3745-89-03 Procedure for laboratory certification.  

  • Text Box: ACTION: To Be Refiled Text Box: DATE: 03/21/2016 2:23 PM

     

     

     

    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

    susan.kramer@epa.ohio.gov

    Email

    3745-89-03

    Rule Number

    AMENDMENT

    TYPE of rule filing

    Rule Title/Tag Line              Procedure for 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 explains the procedure for obtaining laboratory certification. It includes fee information and references Section 3745.11 of the Revised Code. The rule also describes the allowable amounts of unacceptable results to match U.S. EPA's requirements and references the latest editions of Ohio EPA's laboratory certification manuals (chemical and microbiological). Additionally, the rule contains information explaining that the director may issue, deny, suspend or revoke certification in accordance with rule 3745-89-06 of the Administrative Code. Revisions includes updating cross-references, adding a reference to Chapter 3745-90 and adding a provision to certify laboratories for analyzing total microcystins and cyanobacteria screening.

    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 requirements in section 3745.11 of the Revised Code and several rules in the Administrative Code. In accordance with section 121.76 of the Revised Code, these references are exempt from the requirements of sections 121.71 to

    121.75 of the Revised Code.

    This rule also incorporates by reference a U.S. EPA document entitled "Manual for the Certification of Laboratories Analyzing Drinking Water" dated January 2005, as supplemented June 2008 and November 2012, and two Ohio EPA documents entitled "Ohio EPA Laboratory Manual for the Microbiological Analyses of Public Drinking Water 2014." The 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 the U.S. EPA and the Ohio EPA, who provide the national and state leadership in certification of laboratories for environmental monitoring, respectively. In addition, this rule includes information on how the person 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 increase revenues. 43,400.00

    Ohio EPA's revenues will somewhat increase after this rule becomes effective because laboratories applying to become certified to perform microcystins and cyanobacteria analyses will be subject to certification fees. Currently, the Division of Environmental Services, Laboratory Certification Section has given temporary acceptance to some certified laboratories that are using the appropriate techniques

    for these analyses. If every laboratory that currently has acceptance would apply for certification to perform these analyses, then every three years the Laboratory Certification Section would see increased revenue of about $43,400. However, it is likely the increase in revenues will somewhat counterbalance the increase in Ohio EPA's expenditures to certify laboratories for these analyses.

    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 an explanation of the 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 applying for certification from Ohio EPA to submit a detailed laboratory plan, a quality assurance plan, an application for certification and the appropriate fee.

    Text Box: ACTION: To Be Refiled                                                                                                                                              Text Box: DATE: 03/21/2016 2:23 PM

    Page B-1                                                                                   Rule Number: 3745-89-03

    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 the attachment to this rule, "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? Yes

    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.

    This rule exceeds the scope of federal requirements by not accepting all federally approved analytical methods. For example, the Laboratory Certification Section does not certify ASTM methods. ASTM methods are almost identical to their Standard Method counterparts. The difference is in the quality control (QC) requirements for the ASTM methods, which are less stringent than those in the Standard Methods. The more stringent Standard Methods allow for greater confidence in the results and the associated QC requirements. This is a practice that the Agency has had in place for several years.

    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 the attachment to this rule, "Cost of compliance for rules 3745-89-03 and 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.

    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.

    Text Box: ACTION: To Be Refiled                                                                                                                                              Text Box: DATE: 03/21/2016 2:23 PM

    Page E-1                                                                                   Rule Number: 3745-89-03

    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: 3745-89-03

    (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 ? Yes

    What is the rationale for not incorporating the federal counterpart?

    This rule exceeds the scope of federal requirements by not accepting all federally approved analytical methods. For example, the Laboratory Certification Section does not certify ASTM methods. ASTM methods are almost identical to their Standard Method counterparts. The difference is in the quality control (QC) requirements for the ASTM methods, which are less stringent than those in the Standard Methods. The more stringent Standard Methods allow for greater confidence in the results and the associated QC requirements. This is a practice that the Agency has had in place for several years.

    (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

    Text Box: ACTION: To Be Refiled                                                                                                                                              Text Box: DATE: 03/21/2016 2:23 PM

    Cost of Compliance for rules 3745-89-03 to 3745-89-04 RSFA Attachment

    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 the total annual cost for all labs in Ohio to maintain their certification is approximately $517,650.00.

    The new provisions in this rule will increase the cost of compliance for the laboratories wanting to become certified to perform microcystins and  cyanobacteria analyses. Currently, the Division of  Environmental Services, Laboratory Certification Section has given temporary acceptance to some certified laboratories that are using the appropriate techniques for these analyses. If every laboratory that currently has acceptance would apply for certification to perform these analyses, then every three years the Laboratory Certification Section would see increased revenue of about $43,000.

    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 total annual  costs 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.

    *The estimates presented were updated using the U.S. Bureau of Labor Statistics inflation calculator (Oct. 2014).

    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.*

    *The estimates presented were updated using the U.S. Bureau of Labor Statistics inflation calculator (Oct. 2014).

    Dec. 2015

    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.

    Lastly, if every laboratory with current acceptance to perform the microcystins and cyanobacteria analyses applied to become certified, the total for certification fees would increase by $43,000 every three years.

    Dec. 2015                                                                                                                                                                                Page 2