Section 8(d) of the Toxic Substances Control Act (TSCA) and 40 CFR part 716 require manufacturers and processors of chemicals to submit lists and copies of health and safety studies relating to the health and/or environmental effects of certain chemical substances and mixtures. In order to comply with these reporting requirements, respondents must search their records to identify any health and safety studies in their possession, copy and process relevant studies, list studies that are currently in progress, and submit this information to EPA. EPA uses this information to construct a complete picture of the known effects of the chemicals in question, leading to determinations by EPA of whether additional testing of the chemicals is required. The information enables EPA to base its testing decisions on the most complete information available and to avoid demands for testing that may be duplicative. EPA uses information obtained via this collection to support its investigation of the risks posed by chemicals and, in particular, to support its decisions on whether to require industry to test chemicals under section 4 of TSCA.
US Code:
15 USC 2607d
Name of Law: Reporting and retention of information / Health and safety studies
There is a net decrease of 6,778 hours (from 8,383 to 1,605) in the total estimated respondent burden compared with that currently in the OMB inventory. This net decrease in burden is due to the following:
⢠The previous ICR incorrectly used a total of 1 robust summary per year as the total number of annual robust summary responses, yielding a total of 12 hours of annual burden. This ICR corrects this burden estimate by using a total of 20 robust summary responses per year, yielding a total annual reporting burden of 240 hours â an increase of 228 hours per year.
⢠This ICR renewal incorporates changes made to Health and Safety Data reporting under TSCA section 8(d) that mandate the use of electronic reporting in lieu of traditional paper-based reporting. The new electronic reporting requirements eliminated the clerical burden associated with transcribing study title lists and photocopying studies for paper-based submissions. This change resulted in a decrease of 40 hours to the average annual reporting burden. While electronic reporting serves to streamline and reduce the administrative/clerical costs and burdens associated with submitting paper-based health and safety studies, the burden savings were not sufficient to offset the new burden associated with CDX registration activities. However, it should be noted that these activities occur only once for each submitter and, since some respondents while most likely have already registered with CDX, this analysis conservatively overestimates the burden and costs actually experienced by respondents.
⢠The new electronic reporting mandate requires that submitters of health and safety data under TSCA section 8(d) register with CDX in order to submit studies electronically. The new annual burden associated with CDX registration activities is 53 hours.
⢠Finally, EPA has reduced the burden estimate by 7,019 hours to reflect the 2012 withdrawal of the cadmium reporting rule as noted above in section 6(d).
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
0575.15_SS_Attachment-3_ConsultationsMsg.pdf
0575.15_SS_Attachment-2_Regulations.docx
Compliance Determination and Data Search