EPAs Interpretative Guidances

On the other hand, where the guidances relax the statutory obUgation to report, a company that does not report does so at peril of violating the statute because the guidances are not binding interpretations of the statute.  

While the statutory language requires reporting immediatel) the EPA has determined that this requirement is met if the information is submitted within thirty days. 68 Fed. Reg. 33129 (June 3, 2003). 

68 Fed. Reg. 33129,33130-31 (June 3,2003). See abo, EPA, Frequent Questions. September 2006, A.5 [hereinafter 2006 Frequent Questions], availabk at http //www.epa.gov/opptintr/ tscaSe/pubs/frequentlyaskedquestionsfaqs.htm. EPA has taken the position that it is authorized to issue binding regulations but has chosen not to do so. 68 Fed. Reg. 33129, 33130 (June 3.2003). 

In the context of TSCA 8(e), all interpretations other than the bare language of the statute itself and the relatively rare court holdings are derived from these EPA guidances. 

Several of these guidances had their genesis in the EPA s Compliance Audit Program (CAP), which was a voluntary self audit program announced 

---

EPA, Office of Regulatory Enforcement, Audit Policy Interpretive Guidance, EC-G-2002-149,2 (Jan. 1997) [hereinafter Audit Interpretive Guide], available through http //www.epa, gov/compliance/incentives/auditing/auditpolicy.html. 

The EPA s Audit Policy Interpretive Guidance gives an example that is an important reminder of the limits of the Audit Policy. According to the Interpretive Guidance, Chiquita Brands International self-reported a criminal violation committed by its subsidiary, John Morrell and Company. While the government chose not to prosecute Chiquita Brands International, it did prosecute and convict John Morrell and Company and several corporate officials for conspiracy and Clean Water Act (CWA) felonies. ... 

While the GALPs apply only to the EPA laboratories, and specifically only to EPA contract labs, they provide importance guidance for the manager of any automated regulated lab. Coupled with the specifications of 21 CFR Part 11 the GALPs can serve as important interpretive material in applying the content and principles of the GLPs to the realities of the modern automated laboratory. 

The EPA provides further guidance for decision-making in this area when the RPD between two results exceeds 40 percent, the EPA conservatively recommends selecting the higher concentration as a true one (EPA, 1996a). This practice, however, often leads to false positive results and may be the cause of unnecessary site remediation. From a practical perspective, in the absence of matrix interferences for an analyte to be present in the sample the agreement between the two results should be better than 40 percent. If matrix interferences are obvious, a chemist experienced in data interpretation should evaluate the chromatograms and make a decision on the presence or absence of the analyte in the sample. 

Dietary supplementation studies with n-3 fatty acids alone have generally not been promising in atopic dermatitis. An initial double-blind study reported a subjective improvement on fish oil compared with the control OA, but no objective improvement on physician assessment.179 A further double-blind study using EPA with saturated fatty acids as the control, showed equal improvement with both supplements and the benefit was attributed to increased clinician guidance,180 while a multicenter study showed a similar improvement in clinical score in subjects taking fish oil or corn oil.181 The latter results might possibly reflect a beneficial effect of both EFA-containing oils, but more likely imply a placebo effect, and illustrate the problems posed both in selection of a suitable control and the interpretation of such studies. 

US EPA has developed a benchmark dose software package that provides various models for quantal, continuous, and nested data (developmental toxicity study results). The software can be downloaded from US EPA s website (see section Relevant Websites) free of charge, and it is frequently updated. This website also provides support documentation, including a software user s manual and a guidance document on the interpretation and use of BMD modeling. 

Terrestrial ecological risk assessments are conducted following the standard framework and guidance published by the US EPA and various states. All but the most basic ecological risk assessments require a team of specialists to gather, analyze, and interpret information about fate and transport of pollutants... 

The terms iso and branched are defined very specifically by Chemical Abstracts Services (CAS). These definitions are used by the EPA in interpreting chemical structures. Despite this clear guidance, designations have been frequently misused. According to commonly accepted nomenclature principles, iso is defined... 

Title I of the CAA Amendments of 1990 contains many new and revised requirements for areas that have not attained the national ambient air quality standards (NAAQS) for ozone, carbon monoxide, particulate matter, sulfur dioxide, nitrogen dioxide, and lead. The EPA developed a guidance document, called the General Preamble to Title I (2), to assist States regarding the interpretation of the various provisions of Title I, as amended. A Supplement to the General Preamble was subsequently published (3) and provides guidance on implementation of Title I NO, provisions. This section of the paper focuses on the Title I requirements related to the ozone NAAQS. 

The EPA has issued guidances on chemical nomenclature, commonly called nomenclature papers, that provide additional insight into its interpretation of the term mixture. These guidances illustrate the EPAs definition of mixtures ... 

EPA s former Office of Toxic Substances (OTS) issued guidance on what constitutes an article. In its October 1,1985 Clarification of the Interpretation of Article Under TSCA, OTS said ... 

EPA posts 8(e) reports it receives on its Web site, which are very useful for benchmarking, as well as for obtaining information about specific chemicals, though they are not very useful for guidance because they are merely industry interpretations. The EPA has also posted searchable summaries of 8(e) submissions in the Toxic Substances Control Act Test Submissions (TSCATS) database. 

MTBE was a citizens suit under TSCA 20 seeking to compel oil companies to report certain information concerning methyl tertiary butyl ether under TSCA 8(e). As the MTBE case makes clear, people bringing citizens suits are not bound by EPA guidance that purports to relax strict compliance with the statutory language. Similarly, there is no reason why any other federal agency would be compelled to interpret TSCA the way the EPA does in the guidances. ... 

The EPA s first guidance concerning this law was in 1978 [23], In 1979 they published a Statement of Enforcement Policy [24] granting exemptions for certain information considered to be unnecessary. The EPA published further interpretation in 1985 [25] and said that it would announce the effective date. That date was never announced, so it is not clear if that guidance was ever in effect. Finally, in 1992 the EPA published a proposed rule pertaining to 6(a)(2) [26]. This proposed rule was not finalized the comment period was reopened in 1996 and was codified in 1998 [27]. This final rule also revoked all other rules and interpretations. 

When time permits, the NRC should rely on the expertise of Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and Health and Human Services (HHS) when interpreting their guidance. The NRC is responsible for promptly releasing plant and radiological data to State and other Federal agencies with protective action responsibilities. 

---