Submission citations

Provides over 64 000 citations to unpublished health and safety studies, chemical tests, and substantial risk data on over 8400 chemical substances submitted to the US EPA under the Toxic Substances Control Act (TSCA). Copies of the original submissions are available from the US EPA (CIS, subset of TOXLINE available on CD-ROM in PolTox I and Toxline from Silver Platter). 

If data has already been submitted to the EPA without any claims of confidentiality, it does not need to be included with the PMN and instead the PMN submitter can identify the recipient by name or office, the date of the prior submission, and any standard literature citation to the reportd Data on exposure pathways outside of the United States does not need to be submitted with a PMN, but all data on health, environmental effects, physical and chemical properties, and environmental fate must be reported no matter where the data was generated. 

Standards can have a restrictive effect on new materials as well. The FDA now requires that if a company cites a standard in its premarket notification, a Form 3654 must be completed, which is intended to detail to the Agency the extent to which the standard was applied. The form can be a grueling exercise if not considered at the beginning of letting the contract for testing or if the impact it may have on the submission is not properly understood. The form must include details of any adaptation of the standard to the device under review, deviations from the standards, requirements not applicable to the device, and the name and address of the test laboratory or certification body involved in assessment of conformance to this standard. If this information is not present in the laboratory report, the applicant must provide the information as an attachment to the form for each standard cited. For many standards, completing this form has become an onerous task. Unfortunately, without this level of disclosure, it can be difficult for the FDA to understand the degree to which the biotextile conforms to the claimed standard. Because such standards citations can become product claims of performance, such detailed information is necessary. 

All abatement verification documents must contain the following information 1) Your name and address 2) the inspection number (found on the front page) 3) the citation and citation item number(s) to which the submission relates 4) a statement that the information is accurate 5) the signature of the employer or employer s authorized representative 6) the date the hazard was corrected 7) a brief statement of how the hazard was corrected and 8) a statement that affected employees and their representatives have been informed of the abatement. 

The administrative law judge shall afford the parties reasonable opportunity to submit proposed findings of fact, conclusions of law, and supporting reasons therefor. If the administrative law judge orders written proposals and arguments, each proposed finding must include a citation to the specific portion of the record relied on to support it. Written submissions, if any, must be served within the time period set by the administrative law judge. 

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