REGULATORY ANALYSIS
For
Rules Pertaining to the Detection, Monitoring and Investigation of Environmental and Chronic Diseases,
Regulation 1, List C
6 CCR 1009-7
Adopted by the Board of Health on February 15, 2012
1.
A description of the classes of persons who will be affected by the proposed rule, including
classes that will bear the costs of the proposed rule and classes that will benefit from the
proposed rule.
The classes of persons affected by the rule amendments are laboratories reporting blood lead
concentration test results. Physicians, health care providers, and clinics performing blood lead
level (BLL) testing in an office or outpatient setting are also required to report results.
The costs of managing additional case data and investigating the additional adult elevated BLLs
(in the range of 10-25 µg/dL) will be borne by department staff. Salaries for staff supporting
these efforts are covered by the awards of federal funds from the Centers for Disease Control and
Prevention (CDC) for the Occupational Health and Safety Surveillance (OHSS) Program and the
Environmental Public Health Tracking (EPHT) Program. CDPHE staff currently refer all
elevated childhood lead tests to local health departments (LHD). Some LHDs have capacity to
track and/or investigate childhood cases. This proposal does not require LHDs to investigate
adult cases in their jurisdiction. However, the CDPHE OHSS Program will work with LHDs to
conduct any cluster or site investigations that may result from increased monitoring of this
condition.
The classes that will benefit from improved surveillance related to this proposed rule change are
the workers diagnosed with this condition, and adult residents exposed to environmental sources
of lead (i.e. shooting/firing ranges). As take-home exposures are also a concern with
occupational lead exposure, workers’ children and families may also benefit.
This proposed rule change does not require employer reporting of lead test results to CDPHE,
and it does not increase the cost or frequency of lead testing. The U.S. Occupational Safety and
Health Administration (OSHA) establishes workplace lead exposure limits and testing
requirements for General Industry (Standard 1910.1025), Construction (Standard 1926.62), and
Shipyard Employment (Standard 1915.1025).
2.
To the extent practicable, a description of the probable quantitative and qualitative impact
of the proposed rule, economic or otherwise, upon affected classes of persons.
In Colorado, laboratory reporting of elevated BLL tests has been conducted since1996. Our
current system collects 600-800 blood lead tests for individuals age 18 and over each year.
Approximately 90% of these have a BLL result of < 10 µg/dL. This figure suggests that some
reporting laboratories already submit all blood lead tests regardless of blood lead concentration
level. Thus, this modification alone is not expected to result in a large increase in reporting, but
it will allow enhanced surveillance of this condition as described below.
In a given year, our system captures 65-70 individuals age 16 and older with a BLL ≥ 10 µg/dL.
Roughly 70% of these cases (about 45 annually) are in the range of 10-25 µg/dL. Thus, the
increase in follow-back surveillance associated with this proposed rule change would require
physician contact for 45 additional cases annually. As this is state-wide data, the increased
workload to any individual health care provider is anticipated to be very small.
Additionally, some BLL test reports are submitted to CDPHE by paper record and must be handentered into the electronic lab reporting database. Only those tests which meet state reporting
requirements are entered into the database. This proposed rule change would likely result in
additional data entry for a small number of paper record cases each year.
3.
The probable costs to the agency and to any other agency of the implementation and
enforcement of the proposed rule and any anticipated effect on state revenues.
As described in question # 1, costs related to implementation and enforcement of the proposed
rule will be covered by existing staff time. Salaries for CDPHE staff involved with adult and
child lead surveillance are currently 100% supported by federal funds from the CDC. There are
no anticipated effects of the rule modifications on state revenues.
Note that CDPHE will work with local health departments with capacity to investigate adult lead
exposure and poisoning cases.
4.
A comparison of the probable costs and benefits of the proposed rule to the probable costs
and benefits of inaction.
More inclusive reporting requirements for adult blood lead concentrations will benefit citizens
because the associated public health surveillance activities will contribute to improved
knowledge of the incidence and prevalence of this condition in Colorado. This information can
then be used to plan for services and to determine the epidemiology of this condition.
5.
A determination of whether there are less costly methods or less intrusive methods for
achieving the purpose of the proposed rule.
Conducting surveillance for environmental and chronic diseases of public health significance is a
standard procedure of disease control. No alternative methods are available to achieve the
purposes of the authorizing statutes.
6.
A description of any alternative methods for achieving the purpose of the proposed rule
that were seriously considered by the agency and the reasons why they were rejected in
favor of the proposed rule.
No alternative methods for achieving the purpose of the proposed rules were considered because
the rules utilize the widely acted, proven public health methodology of surveillance and
epidemiological investigation.
7.
To the extent practicable, a quantification of the data used in the analysis; the analysis
must take into account both short-term and long-term consequences.
Please refer to the answer to question #2 above for short term consequences. Long term
consequences associated with adult lead surveillance will depend more on the efforts and
capacity of the Occupational Health & Safety Surveillance Program. The Program intends to
conduct a formal evaluation of the adult lead surveillance system, and will use this information
to conduct employer and laboratory outreach and education to promote appropriate lead testing
and reporting. Approval of this proposal will allow for more straight forward messaging about
Colorado’s reporting requirements during this effort.