Hoffmann – La Roche, Incorporated

Posted on July 10, 2015

Client: Hoffmann - La Roche, Incorporated
Location: Nutley, New Jersey

Major Components

  • Part B Permit Application
  • Hazardous Waste Minimization Plan
  • Remediation of Mercury Contamination
  • Regulatory Analysis/Compliance Evaluation
  • Hazardous Waste Tank Assessment
  • Spill Prevention, Control and Countermeasure Plan
  • Secondary Containment Integrity Assessment
  • Closure of Hazardous Waste Drum Storage Area
  • Storm Water Pollution Prevention Plan

Project Description

Introduction

The Hoffmann-La Roche, Incorporated facility located in Nutley, New Jersey, is a 125-acre pharmaceutical facility engaged in research, development and manufacture of pharmaceutical preparations (consisting of final dosage forms such as tablets, capsules, ointments and sterile products in vials and ampules) and the organic synthesis of medicinal chemicals, such as tranquilizers and synthetic vitamins. The firm was initially retained by Hoffmann-La Roche in March of 1993 to provide engineering services with regard to regulatory and compliance determinations relative to various wastewater treatment processes at the facility. Since that time, the firm has had the opportunity to provide engineering services that have supported the preparation and issuance of a Hazardous Waste Facility Part B Permit by the New Jersey Department of Environmental Protection (NJDEP), preparation of plans and specifications for the remediation of an active maintenance facility, the development and implementation of a Hazardous Waste Minimization Plan as well as continued support in the interpretation and implementation of recent environmental regulations including the Land Disposal Restriction Rule and RCRA Air emission standards.

The following presents an overview of the specific environmental engineering and regulatory assignments undertaken by the firm in support of Hoffmann-La Roche operations.

Part B Permit Application

As part of this project, the firm prepared a Part B renewal application for the Nutley facility. The renewal application was  organized to correspond with the NJDEP Hazardous Waste Facility Part B Permit Application Review Checklist and included the following:

  • Enhanced record keeping system for the numerous waste types generated and managed at the facility;
  • Detailed acceptance protocols for all waste generated at the facility;
  • Revised Waste Analysis Plan and Quality Assurance/Quality Control (QA/QC) Plan;
  • Updated Contingency Plan and Preparedness and Prevention Plan;
  • Provision for a comprehensive, computerized waste tracking system for improved QA/QC and operational efficiency;
  • A detailed and comprehensive Closure Plan and closure cost estimate; and
  • Detailed facility inspection reporting system.

The permit application was submitted to the NJDEP and subsequently issued to Hoffmann-La Roche.

Hazardous Waste Minimization Plan

The firm was retained by Hoffmann-La Roche in order to provide engineering and technical support in the development and implementation of its Hazardous Waste Minimization/Pollution Prevention Plan. In order to complete the project, the firm methodically evaluated each affected process operation with the goal of identifying cost-effective waste reduction opportunities. Alternatives investigated included the evaluation of administrative controls such as training and optimizing chemical inventory and management techniques through process optimization and modification, chemical substitution, and chemical reprocessing technology alternatives. The facility audits and waste evaluations culminated in the preparation of draft and final Hazardous Waste Minimization/Pollution Prevention Plan. The plan presented a menu of waste reduction projects with implementation schedules, along with the preparation of cost estimates and a calculated percent of waste reduction projected through the year 2000. In many cases, significant economic benefit to the company was realized.

Remediation of Mercury Contamination

The firm was retained by Hoffmann-La Roche to prepare plans and specifications for remediation of mercury contaminated flooring in an active maintenance building at the Nutley, New Jersey facility. The firm delineated the levels and extent of contamination, evaluated logistical considerations and prepared bidding documents which included specifications for removal, treatment, transportation and disposal of contaminated materials in accordance with applicable regulations and Hoffmann-La Roche’s internal standards including health and safety procedures. In addition, an engineering cost estimate was prepared for the remediation.

Regulatory Analysis/Compliance Evaluation

The firm routinely provides Hoffmann-La Roche with technical/regulatory support with regard to federal and state environmental programs, such as the 40 CFR Subpart X requirements for miscellaneous units, Land Disposal Restrictions, and RCRA Air Emission Standards. A brief description of the various regulatory analysis/compliance evaluations undertaken by the firm is described in more detail below.

  • Provided regulatory analysis regarding the applicability of 40 CFR Subpart X and related regulations to various thermal treatment units at the facility. The firm conducted an extensive review of the regulations, prepared regulatory/ compliance determinations and met with representatives of the United States Environmental Protection Agency Region II to negotiate the specific requirements that would be applicable to facility operations;
  • Provided regulatory analysis regarding the potential applicability of the Phase II and III Land Disposal Restrictions to the management of industrial wastewater generated as a result of manufacturing operations;
  • Provided regulatory analysis regarding the potential applicability of the Subpart CC Air Emission Standards for Tanks,  Containers and Surface Impoundments at TSD facilities utilized in the management of hazardous waste generated as a result of manufacturing operations. The regulatory discussion provided background information regarding the management of  industrial wastewater and solvent waste streams in portable units at the facility, a discussion of the regulatory applicability of the Subpart CC Air Emission Standards, as well as a summary of the specific control measures that would be required to be implemented by the effective date of the rule;
  • Developed a soil management operating procedure to be utilized in the evaluation and management of excavated soil at the facility. This operating procedure included a soil management decision tree that provided a flow chart of activities to be conducted to address the sampling, analysis, classification and disposal of soil in accordance with guidance documents issued by the NJDEP;
  • Provided information regarding wetlands protection and storm water management programs as it related to the construction of a new manufacturing facility located in South Carolina; and
  • Provided regulatory analysis regarding the NYSDEC enforcement policy on the RCRA 3004(j) storage prohibition of mixed waste at generator sites.

Hazardous Waste Tank Assessment

This project involved conducting inspections of three aboveground hazardous waste storage tanks at the Nutley facility. The purpose of the inspection, in part, was to satisfy the technical requirements of the NJDEP and federal requirements to conduct tank integrity assessments of hazardous waste storage tanks. The integrity assessments took into consideration the following:

  • Available design standards and/or design drawings for each tank system and its ancillary equipment;
  • The characteristics of the waste stored within each tank system and its compatibility with the materials of construction of the unit;
  • Applicable corrosion protection measures;
  • The age of each tank system, if available; and
  • The results of recently performed leak tests, internal inspections, or other tank integrity evaluations.

The findings of the hazardous waste storage tank assessments were documented in a report that included recommendations
for improving the status of compliance.

Spill Prevention, Control and Countermeasure Plan

The firm was retained by Hoffmann-La Roche to prepare a Spill Prevention Control and Countermeasure (SPCC) Plan for its pharmaceutical manufacturing plant in Nutley, New Jersey. As part of this project, the firm evaluated approximately 15  petroleum storage tanks with respect to spill potential, possible spill consequences and required emergency response. The SPCC Plan was prepared in accordance with the applicable federal and state laws and regulations and addressed the following subject areas:

  • Facilities used for storage, loading/unloading and transfer of oil;
  • Secondary containment facilities;
  • Storm water drainage facilities; and
  • Past oil spill incidents;
  • Programs established by Hoffmann-La Roche for operator training, inspection, testing, monitoring, reporting and security;
  • Procedures to be followed in the event of an oil spill; and
  • A program for further controlling or reducing the possibility of oil spills.

In addition, the firm reviewed the Discharge Prevention, Containment and Countermeasure (DPCC) Plan and the Discharge Cleanup and Removal (DCR) Plan required by New Jersey regulation to ensure consistency with the SPCC Plan.

Closure of Batch Still, Condenser and Receiver

This project involved documenting field activities associated with the proper RCRA closure of the permitted batch still, condenser and receiver located Building 30 at the Nutley facility and certifying that the closure of this equipment was done in accordance with the specifications in the approved closure plan and the requirements found at 40 CFR 264.115.

Activities associated with this project included:

  • Notification and coordination with the NJDEP;
  • Engineering oversight of decontamination procedures;
  • Collection of rinse water samples for laboratory analysis; and
  • Preparation of closure certification/report.

Hazardous Waste Drum Storage Area 2 Secondary Containment Integrity Assessment

Hoffmann-La Roche was required by the NJDEP to conduct an integrity assessment of an area known as Hazardous Waste Drum Storage Area 2 at the Nutley facility prior to conversion from a permitted storage facility to a less than 90-day storage area. The firm was retained to conduct and document this integrity assessment which included the following activities:

  • Visual inspection of the drum storage pad for cracks, gaps or other damage;
  • Inspection of storage and containment areas for evidence of waste or waste residues;
  • Review of facility records of any spills or leaks that occurred in the area; and
  • Assessment of the storm water containment system.

The findings of the assessment were documented in a written report and certified by a Professional Engineer licensed in the State of New Jersey.

Permanent Closure of Hazardous Waste Drum Storage Area 1

The firm provided engineering services to document and certify that the Hazardous Waste Drum Storage Area 1 located at the Nutley facility was closed in accordance with the specifications in the approved closure plan as required by Condition 5 (a), Section III of the Part B Permit.

Activities associated with this closure of this area included:

  • Notification and coordination with the NJDEP;
  • Engineering oversight of decontamination procedures;
  • Collection of rinse water samples for laboratory analysis; and
  • Preparation of closure certification/report.

Storm Water Pollution Prevention Plan

As part of this project, the firm was retained to update the Storm Water Pollution Prevention Plan (SPPP) for the western section of the Nutley facility. An SPPP is required under the NJDEP Basic Industrial Stormwater General Permit to ensure that there is no exposure of industrial material to storm water that is discharged to surface or groundwater, and that there is no discharge of any unpermitted domestic sewage, noncontact cooling water or process water. The section of the Nutley facility to the west of the Conrail Railroad easement is subject to this permit and SPPP requirements. Specific activities associated with the project included:

  • Inspection of source areas where industrial materials are used or stored;
  • Review of best management practices utilized to prevent storm water contact with industrial materials;
  • Review of maintenance, inspection and training schedules; and
  • Review of internal reporting procedures and site incident history.

Following the facility inspection and review of documents, the facility SPPP was revised and updated to include new source areas and related best management practices.

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