AG-6395-S-12-0093.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

APHIS-MRPBS-ASD-6395

100 N 6TH STREET

Butler Square, 5th Floor ASD Procurement Branch

USDA APHIS MRPBS

CODE 16. ADMINISTERED BYCODE

X

X

541690

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORAPHIS-MRPBS-ASD-6395

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

08/09/2012 1500 CT

06/28/2012

612-336-3625LEAH SCHULTZ

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

AG-6395-S-12-0093

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 37 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

MINNEAPOLIS MN 55403

TELEPHONE NO.

17a. CONTRACTOR/

Washington DC 20250-0268 1400 Independence Avenue SW USDA- National Organic Program

15. DELIVER TO

MINNEAPOLIS MN 55403

100 N 6TH STREET

Butler Square, 5th Floor ASD Procurement Branch

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$14.0

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

USDA APHIS MRPBS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOSB

PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Tax ID Number: Not Available DUNS Number: Not Available Please refer to Sections 1.0 - 5.0 below for the terms and conditions of this solicitation.

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED

NATHAN D. JOHNSON

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37 2 of

AG-6395-S-12-0093

SOLICITATION | 6/28/2012| Page 3 of 37

National Organic Program (NOP) Technical Reports to Support the National List of

Allowed and Prohibited Substances in Organic Agriculture

1.0 STATEMENT OF WORK

1.1 Objective

This requirement is to provide USDA’s National Organic Program (NOP) with technical analysis and technical report development services to support the development and maintenance of the National List of Allowed and Prohibited Substances in Organic Agriculture.

NOP intends to establish a five-year Blanket Purchase Agreement (BPA). It is anticipated that multiple awards will be made from this solicitation with corresponding call orders for specific requirements.

1.2 Background

The Organic Foods Production Act of 1990 (OFPA), (7 U.S.C. 6501 et seq.) established the National Organic Program (NOP) and required the development of the USDA organic regulations (published at 7 CFR part 205). The organic regulations include sections called “The National List of Allowed and Prohibited Substances” (or National List) (Regulations §§ 205.600 through 205.607).

1.2.1. About the National List

The National List identifies the synthetic substances that may be used, and the non-synthetic substances that may not be used, in organic production. The OFPA and the organic regulations define a synthetic substance as “a substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from naturally occurring plant, animal, or mineral sources, except that such term shall not apply to substances created by naturally occurring biological processes.” A non-synthetic (natural) substance is defined by the organic regulations as “a substance that is derived from mineral, plant, or animal matter and does not undergo a synthetic process as defined in section 6502(21) of the Act…For the purposes of this part, nonsynthetic is used as a synonym for natural as the term is used in the Act.”

The National List also identifies non-organic substances that may be used in organic handling. The OFPA and organic regulations, in § 205.105, specifically prohibit the use of any synthetic substance for organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any nonagricultural substance and non-organic agricultural substance used in organic handling must also be on the National List.

The National List is a living part of the USDA organic regulations. As required by OFPA, any person may petition substances for inclusion on or removal from the National List. The OFPA authorizes the National Organic Standards Board (NOSB) to evaluate these petitions, and then develop and forward recommendations to the Secretary of Agriculture on proposed amendments to the National List. In addition, all substances on the National List must be reevaluated every five years, in a process called a “sunset review.” The NOSB is a Federal Advisory Board made up of volunteers from the organic community.

SOLICITATION | 6/28/2012| Page 4 of 37

The Technical Reports produced under this BPA will be used by the NOSB in its capacity to review different substances, and by the NOP to inform National List rulemaking.

1.2.2. Technical Report Business Process and Workflow

The development of Technical Reports is part of a well-defined process and workflow for substance evaluation that involves the NOP, the contractor, and the NOSB. A general overview of the workflow associated with this contract is as follows:

• NOP receives a new or revised petition from external people/parties, or a Sunset review process begins. Substances may also be raised for evaluation through other mechanisms.

• The NOP reviews the petition for eligibility and completeness, in conformance with the petition submission procedures (72 FR 2167, January 17, 2007).

• The NOP sends written notification to the appropriate NOSB Subcommittee with a copy of the petition and a request for any questions that the NOSB wishes to be specifically addressed in the Technical Report associated with the substance.

• The NOSB has 60 days to submit these questions to the NOP.

• Once the NOSB sends its questions to the NOP, the NOP will develop the requirements for a

Technical Report, which will include any relevant information needed to support both the winning contractor’s proposal and task performance. As a standard, proposals will be due one week after the requirements are released.

• NOP evaluates proposals and USDA issues a call order to the successful contractor. As a standard, call orders will be issued within approximately two weeks of the proposal due date.

• The contractor completes the draft Technical Report and delivers to the NOP for review.

• The Draft Technical Report is reviewed by the NOP and NOSB (and other subject matter expert reviewers as needed) and feedback is provided to the contractor.

• The contractor makes revisions as needed and submits a final Technical Report.

• All final Technical Reports are posted for the public on the NOP website.

1.3 Principal Task Areas

There are three task areas associated with this contract, associated with different kinds of Technical Report. The specific requirements for each report will be driven by the particular substance or substances being evaluated, and will be outlined in each requirement. A task order call may include one or multiple substances resulting in one or multiple reports in one award. Each individual call will describe the requirements for that task.

1.3.1. Initial Assessment Technical Reports

Initial Assessment Technical Report requirements will be issued when initial information about a substance is needed for an initial assessment of its characteristics. These reports will focus on answering selected key questions about a substance; the questions and the extent of the analysis to be performed would be included in the requirements. Examples of questions could include:

• Determination of the legality of a substance’s petitioned use under Food and Drug Administration (FDA), USDA, or Environmental Protection Agency (EPA) authorities for use in conventional (i.e. non-organic) production or handling.

SOLICITATION | 6/28/2012| Page 5 of 37

• Determination of certain “threshold issues,” such as technical information to determine whether a substance is synthetic or nonsynthetic.

• Questions about the most prevalent processes used to manufacture or formulate the petitioned substance, or chemical changes that may occur during manufacture or formulation of the petitioned substance when this substance is extracted from naturally occurring plant, animal, or mineral sources.

Initial Assessment Technical Reports will be generally assigned a due date of 60 days after the call order is awarded. Additional time may be requested by the contractor, but the final deadline will be set at NOP’s discretion.

1.3.2. Full Evaluation Technical Reports

Full Evaluation Technical Report requirements will be issued when complete information is needed to support substance evaluations. Each Full Evaluation Technical Report is to include the following:

A. Background Information about the Substance: Each report is to include information about the petitioned substance, referencing published scientific information, as applicable:

• Substance Identification. Chemical, trade and/or other names, CAS numbers, IUPAC number, INS numbers, and/or other codes, common names and synonyms.

• Substance Characterization. Composition, properties, specific uses, approved legal uses, the action (technical function) of the substance, and combinations of the substance.

• Regulatory Status. Includes historic use and status under OFPA and the NOP Final rule. Also cite EPA and/or FDA regulations, state regulations, and Codex.

• Regulatory Status (Organic Standards). Cite status under other organic standards, such as IFOAM, European Union Organic Regulations, Japan Agricultural Standard, Canadian Organic Products Regulation Standard, as applicable. Also include status on the Codex Guidelines for the Production, Processing, Labeling and Marketing of Organically Produced Foods (GL 32-1999), if applicable.

B. Responses to Evaluation Questions: Each Report is to include responses to the technical evaluation questions provided in Attachment A of this Solicitation. These questions are adapted from the OFPA substance evaluation criteria (7 U.S.C. 6517(c)(1)(A) and (B); 6517(c)(2); 6518(m)) and the NOP regulations (§ 205.600(a)). In general, these items address a substance’s potential for adverse impacts on human health and the environment and its compatibility with organic agriculture. The questions may change slightly over time; the most current list of questions will always be provided as an attachment to individual calls so that contractors are clear as to what is required for that call.

Many of the petitioned substances will be pesticides, animal drugs, feed or food additives regulated by the EPA and/or FDA. The EPA and FDA review and approval processes assess risks to humans, animals, and the environment, which are important considerations in organic agriculture. These risk reviews, which include hazard identifications, hazard characterizations, exposure assessments, and risk characterizations, should be consulted when available.

Additional information must be compiled to evaluate all required criteria under OFPA, including the effects on the agroecosystem and biodiversity; possibility of environmental contamination

SOLICITATION | 6/28/2012| Page 6 of 37 during manufacture, use, misuse or disposal; alternative substances and practices to the petitioned substance; and compatibility with a system of sustainable and organic agriculture.

Responses are to be based upon:

• Independent peer reviewed research and regulatory publications, whenever possible. Any information derived from the petition should be verified by reputable independent sources. If the petitioned information cannot be independently verified, it must be cited as such.

• Data from the petitioned substance’s original review and approval process conducted under EPA or FDA regulatory authority.

• Subsequent data and reports from the National Institute of Environmental Health Sciences (NIEHS) and established peer-reviewed scientific journals addressing, but not limited to, human health, environment, nutrition, and conventional or organic agriculture production and handling should also be incorporated.

All data sources used in preparing responses are to be reliable and competent, and all references must be cited. All responses should provide a summary of pertinent findings/conclusions in the literature and indicate whether the findings/conclusions are supported by the majority of the literature. When the literature reviewed is inconclusive or disputed, the response should reflect the preponderance of the reported data and provide a summary of other conclusions.

C. Responses to Additional Questions: Requirements may include additional questions that must be answered for a substance for its effective evaluation.

Full Evaluation Technical Reports will be generally assigned a due date of 120 days after the call order is awarded. Additional time may be requested by the contractor, but the final deadline will be set at NOP’s discretion.

1.3.3. Supplemental Technical Reports

Supplemental Technical Report requirements will be issued when supplemental information is needed to support substance evaluation by the NOSB. This may include updates to basic information about a substance or substances, or specific questions about one or more substance. Supplemental Technical Reports may also be non-substance specific, but relate more generally to methods related to material evaluation or other National List related topics. The NOP will provide a template for the report that is required in the specific requirements.

These reports will be generally assigned a due date of 60 days after the call order is awarded. Additional time may be requested by the contractor, but the final deadline will be set at NOP’s discretion.

SOLICITATION | 6/28/2012| Page 7 of 37

1.4 Place of Performance, Research Resources, Copyrights, and Ownership

NOP shall have full, complete ownership of all deliverables produced by the contractor to fulfill the requirements of the BPA. All final Technical Reports become part of the public domain and accessible online.

To assist development of Technical Reports, the NOP will reimburse contractors for documented costs incurred for literature searches arranged by the technical report contractor with the National Agricultural Library. This access should enhance the technical report contractor’s ability to perform literature searches of established, peer-reviewed scientific journals on an as needed basis.

We expect that all tasks under the BPA will be conducted in contractor facilities; government work space and equipment will not be provided.

Reference materials procured by the contractor outside the National Agricultural Library to support the BPA will remain the property of the contractor, and may not be directly invoiced to the government.

1.5 Work to be Performed by Others

The NOP will coordinate all reviews of the draft Technical Reports created by contractors. This includes reviews by the NOSB and any federal agency that NOP selects to review draft reports.

1.6 Type of Contract, Number of Awards, and Estimated Dollar Amounts

It is anticipated that multiple BPA awards will be made from this solicitation and that the awards will be made on/about September 30, 2012. Contractors awarded BPA’s through this solicitation will subsequently compete for individual call orders.

Current estimates for Technical Report services are $200,000 to $400,000 dollars per year. Future funding levels will be driven both by the NOP budget and by the number of petitions received for consideration by the NOSB. For reference, in 2011, the NOP approved approximately 30 Technical Reports.

The total estimated amount of this requirement over 5 years is $1 million to $2 million with no single contractor eligible to receive greater than $500,000 under the BPA.

Call orders will generally range from $2,000 to $20,000. No single call order award may exceed $25,000.

Call order requirements will be competed among at least three of the BPA awarded contractors. Some requirements may be set-aside for small businesses.

1.7 Evaluation Factors for Selection/Method of Award

The awards resulting from this solicitation, including call orders, will be awarded to the responsible offerors whose proposals best demonstrates each factor outlined below and is determined most advantageous to the Government, cost and other factors considered. Note: This is a best value trade-off procurement not lowest bid. The Government reserves the right to award to other than the lowest priced offeror. However, the Government will not make an award at a significantly higher overall cost to

SOLICITATION | 6/28/2012| Page 8 of 37 achieve slightly superior technical expertise. Competitive range may be established if deemed necessary by the contracting officer.

• Factor 1: Price

• Factor 2: Technical Approach and Capability

• Factor 3: Management Approach/Project Staffing/Quality Assurance

• Factor 4: Past Performance

Technical approach and capability, management approach/project staffing/quality assurance, and past performance, when combined, are more important than price.

1.7.1 Factor 1: Price

Price will be the least important factor. For the BPA award, price competitiveness will be evaluated based on the itemized pricing for the sample tasks provided below.

1.7.2 Factor 2: Technical Approach & Capability

A. Technical Approach Proposals will be evaluated on how well each offeror demonstrates an understanding of the technical objectives of each sample task and overall feasibility and practicality of accomplishing the work at a very high level of quality. Within each sample task, this understanding will be evidenced by how comprehensively each proposal discusses project goals, objectives, and tasks to be performed, and the interrelationships and complexities of these tasks. This section of the proposal should highlight core competencies and demonstrate any unique qualifications.

Vendors should discuss their overall technical approach to the research and analysis required to develop each Technical Report, as well as any unique competencies or capabilities that would support performance under this solicitation.

Price will be evaluated as a separate factor (see Factor 1).

B. Technical Capability In addition to the sample task approaches, the offeror’s proposal should include its overall ability to produce a high quality work product. This includes demonstrating an understanding of the factors involved in substance evaluation in organic agriculture, principles of objective scientific research, and showing the ability to develop reports that will be of high value to the NOSB’s decision-making processes. The vendor should also discuss potential problems and constraints likely to be encountered in performing the work and proposed alternatives and solutions to resolve difficulties.

The clarity, style, and format of the proposal will be considered as an indication of the quality of its written work.

1.7.3 Factor 3: Management Approach/Project Staffing/Quality Assurance

Proposals will be evaluated on the vendors’ described approach for managing call orders under the BPA.

The vendor should include an overview of the organizational structure and roles that will be involved in

SOLICITATION | 6/28/2012| Page 9 of 37 administering, performing, and overseeing the work of the BPA. The vendors’ discussion should include its approach to the following factors, as well as any others that the vendor believes is important in its management of the BPA:

A. Staffing: Offeror’s proposal should detail the principal staff contacts for this solicitation and their respective roles and area of expertise. The proposed staff qualifications should identify competence in conducting scientific or technical research and analysis, and in developing deliverables similar to those required under this solicitation.

Offerors shall submit resumes of proposed key personnel identifying organizational affiliation, experience, educational background and training. Resumes should clearly list each person’s expertise in the areas covered by the organic regulations and National List (i.e., substances in crops, livestock, and handling). The vendor is asked to highlight any specific areas of subject matter expertise within these categories for individuals as well (e.g., within livestock, expertise with poultry, dairy, aquaculture, etc.).

Further, the vendor should discuss how staff are identified and assigned to specific call orders, and how staffing planning is done such that personnel assigned to individual call orders are well qualified to conduct the work, while also ensuring that projects can be completed in the time allowed. Availability of proposed staff and their designated responsibility will also be evaluated; this includes the experience, managerial competence and time commitment of any proposed Project Manager.

B. Quality Management: Vendor should discuss its approach to ensuring high quality and thoroughness in the development of reports, from research through final deliverable review. The vendor should discuss how personnel assigned to the BPA are trained on BPA-related topics, such as the work required and the performance expectations. Vendor should discuss its approach for managing communication with the NOP, both from contractual and technical viewpoints; and its approach for distributing information about the requirement within its team.

C. Conflict of Interest: How vendor implements Federal Acquisition Regulations related to

Conflict of Interest prevention for contractor employees and subcontractors. This should include a discussion of how the vendor identifies and prevents personal conflicts of interest, defined as a situation in which an employee or subcontractor has a financial interest, personal activity, or relationship that could impair the employee’s ability to act impartially and in the best interest of the Government when performing under the BPA. Please note the additional certification requirement required in Section 3.1.2 when submitting a quote for a call order requirement.

D. Teaming or Subcontracting: While teaming and subcontracting is not required, if the vendor decides to team or subcontract in order to staff the BPA, then the proposal should discuss how these arrangements are managed.

SOLICITATION | 6/28/2012| Page 10 of 37

1.7.5 Factor 4: Past Performance

Offerors' proposals should include 3-5 examples of past performance that demonstrate the vendors’ past work that is most similar in size and scope to this requirement. Each example should include the name of the client organization; a short description or the work performed and the resulting deliverables; the contract’s dollar amount and period of performance; and a name, email, and phone number for a client contact that can speak to the vendors work.

The evaluation of this factor will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

Past performance assessments may be based on information such as the contracting officer and evaluator’s knowledge of previous experience with the supply or service being acquired, customer surveys, or other reasonable basis. The assessment will consider the firm’s record of conforming to specifications and to standards of good workmanship / customer service. In addition, adherence to contract schedules, including the administrative aspects of performance, will be taken into consideration. Offers lacking past performance will receive a neutral rating on this factor.

1.8 Proposal Submission Requirements

1.8.1 Format

Proposals for this solicitation are not to exceed 50 pages in length, including the proposal cover letter.

The page limit does not include personnel resumes or responses to the sample task orders. Please note that there are page limitations for each sample task identified in Section 2.0. Margins should be set at a minimum of 1-inch all sides, and text font should be 11-point or more for readability. We reserve the right to consider proposals that exceed the maximum page length, but are not required to evaluate items that exceed page limitations.

Proposals shall include a cover page with company name, DUNS number, and Tax ID number. Also, please include a completed and signed SF 1449. Consider the evaluation factors listed in Section 1.7 above when creating your proposal to receive the highest possible rating.

1.8.2 Proposal due date, time, and format

Proposals are due via email or mail no later than 3:00 PM CDT on August 9, 2012. It is the contractor’s responsibility to ensure proposals are received on time. Email submittals with the proposal as a single complete PDF attachment are preferred. If submitting via email, please note that file size limitations, formatting, or other problems may hamper receipt, so please verify that the contracting officer has received your proposal. Please note that the first address listed below (USDA APHIS MRPBS) is the official location for receipt of proposals. If sent by mail, please send one (1) copy of your proposal to each of the following addresses:

SOLICITATION | 6/28/2012| Page 11 of 37

1. USDA APHIS MRPBS

Attn: Leah Schultz – Contracting 100 North 6th Street Suite 510 – C Butler Square Minneapolis, MN 55403 Leah.h.schultz@aphis.usda.gov Direct: 612-336-3625

2. National Organic Program

Attn: Jennifer Tucker 1400 Independence Ave SW – Room 2648S; Stop 0628 Washington D.C. 20250

1.9 Questions

All questions must be submitted via email no later than July 31, 2012 to Leah Schultz at: leah.h.schultz@aphis.usda.gov.

2.0 SAMPLE TASKS

These tasks are sample tasks, both to illustrate the types of reports that have been required in the past, and to provide a concrete statement of work against which vendors can develop pricing proposals. Call order awards will not be made against these sample tasks – they are provided to support the proposal development and evaluation process only.

2.1 Sample Task #1 – Full Evaluation Technical Report

2.1.1 Scope of Work

For this requirement, the National Organic Program (NOP) on behalf of the National Organic Standards Board (NOSB) Handling Subcommittee, requests a Full Evaluation Technical Report on livestock vaccines produced from excluded methods (i.e. vaccines produced using genetically modified organisms (GMOs) or genetic engineering).

The report must address the National List Evaluation Questions applicable to materials used in livestock production. The Committee has also requested that the report address additional questions for this class of substances. The National List Livestock questions are provided in Attachment A of this Solicitation; the additional questions are provided below.

Vaccines are currently allowed for use in organic livestock production and are listed on the National List, 7 CFR Part 205, as noted below:

§ 205.2 Terms defined.

Biologics. All viruses, serums, toxins, and analogous products of natural or synthetic origin, such as diagnostics, antitoxins, vaccines, live microorganisms, killed microorganisms, and the antigenic mailto:Leah.h.schultz@aphis.usda.gov mailto:leah.h.schultz@aphis.usda.gov http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1c17b79cd94d4df8eaa7cd46f028ada8&rgn=div5&view=text&node=7:3.1.1.9.32&idno=7#7:3.1.1.9.32.1.354.2

SOLICITATION | 6/28/2012| Page 12 of 37 or immunizing components of microorganisms intended for use in the diagnosis, treatment, or prevention of diseases of animals.

Excluded methods. A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture.

§ 205.105 Allowed and prohibited substances, methods, and ingredients in organic production and handling.

To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s)),” the product must be produced and handled without the use of:

(a) Synthetic substances and ingredients, except as provided in §205.601 or §205.603;

(e) Excluded methods, except for vaccines: Provided, that, the vaccines are approved in accordance with §205.600(a);

§ 205.238 Livestock health care practice standard.

(a) The producer must establish and maintain preventive livestock health care practices, including:

(6) Administration of vaccines and other veterinary biologics.

(c) The producer of an organic livestock operation must not:

(2) Administer any animal drug, other than vaccinations, in the absence of illness;

§ 205.603 Synthetic substances allowed for use in organic livestock production.

In accordance with restrictions specified in this section the following synthetic substances may be used in organic livestock production:

(a) As disinfectants, sanitizer, and medical treatments as applicable.

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1c17b79cd94d4df8eaa7cd46f028ada8&rgn=div5&view=text&node=7:3.1.1.9.32&idno=7#7:3.1.1.9.32.2.354.6 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1c17b79cd94d4df8eaa7cd46f028ada8&rgn=div5&view=text&node=7:3.1.1.9.32&idno=7#7:3.1.1.9.32.2.354.6 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1c17b79cd94d4df8eaa7cd46f028ada8&rgn=div5&view=text&node=7:3.1.1.9.32&idno=7#7:3.1.1.9.32.7.354.4

SOLICITATION | 6/28/2012| Page 13 of 37

Biologics—Vaccines.

Additional Questions / Information Requested from NOSB Livestock Subcommittee:

• What constitutes a GMO vaccine; i.e., are there different levels of GMO use that could determine if a vaccine is labeled GMO?

• Are there [livestock] diseases that are only covered with GMO vaccines?

• What is the proportion of GMO/non-GMO vaccines currently available [for livestock]?

• What is the proportion of GMO/non-GMO vaccines currently in development [for livestock]?

• Are there effective alternative(s) to GMO vaccines, such as a combination of conventionally produced vaccines, nosodes, etc.?

• Studies on the potential harm from the use of GMO vaccines.

• Can animals, or their offspring, be tested to determine GMO vaccine use?

• Benefits of GMO vaccines vs. non-GMO vaccines in the broadest sense, not just cost of production or time required from research to market.

• Does scale, or amount of use, impact type of vaccine developed (i.e., does the organic market warrant development of non-GMO vaccines)?

Related Documents:

• NOSB Final Recommendation on Vaccines in 205.105 (November 5, 2009)

• NOP Response to NOSB Recommendations (September 30, 2010)

• APHIS Center for Veterinary Biologics, Veterinary Biological Product Catalog (PDF)

2.1.2. Deliverables and Period of Performance

Deliverables for this requirement shall include:

• Draft Technical Report – Due to NOP within 120 days of call order award

• Final Technical Report (Incorporating NOP, NOSB, and Peer Review comments) – Due to NOP 30 days after final comments are provided to the contractor

2.1.3. Proposal Requirements

Provide a proposal of no more than 12 total pages of length that includes the following:

• Proposed approach to research and development of the Technical Report

• Identify key personnel proposed for assignment to the call order along with relevant experience

• Proposed fixed price itemizing estimated number of hours and hourly rates for key personnel contributing to the deliverables listed above.

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5081499&acct=nosb http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5086856&acct=nopgeninfo http://www.aphis.usda.gov/animal_health/vet_biologics/publications/CurrentProdCodeBook.pdf

SOLICITATION | 6/28/2012| Page 14 of 37

2.2 Sample Task #2 – Supplemental Technical Report - Sunset Evaluation Request

2.2.1 Scope of Work

For this requirement, the National Organic Program (NOP) on behalf of the National Organic Standards Board (NOSB) Handling Subcommittee, requests a Supplemental Technical Report for agar-agar for use in organic handling. This substance is currently listed on the National List, as indicated below. The current allowance for agar-agar is scheduled to sunset, or expire, on November 3, 2013. A previous technical advisory panel report was completed in 1995 and is available through the link below.

The current listing for this substance is as follows: § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).”

The following nonagricultural substances may be used as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s))” only in accordance with any restrictions specified in this section.

(a) Nonsynthetics allowed:

Agar-agar.

Additional Information Requested by NOSB Handling Subcommittee: The report should specifically address any new food uses, manufacturing methods, or sources of agar-agar since approximately 1995, and should thoroughly evaluate alternative organic inputs which could provide similar functionality in foods.

Related Documents: Technical Advisory Panel Report for Agar-Agar (1995)

2.2.2 Deliverables and Period of Performance

Deliverables for this call order shall include:

• Draft Technical Report – Due to NOP within 60 of the call order award

• Final Technical Report (Incorporating NOP, NOSB, and Peer Review comments) – Due to NOP 30 days after final comments are provided to the contractor

2.2.3 Proposal Requirements

Provide a proposal of no more than 8 total pages of length that includes the following:

• Proposed approach to research and development of the Technical Report

• Identify key personnel proposed for assignment to the call order

• Proposed fixed price itemizing estimated number of hours and hourly rates for key personnel contributing to the deliverables listed above.

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5066961&acct=nosb

SOLICITATION | 6/28/2012| Page 15 of 37

2.3 Evaluation of Sample Tasks

Sample tasks will be evaluated in accordance with Section 1.7 above.

3.0 CONTRACT ADMINISTRATION

3.1 Call Orders

Call orders will be issued against the BPA on a firm fixed price basis.

3.1.1 Competition

All call orders will be competed among at least three of the contractor awardees. No contractor may receive over $500,000 of orders during the term of the contract.

The following individuals have authority to request proposals:

• Dr. Lisa Brines, NOP

• Dr. Jennifer Tucker, NOP

• APHIS Procurement Personnel

3.1.2 Proposal Evaluation

Proposal evaluation criteria will be determined when the requirements for a call order are issued.

However, in general, call order proposals will be evaluated based on a best value approach based on the following criteria:

Technical Approach Management Approach/Project Staffing/Quality Assurance (if applicable) Price

Technical approach and Management Approach/Project Staffing/Quality Assurance, when combined, are of greater importance than price.

***Please note that accompanied with a submission for a call order requirement must be a certification that no conflict of interest exists as between the contractor (as a whole and as it related to its agents) and the subject of the requested technical report. This certification must be submitted to be considered for the call order award.*** See Federal Acquisition Regulations (FAR). “Subpart 3.11—Preventing Personal Conflicts of Interest for Contractor Employees Performing Acquisition Functions” for more information about how COI is defined.

https://www.acquisition.gov/far/current/pdf/FAR.pdf

SOLICITATION | 6/28/2012| Page 16 of 37

3.1.3 Issuance

Orders may be placed by a warranted contracting officer via mail, fax or through email. Copies of any call orders issued must be sent to each of the following:

Nathan Johnson: Nathan.d.johnson@aphis.usda.gov Leah Schultz: leah.h.schultz@aphis.usda.gov

3.2 Invoicing Information

Invoices may be issued upon completion of the call order. Invoices shall be sent to the address indicated on the call order.

A proper invoice must include:

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Name, title, and phone number of person to notify in event of defective invoice; and

(vii) Taxpayer Identification Number (TIN).

The Government reserves the right to reject an invoice that does not include the information above.

3.3 Points of Contact

For questions regarding general contract administration, please contact Leah Schultz, Contract Specialist, at 612-336-3625 or Leah.h.schultz@aphis.usda.gov. Also, please feel free to contact the Contracting Officer, Nathan Johnson at 612-336-3404 or Nathan.d.johnson@aphis.usda.gov

3.4 Contracting Officer’s Representative (COR)

The Contracting Officer (CO) has designated a Contracting Officer’s Representative (COR). Specific COR’s for each call order will be identified when the call order is awarded.

The COR is responsible for monitoring the performance of work under this contract and is the local Government contact. In no event, however, will any understanding, agreement, modification, change order, or other matter deviating from the terms of the contract be effective or binding upon the Government unless advance authorization is received from the Contracting Officer, and proper contractual documents executed by the Contracting Officer prior to performing the work.

The COR shall inform the Contracting Officer as soon as possible of any understandings, tentative agreements, recommended modifications, and actions or inactions of the Contractor or the Government which could affect the Contractor’s ability to comply with the contract performance requirements or completion times.

mailto:Nathan.d.johnson@aphis.usda.gov mailto:leah.h.schultz@aphis.usda.gov mailto:Leah.h.schultz@aphis.usda.gov mailto:Nathan.d.johnson@aphis.usda.gov

SOLICITATION | 6/28/2012| Page 17 of 37

Whenever, in the opinion of the Contractor, the COR requests effort outside the scope of the contract, the Contractor shall so advise the COR. If the COR persists and there still exists a disagreement as to proper contractual coverage, the Contracting Officer shall be notified immediately.

PROCEEDING WITH WORK WITHOUT PROPER CONTRACTUAL COVERAGE AND APPROVAL OF THE COR

COULD RESULT IN A BREACH OF CONTRACT AND NONPAYMENT.

The designation (delegation of authority) is provided in writing to the COR and is available to the Contractor. The delegation of authority clearly explains the COR’s roles and responsibilities on the contract and limitations of authority.

The following contacts are the only persons authorized to interact with the contractor on this contract:

1. Contracting Officer – For contract related issues:

Nathan Johnson, Contracting Officer Specialist - (612) 336-3404 Nathan.d.johnson@aphis.usda.gov

2. Contracting Specialist – For contract related issues:

Leah Schultz, Contracting Specialist – (612) 336-3625 Leah.h.schultz@aphis.usda.gov

3. Contracting Officers Representative (COR) – For requirement related issues:

Jennifer Tucker

4.0 Contract Clauses

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions—Commercial Items (Oct 2008).

CLAUSES INCORPORATED BY FULL TEXT

52.252-2 Clauses Incorporated by Reference (Feb 1998).

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

http://acquisition.gov/far/index.html

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jan 2012)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

mailto:Nathan.d.johnson@aphis.usda.gov mailto:Leah.h.schultz@aphis.usda.gov http://acquisition.gov/far/index.html

SOLICITATION | 6/28/2012| Page 18 of 37

(1) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)).

____ Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

(4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Feb 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note).

(6) 52.209-6, Protecting the Government’ Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Dec 2010) (31 U.S.C. 6101 note). (Applies to contracts over $30,000). (Not applicable to subcontracts for the acquisition of commercially available off-the-shelf items).

(8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 740 of Division C of Public Law 111-117, section 743 of Division D of Public Law 111-8, and section 745 of Division D of Public Law 110-161).

(10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C.

657a).

(14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3))

(23) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2012) (15 U.S.C.

632(a)(2)).

(26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

(28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

(29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(30) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

(31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

(32) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

(33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

SOLICITATION | 6/28/2012| Page 19 of 37

(34) 52.222-54, Employment Eligibility Verification (Jan 2009). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

(38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).

(42) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(47) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct.

2003) (31 U.S.C. 3332).

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

(6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110- 252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

SOLICITATION | 6/28/2012| Page 20 of 37

(ii) 52.219-8, Utilization of Small Business Concerns (Dec 2010) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) [Reserved]

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C.

793).

(vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(viii) 52.222-41, Service Contract Act of 1965, (Nov 2007), (41 U.S.C. 351, et seq.)

(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___ Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (Nov 2007) (41 U.S.C. 351, et seq.)

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (Feb 2009) (41 U.S.C. 351, et seq.)

(xii)…