducting permanent rulemaking considering essentially the same revisions to Section 5193 that were adopted in the emergency rule. The Standards Board accepted written comments on these proposed revisions until February 22, 1999 and heard verbal comments during a public hearing at its monthly meeting on February 18, 1999 at the Harris State Building in Oakland.
To view a copy of the proposed permanent rule which was considered at the public hearing on February 18, 1999 go to http://www.dir.ca.gov/DIR/OS&H/OSHSB/sharps.html which will provide the proposed rule in strikeout/underline format.
To view the Informative Digest for this rulemaking go to http://www.dir.ca.gov/DIR/OS&H/OSHSB/sharps1.html.
To view the Initial Statement of Reasons for this rulemaking go to http://www.dir.ca.gov/DIR/OS&H/OSHSB/sharps2.html.
In response to public comments received during the February 18, 1999 Public Hearing process, minor changes were made to the original proposal. A copy of these further changes can be obtained by contacting the Standards Board at firstname.lastname@example.org or 916-322-3640. In a "15-day notice" process, the Standards Board accepted comments on these changes to the final rule proposal from May 14, 1999 to June 3, 1999.
On June 17, 1999 the Standards Board voted to adopt the proposed revisions to Section 5193 as a final rule. Text of the proposed final rule adopted on June 17 can be accessed at http://www.dir.ca.gov/DIR/OS&H/OSHSB/bloodbornefinal.html. Before it can become effective the proposed final rule as adopted will be submitted to the Office of Administrative Law for review and approval, followed by signing by the Secretary of State. Because it will not be possible for this process to be completed by July 1, 1999, employers and others should note that all requirements of the emergency regulation, which is almost identical to the final rule, will take effect July 1, 1999 as detailed below. Once the final rule is approved by the Office of Administrative Law and signed by the Secretary of State it will replace the emergency rule as a permanent regulation.
Summary of emergency and proposed permanent revisions
The major purpose of the emergency and proposed permanent revisions to Section 5193 is to increase protection from sharps injuries, which can transmit bloodborne pathogens in the workplace, by putting into place stronger requirements for employers to use needles and other sharps which are engineered to reduce the chances of inadvertent needlesticks or sharps injuries.
The major revisions consist of the following:
1. (Operative July 1, 1999) Subsection (d)(3)(A):
Addition of requirements to use "needleless systems, needle devices with engineered sharps injury protection, and non-needle sharps with engineered sharps injury protection," subject to 4 exceptions, which are: (1) lack of market availability; (2) information indicating that the device will jeopardize patient care or safety; (3) information indicating that the device is not more effective in reducing sharps injuries than the device currently used by the employer; and (4) lack of sufficient information to determine whether a new device on the market will effectively reduce the chances of a sharps injury.
2. (Operative when the emergency standard takes effect) Subsections (c)(2)(A) and (c)(2)(B):
A requirement to keep a sharps injury log, which records the date and time of each sharps injury resulting in an exposure incident, as well as the type and brand of device involved in the exposure incident.
3. Operative July 1, 1999) Subsection (c)(2)(C):
A series of 8 additional items of information pertaining to the circumstances under which a logged sharps injury occurred, which must be included in the sharps injury log.
4. Operative July 1, 1999: Subsections (c)(1)(B) 4. through (c)(1)(B)(8), and (c)(1)(D)(2):
A series of new requirements which are related to the new provisions described above and improve the effectiveness of the exposure control plan required by subsection (c).
5. (Operative when the emergency standard takes effect)
The addition of Hepatitis C, or "HCV" as a specifically identified bloodborne pathogen wherever HIV and HBV are mentioned in the regulation.
6. (Operative when the emergency standard takes effect)
A substantial reorganization of subsection (d) of the bloodborne pathogens standard, which contains all of the requirements for engineering, work practice, and PPE control measures.
Cal/OSHA Consultation Service
On-site assistance with understanding and implementation of the emergency and permanent rules can be requested by contacting the Cal/OSHA Consultation Service at 1-800-963-9424. Offices are located in San Diego, Van Nuys, Oakland, and Sacramento.
Please note that the Consultation Service publication "Bloodborne Pathogens Resource Package" last revised March 1993 will need to be revised for the new regulatory requirements once the permanent rulemaking discussed above is completed. However, much of the interpretative information provided in that document continues to be applicable. It should be noted that the emergency and proposed permanent revisions to Section 5193 include renumbering of subsections and addition and reorganization of existing language for the purpose of clarifying employers' responsibilities under the standard.
There is a wealth of information on the internet that can provide assistance in understanding and complying with the revised Cal/OSHA standard for bloodborne pathogens. These include:
Safety & Health Fact Sheet: Safety Needles & Needleless Systems. This fact sheet includes a summary of the new requirements, suggested approaches for coming into compliance, frequently asked questions, and a list of additional resources.
http://www.osha.gov This is the website of federal OSHA. Click on the Subject Index box on the homepage and choose "bloodborne pathogens" and also "needlestick injuries" for a range of information on safer needle devices, hazards in particular healthcare settings, etc.
http://www.dhs.ca.gov/ohb/SHARPS/Default.htm This is the website of The Sharps Injury Control Program (SHARPS) in the California Department of Health Services' Occupational Health Branch. The program was established by Senate Bill 2005 to study sharps injuries in hospitals, skilled nursing facilities, and home health agencies in California.
http://hsc.virginia.edu/~epinet/ This is the website of the International Healtcare Worker Safety Center at the University of Virginia. The Center developed and distributes software for tracking sharps injuries. The website also offers access to extensive information on sharps injury collected from the approximately 70 hospitals that participate in the EPINet data-sharing network coordinated by the International Health Care Worker Safety Center. The Center also publishes Advances in Exposure Prevention.
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