Attachment J-3B Samp Task Order SOW CFSAN 75F40123R00003.pdf

Attachment J-3B Task Order SOW (CFSAN)

TASK ORDER FOR CFSAN FOR COMPREHENSIVE WASTE MANAGEMENT SERVICES

CHEMICAL, RADIOACTIVE MEDICAL PATHOLOGICAL WASTE COLLECTION, MINIMIZATION

AND DISPOSAL SERVICE, DANGEROUS GOODS SHIPPING AND MULTI-HAZARDOUS MATERIAL

INVENTORY MANAGEMENT SERVICES

NOTE: The Government reserves their right to revise the number and types of services being requested.

CFSAN

Site Specific Waste Scope of Work

Background Information

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

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.

General Requirements

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 the following:

1) 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;

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

3) Characterization of unknown chemicals, radioactive materials, and gases;

4) Identification of controlled substances for disposal;

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

6) Relocation of hazardous materials to other facilities;

7) Biological decontamination of laboratory suites and equipment in conjunction with industry methods for validating the effectiveness of the decontamination process

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

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

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

11) Temporary Temperature Controlled Trailer Storage

12) Surplus Environmental Equipment Pickup form MCTR and GCSL line item 20 C & D

13) Multi-Hazardous Material Inventory Management Services

14) Technical engineering evaluation of waste storage areas to facilitate waste handling

Government Responsibilities

The generator (the person that creates the waste) is responsible for properly identifying and labeling wastes and surplus chemicals prior to removal by the Contractor.

The FDA will provide training to all new permanent contract staff on the FDA Contingency Plan and Emergency Procedures as required by 40 CFR 265.16. Annual updates of this training will also be provided.

Scheduling

The Contractor shall provide the services described in this contract during routine working hours, 7:00AM – 4:00 PM, 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 emergency response activities. This will be the exception and not the rule. If necessary, arrangements will be coordinated through the COR or designated dangerous goods shipping coordinator.

Non-routine and emergency services may be required for emergency response activities, or to accommodate unusual workloads. The COR is the authorized individual who may request the additional 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.

Compliance

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 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 contract.

Environmental Compliance

FDA realizes its responsibility of being a good steward to the environment and maintains a proactive relationship with all regulatory agencies to fulfill this responsibility. It is FDA’s goal to achieve compliance at all facilities by having a proactive environmental management program in place. Contractors that work for FDA must realize how important environmental management is to the agency, and in turn, must act as an active partner in FDA’s environmental management program. It is extremely important for the FDA to have a sound environmental management program that fully supports its regulatory and research missions.

The Contractor shall comply with all federal, state, interstate, and local laws, regulations, ordinances, and FDA facility operating permits and licenses applicable to activities and services performed under this contract. Failure to comply with all applicable Federal, State, and local hazardous waste regulations may result in the termination of the contract.

The Contractor shall have all trucks maintained in good operating condition; shall have all stickers, permits, and licenses required by federal, state, interstate and local authorities for the transportation of wastes and hazardous materials in commerce; and shall have vehicles suitable for the task of safely transporting, loading, and unloading such wastes and materials at the FDA facilities. The Contractor shall have certified drivers using certified transport vehicles (vehicles which have passed a DOT examination) to transport wastes via trucks in route to EPA permitted hazardous waste transfer, storage, and disposal facilities (TSDRF). The Contractor shall placard all vehicles hauling hazardous wastes or materials on the open highway in accordance with DOT regulations.

The Contractor shall have all applicable licenses and permits necessary to perform the work required under this contract prior to the start of the work.

The Government will not be liable to the Contractor for the cleanup of spills, accidental releases to the environment, or potential exposures of contract personnel, due to the fault of the Contractor or their Subcontractors.

Chemical / Regulatory Compliance

The Contractor shall compile and assist the COR to file Federal and state hazardous waste activity reports when and where required. For example, the Code of Maryland Regulations (COMAR 26.13.03.06B requires the filing of a report on hazardous waste generation once every two years.)

The Contractor must inform the COR as soon as possible about any regulatory issues actually or perceptually involving FDA's waste which may result from Federal, State, or local inspections of the Contractor's waste handling facilities.

The Contractor shall notify the COR within five days of any such incidents or regulatory issues by means of a full, written report.

Radioactive / Regulatory Compliance

The Contractor shall provide all aspects of a comprehensive, cradle-to-grave chemical/ radioactive and mixed waste service for the FDA. The Contractor shall perform all contract operations in compliance with applicable occupational health and safety, transportation, environmental protection and radiation control regulations.

Medical Pathological / Regulatory Compliance

The agencies and regulatory titles listed below constitute the primary regulatory framework under which waste management operations described in this contract must be carried out. 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:

Dangerous Goods Shipping / Regulatory Compliance

This dangerous goods service will be exercised by the site-specific COR.

Multi-Hazardous Material Inventory Management / Regulatory Compliance

The Contractor shall comply with applicable federal, state, and local laws, regulations, ordinances, and proposed FDA Safety Management Guide (SMG) for activities and services performed under this contract. This hazardous material inventory management service will be exercised by the site-specific

COR.

Integration of Services

The Contractor shall integrate the chemical, radioactive and medical pathological waste services, Dangerous Goods Shipping and Multi-Hazardous Material Inventory Management Services where possible to maximize effective use of personnel, equipment and supplies. Extreme care shall be taken to minimize the potential for cross contamination of radioactive, biological and chemical wastes by use of separate containment within collection vehicles, carts and or/trucks. Management of daily activities must be coordinated between the Contractor's operational supervisors. Incorporation of the Dangerous Goods Shipping and Multi-Hazardous Material Inventory Management for FDA Nationwide.

OSHA Requirements

The Contractor is responsible to address OSHA's requirements in 29 CFR 1910.120 for hazardous waste operations and emergency response for such operations, as they relate to the health and safety of the Contractor's employees.

Emergency Response and Remediation of Spills

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.

Hazardous Material Emergency Response

The Contractor shall provide emergency spill response and cleanup services to the FDA facilities nationwide to mitigate any radioactive spills or releases. The Contractor shall respond to any situation where there is a release or spill of radioactive materials within four (4) hours of telephone notice by the COR.

Dangerous Goods Shipping Emergency Response

A person who offers a hazardous material for transportation must provide an emergency response telephone number, if required, (including the area code or international access code) for use in the event of an emergency involving the hazardous material.

1. UNMC has registered with CHEMTREC to provide emergency response information. CHEMTREC was founded by members of the Chemical Manufacturers Association and is the nation's premier hazardous material emergency response source. CHEMTREC specialists have access to over 1.5 million SDSs and can ensure that emergency personnel at the scene of an accident or spill have the assistance they need.

2. All shippers will use the CHEMTREC telephone number as the emergency contact number for domestic shipments. The CHEMTREC number is (800) 424-9300.

3. If the package is shipped outside the USA, then you must also add the international telephone number (703) 527-3887.

4. Certified shippers must keep on file, available for inspection, shipping documentation (air bills, shipper’s declarations, and bill of lading) for two (2) years after the acceptance of the material by the initial carrier.

Shippers must also keep current copies of vendor package

Housekeeping and Maintenance Responsibilities

The Contractor shall provide all labor, materials, and equipment necessary to maintain the waste marshalling area in the same condition as when the Contractor arrives. Acceptable housekeeping includes proper placement of wastes, containers, materials, and equipment so as to provide a safe, healthful, clean, neat, and well-organized working environment within all of the FDA facilities.

Security Requirements

The Contractor shall take all reasonable precautions to ensure that the security of all FDA personnel, research programs, facilities, property, data, records, and materials are not jeopardized by contract operations.

Contractor must comply with both physical and personnel FDA security requirements including the immediate reporting of suspicious individuals in FDA facilities. FDA security will provide a briefing on requirements upon award of the contract.

Chemical Waste Scope of Work (See IDIQ for further details)

The Contractor shall provide all aspects of a comprehensive, agency-wide, cradle to grave chemical waste service for the FDA. The Contractor shall perform all contract operations in compliance with applicable occupational health and safety, transportation, environmental protection and hazardous material control regulations.

The specific objectives are:

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

Site Specific Chemical Waste SOW CFSAN-College Park

1) Report to site on each Friday.

2) Pick-up hazardous/chemical waste as directed by the site project officer (SPO), as requested by recorded message by the research community, and by sweeping the laboratory satellite accumulation areas.

3) Identified waste shall be removed from laboratories only when accompanied with a completed waste form.

4) The Contractor shall provide an empty 5 gallon containers, one gallon and half gallon wide mouth containers, and blank self-adhesive label for each container removed.

5) The Contractor shall remove empty reagent containers from the chemical stock room’s designated area. The containers shall be taken to the 90 day area. The containers will be properly disposed of.

6) The waste will be spot tested in the 90 day accumulation area to assure accuracy of the constituents listed on the waste form (e.g., pH test paper test, KI-Starch paper spot oxidizer test).

7) Waste will be segregated by hazard class/compatibility in the 90 day hazardous waste storage area.

Shipping containers and/or temporary secondary storage containers will be marked with the words “Hazardous Waste” and the accumulation start date (the date the container was brought to the 90 day area).

8) The waste form will be completed by adding the date entered into the 90 day area and initialed.

9) Prior to the allowed 90 day accumulation time, the waste will be processed in one the following ways:

a ) The container will be shipped as is.

b) The contents of the container will be consolidated into a larger container ,or

c) The container will be lab packed.

10) The resulting containers will be profiled and scheduled into TSDF., Inc, as necessary.

11) The containers will be entered on a Hazardous Waste manifest, labeled and marked per DOT and EPA, and State specifications. Land ban notifications will be prepared. A cross reference sheet and container content sheets will be prepared.

12) The paperwork package will be presented in an orderly fashion to the SPO for examination and execution prior to the shipment.

13) On the following Friday morning, the Contractor Project Manager shall meet with the SPO to make necessary changes to the paperwork and to receive executed copied of the manifests.

14) The Waste shall be transported to the assigned Treatment, Storage, or Disposal Facility.

15) A Detailed summary of the shipment will be entered into a Microsoft Access data base for Biennial reporting requirements.

16) A detailed accounting of Time and Material provided on this specific task order will be prepared by the end of each working week (weekly statement). This statement will be in Microsoft Excel Format.

17) Weekly statements will be tabulated for each task order which work was performed in that calendar month at the end of each month. An Excel spreadsheet will be prepared in the format of Line Item Costing in the contract with the addition of the following data: Monthly starting quantities for each line item provide in the task, ending quantities, Quantities used during the month, a monthly Cost Total, and financial beginning balance and ending balance. This spread sheet will track bio-hazardous and Radiological waste activities as well.

18) Each shipment cycle will be assigned a unique number. As a shipping cycle is completed the weekly statements will be tabulated yielding a total cost for this shipment. This information will be maintained in an Access Database.

19) The Contractor shall provide all necessary shipping containers. Containers that were consolidated will be either rinsed and reused or disposed of.

20) The Contractor shall maintain adequate materials and supplies to perform this scope of work as well as spill mitigation supplies.

21) Manifest Copy 3: TSD Facility: Mail to Generator will be mailed to the SPO.

22) Biennial reports will be prepared and delivered to the CPO by February 15 of each odd numbered year.

23) The Contractor shall perform a weekly inspection of the 90 day accumulation area per 40CFR262.34.

Site Specific Chemical Waste SOW CFSAN-MOD1/BRF

1) Report to site on the first working Monday of the month.

2) Pick-up hazardous/chemical waste as directed by the site project officer (SPO), or by roving the hallways and inquiring of the research community as to their chemical waste removal needs.

3) Identified waste will be removed from laboratories only when accompanied with a completed waste form.

4) The Contractor shall provide an empty 5 gallon containers and blank self-adhesive label for each container removed.

5) The Contractor shall remove empty reagent containers from the chemical stock rooms designated area. The containers will be taken to the 90 day area. The containers shall be properly disposed of.

6) The waste will be spot tested in the 90 day accumulation area to assure accuracy of the constituents listed on the waste form (e.g., pH test paper test, KI-Starch paper spot oxidizer test).

7) Waste will be segregated by hazard class/compatibility in the 90 day hazardous waste storage area.

Shipping containers and/or temporary secondary storage containers will be marked with the words “Hazardous Waste” and the accumulation start date (the date the container was brought to the 90 day area).

8) The waste form will be completed by adding the date entered into the 90 day area and initialed.

9) After the third pick-up cycle the waste will be processed in one the following ways:

d) The container will be shipped as is.

e) The contents of the container will be consolidated into a larger container ,or

f) The container will be lab packed.

10) The resulting containers will be profiled and scheduled into TSDF., Inc, as necessary.

11) The containers will be entered on a Hazardous Waste manifest, labeled and marked per DOT and EPA, and State specifications. Land ban notifications will be prepared. A cross reference sheet and container content sheets will be prepared.

12) The paperwork package will be presented in an orderly fashion to the SPO for examination and execution prior to the shipment.

13) On the following Thursday morning, the Contractor Project Manager will meet with the SPO to make necessary changes to the paperwork and to receive executed copied of the manifests.

14) The Waste will be transported to the assigned Treatment, Storage, or Disposal Facility.

15) A Detailed summary of the shipment will be entered into a Microsoft Access data base for Biennial reporting requirements.

16) A detailed accounting of Time and Material provided on this specific task order will be prepared by the end of each working week (weekly statement). This statement will be in Microsoft Excel Format.

17) Weekly statements will be tabulated for each task order which work was performed in that calendar month at the end of each month. An Excel spreadsheet will be prepared in the format of Line Item

18) Costing in the contract with the addition of the following data: Monthly starting quantities for each line item provide in the task, ending quantities, Quantities used during the month, a monthly Cost Total, and financial beginning balance and ending balance. This spread sheet will track bio-hazardous and Radiological waste activities as well.

19) Each shipment cycle will be assigned a unique number. As a shipping cycle is completed the weekly statements will be tabulated yielding a total cost for this shipment. This information will be maintained in an Access Database.

20) The Contractor shall provide all necessary shipping containers. Containers that were consolidated will be either rinsed and reused or disposed of.

21) The Contractor shall maintain adequate materials and supplies to perform this scope of work as well as spill mitigation supplies.

22) Manifest Copy 3: TSD Facility: Mail to Generator will be mailed to the SPO.

23) Biennial reports will be prepared and delivered to the CPO by February 15 of each odd numbered year.

24) The Contractor shall perform a weekly inspection of the 90 day accumulation area per 40CFR262.34.

Site Specific Chemical Waste SOW CFSAN-University Station

1) Report to site on each Tuesday.

2) Pick-up hazardous/chemical waste and broken glass as directed by the site project officer (SPO) or his representative. A list waste needs to be pick-up will be provided.

3) Identified waste will be removed from laboratories only when accompanied with a completed waste form.

4) The Contractor shall provide an empty 5 gallon container and blank self-adhesive label for each container removed.

5) The Contractor shall remove empty reagent containers from the chemical stock room area. The containers will be taken to the 90 day area. The containers will be properly disposed of.

6) The waste will be spot tested in the 90 day accumulation area to assure accuracy of the constituents listed on the waste form (e.g., pH test paper test, KI-Starch paper spot oxidizer test).

7) Waste will be segregated by hazard class/compatibility in the 90 day hazardous waste storage area.

Shipping containers and/or temporary secondary storage containers will be marked with the words “Hazardous Waste” and the accumulation start date (the date the container was brought to the 90 day area).

8) The waste form will be completed by adding the date entered into the 90 day area and initialed.

9) Prior to the allowed 90 day accumulation time, the waste will be processed in one the following ways:

g) The container will be shipped as is.

h) The contents of the container will be consolidated into a larger container ,or

i) The container will be lab packed.

10) The resulting containers will be profiled and scheduled into TSDF., Inc, as necessary.

11) The containers will be entered on a Hazardous Waste manifest, labeled and marked per DOT and EPA, and State specifications. Land ban notifications will be prepared. A cross reference sheet and container content sheets will be prepared.

12) The paperwork package will be presented in an orderly fashion to the SPO for examination and execution prior to the shipment.

13) On the following Friday morning, the Contractor Project Manager will meet with the SPO to make necessary changes to the paperwork and to receive executed copied of the manifests.

14) The waste will be transported to the assigned Treatment, Storage, or Disposal Facility.

15) A Detailed summary of the shipment will be entered into a Microsoft Access data base for Biennial reporting requirements.

16) A detailed accounting of Time and Material provided on this specific task order will be prepared by the end of each working week (weekly statement). This statement will be in Microsoft Excel Format.

17) Weekly statements will be tabulated for each task order which work was performed in that calendar month at the end of each month. An Excel spreadsheet will be prepared in the format of Line Item Costing in the contract with the addition of the following data: Monthly starting quantities for each line item provide in the task, ending quantities, Quantities used during the month, a monthly Cost Total, and financial beginning balance and ending balance. This spread sheet will track bio-hazardous and Radiological waste activities as well.

18) Each shipment cycle will be assigned a unique number. As a shipping cycle is completed the weekly statements will be tabulated yielding a total cost for this shipment. This information will be maintained in an Access Database.

19) The Contractor shall provide all necessary shipping containers. Containers that were consolidated will be either rinsed and reused or disposed of.

20) The Contractor shall maintain adequate materials and supplies to perform this scope of work as well as spill mitigation supplies.

21) Manifest Copy 3: TSD Facility: Mail to Generator will be mailed to the SPO.

22) Biennial reports will be prepared and delivered to the CPO by February 15 of each odd numbered year.

23) The Contractor shall perform a weekly inspection of the 90 day accumulation area per 40CFR262.34.

Site Specific Chemical Waste SOW CFSAN-Moffet Center, Dauphin Island

1) Pick-up hazardous/chemical waste as directed by the site project officer (SPO). The SPO will provide completed waste forms two weeks prior for all waste to be picked up.

2) The waste will be spot tested to assure accuracy of the constituents listed on the waste form (e.g., pH test paper test, KI- Starch paper spot oxidizer test).

3) The waste will be processed in one the following ways:

j) The container will be shipped as is.

k) The container will be lab packed.

4) The resulting containers will be profiled and scheduled into the Contractor, as necessary.

5) The containers will be entered on a Hazardous Waste manifest, labeled and marked per DOT and EPA, and State specifications. Land ban notifications will be prepared. A cross reference sheet and container content sheets will be prepared.

6) The paperwork package will be presented in an orderly fashion to the SPO for review and approval in enough advanced time as to not hinder the shipment of the waste.

7) The Waste will be transported to the assigned Treatment, Storage, or Disposal Facility.

8) A Detailed summary of the shipment will be entered into a Microsoft Access data base for Biennial reporting requirements.

9) A detailed accounting of Time and Material provided on this specific task order will be prepared by the end of each working week (weekly statement). This statement will be in Microsoft Excel Format.

10) Weekly statements will be tabulated for each task order which work was performed in that calendar month at the end of each month. An Excel spreadsheet will be prepared in the format of Line Item Costing in the contract with the addition of the following data: Monthly starting quantities for each line item provide in the task, ending quantities, Quantities used during the month, a monthly Cost Total, and financial beginning balance and ending balance. This spread sheet will track bio-hazardous and Radiological waste activities as well.

11) Each shipment cycle will be assigned a unique number. As a shipping cycle is completed the weekly statements will be tabulated yielding a total cost for this shipment. This information will be maintained in an Access Database.

12) The Contractor shall provide all necessary shipping containers. Manifest Copy 3: TSD Facility: Mail to Generator will be mailed to the SPO.

13) Biennial reports will be prepared and delivered to the CFSAN CPO by February 15 of each odd numbered year.

Site Specific Chemical Waste SOW CFSAN-Ammendale

1) Pick-up hazardous/chemical waste as directed by the site project officer (SPO) every three months.

2) The Contractor shall provide an empty 55 gallon containers for each container removed.

3) The resulting containers will be profiled and scheduled into TSDF., Inc, as necessary.

4) The containers will be entered on a Hazardous Waste manifest or Bill of Lading, labeled and marked per DOT and EPA, and State specifications. Land ban notifications will be prepared. A cross reference sheet and container content sheets will be prepared.

5) The paperwork package will be presented in an orderly fashion to the SPO for examination and execution prior to the shipment.

6) The Waste will be transported to the assigned Treatment, Storage, or Disposal Facility.

7) A Detailed summary of the shipment will be entered into a Microsoft Access data base for Biennial

8) reporting requirements.

9) A detailed accounting of Time and Material provided on this specific task order will be prepared by the end of each working week (weekly statement). This statement will be in Microsoft Excel Format.

10) Weekly statements will be tabulated for each task order which work was performed in that calendar month at the end of each month. An Excel spreadsheet will be prepared in the format of Line Item Costing in the contract with the addition of the following data: Monthly starting quantities for each line item provide in the task, ending quantities, Quantities used during the month, a monthly Cost Total, and financial beginning balance and ending balance. This spread sheet will track bio-hazardous and Radiological waste activities as well.

11) Each shipment cycle will be assigned a unique number. As a shipping cycle is completed the weekly statements will be tabulated yielding a total cost for this shipment. This information will be maintained in an Access Database.

12) Biennial reports, if necessary, will be prepared and delivered to the CPO by February 15 of each odd numbered year.

Radioactive Waste SOW (See IDIQ for further details)

The Contractor shall provide all aspects of a comprehensive, agency-wide, cradle to grave radioactive and mixed waste service for the FDA. The Contractor shall perform all contract operations in compliance with applicable occupational health and safety, transportation, environmental protection and radiation control regulations.

1. Laboratory waste pickup of radioactive and mixed waste

2. Transport of waste from laboratories to radiation waste facility

3. Processing of radioactive and mixed waste

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

5. Off-site disposal of radioactive and mixed waste

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

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

8. 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

9. Consultation services on LLRW management issues.-

10. Provide labor, materials, equipment, supplies and supervision to perform ancillary radiation services in accordance with established line items

Site Specific Radioactive Waste SOW CFSAN – MOD1

1) Report to site on date scheduled by site project officer (SPO).

2) Pick-up prepackaged radioactive waste as directed by the SPO from radioactive material use laboratories and/or storage areas.

3) The waste will be inspected and segregated into waste types for final shipment packaging. Waste will be packaged according to profile and waste acceptance criteria of the assigned receiving facility.

4) The shipment paperwork, including a radioactive shipment record (manifest) and hazardous waste manifest (if required) and land ban (if required) will be presented in an orderly fashion to the SPO, or designee, once all packages have been inspected and entered onto the manifest.

5) Once the SPO, or designee has signed the paperwork, the waste will be loaded for transport to the assigned Disposal Facility.

6) A copy of the completed Manifest(s) will be mailed to the SPO once the waste has been disposed.

Medical Pathological Waste Scope of Work (See IDIQ for further details)

The Contractor shall provide medical pathological waste services. It may include, but is not limited to, bio contaminated lab ware, broken glass, sharps, human tissue, blood and blood derivatives and small and large animal tissues and carcasses. The Contractor shall provide a means of disposing carcasses, such as a large, 1-cubic yard rolling cart, that is compliant with federal and local regulations and poses minimal additional handling or preparation on the part of the generator.

a ) Pick up, loading, manifesting, transportation, treatment, and/or disposal of such wastes at specified facilities.

b) Emergency response to spills, leaks, accident cleanup, or other environmental releases involving biohazardous materials.

c) BSL-3 Lab decontamination services.

Site Specific Medical Pathological Waste SOW CFSAN-College Park

1) Report to site each Tuesday (non-holiday).

2) Pick-up prepackaged biological waste as directed by the site project officer (SPO) from a single predetermined marshalling area.

3) The waste shall be inspected for proper packaging and weighed. Boxes weighing more than 40 gross pounds will either be refused for collection or accepted for transport and billed at a per pound rate.

4) For each package accepted for transport, one box and one liner will be left in replacement.

5) The number of packages and weight of all packages will be entered on a Medical Waste manifest and all packages will be marked per DOT and State specifications.

6) The shipment paperwork will be presented in an orderly fashion to the SPO, or designee once all packages have been inspected and entered onto the manifest.

7) Once the SPO, or designee, has signed the manifest, the waste will be loaded for transport to the assigned

Disposal Facility.

8) A copy of the completed Manifest will be mailed to the SPO once the waste has been disposed.

Site Specific Medical Pathological Waste SOW CFSAN-MOD1

1) Report to site each Tuesday (non-holiday).

2) Pick-up prepackaged biological waste as directed by the site project officer (SPO) from a single predetermined marshalling area.

3) The waste shall be inspected for proper packaging and weighed. Boxes weighing more than 40 gross pounds will either be refused for collection or accepted for transport and billed at a per pound rate.

4) For each package accepted for transport, one box and one liner will be left in replacement.

5) The number of packages and weight of all packages will be entered on a Medical Waste manifest and all packages will be marked per DOT and State specifications.

6) The shipment paperwork will be presented in an orderly fashion to the SPO, or designee once all packages have been inspected and entered onto the manifest.

7) Once the SPO, or designee has signed the manifest, the waste will be loaded for transport to the assigned

Disposal Facility.

8) A copy of the completed Manifest will be mailed to the SPO once the waste has been disposed.

Dangerous Goods Shipping SOW (See IDIQ for further details)

The Contractor shall be responsible for shipping dangerous goods.

UPS and FDEX require shipper (FDA) to have dangerous goods software and a subscription to ship dangerous goods. Software to be purchased by FDA and installed by IT.

d) Classifying the material – Is it regulated? Is it forbidden for transport?

e) Identifying the material – select the proper shipping name

f) Choosing the right packaging

g) Packaging it correctly

h) Marking & Labeling the shipment correctly

i) Supplying additional required documentation – dangerous goods declaration forms

j) Making shipping arrangements – i.e. permits, customs documents for overseas shipments

k) Transporting things safely around FDA locations – hand carrying & vehicle transport

Dangerous Goods Shipping SOW CFSAN

1) Offer assistance when needed to S&R at CP and MOD1for outgoing DGS.

2) Offer assistance when needed to CSDO’s at GCSL and MCTR for outgoing DGS.

3) Work with S&R and CSDO’s in maintaining an inventory supply of DGS supplies for all sites.

4) Transport DGS between local FDA and Government Facilities.

5) Be available to classify, identify, select packing, pack, mark and label, complete paperwork and ship DGS via approved FDA / CFSAN carrier upon request .

Multi-Hazardous Material Inventory Management SOW (See IDIQ for further details)

The Contractor shall be responsible for inventory control and delivery.

Laboratory operations at the Food and Drug Administration (FDA) frequently receive hazardous materials that need to be kept in an inventory according to Federal regulations (Emergency Planning and Community Right to Know Act, otherwise known as EPCRA, Sections 311 and 312).

This data will be collected and either put directly into the inventory database program or populated into an Excel spreadsheet in a format that can be imported into the chemical inventory database program. The ESO will provide additional guidance on proper use of the chemical inventory database program as needed. The Contractor shall also be capable of identifying any chemicals that may be hazardous in their current condition e.g. (peroxide forming chemicals stored past their expiration due date, damaged or corroded chemical containers, improperly stored chemicals, etc.). Any hazardous materials identified as hazardous in their current condition shall be reported to the ESO and COR.

l) Procure services to complete a comprehensive inventory of laboratory hazardous materials

(chemical, radioactive, and biological materials).

m) Manage the chemical inventory system.

This data will be collected and either put directly into the inventory database program or populated into an Excel spreadsheet in a format that can be imported into the hazardous material inventory database program.

The FDA Biosafety Officer (BSO) will provide additional guidance on proper use of the biological inventory database program as needed. The Contractor shall also be capable of identifying any biological materials. Any biological materials identified as hazardous in their current condition should be reported to the BSO and COR.

Multi-Hazardous Material Inventory Management SOW CFSAN- College Park

1. Report to site on every Monday and Friday.

2. Chemical inventory in College Park will be processed in three ways. TES employee will have to

i. Coordinate with Shipping & Receiving to take inventory of chemicals in stock room

ii. Coordinate with the researchers to take inventory of chemicals (after the pre barcoded chemicals are delivered for the researchers’ urgent needs)

iii. Coordinate with the researchers to take inventory of existing chemicals in the lab

3. For chemicals in the stock room for College Park, Shipping & Receiving will place incoming chemicals on the designated shelf for inventory purposes.

4. Before Health Rx system is up and running, TES employee will take inventory of the chemicals by using preprinted barcode labels and excel spread sheet provided by Health Rx.

5. The Contractor employee shall inventory the chemicals from that shelf by assigning a barcode to each chemical.

6. The Contractor employee shall input data on each chemical in the following ways:

i. Barcode

ii. CAS

iii. IUPAC name iv . Manufacturer

v. Grade/concentration,

vi. Quantity

vii. Unit

viii. Hazard class, ix . Potentially hazardous to environment

x. Location

xi. Lab

xii. Responsible party

xiii. Received date* xiv . Expiration date*

(Please refer to Standard Operating Procedure for details)

7. The Contractor employee shall assign the dates following the steps above for all chemicals except peroxide formers. Special rule: Peroxide forming chemicals will have 1 year expiration date from the day that they are opened.

8. After chemicals in the stock room are barcoded and inventoried accordingly, the Contractor employee shall record the data in the excel spreadsheet provided by Health Rx.

9. If there is any chemical spill or leakage during the inventory process, isolate the chemical container in a gray tote, place it under the fume hood and contact Contracting Officer Representative (COR) or Site Project Officer (SPO) immediately.

10. Expired chemicals in the stock room are not required to get barcoded. However, the Contractor employee shall be responsible for notifying COR and the responsible party for any expired chemical found in the stock room.

11. After taking inventory of the chemicals in the stock room, the Contractor employee will notify Shipping & Receiving.

12. Shipping & Receiving will stock and deliver the barcoded chemicals to the researchers. The Contractor employee is not responsible for stocking and delivering of the barcoded chemicals.

13. Shipping & Receiving is responsible for notifying the Contractor employee about the transfer of chemicals from the stock room to the labs in College Park via email. Shipping & Receiving is required to provide the Contractor employee with the barcode number, chemical name, researcher’s name and the room number of the lab.

14. The Contractor employee shall update the inventory database based upon the information provided by Shipping & Receiving about the transfer of chemicals.

15. Stock room inventory will occur on a regular basic. Once the existing chemicals in the stock room are inventoried, the Contractor employee shall focus on lab inventory in College Park.

16. For the chemicals that are taken out of the stock room before the inventory can occur (for the researcher’s urgent needs), the inventory will take place in following ways:

a . Shipping & Receiving is required to write down the researcher’s name, room number and the name of the chemical at a minimum and provide that information to the Contractor employee.

b. The Contractor employee shall then contact the researcher to barcode the chemical and record the data in inventory database.

Or

c. The researcher will need to communicate with either Shipping & Receiving or the Contractor employee or both about the transfer of chemical from stock room to the lab.

d. The Contractor employee shall meet with the researcher to barcode the chemical and record the data in inventory database.

17. For chemicals in the labs, the Contractor employee shall coordinate lab inventory with Principal Investigator (PI) of the lab.

18. The Contractor employee will identify and collect chemicals that are expired in the lab.

19. PI will decide which chemicals to keep as their standard. If some chemicals are considered to be standard 5 year expiration date does not apply to those chemicals.

20. The Contractor employee shall work with the PI to assign an expired date which will be 5 more years added.

21. The Contractor employee shall issue a sticker (which identifies Standards) to the PI.

22. The Contractor employee shall coordinate with the PI and waste management team to dispose the unwanted expired chemicals safely.

23. Waste management shall then dispose the expired chemicals as a result of the inventory.

24. The Contractor employee will barcode the existing chemicals in the lab and uploads the data into inventory database.

25. The Contractor employee will conduct reconciliation annually in each work site and update the database as needed.

Multi-Hazardous Material Inventory Management SOW CFSAN- MRC

1. Report to site on every Tuesday.

2. Chemical inventory in Mod 1 will be processed in three ways. TES employee will have to

i. Coordinate with Shipping & Receiving to take inventory of chemicals in stock room

ii. Coordinate with the researchers to take inventory of chemicals (after the pre barcoded chemicals are delivered for the researchers’ urgent needs)

iii. Coordinate with the researchers to take inventory of existing chemicals in the lab

3. For chemicals in the stock room for Mod 1, Shipping & Receiving will place incoming chemicals on the designated shelf for inventory purposes.

4. Before Health Rx system is up and running, TES employee will take inventory of the chemicals by using preprinted barcode labels and excel spread sheet provided by Health Rx.

5. The Contractor employee shall inventory the chemicals from that shelf by assigning a barcode to each chemical.

6. The Contractor employee shall input data on each chemical in the following ways:

a . Barcode

b. CAS

c. IUPAC name

d. Manufacturer

e. Grade/concentration,

f. Quantity

g. Unit

h. Hazard class,

i. Potentially hazardous to environment

j. Location

k. Lab

l. Responsible party

m. Received date*

n. Expiration date*

(Please refer to Standard Operating Procedure for details)

7. The Contractor employee shall assign the dates following the steps above for all chemicals except peroxide formers. Special rule: Peroxide forming chemicals will have 1 year expiration date from the day that they are opened.

8. After chemicals in the stock room are barcoded and inventoried accordingly, the Contractor employee shall record the data in the excel spreadsheet provided by Health Rx.

9. If there is any chemical spill or leakage during the inventory process, isolate the chemical container in a gray tote, place it under the fume hood and contact COR or SPO immediately.

10. Expired chemicals in the stock room are not required to get barcoded. However, TES employee is responsible for notifying COR and the responsible party for any expired chemical found in the stock room.

11. After taking inventory of the chemicals in the stock room, the Contractor employee shall notify Shipping & Receiving.

12. Shipping & Receiving will stock and deliver the barcoded chemicals to the researchers. The Contractor employee is not responsible for stocking and delivering of the barcoded chemicals.

13. Shipping & Receiving is responsible for notifying the Contractor employee about the transfer of chemicals from the stock room to the labs in University Station via email. Shipping & Receiving is required to provide the Contractor employee with the barcode number, chemical name, researcher’s name and the room number of the lab.

14. The Contractor employee shall update the inventory database based upon the information provided by Shipping & Receiving about the transfer of chemicals.

15. Stock room inventory shall occur on a regular basic. Once the existing chemicals in the stock room are inventoried, the Contractor employee will focus on lab inventory in Mod 1.

16. For the chemicals that are taken out of the stock room before the inventory can occur (for the researcher’s urgent needs), the inventory will take place in following ways:

a . Shipping & Receiving is required to write down the researcher’s name, room number and the name of the chemical at a minimum and provide that information to TES employee.

b. The Contractor employee shall then contact the researcher to barcode the chemical and record the data in inventory database.

c. The researcher will need to communicate with either Shipping & Receiving or the

Contractor employee or both about the transfer of chemical from stock room to the lab.

d. The Contractor employee shall meet with the researcher to barcode the chemical and record the data in…