United States Environmental Protection Agency

Pathogen Equivalency Committee

## 

Pathogen Reduction Equivalency Application Package

**For**

**Biosolids Treatment Processes**

(PLEASE CAREFULLY READ ATTACHED INSTRUCTIONS BEFORE COMPLETING THIS
APPLICATION)

<table style="width:100%;">
<colgroup>
<col style="width: 4%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 6%" />
<col style="width: 5%" />
<col style="width: 2%" />
<col style="width: 12%" />
<col style="width: 2%" />
<col style="width: 3%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 6%" />
<col style="width: 5%" />
<col style="width: 2%" />
<col style="width: 12%" />
<col style="width: 4%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="16"><p><strong>A. Nature of Equivalency Request:</strong>
Select the appropriate boxes indicating the level of pathogen
destruction achieved and the equivalency status for which you are
seeking a determination.</p>
<p><strong><u>Pathogen Reduction Achieved</u></strong> <strong><u>Level
of Equivalency Sought</u></strong></p>
<p> Process to Significantly Reduce Pathogens (PSRP) National</p>
<blockquote>
<p> Process to Further Reduce Pathogens (PFRP) Site-Specific</p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="8"><h4 id="b.-applicant-information">B. Applicant
Information: </h4></td>
<td colspan="7"><strong>C. Facility Information (if
applicable):</strong></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8"></td>
<td colspan="8"></td>
</tr>
<tr class="even">
<td></td>
<td>Name:</td>
<td colspan="5">     </td>
<td></td>
<td></td>
<td>Name:</td>
<td colspan="5">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2">Mailing Address:</td>
<td colspan="4">     </td>
<td></td>
<td></td>
<td colspan="2">Facility Location:</td>
<td colspan="4">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="6">     </td>
<td></td>
<td></td>
<td colspan="6">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="6">     </td>
<td></td>
<td></td>
<td colspan="6">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="6">     </td>
<td></td>
<td></td>
<td colspan="6">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2">Contact Person:</td>
<td colspan="4">     </td>
<td></td>
<td></td>
<td colspan="2">Contact Person:</td>
<td colspan="4">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="2">Contact Title:</td>
<td colspan="4">     </td>
<td></td>
<td></td>
<td colspan="2">Contact Title:</td>
<td colspan="4">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2">Mailing Address:</td>
<td colspan="4">     </td>
<td></td>
<td></td>
<td colspan="2">Mailing Address:</td>
<td colspan="4">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="2"></td>
<td colspan="4">     </td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="4">     </td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="2"></td>
<td colspan="4">     </td>
<td></td>
<td></td>
<td colspan="2"></td>
<td colspan="4">     </td>
<td></td>
</tr>
<tr class="even">
<td></td>
<td colspan="2">Telephone No.:</td>
<td>(   )</td>
<td>   </td>
<td>-</td>
<td>    </td>
<td></td>
<td></td>
<td colspan="2">Telephone No.:</td>
<td>(   )</td>
<td>   </td>
<td>-</td>
<td>    </td>
<td></td>
</tr>
<tr class="odd">
<td colspan="16"><strong>D. Treatment Process</strong>
<strong>Name:</strong>      </td>
</tr>
<tr class="even">
<td colspan="16"><p><strong>E.</strong> <strong>Process
Description:</strong> Provide a brief overall description of the
biosolids treatment process being evaluated for equivalency.</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="16"><ol start="6" type="A">
<li><p><strong>Comparison to Established Pathogen Reduction
Processes:</strong> Does the proposed process meet the operating
conditions of an established pathogen reduction alternative as listed in
40CFR Part 503? Yes No </p></li>
</ol>
<blockquote>
<p>If Yes, indicate the appropriate alternative below and explain how
the process in question varies from the established method.</p>
</blockquote>
<p><strong>Class A:</strong> Alternative 1 Alternative 2</p>
<p> Alternative 5       Alternative 6      </p>
<p><strong>Class B:</strong> Alternative 2       Alternative 3      </p>
<blockquote>
<p><em>(For Class A Alternatives 5 and 6 and Class B Alternatives 2 and
3, list the specific Process to Further Reduce Pathogens (PFRP) or
Process to Significantly Reduce Pathogens (PSRP))</em></p>
<p><strong>Variation:</strong>      </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="16"><ol start="7" type="A">
<li><p><strong>Operating Conditions:</strong> Provide a <u>brief</u>
description of the specific process operating parameters that must be
maintained to achieve consistent pathogen destruction. The description
should include specific information on the physical, chemical, and
biological requirements such as, temperature, pH, solids concentration,
etc.</p></li>
</ol>
<blockquote>
<p><strong>     </strong></p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="16"><ol start="8" type="A">
<li><p><strong>Performance:</strong> Provide average reductions recorded
under the operating conditions described under Section G.</p></li>
</ol>
<table style="width:100%;">
<colgroup>
<col style="width: 36%" />
<col style="width: 22%" />
<col style="width: 22%" />
<col style="width: 18%" />
</colgroup>
<tbody>
<tr class="odd">
<td></td>
<td>Untreated Sludge</td>
<td>Treated Sludge</td>
<td>Reduction</td>
</tr>
<tr class="even">
<td>Total Solids (%)</td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="odd">
<td>Volatile Solids (%)</td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="even">
<td>Pathogens/Indicator:</td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td><strong>fecal coliform</strong> (MPN/g TS)*</td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="even">
<td><strong><em>Salmonella</em> sp.</strong> (MPN/4g TS)</td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="odd">
<td><strong>enteric viruses</strong> (PFU/4g TS)</td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="even">
<td><strong><em>Ascaris</em> ova</strong> (viable ova/4g TS)</td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="odd">
<td>Other (include units):</td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="odd">
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="even">
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
<tr class="odd">
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
<td><strong>     </strong></td>
</tr>
</tbody>
</table>
<blockquote>
<p>* CFU/g TS is allowable for PSRP equivalencies only. Check box if
this substitution was made  </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="16"><ol start="9" type="A">
<li><p><strong>Process Reliability:</strong> Provide a brief description
of the uncontrolled conditions which affect the process’s ability to
achieve consistent and reliable results, such as, ambient temperatures
and other weather conditions or environmental factors, sensitivity to
loading variations, pH, chemicals which may be used upstream in the
wastewater treatment process, etc.</p></li>
</ol>
<p>     </p></td>
</tr>
</tbody>
</table>

+-----------------------------------------------------------------------+
| J.  **Applications:** Provide a brief description of the intended use |
|     of the sludge once treated. Include vector attraction reduction   |
|     options, if applicable, advantages of this process, etc.          |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| K.  **Full Application for Equivalency Recommendation:** Attach a     |
|     copy of the full application for equivalency recommendation.      |
+-----------------------------------------------------------------------+
| L.  **Quality Assurance Project Plan (QAPP):** Attach a copy of the   |
|     approved QAPP. Any deviations from the QAPP must be documented    |
|     either within the application or in a separate QAPP addendum      |
|     provided here.                                                    |
+-----------------------------------------------------------------------+
| M.  **Analytical Results:** Attach copies of the microbiological      |
|     results for produced from fulfilling the QAPP. In addition,       |
|     provide analytical results for the specific process operating     |
|     parameters identified. All results must also be summarized in     |
|     tabular form.                                                     |
+-----------------------------------------------------------------------+
| N.  **References:** Provide a list of any literature cited or         |
|     literature that would be useful in assessing the process itself   |
|     and associated findings.                                          |
+-----------------------------------------------------------------------+
| O.  **Certification:** I hereby certify that the information and data |
|     contained in this application have been collected under the       |
|     direction of the QAPP and are accurate.                           |
|                                                                       |
| **NAME AND OFFICIAL TITLE (Use Corporate or Professional Seal As      |
| Appropriate):**                                                       |
|                                                                       |
| **Name:** [     ]{.underline} **Title:** [     ]{.underline}          |
|                                                                       |
| **Signature:**                                                        |
|                                                                       |
| **Telephone:** [(   )   ]{.underline} -[    ]{.underline} **Date      |
| Signed:** [  ]{.underline}/ [  ]{.underline}/ [    ]{.underline}      |
+-----------------------------------------------------------------------+
| **Sworn and subscribed to before me:**                                |
|                                                                       |
| **This** [     ]{.underline} **day of** [     ]{.underline} **, 20**  |
| [     ]{.underline}                                                   |
|                                                                       |
| [     ]{.underline}                                                   |
|                                                                       |
| **Notary Public**                                                     |
|                                                                       |
| **(Notary Public Seal and Stamp)**                                    |
+-----------------------------------------------------------------------+

United States Environmental Protection Agency

Pathogen Equivalency Committee

## 

Pathogen Reduction Equivalency Application Package

**For**

**Biosolids Treatment Processes**

# INSTRUCTIONS

**Help With This Form**

![](media/image1.wmf){width="2.625in" height="1.875in"}**[U.S. Pathogen
Equivalency Committee Website]{.underline}**

You can access the Pathogen Equivalency Committee website 7days a week,
24 hours a day at:

[http://www.epa.gov/ORD/NRMRL/pec/]{.underline}

Many basic questions can be answered and guidance documents to assist in
the successful completion of an equivalency application can be accessed
by visiting the U.S. Pathogen Equivalency Committee website. This should
be your first source of information for help in completing this form.

![](media/image2.wmf){width="2.0208333333333335in" height="2.0in"}

**[Contacting the U.S. Pathogen Equivalency Committee]{.underline}**

You can communicate with the U.S. Pathogen Equivalency Committee (PEC)
at your convenience through the PEC's e-mail address:

[pec@epa.gov]{.underline}

If you are unable to find the information you are seeking, the PEC can
be contacted by e-mail. If preferred, you may request to speak to a
committee member by telephone. Simply indicate this preference in your
e-mail and be sure to leave your phone number, days and time of
availability and a brief description of your problem or question. A
committee member would be happy to return your e-mail or set up a
telephone call in a timely manner.

**Before You Fill In This Form**

**[Checklist of Prerequisites to This Form]{.underline}**

 *Have you contacted your Permitting Authority?*

> Your permitting authority should be the first point of contact on new
> applications for equivalency recommendation, especially if you are
> operating in conjunction with a specific treatment plant. You can
> identify your permitting authority through the State and Regional
> Coordinator Locator on the PEC website
> (<http://www.epa.gov/ORD/NRMRL/pec/>). All necessary contact
> information is provided.

 *Have you prepared a Quality Assurance Project Plan (QAPP)?\**

> A QAPP acts as a roadmap to successfully guide you through the
> collection of all necessary laboratory and field studies conducted in
> support of equivalency. See the Quality Assurance Project Plan page on
> the PEC website (<http://www.epa.gov/ORD/NRMRL/pec/>) for more
> information on the value of a QAPP and guidelines on how to develop
> one.

 *Has the Pathogen Equivalency Committee or Other Appropriate Authority
Reviewed and Approved your QAPP?\**

> The PEC or other appropriate authority (such as your permitting
> authority or university) should have reviewed and approved your QAPP
> **before** any data is collected in support of this application for
> equivalency recommendation. The approved QAPP must be included in this
> package (see L. on the form) for reference and any deviations from the
> approved QAPP must be indicated.

 *Have you completed all necessary laboratory and field studies as
detailed in your approved QAPP?\**

> Once your QAPP is approved it must be fulfilled. Unless documented
> with acceptable explanation, deviations from the approved QAPP will
> result in an incomplete equivalency application package.
>
> \*It is highly encouraged and greatly preferred that an applicant
> collect no data without operating under a QAPP or a similar type of
> document, other than preliminary proof-of-concept studies which are
> typically limited in scope. However, under some circumstances the
> Pathogen Equivalency Committee will accept applications in which all
> or some of the data presented was collected outside of a QAPP. In
> these cases, the data must still be collected using appropriate
> quality assurance and quality controls and the applicant must be able
> to provide the level of detail on required in the *Application
> Guidelines for Equivalency Recommendation* (see Line Instructions for
> K.) for the experimental approach, sampling and spiking procedures,
> analytical methods and quality assurance/quality control measures.
> These sections of the full application are typically roled over
> directly from the QAPP and are necessary to make an educated
> assessment on the equivalency of new/emerging sludge disinfection
> processes.

**Letter Instructions For This Form**

**[A.]{.underline}** **Nature of Equivalency Request:** Check one (and
only one) box in each column. For definitions of PSRP and PFRP visit the
PEC website (<http://www.epa.gov/ORD/NRMRL/pec/>). Please note that the
supporting data required for PSRP and PFRP equivalencies are different
therefore the pathogen reduction type would have been selected prior to
the development of the QAPP. The scope of equivalency, national versus
site-specific, would also likely be reflected in the QAPP as a national
equivalency may require additional data beyond that necessary for a
site-specific equivalency recommendation. Thus, the boxes checked in
this section are predetermined with the development and approval of the
QAPP.

**[B.]{.underline} Applicant Information:** Provide the name and contact
information for the business, organization, or facility submitting this
application package. Be sure to identify one individual as your contact
person.

**[C.]{.underline} Facility Information:** If the research conducted in
this application package was completed in cooperation with a specific
wastewater treatment plant or biosolids treatment facility, please
provide the name and contact information, including a contact person,
for this facility.

**[D.]{.underline} Treatment Process Name:** Provide the full name of
your treatment process, including any acronyms, trademarks, etc.

**[E.]{.underline} Process Description:** Provide a concise description
of your treatment process. All essential conditions necessary to achieve
the required level of pathogen reduction should be included in your
description. Noteworthy process design characteristics or unique
components to the treatment process should also be included here. **Do
not** include any information deemed confidential in this description.
If a recommendation for equivalency is awarded, this description will be
used by the Pathogen Equivalency Committee in their next revision of the
White House Document and on their website on the Equivalent Processes
page.

**[F.]{.underline}** **Comparison to Established Pathogen Reduction
Processes:** If your treatment process meets the operating conditions of
an established pathogen reduction alternative under either Class A or B
it should be indicated here. Descriptions of each alternative, as well
as descriptions of specific processes under Class A Alternatives 5 & 6,
and Class B Alternatives 2 & 3, can be found on the PEC website
(<http://www.epa.gov/ORD/NRMRL/pec/>) under the White House Document
page. In addition, recently recommended equivalent processes (i.e.,
processes which were awarded their equivalency after the most recent
version of the white house document) can be found on the Equivalent
Processes page. The variation(s) between your treatment process and the
established alternative/process should be indicated.

**[G.]{.underline} Operating Conditions:** Summarize the operating
conditions of the key components of your treatment process under which
consistent and reliable pathogen reduction can be expected.

**[H.]{.underline} Performance:** Summarize the solids concentrations
and the pathogen reductions observed during data collection under the
operating conditions listed in Section G. **Do not** include any data
taken outside these operating conditions. Arithmetic means should be
used for the solids parameters and geometric means should be used for
the organism densities. All numbers should be presented in the indicated
units. The total solids denominator in the organism densities should be
expressed as a dry weight basis. Fecal coliform density is the only
parameter with some choice in units. When PSRP equivalency is sought
regulations allow you to choose between the multiple tube fermentation
and membrane filtration methods. If membrane filtration is used, CFU/g
TS will be substituted for MPN/g TS and the check box should be checked.
Otherwise, the default units of MPN/g TS will be applicable. Reductions
for the solids should be left in percentages, but **reductions for the
organism densities should be expressed in log transforms**.

**[I.]{.underline}** **Process Reliability:** Any conditions which may
affect the level of pathogen reduction achieved by your process should
be listed here.

**[J.]{.underline} Applications:** Provide a brief statement on the
expected applications of the biosolids produced by your process. If you
process itself concurrently meets a vector attraction reduction option,
note which option as well as any special conditions that must be met to
achieve vector attraction reduction concurrently to pathogen reduction.
If your process does not achieve vector attraction reduction inherently,
list which options may best be paired with your process. If you foresee
any unique benefits to using you product for a particular application
over biosolids produced with any other alternative/process, discuss it
briefly here.

**[K.]{.underline} Full Application for Equivalency Recommendation:**
This section contains the real meat of the equivalency application
package. The full application should contain a detailed account of the
results from the laboratory and field studies laid out in the QAPP, all
supporting information, and the rationale for receiveing a
recommendation for equivalency from the PEC. Refer to the *Application
Guidelines for Equivalency Recommendation* on the How to Apply page of
the PEC website (<http://www.epa.gov/ORD/NRMRL/pec/>) for specific
guidance on the develpoment of this document.

**[L.]{.underline} Quality Assurance Project Plan (QAPP):** The QAPP
provides an important foundation for any research project. Refer to the
*QAPP Guidelines for Applied Research Projects* document found on the
Quality Assurance Project Plan page of the PEC website
(<http://www.epa.gov/ORD/NRMRL/pec/>) for specific guidance on the
development of this plan. The QAPP must be included in the application
package for reference and any deviations from the QAPP must be
documented either within the application or in a separate QAPP addendum.

**[M.]{.underline} Analytical Results:** Provide copies of all results
from the laboratory and field studies performed under the approved QAPP.
Raw (i.e., unmanipulated) data is preferable here as the averaged or
otherwise analyzed data be provided in the results section of your full
application. Laboratory reports from a third party can be included. Data
should be in order by date and all operating conditions or other
measured parameters associated with the microbiological data should be
clearly indicated. Quality assuance and quality control data, such as
blanks and matrix spikes or recovery controls must also be included in
this section.

**[N.]{.underline}** **References:** A complete list of all literature
cited must be included.

**[O.]{.underline}** **Certification:** Certification is mandatory. This
application package must be signed and notarized in order to be accepted
for consideration by the PEC. This step is meant to deter falsification
of data. An equivalency recommendation based on falsified data may have
serious public health consequences and certification provide
accountability.

**Where and How to Submit Your Application Package**

**[What to Submit]{.underline}**

Once your application package is complete, submit the original
Equivalency Application Package Form containing the notary public seal
and all attachments detailed within, plus one complete copy of the
entire package. Additional copies of the equivalency application package
may be requested after the completeness of the package has been
verified. A copy of the application package should also be submitted
concurrently to your permitting authority. For contact information see
the State and Regional Coordinator Locator on the PEC website
(<http://www.epa.gov/ORD/NRMRL/pec/>).

**[Where to Submit]{.underline}**

Send equivalency application packages to: James E. Smith, Jr., PEC chair

> U.S. Environmental Protection Agency
>
> MS-421
>
> 26 West Martin Luther King Dr.
>
> Cincinnati, OH 45268

**What To Do Next**

**Be Patient!** Obtaining a recommendation of equivalency requires a
thorough examination of the process, which can be lengthy (3 or more
months from the time the committee receives a completed application),
but feel free to inquire on the progress of the review by contacting the
Pathogen Equivalency Committee through their e-mail address:
[pec@epa.gov]{.underline}.