FY 2022-2026 OCSPP/OPPT Data Quality Record for Goal 7, Objective 7.1

Data Quality Record for Long-Term Performance Goals

Long-Term Performance Goal Text: By September 30, 2026, review 90% of risk mitigation requirements
for past TSCA new chemical substances decisions compared to the FY 2021 baseline of none.

Corresponding Annual Performance Goal: Percentage of past TSCA new chemical substances decisions
with risk mitigation requirements reviewed.

Goal Number/Objective: Goal 7/Objective 7.1

NPM Lead: Office of Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution Prevention
and Toxics (OPPT)

la. Purpose of Long-Term Performance Goal:

Under the Toxic Substances Control Act (TSCA) anyone who plans to manufacture (defined to
include importation) a new chemical substance for a non-exempt commercial purpose is required to
provide EPA with notice before initiating the activity. A similar notification requirement applies to any
person who intends to manufacture or process any chemical substance for a use which EPA has
determined is a significant new use. On receiving notification, EPA commences a review of the new
chemical substance or significant new use to determine whether the substance or use will present an
unreasonable risk of injury to human health or the environment. This review culminates in a final
determination by EPA, as defined below.

Under TSCA, an affirmative determination is required. Following completion of new chemical
review, EPA is authorized to impose restrictions on the manufacture, processing, distribution in
commerce, use, or disposal of a new chemical substance, up to and including a ban, if necessary, to
protect human health or the environment. This is generally accomplished through the issuance of a
TSCA Section 5(e) or 5(f) order and/or a Significant New Use Rule (SNUR).

This long-term performance goal (LTPG) tracks the percentage of risk mitigation requirements in EPA
TSCA Section 5 orders or SNURs that EPA reviews for adherence/non-adherence with these
requirements. EPA will establish a baseline and review compliance with restrictions in TSCA section 5
orders or SNURs by cross-walking action requirements with information reported to the Chemical Data
Reporting (CDR) rule. Instances of non-compliance will be relayed to EPA's Office of Enforcement and
Compliance Assurance. For more information: https://www.epa.gov/reviewing-new-chemicals-under-
toxic-substances-control-act-tsca/basic-information-review-new.

lb. Performance Measure Term Definitions:

Review: To compare new chemical risk mitigation requirements to the actual performance of the
entities to which such requirements apply.

Risk Mitigation Requirements: The specific requirements contained in EPA TSCA Section 5 orders or
SNURs that can be cross-walked with information reported to CDR (i.e., site related and production
volume information). This may include additional off-site compliance monitoring, on-site inspections,
issuance of compliance advisory or guidances, request for information/subpoenas, and
modifications/updates to TSCA section 5 consent orders, SNURs, or other applicable regulations, as
appropriate.

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lc. Unit of Measure:

Risk mitigation requirements reviewed for TSCA new chemical substances.

2a. Data Source:

• Primary (Original) Source(s) of Data and Name(s) of Relevant Information System(s): Consent orders
and requirements in EPA CDR system.

• Entity That Reports Data to the System: EPA/OCSPP/OPPT/New Chemicals Division (NCD) will report
the data.

• Frequency and Timing at Which Primary Data are Reported to EPA: NCD will track progress on
reviewing risk mitigation requirements included in past TSCA consent orders for TSCA new chemical
substances on a continual basis. Data can be reported at any time.

• Smallest Unit for Which Data are Collected: Individual risk mitigation requirement for TSCA new
chemical substance.

2b. Data Needed for Interpretation of (Calculated) Performance Result:

• Baseline: EPA has not conducted this activity prior to FY 2022, so no baseline for this long-term
performance goal is possible. No TSCA new chemical substances with risk mitigation requirements
were reviewed to confirm manufacturers are adhering to TSCA section 5 consent orders and SNUR
requirements in FY 2021.

• Tracking Progress: Progress toward strategic target is reported monthly, monitored via

the associated annual performance goal, and reviewed by senior management on a quarterly basis.

• Universe: The universe includes all risk mitigation requirements for TSCA new chemical substances
established from the beginning of the program to the present.

3. Calculation Methodology:

Performance results will be calculated by comparing the number of risk mitigation requirements
reviewed to the total number of risk mitigation requirements for TSCA new chemical substances
established from the beginning of the program to the present.

4. Quality Assurance/Quality Controls:

This is a new activity that does not require a Quality Assurance Project Plan (QAPP). Standard operating
procedures for this activity will be developed and documented. Results will be reviewed by senior
management on a quarterly basis.

5. Data Limitations/Qualifications:

EPA anticipates data errors will be minimal. This LTPG does not report on the findings of the review of
new chemical risk mitigation requirements.

6. Technical Contact:

Madison Le (OCSPP), 202-564-5754, le.madison@epa.gov

7. Certification Statement/Signature:

I certify the information in this DQR is complete and accurate.

DAA Signature Original signed bv Richard Keigwin Date 5/17/2022

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