We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on June 22, 2011 (76 FR 36387). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (76 FR 36387, June 22, 2011) or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect about 184 products of U.S. registry. We also estimate that it will take about 7 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $197 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $145,728, or $792 per product.

In addition, we estimate that any necessary follow-on actions would take about 5 work-hours and require parts costing $10,700, for a cost of $11,125 per product. We have no way of determining the number of products that may need these actions.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator.“Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

1. Is not a ”significant regulatory action” under Executive Order 12866;

2. Is not a ”significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 36387, June 22, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on May 11, 2011 (76 FR 27281). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states that:

The cracks originating from the root of the buttress threads in the blade ports are caused by high-cycle fatigue.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM published in the Federal Register on May 11, 2011 (76 FR 27281) or on the determination of the cost to the public.

Since we published the NPRM in the Federal Register on May 11, 2011 (76 FR 27281), we changed the AD Docket No. from FAA-2011-0033, to FAA-2011-0735. The original number was inadvertently used both by the FAA Engine & Propeller Directorate, and the FAA Transport Airplane Directorate.

Also since we published the NPRM in the Federal Register on May 11, 2011 (76 FR 27281), we became aware that Dowty Propellers made minor changes to Alert Service Bulletin (ASB) No. 61-1043, Revision 6, and issued Revision 7, dated March 1, 2011. Revision 6 of the ASB had an incorrect Non-Destructive Testing (NDT) reference in Effectivity paragraph 1.D. We do not reference that paragraph in this AD, however, we changed the AD to reference the most current ASB, which is Revision 7.

We reviewed the available data and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

Based on the service information, we estimate that this AD will affect about 2 propellers installed on one airplane of U.S. registry. We also estimate that it will take about 1 work-hour per propeller to comply with this AD. The average labor rate is $85 per work-hour. Required parts will cost about $20,000 per propeller. Based on these figures, we estimate the cost of the AD on U.S. operators to be $40,170.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (phone: (800) 647-5527) is provided in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We received four reports of GE CT7-8 series turboshaft helicopter engines experiencing unrecoverable engine stalls, during hover in a left-roll attitude. Investigation revealed that during a prolonged left roll, excessive return oil from the AGB may return to the A-sump and exceed the sump's scavenging capability. The sump then floods, leading to over-heated oil, which preheats the air entering the engine's compressor. This preheated air causes inlet thermal distortion. This condition, if not corrected, could result in an unrecoverable engine stall, leading to a helicopter forced landing or accident. We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in the Federal Register on May 2, 2011 (76 FR 24407). That NPRM proposed to require the installation of an AGB axis-A oil slinger nut to the axis-A shaft assembly.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM published in the Federal Register on May 2, 2011 (76 FR 24407).

Since we issued the NPRM published in the Federal Register on May 2, 2011 (76 FR 24407), GE issued a revision to the service bulletin we are incorporating by reference in this AD. The revision includes new information in the procedure required to torque the oil slinger nut. This AD incorporates by reference, GE Aircraft Engines CT7-8 Turboshaft Engine Service Bulletin No. CT7-8 S/B 72-0033, Revision 1, dated April 28, 2011.

Also since we issued the NPRM published in the Federal Register on May 2, 2011 (76 FR 24407), we discovered that in the applicability paragraph, we inadvertently omitted engine serial number 953071. We corrected that omission in paragraph (c) (4) by changing “CT7-8E, engine S/Ns 953068 and below, and S/Ns 953070 and 953072” to “CT7-8E, engine S/Ns 953068 and below, and S/Ns 953070 through 953072”.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes are consistent with the intent that was proposed in the NPRM published in the Federal Register on May 2, 2011 (76 FR 24407) for correcting the unsafe condition.

We estimate that this AD will affect 80 engines installed on helicopters of U.S. registry. We also estimate that it will take about one work-hour per engine to perform the actions required by this AD, and that the average labor rate is $85 per work-hour. Required parts will cost about $700 per engine. Based on these figures, we estimate the total cost of the AD to U.S. operators to be $62,800.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, part A, subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to the specified products. That NPRM was published in the Federal Register on January 18, 2011 (76 FR 2840). That NPRM proposed to require inspecting to determine the clearance and any wire bundle damage between wire bundle W443 and the left forward rudder quadrant, followed by adjusting the minimum clearance between the wire bundle and the left forward rudder quadrant, and repairing any wire bundle damage.

We gave the public the opportunity to participate in developing this AD. We have considered the comments received. The following presents the comments received on the proposal and the FAA's response to each comment.

American Airlines, Delta Air Lines, and Continental Airlines (CAL) support the NPRM (76 FR 2840, January 18, 2011), and stated that they have been inspecting the affected airplanes in accordance with the original issue and revision 1 of the service information cited in the NPRM.

CAL requested that the FAA ask Boeing to add the appropriate ICAs to the Boeing 737NG Aircraft Maintenance Manual (AMM), because CAL is concerned about inadvertently undoing the corrective actions proposed in the NPRM (76 FR 2840, January 18, 2011) during future maintenance.

We disagree with the request to ask Boeing for ICAs. Current maintenance procedures and inspections ensure that the unsafe condition corrected in accordance with the AD will not be undone during future maintenance. A maintenance task exists to do a general visual inspection (GVI) of the area above the outboard nose wheel well, an inspection derived from the enhanced zonal analysis procedure (EZAP). This GVI of the area includes inspecting the wire bundles for damage and ensures no interference (riding) condition exists. Also, the rudder travel test provided in the AMM already includes steps to verify that wire bundle W443 has a minimum clearance of 0.5 inch from the left forward rudder quadrant at full travel motion while someone operates the rudder pedals, which captures the intent of this AD action. Boeing has updated the 737NG AMM to Revision 45, dated June 15, 2011, to include minimum clearance of 0.5 inch for the rudder travel test. We have not changed the AD in this regard.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD as proposed.

We estimate that this AD will affect 870 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Background

Under current regulations, the DEA registration of any person terminates “if and when such person dies, ceases legal existence, or discontinues business or professional practice * * *.” 21 CFR 1301.52(a) and 1309.62(a). Under these provisions, no further action by DEA is needed to terminate a DEA Certificate of Registration after one of the specified events occurs. However, these regulations are silent about whether the automatic termination provisions apply upon a registrant's voluntary surrender of a DEA registration. Moreover, DEA Forms 104 (for controlled substance registrations) and 104c (for listed chemical registrations), which may be used by registrants to effectuate voluntary surrenders, state that submission of the forms “shall be authority for the Administrator of the Drug Enforcement Administration to terminate * * * my registration without an order to show cause, a hearing, or any other proceedings * * *.” Thus, the forms have led some registrants to believe that DEA must issue a final order revoking the registration after submission of the forms in order to terminate a DEA registration.

DEA regulations, however, do not require further action by DEA's Administrator to terminate a DEA registration after submission of a voluntary surrender and, in practice, DEA treats the submission of a voluntary surrender as an immediate termination of the DEA registration at issue. The only additional action taken by DEA in such cases is the entry of the surrender into DEA's registration database. Further, DEA regulations do not require a registrant to use any particular format to submit a voluntary surrender. DEA accepts voluntary surrenders as long as the registrant submits a signed statement expressing the desire to surrender a registration.

DEA Forms 104 and 104c are internal DEA documents that are available for registrant use. These forms will be revised consistent with this final rule to clarify that a signed voluntary surrender of a registration has the legal effect of immediately terminating the registrant's registration upon delivery of such statement to any DEA employee. No further action by DEA is required.

To address the circumstances described above, DEA published a NPRM proposing the amendment of its regulations to clarify that a DEA registration terminates when DEA, through any employee, receives notice of a voluntary surrender of a DEA registration. 75 FR 32140, June 7, 2010. DEA did not receive any comments regarding the NPRM and is thus finalizing the rule as proposed.

To ensure that there is no confusion as to actions necessary to effectuate the voluntary surrender of a DEA registration, DEA is revising the relevant regulations to state that a DEA registration terminates when DEA, through any employee, receives notice of a voluntary surrender of a DEA registration. Any format may be used as long as the registrant submits a signed statement expressing the desire to surrender a registration.

This regulation has been developed in accordance with the principles of Executive Orders 12866 and 13563. It has been determined that this is not a “significant regulatory action” that requires review by the Office of Management and Budget.

The Deputy Assistant Administrator, Office of Diversion Control, has reviewed this regulation and hereby certifies that it has been drafted in accordance with the provisions of the Regulatory Flexibility Act (5 U.S.C. 601-612), and by approving it certifies that this regulation will not have a significant economic impact upon a substantial number of small entities. This rulemaking merely clarifies the circumstances under which DEA registrations may be surrendered.

This action does not impose a new collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521. The forms discussed in this rulemaking are available to be utilized by registrants on a voluntary basis under specific law enforcement circumstances and are otherwise internal to DEA.

This proposed regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform to eliminate ambiguity, minimize litigation, establish clear legal standards and reduce burden.

This proposed rulemaking does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

This proposed rule will not have tribal implications and will not impose substantial direct compliance costs on Indian tribal governments.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $136,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532.

This rulemaking is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act) (5 U.S.C. 801-808). This rule will not result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation or on the ability of U.S.-based companies to compete with foreign-based companies in domestic and export markets.

For the reasons set out above, 21 CFR parts 1301 and 1309 are amended as follows:

On January 24, 2006 (71 FR 3922), FDA published a final rule entitled “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products” (physician labeling rule). In the preamble to the physician labeling rule, FDA discussed its views on the preemptive effect of both the regulation's codified provisions and, more generally, the FD&C Act. In addition, FDA subsequently published two final rules with preambles that referenced the preemption discussion in the physician labeling rule. See “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile” (72 FR 73589, 73595, December 28, 2007); “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices” (73 FR 49603, 49605-49606, August 22, 2008).

In its decision in Wyeth v. Levine, the Supreme Court addressed the preamble to the physician labeling rule and provided additional guidance in evaluating the preemptive effect of the FD&C Act and FDA regulations. 129 S. Ct. 1187 (2009). In this case, the Court upheld a State tort claim that was based on the manufacturer's failure to provide adequate warnings on the labeling of one of its prescription drug products. The Court held that the State claim was not preempted by the FD&C Act or FDA's labeling requirements, despite the Agency's position in the preamble to the physician labeling rule that such claims frustrate its statutory mandate.

According to the Court, FDA's position “does not merit deference,” in part, because it is “at odds with what evidence we have of Congress' purposes.” Id. at 1201. The Court found that Congress's “silence on the [preemption] issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” Id. at 1200. While the Court acknowledged that “some state-law claims might well frustrate the achievement of congressional objectives,” it found that “failure-to-warn claims” such as the one at issue do not “obstruct the federal regulation of drug labeling.” Id. at 1204. The Court also noted that the manufacturer did not avail itself of FDA regulations that permit changes to a drug's labeling. Id. at 1996-97. And “absent clear evidence that the FDA would not have approved” the type of warning deemed necessary by the State claim, the Court was not willing to “conclude that it was impossible” for the manufacturer “to comply with both federal and state requirements.” Id. at 1198.

In light of the Supreme Court's decision in Wyeth, FDA has concluded that the position on preemption articulated in the preamble to the physician labeling rule, and subsequently referred to in the preambles of the other two rules cited previously in this document, cannot be justified under legal principles governing preemption. The codified provisions in these rules, however, do not include any statements about preemption and would not preempt State law beyond governing principles of preemption. FDA's conclusion about the regulatory preambles, therefore, does not affect the validity or operation of the codified provisions in these three final rules.

FDA also would like to clarify past preamble statements related to preemption resulting from certain express preemption provisions in the FD&C Act concerning nonprescription drugs and food labeling. Some preamble statements in regulations on nonprescription drugs contain the following language: “Currently, [Section 751(a) of the FD&C Act (21 U.S.C. 379r(a))] operates to preempt States from imposing requirements related to the regulation of nonprescription drug products (See section 751(b) through (e) of the act for the scope of the express preemption provision, the exemption procedures, and the exceptions to the provision) * * *. Although this final rule would have a preemptive effect, in that it would preclude States from issuing requirements related to these OTC * * * drug products that are different from or in addition to, or not otherwise identical with a requirement in the final rule, this preemptive effect is consistent with what Congress set forth in section 751 of the act. Section 751(a) of the act displaces both State legislative requirements and State common law duties * * *.”

In addition, FDA is now clarifying preamble statements in regulations on food labeling that contain the following language: “Although this rule has a pre-emptive effect, in that it would preclude states from issuing any * * * requirements * * * that are not identical to those required by the final rule, this pre-emptive effect is consistent with what Congress set forth in Section 403A of the Act [21 U.S.C. 343-1].” (See, e.g., 74 FR 2443, January 15, 2009). Although this language reflects the statutory language in section 403A of the FD&C Act, as codified at 21 U.S.C. 343-1, it does not acknowledge the applicability limitation set forth in section 6(c)(2) of the Nutrition Labeling and Education Act (NLEA), which was not codified. Section 6(c)(2) of the NLEA provided that section 403A of the FD&C Act “shall not be construed to apply to any requirement respecting a statement on the labeling of food that provides for a warning concerning the safety of the food or component of the food” (Pub. L. 101-535, section 6, 104 Stat. 2353 (1990)). FDA clarifies that its past discussions of section 403A of the FD&C Act should have included the language of section 6(c)(2) of the NLEA.

You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this rule. Potentially affected entities may include, but are not limited to:

• Manufacturers, importers, or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after November 4, 2011 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. Persons who must report are described in § 721.5.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.

To determine what would constitute a significant new use for the 36 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, taking into consideration the four bulleted TSCA section 5(a)(2) factors listed in this unit.

EPA is establishing significant new use and recordkeeping requirements for 36 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) number (if assigned for non-confidential chemical identities).

• Basis for the TSCA section 5(e) consent order or, for non-section 5(e) SNURs, the basis for the SNUR ( i.e., SNURs without TSCA section 5(e) consent orders).

• Toxicity concerns.

• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).

• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits ( i.e., limits on manufacture and importation volume) and other uses designated in this rule may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

This rule includes 4 PMN substances (P-06-36, P-06-37, P-09-146 and P-09-147) for which EPA determined, pursuant to TSCA section 5(e), that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal may present an unreasonable risk of injury to human health or the environment. Accordingly, these substances are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I). Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) consent order for the same chemical substance.

This rule also includes SNURs on 32 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “non-5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) Are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.

Chemical names: (P-06-36) Rutile, tin zinc, calcium-doped and (P-06-37) Rutile, tin zinc, sodium-doped.

CAS numbers: (P-06-36) 389623-01-2 and (P-06-37) 389623-07-8.

Effective date of TSCA section 5(e) consent order: February 17, 2009.

Basis for TSCA section 5(e) consent order: The PMN states that the substances will be used as colorants for polymers and industrial coatings. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that the substances may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: Use of personal respiratory equipment, including a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an Assigned Protection Factor (APF) of at least 10, or compliance with a NCEL of 1.5 mg/m 3 as an 8-hour time weighted average; establishment of a hazard communication program; and restricts the company from manufacturing the PMN substances with a d10 particle size less than 100 nanometers, where d10 particle size presents the particle size, as determined by laser light scattering, at which 10 percent by weight of the substance measured is smaller; and corresponding recordkeeping. The SNUR designates as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on structural activity relationship analysis derived from test data on structurally similar respirable, poorly soluble particulates, the PMN substances may cause lung overload and fibrosis in workers exposed to the PMN substances by the inhalation route.

Recommended testing: EPA has determined that the following test would help characterize the human health effects of the PMN substances: A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats. The testing should include a 60-day recovery period to assess the progression or regression of any lesions; and include special attention to histopathology (inflammation and cell proliferation) of the lung tissues and to various parameters of the bronchoalveolar lavage fluid (BALF), e.g., marker enzyme activities, total protein content, total cell count, cell differential, and cell viability. The order does not require submission of the aforementioned information at any specified time or production volume. However, the order's restrictions on manufacturing, import, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citations: 40 CFR 721.10230 (P-06-36) and 40 CFR 721.10231 (P-06-37).

Chemical name: N-arylamino-phenol-formaldehyde condensate (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) uses of the substance will be as a curative to be used with epoxy resin; a curative to be used with isocyanates in urethane systems; and an intermediate for synthesis of epoxy resins. Based on ecological structure-activity relationship (EcoSAR) analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 part per billion (ppb) of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10232.

Chemical name: Linear alkyl epoxide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) uses of the substance will be as site-limited intermediates for personal care ingredients and foam control agents. Based on EcoSAR analysis of test data on analogous epoxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10233.

Chemical name: Hydroxy-chloro-cyclopropyl-heteromonocyclic carboxylic acid (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an industrial intermediate. Based on test data on the PMN substance, and EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 6 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 6 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. Testing should be performed using the flow-through method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10234.

Chemical name: Phenol, 2-ethoxy-4-(ethoxymethyl)-.

CAS number: 71119-07-8.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a perfumery ingredient. Based on EcoSAR analysis of test data on analogous phenols, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10235.

Chemical name: 1-Propanamine, 3-[2-(2-methoxyethoxy)ethoxy]-.

CAS number: 91933-40-3.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a dispersant. Based on test data on an analogous substance submitted under TSCA section 8(e), EPA identified the following toxicity concerns from exposure to the PMN substance: Irritation to eyes; sensitization and corrosion to skin; and irritation to mucous membranes, lungs, and the gastrointestinal tract. For the uses described in the PMN, worker exposure and general population exposure are limited. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. However, EPA has determined that use of the substance other than as described in the PMN, or use of the substance in a consumer product, may result in significant human exposures. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of an acute oral toxicity test (OPPTS Test Guideline 870.1100 or Organisation for Economic Co-operation and Development (OECD) Test Guideline 425); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the intraperitoneal route; and a repeated dose 28-day oral toxicity study in rodents (OPPTS Test Guideline 870.3050 or OECD Test Guideline 407) would help characterize the human health effects of the PMN substance. Testing should be performed on the neutralized PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10236.

Chemical names: (P-09-146) Formaldehyde, polymers with acetone-phenol reaction products and phenol, sodium salts and (P-09-147) Formaldehyde, polymers with acetone-phenol reaction products and phenol, potassium sodium salts.

CAS numbers: (P-09-146) 1065544-88-8 and (P-09-147) 1072227-60-1.

Effective date of TSCA section 5(e) consent order: May 26, 2010.

Basis for TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) use of the substances will be as adhesives. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that the substances may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: Restrictions on formaldehyde residuals and polymer composition in the PMN substances; testing of representative samples at new manufacturing facilities; development and implementation of a written control plan for analysis and compliance with specified chemical composition limits; use only as listed in the consent order; no processing or distribution of the PMNs except when processed under specified conditions, where the PMNs are irreversibly cured into a thermoset polymer matrix; and maintaining certain records. The SNUR designates as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on physical-chemical properties, the PMN substances are expected to be absorbed from the lung and low molecular weight fractions are expected to be poorly absorbed from the gastrointestinal tract. Further, the PMN substances are not expected to be absorbed through the skin. EPA identified concerns for respiratory tract irritation, coughing; skin irritation and redness; eye irritation, watering, and redness; sensitization and severe allergic reactions. Further, based on test data on formaldehyde, a component of the PMN substances and regarded by EPA and International Agency for Research on Cancer (IARC) to be a carcinogen, EPA predicts human carcinogenicity.

Recommended testing: EPA has determined that the following test would help characterize the human health effects of the PMN substances: Determining formaldehyde concentration in air from wood products, using a large scale chamber (American Society for Testing and Materials International (ASTM) Test Guideline E1333-10 or its equivalent) to demonstrate that formaldehyde emissions are equal to or less than 0.04 parts per million (ppm). The order does not require submission of the aforementioned information at any specified time or production volume. However, the order's restrictions on manufacturing, import, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citations: 40 CFR 721.10237 (P-09-146) and 40 CFR 721.10238 (P-09-147).

Chemical names: Trivalent chromium complexes of a substituted beta-naphthol amine azo dye (generic).

CAS numbers: Not available.

Basis for action: The PMNs state that the use of the substances will be as acid dyes for coloring anodized aluminum. Based on test data on analogous substances including Beta-naphthylamine and chromium, EPA determined that the PMN substances may cause blood toxicity (methemoglobinemia), male reproductive toxicity, developmental toxicity, mutagenicity, and oncogenicity to workers and the general public exposed to the PMN substances via the lung or gastrointestinal tract. For the use described in the PMNs, worker inhalation exposure is unlikely, as the substances are imported, processed, and used as a wet press cake (greater than 30 percent water). Significant general population exposure is unlikely, as significant inhalation and drinking water exposures are not expected. Therefore, EPA has not determined that the proposed import, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that domestic manufacture, use of the substances other than as described in the PMNs, or the import, processing, or use of the substances in a powder or solid form (other than as a wet press cake that is comprised of greater than 30 percent water), may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has determined that the results of a bacterial reverse mutation test (OPPTS Test Guideline 870.5100) with the prival modification with a concurrent positive control; and an unscheduled DNA synthesis in mammalian cells in culture (OPPTS Test Guideline 870.5550) in rat hepatocytes on the Beta-naphthylamine reduction product would help characterize the human health effects of the PMN substances. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10239.

Chemical names: (P-09-154) Olefinic carbocycle, reaction products with alkoxysilane (generic); (P-09-155) olefinic carbocycle, reaction products with alkoxysilane, sulfurized (generic); and (P-09-156) olefinic carbocycle, reaction products with alkoxysilane, polysulfurized (generic).

CAS numbers: (P-09-154) Not available; (P-09-155) not available; and (P-09-156) not available.

Basis for action: The PMNs state that the generic (non-confidential) uses of the substances will be as a processing additive intermediate (P-09-154 and P-09-155) and as a processing additive (P-09-156). Based on EcoSAR analysis of test data on analogous alkoxysilanes, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance (P-09-154) and 6 ppb of the PMN substance (P-09-156) in surface waters. Based on test data on analogous alkoxysilanes and thiols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance (P-09-155) in surface waters. As described in the PMNs, the substances will not be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability—CO 2 in sealed vessels test (OPPTS Test Guideline 835.3140); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. Testing should be performed on P-09-155. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citations: 40 CFR 721.10240 (P-09-154); 40 CFR 721.10241 (P-09-155); and 40 CFR 721.10242 (P-09-156).

Chemical names: (P-09-193) Phosphonic acid, P-[2-[bis(2-hydroxyethyl)amino]ethyl]-, bis(2-chloroethyl) ester and (P-09-195) Phosphonic acid, P-[2-[bis(2-hydroxyethyl)amino]ethyl]-, 2-[bis(2-chloroethoxy)phosphinyl]ethyl 2-chloroethyl ester.

CAS numbers: (P-09-193) 55088-28-3 and (P-09-195) 1094213-37-2.

Basis for action: The PMNs state that the substances will be used as intermediates in the manufacture of a polyurethane flame retardant. Based on the alkylating activity of the PMN substances, EPA has concerns for oncogenicity, mutagenicity, developmental toxicity, dermal and respiratory sensitization, and irritation to all tissues. Additionally, the Agency has concern for liver toxicity, kidney toxicity, heart toxicity, developmental toxicity, and neurotoxicity based on test data for analog substances submitted to the Agency under TSCA section 8(e). Based on EcoSAR analysis of test data on structurally similar aliphatic amines, EPA predicts toxicity to aquatic organisms at concentrations that exceed 8 ppb in surface waters. As described in the PMN, significant worker dermal and inhalation exposure is unlikely for the use described in the PMN due to the use of personal protective equipment and engineering controls. Further, significant general population and environmental exposure is unlikely as the substances are not released to water. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of these substances may present an unreasonable risk. EPA has determined, however, that use of the substances other than as intermediates in the manufacture of a polyurethane flame retardant, use of the substances without the use of impervious gloves where there is potential for dermal exposure, or any use of the substances resulting in release to surface waters may cause significant adverse health or environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate, acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substances. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentration. Testing should be performed on P-09-193. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citations: 40 CFR 721.10243 (P-09-193) and 40 CFR 721.10244 (P-09-195).

Chemical name: Branched and linear fatty alcohol ethoxylate (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an intermediate in the manufacture of nonionic surfactants. Based on EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 ppb of the PMN substance in surface waters. For the use described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 14 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as an intermediate in the manufacture of nonionic surfactants may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10245.

Chemical name: Alkylpolyhydroxy polymer (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a drilling fluid additive. Based on EcoSAR analysis of test data on analogous alkyl ethoxylate nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 56 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10246.

Chemical name: Bis-phenoxyethanol fluorene diacrylate (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a raw material in ultra violet (UV) curable inks and coatings. EPA identified health and environmental concerns because the substance may be a persistent, bio-accumulative, and toxic (PBT) chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substance will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 5,000. Also, based on test data on analogous acrylates, EPA believes exposure to the PMN substance may cause systemic human health effects and predicts toxicity to aquatic organisms. As described in the PMN, significant worker exposure is unlikely and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10247.

Chemical name: Aromatic bromide (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as a synthetic intermediate. EPA identified health and environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999). EPA estimates that the PMN substance will persist in the environment more than six months and estimates a bioaccumulation factor of greater than or equal to 5,000. Also, based on test data on analogous brominated aromatics and neutral organics (aryl halides), EPA believes exposure to the PMN substance may cause systemic human health effects and predicts toxicity to aquatic organisms. As described in the PMN, significant worker exposure is unlikely and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN or any predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10248.

Chemical name: Disubstituted phenol (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on test data on analogous anilines and phenols, as well as on test data submitted to the Agency under TSCA section 8(e), EPA identified concerns for liver toxicity, mutagenicity, carcinogenicity, developmental toxicity, neurotoxicity, and male reproductive system toxicity to workers from inhalation exposure to the PMN substance. Additionally, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the PMN substance in surface waters. For the use described in the PMN, significant worker exposure is unlikely due to the use of personal protective equipment. Furthermore, significant environmental exposure is unlikely as the substance is not released to surface water resulting in surface water concentrations that exceed 6 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use other than as a chemical intermediate, or exceedance of the manufacture and import limit of 100 kg per year may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) prolonged exposure; a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) using rainbow trout and a 60-day minimum duration; and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10249.

Chemical name: Zirconium lysine complex (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesion promoter and corrosion inhibitor. Based on EcoSAR analysis of test data on analogous inorganic zirconium compounds, EPA predicts toxicity to aquatic organisms at concentrations that exceed 120 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 120 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 120 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10250.

Chemical name: Fatty acids, reaction products with alkanolamine (generic).

CAS number: Not available.

Basis for action: The PMN states that the substance will be used as an intermediate for a product used as a component of a multipurpose additive in gasoline. Based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 400 ppb of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 400 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as an intermediate could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i).

Recommended testing: EPA has determined that the results of an aerobic and anaerobic transformation in aquatic sediment systems (OECD Test Guideline 308); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. EPA also recommends performing the fate testing first as the results may mitigate the need for further toxicity testing or change the testing requirements. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10251.

Chemical name: Thiosulfuric acid (H 2 S 2 O 3 ), manganese(2+) salt (1:1).

CAS number: 1033050-53-1.

Basis for action: The PMN states that the substance will be used as a micronutrient manganese source for selected agricultural crops. Based on EcoSAR analysis of test data on analogous manganese salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 400 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 400 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 400 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with mean measured concentrations. Algal testing should be performed using the static method with mean measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10252.

Chemical name: Butanedioic acid, 2-methylene-, polymer with 2,5 furanedione, copper(2+) manganese(2+) sodium zinc salt, hydrogen peroxide-initiated.

CAS number: 1134078-27-5.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a seed coating to provide micronutrients. Based on EcoSAR analysis of test data on analogous soluble complexes of zinc, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 34 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 34 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 34 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability-CO 2 in sealed vessels (headspace test) (OECD Test Guideline 310); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends performing the fate testing first as the results may mitigate the need for further toxicity testing or change the testing requirements. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10253.

Chemical name: Substituted acrylamide (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a raw material. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous amides and acrylamides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 21 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 21 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 21 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075) using the flow-through method with measured concentrations, and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) using the static method with measured concentrations would help characterize the environmental effects of the PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10254.

Chemical name: Vinyl carboxylic acid ester (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a monomer. Based on test data on the PMN substance and analogous vinyl esters, EPA identified concerns for dermal sensitization; dermal irritation; mutagenicity; neurotoxicity; and blood, liver, kidney, spleen, brain, testes, developmental, and reproductive toxicity to the general population if exposed to the PMN substance. In addition, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 15 ppb of the PMN substance in surface waters. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(i). At the production volume stated in the PMN, general population exposure is limited. Further, as described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 15 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk under TSCA section 5(e). However, EPA has determined that annual manufacture (including importation) of this PMN substance at volumes greater than 100,000 kilograms per year may result in significant human exposures. Further, EPA has determined that any use of the substance resulting in surface water concentrations exceeding 15 ppb may cause significant adverse environmental effects.

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the human health and environmental effects of the PMN substance. Aquatic toxicity testing should be performed using the flow-through method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10255.

Chemical name: Benzoic acid, 4-(dimethylamino)-, 1,1′-[(methylimino)di-2,I-ethanediyl] ester.

CAS number: 925246-00-0.

Basis for action: The PMN states that the substance will be used as a co-photoinitiator for UV-curable pigmentation inks; co-photoinitiator for photoresists, optical fibers, and printed plates; co-photoinitiator for UV-curable coatings; and co-photoinitiator for UV-curable adhesives and other coatings. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous aliphatic amines and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3100); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. Testing should be performed using the flow-through method with mean measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. EPA also recommends that the fate testing be performed first as the results may mitigate the need for further toxicity testing or change the testing recommendations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10256.

Chemical name: Butyl aromatic bisurea (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a sealant. Based on EcoSAR analysis of test data on analogous substituted urea, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10257.

Chemical names: (P-09-535) Aromatic hydrocarbon (generic) and (P-09-540) Halogenated aromatic hydrocarbon (generic).

CAS numbers: (P-09-535) Not available and (P-09-540) not available.

Basis for action: The PMNs state that the substances will be used as synthetic intermediates. EPA has identified health and environmental concerns because the substances may be PBT chemicals, based on physical/chemical properties of the PMN substances, as described in the New Chemicals Program's PBT Category (64 FR 60194; November 4, 1999). EPA estimates that the PMN substances will persist in the environment more than two months and estimates bioaccumulation factors that are greater than or equal to 5,000. Also, based on test data on analogous poly-aromatic hydrocarbons, EPA predicts chronic adverse human health effects. As described in the PMNs, significant worker exposure is unlikely and the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any predictable or purposeful release containing the PMN substances into the waters of the United States may cause serious health effects and significant adverse environmental effects, since the PMN substances have been characterized by EPA as PBT. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substances. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citations: 40 CFR 721.10258 (P-09-535) and 40 CFR 721.10259 (P-09-540).

Chemical name: Benzene, 1,3-bis(1-chloro-1-methylethyl)-.

CAS number: 37133-18-9.

Basis for action: The PMN states that the substance will be used as a site-limited starting material in novel polymer synthesis reactions. EPA has identified health and environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999). EPA estimates that the PMN substance will persist in the environment more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. In addition, based on the potential for the PMN to be an alkylating agent, EPA identified concerns for oncogenicity, developmental toxicity, sensitivity, and corrosion to all tissues from dermal and respiratory exposure. Further, based on EcoSAR analysis of test data on analogous benzyl halides, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposure is unlikely due to the use of adequate dermal and respiratory protection and the substance is not expected to be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant adverse environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category (64 FR 60914; November 4, 1999) should help characterize the PBT attributes of the PMN substance. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10260.

Chemical names: (P-09-589) Oxime, di-Me silane (generic) and (P-09-590) Oxime, Me vinyl silane (generic).

CAS numbers: (P-09-589) Not available and (P-09-590) not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as chain extenders. Based on test data on the PMN substances and the expected hydrolysis product, EPA identified concerns for carcinogenicity, dermal sensitization, blood effects, reproductive toxicity, and neurotoxicity to workers and the general population exposed dermally or by inhalation to the PMN substances. In addition, based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substances in surface waters. As described in the PMNs, worker exposure will be minimal due to the use of adequate personal protective equipment, general population inhalation and dermal exposure is not expected, and the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances without the use of impervious gloves where there is potential for dermal exposure, annual manufacture (including importation) of each of the PMN substances at volumes greater than 20,000 kilograms, or any use of the substances resulting in release to surface waters may cause serious health effects and/or significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a two-generation reproduction toxicity test (OECD Test Guideline 416); a ready biodegradability test (OPPTS Test Guideline 835.3110); a porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test; freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substances. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Testing should be performed on P-09-589. EPA recommends that the fate testing be performed first as the results may mitigate the need for further testing or change the testing requirements. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citations: 40 CFR 721.10261 (P-09-589) and 40 CFR 721.10262 (P-09-590).

Chemical name: Phenol, 4-(1,1-dimethylethyl)-2-nitro-.

CAS number: 3279-07-0.

Basis for action: The PMN states that the substance will be used as a raw material (reactant) for production of intermediate for a photographic chemical. Based on test data on the PMN substance, and test data submitted under TSCA section 8(e) on analogous aminophenols, EPA identified concerns for irritation to the eye and skin, mutagenicity, neurotoxicity, developmental, liver, blood, and reproductive toxicities to workers and members of the general population if exposed to the PMN substance. In addition, based on EcoSAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. For the uses described in the PMN, significant worker exposure is unlikely, as dermal/inhalation exposure is not expected; the substance is not released to surface waters; and the substance is not expected to result in significant exposure to the general population. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN or any use of the substance resulting in release to surface waters may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity with the reproduction/development toxicity screening test (OPPTS Test Guideline 870.3650); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test; freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10263.

Chemical name: Polycarbocyclic methacrylate (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymeric component. Based on EcoSAR analysis of test data on analogous methacrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guidelines 835.3110); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA recommends that the special considerations for conducting laboratory studies (OPPTS Test Guideline 850.1000) be followed to facilitate solubility in the test media, because of the PMN's low water solubility. Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10264.

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 4 of the 36 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160 (see Unit II.).

In the other 32 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.

• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.

• EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.

• EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/newchems/pubs/invntory.htm.

EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is December 5, 2011 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before November 4, 2011.

If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before November 4, 2011, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.

Significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule, October 5, 2011.

To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 4 chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 23 of the 36 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions (per §§ 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements because a person could defeat the SNUR by initiating the significant new use before the rule became effective, and then argue that the use was ongoing before the effective date of the rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires.

EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person meets the conditions of advance compliance under § 721.45(h), the person is considered exempt from the requirements of the SNUR.

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:

1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).

2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).

In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. The American Society for Testing and Materials International (ASTM) standards are available at http://www.astm.org/Standard/index.shtml.

In the TSCA section 5(e) consent orders for four of the chemical substances regulated under this rule, EPA has established restrictions in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These restrictions will not be removed until EPA determines that the unrestricted use will not present an unreasonable risk of injury or result in significant or substantial exposure or environmental release. This determination is usually made based on the results of the required or recommended toxicity tests.

The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Potential benefits of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1). Today's rules cross-reference § 721.1725(b)(1) (which is similar to the procedure in § 721.11, for situations where the chemical identity of the chemical substance subject to a SNUR is CBI) in each SNUR that includes specific significant new uses that are CBI.

Under these procedures a manufacturer, importer, or processor may request that EPA determine whether a proposed use would be a significant new use under the rule. The manufacturer, importer, or processor must show that it has a bona fide intent to manufacture, import, or process the chemical substance and must identify the specific use for which it intends to manufacture, import, or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture, import, or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers, importers, and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture, import, or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

According to § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in §§ 721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2010-1075.

This rule establishes SNURs for several new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a handful of notices per year. For example, the number of SNUNs was four in Federal fiscal year 2005, eight in FY2006, six in FY2007, eight in FY2008, and seven in FY2009. During this five-year period, three small entities submitted a SNUN. In addition, the estimated reporting cost for submission of a SNUN ( see Unit XI.) is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this rule. As such, EPA has determined that this rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).

This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This rule does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this rule.

This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR parts 9 and 721 are amended as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0053 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 5, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0053, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of March 29, 2011 (76 FR 17375) (FRL-8867-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PPs 0F7714 and 0F7715) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.626 be amended by establishing tolerances for residues of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl-2-hydroxypropyl]-1,2-dihydro-3 H -1,2,4-triazole-3-thione and its desthio metabolite, in or on the raw or processed agricultural commodity rice, grain at 0.25 parts per million (ppm); rice, hulls at 1.0 ppm; alfalfa, forage and alfalfa, hay at 0.02 ppm and potato, tuber at 0.02 ppm (PP 0F7714). In a separate petition (PP 0F7715) Bayer CropScience also proposed use of the currently established tolerances for residues of prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl-2-hydroxypropyl]-1,2-dihydro-3 H -1,2,4-triazole-3-thione and its desthio metabolite, in or on the raw agricultural commodities pea and bean, dried shelled, except soybean, subgroup 6C; soybean, forage; soybean, hay; soybean, seed; rice, seed to support the use of prothioconazole as a seed treatment on these crops. That notice referenced a summary of the petitions prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has determined that it is appropriate to modify the existing grain crop groups rather than establish separate rice grain and rice straw tolerances. The rice grain tolerance will now be covered by the modified tolerance of 0.35 ppm for grain, cereal group 15, except sweet corn and sorghum. Likewise, the rice straw tolerance will now be covered by the modified tolerance of 5.0 ppm for grain, cereal, forage, fodder, and straw, group 16, except sorghum; straw. Also, the EPA is establishing a tolerance for rice hulls at 0.90 ppm, instead of the proposed tolerance of 1.0 ppm. The reasons for these changes are explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for prothioconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with prothioconazole follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Prothioconazole has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin or eye irritant. Prothioconazole's metabolite, prothioconazole-desthio, also has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin irritant, but it is a slight eye irritant. The subchronic and chronic studies show that the target organs at the lowest observable adverse effects level (LOAEL) include the liver, kidney, urinary bladder, thyroid and blood. In addition, the chronic studies showed body weight and food consumption changes, and toxicity to the lymphatic and GI systems.

Prothioconazole and its metabolites may be developmental toxicants, producing effects including malformations in the conceptus at levels equal to or below maternally toxic levels in some studies; particularly those studies conducted using prothioconazole-desthio. Reproduction studies in the rat with prothioconazole and prothioconazole-desthio suggest that these chemicals may not be reproductive toxicants. Acute and subchronic neurotoxicity studies were conducted in the rat using prothioconazole. A developmental neurotoxicity study was conducted in the rat using prothioconazole-desthio.

The available data show that the prothioconazole-desthio metabolite produces toxicity at lower dose levels in subchronic, developmental, reproductive, and neurotoxicity studies as compared with prothioconazole and the two additional metabolites that were tested.

The available carcinogenicity and/or chronic studies in the mouse and rat, using both prothioconazole and prothioconazole-desthio, show no increase in tumor incidence. Therefore, EPA has concluded that prothioconazole and its metabolites are not carcinogenic, and are classified as “Not likely to be Carcinogenic to Humans” according to the 2005 Cancer Guidelines.

Specific information on the studies received and the nature of the adverse effects caused by prothioconazole as well as the no-observed-adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies are discussed in the final rule published in the Federal Register of May 28, 2010 (75 FR 29910) (FRL-8828-6).

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for prothioconazole used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of May 28, 2010 (75 FR 29910) (FRL-8828-6).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prothioconazole and its metabolites and/or degradates, EPA considered exposure under the petitioned-for tolerances as well as all existing prothioconazole tolerances in 40 CFR 180.626. EPA assessed dietary exposures from prothioconazole in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA conducted a moderately refined acute dietary exposure assessment. Empirical processing factors, average field trial residues (since all of the plant commodities included in this assessment are blended food forms, except sweet corn), and livestock commodity residues derived from feeding studies and a reasonably balanced dietary burden (RBDB) were incorporated into the moderately refined acute assessment. The assessment also assumed 100 percent crop treated (PCT). Since no observed effects would be attributable to a single dose exposure for the general U.S. population (including infants and children), females 13-49 years of age was the only population subgroup included in the acute assessment.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA conducted a moderately refined chronic dietary exposure assessment. Empirical processing factors, average field trial residues, and livestock commodity residues derived from feeding studies and a reasonably balanced dietary burden (RBDB) were incorporated into the chronic assessment; 100 PCT was assumed.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or non-linear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used and a cancer RfD is calculated based on an earlier non-cancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized.

Based on the data summarized in Unit III.A., EPA has concluded that prothioconazole is “Not Likely to be Carcinogenic to Humans.” Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. Average residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for prothioconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prothioconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of prothioconazole for the acute dietary risk assessment, the estimated surface water concentration value of 94.7 parts per million (ppb) was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the estimated surface water concentration value of 84.3 ppb was used to assess the contribution to drinking water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Prothioconazole is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Prothioconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events. In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

Prothioconazole is a triazole-derived pesticide. Triazole-derived pesticides can form the common metabolite, 1,2,4-triazole and three triazole conjugates (triazole alanine, triazole acetic acid, and triazolylpyruvic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including prothioconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites ( e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures ( i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor (SF) for the protection of infants and children. The assessment included evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's risk assessment can be found in the propiconazole reregistration docket at http://www.regulations.gov, docket ID number EPA-HQ-OPP- 2005-0497 and an update to assess the addition of the commodities included in this action may be found in docket ID number EPA-HQ-OPP-2010-0621 in the document titled “Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address Tolerance Petitions for Metconazole.”

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is evidence of increased susceptibility following prenatal/or postnatal exposure in:

i. Rat developmental toxicity studies with prothioconazole as well as its prothioconazole-desthio and sulfonic acid K salt metabolites.

ii. Rabbit developmental toxicity studies with prothioconazole-desthio.

iii. A rat developmental neurotoxicity study with prothioconazole-desthio; and

iv. Multi-generation reproduction studies in the rat with prothioconazole-desthio. Effects include skeletal structural abnormalities, such as cleft palate, deviated snout, malocclusion, extra ribs, and developmental delays. Available data also show that the skeletal effects such as extra ribs are not completely reversible after birth in the rat, but persist as development continues.

Although increased susceptibility was seen in these studies, the Agency concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of prothioconazole because:

• Developmental toxicity NOAELs and LOAELs from prenatal exposure are well characterized after oral and dermal exposure;

• The off-spring toxicity NOAELs and LOAELs from postnatal exposures are well characterized; and

• The NOAEL for the fetal effect malformed vertebral body and ribs is used for assessing acute risk of females 13 years and older and, because it is lower than the NOAELs in other developmental studies, is protective of all potential developmental effects.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for prothioconazole is complete, including required functional immunotoxicity testing. The EPA began requiring functional immunotoxicity testing of all food and non-food use pesticides on December 26, 2007.

ii. There is an acceptable battery of neurotoxicity studies including a developmental neurotoxicity study. Although offspring neurotoxicity was found, characterized by peripheral nerve lesions in the developmental neurotoxicity studies on prothioconazole-desthio, the increase was seen only in the highest dose group at 105 mg/kg/day, was not considered treatment related, and a clear NOAEL was established for this study.

iii. Although increased susceptibility was seen in the developmental and reproduction studies, the Agency concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of prothioconazole for the reasons explained in Unit III.D.2.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment is moderately refined utilizing empirical processing factors, 100 PCT, average crop field trial residue levels, and livestock maximum residues. Results from ruminant feeding studies and poultry metabolism studies were used to determine the maximum residue levels for livestock commodities. The crop field trials were performed using maximum application rates and minimum pre-harvest intervals. Although the Agency is requiring extended confirmatory storage stability data; interim storage stability data do not indicate that residue concentrations decline and therefore the assessment should not underestimate risk from dietary exposure. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to prothioconazole in drinking water. These assessments will not underestimate the exposure and risks posed by prothioconazole.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

Based on the proposed and existing crop uses for prothioconazole, dietary aggregate exposures ( i.e., food plus drinking water) are anticipated. There are no residential uses for prothioconazole and, therefore, no residential exposures are anticipated. Consequently, only dietary (food plus drinking water) exposures were aggregated for this assessment.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and drinking water to prothioconazole will occupy 24% of the aPAD for females 13-49 years of age, the only population group at risk for acute effects.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prothioconazole from food and drinking water will utilize 21% of the cPAD for the general U.S. population and 62% of the cPAD for all infants <1 year old, the population group receiving the greatest exposure.

3. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, prothioconazole is not expected to pose a cancer risk to humans.

4. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to prothioconazole residues.

Adequate liquid chromatography methods with tandem mass spectrometry detection (LC/MS/MS) are available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established MRLs for residues of desthio-prothioconazole in barley at 0.2 ppm; oats, rye, and wheat at 0.05 ppm each; in the fodder (dry) of cereal grains at 5 ppm; and in the straw (dry) of cereal grains at 4 ppm. There are currently no established Mexican MRLs for prothioconazole. Canadian MRLs have been established for prothioconazole per se in/on several commodities, including barley (0.35 ppm), wheat (0.07 ppm). Harmonization of the proposed tolerances with the existing Codex for prothioconazole is not possible at this time because of differences in tolerance expression and use patterns. The MRL expression for Codex is prothioconazole-desthio and is thus not compatible with the U.S. tolerance definition, the sum of prothiocoanzole and prothioconazole-desthio. EPA generally includes the parent in all residue definitions for tolerance enforcement, whereas Codex routinely excludes the parent if it is shown to be a small part of the actual total residue. Prothioconazole is a minor component of the total residue on the crops tested. Much of the Codex cereal grain supervised field trial data are from Europe, where the use pattern is different resulting in lower measured residues.

The tolerance definition for plant commodities in Canada was recently changed and is now harmonized with the U.S. residue definition. The barley tolerance of Canada agrees with the U.S. tolerance for cereal grains (except sweet corn, sorghum, and rice) of 0.35 ppm. However, the Canada tolerance for wheat is lower (0.07 ppm) than the existing U.S. group tolerance. EPA establishes crop group tolerances, as opposed to individual commodity tolerances, whenever there are adequate data for the representative commodities of that group and proposed use. There must be an acceptable range of residues over all the representative commodities. Wheat falls under this crop group practice in this case. Canada does not routinely establish animal feed commodity tolerances, and therefore there are no harmonization issues with forage, stover, hay, and straw.

The proposed rice grain tolerance level of 0.25 ppm is lower than the existing tolerance level (0.35 ppm) for grain, cereal group 15, except rice and sweet corn and sorghum. The existing cereal grain group 15 tolerance excludes rice, but the present evaluation of rice field trial data allows expansion of that group to include rice. Therefore, in this action, EPA is revising the existing cereal group to read grain, cereal group 15 (except sweet corn and sorghum). Likewise, the rice straw tolerance level is lower than the existing tolerance level (5.0 ppm) for grain, cereal, forage, fodder, and straw, group 16, except sorghum and rice straw, and therefore this crop group is being revised to include rice straw. Also, the submitted data support a tolerance of 0.90 ppm for rice hulls as determined from the rice to hull processing factor (from the rice processing study) applied to the highest average field trial residue, or 4.4 × 0.19 ppm, or 0.9 ppm instead of the proposed tolerance of 1.0 ppm.

Therefore, tolerances are established for residues of prothioconazole (2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3 H -1,2,4-triazole-3-thion) and its metabolite prothioconazole-desthio (α-(1-chlorocyclopropyl)-α-[(2-chlorophenyl)methyl]-1 H -1,2,4-triazole-1-ethanol), in or on alfalfa, forage at 0.02 ppm; alfalfa, hay at 0.02 ppm, potato at 0.02 ppm and rice, hulls at 0.90 ppm. The existing tolerance for Grain, cereal, group 15, except sweet corn, sorghum, and rice is changed to Grain, cereal, group 15, except sweet corn and sorghum and the existing tolerance for Grain, cereal, forage, fodder and straw, group 16, except sorghum and rice; straw is changed to Grain, cereal, forage, fodder and straw, group 16, except sorghum, straw.

Further, seed treatment uses on soybean, dried shelled pea and bean (except soybean) subgroup 6C and rice are covered by existing and currently established tolerances for these commodities.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the national government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0906 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 5, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2009-0906, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of February 4, 2010 (75 FR 5790) (FRL-8807-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9E7606) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the fungicide isopyrazam, in or on banana at 0.05 ppm parts per million (ppm). That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for isopyrazam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with isopyrazam follows:

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Isopyrazam is of low acute toxicity by the oral, dermal and inhalation routes, and is not a skin or eye irritant. The primary target organ for isopyrazam toxicity is the liver based on subchronic and chronic oral studies in the rat, mouse rabbit and dog. The principal effects observed in these studies are increased organ weight and centrilobular hepatocyte hypertrophy. Liver toxicity is usually accompanied by reductions in body weight and food consumption. Isopyrazam does not cause reproductive toxicity. Developmental effects (eye abnormalities) were observed in the absence of maternal toxicity in two range finding developmental toxicity studies in rabbits providing some evidence of sensitivity/susceptibility following pre- and/or postnatal exposure. Developmental studies in rats produced developmental effects but only at doses that were also maternally toxic. Acute and subchronic oral neurotoxicity studies in rats show no evidence of neurotoxicity. Effects characteristic of neurotoxicity (side-to-side head wobble, ataxia, reduced stability) were observed on day 2 in one subchronic oral study in dogs and at week 4 in a second subchronic dog study. These effects were not observed in the chronic dog study. However, EPA concluded for the following reasons that it is unlikely that there was a neurotoxic basis for these effects. First, the effects were seen only in a study not specifically conducted to identify neurotoxic potential and where detailed clinical and histopathological analyses for neurotoxic effects were not performed whereas isopyrazam showed no evidence of neurotoxicity in the available acute and subchronic neurotoxicity studies. Second, isopyrazam is not structurally similar to known neurotoxicants or neurotoxic classes of chemicals. Finally, its pesticidal mode of action does not demonstrate potential for neurotoxicity. Based on these findings, a developmental neurotoxicity study for isopyrazam is not required.

There is no evidence of immunotoxicity based on a 28-day dietary immunotoxicity study in rats. The lowest observed adverse effect level (LOAEL) for immunotoxicity was not identified and the no observed adverse effect level (NOAEL) for immunotoxicity is 1,356 milligrams/kilograms (mg/kg). The study NOAEL was 127 mg/kg/day, based on transient body weight loss and high liver weights at both 608 and 1,356 mg/kg/day. The toxicology database for isopyrazam does not show any evidence of treatment-related effects on the immune system. The overall weight of evidence suggests that this chemical does not directly target the immune system.

Isopyrazam is classified as “Likely to be Carcinogenic to Humans” based on tumors in male and female rats. Specific information on the studies received and the nature of the adverse effects caused by isopyrazam as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in document “Isopyrazam Human Health Risk Assessment for the Establishment of a Tolerance for isopyrazam (SYN52043) Fungicide in/on Imported Banana,” on pp. 8-12 in docket ID number EPA-HQ-OPP-2009-0906.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOC) to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed the NOAEL and the lowest dose at which adverse effects of concern are identified the LOAEL. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

PODs for incidental oral, dermal and inhalation exposure are not needed to assess risk for the requested tolerance on bananas because use of isopyrazam will only lead to dietary exposure, and have therefore not been selected for this risk assessment.

The acute POD of 30 mg/kg/day (NOAEL) was selected based on the NOAEL from a subchronic toxicity study in dogs. In that study, clinical signs of toxicity (side-to-side head wobble) were observed beginning on day 2 and continuing throughout the study in 1 of 4 male dogs at the LOAEL of 100 mg/kg/day. Transient clinical signs (side-to-side head wobble, ataxia, reduced stability) were also observed at 300 mg/kg/day in 3 of 4 male dogs on days 2 and 3 only. An uncertainty factor of 100x (10x to account for interspecies extrapolation and 10x for intraspecies variation) was applied to the NOAEL to obtain an aRfD of 0.30 mg/kg/day. This endpoint is considered to occur following a single dose and is applicable to the population of concern (general population, including infants and children). It is considered to be a very conservative endpoint since it is based on observations in 1/4 dogs and these acute clinical signs were not reproduced in a second 90-day study in dogs or in the chronic dog study. This endpoint is also protective of the effects seen at the limit dose (2,000 mg/kg/day) in the acute neurotoxicity study in rats (decreased rearing and locomotor activity) and the developmental effect (bilateral microphthalmia) in the developmental rabbit studies (at doses ≥400 mg/kg/day). Therefore, a separate acute dietary endpoint for females of reproductive age is not necessary. As discussed in this unit, EPA has reduced the Food Quality Protection Act (FQPA) Safety Factor (SF) to 1x, and thus the acute Population Adjusted Dose (aPAD) is equivalent to the acute Reference Dose (aRfD).

The chronic POD of 5.5 mg/kg/day was selected based on the NOAEL in a chronic toxicity/carcinogenicity feeding study in rats. The LOAEL in that study was 27.6 mg/kg/day based on decreased body weight and body weight gain in females; increased incidences of hepatocellular hypertrophy, pigment in centrilobular hepatocytes, eosinophilic foci of altered hepatocytes, vacuolation of centrilobular hepatocytes, bile duct hyperplasia, and bile duct fibrosis in both sexes; and brown pigment in the kidney in females. An uncertainty factor of 100x (10x to account for interspecies extrapolation and 10x for intraspecies variation) was applied to the dose to obtain the chronic reference dose (cRfD) of 0.055 mg/kg/day. As discussed in this unit, EPA has reduced the FQPA SF to 1x, and thus, the chronic population adjusted dose (cPAD) is equivalent to the cRfD.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isopyrazam, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from isopyrazam in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

A conservative acute dietary (food only) exposure analysis was performed for the general U.S. population and various population subgroups. Tolerance level residues and 100 percent crop treated (PCT) assumptions were used. Dietary Exposure Evaluation Model (DEEM) default processing factors were used for processed commodities, since separate tolerances are not considered necessary for processed banana commodities.

ii. Chronic exposure. Conservative chronic and cancer dietary (food only) exposure analyses were performed for the general U.S. population and various population subgroups. Tolerance level residues and 100 PCT assumptions were used. DEEM default and empirical processing factors were used for banana processed commodities, since separate tolerances for these commodities were not considered necessary.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. If quantitative cancer risk assessment is appropriate, cancer risk may be quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that isopyrazam should be classified as “Likely to be Carcinogenic to Humans”.

A linear quantification of carcinogenic potential was required for isopyrazam based on rat tumors. A cancer slope factor or Q1* of 0.00629 (mg/kg/day)  −1 was calculated based on an increase in liver adenomas and/or carcinomas in female rats. The resulting cancer aggregate (food) exposure estimate was less than the level of concern. Cancer risk was 1.3 × 10 −7 for the general U.S. population. Cancer risk was quantified using the same estimates as discussed in Unit III.C.1.ii.

2. Dietary exposure from drinking water. An assessment of residues in drinking water is not needed because there is no drinking water exposure associated with the establishment of a tolerance on imported crops.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Isopyrazam is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found isopyrazam to share a common mechanism of toxicity with any other substances, and isopyrazam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isopyrazam does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10x) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10x, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is some evidence for increased susceptibility following pre- and or postnatal exposures based on effects seen in range finding developmental toxicity studies in rabbits. Developmental effects (eye abnormalities) were observed in two preliminary developmental studies in Himalayan rabbits in the absence of maternal toxicity. These effects occurred at relatively high doses (200-400 mg/kg/day). There was no evidence of increased susceptibility in the main study in New Zealand white rabbits. In range finding and definitive developmental toxicity studies in rats, neither quantitative nor qualitative evidence of increased susceptibility of fetuses to in utero exposure to isopyrazam was observed. There was no evidence of increased susceptibility in a 2-generation reproduction study following pre- or postnatal exposure to isopyrazam. There is no evidence of neuropathology or abnormalities in the development of the fetal nervous system from the available toxicity studies conducted with isopyrazam. Clear NOAELs/LOAELs were established for the developmental effects seen in rats and rabbits as well as for the offspring effects seen in the 2-generation reproduction study and a dose-response relationship for the effects of concern is well characterized. The dose used for the acute dietary risk assessment (30 mg/kg/day), based on effects seen in the subchronic dog study, is protective of the developmental and offspring effects seen in rabbits at 200-400 mg/kg/day. Based on these considerations, there are no residual uncertainties for pre-and/or postnatal susceptibility.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings:

i. The toxicity database for isopyrazam is complete and adequate for assessing increased susceptibility under FQPA;

ii. There is no indication of increased susceptibility of fetuses to in utero and/or postnatal exposure in the developmental and reproductive toxicity studies in rats;

There is some evidence for increased susceptibility following pre- and or postnatal exposures based on effects seen in range finding developmental toxicity studies in rabbits. However, based on the discussion above, EPA has concluded that there are no residual uncertainties for pre-and/or postnatal susceptibility.

iii. The dietary risk assessment is based on parent plus metabolite residues in/on banana, and will not underestimate dietary exposure to isopyrazam. For the acute, chronic and cancer dietary analyses, tolerance level residues of parent plus metabolite and 100 PCT assumptions were used for all treated commodities. There are no residual uncertainties identified in the exposure databases.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate margin of exposure (MOE) exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to isopyrazam will occupy less than 1% of the aPAD for all populations.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isopyrazam from food will utilize less than 1% of the cPAD for all populations receiving the greatest exposure. There are no residential uses for isopyrazam.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isopyrazam is not registered in the U.S. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for isopyrazam.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isopyrazam is not registered in the U.S. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for isopyrazam.

5. Aggregate cancer risk for U.S. population. The Cancer Assessment Review Committee (CARC) classified isopyrazam as Likely to be Carcinogenic to Humans. This classification was based on the presence of thyroid follicular cell tumors in male rats, and liver and uterine tumors in female rats at doses that were adequate to evaluate the carcinogenic potential of isopyrazam. No treatment-related tumors were seen in mice. There is no mutagenic concern for isopyrazam.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to isopyrazam residues.

Adequate enforcement methodology (Method GRM006.01B) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for isopyrazam on banana.

Therefore, a tolerance is established for residues of isopyrazam, in or on banana at 0.05 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the national government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

A final rule designating critical habitat for the marbled murrelet was published in the Federal Register on May 24, 1996 (61 FR 26256), and is available under the “Supporting Documents” section for this docket in the Federal eRulemaking Portal: http://www.regulations.gov at Docket Number FWS-R1-ES-2008-0079. It is our intent to discuss only those topics directly relevant to the revised designation of critical habitat for the marbled murrelet in this final rule.

The marbled murrelet is a small seabird of the Alcidae family. The marbled murrelet's breeding range extends from Bristol Bay, Alaska, south to the Aleutian Archipelago; northeast to Cook Inlet, Kodiak Island, Kenai Peninsula, and Prince William Sound; south along the coast through the Alexander Archipelago of Alaska, British Columbia, Washington, and Oregon; to northern Monterey Bay in central California. Birds winter throughout the breeding range and occur in small numbers off southern California. Marbled murrelets spend most of their lives in the marine environment where they forage in near-shore areas and consume a diversity of prey species, including small fish and invertebrates. In their terrestrial environment, the presence of platforms (large branches or deformities) used for nesting in trees is the most important characteristic of their nesting habitat. Marbled murrelet habitat use during the breeding season is positively associated with the presence and abundance of mature and old-growth forests, large core areas of old-growth, low amounts of edge habitat, reduced habitat fragmentation, proximity to the marine environment, and forests that are increasing in stand age and height.

Two subspecies of the marbled murrelet were previously recognized, the North American murrelet ( Brachyramphus marmoratus marmoratus ) and the Asiatic murrelet ( B. marmoratus perdix ). New published information suggests that the Asiatic murrelet is a distinct species (Friesen et al. 1996, 2005), and the American Ornithologists' Union officially recognized the long-billed murrelet ( B. perdix ) and the marbled murrelet ( B. marmoratus ) as distinct species in the “Forty-first Supplement to the Checklist of North American Birds” (American Ornithologists' Union 1997). Therefore, in this rule we are revising 50 CFR 17.11 to adopt the taxonomic clarification for the marbled murrelet to reflect the change from Brachyramphus marmoratus marmoratus to Brachyramphus marmoratus.

For additional information on previous Federal actions concerning the marbled murrelet, refer to the final listing rule published in the Federal Register on October 1, 1992 (57 FR 45328), the final rule designating critical habitat published in the Federal Register on May 24, 1996 (61 FR 26256), and the proposed rule published in the Federal Register on July 31, 2008 (73 FR 44678). In the 1996 final critical habitat rule, we designated 3,887,800 ac (1,573,340 ha) of critical habitat in 32 units on Federal and non-Federal lands. On September 24, 1997, we completed a Recovery Plan for the marbled murrelet in Washington, Oregon, and California (Service 1997). On January 13, 2003, we entered into a settlement agreement with the American Forest Resource Council and the Western Council of Industrial Workers, whereby we agreed to review the marbled murrelet critical habitat designation and make any revisions deemed appropriate after a revised consideration of economic and any other relevant impacts of designation. On April 21, 2003, we published a notice initiating a 5-year review of the marbled murrelet (68 FR 19569), and published a second information request for the 5-year review on July 25, 2003 (68 FR 44093). The 5-year review evaluation report was finished in March 2004 (McShane et al. 2004), and the 5-year review was completed on August 31, 2004.

On September 12, 2006, we published a proposed revision to critical habitat for the marbled murrelet, which included adjustments to the original designation and proposed several exclusions under section 4(b)(2) of the Act (71 FR 53838). On June 26, 2007, we published a notice of availability of a draft economic analysis (72 FR 35025) related to the September 12, 2006, proposed critical habitat revision (71 FR 53838). On March 6, 2008, we published a notice in the Federal Register (73 FR 12067) stating that the critical habitat for marbled murrelet should not be revised due to uncertainties regarding Bureau of Land Management (BLM) revisions to its District Resource Management Plans in western Oregon, and this notice fulfilled our obligations under the settlement agreement.

On July 31, 2008, we published a proposed rule to revise currently designated critical habitat for the marbled murrelet by removing approximately 254,070 acres (ac) (102,820 hectares (ha)) in northern California and Oregon from the 1996 designation (73 FR 44678). A revised 5-year review was completed on June 12, 2009. On January 21, 2010, in response to a petition to delist the marbled murrelet, we published a notice in the Federal Register (75 FR 3424) determining that removing the murrelet from the Endangered Species List was not warranted. We also found that the Washington/Oregon/California population of the murrelet is a valid distinct population segment (DPS) in accordance with the discreteness and significance criteria in our 1996 DPS policy (61 FR 4722; February 7, 1996) and concluded that the species continues to meet the definition of a threatened species under the ESA.

We requested written comments from the public on the proposed revised designation of critical habitat for the marbled murrelet in a proposed rule published on July 31, 2008 (73 FR 44678). During the comment period, which closed on August 30, 2008, we received 42 comments from organizations or individuals directly addressing the proposed critical habitat designation. Through template campaigns sponsored by The Wildlife Society and Conservation Northwest, we received an additional 2,825 comments.

The comment period was reopened on February 11, 2009 (74 FR 6852), and closed on March 13, 2009, during which we received 14 comments, which included 4 peer reviewers, 1 Federal agency, and 9 organizations or individuals. Nearly all commenters opposed the revision or reduction of some aspects of the designation of critical habitat for the marbled murrelet.

Several comments we received were outside the scope of the proposed rule, which was limited to (1) The proposed removal of approximately 191,000 ac (77,295 ha) of critical habitat in northern California and southern Oregon based on the very low likelihood of marbled murrelet occurrence as is discussed in further detail below; (2) the proposed removal of approximately 63,000 ac (25,495 ha) of critical habitat in Douglas and Lane Counties, Oregon, that were designated farther than 35 miles inland, based on criteria identified in the 1997 Recovery Plan for the Marbled Murrelet (Washington, Oregon, and California Populations); and (3) the proposed taxonomic revision of the scientific name of the marbled murrelet. Examples of comments outside of the scope of the proposed rule included:

(a) Requests that we remove approximately 1,840 ac (744.6 ha) of existing critical habitat designated at Naval Radio Station Jim Creek in Washington pursuant to section 4(a)(3)(B)(i) of the Act;

(b) Requests that we designate additional critical habitat in certain areas ( e.g., southwestern Washington, northwestern Oregon, Olympic Adaptive Management Area, Siskiyou and Six Rivers National Forests, Redwood National Park, and other areas);

(c) Requests that we designate marine areas as critical habitat;

(d) Claims of inconsistency with statutory requirements ( e.g., occupancy at the time of listing, definition of occupied habitat, reliance on 1996 primary constituent elements (PCEs));

(e) Disagreement with the suitable marbled murrelet habitat acreage estimates in Oregon, Washington, and California;

(f) Recommendations to exclude critical habitat from all Federal lands including Wilderness areas and Congressionally withdrawn lands in general based on the conservation adequacy of existing management plans;

(g) Requests for the exclusion of Federal lands in northern California based on approved management plans;

(h) Requests that we eliminate overlapping protections for Wilderness Designations and Congressional Withdrawal areas in northern California; and

(i) Requests that we update land status records related to critical habitat boundaries.

These comments are beyond the scope of the proposed rule, and some would require separate rulemaking to be considered. Accordingly, we have not specifically responded to these comments in this final rule.

Comments within the scope of the proposed rule have been addressed in the following summary and have been incorporated into the final rule as appropriate. We did not receive any requests for a public hearing.

In accordance with our policy published in the Federal Register on July 1, 1994, (59 FR 34270), we solicited opinions from nine knowledgeable individuals with scientific expertise that included familiarity with the species, the geographic region in which the species occurs, and conservation biology principles. We received responses from four of the peer reviewers who were solicited. We reviewed all comments received from the peer reviewers for substantive issues and new information regarding murrelet critical habitat. We have addressed peer review comments in the following summary and have incorporated them into this final rule as appropriate.

Several comments refer to inland zone 1 and inland zone 2, which are based on the Forest Ecosystem Management Assessment Team (FEMAT) murrelet zone lines. For clarification, inland zone 1 extends 10-40 miles (mi) (16-64 kilometers (km)) inland from the marine environment, depending on the particular geographic area involved. The majority of murrelet occupied sites and sightings occur in this zone. Inland zone 2 includes areas further inland from the eastern boundary of inland zone 1, and is characterized by relatively low numbers of murrelet sightings, which is partially a function of few inventories. Specific distances for inland zone 2 vary by geographic area (Thomas et al. 1993 (FEMAT), pp. IV-23-24).

Comment 1: Each of the four peer reviewers concurred with the proposed reclassification of the marbled murrelet to full species status. They stated the reclassification of the marbled murrelet to full species status is supported by the literature, and that the American Ornithologists' Union (the authoritative source for taxonomy and nomenclature of birds in North America) recognizes the marbled murrelet as a distinct species.

Our Response: We agree and note there is no disagreement in the literature or by the experts on the reclassification of marbled murrelet to full species status. We are finalizing the taxonomic revision of the scientific name of the marbled murrelet from Brachyramphus marmoratus marmoratus to Brachyramphus marmoratus in this rule.

Comment 2: One reviewer stated that the surveys used to determine occupancy in the areas proposed for revision were conducted under earlier survey protocols requiring fewer visits than the currently recognized protocol (Mack et al. 2003, pp. 12-16). Accordingly, the results contain a level of uncertainty that, although not egregious, should be recognized before a final decision is made. In areas of low detections it is difficult for audio/visual surveys to detect single birds, whereas the current protocol may have detected additional murrelets.

Our Response: The 2003 Marbled Murrelet Inland Survey Protocol (Mack et al. 2003) recommends five survey visits in each of 2 years to determine occupancy with an 85.3 percent probability of detecting occupancy in a given year. The 2-year intensive survey protocol accounts for years where breeding effort is low, resulting in fewer or no detections in otherwise occupied stands (Mack et al. 2003, p. 13). The probability of detecting occupancy decreases from 85.3 percent to 79.2 percent in any given year when conducting one less site visit per year, which increases the level of uncertainty associated with the survey results by approximately 6.1 percent (Mack et al. 2003, p.13). The studies we relied on in the areas proposed for revision in California, Hunter et al. (1998) and Schmidt et al. (2000), reported on surveys conducted across large landscapes in northern California's inland zone 2, using the Ralph et al. (1994) murrelet survey protocol. This protocol recommended only four survey visits in each of 2 years to determine occupancy. We acknowledge the studies we relied on used a survey protocol requiring fewer visits than is the current standard. However, given the large combined number of surveys (2,218) conducted in these studies, the additional/associated project-level surveys that have occurred since with no detections, the absence of historical records of murrelet presence in inland zone 2 in California based on U.S. Forest Service (USFS) and BLM records, and the apparent climatic differences between inland zone 2 areas and the closest known occupied murrelet sites within inland zone 1, we conclude from the best available scientific information that there is a very low likelihood of murrelet occupancy within inland zone 2 in California.

In southern Oregon, Federal agencies undertook a comparable evaluation of the probability of marbled murrelet inland habitat use as forest types shift from the hemlock/tanoak vegetation zone to the mixed-conifer/evergreen vegetation zone (Alegria et al. 2002, pp. 1-44). This evaluation was based on survey results from the Medford District BLM, and the Siskiyou and Rogue River National Forests from 1988 to 2001 that documented the inland distribution of marbled murrelets to be strongly associated with the hemlock/tanoak habitat zone, which ranges from 13 to 37 mi (20.9 to 59.5 km) inland from the Pacific Ocean. The distribution of survey sites with murrelet presence or occupancy occur farther inland where the hemlock/tanoak zone extends farther inland, which suggests that forest type influences murrelet occurrence, rather than absolute distance from the coast (Alegria et al. 2002, p. 15).

For the purposes of the analysis, marbled murrelet survey areas were categorized as western hemlock-tanoak (the primary range of the marbled murrelet), a 6.5-mile transition zone east of the primary range, and the far inland zones. The statistical modeling evaluated the hypothesis that marbled murrelets would be present on no more than 3 percent (95 percent confidence) of the habitat in the far inland zones. The final analyses concluded, with 95 percent confidence, that an even smaller proportion (1.2 percent) of the landscape may have murrelet presence that was not actually detected. The analysis of 9,795 survey visits suggests that murrelets are not present in more than 98 percent of the sampled units in the far inland zones (Alegria et al., 2002, pp. 13-15). Only one distant auditory detection in 4,634 survey visits occurred within the area more than 6.5 mi (10.4 km) inland of the hemlock/tanoak vegetation type (Alegria et al., 2002, p. 16). Accordingly, our interpretation of the most recent data supports a determination that, in southern Oregon, murrelet use is strongly associated with tanoak/hemlock forest, rather than a 35 miles (56 kilometers) distance from the Pacific Ocean. The 35-mile (56-km) distance identified in the 1997 Marbled Murrelet Recovery Plan was based on the best available information before the Service at that time. Therefore, based on the best available scientific information, we conclude that there is a very low likelihood of murrelet occurrence in the area we are removing from critical habitat designation in southern Oregon, and, accordingly, impacts to the species in this area would be negligible.

Comment 3: One reviewer asked if radar studies were conducted and if so, suggested that we document the results.

Our Response: We are unaware of any ornithological radar surveys conducted in or near the areas proposed for revision in Oregon. In California, Schmidt et al. (2000), used ornithological radar instruments to survey for murrelets at three sites beyond their study area where murrelets had been previously detected far inland. These sites include Onion Mountain and Notice Creek within the eastern portion of inland zone 1, and Indian Creek within inland zone 2. However, murrelets were detected only at the Notice Creek site using this method. Previous audio-visual detections at Indian Creek have not been validated using either audio-visual surveys or ornithological radar. Cooper and Blaha (2005, 2006) used ornithological radar to survey five sites along Pine Creek on the western boundary of the Hoopa Valley Indian Reservation in California (inland zone 1), to confirm murrelet presence that had been documented in previous audio-visual surveys. Marbled murrelets were detected at two of the sites, approximately 7 miles west of the inland zone 2 boundary. Although the number of ornithological radar surveys in California in or near inland zone 2 is limited, the available data are consistent with the results of other surveys. Those surveys failed to detect murrelet presence within inland zone 2 or the easternmost portion of inland zone 1.

Comment 4: Two of the four reviewers who commented on the proposed removal of critical habitat in Douglas and Lane Counties in Oregon considered the rationale behind the revisions to be unsupported by the literature or information presented in the proposed rule. One reviewer suggested that a more thorough analysis of existing surveys be conducted before revising the inland boundary of critical habitat in these areas. Another reviewer requested more documentation that a majority of occupied sites occur within inland zone 1, and recommended that the critical habitat designation in Douglas and Lane Counties in Oregon not be revised until all of the existing data are thoroughly analyzed and additional systematic surveys have been conducted.

Our Response: Based on peer review and public comments, we have concluded that the proposed revision of critical habitat in Douglas and Lane Counties, Oregon, is not adequately supported by the literature and that currently available scientific information is inadequate to support a revision of critical habitat in this area. Accordingly, critical habitat in Lane and Douglas Counties, Oregon, remains designated as critical habitat, based on the best available scientific information.

Comment 5: One peer reviewer questioned whether the areas proposed for removal are within or outside of the currently occupied area, and stated that the failure to detect murrelets does not mean that they do not use an area, given the difficulty of surveying this secretive species.

Our Response: See response to peer reviewer Comment 2. Based on the detailed statistical analysis of the survey data, and the similarity of the areas not surveyed to the areas surveyed immediately to the north and south, there is low likelihood that murrelets occupy the areas proposed for removal from critical habitat designation in southern Oregon and northern California.

Comment 6: One reviewer pointed out that the habitat proposed for removal from critical habitat designation may act as a buffer of sorts for currently occupied habitat, particularly where it abuts the eastern edge of obviously occupied habitat. Increases in timber harvest or recreation in these areas would potentially bring edge effects (especially increased numbers of nest predators) closer to occupied habitat, and may reduce the suitability of the currently occupied habitat. The reviewer stated that maintenance of a buffer is essential to the conservation of murrelets in currently occupied habitat.

Our Response: In northern California, critical habitat remains designated over an area that ranges from 15 mi (24 km) to 20 mi (32 km) wide, between the west side of inland zone 1 within the redwood vegetation type (which contains more than 95 percent of the known occupied murrelet sites), and the revised eastern boundary of inland zone 1 within the Douglas-fir/tanoak vegetation type. In southern Oregon, critical habitat remains designated within a 6.5-mi-wide (10.5-km-wide) area between large amounts of known occupied murrelet habitat within the hemlock/tanoak vegetation type west of inland zone 1, and the break in vegetation to the mixed-conifer/evergreen vegetation type to the east. On a large landscape scale, these areas are generally managed to protect the PCEs of murrelet critical habitat (see Primary Constituent Elements below), although they have not been intensively surveyed. As a result, there is a significant distance between the eastern-most known occupied murrelet sites and the areas being removed from critical habitat designation in northern California and southern Oregon. These areas, while not “buffers,” may help maintain the suitability of known nesting habitat by decreasing the potential for indirect impacts related to timber harvest activities or increased predation.

Comment 7: One reviewer stated that it is essential to conserve a wide range of habitat to increase the chances that a species will be able to adapt to dynamic changes in the habitat. In his view, the areas proposed for removal from critical habitat represent small and large habitat remnants that may provide future refuges from warm temperatures, violent coastal storms, disease, invasive competitive species or predators, or extensive fire. He stated that both large and small fragments of mature, structurally complex forest located away from human activity may provide useful nesting habitat that is essential to conservation.

Our Response: On May 24, 1996, we designated 3,887,800 ac (1,573.340 ha) of critical habitat on Federal and non-Federal lands in Washington, Oregon, and California (61 FR 26256). While this revision will remove approximately 189,671 acres (76,760 ha) from the designation in Oregon and California, it only affects areas that are not essential to the conservation of the species based on the best scientific information available (see response to peer review comment 2). Accordingly, we do not believe the areas that are being removed would provide future nesting habitat, refuges from warm temperatures, violent coastal storms, disease, invasive competitive species or predators, or extensive fire, since these areas are not likely to be used by murrelets. The remaining critical habitat designation encompasses a wide range of habitat distributed throughout the range of the marbled murrelet from the Canadian border through California, and inland from the coast, which represents large and small fragments of mature, structurally complex forest that are located away from human disturbance.

Comment 8: One reviewer noted that, if critical habitat designation is removed, it is likely the areas affected will be harvested for timber or receive greater recreational use, either of which will reduce the suitability as nesting habitat. Another reviewer commented that there is a strong correlation between murrelet population size and the amount of nesting habitat adjacent to the birds, and there is reason to believe that further loss of adjacent habitat could result in population decline.

Our Response: The critical habitat areas being removed in southern Oregon and northern California are outside of known nesting habitat, not likely to be occupied by murrelets, and not essential to the conservation of the species (see response to Peer Review Comment 2 ).

Comment 9: One reviewer commented that there appeared to be little reason to revise the critical habitat designation, which in the reviewer's view would limit the conservation options for murrelets. The reviewer noted that the proposal did not articulate any economic or security issues, and suggested that, in uncertain times, it is prudent to be conservative and “hedge your bets when the consequences of loss are high, especially when the costs are low.”

Our Response: We disagree that future conservation options will be limited by this revision. Marbled murrelets remain protected as a listed species wherever they occur, regardless of a critical habitat designation. Federal agencies have an independent responsibility under section 7(a)(1) of the Act to use their authorities to carry out programs for the conservation of endangered and threatened species, and a requirement under section 7(a)(2) of the Act to ensure that their actions do not jeopardize listed species. The take of listed species is prohibited by section 9 of the Act without a permit under sections 10(a)(1)(A) or 10(a)(1)(B) of the Act, or an incidental take statement under section 7(b)(4)(C) of the Act.

The Marbled Murrelet Recovery Plan states that recovery actions in southern Oregon and northern California should be focused on preventing the loss of occupied nesting habitat, minimizing the loss of unoccupied but suitable habitat, and decreasing the time for development of new suitable habitat (Service 1997, p. 128). Recovery task 4.1.4 in the Recovery Plan states: (1) A definition of suitable marbled murrelet habitat should be developed for each Conservation Zone to better determine and map appropriate areas for murrelet recovery; (2) the components of suitable marbled murrelet habitat are generally known but a description of suitable marbled murrelet habitat for each zone is lacking; and (3) once definitions are developed, mapping marbled murrelet habitat can be accomplished with greater accuracy (Service 1997, p. 149). Recovery task 4.1.6 states that intensive surveys should be conducted to identify nesting areas and delineate the inland boundary of nesting habitat (Service 1997, p. 150).

Intensive surveys to determine murrelet presence in southern Oregon indicate that the inland distribution of marbled murrelets is strongly associated with the hemlock/tanoak habitat zone, and not the distance from the coast. This is probably due to the maritime climate that provides milder, wetter conditions that favor development of larger trees and more abundant moss cover. The hemlock/tanoak zone transitions relatively rapidly to the mixed-conifer/mixed-evergreen zone that has hotter, drier climate. This rapid transition to less favorable conditions for murrelets may explain why they aren't detected beyond the hemlock/tanoak vegetation zone (Alegria et al., 2002, pp. 15-16).

There are no historical or current survey records documenting murrelet presence in inland zone 2 in California (Hunter et al., 1998; Schmidt et al., 2000). Studies conducted by Hunter et al. (1997, p. 20), indicate that the northern Inner North Coast Ranges of California are not within the current range of the marbled murrelet, which could be influenced by several factors, including habitat structure, elevation, predator abundance, distance inland, and climatic conditions. Daily maximum summer temperatures were significantly higher within the zone 2 study area than at inland sites documented with murrelets closer to the coast (Hunter et al., 1998); summer temperature is often inversely correlated with humidity and cloud cover (Anthes et al., 1975); in California, the vast majority of murrelet records are from redwood-dominated stands (E. Burkett, pers. com); and the historical inland extent of redwood forests in California closely matches the inland extent of marine air influences and summer fog (Major 1977) (in Schmidt et al., 2000, pp. 21-22). This evidence, combined with the distance from the closest known occupied murrelet sites within inland zone 1 (9 mi (14 km) west and 15 mi (25 km) west; Schmidt et al. 2000, p. 11; Hunter et al., 1997, p. 7) indicates a very low likelihood of murrelet occupancy within inland zone 2 in California. Accordingly, the areas designated as critical habitat in 1996 in southern Oregon that are not within the hemlock/tanoak habitat zone, and the areas within inland zone 2 in California, are not considered suitable habitat for marbled murrelet recovery.

The biological criteria used to identify critical habitat in the final rule (61 FR 26265; May 24, 1996) include suitable nesting habitat, survey data, proximity to marine foraging habitat, large contiguous blocks of nesting habitat, and rangewide distribution. Based on the best available information, there is no biological rationale to support retaining marbled murrelet critical habitat in areas that are neither presently used ( i.e., unoccupied), nor likely to be used in the future by the species ( i.e., unsuitable). Consequently, we believe the removal of critical habitat from areas that are not essential to the conservation of the species in southern Oregon and northern California is appropriate. Removing critical habitat from these areas will allow Federal agencies to focus their conservation efforts on the areas that currently provide murrelet habitat and have a greater likelihood of providing habitat into the future. The designation of critical habitat in Douglas and Lane Counties in Oregon is not affected by this revision, and these lands will continue to provide a conservation benefit to the species.

Comment 10: Commenters stated the murrelet recovery plan identifies the Northwest Forest Plan (NWFP) reserves as the backbone of the recovery effort, but Late-Successional Reserves (LSRs) are administrative designations that can be removed. In addition, the Evaluation Report for the 5-Year Status Review for the Marbled Murrelet (McShane et al., 2004; p 4-76) indicates there are problems with placing too much reliance on the NWFP. Commenters also stated that if the NWFP remains in effect and is not altered substantially from its current form, the projected acreage of USFS and BLM lands in the Pacific Northwest that support stands older than 200 years (200 years defines the lower limit of old-growth forest) is expected to increase substantially by the year 2050. They also commented that the Recovery Plan for the Marbled Murrelet states “it will take 50 to 100 years or more to develop new suitable nesting habitat within most reserve areas,” however, the NWFP is being dismantled before it has had a chance to succeed. Other commenters stated that the LSRs need critical habitat designation to ensure they are managed for long-term recovery of the species.

Our Response: Based on the best available scientific information related to survey data, there is a very low likelihood that murrelets occupy the areas being removed from critical habitat designation in southern Oregon and northern California (see responses under Peer Reviewer Comments above). The areas being removed are no longer considered suitable habitat. Accordingly, these areas are not essential to the conservation of the species, and murrelet recovery would not be affected by the management of these specific areas. This revision of critical habitat will help Federal agencies focus their conservation efforts on the areas that currently provide habitat for murrelets, and areas that have a greater likelihood of providing habitat into the future. Based on the best available scientific information, the areas that were designated as critical habitat in Lane and Douglas Counties, Oregon, in 1996 have been determined to contain the physical or biological features essential to the conservation of the species and are not being revised.

Comment 11: One commenter stated that the Service must present a balanced economic analysis, including benefits of old-growth habitat conservation and restoration, and that an economic analysis must be prepared if BLM lands are designated in order to address consequences to communities and counties.

Our Response: Section 4(b)(2) of the Act requires that the Service consider economic impacts when “specifying any particular area as critical habitat.” Characterizing the potential economic benefits of critical habitat designation can provide context to the potential economic cost estimates, where that information is available. However, since this final rule removes critical habitat that was previously “specified,” and we are not removing these areas under Section 4(b)(2) on economic grounds, we have determined that a new economic analysis is not required.

Comment 12: Some commenters stated that the proposal to revise critical habitat should be withdrawn and replaced with a delisting proposal, and the Service should not designate critical habitat for a species that no longer warrants ESA protection.

Our Response: We disagree. The marbled murrelet DPS in Washington, Oregon, and California continues to warrant protection under the Act, for the reasons described in the 12-month Finding on a Petition to Remove the Marbled Murrelet from the List of Endangered and Threatened Wildlife, published in the Federal Register on January 21, 2010 (75 FR 3424). That finding determined that the DPS continues to meet the definition of a threatened species based on the species' population size and trajectory, in light of the scope and magnitude of existing threats.

Comment 13: Commenters stated there is no need to modify critical habitat in areas that are currently designated as LSRs, and there is little or no incremental cost to conserve marbled murrelet critical habitat in LSRs and riparian reserves, because these areas are already established for the purpose of conserving late successional wildlife.

Our Response: Section 3(5)(A) of the Act defines critical habitat as (1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with section 4 of this Act, on which are found those physical or biological features (a) Essential to the conservation of the species, and (b) which may require special management considerations or protection; and (2) specific areas outside the geographical area occupied by the species at the time it is listed in accordance with the provisions of section 4 of the Act, upon a determination that such areas are essential for the conservation of the species. The survey data for southern Oregon and northern California, along with the quality and quantity of habitat in this area, indicate there is a very low likelihood that murrelets occupy the LSRs or the other areas being removed from the 1996 critical habitat designation, and are unlikely to occupy these areas in the future (see responses under Peer Reviewer Comments ). Accordingly, based on the best available scientific information, we have determined that these areas are not essential to the conservation of the species; therefore, requiring Federal agencies to enter into section 7 consultation with the Service on effects to critical habitat in these areas would be inconsistent with the Act. However, critical habitat in Lane and Douglas Counties, Oregon, will remain as designated in 1996, since those areas are occupied and essential to the conservation of the species.

Comment 14: The BLM suggested (a) Adding language to the final rule that clearly articulates that the PCEs must be present on the lands within the mapped critical habitat units for the area to meet the statutory definition of critical habitat; (b) that the final rule clarify that activities proposed to occur on lands that do not contain PCEs within the mapped critical habitat units will not be subject to a destruction or adverse modification determination because such lands, by definition, are not critical habitat; and that (c) the proposed rule provide better guidance in regard to the functionality of forest stands in support of a critical habitat designation, particularly as related to the issue of fragmentation. BLM also expressed a concern that outdated land status information was used to prepare the proposed rule in northern California. They indicated that this is problematic in two key areas: Lacks Creek west of and adjacent to the Hoopa Reservation; and Gilman Butte east of the King Range National Conservation Area and south of Humboldt Redwoods State Park. The BLM also requested that we remove critical habitat from all areas not in the western hemlock/tanoak vegetation on the Grants Pass and Glendale Resource Areas of the Medford District. The agency commented that this area lacks murrelet recovery habitat, and historical observations and recent protocol surveys have not documented murrelet occupancy. The areas described include the southeasternmost 2 square miles of CHU OR-07-g, and the northeasternmost 24 square miles of CHU OR-07-f.

Our Response: (a) Areas outside of the geographical area occupied by a species at the time it is listed under the Act ( i.e., unoccupied habitat) can be designated as critical habitat if the areas are essential to the conservation of the species; unoccupied areas considered essential may not necessarily contain the PCEs of physical or biological features. However, for the marbled murrelet, each of the areas designated as critical habitat is within the geographical area occupied by the species at the time it was listed under the Act, and contains those physical or biological features essential to the conservation of the species, which may require special management considerations or protection. Accordingly, each of the areas delineated and mapped in this final rule meet the definition of critical habitat.

(b) The marbled murrelet PCEs include individual trees with potential nest platforms and forest lands of at least one half site-potential tree height regardless of contiguity, within 0.8 km (0.5 mi) of individual trees with potential nesting platforms and that are used or potentially used by the marbled murrelet for nesting or breeding. Activities that occur within or adjacent to lands designated as critical habitat may still have an effect on PCEs, depending on the particular aspects of the Federal action involved. The preamble to the 1996 final critical habitat rule (61 FR 26265; May 24, 1996), states that “within the boundaries of designated critical habitat, only those areas that contain one or more primary constituent elements are, by definition, critical habitat. Areas without any primary constituent elements are excluded by definition.” However, this language is not in the final critical habitat rule itself and is no longer accurate. The potential effects of Federal actions that may affect any area within the boundaries of designated critical habitat will need to be evaluated on a project-specific basis during the section 7(a)(2) consultation process.

(c) The removal, modification, or fragmentation of forested areas can directly impact nesting structures, nesting substrate, and the vertical and horizontal cover provided by the surrounding forest. Fragmentation of forested areas can result in habitat isolation and increased edge, which can negatively impact the quality of the remaining nesting habitat primarily through increased predation, modification of the microclimate, and potential windthrow of nest trees. Examples of Federal actions that may affect marbled murrelet nesting habitat include timber harvest, salvage logging, hazard tree removal, road construction, recreational or other developments, fuels reduction projects, and indirect harvest-related effects such as windthrow. The key factor related to an adverse modification determination is whether, with implementation of a proposed Federal action, the affected critical habitat would continue to serve its intended conservation role for the species, or retain those physical or biological features that relate to the ability of the area to periodically support the species. The role of critical habitat is to support the life-history needs of the species and provide for conservation. Activities that may destroy or adversely modify critical habitat are those that would alter the physical or biological features to an extent that appreciably reduces the conservation value of critical habitat for the marbled murrelet.

The areas referred to by BLM within CHU OR-07-g and CHU OR-07-f occur within the 6.5-mile area designed to support murrelets that might use the area between the western hemlock/tanoak and mixed-conifer/evergreen vegetation zones. These areas were not considered for removal because of their proximity to occupied habitat (see response to Comment 6 under Peer Reviewer Comments ).

We did not receive any comments from any State in response to the proposed rule.

In preparing this final rule, we reviewed and fully considered comments from the public and peer reviewers that we received in response to the proposed rule published in the Federal Register on July 31, 2008 (73 FR 44678).

Based on the comments received, we have determined that the proposed removal of 63,000 ac (25,495 ha) of critical habitat designated in Douglas and Lane Counties in Oregon is not supported by the best available scientific information and would not be appropriate. Based on the best available scientific information, these areas contain the physical or biological features essential to the conservation of the species, and will continue to be designated as critical habitat. Therefore, we have removed instructions to remove the following critical habitat units from this final rule: OR-03-c, OR-03-e, OR-04-f, OR-04-g, OR-04-i, OR-04-j, and OR-06-d.

Systematic surveys such as those conducted by Hunter et al. (1998), Schmidt et al. (2000), and Alegria et al. (2002) were not conducted in a relatively small area (approximately 71,000 ac) in northern California located between the Klamath River and the Oregon border, and between the much larger areas surveyed by Hunter et al. (1998), Schmidt et al. (2000), and Alegria et al. (2002). However, based on the similarity of mixed-conifer habitat surveyed to the north and south, the lack of detections from the areas immediately north and south, and the lack of historical detections, we believe there is a very low likelihood that murrelets occur within inland zone 2 and the far eastern portions of inland zone 1 located between the Klamath River and the Oregon border in northern California. In light of what the current data indicate regarding the forest types that murrelets use for nesting (see response to Comment 9), we conclude that it is unlikely that murrelets will occupy these areas in the future. Accordingly, we have revised the critical habitat boundary in this area.

The critical habitat revision in southern Oregon and northern California is appropriate, based on the best available scientific information, which indicates the likely distribution of nesting birds is not as far inland as was delineated in 1996. We have no historical or current survey records documenting murrelet presence in the areas being removed in northern California, and the best available information indicates the inland range of the murrelet from the Pacific Ocean is delimited by the hemlock/tanoak habitat zone, rather than specific distance from the coast. Accordingly, we are revising the designation of critical habitat for the marbled murrelet from the 1996 critical habitat designation (61 FR 26254; May 24, 1996) to reflect the removal of approximately 189,700 ac (76,700 ha) of area from critical habitat designation in 8 units in southern Oregon and northern California. The critical habitat units affected by the revision are depicted in Table 1 and Table 2. The remaining critical habitat units that were designated in the May 24, 1996, final rule are not affected by this revision. Approximately 3,698,100 ac (1,497,000 ha) of critical habitat is now designated for the marbled murrelet.

Critical habitat is defined in section 3 of the Act as:

(1) The specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features

(a) Essential to the conservation of the species, and

(b) Which may require special management considerations or protection; and

(2) Specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.

Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot otherwise be relieved, may include regulated taking.

Critical habitat receives protection under section 7 of the Act through the requirement that Federal agencies ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Where a landowner seeks or requests Federal agency funding or authorization for an action that may affect a listed species or critical habitat, the consultation requirements of section 7(a)(2) of the Act would apply, but even in the event of a destruction or adverse modification finding, the obligation of the Federal action agency and landowner is not to restore or recover the species, but to implement reasonable and prudent alternatives to avoid destruction or adverse modification of critical habitat.

For inclusion in a critical habitat designation, habitat within the geographical area occupied by the species at the time of listing must contain the physical or biological features which are essential to the conservation of the species and which may require special management considerations or protection. Critical habitat designations identify, to the extent known using the best scientific and commercial data available, those physical or biological features that are essential to the conservation of the species (such as space, food, cover, and protected habitat), focusing on the principal biological or physical constituent elements (primary constituent elements, or PCEs) within an area that are essential to the conservation of the species (such as roost sites, nesting grounds, seasonal wetlands, water quality, tide, soil type). PCEs are the elements of physical and biological features that, when laid out in the appropriate quantity and spatial arrangement to provide for a species' life-history processes, are essential for the conservation of the species.

Under the Act, we can designate critical habitat in areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. We designate critical habitat in areas outside the geographical area occupied by a species only when a designation limited to its range would be inadequate to ensure the conservation of the species. When the best available scientific data do not demonstrate that the conservation needs of the species require such additional areas, we will not designate critical habitat in areas outside the geographical area occupied by the species. An area currently occupied by the species but that was not occupied at the time of listing may, however, be essential to the conservation of the species and may be included in the critical habitat designation.

Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific and commercial data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the Federal Register on July 1, 1994 (59 FR 34271)), the Information Quality Act (section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658)), and our associated Information Quality Guidelines provide criteria, establish procedures, and provide guidance to ensure that our decisions are based on the best scientific data available. They require our biologists, to the extent consistent with the Act and with the use of the best scientific and commercial data available, to use primary and original sources of information as the basis for recommendations to designate critical habitat.

When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information developed during the listing process for the species. Additional information sources may include the recovery plan for the species, articles in peer-reviewed journals, conservation plans developed by States and counties, scientific status surveys and studies, biological assessments, or other unpublished materials and expert opinion or personal knowledge. Substantive comments received in response to proposed critical habitat designations are also considered. A five-year review summarizing the biological, ecological, and population information on the marbled murrelet was completed on June 12, 2009 (Service 2009). That report also evaluated current threats and how they may have changed since the species was listed. This information was considered in the completion of this revised designation, as was information from the 12-month Finding on a Petition to Remove the Marbled Murrelet from the List of Endangered and Threatened Wildlife (75 FR 3424; January 21, 2010). We also reviewed the scientific data and other information used to finalize the 1996 critical habitat designation, which included research published in peer-reviewed articles, agency reports, unpublished data, and various Geographic Information System (GIS) data layers ( e.g., land cover type information, land ownership information, topographic information). We reviewed the conservation needs of the marbled murrelet described in the recovery plan (Service 1997), and considered new scientific information and data available from State, Federal, and tribal agencies, as well as academia and private organizations.

Habitat is dynamic, and species may move from one area to another over time. Furthermore, we recognize that designation of critical habitat at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not promote the recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will continue to be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act, (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species, and (3) the prohibitions of section 9 of the Act if actions occurring in these areas may affect the species. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans (HCPs), or other species conservation planning efforts if new information available at the time of these planning efforts calls for a different outcome.

In accordance with section 3(5)(A)(i) and 4(b)(1)(A) of the Act and regulations at 50 CFR 424.12, in determining which areas within the geographical area occupied at the time of listing to designate as critical habitat, we consider those physical or biological features essential to the conservation of the species and which may require special management considerations or protection. These include, but are not limited to:

(1) Space for individual and population growth and for normal behavior;

(2) Food, water, air, light, minerals, or other nutritional or physiological requirements;

(3) Cover or shelter;

(4) Sites for breeding, reproduction, or rearing (or development) of offspring; and

(5) Habitats that are protected from disturbance or are representative of the historical, geographical, and ecological distributions of a species.

We derive the specific elements of physical or biological features required for the marbled murrelet from its biological needs as described in the “Background” section of the final rule designating critical habitat for the marbled murrelet. The PCEs identified in the May 24, 1996, final critical habitat designation (61 FR 26254) have not been revised and remain applicable to this final revision of critical habitat for the marbled murrelet.

The criteria used to identify critical habitat areas described in the May 24, 1996, Federal Register remain applicable to this final revision of critical habitat for the marbled murrelet. These include suitable nesting habitat, information on presence/absence and occupancy, proximity to marine foraging habitat, large contiguous blocks of nesting habitat, rangewide distribution, and adequacy of existing protection and management (61 FR 26265).

In our 1996 designation of marbled murrelet critical habitat, we considered several factors in determining whether particular units met the definition of critical habitat, including available survey data, the proximity to marine foraging habitat, and the presence of large contiguous blocks of suitable nesting habitat. The physical or biological features associated with marbled murrelet critical habitat focused on individual trees with potential nesting platforms, and forested areas within 0.8 kilometers (0.5 miles) of individual trees with potential nesting platforms that had a canopy height of at least one-half the site potential tree height (SPTH) (the average maximum height for trees given local growing conditions). We determined that these features were essential because they provided suitable nesting habitat for successful reproduction. On a landscape basis, we believed that forests with canopy height of at least one-half the SPTH were more likely to be occupied, and hence were more likely to contribute to the conservation of the marbled murrelet (61 FR 26264; May 24, 1996).

For the 1996 critical habitat designation, we used survey results (including those showing the lack of detections) as indicators of the presence or absence of marbled murrelets in specific areas. However, survey efforts were minimal in many areas, coverage of areas surveyed was discontinuous, and information was of limited use in designating critical habitat in some portions of the range (61 FR 26274; May 24, 1996). The original delineation of zone 2 was based on relatively few far-inland marbled murrelet records, and considered the lack of comprehensive inland surveys throughout its range. Because of this paucity of survey data, the actual inland range and distribution of this species were unknown (Hunter et al. 1998, p. 93). We stated in the 1996 final rule that we would continue to monitor and collect new information, and may revise the critical habitat designation in the future if new information supports a change (61 FR 26272; May 24, 1996).

We have reassessed the 1996 critical habitat designation in southern Oregon and northern California, after considering the results of extensive surveys in these areas. Although the best available information in 1996 indicated a high probability of occupancy after applying the critical habitat methodology, new information collected from site-specific surveys has since confirmed that marbled murrelets do not use these areas. Recovery task 4.1.4 in the 1997 Marbled Murrelet Recovery Plan recommends that a definition of suitable marbled murrelet habitat be developed for each conservation zone to determine and map appropriate areas for marbled murrelet recovery with greater accuracy (Service 1997, p. 149), and task 4.1.6 recommends intensive surveys to identify nesting areas and delineate the inland boundary of murrelet nesting habitat (Service 1997, p. 150). Intensive surveys that have been conducted since 1997 have given us a more comprehensive understanding of the species biological needs, and the specific areas that are essential for the recovery of the species. Those are the areas that should be the focus of collective recovery efforts, rather than areas that may experience infrequent or occasional use at low levels.

Accordingly, we have determined that the areas being removed are not essential to the conservation of the species and do not meet the definition of critical habitat. Zone 2 includes areas from 35 mi (56.3 km) to 50 mi (80.5 km) from marine environments, depending on geographic location (Thomas 1993 (FEMAT), p. IV-24). In zone 2 in northern California and southern Oregon, 189,671 ac (76,757 ha) are being removed where extensive surveys have demonstrated marbled murrelets are very unlikely to be found (Hunter et al. 1997, pp. 16-25; Schmidt et al. 2000, pp. 16-22). Both of these studies acknowledge that it is possible that marbled murrelets may occasionally use some portion of the study areas; however, if the species does occur, the number of individuals is probably very low. Accordingly, the habitat in these areas does not contain elements of the physical or biological features in an appropriate quantity and spatial arrangement that are essential for the conservation of the species.

We are, therefore, revising the 1996 final designation of critical habitat for the marbled murrelet to reflect the removal of three critical habitat units (CA-10-a, CA-11-c, and CA-11-d) and the revision of five critical habitat units (CA-01-d, CA-01-e, CA-11-b, OR-07-d, and OR-07-f) in northern California and southern Oregon. No other critical habitat units designated in the May 24, 1996, final rule are affected by this revision. Each of the designated areas are within the geographical area occupied by the species at the time of listing, contain the physical or biological features essential to the conservation of the species, and may require special management considerations or protection.

The critical habitat areas described below reflect the best available scientific information regarding areas that no longer meet the definition of critical habitat for the marbled murrelet in Zone 2, because they are not essential to the conservation of the species.