75F40123R00003.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

DAP

Beltsville MD 20705 4041 Powder Mill Road ATTN: Monifa Coleman

DHHS/FDA/OAGS/DAP

WO66 CODE 16. ADMINISTERED BYCODE

X

X

562112

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAP

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

11/29/2022 1000 ET

11/06/2022

MONIFA COLEMAN

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40123R00003

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 161 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

Silver Spring MD 20993 Building 66 10903 New Hampshire Avenue The US Food and Drug Administration

WO66

15. DELIVER TO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Monifa Coleman

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$41.50

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAP

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

FDA Hazardous Waste Management Services:

Contract Type:

Single Award Hybrid Contract Type IDIQ, Firm-Fixed Price (FFP), Time and Materials (T&M), or Labor Hour (LH), for Comprehensive Hazardous Waste Management Services for the Collection, Transportation and Disposal of Chemical, Radioactive and Radioactive Waste, Nationwide.

The contract will cover a base period of One-Year

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

MONIFA N. COLEMAN

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

FDA PAYMENT SVCS

Attn: FDA Vendor payment Team

COLE RM8050

8455 Colesville Road Silver Spring MD 20993

FDA PAYMENT SVCS

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

(12 months) and anticipated four (4) One-Year periods, which may be unilaterally exercised by the Government.

Funding will be obligated within Individual Task

Orders.

Period of Performance: 12/20/2022 to 12/19/2027

1 Base Period POP: 12/20/2022 through 12/19/2023

FDA Hazardous Waste Management Services

Period of Performance: 12/20/2022 to 12/19/2023

2 Option Period POP: 12/20/2023 through 12/19/2024

FDA Hazardous Waste Management Services

(Option Line Item)

Period of Performance: 12/20/2023 to 12/19/2024

3 Option Period 2 POP: 12/20/2024 through

12/19/2025

FDA Hazardous Waste Management Services

(Option Line Item)

Period of Performance: 12/20/2024 to 12/19/2025

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

161 2 of

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 161

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75F40123R00003

4 Option Period 3 POP: 12/20/2025 through

12/19/2026

FDA Hazardous Waste Management Services

(Option Line Item)

Period of Performance: 12/20/2025 to 12/19/2026

5 Option Period 4 POP: 12/20/2026 through

12/19/2027

FDA Hazardous Waste Management Services

(Option Line Item)

Period of Performance: 12/20/2026 to 12/19/2027

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

75F40123R00003 FDA Hazardous Waste Management Services

SECTION B – SUPPLIES OR SERVICES AND PRICES

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Food and Drug Administration (FDA) has a requirement for Chemical, Radioactive, Medical Pathological, Device Waste Collection, Minimization and Disposal Service, Dangerous Goods Shipping and Multi-Hazardous Material Inventory Management Services, in multiple buildings and locations throughout the United States, including Puerto Rico, as defined in Attachment J-1 Locations and Place of Performance 75F40123R00003.

The Contractor shall provide, either directly or through qualified sub-Contractors, all aspects of a comprehensive, cradle to grave chemical, radiological and medical pathological waste management service for FDA.

To fully support this requirement, the Contractor shall supply all labor (full-time employees with the applicable credentials as specified in Attachment J-2 Labor Categories 75F40123R00003, materials, manifests, shipping papers/forms/labels, containers, equipment, vehicles, and managerial services, as needed and necessary, to safely accomplish under the specifications of this contract the pickup of hazardous chemicals or chemical/biological wastes at individual laboratories and/or waste storage areas. Such wastes shall then be segregated, packaged, labeled, manifested, transported, and stored, recycled, disposed of or treated off-site by the Contractor.

B.2 TYPE OF CONTRACT: FAR 52.216-1 (APR 1984)

This is a Single Award Indefinite-Delivery/Indefinite Quantity (IDIQ) Task Order oriented contract providing for a hybrid mix of contract type. The Period of Performance (POP) shall be for a one (1) year Base Period with four(4) one-year Option Periods. The contract shall include a not-to-exceed ceiling amount.

At the discretion of the Contracting Officer (CO), the Government may use a variety of contract types when issuing Task Orders (TOs) under this contract - including Fixed

Price (FP), Time and Materials(T&M), Labor-Hour(LH), or a combination thereof.

Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government’s determination of the contract type.

B.3 MINIMUM AND MAXIMUM CONTRACT AMOUNTS

During the contract POP specified in Ordering Clause FAR 52.216-18, the Government will place TOs against the IDIQ contract. The guaranteed minimum amount for this contract shall be satisfied by the issuance of the first TO. The maximum contract amount, inclusive of the five (5) year ordering period under the contract shall not exceed $40,000,000.00.

B.4 MINIMUM ORDERING REQUIREMENTS/QUANTITIES

The Government has no obligation to issue TOs beyond the stated minimum TO award.

There will be a one time “minimum guarantee” during the life of the contract which includes all option periods, if exercised.

The guaranteed minimum for this contract shall be satisfied by the award of the first

TO.

B.5 FUNDING

Funds for the services provided will be obligated, at the task order level, as they become available, or excess funds de-obligated at the TO level, by modification to the TO awards by the Government. The Contractor will only be paid for effort that has been authorized by the Government and performed in accordance with the contract specifications, except for the minimum amount guaranteed if the Contractor meets the requirements as stated in Section B.3.

B.6 SCHEDULE OF HOURLY FULLY BURDENED RATES

The Contractor’s fully-loaded labor rates for all personnel shall apply for the base and respective Option Periods, as requested. These rates shall be used by the Contractor as the ceiling labor rates when submitting price proposals in response to RFTOPs and change orders issued under the contract.

B.7 HOURLY FULLY BURDENED RATES

Attachment J-4 Pricing Schedule 75F40123R00003 worksheet outlines the various types of labor categories anticipated during the performance of this contract. The Contractor shall use the pricing worksheet to propose fixed rates for each labor category that shall apply throughout the life of the contract. The Contractor shall propose the necessary hourly rates for each labor category, for the Base Period and each Option Period. The loaded hourly rates for each labor category shall be fully burdened to include wages, indirect costs (including local travel, fringe benefits, overhead, general and administrative, and profit.

B.8 CONSIDERATION AND PAYMENT

The Contractor shall provide the necessary personnel, equipment, supplies and support services to perform as described in Section C. In consideration for successful performance of the requested services, the Contractor shall be paid upon the presentation of a proper invoice in accordance with the applicable invoice clause with the Task Order type specified (i.e. Fixed Price, Time- and-Material and/or Labor Hour basis).

The Contractor shall comply with FAR 52.232-7, Payments Under Time and Material and Labor- Hour Contracts or 52.232-25 Prompt Payment. Upon presentation of a proper invoice, payment will be made no more frequently than monthly, in arrears, for services/supplies rendered to and accepted by the Government.

The Contractor shall not exceed the maximum, loaded hourly direct labor rates for each labor category listed in the contract.

**The stated labor categories represent FDA’s estimates as to the type of expertise required under this contract. If proposed labor categories are different, Offerors shall map their labor category titles to those in the Attachment J-4 Pricing Schedule 75F40123R00003 worksheet.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C. 1 GENERAL

C.1.1 BACKGROUND

The Food and Drug Administration (FDA) is responsible for arranging proper disposal of chemical, medical pathological, radioactive and mixed wastes generated by the research laboratory activities within FDA facilities nationwide, including Puerto Rico.

FDA laboratory operations include the use and generation of diversified chemical, radioactive, and medical pathological wastes of varying toxicities and quantities.

FDA recognizes its responsibilities to ensure that its facilities are in compliance with existing and proposed regulations imposed upon entities which generate, transport, store, treat, and dispose of hazardous chemical compounds. The FDA acknowledges however, that the field of hazardous waste disposal services is a dynamic and ever-changing industry, which is significantly impacted by State and Federal regulations and by the influx of new technological advancements.

To fully support this agreement the Contractor shall provide necessary full-time employees with the applicable credentials as specified in the SOW, to support environmental services for the FDA service locations.

C.1.2 OBJECTIVE

The Contractor shall provide, either directly or through qualified sub-Contractors, all aspects of a comprehensive, cradle to grave chemical, radiological, and medical pathological waste management services for FDA.

C.1.3 SCOPE OF WORK

To provide hazardous chemical, radioactive and medical pathological waste disposal services, dangerous goods shipping and inventory management services to FDA research laboratories. This shall involve but not limited to the following:

i) The collection, sorting, packaging, manifesting, transportation, and off-site storage, recycling, treatment and/or disposal of such wastes, including any materials or equipment required to perform this service,

ii) Sampling and analysis of the waste stream to identify and characterize chemical, radiological, and multi-hazardous wastes for storage, transportation, treatment or disposal,

iii) Characterization of unknown chemicals, radioactive materials, and gases,

iv) Identification of controlled substances for disposal, on-site storage, and acquisition of license that will permit treatment and disposal, as necessary, and as may occur in the discovery of an orphaned controlled substance(s) at FDA owned or leased property,

v) Emergency and urgent response/remediation/removal of spills, leaks, or other environmental releases involving hazardous waste or materials including items that is potentially explosive and extremely toxic.

vi) Relocation of hazardous materials to other facilities,

vii) Chemical and radioactive decontamination, remediation and decommissioning services for facilities.

ix) Consultation and administrative services on waste management issues regarding waste to be handled by the sub-Contractors.

viii) Dangerous goods packaging services and training, per DOT and IATA.

ix) Temporary Temperature Controlled Trailer Storage

xi) Surplus Environmental Equipment Pickup and Transport

xii) Multi-Hazardous Material Inventory Management Services

xiii) Technical engineering evaluation of waste storage areas to facilitate waste handling.

C.1.4 SCHEDULING

The Contractor shall provide the services described in this contract during routine working hours, 7:00AM – 4:00 PM Eastern Time (ET), Monday through Friday. If the Contractor is scheduled to work all day at an FDA facility to pick-up waste, one half hour shall be allocated for lunch. All Federal holidays will be observed, and the Contractor shall not be required to provide routine services on Federal holidays or on days when the Government facility is closed for inclement weather.

Unscheduled, rapid response services may be required for urgent response activities.

This will be the exception and not the rule. If necessary, arrangements will be coordinated through the Contracting Officer Representative (COR) or designated waste coordinator. The Contractor shall be available for remediation of non- emergency spills and to conduct urgent waste removals. The Contractor shall respond to such requests within four hours (4) of notice.

C.1.5 APPLICABLE DOCUMENTS

The Contractor shall comply with all applicable sections of the laws and regulations listed below and any other applicable laws and regulations that are not listed:

1. U.S. Environmental Protection Agency (EPA): Title 40 CFR.

2. U.S. Department of Transportation (DOT): Title 49 CFR.

3. U.S. Department of Labor (DOL): Title 29 CFR.

4. U.S. Nuclear Regulatory Commission (NRC): Title 10 CFR 19 and 20, 30, 40 and 70.

5. U.S. Drug Enforcement Administration (DEA): Title 21 CFR.

6. U.S. Public Health Service (PHS): Title 45 CFR.

7. Applicable State Environmental Regulations: MD, IL, AL, MA, MO, AR, PA, MI, OH, NY, KS, WA, CA, GA, CO, FL and Puerto Rico.

8. Hazardous waste receiving states: The Contractor shall, when shipping hazardous wastes to another state for disposal, comply with all receiving state requirements regarding the shipping, receiving, storage, treatment, and disposal of such waste.

9. Recycling, treatment, disposal, and storage facilities: The Contractor shall comply with all requirements for waste packaging, etc. imposed by TSDFs that accept FDA wastes and surplus chemicals.

7. Maryland Department of the Environment: Title 26 COMAR.

8. Treatment and disposal facilities: The Contractor shall comply with all requirements for waste packaging, etc. imposed by the treatment and disposal facilities that accept FDA wastes

9. Title 42 Code of Federal Regulations, Public Health

10. IATA, Dangerous Goods Regulations

11. ICAO, Technical Instructions for the Safe Transport of Dangerous Goods by Air

12. Carrier specific rules and instructions (FEDEX, DHL, UPS, USPS, Commercial Airlines, etc.) Secondary Company References

13. The Contractor shall meet the Department of Transportation Emergency Response Communication Standards (49 CFR 171 and 172.604) applicable to the shipment of hazardous waste. This regulation requires that a comprehensive emergency response service be in place with a 24-hour emergency telephone number, DOT Emergency Response Guide information, and the provision of two technical names for generic N.O.S. descriptions on all hazardous waste shipping papers.

14. The Contractor shall comply with all existing FDA permits, licenses, and decrees listed below, any revisions thereto, and any other future permits and licenses which become effective during the term of the agreement.

C.2.0 SPECIFIC REQUIREMENTS/TASKS

C.2.1 CHEMICAL WASTE SCOPE OF WORK

The Contractor shall supply all labor, materials, manifests, shipping papers/forms/labels, containers, equipment, vehicles, and managerial services, as needed and necessary, to safely accomplish under the specifications of this contract the pickup of hazardous chemicals or chemical/biological wastes at individual laboratories and/or waste storage areas. Such wastes shall then be segregated, packaged, labeled, manifested, transported, and stored, recycled, disposed of or treated off-site by the Contractor.

The Contractor shall have access to a treatment, storage and disposal facility (TSDRF) capable of receiving and managing a majority of the hazardous waste generated by FDA.

The Contractor shall have access to a treatment, storage and disposal facility (TSDRF) capable of receiving FDA wastes to supplement any storage-only facilities. All operations of this facility are to be monitored by the Contractor to ensure compliance with all applicable federal and state regulations.

The Contractor shall be expected to move any explosive or otherwise reactive materials, which is deemed safe to handle to a location specified by the Contracting Officer Representative (COR) or the designated waste coordinator. The Contractor may be required to provide part or all of the response action, depending on the nature of the incident, available on-site facilities, and the Contractor's capabilities to handle the material.

The Contractor may be required to provide available off-site facilities to manage and dispose of some reactive materials.

In the event the chemicals are not completely identified by name or concentration of materials in spent mixtures (if concentration data is required for transportation, redistribution, storage, treatment, or disposal), the Contractor shall notify the COR or the Center Safety Officer of the waste in question, the location, and any further information pertinent to the identity of the waste or the generator of the waste.

Surplus and otherwise unused chemicals shall be collected by the Contractor with waste chemicals during routine waste pick-ups.

C.2.1.1 CHEMICAL AND BIOLOGICAL WASTES

The Contractor may be asked to dispose of chemically contaminated biological waste.

FDA will treat some of this combination type of waste by autoclaving or chemical treatment prior to disposing of the waste. Some of these combination wastes, however, cannot be treated to remove the regulated medical waste label. Animal carcasses, sharps, etc. containing test materials, traces of heavy metals, or other substances classified as hazardous waste (in accordance with 40 CFR 261) cannot be handled by routine biological waste treatment methods and are accordingly classified as chemical/biological because more than one hazard is present. The FDA presently has a mechanism in place to handle all purely biological waste. However, the Contractor shall make special arrangements for disposing of this combination waste in accordance with the EPA requirements for both regulated medical waste and hazardous waste.

C.2.1.2 CONTROLLED SUBSTANCES

The Contractor shall be able to identify Controlled Dangerous Substances, as defined in Title 21, CFR, Part 1308 and recognize on which DEA schedule they are listed. The Contractor must have the appropriate license to treat these substances onsite per DEA regulations. The Contractor shall provide detailed technical assistance to FDA researchers with proper disposition of controlled substances and shall be capable of treatment and disposal of Drug Enforcement Administration (DEA) substances.

C.2.1.3 ASBESTOS

FDA laboratories generate small waste items containing asbestos such as gloves, insulation tape for condensers, heating mantles, and insulation from equipment. Larger amounts of asbestos waste may be generated from abatement and/or decommissioning projects. The Contractor may be required to dispose of such wastes.

C.2.1.4 UNIVERSAL WASTE

FDA laboratories generate universal waste in the form of batteries, pesticides, thermostats, waste oils and fluorescent lamps. The Contractor shall be responsible to manage universal waste within required annual storage limits. The Contractor shall remove spent or waste batteries from the facilities and transport them to designated areas for accumulation and subsequent off-site for recycling, treatment, or disposal.

Appropriate spill kits shall be carried while transporting batteries containing liquid electrolytes. FDA or its agent will collect the fluorescent lamps during preventative maintenance. Fluorescent lamps will be turned over to the Contractor for processing.

Processing of fluorescent lamps involves packaging and shipping them off site for recycling.

C.2.1.5 EMPTY DRUMS, REAGENT CONTAINERS, & LABORATORY

GLASSWARE

The Contractor shall remove any empty drums or other chemical containers with a capacity of five gallons or greater and deliver them to designated off-site disposal or recycling facilities. All containers shall be emptied, that is, the wastes or hazardous materials shall be removed using practices commonly employed to remove materials.

The containers will then be rinsed three times, the rinsate collected as hazardous wastes, and the containers collected accumulatively for disposal or recycling.

The Contractor shall collect empty reagent, bar coded containers which previously contained reagents for inventory control by FDA or its agent at applicable locations.

Empty reagent containers shall be turned over to the Contractor for processing.

Processing of empty reagent containers by the waste Contractor involves sorting and disposal of plastic and metal containers via the sanitary refuse. Glass containers are to be recycled, where possible, employing the Government glass crusher. Any reagent containers that are either full or contain waste shall require removal of barcode information prior to processing. These containers must be handled as waste and disposed of as such due to the nature of the hazard. Barcode information shall be collected by the waste Contractor and turned over to the COR or the facility’s designated waste coordinated.

A specific policy for empty containers for each FDA facility shall be provided to the Contractor in facility-specific task orders. Waste containers previously used for accumulation of wastes in the laboratories shall be rinsed, inspected and, if found in good condition, shall be returned to the generators for reuse.

C.2.1.6 HALOGENATED DIBENZO-P-DIOXINS AND FURANS

The Contractor shall supply appropriate waste disposal for halogenated dibenzo-p-dioxins and furans. The Contractor shall pack the dioxin waste in containers acceptable for different disposal methods (landfill or incineration).

C.2.1.7 OTHER LIQUIDS, GASES AND SOLIDS

The Contractor shall supply waste disposal for an assortment of waste items, to include corrosive liquids, solid hazardous waste, contaminated materials, used column packings, pump oils, compressed gas cylinders, lecture bottles, etc. Some of these items require special packing and arrangements for disposal. Chemically contaminated laboratory articles such as gloves and pipettes contaminated with hazardous chemicals and other solid chemical wastes shall be packaged in containers which safeguard against sharp objects protruding through the package, prevents leaks, and allows visual inspection.

Some materials may contain contamination from the manufacturing process, which will cause the materials to be classified as hazardous waste when disposed. One example is the presence of any chemicals on the Toxicity Characteristic (TC) waste list. The Contractor shall keep informed whenever such common materials are found to contain TC wastes at regulated levels and advise the COR of such issues. The COR will also notify the Contractor whenever any materials are suspected of or found to have contamination of TC wastes. Once notified, the Contractor shall handle all such materials as hazardous waste until further notification from the COR.

C.2.1.8 WASTE FOR RECYCLING

Any waste which is stored on site for recycling may be stored in the waste marshalling area for accumulation, but the storage time is limited to the time periods allowed under 40 CFR 262.34 for accumulation time if the material is a RCRA defined hazardous waste.

(a) Recovery of Precious Metals

The Contractor may collect unused or surplus chemicals that contain gold, silver, platinum, palladium, iridium, osmium, rhodium, ruthenium, or any compound or combination of these metals with waste chemicals during routine waste pick-up activities. FDA will designate the location, preferably a locked cabinet, within the waste marshalling area for storage of precious metals. The Contractor shall date the container as it is received and immediately place such materials in the designated location. The Contractor shall notify the COR or the designated waste coordinator, who will review the contents of the cabinet. If an economically significant amount, of precious metals has accumulated in the storage cabinet to warrant shipment, the COR will request the Contractor to ship the metals to an approved off-site metals recovery facility. If the COR finds a chemical in the storage cabinet to be unsuitable for storage as precious metals, he will direct the Contractor to handle the metal as hazardous waste. The Contractor shall then dispose of the material or chemical according to procedures specified in this contract for wastes.

(b) Recovery of Mercury

The Contractor shall collect all mercury waste during routine waste pick-up activities.

Routine laboratory waste contaminated with mercury where the mercury cannot be readily or safely separated from the waste materials, mercury salts, and organic mercury will be handled as RCRA hazardous waste and handled in accordance with the provisions of this contract. Metallic mercury, which can be separated from laboratory waste, shall be segregated from the other waste in the waste marshalling area and stored in an area designated by FDA for mercury storage. An example of such separable mercury is mercury from broken thermometers and mercury from electrodes in equipment.

(c) Recoverable Lead Items

FDA generates lead pigs, which have been used to ship radioactive materials to FDA.

The FDA radiation safety officer or designee will survey the pigs prior to removal from the waste collection area and certify via an accompanying memo that the pigs are free of contamination from radioactive materials. The Contractor shall pick-up the pigs and store them in the accumulation area until sufficient quantity is ready to ship as scrap lead to a recycling firm.

C.2.1.9 WASTE PICKUP

It is anticipated that pickups shall be made at any laboratory or storage area within FDA facilities, as directed by the COR and/or designated waste coordinator at each facility.

The COR or the designated waste coordinator will notify the Contractor when there is sufficient quantity of waste to schedule a waste pickup. If the Contractor believes certain waste to be an imminent hazard, the Contractor must notify the COR immediately, and steps will be taken by both the COR and the Contractor to alleviate the hazard. Such waste must be removed for disposal as soon as possible.

Certain areas within FDA facilities are restricted and entry by contract personnel into such areas is prohibited unless certain rules or policies are followed. The COR will inform the contract personnel at the start of the contract, which areas are prohibited from routine entry, such as corridors, elevators, laboratories, rooms, etc. and under what circumstances such areas may be accessed.

C.2.1.10 WASTE MARSHALLING

Waste chemicals shall be collected, segregated, packaged, and manifested at a site designated by the COR at each facility and shipped directly to the Contractor's recycling, treatment, storage, or disposal (TSDRF) facility. The Contractor shall bulk or consolidate compatible wastes from multiple containers into single or fewer containers.

Flammable solvents shall only be bulked at those sites which have designated facilities.

At other FDA locations, the Contractor shall lab- pack the solvents for disposal. The Contractor shall be responsible for weekly inspections of marshalling areas unless otherwise directed. At the smaller FDA facilities, the designated waste coordinator will be responsible for weekly inspections.

The Contractor shall provide all containers meeting UN/DOT specifications, packaging materials, labels, liners, etc. for holding, storing, and shipping wastes as needed.

Shipping containers shall be marked and labeled to indicate the container's contents and to comply with all applicable waste storage and transportation regulations and specific hazardous material category contract requirements as outlined below. Examples of large or unusual items are, contaminated HEPA filters from hoods, fume hoods, laboratory casework, incinerators, tanks, contaminated equipment, animal carts and animal carcasses, roll off containers, etcetera.

When assigning EPA or state waste code numbers to the waste stream for completing the waste contents sheet, FDA considers all waste received in conventional waste containers to be spent materials unless information is provided by the generator to the contrary. All waste received in the original containers with the original labels intact is considered unused, or off-spec materials unless information is provided by the researcher to the contrary. All primary standards of "P" and "U" chemicals and products where such chemicals are the active ingredients shall be assigned the waste code numbers for off-spec materials. The Contractor shall assign the waste code numbers in accordance with this policy.

FDA does not presently hold any permitted exceptions from EPA to the regulated storage time to hold or store waste any longer than specified in the regulations. Any waste, which is held pending the terms of this contract, must be in strict adherence of the regulated time frames. At the locations of the small generators where waste pickups are less frequent, every effort shall be made to remove the waste on the day of the pick-up.

1) Surplus Chemicals Accumulated for Recycling use: Unopened surplus chemicals which will be accumulated for recycling use at FDA facilities is an exception to the waste removal requirements.

2) Wastes Held for Analysis or Off-Site TSDF Approval: Any wastes, including unidentified wastes, that have been sampled and are undergoing analyses to comply with DOT, EPA, or TSDF requirements before shipment may be held pending the results of the analysis.

3) Wastes for Which No Disposal Outlets Are Available: Certain hazardous wastes, such as dioxin or mixed chem/rad waste, must be held because there are no accepted off-site recycling, treatment, and disposal outlets. FDA anticipates that this type of waste will be minimal.

The Contractor shall provide all sampling equipment, supplies, materials, sample packaging and shipping, and laboratory services necessary to analyze and characterize wastes for storage, shipping, treatment, recycling, or disposal; meet all requirements of applicable regulations, FDA operating permits and licenses; monitor environmental media for waste related pollutants as directed by the COR and to meet waste characterization requirements of the contract. The Contractor shall perform all sampling and analysis of incompletely identified wastes necessary to accurately identify the waste in accordance with EPA and DOT requirements, the terms of this contract, and the requirements of the recycling facility or TSDF. The Contractor shall notify the COR of the presence of unidentified waste in the daily report of unprocessed waste and other issues. The Contractor shall complete the characterization of the waste within 45 days after sample collection. The Contractor shall have the capability to perform all required analyses, including chemical analysis of chemical/biological wastes, at qualified laboratories located off-site. The Contractor shall also be capable of providing appropriate tests for the characterization of the physical hazards in addition to the identification of specific chemicals. Examples of typical analyses requested of the Contractor shall include TCLP analyses of waste samples, wastewater discharge analyses, analyses of incinerator ash, analyses of animal tissue for chemical residue, and analyses of air samples from waste activities.

C.2.1.11 TRANSPORTING WASTES

If a release or incident involving FDA waste in transit occurs during transit, the Contractor shall notify the COR and/or the Contracting Officer (CO)as soon as possible and shall work under the direction of the local regulatory authority responding to the incident. The Contractor shall be responsible for cleanup and shall dispatch its own remedial resources to perform the cleanup operation or may use services as provided by or acceptable to regulatory authorities. The Contractor shall not ship any site cleanup residues for storage, treatment, or disposal without the prior knowledge of the COR or the Contracting Officer unless the Contractor is unable to contact either officer or emergency response requirements dictate immediate shipment.

The Contractor shall prepare all data and information required for waste transportation, treatment, or disposal as required by EPA, DOT, and the receiving facilities. A Uniform Hazardous Waste Manifest (EPA Form 8700-22, or latest version thereof) or the manifest required by the state receiving the waste shall be properly completed by the Contractor for all shipments of chemical and chemical/biological wastes. If the receiving state does not have a special manifest form, then the Contractor shall use the manifest of the generator state. The Contractor shall provide whatever manifests are required for each jurisdiction for the shipment of the wastes.

The Contractor shall complete a landfill ban notification and certification form, as required by 40 CFR 268.7 for all shipments of hazardous waste. This completed form must be submitted to the COR, or the designated waste coordinator, for review and signature along with the hazardous waste manifest. The signed original form must accompany the waste and the COR retains a copy of it.

The Contractor shall provide services to meet the Department of Transportation Emergency Response Communication Standards (49 CFR 171 and 172.604) applicable to the shipment of hazardous waste.

The Contractor shall include with the waste shipments adequate directions to contain a spill of the waste in the event such should happen. The Contractor may request SDS from FDA for materials shipped as waste to supplement this information. The Contractor assumes all responsibility of the waste should a spill or incident occurs during shipment, which places the waste at risk.

C.2.1.12 DISPOSAL OF WASTES

The Contractor shall provide appropriate transfer and TSDFs for all FDA wastes and surplus chemicals, which minimize the potential liability of FDA. All new or alternate transfer, storage, treatment and disposal facilities that the Contractor proposes to use for

FDA wastes which were not approved by FDA at the time of the initial contract award must be accepted in writing by the COR prior to use.

The Contractor shall provide the COR for review and approval any regulatory compliance documentation on any transfer or TSDF facility prior to the first use of a proposed facility. Minimally this document shall include:

1) copies of all regulatory permits and licenses (Permits for facilities used for chemical wastes must list all EPA and state hazardous waste numbers the facility is permitted to accept, and processes as described in 40 CFR 261, subparts C and D),

2) copies of environment impairment insurance binders,

3) copies of the last two regulatory inspections; and

4) a summary of the facility's regulatory compliance status including notices of violations, fines, RCRA corrective actions, compliance agreements, and permit modifications.

The Contractor shall not employ the services of a subcontractor, including TSDFs, without prior approval of the COR.

Storage, treatment, or disposal of hazardous chemical wastes shall only be carried out in facilities that have been issued final operating Part B permits (permitted TSDFs with full RCRA permit status) pursuant to RCRA and implemented by the hazardous waste regulatory authorities of jurisdiction. Facilities that have applied for permits, but are still in interim status, may be used only

(1) upon written certification by the Contractor that no fully permitted facilities are available for the waste, and (2) upon written approval by the COR of the interim facility status facility.

The COR's approval of a transfer facility or TSDF constitutes FDA's acceptance of the facility for use under this contract. It does not indemnify the Contractor, subcontractor, transporter, generator, or facility against the consequences of any present or future regulatory noncompliance or other form of liability.

The Contractor shall provide all necessary documentation to demonstrate that the waste received final treatment or disposal in accordance with the regulations to remove all hazardous properties. The Contractor shall either (1) treat the waste so that such waste no longer meets the definition of a hazardous waste in 40 CFR 261 et seq., or (2) dispose of the waste by a RCRA handling method specified in 40 CFR 264/265, appendix 1, Table 2, paragraphs 2 and 3. Waste handling codes that describe methods of storage do not meet the conditions of final treatment or disposal. Interim treatment of the waste whereas the waste remains hazardous as defined in 40 CFR 261 et seq. does not meet the conditions of final treatment or disposal under this contract. When wastes are shipped, the Contractor shall ensure that a clear audit trail exists for all shipments of wastes between FDA facilities and their final destination.

A Certificate of Final Disposition must itemize each container or drum received at the treatment or disposal facility by its assigned unique FDA transportation container number and document (1) its recycling, treatment, or disposal (RTD) date, (2) the method of recycling, treatment or disposal (by the EPA Treatment Code Number or official RTD name), and (3) the location and name of the RTD facility. This certificate shall be forwarded to the COR within six (6) months of the date the waste was received at the RTD facility. If the waste final disposition certificate cannot be issued for the entire waste pickup and some drums were treated six months prior to the other drums awaiting treatment/disposal, then a partial waste final disposition certificate must be issued by the Contractor.

If the FDA wastes are disposed of in a secured chemical landfill facility, the Certificate of Final Disposition shall also indicate the location within the landfill where the waste container was buried through the use of cell numbers, coordinates, or other appropriate permanent identifiers.

The Contractor shall receive written approval from the COR before shipping any waste to a recycling, treatment, storage, or disposal facility. All such facilities must minimize the potential liability for FDA, operate in compliance with all environmental laws, and provide a clear paper trail for the final disposition or recycling of the waste.

Recycling facilities and outlets must provide prompt reprocessing and reuse of the wastes, operate in compliance with all environmental regulations and provide a clear audit trail for the final disposition of the wastes. Prior to the first use of a proposed recycling facility, the Contractor shall submit all required compliance information for a facility or proposed recycling outlet to the COR for review and written approval. The COR may require the Contractor to furnish information on the proposed facility including, but not limited to: (1) current copies of the facility's operating permits and licenses, (2) copies of environmental impairment insurance binders, and (3) a description of end point use and final destination for all wastes and surplus materials received, including any waste residuals generated by the recycling process.

The Contractor shall provide a report for each recycling facility or outlet used under this contract when requested by the COR. The report shall include the following: (1) copies of the last two regulatory inspections, (2) copies of environmental impairment insurance binders, (3) copies of current regulatory permits and licenses, and (4) a summary of the facility's regulatory compliance status, including notices of violations, fines, RCRA corrective actions, compliance agreements, and permit modifications. The Contractor shall notify the CO and COR in writing of any significant changes in recycling facility operations, permits and licenses, and regulatory compliance issues, which may affect the Contractor's abilities to meet contractual obligations.

C.2.1.13 EMERGENCY SPILL RESPONSE

The Contractor shall provide an emergency spill response and remediation service to the FDA facilities within the metropolitan Washington, DC area to mitigate any chemical spills or releases. The Contractor shall be able to respond to any release or spill of hazardous materials within four (4) hours of telephoning the Contractor. The Contractor shall provide remediation services as needed at other FDA facilities. The Contractor shall ensure that all contractual personnel fully understand and comply with the contingency and spill prevention control and countermeasures plans of each FDA facility.

All FDA employees are evacuated during an emergency, none are permitted to assist in the emergency, and FDA operates emergency action plans meeting 29 CFR 1910.38 requirements. Non-routine and emergency services may be required for emergency response activities. The COR is the authorized individual who may request the emergency services. Emergency response to a spill or release shall take top priority. The Contractor shall be available for remediation of spills, to conduct emergency waste removals, and other emergency activities. The Contractor must respond to emergency spill situations or emergency waste removal requests within four hours (4) of notice.

C.2.1.14 SPECIAL SERVICES FOR DECOMMISSIONING FACILITIES AND

SPECIAL PROJECTS

The Contractor shall provide chemical and biological decommissioning services in accordance with applicable Federal, State and local laws and regulations as well as with specific task orders for such services. Such services are necessary when FDA plans to renovate or permanently vacate laboratory space. Chemical decommissioning typically includes the removal of confirmed contaminants, final sampling to ensure remediation efforts were successful, and submission of a report including all related documentation.

C.2.1.15 SAFETY SUPPORT SERVICES

The Contractor shall provide all labor, materials, and equipment necessary for the following listed safety support services:

1) Spill Station Maintenance:

2) Visitor Eyeglass Station Maintenance.

3) Emergency Shower Testing.

4) Restroom Bio-Hazardous Sharps Containers

5) Respirator fit testing using Government Furnished Equipment (GFE).

The Contractor shall provide safety and environmental services to aid in compliance with federal and state environmental, safety, and transportation regulations. Services shall include:

a. Chemical/waste/safety supply Audits & Inventory Management

b. Permits and License - Emergency communication devices, NRC license, UPS and FEDEX dangerous goods license software, CHEMTREC for all sites and inventory software support fees.

c. Safety Data Sheet (SDS) Development

C.2.2 RADIOACTIVE WASTE SCOPE OF WORK

The Contractor shall provide all aspects of a comprehensive, agency-wide, cradle to grave radioactive and mixed waste service for the FDA. Provide labor, materials, equipment, supplies and supervision to perform ancillary radiation services in accordance with established line items. The waste generated at FDA facilities will generally include, but is not limited to, radioactively contaminated: laboratory paper, plastic, glass, sealed sources, liquid scintillation fluids, aqueous liquids, spill materials, bio-hazardous (animal carcasses and excreta) and non-regulated laboratory items, (e.g.:

food, drugs).

The waste streams tend to be small in volume, and are primarily:

1) Dry Active Waste (DAW)

2) Aqueous Liquids (AQLD)

3) Mixed Waste (MW)

The specific objectives are:

a. Laboratory waste pickup of radioactive and mixed waste

b. Transport of waste from laboratories to radiation waste facility

c. Processing of radioactive and mixed waste

d. Sampling and analysis of the waste stream to identify and characterize wastes for storage, transportation, treatment or disposal

e. Off-site disposal of radioactive and mixed waste

f. Management and operation of radioactive waste facilities at FDA Facilities.

g. Responding to spills, leaks, or other environmental releases involving radioactive/mixed wastes and radioactive materials

h. Provide all labor, management support, data tracking services, vehicles, equipment, containers and supplies necessary for the collection, receiving, processing, packaging, transportation, treatment, sampling, analysis, of wastes being managed

i. Consultation services on LLRW management issues.

C.2.2.1 PICKUP PROCEDURES

The Contractor shall perform all radioactive and mixed waste pickups or moves and deliver replacement waste collection containers to the requester's work site and shall provide all tags, labels and forms required for marking, labeling, dating, identification and receipt of collected wastes.

C.2.2.2 TRANSPORTING WASTES

The Contractor shall provide all labor, equipment and supplies necessary for the safe transportation of wastes within and between FDA installations, and from FDA installations to FDA accepted off-site locations for treatment, storage, disposal, and recycling. The Contractor shall prepare applications for and procure all permits required for the operations of all the vehicles used by the Contractor.

C.2.2.3 MARSHALLING AND HANDLING OF COLLECTED WASTES

The Contractor shall transport the wastes collected to the FDA waste management facility. The collected waste must be off-loaded to the appropriate area, segregated, characterized and processed for shipment to off-site disposal or for on-site treatment.

C.2.2.4 PRELIMINARY PROCESSING PROCEDURES

The Contractor shall perform preliminary processing for the different types of radioactive waste. This may require the use of different size disposal containers, flammable requirements for bulking, and offsite burial.

C.2.2.5 PACKAGING, LABELING, MARKING OF WASTE STORAGE &

SHIPPING CONTAINERS

Each type of DAW placed in on-site storage for radioactive decay shall be segregated and labeled in accordance with FDA’s NRC radioactive materials license. Conditions are listed as follows:

a. Each container shall have the following information affixed to the top:

the date the container was sealed, the longest-lived isotope in the drum, total activity, the date when the isotope with the longest half-life will reach its tenth half-life, and the name of the individual who sealed the container.

b. Before disposal as regular waste a report including the following shall be submitted to the COR for review: The date when the byproduct material was placed in storage, the disposal date, the radionuclide disposed, the total volume stored, the survey instrument used, the background dose rate, the dose rate measurement at the surface of the waste container, and the name of the individual who performed the disposal.

Waste, which is to be shipped off-site for disposal, shall be packaged to meet all DOT shipping requirements and processing or disposal facility acceptance criteria.

C.2.2.6 WASTE CHARACTERIZATION AND ANALYSIS

The Contractor shall provide all sampling equipment, supplies, materials, sample packaging and shipping, and laboratory services necessary to analyze and characterize radioactive and mixed wastes for storage, shipping, treatment, recycling, or disposal;

meet all requirements of applicable regulations, FDA operating permits and licenses;

monitor environmental media for waste related pollutants as directed by the COR and to meet waste characterization requirements of the contract. In general, characterization shall be accomplished by evaluation, compilation, and review of, data from waste observations; sampling and analysis; comparison with existing waste profile data; and by generator and Contractor knowledge of generator…