Document ID: EPA-R09-OAR-2022-0253-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2022-04-13T04:00Z

From:	Tong, Stanley
 To:	LEVIN, NANCY
 Subject:	RE: Q: Pharmaceutical CTG and SD 67.15
 Date:	Tuesday, December 31, 2019 6:59:13 AM
           Attachments:	RE SD RACT SIP Pharmaceutical Shipbuilding Landfills.msg RE Q Pharmaceutical CTG and SD 67.15.msg

Yes, I agree Pharmaceutical CTG is a neg dec for San Diego  -  See 2 emails attached.

1. Pharmaceuticals CTG  -  From Nick's and Joe's info, I conclude SD doesn't have sources subject to the CTG - they should adopt a neg dec.
The SIP approved rule should be fixed - has some problems.

[ndl : If SD adopts neg dec, then we'd just "recommend" they update rule, correct? i.e., Not needed for RACT now, but if later on they exceed CTG threshold, current SIP rule would not be approvable as RACT.]
Stan  -  I agree  -  recommend they update/fix the rule. I also believe that based on Joe Herzig's description, SD doesn't have Synthesized Pharmaceutical facilities, so even if emissions increase for those below facilities close to 2.7 tpy, they'd still not be subject to the CTG  -  they don't do that type of operation.

From: LEVIN, NANCY <Levin.Nancy@epa.gov>
Sent: Friday, December 27, 2019 2:26 PM
To: Tong, Stanley <Tong.Stanley@epa.gov>
Subject: FW: Q: Pharmaceutical CTG and SD 67.15

Hi Stan,
Based on this info, I believe you concluded that SD has no facilities that synthesize pharmaceuticals and meet the CTG threshold. Just wanted to confirm before I tell Nick.
Thanks.

Nancy Levin | 415-972-3848 | Rules and Planning
Air Division | Region IX| U.S. Environmental Protection Agency

From: Tong, Stanley <Tong.Stanley@epa.gov>
Sent: Friday, April 05, 2019 9:59 AM
 To: Herzig, Joe <Joe.Herzig@sdcounty.ca.gov> Cc: LEVIN, NANCY <Levin.Nancy@epa.gov> Subject: RE: Q: Pharmaceutical CTG and SD 67.15

 Joe,
 Thanks for providing this information. I will talk with Nancy Levin next week, but I think this is all I need. Stan

 Stanley Tong
 US EPA Region IX - Air Division, Rules Office (AIR 4) 75 Hawthorne St., San Francisco, CA 94105 tong.stanley@epa.gov 415 947 4122 (w)

From: Herzig, Joe <Joe.Herzig@sdcounty.ca.gov>
Sent: Friday, April 05, 2019 9:50 AM
To: Tong, Stanley <Tong.Stanley@epa.gov>
Subject: RE: Q: Pharmaceutical CTG and SD 67.15 Stanley,
  < 5 (permit condition)
 Beckman Coulter Inc

Genentech Inc.
< 3.7 (Eng. Eval)
Illumina
< 2.9 (various)
J&D Laboratories Inc
< 10.3 (permit
condition)
Select Supplements Inc
< 2.8 (Eng. Eval)
SenDx Medical Inc
< 2.7 (permit
condition)

Beckman Coulter Inc. manufactures medical diagnostic solutions. These are typically aqueous solutions and emissions are likely much less than 2 tons per year.

Genentech Inc. manufactures pharmaceuticals however the vast majority of the emissions are attributed to their facility wipe cleaning using IPA in wipes and with spray bottles to maintain a sterile working environment.

Illumina manufactures oligonucleotides (not used as medications) and the emissions are from the carrier solvent evaporation. J&D Laboratories Inc. does mixing and encapsulation of softgel vitamins.
Select Supplements Inc. does mixing and encapsulation of softgel vitamins.

SenDx Medical Inc. manufactures medical devices, and various calibration and membrane solutions.

Let me know if you need any more information. Regards,
 Joseph N. Herzig
 Air Pollution Control Engineer
 San Diego County Air Pollution Control District (858) 586-2713
 Joe.Herzig@sdcounty.ca.gov

From: Tong, Stanley [mailto:Tong.Stanley@epa.gov]
 Sent: Thursday, April 04, 2019 1:34 PM
 To: Herzig, Joe <Joe.Herzig@sdcounty.ca.gov>
 Subject: FW: Q: Pharmaceutical CTG and SD 67.15 Joe,
 EPA's CTG applies to synthesized pharmaceutical manufacturing facilities where VOC emissions from vents (from reactors, distillation operations, crystallizers, centrifuges, and vacuum dryers) emit 15 lb/day (~2.7 tpy) or more.

 For the 6 facilities below listed as <2.7 tpy or higher, please give me a short description (1-2 sentence is fine) of what they do/make?
 This will help me determine if the Pharmaceutical CTG applies. Thanks.

 Stan

 Stanley Tong
 US EPA Region IX - Air Division, Rules Office (AIR 4) 75 Hawthorne St., San Francisco, CA 94105 tong.stanley@epa.gov 415 947 4122 (w)

From: Cormier, Nick <Nick.Cormier@sdcounty.ca.gov>
Sent: Friday, March 29, 2019 5:15 PM
To: Tong, Stanley <Tong.Stanley@epa.gov>
Cc: Herzig, Joe <Joe.Herzig@sdcounty.ca.gov>; Kathleen.Keehan@sdcounty.ca.gov
Subject: RE: Q: Pharmaceutical CTG and SD 67.15

Hi Stan,

Just to update you on this request; I think we'll need EPA to give us some additional clarification from you on what you define as "chemical synthesis" in regards to pharmaceuticals. We reviewed the facilities in the list I provided yesterday, most of which are involved in the biotech industry. It's not as clear cut to lump some of these facilities into one bucket or another, unfortunately. Some may be subject to our pharmaceuticals rule, but some might only be subject to it because it was the "best fit" at the time  -  whether or not their operations qualify as "chemical synthesis" is a bit of quandary to us. We'll do the best we can with the information we know.

In my absence, please contact Joe Herzig from our Rule Development division (cc'd) next week when you return to clarify what you're looking for. Joe previously worked with some of these facilities and has some knowledge of the technical processes involved for some of them.

Below are some of the emission totals I was able to procure from records at my disposal. I've asked our inventory staff for the exact numbers, but they weren't able to get me that by this afternoon. As you can see, with the possible exception of one facility emitting around 10 tpy, most appear to be fairly small emitters of VOC, if it's of any help.

DBA
EQUIP_LOCATION_ADDRESS
ZIP_CODE
VOC (tons/year)
(source found)
Beckman Coulter Inc
2470 Faraday Av Carlsbad, CA
92010
< 5 (permit
condition)
Campbell Membrane Technology
1168 N Johnson Ave El Cajon, CA
92020
< 1.2 (source test)
Carlsbad Technology, Inc.
5923 Balfour Court Carlsbad, CA
92008
< 0.6 (Eng. Eval)
Genentech Inc.
1 Antibody Way Oceanside, CA
92056
< 3.7 (Eng. Eval)
Illumina
5200 Illumina Way San Diego, CA
92122
< 2.9 (various)
IONIS PHARMACEUTICALS
2282 FARADAY AV CARLSBAD, CA
92008
< 1.9 (permit
condition)
J&D Laboratories Inc
2710 Progress St Vista, CA
92081
< 10.3 (permit
condition)
Pacira Pharmaceuticals
10450 Science Center Drive San Diego, CA
92121
< 1 (Eng. Eval)
Select Supplements Inc
5800 Newton Dr Carlsbad, CA
92008
< 2.8 (Eng. Eval)
SenDx Medical Inc
1945 Palomar Oaks Way Carlsbad, CA
92011
< 2.7 (permit
condition)
Versum Materials US, LLC
1969 Palomar Oaks Way Carlsbad, CA
92011
< 1.9 (permit
condition)

Regards,
Nick Cormier
 Air Quality Specialist
 County of San Diego Air Pollution Control District 10124 Old Grove Rd.
 San Diego, CA 92131 Phone: (858) 586-2798
 Fax: (858) 586-2601

From: Tong, Stanley <Tong.Stanley@epa.gov>
Sent: Thursday, March 28, 2019 10:58 AM
To: Cormier, Nick <Nick.Cormier@sdcounty.ca.gov>
Subject: RE: Q: Pharmaceutical CTG and SD 67.15

Thanks  -  I'm looking at the Pharmaceutical CTG  -  trying to see if any companies actually manufacture, by chemical synthesis "synthesized Pharmaceutical" products.

CTG does not cover fermentation/extraction of organic chemicals from vegetative materials or animal tissues, and formulation and packaging of the product.

I think the first cut is if any facilities actually does chemical synthesis  -  then of those that do, what are their emissions.

From: Cormier, Nick <Nick.Cormier@sdcounty.ca.gov>
Sent: Thursday, March 28, 2019 10:17 AM

To: Tong, Stanley <Tong.Stanley@epa.gov>
Subject: RE: Q: Pharmaceutical CTG and SD 67.15 Hi Stan,
Saw your voicemail  -  I'm on a conference call until Noon but I think I understand what you're looking for.

Below is the preliminary list of facilities that are involved in pharmaceutical manufacturing in the County, as well as addresses. I'm waiting on our folks to track down the emission totals for each. Just judging by the names, my guess is none are considered major sources of VOC or NOx. I also need to research each site to see what they do; I'm not sure I can get that complete info by tomorrow, as I'm not familiar with any of them. My guess is most are involved in the biotech field, but how they make their respective products is something I need more info on.

DBA
EQUIP_LOCATION_ADDRESS
ZIP_CODE
Beckman Coulter Inc
2470 Faraday Av Carlsbad, CA
92010
Campbell Membrane Technology
1168 N Johnson Ave El Cajon, CA
92020
Carlsbad Technology, Inc.
5923 Balfour Court Carlsbad, CA
92008
Genentech Inc.
1 Antibody Way Oceanside, CA
92056
Illumina
5200 Illumina Way San Diego, CA
92122
IONIS PHARMACEUTICALS
2282 FARADAY AV CARLSBAD, CA
92008
J&D Laboratories Inc
2710 Progress St Vista, CA
92081
Pacira Pharmaceuticals
10450 Science Center Drive San Diego, CA
92121
Select Supplements Inc
5800 Newton Dr Carlsbad, CA
92008
SenDx Medical Inc
1945 Palomar Oaks Way Carlsbad, CA
92011
Versum Materials US, LLC
1969 Palomar Oaks Way Carlsbad, CA
92011

Regards,
Nick Cormier
 Air Quality Specialist
 County of San Diego Air Pollution Control District 10124 Old Grove Rd.
 San Diego, CA 92131 Phone: (858) 586-2798
 Fax: (858) 586-2601

 From: Cormier, Nick
Sent: Thursday, March 28, 2019 9:38 AM
To: 'Tong, Stanley' <Tong.Stanley@epa.gov>; Ortega, Angela <Angela.Ortega@sdcounty.ca.gov>
 Subject: RE: Q: Pharmaceutical CTG and SD 67.15 Hi Stan,
 I'm tracking down this information. I'm aiming to get it to you by tomorrow COB.

 Regards,
 Nick Cormier
 Air Quality Specialist
 County of San Diego Air Pollution Control District 10124 Old Grove Rd.
 San Diego, CA 92131 Phone: (858) 586-2798
 Fax: (858) 586-2601

From: Tong, Stanley <Tong.Stanley@epa.gov>
Sent: Wednesday, March 27, 2019 11:15 AM
To: Cormier, Nick <Nick.Cormier@sdcounty.ca.gov>; Ortega, Angela <Angela.Ortega@sdcounty.ca.gov>
Subject: Q: Pharmaceutical CTG and SD 67.15 Nick or Angie

What facility(s) (name/address/emissions)? are subject to Rule 67.15 Pharmaceutical and Cosmetic manufacturing? Do they make pharmaceuticals OR do they make cosmetics?
If pharmaceutical  -  can you give me something that describes what they do? e.g.,  -  make pharmaceutical products and intermediates by chemical synthesis?
Or do they produce/recover materials using fermentation, extraction of organic chemicals from vegetative materials or animal tissues?

Stan

 Stanley Tong
 US EPA Region IX - Air Division, Rules Office (AIR 4) 75 Hawthorne St., San Francisco, CA 94105 tong.stanley@epa.gov 415 947 4122 (w)