ENB Region 2 Completed Applications 09/07/2005

The Department has prepared a Draft Permit and has made a tentative determination to approve this application. The applicant currently has an Air State Facility permit and operates a pharmaceutical formulation and preparation plant that produces pharmaceutical tablets and capsules. Air emission sources include: oven drying and wet mixing; film coating; dry mixing; tablets compression and encapsulation; seeds manufacturing; and fluid bed granulation /drying. The facility is proposing to operate its VOC emitting sources under a Part 233 variance until the end of 2007 by which time it will have relocated significant VOC emitting sources to North Carolina. Also, the applicant proposes to install a scrubber to control HCI emissions which are subject to Part 212. The facility's VOC emissions are greater than 25 tons per year and as such is subject to Title V requirements. In accordance with 6NYCRR Parts 621.5(d)(9) and 201-6.4(c), the Administrator of the United States Environmental Protection Agency (USEPA) has the authority to bar issuance of any Title V Facility Permit if it is determined not to be in compliance with applicable requirements of the Clean Air Act or 6NYCRR Part 201.

Persons wishing to inspect the subject Title V files, including the application with all relevant supporting materials, the draft permit, and all other materials available to the DEC (the "permitting authority") that are relevant to this permitting decision should contact the DEC representative listed below.  It is recommended that an appointment be made to confirm the availability of the subject files.  The DEC will endeavor to make the files available within 2 business days of contact, during normal business hours (8:30 am through 4:45 pm), unless the requestor wishes to inspect the files at a later date.

DEC will evaluate the application and the comments received on it to determine whether to hold a public hearing.  A public hearing may be legislative or adjudicatory.  A legislative public hearing is a proceeding which provides an additional opportunity for public comment.  DEC's determination to hold a legislative public hearing will be based on whether a significant degree of public interest exists.   If a legislative public hearing is to be held, a Notice of Hearing will be published which will include the time and place of the hearing and submitting comments.   The applicant and all persons who  have filed comments on the permit will be notified by mail of the public hearing.  Comments and requests for a legislative public hearing should be in writing and addressed to the Department representative listed below.

An adjudicatory public hearing is a trial type proceeding which provides the opportunity for adjudication on the basis of evidence, including direct testimony and cross examination.  An adjudicatory hearing is held only if substantive and significant issues relating to any findings or determinations the Department is required to make pursuant to the Environmental Conservation Law exist.   A copy of the Department's permit hearing procedures is available upon request or on the Department web site at: http://www.dec.state.ny.us/website/ohms/gudph1.htm.