EPA’s TSCA Inventory Reset and TSCA Program
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The Toxic Substances Control Act of 1976 (TSCA) provides the Environmental
Protection Agency (EPA) with comprehensive authority to regulate the
manufacturing, importing, processing, distributing, use, and disposal of chemical
substances and mixtures for commercial purposes in the United States. EPA
also sets the testing requirements necessary to evaluate the safety of each
chemical or mixture of chemicals to meet the TSCA safety standard of no
“unreasonable risk of injury to human health or the environment”. Certain
substances are excluded from TSCA, including, among others, food, drugs,
cosmetics and pesticides.
TSCA section 8(b) requires EPA to compile, keep current, and publish a list of
each chemical substance that is used commercially. However, not all of these
chemicals have been evaluated under the TSCA safety standard of no
unreasonable risk of injury to human health or the environment. In general, the
purpose of this list, the Chemical Substances Inventory (TSCA Inventory), is to
identify what chemical substances exist in U.S. commerce. Substances not
included on the Inventory are considered to be new chemical substances and are
subject to the Premanufacture Notification (PMN), Microbial Commercial Activity
Notice (MCAN), or exemption requirements set forth in TSCA section 5(a)(1).
TSCA Inventory
There are are currently almost 84,000 chemicals on the TSCA Inventory, with
almost 22,000 chemicals added to the Inventory through new chemical review
since 1979. In 1986, EPA promulgated the Inventory Update Rule (IUR) requiring
companies to update production volume data for certain chemicals on the TSCA
Inventory every 4 years providing a snapshot of currently comercialized
chemicals. Since the IRU does not require reporting for all chemicals on the
TSCA Inventory, EPA cannot determine which chemicals are in commerce at any
given time. In 2003, comments and revisions to the rule were published and in
2006 companies were required to update the production information again. The
next submission and volume update will be between June 1 and September 30
2011, reporting production of chemicals manufactured in 2010 over 25,000
pounds and manufacturing exposure related information (inorganics are no
longer excluded). There is additional information required for manufacture of
greater than 300,000 pounds including process or use category, North American
Industry Classification System (NAICS) Code, industrial function category,
percent production volume, number of use sites, number of potentially exposed
workers, and consumer/commercial information such as use category, use in or
on products intended for use by children, and maximum concentration.
The TSCA Inventory supports many of EPA’s TSCA regulatory functions and it
must be kept current and otherwise accurate to identify substances that are
manufactured, imported or processed in the United States. In order to keep the
TSCA Inventory current. EPA is considering a threeyear period for “cleaning up”
EPA’s TSCA Inventory Reset and TSCA Program
(i.e., resetting) the Inventory. Under this approach, a “clean” reset Inventory
would be developed such that any chemical not certified as actively being
manufactured commercially in the U.S. would be removed from the TSCA
Inventory. Any chemical substances for which a certification was not received
would be removed from the TSCA Inventory and re-instatement would require a
new TSCA § 5(a) PMN/MCAN application, review and approval.
The PMN/MCAN or Exemption Application
Currently EPA does not specify a minimum or maximum set of data that must be
submitted with a PMN/MCAN application. Rather, the applicant must requires the
submitter to provide information about the manufacturing process and waste
streams, worker and consumer exposures, mammalian and environmental risk,
and physicochemical data that the applicant believes will meet the Agencies
requirements when reviewed. The data submitted with the application may
include laboratory data, literature citations and modeled estimates. The
development of a PMN/MCAN regulatory package is approached on a case-bycase basis and the applicant tries to identify potential areas of regulatory concern
in the planning stage and submit appropriate studies with the application for
Agency review.
This approach, in theory, according to EPA, avoids the unnecessary expenditure
of laboratory resources and regulatory delays and setbacks from TSCA Section
5(e) consent-order negotiations that may cause additional marketplace entry
delays. However, in recent practice, EPA is “requesting” more and more
additional data in addition to the data set the applicant chooses to submit.
Conducting and providing this additional data is causing significant delays in the
review and approval process in addition to EPA not being able to meet their 90day statutory deadline for review. Even experienced applicants are finding it
difficult to provide an adequate data set in the eyes of the EPA reviewers and
industry may soon be asking the Agency to provide a specific data set necessary
to support an application in order to avoid these extended delays. EPA
regulation set a 90-day review time for PMN applications and many recent
applications are taking up to a year or more for the Agency to review and issue
the inventory listing. One way the applicant can avoid this data is to produce
chemicals that qualify under the low risk polymer exemption.
Polymer Exemption from the Requirement of a PMN
EPA has developed criteria to assess hazards associated with new polymeric
substances based on its experience that the manufacture, processing,
distribution in commerce, use, and disposal of new chemical substances meeting
certain criteria would not present an unreasonable risk of injury to human health
or the environment, and established the Polymer Exemption in 1984. In 1995 the
Agency adjusted both the criteria used to determine whether a new chemical
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EPA’s TSCA Inventory Reset and TSCA Program
substance could meet the exemption and the procedures to be followed by
manufacturers using the exemption. It is the intention of the Agency through
these exemptions to encourage manufactures to produce and use safer polymers
and that the exemption rule will reduce industry's reporting burden for this
category of chemical substances. This will allow the Agency to concentrate its
resources on substances expected to pose higher risk.
The 1995 amendments were similar to the 1984 exemption but expanded
exemptions for polymers that meet Agency's low-risk criteria. The effect was to
eliminate unnecessary EPA review of eligible (low risk) polymers, to transfer the
burden of ensuring eligibility from EPA to the manufacturer, to encourage the
manufacture of safer chemicals and substances produced with low exposure and
low release, and to reduce the number of PMN applications (34% of PMNs filed
before the amendments would qualify for the revised polymer exemption).
Under the terms of the polymer exemption as amended in 1995, manufacture
and distribution of polymers meeting the exemption criteria can take place
without submission of a PMN/MCAN application or an exemption notice prior to
commencement of manufacture for a commercial purpose. Manufacturers are
required to submit information on the method of manufacture and product
chemistry of the polymer and EPA responds with a qualification letter within 90days. Recordkeeping requirements to document compliance with the exemption
criteria are retained as part of the rule and manufacturers of exempted polymers
are required to submit an annual report on the number of exempted polymers for
which they manufacture or import under terms of the exemption during the
preceding calendar year.
The exemption now relies on comprehensive recordkeeping for compliance
purposes, adopts the international Organization for Economic Cooperation and
Development (OECD) definition of "polymer" and amends therule allowing the
"two percent" reporting rule for polymers to allow greater flexibility for polymer
manufacture. The two percent rule allows up to a two percent addition to the
backbone only with out requiring a change in Chemical Abstracts Service
Registry Number (CASRN).
Most eligibility criteria remain the same: polymers with molecular weight (MW) of
1,000 daltons or greater and less than 10,000 daltons are eligible, with
restrictions on low MW species and reactive functional groups; polymers with
MW of 10,000 daltons or greater, with restrictions on low MW species. Polymers
which were and remain ineligible for exemption include those which degrade,
decompose, or depolymerize.
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EPA’s TSCA Inventory Reset and TSCA Program
The changes made in 1995 have made the polymer exemption generally less
restrictive: the list of allowable elements has been expanded to include chlorine,
bromine, iodine as monatomic counterions; and fluorine, chlorine, bromine and
iodine if covalently bound to carbon; biopolymers which meet the polymer
definition are no longer excluded; polymers that are cationic or anticipated to
become cationic in aquatic environments are now eligible for exemption if the
polymer is solid, not soluble or dispersible in water and will be used only in solid
phase, or equivalent weight is equal to or greater than 5,000 daltons; and there is
an expanded list of specified reactants for polyesters.
New restrictions make ineligible for exemption, however, several classes of
polymers: polymers that are prepared from monomers or other reactants that are
not on the TSCA Inventory are ineligible, as are water-absorbing polymers with
number-average MW equal to or greater than 10,000 daltons. The full definition
that describes polymers that meet the exemption rule can be found in 40CFR
Section 723.250.
The 2007 Montebello Agreementand The 2005 Security and Prosperity
Partnership of North America (SPP)
On August 20-21, 2007, United States President George Bush, Canadian Prime
Minister Stephen Harper and Mexican President Felipe Calderon met in
Montebello, Quebec, to discuss the Security and Prosperity Partnership of North
America (SPP). Upon conclusion of the meeting the U.S. Environmental
Protection Agency announced, as part of a trilateral agreement (the Montebello
Agreement), a major shift in how chemicals will be addressed and managed in
the U.S. Canada and Mexico. The Montebello Agreement sets out a plan to
coordinate risk assessment and risk management activities across North
America, building on work done under the Canadian Chemicals Management
Plan and the U.S. EPA High Production Volume (HPV) Chemical Challenge. The
goal of the agreement is to enhance trade among the three countries, while
ensuring protection of human health and the environment and while retaining
sovereignty.
The chemicals policy debates in the U.S. accelerated several years ago when
environmental groups saw the European REACh system as a model to achieve
their goal of banning toxic chemicals. The Montebello Agreement provides a
unique opportunity to affect the future of chemicals management policy in the
NAFTA regions. It is the only regional model that is truly tiered, targeted and riskbased. The Agreement provides regions that do not currently have chemicals
management policies a rational and workable alternative to REACh in the
Americas.
SPP Regional Commitments
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EPA’s TSCA Inventory Reset and TSCA Program
The regional commitments under the SPP provide for work on cooperative efforts
such as the U.S and Canada working with Mexico to establish a Mexican
chemical inventory, update and coordinate the existing inventories in the U.S.
and Canada and strengthen the North American chemical management regime.
EPA and the Pesticide Management Regulatory Agency (PMRA, Canada) have
begun sharing data and information to aid chemical assessment and
management as well as coordinate approaches to develop international
standards. Both countries are working with the Mexican authorities to enhance
Mexico’s capacity for chemical assessment and management.
Chemical Assessment and Management Program (ChAMP)
ChAMP has been superseded by the comprehensive approach to enhancing the
Agency’s current chemicals management program announced by Administrator
Lisa Jackson on September 29, 2009.
To fulfill commitments made under the SPP launched in March of 2005 between
the United States, Canada and Mexico, and the Montebello Agreement of 2007
EPA created ChAMP and these commitments will now be made under the
comprehensive approach. EPA has established Essential Principles for Reform
of Chemicals Management Legislation by publishing the following principals for
the review of chemicals regulated under TSCA:
Essential Principles for Reform of Chemicals Management Legislation
The U.S. Environmental Protection Agency (EPA) is committed to working with
the Congress, members of the public, the environmental community, and the
chemical industry to reauthorize the Toxic Substances Control Act (TSCA). The
Administration believes it is important to work together to quickly modernize and
strengthen the tools available in TSCA to increase confidence that chemicals
used in commerce, which are vital to our Nation’s economy, are safe and do not
endanger the public health and welfare of consumers, workers, and especially
sensitive sub-populations such as children, or the environment.
The following Essential Principles for Reform of Chemicals Management
Legislation (Principles) are provided to help inform efforts underway in this
Congress to reauthorize and significantly strengthen the effectiveness of TSCA.
These Principles present Administration goals for updated legislation that will
give EPA the mechanisms and authorities to expeditiously target chemicals of
concern and promptly assess and regulate new and existing chemicals.
Principle No. 1: Chemicals Should Be Reviewed Against Safety Standards That
Are Based on Sound Science and Reflect Risk-based Criteria Protective of
Human Health and the Environment.
EPA should have clear authority to establish safety standards that are based on
scientific risk assessments. Sound science should be the basis for the
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EPA’s TSCA Inventory Reset and TSCA Program
assessment of chemical risks, while recognizing the need to assess and manage
risk in the face of uncertainty.
Principle No. 2: Manufacturers Should Provide EPA With the Necessary
Information to Conclude That New and Existing Chemicals Are Safe and Do Not
Endanger Public Health or the Environment.
Manufacturers should be required to provide sufficient hazard, exposure, and use
data for a chemical to support a determination by the Agency that the chemical
meets the safety standard. [However EPA has not defined a specific data set
needed to make such determinations, TSCA state that the manufacturer will
submit the data they have or that they determine will be sufficient, thus
some PNM reviews are over two years old for the 90-day statutory review]
Exposure and hazard assessments from manufacturers should be required to
include a thorough review of the chemical’s risks to sensitive subpopulations. [if
such populations exist, how will they be found and how much effort will be
required by EPA to seek them out?]
Where manufacturers do not submit sufficient information, EPA should have the
necessary authority and tools, such as data call in, to quickly and efficiently
require testing or obtain other information from manufacturers that are relevant to
determining the safety of chemicals. [EPA has always had this authority] EPA
should also be provided the necessary authority to efficiently follow up on
chemicals which have been previously assessed (e.g., requiring additional data
or testing, or taking action to reduce risk) if there is a change which may affect
safety, such as increased production volume, new uses or new information on
potential hazards or exposures. EPA’s authority to require submission of use and
exposure information should extend to downstream processors and users of
chemicals.
Principle No. 3: Risk Management Decisions Should Take into Account
Sensitive Subpopulations, Cost, Availability of Substitutes and Other Relevant
Considerations.
EPA should have clear authority to take risk management actions when
chemicals do not meet the safety standard, with flexibility to take into account a
range of considerations, including children’s health, economic costs, social
benefits, and equity concerns.
Principle No. 4: Manufacturers and EPA Should Assess and Act on Priority
Chemicals, Both Existing and New, in a Timely Manner.
EPA should have authority to set priorities for conducting safety reviews on
existing chemicals based on relevant risk and exposure considerations. Clear,
enforceable and practicable deadlines applicable to the Agency and industry
should be set for completion of chemical reviews, in particular those that might
impact sensitive sub-populations [This is the third time Sensitive
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EPA’s TSCA Inventory Reset and TSCA Program
Subpopulations have been mentioned, what is the definition of a
subpopulation, one person?]
Principle No. 5: Green Chemistry Should Be Encouraged and Provisions
Assuring Transparency and Public Access to Information Should Be
Strengthened.
The design of safer and more sustainable chemicals, processes, and products
should be encouraged and supported through research, education, recognition,
and other means. The goal of these efforts should be to increase the design,
manufacture, and use of lower risk, more energy efficient and sustainable
chemical products and processes.
TSCA reform should include stricter requirements for a manufacturer’s claim of
Confidential Business Information (CBI). Manufacturers should be required to
substantiate their claims of confidentiality. Data relevant to health and safety
should not be claimed or otherwise treated as CBI. EPA should be able to
negotiate with other governments (local, state, and foreign) on appropriate
sharing of CBI with the necessary protections, when necessary to protect public
health and safety. [No discussion of data compensation was made, so the
data you are required to produce and pay to produce could be available
publicly unless EPA addresses this issue]
Principle No. 6: EPA Should Be Given a Sustained Source of Funding for
Implementation.
Implementation of the law should be adequately and consistently funded in order
to meet the goal of assuring the safety of chemicals, and to maintain public
confidence that EPA is meeting that goal. To that end, manufacturers of
chemicals should support the costs of Agency implementation, including the
review of information provided by manufacturers. [Again the “people” no
longer pay for safety from tax dollars, if so many programs are funded by
fees on industry where are the tax dollars going, EPA just received the
largest budget In history]
Goals of ChAMP that should be exceeded by the new comprehensive
regulation
Under TSCA the United States will complete, by 2012, screening-level hazard
and risk characterizations and initiate action, as appropriate, on more than 6,750
chemicals produced above 25,000 pounds per year and less than 1,000,000
pounds per year are considered Moderate Production Volume (MPV) chemicals.
These actions include gathering and/or generating needed information, instuting
control measures (limiting use), identify the compounds as low priority, or
approve the chemicals for re-listing. These actions will be posted on the TSCA
web page and transparent to the public.
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EPA’s TSCA Inventory Reset and TSCA Program
EPA may reassess the data base submitted under the voluntary HPV program
and request data to fill any data gaps identified. A similar program will be
initiated for the estimated 6,750 MPV chemicals. This program will be modeled
after the OECD HPV Screening Information Data Set (SIDS) (1) program. EPA
will also encourage the submission of Structural Activity Relationship (SAR) data
and category approaches to evaluate similar chemicals.
The SIDS program collects all available test data on chemical identity, physical
characteristics, sources and levels of exposure, environmental fate and
pathways, ecotoxicological and toxicological data and the sponsor country
reviews the existing data. If additional testing is needed to complete the SIDS
dossier, the testing is conducted and incorporated into the SIDS dossier with a
SIDS Initial Assessment Report (SIAR) and discussed at an OECD meeting and
initial conclusions are filed.
Where additional information is needed under the TSCA program, EPA has
several mechanisms to collect the needed studies and complete their review.
EPA will contact producers requesting the information as an informal action to
gather available informantion in the producers files. They will also search for
data that may have been submitted previously to other agencies, Canada, the
OECD. Note: EPA has not mentioned obtaining data from the European REACh
program that would be pertinent to their review under TSCA. Additional data to
review and methods of data gathering are TSCA §8(a) exposure and release
reporting information, TSCA §5(a)(2) Significant New Use Rules (SNURs)
reports, TSCA §4 test rules, engage stakeholders on voluntary action, a Design
for the Environment (DfE) or any other risk reduction measure deemed
appropriate.
Chemicals with risk concerns would be considered for listing on the TSCA
§5(b)(4) risk list. This would require rulemaking by EPA and a finding of “may
present an unreasonable risk”. EPA believes this finding could provide an
incentive for industry product stewardship programs to minimize risk. EPA will
continue to post priority lists of HPV and MPV chemicals based on their
assessment of Hazard Charscterizations (HCs) and Risk-Based Prioritizations
(RBPs) by using any available data.
As an initial effort under TSCA, EPA began, in 2007, posting screening-level HCs
and expanded this effort in 2008 by posting RBPs. The RBPs summarize basic
hazard and exposure information on HPV chemicals, identify potential risks, note
scientific issues and uncertainties, and indicate the initial priority being assigned
by the Agency for potential future appropriate action (re-listing, requireing more
data or de-listing).
In 2008, as part of the TSCA commitments, EPA began developing initial
evaluations of MPV chemicals. The evaluation of the first set of these chemicals
consists of development of a hazard characterization and hazard-based
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EPA’s TSCA Inventory Reset and TSCA Program
prioritizations.
After receiving input from stakeholders and after careful
consideration, EPA will proceed with the two enhancements to TSCA including:


Developing an HPV Challenge-type program for "inorganic" HPV
chemicals, and
Resetting the TSCA Inventory to reflect the chemicals actually in
commerce.
HPV Challenge-type program for "inorganic" Chemicals
Inorganics were first included on the IUR in 2006 and no exposure data is
required to be reported until 2011. There are estimated to be between 400 and
500 HPV inorganic chemicals to be investigated and EPA is considering an IHPV
challenge program mirroring the voluantary HPV challenge program. EPA will
assess existing information, prioritize chemicals according to risk or potential risk
and initiate actions on the chemicals with the highest risk potential by 2012 and
complete the review, assessment process for listing or action by 2014.
Resetting the TSCA Inventory
TSCA §8(b) requires EPA to “compile, keep current, and publish” the TSCA
inventory of chemicals. EPA has been adding chemicals to this list and
publishing the list for more than 30 years and industry would contend that by
doing so the list is being kept current. However, EPA believes the nearly 84,000
chemicals on the inventory have not been kept current according to what is
currently in the market place or are being produced in only low or episodic
volumes. EPA believes that by resetting the inventory to reflect only chemicals
regularly produced in more then “low” volumes (maybe less than 25,000 pounds,
there is no set level) and currently in commerce would provide a more
meaningful and useable resource to the agency and industry. The current idea is
a “snapshot” approach of setting the inventory based on a 3-year window on
production. Any chemicals not being produced or imported in a 3-year period
would be removed and would require a PMN/MCAN or application for an
exemption to be listed.
Since the IUR does not require reporting for all chemicals on the inventory it is
not clear which chemicals that are not subject to IUR reporting are in commerce
at any given time. The 3-year snapshot approach would require reporting of all
inventory chemicals every year for three years to create the snapshot EPA
proposes to use to reset the TSCA inventory.
EPA would place the current TSCA Inventory online with the Chemical Abstracts
Service Registry Numbers (CASRN) and the Chemical Abstracts (CA) index
names for the non-confidential substances and the TSCA accession numbers for
the confidential chemicals. Manufacturers and importers certify the chemicals
they manufacture or import and submit an electronic certification by a
predetermined date.
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EPA’s TSCA Inventory Reset and TSCA Program
At the close of the certification period EPA would publish an interim reset TSCA
Inventory and a period of time would be set for comments and correction to the
interim list prior to setting the inventory to the new list created by this process. A
PMN/MCAN or exemption application would be necessary to add a chemical
back to the list.
The Commission for Environmental Cooperation (CEC) is an international
organization created by Canada, Mexico and the United States under the North
American Agreement on Environmental Cooperation (NAAEC) complementing
the environmental provisions of the North American Free Trade Agreement
(NAFTA) for the purpose of addressing regional environmental concerns, to help
prevent potential trade and environmental conflicts, and to promote the effective
enforcement of environmental law.
For a decade the CEC, through the Sound Management of Chemicals (SMOC)
work group has delt with individual chenical issues in North America. The SMOC
is now focussed on regional implementation of the Strategic Approach to
International Chemicals Management (SAICM) in North American according to
EPA. The SPP regional and national commitments in the U.S. provides another
avenue to complement SMOC’s efforts and realize progress in chemical
management expanding the efforts to the NAFTA region.
SPP actions and Timing under REACh
Because the REACh first registration deadline for HPV chemicals is December
2010 and the first authorization candidate list under TSCA is expected in late
2008, REACh submitters and evaluators will benefit from U.S. and Canadian
work according to EPA, however it is unknown if EPA has taken any steps to
coordinate data requirements or assessments with the European Chemicals
Agency (ECHA). In addition, EPA anticipates that the REACh dossiers could
meet future testing needs for the TSCA Inventory.
TSCA Vs. REACh
Dr. Richard Denison, Environmental Defense Fund (EDF) Senior Scientist said,
“TSCA just doesn’t have the reach of REACH, despite EPA’s efforts to claim
otherwise. It will yield far less data on far fewer chemicals. In its haste to catch up
with other global initiatives, EPA intends to make decisions about risk using
incomplete or poor quality information, especially with respect to how chemicals
are used and how people and the environment are exposed to them.” He said
many of TSCA’s shortcomings can be directly traced to structural deficiencies in
the authority EPA has been provided under the Toxic Substances Control Act
(TSCA), the main U.S. statute that governs how tens of thousands of chemicals
are produced, used and disposed of in the United States.
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EPA’s TSCA Inventory Reset and TSCA Program
If you meet the requirements of REACh will you meet the requirements of TSCA?
The current answer is MAYBE. Until EPA sets a standard data set as REACh is
striving to do we will not know.
To meet the requirements of the TSCA Inventory reset, TSCA and the
requirements of REACh contact Spring Trading Company.
www.springtradingcompany.com
(281) 367- 9356
Toll Free (877) 227- 2597
Spring_trading@yahoo.com
or
james@springtradingcompany.com
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