Quality Assurance for Tribal FIFRA Enforcement Grants

David R. TaylorEPA Region 9

Quality Assurance Office

What are QA requirements under FIFRA?

Grant regulations and the CFR requires grantees collecting environmental data using Federal grant funds to have a quality system in place.

More importantly, it makes sense to have a system in place that ensures data of know quality will be used for decision making.

How do I establish a Quality System?

EPA expects grantees will prepare a Quality Management Plan (QMP) and/or a Quality Assurance Project Plan (QAPP) and then implement it.

Guidances for QMP and QAPP preparation describe the expected components of a Quality System.

What is a QMP?

A QMP is a document that describes a Quality System.

Policy document. Identifies QA Officer or how QA

function will be handled. Describes system, not day to day

data gathering operations.

Do I have to prepare a QMP?

EPA Regions differ in implementation of this requirement. Some require a QMP. Some accept QMP as part of QAPP. Some only expect a QAPP at this time. Check with Regional QA Officer and/or

EPA Project Officer.

What if we can’t afford a QA Officer?

Few small organizations have a QA Officer.

Must describe how QA function will be carried out independent of data generation

Some options Set aside time by supervisor or staff Another staff person (e.g., 2nd inspector) Person from another organization

What is a QAPP?

QAPP is a document that describes the data generation process, including sample collection, sample analysis, quality control, data review, and most importantly, decision making (i.e., how will the data be used?).

Environmental Measurements under FIFRA

Use/Misuse* Formulations* Worker Health and Safety** Groundwater Investigations** Special Projects*** Enforcement related, measurements involved

** Usually no measurements *** Usually one time event, no enforcement

QA Plan Options - QMP

EPA Requirements for Quality Management Plans (“R-2”)

Guidance for Quality Management Plan Development for EPA Funded Environmental Cooperative Agreements with State and Tribal Agencies

QA Plan Options –QA Project Plan

Guidance for the Preparation of Quality Assurance Project Plans (“G-5”)

Guidance for Quality Assurance Project Plan Development for EPA Funded Cooperative Agreements with State and Tribal Agencies for the Conduct of FIFRA Pesticide Programs

Critical Elements of an Enforcement QAPP

Description of how program is structured Project Organization Decision Makers

Critical Elements of an Enforcement QAPP

Overview of program components (e.g., use/misuse, formulations, worker health and safety, etc.

Description of how program is implemented (e.g., different activities, who carries them out, typical sequence of events, etc.)

Critical Elements of an Enforcement QAPP

Description of decisions to be made with the data

Criteria upon which decisions are to be made

Decision maker if not identified earlier

Critical Elements of an Enforcement QAPP Description of documentation

requirements with relevant examples (e.g., inspector incident report, lab submission form, chain of custody, field sampling plan template, etc.)

Description of how samples are collected or references to appropriate protocols (e.g., NEIC Manual, EPA Inspector Manual, field SOPs)

Critical Elements of an Enforcement QAPP

Description of how samples are packaged and shipped, chain of custody, holding times, etc.

Description of how and where samples are analyzed (expectation is use of state agricultural laboratory, but could be a commercial laboratory). Documentation not on file with EPA would need to be supplied.

Must we use our State Agricultural Laboratory (SAL)?

No, but it is recommended... Only a small number of pesticides are

covered by EPA methods. This may mean method development costs.

Lack of familiarity with some pesticides may impact analysis.

SAL will be more likely to have developed QC criteria for unusual pesticides – a data quality issue

Must we use our State Agricultural Laboratory (SAL)?

Few commercial labs have extensive experience with unusual matrices (e.g., different types of foliage, fruits and vegetables, wipe samples).

Commercial laboratory may not have necessary equipment/instruments.

Few commercial laboratories have experience with high concentration formulation samples.

Must we use our State Agricultural Laboratory (SAL)?

Use of a SAL may expedite review of QAPP

Critical Elements of an Enforcement QAPP

Discussion of data review and flagging procedures

References/Further Information

Region 9 QA website: www.epa.gov/region09/qa

Taylor.David@epa.gov New Tribal FIFRA Enforcement

QAPP Guidance (in preparation by Region 9 QA Office) due in fall

Earlier cited FIFRA Documents

References/Further Information

National QA web site: www.epa.gov/quality

Training

Proposed training will be November 8-9, 2005 in Reno, Nevada, sponsored by EPA and the Pyramid Lake Paiute Tribe

Training will include use of a computer to develop QAPP on site

Each tribal staff person will need to know and understand how his or her program works and will need to bring relevant information