Titles of Regulations: 12VAC5-90. Regulations for Disease Reporting and Control (adding 12VAC5-90-215).

12VAC5-120. Regulations for Testing Children for Elevated Blood-Lead Levels (repealing 12VAC5-120-10 through 12VAC5-120-90).

Statutory Authority: §§ 32.1-12, 32.1-35, and 32.1-46.1 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: August 31, 2015.

Agency Contact: Diane Woolard, Ph.D., Director, Division of Surveillance and Investigation, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-8124, or email diane.woolard@vdh.virginia.gov.

Basis: Section 32.1-35 of the Code of Virginia directs the State Board of Health to promulgate regulations specifying which diseases occurring in the Commonwealth are to be reportable and the method by which they are to be reported. Section 32.1-46.1 of the Code of Virginia authorizes the board to establish a protocol for the identification of children with elevated blood lead levels. The State Board of Health is empowered to adopt such regulations as are necessary to carry out provisions of laws of the Commonwealth administered by the State Health Commissioner by § 32.1-12 of the Code of Virginia.

Purpose: The proposed amendment will improve the ability of the Virginia Department of Health to conduct surveillance and implement disease control for detectable blood lead levels in children. The Virginia Department of Health is proposing an amendment to the regulations in order to bring them into compliance with recent changes in the field of environmental disease control that are needed to protect the health of the residents of Virginia. The changes will position the agency to better detect and respond to these illnesses to protect the health of the public.

The amendments to the cancer reporting and gamete donor testing requirements that were included in the Notice of Intended Regulatory Action will not be pursued at this time.

Substance: The section on testing children to determine their blood lead levels is new to the Regulations for Disease Reporting and Control (12VAC5-90) but reflects minor amendments to existing requirements that are currently included in another set of agency regulations, 12VAC5-120. The agency decided it was a logical and efficient change to incorporate the lead testing requirements into the set of regulations that addresses the reporting of elevated blood lead levels. Having one set of regulations on this topic should reduce confusion among the regulated community.

12VAC5-120, the existing regulation pertaining to the identification of children with elevated blood lead levels, is being repealed as its content is being incorporated into 12VAC5-90. Some changes to the requirements are proposed as well. The changes simplify and clarify the requirements, remove unnecessary references to guidelines and nonmandatory actions, and reflect current Centers for Disease Control and Prevention recommendations. The proposed amendment to 12VAC5-90 pertaining to blood lead levels in children reflects a similar schedule of testing, risk factors for testing, criteria for determining low risk, and need for confirmatory testing as is currently provided in 12VAC5-120.

Issues: The primary advantages to the public will be clearer rules for testing children for exposure to lead and less confusion that is inherent in maintaining two sets of regulations pertaining to the same subject and procedures.

The primary advantages to the agency are the same as for the public. That is, elimination of the confusion caused by needing to track multiple sets of regulations or the potential for inconsistent requirements in different regulations.

No disadvantages or other pertinent matters of interest to the regulated community have been identified.

Small Business Impact Review Report of Findings: This regulatory action serves as the report of the findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health proposes to consolidate rules for testing lead levels above certain thresholds in children’s blood and for reporting of cases.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Currently, there are two related regulations on testing lead levels in children's blood. One of the regulations (12VAC5-120) addresses testing for blood levels and various subsequent actions that must be taken if the lead levels are above certain thresholds. The other regulation (12VAC5-90) addresses reporting of cases if the test results are above the thresholds. This proposed action will consolidate both sets of regulations in 12VAC5-90 and will clarify the existing language. While the proposed changes also include a minor change in the lead levels that trigger subsequent action, according to VDH, the proposed levels have been followed in practice for a few years already. Since the proposed action will consolidate two separate sets of regulations under one, it will likely improve the clarity of the regulations and help the public find all of the testing and reporting requirements on this subject in one chapter. Because there will be no change in practice, no significant economic impact is anticipated.

Businesses and Entities Affected. These regulations apply primarily to physicians who diagnose and treat children. There are approximately 1,200 pediatricians and 3,300 family practitioners in Virginia.

Localities Particularly Affected. The regulations apply throughout the Commonwealth.

Projected Impact on Employment. The proposal amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments are unlikely to significantly affect small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments are unlikely to adversely affect small businesses.

Real Estate Development Costs. The proposed amendments are unlikely to affect real estate development costs.

Legal Mandate. General: The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order Number 17 (2014). Section 2.2-4007.04 requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the report should include but not be limited to:

• the projected number of businesses or other entities to whom the proposed regulation would apply,

• the identity of any localities and types of businesses or other entities particularly affected,

• the projected number of persons and employment positions to be affected,

• the projected costs to affected businesses or entities to implement or comply with the regulation, and

• the impact on the use and value of private property.

Small Businesses: If the proposed regulation will have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include:

• an identification and estimate of the number of small businesses subject to the proposed regulation,

• the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents,

• a statement of the probable effect of the proposed regulation on affected small businesses, and

• a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation.

Additionally, pursuant to § 2.2-4007.1, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules is notified at the time the proposed regulation is submitted to the Virginia Register of Regulations for publication. This analysis shall represent DPB's best estimate for the purposes of public review and comment on the proposed regulation.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the results of the analysis performed by the Department of Planning and Budget, specifically, the benefits likely exceed the costs for all proposed changes.

Summary:

The proposed amendments incorporate the testing and risk determination criteria for identifying children with elevated blood lead levels into 12VAC5-90 and repeal 12VAC5-120, the existing regulation pertaining to blood lead testing of children.

Part IX
Protocol for Identification of Children with Elevated Blood Lead Levels

12VAC5-90-215. Schedule and criteria for and confirmation of blood lead testing and information to be provided.

A. Schedule for testing. Every child shall be tested to determine the blood lead level at 12 months and 24 months of age if the health care provider determines that the child meets any of the criteria listed in subsection B of this section. Children 25 months through 72 months of age who present for medical care and meet any of criteria of subsection B of this section shall also be tested if they have either not previously been tested for blood lead level or were previously tested but experienced a change since testing that has resulted in an increased risk of lead exposure based on the criteria listed in subsection B of this section.

B. Criteria for testing.

1. The child is eligible for or receiving benefits from Medicaid or the Special Supplemental Nutrition Program for Women, Infants and Children (WIC);

2. The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1960;

3. The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1978 that has (i) peeling or chipping paint or (ii) recent (within the last six months) ongoing or planned renovations;

4. The child is living in or regularly visiting a house, apartment, dwelling, or other structure in which one or more persons have blood lead testing yielding evidence of lead exposure;

5. The child is living with an adult whose job, hobby, or other activity involves exposure to lead;

6. The child is living near an active lead smelter, battery recycling plant, or other industry likely to release lead;

7. The child's parent, guardian, or other person standing in loco parentis requests the child's blood be tested due to any suspected exposure; or

8. The child is a recent refugee or immigrant or is adopted from outside of the United States.

C. Exceptions. A child who does not meet any of the schedule or criteria provided in subsection A or B of this section is considered to be at low risk, and testing is not required but may be conducted at the discretion of the health care provider. The testing requirement shall be waived if the parent, guardian, or other person standing in loco parentis of a child objects to the testing on the basis that the procedure conflicts with his religious tenets or practices.

D. Confirmation of blood lead levels. Blood lead level testing shall be performed on venous or capillary blood. Tests of venous blood performed by a laboratory certified by the federal Centers for Medicare & Medicaid Services in accordance with 42 USC § 263a, the Clinical Laboratory Improvement Amendment of 1988 (CLIA-certified), are considered confirmatory. Tests of venous blood performed by any other laboratory and tests of capillary blood shall be confirmed by a repeat blood test, preferably venous, performed by a CLIA-certified laboratory. Such confirmatory testing shall be performed in accordance with the following schedule:

1. Within one to three months if the result of the capillary test is at or above the CDC's reference value and up to 9 micrograms of lead per deciliter of whole blood (µg/dL).

2. Within one week to one month if the result of the capillary test is 10-44 µg/dL. The higher this test result, the more urgent the need for a confirmatory test.

3. Within 48 hours if the result of the capillary test is 45-59 µg/dL.

4. Within 24 hours if the result of the capillary test is 60-69 µg/dL.

5. Immediately as an emergency laboratory test if the result of the capillary test is 70 µg/dL or higher.

E. Information to be provided. As part of regular well-check visits for all children, the health care provider shall make available to parents, guardians, or other persons standing in loco parentis information on the dangers of lead poisoning, potential sources of lead and ways to prevent exposure, and a list of available lead-related resources. When blood lead level testing is performed, the health care provider shall share the child's blood lead level test result with the child's parent, guardian, or other person standing in loco parentis and report to the local health department in accordance with the requirements of 12VAC5-90-80.