*This document is one of three the Implementation Work Group prepared in
the course of developing specific recommendations for the FACDQ to
consider. It is intended to be an informational document only. The
recommendations are presented in a separate document.*

**How Do We Promulgate?**

Once the rule is issued in Dec. 2009, what are the DL~nat~ and the
QL~nat~ for uses purposes? Can it be the existing MDL and/or ML until
amended through subsequent rulemaking using the new approach(es)? If
not, then how does the program function without national benchmarks for
some Part 136 methods? Even if we use the existing MDLs and MLs, many
methods do not currently have MDLs and MLs. What if the most
sensitive/appropriate methods do not have a DL~nat~ or QL~nat~ but a
less sensitive/appropriate method does? **EPA These issues are covered
below as well.**

-   **Timeline to Implement FAC Recommendations:**

1.  Dec. 2007 FACDQ consensus report on approach(es) and uses

EPA

-   Confirmatory testing of consensus approach(es)

-   Begins rule-making process

-   Begins planning training/outreach activities

States

-   Continue existing approaches for handling D/Q issues or begins to
    transition as the states choose

> Permittees

-   No change in permits unless states begin to react/transition

> Laboratories

-   No change unless states begin to react/transition

2.  Dec. 2008 EPA proposes rule. Assuming a FACDQ recommendation that
    EPA accepts, propose to amend

-   Part 136 (Analytical Methods) to add new approach(es).

-   Part 122 (EPA Administered Permit Programs: The National Pollutant
    Discharge Elimination System) to add uses provisions.

> EPA

-   Takes comments and continues rulemaking accordingly

-   Conducts training/outreach for states, permittees, labs

> States

-   Comments on proposed EPA rules

-   Participates in EPA training/outreach

-   Continues existing approaches or transitions

-   Begins planning if federal rules are implementable with or without
    state rules

> Permittees

-   Comments on proposed EPA rules

-   Still no change in permits, unless...

> Laboratories

-   Comments on proposed EPArules

-   Still no change unless...

3.  Dec. 2009 Final rule. All DLs and QLs promulgated after this date
    would be required to use the new approach(es). All previously
    promulgated MDLs or MLs would still be valid unless re-promulgated
    using the new approach(es). Preamble to this final rule could
    contain guidance to stakeholders or it could be a separate document
    issued at the same time. Rules should contain dates by which
    entities need to have accomplished certain tasks

-   Time lag for states to modify rules to fully implement regulations

-   Time by which labs need to be fully using the new procedures

> EPA

-   EPA publishes final rule and announces effective date ( ) days
    before actual effective date

-   Implements new rules or oversight of states where delegated

-   Begins promulgation of National Quantitation Limits based on
    priority

> States

-   Begin implementing federal rules or begin state rule promulgation
    (if rules are necessary, it may take another year or two)

-   May need to maintain duplicate system for methods/analytes with
    National QLs versus those without

-   Plan training/outreach to permittees

> Permittees

-   Newly issued permits may specify procedures to be used to set DL and
    QL and other steps resulting from new rules

-   Existing permits may be modified by states to contain new procedures

-   Existing permits may automatically signal changes because of
    language that anticipates rule-making

-   If state does not modify permits or have automatic change language
    in permits, some permits could go 5 years under the current
    requirements

> Laboratories

-   Begin using new procedure

-   May need to maintain duplicate procedures or nomenclature

4.  December 31, 2010 Date by which time labs must have generated QLs
    and Dls using the new procedure

5.  December 31, 2011 Date by which time delegated states must have
    fully implemented procedures that comply with federal requirements

6.  ~~Timeline -- Full implementation will take place over a number of
    years~~

-   ~~Time till EPA is able to promulgate single and multi/inter lab
    procedures, Part 122 changes and any other regulation reference
    changes is estimated to take about 24 months.~~

-   ~~Time for labs to bring switch from MDL to modified ACIL -- with
    the rule noticing requirements of EPA promulgation, labs will have
    advance notice of when changes will likely officially take place.~~

-   ~~Some states will need to change rules to formally incorporate what
    EPA promulgates. This could take another year or two or more.~~

-   ~~Initially, there may be very few analytes that have national QLs.
    States may have to maintain two systems for dealing with this issue
    **State**~~

-   ~~**[Transition Time for labs from Old to New
    Procedure.]{.underline}** One year? **Lab**~~

7.  ~~We would also need to determine the implementation timing.  That
    is when would the new 40 CFR, Part 136, Appendix B procedure take
    effect?  Immediately, or after 90 days, or must State rules be
    changed first?  If some States adopt the need procedure before
    others, the labs may be in an odd predicament of having two maintain
    and report two sets of estimates, depending upon the client.  Also,
    when would the revised reporting for DMRs take effect? **Ind**~~

-   **What else needs to be Promulgated besides what's currently in the
    Uses Document and the Procedures for determining QLs and DLs?**

1.  Currently 40 CFR Part 136 does not require the Appendix B D/Q
    procedure to be used by labs working on CWA programs (except in a
    footnote for a few methods). There should be a requirement to use
    the procedure inserted somewhere in Part 136**. States**

2.  ~~Most Appropriate (sensitive) Method Issues **States**~~

-   ~~Issue where a method has a National QL but the method is not the
    most appropriate. May need to change the Uses Document
    Recommendation 6.B. to apply to "...NPDES Permits and Compliance
    Uses When No National Quantitation Limit Exists or when the existing
    National Quantitation Limit is for a method that is not the most
    appropriate method.~~ Already captured in Uses Document.

> ~~On the issue of Most Appropriate (Sensitive) Method - if we go with
> the language in green (on my version), and there is a more sensitive
> method with no QL Nat, would that result in a permittee not having to
> follow the calculation and reporting requirements in item 6.A.2 of the
> latest uses document even though there is a QL Nat. I don\'t
> necessarily disagree with that outcome, but we should be clear that
> there could be situations (many if a state were to set things up that
> way) where the QL Nat would be \"moot\" unless it performed well in
> different matrices, etc.~~ Ditto

3.  State Flexibility **States**

-   States have specific issues. One state may have situations that do
    not pertain elsewhere. There needs to be flexibility for individual
    states to run programs in ways that make sense for the situations
    they face.

4.  How do you address existing methods that do not have MLs in Part
    136? **States** -- Do we grandfather in existing MLs as National
    Quantitation Limits?

May be the need to differentiate the \"old\" MDL from the \"new \"MDL\",
as well as the QL\'s. There are several reasons for making the
distinction:

a)  EPA should not mix the old DL/QL information with the DL/QL from the
    new procedure. In feeding the DL/QL information it is necessary that
    only data from the new procedure DL/QL be used to help
    determine/update a national table.

b)  b\) States will need to know this information in order to properly
    feed the EPA database. In addition, the states may need to know the
    \"old\" vs the \"new\" to understand why the permittee\'s limits may
    have changed or are different from other permits.

-   c\) Regulators (field staff & office staff) will need to understand
    why sample reports have potentially significant differing DL/QL\'s
    from laboratory to laboratory

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-   **Issues that are dependent on which alternative we recommend for
    generating National Quantitation Limits**

1.  We should also state that Alternate Test Procedures (ATP\'s) will be
    required to use the new procedure(s) and meet (or be more sensitive)
    than existing DL/QL\'s

> **States**

2.  **[Including national QLs in methods prior to promulgation could
    create logistical problems.]{.underline}**

Authority for issuing QLnats probably lies with EPA. How are third party
method developers going to do this? New methods to be considered by EPA
for approval in Part 136 could be required to include single and
multilab QL/DL determined according to procedures recommended by the
FACDQ. EPA could then use this information as the basis for QL nat. This
would allow EPA flexibility to have a single QLnat by analyte as a
threshold for reporting, if so desired, by examining single and multilab
QLs for all methods for a given analyte.

RB: Requiring QLnats in a new method to be adopted at Part 136 could
prove a serious barrier to the adoption of new methods. For example,
none of the methods recently adopted in the Methods Update Rule would
have been able to be included without very considerable additional
expenditures **Lab**

3.  **[Promulgating QLnats by analyte and method could create confusion
    in situations where not all approved methods contain a
    QLnat.]{.underline}**

RB: This is especially true in the case where the method with the QLnat
is not the most sensitive method **Lab**