Attachment_I.pdf

Attachment I

National Institute of Environmental Health Sciences (NIEHS) Standard Specifications for Screened Hardwood Laboratory Animal Bedding

PURPOSE AND SCOPE

This standard establishes the requirements for the purchase of screened hardwood laboratory animal bedding for NIEHS. Standard includes product and product processing, plant sanitation, pest management, manufacturing and warehouse facilities, production and warehouse facility grounds, equipment and machinery, packaging, transportation, and inspection, test procedures and quality assurance and control.

APPLICATION

The standard is applicable to all screened hardwood laboratory animal bedding (consisting of Birch, Beech, or Maple) purchased under NIEHS contracts, unless otherwise specified.

REQUIREMENTS

1. Product and Product Processing

a. The raw material processed for the product covered by this specification shall be from Beech, Birch, Maple, or any mixture thereof. No other species of wood shall be acceptable nor shall the presence of other species be permitted with any single species or mixture of acceptable species. For each lot, the contractor shall notify the Contracting Officer’s Representative (COR) of the species or combination of species to be furnished.

b. The finished product shall be a cube cut type and shall be free of splinters, shavings, and contain less than 0.1% dust by weight (particles less than 300um) passing through a #50 standard sieve. The particle size of the finished product should pass through a #8 standard sieve (<2.36 mm in size). After a sample has been shaken in a RO-Tap Sieve Shaker for 3 minutes, not more than 5% (by weight) within an error range of +/- 0.05% shall pass through a #20 standard sieve (American Soc. for Testing and Materials (ASTM) Specifications); and less than 0.1% dust (by weight) within an error range of +/- 0.05% shall pass through a #50 standard sieve (ASTM Specifications).

c. Decayed raw materials or raw materials that have been used for other purposes (i.e.

used lumber) shall not be used in products covered by this standard. The raw material to be processed for animal bedding shall be free of bark, and all foreign materials.

d. The product shall be processed in a closed system with the exception of aspirators which are necessary to control dust. This system shall include the following:

1) Thermal Dryers, when needed, are used to reduce the inherent moisture content of the product and/or to control pathogenic bacteria. Unless otherwise specified in the applicable product specification, the laboratory animal bedding shall contain at least 6% but not more than 12% moisture (based on moisture removal by moisture determination balance) at the time of delivery. The air temperature at the exhaust vent of the dehydrator shall be a minimum of 150°F.

2) Aspiration is used to decrease the amount of dust in the bedding. The product shall be subjected to aspiration during the manufacturing process. The aspiration shall decrease the dust content on the bedding to levels that will not inhibit in any way the normal respiratory process of laboratory animals reared on the bedding.

3) Screening apparatus to standardize the particle size of the product. The bedding shall be screened so the minimum and maximum particle size is in accordance with the applicable product specification.

e. Production apparatus used to manufacture products containing additives such as rodenticides, anti-helminthics, anti-microbials, insecticides, hormones, antibiotics, growth promoters, fumigants or any chemicals deemed to interfere with NIEHS research shall not be used to manufacture laboratory animal bedding without prior written approval from the Contracting Officer. In order to obtain such approval, the bedding contractor may be asked to provide: (1) details of the procedures designed to ensure the manufacture of uncontaminated bedding or (2) reports of negative assays for the contaminant in question for each batch of bedding manufactured for the NIEHS.

Under the latter option, the assay shall be conducted at no cost to the government.

2. Plant Sanitation

a. The Manufacturer shall have a written Standard Operating Procedure (SOP) for the maintenance and sanitation of the receiving, production, and storage areas.

These SOP's shall provide, in detail, methods that are used to ensure these areas remain orderly, sanitary, properly maintained and pest free to comply with the standards herein. These SOP's shall also contain a schedule for the maintenance and sanitation of the aforementioned areas. A copy of these SOP's with the name and title of person(s) responsible for ensuring that these duties are performed shall be provided to the Government Inspector at time of inspection of the facility.

b. To prevent contamination of raw materials and product, plant sanitation methods at a minimum shall include the following:

1) Daily cleaning and removal of all loose raw material and debris from floors around production apparatus.

2) Periodic removal of trash, dirt, and other debris lodged on floors, walls, I-beams, pipes, and ceilings of the production facilities and warehouses.

3. Pest Management

a. The manufacturer shall have in place a documented integrated pest management program provided by a licensed pest control company. The pest control company shall adhere to all applicable local, State, and Federal regulations. The program shall consist of regularly scheduled pest management services, including monitoring for pests (pests include invertebrate and vertebrate animals), and surveying facilities for conditions that promote pest activity. The program shall emphasize the use of non-chemical pest management methods such as traps, exclusion, harborage reduction, and strive to provide corrective actions or recommendations that will provide long lasting control while reducing pesticide usage. The manufacturer shall maintain accurate and complete records of all pest management activities and shall provide these records to the Government Inspector at the time of facility inspection.

b. Manufacturing and product storage areas shall be effectively rodent and avian proofed.

These areas shall be free of insects, rodents, and birds at all times.

c. Pest management records shall be maintained in a log book and contain at a minimum the following sections:

1) Program Information - this section shall contain pest management company contacts and service personnel information.

2) Client Pest Sighting- this section is intended for facility personnel to record pest sightings and to communicate that to the pest management professional servicing the facility.

3) Pesticides - this section shall include a list of primary pesticides to be applied at the manufacturing facility. A current copy of each pesticide label and MSDS, (material safety data sheets) shall be included in the order it was listed.

4) Facility Map - a floor plan(s) shall be used to indicate the location of any type of pest management device, i.e., sticky trap, pheromone trap, light trap, rodent trap etc. used in the integrated pest management program. The locations of pest control and monitoring devices shall be maintained and kept current.

5) Service Reports - Pest management services performed at the facility shall be placed in this section. Service report records shall include but not be limited to:

a. Results of monitoring and inspections, including accepted common/generic names of all pests, numbers of each pest, and the location in the facility they were trapped or observed.

b. Pest sightings and conditions conducive to pest infestation shall be reported on pest management data sheets.

c. Specific written recommendations evaluating sanitation conditions, structural repairs i.e., caulking, sealing, and harborage reduction, as well as, operational changes that will prevent and/or reduce pest problems and enhance the effectiveness of the pest management program.

d. Include the control products applied, the concentrations and quantities of all pesticides applied, the accepted Environmental Protection Agency common names (generic names), method(s) of application, area of application in the bedding mill, warehouse, and other surrounding grounds.

d. "Restricted Use" pesticide application will be undertaken by a certified pesticide applicator or licensed pest control contractor or under the direct supervision of same in accordance with label directions and local, State and Federal regulations.

e. "General Use" pesticides, in states not requiring certification, may be undertaken by a person who has attended a pesticide seminar or been trained by a licensed applicator and who has demonstrated to have expertise and knowledge in the correct and safe use of pesticides or is under direct supervision of a Certified Pesticide Applicator. All applications shall be made in compliance with label directions.

f. Outside bait stations designed for vermin control using EPA registered rodenticide baits shall be tamper resistant, labeled, locked, dated, and secured in place around the facility's perimeter. Bait station covers should be secured by material that cannot be easily damaged.

g. Internal measures for rodent control monitoring programs shall include devices such as glue boards, mechanical traps, and extended trigger traps but not feeding stations.

h. No domestic animals or fowl, wild animals or birds shall be confined in or have entry to building(s) housing production equipment, delivery site of and providing storage for bedding ingredients or storage for the finished product. Provide, where necessary, effective screening or other protection against pests.

i. The manufacturer shall have in place a program that discourages the nesting and lofting of nuisance birds and other feral animals on the exterior of buildings and on the grounds immediately surrounding the production and storage facilities which is controlled by the manufacturer.

4. Manufacturing and Warehouse Facilities

a. Facilities and manufacturing apparatus used for preparation of laboratory animal bedding shall not be used for manufacturing or storing of any products to which fertilizers, rodenticides, insecticides, hormones, germicides, bactericides, or fumigants have been added.

b. Premises shall be dry, reasonably clean, and free of dirt, trash, animal and bird excreta and other foreign matter that could contaminate bedding being processed or stored. The premises are defined as the interior of the building and surrounding grounds controlled by the manufacturer.

c. All structural beams, supports, and other structural systems that are painted shall be maintained in an appropriate manner to preclude or eliminate chipping, flaking, and peeling paint.

d. Space should be provided for proper placement of equipment, storage of materials, and adequate aisles or work space between equipment and/or structures shall be maintained to allow for effective maintenance, cleaning, and pest management.

e. Floors, walls, and ceilings shall be of such construction as to be adequately cleanable and kept in good repair.

f. Fixtures, ducts, and pipes shall be installed in such a manner that drip or condensate does not contaminate raw materials and finished product.

g. Lighting shall be provided in all areas to allow effective housekeeping, pest management, and bedding production. Light bulbs, fixtures, mirrors, skylights, or other glass suspended over raw material, product zones, and packaging areas shall be of the safety type or otherwise protected to prevent breakage.

h. In wet processing areas floor drains with grates shall be installed, maintained, and operational. Floors in wet processing areas shall be maintained to allow proper drainage and prevent accumulation of water and debris.

i. Rest room facilities shall be adequate and readily accessible to all personnel involved in the manufacture, storage, and transport of the laboratory animal bedding.

j. Bags of laboratory animal bedding shall be stacked on pallets at least 18 inches away from the walls in order to facilitate cleaning, rotation, and pest management surveillance activities.

k. To eliminate the potential for contamination of laboratory animal bedding, raw material, finished product, and packaging supplies shall not be stored in the same warehouse with products containing antibiotics, drugs, fertilizers, toxic chemicals, or any chemical compounds known to be undesirable. If this is not practical, the bedding shall be stored at a minimum of 30 feet from any potential contaminant and written standard operating procedures describing how the bedding will remain segregated from potential contaminants must be provided to the Government Inspector for approval.

5. Production and Warehouse Facility Grounds

a. The grounds surrounding the production and warehouse facilities under control of the operator shall be kept in a condition that will protect against the contamination of the raw materials and finished product. The grounds are defined as drive ways, parking lots, receiving, shipping, and storage areas and buildings.

b. The bedding manufacturer shall have a SOP for the maintenance of grounds which shall include but are not limited to: properly storing equipment, removing litter and waste within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests.

6. Equipment and Machinery

a. Regulating and recording controls, thermometers, or other temperature measuring devices shall be installed and routinely calibrated on any equipment intended to ensure product quality. The manufacturer is responsible for determining calibration schedule. Records of the calibrations shall be provided to the government inspector at the time of inspection.

b. Maintenance records for the production equipment, scales, and regulating and recording controls shall be made available to the NIEHS inspectors at the time of inspection of the facility. All equipment shall be maintained and cleaned on a regular basis as determined by the bedding manufacturer. Maintenance and cleaning records shall be provided to the Government Inspector at the time of inspection.

c. All equipment shall be so constructed and maintained as to prevent lubricants and coolants from becoming unsafe additives in raw materials or finished bedding.

d. The manufacturer is required to have equipment (ie. Ro-Tap or similar) that can ensure the bedding particle size is in compliance with NIEHS specifications.

e. The manufacturer is required to have equipment (ie. moisture balance) that can ensure the bedding moisture is in compliance with NIEHS specifications.

7. Packaging

a. Bags, Paper: Paper bags shall be new and unused and shall be suitable for domestic shipments, handling, and covered storage. Paper bags shall be of at least two (2) wall constructions with each wall fabricated of Kraft paper having a thickness of at least .006 inch. Each layer of paper shall be perforated containing pinpoint holes 2.0 inches apart, prior to the construction of the bags. The holes in each layer of paper should be offset so that one cannot see through the holes in the bag. Inner wall shall be arranged within the outer walls in such a manner that each wall will bear its share of the burden.

Bags shall be a square or box type construction and the overall size shall be commensurate with the maximum content specified, so that when filled, shall retain its square or box type construction and shall provide suitability for handling, palletizing and storage. Product must be packaged with at least 35 lbs of bedding per bag and bag should be at least a 2.2 cu. ft. capacity and also leave room for expansion during autoclaving process. The bottom or factory closed end will be pasted in such a manner that the square or box type construction is maintained. The adhesive used in securing any pasted ends and/or sides shall be such that it will prevent accidental opening when handled, autoclaved, or transported. The use of a corrosive type staple and adhesive tape will not be acceptable. Bags may be factory closed on top and provided with a filling valve or tuck-in sleeve. The top closure method shall provide a securely held positive closure against sifting or spilling.

b. Adhesive Toxicity: The adhesive used in the fabrication of the bags shall have no adverse or toxic effect on the contents of the bag prior to or when subjected to steam sterilization. The successful bidder may be required to furnish to the Contracting Officer a certificate stating that the adhesive used contains no known toxic material.

c. Adhesive Resistance to Heat: The adhesive bond shall resist a maximum temperature of 270°F for a minimum period of one hour when bag and contents are subjected to sterilization by autoclaving.

d. Marking: Each bag shall be clearly marked (either on the bag or via tag) with the appropriate nomenclature and NIEHS Stock Number as follows:

Bedding, Hardwood, Screened

NIEHS – 90000

(Name and location of manufacturing plant) Manufacture Date

Other markings shall include the net weight and the bag manufacturer's trademark or identification.

e. Three trailer loads of bedding (approx. 3,300 bags or 115,500 lbs of bedding) shall be manufactured consecutively as per specifications. The bags shall be identified by assigning the same lot number and date of manufacture to all bags produced in the three trailer load run and stored by the contractor in a vermin-free warehouse or other vermin-free facility until the bedding is cleared for shipment and ordered by NIEHS.

Before shipping the final truckload (last 1100 bags of the current lot of bedding), the contractor shall manufacture the next lot of 3,300 bags of bedding. The contractor shall collect one (1) each 1 lb. bag of bedding (collected throughout the production run), to serve as a representative sample of this new lot of bedding. This sample is to be used as the Quality Assurance Test Sample. The sample 1 lb. bag will be shipped via overnight delivery to NIEHS for testing.

The contractor is responsible for the cost of shipping this sample bag to NIEHS.

The contractor shall be notified when bedding meets contract specifications and when to ship additional quantities.

f. Deliveries shall be in truckload lots. One truckload shall contain no less than 1,100 bags of bedding, 44 pallets per truckload, 25 bags per pallet. All pallets used for delivery shall be clean, sturdy, and visibly free of pests and other extraneous contaminants. Pallets shall remain the property of the contractor and shall be exchanged on a pallet-for-pallet basis at the time of delivery.

8. Transportation

a. Railroad cars and trucks used to transport laboratory animal bedding shall be as free as is practical of dirt, trash, pests, and objects that could puncture paper bags.

b. The vehicles shall be water tight and so constructed to prevent entrance of rodents, birds or insects.

c. Laboratory animal bedding shall not be transported with products containing antibiotics or drugs, fertilizers or any chemical compounds known to be undesirable.

d. Laboratory animal bedding shall not be shipped on pallets that are dirty, broken, contaminated with chemical compounds and/or pest feces, or that are contaminated with or harbor insects.

e. Delivery shall be “FOB Destination” within the Consignee’s premises to the NIEHS at the following location:

NIEHS – WAREHOUSE

Bldg. 104, South Campus 111 TW Alexander Drive Research Triangle Park, NC 27709

Deliveries shall be made Monday through Friday (excluding Federal Holidays) between 8:30 AM and 2:00 PM. Trucks arriving after 2:00 pm will not be allowed to remain overnight at NIEHS and must return the following day for unloading. Supplies scheduled for delivery on a Federal holiday shall be made the following workday.

The contractor shall provide delivery to the site designated above.

Government personnel will off-load and deliver product inside the facility. The contractor shall notify NIEHS Warehouse Manager at 919-541-2913 of exact delivery date and time 24 hours prior to delivery.

The term "FOB" Destination within the Consignee's Premises" means delivered free of expense to the Government. Reference FAR Clause 52.247-35, entitled "FOB Destination, Within Consignee's Premises" (April, 1984), which is incorporated herein by reference with the same force and effect as if given in full text. Upon request, the Contracting Officer will make the full text available.

9. INSPECTION AND TEST PROCEDURES

a. Quality Assurance - Product - Bedding shall be inspected for coarseness, splinters, slivers, bark, dirt, trash, stones, metal, other foreign materials, sandings, dust, moisture content, packaging and marking of each lot of bedding. Bedding shall be tested for chemical and microbial contaminants. The finished product shall be free of pesticides, wood preservatives, aflatoxins and pathogenic bacteria. The maximum permissible levels are outlined on page 12 of this specification.

b. Responsibility for Inspection – Unless otherwise specified in the contract, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified, the contractor may utilize their own facilities or any commercial laboratory acceptable to the Government. 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.

c. Facility - 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 will be subjected to inspection by authorized personnel of the NIEHS. Failure to comply with the requirements of this standard shall constitute sufficient grounds for withholding contract award or for cancellation of existing contract(s).

d. Rejection - If at any time NIEHS finds that a lot of the product does not meet the specifications and standards requirements, this lot shall not be shipped to NIEHS; or if already shipped or delivered, the lot or any remaining part thereof shall be retrieved by the contractor at no expense to NIEHS and an acceptable replacement shipment will be provided at no additional expense. If a shipment of bedding is found unacceptable due to discrepancy in the report, the contractor will be notified immediately by telephone of the circumstances leading to the rejection.

Heat Treated Hardwood Bedding Maximum Levels of Contaminants

MICROBIOLOGICAL CONTAMINANTS

Standard Plate Count < 5000 Coliform < 10 Yeast and Molds < 100 Salmonella/Shigella Neg

All values in total viable organisms/gm of bedding

CHEMICAL CONTAMINANTS

Pesticide Residues (ppm) < 1.0 Chlorinate Hydrocarbon (ppm) Alpha BHC < .05 Beta BHC < .05 Lindane < .05 Aldrin < .05 Heptachlor Epoxide < .05 Dieldrin < .05 Endrin < .05

DDT < .05

DDD < .05

DDE < .05

Organophosphates (ppm) Diazinon < 0.1 Ethyl Parathion < 0.1 Methyl Parathion < 0.1 Malathion < 0.5 Ethion < 0.1 Ronnel Triothion < 0.1

Polychlorinated Biphenyls (PCB’s) (ppm) < 0.2 Pentachlorophenol (PCP) (ppm) < 0.1

Aflatoxins (ppb) < 20

Heavy Metals (ppm) Lead < 1.0 Mercury < 0.1 Cadmium < 0.2 Arsenic < 1.0

All values in ppm except for Alfatoxins in ppb