Air Toxics Notebook
Pharmaceutical Production -  Subpart GGG

Applicability: eCFR Subpart GGG [ecfr.gov]

This subpart applies to:
  1. Manufactures of pharmaceutical product which process, use, or produce HAPs and are located at plant site that is a major source.

"Pharmaceutical product" means any of the following, except for nonreactive solvents, excipient, binder, or filler or any material produced in a chemical manufacturing process units that is subject to subpart F and G of this part:
  1. Any material described by SIC code 2833 or 2834;
  2. Any material whose manufacturing process is described by NAICS code 325411 or 325412;
  3. A finished dosage form of a drug (e.g., tablet, capsule, solution, etc);
  4. Any active ingredient or precursor that is produced at a facility whose primary manufacturing operations are described by SIC code 2833 or 2834;
  5. At facilities whose primary operations are not described by SIC code 2833 or 2834, any material whos primary use is as an active ingredient or precursor.

*Major Sources of HAPs emit or have the potential to emit:
  • ≥ 10 tons/year of any single HAP; or
  • ≥ 25 tons/year of total HAPs.
  • Area Sources emit less than Major Sources.

Exempt to this Subpart:
  1. Research and development facilities
Rules apply to small, area sources? No
Known Sources in NDEQ Jurisdiction: No
Date of Original Final Rule: 9/21/98
Amendments Dates: 04/21/2011 - Final Rule
05/13/2005 - Direct Final Rule; Amendments
08/02/2001 - Final Rule; Corrections and Amendments
08/29/2000 - Final Rule; Amendments
09/21/1998 - Final Rule
State Regulations (Title 129): As of September 28, 2022: Title 129, Chapter 13, Section 002.42

Previously: Title 129, Chapter 28, Section 001.39.

Sources are also responsible for ensuring they are in compliance with current federal requirements found for this subpart in the CFR.
Federal Regulations: 40 CFR 63.1250
Related Rules:

NESHAP – 40 CFR Part 63

Subpart FOrganic Hazardous Air Pollutants from the Synthetic Organic Chemical Manufacturing Industry (SOCMI)
Subpart G Equipment Specific Organic HAPs from SOCMI
Regulations and Federal Registers:
eCFR Subpart GGG [ecfr.gov]

(See attached file: 3G - Fed. Reg. 2011-04-21 - Final Residual Risk.pdf)

(See attached file: 3G - Fed. Reg. 2006-04-20 - Amendments.pdf)

(See attached file: 3G - Fed. Reg. 2005-05-13 - Direct Final Rule; amendments.pdf)

(See attached file: 3G - Fed. Reg. 2003-06-23 - Amendments.pdf)

(See attached file: 3G - Fed. Reg. 2001-08-02 - Direct Final Rule; corrections and amendments.pdf)

(See attached file: 3G - Fed. Reg. 2000-08-29 - Final Rule; amendments.pdf)

(See attached file: 3G - Fed. Reg. 1998-09-21 - Final Rule.pdf)

SizeFile Name
601 KB 3G - Fed. Reg. 2011-04-21 - Final Residual Risk.pdf
291 KB 3G - Fed. Reg. 2006-04-20 - Amendments.pdf
184 KB 3G - Fed. Reg. 2005-05-13 - Direct Final Rule; amendments.pdf
281 KB 3G - Fed. Reg. 2003-06-23 - Amendments.pdf
229 KB 3G - Fed. Reg. 2001-08-02 - Direct Final Rule; corrections and amendments.pdf
350 KB 3G - Fed. Reg. 2000-08-29 - Final Rule; amendments.pdf
934 KB 3G - Fed. Reg. 1998-09-21 - Final Rule.pdf
Forms:
Important Dates:
FAQs, Fact Sheets, and Rule Summaries: EPA's Subpart GGG Website [epa.gov] - contains federal register notices, technical information, and implementation tools
Presentations, Training and Articles:
Other Information and Resources:
Notes:
Page Last Updated: 11/2/22