Qualifications Summary
Regulatory expert with in-depth experience providing private companies with cost-effective compliance solutions. Mr. Busby has extensive experience in dealing with EPA, FDA, OSHA, NJDEP, US Customs and ISO 9000 rules and regulations. Past work includes the develop of risk management and standard operating procedures to provide pharmaceutical and biotech facilities with a safer work environment ensuring community right-to-know compliance (SARA Title III) including emergency planning, emergency release notification, record keeping and annual hazardous material inventory reporting. He has also conducted site audits for pharmaceutical and biotech companies in order to establish applicability and compliance with current OSHA rules and regulations. Other past work includes an independent assessment of waste in both chemical blending and durable product manufacturing including waste stream management.
Experience
Pharmaceutical Industry Experience
Conduct thorough site audits to establish the need for various health and safety related programs which will ensure complete local and federal compliance. Program elements include:
- Resource Conservation and Recovery Act (RCRA) Requirements
- Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Requirements
- Occupational Safety and Health Administration (OSHA) Requirements
- Integrated Contingency Planning and Community Right-To-Know Act (EPCRA) Requirements
Biotech Experience
Provide on-site support as a health and safety consultant. Develop programs in order to ensure compliance with applicable state and federal regulations and the safety of employees and visitors.
- Comprehensive Health and Safety Plans
- Train and assist company employees
- Review of current on-site chemicals and corresponding Material Safety Data Sheets (MSDSs).
- Ensure current records are complete and accurate.
Materials Development Industry Experience
Conduct independent assessments of waste streams for multiple manufacturing environments in both chemical blending and durable product manufacturing industries, including waste stream management.
- Coordinate data gathering with environmental and process staff
- Review waste data and hazardous characteristics
- Reconcile DOT and RCRA codes
- Evaluated waste stream constituents
- Coordinate and review constituent database management
- Develop electronic process flow documentation
- Propose waste consolidation scheme
Other Current Experience
- Prepare and submit industrial wastewater permitting applications.
- Review and establish sampling procedures based on federal and local regulations pertaining to air and water standards.
- Develop, implement and certify site closure plans in accordance with current RCRA regulations
- Assist clients in disseminating SOP and waste management procedure materials internally by making them available in other media formats such as HTML and PDF.
- Ensure underground storage tank compliance including permitting, spill protection, record keeping and closure.
- Determine facility Clean Air Act compliance, complete and submit air permits, monitor air quality and submit samples for analysis.
- Conduct Phase I Site Investigations and Phase II Site Remediation Projects according to current ASTM standards.
- Developed and implemented FDA Hazard Analysis and Critical Control Point (HACCP) plans for clients in the seafood industry.
- Conducted risk assessment for foreign seafood suppliers in Taiwan, Venezuela, and Sri Lanka to ensure strong relationships, quality assurance and U.S. compliance.
Education
University of Maryland – MS in Environmental Management, Marine Estuarine Environmental Science Ph.D. Program
Gettysburg College, Gettysburg, PA – BA Business Management. Minor in Environmental Studies
Occupational Safety and Health Administration: Level 1 Certified, 2002
National Oceanic and Atmospheric Association: Hazard Analysis and Critical Control Point Plan certified, 2000