OPP Standard Operating Procedure 

Final: January 18, 2007

 Inclusion of Water Quality & Impaired Water Body Data in 

OPP’s Registration Review Risk Assessment & Management Process

Goal:  Establish a process for the voluntary submission of state &
tribal surface and ground water quality data, including but not limited
to Clean Water Act (CWA) 303(d) & 305(b) data, for consideration in
exposure characterizations for ecological risk assessments and in risk
management decisions for pesticide registration review. 

Background:  EPA’s Office of Pesticide Programs (OPP) published the
final rule for pesticide registration review on August 9, 2006 with an
effective date of October 10, 2006 (ref.    HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/" 
www.epa.gov/oppsrrd1/registration_review/ ).  This program ensures that
all pesticides continue to meet current health and safety standards. 
The Congressional goal is to review all existing pesticides every 15
years. 

Process for Identification & Submission of Water Quality Data for
Registration Review:

Problem Formulation –begins well in advance of initiation of risk
assessment

Review schedule for opening registration review case dockets – with
focus on the first two years (e.g., FY07 & FY08 in the first schedule). 
– Regional water & pesticide staff with input from OPP

Identify Clean Water Act (CWA) 303(d) listed water bodies where the
pesticide scheduled for review is the cause of impairment, and other
state/tribal water quality concerns associated with the scheduled
pesticides based on CWA 305(b) biennial reports, other surface or ground
water monitoring, or other sources.  Water quality concerns include fish
tissue and sediment concerns.  - Regional water and pesticide staff
provide a single ‘report’ per region indicating pesticides for which
data may be provided.

For registration review cases associated with 303(d) listings, mine
existing data that support the listing of each water body, and any other
related data.  Information on any current mitigation should also be
submitted.  - Regional water and pesticide staff, working with states
and tribes as appropriate.

Mine monitoring data* associated with other surface or ground water
quality concerns – EPA regional pesticide and water staff, working
with states and tribes as appropriate.

Data should conform to the quality standards in Appendix A to the extent
possible to ensure they can be used quantitatively or qualitatively in
pesticide risk assessments.

Submit all selected data, data links, or other information to OPP in
advance of the docket opening that begins the registration review
process, so that useful data can be cited and be available for public
comment.  Any data submitted later should be submitted during the public
comment period if possible.  OPP would prefer to have the submissions in
the last quarter of the fiscal year preceding the year in which the
pesticide is scheduled to begin registration review.   – Regional
water and pesticide staff, working with states, tribes and OPP as
needed.



Risk Assessment

Consider information on impaired water bodies or other water quality
data of concern in characterization of predicted ecological risks when a
revised risk assessment is needed.   – OPP, with OW and regional
consultation/collaboration  [Note:  OPP’s ecological risk assessment
may identify additional issues  beyond Clean Water Act 303(d) listings.]

Publish preliminary risk assessment for public comment along with
supporting materials (generally 60 days) and ask for comment as well on
possible/practical risk management options – OPP

Risk Management

Develop risk management options to address impaired water bodies and
other documented water quality issues, to the extent that the problem
may be attributed to use of the pesticide.  – OPP, with OW and
regional consultation/collaboration

Develop monitoring plan options as a condition of registration, based on
a determination of risks-benefits, to establish the extent to which
additional water bodies may be impaired by the chemical – OPP, with OW
and regional consultation/collaboration. 

Issue Risk Management Decision – OPP

Issue an interim or final registration review decision for comment,
stating whether the pesticide meets, or does not meet, the FIFRA
standard for registration, including the basis for the proposed
findings, proposed risk mitigation standards, additional data needs,
proposed labeling changes, and deadlines to be set for completing
required actions.

Issue an interim or final registration review decision, including an
explanation of any changes and responses to significant comments.

Ensure risk mitigation measures are implemented, including label
changes.

Attachment:  Appendix A:  Options for Providing Data or Data Locations
to EPA/OPP

Appendix A:  Options for Providing Data or Data Locations to EPA/OPP

OPP Standard Operating Procedure:

Inclusion of Water Quality & Impaired Water Body Data in 

OPP’s Registration Review Risk Assessment & Management Process

There are several options for providing the data or data locations to
EPA/OPP: 

1.  If the data are already in the new STORET database, then simply let
OPP know where the dataset is located within the database.

2.  If the data are in legacy versions of STORET, or in other data
systems, then OPP would like to get the type of metadata and detailed
data described in the following sections.

(n.b., As a point of reference, The National Water Quality Monitoring
Council, a consortium of federal, tribal, state and local agencies,
academia, and the private and public sector water supply industries,
developed guidance on water quality data elements that enhance the
evaluation and sharing of water quality data.  The data elements
identified below were derived from this guidance (  HYPERLINK
"http://acwi.gov/methods/data_projects/index.html" 
http://acwi.gov/methods/data_projects/index.html , accessed 10/2/2006). 
In addition, detailed guidance on elements included in data quality
standards may be found in the Environmental Sampling, Analysis and
Results (ESAR) Data Standard issued by the Environmental Data Standards
Council:    HYPERLINK
"http://www.envdatastandards.net/content/article/detail/649?PHPSESSID=f4
d35d5d72960a91284c065c6ed71f9a" 
http://www.envdatastandards.net/content/article/detail/649?PHPSESSID=f4d
35d5d72960a91284c065c6ed71f9a  )

Sample data should include at a minimum:

Bibliographic reference 

Data included in an EPA risk assessment need to be citable.  The
reference would ideally be for a report on the study in which the data
were collected.  If the bibliographic citation is a website, it should
reference the page containing the data in question (not the general site
for the database), and must identify the date the page was accessed.  A
database that is on the web containing data from multiple studies is
acceptable, as long as a lead contact (i.e. study director or collecting
organization) for the study that collected the specific data in question
is provided.  

Sample collection date (and time, if available)

Sample ID

Location description (Water body name in National Hydrography Dataset,
and location descriptor such as: latitude/longitude, FIPS code, water
body & segment) 

Sample media (e.g. water, filtered water, bed sediment, tissue, etc.)

Concentration detected and measurement units

Detection limit and analytical method

Other important information that aid in interpreting monitoring data
are:

What was the purpose of the study (i.e. study design rationale)? (a
reconnaissance study, targeted to compounds of interest, TMDL plan,
statistically designed)

QA/QC for sample collection and analytical methods, including a
discussion of any limitations of the data 

Time of sample (e.g. date, time; duration (if a composite), timing to
stream hydrograph, if flow-weighted sample)

Sample collection method (e.g. grab or composite)

Toxicity testing, if conducted.  (Include test methodology, test
species, endpoint assessed, and any toxicity identification
evaluation(s) which identified the specific toxicant(s) causing
toxicity.)   

Metadata (ancillary data) are needed when using the data quantitatively,
such as

Land use, including cropping pattern, agriculture/urban, etc.

Pesticide usage that could affect water quality at sampling location

Did the sampling methodology & analytical methods go through a formal QA
process

Is the formal QA process documented (e.g. in a report or on a website
address)

For pesticides that adsorb to sediments:  percent organic carbon, bulk
density, etc.

Relevant organism parameters (size or life stage)

For some chemicals, environmental conditions may affect mobility and
persistence (for example:  temperature, pH, hardness, turbidity).  If
this is known to occur, information on the parameter would be helpful in
interpreting the data.

OPP recognizes that raw data for all the parameters listed above may not
be available in all monitoring studies, particularly for older studies,
and that the types of water quality data collected might be different
between monitoring programs.  There is no need for states to create or
reformat any data – OPP will attempt to use what is available, either
qualitatively or quantitatively.  In that spirit:

If the supporting data were collected in a monitoring program conducted
by the states themselves, OPP would like to receive the detailed
monitoring data and a copy of any report describing the purpose and
design of the monitoring study, or internet web address leading to this
information.  

If the data were collected by an outside party, such as university
researchers, then citations of published reports or copies of the
reports themselves would provide the needed context.  (Note, please do
not submit NAWQA data if it was used as the basis of a 303(d) listing or
identification of a water body of concern, instead please reference the
specific NAWQA dataset.) 

If any 303(d) listings or other water quality concerns for pesticides
were based on watershed characteristics or expected pesticide use, and
not actual pesticide detections in surface water, such information could
help inform OPP's risk assessment, as well.

In summary, OPP is interested in seeing all available data for a
specific water body of concern to a State.  If a monitoring study is
already contained within the new STORET all that is required is its
location within the database.  For monitoring studies not contained with
the new STORET, please submit data, or provide database locations, with
associated documentation or references, as described above.

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