Environmental Protection Agency February 2, 2011 – Federal Register Recent Federal Regulation Documents

In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request for a new collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is scheduled to expire on July 31, 2011. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.

This regulation establishes tolerances for residues of bispyribac-sodium in or on fish, freshwater. Valent U.S.A. Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This regulation amends tolerances for residues of cyprodinil in or on fruit, pome, group 11 and apple wet pomace. This regulation also establishes tolerances for meat byproducts of cattle, goats, horses and sheep. Syngenta Crop Protection requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This regulation establishes tolerances for residues of sulfentrazone in or on multiple commodities. Additionally, this regulation deletes existing tolerances on commodities superseded by the establishment of crop subgroups. This regulation also deletes a time- limited tolerance on bean, succulent seed without pod (lima bean and cowpea), as the tolerance expired on December 31, 2007. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

EPA proposes to amend the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The proposed amendments would broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. They would also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally the proposed amendments would identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). In seeking comments on these proposed amendments, EPA does not imply that the current Federal Policy for the Protection of Human Subjects (the ``Common Rule''), which governs research with human subjects conducted or supported by EPA and many other Federal departments and agencies, is inadequate. Indeed, the amendments proposed here would make no changes to the Common Rule or EPA's codification of the Common Rule. Rather, EPA is proposing these amendments to other portions of its regulation as a result of a settlement agreement, and is now seeking comment on these proposed amendments. The settlement agreement makes clear that EPA retains full discretion concerning what amendments are proposed, and what, if any, amendments are finalized. Furthermore, no research has been identified that is outside the scope of EPA's current rule, but that would be within the scope of these proposed amendments. EPA seeks comments on the need for and value of the proposed changes.