. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/115 
18 May 2005 
 (05-2020) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Environmental Protection Agency  (EPA) (120) 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   pharmaceutical 
production  (HS Chapter:  30;  ICS:  13) 
5. Title, number of pages and language(s) of the notified document:   National Emission 
Standards for Pharmaceuticals Production  (3 pages, in English) 
6. Description of content:   On 21 September 1998, EPA pr omulgated national emission 
standards for pharmaceuticals production (40 CF R part 63, subpart GGG).  This action 
proposes to amend the national emission st andards for pharmaceuticals production to 
include provisions for planned routine mainte nance of wastewater tanks and alternative 
monitoring for condensers and scrubbers.  The pr oposed amendments also  reference general 
standards for containers. 
In the Rules and Regulations section of this Federal Register, we are taking direct final 
action on the proposed amendments because we  view the amendments as noncontroversial 
and anticipate no adverse comments.  We have explained our reasons for the amendments in 
the preamble to the direct final rule.  If we  receive no adverse comments, we will take no 
further action on the proposed amendments.  If we receive adverse comments, we will withdraw those provisions on which we received adverse comments.  We will publish a 
timely withdrawal in the Federal Register i ndicating which provisions will become effective 
and which provisions are being withdrawn.  If part or all of the direct final rule in the Rules 
and Regulations section of today's Federal Regi ster is withdrawn, all comments pertaining 
to those provisions will be addressed in a s ubsequent final rule based on the proposed 
amendments.  We will not institute a second co mment period on the sub sequent final action. 
Any parties interested in commenting must do so at this time. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of the environment G/TBT/N/USA/115 
Page 2  
 
 8. Relevant documents:   70 Federal Register (FR) 25671 13 May 2005;  Title 40 Code of 
Federal Regulations (CFR) Part 63.  Will a ppear in the Federal Register when adopted. 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:  13 June 2005 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Full Text of this Notification is Now Available on the Internet at URLs: 
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/05-
9476.htm 
http://a257.g.akamaitech.net/7/257/24 22/02jan20051800/edocket.access.gpo.gov/2005/pdf/
05-9476.pdf