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SAFE CHEMICALS ACT OF 2011Summary of Proposed Legislative Changes

There is broad agreement that the Toxic Substances Control Act (TSCA) must bemodernized to adequately protect Americans from toxic chemicals. Senator Lautenberg

introduced the Safe Chemicals Act of 2011, which is a risk-based approach to TSCA reform. Itrequires chemical companies to demonstrate the safety of industrial chemicals and directs theEnvironmental Protection Agency (EPA) to evaluate safety based on the best available science.

It also encourages the development of safer alternatives to existing chemicals and reduces the use

of animal-based testing.

Since the bills introduction, there have been numerous hearings, stakeholder meetings,

and analysis of this legislation. Based on extensive input from fellow senators, the regulated

community, environmental organizations, public health experts, and state regulators, Senator

Lautenberg has developed an amendment to the bill. The proposed new language maintains theessential elements of the introduced bill, but:

Better Focuses Resources on Priority Chemicals: The amendment directs EPA to useits resources more efficiently by evaluating chemicals in stages, screening chemicals tolimit the number that require a full safety standard determination, and prioritizing

chemicals in need of safety standard determinations.

o Existing Chemicals Evaluated in Batches: The amendment introduces theconcept of batching existing chemicals for evaluation. The language directs EPA

to review the chemicals on its inventory in batches of approximately 6,000

chemicals over a five year period. This allows EPA to work through a large

backlog of existing chemicals in an orderly and efficient manner.

o Chemicals Screened Before Prioritization: Before requiring a safety standarddetermination, EPA will screen out chemicals of very low and very high concern,and identify chemicals for which additional information is required. These stepslimit the universe of chemicals that require prioritization and a full safety standard

determination.

o Priority Chemicals Undergo Safety Standard Determination: The amendmentestablishes three priority levels to guide the order of safety standard

determinations. This is intended to focus efforts on those chemicals that are most

likely to pose unacceptable risk.

o Immediate Action on Asbestos: Asbestos is identified as a substance of veryhigh concern, and EPA must require exposure and risk reduction measures.

Requires New Information and Testing Only When Necessary: Under theamendment, EPA relies first on existing information before requiring companies tosubmit new information to the agency. Throughout the new language, EPA is directed to

rely on existing information first and require additional testing only to the extent

necessary to demonstrate safety.

o Minimum Information Requirements Targeted: The minimum informationsets are tailored to fit the different stages of evaluation. This is intended to

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minimize the data burden for regulated entities, while still providing EPA with the

necessary information to make decisions.

o Use Reporting Narrowed: EPA is given authority to require use reporting everyfour years, similar to the current Chemical Data Reporting (CDR) rule

requirements, for both manufacturers and processors. Information is limited to

what is available to individual companies.

Better Protects Confidential Business Information (CBI) and EncouragesInnovation: A number of provisions help foster innovation and protect trade secrets.

o CBI Protections Enhanced: EPA is required to provide varying levels of CBIprotection depending on the informations category. The first is information that

is always protected indefinitely, which includes trade secrets and precise

production information. The second category includes chemical identity, whichcan be protected for a specified period of time based on market conditions.

Finally, some information is never protected, including health and safety

information, agency decisions, and general market information.

oNew Chemicals Process: Companies are able to bring new chemicals quicklyinto commerce through a process that is similar to existing TSCA requirements,

but with enhanced data and safety requirements.

SUMMARY OF CHEMICAL EVALUATION PROCESS

The process established by the proposed new language would begin by updating theinventory of chemicals currently in commerce (Sec. 8). This would establish the universe of

existing chemicals that EPA needs to evaluate. These existing chemicals (Sec. 6) would then be

evaluated for health and safety over an extended period of time. This would be accomplished by

creating batches of about 6,000 chemicals for EPA to review over a five-year period of time.

Within each batch, EPA would identify chemicals that are either of very high concern (whichrequire expedited risk assessment), very low concern (which require no further immediate

action), and would also identify chemicals that require additional safety information and thosethat require a full risk-assessment-based safety standard determination. EPA would then focus

on the highest priority chemicals for safety determinations, and, when necessary, additional

testing and data could be required (Sec. 4). Risk management would be required where

necessary to allow a chemical to meet the safety standard.

For new chemicals (Sec. 5), the process would be similar to the process in existing TSCA.

Manufacturers would submit a pre-manufacture notice (PMN), along with a set of basicinformation on the chemical. EPA would then perform an initial screening of the chemical based

on that information set and other existing information. Chemicals of very low concern would be

included on the active inventory without further review. Chemicals likely to meet the safety

standard would also be placed on the inventory and await further evaluation in the next batch ofchemicals (in the meantime, the chemical could still be manufactured and sold in commerce). If

a new chemical substance was found to be a substance of very high concern or unlikely to meet

the safety standard, it would be prohibited from entering commerce until it is proven to meet thesafety standard.