Federal Regulatory Support:
Compliance Audit - TSCA

With regulations on premanufacture notification (PMN), chemical data reporting (CDR),

human health

and

environmental

reporting,

toxicological

testing, significant new use rules (SNURs), and

imports and exports

, a company’s

TSCA compliance program

is vulnerable to technical and administrative oversights. While the primary objective of a TSCA compliance audit is to identify potential TSCA program vulnerabilities, these audits can also help improve TSCA standard operating procedures (SOPs), enhance an understanding of TSCA regulation and avert potentially sizeable monetary penalties from non-compliance. TSCA audits occur as mandatory or voluntary audits.

Mandatory audits typically arise in two ways: after EPA identifies a violation, or when a company voluntarily reports a violation. If EPA identifies a violation, a company may be required to conduct an audit pursuant to a consent agreement with EPA. Penalties for violations include large monetary sums, litigation and even a product line being shut down. A “self-confessed” violation may be discovered when a company TSCA compliance audit for mock inspection of a chemical manufacturing facilityconducts a voluntary audit and finds violations that it subsequently reports to EPA. The incentive for “self-confession” comes from EPA’s audit policy, which provides substantial reductions in penalties compared to a violation discovered by the Agency.

Voluntary audits are used to diligently monitor TSCA compliance, which is essential for any company trying to avoid violations. A pre-emptive review will validate a company’s TSCA compliance, offer operational and procedural improvements, or catch a potential violation in time to significantly reduce penalties levied by EPA.

TSCA Audit Types

Systems Audit: A systems audit is designed to evaluate how well a company’s operations comply with TSCA. This type of audit is not conducted by a product-by-product review, but rather as a review of the management system that drives a company’s TSCA compliance program. During the audit process, records are often examined to assess the effectiveness of the compliance program, with the focus on prospective compliance, not past performance.

Mock Inspection: A mock inspection may be initiated to prepare for an actual EPA inspection – after being notified an inspection is forthcoming – or preemptively to identify any risk of non-compliance. The objective of a mock inspection is to evaluate the company exactly as an EPA inspector would, and to assess whether there are potential violations or questions regarding the company’s ability to comply with TSCA. This audit is most valuable to a company that has a functioning TSCA compliance program, but wishes to verify its effectiveness.

Product Audit: A product audit is an in-depth review of a company’s products, production and subsequent compliance with TSCA. The scope of a product audit, and all necessary information and resources, should be identified from the start. These resources might include a review of company procedures, research and development activities, production records, computer records and systems, sales TSCA compliance audit conducted on a company’s chemical product lineand purchasing records, and compliance programs and initiatives. A process for

analyzing and interpreting

the collected information is essential to meet audit objectives, and must be conducted by someone well-versed in TSCA compliance.

TSG’s TSCA experts have substantial experience conducting systems audits, mock inspections and product audits. TSG’s extensive auditing expertise allows us to provide comprehensive TSCA audits to ensure that all products, facilities and system operations are TSCA compliant. After a full systems assessment, TSG provides companies with a report documenting our findings and recommendations, as well as verification that compliance systems exist, and an evaluation of how well they are functioning. TSG’s regulatory consultants are highly knowledgeable of the EPA inspection process, allowing us to provide a complete assessment of potential violations, suggest improvements and provide overall TSCA compliance insight. We also ensure that the collected and analyzed data is well-documented. TSG provides clearly written reports on audit finding – with recommended corrective actions – which are essential to any product, facility or systems audit.
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