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U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
EPA's Handling of a
Proposed Alternative Method
for Measuring Oil and Grease
in Wastewater Met
Requirements But Controls
Need to Be Strengthened
Report No. 13-P-0317
July 11, 2013
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Report Contributors:
Rick Beusse
Erica Hauck
Richard Jones
Abbreviations
ADP
Action Development Process
ATP
Alternate Test Procedure
CFR
Code of Federal Regulations
CWA
Clean Water Act
EASB
Engineering and Analytical Support Branch
EPA
U.S. Environmental Protection Agency
MUR
Methods Update Rule
NODA
Notice of Data Availability
NPDES
National Pollutant Discharge Elimination System
NTTAA
National Technology Transfer and Advancement Act
OIG
Office of Inspector General
OMB
Office of Management and Budget
OST
Office of Science and Technology
OW
Office of Water
VCSB
Voluntary Consensus Standards Body
Hotline
To report fraud, waste, or abuse, contact us through one of the following methods:
email: OIG Hotline@epa.gov write: EPA Inspector General Hotline
phone: 1-888-546-8740 1200 Pennsylvania Avenue, NW
fax: 202-566-2599 Mailcode 2431T
online:
http://www.epa.gov/oiq/hotline.htm
Washington, DC 20460
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^tDSr"'^ U.S. Environmental Protection Agency 13-P-0317
f 'ro Office of Inspector General July 11,2013
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
July 11,2013
MEMORANDUM
SUBJECT: EPA's Handling of a Proposed Alternative Method for Measuring Oil and Grease
in Wastewater Met Requirements But Controls Need to Be Strengthened
Report No. 13-P-0317
This is our report on the subject evaluation conducted by the Office of the Inspector General (OIG) of
the U.S. Environmental Protection Agency (EPA). This report describes issues the OIG identified and
makes recommendations to address these issues. The report represents the opinion of the OIG and does
not necessarily represent the final EPA position. Final determinations on matters in this report will be
made by EPA managers in accordance with established audit resolution procedures.
Action Required
You are not required to provide a written response to this final report, because you agreed to all
recommendations and provided corrective actions and planned completion dates that meet the intent of
our recommendations. Recommendations 1 and 3 remain open with corrective actions ongoing.
Please update the EPA's Management Audit Tracking System as you complete the planned corrective
actions for recommendations 1 and 3. Since the Office of Water already completed actions that meet the
intent of recommendation 2, we are closing recommendation 2 upon issuance of this final report.
Please notify my staff if there is a significant change in the agreed-to corrective actions.
We have no objections to the further release of this report to the public. We will post this report on our
website at http://www.epa.gov/oig.
FROM
Arthur A. Elkins Jr.
TO
Nancy Stoner, Acting Assistant Administrator
Office of Water
If you or your staff have any questions regarding this report, please contact Assistant Inspector General
for Program Evaluation Carolyn Copper at (202) 566-0829 or copper.carolyn@epa.gov. or Director for
Air and Research Evaluations Rick Beusse at (919) 541-5747 or beusse.rick@epa.gov.
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EPA's Handling of a Proposed Alternative Method
for Measuring Oil and Grease in Wastewater Met
Requirements But Controls Need to Be Strengthened
13-P-0317
Table of C
Chapters
1 Introduction 1
Purpose 1
Background 1
Scope and Methodology 4
2 EPA Adhered to Applicable Laws and Regulations
But Needs a Framework and Procedures for Conducting
Reviews of Methods Like ASTM D7575 6
EPA's Review of ASTM D7575 Adhered to Applicable Laws,
Regulations, Policies, Procedures, and Guidance 6
ASTM D7575 Posed Unique Challenges, and EPA Took
Appropriate Steps to Make an Informed Decision 8
OW Lacked Procedures for Reviewing Proposed Methods
for Method-Defined Analytes 12
OWs Method Review Process Lacked Other Important
Management Controls 13
Conclusions 15
Recommendations 15
Agency Comments and OIG Evaluation 16
Status of Recommendations and Potential Monetary Benefits 17
Appendices
A EPA's Adherence to Applicable Laws, Regulations,
Policies, and Guidance 18
B Agency Comments on Draft Report 20
C Distribution 22
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Chapter 1
Introduction
Purpose
The U.S. Environmental Protection Agency (EPA) Office of Inspector General
(OIG) received a hotline complaint concerning EPA's handling of
"ASTM D7575," a proposed alternative method for measuring oil and grease in
wastewater. In response to the allegations, we assessed whether EPA adhered to
applicable laws, regulations, policies, procedures, and guidance in reviewing
ASTM D7575 as an alternative method1 for measuring oil and grease, and in
issuing the proposed Methods Update Rule (MUR) and subsequent Notice of Data
Availability (NODA).
Background
The Clean Water Act (CWA) requires EPA to establish and promulgate test
procedures (i.e., methods) to measure pollutants regulated by CWA programs.
This includes establishing methods for measuring pollutants in wastewater under
the National Pollutant Discharge Elimination System (NPDES) program.
Under this program, point source2 discharges must meet the discharge limits for
regulated pollutants as identified in their NPDES permits. To determine
compliance, regulated pollutants must be measured using available methods
approved by EPA.
Oil and grease3 is a regulated wastewater pollutant that is included in hundreds of
thousands of NPDES permits. However, oil and grease differs from many other
wastewater pollutants in that oil and grease is a method-defined analyte.
A method-defined analyte is an analyte (e.g., pollutant) that is defined solely by
the method used to measure the amount of the analyte. In the case of oil and
grease, measurement for regulatory purposes is dependent on the use of
EPA Method 1664A. This method uses n-hexane as an extracting solvent for
determining the amount of oil and grease in a wastewater sample. As such, the
measurement of oil and grease depends on the use of n-hexane to extract oil and
grease from the sample.
1 We use the term "alternative method" to mean a method that could be used in lieu of, or as a replacement for, the
existing approved method for oil and grease.
2 CWA Section 502(14) generally defines a point source as "any discernible, confined and discrete conveyance,
including but not limited to any pipe, ditch, channel, tunnel, conduit, well, discrete fissure, container, rolling stock,
concentrated animal feeding operation, or vessel or other floating craft, from which pollutants are or may be
discharged."
3 "Oil and grease" is a singular category of pollutant that is regulated by the CWA. Although they may be different
substances, oil and grease are regulated as one singular pollutant.
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Two Routes for Nationwide Approval of New Methods and
Method Modifications
The Office of Science and Technology (OST) within EPA's Office of Water
(OW) is responsible for reviewing and promulgating methods for measuring
pollutants for CWA applications, including alternatives to existing methods.
Specifically, OST's Engineering and Analytical Support Branch (EASB) reviews
proposed new methods and modifications to existing methods that are submitted
for approval. If EASB finds that a method or modification meets certain criteria,
it conditionally approves the method or modification. Methods that EASB
conditionally approves must then be proposed and promulgated through the
formal rulemaking process. Because promulgating individual methods separately
would be very resource-intensive, EASB periodically4 combines numerous
proposed methods and modifications into a proposed MUR. Once these rules are
finalized, the approved methods are codified per the Code of Federal Regulations
(CFR) at 40 CFR Part 136 and can be used nationwide to determine compliance
with NPDES permits.
As shown in figure 1, there are two distinct routes through which a proposed new
method or modification may be reviewed and approved by EPA in 40 CFR Part 136.
Figure 1: Routes of method review and approval
New Method
Modification
Developed
Source: OIG analysis.
VCSB - Voluntary Consensus Standards Body
Method
Denied
4 According to EASB, methods update rules are promulgated approximately every 4 years.
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The first route is EPA's Alternate Test Procedure (ATP) program. Under this
program, method developers submit an application for a proposed new method or
modification directly to EASB for nationwide use. The ATP program has
established formal protocols for reviewing new methods and modifications
submitted through this route. These protocols lay out specific requirements, such
as validation studies that must be conducted for the method to be proposed by
EPA in a MUR.
The second route involves methods that are adopted by a voluntary consensus
standards body (VCSB)5 such as ASTM International6 and Standard Methods.7
VCSBs may submit methods and modifications they have adopted to EPA under
the provisions of the National Technology Transfer and Advancement Act
(NTTAA) of 1995. The NTTAA requires EPA to adopt methods approved by
VCSBs unless doing so would be inconsistent with applicable laws or otherwise
impractical. Methods submitted to EPA via either route (ATP or NTTAA) must
be reviewed by EASB and, if appropriate, proposed and ultimately promulgated
in a MUR.
EPA's Rulemaking and Review of Proposed Methods Are Governed
by Multiple Statutes, Regulations, Policies, and Guidance
Regardless of the route of approval used, there are several laws, regulations, and
guidance - generally referred to as criteria - that govern EPA's methods update
rulemakings and review of proposed methods. These include the following:
Table 1: Criteria governing EPA's rulemaking process and review of proposed methods
Criteria document
Brief description
Administrative Procedure Act
This act lays out the general requirements for rulemakings for all federal
agencies. This includes the publication of proposed rules in the Federal Register.
Clean Water Act
Section 304 (h) of the CWA requires EPA to promulgate guidelines establishing
test procedures for the measurement of pollutants under the NPDES program.
40 CFR Part 136
40 CFR Part 136 describes EPA's general guidelines for establishing test
procedures for analysis and measurement of pollutants regulated under the
NPDES program. It also lays out the application process to be followed by
method developers when submitting an application to EPA under the CWA ATP
program.
EPA's Action Development
Process (ADP): Guidance for
EPA Staff on Developing Quality
Actions (revised March 2011)
The ADP is a comprehensive framework to ensure that EPA develops quality
actions, including rulemakings. Its intent is to ensure the use of quality
information and an open process to support Agency actions.
Source: OIG analysis.
5 A VCSB is a domestic or international organization that plans, develops, establishes, or coordinates voluntary
consensus standards using agreed-upon procedures.
6 ASTM International, formerly known as the American Society for Testing and Materials, was established in 1898,
and provides a global forum for the development and publication of international voluntary consensus standards.
ASTM has over 30,000 members from 150 countries.
7 Standard Methods, like ASTM International, is a voluntary consensus standard body that regularly submits
methods to OW for approval.
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In addition, the NTTAA and Office of Management and Budget (OMB)
Circular A-l 19 apply specifically to methods developed by VCSBs. These are
summarized below.
Table 2: Criteria applicable to methods developed by VCSBs
Criteria document
Brief description
NTTAA
Section 12(d) states that federal agencies shall use technical standards developed or
adopted by VCSBs, unless doing so would be inconsistent with applicable law or
otherwise impractical. EPA has interpreted technical standards to include test methods.
OMB Circular A-119
(revised February 1998)
This circular establishes policies for federal agencies in implementing the NTTAA. The
circular states that agencies have discretion to decline to use a standard developed by
a VCSB, if the agency determines that such standards are inconsistent with applicable
law or otherwise impractical.
Source: OIG analysis.
EPA Reviewed Proposed Alternative Method ASTM D7575 During Its Most
Recent Methods Update Rulemaking
EPA reviewed ASTM D75758 as part of its most recent methods update
rulemaking as an alternative method for oil and grease. EPA issued a proposed
MUR in September 2010 that included numerous new methods and method
modifications. In the proposed MUR, EPA stated that it was not planning to
approve ASTM D7575 because it does not use n-hexane to extract oil and grease.
However, after the proposed MUR was issued, EPA received additional
information on ASTM D7575 and conducted additional review of the method.
Subsequently, in December 2011, EPA issued a NODA to reconsider ASTM
D7575 as an alternative method for oil and grease, and requested public comment
on the method. EPA's review and handling of ASTM D7575 is discussed in
greater detail in chapter 2.
Scope and Methodology
We conducted our review from April 2012 to March 2013. We conducted this
performance review in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the review to obtain
sufficient, appropriate evidence to provide a reasonable basis for our findings and
conclusions based on our review objectives. We believe that the evidence
obtained provides a reasonable basis for our findings and conclusions based on
our review objective.
To address our objective, we reviewed the proposed MUR, the NODA to
reconsider ASTM D7575, the final MUR, and relevant information in the
rulemaking docket. We also reviewed the analyses and studies conducted by the
method developer and ASTM, as well as documents pertaining to EPA's review
8 We use the term "ASTM D7575" in this report to refer to the alternative method for oil and grease from its initial
development through its adoption by ASTM. However, the method did not obtain the designation of ASTM D7575
until it was adopted by ASTM in January 2010.
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of the method. We reviewed applicable statutes, regulations, policies, procedures,
and guidance, including the following:
• Clean Water Act (CWA)
• National Technology Transfer and Advancement Act (NTTAA)
• Administrative Procedure Act
• 40 CFR Part 136 - Guidelines Establishing Test Procedures for the
Analysis of Pollutants
• EPA's Action Development Process (ADP) Guidance
(revised March 2011)
• Protocol for EPA Approval of Alternate Test Procedures for Organic and
Inorganic Analytes in Wastewater and Drinking Water (OW, March 1999)
• Protocol for EPA Approval of New Methods for Organic and Inorganic
Analytes in Wastewater and Drinking Water (OW, March 1999)
We interviewed EPA OW personnel, including EASB staff and managers,
Office of Groundwater and Drinking Water staff, OW's senior regulatory
manager, and OW's Deputy Assistant Administrator. We also interviewed EPA's
standards executive (the Agency's NTTAA expert), and staff and managers from
EPA's Office of General Counsel, Office of Congressional and Intergovernmental
Relations, and Office of Policy. We also interviewed the complainant and
reviewed documents, emails, and other materials provided.
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Chapter 2
EPA Adhered to Applicable Laws and Regulations
But Needs a Framework and Procedures for
Conducting Reviews of Methods Like ASTM D7575
EPA's review of ASTM D7575 and issuance of the proposed MUR and
subsequent NODA adhered to applicable laws, regulations, policies, procedures,
and guidance. However, during our review, we found management control
weaknesses that need to be addressed. Specifically, EPA lacked a framework and
procedures for reviewing alternative methods for method-defined analytes, such
as ASTM D7575, which led to challenges in reviewing the method. The primary
challenge EPA faced was in assessing the comparability of ASTM D7575 to the
existing method for measuring oil and grease. EPA's lack of established
procedures stemmed from the fact that it generally had not considered approving
proposed alternative methods for method-defined parameters in the past, and
requests to do so had been very rare. Because of its inexperience in reviewing
such methods, OW had to devise the review process for ASTM D7575 as it went
along. We found that OW took appropriate steps to review ASTM D7575 and
make an informed decision, despite the challenges it faced and its lack of
procedures for reviewing such alternative methods. However, the lack of an
established review framework, and other management control weaknesses,
contributed to confusion and delays in the review process, and contributed to
concerns from stakeholders regarding preferential treatment of ASTM D7575.
If not addressed, these weaknesses have the potential to affect the timeliness of
future EPA method reviews and perceptions of EPA's fairness and transparency.
EPA's Review of ASTM D7575 Adhered to Applicable Laws,
Regulations, Policies, Procedures, and Guidance
EPA adhered to applicable statutes, regulations, policies, procedures, and
guidance during its review of ASTM D7575. Specifically, we found that EPA
adhered to the following in its review of ASTM D7575:
• The Administrative Procedure Act
• The CWA
• 40 CFR Part 136
• EPA's ADP: Guidance for EPA Staff on Developing Quality Actions
(revised March 2011)
• The NTT A A
• OMB Circular A-l 19 (revised February 1998)
Appendix A provides details on EPA's adherence to each of the above criteria
during its review of ASTM D7575.
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Two key documents governing EPA's actions in the MUR rulemaking and review
of ASTM D7575 are the EPA's ADP guidance and the NTTAA. EPA's actions to
adhere to the requirements of these two documents are discussed in detail below.
Action Development Process Guidance
The ADP provides guidance for properly categorizing the type and significance of
EPA's actions. This process is known as "tiering" the Agency action. The ADP
also provides guidance for assembling workgroups and selecting the appropriate
action for the desired outcome. In reviewing ASTM D7575, OW followed the
ADP guidance related to these three areas.
EPA tiered the MUR as a Tier 3 action, which we believe is an appropriate tier
level for this action. Per the ADP, significant actions such as rulemakings are tiered
according to multiple factors. These factors include the complexity of the action,
the need for cross-agency input and senior leadership involvement, and potential
impacts. Actions are designated as Tier 1, Tier 2, or Tier 3. Tier 1 actions are the
most complex and have the greatest need for cross-agency input and senior
leadership involvement, and the greatest potential impacts. According to the
Director of the Regulatory Management Division in EPA's Office of Policy,
almost all MURs across the Agency are Tier 3 actions. Further, the Director said
that NODAs are typically tiered the same as the adjoining rulemaking. Thus, it was
acceptable for OW to tier the NODA for ASTM D7575 as a Tier 3 action because
this was consistent with the tiering of the associated MUR.
For Tier 3 rules, a workgroup is not required. However, it is required for actions
tiered at higher levels (i.e.. Tier 1 and Tier 2). Although not required by EPA's
ADP guidance, OW assembled an intra-agency workgroup to review both the
MUR and NODA. The workgroup chair shared drafts of the proposed MUR, the
NODA, and the final MUR with workgroup members for review and comment.
Also, the decision to issue the NODA involved senior EPA leadership. The
OW Deputy Assistant Administrator reviewed a couple of options pertaining to
ASTM D7575 and selected the option he determined to be most appropriate. This
is consistent with EPA's ADP guidance.
National Technology Transfer and Advancement Act
The NTTAA requires EPA to use test methods adopted by VCSBs, such as
ASTM D7575, unless the Agency determines that the method does not meet
Agency requirements. EPA considered ASTM D7575 in accordance with the
NTTAA. After ASTM approved the method, EPA staff reviewed the data from
the ASTM studies. In particular, EPA focused on the assessments of
comparability between ASTM D7575 and Method 1664A. Further, EPA spent
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considerable time and effort reviewing the method to determine whether it was
practical and appropriate to approve the method.
ASTM D7575 Posed Unique Challenges, and EPA Took Appropriate
Steps to Make an Informed Decision
The proposal of ASTM D7575 as an alternative method for oil and grease posed
unique challenges to EPA because oil and grease, unlike most other pollutants, is
a method-defined analyte. The measurement of oil and grease is dependent on the
use of n-hexane to extract oil and grease from a sample. This is outlined in EPA
Method 1664A. ASTM D7575, in contrast, does not use n-hexane. Instead, it uses
an extracting membrane. Further, Method 1664A uses gravimetric measurement,
whereas ASTM D7575 uses infrared absorption measurement to measure a
sample. Thus, the two methods use different determinative techniques.9 Because
of these differences, the main challenge for EPA was to assess whether using
ASTM D7575 to measure oil and grease in a sample would yield results
comparable to using EPA Method 1664A.
While EPA has a protocol10 for assessing comparability between methods for
non-method-defined analytes, it does not have an established process to assess
comparability for method-defined analytes. Prior to ASTM D7575, EPA's
informal practice had been generally to deny proposals for new or alternative
methods for method-defined analytes based on different determinative techniques.
Further, such requests were very rare. The only time that EPA had approved a
new method for measuring oil and grease in wastewater was when the Agency
had to change its former method because it used Freon as the extracting solvent.
EPA had to discontinue using Freon under the 1987 Montreal Protocol on
Substances that Deplete the Ozone Layer. After conducting several comparability
studies, EPA approved Method 1664A in 1999 for measuring oil and grease in
wastewater. This changed the extracting solvent from Freon to n-hexane.
However, ASTM D7575 appeared to have some advantages over EPA Method
1664A that, in combination with additional data received after the proposed
MUR, led EPA to reconsider its informal practice to deny such methods. For
example, ASTM D7575 does not use n-hexane, which poses potential health risks,
particularly at higher levels. Also, ASTM D7575 had potential to lower analytical
costs to users. ASTM International also approved ASTM D7575. Under the
provisions of the NTTAA, EPA is required to adopt methods approved by VCSBs
like ASTM International, unless doing so would be inconsistent with applicable
laws or otherwise impractical. As such, after reviewing additional data, EPA
decided to review ASTM D7575 to determine its viability as an alternative to
EPA Method 1664A. Its viability hinged primarily on its comparability to Method
9 A determinative technique is defined as the way in which an analyte is identified and quantified.
10 Protocol for EPA Approval of Alternate Test Procedures Methods for Organic and Inorganic Analytes in
Wastewater and Drinking Water (EPA 821-B-98-002, March 1999).
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1664A - specifically, whether it would produce measurement results comparable
to Method 1664A. Details concerning EPA's review and assessment of ASTM
D7575 are described below.
EPA's Review of ASTM D7575 Prior to Issuance of the Proposed MUR
In April 2009, the company that initiated development of ASTM D7575
(hereinafter, "the method developer") sent an early version of the method to the
ATP coordinator in EASB and asked him to review the method. The method
developer did not submit an ATP application for formal evaluation under the ATP
program. In an email response to the method developer, the ATP coordinator
outlined several concerns with the draft method. He also stated that "multi-matrix,
multi-lab full validation" would be required before EPA would consider
approving the method.
After this communication, the method developer began working with ASTM
International to get the method adopted by the organization. In September 2009,
the method developer submitted to EPA a summary report of its multi-laboratory
validation study for D7575. The study was conducted for ASTM as part of the
ASTM approval process. Soon after, the ATP coordinator asked to see all of the
raw data from the study. Later that month, EPA requested that its independent
contractor review the information provided on D7575 and the validation study.
The contractor had concerns with the data, including that there was no raw data
from the labs. The contractor agreed with the need for further testing of ASTM
D7575. In January 2010, ASTM adopted D7575.11
In March 2010, the EPA MUR workgroup was asked to review and comment on
ASTM D7575. In response, several EPA regional staff expressed concerns. In
particular, there were concerns with the comparability of ASTM D7575 to EPA
Method 1664A. There were also concerns because oil and grease is an analyte
defined by Method 1664A. EPA did not recommend ASTM D7575 for approval
in the September 2010 proposed MUR because it does not use n-hexane as the
extracting solvent. ASTM D7575 used a different extraction technique than EPA
Method 1664A.
EPA's Review of ASTM D7575 After Issuance of the Proposed MUR
Upon learning that ASTM D7575 was not going to be recommended for approval in
the proposed MUR, the method developer contacted its senator's office. According
to documentation provided to EPA by the method developer, the method developer
had been under the impression that EPA was going to recommend ASTM D7575 for
approval in the proposed MUR. Staff from the senator's office contacted EPA about
its decision. A congressional liaison specialist in EPA's Office of Congressional and
Intergovernmental Relations told us that it is quite common for senators to contact
11 ASTM sent a letter to EPA on September 21, 2010, formally requesting that the Agency consider ASTM D7575
as an alternative method for determining oil and grease in wastewater.
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EPA on behalf of the interests of their constituents. He estimated that his office
receives calls from members of Congress almost daily. Although a senator's
involvement on a specific issue may bring additional attention to that issue, it does
not mean that preferential treatment occurred, according to the congressional liaison
specialist. He said the senator's staff were primarily concerned with whether method
ASTM D7575 received a fair and thorough review by EPA.
After the senator's office contacted EPA, Agency managers and staff attended
several meetings with the method developer, ASTM, and staff from the senator's
office. At these meetings, EPA staff discussed concerns they had with ASTM
D7575, specifically with its comparability to Method 1664A. Some EPA staff,
particularly the ATP coordinator, had concerns about whether the data from the
ASTM studies showed that ASTM D7575 was comparable to Method 1664A.
EPA requested that the method developer and ASTM provide more data on
ASTM D7575, particularly assessments of comparability between ASTM D7575
and Method 1664A. In October 2010, the method developer provided the
following data to EASB:
• Raw data from the single- and multi-lab studies conducted for ASTM
approval
• An expanded validation report
• Comparability statistics from the single lab validation
• Answers to EPA's most recent questions
An EPA contractor reviewed the method developer's data and concluded that
ASTM D7575 was not statistically comparable to EPA Method 1664A in most
scenarios. EPA statisticians also reviewed the data and reached similar
conclusions.
In addition, EPA received and reviewed numerous public comments to the
proposed MUR that pertained to ASTM D7575. One commenter submitted an
analysis conducted by a statistician which concluded that ASTM D7575
"is statistically equivalent" to Method 1664A. Another commenter submitted a
report documenting the health risks posed by n-hexane, the solvent used in
EPA Method 1664A. Also, the method developer submitted over 80 documents in
its comments on the proposed rule. Most of these documents did not provide new
data on ASTM D7575 beyond what was provided to EASB via email in
October 2010.
In June 2011, ASTM provided written responses to several EPA questions
pertaining to technical issues and the statistical analyses conducted by the method
developer and ASTM. In its written responses, ASTM made it clear that its
intention was for D7575 to be an alternative method to EPA Method 1664A,
with the same regulatory standing as Method 1664A. ASTM also stated that it
disagreed with the EPA contractor's statistical assessment.
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Despite the new information provided by the method developer and ASTM,
EASB staff continued to have concerns about comparability of ASTM D7575
with EPA Method 1664A. In particular, they were concerned with the breadth of
matrices (types of wastewater samples) that had been tested. Thus, in June 2011,
EASB requested that ASTM test ASTM D7575 in three additional matrices
selected by EASB staff. According to the EASB branch chief, EPA told ASTM
that EPA would consider issuing a NODA for ASTM D7575 if ASTM tested
these additional matrices, pending positive results. ASTM subsequently tested the
three additional matrices12 and issued a report to EPA in November 2011.13 In that
report, ASTM concluded that the results for the new matrices demonstrated
comparability between ASTM D7575 and Method 1664A.
OW looked at the new matrices tested along with all other data submitted by the
method developer and ASTM after the proposed MUR. Based on this information,
OW determined that it was worthwhile to issue a NODA to reconsider ASTM
D7575 and obtain public comment on the information obtained to date.
EPA Issued NODA to Reconsider ASTM D7575
On December 14, 2011, EPA published a NODA to reconsider ASTM D7575 as
an alternative to Method 1664A. The NODA was based primarily on the new
information from the method developer and ASTM. In the NODA, EPA did not
state whether they would be approving ASTM D7575 as an alternative to
Method 1664A (i.e., with the same regulatory standing). Rather, EPA stated that
ASTM D7575 was a good "stand alone method." EPA provided the following
three reasons for reconsidering ASTM D7575:
1. EPA's analysis demonstrates ASTM D7575 is an acceptable stand-alone
method for the measurement of oil and grease in wastewater, producing
results "generally very close" to those obtained using EPA Method 1664A
for the matrices tested.
2. ASTM D7575 has advantages over 1664A, including that its membrane is
a green technology (e.g., it uses a solventless extraction, there is no
solvent waste, and no analyst exposure to solvent).
3. ASTM D7575 may offer other advantages such as ease of analysis,
reduced analysis time, and lower analytical costs.
In the NODA, EPA solicited public comment on several topics. These included
whether EPA should reconsider promulgating ASTM D7575 as an additional
method for oil and grease, and provisions pertaining to side-by-side comparisons
for permitting purposes.
12 The three additional matrices that ASTM tested were from the following categories: a large refinery, a large food
and restaurant complex, and a large chemical manufacturer.
13 Study Report from the Testing of Additional Industrial Wastewater Matrices in Support of ASTM Standard D7575
for USEPA's Reconsideration of this Method in the Forthcoming Method Update Rule (ASTM D19.06
Subcommittee, November 2011).
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EPA Issued Final Decision to Not Approve ASTM D7575 on a
Nationwide Basis
On March 6, 2013, EPA issued a notice of final decision in the Federal Register,
stating that it is not approving ASTM D7575 as an alternative method for oil and
grease on a nationwide basis. According to the notice, this decision was based
primarily on the fact that oil and grease is a method-defined analyte and
comparability between ASTM D7575 and Method 1664A had not been
established on a wide-scale basis. However, EPA stated that permittees could
apply for limited use approval through the regional ATP coordinators to use
ASTM D7575 for limited, specific uses. Such approval would require
demonstrating comparability between ASTM D7575 and 1664A for the intended
use by the permittee. Additionally, OW developed and provided guidance to the
regional ATP coordinators for evaluating the comparability of ASTM D7575 to
EPA Method 1664 for limited use approvals. This guidance was issued to the
regions at the time the final decision was published in March 2013.
OW Lacked Procedures for Reviewing Proposed Methods for
Method-Defined Analytes
The challenges posed by ASTM D7575 stemmed from the fact that EPA had not
considered a new, VCSB-approved method for oil and grease in the past, and did
not have a procedure in place for reviewing proposed methods for method-defined
analytes. As such, EPA had no clearly defined data requirements or criteria to
assess the comparability of ASTM D7575 and EPA Method 1664A. This resulted
in confusion between the method developer and EPA. It also led to numerous
formal and informal exchanges regarding data requirements and next steps. In the
end, OW used the comparison studies done when EPA replaced Freon in 1999 as
a general framework for reviewing ASTM D7575. However, an OW manager told
us it is uncertain whether that is the best approach to use.
OW managers told us they are uncertain about a one-size-fits-all approach to
approving proposed methods for method-defined analytes. At the same time,
they want to provide flexibility to method developers to foster technological
advancements in measurement methods. OW managers realize that new methods
may be improvements over existing methods. They also anticipate that EPA will
get more requests of this nature in the future, particularly now that they have
considered an alternative method for oil and grease that does not use n-hexane.
OW's protocol14 for reviewing new methods (for non-method-defined analytes)
under the ATP program sets the expectation that the ATP and rulemaking
processes can take a year or more to promulgate a major modification or a new
technology. However, the Agency's review of ASTM D7575 took more than
14Protocol for EPA Approval of New Methods for Organic and Inorganic Analytes in Wastewater and Drinking
Water (EPA 821-B-98-003, March 1999).
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3 years to complete. Much of this delay was due to the lack of a formal procedure
for reviewing new methods for method-defined analytes, and the resulting
confusion about what data and statistical analyses are required to assess
comparability. An established framework and procedures for method-defined
analytes that is communicated up front to the method developer and/or VCSB
would better explain EPA's expectations for data quality. It would also reduce the
confusion around EPA's data requirements.
OW's Method Review Process Lacked Other Important
Management Controls
In addition to the lack of procedures for reviewing alternative methods for
method-defined analytes, we found that EPA's method review process lacked
other important management controls. Specifically, regarding EPA's review of
ASTMD7575:
¦ EPA lacked a firm "cut-off date for
method submissions for the MUR,
resulting in Agency staff and external
stakeholders having different
interpretations of a July 2009
"pens down" memorandum.
¦ EPA did not clearly and consistently
communicate with the method developer
and ASTM regarding potential pathways
for approval and other key matters.
Ambiguous "Cut-off" Date for
Methods Submissions
In the most recent MUR rulemaking, OW
provided notice to methods developers as to when
it would no longer accept additional proposed
methods for consideration in the rulemaking. This
notification to stakeholders is known as the pens
down memorandum. On July 20, 2009, the ATP
coordinator sent a pens down memo, written by
the former EASB branch chief, via email to a
limited number of external stakeholders. The
memo stated that:
.. .Because all of us want these valuable
revisions out for internal Agency review
and subsequent public review, we are
drafting the proposed rule with the
methods and suggestions collected so far.
"Pens Down" Memorandum
We have received many helpful
suggestions, insights, and products from
Part 136 community members including
ASTM International, the Standard Methods
Committee, laboratory auditors, and
method developers. We are now moving
forward to incorporate the many
improvements and revisions. Our scientists
are assembling and writing the
documentation required to publish
proposed changes to the regulations at
40 CFR Part 136. Publication in the
Federal Register, and responding to public
comment are part of the critical path to
allow the 136 community to use these tools
for compliance monitoring.
Because all of us want these valuable
revisions out for internal Agency review
and subsequent public review, we are
drafting the proposed rule with the methods
and suggestions collected so far.
Thus, you have no need to begin or rush
development of a new laboratory study, or
ongoing method-testing project. Meanwhile
if you have a new method, you may ask to
put it into the queue of methods in the
Clean Water Act (CWA) and Safe Drinking
Water Act (SDWA) alternate test procedure
(ATP) programs. We remind developers
that the flexibility at 40 CFR Part 136.6 to
modify and use a Part 136 method has
eliminated the previous need for EPA to
review, under the ATP program, most
modifications. In addition, the 1996 SDWA
amendments allow use of methods for
drinking water compliance monitoring
without conducting the rulemaking
required for CWA methods.
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Thus, you have no need to begin or rush development of a new laboratory
study, or ongoing method-testing project. Meanwhile if you have a new
method, you may ask to put it into the queue of methods in the Clean
Water Act (CWA) and Safe Drinking Water Act (SDWA) alternate test
procedure (ATP) programs....
OW's memo did not clearly state whether a method must be fully approved by the
date of the memo or whether the method could still be in review (i.e., not
finalized). This resulted in ambiguity and differing perceptions of the meaning of
the memo. The ATP coordinator said his interpretation was that the method
submission process must have been completed by the memo date. However, the
current EASB branch chief said that the memo meant if a method developer has
not submitted a new method or started the approval process they should not
bother doing so now. In her view, the memo did not mean that all data for a
specific method had to be submitted by that date.
The ATP coordinator and another method developer interpreted the pens down
memo as an approval cut-off date. Thus, when Method D7575, which was
adopted by ASTM almost 6 months after the cut-off date, was included in the
proposed MUR, these stakeholders perceived this as preferential treatment. For
example, the other method developer wrote to EPA stating that EPA should have
also considered its method after the cut-off date, as EPA had done with ASTM
D7575.15 The company said that EPA was not providing its proposed method
with a "level playing field in comparison with other methods." Further, the ATP
coordinator stated that EPA continued to review ASTM D7575 past the
pens down deadline but did not consider other methods.
Processes for Communications With Stakeholders Need Improvement
OW did not clearly and consistently communicate with the method developer and
ASTM during its review of ASTM D7575. When the method developer first
approached OW staff in April 2009, the Agency did not clearly explain that there
were two distinct approval pathways: through EPA's ATP process or through a
VCSB. Further, this information had not been communicated on EPA's public
website. According to the EASB branch chief, EPA recognizes this issue and has
recently clarified with ASTM International the two distinct pathways for
obtaining approval.
Following the method developer's decision to seek approval through ASTM,
EPA did not clearly explain to the method developer that communications from
that point forward should be between EPA and ASTM, not between EPA and the
method developer. EASB staff continued to communicate directly with the
method developer throughout and following ASTM's review of D7575. For
15 The method submitted by this other method developer was not reviewed and conditionally approved by EPA until
late June 2010, less than 3 months before the proposed MUR was published, whereas ASTM D7575 was adopted by
ASTM in January 2010.
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example, the method developer continued to submit materials for EPA review
after submitting them to ASTM. The method developer also believed that EASB
staff had approved its validation study plans, which EASB staff have denied.
EPA's continued correspondence with the method developer led to confusion as
to whether EPA was planning to recommend ASTM D7575 for approval. Based
on our review of written communications between the method developer and
EPA, EPA did not state that it was planning to recommend ASTM D7575 for
approval. However, we identified one email the former EASB branch chief sent to
the method developer that was open to interpretation. The method developer
viewed this email as evidence that ASTM D7575 would be recommended in the
proposed MUR.
EPA's ongoing communication with the method developer also contributed to the
perception from some stakeholders that the method developer received
preferential treatment. In our view, OW's lack of controls governing its
communications with external stakeholders contributed to this perception.
Conclusions
EPA's review of ASTM D7575 adhered to applicable laws, regulations, policies,
procedures, and guidance. Further, EPA took appropriate steps to address the
challenges posed by ASTM D7575 and to make an informed decision, despite the
lack of an established procedure for reviewing proposed new or alternative
methods for method-defined analytes. Improved management controls are needed
to ensure that EPA's method reviews avoid perceptions of partiality and
unfairness. Such controls would also ensure that reviews are completed in a more
transparent, timely manner. The lack of a formal procedure for reviewing new
methods for method-defined parameters, the lack of a clearly defined "cut-off
date for method submissions, and the failure to clearly communicate the two
approval pathways played substantial roles in the issues observed. In our view,
these management control weaknesses also have the potential to impact future
EPA method reviews if not addressed.
Recommendations
We recommend that the Assistant Administrator for Water:
1. Establish a procedure for reviewing proposed methods for method-defined
analytes. This procedure should provide a general framework for review
and address, at a minimum, the following issues:
• Data to be submitted by the method developer or VCSB.
• Statistical tests or analyses to be conducted to determine
comparability between the new proposed method and the existing
approved method.
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2. Establish procedures for designating official cut-off dates for future
proposed MURs, and include these procedures on OW's website
3. Clarify on EPA's website OW's procedures and communications policies
regarding the two distinct routes through which new methods may be
approved by EPA.
Agency Comments and OIG Evaluation
OW generally agreed with our recommendations and provided a corrective action
plan with milestone dates to address recommendations 1 and 3. OW's proposed
corrective actions and planned completion dates for recommendations 1 and 3
meet the intent of our recommendations. These recommendations will remain
open pending completion of the proposed corrective actions.
For recommendation 2, OW issued a memorandum on June 6, 2013, that outlines
procedures for establishing cut-off dates for future MUR rulemakings, including
posting the cut-off dates on OW's website at least 6 months before proposing a
MUR. According to the memorandum, OW will also post an explanation on its
website as to what the cut-off dates mean. This action meets the intent of
recommendation 2. Therefore, we are closing recommendation 2 upon issuance
of this report.
No further EPA response to this report is required. Appendix B contains the
Agency's response to our draft report, including its planned actions for each
recommendation. The Agency also provided technical comments on the draft
report, which we have incorporated into our report as appropriate.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
POTENTIAL MONETARY
BENEFITS (In $000s)
Rec.
No.
Page
No.
Subject
Status1
Action Official
Planned
Completion
Date
Claimed
Amount
Agreed-To
Amount
15 Establish a procedure for reviewing proposed
methods for method-defined analytes. This
procedure should provide a general framework for
review and address, at a minimum, the following
issues:
• Data to be submitted by the method
developer or VCSB.
• Statistical tests or analyses to be conducted
to determine comparability between the new
proposed method and the existing approved
method.
Assistant Administrator
for Water
12/31/13
16 Establish procedures for designating official cut-off
dates for future proposed MURs, and include these
procedures on OW's website.
16 Clarify on EPA's website OW's procedures and
communications policies regarding the two distinct
routes through which new methods may be
approved by EPA.
Assistant Administrator 6/6/13
for Water
Assistant Administrator 9/30/13
for Water
0 = recommendation is open with agreed-to corrective actions pending
C = recommendation is closed with all agreed-to actions completed
U = recommendation is unresolved with resolution efforts in progress
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Appendix A
EPA's Adherence to Applicable Laws, Regulations,
Policies, and Guidance
Table A-l below lists the statutes, regulations, policies, and guidance (i.e., criteria documents)
that are applicable to EPA's review and handling of ASTM D7575. The table provides a brief
description of the applicable requirements for each criteria document and a description of the
actions EPA took regarding those requirements.
Table A-1: Summary of EPA actions taken to meet applicable requirements
Key criteria
Description of applicable criteria or requirements
Description of actions regarding
applicable requirements
Administrative
Procedure Act
This act discusses the general requirements federal
agencies must follow for rulemakings. It states that
agencies must provide notice of proposed rulemakings
in the Federal Register. After this notice, the agency
must provide the opportunity for public comment on the
proposal.
EPA published its September 2010
proposed MUR and December 2011
NODA in the Federal Register. EPA
provided periods of public comment for
both.
Clean Water Act
Section 304(h) requires EPA to promulgate guidelines
establishing test procedures for the measurement of
pollutants regulated under the NPDES program
(i.e., Section 402).
EPA developed these guidelines, which
are codified in 40 CFR Part 136.
40 CFR
Part 136
40 CFR Part 136 establishes guidelines for test
procedures (methods) to be used in wastewater
programs, specifically the NPDES program and its
related applications, permits, and reports. It lists all the
methods that have been approved and promulgated by
EPA for use.
Part 136 describes the application and approval
process to be followed for methods submitted to the
ATP program. The guidelines require comparability
data to be submitted which show how the proposed
method performs in comparison to an already-approved
method. After the ATP coordinator reviews the
proposed method, he or she is to recommend to the
Administrator whether to accept or reject the method.
Methods recommended for approval are to be
published in the Federal Register for public comment,
and subsequently a final decision on approval is to be
made in the Federal Register.
Part 136 does not discuss the review and approval of
methods submitted to EPA via the NTTAA.
Although D7575 was submitted under
the NTTAA, not the ATP program,
EPA required the method developer
and ASTM to submit comparability data
as required by 40 CFR Part 136. EPA
used those data to assess how ASTM
D7575 performs in comparison to
EPA Method 1664A.
Further, EPA published the NODA in
the Federal Register to obtain public
comment on whether to reconsider
ASTM D7575.
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Key criteria
Description of applicable criteria or requirements
Description of actions regarding
applicable requirements
EPA's Action
Development
Process (ADP):
Guidance for
EPA Staff on
Developing
Quality Actions
(revised March
2011)
Under the ADP, each new regulatory action is assigned
a tier level that appropriately corresponds to the level of
complexity, needed cross-Agency input, controversy/
visibility, and need for involvement by top-level
managers. Actions are assigned as Tier 1, Tier 2, or
Tier 3 actions. Tier 1 actions are the most complex,
require the most cross-agency collaboration, and have
the highest need for involvement by top-level
managers.
The ADP contains many specific requirements for
actions that are tiered at more elevated levels
(i.e., Tier 1 and Tier 2). These include forming
intra-agency workgroups and developing options
selections to present to senior officials in EPA.
However, these are voluntary for Tier 3 actions.
EPA tiered the MUR as a Tier 3 action.
The NODA is also a Tier 3 action since
it is an outgrowth of the MUR.
EPA convened a workgroup for the
MUR rulemaking, although this is not
required for Tier 3 actions.
National
Technology
Transfer and
Advancement
Act
Per section 12(d) of the NTTAA, federal agencies shall
use technical standards developed or adopted by
VCSBs, unless doing so would be inconsistent with
applicable law or otherwise impractical.
EPA assessed the viability of ASTM
D7575 per the requirements of the
NTTAA. It spent considerable effort in
attempting to determine whether
approving ASTM D7575 as an
alternative for EPA Method 1664A
would be practical, specifically by
assessing comparability between the
two methods.
OMB Circular
A-119 (revised
February 1998)
OMB Circular A-119 is OMB's implementing guidance
for the NTTAA for federal agencies. It states that
agencies "must use voluntary consensus standards,
both domestic and international, in its regulatory and
procurement activities in lieu of government-unique
standards, unless use of such standards would be
inconsistent with applicable law or otherwise
impractical. In all cases, your agency has the discretion
to decline to use existing voluntary consensus
standards if your agency determines that such
standards are inconsistent with applicable law or
otherwise impractical."
EPA spent considerable effort in trying
to determine whether approving the use
of ASTM D7575 would be practical,
specifically considering its comparability
to EPA Method 1664A. Note that the
OMB circular provides EPA discretion
in declining the use of ASTM D7575 if it
determines it is impractical.
Source: OIG analysis.
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Appendix B
Agency Comments on Draft Report
May 15, 2013
MEMORANDUM
SUBJECT: Response to Office of Inspector General Draft Report No. OPE-FY12-0013
"Results of Hotline Complaint Review Concerning EPA's Handling of a Proposed
Alternative Method for Measuring Oil and Grease in Wastewater," dated March
28, 2013
FROM: Nancy K. Stoner
Acting Assistant Administrator
TO: Arthur A. Elkins, Jr.
Inspector General
Thank you for the opportunity to respond to the issues and recommendations in the subject report.
Following is a summary of the Agency's overall position, along with its position on each of the
report recommendations. For those report recommendations with which the Agency agrees, we
have provided either high-level intended corrective actions and estimated completion dates to the
extent we can or reasons why we are unable to provide high-level intended corrective actions and
estimated completion dates at this time. For your consideration, we have included a version of the
report with our suggested edits and comments as an attachment to supplement this response.
AGENCY'S OVERALL POSITION
The Office of Water generally agrees with the draft report. We note that the objective as stated in
the draft report was to "evaluate whether the EPA, in reviewing ASTM D7575, adhered to
applicable laws, regulations, policies, procedures, and guidance," and that the investigation
concludes that the EPA did, in fact, adhere to applicable laws, regulations, policies, procedures,
and guidance in handling the proposed alternative oil and grease method, ASTM D7575.
AGENCY'S RESPONSE TO REPORT RECOMMENDATIONS
Agreements
No.
Recommendation
High Level Intended
Correction Action
Estimated Completion
by Quarter and FY
1
Establish a procedure for reviewing
proposed methods for method-defined
analytes.
1.1 The OW will
establish a
procedure for
reviewing
proposed methods
for method-
The EPA expects to
have a draft procedure
by December 2013.
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defined analytes
for CWA use
2
Establish procedures for designating
official cut-off dates for future
proposed MURs, and include these
procedures on the OW's website
1.1 When the EPA
initiates a methods
update rulemaking
(MUR), it will
designate cut-off
dates for
consideration of a
method for the
MUR
1.2 The OW will post
these dates on its
website
1.3 If the MUR is
delayed and the
EPA determines it
is appropriate to
extend these dates,
OW will post
revisions to its
website
The OW will make
such determinations
and post the
information on its
website within a
sufficient amount of
time prior to
proposing a MUR,
generally at least 6
months. [16]
3
Clarify on the EPA's website OW's
procedures and communications
policies regarding the two distinct
routes through which new methods
may be approved by the EPA
The OW will clarify
on its website its
procedures and
communications
policies regarding the
two distinct routes
through which new
methods may be
approved by the EPA
in 40 CFR Part 136
The OW plans to post
this information to its
website in 3rd Quarter
FY 2013. [17]
Thank you for the opportunity to review the draft report. The Office of Water generally agrees
with the draft recommendations. Please contact Jan Matuszko at 202-566-1035 if you have any
questions or need additional information.
Attachment
cc: EPA IG Liaison Team
16 Subsequent to this action plan, OW clarified its response to Recommendation 2. On June 6, 2013, OW issued a
memorandum to staff that outlines OW's procedures for establishing cut-off dates for future MUR rulemakings,
including posting the cut-off dates on OW's website at least 6 months before proposing a MUR. According to the
memorandum, OW will also post an explanation on its website as to what the cut-off dates mean.
17 On July 2, 2013, the Director of OW's Engineering and Analysis Division requested that the planned completion
date for the corrective action for recommendation 3 be changed to September 30, 2013. We agreed with this change.
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Distribution
Office of the Administrator
Assistant Administrator for Water
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for External Affairs and Environmental Education
Principal Deputy Assistant Administrator for Water
Audit Follow-Up Coordinator, Office of Water
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