Schedule and SOW.doc

Schedule and SOW

TITLE OF CONTRACT

Petition for an Exemption from a Tolerance for a Pesticide Active Ingredient – Sodium Nitrite (CAS # 7632-00-0)

INTRODUCTION

Within the next few years, USDA will be submitting a pesticide registration application to the US Environmental Protection Agency (EPA) in accordance with Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; 7 USC 136) Section 3 for a product for use for controlling feral swine. EPA has classified this pesticide product as having a terrestrial food use pattern (40 C.F.R. § 158.100 – Pesticide use patterns; https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-158) (1). All of the applicable data requirements listed in 40 C.F.R. § 158 – Data requirements for pesticides (https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-158) (2) for a terrestrial food use product application must be met and included in USDA APHIS’ application before EPA will initiate a review.

The purpose of the work requested here is for the contractor to draft a petition to EPA for an exemption from the requirement for a tolerance for the pesticide’s active ingredient, sodium nitrite (CAS # 7632-00-0), contained in the formulated product. USDA will provide the specific concentration to the vendor performing the work once the contract is awarded. The end-use product will be applied during operational use in bait stations specifically designed to limit access to feral swine and following use restrictions that avoid exposure to the public. The fast-acting mechanism of action of the end-use product’s active ingredient in feral swine will minimize the potential for any residues from the end-use product to enter food or feed and will minimize potential direct exposure of hunters or other people or animals to the end-use product.

DEFINITIONS

1) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA): The primary federal pesticide law (7 USC 136).

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

PURPOSE

The purpose of this contract is to draft the final petition for an exemption from a tolerance for the pesticide’s active ingredient, sodium nitrite (CAS # 7632-00-0). The petition is an EPA requirement for registration of a food use pesticide product that requires pesticide tolerance determinations and will be incorporated into EPA’s human health review to evaluate potential exposure of humans to any residues from the active ingredient from exposed feral swine.

SCOPE OF WORK

The work tasks included are:

1) Draft a written petition for an exemption from a tolerance for the active ingredient, sodium nitrite (CAS # 7632-00-0) to support a pesticide product registration and that meets EPA’s requirements listed in EPA’s Pesticide Registration Manual: Chapter 11 – Tolerance Petitions (https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-11-tolerance-petitions#tolerances) (3) and 40 C.F.R. § 180.7 – Petitions proposing tolerances or exemptions for pesticide residues in or on raw agricultural commodities or processed foods (https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180) (4).

The petition must include the following:

a. An informative summary of the petition and the data, and any other information and arguments submitted or cited in support of the petition, as described in EPA’s Pesticide Registration Manual: Chapter 11 – Tolerance Petitions (3).

i. The Reasonable Grounds section of this petition must include a dietary risk analysis using the Dietary Exposure Evaluation Model - Food Commodity Intake Database (DEEM-FCID) (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/deem-fcidcalendex-software-installer) (5) to assess human dietary exposure (including infants and children) to support the request for an exemption from the requirement for a tolerance for the active ingredient.

b. A final written Federal Register Notice of Filing (NOF) for the petition formatted as described in EPA’s Pesticide Registration Manual: Registrant Summary of Pesticide Petitions for EPA's Notice of Filing (https://www.epa.gov/pesticide-registration/pesticide-registration-manual-registrant-summary-pesticide-petitions-epas) (6).

CONTRACTOR RESPONSIBILITIES

The Contractor shall provide the following services:

1) Review existing data and waivers provided by USDA. Find and evaluate the most relevant publicly available scientific data and other information required to support the petition. Find and evaluate any maximum residue levels established by the Codex Alimentarius Commission for the pesticide chemical residues (nitrite and nitrate) addressed in the petition.

2) Draft a written petition for an exemption from a tolerance for the active ingredient, sodium nitrite (CAS # 7632-00-0) to support a pesticide product registration and that meets EPA’s requirements listed in EPA’s Pesticide Registration Manual: Chapter 11 – Tolerance Petitions (https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-11-tolerance-petitions#tolerances) (3) and 40 C.F.R. § 180.7 - Petitions proposing tolerances or exemptions for pesticide residues in or on raw agricultural commodities or processed foods (https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180) (4).

The petition must include the following:

a. An informative summary of the petition and the data, and any other information and arguments submitted or cited in support of the petition, as described in EPA’s Pesticide Registration Manual: Chapter 11 – Tolerance Petitions (3).

i. The Reasonable Grounds section of this petition must include a dietary risk analysis using the Dietary Exposure Evaluation Model - Food Commodity Intake Database (DEEM-FCID) (https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/deem-fcidcalendex-software-installer) (5) to assess human dietary exposure (including infants and children) to support the request for an exemption from the requirement for a tolerance for the active ingredient.

b. A final written Federal Register Notice of Filing (NOF) for the petition formatted as described in EPA’s Pesticide Registration Manual: Registrant Summary of Pesticide Petitions for EPA's Notice of Filing (https://www.epa.gov/pesticide-registration/pesticide-registration-manual-registrant-summary-pesticide-petitions-epas) (6).

USDA 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 provide the following:

1) Provide the proposed application methods and rates for the active ingredient, sodium nitrite, and end-use product (will provide a draft pesticide label).

2) Provide USDA’s pesticide registration data, non-guideline reports and publications, and waiver requests for sodium nitrite and the end-use product.

3) Keep the contractor up to date on any changes to the list of data submissions that will be used to support application for registration for the end-use product.

4) Review, comment, and approve the final written petition for exemption from a tolerance for the active ingredient, sodium nitrite.

APPLICABLE STANDARDS

Federal Code of Regulations 40 C.F.R. § 158 – Data Requirements for Pesticides Federal Code of Regulations 40 C.F.R. § 180 – Tolerances and Exemptions for Pesticide Chemical Residues in Food.

PERIOD OF PERFORMANCE

It is expected that meeting the requirements of the contract will take no more than 5 months.

PLACE OF PERFORMANCE

The performance shall be conducted by the contractor in accordance with the contractor’s company policies.

ACCEPTANCE CRITERIA

The USDA APHIS WS NWRC RU will represent USDA as the technical representative in matters related to the study.

1) The contractor will provide the draft written petition for exemption the requirement of a tolerance for sodium nitrite to the technical representative.

2) The technical representative will review the draft petition and provide comments, if necessary. The contractor will work with the technical representative to finalize the petition. The technical representative will approve the final draft of the petition.

PAYMENT SCHEDULE

Payment will be authorized after acceptable completion of each milestone/deliverable identified in the price schedule.

CONTRACTOR QUALIFICATIONS

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

1) The contractor must demonstrate experience preparing at least 2 pesticide food tolerance or tolerance exemption petitions for pesticide active ingredients within the past 10 years. The contractor may choose the most appropriate documentation to demonstrate the prior experience and redact confidential information. The documentation shall be submitted with the quote.

REFERENCES

(1) 40 C.F.R. § 158.100 – Pesticide use patterns: https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-158)

(2) 40 C.F.R. § 158 – Data requirements for pesticides: https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-158

(3) EPA’s Pesticide Registration Manual: Chapter 11 – Tolerance Petitions: https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-11-tolerance-petitions#tolerances

(4) 40 C.F.R. § 180.7 – Petitions proposing tolerances or exemptions for pesticide residues in or on raw agricultural commodities or processed foods: https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180

(5) Dietary Exposure Evaluation Model - Food Commodity Intake Database (DEEM-FCID): https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/deem-fcidcalendex-software-installer

(6) EPA’s Pesticide Registration Manual: Registrant Summary of Pesticide Petitions for EPA's Notice of Filing: https://www.epa.gov/pesticide-registration/pesticide-registration-manual-registrant-summary-pesticide-petitions-epas

INVOICING

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

Technical Contact:

Emily Ruell Acting Registration Manager

USDA/APHIS/WS/National Wildlife Research Center

4101 LaPorte Avenue

Fort Collins, CO 80521

970-266-6161 Emily.W.Ruell@usda.gov

IPP Invoicing Contact:

Tammy Wagner Budget Analyst

USDA/APHIS/Wildlife Services

National Feral Swine Damage Management Program

4101 LaPorte Avenue

Fort Collins, CO 80521

Ph: 970-266-6159

Tammy.L.Wagner@usda.gov

PRICE SCHEDULE

Petition for an exemption from a tolerance for the pesticide active ingredient sodium nitrite

Subtotal

Optional – To be exercised if needed by written permission by the USDA technical representative.

Total