FBO Notice Attachment-Questions and Answers to Draft RFP.pdf

SPECIAL NOTICE

USDA, FARM SERVICE AGENCY, COMMODITY OPERATIONS

March 7, 2011

The following questions/comments were submitted in response to the December 14, 2011, publication of the draft Request for Proposals for Emergency Food Products (EFP) AG-INTP-S-11-9984. All questions/comments pertinent to the draft RFP are included below with the Government’s answer following each question. Note: Questions regarding the internal operations and staffing of the Government will not be addressed as they are not relevant to the draft RFP.

1. Question: Please advise if the Government has any interest in adding APack Ready Meals to the list of potential products.

Answer: The Government, at this point, does not anticipate adding other products to the RFP.

2. Question: Is the Government considering a solicitation for 4C Powdered Beverages, MRE/ UGR-A, UGR-H&S. (small sticks -shake in bottle water) -Splenda - Vit C -many with Antioxidants, Iced Teas/ PSD/ Vitamin Drinks/ energy Drinks (in "sticks" & Tubs)?

Would you consider them for use in this program (USAID)?

Answer: The Government, at this point, does not anticipate adding other products to the EFP RFP or issuing a separate RFP for these products. Further, the Government does not anticipate the inclusion of these types of products in humanitarian food aid programs.

3. Question: Can you please identify the delivery order lead-time/delivery schedule provision?

Under F.4, 4K52.216-3 Delivery Instructions, for delivery orders issued against the IQC,

(a) the Government shall issue delivery instructions to the Contractor subject to the ordering clause of the contract, 52.216-18, Ordering; the order limitation clause of the contract, 52.216-19, Order Limitation; and the Surge Option clause of the contract.

While I see the minimum delivery order under 52.216-19 is 18 M.T., I cannot see the lead-time for such or greater orders. F-2 states “The base period of performance of this contract is from 12 weeks after contract award through… “. Is it implied that the 12 week period is the initial order lead-time?

Please provide the actual order lead-time (e.g. 90 days, 120 days) for any order(s) issued under the contract. When defining the order lead time, please take into consideration that the white tri-laminate pouches and carton and shipping case appear to be specific to these USDA non-commercial items, and will have a long lead time, of 90-120 days.

Answer: With regard to lead times, the initial order lead time is the 12 week period stated at F.2, any final EFP RFP will contain an additional clause specifying the lead time for subsequent orders after the initial order.

4. Question: In consideration of the long lead-time for packaging materials and the immediate RDD that will be needed for emergency food products, has USDA given consideration to purchasing and pre-positioning such items at the contractor’s facility using government-owned/vendor-managed inventory terms? If you elect to execute such plan, please provide the initial purchase quantities, the stated storage period covered by the contract unit prices (e.g. 1 year), and the replenishment terms.

Answer: The Government will not be utilizing Government-furnished property in the execution of this contract. The contractor will be responsible for obtaining all materials used under the contract.

5. Question: Re the contract production schedule as cited at F-20 Surge Option and at Section L/M factor 6 Production Capacity/Schedule, which states “Offeror shall provide their rate of production (production schedule) of each type of product offered. The rate of production shall be stated in terms of units of product (CLIN) per seven day work week”.

Under I.16.5, the Government shall pay the contractor $20k as equitable adjustment if the IQC min is not purchased. While this may be sufficient to compensate for unrecovered overheads, it is certainly not sufficient to reimburse the cost of packaging materials to produce the IQC min. Accordingly, it would not be prudent for a contractor to purchase and preposition the packaging materials until a delivery order is placed, and the long lead time for packaging materials must be factored into the production plan.

I would recommend that in order to successfully execute any emergency mission in a timely manner, that the USDA give serious consideration to purchasing a pre-positioned inventory and the Production Capacity at technical evaluation factor 6 be re-defined as the Order FOB Origin Delivery Schedule, taking into account all material lead-times, production rates, inspection times, and shipping arrangement times. This schedule would represent the lead times for any orders issued under the contract.

Under the Surge option Clause, the weekly delivery quantities can be increased by 50% (or you may consider greater, to account for multiple shifts and surge capacity), but the delivery times could not be expedited.

Answer: Section I.16.5, Compensation to the Contractor for Government Failure to Order Minimum Contract Amount, will be modified to clarify that the monetary sum payable to a contractor in the event the Government fails to order the minimum quantity is payable for each contract line item.

With regard to purchasing a “pre-positioned inventory” and changing technical evaluation factor number 6, the Government will determine when to issue delivery orders under the contract to meet its needs. That may or may not include purchasing product prior to any pertinent emergency mission. As a result, the Government will not alter the technical evaluation factor number 6.

6. Question: With regard to Section B.2.1: Given the long lead-times related to production/delivery, would the USDA consider relaxing the Production report to milestone reporting?

Answer: Given the purpose for procuring these supplies and the intended recipients, and the circumstances under which the Government may be issuing specific delivery orders, the Government is interested in closely monitoring the work to be performed. As a result, the Government will not relax the milestone reporting under B.2.1.

7. Question: With regard to Section B.2.2: If the contractor is a USDA and military sanitarily approved/listed facility, can the USDA waive, or relax sanitation reports submissions from the twice per month?

Answer: Given the purpose for procuring these supplies and the intended recipients, and the circumstances under which the Government may be issuing specific delivery orders, the Government is interested in closely monitoring the work to be performed. However, given the requirements for audit and approval of the facility by USDA-AMS, the Government will consider relaxing the requirement under B.2.2.

8. Question: The contract is a supply contract. As such, much of the offerors’ technical capability regarding its ability to perform will be best assessed thru evaluation of the finished PDM cases and the factors 4 & 5 Experience and Past Performance submissions than the Factor 1 Management Approach, which appears somewhat redundant to the requirements of the contract; e.g. GMPs, QSP, progress reporting, etc.. These proposal elements lead to fluff and salesmanship in proposals, and are usually over-reaching and unenforceable. In effort to streamline proposal and evaluation, please consider deleting Factor 1, Management Approach.

Answer: With regard to the specific elements cited in Section M, Factor 1 (Management Approach), the Government believes that these elements are important to the successful execution of any resulting contract. As noted in Item 11 at Section A.2 and in Section C, the Government reserves the right to incorporate into any resulting contract all or any portion of an offeror’s proposal, including management approach. The Government believes the various evaluation factors are necessary to obtain important information that will be considered as part of the proposal evaluation.

9. Question: Request that Factor 3B, Product Packaging and Marking be deleted, as the detailed specifications clearly define the requirements, the PDMs will confirm understanding and conformance, and contractor inspection and any Government verification testing will assure compliance.

Answer: This subfactor does not only address the ability of the offeror to properly package a product, but is intended to provide important information on selection strategies for subcontractors and consideration of lead times which may be critical to meeting delivery criteria.

10. Question: Can you advise if, in order to submit an offer, a firm must be pre-qualified in accordance with the KCCO document titled Qualification Requirements For Prospective Contractors Selling Commodities To USDA found at:

http://www.fsa.usda.gov/FSA/webapp?area=home&subject=coop&topic=pas-vr?

Answer: No. The referenced document contained a typographical error which might lead one to believe it applied to KCCO acquisitions conducted using requests for proposals. The document was intended to apply only to KCCO acquisitions using sealed bidding and it has been corrected to remove the error. The RFP contains all of the representations and instructions in Part IV (Sections K, L, and M) that a potential offeror will need in order to participate in the acquisition.

11. Question: Section I.19.1, includes 52.219-7 Notice of Partial SB set-aside, but Section L-5-7 states

“unrestricted”. Please clarify.

Answer: Section I.19.1, 52.219-7 Notice of Partial Small Business Set-Aside, was included in the draft RFP in error. Any final RFP will not contain this clause.

12. Question: Which mixed tocopherols are required for the A-20 paste?

• Mixed Tocopherols Concentrate 50%

• Mixed Tocopherols Concentrate 70%

• Mixed Tocopherols Concentrate 90%

• Mixed Tocopherols Powder 20%

• Mixed Tocopherols Powder 30%

The draft RFP describes the tocopherol in the A-20 Paste as a di-tocopherol acetate.

Which of your listed tocopherols is specifically used?

http://www.fsa.usda.gov/FSA/webapp?area=home&subject=coop&topic=pas-vr�

Answer: Mixed Tocopherols Concentrate 50% was used in the development of these products.

Guidance on the formulation and manufacturing of these products can be found in the Final Report on Development of an Emergency Food Product available at:

www.usaid.gov/our_work/humanitarian_assistance/ffp/final_efp.2.12.09.doc

13. Question: Is there a specific caloric value that each product should contain? As one who operates programs in the field, it would be helpful for us to know how many calories we can deliver with each bar or paste

Answer: The product is designed to meet a minimum of 2200 kcal per day when nine packages are consumed. Minimum caloric value of each package would therefore be approximately 250 kcal per package. The caloric value information for each product is a part of the nutritional label markings to be placed on the primary packaging. Please refer to the marking exhibits found in Section D.4.1.1.5 (A-20 Paste), D.4.1.2.5 (A-28 Rice Bar), and D.1.3.5 (Wheat Bar).

14. Question: Do the levels listed in the nutrient requirements per serving take into consideration any endogenous levels from the other ingredients (i.e., nonfat dry milk, whey protein, etc)?

Answer: The tables listed as “nutrient requirements per serving” in the RFP are specifications for the vitamin and mineral premix formulae. Endogenous nutrients are not considered in these tables. Further guidance on the formulation and manufacturing of these products can be found in the Final Report on Development of an Emergency Food Product available at:

15. Question: What are the processing conditions that the premix will be subjected to? We believe the optimum fill temperature should be between 130-140 degrees.

Answer: Fill temperature should be between 120-140 degrees. Guidance on the formulation and manufacturing of these products can be found in the Final Report on Development of an Emergency Food Product available at:

16. Question: The “encapsulated Vitamin A”: Will this stand up to the temperatures for this filling temperature?

Answer: After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be found in the Final Report on Development of an Emergency Food Product available at:

www.usaid.gov/our_work/humanitarian_assistance/ffp/final_efp.2.12.09.doc

Storage stability data indicate that the encapsulated vitamin A will tolerate the production procedures outlined in the report.

17. Question: With regard to the tocopherols, which are required for the A-20 paste?

http://www.usaid.gov/our_work/humanitarian_assistance/ffp/final_efp.2.12.09.doc� http://www.usaid.gov/our_work/humanitarian_assistance/ffp/final_efp.2.12.09.doc�

• Mixed Tocopherols Concentrate 50%

• Mixed Tocopherols Concentrate 70%

• Mixed Tocopherols Concentrate 90%

• Mixed Tocopherols Powder 20%

• Mixed Tocopherols Powder 30%

Answer: Mixed Tocopherols Concentrate 50% was used in the development of these products.

Guidance on the formulation and manufacturing of these products can be found in the Final Report on Development of an Emergency Food Product available at:

18. Question: With regard to Section C.1.1.1. – The A-20 commodity requirements as included do not highlight a target population. Despite the fact that the product in question is meant for short-term use and considering the fact that nutritional needs of adults, young children and other vulnerable populations vary, can you provide any clarity as to the target population especially as relates to the nutritional fortification requirements? Will this product target children under 2 years old in addition to older children, pregnant / lactating women and other adults?

Is there a varied recommended daily intake based on age and/or weight? The draft document specifies nine 50 gram pouches per day but does not include recommendations based on age and/or weight. Indicating the number of pouches per day for adults relative to children on the packaging itself may be useful.

Answer: The package size is specifically designed so that daily portions can be tailored to the age of the beneficiary, that is, an adult would receive nine packages per day and children would receive fewer based on their age and caloric needs. The products must be appropriate for highly mobile populations displaced by natural disaster or conflict, which would preclude packaging in multi-use containers.

These products are meal replacements, as indicated in the RFP. The entire packet of 9 pouches or bars provides the minimum calories recommended by SPHERE for an adult.

The daily ration is broken down into 9 portions, each of which provides approximately 50 grams of food, with a caloric value of approximately 250 calories for each. Recipients may eat as much or as little as needed. The smallest pouch may be an appropriate amount for a 6-12 month old infant that is also breastfed or may be too little. Appetite is the decisive factor. A 5-person family would receive 5 rations and would be able to balance as needed, with some members eating more food and some eating less depending on age, size or physical condition.

19. Question: Section C.1.1.1.A, Quality of A-20, states, in part, “No alcohol or any known allergens, such as, but not limited to, peanuts shall be used in the manufacture of these items.”

Is A-20 targeted for domestic and/or international distribution? If paste A-20 is destined for international distribution we suggest that peanuts not be precluded, as allergens to peanuts is not a serious concern. Over the last decade, there has been effective distribution of emergency foods in developing world settings via UNICEF, WFP, MSF and others. In the case that peanuts are allowable, Plumpy’soy®, a product Edesia has the capacity to produce, could potentially be adapted to meet the nutritional and product specifications for A-20.

Answer: The sentence, “No alcohol or any known allergens, such as, but not limited to, peanuts shall be used in the manufacture of these items,” will be changed for all three products.

The new sentence will read, “No alcohol or any known allergen other than the ingredients in the specified product formulation shall be used in the manufacture of these products.”

20. Question: C.1.1.1.C., Formulation, states, in part, “The sources of protein may be dairy, legumes and protein isolates.”

However, the ingredient list included is much more specific. Is there any flexibility in the ingredient list as long as the nutritional value of the product remains consistent with the specifications?

Answer: The sentence, “The sources of protein may be dairy, legumes and protein isolates,” will be removed for all three products. The products are meant to be produced using the formulation specified, and this sentence incorrectly states that there is variation allowed.

The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be found in the Final Report on Development of an Emergency Food Product available at:

21. Question: C.1.1.1.D., Fortification, states, in part, “Specific vitamins shall be encapsulated to provide the required product shelf life and to avoid objectionable odors and flavors.”

Although encapsulated vitamins are generally used in energy bars, based on our experience it is not necessary to encapsulate vitamins in food pastes for the purpose of shelf life issues. The majority of existing vitamin and mineral premixes being used for ready-to-use foods do not use encapsulated vitamins, yet the finished products carry a two-year shelf life. Would you consider removing the specification for encapsulation or making it optional?

Answer: The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be found in the Final Report on Development of an Emergency Food Product available at:

www.usaid.gov/our_work/humanitarian_assistance/ffp/final_efp.2.12.09.doc

Storage stability data indicate that the encapsulated vitamin A will tolerate the production procedures outlined in the report.

22. Question: Section E.2.1.1, Plant systems audit, states, in part, “A plant systems audit conducted by USDA-Agricultural Marketing Service or contractor personnel under the direction or supervision of Government personnel, within 12 months prior to the date of the awarding of the contract.”

What are the selection criteria for a third party auditor? Considering our facility has already been successfully audited by SCMS, UNICEF, WFP and MSF, will we still be subject to a plant systems audit as a prerequisite for award of an IQC?

Answer: There is currently no agreement of reciprocity between USDA and UN agencies such as WFP and UNICEF regarding auditing and approval of sources, therefore the requirement for audit by the USDA Agricultural Marketing Service is mandatory at this time.

23. Question: With regard to Section L., Exhibit 1, we agree that including both regular pricing and

“Surge Price” in the price proposal is an important acknowledgment of the challenges associated with meeting emergency needs. Can you provide some clarity on what constitutes a surge/emergency order?

Answer: The terms of the contract give the Government unilateral authority to invoke the Surge Clause. As such, it is solely at the Government’s discretion whether or not to invoke the Surge Clause of the contract.

24. Question: With regard to A-20, the requested packaging is a 50 gram pouch, with a suggested nine pouches a day dosage. To minimize excess packaging would you consider another option like a cup or a 100 gram pouch instead? Cutting back on packaging materials would help to bring down costs and minimize waste.

Answer: The package size is specifically designed so that daily portions can be tailored to the age of the beneficiary, that is, an adult would receive nine packages per day and children would receive fewer based on their age and caloric needs. The products must be appropriate for highly mobile populations displaced by natural disaster or conflict, which would preclude packaging in multi-use containers.

Unless as may be otherwise noted in this document, changes to formulation or packaging will not be considered.

The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and time shelf life testing, air drop tests, and field trials. Much of this information can be

25. Question: C.1.1.2.D., Formulation, states, in part, “The sources of protein may be rice, dairy, legumes, and protein isolates.” and C.1.1.3.D., Formulation, states, in part, “The sources of protein may be wheat, dairy, legumes, and protein isolates.”

Are we to assume that this is a permissive list allowing any legumes and a variety of protein isolates? The ingredient paragraphs seem to restrict product contents to a more defined list, including three specific types of flour, three protein products (dried milk powder, whey protein concentrate and isolated pea protein) and other ingredients including vegetable oil, sugar and salt. A similar situation seems to exist with the paste.

Answer: The sentence, “The sources of protein may be dairy, legumes and protein isolates,” will be removed for all three products. The products are meant to be produced using the formulation specified, and this sentence incorrectly states that there is variation allowed.

The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be

26. Question: Does this ingredient list prevent the use of soy protein isolates or concentrate, which have comparable amino acid composition and PSCAAS values to dairy products, and can deliver the nutritional and functional features desired in these bars and paste? Decades of peer reviewed nutrition science supports the position that certain soy protein products are comparable to animal protein sources, including dairy. An added benefit of soy protein is lower cost than dairy protein. In addition, just as with dairy ingredients, these soy protein ingredients are in abundant U. S. domestic supply, and produced from locally grown soybeans. Furthermore, these soy protein ingredients have a long history of use by food processors with significantly reduced price and supply volatility compared to the dairy ingredients that are now included in the recommended list.

Answer: Unless as may be otherwise noted in this document, changes to formulation or packaging will not be considered. The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be

27. Comment: The food aid community and its products are moving toward more flexibility in order to target more specific beneficiary groups. Nutrition, functionality, supply and economic goals will be best served by a comprehensive list of ingredient options which meet technical requirements, but do not unnecessarily restrict manufacturers.

Answer: Unless as may be otherwise noted in this document, changes to formulation or packaging will not be considered. The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be

28. Question: Section C.1.1.1, Subsection A (Page 10 of 142), reads, “The A-20 paste shall be suitable for use by the Federal Government as a meal replacement in emergencies in order to prevent the onset of malnutrition in any cultural setting. The A-20 paste will be used by multiple ethnic and cultural groups. No animal products other than dairy products shall be used. No alcohol or any known allergens, such as, but not limited to, peanuts shall be used in the manufacture of these items. The A-20 paste is expected to be used for a period of three to seven days, with a maximum usage of 15 days."

We suggest the following changes:

The sentence that begins, "No alcohol or any known allergens ..." is not consistent with the previous sentence since dairy protein is a recognized food allergen. Therefore, we request you re-word the allergen sentence to allow for accepted sources of dietary protein for which allergenicity is not a major concern, as is the case with dairy protein.

Specifically, we request that dairy and soy protein be allowed, and suggest the following wording: "No alcohol or any know allergens such as peanuts, with the exception of dairy and soy, shall be used in the manufacture of these items.

Section C.1.1.1, Subsection C (Page 10 of 142), reads, in part, “The A-20 paste formula shall have a protein content of not more than 11.0 percent or less than 9.00 percent of kilocalories and a protein digestibility corrected amino acid score (PDCAAS) of 1.0. The sources of protein may be dairy, legumes and protein isolates." and "The A-20 paste shall contain nonfat dry milk powder, whey protein concentrate (80.0 percent protein), Isolated pea protein (82.0 percent). . ."

We request this paragraph be amended to include soy protein isolate and soy protein concentrate as follows:

• "The sources of protein may be dairy, soy and other legumes.”

• "The A-20 paste shall contain nonfat dry milk powder, whey protein concentrate (80.0 percent protein), soy protein isolate (90.0 percent protein), soy protein concentrate (72.0 percent protein), isolated pea protein (82.0 percent protein) ...

In accordance with the PDCAAS values for currently available RUTF paste products, we recommend the sentence read “... a protein digestibility corrected amino acid score (PDCAAS) of 0.9."

Section C.1.1.2, Subsection A (Page 13 of 142), reads, “The A-28 rice bar shall be suitable for use by the Federal Government as a meal replacement in emergencies in order to prevent the onset of malnutrition in any cultural setting. The A-28 rice bar will be used by multiple ethnic and cultural groups. No animal products other than dairy products shall be used. No alcohol or any known allergens, such as, but not limited to, peanuts shall be used in the manufacture of these items. The A-28 rice bar is expected to be used for a period of three to seven days, with a maximum usage of 15 days."

We suggest the following changes:

• The sentence that begins “No alcohol or any known allergens ...” is not consistent with the previous sentence since dairy protein is a recognized food allergen. Therefore, we request you re-word the allergen sentence to allow for accepted sources of dietary protein for which allergenicity is not a major concern, as is the case with dairy protein.

Specifically, we request that dairy and soy protein be allowed, and suggest the following wording: "No alcohol or any know allergens such as peanuts, with the exception of dairy and soy, shall be used in the manufacture of these items."

Section C.1.1.2, Subsection B (Page 13 of 142), reads, “The rice-based pre-cooked cereal formula shall contain white rice flour, dehulled and kilned oat flour (9.0 percent protein), potato flour, nonfat dry milk powder, whey protein concentrate (80.0 percent protein) . . “

We request this paragraph be amended to include soy protein isolate and soy protein concentrate as follows:

• "The rice-based pre-cooked cereal formula shall contain white rice flour, dehulled and kilned oat flour (9.0 percent protein), potato flour, nonfat dry milk powder, whey protein concentrate (80.0 percent protein), soy protein Isolate (90.0 percent protein), soy protein concentrate (72.0 percent protein), sugar, isolated pea protein ...”

Section C.1.1.2, Subsection D (Page 13 of 142), reads, in part, "The A-28 rice bar formula shall have a protein content of not more than 11 .0 percent or less than 9.00

(PDCAAS) of 1.0. The sources of protein may be rice, dairy, legumes, and protein isolates.” and "The A-28 rice bar shall contain the rice-based cereal pre-cooked cereal mix . . ."

We request this paragraph be amended to include soy protein isolate and soy protein concentrate as follows:

• "The sources of protein may be rice, dairy, soy and other legumes."

• "The A-28 rice bar shall contain the rice-based cereal pre-cooked cereal mix, nonfat dry milk powder, whey protein concentrate (80.0 percent protein), soy protein isolate (90.0 percent protein), soy protein concentrate (72.0 percent protein), isolated pea protein (82.0 percent protein), vitamin and mineral pre-mix ... "

• In accordance with the PDCAAS values for currently available RUTF paste products we recommend the sentence read " ... a protein digestibility corrected amino acid score (PDCAAS) of 0.9."

Section C.1.1.3, Subsection A (Page 16 of 142) reads, "The A-29 wheat bar shall be suitable for use by the Federal Government as a meal replacement in emergencies in order to prevent the onset of malnutrition in any cultural setting. The A-29 wheat bar will be used by multiple ethnic and cultural groups. No animal products other than dairy products shall be used. No alcohol or any known allergens, such as, but not limited to, peanuts shall be used in the manufacture of these items. The A-29 wheat bar is expected to be used for a period of three to seven days, with a maximum usage of 15 days.”

We suggest the following changes:

• The sentence that begins, "No alcohol or any known allergens. . . " is not consistent with the previous sentence since dairy protein is a recognized food allergen. Therefore, we request you re-word the allergen sentence to allow for accepted sources of dietary protein for which allergenicity is not a major concern, as is the case with dairy protein.

Specifically, we request that dairy and soy protein be allowed, and suggest the following wording:

• "No alcohol or any know allergens such as peanuts, with the exception of dairy and soy.

shall be used in the manufacture of these items."

Section C.1.1.3, Subsection B (Page 16 of 142) reads, in part, "The wheat-based pre-cooked cereal formula shall contain white wheat flour (9.0 to 11.0 percent protein), dehulled and kilned oat flour (9.0 percent protein), potato flour, nonfat dry milk powder, whey protein concentrate (80.0 percent protein). . ."

We request this paragraph be amended to include soy protein isolate and soy protein concentrate as follows:

• "The wheat-based pre-cooked cereal formula shall contain white wheat flour (9.0 to

11.0 percent protein). dehulled and kilned oat flour (9.0 percent protein) potato flour.

nonfat dry milk powder, whey protein concentrate (80.0 percent protein), soy protein Isolate (90.0 percent protein), soy protein concentrate (72.0 percent protein) sugar, isolated pea protein ... "

Section C.1.1.3, Subsection D (Page 16 of 142), reads, in part, "The A-29 wheat bar formula shall have a protein content of not more than 11.0 percent or less than 9.00

(PDCAAS) of 1.0. The sources of protein may be wheat, dairy, legumes, and protein isolates.” And "The A-29 wheat bar shall contain the heat-based cereal pre-cooked cereal mix. . . "

We request this paragraph be amended to include soy protein isolate and soy protein concentrate as follows:

• “The sources of protein may be wheat, dairy, soy and other legumes."

• "The A-29 wheat bar shall contain the wheat-based cereal pre-cooked cereal mix, nonfat dry milk powder, whey protein concentrate (80.0 percent protein), soy protein isolate (90.0 percent protein). soy protein concentrate (72.0 percent protein), isolated pea protein (82.0 percent protein), vitamin and mineral pre-mix. . . “

• In accordance with the PDCAAS values for currently available RUTF paste products we recommend the sentence read " ... a protein digestibility corrected amino acid score (PDCAAS) of 0.9."

The reasons for requesting these changes are that:

• Soy is a high quality, complete protein, and is the only complete vegetable protein shown to maintain nitrogen balance when fed as the sale protein source at minimum recommended intake levels. Specifically, Isolated Soy Protein and soy protein concentrates have been shown to be "complete" proteins when fed as the sale protein source at minimum recommended intake levels.

• Isolated soy protein and soy protein concentrate meet all published estimates of the essential amino acid requirements of children and adults. It is, therefore, a complete protein comparable to meat milk and egg protein.

• Isolated soy protein and soy protein concentrate are highly digestible, comparable in digestibility to milk, fish and egg protein.

• Soy protein is the only protein that has been granted a health claim for helping to maintain heart health. Human clinical data adequately and unequivocally shows soy protein to be efficacious in lowering total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C). In 1999 FDA authorized an unqualified health claim for soy protein and the risk of coronary heart disease (CHD). A significant amount of new information has been published since the authorization of the final rule in 1999 (64 Fed. Reg. 57700- 57733).

• With regard to the PDCAAS specifications that are written into this draft, it is important to note that Ready-to-Use Therapeutic Foods (RUTF), at the 50% dairy protein level, have a PDCAAS of 0.88. For this reason, the formulas recommended for products in this RFP will likely have a PDCAAS of 0.88 or lower. We therefore recommend that the PDCAAS standard be adjusted to a more achievable level. As a point of reference, the USDA's National School Lunch Program guidelines define a product having a PDCAAS of 0.8 as being high quality protein.

• Soy protein ingredients are both less costly and less volatile in price compared to dairy protein sources.

Answer: Unless as may be otherwise noted in this document, changes to formulation will not be considered. There will be no change to the required PDCAAS.

The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be found in the Final Report on Development of an Emergency Food Product available at:

www.usaid.gov/our_work/humanitarian_assistance/ffp/final_efp.2.12.09.doc

The sentence, “No alcohol or any known allergens, such as, but not limited to, peanuts shall be used in the manufacture of these items,” will be changed for all three products.

The new sentence will read, “No alcohol or any known allergen other than the ingredients in the specified product formulation shall be used in the manufacture of these products.”

The sentence, “The sources of protein may be dairy, legumes and protein isolates,” will be removed for all three products. The products are meant to be produced using the formulation specified, and this sentence incorrectly states that there is variation allowed.

29. Question: Section C.1.1.1.C., Formulation (Page 10) states, in part, “. . . 7.0 to 10.0 percent calories from polyunsaturated fatty acids (PUFA) . . .”

We recommend a change to, “7.0 to 15% calories from polyunsaturated fatty acids”.

We tested paste formulations with up to 10% calories from PUFA, the pastes are very dry, making the filling process very challenging. By increasing the PUFA up to 15% calories, the paste is flowable, we can achieve consistency weight control, and the paste is less likely to become clogged/stuck inside the filling pipes. The IOM* recommends at least 7.0 to 10.0% calories from polyunsaturated fat, not maximum. Please consider increasing the PUFA to 15% calories.

* High-Energy, Nutrient-Dense Emergency Relief Food Product, 2002.

Section C.1.1.1.E., Analytical and microbiological requirements (Page 11) states that PUFA shall be 7.0 to 10.0 percent of kilocalories

We recommend changing PUFA to 7.0 to 15.0% kilocalories.

Answer: Unless as may be otherwise noted in this document, changes to formulation will not be considered. There will be no change to the PUFA requirement due to the unknown effects it may have on product shelf life and acceptability.

The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be

Section C.1.1.1.G., Shelf-Life (Page 11) states, in part, “A-20 paste shall not be more than 30 days old on date of delivery to . . . “.

Can the shelf-life be up to 4 months old on date of delivery? UNICEF and World Food Programme’s specifications for RUTF (shelf-life of 24 months) are currently 4 months.

As micro and nutritional analysis require at least 10 days, this will only allow 20 days for the manufacturer to schedule and produce the paste. The shelf-life of the paste should still have at least 20 months for distribution.

Answer: The requirement will be changed to “not more that 45 days when shipped from the manufacturer.”

Section C.1.1.2.B., Ingredients (Page 13) states, in part, “The pre-cooked cereal mix shall be cooked using a high temperature short time cooking (HIST) extruder configured with 4 - 6 mm (0.16 - 0.24 in) circular die holes.

This processing method is one means of producing, but certainly not the only method. By requiring an extruder, the solicitation is inadvertently reducing the production base and potentially increasing unit costs, as most small and medium sized bakeries do not use high temperature short time cooking extruder (HIST) extruders which are relatively expensive pieces of equipment more often found in large business and R&D facilities.

Can the current method required for cooking the pre-cooked cereal mix used in the A-28 bar style A & B, be expanded to allow other production methods used in the bakery industry? From a contracting point of view, this recommended production modification has the benefit of increasing and opening the production base to a greater number of potential offerors. This will not only drive down unit costs, but ensures that the government does not find itself in a potential sole source situation.

As alternatives, we would like to propose the cooking method to be expanded to include the following baking methods:

1. Continuous Oven: Bake bars in continuous forced air oven until bar moisture is <9.5% and water activity is <0.4, such that maximum internal temperature does not exceed 145˚F.

2. Batch Oven: Bake in forced air oven until bar moisture is <9.5% and water activity is <0.40, such that maximum internal temperature of mixture does not exceed 145 ˚F.

Both methods produce the same results and maintain the integrity of the vitamin pre-mix as called for in section E. Fortification (pp. 13 – 14).

Answer: Unless as may be otherwise noted in this document, changes to the specifications will not be considered at this time. The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and time shelf life testing, air drop tests, and field trials. Much of this information can be found in the Final Report on Development of an Emergency Food Product available at:

www.usaid.gov/our_work/humanitarian_assistance/ffp/final_efp.2.12.09.doc

Section C.1.1.2.E., Footnote 3 (Page 14) states that, “Iron for Bars shall be as ferrous EDTA.”

According to DSM, Ferrous EDTA is not allowed in U.S. as a supplement. This will be difficult to source. Please consider using ferrous fumarate.

Answer: Ferrous fumarate is allowed for the paste, but using only ferrous fumarate with cereals presents a challenge for iron absorption. Fe Na EDTA was used in the production of pilot scale and commercial scale prototypes for the A-28 and A-29 bars. The requirements for the allowable use of Fe Na EDTA will be verified.

Section C.1.1.2.H., Shelf-Life (Page 14) states, in part, “The A-28 rice bar shall not be more than 30 days old on date of delivery to . . .”

Can the shelf-life be up to 4 months old on date of delivery? UNICEF and World Food Programme’s specifications for bars (shelf-life of 24 months) are currently 4 months. As micro and nutritional analysis require at least 10 days, this will only allow 20 days for the manufacturer to schedule and produce the paste. The shelf-life of the bar should still have at least 20 months for distribution.

Answer: The requirement will be changed to “not more that 45 days when shipped from the manufacturer.

Section C.1.1.3.B., Ingredients (Page 16) states, in part, “The pre-cooked cereal mix shall be cooked using a high temperature short time cooking (HIST) extruder configured with 4 - 6 mm (0.16 - 0.24 in) circular die holes.”

This processing method is one means of producing, but certainly not the only method. By requiring an extruder, the solicitation is inadvertently reducing the production base and potentially increasing unit costs, as most small and medium sized bakeries do not use high temperature short time cooking extruder (HIST) extruders which are relatively expensive pieces of equipment more often found in large business and R&D facilities.

Can the current method required for cooking the pre-cooked cereal mix used in the A-29 bar style A & B, be expanded to allow other production methods used in the bakery industry. From a contracting point of view, this recommended production modification has the benefit of increasing and opening the production base to a greater number of potential offerers. This will not only drive down unit costs, but ensures that the government does not find itself in a potential sole source situation.

As alternatives, we would like to propose the cooking method to be expanded to include the following baking methods:

1. Continuous Oven: Bake bars in continuous forced air oven until bar moisture is <9.5% and water activity is <0.4, such that maximum internal temperature does not exceed 145˚F.

2. Batch Oven: Bake in forced air oven until bar moisture is <9.5% and water activity is <0.40, such that maximum internal temperature of mixture does not exceed 145 ˚F.

Both methods produce the same results and maintain the integrity of the vitamin pre-mix as called for in section E. Fortification (pp. 16 – 17).

Answer: Unless as may be otherwise noted in this document, changes to the specifications will not be considered at this time. The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be found in the Final Report on Development of an Emergency Food Product available at:

www.usaid.gov/our_work/humanitarian_assistance/ffp/final_efp.2.12.09.doc

Section C.1.1.3.E., Footnote 3 (Page 17) states that, “Iron for Bars shall be as ferrous EDTA.

According to DSM, Ferrous EDTA is not allowed in U.S. as a supplement. This will be difficult to source. Please consider using ferrous fumarate.

Answer: Ferrous fumarate is allowed for the paste, but using only ferrous fumarate with cereals presents a challenge for iron absorption. Fe Na EDTA was used in the production of pilot scale and commercial scale prototypes for the A-28 and A-29 bars. The requirements for the allowable use of Fe Na EDTA will be verified.

Section C.1.1.1.G., Shelf-Life (Page 17) states, in part, “The A-29 wheat bar shall not be more than 30 days old on date of delivery to. . .”

Can the shelf-life be up to 4 months old on date of delivery? UNICEF and World Food Programme’s specifications for bars (shelf-life of 24 months) are currently 4 months. As micro and nutritional analysis require at least 10 days, this will only allow 20 days for the manufacturer to schedule and produce the paste. The shelf-life of the bar should still have at least 20 months for distribution.

Answer: The requirement will be changed to “not more that 45 days when shipped from the manufacturer.”

Section D.4.1.1.2.A, A-20 Paste Packaging (Pouch) Requirements (Page 21) states, in part, “The pouch shall be either nitrogen flushed or vacuum packed.”

Nitrogen flushing a paste will cause the paste to solidify instantly, so this filling process is not recommended. Most manufacturers do not have vacuum packaging capabilities. As long the paste has minimum 24 months of shelf-life, packaging at ambient conditions should be allowed. Packaging the paste with either nitrogen or vacuum should not be a requirement.

From a contracting point of view, this recommended production modification has the benefit of increasing and opening the production base to a greater number of potential offerers. This will not only drive down unit costs, but ensures that the government does not find itself in a potential sole source situation.

Answer: Unless as may be otherwise noted in this document, changes to the specifications will not be considered at this time. The three products identified in this RFP are the result of many years of intensive research, development, testing, and evaluation. There are no commercial equivalents to these products, and the RFP is not meant to allow any variation in formulation, manufacturing, or packaging than those identified in the RFP.

After applied research and advanced technical development, the products were produced on a pilot scale, and eventually on a larger scale under research and development contracts. The products were then subjected to acceptability testing, real-time shelf life testing, air drop tests, and field trials. Much of this information can be found in the Final Report on Development of an Emergency Food Product available at:

www.usaid.gov/our_work/humanitarian_assistance/ffp/f…