3745-89-05 Requirements for maintaining laboratory certification.

 

 

 

Rule Summary and Fiscal Analysis (Part A)

 

Ohio Environmental Protection Agency

Agency Name

 

Division of Drinking and Ground Water (DDAGW)

Susan Kramer

Division                                                                  Contact

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

614-644-2763        614-644-2909

Agency Mailing Address (Plus Zip)                                       Phone                     Fax

[e-mail]

Email

3745-89-05

Rule Number

AMENDMENT

TYPE of rule filing

Rule Title/Tag Line              Requirements for maintaining laboratory certification.

RULE SUMMARY

1.  Is the rule being filed for five year review (FYR)? No

2.  Are you proposing this rule as a result of recent legislation? Yes

Bill Number: SB1                   General Assembly: 131           Sponsor: Sen. Gardner and

Sen. Peterson

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: 6109.03, 6109.04

5.  Statute(s) the rule, as filed, amplifies or implements: 6109.03, 6109.04, 3745.50

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

This rule is proposed with amendments in response to recently enacted section 3745.50(C) of the Revised Code, which requires the Director of Ohio EPA to develop and implement protocols and actions for cyanotoxin testing in public water systems.

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 requirements for maintaining laboratory certification. Revisions to the rule include adding references to Chapter 3745-90.

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 rules in the Administrative Code. In accordance with section

121.76 of the Revised Code, such references are exempt from the requirements of section 121.71 to 121.75.

This rule also incorporates by reference two Ohio EPA documents entitled "Ohio EPA Laboratory Manual for the Microbiological Analyses of Public Drinking Water 2014" and the "Ohio EPA Laboratory Manual for the Chemical Analyses of Public Drinking Water 2014." Ohio EPA believes these manuals are exempt from sections 121.71 to 121.74 of the Revised Code because they are generally accepted industry standards that are readily available to persons who are reasonably expected to be affected by the rule. The referenced manuals are published by Ohio EPA. In addition, this rule includes information on how persons and businesses affected by this rule, the laboratories and analysts who perform analyses of drinking water for public water systems in Ohio, can obtain copies of each of the manuals.

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:

This rule is being revised to correct the year listed on the public notice from 2015 to 2016.

12.  Five Year Review (FYR) Date: 5/4/2020

(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 RSFA Part B for a summary of the estimated cost of compliance.

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 include 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 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 to maintain specific types of documentation for their certification.

                                                                                                                                             

Page B-1                                                                                   Rule Number: 3745-89-05

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.

This rule requires laboratories to maintain records of their compliance with the certification requirements in Chapter 3745-89. The cost associated with record maintenance includes the cost of storage, and will depend on the volume of records to be maintained as well as how they are maintained. Most laboratories use paper records, while some commercial laboratories have adopted electronic record keeping systems.

For a laboratory using paper records, maintenance could required from one to several filing cabinets. The cost could range from $325 to $1,517 for purchasing filing cabinets or maintaining a large amount of records at an off-site location (e.g., National Centers in Ohio). The cost for an electronic Laboratory Information System (LIMS) database, for a laboratory processing a high volume of samples, is estimated to be between $40,000 and $60,000 for hardware and software, and approximately $271 for an annual software license fee for each person using it.

Please note that commercial laboratories will have LIMS to process all samples regardless of whether or not they are certified for drinking water sampling. This cost is not a direct result of the drinking water laboratory certification program.

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.

For a laboratory using paper records, maintenance could required from one to several filing cabinets. The cost could range from $325 to $1,517 for purchasing filing cabinets or maintaining a large amount of records at an off-site location (e.g., National Centers in Ohio). The cost for an electronic Laboratory Information System (LIMS) database, for a laboratory processing a high volume of samples, is estimated to be between $40,000 and $60,000 for hardware and software, and approximately $271 for an annual software license fee for each person using it.

Please note that commercial laboratories will have LIMS to process all samples regardless of whether or not they are certified for drinking water sampling. This cost is not a direct result of the drinking water laboratory certification program.

(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.

The agency's ability to pay is already established and will be unaffected.

There will be some increased costs to local government. The 1996 Amendments to the Safe Drinking Water Act provided capitalization grants to states with primary enforcement authority to help fund infrastructure improvements needed to comply with the new requirements. These grants fund the Water Supply Revolving Loan Fund, which provides low-interest loans to community and not for profit water systems. Loans can provide support for design work in addition to capital improvements. Ohio EPA has dedicated funds from the WSRLA to assist with some of the costs associated with these rules. Specifically, Ohio EPA has made $1 million in grants available to surface water public water systems to enhance their monitoring capacity for cyanotoxins and harmful algal blooms. A public water system can apply for up to $30,000 to purchase equipment for monitoring and analysis and to fund training. In addition, fifty million dollars in zero-percent interest rate loans are available to surface water public water systems for enhanced water treatment infrastructure.

Operating costs would also be supported through conventional mechanisms such as collecting fees from customers based on the amount of water used or rental fees.

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

Some of the requirements of the rules will provide new economic opportunities for commercial certified laboratories performing sample analysis.

                                                                                                                                             

Page E-1                                                                                   Rule Number: 3745-89-05

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 September 22 to October 23, 2015. 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. In addition, U.S. EPA's "Drinking Water Health Advisory for the Cyanobacterial Microcystin Toxins," published in June 2015 was considered. Copies will be furnished upon request.

Page E-2                                                                                   Rule Number: 3745-89-05

(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