SJDO_TE-18 Federal Requireme.pdf

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Attached to
FDA San Juan Operations and Maintenance Facility Services Federal contract opportunity
Solicitation number
75F40123Q00016
Issued by
Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services

About this file

This document outlines federal requirements for a facilities operations and maintenance contract with the Food and Drug Administration. The contractor will be responsible for complying with over 80 publications, codes, and regulations governing areas such as laboratory practice, occupational safety, environmental protection, building services, and energy efficiency. Responsibilities will include maintenance, repair, and operation of buildings and systems at the FDA San Juan facility. The contractor must adhere to stringent health, safety, and environmental standards from agencies like OSHA, EPA, NFPA, ASHRAE, and ANSI. The initial contract term is one year with four optional one-year extensions.

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Technical Exhibit 18 - FEDERAL REQUIREMENTS

The following publications are incorporated by reference. Unless a specific date is provided, references are for the current edition published at the time of issue of the solicitation.

1. 21 CFR 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) Department of Health and Human Services/Food and Drug Administration.

2. 29 CFR 1910.144 (Safety Color Code for Marking Physical Hazards).

3. 29 CFR 1910, Subparts 0 (Machinery and Machine Guarding) and P (Hand Portable Powered

Tools and Other Hand-Held Equipment).

4. Resource Conservation and Recovery Act (EPA), applicable regulations in 40 CFR, Parts, 260-280.

5. 21 CFR 2.31 Chapter 1, Subchapter A (Animal Welfare Act).

6. Guide for the Care and Use of Laboratory Animals - Institute for Laboratory Animal Resources, National Research Council, Revised 1996.

7. Federal, State and Local Codes.

8. National Fire Protection Association (NFPA) National Fire Codes.

9. Flat Glass Marketing Association (FGMA) Glazing Manual and Sealant System.

10. American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code.

11. National Plumbing and WSSC Plumbing/Gasfitting code.

12. American Society for Heating, Refrigeration, and Air Conditioning Engineers (ASHRAE) Guide and

Data Books.

13. Sheet Metal and Air Conditioning National Association (SMACNA) Standard.

14. National Electrical Code

15. Clean water Act (EPA) applicable regulations in 40 CFR, Parts 25, 104-117, 129, 131, 135-136.

16. Executive Orders regarding Energy Conservation Management and Environmental

17. Biosafety in Microbiological and Biomedical Laboratories 5Th Edition.

18. SMACNA Sheet Metal and Air Conditioning Contractors National Association HVAC Systems

Testing, Adjusting & Balancing

19. AHERA Asbestos Hazard Emergency Response Act

20. ASHRAE Guideline 1HVAC Commissioning Process

21. ASHRAE Guideline 4 Preparation of Operating and Maintenance Documentation for Building

Systems

22. ANSI/ASHRAE Standard 15 Safety Code for Mechanical Refrigeration

23. ANSI/ASHRAE Standard 34 Number Designation and Safety Classification of Refrigerants

24. ANSI/ASHRAE Standard 55, Thermal Environmental Conditions for Human Occupancy

25. ANSI/ASHRAE Standard 62, Ventilation for Acceptable Indoor Air Quality

26. ANSI/ASHRAE Standard 100, Energy Conservation in Existing Buildings/Commercial

27. ANSI/ASHRAE Standard 111, Practices for Measurement, Testing, Adjusting, and Balancing of

Building Heating, Ventilation, Air-Conditioning, and Refrigeration Systems;

28. ASME Boiler and Pressure Vessel Code

29. ASME CSD-1 Control and Safety Devices of Automatically Fired Boilers

30. National Board of Boiler and Pressure Vessel Inspectors, National Board Inspection Code

31. OSHA 29 CFR 1910 https://www.osha.gov/laws-regs/regulations/standardnumber/1910 and 29

CFR1926 https://www.osha.gov/laws-regs/regulations/standardnumber/1926

32. CSI Master Format

33. Clean Air Act

34. Clean Water Act

35. EPA Green Book

36. EPA Purple Book https://www.osha.gov/laws-regs/regulations/standardnumber/1910%20and%2029

37. FMR Federal Management Regulations

38. General Services Administration (GSA) Handbook, Building Management, PBS P 5800.18A

39. General Services Administration Public Buildings Service, Preventive Maintenance Guide, Effective Date: January 01, 2022

40. International Building Code

41. International Fire Code

42. International Plumbing Code

43. International Mechanical Code

44. NETA Maintenance Testing Specification for Electrical Power Distribution Equipment and

Systems

45. NFPA 10, Standard for Portable Fire Extinguishers

46. NFPA 12, Carbon Dioxide Extinguishing Systems

47. NFPA 12A, Standard on Halon 1301 Fire Extinguishing Systems

48. NFPA 13, Installation of Sprinkler Systems

49. NFPA 17, Dry Chemical Extinguishing Systems

50. NFPA 17A, Wet Chemical Extinguishing Systems

51. NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection

Systems

52. NFPA 70, National Electrical Code (NEC)

53. NFPA 70E, Standard for Electrical Safety in the Workplace

54. NFPA 72, National Fire Alarm Code

55. NFPA 80, Standard for Fire Doors and Other Opening Protectives

56. NFPA 85, Boiler and Combustible Systems Hazards Code

57. NFPA 92A, Standard for Smoke Control Systems Utilizing Barriers and Pressure Differences

58. NFPA 92B, Standard for Smoke Management Systems in Malls, Atria, and Large Spaces

59. NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking

Operations

60. NFPA 101, Life Safety Code

61. NFPA 105, Standard for the Installation of Smoke Door Assemblies and Other Opening

Protectives

62. NFPA 110, Standard for Emergency and Standby Power Systems

63. NFPA 111, Standard on Stored Electrical Energy Emergency and Standby Power Systems

64. NFPA 2001, Standard on Clean Agent Fire Extinguishing Systems

65. NICET National Institute for Certification in Engineering Technologies publications and issuances

66. NIOSH National Institute for Safety and Health publications and issuances

67. DOE/EE-0157, International Performance Measurement and Verification Protocol

68. R.S. Means Facilities Construction Cost Data

69. USGBC LEED for Existing Buildings (LEED-EB)

70. NEMA TP-1, National Electrical Manufacturers Association, Guide for Determining Energy

Efficiency for Distribution Transformers, https://www.nema.org/standards/view/guide-for-determining-energy-efficiency-for-distribution-transformers#download.

71. NEMA MG-1. National Electrical Manufacturers Association, Motors and Generators

72. NEMA Application Guide for AC Adjustable Speed Drive Systems

73. ANSI/IWCA I-14.1, Window Cleaning Safety Standard

74. Safe Drinking Water Act, PL 99-339, as amended

75. Title 40 CFR, Part 761, PCBs in Electrical Transformers

76. Title 40 CFR, 141.43, Sections A and D, Environmental Protection Agency Safe Drinking Water

77. 41 CFR Part 102-74, Subpart C. – FMR (Facility Management) https://www.gsa.gov/policy-regulations/regulations/federal-management-regulation-fmr/i449022.

78. 40 CFR, Protection of the Environment (all applicable sections of Chapter 1) https://www.epa.gov/laws-regulations/regulations.

79. ANSI Z245.1, Mobil Refuse Collection and Compactor Equipment-Safety Requirements, https://www.waste360.com/mag/waste_ansi_new_guidelines.

80. Executive Order 13423, Strengthening Federal Environmental, Energy, and Transportation Management and all implementing guidance documents, http://fedcenter.gov/programs/eo13423

81. Recovered Materials Advisory Notices, http://www.epa.gov/cpg.

82. BioBasedProducts, https://www.biopreferred.gov/BioPreferred/faces/pages/BiobasedProducts.xhtml.

83. Comprehensive, Procurement, Guidelines (CPG), https://www.epa.gov/smm/comprehensive-procurement-guideline-cpg-program.

84. All applicable Federal, State and Local codes and regulations.

https://www.gsa.gov/policy-https://www.gsa.gov/policy-https://www.epa.gov/smm/comprehensive-https://www.epa.gov/smm/comprehensive-

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