• While legislative reform is under way, EPA is using the existing
Toxic Substances Control Act to the greatest extent possible.
• Comprehensive effort includes:- New regulatory risk management actions- Development of chemical-specific Action Plans which will
focus risk management efforts on chemicals of concern.
- Requiring industry to submit
information needed tounderstand chemical risks.
- Increasing public access to
information about chemicals.

Office of Pollution Prevention and Toxics2• Range of risk management activities outlined inaction plans:– TSCA test rules and significant new use rules– New Toxics Release Inventory reporting– Design for the Environment and Green Chemistry
approaches for alternatives assessment– TSCA Section 5(b)(4) Chemicals of Concernlist– TSCA Section 6 actions to ban or limit uses

Office of Pollution Prevention and Toxics3•Part of Administrator Jackson’s plan to enhance EPA’s chemical management
program:– Identify chemicals that pose concern to the public– Move quickly to evaluate and determine what actions need to be taken to address risks– Initiate appropriate action•Selection Criteria:
Chemicals identified as persistent, bioaccumulative, and toxic
High production volume chemicals
Chemicals in consumer products
Chemicals potentially of concern for children’s health because of reproductive ordevelopmental effects– Chemicals subject to review and potential action in international forums– Chemicals found in human biomonitoring programs––––•

Actions may include initiating regulatory action to label, restrict, or ban achemical, or to require the submission of additional data needed todetermine the risk.

Office of Pollution Prevention and Toxics

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– Eight Action Plans Released to date:• Eight phthalates – 12/30/09• Penta, octa, and decaBDE – 12/30/09• Hundreds of perfluorinated chemicals – 12/30/09• Range of short-chain chlorinated paraffins – 12/30/09• BPA – 3/29/10• 48 benzidine dyes – 8/18/10• Hexabromocyclododecane (HBCD) – 8/18/10• Range of NP/NPE mixtures – 8/18/10– Under development:• Diisocyanates• Siloxanes

Office of Pollution Prevention and Toxics

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Uses:•Used as flame retardants in a number of applications, including textiles, plastics, wire
insulation, and automobiles.

Concerns:•Concerns that certain PBDE congeners are persistent, bioaccumulative, and toxic to bothhumans and the environment. Various PBDEs also studied for ecotoxicity in mammals, birds,fish, and invertebrates. In some cases, current levels of exposure for wildlife may be at ornear adverse effect levels.

•Not chemically bound to plastics, foam, fabrics, or other products, making them more likely
to leach out.

•Manufacture and import of penta- and octaBDE phased out in 2004, but component
congeners are being detected in humans and the environment, with some reports indicatinglevels are increasing.

Office of Pollution Prevention and Toxics

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EPA Actions:•Initiate rulemaking to add commercial PDBE mixtures and/or the congeners to theConcern List under TSCA section 5(b)(4).

•

Initiate rulemaking to propose a TSCA section 5(a)(2) significant new use rule(SNUR).

•

Support and encourage the voluntary phase-out of manufacture and import of cdecaBDE.
– Commitments received from principal manufacturers and importers to initiate
reductions in the manufacture, import and sales of c-decaBDE, with all sales tocease by December 31, 2013.
– Intend to encourage other importers of c-decaBDE to join this initiative.
– Intend to develop DfE and Green Chemistry alternatives analysis.

•Initiate rulemaking to propose a simultaneous SNUR and the previously
announced test rule for c-decaBDE.

Office of Pollution Prevention and Toxics

7• The SNUR and Test Rule will be proposed simultaneously• The proposals will indicate when EPA expects manufacture
and processing to cease• If activities have ceased as expected, EPA will promulgate theSNUR designating them as significant new uses
– No test rule would be required• If any activities are ongoing, EPA will promulgate a test rule
requiring persons who continue to manufacture, import, or
process any of the PBDEs, including PBDEs contained inarticles, to conduct testing• On December 17, 2009, as the result of negotiations
with EPA, the major U.S. producers and the largest
U.S. importer of decaBDE announced commitments
to:– end production, and importation of decaBDE for
all uses except military and transportation by
December 31, 2012
– end production, and importation for all uses by
the end of 2013

Uses:•Category of brominated flame retardants usedin expanded polystyrene foam (EPS) in the building
and construction industry, and in consumer products.

Concerns:••••Exposure to HBCD from products and dust in the home and workplace, as well as
in the environment.
Found world-wide in the environment and wildlife. Also found in human breast
milk, adipose tissue, and blood.
Shown to bioaccumulate in living organisms and biomagnify in the food chain.
Persistent in the environment and transported long distances.
Highly toxic to aquatic organisms. Also presents human health concerns based onanimal test results indicating potential reproductive, developmental andneurological effects.

EPA Actions:•

Consider initiating rulemaking under TSCA section 5(b)(4) to add to the Concern List..

•Initiate rulemaking under TSCA section 5(a)(2) to designate manufacture or processing of
HBCD for use as a flame retardant in consumer textiles as a significant new use. Would also
apply to imports of consumer textiles articles containing HBCD.

•Consider initiating rulemaking under TSCA section 6(a) for potentially comprehensive ban on
manufacturing, processing, distribution in commerce and use, or a more targeted regulation
to address specific activities.

•Initiate rulemaking to add HBCD to the Toxics Release Inventory (TRI).

•Conduct Design for the Environment (DfE) alternatives assessment of HBCD.

EPA Actions:•Initiate rulemaking to establish a Chemical Concern List under TSCA section 5(b)(4).

•

Initiate rulemaking to add the six phthalates not already on the Toxics Release
Inventory (TRI).

•Prior to rulemaking under TSCA section 6(a), intend to cooperate with CPSC and FDA
to more fully assess use, exposure and substitutes.
–Plan to consider the results of the cumulative assessment currently being developed and due to becompleted by CPSC in 2012 pursuant to the Consumer Product Safety Improvement Act of 2008, as
well as the ongoing review of phthalates at FDA and the assessment for EPA’s IRIS program.

•May pursue additional rulemaking under TSCA section 5(a)(2).

•EPA intends to conduct a Design for the Environment and Green Chemistryalternatives assessment.

Office of Pollution Prevention and Toxics

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EPA Actions:• Initiate rulemaking to add four dyes to the existing TSCAsection 5(a)(2) significant new use rule (SNUR) for benzidinebased substances.
• Initiate rulemaking to propose a new TSCA section 5(a)(2)
SNUR for benzidine congener-based dyes.

• Consider initiating action under TSCA section 6, if determinedthat any dyes are present in imported finished textiles, or
have other ongoing uses in consumer products which presentconcerns.
Office of Pollution Prevention and Toxics

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EPA actions:•Continue with the 2010/15 PFOA Stewardship Program to work with companies toeliminate long-chain PFCs from emissions and products.

•Consider initiating rulemaking under TSCA section 6.

•EPA will develop more detailed assessments to support the TSCA section 6 rule –potentially indicating that a different approach to risk management is appropriate.
Other steps might include:– A rule addressing the PFAS sub-category expanding reach of three Significant New Use Rules(SNURs) promulgated over the past decade.
– A rule addressing the PFAC sub-category expanding the reach of the 2010/15 PFOA
Stewardship Program beyond the eight participating companies and further addressing
concerns for potential PFAC exposure through use of PFAC-containing articles.

•Also continue to evaluate alternatives under EPA's New Chemicals Program andcollaborate internationally to manage PFCs.

EPA Actions:•

Intend to require submission of Pre-Manufacture Notices for the SCCP,
MCCP, and LCCP fractions not on the TSCA Inventory and, if appropriate,initiate action under TSCA section 5.

•

Intend to initiate action under TSCA section 6(a) to ban or restrict themanufacture, import, processing or distribution in commerce, export, anduse.

•Intend to further evaluate whether the manufacturing, processing,
distribution in commerce, use and/or disposal of MCCPs and LCCPs should
also be addressed under TSCA section 6(a).

•Intend to evaluate the potential for disproportionate impact on children
and other sensitive sub-populations.

EPA Actions:•Support and encourage voluntary phase-out of NPEs in industrial laundry detergents–Expand the scope of Safe Detergent Stewardship Initiative, and encourage those industries to makecommitments under SDSI.

•Develop an alternatives analysis and encourage elimination of NPE in other industries
that discharge NPEs to water (i.e. the pulp and paper processing and textile processingsectors)•Initiate rulemaking to simultaneously propose a significant new use rule (SNUR) underTSCA section 5(a) and a test rule for NP and NPEs under TSCA section 4•Issued an advance notice of proposed rulemaking (ANPRM) for NP and NPEs on June 17,2009.

•Consider rulemaking under TSCA section 5(b)(4) to add to the Concern List

•Initiate rulemaking to add to the Toxics Release Inventory (TRI)EPA Actions:• Initiate rulemaking under TSCA section 5(b)(4) to add to the Concern List.

• Consider initiating rulemaking under TSCA section 4(a) to develop data on
environmental effects relevant to a further determination that BPA either does ordoes not present an unreasonable risk of injury to the environment.
• Initiate alternatives assessment activities under DfE program to encourage
reductions in BPA releases and exposures.
– One activity, initiated in April 2010, will address thermal paper coatings used inapplications such as cash register receipts.
– Additionally, intend to initiate alternatives analyses for BPA used in foundry
castings since• Will continue to consult and coordinate closely with FDA, CDC, and the National
Institute of Environmental Health Sciences to better determine and evaluate thepotential health consequences.

•Proposed in August to amend the reporting requirements of the TSCA
Inventory Update Reporting (IUR) rule.

•Purpose is to meet four primary goals: (1) Tailor the information collected tobetter meet the Agency’s overall information needs; (2) Increase its ability toeffectively provide public access to the information; (3) Obtain new andupdated information relating to potential exposures to a subset of chemicalsubstances listed on the TSCA Inventory; and (4) Improve the usefulness ofthe information reported.

•Rule is targeted for finalization in 2011•

••
•
•

•
•

Require reporting if the production volume of a chemical substance met or exceeded the25,000 lb. threshold in any calendar year since the last principal reporting year (proposed
method would be effective after the 2011 submission period).
Require reporting of production volume for all years since the previous principal reporting
year (i.e., 2005).
Eliminate the 300,000 lb. threshold for processing and use information, thereby requiring allreporters of non-excluded substances to report information in all parts of the IUR Form U.
Revise the list of consumer and commercial product categories for the reporting of
consumer and commercial use information.
Require upfront substantiation when processing and use information is claimed asconfidential business information (CBI).
Change the reporting frequency from every five years to every four years.
Eliminate the 25,000 lb. threshold for certain chemical substances that are the subject ofparticular TSCA rules and/or orders and to require manufacturers (including importers) of
such chemicals to report under the IUR rule, regardless of the production volume.

Nanoscale Materials• Chemical substances as defined by TSCA
• More than 100 new chemical notices for NMs have been
received since 2005
• The Agency has taken a number of actions to control and limit
exposures to these NMs including:– limiting the uses of the nanoscale materials,– requiring the use of personal protective equipment, such as
impervious gloves and NIOSH approved respirators,– limiting environmental releases, and– requiring testing to generate health and environmental effects data.

Nanoscale Materials• OPPT conducted a voluntary reporting program for nanoscalematerials based on existing chemicals• As a follow-up to the voluntary program EPA is developing thefollowing proposed actions under TSCA.
– SNUR to require reporting of new nanoscale materials that are existingchemicals– Section 4 rule to require testing of certain nanoscale materials– Section 8(a) rule to require reporting of available use, production
volume, exposure, and toxicity data for existing nanoscale materials

• Current Efforts:– Addition of 530 chemicals on public version of TSCA Inventory– New policy for review of Confidential Business Information (CBI) chemicalidentity claims for notices of substantial risks– Free access to consolidated Inventory – EPA and Data.Gov websites– Integrated TSCA facility and chemical information into Envirofacts– New policy for review of CBI chemical identity claims for all health andsafety studies– Assistant Administrator letter to industry trade associations and 32
companies urging release of unwarranted CBI claims– Proposed IUR modifications for 2012 reporting•
•
•

•

•

Captures over 30 years and $2 billion of in vivo animal testing data in a
publically accessible & searchable format.
Stores detailed study design, dosing, and observed treatment-related
effects using standardized vocabulary.
Three study types• Chronic/Cancer rat and mouse• Rat multigenerational reproduction• Rat & Rabbit developmental
ToxRefDB currently includes detailed study and effect information on 474
chemicals, primarily pesticide active ingredients, and will continue toexpand.
Enables linkages to other public hazard, exposure and risk resources byintegrating with ACToR (Aggregated Computational Toxicology Resource).

ACToR API
ChemicalInternetSearches

ACToR Core

ToxRefDBTabular Data,
Links to Web
Resources

In Vivo Study
Data - OPP

Chemical ID,
Structure

ToxMiner

ExpoCastDB

Exposure Data –ToxCast Data –NCCT, ORD,
NERL, NCCT
Collaborators(In Development)(Currently Internal)

• To learn more about TSCA and EPA’s Enhanced
Chemical Management Program:
http://www.epa.gov/opptintr/• For more information in ToxRefDB:
http://www.epa.gov/ncct/toxrefdb/
http://www.epa.gov/ncct/actor/