Statement_of_Work.doc

STATEMENT OF WORK

TITLE OF CONTRACT

In vitro Mammalian Chromosome Aberration Testing of Sodium Nitrite

INTRODUCTION

Within the next few years, USDA APHIS will be submitting a pesticide registration application to the US EPA under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; 7 USC 136) Section 3 for a product containing the unregistered active ingredient, sodium nitrite, for controlling feral swine. EPA has classified this pesticide product for feral swine as having a terrestrial food use pattern (40 CFR 158). All of the applicable data requirements listed in 40 CFR 158 for a terrestrial food use product application must be met and included in USDA APHIS’ application before EPA will initiate a review.

One of these data requirements is the in vitro chromosome aberration test to determine if the unregistered active ingredient, sodium nitrite, causes structural chromosome aberrations in cultured Chinese hamster cells, following the requirements of OPPTS 870.5375 (40 CFR 158, Subpart F) (1). This study must also be conducted following EPA FIFRA regulatory requirements for Good Laboratory Practice Standards (GLPs; 40 CFR 160) (2).

DEFINITIONS

a. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA): The federal pesticide regulation legislation (7 USC 136).

b. U.S. Environmental Protection Agency (EPA): The federal regulatory agency responsible for the regulation of pesticides including pesticide product registration under FIFRA.

c. Unregistered active ingredient: An active ingredient is “…an ingredient which will prevent, destroy, repel, or mitigate any pest” (7 USC 136(a)(1)). An active ingredient is unregistered when it is not already an active ingredient within currently-registered pesticide products.

d. Good Laboratory Practices (GLP): The set of organizational processes and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported intended to assure the quality and integrity of non-clinical laboratory studies intended to support research or marketing permits for products regulated by government agencies including the EPA (40 CFR 160) (2).

PURPOSE

The purpose of this requisition is to fulfill one of the data requirements for a future USDA APHIS pesticide registration application to EPA for a toxicant for feral swine containing sodium nitrite. This study will evaluate whether exposure to the unregistered active ingredient, sodium nitrite, causes structural chromosome aberrations in cultured Chinese hamster cells, and will be conducted in accordance with EPA OPPTS 870.5375 and EPA FIFRA GLP requirements.

SCOPE OF WORK

The scope of this contract will include drafting a study protocol, laboratory testing, data analysis, final report writing, and quality assurance reviews for this study in accordance with EPA OPPTS 870.5375 and EPA FIFRA GLP requirements).

LABORATORY REQUIREMENTS

The requirement is to complete a study in accordance with EPA OPPTS 870.5375 and EPA FIFRA GLP requirements. The requirements include:

a. Compliance with EPA FIFRA GLP requirements (2) for all aspects of the study.

b. Drafting a study protocol, which will be approved by the study sponsor’s representative (USDA APHIS WS NWRC RU) prior to initiation of any laboratory testing of the test substance.

c. Conducting laboratory testing of the test substance in accordance with EPA OPPTS 870.5375 and the approved study protocol.

a. Per the guidance, this in vitro study is conducted using an appropriate mammalian cultured cell line.

b. At least three analyzable concentrations should be used. In addition, concurrent positive and negative (solvent or vehicle) controls both with and without metabolic activation should be included in each experiment.

a. Duplicate cultures should be used at each concentration, and are strongly recommended for negative/solvent control cultures. Where minimal variation between duplicate cultures can be demonstrated (see paragraphs (i)(13) and (i)(14) of this guideline), from historical data, it may be acceptable for single cultures to be used at each concentration.

d. Any amendments to the study protocol will be approved by the sponsor’s representative (USDA APHIS WS NWRC RU) prior to implementation.

e. Analysis of results in accordance with EPA OPPTS 870.5375.

f. Drafting a final study report and obtaining approval of the final report from the sponsor’s representative (USDA APHIS WS NWRC RU) prior to finalization and signing of the final report. The final report must be formatted in compliance with EPA’s PRN 2011-3: Standard Format for Data Submitted under FIFRA and Certain Provisions of FFDCA (3).

PERIOD OF PERFORMANCE

The Contractor shall complete the order within 12 months of contract award.

LABORATORY DELIVERABLE REQUIREMENTS

The Contractor shall provide for this study:

a. A draft and final study protocol, and any amendments (as applicable).

b. Testing/Study Phase

c. Analysis of results

d. A draft final report and the completed final report.

e. All documentation will be completed in accordance with EPA FIFRA GLP requirements.

f. Test substance and sample disposal.

USDA APHIS RESPONSIBILITIES

The USDA APHIS Wildlife Services (WS), National Wildlife Research Center (NWRC), Registration Unit (RU) will serve as the USDA APHIS sponsor’s representative. The sponsor’s representative will:

a. Provide the contract laboratory with the test substance (technical grade sodium nitrite), or ensure acquisition from another source as appropriate.

b. Review, comment, and approve of the study protocol, any amendments (as applicable), and the final report.

APPLICABLE STANDARDS

a. All aspects of the study and study records will be completed in compliance with EPA FIFRA GLP standards (40 CFR part 160) (2). The contract laboratory will be responsible for compliance with all EPA FIFRA GLP regulations.

b. The final report will be formatted to conform to EPA’s PRN 2011-3: Standard Format for Data Submitted under FIFRA and Certain Provisions of FFDCA (3).

PLACE OF PERFORMANCE

The order shall be conducted within the Contractor’s research facilities.

ACCEPTANCE CRITERIA

The USDA APHIS WS NWRC RU will represent USDA APHIS, as the study sponsor’s representative in matters related to this study.

a. To the sponsor’s representative, the contract laboratory will provide a draft study protocol prior to the start of the study, any draft amendments to the study protocol during the study (if applicable), and provide a draft final study report at the conclusion of the study.

b. The sponsor’s representative will review all draft documents and provide comments if necessary. The contract laboratory will work with the sponsor’s representative to finalize all documents. The sponsor’s representative will approve and sign all documents.

c. The study will begin after the protocol is approved by the sponsor’s representative. The protocol will be in compliance with EPA FIFRA GLP standards (2). Any protocol deviations or amendments must be approved by the sponsor’s representative, and the contract laboratory will document such changes in compliance with EPA FIFRA GLP standards (2).

d. The study final report will be in compliance with EPA FIFRA GLP standards.

SPECIAL REQUIREMENTS

The contract laboratory shall have demonstrated successful experience in conducting the study in accordance with OPPTS 870.5375 (1) and in compliance with EPA FIFRA GLP standards.

PAYMENT SCHEDULE

Payment will be authorized after completion of study and final report is completed.

CONTRACTOR QUALIFICATIONS

All offers will be evaluated based on Lowest Price Technically Acceptable (LPTA).

Technical Acceptability will be assessed on a pass/fail basis of the following factors:

a. The laboratory must have had at least one inspection or data audit by the U.S. EPA for compliance with EPA FIFRA GLP standards within the last 10 years. If one or more audits were conducted in the past 10 years, the three most recent closed audits within the timeframe must not have resulted in EPA’s rejection of a study either partially or fully due to failure to comply with all EPA GLP standards. Provide documentation of the one, or if available in the previous 10 years, up to three most recent audit findings. Foreign companies may provide the results of the most recent inspection by their authority responsible for GLP compliance.

b. The laboratory must have a record of conducting this type of study per the OPPTS 870.5375 guideline. The laboratory must provide documentation from the facility’s ‘Master Schedule’ of at least one of these studies within the past five years.

c. The intended Study Director contributing to this study must demonstrate prior experience participating in at least one other of this type of study per the OPPTS 870.5375 guideline. The laboratory must provide documentation of personnel experience. A statement summarizing key personnel experience in at least one study of this type shall meet the requirement.

REFERENCES

1. Health Effects Test Guidelines: OPPTS 870.5375 In Vitro Mammalian Chromosome Aberration Test, August 1998, p. 1-13, https://www.regulations.gov/document?D=EPA-HQ-OPPT-2009-0156-0029

2. Good Laboratory Practices Standards, 40 CFR, Part 160, 2016 ed., http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=efa9dd97aedac90d1fe9419044fe13dc&ty=HTML&h=L&mc=true&r=PART&n=pt40.24.160

3. 2011-3: Standard Format for Data Submitted Under FIFRA and Certain Provisions of FFDCA, November 30, 2011, p. 1-23, https://www.epa.gov/pesticide-registration/prn-2011-3-standard-format-data-submitted-under-fifra-and-certain-provisions

INVOICING

The contractor shall provide invoices detailing description of work/tasks performed and processed through the Invoice Processing Platform (IPP).

Contacts:

Technical Contact:

Jeanette O’Hare

Registration Manager

USDA/APHIS/WS/National Wildlife Research Center

4101 LaPorte Avenue Fort Collins, CO 80521

970-266-6156

Jeanette.r.ohare@aphis.usda.gov

IPP Invoicing Contact:

Esmeralda Reynolds Budget Analyst

USDA/APHIS/Wildlife Services

National Feral Swine Damage Management Program

4101 LaPorte Avenue

Fort Collins, CO 80521

Ph: 970-266-6311

Esmeralda.Reynolds@aphis.usda.gov