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)

Julie Spangler

Division                                                                  Contact

50 W. Town St. Suite 700 Columbus OH 43215-0000 614-644-2752

Agency Mailing Address (Plus Zip)                                       Phone                     Fax

[e-mail]

Email

3745-89-04

Rule Number

AMENDMENT

TYPE of rule filing

Rule Title/Tag Line              Renewal of laboratory certification.

RULE SUMMARY

1.  Is the rule being filed for five year review (FYR)? 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: 3745.11, 6109.04

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

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

This rule has been reviewed pursuant to the five year rule requirements set forth in section 106.03 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:

This rule describes the process and requirements for renewal of a laboratory's certification. Changes include the addition of detailed renewal fee information and a requirement for annual review of the quality assurance plan.

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 refers to the Ohio Administrative and Revised Codes. In accordance with 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. If applicable, indicate each specific paragraph of the rule that has been modified:

Ohio EPA held the rules in TBR status to hold an additional public hearing. The rules are now being refiled without change.

12.  Five Year Review (FYR) Date: 1/5/2015

(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.

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

Ohio EPA will determine compliance with the rule requirements and issue notices of violation as appropriate. These activities are within the normal operating business of the agency and are not expected to have an impact on the agency's current budget or require additional appropriations.

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:

Please see Attachment I for an estimated cost of compliance for rules 3745-89-03 and 3745-89-04 of the Administrative Code.

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.

S.B. 2 (129th General Assembly) Questions

18.  Has this rule been filed with the Common Sense Initiative Office pursuant to

R.C. 121.82? Yes

19.  Specific to this rule, answer the following:

A.) Does this rule require a license, permit, or any other prior authorization to engage in or operate a line of business? Yes

Rules in Chapter 3745-89 of the Administrative Code are operating procedures and various requirements for laboratories that have or are seeking certification.

B.) Does this rule impose a criminal penalty, a civil penalty, or another sanction, or create a cause of action, for failure to comply with its terms? Yes

Violation of this rule could subject a laboratory or public water system to potential civil, administrative or criminal penalties, or suspension or revocation of their laboratory certification in accordance with Chapter 6109 of the Revised Code.

C.) Does this rule require specific expenditures or the report of information as a condition of compliance? Yes

This rule requires laboratories seeking renewal of Ohio EPA certification to submit a complete application and fee.

                                                                                                                                             

Page B-1                                                                                   Rule Number: 3745-89-04

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

Yes                              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.

Some laboratories are, in part, a public water system, and those incurring costs to comply with this rule may pass some or all of the costs on to their consumers (which may include schools in their service area). However, this is a business decision of each water system over which Ohio EPA has no jurisdiction, and as such, it is difficult for the agency to predict the cost to each individual consumer of the water system. Please see Attachment I for an estimated cost of compliance for rules 3745-89-03 and 3745-89-04.

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 Attachment I for an estimated cost of compliance for rules 3745-89-03 and 3745-89-04.

Page B-2                                                                                   Rule Number: 3745-89-04

(a)  Personnel Costs

See above.

(b)  New Equipment or Other Capital Costs

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.

There are no new requirements imposed by the amendments to this rule; therefore, the agency's and local government's ability to pay are already established and will be unaffected.

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

While there are some costs associated with this rule which may have a negative affect on economic development, the availability of a safe, reliable and adequate water supply, as demonstrated through tests run by certified laboratories, is essential to Ohio's economic success.

                                                                                                                                             

Page E-1                                                                                   Rule Number: 3745-89-04

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 ? Yes

Please list each contact.

Ohio EPA invited interested parties to comment on this rule during the period of July 3 to August 4, 2014. Comments received were considered. A list of interested parties will be furnished upon request.

(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.)

40 CFR Part 142.10 was considered. A copy of this rule will be furnished upon request.

Page E-2                                                                                   Rule Number: 3745-89-04

(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

Not Applicable

(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

                                                                                                                                             

RSFA for rules 3745-89-03 to 3745-89-04

Attachment I, Estimated Cost of Compliance

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 382 certified laboratories exist in Ohio at this time, many of which maintain multiple certifications. County, township and municipal labs account for approximately 95% (362 labs) of the certified laboratories in Ohio. The remaining labs are privately owned. Ohio EPA records indicate that labs spend approximately $517,650.00 annually in fees to the Agency to maintain their certifications.

Proficiency Testing

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 are estimated at $144,155.00.* This estimate includes the cost of the product. All other costs (e.g., indirect and 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 for which the lab applies, the cost will vary. Some labs are only certified to perform very basic testing, while others may be certified to perform more extensive 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 (e.g., copying, mailing, updating, etc.) costs. Capital and operations costs are not applicable. Estimates for developing the plans ranged from ten to ninety hours. Estimates on rates of lab personnel who write the plan vary from $11.00 to $54.00 per hour.*

Quality Assurance Plan Expenses

Cost Category                    Low Estimate                                                 High Estimate

Personnel Costs Indirect Costs

10 hours at $11/hour = $110 15% of $110 = $17

90 hours at $54/hour = $4,860 15% of $4,860 = $729

Totals                                    $127                                                                $5,589

Totals

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

Certification Fees:                               $517,650.00 Proficiency Tests:                               $144,155.00

$661,805.00 (Average of $1732.00 per lab)

In addition, each lab will spend approximately $127 to $5,589 as a one-time cost to develop a quality assurance plan.

*The estimates presented were updated using the U.S. Bureau of Labor Statistics inflation calculator.