Chemical Regulatory Considerations
for College/University Laboratory &
Environmental Health Professionals
Bradley Grams, Chemical Programs Coordinator
U.S. EPA, Region 5, Land & Chemicals Division
Objectives
• General awareness, background and
overview of the TSCA PCB regulations
• General awareness, background and
overview of EPCRA and TSCA more broadly
• Discussion of common concerns, issues and
findings of non-compliance
• Overview of the Regional Role in program
implementation
Polychlorinated biphenyl (PCB)
Regulatory Requirements
Background
• Domestically manufactured from 1929 until 1979
• Chemical properties
• Industrial and commercial applications
Where are PCBs now?
• Products and materials produced before
1979
o Transformers and capacitors and other electrical
equipment including voltage regulators, switches, reclosers, bushings, and electromagnets
o Oil used in motors and hydraulic systems
o Old electrical devices or appliances containing PCB
capacitors
o Fluorescent light ballasts
Other PCB Sources
• Cable insulation
• Thermal insulation material including
fiberglass, felt, foam, and cork
• Adhesives and tapes
• Oil-based paint, floor finish, caulking
• Plastics
• Carbonless copy paper
TSCA
• Toxic Substance and Control Act (TSCA)
prohibits the manufacture of PCBs, controls
the phase-out of their existing uses and sees
to their safe disposal
• Not delegated to the states
PCB Regulations (40 CFR Part 761)
• Basic Principles
– PCBs are regulated specifically from “cradle to
grave”
– You must find permission in the regulation for any
action you desire to take; without specific
authorization, it is not permitted.
– Always check the definition of terms used and the
coverage of the specific Sub-Part before requesting
activity authorization
Key Compliance Requirements
• General
Management
• PCB Equipment
Marking
• Records for PCBs
• PCB Transformers
•
•
•
•
•
PCB Spills
PCB Items
PCB Storage
PCB Transportation
PCB Disposal
General Management
• Current status of any ongoing or
unresolved consent orders, compliance
agreements, NOVs, etc.
• Determine activities or facilities which
are regulated
• PCB concentrations are required to be
established
General Management
• May not manufacture PCBs without an
exception
• May not distribute in commerce for use other
than resale and in a totally enclosed manner
– Must maintain record of transfer of ownership
• Workers in direct contact with PCBcontaminated surfaces must be protected
PCB Equipment Marking
• Storage rooms and certain
equipment that contains
PCBs must be marked with
an ML marking
• Includes access points for
remediation waste, PCB
transformers, storage for
disposal areas, and voltage
regulators
Records for PCBs
• Required to have a US EPA ID number (may be
different than RCRA ID), unless exempted.
• Must notify of PCB waste handling activities
using US EPA Form 7710-53
• Annual document log completed by July 1
– records maintained since inception and kept for 3
years after no longer used or stored
Records for PCBs
• Spill cleanup records
maintained for 5 years
• Disposer and Storer
records requirements
– Annual records, document
log and annual report
– Annual report due by July
15
PCB Transformers
• Use restrictions
– Can’t pose a risk to food or feed
• Must register transformer
– No later than 30 days after identified as PCB
transformer
– Maintain records of registration with required
inspection records
• No combustible materials stored within 5m
PCB Transformers
• Servicing requirements
• Inspections once every 3 months and records
• Leaking transformer required to be
repaired/replaced; inspected daily
• National Response Center notification of fires
PCB Spills
• Requires reporting of spills in excess of 50 ppm in
addition to CWA or CERCLA
– Spill into water/sewer; grazing lands or vegetable gardens;
or >10lbs PCBs by weight
• Subpart G Spill Cleanup Policy
– Only applies to spills cleaned up within 72 hours; otherwise
40 CFR 761.61 applies and needs EPA approval before
work
• Maintain records of clean-up
PCB Items
• Heat transfer and hydraulic systems
– Verify testing of system to determine PCB
concentration. May only be used if <50 ppm PCB
• Electromagnets, switches and voltage
regulators may contain PCBs if certain
requirements met
PCB Storage
• Storage for reuse
• Storage for disposal
• Commercial storage
Storage for Reuse
• PCBs to be used for refilling, awaiting repair or
installations, and spares or replacements
• 5-year storage for reuse
–
–
–
–
Must meet use conditions per 40 CFR 761.35
Must be marked
Not required to be in a 40 CFR 761.65 storage area
Required record keeping (Annual Document Log)
• Indefinite storage allowed in 65(b) storage area or
equivalent
Storage for Disposal
• PCB waste >50 ppm (also includes remediation
waste)
• Have to remove from storage within 9 months and
dispose of waste within 1 year
• May store in non-compliant storage area up to 30 days
from date removed from service under certain
requirements
– Liquid PCBs require SPCC plan
Storage for Disposal (cont’d)
• 40 CFR 761.65 storage area design requirements
• Large, non-leaking and structurally undamaged
equipment may be stored on pallets next to a storage
area
– Weekly inspections
• Operational requirements
– Marking, leaks, handling equipment, inspections
– Containers comply with U.S. DOT specifications
Commercial Storage
•
•
•
•
Stores other people’s waste
Transfer facility exempt if stored less than 10 days
Must notify using Form 7710-53
<500 gallons, exempt from Approval, but still subject to
regulatory requirements for Storers
Commercial Storage (cont’d)
• >500 gallons requires EPA approval prior to
storing
• PCB Storage Approval includes specifications
in facility application
• Closure plans and notification requirements
• Inspection and records requirements
PCB Transportation
• Generator responsible for ensuring waste is hauled by
a PCB Transporter
• Manifest requirements parallel to RCRA
• Verify that transporter has notified EPA of PCB activity
using form 7710-53
• Some exemptions for hauling waste between your
own facilities
PCB Disposal
• Method of disposal is dependent upon the type of PCB
waste – See Subpart D 761.60
• Thou shall not dilute! Diluted waste is disposed at its
source concentration
• Cannot solidify wastes to avoid incineration
• No open burning of PCB wastes
• Water discharge restrictions
• Multi-phasic wastes
PCB Disposal (cont’d)
• Subpart D (40 CFR 761.60) lists disposal
options:
– Incineration
– Alternate Technology
– High Efficiency Boiler
– Scrap Metal Recovery Oven/Smelter
– Landfill
– Decontamination
PCB Disposal (cont’d)
• Written notifications to landfill required under
certain circumstances.
• Disposal facility must prepare a certificate of
disposal (COD) for each shipment of
manifested waste it receives.
• Maintain COD with annual records
Typical Records to Review
• Inspection, storage, maintenance, and disposal
records for PCBs & PCB Items
• PCB Equipment inventory and sampling results
• Manifest and Certificates of Disposal
Typical Records to Review (cont’d)
• Correspondences with regulatory agencies
regarding non-compliance situations
• Annual reporting
• SPCC Plans
Typical Physical Features to Inspect
• PCB storage areas
• Potential PCB Sources (as discovered)
• Equipment, fluids, and other items used
or stored at the facility containing PCBs
Resources
• US EPA Polychlorinated Biphenyls (PCBs) Home
Page
http://www.epa.gov/epawaste/hazard/tsd/pcbs/index.ht
m
• PCB Question and Answer Manual
http://www.epa.gov/epawaste/hazard/tsd/pcbs/pubs/q
acombined.pdf
• Polychlorinated Biphenyl Inspection Manual:
http://www.epa.gov/compliance/resources/publications
/monitoring/tsca/manuals/pcbinspect/
Resources (cont’d)
• Polychlorinated Biphenyls (PCB) Penalty Policy. Issued
April 9, 1990
http://www2.epa.gov/enforcement/polychlorinated-biphenylspcb-penalty-policy
• Protocol for Conducting Environmental Compliance Audits
of Facilities with PCBs, Asbestos, and Lead-based Paint
Regulated under TSCA
http://www.epa.gov/compliance/resources/policies/incentives/au
diting/apcol-tsca.pdf
Regional Contacts
• PCB Coordinator & Remediation Issues:
Peter Ramanauskas / +1 (312) 886-7890 / ramanauskas.peter@epa.gov
• PCBs in Use & PCB Activity Registration:
Brad Grams / +1 (312) 886-7747 / grams.bradley@epa.gov
• Enforcement/Compliance:
David Star / +1 (312) 886-6009 / star.david@epa.gov
• Commercial Storage/Disposal:
Mary Setnicar / +1 (312) 886-0976 / setnicar.mary@epa.gov
• Outside Region 5:
tsca-hotline@epa.gov / +1 (202) 554-1404
Questions?
Beyond PCBs: Other Requirements
of the Toxic Substances Control Act
(TSCA)
Toxic Substances Control Act (TSCA)
Consists of Six Titles:
–
–
–
–
–
–
Title I: Control of Toxic Substances
Title II: Asbestos Hazard Emergency Response
Title III: Indoor Radon Abatement
Title IV: Lead-Based Paint Exposure
Title V: Healthy High Performance Schools
Title VI: Formaldehyde in Wood Products
TSCA Title I (Core)
Title I includes provisions for:
– Regulation of hazardous chemicals and mixtures
– Controlling manufacture, import and testing of new
and existing chemicals and mixtures
– Managing imminent hazards
– Reporting and recordkeeping
Intended to prevent unreasonable risks of injury to human health
or the environment associated with the manufacture, processing,
distribution in commerce, use or disposal of chemical substances.
38
TSCA Chemicals
Any chemical which is not:
– Regulated by FFDCA (food, drug, cosmetic,
etc.)
– Regulated by FIFRA (pesticides)
– Tobacco or a tobacco product
– Regulated by the Atomic Energy Act
– Taxed under Section 4181 of Internal
Revenue Code (firearms and ammunition)
When is a chemical a “TSCA Chemical”?
CERCLA
CAA
TSCA
Disposal
or
Release
FIFRA
Stream of
Commerce
EPCRA
RCRA
FFDCA
CWA
40
TSCA Requirements: the Inventory
TSCA §8(b):
“The Administrator shall
compile, keep current, and
publish a list of each
chemical substance which
is manufactured or
processed in the United
States.”
TSCA Chemicals
“Existing”
“New”
TSCA Requirements: the Inventory
(cont’d)
CDR: Chemical Data Reporting
– Manufacturers/importers of existing chemicals
> 25,000 lbs per reporting year
– Additional processing and use information required
for chemical substances manufactured/imported
> 100,000 pounds
– Four year cycle, next report due 2016
– Electronic reporting via CDX
TSCA Requirements: the Inventory
(cont’d)
Non-Confidential:
– Publicly available online
Confidential:
– EPA:
• Must be CBI cleared
• Contact EPA for questions
– Public:
• Bona Fide request
TSCA New Chemicals: § 5 PMNs
Manufactured
in small
quantities for
R&D
purposes?
Yes
No Section 5
submission
required
No
Manufactured or
imported < 10,000 kg
each year?
Yes
Section 5 exemption
notice must be filed
No
Low environmental
Yes
releases & low human
exposure?
No
Manufactured or
imported only for test
marketing?
No
A polymer?
No
Yes
Yes
Premanufacturing
Notice (PMN) required
> 90 days before
manufacture or import
Outcome - Chemical Inventory Listing
Other Outcomes: § 5(e) Orders
Issued as part of PMN process when:
– there is insufficient information to evaluate the human health and environmental
effects, and
– that the substance may present an unreasonable risk of injury to human health or
the environment (the "risk-based" finding), or
– that the substance will be produced in substantial quantities and may be
anticipated to enter the environment in substantial quantities or there may be
significant or substantial human exposure (the "exposure-based" finding).
Usually will require:
– Toxicity or fate data before exceeding a production threshold
– “risk based” = exposure controls (PPE, disposal requirements, limitation on
release to water, haz. communication)
– “exposure based” = testing at a specified exposure level, possible risk
communication
Applies only to PMN holder
Other Outcomes:
Significant New Use Rules (§5(a)(2))
5(e) Order
• Pertains only
to PMN
submitter
NOC
• Chemical on
inventory
SNUR
• Applies to all
manufacturers
The SNUR requires that manufacturers, importers and
processors of certain substances notify EPA at least 90
days before beginning any activity that EPA has
designated as a "significant new use."
PMN Outcomes: § 5(f) Actions
If EPA determines that a new chemical will
present unreasonable risk before a TSCA section
6 rule can be promulgated, EPA may
– Limit the amount or impose other restrictions on the
substance via an immediately effective proposed
rule, or
– Completely prohibit the substance by issuing a
proposed order or applying to a US District Court for
an injunction
Existing Chemicals: Testing (§ 4)
TSCA § 2: “It is the policy of
the United States that
adequate data should be
developed with respect to the
effect of chemical substances
and mixtures on health and the
environment and that the
development of such data be
the responsibility of those who
manufacture and those who
process such chemicals and
mixtures.”
Test Rule
Risk Finding
• Hazard
• Exposure
Data
inadequacy
Testing
Need
Existing Chemicals: Interagency Testing
Committee
• Lead by EPA, ~14 governmental agencies
participate
• Recommend chemicals in need of additional
testing/information
• Edits Priority Testing List and requests EPA to
add the chemicals to Preliminary Assessment
Information Reporting (PAIR) rules
Existing Chemicals: § 8(a) PAIR
Manufacturers/Importers
required to report:
– Quantity of chemical
produced and/or
imported
– Amount of chemical lost
to the environment
during production or
importation
– Quantity of enclosed,
controlled and open
releases of the chemical
– Per release, the number
of workers exposed and
the number of hours
exposed
Existing Chemicals: § 6 Actions
If there is a reasonable basis to conclude that the
chemical's manufacture, processing, distribution, use or
disposal presents an unreasonable risk, EPA may by
rule take action to:
•
•
•
•
•
Prohibit or limit manufacture, processing, or distribution in commerce
completely or above a specified limit;
Require adequate warnings and instructions with respect to use, distribution,
or disposal;
Require recordkeeping;
Prohibit or regulate any manner of commercial use or disposal; and/or
Require manufacturers or processors to give notice of the unreasonable risk
of injury, and to recall products if required.
TSCA’s Risk Assessment
New Chemicals
PMN/SNUN
Existing Chemicals
CDR Data § 8(a)
Interagency Testing Committee § 4
Exemptions: R&D, LVE, Polymers, articles, etc.
PAIR § 8(a)
§ 5(e) Order and SNUR
Unpublished health and safety reporting § 8(d)
Test Tule § 4
NOC
Section 6 Rulemaking
TSCA Requirements: § 8 Recordkeeping
• 8(c) requires companies to record, retain, and in some
cases report to EPA, "allegations of significant adverse
reactions" to any TSCA chemical or mixture, both new and
existing, that they manufacture, import, process, or
distribute, even if the allegation is completely
unsubstantiated.
• Section 8(c) exceptions:
– Those alleging "known human effects."
– Those involving adverse reactions to the environment if the
alleged cause can be directly attributable to an incident of
environmental contamination that has already been reported to
the U.S. Government.
– Anonymous allegations.
TSCA Requirements: § 8 Recordkeeping
Section 8(e) requires “any person who manufactures, imports,
processes, or distributes in commerce a chemical or mixture
subject to TSCA, and who obtains any information which
reasonably supports the conclusion that such substance or
mixture presents a substantial risk of injury to health or the
environment, must, within 30 days, inform EPA of such
information unless such person has actual knowledge that EPA
already knows of it.”
•
•
•
No exemptions for small businesses, small production or importation volumes, or
commercial activities such as manufacture for export only or research and development.
Does not require submission if the person does not manufacture, import, process or
distribute commercially.
Does not require submission if person no longer imports, manufactures, processes or
distributes in commerce
TSCA Requirements: § 12(b) Exports
Exporters of TSCA chemicals must file an Export Notice
with EPA if they export a product containing a chemical
or mixture which is subject to:
–
–
–
–
a §§ 4 or 5(b) data submission requirement,
a proposed or final §§ 5 or 6 rule
a final § 5 order, or
a pending action or grant of final relief under §§ 5 or 7
TSCA Requirements: § 12(b) Exports
Export Notices must be provided in writing contain the
following information:
–
–
–
–
Name and address of exporter
Name of chemical being exported
Section of TSCA triggering Export Notice
Date of export or intended export
TSCA Requirements: § 12(b) Exports
Chemicals subject to
notification can be found
online:
http://www.epa.gov/oppt/import
-export/pubs/12(b)list_2013.pdf
TSCA Requirements: § 13 Imports
Import certification submitted to CBP
at time of entry, either “positive” …
“I 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
thereunder.”
…or “negative”
“I certify that all chemical
substances in this shipment are
not subject to TSCA.”
TSCA Requirements: § 13 Imports
Certifications:
• must be in writing
• no specific form required
• “self implementing”
• “blanket” certifications
accepted
TSCA Requirements: § 13 Imports
February 19, 2014: President
Obama signs executive order
requiring the “streamlining of imports
and exports” in the United States.
May 12, 2014: OSCPP AA Jim
Jones signs “option selection” memo
for TSCA Certification integration
into ACE.
Ongoing: OPPT, with support from
OECA and Regions, writing new rule
for electronic certifications
TSCA Reporting Requirements
New Chemicals
Existing Chemicals
§ 8(c) recordkeeping
SNUR requirements § 5
§ 8(e) reporting
CDR reporting § 8(b)
§ 13 import certifications
§ 8(c) recordkeeping
§ 13 import certifications
§ 12 export notifications
Contacts
Program:
Brad Grams / +1 (312) 886-7747 / grams.bradley@epa.gov
Enforcement:
Claudia Niess / +1 (312) 886-7598 / niess.claudia@epa.gov
Outside Region 5:
TSCA Hotline / +1 (202) 554-1404 / tsca-hotline@epa.gov
Questions?
Introduction to EPCRA
Compliance
What is EPCRA?
• EPCRA = Emergency Planning and Community Rightto-Know Act
• Created to help communities plan for emergencies
involving hazardous substances
• Requires:
– hazardous chemical emergency planning by federal, state
and local governments, tribes, and industry.
– industry to report on the storage, use and releases of
hazardous chemicals to federal, state, and local
governments.
EPCRA Provisions
• EPCRA has four provisions:
– Emergency Planning (§§301-303)
– Emergency Release Notification (§304)
– Hazardous Chemical Storage Reporting Requirements
(§§311-312)
– Toxic Chemical Release Inventory (§313)
• Information collected from these four requirements
helps states and communities develop a broad
perspective of chemical hazards for the entire
community, as well as for individual facilities
Emergency Response Plans
• Emergency Response plans contain information that
community officials can use at the time of a chemical
accident.
• Community emergency response plans for chemical
accidents were developed under section 303.
• Local Emergency Planning Committees (LEPCs) are
required to update these plans annually.
Plan Contents
• The plans must:
– Identify facilities and transportation routes of extremely hazardous substances;
– Describe emergency response procedures, on and off site;
– Designate a community coordinator and facility coordinator(s) to implement the
plan;
– Outline emergency notification procedures;
– Describe how to determine the probable affected area and population by
releases;
– Describe local emergency equipment and facilities and the persons responsible
for them;
– Outline evacuation plans;
– Provide a training program for emergency responders (including schedules); and,
– Provide methods and schedules for exercising emergency response plans.
Emergency Notification Requirements
• Facilities must immediately notify the LEPC and SERC/TERC if
there is a release into the environment of a hazardous
substance that is equal to or exceeds the reportable quantity.
• This requirement covers the 355 extremely hazardous
substances, as well as the more than 700 hazardous
substances subject to the emergency notification requirements
under CERCLA section 103(a)
• Initial notification can be made by telephone, radio, or in
person. Emergency notification requirements involving
transportation incidents can be met by dialing 911, or in the
absence of a 911 emergency number, calling the operator.
Content of Notification
• This emergency notification must include:
–
–
–
–
–
–
The chemical name;
An indication of whether it is an extremely hazardous substance;
An estimate of the quantity released into the environment;
The time and duration of the release;
Whether the release occurred into air, water, and/or land;
Any known or anticipated acute or chronic health risks associated with
the emergency, and where necessary, advice regarding medical
attention for exposed individuals;
– Proper precautions, such as evacuation or sheltering in place; and,
– Name and telephone number of contact person.
• A written follow-up notice must be submitted to the
SERC/TERC/LEPC as soon as practicable after the release.
Community Right-to-Know
• Under OSHA, employers must maintain a material safety data
sheet (MSDS, now SDS) for any hazardous chemicals stored or
used in the work place.
• SDSs for chemicals or a list of these chemicals held above
certain threshold quantities must be submitted to the
SERC/TERC, LEPC, and local fire department.
• If the facility owner or operator chooses to submit a list of
chemicals, the list must include the chemical or common name
of each substance and must identify the applicable hazard
categories.
• If a list is submitted, the facility must submit a copy of the SDS
for any chemical on the list upon request.
Toxics Release Inventory (TRI)
• Section 313 of EPCRA established the TRI
• TRI tracks the management of certain toxic chemicals that pose
a threat to human health and the environment.
• Facilities in different industry sectors must annually report how
much of each chemical they managed through recycling,
energy recovery, treatment and environmental releases.
• TRI reporting forms must be submitted to EPA and the
appropriate state or tribe by July 1 of each year. These forms
cover environmental releases and other management of toxic
chemicals that occurred during the previous calendar year.
TRI Thresholds
• A facility is required to report to the TRI Program if it
meets ALL of these criteria:
– The facility is included in a TRI-covered North American
Industry Classification System (NAICS) code (see the TRI
NAICS code webpage or Table I of the current Reporting
Forms and Instructions for a complete list); and
– The facility has 10 or more full-time employee equivalents
(i.e. >/=20,000 hours); and
– The facility manufactures (includes import), processes or
otherwise uses any TRI chemical in quantities greater than
the established threshold in the course of a calendar year.
EPCRA Thresholds
Contacts
Program:
Brad Grams / (312) 886-7747 / grams.bradley@epa.gov
Enforcement:
Meghan Dunn (TRI) / (312) 886-6191 / dunn.meghan@epa.gov
Mick Hans (non-313) / (312) 353-5050 / hans.mick@epa.gov
Outside Region 5:
EPCRA Hotline / +1 (800) 424-9346
Questions?