3745-89-04 Renewal of laboratory certification.

 

 

 

Rule Summary and Fiscal Analysis (Part A)

 

Ohio Environmental Protection Agency

Agency Name

 

Division of Drinking and Ground Water (DDAGW)

Gina L. Hayes

Division                                                                  Contact

50 West Town Street, Suite 700 PO Box 1049 Columbus OH 43216-1049

614-644-3497        614-644-2909

Agency Mailing Address (Plus Zip)                                       Phone                     Fax

3745-89-04

Rule Number

NO CHANGE

TYPE of rule filing

Rule Title/Tag Line              Renewal of laboratory certification.

RULE SUMMARY

1.  Is the rule being filed consistent with the requirements of the RC 119.032 review? Yes

2.  Are you proposing this rule as a result of recent legislation? No

3.  Statute prescribing the procedure in accordance with the agency is required to adopt the rule: 119.03

4.  Statute(s) authorizing agency to adopt the rule: RC Section 3745.11, 6109.04

5.  Statute(s) the rule, as filed, amplifies or implements: RC Section 3745.11, 6109.04

6.  State the reason(s) for proposing (i.e., why are you filing,) this rule:

This rule is being filed to fulfill the five year rule review requirements of section

119.032 of the Revised Code.

7.  If the rule is an AMENDMENT, then summarize the changes and the content of the proposed rule; If the rule type is RESCISSION, NEW or NO CHANGE, then summarize the content of the rule:

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The rule describes the process and requirements for renewal of a laboratory's certification.

8.  If the rule incorporates a text or other material by reference and the agency claims the incorporation by reference is exempt from compliance with sections

121.71 to 121.74 of the Revised Code because the text or other material is generally available to persons who reasonably can be expected to be affected by the rule, provide an explanation of how the text or other material is generally available to those persons:

This rule includes references to the Ohio Administrative and Revised Codes. According to Section 121.76 of the Revised Code, these references are exempt from the requirements of Sections 121.71 to 121.75.

9.  If the rule incorporates a text or other material by reference, and it was infeasible for the agency to file the text or other material electronically, provide an explanation of why filing the text or other material electronically was infeasible:

Not Applicable.

10.  If the rule is being rescinded and incorporates a text or other material by reference, and it was infeasible for the agency to file the text or other material, provide an explanation of why filing the text or other material was infeasible:

Not Applicable.

11.  If revising or refiling this rule, identify changes made from the previously filed version of this rule; if none, please state so:

Not Applicable.

12. 119.032 Rule Review Date: 7/10/2008 and 07/10/2013

(If the rule is not exempt and you answered NO to question No. 1, provide the scheduled review date. If you answered YES to No. 1, the review date for this rule is the filing date.)

NOTE: If the rule is not exempt at the time of final filing, two dates are required: the current review date plus a date not to exceed 5 years from the effective date for Amended rules or a date not to exceed 5 years from the review date for No Change rules.

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FISCAL ANALYSIS

13.  Estimate the total amount by which this proposed rule would increase / decrease either revenues / expenditures for the agency during the current biennium (in dollars): Explain the net impact of the proposed changes to the budget of your agency/department.

This will have no impact on revenues or expenditures. 0.00

This rule will have no impact on agency revenues or expenditures.

14.  Identify the appropriation (by line item etc.) that authorizes each expenditure necessitated by the proposed rule:

Not Applicable.

15.  Provide a summary of the estimated cost of compliance with the rule to all directly affected persons. When appropriate, please include the source for your information/estimated costs, e.g. industry, CFR, internal/agency:

As is explained in RSFA Attachment B - Estimated cost of compliance, it is estimated that the labs in Ohio will spend an estimated $579,500 per year to comply with the requirements of rule 3745-89-03 and this rule. This breaks down to an average of $1,588 per certified laboratory per year.

16.  Does this rule have a fiscal effect on school districts, counties, townships, or municipal corporations? Yes

You must complete Part B of the Rule Summary and Fiscal Analysis in order to comply with Am. Sub. S.B. 33 of the 120th General Assembly.

17.  Does this rule deal with environmental protection or contain a component dealing with environmental protection as defined in R. C. 121.39? Yes

You must complete the Environmental rule Adoption/Amendment Form in order to comply with Am. Sub. 106 of the 121st General Assembly.

                                                                                                                                             

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Rule Summary and Fiscal Analysis (Part B)

1.  Does the Proposed rule have a fiscal effect on any of the following?

(a)  School Districts

(b)    Counties                                 (c) Townships           (d) Municipal

Corporations

No                                Yes                              Yes                              Yes

2.  Please provide an estimate in dollars of the cost of compliance with the proposed rule for school districts, counties, townships, or municipal corporations. If you are unable to provide an estimate in dollars, please provide a written explanation of why it is not possible to provide such an estimate.

Please see RSFA Attachment B.

3.  If the proposed rule is the result of a federal requirement, does the proposed rule exceed the scope and intent of the federal requirement? No

4.  If the proposed rule exceeds the minimum necessary federal requirement, please provide an estimate of, and justification for, the excess costs that exceed the cost of the federal requirement. In particular, please provide an estimate of the excess costs that exceed the cost of the federal requirement for (a) school districts, (b) counties, (c) townships, and (d) municipal corporations.

Not Applicable.

5.  Please provide a comprehensive cost estimate for the proposed rule that includes the procedure and method used for calculating the cost of compliance. This comprehensive cost estimate should identify all of the major cost categories including, but not limited to, (a) personnel costs, (b) new equipment or other capital costs, (c) operating costs, and (d) any indirect central service costs.

Please see RSFA Attachment B.

(a)  Personnel Costs

See above.

(b)  New Equipment or Other Capital Costs

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See above.

(c)  Operating Costs

See above.

(d)  Any Indirect Central Service Costs

See above.

(e)  Other Costs

See above.

6.  Please provide a written explanation of the agency's and the local government's ability to pay for the new requirements imposed by the proposed rule.

The agency's and local government's ability to pay are already established and will be unaffected by this rulemaking.

7.  Please provide a statement on the proposed rule's impact on economic development.

This rule will have no impact on economic development.

                                                                                                                                             

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Environmental Rule Adoption/Amendment Form

Pursuant to Am. Sub. H.B. 106 of the 121st General Assembly, prior to adopting a rule or an amendment to a rule dealing with environmental protection, or containing a component dealing with environmental protection, a state agency shall:

(1)    Consult with organizations that represent political subdivisions, environmental interests, business interests, and other persons affected by the proposed rule or amendment.

(2)   Consider documentation relevant to the need for, the environmental benefits or consequences of, other benefits of, and the technological feasibility of the proposed rule or rule amendment.

(3)  Specifically identify whether the proposed rule or rule amendment is being adopted or amended to enable the state to obtain or maintain approval to administer and enforce a federal environmental law or to participate in a federal environmental program, whether the proposed rule or rule amendment is more stringent than its federal counterpart, and, if the proposed rule or rule amendment is more stringent, the rationale for not incorporating its federal counterpart.

(4)   Include with the proposed rule or rule amendment and rule summary and fiscal analysis required to be filed with the Joint Committee on Agency Rule Review information relevant to the previously listed requirements.

(A)  Were organizations that represent political subdivisions, environmental interests, business interests, and other persons affected by the proposed rule or amendment consulted ? No

Please list each contact.

According to Sections 119.03 and 6109.04 (D) of the Revised Code, interested parties need only be consulted if a rule is being adopted, amended, or rescinded. This rule is being filed as "no change" pursuant to a 119.032 rule review and therefore no interested party consultation is necessary.

(B)  Was documentation that is relevant to the need for, the environmental benefits or consequences of, other benefits of, and the technological feasibility of the proposed rule or amendment considered ? Yes

Please list the information provided and attach a copy of each piece of documentation to this form. (A SUMMARY OR INDEX MAY BE ATTACHED IN LIEU OF THE ACTUAL DOCUMENTATION.)

CFR § 142.10 Requirements for determination of primary enforcement responsibility: (3)(i) The establishment and maintenance of a State program for the

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certification of laboratories conducting analytical measurements of drinking water contaminants pursuant to the requirements of the State primary drinking water regulations including the designation by the State of a laboratory officer, or officers, certified by the Administrator, as the official(s) responsible for the State's certification program. The requirements of this paragraph may be waived by the Administrator for any State where all analytical measurements required by the State's primary drinking water regulations are conducted at laboratories operated by the State and certified by the Agency. Until such time as the Agency establishes a national quality assurance program for laboratory certification the State shall maintain an interim program for the purpose of approving those laboratories from which the required analytical measurements will be acceptable.

ORC 6109.04 (C)(6): [The director may] establish and maintain a program for the certification of laboratories conducting analyses of drinking water.

(C)  Is the proposed rule or rule amendment being adopted or amended to enable the state to obtain or maintain approval to administer and enforce a federal environmental law or to participate in a federal environmental program ? Yes

Is the proposed rule or rule amendment more stringent than its federal counterpart ? No

(D)  If this is a rule amendment that is being adopted under a state statute that establishes standards with which the amendment is to comply, is the proposed rule amendment more stringent than the rule that it is proposing to amend? No

Not Applicable

                                                                                                                                             

Certification fees

Rules 3745-89-03 and 3745-89-04 require that laboratories in Ohio be certified every three years to perform analysis of drinking water. Approximately 365 certified labs exist in Ohio at this time, many of which maintain multiple certifications. County, township, and municipal labs account    for approximately 89% (325 labs) of the certified labs in Ohio. The rest are commercial (private) labs. Ohio EPA records indicate that labs have spent approximately $326,000 annually in      fees to the agency to maintain their certifications. Taking into account the increase in certification fees made by House Bill 95, effective July 1, 2003, we estimate that laboratories will now spend an approximate $446,500 annually in fees to maintain their certification.

Proficiency testing

Also as part of the laboratory certification program, labs must perform analysis of proficiency test samples annually. Based on price quotes from various vendors, the annualized costs of performance testing for all labs in Ohio is estimated at approximately $133,000. This estimate includes the cost of the product. All other costs (indirect, personnel) are negligible.

Quality Assurance Plan

As part of the certification process, laboratories must submit a quality assurance plan for approval by the director. Depending upon the number and type of certifications the lab applies for, the cost will vary. Some labs are only certified to perform very basic testing, while others may be certified to perform all types of testing. High and low estimates for developing the plans are outlined below. These costs were obtained from various

labs in Ohio and from agency personnel. Costs to develop these plans include personnel costs to write the plans and indirect (copying, mailing, updating, etc...) costs. Capital costs and operational costs are not applicable. Estimates for developing the plans ranged from 10 hours up to 90 hours. Estimates on rates of lab personnel who write the plan vary from $10/hour up to $50/hour.

Quality Assurance Plan Expenses

Cost category	Low estimate	High estimate
Personnel costs Indirect costs	10 hours at $10/hour = $100 15% of $100 = $15	90 hours at $50/hour = $4500 15% of $4500 = $675
TOTALS	$115	$4175

Totals

Total statewide costs for this rule (on an annual basis) are approximately:

Certification fees	$446,500
Proficiency testing	$133,000
	$579,500	(Average of $1,588 per lab)

In addition, each lab will spend an additional $115 to $4175 as a one-time cost to develop a quality assurance plan.

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