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BioTox

Providing Sound Science to Toxicology Issues

 

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CAPABILITIES

IDENTIFICATION of regulatory/technical matters that could impact manufacturing operations both in-house and up-line suppliers. This includes all aspects of toxicology and industrial hygiene regulatory compliance, planning, product stewardship and risk management for:

  • commercial chemicals, foods and food additives
  • agriculture, pharmaceuticals
  • petrochemicals

PLAN procedures to handle client needs and regulatory mandates. This includes development, analysis and evaluation of health and environmental safety data such as:
  • comprehensive literature surveSpecific disciplines include the following: ys, critical data review and evaluation
  • robust data summaries, TSCA/OECD Testing Plans
  • automated data access programs, exposure and risk assessment
  • protocol development, study monitoring & report audits
  • quality assurance auditing, GLP compliance inspections
  • HazCom, OSHA
  • exposure monitoring, worker education
  • endocrine disruptors

PREPARE paperwork for the following agencies and/or regulations:

  • FIFRA (Pesticides, Monitoring Data/Quality Assurance Review
  • TSCA (Sections 4 & 5), Hazard Communication Standards
  • FDA, Accidental Exposure Procedures
  • CERCLA/SARA (Superfund), ANSI/MSDS Preparation
  • RCRA, MSDS updates and maintenance
  • OSHA Activities including State Permitting
  • Community Right-to-Know Chemical Hygiene Plans
  • IH Workplace Evaluations, OECD SIDS Dossiers, OECD SIARs, HVP Documents
  • Proposition 65 compliance
  • LHAMA Certifications
  • F-Value Assessments
  • PMN Submissions
  • GRAS Notifications

RESPOND to FIFRA and TSCA (Test Rules), CPSC as well as FDA and other agency mandates:
  • interpretation of CWA, TSCA, FIFRA, CAA, CERCLA, SDWA, RCRA, REACH, SARA, OSHA, etc. from a business perspective: impact, timing and relevance of these regulations and presentation of a balanced perspective to authorities.
  • experienced in expert counsel for litigation review and document preparation.
  • determination of economic impact of agency regulations.

MONITOR Environmental and Toxicological Regulations for legal and scientific compliance:
  • First-hand experience with numerous trade organizations and animal welfare groups including: CIIT, ACC (formerly CMA), CSMA, SOCMA, NABR, AIHC, IISRP, AMP and CAAT (Johns Hopkins).
Hands-on contract and corporate laboratory experience in design, integration, oversight, implementation, and management of major animal testing programs and facilities. 
 
  • Specific disciplines include: 
    • acute and chronic mammalian toxicology 
    • genetic toxicology
    • environmental toxicology
    • developmental toxicology
    • inhalation toxicology
    • neurotoxicity
    • biochemistry/pharmacokinetics 
    • carcinogenicity

MANAGEMENT of Regulatory Affairs and General Toxicology Issues:

In-depth experience with technical management of task force groups on Isopropanol, Phthalate Esters, Butadiene, Ethylene/Propylene, Oxo Process, Neurotoxicity, Acetone, Acetophenone and Acrylonitrile including development of appropriate study designs, selection of qualified testing organizations, management of regulatory test programs, interaction with agency staffers and contract laboratory scientists and preparation of comments to EPA & FDA.  Risk in the workplace: By thorough evaluation of historical data on worker accidents and a review of facility design, BioTox can assist designing a program to provide minimal liability exposure for the manufacturer as well as a safe environment for the employee.