STATEMENT_OF_WORK_FINAL.pdf

ATTACHMENT II-STATEMENT OF WORK

STATEMENT OF WORK (SOW)

NIEHS SPECIFICATIONS FOR

OPEN FORMULA RAT AND MOUSE RATION

18% CRUDE PROTEIN AUTOCLAVABLE (NIH-31)

1. SCOPE

1.1 This specification is for an open formula, autoclavable rat and mouse ration containing 18% crude protein and void of any feed additives containing antibiotics or exogenous estrogens and certified limits on chemical and microbial contaminants as listed in section 2.1.4.

1.2 Orders shall be placed according to the requirements of the Government, generally every 4-8 weeks, as needed. Feed is ordered by tractor-trailer load of up to 1600 bags per shipment (80 bags/pallet, 20 pallets/truck load). Each bag contains 25 lbs. of feed. All feed must be milled within 6 weeks of delivery.

2. REQUIREMENTS

2.1 Material: Material shall be as specified herein.

2.1.1 INGREDIENTS: NIH-31 Rodent Diet

Ingredient Percentage by Weight Fishmeal (60% protein) 9.0 Soybean meal (48.5% protein) 5.0 Alfalfa meal (17% protein) 2.0 Corn gluten meal (60% protein) 2.0 Ground whole wheat 35.5 Ground #2 yellow shelled corn 21.0 Ground whole oats 10.0 Wheat middlings 10.0 Brewers dried yeast 1.0 Soy oil 1.5 Salt 0.5 Dicalcium phosphate 1.5 Ground limestone 0.5 Premixes 0.5 Total: 100.00

Mineral Fortification per ton (2,000 lbs) of Finished Product

Mineral Ingredient Amount Source Cobalt 400 mg Cobalt carbonate Copper 4 g Copper sulfate Iron 60 g Iron sulfate Magnesium 400 g Magnesium oxide Manganese 100 g Manganese oxide Zinc 10 g Zinc oxide Iodine 1500 mg Calcium iodate

Vitamin Fortification per ton (2,000 lbs) of Finished Product

Vitamin Ingredient Amount Source Vitamin A 22,000,000 IU Vitamin A Palmitate or Acetate Vitamin D3 3,800,000 IU D activated animal sterol Vitamin B12 40,000 mcg Vitamin K 20 g Menadione Alpha Tocopherol Acetate 15 g Choline 700 g Choline Chloride Folic Acid 1 g Niacin 40 g D-Pantothenic Acid 25 g d-Calcium pantothenate Riboflavin 5 g Thiamine 65 g Thiamine mononitrate Pyridoxine 5 g Pyridoxine hydrochloride Biotin 120 mg d-Biotin

Note: These concentrations of vitamins and minerals shall be added to the ration via two separate (vitamin and mineral) premixes with one of the major ingredients as a carrier. The amount of this ingredient used in the final formulation may be adjusted so that the total amount of ingredients will equal 100%. Vitamin and mineral concentrations in the premixes shall be made so that a minimum of one (1) pound of each premix is required per ton of finished product. In the case of mineral fortification, the actual amount of each element required is specified. Therefore, the contractor shall adjust the amount of each compound used in the premix according to its mineral concentration.

2.1.2 NUTRIENT STANDARDS:

Micro Analysis: The total calculated concentration of nutrients in the ration from ingredients and from the fortifications at the time of manufacture shall be as follows:

Component Requirement Levels Proximate Composition (% by wt.):

Crude Protein (Minimum) 18.0 Crude Fat (Minimum) 4.0 Crude Fiber (Maximum) 5.0 Ash (Maximum) 8.0 Moisture Content (%) (Maximum) 12.5

Component

Minimum Levels

Essential Amino Acids (% of total diet):

Arginine 0.90 Cysteine 0.25 Glycine 0.95 Histidine 0.38 Isoleucine 0.95 Leucine 1.40 Lysine 0.85 Methionine 0.35 Phenylalanine 0.85 Threonine 0.65 Tryptophan 0.20 Tyrosine 0.60 Valine 0.90 Vitamins:

Vitamin A (IU/kg) 20.0 Vitamin D (IU/kg) 4.0 Vitamin K (ppb) 20.0 Alpha Tocopherol (ppm) 45.0 Thiamine (ppm) 70.0 Riboflavin (ppm) 7.0 Niacin (ppm) 80.0 Pantothenic Acid (ppm) 30.0 Pyridoxine (ppm) 10.0 Folic Acid (ppm) 2.0 Biotin (ppm) 0.2 Vitamin B12 (ppb) 40.0 Choline (ppm) 1900.0 Minerals:

Calcium (%) 1.15 Phosphorous (%) 0.85 Potassium (%) 0.75 Sodium (%) 0.30

Magnesium (%) 0.15 Iron (ppm) 345.00 Manganese (ppm) 140.00 Zinc (ppm) 40.00 Copper (ppm) 12.00 Iodine (ppm) 1.80 Cobalt (ppm) 0.70

2.1.3 NUTRIENT ANALYSIS OF FINAL PRODUCT

For the purposes of the specification listed in this section, a "batch" shall be defined as one continuous production run which may or may not consist of several small batches. Analysis for nutrient content of the finished product shall be conducted in accordance with the procedures of the Association of Official Agricultural Chemists (most recent issue). All nutrient contents of the finished product shall be expressed as a percentage by weight on an air-dry basis. The contractor will provide the Contracting Officer’s Representative (COR) a copy of the nutrient analysis for each batch to review prior to approval of shipment. This analysis should include at a minimum the following:

• Crude Protein

• Crude Fat

• Crude fiber

• Ash

• Moisture content

2.1.4 MAXIMUM ACCEPTABLE LEVEL OF CHEMICAL OR MICROBIAL

CONTAMINANTS:

For the purposes of the specification listed in this section, a "batch" shall be defined as one continuous production run. Prior to delivery of each batch of finished, the contractor will provide certification via email to NIEHS that the concentrations of the contaminating chemicals or microorganisms listed in this section do not exceed the listed maximum concentration level (MCL). The testing will be performed by an independent testing laboratory(s) of the contractor’s choosing as long as the laboratory(s) is/are certified to perform the test according to acceptable industry standards.

Slight increases above the listed MCL for a few of the contaminating chemicals may be allowed; however, NIEHS shall review and approve any increases prior to approval of delivery and use the feed scoring system described below in this section as the basis for this review. No increases in contaminating microorganisms will be accepted.

CONTAMINANT Maximum Concentration Level (MCL) MYCOTOXINS (ppb) Aflatoxin -Total 5 Aflatoxin B1 2 NITROSAMINE (ppb) Total Volatile 15

N-nitrosodimethylamine (NDMA) 10 HEAVY METALS (ppm):

Lead 1 Cadmium 0.15 Mercury 0.05 Arsenic 0.6 Selenium 0.5 CHLORINATED HYDROCARBONS (ppm) Alpha BHC 0.02 Beta BHC 0.02 Delta BHC 0.02 Gamma BHC (Lindane) 0.02

Endosulfan sulfate 0.03 Endosulfan I 0.02 Endosulfan II 0.02

Heptachlor 0.02

DDE 0.02

DDD 0.03

DDT 0.02

Hexachlorobenzene (HCB) 0.02 Mirex 0.02 Methoxychlor 0.05 Dieldrin 0.02 Endrin 0.02 Telodrin 0.02 Chlordane 0.05 Toxaphene 0.1 ORGANOPHOSPHATES (ppm) Ronnel 0.02 Ethion 0.02 Trithion (Carbophenothion) 0.05 Diazinon 0.20 Methyl Parathion 0.03 Parathion (Ethyl Parathion) 0.02 Malathion 0.50 PCBs (ppm) 0.20 Miscellaneous Nitrate (ppm) 20 Nitrite (ppm) 5 Total Daidzein and Genistein (ppm) 200 Butylated Hydroxyanisole (BHA) (ppm) 10 Butylated Hydroxytoluene (BHT) (ppm) 5 Total Bacterial Plate Count (CFU/g) 200,000

Coliform (MPNa/g) 2,000 E.coli (MPN/g) 25 Salmonella (/g) 0 a MPN = Most Probable Number

A flexible feed scoring system as described in Rao and Knapka (1987) will be the basis for the review performed by the COR of any chemical contaminant concentrations that exceed the MCL listed above. A batch of a finished product (feed) with concentrations of contaminants equal to or less than the MCL listed above will be graded with a total score of 100 points and approved for delivery. If any chemical contaminant exceeds the MCL, points will be deducted for levels above the MCL of each contaminant. One point will be deducted for each 0.20 ppm above the maximum allowable level for arsenic, selenium, lead and malathion. Deduction of one point for each 0.02 ppm above the MCL for cadmium, mercury, PCB’s and methoxychlor. For all other pesticides and miscellaneous contaminants, a deduction of one point for each contaminant with an increase equivalent to the MCL.

If the final score is 95 or above, the COR will approve delivery of the finished product.

Batches of finished product with scores between 91 and 94 points may be approved as partial delivery in a volume of the COR’s discretion. The government will only be charged for the bags delivered. If the score is 90 or below, the batch of feed will not be accepted by NIEHS.

2.1.5 INGREDIENT STANDARDS

Ingredients used in the manufacture of this ration must not be contaminated with any more than 3 percent of foreign materials such as other grains, weed seed, chaff, etc. Nor shall any mold, dust, or insect-rodent infestation be allowed. The average minimum nutrient concentrations of ingredients used in the manufacture of this rations shall be consistent with to the values published in the national Academy of Sciences Publication 1684. "United States - Canadian Tables of Feed Composition". The Contractor is required to provide NIEHS a feed analysis on every feed batch to show that an effective ingredient quality control program is being followed.

2.1.6 FEED ADDITIVES AND PROCESSING RESTRICTIONS:

The product shall contain no antibiotics or estrogen additives of any kind. All milling and warehousing conditions and/or restrictions as specified in Section 6 apply to the feed covered by this specification. In addition, equipment used in manufacture of this feed shall not be used to manufacture feeds which contain antibiotic or estrogen additives.

2.1.7 ALTERATION OF PRODUCT:

The product shall not be altered in any manner so as to affect the final nutrient content without prior approval from the COR of the NIEHS.

2.1.8 CERTIFICATION OF PROCESSING:

The Contractor shall carry through without operational delay the milling or manufacturing process, all testing and approval from the COR which shall be completed not more than twenty-one (21) days prior to delivery of the product.

3. QUALITY ASSURANCE PROVISIONS:

3.1 RESPONSIBILITY FOR INSPECTION:

The Government reserves the right to perform any of the inspections set forth in the specifications where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.

4. PREPARATION FOR DELIVERY:

4.1 FORM:

The finished product shall be furnished in oval shape pellets 5/8-3/4" wide, 3/8-7/16" thick, and W-l" long.

4.2 PRODUCT SAMPLE:

Each sample shall be identified as to the name of manufacturer, the name of the product, the NIEHS stock number and the date of manufacture. The date of manufacture shall be considered as the batch production number. No coding of these items shall be allowed. If more than one milling date constitutes a batch for analysis purposes, each milling date must be recorded on the sample, if the dates are more than two consecutive dates.

4.3 MARKING:

Each bag shall be marked (via tag) with the name of the product, the name of the manufacturer, the new weight, the guaranteed analysis of its contents, the date (month, day, and year) the manufacturing process was completed and the batch number under which it was processed.

Codes or coding shall not be acceptable for any markings specified herein.

4.4 PACKAGING:

The finished product shall be packaged in commercially acceptable laminated 50 lb. capacity paper bags, 25 lbs. of product per bag. The 3-ply laminated bags must withstand autoclaving at 250° for 20 minutes and must be perforated with pinpoint holes two inches apart (2" squares). Individual sheets of paper for each bag should be perforated and the holes offset so that one cannot see through the bags.

4.5 PALLETIZING OF FEED BAGS:

Bags of feed shall be delivered palletized. The bags shall be palletized 80 bags per pallet.

This shall be the responsibility of the contractor. The feed shall be held and stored on new, insect and vermin-free, pallets (80 bags/pallet). Feed must be stretch wrapped on pallets prior to delivery to prevent bags from slipping off pallets during storage and shipment. Feed must be cooled prior to stretch-wrapping and palletizing.

5. NOTES:

5.1 DELIVERY SCHEDULE:

No delivery schedule shall be specified until the Contractor has been notified of acceptability of the representative test products and approval for shipment by the COR.

6. ANIMAL FEED PROCESSING AND MILL SANITATION:

6.1 PURPOSE AND SCOPE:

This standard establishes sanitation requirements applicable to the process of animal feed, the mill wherein the feed is processed and the premise wherein the feed is stored.

6.2 REQUIREMENTS:

6.2.1 Processing and Sanitation:

a. Manufacturer's premises shall be clean and free of dirt, trash and other foreign matter that could contaminate feed being processed or stored.

b. No domestic animals or fowl, wild animals, rodents or birds shall be confined in or have entry to the confines of the building(s) housing the milling equipment, providing storage for feed ingredients, or storage for the finished food products.

c. Bagged feed ingredients and finished products shall be stored so as to permit inspection of floor-wall junctures in all storage areas. There shall be no evidence of rodent-damaged bags containing feed ingredients or finished products.

d. Plant premises, milling and storage areas shall be effectively rodent and bird- proofed.

e. Plant premises, milling and storage areas shall be reasonable free of insect pests and rodents and completely free of birds.

6.2.2 Plant Sanitation Methods:

Plant sanitation methods shall include the following:

a. Daily cleaning and removal of all loose feed materials lodged on the floors, walls, and ceilings.

b. Removal of all insect-infested feed or raw materials as soon as detected.

c. Floors, walls, ceilings, overhead beams and piping shall be free of all contaminating material, such as rodent or bird droppings.

d. All feed or raw materials shall be stored in containers or other storage facilities which satisfactorily prevents entry and contamination by rodents and birds.

e. Milling machines used for preparation of animal feed shall not be used for any other feed product to which rodenticide, insecticide, hormones, antibiotics, or fumigants have been added.

6.3 INSPECTION:

Prior to award of contract or at any time during the effective period of the resulting contract, the contractor's plant, plant facilities and milling operations may be subject to inspection by Sanitary Engineers of the NIEHS, or the duly authorized personnel. Failure to comply with the requirements of this standard shall constitute sufficient grounds for withholding contract award or for cancellation of existing contract(s).

References:

1. Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds: June 6, 2000; Revised November 9, 2001 – http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformati on/ucm109231.htm

2. Rao, GN and JJ Knapka. 1987. Contaminant and Nutrient Concentrations of Natural Ingredient Rat and Mouse Diet Used in Chemical Toxicology Studies. Fundamental and Applied Toxicology 9, pp. 329-338.

http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm109231.htm http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm109231.htm