Persons Subject to Reporting

The TSCA 8(e) reporting obligation appUes to any person engaged in the manufacture, import, processing, or distribution in commerce of the chemical substance at issue. The term person is defined by the Agency to include natural persons, business entities (a firm, corporation, sole proprietorship, joint venture, partnership, or association), any State or poUtical subdivision 

TSCA Section 8(e) Notification of Substantial Risk Policy Clarification and Reporting Guidance. 68 Fed. Reg. 33129, 33131 (June 3. 2003) [hereinafter 2003 Reporting Guidance]. 

The EPA posts 8(e) reports athttp //www.epa.gov/opptintr/tsca8e/pubs/8eandfyisubmissions. htm. 

The TSCATS database is accessible through the EPA Web site, available at http //www.epa. gov/opptintr/tsca8e/pubs/basicinformation.htm. 

There is no de minimis exemption for manufacturing, importing, processing, or distributing small amounts of a chemical, nor is there an exemption for small businesses.  

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The data on anticancer effects of DR on humans are limited. It has been shown in humans that obese persons subjected to DR have decreased rectal cell proliferation, a biomarker related to colon cancer. In a recent retrospective study in Swedish women, it was noted that women with less caloric intake had substantially lower incidence of breast cancer. These reports indicate that the anticancer effects of DR observed in the experimental models are reproducible in humans. 

Any person who manufactured or imported for commercial purposes a reportable chemical substance in the amount of twenty-five thousand pounds or more at any one owned or controlled site during the calendar year is subject to reporting for that chemical substance. For importers, the site of importation is the site of the operating unit that is directly responsible for importing the substance and controls the import transaction, which can in some instances be the organization s domestic headquarters. ... 

C.RR. 716.5. In 1998, EPA narrowed the scope of persons subject to TSCA 8(d) reporting to generally exclude processors as part of regulatory reform, concluding that narrowing the scope of persons covered would have but a negUgible impact on the type and comprehensiveness of information submitted. 63 Fed. Reg. 15765 (Apr. 1,1998). 

TSCA 8(0 clarifies that only commercial manufacture or processing comes within the scope of 8, and so chemicals manufactured, imported, or processed for purely academic purposes are not subject to reporting under TSCA 8(e).A person does not have a reporting obligation for chemicals that are used and not otherwise manufactured, imported, processed, or distributed. In this context, used means used as a chemical processing aid, catalyst, or reaction solvent. People who use paints and coatings are subject to 8(e) reporting. 

AR564 10.1 Compilation of reporting requirements for persons subject to NRC regulations (Rev.4,... 

This is similar to the simple atom-atom truncation except that dipolar groups will never be split by the cutoff distance. There is still the problem of discontinuities, but these are less extreme than in the case of atom-atom truncations. In cases where water is explicitly included, this approach exhibits the curious phenomena of hot water and cold protein if the entire system is coupled to a heatbath. This is because the more mobile atoms (the water) are subjected to more discontinuities which makes them hotter than the less mobile atoms (the protein) (Levitt, M., Weizmann Institute, personal communication, 1986.). It should be noted that this is one of the most commonly used methods of truncation for simulations where CHARMM is not used. For the group-group truncation, these calculations are in progress and will be reported elsewhere. For this type of truncation, both methods where the list is updated on... 

In the first of these studies, the researchers identified the areas of the brain that are associated with normal sadness. They asked volunteer subjects to think about some very sad personal experiences - and about some emotionally neutral experiences - while their brains were being imaged in a PET scanner. When thinking about the sad experiences, the volunteers reported feeling intense sadness, and many of them became tearful. The PET scans showed the changes in brain activity that accompanied these sad feelings. They demonstrated increased blood flow in the limbic system - a part of the brain that is involved in the control of emotion - and decreased blood flow in parts of the brain that are involved in the control of attention. 

All clinical trials should be subjected to QA, either by an in-house department or by external consultants. QA is defined as all those planned and systematic actions that are established to ensure that the trial is performed and the data generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements(s) (ICH GCP 1 -46). Those persons... 

The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Trial Subjects involved in the Clinical Trial. Personal data shall not be disclosed to the Sponsor by the NHS Trust save where this is required directly or indirectly to satisfy the requirements of the Protocol or for the purpose of monitoring or adverse event reporting. The Sponsor shall not disclose the identity of Clinical Trial Subjects to third parties without prior written consent of the Clinical Trial Subject, in accordance with the requirements of the Data Protection Act 1998 and the principles set out in the Report of the Caldicott Committee on the review of patient identifiable information dated December 1997, a copy of which the NHS Trust shall supply to the Sponsor on request. 

In a very early study, Shaffer et al. (1945) administered single oral doses of 5 and 10 g di(2-ethylhexyl) phthalate to two human subjects and reported that approximately 4.5% of the dose was excreted in the urine within 24 h. Schmid and Schlatter (1985) also administered di(2-ethylhexyl) phthalate orally to two human subjects, but at the much lower dose of 30 mg per person. These authors reported that 11-15% of the dose was excreted in the urine and a urinary elimination half-life of about 12 h can be estimated from the data. In the same study, the two volunteers also received 10 mg di(2-ethylhexyl) phthalate daily for four days, there being no evidence of accumulation, with 11 and 33 % of the dose recovered each day in the urine. In contrast, Rubin and Schififer (1976) reported data from two patients receiving platelet transfusions from bags containing di(2-ethylhexyl) phthalate, who excreted between 60 and 90% of the infused dose in the urine collected for 24 h after transfusion. 

EXTENSIONS AND COMMENTARY These qualitative comments are not true quotations, but have been reconstructed from the published summaries of the human trials reported by several South American researchers. I have personally never tasted DON and have only these fragments from which to create a portrait of activity. A brief quotation, from a note published by these researchers in a bulletin that is restricted to forensic scientists serving law enforcement agencies, is certainly subject to a number of interpretations. It reads as follows This action [a strong stimulant action reminiscent of amphetamine] seems to reduce the incidence of insightful, and therefore potentially unpleasant experiences, and thus [DON seems likely] to appear on the market as an illicit recreational drug. I must admit that I have tried, and I am still not able, to interpret this quotation. 

Although these reactions result in an increased respirable aerosol mass, little is known about human health effects associated with these particular condensed reaction products. Tamas et al. (2006) observed a correlation between the number concentration of SOAs, from the limonene-ozone reaction in an office, and sensory load reported by 20 human subjects. Additionally, a screening study indicates that perfume wearers will be subjected to a personal reactive cloud of reaction products, such as fine aerosols (Corsi et al., 2007). 

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