amendment_01.pdf

pOMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1 1

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. Pp

01 08/09/2018 n/a

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE USDA, APHIS, MRP BS, ASD, Contracting Butler Square, 5th Floor 100 North Sixth Street Minneapolis, MN 55403

( ) 9A. AMENDMENT OF SOLICITATION NO.

X

9B. DATED (SEE ITEM 11)

07/26/2012

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer :_X__is extended, __ is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:(a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

( ) A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN

ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER Specify type of modification and authority)

E. IMPORTANT: Contractor: is not,_____is required to sign this document and return ___ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

A. The purpose of amendment 01 to solicitation 12639518Q0180 is to remove CLIN 3: OPPTS 860.1480 requirements and related language in the Statement of work. See attached ‘change pages’ with a revised schedule and SOW with OPPTS 860.1480 requirements removed via ‘strike through and red text’.

B. The quote due date is extended from 08/14/2018 to 08/21/2018 1:30 CT

Except at provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

BY

(Signature of Contracting Officer)

08/09/2018

NSN 7540-01-152-8070 30-105 STANDARD FORM 30

(REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

FAR (48 CFR) 53.2

SCHEDULE:

NOTE: The unit price listed will be a firm fixed price. No price ranges will be accepted.

CLIN 1: OPPTS 860.1340 Qty. Unit Price Total Price

101 – Finalization of study protocol -method development

102 – Completion of study phase and analysis of laboratory results

103– Finalization of final report 1 __________ __________

Option: OPPTS 860.1340

104 – Additional tissue 2 __________ __________

CLIN 2: OPPTS 860.1380 Storage

201 – Finalization of study protocol -storage stability data

202 – Completion of study phase and

203 – Finalization of final report 1 __________ __________

204 – Additional tissue 2 __________ __________

CLIN 3: OPPTS 860.1480

301 – Finalization of study protocol – residues in meat

302 – Completion of study phase and

303 – Finalization of final report 1 __________ __________

304 – Additional tissue 2 __________ __________

Total

STATEMENT OF WORK

Residue Analytical Method Development, Residue Storage Stability Testing, and Residues in Meat 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.

These data requirements provide the residue data for the unregistered active ingredient, sodium nitrite upon which judgments are made by EPA as to the identity and magnitude of residues resulting from the proposed use, and they must provide a means for enforcement of the tolerance if granted. The meat residue study will be conducted in pigs. The analytical method development, and storage stability studies will all be conducted using pig tissues. All testing and submissions will follow the requirements of OPPTS guidelines 860.1340 (1), 860.1380 (2) and

860.1480 (3) (40 CFR 158, Subpart F). The independent laboratory validation (ILV) of the developed method as described in OPPTS 860.1340 (1) is not a requirement of this statement of work (SOW). These studies must also be conducted following EPA FIFRA regulatory requirements for Good Laboratory Practice Standards (GLPs; 40 CFR 160) (4).

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) (4).

PURPOSE

The purpose of this requisition is to fulfill three of the data requirements for a future USDA APHIS pesticide registration application to EPA for a toxicant for feral swine containing sodium nitrite. These studies will 1) develop an analytical method to measure nitrite residues in pig tissues, 2) evaluate the storage stability of residues in pig tissues, 3) conduct a dosing study of sodium nitrite in pigs to determine nitrite residues in meat when administered sodium nitrite orally. These studies will be conducted in accordance with EPA OPPTS guidelines 860.1340,

860.1380 and 860.1480, 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 each study in accordance with EPA OPPTS guidelines 860.1340, 860.1380 and 860.1480, and EPA FIFRA GLP requirements.

LABORATORY REQUIREMENTS

The requirement is to complete each study in accordance with EPA OPPTS guidelines 860.1340,

860.1380 and 860.1480, and EPA FIFRA GLP requirements. The requirements for each study include:

a. Compliance with EPA FIFRA GLP requirements (4) 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 guidelines 860.1340, 860.1380 and 860.1480, and the approved study protocol.

a. OPPTS 860.1340 – development and validation of an analytical method to measure nitrite and metabolite (if present) levels in pig muscle, fat, liver, and a contingency for one additional tissue. This SOW does NOT include the independent lab validation ILV.

b. OPPTS 860.1380 – nitrite residue and metabolite (if present) stability testing in pig muscle, fat, liver, and a contingency for one additional tissue.

c. OPPTS 860.1480 – animal study with a minimum of 4 treatment groups including negative controls with a minimum of three animals per treatment. Also analysis of pig muscle, fat, liver, and a contingency for one additional tissue to measure nitrite and metabolite (if present) levels.

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 guidelines 860.1340, 860.1380 and 860.1480.

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 (5).

PERIOD OF PERFORMANCE

It is expected that meeting the requirements of the contract will take less than 12 months.

LABORATORY DELIVERABLE REQUIREMENTS

The Contractor shall provide for each study:

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

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

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

d. Test substance and sample disposal.

USDA APHIS DELIVERABLES

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 protocols, any amendments (as applicable), and the final reports.

Period of performance The Contractor shall complete the requirements within 12 months of award..

APPLICABLE STANDARDS

a. All aspects of each study and study records will be completed in compliance with EPA FIFRA GLP standards (40 CFR part 160) (4). The contract laboratory will be responsible for compliance with all EPA FIFRA GLP regulations.

b. The final reports will be formatted to conform to EPA’s PRN 2011-3: Standard Format for Data Submitted under FIFRA and Certain Provisions of FFDCA (5).

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 each study.

a. To the sponsor’s representative, the contract laboratory will provide a draft study protocol prior to the start of each study, any draft amendments to the study protocol during the study (if applicable), and provide a draft final study report at the conclusion of each 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. Each study will begin after the protocol is approved by the sponsor’s representative. The protocol will be in compliance with EPA FIFRA GLP standards (4). 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 (4).

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

SPECIAL REQUIREMENTS

The contract laboratory shall have demonstrated successful experience in conducting studies in accordance with OPPTS guidelines 860.1340 (1), 860.1380 (2) and 860.1480 (3) and in compliance with EPA FIFRA GLP standards.

EVALUATION

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 these studies per the OPPTS guidelines 860.1340, 860.1380 and 860.1480. The laboratory must provide documentation from the facility’s ‘Master Schedule’ of at least one of each 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 guidelines 860.1340, 860.1380 and 860.1480. 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 860.1340 Residue Analytical Method, August 1996, p. 1-14, https://www.regulations.gov/document?D=EPA-HQ-OPPT-2009-0155-

2. Health Effects Test Guidelines: OPPTS 860.1380 Storage Stability Datas, August 1996, p.

1-17, https://www.regulations.gov/document?D=EPA-HQ-OPPT-2009-0155-0009

3. Health Effects Test Guidelines: OPPTS 860.1480 Residue Analytical Method, August 1996, p. 1-16, https://www.regulations.gov/document?D=EPA-HQ-OPPT-2009-0155-

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

5. PRN 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). Payments will be made for acceptable work completed.