At a Gla

23-P-0026
August 2, 2023

The EPA Lacks Complete Guidance for the New Chemicals Program to
Ensure Consistency and Transparency in Decisions

Why We Did This Audit

To accomplish this objective:

The U.S. Environmental Protection
Agency Office of Inspector General
conducted this audit to determine the
extent to which the EPA is using and
complying with applicable records
management requirements, quality
assurance requirements, and employee
performance standards to review and
approve new chemicals under the Toxic
Substances Control Act of 1976. This
audit was initiated in response to several
complaints submitted to the OIG Hotline.

The Toxic Substances Control Act
requires the EPA to, upon receipt of a
premanufacture notice for a new
chemical, determine within 90 days
whether the chemical presents an
unreasonable risk to human health or the
environment. The EPA's New Chemicals
Program, as mandated by section 5 of
the Act, "helps manage the potential risk
to human health and the environment
from chemicals new to the marketplace."
The New Chemicals Division manages
the New Chemicals Program. For fiscal
year 2023, the EPA received
$82.8 million for its chemical review
programs.

To support this EPA mission-related
effort:

•	Ensuring the safety of chemicals.

To address these top EPA
management challenges:

•	Providing for safe use of chemicals.

•	Safeguarding scientific integrity.

Address inquiries to our public affairs
office at (202) 566-2391 or
OIG.PublicAffairs@epa.gov.

What We Found

The EPA has not complied with applicable recordkeeping and quality assurance
requirements when implementing the New Chemicals Program. Specifically, the New
Chemicals Division, or NCD, has not finalized guidance for many of the program's
activities, such as standard operating procedures for recordkeeping and conducting
exposure and hazard assessments. According to the EPA's Guidance for Preparing
Standard Operating Procedures (SOPs), developing and using standard operating
procedures are integral parts of a successful quality system, as they provide individuals
with the information to properly perform a job. They also facilitate consistency in the
quality and integrity of a product or end result.

In addition, prior to September 2021, the NCD's Toxic Substances Control Act
recordkeeping applications did not track edits to records that were developed during the
new chemicals review process, which affected transparency. The NCD also used multiple
recordkeeping applications, which were not integrated and were frequently inaccessible.
The EPA's Records Management Policy requires each EPA program office to create,
receive, and maintain records that provide adequate and proper documentation of its
activities and decisions.

These deficiencies existed because the NCD lacked sufficient staff resources to conduct
reviews within the statutory time frames, as well as to develop and finalize guidance. The
absence of final guidance increases the risk that the New Chemicals Program does not
meet its legislative intent to prevent unreasonable risk to human health and the
environment. Furthermore, the EPA has the authority to collect fees to offset the costs of
implementing the requirements under the Toxic Substances Control Act, but it has fallen
short of collecting the amount of fees it originally projected.

Finally, complaints submitted to the OIG Hotline alleged that NCD staff were pressured to
focus on deadlines instead of potential risks when conducting new chemical reviews. We
found no evidence that the NCD explicitly includes the Toxic Substances Control Act
statutory 90-day review requirement as an employee performance standard.

The EPA's NCD lacks assurance that the new chemicals review process
operates as intended and achieves its objective to protect human health
and the environment.

Recommendations and Planned Agency Corrective Actions

We make four recommendations to the assistant administrator for Chemical Safety and
Pollution Prevention, including that the EPA develop, update, and finalize guidance for the
New Chemicals Program; assess and update the NCD's recordkeeping applications, as
needed; and address workload issues. The Agency agreed to all four recommendations,
which are resolved with corrective actions pending.

List of OIG reports.


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