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Biocraft Site Kirsten E. 1laue1', &quire Administrative Officll5: Director, Legal Affairs TEVA PHARMACEUTICALS' USA 1090 Hor~ham Road. PO BOll 1090 North Wale~, PA 19454-1090 Direct Dial: (215) 591 81>28 Phone: (2151591 3000 Direct Fax: (215) 591 6813 Toll Free: (6681 TEVA USA kir~len.bauer.tevau5a.com April 14, 2003 Ms. Kedari Reddy, Assistant Regional Counsel Office of Regional Counsel- Region II U.S. Environmental Protection Agency 290 Broadway - 17th Floor New York, New York 10007-1866 Re: Former Biocraft Laboratories, Inc. (now known as Teva Pharmaceuticals USA, Inc.) facility in Waldwick, New Jersey Lower Passaic River Study Area Response to USEPA Request for Information Pursuant to 42 U.S.C. §§ 9601-9675 Dear Ms. Reddy: This letter responds to the U.S. Environmental Protection Agency (USEPA) Request for Information, pursuant to 42 U.S.C. §§ 9601-9675. dated February 27.2003. addressed to both Teva Pharmaceuticals USA, Inc. and Biocraft Laboratories. Inc., in connection with the Lower Passaic River Study Area (the "Request for Information"). In or about June J 996, pursuant to an Agreement and Plan of Merger. Biocraft Laboratories, Inc. ("Biocraft") became a wholly·owned subsidiary of Teva Pharmaceutical Industries Limited, an Israeli public company. In or about July 1996. as part of a reorganization of the parent company's United States operations. TAG Pharmaceuticals. Inc.. another subsidiary of Teva Pharmaceutical Industries Limited was merged into Biocraft, with Biocraft being the surviving entity. Thereafter, Biocraft was renamed Teva Pharmaceuticals USA, Inc. ("Teva"). Subsequently, a decision was made to close all pharmaceutical manufacturing operations at Teva's (flkla Biocraft) Waldwick, New Jersey plant in or about September 1997, and the plant has been inactive for approximately 6 years. In a conversation between Teva's outside counsel and Ms. Kedari Reddy on March 5, 2003. Ms. Reddy clarified that although the USEP A's Request for Information was .addressed to both Biocraft and Teva, insofar as Biocraft no longer exists, a response is required only from Teva. Accordingly. the responses provided below are provided only by Teva. 854850001 TIERRA-B-008918 Ms. Kedari Reddy April 14, 2003 The scope of the Passaic River Study Area as published on USEPA's website (http://www.epa.gov/region02/superfund/pass_ou2.htm) covers all parts of the Passaic River from one mile south of the Second River Tributary in northern Newark, to the mouth ofthe Passaic River in Newark Bay. Teva's Waldwick Plant is not located within that Study Area. However, Ms. Reddy clarified that the USEPA's Request for Infonnation in connection with the Passaic River Study Area has been extended to include all tributaries to that stretch of the Passaic River. Teva's Waldwick Plant is located in the vicinity of the Allendale Brook, which feeds into the Ho-HoHKus Brook, which feeds into Saddle River, which enters the Passaic River at Garfield-Wallington. Accordingly, based on the oral understandings and clarifications provided by Ms. Reddy, the responses set forth below are only for Teva's plant (Block 154, Lot 46) located at 12 Industrial Park, Waldwick, New Jersey (the "Plant"). Insofar as Teva's Waldwick Plant ceased operations and has been inactive for approximately 6 years, many of the documents associated with that Plant have either been destroyed or stored in multiple locations, which storage locations may not yet have been identified. Moreover, many of the fonner Biocraft and Teva personnel associated with that Plant no longer work for Teva and their whereabouts are unknown. Nevertheless, Teva is in the process of trying to locate and identify additional documentation that may be responsive to the USEPA's Request for Information. If any such documentation is located and is determined to be responsive, Teva will supplement its responses. Teva's responses to the USEPA Request for Information follow each ofUSEPA's Requests for Infonnation, and are set forth below. USEPA Request for Information 1): How long has your company operated at the facility? Ifyour company no longer operates at this facility, during what years did your company operate at the facility? Response 1): Biocraft purchased the property (Block 154, Lot 46), built the Plant and associated site improvements, and began operations in or about 1972. See above for a description of the 1996 merger between Biocraft and Teva. Teva ceased operations and closed the Plant in or about 1997. USEPA Request for Information 2)a): Does your company have or has it in the past had a permit or permits issued pursuant to the Resource Conservation and Recovery Act 42 u.s.c. §§ 690/- et. seq.? Response 2}a): Teva is unaware of any permits having been issued to the fonner Biocraft Waldwick Plant pursuant to the Resource Conservation and Recovery Act. USEPA Requestfor Information 2)b): Does your company have or has it had in the past had a permit or permits issued to the Federal Pollution Control Act. 22 U.S.c. § 1251, et. seq.? If "yes" please provide the years that your company held such a permit. Response 2)b): During the periods specified below, the Plant had the following Federal Pollution Control Act permits: 2 854850002 TIERRA-B-008919 Ms. Kedari Reddy April 14, 2003 From To Discharge Type & Quantity, if DischargelDisposal Point , known 1/1/96 12/31/01 Industrial Wastewater Publicly Owned Treatement Pretreatment Discharge - Works - Northwest Bergen Approximately 7,800 gpd County Utilities Authority (Manufacturing Plant) (Pennit No. 95002) 6/23/93 11/1/97 New Jersey Pollutant Discharge Allendale Brook (Permit No. Elimination System (NJPDES) NJ0088315) Storm Water Discharge Permit (Manufacturing Plant) USEPA Request for Information 3): Did your company receive. utilize. manufacture. discharge. release. store. or dispose of any materials containing the following substances: Response 3): Former Biocraft Waldwick Plant Materials List Yes No 2,3,7,8 tetrachlorodibenzo-p-dioxin X 2,4-Dichlorophenoxy acetic acid (2,4-D) X 2,4,5- Trichlorophenoxy acetic acid (2,4,5- T) X 2,4,5~Trichlorophenol (2,4,5- TCP) X or other dioxin compounds X Dichlorodiphenyl-trichloroethate (DDT) X Benzene • X· Ethyl Benzene X Total Petroleum Hydrocarbons (TPEH) X Poly Aromatic Hydrocarbons (PAH) X If yes please list specified compounds No.2 Fuel Oil Toluene X Xylene X PCBs X Antimony * x* Argon X Arsenic * X* Cadmiwn * X* Chlorine X Chromium * X* Copper * X* Iron • x* Lead * X* Mercury * x* Nickel * x* 3 854850003 TIERRA-B-008920 Ms. Kedari Reddy April 14, 2003 Silver * x* Sulfur * x* Titanium X Vanadium X Zinc * x* Cyanide X Acetone X Acetylene X Acetylene Tetrabromide X 2-butoxy ethanol X Bis (2-ethyl hexyl) phthalate X Chlorodifluoromethane X Chloropentafluoromethane X Chlorotrifluoromethane X Dibutyl phthalate X Dichlorofluormethane X Naphtha X Silver Nitrate * X* Sodium Bisulfide X Sodium Hydroxide X Sodium Nitrate X Tungsten X * _Indicates small Laboratory Quantities Only (See Table I, attached) 4)a): Provide a description of the manufacturing process for which all hazardous substances. including but not limited to, the substances in response to item (3), were a product or by-product. Response to 4)a): The Waldwick Plant manufactured semi-synthetic penicillin products in bulk fonn using a proprietary process. In general, the penicilJin products were manufactured in separate production runs which would last a minimum of one week for each product. The penicillins were manufactured using batch chemical processes which involved the following key steps: (1) chemical reactions (one or more), (2) batch extraction, (3) crystallization, (4) centrifuging, (5) drying, (6) compaction, (7) milling, and (8) blending. Most materials used at the Plant were delivered in bulk (tank truck) and drum quantities. Raw materials used in manufacturing generally included methylene chloride, acetone, hydrochloric acid, sodium hydroxide, and liquid nitrogen. Materials stored in drums included triethylamine, dimethyl acetamide, 2,6-lutidine, and pivaloyl chloride. Small quantities of hazardous materials also were used and stored in laboratories located in the Plant. 4 854850004 TIERRA-B-008921 Ms. Kedari Reddy April 14, 2003 USEPA Requestfor Information 4)b): During what parts of the manufacturing processes identified in the response to items 4)a), above, were hazardous substances, including but not limited to, the substances listed in response to item (3), generated? i) Describe the chemical composition of these hazardous substances. ii) For each process, what amount of hazardous substance was generated per volume offinished product? Iii) Were these hazardous substances combined with wastes from other processes? If so, wastes from what processes? Response to 4)b): Hazardous substances were part of the following manufacturing process key steps described in response to Request for Information 4)a) above: (1) chemical reactions (one or more). (2) batch extraction, (3) crystallization. (4) centrifuging. and (5) drying. Response to 4)b)i): See Response to 4)a) above. Onsite boilers for steam generation were fired using natural gas or No.2 fuel oil. Response to 4)b)ii): The Waldwick Plant manufactured semi-synthetic penicillin products in bulk form using a proprietary process over an approximately 25 year period. In general. the penicillin products were manufactured in separate production runs which would last a minimum of one week for each product. The amount of hazardous substances generated per volume of finished products varied depending on the type of penicillin manufactured and the duration of the particular production run. As of the date of this response. Teva has been unable to locate any responsive documents identifying the volume of hazardous substances per volume of finished product. This response letter will be supplemented if responsive documents are located in the future. Response to 4)b)iii): Teva does not believe that hazardous substances were combined with wastes from other processes. USEPA Request for Information 5): Describe the methods of collection, storage, treatment, and disposal of all hazardous substances, including, but not limited to, the substances listed in response item (3) and (4).
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