AG-INTP-S-11-9984 EFP.pdf

March 30, 2011

Solicitation No. AG-INTP-S-11-9984

United States Department of Agriculture

FARM SERVICE AGENCY

Kansas City, Missouri

The USDA requests competitive proposals from all responsible sources to supply Emergency Food Products (EFP) for use in international food aid programs administered by USDA, Foreign Agricultural Service (FAS) and the U.S. Agency for International Development. These products include: Ready-To-Eat (Meal Replacement): Paste (A-20), Rice Bar (A-28), Wheat Bar (A-29) to be delivered to various locations in the continental United States.

Indefinite-delivery, indefinite-quantity, firm fixed-price contracts with one base year and two option years for noncommercial items are contemplated.

This solicitation incorporates Federal Acquisition Regulation clauses and provisions in effect through FAC 2005-49.

Table of Contents

Part I—The Schedule

Section A Solicitation/Contract Form

A.1 SF-33

A.2 Advisory Regarding Submission of Proposals

Section B Supplies or services and prices/costs B.1 Supplies B.2 Incidental deliverables

Section C Description/specifications/statement of work C.1.1.1 Ready-to-Eat Paste (A-20) Commodity Requirements C.1.1.2 Ready-to-Eat Rice Bar (A-28) Commodity Requirements C.1.1.3 Ready-to-Eat Wheat Bar (A-29) Commodity Requirements

Section D Packaging and Marking Requirements D.4.1.1 Ready-to-Eat Paste (A-20) Packaging and Marking Specifications D.4.1.2 Ready-to-Eat Rice Bar (A-28) Packaging and Marking Specifications D.4.1.3 Ready-to-Eat Wheat Bar (A-29) Packaging and Marking Specifications

Section E Inspection and acceptance Section F Deliveries or performance Section G Contract Administration Data Section H Special Contract Requirements

H.1 4K52.215-70 Key personnel (May 2010) H.2 4K52.225-1 U.S. Origin Product (May 2009) H.3 4K52.225-2 U.S. Origin Product – Ingredient Waivers H.4 Release of Claims During Contract Closeout H.5 Contractor Performance Evaluation

Part II—Contract Clauses Section I Contract clauses

I.2 Definitions of Words and Terms I.3 Improper Business Activity and Personal Conflicts of Interest I.4 Administrative Matters I.9 Contractor Qualifications I.11 Describing Agency Needs I.15 Contracting by Negotiation I.16 Contract Type I.17 Special Contracting Methods I.19 Small Business Programs I.22 Application of Labor Laws to Government Acquisitions I.23 Environment, Energy and Water Efficiency, Renewable Energy Technologies, Occupational Safety, and

Drug-Free Workplace I.25 Foreign Acquisition (Buy American Requirements and Trade Agreements) I.26 Other Socioeconomic Programs I.27 Patents, Data, and Copyrights I.29 Taxes I.32 Contract Financing I.33 Protests, Disputes, and Appeals I.42 Contract Administration and Audit Services I.43 Contract Modifications I.44 Subcontracting Policies and Procedures I.49 Termination of Contracts I.52 Other Clauses I.53 Forms

Part III—List of Documents, Exhibits, and Other Attachments Section J List of attachments

Attachment 1 Sample Production Report - Data Elements Attachment 2 Sample Sanitation Report Attachment 3 Sample Reporting of Equipment Calibration Results Attachment 4 Sample KC-366, Shipping Information Log

Attachment 5 Sample FGIS Form 952 Attachment 6 Sample Personnel Resume Format Attachment 7 Customer Satisfaction Survey Attachment 8 Sample Quality System Plan (QSP) Attachment 9 Sample Contractor’s Closing Statement Form Attachment 10 Reference Notes

Part IV—Representations and Instructions Section K Representations, certifications, and other statements of offerors or respondents Section L Instructions, Conditions, and Notices to Offerors or Respondents

L.1 Pre-Proposal Information L.2 Submission of Proposals L.3 52.215-1 Instructions to Offerors—Competitive Acquisition (Jan 2004) L.4 Proposal Preparation Instructions L.5 Other Solicitation Provisions L.6 Debriefing of offerors Exhibit 1 – Price Proposal

Section M Evaluation factors for award

Deborah.martinek@kcc.usda.gov

5 p.m.

03/30/2011

Solicitation No. AG‐INTP‐S‐11‐9984 Section A Page 4 of 141

Part I—The Schedule Section A Solicitation/Contract Form

A.1 SF-33

Solicitation No. AG-INTP-S-11-9984 Section A Page 5 of 141

Section A – Solicitation/Contract Form (ADVISORY)

A.2 Advisory Regarding Submission of Proposals

1. Proposals In order to comply with the provisions of the solicitation, your proposal shall include a technical proposal and a price proposal. See Section L, paragraphs L.3 and L.4.

2. Mistake in Proposal

Have you reviewed the technical proposal and price proposal for possible errors?

3. Amendments

Have you acknowledged receipt of all amendments? If in doubt, please contact the person listed in Section 10 of Form SF-33 or access the solicitation on the FedBizOpps website at www.fbo.gov.

4. Sealed Proposals

Sealed envelopes containing proposals shall be marked to show the offeror’s name and address, the solicitation number, amendments received and acknowledged, and the date and time proposal are due.

5. Amended Proposal Pages

If any of the amendments include amended proposal pages, the amended proposal pages shall be used in submitting your proposal.

6. Section K, Representations and Certifications

Section K must be submitted with your proposal.

7. Delivery of Proposals

If submitting proposals using express mail, address them to Attn: AG-INTP-S-11-9984 USDA-Farm Service Agency Beacon Facility- Mail Stop 8738 9240 Troost Ave Kansas City, MO 64131-3005

8. Importance of Sections L and M

Offerors should carefully read Sections L and Section M of this solicitation for information on submission requirements and evaluation of proposals.

9. Late Proposals

Late proposals shall be handled in accordance with solicitation provision 52.215-1 (see Section L.3).

10. Offerors are advised that the following numbering system is used for solicitation provisions and contract clauses. (The numbering system identifies the source of the contract term.)

52.201-1 “52” refers to Part 52 of the Federal Acquisition Regulation (FAR) (The FAR is Chapter 1 of Title 48 of the Code of Federal Regulations; or 48 C.F.R. 1)

452.201-71 “452” refers to the USDA supplement to the FAR—the Agriculture Acquisition Regulation (AGAR) (The AGAR is Chapter 4 of Title 48 of the Code of Federal Regulations; or 48 C.F.R. 4)

4K52.201-71 “4K52” refers to USDA contracting activity specific clauses; the suffix “K” within “4K52” indicates the term is specific to USDA’s Farm Service Agency commodity procurements.

11. Offerors are advised that the Government reserves the right to accept and incorporate into any resulting contract all or any portion of the offeror’s proposal submitted under the solicitation (see Section C).

http://www.fbo.gov/�

Solicitation No. AG-INTP-S-11-9984 Section A Page 6 of 141

12. Offerors are advised that, as part of its technical proposal, they are required to submit a Product Demonstration Model for each CLIN offered (see Section L).

Solicitation No. AG-INTP-S-11-9984 Section B Page 7 of 141

Section B Supplies or services and prices/costs

B.1 Supplies

The USDA, Farm Service Agency, Kansas City Commodity Office (KCCO) procures subsistence commodities on behalf of the USDA, Foreign Agricultural Service (FAS) and the U.S. Agency for International Development (USAID) for international food assistance programs. The amount and frequency of commodity procured is dependent upon the needs of the program administering agencies, FAS and USAID. Offerors shall demonstrate ability to supply a quality product that meets specifications by the required delivery date.

The Government intends to award a contract to the offeror which demonstrates the best value to the

Government. Trade-off procedures will be utilized, if it is determined to be in the best interest to the Government to award to other than the lowest price offeror or other than the highest technically rated offeror.

The Government reserves the right to award without discussions.

These food products must be safe for human consumption, good-tasting, wholesome, and meet the quality requirements as specified in this solicitation and related contract documents. The types and pack sizes anticipated to be purchased are listed below.

CLIN* Commodity Unit Size Minimum

Contract Amount Maximum

Contract Amount**

0001 Ready-To-Eat Paste (A-20) 50 gram pouch 2 million units 50 million units

0002 Ready-To-Eat Rice Bar (A-28) 55.5 gram bar 1.8 million units 27 million units

0003 Ready-To-Eat Wheat Bar (A-29) 55.5 gram bar 1.8 million units 27 million units

*Contract Line Item Number **The maximum contract amounts stated above are not guaranteed to be purchased. Please see the contract clause at Section I, paragraph I.16.3, 52.216-22, Indefinite Quantity.

B.2 Incidental deliverables

B.2.1 Reporting on Production

The Contractor shall provide the Government a weekly production report. The report should denote delivery order number; quantity ordered; quantity manufactured; and, for any outstanding production, the updated completion date for the remaining quantity. The Government reserves the right to increase the frequency of the production reporting, if key thresholds specified in the Quality Control Plan develop a trend for non-conformance with the finished product specification. (See Section J, Attachment 1, Sample Production Report.)

B.2.2 Reporting on Sanitation

The Contractor shall apply Good Manufacturing Practice in Manufacturing, Packaging, or Holding Human Food (see 21 CFR 110). The Contractor shall provide a copy of the sanitation reports according to the schedule outlined in its Quality Control Plan. (See Section J, Attachment 2, Sample Sanitation Report.)

B.2.3 Reporting of Equipment Calibration Results

The Contractor shall provide copies of documentation maintained in accordance with their written procedures on equipment calibration in order to comply with Code of Federal Regulations (CFR), Title 21, Subpart 111.2—regarding calibrating, inspecting, and checking automated, mechanical, and electronic equipment and instruments; and the maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.

Solicitation No. AG-INTP-S-11-9984 Section B Page 8 of 141

A summary sheet (see Section J, Attachment 3, Sample Reporting of Equipment Calibration Results.)

shall be provided for all calibration reports submitted to indicate if results were a) within manufacturer or industry standards, or b) failed to meet manufacturer or industry standards for the testing methodology. In the case of the latter, the Contractor shall also attach written explanation of the corrective actions taken. If the calibration results cause contractor’s previous product test results to be questioned, the Contractor shall provide complete information about production lots, delivery locations and any other relevant information.

The Reporting of equipment calibration results shall be provided: (1) Before first use of equipment requiring calibration; and (2) At the frequency specified in writing by the manufacturer of the instrument and control; or (3) At routine intervals or as otherwise necessary to ensure the accuracy and precision of the instrument and control. However, the Government reserves the right to increase the frequency of report submission.

B.2.4 Reporting on Shipments

The Contractor shall provide the Government a KC-366, Shipment Information Log, for each Notice to Deliver (N/D), and annotate in Part 1 of the form when the shipment is complete. For complete details on reporting on shipments see the clause at Section F, paragraph F.6, 4K52.216-4, Shipment and Delivery.

A sample KC-366 is included in Section J, Attachment 4, of this solicitation.

A fillable version can be downloaded at http://www.fsa.usda.gov/Internet/FSA_File/kc366.pdf .

B.2.5 Quality System Plan

Quality System Plans submitted as part of the proposal shall become part of the contract. Contractors will be required to submit periodic reports, at least semi-annually, on their processes, procedures, and operations to stay in conformance with their Quality System Plan. The Government reserves the right to increase the frequency of such reporting based on Government’s evaluation of Contractor’s past performance with regard to quality on delivery orders. The Government further reserves the right to conduct periodic audits of the Contractor to determine if they are in compliance with the Quality System Plan and the terms of the contract.

B.2.6 Resumes for Key Personnel

In the event Contractor requests substitution of key personnel, identified in Contractor’s proposal, and pursuant to paragraph H.1, Contractor shall submit resumes of proposed substitutes. See Section J, Attachment 6, for a sample resume format.

B.2.7 Supporting Documentation for Invoices

Contractors shall submit with their invoices for payment the USDA- Agricultural Marketing Service - Dairy Programs- Dairy Grading Branch certificates, as stipulated in Section E.2, covering the dairy components of the production lots for which invoices are submitted.

Contractors shall submit with their invoices for payment the Certificates of Analysis (COA) and Certificates of Conformance (COC), as stipulated in Section E.2.

http://www.fsa.usda.gov/Internet/FSA_File/kc366.pdf� http://www.fsa.usda.gov/Internet/FSA_File/kc366.pdf�

Solicitation No. AG-INTP-S-11-9984 Section C Page 9 of 141

Section C Description/specifications/statement of work

The USDA intends to acquire noncommercial, emergency food products (EFP) for use in international food aid programs administered by USDA, Foreign Agricultural Service (FAS) and the U.S. Agency for International Development (USAID), through award of indefinite-delivery, indefinite-quantity, fixed-price contracts with one (twelve month) base year and up to two option years. The products include Ready-To-Eat Meal Replacement:

Paste (A-20), Rice Bar (A-28), Wheat Bar (A-29) and will be delivered by the commodity supplier to the locations identified in Section F.

The Government reserves the right to accept and incorporate into any resulting contract all or any portion of the offeror’s proposal submitted under the solicitation. The expectation of the Government is that contractors shall, in performance of this contract, not only provide supplies that conform to the product specifications, but, shall also execute, for example, its management approach, quality control (including quality system plan), and technical approach in conformance with their proposals. Contractors that fail to perform as stipulated in their proposals shall be in default of the contract and subject to the Default clause of the contract (see I.49.2, 52.249- 8, Default (Fixed-Price Supply and Service)).

C.1 452.211-72 Statement Of Work/Specifications (Feb 1988)

The Contractor shall furnish the necessary personnel, material, equipment, services and facilities (except as otherwise specified), to meet the requirements of the Statement of Work/Specifications referenced in C.1.1.

(End of Clause)

C.1.1 Non-commercial Formulations of Emergency Food Products (EFP)

The Contractor shall produce product formulations specified by the Government. This includes conformance with the special contract requirements in Section H, which requires that 100 percent of agricultural products, including all ingredients, be of U.S. origin (unless waived). The product formulations of this Statement of Work/Specifications begin on the next page and are organized as follows:

C.1.1.1 Ready-to-Eat Paste (A-20) Commodity Requirements C.1.1.2 Ready-to-Eat Rice Bar (A-28) Commodity Requirements C.1.1.3 Ready-to-Eat Wheat Bar (A-29) Commodity Requirements

Note: Section C continues with subparagraph C.1.2.

Solicitation No. AG-INTP-S-11-9984 Section C Page 10 of 141

C.1.1.1 Ready-to-Eat Paste (A-20) Commodity Requirements

A. Quality of A-20 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 allergen other than the ingredients in the specified product formulation shall be used in the manufacture of these products. The A-20 paste is expected to be used for a period of three to seven days, with a maximum usage of 15 days.

B. Dairy Ingredients The nonfat dry milk shall meet the Standard of Identity for Nonfat Dry Milk (21 CFR § 131.125), and the U.S. Standard for Extra Grade as defined in the United States Standards for Grades of Nonfat Dry Milk (Spray Process) and shall be no more than 9 months old. The dry whey shall meet the U.S. Standard for Extra Grade as defined in the United States Standards for Dry Whey and shall be no more than 9 months old.

All dairy ingredients utilized in the A-20 paste must be certified by the dairy ingredient manufacturer that the dairy ingredients provided are melamine and Enterobacter sakazakii free and a Certificate of Conformance (COC) must be provided by the subcontractor to the prime contractor.

C. Formulation The A-20 paste formula shall have a protein content of not more than 11.0 percent or less than 9.0 percent of kilocalories and a protein digestibility corrected amino acid score (PDCAAS) of 1.0. The A-20 paste shall contain less than 0.5 g of trans fat per serving, have approximately 10.0 percent kilocalories from saturated fat; have 7.0 to 10.0 percent kilocalories from polyunsaturated fatty acids (PUFA) vegetable oils; and the vegetable oil ratio of linoleic acid to α-linolenic acid should be between 5:1 to 10:1. The A-20 paste shall contain nonfat dry milk powder, whey protein concentrate (80.0 percent protein), isolated pea protein (82.0 percent protein), cream powder (76.0 percent fat), soybean oil, maltodextrin, confectionary sugar (6x’s or 10x’s), salt, lecithin (liquid), vitamin and mineral pre-mix, natural and/or artificial colors, and antioxidants (ascorbyl Palmitate, BHA, and mixed tocopherols). The A-20 paste may contain natural flavors.

D. Fortification

The A-20 paste shall be fortified with a vitamin and mineral premix, meeting requirements listed below.

The vitamins and minerals used in the premix shall be USP-FCC compliant, unless otherwise specified and specific vitamins shall be encapsulated to provide the required product shelf life and to avoid objectionable odors and flavors. The manufacturer will provide a Certificate of Conformance (COC) stating that the vitamin and mineral premix meets the requirement listed below.

Nutrient requirements per serving 50 g – A-20 Paste

Encapsulated vitamin A (as Palmitate) 126.67µg RAE Vitamin D3 (as Cholecalciferol) 1.11 µg.

Vitamin E (as acetate, USP) 3.33 I.U.

Vitamin K1 (as Phytonadione, FCC) 0.011 mg Encapsulated vitamin C (as Ascorbic Acid) 24.44 mg Encapsulated vitamin B1 (as Thiamin Mononitrate) 0.20 mg Vitamin B2 (as Riboflavin) 0.20 mg Niacin (as Niacinamide) 1.33 mg Vitamin B6 (as Pyridoxine HCl) 0.22 mg Folic Acid 0.044 mg Vitamin B12 (as Cyanocobalamin, USP) 2.78 µg Biotin (FCC) 5.56 µg Pantothenic Acid (D-Calcium Pantothenate, USP) 0.78 mg Calcium (as Tricalcium Phosphate, FCC) 66.67 mg Phosphorus (as Dipotassium Phosphate, FCC and as Tricalcium Phosphate, FCC) 111.11 mg

Magnesium (as Magnesium Oxide, USP) 22.2 mg Zinc (as Zinc Oxide, USP) 2.44 mg Copper (as Cupric Oxide) 0.10 mg Manganese (as Manganese Sulfate) 0.056 mg

Solicitation No. AG-INTP-S-11-9984 Section C Page 11 of 141

Selenium (as Sodium Selenate) 4.44 µg Chromium (as Chromium Chloride (6 H2O), USP) 2.78 µg Iodine (as Potassium Iodide) 0.011 mg Iron 2.0 mg 1/ Potassium (as Dipotassium Phosphate, FCC) 205.44 mg

1/ Iron for A-20 Paste shall be as ferrous fumarate.

E. Analytical and microbiological requirements shall be as follows:

Requirement Tolerance Water activity (aw) Less than 0.60 PUFA 7.0 to 10.0 percent of kilocalories Saturated Fat 10.0 percent of kilocalories Protein 9.0 to 11.0 percent of kilocalories Standard plate count Not more than 10,000 per g Coliform Less than 10 Colony Forming Units (CFU per g or less than 3 MPN (Most Probable Number) per g 2/ Yeast and Mold Not more than 100 per g Salmonella Negative E. coli Less than 10 CFU per g or less than 3 MPN per g 2/ Listeria monocytogenes Negative Staph. Aureus Negative Vitamin A Not more than 125.0 percent and not less than 75.0 percent as stated on label Vitamin B1 Not more than 125.0 percent and not less than 75.0 percent as stated on label Vitamin C Not more than 125.0 percent and not less than 75.0 percent as stated on label Iron Not more than stated on label

2/ Findings indicate zero colonies (CFU) per plate or zero tubes producing gas for MPN.

F. Processing The A-20 paste must be processed in accordance with FDA Current Good Manufacturing Practices (21 CFR Part 110), HACCP (Hazard Analysis of Critical Control Points), ISO (International Organization for Standardization), or other standards that assure the quality of the product. The dry ingredients shall be Food Chemicals Codex (FCC) purity or U.S. Pharmacopeia (USP) – National Formulary quality, as appropriate, and free from foreign materials. All additives shall not exceed levels allowable by the Codex Alimentarius.

G. Shelf Life A-20 paste shall not be more than 45 days old on the date of shipment and shall have a shelf life of at least 24 months at 26.7°C (80°F). The Contractor shall provide a certificate of conformance that the product has a 2 year shelf life when stored at 26.7°C (80°F).

H. Foreign Material

The A-20 paste shall be clean, sound, wholesome, and free from evidence of rodent or insect infestation.

I. Appearance and texture The A-20 paste shall have a smooth homogeneous finish and shall be lump free, the oil shall not separate and shall be free of a gritty, grainy, and sandy texture.

J. Flavor and odor The A-20 paste shall have a pleasing sweet, clean dairy flavor and odor. The A-20 paste shall be free from foreign odors and flavors such as, but not limited to burnt, scorched, rancid, malted, sour, or stale.

K. Color.

The A-20 paste shall have an off white to tan color. The A-20 paste shall not have a dull, grey tinge, or other abnormal cast. The A-20 paste shall show no evidence of excessive heating (materially darkened or scorched).

Solicitation No. AG-INTP-S-11-9984 Section C Page 12 of 141

C.1.1.2 Ready-to-Eat Rice Bar (A-28) Commodity Requirements

A. Quality of A-28 The A-28 rice bar shall be suitable for use by the Federal Government as meal replacements 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 allergen other than the ingredients in the specified product formulation shall be used in the manufacture of these products. 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.

B. Ingredients A-28 Rice Bar Pre-Cooked Cereal Mix (Component of D below) The A-28 rice bars are compressed bars, manufactured from a pre-cooked cereal mix, and rice-based. 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), sugar, isolated pea protein (82.0 percent protein), soybean oil, soy lecithin, and salt. 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.

C. Dairy Ingredients The nonfat dry milk shall meet the Standard of Identity for Nonfat Dry Milk (21 CFR § 131.125), and the U.S. Standard for Extra Grade as defined in the United States Standards for Grades of Nonfat Dry Milk (Spray Process) and shall be no more than 9 months old. The dry whey shall meet the U.S. Standard for Extra Grade as defined in the United States Standards for Dry Whey and shall be no more than 9 months old.

All dairy ingredients utilized in the A-28 rice bar must be certified by the dairy ingredient manufacturer that the dairy ingredients provided are melamine and Enterobacter sakazakii free and a Certificate of

D. Formulation The A-28 rice bar formula shall have a protein content of not more than 11.0 percent or less than 9.0 percent of kilocalories and a protein digestibility corrected amino acid score (PDCAAS) of 1.0. The A-28 rice rice bar shall have approximately 10.0 percent kilocalories from saturated fat; have 7.0 to 10.0 percent kilocalories from PUFA vegetable oils; and the vegetable oil ratio of linoleic acid to α-linolenic acid should be between 5:1 to 10:1. The A-28 rice bar shall contain the rice-based cereal pre-cooked cereal mix, vitamin and mineral pre-mix, cream powder (76.0 percent fat), rice syrup, partially hydrogenated soybean oil, canola oil, maltodextrin, confectionary sugar (6x’s), salt, soy lecithin (liquid), and antioxidants (ascorbyl Palmitate, BHA, and mixed tocopherols).

E. Fortification

The A-28 rice bar shall be fortified with a vitamin and mineral premix, meeting requirements listed below.

The vitamins and minerals used in the premix shall be USP-FCC compliant, unless otherwise specified and specific vitamins shall be encapsulated to provide the required product shelf life and to avoid objectionable odors and flavors. The manufacturer will provide a Certificate of Conformance (COC) stating that the

Nutrient requirements per serving 55.5 g - Bar

Encapsulated vitamin A (as Palmitate) 116.55 µg RAE Vitamin D3 (as Cholecalciferol) 1.11 µg.

Vitamin E (as acetate, USP) 3.33 I.U.

Vitamin K1 (as Phytonadione, FCC) 0.011 mg Encapsulated vitamin C (as Ascorbic Acid) 31.10 mg Encapsulated vitamin B1 (as Thiamin Mononitrate) 0.19 mg Vitamin B2 (as Riboflavin) 0.20 mg Niacin (as Niacinamide) 1.33 mg Vitamin B6 (as Pyridoxine HCl) 0.22 mg Folic Acid 0.044 mg Vitamin B12 (as Cyanocobalamin, USP) 2.78 µg Biotin (FCC) 5.56 µg

Solicitation No. AG-INTP-S-11-9984 Section C Page 13 of 141

Pantothenic Acid (D-Calcium Pantothenate, USP) 0.78 mg Calcium (as Tricalcium Phosphate, FCC) 66.67 mg Phosphorus (as Dipotassium Phosphate, FCC and as Tricalcium Phosphate, FCC)

111.11 mg

Magnesium (as Magnesium Oxide, USP) 22.2 mg Zinc (as Zinc Oxide, USP) 2.06 mg Copper (as Cupric Oxide) 0.10 mg Manganese (as Manganese Sulfate) 0.056 mg Selenium (as Sodium Selenate) 4.44 µg Chromium (as Chromium Chloride (6 H2O), USP) 2.78 µg Iodine (as Potassium Iodide) 0.011 mg Iron 1.89 mg 3/ Potassium (as Dipotassium Phosphate, FCC) 204.44 mg

3/ Iron for Bars shall be as ferrous EDTA.

F. Analytical and microbiological requirements shall be as follows:

Moisture Less than 9.5 percent for A-28 Rice Bars Water activity (aw) Less than 0.60 PUFA 7.0 to 10.0 percent of kilocalories Saturated Fat 10.0 percent of kilocalories Protein 9.0 to 11.0 percent of kilocalories Standard plate count Not more than 10,000 per g Coliform Less than 10 Colony Forming Units (CFU per g or less than 3 MPN (Most Probable Number) per g 4/ Yeast and Mold Not more than 100 per g Salmonella Negative E. coli Less than 10 CFU per g or less than 3 MPN per g 4/ Listeria monocytogenes Negative Staph. Aureus Negative Vitamin A Not more than 125.0 percent and not less than 75.0 percent as stated on label Vitamin B1 Not more than 125.0 percent and not less than 75.0 percent as stated on label Vitamin C Not more than 125.0 percent and not less than 75.0 percent as stated on label

4/ Findings indicate zero colonies (CFU) per plate or zero tubes producing gas for MPN.

G. Processing

The A-28 rice bar must be processed in accordance with FDA Current Good Manufacturing Practices (21 CFR Part 110), HACCP (Hazard Analysis of Critical Control Points), ISO (International Organization for Standardization), or other standards that assure the quality of the product. The dry ingredients shall be Food Chemicals Codex (FCC) purity or U.S. Pharmacopeia (USP) – National Formulary quality, as appropriate, and free from foreign materials. All additives shall not exceed levels allowable by the Codex Alimentarius.

H. Shelf Life A-28 rice bar shall not be more than 45 days old on the date of shipment and shall have a shelf life of at least 24 months at 26.7°C (80°F). The Contractor shall provide a certificate of conformance that the product has a 2 year shelf life when stored at 26.7°C (80°F).

I. Foreign Material The A-28 rice bars shall be free from evidence of rodent or insect infestation.

J. Appearance and texture The A-28 rice bars shall be compressed into a rectangular shape 63.5 mm long by 44.4 mm wide by 14.7 to

Solicitation No. AG-INTP-S-11-9984 Section C Page 14 of 141

16.0 mm thick. The A-28 rice bars shall have a smooth exterior, easily crumble with gentle finger pressure, and the interior particle size is uniform. The texture is to be firm enough to easily be unwrapped by the consumer without breaking into pieces but soft enough to be bitten into and chewed. The texture should be soft enough to be easily crumbled by hand into a container so that it can be mixed with water to form porridge. Odor will be of a grain (rice) with no scorched dairy notes. The appearance of the bar shall be a uniform, medium to dark tan color with the absence of dark spots (which are an indication of inadequate mixing).

K. Flavor and odor The A-28 rice bars shall have a slightly sweet grain odor (appropriate for the style of bar) with a blended cereal flavor of the pre-cooked cereal mix. The A-28 rice bars shall not possess distinct flavor notes attributable to the protein sources or the vitamins and minerals. The A-28 rice bars shall not contain any artificial flavoring.

L. Color The A-28 rice bars shall have a light to medium tan color. The A-28 rice bars shall show no evidence of excessive heating (materially darkened or scorched).

Solicitation No. AG-INTP-S-11-9984 Section C Page 15 of 141

C.1.1.3 Ready-to-Eat Wheat Bar (A-29) Commodity Requirements

A. Quality of A-29 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 allergen other than the ingredients in the specified product formulation shall be used in the manufacture of these products. 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.

B. Ingredients A-29 Wheat Bar Pre-Cooked Cereal Mix (Component of D below) The A-29 wheat bars are compressed bars, manufactured from a pre-cooked cereal mix, and wheat-based.

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), sugar, isolated pea protein (82.0 percent protein), soybean oil, soy lecithin, and salt. 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.

C. Dairy Ingredients The nonfat dry milk shall meet the Standard of Identity for Nonfat Dry Milk (21 CFR § 131.125), and the U.S. Standard for Extra Grade as defined in the United States Standards for Grades of Nonfat Dry Milk (Spray Process) and shall be no more than 9 months old. The dry whey shall meet the U.S. Standard for Extra Grade as defined in the United States Standards for Dry Whey and shall be no more than 9 months old.

All dairy ingredients utilized in the A-29 wheat bar must be certified by the dairy ingredient manufacturer that the dairy ingredients provided are melamine and Enterobacter sakazakii free and a Certificate of

D. Formulation The A-29 wheat bar formula shall have a protein content of not more than 11.0 percent or less than 9.0 percent of kilocalories and a protein digestibility corrected amino acid score (PDCAAS) of 1.0. The A-29 wheat bar shall have approximately 10.0 percent kilocalories from saturated fat; have 7.0 to 10.0 percent kilocalories from PUFA vegetable oils; and the vegetable oil ratio of linoleic acid to α-linolenic acid should be between 5:1 to 10:1. The A-29 wheat bar shall contain the wheat-based cereal pre-cooked cereal mix, vitamin and mineral pre-mix, cream powder (76.0 percent fat), rice syrup, partially hydrogenated soybean oil, canola oil, maltodextrin, confectionary sugar (6x’s), salt, soy lecithin (liquid), and antioxidants (ascorbyl Palmitate, BHA, and mixed tocopherols).

E. Fortification

The A-29 wheat bar shall be fortified with a vitamin and mineral premix, meeting requirements listed below.

The vitamins and minerals used in the premix shall be USP-FCC compliant, unless otherwise specified and specific vitamins shall be encapsulated to provide the required product shelf life and to avoid objectionable odors and flavors. The manufacturer will provide a Certificate of Conformance (COC) stating that the

Nutrient requirements per serving 55.5 g - Bar

Encapsulated vitamin A (as Palmitate) 116.55 µg RAE Vitamin D3 (as Cholecalciferol) 1.11 µg.

Vitamin E (as acetate, USP) 3.33 I.U.

Vitamin K1 (as Phytonadione, FCC) 0.011 mg Encapsulated vitamin C (as Ascorbic Acid) 31.10 mg Encapsulated vitamin B1 (as Thiamin Mononitrate) 0.19 mg Vitamin B2 (as Riboflavin) 0.20 mg Niacin (as Niacinamide) 1.33 mg Vitamin B6 (as Pyridoxine HCl) 0.22 mg Folic Acid 0.044 mg Vitamin B12 (as Cyanocobalamin, USP) 2.78 µg Biotin (FCC) 5.56 µg

Solicitation No. AG-INTP-S-11-9984 Section C Page 16 of 141

Pantothenic Acid (D-Calcium Pantothenate, USP) 0.78 mg Calcium (as Tricalcium Phosphate, FCC) 66.67 mg Phosphorus (as Dipotassium Phosphate, FCC and as Tricalcium Phosphate, FCC)

111.11 mg

Magnesium (as Magnesium Oxide, USP) 22.2 mg Zinc (as Zinc Oxide, USP) 2.06 mg Copper (as Cupric Oxide) 0.10 mg Manganese (as Manganese Sulfate) 0.056 mg Selenium (as Sodium Selenate) 4.44 µg Chromium (as Chromium Chloride (6 H2O), USP) 2.78 µg Iodine (as Potassium Iodide) 0.011 mg Iron 1.89 mg 5/ Potassium (as Dipotassium Phosphate, FCC) 204.44 mg

5/ Iron for Bars shall be as ferrous EDTA.

F. Analytical and microbiological requirements shall be as follows:

Moisture Less than 9.5 percent for A-29 Wheat Bars Water activity (aw) Less than 0.60 PUFA 7.0 to 10.0 percent of kilocalories Saturated Fat 10.0 percent of kilocalories Protein 9.0 to 11.0 percent of kilocalories Standard plate count Not more than 10,000 per g Coliform Less than 10 Colony Forming Units (CFU per g or less than 3 MPN (Most Probable Number) per g 6/ Yeast and Mold Not more than 100 per g Salmonella Negative E. coli Less than 10 CFU per g or less than 3 MPN per g 6/ Listeria monocytogenes Negative Staph. Aureus Negative Vitamin A Not more than 125.0 percent and not less than 75.0 percent as stated on label Vitamin B1 Not more than 125.0 percent and not less than 75.0 percent as stated on label Vitamin C Not more than 125.0 percent and not less than 75.0 percent as stated on label

6/ Findings indicate zero colonies (CFU) per plate or zero tubes producing gas for MPN.

G. Processing

The A-29 wheat bar must be processed in accordance with FDA Current Good Manufacturing Practices (21 CFR Part 110), HACCP (Hazard Analysis of Critical Control Points), ISO (International Organization for Standardization), or other standards that assure the quality of the product. The dry ingredients shall be Food Chemicals Codex (FCC) purity or U.S. Pharmacopeia (USP) – National Formulary quality, as appropriate, and free from foreign materials. All additives shall not exceed levels allowable by the Codex Alimentarius.

H. Shelf Life A-29 wheat bars shall not be more than 45 days old on the date of shipment and shall have a shelf life of at least 24 months at 26.7°C (80°F). The Contractor shall provide a certificate of conformance that the product has a 2 year shelf life when stored at 26.7°C (80°F).

I. Foreign Material The A-29 wheat bars shall be free from evidence of rodent or insect infestation.

J. Appearance and texture The A-29 wheat bars shall be compressed into a rectangular shape 63.5 mm long by 44.4 mm wide by 14.7

Solicitation No. AG-INTP-S-11-9984 Section C Page 17 of 141 to 16.0 mm thick. The A-29 wheat bars shall have a smooth exterior, easily crumble with gentle finger pressure, and the interior particle size is uniform. The texture is to be firm enough to easily be unwrapped by the consumer without breaking into pieces but soft enough to be bitten into and chewed. The texture should be soft enough to be easily crumbled by hand into a container so that it can be mixed with water to form porridge. Odor will be of a grain (wheat) with no scorched dairy notes. Appearance of bar shall be a uniform, medium to dark tan color with the absence of dark spots (which are an indication of inadequate mixing.

K. Flavor and odor The A-29 wheat bars shall have a slightly sweet grain odor (appropriate for the style of bar) with a blended cereal flavor of the pre-cooked cereal mix. The A-29 wheat bars shall not possess distinct flavor notes attributable to the protein sources or the vitamins and minerals. The A-29 wheat bars shall not contain any artificial flavoring.

L. Color The A-29 wheat bars shall have a medium tan to dark tan color. The A-29 wheat bars shall show no evidence of excessive heating (materially darkened or scorched).

Solicitation No. AG-INTP-S-11-9984 Section C Page 18 of 141

C.1.2 Quality System Plan (QSP) The contractor shall have in place a quality system plan appropriate for the manufacture and sale of food for human consumption. The QSP format shall be a standard report format with title page, table of contents, material and appendices.

C.1.3 Finished Product Packaging and Quality Control

The Contractor shall package the finished product formulations as required by the Government. The packaging and marking specifications of this Statement of Work/Specifications are contained in Section D.

C.1.4 Finished Product Handling and Warehousing and Quality Control

The Contractor shall provide for the handling, warehousing and physical security of the finished product formulation(s) to maintain the optimum nutritional characteristics of the finished product.

C.1.5 Reporting, Invoicing, Problem Resolution and Using Government Information Technology Systems

The Contractor shall support administrative activities timely and as required by the Government. See Sections E, F and G for additional resource requirements. The Contractor shall use Government information technology systems to facilitate contract administration.

C.2 Objectives

Agricultural commodities, and the products of agricultural commodities, to be purchased through contracts awarded under this solicitation will be donated by the Government on behalf of the people of the United States under the following programs to meet the goals cited below:

FAS Programs

• The McGovern-Dole Program Food for Education and Child Nutrition Program supports school feeding and maternal and child nutrition projects in low-income, food-deficit countries that are committed to universal education in order to reduce the incidence of hunger, and improve food security.

• The Food for Progress Program supplies agricultural commodities for direct distribution to aid recipients or for monetization programs (where the local sale of commodities is used to generate revenue in support of agricultural, economic, or infrastructure development programs) in developing countries and emerging democracies committed to introducing and expanding free enterprise in the agricultural sector.

• Section 416(b) which allows for the donation of surplus commodities acquired through price support operations, to private welfare organizations for the assistance of needy persons outside of the United States.

U.S. AID Programs

• The Food for Peace Program, also known as P.L. 480, Title II, established to:

1. Address famine and food crises, and respond to emergency food needs, arising from man-made and natural disasters;

2. Combat malnutrition, especially in children and mothers;

3. Carry out activities that attempt to alleviate the causes of hunger, mortality and morbidity;

4. Promote economic and community development;

5. Promote food security and support sound environmental practices;

6. Carry out feeding programs; and,

7. Promote economic and nutritional security by increasing educational, training, and other productive activities

• The Bill Emerson Humanitarian Trust (BEHT), a reserve of commodities and cash for use in the Food for

Peace programs to meet food aid needs.

C.3 4K52.211-1 Regulatory Requirements for Commodities and their Manufacture The commodity shall conform to the applicable provisions of the "Federal Food, Drug, and Cosmetic Act" (21 U.S.C. 301 et. seq.), as amended, and the relevant regulations. The contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations related to its performance under this contract.

Solicitation No. AG-INTP-S-11-9984 Section D Page 19 of 141

Section D Packaging and Marking Requirements

D.1 Background The USDA intends to acquire noncommercial, emergency food products for use in international food aid programs administered by USDA, Foreign Agricultural Service (FAS) and the U.S. Agency for International Development (USAID), through award of indefinite-delivery, indefinite-quantity, fixed-price contracts with one (twelve month) base year and up to two option years. The products include Ready-To-Eat Meal Replacement:

Paste (A-20), Rice Bar (A-28), Wheat Bar (A-29) and will be delivered by the commodity supplier to the locations identified in Section F.

D.2 4K52.211-2 Regulatory Requirements for Packaging

(a) All containers and packaging materials shall be constructed to meet the requirements of the Food and Drug Administration for safe contact with the packaged product.

(b) In addition, all containers and packaging materials shall be constructed to comply with the sum concentration levels of lead, cadmium, mercury, and hexavalent chromium addressed by the Coalition of Northeast Governors (CONEG) model legislation. The sum of the concentration levels of lead, cadmium, mercury, and/or hexavalent chromium present in any package or packaging component shall not exceed 100 parts per million. Concentration levels shall be determined using American Standard of Testing Materials test methods, as revised, or U.S.

Environmental Protection Agency test methods for evaluating solid waste, S-W 846, as revised.

(End of clause)

D.3 452.247-73 Packing For Overseas Shipment (Feb 1988) Supplies shall be packed for overseas shipment in accordance with the best commercial export practice suitable for water movement to arrive undamaged at ultimate destination.

(End of Clause)

D.4 Packaging and Marking Requirements

All container and packaging markings shall be compliant with the Fair Packaging and Labeling Act.

Compliant labeling requirements are included in the packaging and marking requirements that follow. These requirements are organized as follows:

D.4.1.1 Ready-to-Eat Paste (A-20) Packaging and Marking Requirements D.4.1.2 Ready-to-Eat Rice Bar (A-28) Packaging and Marking Requirements D.4.1.3 Ready-to-Eat Wheat Bar (A-29) Packaging and Marking Requirements

Solicitation No. AG-INTP-S-11-9984 Section D Page 20 of 141

D.4.1.1 Ready-to-Eat Paste (A-20) Packaging and Marking Specifications

1. Containers and Materials A. All containers and packaging shall be constructed to meet the requirements of the Food and Drug

Administration (FDA) for safe contact with the packaged product. The contractor shall obtain and maintain documentation from the container or packaging material manufacturer to verify that the containers and packaging materials used in this contract were in compliance with the Government’s regulatory requirements for safe contact with food products as required in the clause at Section D, paragraph D.2, 4K52.211-2, Regulatory Requirements for Packaging.

B. Questions concerning the containers and materials should be directed to:

USDA/FSA/DACO

Room 5754–S, Stop 0551 1400 Independence Avenue, SW Washington, DC 20250-0551 ATTN: Packaging

C. If the contractor purchases packaging and container ingredients from a foreign country and/or the package and container is manufactured in a foreign country, the package and container SHALL NOT display country of origin labeling. Phrases similar to but not inclusive of, “Made in [Name of Foreign Country.]” or “Product of [Name of Foreign Country.]” are strictly prohibited.

D. Containers with Incorrect Markings The appearance of containers in commercial or other channels either filled or unfilled bearing markings identifying the containers as part of a Government contract may cause the Government expense in determining whether commodities have been diverted from authorized use and in answering inquiries. The contractor shall take all necessary action to prevent the appearance in commercial or other channels of containers and container materials bearing any markings required under a Government contract, including those held by the contractor or others; e.g., overruns, misprints, etc. The contractor shall ensure that any container from a Government contract that appears in commercial or other channels shall have all markings required under this contract permanently obliterated.

2. A-20 Paste Primary Packaging (Pouch) Requirements A. The flat pouch for A-20 paste shall be a heat sealed tri-laminate pouch with interior dimensions of 50.8 mm wide by 152.4 mm long + 3.2 mm (2 in wide by 6 in + 1/8 long). The pouch shall be either nitrogen flushed or vacuum packed. The pouch material shall be fabricated from a 3-ply laminate consisting from inside to outside of minimum 0.0508 mm (0.002 in) thick polyolefin, extrusion coated or laminated to 0.00889 mm (0.00035 in) thick aluminum foil, laminated to 0.0127 mm (0.0005 in) thick polyester. The three plies shall be laminated so that the aluminum foil is between the other two layers. The pouch color shall be white. The polyolefin layer of pouch material shall be suitably formulated for hot filling or post-fill processing, as applicable. Heat sealed pouches shall be provided with appropriate tear nicks, notches or serrations to facilitate easy opening of the pouch. Closure shall be accomplished with a 9.525 mm + 3.175 mm (3/8 + 1/8 in) wide heat seal. The closure seal shall be free of entrapped matter (for example, product residue) that reduces the effective closure seal to less than 1.5875 mm (1/16 in) wide. Not less than 24 hours after filling and sealing, the pouches shall withstand an internal pressure of 6 pounds per square inch gauge (psig) for 30 seconds without rupture or seal separation greater than 1.5875 mm (1/16 in) or seal separation that reduces the effective closure seal width to less than

1.5875 mm (1/16 in). The filled and sealed pouch shall not leak or show evidence of delamination. The pouch shall show no fold-over wrinkles or aberrations in the pouch material or heat seals. The pouch material shall not transfer any foreign flavor or odor to the product being packaged.

B. Primary packages shall be marked with Production date; Best when Used by Date; Production lot code; and the words "Not To Be Sold or Exchanged". All package marking and labeling should comply with the exhibits in paragraph 5 below.

3. A-20 Paste Secondary Packaging (Pouch) Requirements

Secondary Packaging – Nine pouches of paste shall be packaged in a white click-lock paperboard carton constructed of 26 point (or equivalent) paperboard. Inside dimensions shall be nominally 7 inches in length by 5 inches in width by 2-1/4 inches in depth.

Solicitation No. AG-INTP-S-11-9984 Section D Page 21 of 141

4. A-20 Paste Tertiary Packaging (Pouch) Requirements A. Corrugated Fiberboard Shipping Containers (Shipping Container) – Eighteen (18) secondary cartons of A-20

Paste will be packed in a fiberboard container. The dimensions of the fiberboard container will be based on the size of the secondary containers such that there is no slack space within the container. The shipping containers will be securely closed with hot melt adhesive or transparent tape. Metal staples shall not be used.

B. The shipping container shall comply with the following unitization requirements:

(1) All shipments of packaged products shall be unitized (palletized and stretch wrapped).

(2) Pallets shall be:

a. Constructed to facilitate the safe handling and transportation of the packaged product, as a unit, without loss or damage.

b. 48 X 40 inches, four-way or partial four-way, and reversible or nonreversible flush stringer.

c. Suitable for use in the shipment of food products.

(3) Plastic stretch wrap shall be:

a. Constructed of a plastic film which is to be stretched a minimum of 50 percent beyond its original length when stretched around the pallet load.

b. Applied as tightly as possible around all tiers of the palletized shipping containers. The shipping containers shall be held firmly in place by the stretch wrap.

(4) Pallet loads shall be:

a. Stacked in such a way as to minimize the amount that shipping containers overhang the edges of pallets.

b. Blocked and braced or otherwise loaded into the conveyance in a manner that prevents shifting during transit.

c. Suitable for use in the international shipment of food products.

5. A-20 Paste Marking Requirements Following are the marking exhibits for the A-20 Paste primary, secondary, and tertiary packaging. All packaging shall meet the USAID Branding/Markings requirements described on USAID’s website. Artwork for the marking requirements specified below is available on the United States Agency for International Development’s (USAID) website at: http://www.usaid.gov/our_work/humanitarian_assistance/ffp/frdefp.html.

http://www.usaid.gov/our_work/humanitarian_assistance/ffp/frdefp.html�

Solicita…