Sol_SOL-DC-16-00021.pdf

SOL-DC-16-00021

SOLICITATION, OFFER AND AWARD

4. TYPE OF SOLICITATION2. CONTRACT NUMBER 3. SOLICITATION NUMBER

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

ORDER UNDER DPAS (15 CFR 700)

6. REQUISITION/PURCHASE NUMBER

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

NEGOTIATED (RFP)

SEALED BID (IFB)

5. DATE ISSUED

1. THIS CONTRACT IS A RATED RATING PAGE OF PAGES

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C. E-MAIL ADDRESS

EXT.NUMBERAREA CODE

B. TELEPHONE (NO COLLECT CALLS)A. NAME

10. FOR

INFORMATION

CALL:

CAUTION: LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

(Date)(Hour) local timeuntildepository located in copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the

SOLICITATION

9. Sealed offers in original and

PART IV - REPRESENTATIONS AND INSTRUCTIONS

OTHER STATEMENTS OF OFFERORS

EVALUATION FACTORS FOR AWARD

INSTRS., CONDS., AND NOTICES TO OFFERORS

REPRESENTATIONS, CERTIFICATIONS AND

LIST OF ATTACHMENTS

CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

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K

L

M SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/CONTRACT FORM

PART II - CONTRACT CLAUSESPART I - THE SCHEDULE

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G

F

E

D

C

B

A

SEC. DESCRIPTION PAGE(S) (X) DESCRIPTION SEC. (X)

11. TABLE OF CONTENTS

18. OFFER DATE17. SIGNATURE

SUCH ADDRESS IN SCHEDULE.

IS DIFFERENT FROM ABOVE - ENTER

15C. CHECK IF REMITTANCE ADDRESS

EXT.NUMBERAREA CODE

15B. TELEPHONE NUMBER

(Type or print)AND

ADDRESS

OF

OFFEROR

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME

DATEAMENDMENT NO.DATEAMENDMENT NO.

and related documents numbered and dated):

amendments to the SOLICITATION for offerors

(The offeror acknowledges receipt of

14. ACKNOWLEDGEMENT OF AMENDMENTS

CALENDAR DAYS (%)30 CALENDAR DAYS (%)20 CALENDAR DAYS (%)10 CALENDAR DAYS (%)

(See Section I, Clause No. 52.232.8)

13. DISCOUNT FOR PROMPT PAYMENT

designated point(s), within the time specified in the schedule.

by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ______________ calendar days (60 calendar days unless a different period is inserted

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

OFFER (Must be fully completed by offeror)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

28. AWARD DATE

(Signature of Contracting Officer)

27. UNITED STATES OF AMERICA

25. PAYMENT WILL BE MADE BY

26. NAME OF CONTRACTING OFFICER (Type or print)

CODE 24. ADMINISTERED BY (If other than Item 7)

ITEM

(4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

41 U.S.C. 253 (c) ( 10 U.S.C. 2304 (c) (

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION20. AMOUNT19. ACCEPTED AS TO ITEMS NUMBERED

AWARD (To be completed by government)

CODE

05/10/2016 X

HPOD

HPOD

US Environmental Protection Agency William Jefferson Clinton Building 1200 Pennsylvania Avenue, N. W.

Mail Code: 3803R Washington DC 20460

1430 ET 06/09/2016

Sheila Dolan 202 Dolan.Sheila@epa.gov

564-4348

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PAGE(S)

Sheila Dolan

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is unusable

STANDARD FORM 33 (Rev. 9-97)

Prescribed by GSA - FAR (48 CFR) 53.214(c)

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 68

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

SOL-DC-16-00021

(A) (B) (C) (D) (E) (F)

Delivery Location Code: HPOD

HPOD

US Environmental Protection Agency

William Jefferson Clinton Building

1200 Pennsylvania Avenue, N. W.

Mail Code: 3803R

Washington DC 20460 USA

0001 Technical Support for the Assessment of Pesticide

Regulatory Activities.

Guaranteed Minimum: $25,000.00

Contract Ceiling: $20,000,000.00

Offers providing less than 90 calendar days for

Government acceptance after the date offers are due will not be considered and will be rejected.

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

NSN 7540-01-152-8067

TABLE OF CONTENTS

AWARD/CONTRACT………………………………………………………………………………………………..1

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS………………………………………………….2

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT………………………………………..5

SECTION D – PACKAGING AND MARKING……………………………………………………………

SECTION E – INSPECTION AND ACCEPTANCE…………………………………………………………….…24

SECTION F – DELIVERIES OR PERFORMANCE………………………………………………….……………26

SECTION G – CONTRACT ADMINISTRATION DATA………………………………………….……………..27

SECTION H – SPECIAL CONTRACTING REQUIREMENTS…………………………………………....…..…29

SECTION I – CONTRACT CLAUSES…………………………………………………………………………….37

SECTION J – LIST OF ATTACHMENTS…………………………………………………………………………41

SECTION K – REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS….42

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS…………………………….48

SECTION M – EVALUATION FACTORS FOR AWARD……………………………………………………….62

SECTION B - SUPPLIES OR SERVICES/PRICES

B.1 EPA-B-16-101 MINIMUM AND MAXIMUM AMOUNTS

During the period specified in the "Ordering" clause, the Government shall place orders totaling a minimum of $25,000.00. The amount of all orders shall not exceed $20 million per contract.

B.2 CONTRACT TYPE

This is a multiple award Indefinite Delivery Indefinite Quantity (IDIQ) contract. Task orders will be competitively placed per the procedures set forth in this section and in accordance with the fair opportunity process per FAR 16.505(b)(1) and exceptions to the fair opportunity process per FAR 16.505(b)(2). Task orders will be firm fixed price or time and materials. Task order type will be stated in the task order solicitation.

B.3 AWARD OF TASK ORDERS

After contracts are awarded by the Government, services will be ordered by the issuance of individual task orders awarded on a competitive basis per FAR 16.505 (b)(1). Each awardee will be given a fair opportunity to be considered for award of each individual task order.

The fair opportunity process will operate as follows:

a. Task Orders – General:

(1) A written task order, in accordance with the terms and conditions set forth herein, shall be the only basis for acquisition of services under this contract.

(2) Orders will be placed directly with the contractor by U.S. Environmental Protection Agency (USEPA) Contracting Officers as a result of a Request for Task Order Proposal (RFTOP) competition.

(3) Some orders may be exempt from competition in accordance with FAR 16.505(b)(2) and Section B.4 “Fair Opportunity Exceptions,” as shown below.

(4) The contractor shall be responsible for performance in accordance with the terms and conditions of the contract when a task order is placed by an USEPA Contracting Officer.

(5) In accordance with FAR 5.202, task orders placed under any resultant contract need not be synopsized.

(6) Contractors may not protest the award of the task order issued under the resultant contracts, except on the grounds that the order increases scope, period, or maximum value of the contract or orders valued in excess of $10 million. Protests of orders in excess of $10 million may only be filed with the Government Accountability Office, in accordance with the procedures at FAR 33.104.

b. Ordering Procedures:

RFTOP - When the Government identifies a requirement for work to be performed under this contract as described in Section C, the USEPA Contracting Officer will issue a written RFTOP to each Multiple Award IDIQ Base Contract awardee. The RFTOP will contain information comparable to a competitive solicitation. Such information will include, but is not limited to:

(1) Performance Work Statement (PWS) that identifies the Government's requirement,

(2) instructions to the contractors for responding to the RFTOP including the time frame for submission,

(3) evaluation and award factors, and

(4) any other relevant instructions to the contractor, e.g. Government acceptance of initial offer without discussions.

RFTOPs will be sent through FedConnect to each awardee and responses will be required electronically through FedConnect. If a contractor is unable to submit a proposal in response to the RFTOP, the contractor shall notify the Contracting Officer electronically through FedConnect in accordance with the below waiver from submission procedures.

WAIVER FROM SUBMISSION. Each multiple award contractor shall submit a task order proposal to each RFTOP unless a written Waiver from Submission is obtained from the USEPA Contracting Officer. A waiver may only be granted when:

1. The multiple award contractor certifies that a significant conflict of interest exists and no mitigation of the conflict of interest is possible, or

2. A compelling reason exists for abstaining from the competitive process.

The contractor shall submit any request for a Waiver from Submission through FedConnect to the USEPA Contracting Officer within five (5) calendar days of the RFTOP issuance. The USEPA Contracting Officer will respond within five (5) days of receiving the request granting or denying the waiver. If a waiver is granted by the USEPA Contracting Officer, the contractor is not required to submit a task order proposal to the RFTOP. If a waiver is not granted by the USEPA Contracting Officer, the contractor shall submit a task order proposal to the RFO.

Task Order Evaluation and Selection Procedures - Contractors responding to a RFTOP must submit their proposals through FedConnect within 30 calendar days of issuance unless otherwise specified in the RFTOP. Proposals shall be in Microsoft Word and Microsoft Excel formats; cover letters, forms, and charts may be submitted in PDF.

USEPA reserves the right to award individual task orders on the basis of initial offers received without discussion, therefore proposals should contain the offeror's best terms from a cost/price and technical standpoint. Offerors are advised that in the evaluation process, the price and technical merit importance will be stated in the RFTOP.

Upon receipt of the contractors' proposals, the Government will evaluate proposals received and select the contractor who offers the best value for the task order. All task orders resulting from the RFTOP will be firm fixed price, time and materials or a combination of both pricing structures.

Award of task order will be made as a result of "best value, trade-off" or “lowest priced technically acceptable” source selection. Best value, trade-off means that the Government will perform a price/technical trade-off analysis such that business judgment will be exercised in selecting the most advantageous approach to the Government, considering both the price and technical merit of proposals. The determination of best value will be made by comparing the differences in the value of performance capability factors with the differences in the price proposed.

The Government will not make an award at a significantly higher overall price to the Government to achieve only slightly superior performance capability features. The Government will make this assessment through the development of trade-off analyses that involve the assessment of benefits of superior performance capability features - for example, economic benefits clearly attributable to superior productivity; probability of successful contract performance; and/or unique and innovative approaches or capabilities - versus the added price. Overall price to the Government may become the ultimate determining factor for award of the task orders as proposals become more equal based on the other factors. The degree of equality between offerors' proposals will be measured by the quantity, significance, and applicability of the superior features proposed and not by the total scores achieved.

The Government may also make award based on the lowest priced technically acceptable offeror. The best value method of selection will be stated in the RFTOP for each requirement.

Price reasonableness is of significant importance in the overall task order award decision. Therefore, offerors are reminded that award will be made to the offeror whose proposal provides the combination of features that offers the greatest overall value to the Government.

The price portion of contractor responses to RFTOP will not be assigned quantitative scores. The information contained in the proposals will be analyzed and evaluated to determine reasonableness of each price proposed. Price realism analysis may be performed in accordance with FAR 15.404(d), if necessary, to ensure:

(a) The offeror's proposed prices are realistic for the work to be performed;

(b) The proposed prices demonstrate that the offeror understands the Government's requirements; and

(c) The proposed prices are consistent with the various elements contained in the proposal.

Price reasonableness will be analyzed in accordance with FAR 15.404(b).

Task orders will be issued to the contractor by the USEPA Contracting Officer.

B.4 FAIR OPPORTUNITY EXCEPTIONS FAR 16.505 (b) (2)

Exceptions to the fair opportunity process. The USEPA Contracting Officer shall give every awardee a fair opportunity to be considered for a task order exceeding $3,500 unless one (1) of the following statutory exceptions applies:

(i) The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

(ii) Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

(iii) The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

(iv) It is necessary to place an order to satisfy a minimum guarantee.

(v) In accordance with section 1331 of Public Law 111-240 (15 U.S.C. 644(r)), contracting officers may, at their discretion, set aside orders for any of the small business concerns identified in 19.000(a)(3). When setting aside orders for small business concerns, the specific small business program eligibility requirements identified in part 19 apply.

B.5 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY TASK ORDER OMBUDSMAN

Susan Moroni, Agency Advocate for Competition USEPA Headquarters, Office of Acquisition Management 1200 Pennsylvania Avenue, N. W.

Mail Code: 3801R Washington, DC 20460

Phone: 202-564-4321 Fax: 202-565-2473 Email: Moroni.susan@USEPA.gov mailto:Moroni.susan@usepa.gov

SECTION C - DESCRIPTION/SPECIFICATIONS

C.1 CONTRACT CLAUSES INCORPORATED BY REFERENCE

Clause Database Clause Number Clause Title

EPAAR 1552.211-79 Compliance with EPA Policies for Information Resources Management. (JAN 2012)

C.2 PERFORMANCE WORK STATEMENT (PWS)

Title: Technical Support for the Assessment of Pesticide Regulatory Activities

I. BACKGROUND

The Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) is responsible for the regulation of pesticides through the registration and registration review of pesticides as required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) as amended by the Food Quality Protection Act (FQPA) of 1996.

A central feature of FIFRA is that all pesticides in the United States must be registered with and approved by the EPA, unless specifically exempted (FIFRA section 25), prior to the manufacture, sale and distribution, to ensure that the pesticide poses no serious risks to human health or the environment when used according to the label. OPP is responsible for all registration activities for pesticides, including scientific review and risk-benefit determinations. OPP develops data requirements and guidelines for the conduct of studies by registrants.

The registrants provide data on pesticide product ingredients in support of the establishment of tolerances or exemptions from the requirement of a tolerance for the registration of these products. OPP evaluates the submitted scientific data, and determines whether the data are adequate for making regulatory decisions.

The EPA is also required to conduct a re-evaluation of every pesticide active ingredient every 15 years.

This process is known as Registration Review. It can include conducting new risk assessments;

determining when additional data are needed to ensure that the pesticide products are up to the current scientific and legal standards required by FIFRA, FQPA, FFDCA, and the Pesticide Registration Improvement Renewal Act (PRIA); reviewing new data submitted to support the active ingredient;

updating existing registration documents such as Reregistration Eligibility Documents (REDs), Biopesticide Registration Action Documents (BRADs), or Scoping Documents, science memos, Data Evaluation Records (DERs); and reviewing labels to determine what impact a Registration Review decision makes to the currently approved label.

Data needed to make regulatory decisions for a pesticidal substance begins with the data requirements outlined in 40 CFR Part 158: Data Requirements for Pesticides. This part describes the data and information needed for the various pesticide use patterns: Subpart D1 for Product Chemistry; Subpart E1 for product performance, Subpart F1 for Toxicology; Subpart O1 for Residue Chemistry; Subpart U for Biochemical Pesticides; Subpart V for Microbial Pesticides; and Subpart W for Antimicrobial Pesticides.

Collectively, these data requirements are referred to as “Part 158 data requirements.” The data requirements are further defined in the OCSPP Test Guidelines referenced in the Tasks describe below (http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/final-test-guidelines-pesticides-and-toxic).

http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/final-test-guidelines-pesticides-and-toxic http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/final-test-guidelines-pesticides-and-toxic

1And/or Subpart U/V/W in some cases, depending on the type of pesticide

II. SCOPE OF WORK

The purpose of this procurement is to provide technical expertise for the review and evaluation of various types of data to assist EPA in meeting its legislative mandates. To support EPA's OPP, the contractor shall, upon request, perform a full review and evaluate various data submitted to support pesticide registration.

The contractor shall supply the necessary resources required for the performance of this contract. The scientific quality of reviews, assessments, reports, model tools, statistical programs and software, and their timely preparation in accordance with negotiated schedules, are of paramount importance in the performance of this contract.

The contractor shall have the necessary technical and scientific expertise, knowledge and experience to successfully perform all of the tasks identified below. In addition, the contractor shall have a quality assurance/quality control program that maintains the quality of products, as well as an ongoing training program. This is intended to ensure that the contract staff produces quality products, and feedback from OPP on needed improvements is communicated to the contractor’s staff. The contractor shall maintain and make available upon request complete documentation of QA/QC practices and procedures.

Performance of work under this contract shall be initiated by competitive task orders issued by the Contracting Officer, and will encompass tasks in one or more of the following areas discussed below in Section III (TASKS).

III. TASKS

The contractor shall perform critical reviews of EPA designated studies submitted by the registrants and/or from the open literature, and these reviews will be provided to the task order Contract Officer’s Representative (COR) in DER or other similar study evaluation report form or system, as applicable. A template of the DER format provided to the contractor shall be followed in the preparation of DERs. See DER Templates for Test Guidelines http://www2.epa.gov/pesticide-registration/study-profile-templates.

Specific guidance for completing each section is provided in the DER templates. Each review will encompass all items in the study that contribute to the overall knowledge of the pesticide, and will include the following:

1. An evaluation of the accuracy, credibility and scientific validity of that study;

2. Its suitability for meeting specific data requirements;

3. Any necessary graphic displays of data, and/or summary tables illustrating results of the study;

4. Sound scientific rationale for the conclusions reached on specific studies;

5. Clarity in data presentation and adherence to the template and overall guidance.

An evaluation for each study shall include the following:

(a) Study identifying information;

(b) An in-depth examination of the materials and methods employed;

(c) An in-depth examination of the reported results;

(d) An in-depth discussion of the reviewer’s scientific assessment of the study;

(e) A description of the reviewer’s assessment which summarizes the overall conclusions and significance of the study; and http://www2.epa.gov/pesticide-registration/study-profile-templates

(f) Establishment of a no observable adverse effects levels (NOAEL) and lowest observable adverse effects levels (LOAEL) based on significant toxicological effects, if applicable;

(g) Characterize Good Laboratory Practice (GLP) compliance in study protocols, reviews, and for data evaluations;

(h) Discussion of data’s relevancy for supporting public health claims in review of efficacy data.

The contractor shall also identify whether the studies were performed in accordance with accepted methodologies or guidelines as prescribed in EPA's published guidelines and whether the data reported in the studies are reliable for characterizing exposure and health hazards/risks to humans. In all cases where part or the entirety of a study is considered to be unacceptable as a result of variance from the guidelines or because of technical or scientific reasons (reliability or completeness), the contractor shall detail the specific reasons for making a preliminary conclusion. In addition, the contractor may be tasked to draft residue chemistry summary documents, risk assessments, final rules for tolerances or tolerance exemptions, and regulatory documents such as BRADs, Scoping Documents, and Preliminary Risk Assessments for Registration Reviews.

Studies provided to the contractor for analyses and evaluation may include data on the following: acute toxicity and/or pathogenicity; benefit assessments; chronic toxicity; child resistant packaging; companion animal safety; dermal toxicity including absorption, irritation and/or sensitization; developmental toxicity;

developmental neurotoxicity; ecotoxicity; environmental fate; efficacy; epidemiology; genotoxicity;

immunotoxicity; inhalation toxicity; insect resistance management; mutagenicity; neurotoxicity (acute and sub-chronic); pesticide exposure incidents; product chemistry (Group A & B data, microbial product identity); reproductive toxicity; residue chemistry; sub-acute toxicity; sub-chronic toxicity; occupational and residential exposure; transferable residue; and Tier 1 assays of the Endocrine Disruptor Screening Program (EDSP).

The scientific quality of assessments and reports and their timely preparation in accordance with negotiated schedules are of paramount importance in the performance of this contract. The contractor shall have the technical and scientific knowledge and experience to work effectively from contract startup and throughout the course of the contract to assess residue chemistry data; exposure data; and pesticide health effects data in accordance with the Performance Work Statement and published EPA Guidelines:

40 CFR Part 158 Data Requirements for Pesticides (Subpart D, F, O, U, V and W), Standard Evaluation Procedures (SEPs) for the various studies available from National Technical Information Service (NTIS), EPA Risk Assessment Guidelines (51 FR 33992-34054), and Good Laboratory Practices (GLPs) (40 CFR Part 160).

Toxicological data for pesticide chemicals (active and inert ingredients) are provided by the registrants as required in 40 CFR Part 158. In addition to the information submitted by the registrants, data from studies published in the open literature may also be considered in risk assessments. OPP has developed a document that provides guidance for the use of open literature publications and criteria for judging its quality and relevance in support of OPP human health risk assessments. This document is available at http://www.epa.gov/pesticides/science/lit-studies.pdf.

Some studies may be submitted electronically. Consequently, transportation of studies for review must be provided by the contractor that is timely, most cost-effective, and FIFRA Confidential Business Information (CBI) secure. In addition, the contractor shall provide CBI secure storage for those studies while they are in its custody. At the time of award, the contractor must submit a security plan. An acceptable security plan must be in place to safeguard these studies. To perform under this contract, the contractor will need to have access to FIFRA CBI data submitted by pesticide registrants to EPA.

Disclosure of FIFRA CBI data to contractors is provided for under Section l0 (e) of the FIFRA and 40 CFR 2.307. Accordingly, the contractor must be cleared for access to FIFRA CBI and must control http://www.epa.gov/pesticides/science/lit-studies.pdf

FIFRA CBI data according to the requirements specified for contractors in the EPA publication, FIFRA Information Security Manual, dated July 1988.

The requirements contained in this contract are considered to be performance-based, focusing on the agency's desired results and outcomes. The contractor shall be responsible for determining the most effective means by which these requirements will be fulfilled. In order to fulfill the requirements, the contractor shall design innovative processes and systems that can deliver the required services in a manner that will best meet the agency's performance objectives. This performance-based requirement represents a challenge to the contractor to develop and apply innovative and efficient approaches for achieving results and meeting or exceeding the performance objectives, measures, and standards described below. The agency will monitor the contractor's performance in accordance with the Quality Assurance Surveillance Plan.

TASK 1: PROGRAM/PROJECT MANAGEMENT

The contractor shall provide a single point of contact for the management of each Task Order as well as the overall management of all aspects of this contract. The person shall be known as the Program Manager or Project Manager. The Program Manager shall report on all aspects of the objectives and progress of this contract to the designated CO and CORs via email, through monthly reports. The Project Manager plans, conducts and supervises Task Order projects, necessitating advanced knowledge and the ability to originate and apply new and unique methods and procedures. Provide technical advice and counsel to other professionals. The Program Manager shall notify via email the relevant COR or Task Order COR (TOCOR) of any significant difficulties in accomplishing the tasks listed in the task orders.

The Program Manager shall utilize agile software development methodology on IT type task orders.

Agile development requires that solutions evolve through frequent collaborations between the contractor and the EPA end users.

In cases where performance objectives and minimum Acceptable Quality Levels (AQLs) are not being met, the contractor will make every effort to immediately correct the problems to ensure customer satisfaction. If the problem persists, the Program Manager will submit a plan of corrective action to the TOCOR and the Contract Level COR. The contractor shall have a Quality Assurance (QA)/Quality Control (QC) program that maintains the quality of its products. The Quality Management Plan (QMP) shall be submitted in accordance with the instructions listed in Section L of this solicitation. The Program Manager shall submit Quality Assurance Project Plans (QAPPs) in accordance with the Request for Task Order (RFTOP) instructions.

TASK 2: TOXICOLOGY - Primary Review and Evaluation of Toxicology Data of Active Ingredients or Products of Antimicrobial, Biochemical, Conventional, Inert, and Microbial Chemicals.

A. Antimicrobial Pesticides (Subpart W §158.2230) The contractor shall provide support for the review and evaluation of toxicology studies submitted to OPP on antimicrobial pesticide products or active ingredients as required under Subpart W, as described in OCSPP Test Guidelines Series 870. The studies may include data on the following: acute, subchronic and chronic studies via the oral, dermal, eye, and/or inhalation routes; carcinogenicity; mutagenicity; pre-natal developmental toxicity; developmental neurotoxicity; reproduction and fertility; immunotoxicity, metabolism; pharmacokinetics; epidemiology; child-resistance packaging and other special studies may be included for data evaluations.

The contractor shall conduct expert reviews of these studies following the appropriate SEPs and guidance documents. For product-specific data, the contractor shall use the results from the review to determine the applicable required statements on the product label.

B. Biochemical Pesticides (Subparts U §158.2050) The contractor shall provide support for the review and evaluation of toxicology studies submitted to OPP on biochemical pesticide product active ingredients as required under Subparts U as described in OCSPP Test Guidelines Series 870. The studies may include data on the following: acute, subchronic and chronic studies via the oral, dermal and/or inhalation routes; subchronic toxicity, chronic toxicity;

carcinogenicity; developmental toxicity; reproduction; immunotoxicity, mutagenicity, applicator/user exposure (dermal and inhalation) and biomonitoring studies and other special studies may be included for data evaluations. The contractor shall conduct expert reviews of complex science issues and perform data extraction/entry from toxicological data summaries using computerized data bases. In addition, the contractor shall perform biopesticide-related science reviews and risk assessments which determine qualitative and quantitative potential risks. The contractor shall conduct and document risk assessment(s) in a consistent and scientifically credible fashion relative to the initial drafts of the Final Rules for Food Tolerances (or Exemptions) and BRADs, and in accordance with the format specified and provided by the TOCOR. The contractor shall utilize results and findings of preliminary reviews, or results of secondary reviews, if available, to draft the preliminary risk assessments.

C. Conventional Pesticides (Subpart F §158.1900) The contractor shall provide support for the review and evaluation of toxicology studies submitted to OPP on conventional pesticide product active ingredients in accordance with the Subpart F data requirements as described in OCSPP Test Guidelines Series 870. The studies may include data on the following:

acute, subchronic and chronic studies via the oral, dermal and/or inhalation routes; dermal toxicity;

dermal sensitization, carcinogenicity; pre-natal developmental toxicity; neurotoxicity; metabolism;

mutagenicity; mammalian spermatogonal aberration test; reproductive toxicity; immunotoxicity, epidemiology, hypersensitivity incident reports, companion animal safety, child-resistant packaging and other special studies may be included for data evaluations. The contractor shall conduct expert reviews of these studies following the appropriate SEPs and guidance documents.

The contractor shall also provide support for the Endocrine Disruptor Screen Program (EDSP) by conducting review and evaluation of the EDSP Tier 1 assays as required under the Endocrine Screen Program Test Guidelines Series 890. The Tier 1 assays include the following: in vitro (mammalian) and in vivo (mammals, amphibian and fish) assay: ER Binding; ERα Transcriptional Activation; AR Binding; Steroidogenesis H295R; Aromatase Recombinant; Uterotrophic; Hershberger; Pubertal Male;

Pubertal Female; Amphibian Metamorphosis; and Fish Short-term Reproduction assays. The contractor shall follow the DER templates and employ the SEPs in preparing the DERs using the DER Composers.

Each DER Composer provides web-based structured (manual) data entry tailored to a given EDSP assay and can generate two output files for each study (MRID): an XML file and a Microsoft Word document (Doc/Docx file) formatted as a DER.

In addition, occasionally the contractor will be requested to perform literature searches. The contractor shall obtain additional information to review, e.g., screen and review published open literature toxicity data, conduct literature searches on National Library of Medicine, Toxline, and other standard toxicology/epidemiology databases, e.g. when data gaps are identified and acquire the literature for review in the assessment of health effects for pesticides.

D. Microbial Pesticides (Subparts V §158.2140)

The contractor shall provide support for the review and evaluation of toxicology studies submitted to OPP on microbial pesticide product active ingredients as required under Subparts V as described in OCSPP Test Guidelines Series 870. The studies may include data on the following: Tier I (acute dermal, eye and inhalation); Tier II (acute toxicity, subchronic toxicity/pathogenicity; and Tier III (reproductive fertility, carcinogenicity, immunotoxicity and infectivity/pathogenicity analyses. The contractor shall conduct expert reviews of these studies following the appropriate SEPs and guidance documents.

E. Inert Pesticide Ingredients

The contractor shall provide support for the review and evaluation of toxicology studies submitted to OPP on pesticide product inert ingredients and/or studies available in the published literature. The studies may include data on the following: acute, subchronic and chronic studies via the oral, dermal and/or inhalation routes; pre-natal developmental toxicity; neurotoxicity; reproductive toxicity; immunotoxicity, metabolism; and other special studies may be included for data evaluations. The contractor shall conduct expert reviews of these studies following the appropriate SEPs and guidance documents.

TASK 3: PRODUCT CHEMISTRY - Primary Review and Evaluation of Product Chemistry Data for Antimicrobial, Biochemical, Conventional and Microbial Pesticides

The contractor shall evaluate product chemistry data, labels, and confidential statements of formula (CSFs) submitted by pesticide registrants/applicants seeking registration, reregistration and amendments, and re-submissions of pesticide chemicals. Product chemistry data for registration of pesticide chemicals may include the following: technical grade of active ingredients (TGAI/MP) and end-use products (EP), the product label (related to product chemistry) and the CSF in compliance with 40CFR Data Requirements for the various pesticide use patterns as below:

Antimicrobial chemicals Subpart W §158.2210 Test Guideline Series 830 Biochemical chemicals Subpart U §158.2030 Test Guideline Series 830/880 Microbial pesticides Subpart V §158.2120 Test Guideline Series 830/885 Conventional pesticide chemicals Subpart D §158.310 Test Guideline Series 830

For conventional pesticides, the product chemistry data submitted to meet the requirements for product chemistry fall into two major categories: Information on product identity, composition, and analysis (Group A) and information on specific physical and chemical characteristics (Group B) of pesticide chemicals as described in OCSPP Test Guidelines Series 830.The contractor shall prepare DERs in the Review Forms which includes, Introduction, Summary of Findings and Conclusions. Deficiencies must be clearly defined (i.e., identify deficiencies and what is needed from the applicant to fulfill the data requirement).

TASK 4: RESIDUE CHEMISTRY - Primary Review and Evaluation of Residue Chemistry Data of Active Ingredients for Antimicrobial, Biochemical, Conventional and Microbial Chemicals

The contractor shall conduct a comprehensive examination of all residue chemistry data, waiver requests, and/or study protocol reviews submitted in support of registration of a new active ingredient or proposed/amended use, registration review of existing active ingredients, and concomitant tolerances.

The Contractor shall prepare DERs, Summary Documents, and/or briefing documents (similar to summary documents) which will include a review and discussion of data related to each chemical's use pattern, metabolism in plants and animals, data gathering and enforcement analytical methodology, storage stability, and/or magnitude of residues. The report will provide an overall evaluation of the adequacy of existing or proposed tolerances for the chemical, as well as international harmonization with Canadian, CODEX and/or Mexican maximum residue limits (MRLs). Agency tolerance/MRL calculation models shall be utilized where appropriate. EPA is required to evaluate all data submitted in petitions for tolerances to determine whether adequate information is available to set a tolerance, or issue an exemption, so that public health is adequately protected. Individual task orders as awarded will encompass one or more of the following projects:

Registration Action Support: Residue Chemistry Data Evaluation Record/Summary Document:

The Health Effects Division (HED) has the responsibility of reviewing Residue Chemistry data submitted with applications for the registration of specific pesticide products, including new chemicals and petitions for proposed/amended uses and concomitant tolerances for currently registered pesticides.

Registration Review Support: The agency has implemented a new registration review program that periodically reevaluates pesticides under the mandates of the Federal Insecticide Fungicide and Rodenticide Act. Registration review operates continuously, encompassing all registered pesticides.

On a continuous basis, EPA will review all registered pesticides to determine if they continue to meet the statutory standard for registration.

Revisions of REDs, IREDs, TREDs: Review of Studies Submitted in Response to Phase 4 DCIs, and Updating of Previously Completed Registration Standards, Reregistration Eligibility Decisions (REDs), Interim REDs, and Tolerance Reassessment Eligibility Decisions (TREDs).

As specified in the specific task orders, the contractor shall review and evaluate residue chemistry data, waiver requests, and study protocols submitted in compliance with data requirements cited in the table below. The data assessment report will include a review and discussion of data on a variety of residue chemistry topics and a recommendation as to whether the data are acceptable, upgradeable, or whether a new study will be required. The results of these reviews shall be reported in a template format that will be provided with the RFTOP.

Residue chemistry data requirements for the various pesticide use patterns are:

Antimicrobial chemicals Subpart W §158.2210 Test Guideline Series 860 Biochemical chemicals Subpart U §158.2040 Test Guideline Series 860

Conventional pesticide chemicals Subpart D §158.1400

Test Guideline Series 860;

OECD Residue Chemistry Guidelines/Guidance -http://www.oecd.org/env/ehs/pesticides-biocides/publicationsonpesticideresidues.htm

Microbial chemicals Subpart V §158.2130 Test Guideline Series 885

TASK 5: ECOTOXICITY - Primary Review and Evaluation of Ecotoxicity Data of Active Ingredients for Antimicrobial, Biochemical, Conventional, and Microbial Chemicals

The information required to assess hazards to nontarget organisms is derived from tests to determine pesticidal effects on birds, mammals, fish, terrestrial and aquatic invertebrates and plants. These tests include short-term acute, subacute, reproduction, simulated field, and full field studies arranged in a hierarchical or tier system which progresses from the basic laboratory tests to the applied field tests. The results of each tier of testing must be evaluated to determine the potential of the pesticide to cause adverse http://www.oecd.org/env/ehs/pesticides-biocides/publicationsonpesticideresidues.htm http://www.oecd.org/env/ehs/pesticides-biocides/publicationsonpesticideresidues.htm effects, and to determine whether further testing is required. A purpose common to all data requirements is to provide data which determine the need for precautionary label statements to minimize the potential adverse effects to nontarget organisms. The short-term acute and subchronic laboratory studies provide basic toxicity information which serves as a starting point for the hazard assessment.

These data are used: to establish acute toxicity levels of the active ingredient to the test organisms; to compare toxicity information with measured or estimated pesticide residues in the environment in order to assess potential impacts on fish, wildlife and other nontarget organisms; and to indicate whether further laboratory and/or field studies are needed. Long term studies (i.e., avian, fish, and invertebrate reproduction, life cycle studies and plant field studies) may be required when basic data and environmental conditions suggest possible problems. Data from these studies are used to: estimate the potential for chronic effects, taking into account the measured or estimated residues in the environment;

and to determine if additional field or laboratory data are necessary to further evaluate hazards.

The contractor shall perform critical reviews of EPA - designated fate and transport and effects studies from the open literature or from the registrants, and these reviews will be provided to the TOCOR in a DER or other similar study evaluation report form or system as applicable. These reviews will be sufficiently complete in description and technical data to stand on their own as a source of information for use in risk assessment. Periodically, the contractor shall be asked to screen studies and data-sets. The contractor shall perform an abbreviated review of studies and/or the overall data set to determine if sufficient information is included to determine if they are adequate for a critical review, and to relate the ability of the data-set to meet the data requirements as identified by the TOCOR. In all cases where part or the entirety of a study is considered to be unacceptable as a result of variance from the guidelines or because of technical or scientific reasons (reliability or completeness), the contractor shall detail the specific reasons for making a preliminary conclusion.

Ecotoxicity data requirements for the various pesticide use patterns are:

Antimicrobial chemicals Subpart W §158.2240 Test Guideline Series 850 Biochemical chemicals Subpart U §158.2060 Test Guideline Series 850 Conventional chemicals Subpart G §158.630, 660 Test Guideline Series 850

Microbial pesticide chemicals Subpart V §158.2150 Test Guideline Series 850/885

TASK 6: ENVIROMENTAL FATE - Primary Review and Evaluation of Environmental Fate Data of Active Ingredients for Antimicrobial, Biochemical, Conventional, and Microbial Chemicals

Data generated by environmental fate studies are used to: assess the toxicity to man through exposure of humans to pesticide residues remaining after application, either upon reentering treated areas or from consuming inadvertently-contaminated food; assess the presence of widely distributed and persistent pesticides in the environment which may result in loss of usable land, surface water, ground water, and wildlife resources; and, assess the potential environmental exposure of other nontarget organisms, such as fish and wildlife, to pesticides.

Another specific purpose of the environmental fate data requirements is to help applicants and the EPA to estimate expected environmental concentrations of pesticides in specific habitats where threatened or endangered species or other wildlife populations are at risk.

Degradation studies. Data from hydrolysis and photolysis studies are used to determine the rate of pesticide degradation and to identify pesticides that may adversely affect nontarget organisms.

Metabolism studies. Data generated from aerobic and anaerobic metabolism studies are used to determine the nature and availability of pesticides to rotational crops and to aid in the evaluation of the persistence of a pesticide.

Mobility studies. Data pertaining to leaching, adsorption/desorption, and volatility of pesticides provide information on the mode of transport and eventual destination of the pesticide in the environment. This information is used to assess potential environmental hazards related to: Contamination of human and animal food; loss of usable land and water resources to man through contamination of water (including ground water); and loss of wildlife habitat resulting from pesticide residue movement or transport in the environment.

For the evaluations of environmental fate studies, the contractor shall perform evaluations of difficult/complex studies, reports and compilations of studies and datasets, and provide integrated assessments summarizing and interpreting the information to produce a coherent conclusion of potential effects and/or environmental behavior to characterize the overall significance of the findings. The contractor must also provide a rationale for these conclusions. This may include using statistics to show dose response and spatial/temporal distributions of pesticide behavior and characteristics across ranges of environmental conditions to identify data gaps. Environmental fate data requirements for the various pesticide use patterns are:

Antimicrobial chemicals Subpart W §158.2250 Test Guideline Series 850 Biochemical chemicals Subpart U §158.2060 Test Guideline Series 835/850 Conventional chemicals Subpart L, N §158.1300 Test Guideline Series 835/850

Microbial pesticide chemicals Subpart D §158.2150 Test Guideline Series 850/885

TASK 7: EFFICACY - Review and Evaluation of Product Performance (Efficacy) Data

Requirements to develop data on product performance provide a mechanism to ensure that pesticide products will perform as intended and that unnecessary pesticide exposure to the environment will not occur from the use of ineffective products. Specific performance standards are used to validate the efficacy data in the public health areas, including antimicrobial products used to control microorganisms infectious to man in any area of the inanimate environment, and those pesticides used to control invertebrate pests (insects, spiders, ticks, etc.) that may cause damage to structures or pose a risk to public health, e.g. may directly or indirectly transmit diseases to humans.

The contractor shall perform a primary review of efficacy data for insecticides, particularly those with claims against invertebrates of public health or wood-destroying insect that will be eligible for registration, re-registration and/or registration review; or microbiological efficacy data for antimicrobial products, especially those with public health-related claims. The contractor shall also review efficacy protocols submitted for approval. The contractor shall: review, evaluate, and assess the efficacy studies to determine the adequacy of methods employed and data to support efficacy claims and ensure that all information requirements are met with respect to compliance with EPA OCSPP 810 Series Testing Guidelines and any supplementary guidance and policies; identify deviations from the approved test methods and determine if the performance standards of the Pesticide Assessment Guideline Subdivision G are met; review efficacy protocols submitted for testing new conventional pesticides or new uses of registered products, or for testing antimicrobial products; conduct efficacy reviews of protocols and/or study reports to determine the extent of compliance with 40 CFR Part 160 “Good Laboratory Practices;”

and apply the results from the study review to determine if the label claims and directions for use proposed by the registrant are supported.

The contractor shall, if requested, assist in revising OCSPP 810 series product performance guidelines and compiling all information relevant to EPA presentations to the Scientific Advisory Panel and/or Human Studies Review Board. These documents shall outline the testing requirements for conventional and antimicrobial pesticides used to control invertebrate and microbial pests of public health concern. To that end, the contractor shall compile data collected on testing processes, procedures and performance standards from national and international regulatory agencies together with International Public Health and Agricultural Agencies; and compile data into a report that the OPP can use as the basis for global harmonization of efficacy testing methods and performance standards for public health pesticides.

Antimicrobial chemicals Subpart W §158.2220 Test Guideline Series 810

Biochemical chemicals Subpart U §158.2070 Test Guideline Series 810 Conventional chemicals Subpart E §158.400 Test Guideline Series 810 Microbial pesticide chemicals Subpart V §158.2160 Test Guideline Series 810

TASK 8: OCCUPATIONAL AND RESIDENTIAL EXPOSURE – Review and Evaluation of Exposure Data, and Preparation of Exposure/Risk Assessments for Active Ingredients for Antimicrobial, Biochemical, and…