Successful Resolution of TSCA PMN Matter

Ed Schwartz successfully resolved an administrative enforcement matter in which the US Environmental Protection Agency, Region 4 alleged multiple violations of the Toxic Substances Control Act (TSCA) by a client involved in chemical manufacturing. Specifically, EPA alleged that the client manufactured two chemical products that were included on the TSCA Inventory, without having filed pre-manufacture notices (PMN) or having obtained polymer exemptions in violation of TSCA section 5; and that the client failed to submit an Inventory Update Release (IUR) report in 2006 for the 2005 reporting year for another chemical in violation of TSCA section 8. EPA proposed the assessment of a substantial penalty for the alleged violations. After presenting compelling and unique legal and equitable defenses to EPA, Ed was able to achieve a significant (over 80%) reduction of the originally proposed penalty. In-house counsel for the client was extremely satisfied with the resolution, stating “We could not be more pleased with Ed’s representation. He took the time to understand our business and the situation. He formulated a highly effective strategy, utilizing his intimate, hands-on knowledge of TSCA and the penalty policy, as well as his personal relationships with EPA personnel, to negotiate and achieve a favorable result for our company that, at the outset, seemed impossible. Thanks, Ed.”

Pharmaceutical Waste Management

The focus on pharmaceutical waste is increasing at the Federal and state levels. The United States Environmental Protection Agency (“EPA”) has announced that it will develop a new rule to address the management and disposal of hazardous waste pharmaceuticals generated by healthcare facilities. The new rule would only apply to pharmaceutical waste within the definition of “hazardous waste” under the Resource Conservation and Recovery Act (“RCRA”) and is anticipated to be published for public comment in August 2013.

EPA currently regulates the disposal of pharmaceuticals from healthcare facilities under RCRA’s hazardous waste generator regulations. Therefore, healthcare facilities, including pharmacies, hospitals and retail stores with pharmacies, that dispose of hazardous waste pharmaceuticals may be regulated hazardous waste generators. EPA has posted guidance regarding the management of hazardous waste pharmaceuticals. Many healthcare facilities have had difficulty maintaining compliance with these requirements because of the large variety, but relatively small amount of pharmaceutical waste generated at various locations. Nonetheless, until the new rule is promulgated, healthcare facilities are still required to comply with RCRA generator regulations when disposing of hazardous pharmaceutical waste and may be subject to federal or state enforcement if they fail to comply. Meantime, in the absence of a final federal rule, some states have enacted their own regulations to alleviate some of this burden on health care facilities. It is uncertain how the EPA’s proposed new rule may impact these state regulations.

We can be of assistance if you need to know more about the new proposal for healthcare facility-specific management standards for hazardous waste pharmaceuticals, or to determine your compliance status under currently applicable regulations.

Draft Vapor Intrusion Guidance Issued By EPA

On April 16, 2013, the US Environmental Protection Agency, Office of Solid Waste and Emergency Response (OSWER), released for public comment draft final vapor intrusion guidance documents. The first guidance document is general guidance for all compounds, while the second guidance document focuses on petroleum released from underground storage tanks.

The draft final guidance represents significant changes from the previous versions proposed in 2002. All persons interested in vapor intrusion issues are encouraged to review the guidance documents and provide input to OSWER. Public input must be submitted by May 24, 2013, through an established website for docket number: EPA-HQ-RCRA-2002-0033-007.

Effective Strategy Minimizes TSCA Lead Based Paint Penalty

The US Environmental Protection Agency, Region 4 (EPA) proposed initial penalty of over $300,000 for alleged violation of lead based paint (LBP) regulations threatened the economic survival of our client, the owner of a medium-sized apartment complex in Tennessee. Specifically, EPA alleged that the complex failed to disclose to resident lessees and leasing agents the presence of LBP; failed to provide lessees with an EPA-approved LBP hazard information pamphlet; failed to include in leases a statement disclosing the presence of LBP; failed to provide a list of records and reports regarding LBP in leases; failed to provide a lease statement confirming receipt of that information; failed to provide a lease statement that the leasing agent informed the lessee of the lessors obligations with regard to LBP; and failed to certify in the lease the accuracy of the statements.

Sweetnam and Schwartz devised a plan to assuage the situation. We immediately prepared and implemented a strategy to obtain substantial reduction of the penalties. This consisted of a comprehensive evaluation of the factual basis of the EPA claims and application of the regulations and penalty policy. Based on this review, we made substantive challenges to the alleged violations, recalculation of the proposed penalty, implementation of compliance measures where appropriate, and negotiation of a revised penalty based on relevant equitable and legal factors. Ultimately, the strategy was successful, resulting in a reduction of the penalty to only $6,000.00. This result allowed the client to continue in business with only minor impact to its financial condition.

Lead-Based Paint Rules For Renovation, Repair, and Painting Activities In Public and Commercial Buildings

In April 2008, the EPA issued final regulations under the Toxic Substances Control Act (TSCA) to address lead-based paint hazards in child-occupied and target housing, including residential structures and public and commercial buildings constructed prior to 1978 where children spend a significant amount of time (known as the Lead Renovation, Repair, and Painting (RRP) Rule). The RRP Rule requires, among other things, that contractors and subcontractors be properly trained and certified and use safe work practices to minimize lead dust. The EPA has begun aggressivelyenforcing the RRP Rule. Several environmental and children’s advocacy groups filed suit against EPA seeking to expand the regulatory reach to repairs and renovations at commercial and public buildings (other than child-occupied facilities) to the extent such renovations create lead-based paint hazards.

In 2010, EPA issued an advance notice of proposed rulemaking (ANPRM) concerning renovation, repair,and painting activities in public and commercial buildings. EPA is in the
process of determining whether these activities create lead-based paint hazards, and, for those that do, developing certification, training, and work practice requirements as directed by TSCA. On December 31, 2012, EPA announced its intention to hold a public meeting and to seek comment and data pertaining to the renovation, repair, and painting activities on public and commercial buildings.

According to a Federal Register notice published on May 13, 2013, EPA has announced the public meeting date for June 26, 2013 and has extended the comment period until July 12, 2013. EPA has specifically requested information on:

    • The manufacture, sale, and uses of lead-based paint after 1978;
    • The uses of lead-based paint on public and commercial buildings;
    • The frequency and extent of renovations of public and commercial buildings;
    • Work practices used to renovate public and commercial buildings; and
    • Dust generation and transportation from exterior and interior renovations of public and commercial buildings.

Sweetnam and Schwartz, LLC has significant experience representing construction and demolition contractors and related companies in RRP matters. Any such companies seeking additional information on EPA’s proposed action or seeking to submit comments on the proposed RRP rule are welcome to contact Sweetnam and Schwartz, LLC for assistance.

When A Permit May Not Be A Permit

Years ago when I was an Assistant Regional Counsel at the Environmental Protection Agency (EPA), Region 4 and the lead attorney for wetlands matters, I debated whether to use EPA’s authority under the Clean Water Act (CWA) to veto permits issued by the US Army Corps of Engineers (Corps) that supported major development projects. Clearly, EPA’s authority to override the permits exists under Section 404(c) of the CWA, which states that EPA could withdraw authorization for disposal of dredged or fill material “whenever he determines after notice and opportunity for public hearings, that such discharge of such materials … will have an unacceptable adverse effect ….” on certain environmental resources. Further, this statutory provision had no temporal limitation, meaning that the veto power could be exercised long after the permits are issued. After thoroughly review, however, I determined that the equitable use of this power mandated that the veto be used only during the permit process, rather than years after issuance of the permits. This was the position that EPA had informally adopted, until recently. In a case before the U.S. Court of Appeals for the D.C. Circuit, the court agreed that EPA could veto a permit issued years before by the Corps. As a result of the decision in Mingo Logan Coal Company v. United States Environmental Protection Agency,, a wetlands discharge permit provides no safe harbor whatsoever if EPA, even years after the issuance of the permit by the Corps, chooses to veto the permit.

In 2007, the Corps had issued Mingo Logan’s predecessor in interest a Section 404 permit to fill areas associated with the company’s mining operations. EPA raised concerns during the permit process but decided that the concerns did not warrant veto of the permit. However, over 3 years later, EPA published a final determination to withdraw the fill areas that were specified in Mingo Logan’s wetlands permits. The Court of Appeals found that the plain language manifests the Congress’s intent to confer on EPA a broad veto power extending beyond the permit issuance, such that EPA “has, in effect, the final say on the specified disposal sites ‘whenever’ [it] makes the statutorily required [finding].”

While this decision may be legally correct, it ignores the practical reality that it allows section 404 permits to be revisited at any time the authorized activity may become controversial. Without permit finality, permit holders are at risk that activities, although authorized by the permit, may not be able to be conducted. This puts projects authorized by such permits, especially large scale and multi-phase construction projects, in jeopardy. The only defense to an EPA veto would be that the EPA action is arbitrary and capricious under the Administrative Procedures Act. It is certainly unfortunate that the regulated community can no longer consider a wetlands permit to be the word of the regulatory authorities.


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