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
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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