TOXIC SUBSTANCES CONTROL ACT

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TOXIC SUBSTANCES CONTROL ACT

• bySunil P. Hangal, Ph.D.RTP Environmental
  Associates, Inc.
• Tel [phone]
• Email hangal_at_rtpenv.com

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TOPICS TO BE COVERED

• Introduction
• Definitions
• Brief overview of TSCA requirements
• TSCA Inventory
• Pre-manufacturing notification for new chemicals
  and use
• Information gathering and testing under TSCA
• Chemical importing and exporting under TSCA
• How to prepare for a TSCA audit

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INTRODUCTION

• -TSCA was first enacted in 1976
• It has been amended several times since
• TSCA gives USEPA broad authority to regulate the
  manufacture, use, distribution in commerce, and
  disposal of chemical substance
• The law is overseen by the USEPA office of
  Pollution Prevention and Toxics (OPPT)

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MAJOR OBJECTIVES

• To characterize and evaluate the risks posed by
  chemicals to humans and the environment before
  chemical is introduced to the environment
• Directs USEPA to require manufacturers and
  processors perform heath and environmental
  testing for existing chemicals (Section 4)
• Manufacturing is defined to include importing

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MAJOR OBJECTIVES

• Prevent future risks through pre-manufacturing
  screening and regulatory tracking of new
  chemicals (Section 5)
• Control unreasonable risks already known or as
  they are discovered for existing chemicals
  (Section 6)
• Gather and disseminate information about chemical
  production, use and possible adverse effects on
  human health and the environment (Section 8)

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CHEMICAL SUBSTANCE

• Chemical substance is defined in section 3 of
  TSCA as any organic or inorganic substance of a
  particular molecular identity, including
• - Any combination of such substances occurring
  in whole or in part as a result of a chemical
  reaction or occurring in nature
• - Any element or uncombined radical

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CHEMICAL SUBSTANCE

• Does not include any mixture, any pesticide in
  commerce, tobacco or tobacco product, any
  article, any special nuclear or source material
  and any food, food additives, drug, cosmetic or
  device as defined by FDA.

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MIXTURE

• Defined under section 3 as any combination of two
  or more chemical substances if the combination
  does not occur in nature and is not, in whole or
  in part, the result of chemical reaction
• Except that such terms does not include any
  combination which occurs, in part or whole, as a
  result of a chemical reaction if none of the
  chemical substances comprising the mixture is a
  new chemical substance and if the combination
  could have been manufactured or imported for
  commercial purposes without a chemical reaction
  at the time the chemical substances comprising
  the combination were combined.

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MIXTURES

• Each chemical substance in a mixture must be
  identified and it is necessary to determine if
  each one is in the TSCA Inventory and is in
  compliance with other TSCA rules.

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ARTICLE

• Article is defined under customs service
  regulation 19CFR 12.120(a) and it means a
  manufactured item which (1) is formed to a
  specific shape or design during manufacture, (2)
  has end use functions dependent in whole or part
  upon its shape or design during end use and (3)
  has no change of composition during its end use
  or only those changes in composition which have
  no commercial end purpose separate from that of
  the article.
• Fluids and particles are not considered articles
  regardless of shape or design.

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ARTICLES

• Metal or plastic sheets, wire, coated fabric,
  rolled carpet or plywood sheets are articles.
• Specific chemical coating on a plastic sheet may
  be applicable to TSCA
• Dielectric fluid in a transformer or capacitor is
  considered as part of the article.
• PCB equipment cannot be imported unless an
  exemption is obtained from USEPA.
• Containers such as cylinders or tank cars with
  residue do not require import certification.

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TSCA OVERVIEW

• Toxic Substances Control Act (15 U.S.C. 2601,
  Title 1) was enacted in 1976
• Subsequently Title II was added in 1986 for
  asbestos, Title III was added in 1988 for radon
  and Title IV was added in 1992 for lead.

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TSCA OVERVIEWTITLE I

• Section 3 Definition
• Section 4 Testing of Chemicals Requires
  manufacturers and processors to conduct tests for
  existing chemicals if
• (1) their manufacture, distribution,
  processing, use or disposal may present an
  unreasonable risk of injury to health or
  environment and the potential for environmental
  release or human exposure is significant

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TSCA OVERVIEW

• (2) existing data are insufficient to
  predict the effects of human exposure or
  environmental releases and
• (3) testing is necessary to develop such
  data.

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TSCA OVERVIEW

• Section 5 Pre-manufacturing screening and
  regulatory tracking of new chemical products or
  new uses for existing chemicals.
• Section 6 Risk Management Regulatory control
  for hazardous chemicals. USEPA is required by
  TSCA to regulate only to the extent necessary to
  protect adequately and use least burdensome
  regulatory approach in controlling unreasonable
  risks.

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TSCA OVERVIEW

• Section 7 Imminent Hazard Authorizes USEPA to
  commence a judicial action for seizure of
  chemical substance that USEPA has determined is
  imminently hazardous.
• Section 8 Information Collection and Reporting
  gather and disseminate information about chemical
  production, use and possible adverse effects to
  human health and environment

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TSCA OVERVIEW

• Section 12 Export notification requirements
• Section 13 Import certification requirements
• Other Sections
• Section 9 Relationship to other federal laws
• Section 11 Inspections
• Section 15, 16 and 17 Prohibited acts,
  penalties and enforcement
• Section 20 and 21 Citizens actions
• Section 26 Use of categories versus specific
  substances

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TSCA CHEMICAL SUBSTANCE INVENTORY

• Existing chemicals are included in the TSCA
  Chemical Substance Inventory. Initial Inventory
  in 1979. All chemicals since have gone through
  New Chemical Review.
• Any substance not in Inventory is classified as
  New Chemical.
• 82,000 Chemical Substances are in the Inventory.
• Restrictions on manufacture or use are included
  in the Inventory.

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TSCA INVENTORY

• A new substance can be manufactured for
  commercial purpose only if subject from PMN
  reporting, Low Volume Exemption or naturally
  occurring material.
• New chemicals which submit PMN and NOC (Notice of
  Commencement of manufacture or import) are
  included in the inventory.
• USEPA has policy on how to identify chemicals in
  the inventory with nomenclature guidance.

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TSCA INVENTORY

• Public Inventory is posted by Cornell University
  website.
• If substance is identified as confidential will
  be searched by the agency upon receipt of a
  Notice of Bona Fide Intent to Manufacture.
• A copy of the Inventory can be purchased from
  Government Printing Office or NTIS.
• CORR (Chemicals on Reporting Rules Database)
  provides other TSCA rules an existing chemical
  substances is subject to.

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PRE-MANUFACTURING NOTICE

• PMN required to be submitted at least 90 days
  prior to activity i.e. manufacture or import.
• PMN requires submission of available data on
  potential adverse effects on human health and the
  environment.
• Significant New Use notification may be
  required if there are plans to produce, process,
  or use existing chemical in a way that differs
  from previously permitted uses.
• USEPA may impose restrictions from the review
  of information.

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PMN PROCESS

1. Company submits PMN
2. USEPA conducts initial review
3. USEPA develops hazard profile and
   exposure/release profile
4. Final USEPA decision
5. Company submits NOC
6. Chemical added to inventory
7. Can also obtain Exemption (Low volume, test
   marketing and polymer)

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EXISTING CHEMICALS REPORTING AND TESTING

• Section 8(a)- USEPA can collect information on
  exposure, use and production.
• Section 8(b) Inventory Update. Companies report
  production and use information for substances
  above threshold.
• Section 8(c) Company retain allegation of
  adverse effects on health and the environment and
  submit to USEPA upon request.

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REPORTING AND TESTING REQUIREMENTS FOR EXISTING
CHEMICALS

• Section 8(d) USEPA can collect information on
  ongoing and existing studies.
• Section (e) Immediately report substantial risk
  information to USEPA.
• Section 4 Manufacturers can be required to
  conduct testing on specific chemicals.
• Section 6 USEPA addresses unreasonable risks
  through warning labels, recordkeeping and
  production bans.

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HIGH PRODUCTION VOLUME (HPV) SUBSTANCES

• Industry voluntarily agreed to provide USEPA with
  basic toxicity data for 2,200 chemicals in
  commerce which are produced in volume of 1
  million pounds or greater per year.
• This program began in 1998.
• Voluntary Childrens Chemical Evaluation Program
  for 20 chemicals.
• USEPA will release initial reports evaluating the
  potential hazards of some of these chemicals.

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NORTH AMERICAN AGREEMENT ON INDUSTRIAL CHEMICALS

• USEPA announced on 08.21.07 that it will review
  and take action as needed on more than 9000
  industrial chemicals produced or imported in
  amounts greater than 25,000 pounds per year as
  part of agreement with Canada and Mexico.
• USEPA will use the results of recent Canadian
  results for these moderate volume chemicals.

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SECTION 8(a) REPORTING AS PART OF INVENTORY
UPDATE

• Manufacturers and Importers of certain chemical
  substances are required to report the specific
  chemical identity and quantity, and the site of
  manufacture and importation every four years
  (every 5 years from 2010).
• Reporting obligation based primarily on two
  factors
• a. Is the substance reportable under the
  Inventory Update Rule?
• - Check the Inventory.
• b. Is the industry a manufacturer, importer,
  exporter that is required to report that
  substance?
• -10,000 lbs or more at any single site
  during the fiscal year are required to report.

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REQUIREMENTS UNDER INVENTORY UPDATE RULE

• Required records include the documents that show
  the production volume, plant site and
  site-limited status of each chemical substance.
• Documents maintained on file for four years after
  effective date of applicable reporting period.

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SECTION 8(a) PRELIMINARY ASSESSMENT INFORMATION
RULE (PAIR)

• Site specific exposure related information must
  be reported for chemical substances listed in 40
  CFR 712.
• - Quantity, environmental loss during
  production or importation, chemical release
  quantity and worker exposure information.
• - Report using form 7710-35.

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REPORTING UNDER SECTION 8(c)- ALLEGED SIGNIFICANT
ADVERSE REACTIONS

• Keep files for 30 years of allegations of
  significant adverse reactions to human health or
  environment and provide this information to USEPA
  upon request, e.g.
• - Consumer allegations of personal injury to
  health,
• - Report of occupational disease or injury,
  and
• - Environmental complaints submitted.

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SECTION 8(d) REPORTING HEALTH AND SAFETY STUDIES

• Unpublished studies are required to be reported
  for chemicals in 40CFR716.120.
• Studies are subject to either copy submission or
  listing requirements.
• Reporting required within 60 days of listing.
• Reporting period may no longer be more than 2
  years after listing (sunset).
• Health and safety studies may include
  epidemiological or clinical, occupational
  exposure or toxicological.

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SECTION 8(e) SUBSTANTIAL RISK REPORTING

• If new information is obtained which reasonable
  supports the conclusion that a substance or
  mixture presents a substantial risk shall
  immediately inform USEPA (within 30 days)
• Substantial risk information need not establish
  conclusively that substantial risk exists.
• Typical data is new toxicity or exposure data.
• Trade association and industry consortia data
  reported is designated as FYI.

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SECTION 13- IMPORT REQUIREMENTS

• Positive Certification Statement I hereby
  certify that all chemical substances in this
  shipment comply with all applicable rules or
  orders under TSCA and that I am not offering a
  chemical substance for entry in violation of TSCA
  or any applicable rule or order under TSCA.
• OR
• Negative Certification Statement I certify that
  all chemicals in this shipment are not subject to
  TSCA.

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SECTION 12(b) EXPORT REQUIREMENTS

• Notice of the first export is required within the
  calendar year.
• Export only new chemical does not require
  notification.

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TSCA COMPLIANCE PROGRAM

• TSCA compliance policy and procedures
• TSCA roles and responsibilities
• Control over purchasing, chemical entry,
  manufacturing, distribution, sales and
  information (adverse effects, allegations, risks,
  studies, etc)
• Auditing and reporting
• Document TSCA status through contract, PO and
  certification letters
• Beware of change. Seemingly minor adjustments
  in materials and processes may have TSCA
  implications

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TSCA AUDIT REQUIREMENTS

• PMNs, LVE and other exemptions
• Significant New Use Rules notices and consent
  orders
• Recordkeeping and reporting under TSCA section 8
  rules (PAIR, IUR, etc)
• Company policy to ensure TSCA rules

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INFORMATION REQUIRED FOR TSCA AUDIT

• Accepted chemical name
• CAS or USEPA Accession number
• Molecular formula
• of each chemical in a mixture
• Import dates
• Quantity imported per shipment
• ID used to track each shipment
• Quantity manufactured and dates
• List of product exported and dates

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TSCA AUDIT PREPARATION

• Prepare records
• Review TSCA Inspection Guidance at USEPA website
• Prepare staff
• Demonstrate access and familiarity to TSCA
  resources such as rules, TSCA Inventory, TSCA
  requirements and CORR
• Highlight TSCA compliance policy and procedures