DRAFT NOP SOW.6.5.12.docx

AG-6395-S-12-0093

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. The NOSB is a Federal Advisory Board made up of volunteers from the organic community.

The Technical Reports produced under this BPA will be used by the NOSB in its capacity to consider these substance petitions, 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.

· The NOP review 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, which will include any relevant information needed to support both the winning contractor’s proposal and task performance. At least three contractors will be asked to compete for any particular call order. 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, each associated with a different kind of Technical Report. The specific requirements for each report will be driven by the particular substance being evaluated, and will be outlined in each requirement.

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.

· 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 award. 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 for NOSB reviews. Each Full Evaluation Technical Report is to include the following:

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.

Responses to Evaluation Questions: Each Report is to include responses to the technical evaluation questions provided in the table below. 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 petitioned substance’s potential for adverse impacts on human health and the environment and its compatibility with organic agriculture.

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 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.

Table 1: Evaluation Questions

Evaluation Question #2: Describe the most prevalent processes used to manufacture or formulate the petitioned substance. Further, describe any chemical change that may occur during manufacture or formulation of the petitioned substance when this substance is extracted from naturally occurring plant, animal, or mineral sources. (7 U.S.C. § 6502 (21)). Data Required: The response must describe the processes used to manufacture or formulate the substance, including a discussion of all precursors and/or feedstocks. A description of alternate manufacturing methods and the extent of their commercial use which are not included in the petition, if any, should be presented. The response must also describe, in detail, any chemical changes effected on any naturally occurring precursor or feedstock by all manufacturing or formulation processes. For the purposes of this response, a chemical change includes changes in the molecular structure of the substance or other description of chemical modification.

Evaluation Question #3: Is the substance synthetic? Discuss whether the petitioned substance is formulated or manufactured by a chemical process, or created by naturally occurring biological processes. (7 U.S.C. § 6502 (21)). Data Required: For the purposes of this response, chemical processes are processes include, but are not limited to, acid base reactions, calcification, thermal or catalytic cracking, esterification, hydrogenation, mixing of substances or elements, oxidation-reduction, polymerization, etc., obtained through process units such as compressors, cracking towers, heat exchangers, mixers, reactors, pumps, etc. If the substance is created by a naturally occurring biological process, those process(es) must be described in detail. For the purposes of this response, naturally occurring biological processes are processes include but are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, various metabolic processes, and photosynthesis. Additionally, the petitioned substance may be considered nonsysnthetic if it is an extract of a plant or animal that has not been chemically modified.

Evaluation Question #4: Describe the persistence or concentration of the petitioned substance and/or its by-products in the environment. (7 U.S.C. § 6518 (m) (2)). Data Required: The response must describe whether and how the petitioned substance and/or the breakdown products are persistent or cumulative when used in organic crop or livestock production, as petitioned.

Evaluation Question #5: Describe the toxicity and mode of action of the substance and of its breakdown products and any contaminants. Describe the persistence and areas of concentration in the environment of the substance and its breakdown products. (7 U.S.C. § 6518 (m) (2)). Data Required: The response must describe whether the petitioned substance, its contaminants, or any of its breakdown products have been reported to have toxic effects and are capable of causing adverse health and/or environmental effects either present in the substance or arising from the degradation of the substance over time.

Evaluation Question #6: Describe any environmental contamination that could result from the petitioned substance’s manufacture, use, misuse, or disposal. (7 U.S.C. § 6518 (m) (3)). Data Required: The response must describe the occurrence and severity of reported environmental contamination during the manufacture, use, misuse, or disposal of the petitioned substance. This data may be available through review of assessments performed per EPA, FDA and/or NIEHS review. Data or reports from other U.S. or international universities, agencies or independent groups should be included in this response when available.

Evaluation Question #7: Describe any known chemical interactions between the petitioned substance and other substances used in organic crop or livestock production or handling. Describe any environmental or human health effects from these chemical interactions. (7 U.S.C. § 6518 (m) (1)). Data Required: The response to this request for development of technical information must describe any known chemical interactions between the petitioned substance and other substances allowed for use in organic production or handling as applicable. Describe any common combinations of materials used with the petitioned substance. Describe any substances resulting from these interactions and whether they may cause adverse health and/or environmental effects either present in the substance or arising from the degradation of the substance over time. Toxicity, mode of action, and persistence of the substance and its breakdown products should be explained.

Evaluation Question #8: Describe any effects of the petitioned substance on biological or chemical interactions in the agro-ecosystem, including physiological effects on soil organisms (including the salt index and solubility of the soil) crops, and livestock. (7 U.S.C. § 6518 (m) (5)). Data Required: The response must describe the substances (the petitioned substance and/or its byproducts in combination with naturally occurring substances over time) that are capable of affecting the agro-ecosystem. Explain the effects of these substances, including toxicity, mode of action and environmental persistence of the substance and its breakdown products. Describe whether and how the petitioned substance affects the survival and/ or function of soil organisms, such as, but not limited to earthworms, mites, grubs, bacteria, nematodes, algae, and protozoa by changing soil temperature, water availability, pH levels, nutrient availability, salt concentration, solubility or other parameter. For crops, the response should also describe whether and how the substance affects plant physiology by creating changes in plant pH, nutrient or water utilization, or other parameters. For livestock production, the response should also describe whether and how the substance affects animal physiology by creating changes in behavior, fertility, metabolism or other parameters. Describe the potential or actual impacts, of the substances upon endangered species, population, viability or reproduction of non-target organisms and the potential for measurable reductions in genetic, species or eco-system biodiversity, if possible.

Evaluation Question #9: Discuss and summarize findings on whether the petitioned substance may be harmful to the environment. (7 U.S.C. § 6517 (c) (1) (A) (i) and 7 U.S.C. § 6517 (c) (2) (A) (i)). Data Required: Drawing upon responses to above questions #2-8, and any other relevant information, describe the biological, chemical and physical agents capable of causing harmful environmental effects and the causation, that may be attributed to the substance and/or its breakdown products.

Evaluation Question #10: Describe and summarize any reported effects upon human health from use of the petitioned substance. (7 U.S.C. § 6517 (c) (1) (A) (i), 7 U.S.C. § 6517 (c) (2) (A) (i)) and 7 U.S.C. § 6518 (m) (4)). Data Required: Drawing upon responses to above questions #2-8 and any other relevant information, describe the reported health effects and causation that may be attributed to the petitioned substance and/or its breakdown products.

Evaluation Question #11: Describe all natural (non-synthetic) substances or products which may be used in place of a petitioned substance. (7 U.S.C. § 6517 (c) (1) (A) (ii)) Provide a list of allowed substances that may be used in place of the petitioned substance. (7 U.S.C. § 6518 (m) (6)). Data Required: The response must describe the availability of a non-synthetic or natural substance(s) which could be substituted for petitioned substance. The examination should address:

· a comparison of the effect, form, function, quality, and quantity of the substitute non-synthetic substance or product with the petitioned substance;

· literature, including product or practice description, on performance and test data;

· name and address of the manufacturer(s), if applicable and,

· name and address of producers, if available, who have used the substitute non-synthetic or natural substance under similar conditions and the date of use.

· A list of allowed synthetic substances on the National List that may be used in place of the petitioned substance

Evaluation Question #12: Describe any alternative practices that would make the use of the petitioned substance unnecessary. (7 U.S.C. § 6518 (m) (6)). Data Required: The response to this request for development of technical information must describe the availability of an alternative practice(s) to the use of the petitioned substance. Alternative practices include cultural methods used to enhance crop health and prevent weed, pest, or disease problems without the use of substances. Examples of cultural methods include the selection of appropriate varieties and planting sites; proper timing and density of plantings; irrigation; and extending a growing season by manipulating the microclimate with green houses, cold frames, or wind breaks. Other alternative practices include, but are not limited to, crop rotation, mulching, sanitation measures, and mechanical or physical controls. When assessing alternative practices, the report should address:

· Literature, including practice description, on performance and test data;

· A comparison of the function and effect of the proposed alternative practice with the petitioned substance; and,

· Name and address of producers, if available, who have used the alternative practice under similar conditions and the date of use.

Evaluation Question #2: Is the substance synthetic? Discuss whether the petitioned substance is formulated or manufactured by a chemical process, or created by naturally occurring biological processes (7 U.S.C. § 6502 (21). Data Required: For the purposes of this response, chemical processes are processes include, but are not limited to, acid-base reactions, calcification, thermal or catalytic cracking, esterification, hydrogenation, mixing of substances or elements, oxidation-reduction, polymerization, etc., obtained through process units such as compressors, cracking towers, heat exchangers, mixers, reactors, etc. If the substance is created by a naturally occurring biological process, process(es) must be described in detail. For the purposes of this response, naturally occurring biological processes include, but are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, various metabolic processes, and photosynthesis. Additionally, the petitioned substance may be considered non-synthetic if it is an extract of a plant or animal that has not been chemically modified.

Evaluation Question #3: Provide a list of non-synthetic or natural source(s) of the petitioned substance (7 CFR § 205.600 (b) (1)). Data Required: The response must discuss whether non-synthetic or natural sources of the petitioned substance exist and are available. The report contractor should examine the effect, form, function, quality, and quantity of the naturally sourced version of the petitioned substance, in comparison to manufactured versions. The following information on the any naturally sourced versions should be provided in the report:

· literature, including product or practice description, on performance and test data;

· name and address of the manufacturer, if applicable; and,

· name and address of producers, if available, who have used the naturally-sourced version under similar conditions and the date of use.

Evaluation Question #4: Specify whether the petitioned substance is categorized as generally recognized as safe (GRAS) when used according to FDA’s good manufacturing practices. (7 CFR § 205.600 (b)(5)) If not categorized as GRAS, describe the regulatory status. What is the technical function of the substance? Date Required: The response must indicate whether or not the substance has been determined to be GRAS by FDA. This information may be found in 21 CFR Parts 182, 184, and 186 and on FDA’s "GRAS Notice Inventory" available at http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing. The response should cite the FDA regulatory citation confirming GRAS status.

Evaluation Question #5: Describe whether the primary function/purpose of the petitioned substance is a preservative. If so, provide a detailed description of its mechanism as a preservative. (7 CFR § 205.600 (b)(4)). Data Required: The response must explain why the primary function of the substance is or is not as a preservative. Response should include cite FDA regulations, if applicable.

Evaluation Question #6: Describe whether the petitioned substance will be used primarily to recreate or improve flavors, colors, textures, or nutritive values lost in processing (except when required by law) and how the substance recreates or improves any of these food/feed characteristics. (7 CFR § 205.600 (b)(4)). Data Required: When replacement or improvement of nutrients is required or allowed by regulation, the report evaluators should cite the appropriate regulations.

Evaluation Question #7: Describe any effect or potential effect on the nutritional quality of the food or feed when the petitioned substance is used. (7 CFR § 205.600 (b)(3)). Data Required: The response must indicate whether the use of the petitioned substance affects the levels of nutrients (e.g., proteins, carbohydrates, fats, vitamins, and minerals) commonly found in the food product. Effects may include increasing or decreasing the amount and/or bioavailability of the nutrients.

Evaluation Question #8: List any reported residues of heavy metals or other contaminants in excess of FDA tolerances that are present or have been reported in the petitioned substance. (7 CFR § 205.600 (b)(5)). Data Required: The response must indicate whether the petitioned substance may contain residues of substances that exceed FDA’s Action Levels for Poisonous or Deleterious Substances in Human Food. For the most part, these action levels will relate to residues found in agricultural products. Heavy metals or contaminants addressed through FDA’s action levels. These action levels can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ChemicalContaminantsandPesticides/ucm077969.htm. See the latest edition of Food Chemicals Codex (National Research Council) for accepted reference standards for metals and other contaminants in food ingredients in the U.S.

Evaluation Question #9: Discuss and summarize findings on whether the manufacture and use of the petitioned substance may be harmful to the environment or biodiversity. (7 U.S.C. § 6517 (c) (1) (A) (i) and 7 U.S.C. § 6517 (c) (2) (A) (i)). Data Required: In consideration of the manufacture and use of the petitioned substance and its breakdown products, describe the biological, chemical and physical agents which effect the environment and the mode of action.

Evaluation Question #10: Describe and summarize any reported effects upon human health from use of the petitioned substance. (7 U.S.C. § 6517 (c) (1) (A) (i), 7 U.S.C. § 6517 (c) (2) (A) (i)) and 7 U.S.C. § 6518 (m) (4)). Data Required: Describe reported health effects and causation that may be attributed to the petitioned substance and/or its breakdown products.

Evaluation Information #11: Provide a list of nonsynthetic substances or organic agricultural products that could be alternatives for the petitioned substance. (7 CFR § 205.600 (b)(1)). Data Required: The list should be based upon a comparison of the effect, form, function, quality, and quantity of the recommended organic agricultural product with the petitioned substance. In developing the list, the following should be considered:

· any literature, including product description, on performance and test data;

· the name and address of the supplier/manufacturer, if applicable; and,

· name and address of food manufacturers who have used the substitute for the production of similar food products, the date of use.

Responses to Additional Questions: Requirements may include additional questions that must be answered for that 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 a substance evaluation by the NOSB. This may include updates to basic information about a substance, or specific questions about a particular substance. 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.

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 award(s) will be made from this solicitation and that the award(s) 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 achieve slightly superior technical expertise.

· Factor 1: Price

· Factor 2: Technical Approach

· Factor 3: Management Approach

· Factor 4: Personnel Qualifications

· Factor 5: Past Performance

Technical approach, personnel qualifications, management approach, 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 overall solicitation, price competitiveness will be evaluated based on per deliverable pricing for the sample tasks provided below. For individual call order requirements, the contractor will submit a per deliverable fixed price proposal.

1.7.2 Factor 2: Technical Approach

Proposals will be evaluated on how well each offeror demonstrates an understanding of the technical objectives outlined in this solicitation. Vendors should discuss their overall technical approach to the research and analysis required to develop the Technical Reports, as well as any unique competencies or capabilities that would support performance under this solicitation. The clarity, style, and format of the proposal will be considered as an indication of the quality of its written work.

The vendors' discussion of the work should include its understanding of the factors involved in substance evaluation in organic agriculture, principles of objective scientific research, and demonstrate an 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.

1.7.3 Factor 3: Management Approach

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 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:

· Call Order Staffing: 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.

· Training: 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.

· Quality Management: Vendor should discuss its approach to ensuring high quality and thoroughness in the development of reports, from research through final deliverable review.

· Communications: 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.

· 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.

· 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.

1.7.4 Factor 4: Personnel Qualifications

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.

Offeror 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.).

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.

1.7.5 Factor 5: 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 on the BPA.

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 XX, 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:

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 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 XX, 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 as provided below. Both sets of 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 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.

(4) Biologics—Vaccines.

Evaluation Questions for Livestock:

· Evaluation Question #1: What category in the OFPA does this substance fall under: (A) Is the substance used in production and contain an active ingredient in any of the following categories: copper and sulfur compounds; toxins derived from bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and minerals; livestock parasiticides and medicines and production aids including netting, tree wraps and seals, insect traps, sticky barriers, row covers, and equipment cleansers? (B) Is the substance used in production and contain synthetic inert ingredients that are not classified by the EPA as inerts of toxicological concern (i.e., EPA List 4 inerts)? (7 U.S.C. § 6517(c)(1)(B)(ii)). Is the synthetic substance an inert ingredient which is not on EPA List 4, but is exempt from a requirement of a tolerance, per 40 CFR part 180?

· Evaluation Question #2: Describe the most prevalent processes used to manufacture or formulate the petitioned substance. Further, describe any chemical change that may occur during manufacture or formulation of the petitioned substance when this substance is extracted from naturally occurring plant, animal, or mineral sources. (7 U.S.C. § 6502 (21)). Data Required: The response must describe the processes used to manufacture or formulate the substance, including a discussion of all precursors and/or feedstocks. A description of alternate manufacturing methods and the extent of their commercial use which are not included in the petition, if any, should be presented. The response must also describe, in detail, any chemical changes effected on any naturally occurring precursor or feedstock by all manufacturing or formulation processes. For the purposes of this response, a chemical change includes changes in the molecular structure of the substance or other description of chemical modification.

· Evaluation Question #3: Is the substance synthetic? Discuss whether the petitioned substance is formulated or manufactured by a chemical process, or created by naturally occurring biological processes. (7 U.S.C. § 6502 (21). Data Required: For the purposes of this response, chemical processes are processes include, but are not limited to, acid base reactions, calcification, thermal or catalytic cracking, esterification, hydrogenation, mixing of substances or elements, oxidation-reduction, polymerization, etc., obtained through process units such as compressors, cracking towers, heat exchangers, mixers, reactors, pumps, etc. If the substance is created by a naturally occurring biological process, those process(es) must be described in detail. For the purposes of this response, naturally occurring biological processes are processes include but are not limited to, aerobic and anaerobic digestion, decomposition, fermentation, various metabolic processes, and photosynthesis. Additionally, the petitioned substance may be considered nonsysnthetic if it is an extract of a plant or animal that has not been chemically modified.

· Evaluation Question #4: Describe the persistence or concentration of the petitioned substance and/or its by-products in the environment. (7 U.S.C. § 6518 (m) (2)). Data Required: The response must describe whether and how the petitioned substance and/or the breakdown products are persistent or cumulative when used in organic crop or livestock production, as petitioned.

· Evaluation Question #5: Describe the toxicity and mode of action of the substance and of its breakdown products and any contaminants. Describe the persistence and areas of concentration in the environment of the substance and its breakdown products. (7 U.S.C. § 6518 (m) (2)). Data Required: The response must describe whether the petitioned substance, its contaminants, or any of its breakdown products have been reported to have toxic effects and are capable of causing adverse health and/or environmental effects either present in the substance or arising from the degradation of the substance over time.

· Evaluation Question #6: Describe any environmental contamination that could result from the petitioned substance’s manufacture, use, misuse, or disposal. (7 U.S.C. § 6518 (m) (3)). Data Required: The response must describe the occurrence and severity of reported environmental contamination during the manufacture, use, misuse, or disposal of the petitioned substance. This data may be available through review of assessments performed per EPA, FDA and/or NIEHS review. Data or reports from other U.S. or international universities, agencies or independent groups should be included in this response when available.

· Evaluation Question #7: Describe any known chemical interactions between the petitioned substance and other substances used in organic crop or livestock production or handling. Describe any environmental or human health effects from these chemical interactions. (7 U.S.C. § 6518 (m) (1)). Data Required: The response to this request for development of technical information must describe any known chemical interactions between the petitioned substance and other substances allowed for use in organic production or handling as applicable. Describe any common combinations of materials used with the petitioned substance. Describe any substances resulting from these interactions and whether they may cause adverse health and/or environmental effects either present in the substance or arising from the degradation of the substance over time. Toxicity, mode of action, and persistence of the substance and its breakdown products should be explained.

· Evaluation Question #8: Describe any effects of the petitioned substance on biological or chemical interactions in the agro-ecosystem, including physiological effects on soil organisms (including the salt index and solubility of the soil) crops, and livestock. (7 U.S.C. § 6518 (m) (5)). Data Required: The response must describe the substances (the petitioned substance and/or its byproducts in combination with naturally occurring substances over time) that are capable of affecting the agro-ecosystem. Explain the effects of these substances, including toxicity, mode of action and environmental persistence of the substance and its breakdown products.