Background

The regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-54, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States.

The national plant protection organization (NPPO) of Australia has requested that the Animal and Plant Health Inspection Service (APHIS) amend the regulations to allow fresh litchi fruit ( Litchi chinensis Sonn.) from Australia to be imported into the continental United States. As part of our evaluation of Australia's request, we prepared a pest risk assessment (PRA) and a risk management document. Copies of the PRA and risk management document may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT or viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room).

As part of our evaluation of that request, we prepared a PRA titled “Importation of Fresh Litchi, Litchi chinensis Sonn. Fruit from Australia into the Continental United States” (November 2008). That PRA evaluates the risks associated with the importation of litchi fruit with up to 5 millimeters of stem into the continental United States from Australia. The threshold allowing for a maximum of 5 millimeters of stem on the imported litchi fruit was included in Australia's request and therefore established as the allowable limit in the PRA.

The PRA identified 15 pests of quarantine significance present in Australia that could be introduced into the United States through the importation of litchi fruit, including 3 fruit flies, 7 lepidopteran pests, 2 scales, 2 insect pests, and 1 mite.

Jarvis's fruit fly ( Bactrocera jarvisi ).

Queensland fruit fly ( Bactrocera tryoni ).

Mediterranean fruit fly ( Ceratitis capitata ).

Yellow peach moth ( Conogethes punctiferalis ).

Litchi fruit moth ( Cryptophlebia ombrodelta ).

Orange fruit borer ( Isotenes miserana ).

The moth Cateremna quadriguttella.

Bright cornelian ( Deudorix diovis ).

Dull cornelian ( Deudorix epijarbas dido ).

Flower caterpillar ( Phycita leucomilta ).

Red wax scale ( Ceroplastes rubens ).

Green scale ( Coccus viridis ).

Spherical mealybug ( Nipaecoccus viridis ).

Passionvine mealybug ( Planococcus minor ).

Litchi hairy mite ( Aceria litchii ).

Based on the risk management document, APHIS has determined that measures beyond the standard port of arrival inspection are required to mitigate the risks posed by these plant pests. Therefore, we are proposing to allow the importation of litchi from Australia into the United States only if they are produced in accordance with a systems approach to mitigate pest risk as outlined below. We are proposing to add the systems approach to the regulations in a new § 319.56-55 governing the importation of litchi from Australia.

Paragraph (a) of proposed § 319.56-55 would require that litchi fruit be grown in approved places of production that are registered with and monitored by the NPPO of Australia.

Paragraph (b) of proposed § 319.56-55 would require that litchi fruit be treated with a minimum absorbed irradiation dose of 400 gray in accordance with the provisions of § 305.9 and the PPQ Treatment Manual (table 3-8-1). This is the established generic dose for all insect pests except pupae and adults of the order Lepidoptera. Seven of the insect pests of concern, yellow peach moth, litchi fruit moth, orange fruit borer, the moth Cateremna quadriguttella, bright cornelian, dull cornelian, and flower caterpillar, belong to the order Lepidoptera, and the 400 gray dose is not approved to treat pupae and adults of the order Lepidoptera. However, the life stages of concern for these pests are the eggs and the larvae, because the eggs and the larvae of these species are internal feeders and thus difficult to detect through inspection; the 400 gray dose is approved to treat those stages of the life cycle for Lepidoptera pests. The pupae and adults of these species are external feeders, and we are confident that inspection can detect them. Within part 305, § 305.9 contains a number of other requirements for irradiation treatment, including monitoring by APHIS inspectors and safeguarding of the fruit. Treatment could be conducted at an approved facility in Australia or in the United States.

Paragraph (c) would require that each shipment of fruit be accompanied by a phytosanitary certificate issued by the NPPO of Australia containing an additional declaration stating that the conditions for importation have been met.

The required irradiation treatment would not mitigate the risks posed by the litchi hairy mite ( Aceria litchii ), and because of the mite's microscopic size, inspection alone is not considered sufficient to mitigate the risk of introduction into the United States. Based on the distribution and reported host range of this pest, we estimate it could establish in the continental United States in USDA Plant Hardiness Zones 9 through 11. Neither of its two hosts, longan or litchi, occur naturally in the United States; however, both litchis and longans are commercially grown in the State of Florida and the climatic conditions in Florida present the highest risk for establishment of the pest. For this reason, our regulations generally prohibit the movement of litchi into Florida from areas where the litchi hairy mite is present. Litchi from China, India, and Thailand that are imported under § 319.56-13 and § 319.56-47, respectively, are also not allowed to be imported or distributed in Florida.

Because the litchi hairy mite is not present in Florida and because we have consistently prohibited host movement into Florida from areas where that pest is present, we propose to prohibit the importation and distribution of litchi from Australia into the State of Florida. Accordingly, paragraph § 319.56-55 (d) would stipulate that all cartons of litchi would have to be stamped “Not for importation into or distribution in FL.”

Paragraph (e) would state that only commercial consignments of litchi fruit would be allowed to be imported. Produce grown commercially is less likely to be infested with plant pests than noncommercial shipments. Noncommercial shipments are more prone to infestations because the commodity is often ripe to overripe, could be of a variety with unknown susceptibility to pests, and is often grown with little or no pest control. Commercial shipments, as defined in § 319.56-1, are shipments of fruits and vegetables that an inspector identifies as having been produced for sale and distribution in mass markets. Identification of a particular shipment as commercial is based on a variety of indicators, including, but not limited to, the quantity of produce, the type of packaging, identification of a grower or packinghouse on the packaging, and documents consigning the shipment to a wholesaler or retailer.

Commercially produced fruit in Australia are already subjected to standard commercial cultural and post-harvest practices that reduce the risk associated with plant pests. While not specifically required by this proposal, standard cultural practices other than the twice yearly application of broad spectrum fungicides (e.g., the regular use of sanitation measures, irrigation, fertilization, and pest control) help to further ensure that the pests of concern do not follow the pathway. All export orchards are registered production sites with traceback capability. Harvested fruit is moved to the packinghouses in a manner that would preclude reinfestation by pests. Culling of blemished and damaged fruit occurs in the field and during the post-harvest commercial processing of the fruit.

The regulations in § 319.56-3 provide that all imported fruits and vegetables shall be inspected, and shall be subject to such disinfection at the port of first arrival as may be required by an inspector. The pre-export inspection conducted by APHIS personnel as part of preclearance activities in the country of export typically serves to satisfy the inspection requirement. Section 319.56-3 also provides that any shipment of fruits and vegetables may be refused entry if the shipment is so infested with plant pests that an inspector determines that it cannot be cleaned or treated. We believe that the proposed conditions described above, as well as all other applicable requirements in § 319.56-3, would be adequate to prevent the introduction of plant pests into the continental United States, except Florida, with litchi fruit imported from Australia.

The proposed conditions described above for the importation of litchi fruit from Australia into the continental United States, except Florida, would be added to the fruits and vegetables regulations as a new § 319.56-55.

This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

This proposed rule is in response to a request from Australia to export fresh litchis to all States in the United States except Florida. Litchi is grown in Florida, Hawaii, and California, and U.S. production is estimated to be about 500 metric tons (MT) per year. Based on available information, most, if not all, litchi farms are small entities.

The United States imports litchis from such countries as Taiwan, China, Israel, and Mexico. Australia expects to export about 400 MT of litchis to the United States annually. This amount is equivalent to less than 3 percent of the quantity of litchis that was imported by the United States in 2004, the latest year for which we have data. Most likely, the quantity of litchis expected to be imported from Australia is of even lesser significance when compared to current litchi imports by the United States, given the expanding demand for this fruit.

Any litchi price declines that might result from this rule would be insignificant, especially if, as is likely, at least some litchi imports from Australia were to displace imports from other countries. Moreover, given that the agricultural seasons in the Southern Hemisphere are generally the opposite of those in the Northern Hemisphere, the proposed imports from Australia likely would not directly compete with U.S. litchi production.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

This proposed rule would allow litchi fruit to be imported into the United States from Australia. If this proposed rule is adopted, State and local laws and regulations regarding litchi fruit imported under this rule would be preempted while the fruit is in foreign commerce. Fresh fruits and vegetables are generally imported for immediate distribution and sale to the consuming public and would remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. If this proposed rule is adopted, no retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2009-0084. Please send a copy of your comments to: (1) Docket No. APHIS-2009-0084, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule.

APHIS is proposing to amend the fruits and vegetables regulations to allow, under certain conditions, the importation into the United States of commercial consignments of litchi fruit from Australia. The conditions for the importation of litchi fruit from Australia include requirements for pest exclusion at the production site, irradiation treatment, pest-excluding packinghouse procedures and port-of-entry inspections. The litchi would also be required to be accompanied by a phytosanitary certificate issued by the national plant protection organization (NPPO) of Australia with an additional declaration confirming that the litchi had been produced in accordance with the proposed requirements. This action would allow for the importation of litchi fruit from Australia while continuing to provide protection against the introduction of injurious plant pests into the United States.

Implementing this rule will require the completion of phytosanitary certificates, compliance agreements, preclearance workplans, treatment records and trust fund agreements. We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency s functions, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.5455 hours per response.

Respondents: Foreign business and NPPO of Australia.

Estimated annual number of respondents: 2.

Estimated annual number of responses per respondent: 11.

Estimated annual number of responses: 22.

Estimated total annual burden on respondents: 12 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

The Animal and Plant Health Inspection Service is committed to compliance with the EGovernment Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

Accordingly, we propose to amend 7 CFR part 319 as follows:

Background

The regulations in 9 CFR part 92, “Importation of Animals and Animal Products; Procedures for Requesting Recognition of Regions” (referred to below as the regulations), set forth the process by which a foreign government may request recognition of the animal health status of a region.

Section 92.2 of the regulations requires that such requests be accompanied by information regarding the region that will enable the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture to evaluate the request. Currently, the provisions in paragraph (b) of § 92.2 state that each request must include the following information, which APHIS commonly refers to as “the 11 factors”:

• The authority, organization, and infrastructure of the veterinary services organization in the region.

• Disease status, i.e., is the restricted disease agent known to exist in the region? If “yes,” at what prevalence? If “no,” when was the most recent diagnosis?

• The status of adjacent regions with respect to the agent.

• The extent of an active disease control program, if any, if the agent is known to exist in the region.

• The vaccination status of the region. When was the last vaccination? What is the extent of vaccination if it is currently used, and what vaccine is being used?

• The degree to which the region is separated from adjacent regions of higher risk through physical or other barriers.

• The extent to which movement of animals and animal products is controlled from regions of higher risk, and the level of biosecurity regarding such movements.

• Livestock demographics and marketing practices in the region.

• The type and extent of disease surveillance in the region, e.g., is it passive and/or active; what is the quantity and quality of sampling and testing?

• Diagnostic laboratory capabilities.

• Policies and infrastructure for animal disease control in the region, i.e., emergency response capacity.

Current paragraph (e) of § 92.2 provides that if, after evaluating the information submitted, APHIS believes the action being requested can be safely taken, the Agency will publish a proposed rule in the Federal Register proposing to take such action and will provide a period of time during which the public may comment on the proposal. Current paragraph (f) of § 92.2 provides that, during the comment period, the public will have access both to the information upon which APHIS based its analysis of risk and the analysis itself. Once APHIS reviews and considers all comments received, it makes a final decision regarding the request and publishes that decision in the Federal Register .

In order to conduct a valid evaluation of a region's animal health status and any risk that might be associated with the action requested, it is important that APHIS have complete and pertinent information regarding the region, its disease history, its animal health practices and capabilities, and any effect its import practices or relationship to adjacent regions might have on disease risk.

The 11 factors listed in § 92.2(b) specify the types of information APHIS needs to accomplish its evaluation. To assist foreign governments making a request under § 92.2, APHIS also makes available on its Web site detailed guidance as to the types of information required. This guidance is forth in a document titled “Clarification of Information Requested for Recognition of a Region,” which can be viewed at http://www.aphis.usda.gov/import_export/downloads/info_request.pdf.

Each year, APHIS receives a number of requests to evaluate the animal health status of foreign regions. However, the evaluation process is often hindered because, even with the assistance of the guidance, the initial information sent to APHIS is incomplete and requires APHIS to contact the requesting government for additional information.

Based on our experience, we believe it is advisable to clarify further what information is necessary for APHIS to initiate an evaluation of risk. Therefore, we are proposing to revise the list of factors in § 92.2(b) and to make available more detailed guidance as to the specific types of information encompassed by each factor.

Our experience dealing with requests from foreign governments indicates that the list of 11 factors can be confusing because the information requested in some of the factors overlaps with information requested in other factors. For instance, one of the factors asks for information regarding the degree to which the region is separated from adjacent regions of higher risk through physical or other barriers. A separate factor asks for information regarding the extent to which movement of animals and animal products is controlled from regions of higher risk and the level of biosecurity regarding such movements.

To eliminate such overlap, we propose to consolidate the 11 factors into 8 factors, listed as follows:

• Scope of the evaluation being requested;

• Veterinary control and oversight;

• Disease history and vaccination practices;

• Livestock demographics and traceability;

• Epidemiological separation from potential sources of infection;

• Diagnostic laboratory capabilities;

• Surveillance practices; and

• Emergency preparedness and response.

The type of information required would not change substantively from what we currently require to conduct an evaluation. It would simply be described in what we believe is a more helpful way. More detailed guidance as to the specific types of information encompassed by each factor would be set forth in a guidance document available on the APHIS Web site or by contacting APHIS. Instructions for accessing or obtaining the guidance document would be set forth in § 92.2(b) of the regulations. The revised guidance document, “Clarification of Information Requested for Recognition of a Region,” is available for review and comment as part of this rulemaking and may be viewed on the Regulations.gov Web site or in our reading room. Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule. In addition, a copy may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT .

An overview of the information required for each of the factors, as explained in the guidance document, is as follows:

1. Scope of the evaluation being requested. This factor would require identification of the disease(s) for which an APHIS evaluation is requested; a detailed description of the region, including maps; identification of the animal commodities proposed for export to the United States; and an estimate of the projected annual volume of export for each commodity. Although this type of information is not specifically referenced in the current regulations and guidance document, it is standard practice for APHIS to require such information from a requesting region before beginning an evaluation.

2. Veterinary control and oversight. This factor would require sufficient information for APHIS to assess the infrastructure of the official veterinary services in the region and the ability of the veterinary services to oversee animal health activities, monitor for disease, and implement disease control measures.

3. Disease history and vaccination practices. This factor would require sufficient information to enable APHIS to understand the history of the disease(s) being evaluated in the region, including prior control measures, revisions to those measures as applicable, and the vaccination status and history in the region.

4. Livestock demographics and traceability. This factor would require sufficient information for APHIS to assess the geographic distribution of livestock and wildlife species that are susceptible to the disease(s) under evaluation, patterns of livestock movement within the region, and the ability of the official veterinary services of the region to trace livestock movements in the event of a disease outbreak.

5. Epidemiological separation from potential sources of infection. This factor would require sufficient information to enable APHIS to evaluate the ability of the region to prevent incursions of the disease(s) under evaluation. Relevant risk factors that we would evaluate include the presence of the disease(s) in adjacent regions or in regions with epidemiological links to the requesting region, natural and manmade barriers to disease introduction, trading practices, and inspection practices.

6. Surveillance. This factor would require sufficient information to enable APHIS to determine whether the surveillance system in the region is sufficient to ensure early detection of the disease(s) under evaluation. Countries would need to submit information regarding active and/or passive surveillance as applicable. 1 Documentation regarding collection and analysis of disease and infection data must be sufficient to provide confidence in the disease status of the region.

7. Diagnostic laboratory capabilities. This factor would require sufficient information to enable APHIS to determine whether the animal health laboratory system, diagnostic procedures, and quality assurance measures in the region are sufficient to effectively support surveillance for the disease(s) under evaluation.

8. Emergency preparedness and response. This factor would require information sufficient for APHIS to assess emergency preparedness measures and response capabilities in the region, as well as procedures in place to notify trading partners and other international entities of a disease outbreak.

In regions in which a significant period of time has elapsed since a particular disease or infection has occurred, if it has ever occurred, certain information required as part of the eight factors listed above would not be applicable or necessary. An example of this would be some of the information on surveillance, particularly active pathogen-specific surveillance. In the guidance document for the eight factors above, APHIS asks for detailed information regarding surveillance specific to the pathogen under consideration, including the following: Target populations, targeted prevalence for detection and estimated confidence level, sampling plan, types of samples collected, frequency of sampling, and the targeted and actual numbers of samples collected and the results of screening and confirmatory testing for the past 3 years.

However, if a particular disease or infection has not occurred in a region for many years, the benefit of active surveillance specifically targeting that pathogen would be minimal. In such a case, it would not be necessary for APHIS to receive detailed information from the region regarding active pathogen-specific surveillance. However, to be recognized as free of a disease, it would still be necessary for the region to demonstrate an effective early detection system for the disease(s) under evaluation, as described below.

The World Organization for Animal Health (OIE), of which the United States is a Member country, is the internationally recognized standard-setting body that develops science-based recommendations for the safe trade of animals and animal products. The World Trade Organization has recognized the OIE as the international forum for setting animal health standards, reporting global animal disease events, and presenting guidelines and recommendations on sanitary measures relating to animal health. The OIE recommends criteria for recognizing a country or zone free of a disease based on a significant period of time having elapsed since the disease was last reported, if it was ever reported. 2 Such an area is described by the OIE as being historically free of a disease.

In its Terrestrial Animal Health Code (Code), the OIE recommends that a region may be recognized as historically free of a disease if the disease has never occurred in the region or has not occurred for at least the past 25 years, provided the following conditions have been met for at least the past 10 years:

• The disease has been a notifiable disease;  3

• An early detection system has been in place for all relevant species;

• Measures to prevent disease/infection introduction have been in place and no vaccination against the disease has been carried out unless otherwise provided in the Code; and

• There has been no evidence of infection in wildlife in the region.

Based on APHIS' experience evaluating the animal health status of foreign regions, we concur with the OIE's recommended criteria for being recognized as historically free of a disease, and we are proposing to add a new paragraph (c) in § 92.2 of the regulations that would list the factors we will consider in evaluating whether to recognize a region as historically free. Much of the information is the same as that required for the eight factors discussed above. However, consistent with OIE guidelines, APHIS' evaluations for historically free status will focus on verifying an effective early detection system for the disease(s) under consideration, disease reporting requirements, and measures in place to prevent introduction. Therefore, certain information encompassed by the eight factors would not be required.

In evaluating whether a region can be considered historically free of a disease, we would consider the following six factors:

• Scope of the evaluation being requested;

• Veterinary control and oversight;

• Disease history and vaccination practices;

• Disease reporting;

• Disease detection; and

• Barriers to disease introduction.

As with the eight factors discussed earlier in this document, more detailed guidance as to the specific types of information encompassed by each factor for regions historically free of a disease would be set forth in a guidance document available on the APHIS Web site or by contacting APHIS. Instructions for accessing or obtaining the guidance document would be set forth in § 92.2(c) of the regulations. The guidance document, “Clarification of Information Requested for Recognition of a Historically Free Region,” is available for review and comment as part of this rulemaking and may be viewed on the Regulations.gov Web site or in our reading room.

Consistent with the OIE guidelines, proposed § 92.2(c) would indicate that, for a region to be considered historically free of a disease, the disease must not have occurred in domestic livestock for at least the past 25 years and must not have been reported in wildlife for at least the past 10 years. An overview of the information required for each of the factors, as explained in the guidance document, is as follows.

1. Scope of the evaluation being requested. The information we would require for this factor is the same as that described for the eight factors, above.

2. Veterinary control and oversight. This factor would require sufficient information to enable APHIS to determine whether the veterinary services in the region have had and continue to have sufficient legal authority, organization, and infrastructure to effectively investigate, diagnose, and report the disease(s) under evaluation, if detected.

3. Disease history and vaccination practices. For this factor, the requesting authority would need to indicate when each disease under evaluation was last reported, if ever, in domestic livestock and wildlife in the region. Additionally, if vaccination against the disease(s) has occurred within the past 10 years, the request must include information indicating the reasons for vaccination, the source and type of vaccines used, target populations, recordkeeping requirements, and procedures to distinguish vaccinated animals.

4. Disease reporting. This factor would require sufficient information to enable APHIS to determine whether each disease under evaluation has been legally notifiable in the region for at least the past 10 years.

5. Disease detection. This factor would require sufficient information for APHIS to determine whether an effective early detection system has been in place for at least the past 10 years for the disease(s) under evaluation. An effective early detection system would include, among other things, representative coverage of susceptible animal populations by field services, a training program for detecting and reporting unusual animal health incidents, the ability to undertake effective disease investigation and reporting, and access to laboratories capable of diagnosing and differentiating relevant diseases.

6. Barriers to disease introduction. This factor would require sufficient information for APHIS to determine whether measures have been in place for at least the past 10 years to prevent introduction of the disease(s) under evaluation.

Historically, the evaluations APHIS has conducted in accordance with part 92 have been at the request of a representative of a foreign jurisdiction. We expect that to continue to be the case the great majority of the time. However, there might be instances where APHIS initiates an evaluation on its own initiative. As with evaluations done at the request of a foreign region, we would consider the factors set forth in this proposed rule and, if our intent is to recognize the health status of the region, would give notice in the Federal Register of that intent, make the relevant information and data and our evaluation available to the public, and accept public comment regarding our intent. After reviewing and considering any comments received, we would give notice to the public of our final determination. In this proposed rule, we include a footnote to § 92.2(a) that references such situations.

Current § 92.2(d) states that the information sent to APHIS with requests submitted in accordance with part 92 will be made available to the public prior to initiation by APHIS of any rulemaking action on the request. Current § 92.2(f) provides that, in cases where APHIS does publish a proposed rule based on a request, the public will be provided a period of time to comment on the proposal and that, during the comment period, the public will have access to the information upon which APHIS based its analysis supporting the proposal, as well as its methodology in conducting the analysis.

We believe that the wording of current § 92.2(d) can be confusing. The intent of that paragraph is to give notice to the public that, at the time a proposal is published, information supporting the proposal will have been made available to the public. Such information is posted on the APHIS Web site. However, the wording of current § 92.2(d) does not indicate how early in the process such information will be made available to the public. It has been APHIS' practice to make such information available immediately before publication of a proposed rule. APHIS does not begin an evaluation until it has sufficient information to conduct a valid analysis of a request, and does not take the further action of publishing a proposed rule in the Federal Register unless it believes the results of the evaluation support the action being requested. We believe that, until a proposed rule is ready for publication, it can be confusing and misleading for the public to review what APHIS considers partial information or information with regard to which further action may not be taken. However, we believe it could be useful to the public to know which foreign regions have requested APHIS' recognition of their animal health status. Therefore, in this document, we are proposing to remove the statement in § 92.2(d) that supporting information will be made available to the public prior to initiation of rulemaking and to replace it with the statement that a list of regions that have requested recognition of their animal health status is available to the public. We will continue to make available to the public by the time APHIS publishes a proposal in the Federal Register any relevant information received from a requesting country.

As noted above, current paragraph (e) of § 92.2 provides that if, after evaluating the information submitted with a region's request for APHIS' recognition of its animal health status, APHIS believes the action being requested can be safely taken, the Agency will publish a proposed rule in the Federal Register proposing to take such action and will provide a period of time during which the public may comment on the proposal. However, recent rulemaking by APHIS has made it incorrect to say that a proposed rule will be used in all cases to give notice of APHIS' intent. On January 24, 2011, we published in the Federal Register an interim rule (76 FR 4046-4056, Docket No. APHIS-2006-0074) concerning highly pathogenic avian influenza (HPAI) as it applies to the importation of live birds and poultry and the products of birds and poultry. In that interim rule, we provide for a method of notifying the public of APHIS' intent regarding the HPAI status of a region that differs somewhat from the method currently provided for in § 92.2(e). Instead of publishing a proposed rule, as provided for in current § 92.2(e), the HPAI interim rule indicates that a region will be removed from the list of regions where HPAI is considered to exist only after APHIS makes its evaluation available for public comment through a notice published in the Federal Register . The interim rule provides that, following the close of the comment period, APHIS will publish another notice responding to comments and announcing APHIS' decision.

In order to account for such situations where a notice, rather than proposed rule, will be used to solicit comment regarding APHIS' evaluation of the animal health status of a foreign region, we are proposing to revise paragraph (e) of § 92.2 to provide that, if APHIS believes a request from a foreign region for APHIS' recognition of its animal health status can be safely granted, APHIS will indicate its intent and make its evaluation available for public comment through a document published in the Federal Register . Paragraph (f) of § 92.2 would indicate that, during the comment period, the public will have access to the information upon which APHIS based its evaluation, as well as the evaluation itself, and that, once APHIS has reviewed all comments received, it will make a final determination regarding the request and will publish that determination in the Federal Register .

Additionally, in this document, we are clarifying which requests are governed by § 92.2. The scope of § 92.2 is reflected in its heading, which reads “Application for recognition of the animal health status of a region.” Requests submitted to APHIS in accordance with part 92 are evaluated by the Regionalization Evaluation Services staff of APHIS' Veterinary Services. However, the wording in paragraphs (b), (c), and (e) of current § 92.2 indicates that the section also governs requests for approval to export a particular type of animal or animal product to the United States from a foreign region. Although the evaluations conducted by the Regionalization Evaluation Services staff can ultimately affect which commodities are allowed importation into the United States and under what conditions, requests to import specific types of animals or animal products are governed by parts in 9 CFR other than part 92. To clarify the scope of part 92, we are proposing to remove from that part the references to exportation of a particular type of animal or animal product to the United States from a foreign region.

Currently, § 92.2(c) indicates where requests for recognition of a region, and information supporting such a request, should be sent. That paragraph also requests that, where possible, a copy of the request and supporting information be submitted on a 3.5-inch floppy disk in ASCII or a word processing format. In this proposal, we include the address to which requests and supporting information should be sent in § 92.2(a) instead of § 92.2(c) and propose to remove the request for submission on a 3.5-inch floppy disk. Such disks are no longer commonly used. In proposed § 92.2(a), we request that, where possible, a copy of the request and accompanying information be included in electronic format.

We are also proposing several nonsubstantive wording changes to § 92.2 for the sake of clarity.

This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

We have prepared an economic analysis for this action. The analysis identifies importers and producers of animals and animal products as the small entities most likely to be affected by this action and considers the reduction in time it would take under this proposal for APHIS to initiate and complete an evaluation of the animal disease status of a region. Based on the information presented in the analysis, we expect that decreasing the amount of time and APHIS resources required to initiate and complete such an evaluation would not have a significant economic effect on the entities affected. We invite comment on our economic analysis, which is posted with this proposed rule on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov) and may also be obtained from the person listed under FOR FURTHER INFORMATION CONTACT .

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Animal diseases, Imports, Livestock, Poultry and poultry products, Region, Reporting and recordkeeping requirements.

Accordingly, we propose to amend 9 CFR part 92 as follows:

Table of Contents I. Background. II. Summary of the Proposed Rule. III. Procedural Requirements. A. Review Under Executive Order 12866. B. Review Under Executive Order 12988. C. Review Under the Regulatory Flexibility Act. D. Review Under the Paperwork Reduction Act. E. Review Under the National Environmental Policy Act. F. Review Under Executive Order 13132. G. Review Under the Unfunded Mandates Reform Act of 1995. H. Review Under the Treasury and General Government Appropriations Act, 1999. I. Review Under Executive Order 13211. J. Review Under the Treasury and General Government Appropriations Act, 2001. I. Background

The Department's high dollar contracts that include cost reimbursable elements generally make legal costs, including the cost of litigation, allowable if reasonable and incurred in accordance with the applicable cost principles and contract clauses. Consequently, the Department has an ongoing obligation to monitor, supervise, and control the legal costs that it reimburses.

The Department has a long history of overseeing aspects of its contractors' management of legal matters and costs. This practice was formalized in 1994 when the Department published an interim Acquisition Letter as an interim policy in the Federal Register (59 FR 44981). The interim Acquisition Letter was finalized as a Policy Statement on April 3, 1996 (61 FR 14763). This Policy Statement was followed by a formal rulemaking which added part 719, Contractor Legal Management Requirements, to Title 10 of the Code of Federal Regulations with an effective date of April 23, 2001 (66 FR 4616, 66 FR 19717).

Today's proposed rule revises the current contractor legal management requirements found in part 719, in Chapter 10 of the Code of Federal Regulations. The revisions reflect lessons learned by the Department during the years since implementing part 719. The part establishes regulations to monitor and control legal costs and to provide guidance to aid contractors and the Department in making determinations regarding the reasonableness of outside legal costs, including the costs associated with litigation. Today's amendments to part 719 and the associated portions of the Department of Energy Acquisition Regulation (DEAR) are designed to clarify and streamline existing requirements, improve efficiency of contractor legal management, and facilitate oversight over the expenditure of taxpayer dollars.

Today's proposed rules and guidance slightly expands the coverage of the existing regulations. The proposed rules cover all outside legal costs incurred under the Department's Management and Operating (M&O) contracts, non-management and operating cost reimbursement contracts exceeding $100,000,000, and non-management and operating contracts exceeding $100,000,000 that include cost reimbursable elements exceeding $10,000,000. The proposed rules delete current requirements limiting applicability of the part to contracts involving work performed at facilities owned or leased by the Department. Part 719 would continue to apply to legal counsel retained directly by the Department where the legal costs over the life of the matter for which counsel has been retained are expected to exceed $100,000. The proposed rules also delete the current coverage exception for legal matters handled through retrospective insurance arrangements and make certain portions of the rules applicable to such arrangements.

The proposed regulations continue to require contractor submission of legal management plans, staffing and resource plans, and engagement letters under specific circumstances and set forth the requirements for these submissions. Today's proposed rules require contractors to submit proposed legal settlements requiring Contractor payment of $25,000 or more for Department review and approval. Currently, common practice requires contractors to obtain permission from Department counsel to enter a settlement agreement requiring Contractor payment of $50,000 or more. The Department is seeking public comment regarding the proposed reduction of the threshold to $25,000 and the proposed inclusion of the requirement in the regulations. In order to streamline and simplify the regulations related to contractor litigation, requirements related to initiation, defense, and settlement of litigation have been removed from the DEAR and consolidated in part 719. The proposed rule moves much of the material currently located in the Appendix to part 719 to the part, itself.

The proposed part 719 continues to identify certain costs that generally would be considered unallowable. Certain categories of costs that require Departmental pre-approval in order to be considered for reimbursement are also identified. The proposed rules provide that compliance with part 719 is a prerequisite for allowability of legal costs, but notes that compliance with the part does not guarantee that costs will be determined to be allowable. All costs, whether or not identified as specifically allowable or unallowable, are still subject to the rules of allowability in the Federal Acquisition Regulation (FAR) and the DEAR.

The Department also proposes changes to the DEAR. The changes correspond to the proposed substantive changes to part 719 as well as clarify and streamline the DEAR provisions related to contractor legal management. The proposed rules require inclusion of 48 CFR 952.231-71, Insurance—Litigation and Claims, or 48 CFR 970.5228-1, Insurance—Litigation and Claims, in the majority, but not all contracts, to which part 719 applies. Both Insurance—Litigation and Claims clauses have been revised to delete requirements related to contractor initiation or defense of litigation that are proposed for consolidation in part 719.

Subpart A, sections 719.1-719.8, includes general provisions. The subpart provides definitions and addresses applicability of the part. Section 719.3 states that the part covers all Management and Operating (M&O) contracts, non-management and operating cost reimbursement contracts exceeding $100,000,000, and non-management and operating contracts exceeding $100,000,000 that include cost reimbursable elements exceeding $10,000,000. Sections 719.3 and 719.4 make it clear that any contract exceeding $100,000 that the Department awards directly to retained legal counsel are subject to compliance with the rules. Sections 719.5 and 719.6 describe types of contracts and legal matters not covered by the part. The proposed rules include coverage of certain retrospective insurance arrangements that are excluded from coverage under the current rules. Procedures for exceptions or deviations from the part are set out in section 719.7. In the case of a Department contract, the determination would be made by the Department's General Counsel; in the case of a National Nuclear Security Administration (NNSA) contract, it would be made by the NNSA General Counsel. Section 719.8 states that the sharing of certain information between contractors and the Department does not waive any applicable privilege.

Subpart B, sections 719.10-719.17, describes the requirements for submission of a legal management plan, staffing and resource plan, and annual legal budget. The subpart describes what is to be included in the plans and in the budget. The proposed rules modify the current requirements for legal management plans, in response to lessons learned by the Department and to ensure adequate oversight of contractor legal management. Section 719.11 provides that contractors must submit a legal management plan within 60 days following execution of a contract with the Department or upon request of the contracting officer. Section 719.15 sets out a requirement for submission of a staffing and resource plan for significant matters (those with legal costs estimated to exceed $100,000 over the life of the matter or as determined by Department Counsel). Section 719.16 requires submission of the staffing and resource plan no later than 30 days after the filing of an answer or a dispositive motion in lieu of an answer in a significant matter involving litigation, 30 days after a determination that the cost is expected to exceed $100,000, or 30 days after notification by Department Counsel that a matter is considered significant, whichever is sooner. Section 719.17 requires submission of an annual legal budget for existing or anticipated significant matters.

Subpart C, sections 719.20-719.21, describes the requirements for engagement letters. Engagement letters must be prepared and submitted to Department Counsel for matters where costs are expected to exceed $25,000. Section 719.21 states the requirements for engagement letters. Section 719.21(b)(3) requires the contractor to include the right of the government to inspect, copy and audit documentation of billable fees and other records where the Department is reimbursing the legal costs. Section 719.21(b)(8) requires that the engagement letter set forth an agreement that retained counsel will prepare a staffing and resource plan in accordance with the part. Section 719.21(b)(11) requires that the engagement letter include a requirement that a specific certification be included in invoices. This certification requirement is currently set forth in the Attachment to the part.

Subpart D, sections 719.30-719.35, describes the requirements related to contractor initiation of offensive or defensive litigation, including appeals, and for contractor settlement of legal matters. Current part 719 addresses initiation and defense of litigation in the Appendix to the part. Today's proposed rules delete these portions of the Appendix and move all requirements regarding initiation and notification of litigation to subpart D. The proposed regulations move requirements related to initiation and notification of litigation from the DEAR Insurance—Litigation and claims clauses, 48 CFR 952.231-71 and 48 CFR 970.5228-1, to part 719, subpart D, in order to clarify the requirements and streamline the regulations. Requirements regarding Departmental approval of contractor settlements are currently included in contractor legal management plans. The proposed rules regulate requirements related to contractor settlement of legal matters for the first time. Section 719.33 requires that a contractor obtain permission from Department Counsel to enter a settlement agreement requiring Contractor payment of $25,000 or more. Section 719.34 lists documentation that must be submitted with a contractor's request to settle a matter.

Subpart E, sections 719.40-719.47, describes the policies and limitations for reimbursement of legal costs associated with retained legal counsel. Section 719.40 makes clear that compliance with part 719 is a prerequisite for allowability of legal costs. Sections 719.42-719.44 describe categories of costs that are unallowable or which require special treatment or advance approval. Section 719.43 describes the treatment of outside counsel travel costs. Section 719.45 of the proposed rules makes certain aspects of part 719 applicable to subcontractors and retrospective insurance carriers. Retrospective insurance arrangements are currently excluded from coverage of the current part 719 and the Department is seeking public comment regarding the proposed coverage of retrospective insurance carriers. Coverage of such carriers is proposed in order to ensure consistent management of all contractor legal management costs that may be reimbursed by the Department. Among the proposed requirements is Departmental approval of retrospective insurance carrier settlements of matters involving payment of $25,000 or more. Section 719.46 clearly states that costs covered by the part are subject to audit. Section 719.47 describes what happens when more than one Departmental contractor is party to a legal matter.

Subpart F, sections 719.50-719.52, discusses the roles and responsibilities of Department Counsel. Section 719.50 discusses the limitations of Department Counsel authority. Sections 719.51 and 719.52 set forth parameters for Department Counsel coordination with DOE and NNSA Offices of General Counsel.

The Appendix to part 719 discusses expectations related to alternative dispute resolution. The Appendix also makes clear that there is no presumption of reasonableness attached to incurrence of costs by a contractor and notes that the reasons underlying incurrence of a legal cost may affect its allowability. The Attachment to part 719 includes a model bill format for contractor use.

The Department is also proposing corresponding changes to the DEAR. The clause prescription at 48 CFR 931.205-19 is revised to prescribe insertion of the clause at 48 CFR 952.231-71 in (1) non-management and operating cost reimbursement contracts exceeding $100,000,000, and (2) non-management and operating contracts exceeding $100,000,000 that include cost reimbursable elements exceeding $100,000,000. The clause prescription at 48 CFR 970.2803-2 is revised to prescribe insertion of the clause at 48 CFR 970.5228-1 in all management and operating contracts. Both prescriptions are revised to clarify that the prescribed clauses are to be inserted instead of the clause at 48 CFR 52.228-7. The Insurance—Litigation and claims clauses at 48 CFR 952.231-71 and 48 CFR 970.5228-1 are revised to reflect the above described consolidation of requirements related to initiation and notification of litigation in subpart D of part 719. Other changes to the clauses are included to simplify and clarify their requirements. The cost principle at 48 CFR 931.205-33 is revised to reflect the amended applicability of the DEAR Insurance—Litigation and claims clauses and to clarify the requirement for contractor compliance with part 719 when the part is applicable to a particular contract.

This regulatory action has been determined not to be a significant regulatory action under Executive Order 12866, Regulatory Planning and Review, 58 FR 51735, October 4, 1993. Accordingly, this proposed rule is not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget.

DOE has also reviewed this regulation pursuant to Executive Order 13563, issued on January 18, 2011 (76 FR 3281 (Jan. 21, 2011)). Executive Order 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, agencies are required by Executive Order 13563 to: (1) Propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.

DOE emphasizes as well that Executive Order 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, the Office of Information and Regulatory Affairs has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. DOE believes that today's NOPR is consistent with these principles, including the requirement that, to the extent permitted by law, agencies adopt a regulation only upon a reasoned determination that its benefits justify its costs and, in choosing among alternative regulatory approaches, those approaches maximize net benefits.

With respect to the review of existing regulations and the promulgation of new regulations, Section 3(a) of Executive Order 12988, Civil Justice Reform, 61 FR 4729, February 7, 1996, imposes on executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. With regard to the review required by Section 3(a), Section 3(b) of Executive Order 12988 specifically requires that executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or that it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, these regulations meet the relevant standards of Executive Order 12988.

This proposed rule has been reviewed under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., which requires preparation of an initial regulatory flexibility analysis for any rule that must be proposed for public comment and is likely to have a significant economic impact on a substantial number of small entities. The proposed rule would not have a significant economic impact on small entities because it imposes no significant burdens.

Accordingly, DOE certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities, and, therefore, no regulatory flexibility analysis has been prepared.

The proposed rule would require each covered contractor to submit a legal management plan that describes the contractor's practices for managing legal matters for which it procures the services of retained legal counsel. Under certain circumstances staffing and resource plans, annual legal budgets, and engagement letters are required to be submitted to the Department. Documentation related to initiation of litigation and settlement of legal matters may also be required. This collection of information is required for the Department to determine whether to approve reimbursement of contractors' litigation and other legal expenses.

Under the Paperwork Reduction Act, 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 unless the collection has been reviewed and assigned a control number by Office of Management and Budget (OMB). The existing regulations at 10 CFR part 719 have been assigned OMB control number 1910-5115, 75 FR 38514-02.

The Department is submitting to the Office of Management and Budget (OMB), simultaneously with the publication of this proposed rule, information explaining the proposed amendments to the current collection of information for review and approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

DOE has concluded that promulgation of this proposed rule falls into a class of actions which would not individually or cumulatively have significant impact on the human environment, as determined by DOE's regulations, 10 CFR Part 1021, Subpart D, implementing the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. 4321 et seq. Specifically, this proposed rule is categorically excluded from NEPA review because the amendments to the DEAR would be strictly procedural (categorical exclusion A6). Therefore, this proposed rule does not require an environmental impact statement or environmental assessment pursuant to NEPA.

Executive Order 13132, 64 FR 43255, August 4, 1999, imposes certain requirements on agencies formulating and implementing policies or regulations that preempt state law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the states and carefully assess the necessity for such actions. DOE has examined today's proposed rule and has determined that it would not preempt state law and would 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. No further action is required by Executive Order 13132.

The Unfunded Mandates Reform Act of 1995, Public Law 104-4, requires a federal agency to perform a detailed assessment of costs and benefits of any rule imposing a federal mandate with costs to state, local or tribal governments, or to the private sector, of $100 million or more in any single year. This rulemaking does not impose a federal mandate on state, local or tribal governments or on the private sector.

Section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, requires federal agencies to issue a Family Policymaking Assessment for any rule or policy that may affect family well-being. This proposed rule would have no impact on family well being.

Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use, 66 FR 28355, May 22, 2001, requires federal agencies to prepare and submit to the OIRA, OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.

This proposed rule is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

The Treasury and General Government Appropriations Act, 2001, 44 U.S.C. 3516, note, provides for agencies to review most disseminations of information to the public under implementing guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452, February 22, 2002, and DOE's guidelines were published at 67 FR 62446, October 7, 2002. DOE has reviewed today's proposed rulemaking under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

For the reasons set out in the preamble, the Department of Energy (DOE) proposes to amend Chapter III of Title 10 and Chapter 9 of Title 48 of the Code of Federal Regulations as set forth below:

1. Part 719 is revised to read as follows:

I. Background II. The Rule as Proposed III. Section-by-Section Analysis IV. Regulatory Procedures I. Background a. Why is NCUA proposing this rule?

On July 11, 2011, President Obama issued Executive Order 13579, ordering independent agencies, including NCUA, to consider whether they can modify, streamline, expand, or repeal existing rules to make their programs more effective and less burdensome. 1 Consistent with the spirit of the Executive Order and as part of NCUA's Regulatory Modernization Initiative, the NCUA Board (Board) has decided to propose a rule that streamlines its regulatory program by eliminating RegFlex. The proposed rule would relieve regulatory burden on Federal credit unions (FCUs) because they would no longer need to engage in any process for a RegFlex designation. In addition, FCUs that are currently not RegFlex eligible would receive regulatory relief because the proposal extends to them most of the flexibilities previously available only to RegFlex FCUs.

RegFlex relieves FCUs from certain regulatory restrictions and grants them additional powers if they have demonstrated sustained superior performance as measured by CAMEL rating and net worth classification. 12 CFR 742.1. An FCU may qualify for RegFlex treatment automatically or by application to the appropriate regional director. 12 CFR 742.2. Specifically, an FCU automatically qualifies when it has received a composite CAMEL rating of “1” or “2” during its last two examinations and has maintained a net worth classification of “well capitalized” under part 702 of NCUA's rules for the last six quarters. If an FCU is subject to a risk-based net worth (RBNW) requirement under part 702, it also qualifies for RegFlex treatment when it has remained “well capitalized” for the last six quarters after applying the applicable RBNW requirement. An FCU that does not automatically qualify may apply for a RegFlex designation with the appropriate regional director. 12 CFR 742.2(a) and (b).

The Board established RegFlex in 2002. 66 FR 58656 (Nov. 23, 2001). Since then, NCUA has amended RegFlex a number of times to increase available relief for FCUs from a variety of regulatory restrictions, reduce the criteria to obtain RegFlex status, or enhance safety and soundness for FCUs. 71 FR 4039 (Jan. 25, 2006); 72 FR 30247 (May 31, 2007); 74 FR 13083 (Mar. 26, 2009); 75 FR 66298 (Oct. 28, 2010).

The current RegFlex rule provides RegFlex FCUs with relief from restrictions in the following six areas or “flexibilities”: (1) Charitable contributions; (2) nonmember deposits; (3) fixed assets; (4) zero-coupon investments; (5) borrowing repurchase transactions; and (6) commercial mortgage related securities. It also provides an additional flexibility by specifically authorizing the purchase of obligations from federally insured credit unions beyond those an FCU may purchase under the NCUA's eligible obligations rule, § 701.23.

NCUA proposes to eliminate RegFlex and the charitable contributions rule, and amend the rules that apply to eligible obligations, nonmember deposits, fixed assets, and investments. With this proposal, the Board intends to enable FCUs to engage in the activities permitted by the existing RegFlex rule. As of June 30, 2011, there are 4,534 FCUs, 2,764 of which are RegFlex FCUs. The proposed changes would extend regulatory relief to the remaining 1,770 FCUs that do not currently enjoy a RegFlex designation. NCUA requests your comments on the proposed rulemaking.

The proposed rule places most of the six flexibilities of the RegFlex rule into the subject-specific rules that apply to all FCUs. Under the existing rule, RegFlex FCUs do not have to comply with the charitable contributions rule. The proposed rulemaking, therefore, removes the charitable contributions rule so that all FCUs may make donations based on sound judgment and business practices without regulatory restrictions. At present, RegFlex FCUs do not have to comply with the limits on nonmember deposits. The NCUA Board has reviewed the amount of nonmember deposits currently held by FCUs and proposes an adjustment to the nonmember deposits rule to allow FCUs to accept more nonmember deposits. Likewise, the proposed rulemaking extends the amount of time in which FCUs must occupy unimproved property to six years, as currently permitted for RegFlex FCUs. Finally, the proposed amendments to the investment rule permit extended maturities for zero-coupon investments and borrowing repurchase transactions as well as the ability to purchase commercial mortgage related securities under similar conditions to the existing RegFlex rule. In addition, the proposed rule moves the provisions to buy nonmember and other obligations currently found in the RegFlex rule, into the eligible obligations rule, § 701.23.

This proposal closely follows the analyses the Board previously used when it adopted the various flexibilities in the RegFlex rule. While the proposed rule extends relief to FCUs, the Board recognizes the relief granted by this proposal may not be appropriate for every FCU. Only FCUs with the requisite expertise and policies to engage in the activities addressed in this rulemaking, as well as the financial condition necessary for particular activities, should avail themselves of the proposed new authorities. Each FCU's board of directors bears the ultimate responsibility for its FCU's direction and control. NCUA may also take appropriate supervisory action to address unsafe and unsound practices or conditions.

No, although the proposal modifies some of the RegFlex flexibilities. The Board proposes to establish a maximum maturity of 30 years for zero-coupon investments even though the RegFlex rule does not currently subject RegFlex FCUs to a maturity limit on these investments. The Board believes the maturity cap will have no negative impact on these FCUs. The proposed rule also removes the automatic exemption from the nonmember deposits limit, but the Board does not foresee any adverse impact on FCUs with the proposed change.

RegFlex FCUs currently operating under the automatic exemption criteria for a RegFlex designation will generally continue to be able to avail themselves of the flexibilities found in part 742. Under the proposal, FCUs that received a RegFlex designation from a regional director because they did not meet the standards for automatic qualification will now, like current non-RegFlex FCUs, have certain conditions placed on their previous RegFlex flexibilities, unless they receive approval for additional authority. The Board discusses these conditions further in the section-by-section analysis.

NCUA proposes to remove part 742 in its entirety to eliminate RegFlex. NCUA also proposes to remove or amend the related rules that apply to eligible obligations, charitable contributions, nonmember deposits, fixed assets, investments, and member business loans. As the Board noted when it first adopted RegFlex, the regulatory provisions covered in RegFlex are not specifically required by statute. This proposed rulemaking aims to ease compliance burden and permit greater flexibility for FCUs in managing their operations, while simultaneously retaining certain safety and soundness standards.

The Board also intends to delete an FCU's ability to appeal the revocation of its RegFlex designation to the NCUA's Supervisory Review Committee. NCUA Interpretive Ruling and Policy Statement (IRPS) 11-1, 76 FR 23871 (Apr. 29, 2011). If the Board eliminates RegFlex designations as proposed, there will be no need for such an appeal. In that event, the Board intends to issue a direct final IRPS that would remove RegFlex revocations from the list of material supervisory determinations an FCU may appeal under NCUA IRPS 11-1.

FCUs make charitable contributions under the provision in the FCU Act that authorizes an FCU “to exercise such incidental powers as shall be necessary or requisite to enable it to carry on effectively the business for which it is incorporated.” 44 FR 56691 (Oct. 2, 1979); 64 FR 19441 (Apr. 21, 1999); 12 U.S.C. 1757(17).

The current charitable contributions rule, § 701.25, restricts an FCU's ability to make donations. It only allows an FCU to make charitable contributions or donations to nonprofit organizations located in or conducting activities in a community in which the FCU has a place of business, or to organizations that are tax exempt under § 501(c)(3) of the Internal Revenue Code and operate primarily to promote and develop credit unions. The rule requires an FCU's board of directors to approve charitable contributions based on a determination that the contributions are in the best interests of the FCU and are reasonable given the FCU's size and financial condition. Under the rule, directors may establish a budget for charitable donations and authorize FCU officials to select recipients and disburse funds. The RegFlex rule, § 742.4(a)(1), exempts RegFlex FCUs from the entire charitable contributions rule.

The Board proposes to eliminate the entire charitable contributions rule, § 701.25, so that any FCU can make donations without the prior approval of its board of directors and without regulatory restrictions as to recipients. The Board notes that, even in the absence of a charitable contributions rule, an FCU's authority to make donations is dictated by its incidental powers authority given in the FCU Act. As such, contributions must be necessary or requisite to enable the FCU to effectively carry on its business. See 12 CFR 721.2. Furthermore, FCU directors have a fiduciary duty to direct management to operate within sound business practices and the best interests of the membership under § 701.4. In addition, article XVI, section 4 of the FCU Bylaws prohibits FCU directors, committee members, officers, agents, and employees from conflicts of interest that could arise in the context of making charitable donations.

The FCU Act permits an FCU to receive shares from nonmember public units, political subdivisions  2 and credit unions, but the FCU is subject to the limits in the nonmember deposits rule, § 701.32. 12 U.S.C. 1757(6); 12 CFR 701.32. Under paragraph (b) of § 701.32, the maximum amount of all public unit and nonmember shares that an FCU may hold cannot exceed the greater of 20% of the FCU's total shares or $1.5 million. This means that an FCU holding less than $7.5 million in total shares cannot accept nonmember deposits in excess of $1.5 million, as 20% of $7.5 million is $1.5 million. Under paragraph (c) of § 701.32, nonmember share deposits that an FCU has accepted to meet a matching requirement for a Community Development Revolving Loan Fund loan counts against the nonmember deposit limit once the FCU has repaid the loan. An FCU may request an exemption from the appropriate regional director to exceed the limit. If the regional director denies the request for an exemption, the FCU may appeal the decision to the Board. The RegFlex rule currently exempts RegFlex FCUs from both paragraphs (b) and (c) of § 701.32. RegFlex FCUs, therefore, are not subject to the limit on the amount of deposits they may accept from nonmember public units and credit unions.

Currently, only four RegFlex FCUs exceed the limitation in § 701.32(b) of the greater of 20% of total shares or $1.5 million in nonmember deposits. Each of those FCUs holds more than $1.5 million in nonmember deposits, but less than $3 million. The Board, therefore, proposes to raise the dollar threshold on the nonmember deposit limit in § 701.32(b) to $3 million. The increase in the dollar limit would permit FCUs with less than $7.5 million in total shares to accept up to $3 million in nonmember deposits, compared to their current $1.5 million limit. The Board acknowledges that, by eliminating RegFlex, RegFlex FCUs would lose their blanket exemption from the nonmember deposit cap. From its review of the nonmember deposits presently held by RegFlex FCUs, however, the Board believes the proposal provides all of the necessary flexibility and regulatory relief to all FCUs without adversely affecting any of the RegFlex FCUs that have accepted nonmember deposits in excess of the cap. The Board also continues to recognize the risks that nonmember shares may present. Nonmember shares are characteristically more volatile than core member shares. This additional volatility can pose asset liability management concerns and liquidity concerns. The proposed adjustment to the dollar threshold in paragraph (b)(1) maintains the regulatory relief that RegFlex FCUs have enjoyed, extends relief to FCUs, and remains attentive to safety and soundness considerations.

The FCU Act authorizes an FCU to purchase, hold, and dispose of property necessary or incidental to its operations. 12 U.S.C. 1757(4). Generally, the fixed asset rule provides limits on fixed asset investments, establishes occupancy and other requirements for acquired and abandoned premises, and prohibits certain transactions. 12 CFR 701.36. Fixed assets are defined in § 701.36(e) and include premises. Premises means any office, branch office, suboffice, service center, parking lot, facility, or real estate where a credit union transacts or will transact business.

When an FCU acquires premises for future expansion and does not fully occupy the space within one year, the rule requires the FCU's board of directors to have a resolution in place by the end of that year with plans for full occupation. 12 CFR 701.36(b)(1). Additionally, the FCU must partially occupy the premises within three years, unless the FCU obtains a waiver within 30 months of acquiring the premises. 12 CFR 701.36(b)(1)-(2). Where an FCU is acquiring unimproved land, the partial occupancy requirement often is more difficult to satisfy than if the FCU were purchasing premises with an existing branch building. The existing fixed assets rule and the RegFlex rule extend the three-year time period to six years for RegFlex FCUs, but only with respect to the acquisition of unimproved land. 12 CFR 701.36(d), 742.4(a)(3).

The Board proposes to amend the fixed assets rule to extend the three-year time period to six years for any FCU that is acquiring unimproved land. This extension would not apply, however, to any other kind of premises. As it discussed in previous rulemakings, the Board is aware that the fixed asset rule's three-year partial occupancy requirement, even with a waiver option, may be burdensome for some FCUs. NCUA recognizes many real estate transactions are complex and time consuming. These transactions involve a full array of issues that an FCU must address before it is ready to occupy the premises. This is especially true in the unimproved land context with its construction-related issues. The Board believes it is appropriate to now extend relief from this compliance burden to all FCUs by allowing an FCU up to six years to partially occupy some of the space on a full-time basis if it initially acquired the property as unimproved land. Under the proposed change to paragraph (b)(2) in § 701.36, all FCUs would have additional flexibility they need to manage their fixed asset portfolios, consistent with safe and sound credit union operations.

Under § 703.16(b), an FCU may not purchase a zero-coupon investment with a maturity date that is more than 10 years from the related settlement date. The RegFlex rule exempts RegFlex FCUs from the maximum maturity length of 10 years in the investment rule. 12 CFR 742.4(a)(4). When creating the exemption for RegFlex FCUs, the Board determined it would not have a significant adverse impact on safety and soundness and would increase potential yield with prudent asset liability management. 66 FR 58656, 58659 (Nov. 23, 2001).

Since the adoption of the RegFlex rule, however, NCUA has carefully reviewed the strategic and risk management considerations for permitting the use of long-term zero-coupon investments in credit union portfolios. NCUA has concluded that such long-term investments generally are not appropriate. Zero-coupon investments with maturities exceeding 10 years have higher price sensitivity than other securities, including shorter-term zero-coupon investments. This increased price sensitivity, together with the lack of interim cash flows, makes long-term zero-coupon investments inconsistent with the primary portfolio objectives of safety and liquidity.

The table below shows approximate percentage declines in the price of zero-coupon investments and coupon-bearing Treasury bonds from a 300 basis point increase in rates. The percentage loss on zero-coupon investments increases dramatically with maturity and greatly exceeds that on coupon-bearing Treasury bonds at maturities greater than 10 years. Losses of this magnitude could also make FCUs reluctant to sell zero-coupon investments and recognize losses during periods of liquidity stress.

I. Background Information

On December 9, 2011, SBA published a proposed Early Stage SBIC rule to define a new sub-category of SBICs that will focus on making equity investments in early stage small businesses. This initiative is part of President Obama's “Start-Up America Initiative” to encourage American innovation and job creation by promoting high-growth entrepreneurship across the country to help encourage private sector investment in job-creating startups and small firms, accelerate research, and address barriers to success for entrepreneurs and small businesses.

In order to familiarize the public with the content of the proposed Early Stage SBIC rule, SBA will host several Webinars on the proposed rule. Interested parties may choose any Webinar listed in Section II to attend, although one Webinar will be directed towards participants already familiar with the SBIC program and the other Webinars will be directed to those not familiar with the SBIC program. Webinars will be transcribed or summarized and become part of the administrative record. Since the purpose of the Webinars is to familiarize participants with the proposed rule, comments on specific aspects of the rule will not be solicited during the Webinars. Comments regarding the proposed rule must be submitted at www.regulations.gov/#!documentDetail;D=SBA-2011-0023-0001 .

Each session is expected to last no more than 1 hour.

If you are interested in attending any Webinar, you must pre-register by the registration closing date by sending an email to startupamerica@sba.gov. You must include in the SUBJECT line the date of the Webinar for which you wish to participate, and in the body of the email, please provide the following: Participant's Name, Title, Organization Affiliation, Address, Telephone Number, Email Address, and Fax Number. Please also note if you need accommodation because of a disability. SBA will accommodate all reasonable requests made at least one week in advance of the requested Webinar. You must submit your email by the applicable registration closing date listed in Section II of this notice.

Due to technological limitations, participation is limited to 110 registrants per session. If the requested session is unavailable, SBA will try to schedule you for a different session and notify you via email. Because of the limited number of registrants, please only register for one Webinar. If demand exceeds capacity for all three sessions, SBA may consider holding more Webinars. SBA will announce any additional Webinars through a Federal Register notice and on its Web site, www.sba.gov/inv/earlystage .

SBA will confirm the registration via email along with instructions for participating. SBA will post any presentation materials associated with the Webinars on the day of the Webinar at www.sba.gov/inv/earlystage . Participants are responsible for ensuring their systems are compatible with the Webinar software.

If there are specific questions you would like SBA to address during the Webinars, please send your question(s) to SBA no later than January 4, 2012. If there is time at the end of each Webinar, the Webinar will open for questions from participants. Since the Early Stage SBIC rule is in the proposed rulemaking stage, SBA will not be able to answer questions that are outside the scope of the proposed rule. All participants are encouraged to submit comments regarding the proposed rule at www.regulations.gov/#!documentDetail;D=SBA-2011-0023-0001 .

We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.

We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued Emergency AD No. 2007-0082-E, dated March 27, 2007, to correct an unsafe condition for the Eurocopter Model SA330F, G, J and AS332C, C1, L, L1, and L2 helicopters. EASA advises that the emergency AD was issued following two reports of jamming of one of the fuel shut-off control levers discovered during maintenance. In both cases, this jamming originates from solidified grease in the gearboxes. They also found corrosion in a gearbox. Jamming of a fuel shut-off control lever constitutes an unsafe condition because it prevents the shut off of engine fuel and prevents the parallel-mounted electrical micro switches, normally activated by shutting off both of the fuel shut-off control levers, from switching off the electrical power system during an emergency shut down.

We are proposing this AD because we evaluated all known relevant information and determined that the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs.

Eurocopter has issued an Alert Service Bulletin (ASB), Revision 1, dated March 22, 2007, with 3 different numbers (Nos. 76.00.04, 76.00.03, and 76.03). No. 76.03 applies to the United States type-certificated Model SA330F, G, and J and also applies to the non-type-certificated, military Model 330 helicopters. No. 76.00.04 applies to the United States type certificated Model AS332C, C1, L, L1, and L2 helicopters and also applies to the non type-certificated AS332C1 and military Model 332 helicopters. No. 76.00.03 applies to the non type-certificated military Model 532 helicopters. EASA classified this service information as mandatory and issued Emergency AD No. 2007-0082-E, dated March 27, 2007, to correct the same unsafe condition as identified in the service information.

The proposed AD would require within 50 hours time-in-service (TIS), unless already done, cleaning, inspecting and lubricating each gearbox, and adjusting, as necessary, the fuel shut-off control travel by following the Accomplishment Instructions, paragraph 2.B.2. (reference Figures 3 through 7), of Eurocopter ASB No. 76.03, Revision 1, dated March 22, 2007, for the Model SA330F, G, and J, or ASB No. 76.00.04, Revision 1, dated March 22, 2007, for the Model AS332C, L, L1, and L2 helicopters.

• We use the word “inspect” to describe the actions required by a mechanic versus the word “check.”

• We refer to the compliance time as “hours TIS” rather than “flying hours.”

• We use a different compliance time for inspecting and lubricating the gearboxes.

• We are not including the military model helicopters or the Model AS332C1 in the applicability because they are not type certificated in the U.S.

• We are not requiring measuring the operating loads of the fuel shut-off controls per paragraph 1.1 of the MCAI AD (paragraph 2.B.1 of the ASB).

We estimate that this proposed AD would affect about 29 helicopters of U.S. registry. We also estimate that operators may incur the following costs to comply with this AD: $7,395 for the fleet assuming 3 work-hours to lubricate each gearbox at an average labor rate of $85 per work-hour.

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 proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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, I certify this proposed regulation:

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);

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; 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.

We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

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

The Uruguay Round Agreements Act (URAA) amended 35 U.S.C. 154 to provide that the term of a patent ends on the date that is twenty years from the filing date of the application, or the earliest filing date for which a benefit is claimed under 35 U.S.C. 120, 121, or 365(c). See Public Law 103-465, § 532(a)(1), 108 Stat. 4809, 4983-85 (1994). The URAA also contained provisions, codified at 35 U.S.C. 154(b), for patent term extension due to certain examination delays. Under the patent term extension provisions of 35 U.S.C. 154(b) as amended by the URAA, an applicant is entitled to patent term extension for delays due to interference, secrecy order, or successful appellate review. See 35 U.S.C. 154(b) (1995). The Office implemented the patent term extension provisions of the URAA in a final rule published in April of 1995. See Changes to Implement 20-Year Patent Term and Provisional Applications, 60 FR 20195 (Apr. 25, 1995) (twenty-year patent term final rule).

The American Inventors Protection Act of 1999 (AIPA) further amended 35 U.S.C. 154(b) to expand the list of administrative delays which may give rise to patent term adjustment (characterized as “patent term adjustment” in the AIPA). See Public Law 106-113, 113 Stat. 1501, 1501A-552 through 1501A-591 (1999). Specifically, under the patent term adjustment provisions of 35 U.S.C. 154(b) as amended by the AIPA, an applicant is entitled to patent term adjustment for the following reasons: (1) If the Office fails to take certain actions during the examination and issue process within specified time frames (known as the “A” provision, being in 35 U.S.C. 154(b)(1)(A)); (2) if the Office fails to issue a patent within three years of the actual filing date of the application in the United States (known as the “B” provision, being in 35 U.S.C. 154(b)(1)(B)); and (3) for delays due to interference, secrecy order, or successful appellate review (known as the “C” provision, being in 35 U.S.C. 154(b)(1)(C)). See 35 U.S.C. 154(b)(1). The Office implemented the patent term adjustment provisions of 35 U.S.C. 154(b) as amended by the AIPA in a final rule published in September of 2000. See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR 56365 (Sept. 18, 2000) (patent term adjustment final rule).

The patent term adjustment provisions of the AIPA apply to original ( i.e., non-reissue) utility and plant applications filed on or after May 29, 2000. See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR at 56367. The patent term extension provisions of the URAA (for delays due to secrecy order, interference or successful appellate review) continue to apply to original utility and plant applications filed on or after June 8, 1995, and before May 29, 2000. See id.

In April 2011 the Office proposed to revise the patent term extension and adjustment provisions of the URAA and AIPA to provide, with certain exceptions, that the reopening of prosecution by an examiner would be considered a “decision in the review reversing an adverse determination of patentability,” since in many such situations the reopening of the application after a notice of appeal has been filed is the result of a decision in the pre-BPAI review that there is some weakness in the adverse patentability determination from which the appeal was taken, making it appropriate to treat such situations as a “decision in the review reversing an adverse determination of patentability” under the patent term adjustment and extension provisions. See Revision of Patent Term Extension and Adjustment Provisions Relating to Appellate Review and Information Disclosure Statements, 76 FR 18990 (Apr. 6, 2011). The Office received several comments suggesting that a better approach would be to treat the appellate review period as beginning when jurisdiction passes to the BPAI, rather than on the date a notice of appeal to the BPAI was filed. This approach would give applicants the possibility of obtaining patent term adjustment under the “B” provision for Office delays during the pre-BPAI process (including when prosecution is reopened). Specifically, the Office would not subtract from the “B” period the period of time from the filing of the notice of appeal to the earlier of the filing of a reply brief or the expiration of the period to file the reply brief. The Office has decided to seek public comment on this approach. Accordingly, the Office is proposing to change its interpretation of the appellate review language of the “B” provision (35 U.S.C. 154(b)(1)(B)(ii)), and provide that appellate review begins on the date on which jurisdiction over the application passes to the Board of Patent Appeals and Interferences under 37 CFR 41.35 (rather than the date on which a notice of appeal under 35 U.S.C. 134 was filed as in the current rule).

The “B” provision provides for the possibility of patent term adjustment “if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application in the United States.” 35 U.S.C. 154(b)(1)(B). The “B” provision also provides that certain periods are not included in determining whether the issue of a patent is delayed due to the failure of the Office to issue the patent within three years of its filing date, one of such periods being “any time consumed by appellate review by the Board of Patent Appeals and Interferences or by a Federal court.” 35 U.S.C. 154(b)(1)(B)(ii). Since the period of appellate review by the BPAI or a Federal court is not included in determining whether the issue of a patent is delayed due to the failure of the Office to issue the patent within three years of its filing date under the “B” provision, a later beginning of the appellate review by the BPAI, as now being proposed, would result in the possibility of a greater period of patent term adjustment under the “B” provision vis-à-vis the Office's interpretation of this provision in 2000.

The “C” provision provides for the possibility of patent term adjustment “if the issue of an original patent is delayed due to” inter alia “appellate review by the Board of Patent Appeals and Interferences or by a Federal court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability.” 35 U.S.C 154(b)(1)(C). The Office is also proposing to change its interpretation of the appellate review language of the “C” provision (35 U.S.C. 154(b)(1)(C)(iii)). To change the interpretation of the appellate review language of the “B” provision without also changing the appellate review language of the “C” provision would be difficult to justify because it would require the Office to interpret the same statutory term, “appellate review by the Board,” appearing in two closely related provisions, in two different ways. Doing so violates the well-recognized canon of statutory interpretation that the same terms appearing in related statutory provisions are to be given the same meaning. See, e.g., Yi v. Fed. Bureau of Prisons, 412 F.3d 526, 531 (4th Cir. 2005). Since the period of adjustment under the appellate review portion of the “C” provision is the period of appellate review by the BPAI or by a Federal court, a later beginning of the appellate review by the BPAI, as now being proposed, would result in the possibility of a lesser period of patent term adjustment under the “C” provision vis-à-vis the Office's interpretation of this provision in 2000.

The Office recognizes that there is a question as to whether the URAA should be considered instructive in interpreting the “C” provisions of 35 U.S.C. 154(b) as amended by the AIPA. The Office has, until now, treated the AIPA patent term adjustment provisions as an extension of, rather than a replacement for, the URAA patent term extension provisions. The AIPA (like the URAA) provided patent term adjustment for delays caused by secrecy order, interference proceedings, and successful appellate review (the “C” provision), with the legislative history characterizing this provision as the “existing” provisions. See H.R. Rep. No. 106-464, at 125 (1999). The appellate review provision of the URAA provides for patent term extension if “the issue of a patent is delayed due to appellate review by the Board of Patent Appeals and Interferences or by a Federal court and the patent is issued pursuant to a decision in the review reversing an adverse determination of patentability,” and specifically defines the period of appellate review as “includ[ing] any period beginning on the date on which an appeal is filed under section 134 or 141 of this title, or on which an action is commenced under section 145 of this title, and ending on the date of a final decision in favor of the applicant.” See 35 U.S.C. 154(b)(2) and 154(b)(3)(A) as amended by § 532(a) of the URAA, 108 Stat. at 4984.

Since the appellate review provisions of the AIPA use the same phrase as the URAA appellate review provision (“appellate review by the Board of Patent Appeals and Interferences or by a Federal court”) and the AIPA provides no alternative definition of the date that is the beginning of the period of appellate review by the BPAI or by a Federal court, the Office originally interpreted the beginning of the pendency of “appellate review by the Board of Patent Appeals and Interferences or by a Federal court” (35 U.S.C. 154(b)(1)(C)(iii)) using the guidance provided in 35 U.S.C. 154(b)(3)(A) as amended by the URAA for the beginning of the period of appellate review, namely that the beginning of the period of appellate review is the date on which an appeal to the BPAI is filed under 35 U.S.C. 134. See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR, 17215, 17218 and 17227 (Mar. 31, 2000). The USPTO did not receive any comment on its original interpretation of this provision. Finally, the U.S. Court of Appeals for the Federal Circuit has also in passing characterized the “C” provision of the 35 U.S.C. 154(b)(1)(C) as the patent term extension provisions of the URAA. See Wyeth v. Kappos, 591 F.3d 1364, 1372 (Fed. Cir. 2010) (“Before enactment of the AIPA, section 154(b) only provided extensions for the category that now fall under the C adjustments”).

The Office has reconsidered its prior position and now believes that the better view is that the URAA's express definition of the appellate-review period should not carry over to the “C” provision of AIPA, because the URAA definition is completely absent from the AIPA. It is a canon of statutory construction that Congress is presumed to intend its statutory amendments to have “real and substantial effect.” Intel Corp. v. Advanced Micro Devices, Inc., 542 U.S. 241, 258-59 (2004). Thus, when Congress deletes a term or provision from a statute, it is inappropriate to read that term or provision back into the statute. See id. (holding that because Congress amended 28 U.S.C. 1782(a) to delete the requirement that proceedings covered by the statute be “pending,” Court rejected view that this statute comes into play only for pending proceedings). Likewise, the Office now believes that it is not appropriate to read back into the “C” provision of the AIPA the appellate-review definition that Congress deleted from Title 35. Therefore, the Office is also proposing to change its interpretation of the appellate review language of the “C” provision (35 U.S.C. 154(b)(1)(C)(iii)), and also to provide that appellate review begins on the date on which jurisdiction over the application passes to the BPAI under 37 CFR 41.35 (rather than the date on which a notice of appeal under 35 U.S.C. 134 was filed as in the current rule).

The AIPA also sets forth a number of conditions and limitations on any patent term adjustment accrued under 35 U.S.C. 154(b)(1). Specifically, 35 U.S.C. 154(b)(2)(C) provides, in part, that “[t]he period of adjustment of the term of a patent under [35 U.S.C. 154(b)(1)] shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application” and that “[t]he Director shall prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” 35 U.S.C. 154(b)(2)(C)(i) and (iii). The rules of practice (37 CFR 41.37) require that an appeal brief be filed within two months from the date of filing of the notice of appeal under 35 U.S.C. 134 and 37 CFR 41.31. An applicant, however, may delay or prevent the passing of jurisdiction of the application to the BPAI by: (1) Obtaining an extension of time to file the appeal brief; (2) filing an appeal brief that does not comply with the requirements of 37 CFR 41.37; or (3) seeking further prosecution before the examiner by filing a request for continued examination under 37 CFR 1.114. Therefore, the Office is proposing, under its authority under 35 U.S.C. 154(b)(2)(C), to provide that the failure to file an appeal brief in compliance with 37 CFR 41.37 within two months from the date on which a notice of appeal to the BPAI was filed under 35 U.S.C. 134 and 37 CFR 41.31 constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.

Title 37 of the Code of Federal Regulations, Part 1, is proposed to be amended as follows:

Section 1.703: Section 1.703(b)(4), which defines the period of appellate review in 35 U.S.C. 154(b)(1)(B)(ii), is amended to define this period as the sum of the number of days, if any, in the period beginning on the date on which jurisdiction over the application passes to the BPAI under § 41.35 of this title and ending on the date of a final decision in favor of the applicant by the BPAI or by a Federal court in an appeal under 35 U.S.C. 141 or a civil action under 35 U.S.C. 145. Section 1.703(b)(4) currently defines this period as beginning on the date on which a notice of appeal to the BPAI was filed under 35 U.S.C. 134 and § 41.31.

Section 1.703(e), which defines the period of appellate review in 35 U.S.C. 154(b)(1)(C)(iii), is amended to define this period as the sum of the number of days, if any, in the period beginning on the date on which jurisdiction over the application passes to the BPAI under § 41.35 of this title and ending on the date of a final decision in favor of the applicant by the BPAI or by a Federal court in an appeal under 35 U.S.C. 141 or a civil action under 35 U.S.C. 145. Section 1.703(e) currently defines this period as beginning on the date on which a notice of appeal to the BPAI was filed under 35 U.S.C. 134 and § 41.31.

Section 1.704: Section 1.704(c) is amended to provide that the failure to file an appeal brief in compliance with § 41.37 within two months from the date on which a notice of appeal to the BPAI was filed under 35 U.S.C. 134 and § 41.31 constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Section 1.704(c) would also provide that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date two months from the date on which a notice of appeal to the Board of Patent Appeals and Interferences was filed under 35 U.S.C. 134 and § 41.31 of this title and ending on the date an appeal brief was filed in compliance with 41.37 or a request for continued examination was filed in compliance with § 1.114.

A. Regulatory Flexibility Act: For the reasons set forth herein, the Deputy General Counsel for General Law of the United States Patent and Trademark Office has certified to the Chief Counsel for Advocacy of the Small Business Administration that changes proposed in this notice will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b).

The changes to the rules of practice proposed in this notice: (1) Revise the provisions that define the beginning and ending dates of the period of appellate review under 35 U.S.C. 154(b)(1)(B)(ii) and 154(b)(1)(C)(iii) to provide that this period begins on the date on which jurisdiction over the application passes to the BPAI under 37 CFR 41.35; and (2) provide that that the failure to file a proper appeal brief within two months from the date on which a notice of appeal to the BPAI was filed, as required by 35 U.S.C. 134, constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. This notice does not propose to add any additional requirements (including information collection requirements) or fees for patent applicants or patentees.

The proposed changes to 37 CFR 1.703(b)(4) and (e) merely reinterpret the beginning and ending dates of the period of appellate review under 35 U.S.C. 154(b)(1)(B)(ii) and 154(b)(1)(C)(iii). They do not impose any additional burden on applicants. The proposed change to 37 CFR 1.704(c) specifies that the failure to file a proper appeal brief within two months from the date on which a notice of appeal to the BPAI was filed, as required by 35 U.S.C. 134, constitutes failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application would not have will not have a significant economic impact on a substantial number of small entities because: (1) applicants are not entitled to patent term adjustment for examination delays that result from their delay in prosecuting the application (35 U.S.C. 154(b)(2)(C)(i) and 37 CFR 1.704(a)); and (2) applicants may avoid any consequences from this provision simply by filing an appeal brief in compliance with 37 CFR 41.37 (or filing a request for continued examination under 37 CFR 1.114) within two months from the date on which a notice of appeal to the BPAI was filed as required by 35 U.S.C. 134 and § 41.31.

For the foregoing reasons, neither of the changes proposed in this notice will have a significant economic impact on a substantial number of small entities.

B. Executive Order 12866 (Regulatory Planning and Review): This rule making has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

C. Executive Order 13563 (Improving Regulation and Regulatory Review): The Office has complied with Executive Order 13563. Specifically, the Office has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector and the public as a whole, and provided on-line access to the rule making docket; (7) attempted to promote coordination, simplification and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

D. Executive Order 13132 (Federalism): This rule making does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

E. Executive Order 13175 (Tribal Consultation): This rule making will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).

F. Executive Order 13211 (Energy Effects): This rule making is not a significant energy action under Executive Order 13211 because this rule making is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

G. Executive Order 12988 (Civil Justice Reform): This rule making meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

H. Executive Order 13045 (Protection of Children): This rule making does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).

I. Executive Order 12630 (Taking of Private Property): This rule making will not effect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

J. Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ), prior to issuing any final rule, the United States Patent and Trademark Office will submit a report containing the final rule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the Government Accountability Office. The changes in this notice are not expected to result in an annual effect on the economy of 100 million dollars or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this notice is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).

K. Unfunded Mandates Reform Act of 1995: The changes proposed in this notice do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

L. National Environmental Policy Act: This rule making will not have any effect on the quality of environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

M. National Technology Transfer and Advancement Act: The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rule making does not contain provisions which involve the use of technical standards.

N. Paperwork Reduction Act: The rules of practice pertaining to patent term adjustment and extension have been reviewed and approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) under OMB control number 0651-0020. The changes to the rules of practice proposed in this notice: (1) Revise the provisions that define the beginning and ending dates of the period of appellate review under 35 U.S.C. 154(b)(1)(B)(ii) and 154(b)(1)(C)(iii) to provide that this period begins on the date on which jurisdiction over the application passes to the BPAI under 37 CFR 41.35; and (2) provide that that the failure to file a proper appeal brief within two months from the date on which a notice of appeal to the BPAI was filed, as required by 35 U.S.C. 134, constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. This notice does not propose to add any additional requirements (including information collection requirements) or fees for patent applicants or patentees. Therefore, the Office is not resubmitting information collection packages to OMB for its review and approval because the changes proposed in this notice do not affect the information collection requirements associated with the information collections approved under OMB control number 0651-0020 or any other information collections.

Notwithstanding any other provision of law, no person is required to respond to nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number.

For the reasons set forth in the preamble, 37 CFR part 1 is proposed to be amended as follows:

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

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

• Manufacturers, importers, or processors of the subject chemical substance (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 a final SNUR 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 a proposed or final SNUR 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 email. 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.

Under section 5(a)(2) of TSCA, EPA is re-proposing a SNUR previously proposed for phenol, 2,4-dimethyl-6-(1-methylpentadecyl)- (PMN P-94-209; CAS No. 134701-20-5) in the Federal Register of September 9, 1998 (63 FR 48157) (FRL-6020-8) but which was not finalized. In the 1998 proposed SNUR, based on submitted test data, EPA expressed concerns for liver toxicity, kidney toxicity, adrenal toxicity, and blood toxicity. Additionally, based on submitted test data and analogy to phenols, EPA was also concerned that toxicity to aquatic organisms would occur at concentrations as low as 1 part per billion (ppb). EPA determined that use of the substance as described in the Premanufacture Notice (PMN) did not present an unreasonable risk because workers would not be subject to significant dermal exposures and there were no significant environmental releases. EPA also determined that other potential uses of the substance may result in significant dermal exposures to workers and significant environmental releases. Based on this information, the PMN substance met the concern criteria at § 721.170 (b)(3)(i) and (b)(4)(i). In the 1998 proposed SNUR, EPA proposed worker protection requirements as specified in § 721.63 (a)(2)(i) and (a)(3), release to water restrictions as specified in § 721.90 (a)(1), (b)(1), and (c)(1) and associated recordkeeping requirements.

Recently, EPA re-evaluated the information now available on phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-. Since the PMN was initially reviewed, the Agency's Ecological Structure Activity Relationships (EcoSAR) dataset for phenols has been significantly updated to include 203 chemicals, up from 78 chemicals. The additional number of data points has increased the robustness of the category, which has changed the underlying Quantitative Structure Activity Relationships (QSAR). As a result, when the most recent version of EcoSAR was run for phenol, 2,4-dimethyl-6-(1-methylpentadecyl)- in 2011, the program predicted no adverse ecotoxicological effects at saturation for this substance. Additionally, measured water solubility data submitted to the Agency subsequent to the 1998 proposal support the new EcoSAR prediction of no expected acute or chronic adverse ecological effects.

Therefore, based upon the new EcoSAR predictions and the measured water solubility data, EPA now concludes that the ecological hazard and risk of this substance are low. EPA no longer determines that this substance may present an unreasonable risk to the aquatic environment. As a result EPA, based on the new data received and the Agency's predictive tools, no longer finds that the PMN substance meets the concern criteria at § 721.170 (b)(4)(i). Therefore, EPA is re-proposing this SNUR, retaining the previously proposed worker protection requirements specified in § 721.63 (a)(2)(i) and (a)(3), while removing the proposed release to water restrictions specified § 721.90 (a)(1), (b)(1), and (c)(1).

This proposed SNUR would require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of the chemical substance identified as phenol, 2,4-dimethyl-6-(1-methyl pentadecyl)-, (PMN P-94-209; CAS No.134701-20-5), for any activity preliminarily designated by this proposed SNUR 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. The record established for this proposed SNUR is available in the docket under Docket ID number EPA-HQ-OPPT-2011-0633.

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 those listed in TSCA section 5(a)(2). 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 chemical substance that is the subject of this proposed SNUR, EPA considered relevant information about the toxicity of the chemical substance, 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 proposing to establish significant new use and recordkeeping requirements for the chemical substance identified as phenol, 2,4-dimethyl-6-(1-methylpentadecyl)- (P-94-209). In this unit, EPA provides the following information for this chemical substance:

Chemical name: Phenol 2,4-dimethyl-6-(1-methylpentadecyl)-.

Chemical Abstracts Service (CAS) number: 134701-20-5.

Basis for action: The PMN states that the substance will be used as an antioxidant. EPA is not aware of additional uses of this PMN chemical substance. Based on submitted test data, there is concern for liver toxicity, kidney toxicity, adrenal toxicity, and blood toxicity. However, after review of the PMN EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because workers would not be subject to significant dermal exposures. EPA has determined that other potential uses of the substance may result in significant dermal exposures to workers. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(3)(i).

Recommended testing: EPA has determined that a dermal absorption study (OPPTS Test Guideline 870.3250) would help characterize the health effects of the PMN substance. Test reports should include protocols approved by the EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.5725.

During review of phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-, EPA preliminarily determined that one or more of the criteria of concern established at §  721.170 were met, as discussed in Units II and IV.

EPA is proposing this SNUR for a chemical substance that has undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this proposed rule:

• EPA would 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 would 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 would 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.

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/existingchemicals/pubs/tscainventory/index.html.

EPA is issuing this SNUR by notice and comment procedure, as described in §  721.170(d)(4). In accordance with §  721.170(d)(4)(ii)(A), persons are given the opportunity to submit comments on or before January 27, 2012 on whether EPA should establish notification requirements.

To establish a significant “new” use, EPA must determine that the use is not ongoing. EPA solicits comments on whether any of the uses proposed as significant new uses 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 the proposed rule rather than as of the effective date of the final rule. If uses begun after publication of the proposed rule 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 final, and then argue that the use was ongoing before the effective date of the final rule. Thus, persons who begin commercial manufacture, import, or processing activities with the chemical substances that would be regulated as a “significant new use” through this proposed rule, must cease any such activity before the effective date of the rule if and when finalized. 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 proposed SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be 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. EPA recommended certain testing in Unit IV. 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 OPPTS Test Guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

The recommended tests 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.

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 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 proposed rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2011-0633.

This proposed rule would establish a SNUR for a chemical substance that was the subject of a PMN. 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 would amend the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this proposed rule, if the SNUR is subsequently issued as a final 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 would 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 would not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is discussed in this unit. 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 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 over 1,000 SNURs, the Agency receives on average only 5 notices per year. Of those SNUNs submitted from 2006-2008, only one appears to be from a small entity. In addition, the estimated reporting cost for submission of a SNUN (see Unit IX.) 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 would be impacted by this proposed rule. As such, EPA has determined that this proposed rule would 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 would 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 proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would 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 proposed 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 proposed 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), 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).

Therefore, it is proposed that 40 CFR part 721 be amended as follows:

You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this proposed 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 a final SNUR 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 a proposed or final SNUR 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 email. 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 proposing significant new use rules (SNURs) under section 5(a)(2) of TSCA for two chemical substances which were the subject of PMNs and TSCA section 5(e) consent orders. The two chemical substances are identified as rutile, tin zinc, calcium-doped (PMN P-06-36; CAS No. 389623-01-2) and rutile, tin zinc, sodium-doped (PMN P-06-37; CAS No. 389623-07-8). The proposed SNUR on these substances are based on and consistent with the provisions in the underlying consent orders. The proposed SNURs designate as a significant new use the absence of the protective measures required in the corresponding consent orders. These SNURs would require persons who intend to manufacture, import, or process either of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

In the Federal Register of October 5, 2011 (76 FR 61566) (FRL-8880-2), EPA issued direct final SNURs on these two chemical substances in accordance with the procedures at § 721.160(c)(3)(i). EPA received notice of intent to submit adverse comments on these SNURs. Therefore, as required by § 721.160(c)(3)(ii), in the Federal Register of December 5, 2011 (76 FR 75794) (FRL-9329-5), EPA withdrew the direct final SNURs and is now issuing this proposed rule on the two chemical substances. The record for the direct final SNURs on these substances was established as docket EPA-HQ-OPPT-2010-1075. That record includes information considered by the Agency in developing the direct final rule and the notice of intent to submit adverse comments.

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 authorizes EPA to consider any other relevant factors.

To determine what would constitute a significant new use for the two chemical substances that are the subject of these proposed 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 proposing to establish significant new use and recordkeeping requirements for two 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.

• Chemical Abstracts Service (CAS) number.

• Basis for the TSCA section 5(e) consent order.

• Toxicity concerns.

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

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

This proposed rule concerns two PMN substances that 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.

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 New Chemical Exposure Limit (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).

During review of the PMNs submitted for these two chemical substances, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the human health 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 proposed SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These proposed SNURs are issued pursuant to § 721.160.

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

• EPA would 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 would 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 would 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 would 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/existingchemicals/pubs/tscainventory/index.html.

To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review and are subject to TSCA section 5(e) consent orders. The PMN submitters are prohibited by these TSCA section 5(e) consent orders from undertaking activities which EPA is proposing as significant new uses. EPA solicits comments on whether any of the uses proposed as significant new uses are ongoing.

As discussed in the Federal Register issue 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 the proposed rule rather than as of the effective date of the final 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 final, and then argue that the use was ongoing before the effective date of the final rule. Thus, persons who begin commercial manufacture, import, or processing activities with the chemical substances regulated through this proposed SNUR must cease any such activity before the effective date of the rule, if and when finalized. 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 proposed 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. describes those tests. 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 and test reporting. 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.”

In the TSCA section 5(e) consent orders for the two chemical substances regulated under this proposed rule, EPA has established restrictions in view of the lack of data on the potential human health 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.

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 during the development of the direct final rule. EPA's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2010-1075.

This proposed rule would establish SNURs for two chemical substances that were the subject of PMNs and TSCA section 5(e) consent orders. 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 would amend the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this proposed 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 would 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 would 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 substances, the Agency receives only a handful of SNUNs per year. For example, the number of SNUNs was four in Federal fiscal year (FY) 2005, eight in FY 2006, six in FY 2007, eight in FY 2008, and seven in FY 2009. During this 5-year period, three small entities submitted a SNUN. In addition, the estimated reporting cost for submission of a SNUN (see Unit VIII.) is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impacts of complying with those SNURs are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register issue 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 would be impacted by this proposed rule. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect 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 would 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 proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would 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 proposed 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 proposed 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), 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).

Therefore, it is proposed that 40 CFR part 721 be amended as follows:

You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this proposed 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 a final SNUR 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 a proposed or final SNUR 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 email. 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.

These proposed SNURs would, when finalized, require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of the specific chemical substances identified in the PMNs 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 TSCA section 5(a)(2) factors, listed in Unit III. of this document. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) and 40 CFR part 721 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 final 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 17 chemical substances that are the subject of these proposed 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 proposing to establish significant new use and recordkeeping requirements for 17 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 proposed rule.

This proposed rule includes 7 PMN substances whose reported chemical names include the term “carbon nanotube” or “CNT”. Because of a lack of established nomenclature for carbon nanotubes, the TSCA Inventory names for carbon nanotubes are currently in generic form, e.g., carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT). EPA uses the specific structural characteristics provided by the PMN submitter to more specifically characterize the Inventory listing for an individual CNT. All submitters of new chemical notices for CNTs have claimed those specific structural characteristics as CBI. EPA is publishing the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. Confidentiality claims preclude a more detailed description of the identity of these CNTs. If an intended manufacturer, importer, or processor of CNTs is unsure of whether its CNTs are subject to this proposed SNUR or any other SNUR, the company can either contact EPA or obtain a written determination from EPA pursuant to the bona fide procedures at § 721.11. EPA is using the specific structural characteristics, for all CNTs submitted as new chemical substances under TSCA, to help develop standard nomenclature for placing these chemical substances on the TSCA Inventory. EPA has compiled a generic list of those structural characteristics entitled “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature.” A copy of this list is available in the docket for these proposed SNURs under docket ID number EPA-HQ-OPPT-2010-0279. If EPA develops a more specific generic chemical name for these materials, that name will be made publicly available.

The regulatory text section of this proposed rule specifies the activities designated as significant new uses. Certain new uses, including exceeding production volume limits (i.e., limits on manufacture and importation volume) and other uses designated in this rule, may be claimed as CBI.

This proposed rule includes 15 PMN substances 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 proposed pursuant to § 14;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 has 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 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 proposed rule also includes SNURs on 2 PMN substances that are not subject to a consent order 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 met the criteria set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in these PMNs could result in increased exposures, and therefore should be designated a significant new use. These so-called “non-5(e) SNURs” are being proposed 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 name: Ethane, 2-bromo-1, 1-difluoro-.

CAS number: 359-07-9.

Effective date of the TSCA section 5(e) consent order: February 16, 2010.

Basis for the TSCA section 5(e) consent order: The PMN states that the substance will be used as a chemical intermediate for an herbicide. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order: (1) Requires use of personal protective equipment including impervious gloves and a National Institute for Occupational Safety and Health (NIOSH)-certified supplied-air respirator operated in pressure demand or other positive pressure mode and equipped with a tight-fitting full facepiece with an assigned protection factor (APF) of at least 75, or compliance with a NCEL of 0.5 mg/m 3 as an 8-hour time-weighted average; (2) requires establishment of a hazard communication program; (3) prohibits use of the PMN substance other than as a chemical intermediate for an herbicide; and (4) requires corresponding recordkeeping. The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data on analogous structurally similar alkyl halides, EPA identified health concerns for systemic toxicity, developmental toxicity, reproductive toxicity, and cancer in workers exposed to the PMN substance by the inhalation route.

Recommended testing: EPA has determined that a carcinogenicity test (OPPTS Test Guideline 870.4200) in rats by the inhalation route would help characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed a particular production volume limit without performing this test.

CFR citation: 40 CFR 721.10265.

Chemical names: Multi-walled carbon nanotubes (generic) (P-08-733 and P-08-734).

CAS numbers: Not available.

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

Basis for the TSCA section 5(e) consent order: The PMNs state that the generic (non-confidential) uses of the substances will be as: Reinforcement for composites, conductive additive for composites, and conductive additive for batteries. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that these substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the consent order: (1) Requires use of personal protective equipment including gloves and chemical protective clothing, and a NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 filter with an APF of at least 50; (2) prohibits the domestic manufacture of the PMN substances; (3) restricts use of the PMN substances to those uses specified in the consent order; prohibits the release of the PMN substances into the waters of the United States; and (4) requires corresponding recordkeeping. The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data for analogous chemicals, including other carbon nanotubes, there are concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity of the PMN substances. Based on test data on respirable, poorly soluble particulates, EPA has concerns for lung effects. There are also data suggesting that pulmonary deposition of some nanoscale materials, including carbon nanotubes in the agglomerated form, may induce cardiovascular toxicity when these nanoscale materials are inhaled. The major health concerns are for potential pulmonary toxicity, fibrosis, and cancer to workers exposed via inhalation. Sublethal effects have been noted for some carbon nanoscale substances in fish at levels as low as 100 parts per billion (ppb). Further, studies need to be conducted before EPA can determine a concentration of concern. Such studies must measure actual concentrations of carbon nanotubes and control for the effects of contaminants, solvents, and physical factors such as blockage of gills or intestines.

Recommended testing: EPA has determined that the following tests would help characterize possible effects of the substances. The PMN submitter has agreed not to exceed a specified production limit without performing these tests on one of the PMN substances: A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or Organisation for Economic Co-operation and Development (OECD) Test Guideline 413) with a post-exposure observation period of up to 3 months, bronchoalveolar lavage fluid (BALF) analysis, a determination of cardiovascular toxicity (clinically-based blood/plasma protein analyses), and histopathology of the heart and certain material characterization data.

CFR citation: 40 CFR 721.10266.

Chemical names: (P-09-54) [5,6]Fullerene-C60-Ih; (P-09-55) [5,6]Fullerene-C70-D5h(6); (P-09-56) [5,6]Fullerene-C84-D2; and (P-09-57) [5,6]Fullerene-C84-D2d.

CAS numbers: (P-09-54) 99685-96-8; (P-09-55) 115383-22-7; (P-09-56) 145809-19-4; and (P-09-57) 145809-20-7.

Effective date of the TSCA section 5(e) consent order: August 16, 2010.

Basis for the TSCA section 5(e) consent order: The PMN states that uses of the substances will be as: An intermediate compound for use in producing downstream products that will in turn be used in organic electronic devices and an additive to improve mechanical properties or conductivity; a compound used to improve the mechanical properties of rubbers, plastics, and lubricants; and a compound for use as an additive to increase the conductivity of materials. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that these substances may present an unreasonable risk of injury to human health. To protect against this risk, the consent order: (1) Requires use of personal protective equipment including gloves and protective clothing impervious to the chemical substances and a NIOSH-certified full-face respirator with N-100 cartridges; (2) restricts use of the PMN substances to those uses specified in the consent order; (3) prohibits release of the PMN substances into the waters of the United States; and (4) requires corresponding recordkeeping. The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data on poorly soluble particulates, including some carbon-based nano-sized chemicals, and test data correlating lung irritation to particle size, EPA has concerns for lung effects from inhalation exposure.

Recommended testing: EPA has determined that the following tests would help characterize possible effects of the substances. The PMN submitter has agreed not to exceed a particular production limit without performing these tests on all of the PMN substances: Dry particle size distribution by count for each PMN substance in a form which has the highest content of particles smaller than 10 microns as manufactured, processed, or used in the workplace at sites controlled by the PMN submitter (the method shall be scanning transmission electron microscopy, using a dry particle counting method, with a resolution of less than 1 nanometer and with no counting after dispersion in a solution and evaporating solvent) and dustiness (EN 15051 method).

EPA has determined that the results of the following tests would help characterize the human health effects of the PMN substance. The order does not require the submission of the following information at any specified time or production volume: 90-day inhalation toxicity (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413); dispersion and solubility in fresh water without the use of dispersants or solvents (Refs. 1 and 2). However, the order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance 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 721.10267 (P-09-54); 40 CFR 721.10268 (P-09-55); 40 CFR 721.10269 (P-09-56); and 40 CFR 721.10270 (P-09-57).

Chemical names: (P-09-142 and Chemical A in P-09-416) 3′-H-cyclopropa[1,9][5,6]fullerene-C60-Ih-3′-butanoic acid, 3′-phenyl-, methyl ester; (P-09-143 and Chemical B in P-09-416) 3′H-cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3′-butanoic acid, 3′-phenyl-, methyl ester; and (P-09-144 and Chemical C in P-09-416) 3′H-cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3′-butanoic acid, 3′-phenyl-, methyl ester.

CAS numbers: (P-09-142 and Chemical A in P-09-416) 160848-22-6; (P-09-143 and Chemical B in P-09-416) 609771-63-3; and (P-09-144 and Chemical C in P-09-416) 1051371-21-1.

Effective date of the TSCA section 5(e) consent orders: (P-09-142, P-09-143, and P-09-144) November 1, 2010 and (P-09-416) October 28, 2010.

Basis for the TSCA section 5(e) consent orders: The PMNs state that the uses of the substances will be: As a compound used in fabrication and/or operation of electronic devices that enables or improves the conductivity, efficiency, voltage, or other characteristics of the device, and a compound that improves the mechanical properties of lubricants and plastics (P-09-142, P-09-143, and P-09-144), and as acceptor molecules in a polymer coating in an encapsulated organic photovoltaic electronic device (P-09-416). The orders were issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that these substances may present an unreasonable risk of injury to human health. To protect against these risks, the consent orders: (1) Require the use of personal protective equipment including impervious gloves and chemical protective clothing and use of a NIOSH-certified air-purifying tight-fitting full-face respirator equipped with N-100 cartridges; (2) restrict use of the PMN substances to those uses specified in their respective consent orders; (3) prohibit release of the PMN substances into the waters of the United States; and (4) require corresponding recordkeeping. The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data on poorly soluble particulates, including some carbon-based nano-sized chemicals, and test data correlating lung irritation to particle size, EPA has concerns for lung effects from inhalation exposure.

Recommended testing: EPA has determined that the following tests would help characterize the human health effects of the PMN substances. The consent orders each contain two production limits. The PMN submitters have agreed not to exceed their first production limits without performing a 90-day inhalation toxicity study (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) in rats with a post exposure observation period of up to 3 months, including a BALF analysis, a determination of cardiovascular toxicity (clinically-based blood/plasma protein analyses), and histopathology of the heart and certain material characterization data on the test material which can be any one of these PMN substances. The PMN submitters have also agreed not to exceed the second production limits without providing certain physical-chemical properties on each of the PMN substances.

The consent order for P-09-416 does not require the submission of the following information at any specified time or production volume: Dispersion and solubility in fresh water without the use of dispersants or solvents (Refs. 1 and 2) and daphnid chronic toxicity test (OPPTS Test Guideline 850.1300). However, the order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance 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 721.10271 (P-09-142 and Chemical A in P-09-416); 40 CFR 721.10272 (P-09-143 and Chemical B in P-09-416); and 40 CFR 721.10273 (P-09-144 and Chemical C in P-09-416).

Chemical name: Multi-walled carbon nanotubes (generic) (P-09-188).

CAS number: Not available.

Effective date of the TSCA section 5(e) consent order: December 14, 2010.

Basis for the TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an electric conductive filler to replace conventional material such as carbon black or carbon fiber in matrices such as polymer resin for conductive applications. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the consent order: (1) Requires use of personal protective equipment including gloves and chemical protective clothing impervious to the PMN substance, and a NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 filter with an APF of at least 50; (2) prohibits domestic manufacture in the United States; (3) restricts use of the PMN substance to those uses specified in the consent order; (4) prohibits the manufacture, processing, or use of the PMN substance for commercial or consumer products, or in a consumer product; prohibits release of the PMN substance into the waters of the United States; and (5) requires corresponding recordkeeping. The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data for analogous chemicals including other carbon nanotubes there are concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity of the PMN substance. Based on test data on respirable, poorly soluble particulates, EPA has concerns for lung effects. There are also data suggesting that pulmonary deposition of some nanoscale materials, including carbon nanotubes in the agglomerated form, may induce cardiovascular toxicity when these nanoscale materials are inhaled. The major health concerns are for potential pulmonary toxicity, fibrosis, and cancer to workers exposed via inhalation. Sublethal effects have been noted for some carbon nanoscale substances in fish at levels as low as 100 ppb. Further studies need to be conducted before EPA can determine a concentration of concern. Such studies must measure actual concentrations of carbon nanotubes and control for the effects of contaminants, solvents, and physical factors such as blockage of gills or intestines.

Recommended testing: EPA has determined that the following tests would help characterize possible effects of the PMN substance. The PMN submitter has agreed not to exceed two production volume limits specified in the order without performing these tests: A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) with a post-exposure observation period of up to 3 months, a BALF analysis, determination of cardiovascular toxicity, heart histopathology, data on pulmonary deposition, and certain material characterization and physical-chemical properties on the test material(s).

The order does not require the submission at any specified time or production volume of the following exposure data on representative forms of the PMN substance: Release of the PMN substance after landfill disposal (EPA Method 1320), release of the PMN substance during burning (American Society for Testing and Materials International (ASTM) E1354-09), release of the PMN substance after exposure to sunlight (ASTM D2565-99 (2008)), and release of the PMN substance during shipping and use. However, the order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information. The company may propose alternative methods, guidelines, or representative sets subject to EPA's approval.

CFR citation: 40 CFR 721.10274.

Chemical name: Multi-walled carbon nanotubes (generic) (P-09-417).

CAS number: Not available.

Effective date of the TSCA section 5(e) consent order: March 23, 2010.

Basis for the TSCA section 5(e) consent order: The PMN states that the use of the substance will be as a plastics additive to improve electrical, thermal, and/or mechanical properties. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the consent order: (1) Requires use of personal protective equipment including gloves and protective clothing impervious to the chemical substance and NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 filter with an APF of 50; (2) prohibits the domestic manufacture of the PMN substance; (3) restricts use of the PMN substance to the uses specified in the consent order; (4) prohibits use of the PMN substance in commercial or consumer products; (5) prohibits release of the PMN substance into the waters of the United States during processing and use activities; and (6) requires corresponding recordkeeping. The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data for analogous chemicals including other carbon nanotubes there are concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity of the PMN substance. Based on test data on the PMN substance and respirable, poorly soluble particulates, EPA has concerns for lung effects. There are also data suggesting that pulmonary deposition of some nanoscale materials, including carbon nanotubes in the agglomerated form, may induce cardiovascular toxicity when these nanoscale materials are inhaled. The major health concerns are for potential pulmonary toxicity, fibrosis, and cancer to workers exposed via inhalation. Sublethal effects have been noted for some carbon nanoscale substances in fish at levels as low as 100 ppb. Further studies need to be conducted before EPA can determine a concentration of concern. Such studies must measure actual concentrations of carbon nanotubes and control for the effects of contaminants, solvents, and physical factors such as blockage of gills or intestines.

Recommended testing: EPA has determined that the following test would help characterize the possible effects of the PMN substance. The PMN submitter has agreed not to exceed the production limit without providing certain physical/chemical properties test data. The order does not require the submission of the following information at any specified time or production volume: The results of a combined chronic toxicity/carcinogenicity testing of respirable fibrous particles test (OPPTS Test Guideline 870.8355). However, the order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10275.

Chemical names: Multi-walled carbon nanotubes (generic) (P-10-39) and single-walled and multi-walled carbon nanotubes (generic) (P-10-40).

CAS numbers: (P-10-39) Not available and (P-10-40) not available.

Effective date of the TSCA section 5(e) consent order: August 30, 2010.

Basis for the TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substances will be as composite structures for defense, electronic, and aerospace applications. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that these substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the consent order: (1) Requires use of personal protective equipment including gloves and protective clothing impervious to the chemical substances, and a NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 filter with an APF of at least 50; (2) restricts use of the PMN substances to the uses specified in the consent order; (3) prohibits manufacture, processing, or use of the PMN substance for commercial or consumer products; (4) prohibits release of the PMN substances into the waters of the United States; and (5) requires corresponding recordkeeping. The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data for analogous chemicals including other carbon nanotubes there are concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity of the PMN substances. Based on test data on respirable, poorly soluble particulates, EPA has concerns for lung effects. There are also data suggesting that pulmonary deposition of some nanoscale materials, including carbon nanotubes in the agglomerated form, may induce cardiovascular toxicity when these nanoscale materials are inhaled. The major health concerns are for potential pulmonary toxicity, fibrosis, and cancer to workers exposed via inhalation. Sublethal effects have been noted for some carbon nanoscale substances in fish at levels as low as 100 ppb. Further studies need to be conducted before EPA can determine a concentration of concern. Such studies must measure actual concentrations of carbon nanotubes and control for the effects of contaminants, solvents, and physical factors such as blockage of gills or intestines.

Recommended testing: EPA has determined that the following tests would help characterize the possible effects of the PMN substances. The consent order contains three production limits. The PMN submitter has agreed not to exceed the first production limit without submitting certain material characterization data on both substances. The PMN submitter has agreed not to exceed the second production limit without performing workplace exposure monitoring and characterization testing (including byproducts) as well as quantification and characterization of substances that may be released during exposures typical during the use phase. The PMN submitter has also agreed not to exceed the third production limit without performing a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) with a post-exposure observation period of up to 3 months, a BALF analysis, determination of cardiovascular toxicity, heart histopathology, data on pulmonary deposition, and certain material characterization and physical-chemical properties on either or both of the substances that workers may be exposed to.

CFR citations: 40 CFR 721.10276 (P-10-39) and 40 CFR 721.10277 (P-10-40).

Chemical name: 4,4′-Bipyridinium, 1-(phosphonoalkyl)-1′-substituted-, salt with anion (1:2) (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a constituent in ink formulation. Based on test data on a salt of the anion of the PMN substance and analogous respirable poorly soluble particulates, EPA identified concerns for toxicity concerns to the liver and lung and neurotoxicity to workers exposed to the PMN substance. For the uses described in the PMN, significant worker exposure is unlikely, as dermal and inhalation exposure will be minimal due to adequate personal protective equipment and no domestic manufacture. Therefore, EPA has not determined that the proposed manufacturing method, processing method, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the PMN substance: (1) Without the use of impervious gloves where there is potential for dermal exposure, (2) without the use of a NIOSH-certified respirator with an APF of at least 10 where there is potential inhalation exposure, (3) involving domestic manufacture, (4) other than as described in the PMN, (5) where the annual manufacture and importation volume exceeds 1,000 kilograms, or (6) in the form of a powder or a solid may cause serious health effects. 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 a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10278.

Chemical name: Multi-walled carbon nanotubes (generic) (P-10-246).

CAS number: Not available.

Effective date of the TSCA section 5(e) consent order: April 4, 2011.

Basis for the TSCA section 5(e) consent order: The PMN states that the use of the substance will be as a conductivity additive to resins, rubber, and battery electrodes. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the order: (1) Requires use of personal protective equipment including gloves and protective clothing impervious to the chemical substance, and at minimum, a NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 cartridges or power air purifying particulate respirator with an APF of at least 50; (2) prohibits the domestic manufacture of the PMN substance; (3) restricts use of the PMN substance to the uses specified in the consent order; (4) prohibits release of the PMN substance into the waters of the United States during processing and use activities; and (5) requires corresponding recordkeeping. The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data for analogous chemicals including other carbon nanotubes there are concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity of the PMN substances. Based on test data on respirable, poorly soluble particulates, EPA has concerns for lung effects. There are also data suggesting that pulmonary deposition of some nanoscale materials, including carbon nanotubes in the agglomerated form, may induce cardiovascular toxicity when these nanoscale materials are inhaled. The major health concerns are for potential pulmonary toxicity, fibrosis, and cancer to workers exposed via inhalation. Sublethal effects have been noted for some carbon nanoscale substances in fish at levels as low as 100 ppb. Further studies need to be conducted before EPA can determine a concentration of concern. Such studies must measure actual concentrations of carbon nanotubes and control for the effects of contaminants, solvents, and physical factors such as blockage of gills or intestines.

Recommended testing: EPA has determined that the results of the following tests would help characterize possible effects of the PMN substance. The PMN submitter has agreed not to exceed a specified production time limit before performing these tests on the PMN substance: A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) in rats with a post exposure observation period of up to 3 months, including a BALF analysis, a determination of cardiovascular toxicity (clinically-based blood/plasma protein analyses), and histopathology of the heart and certain material characterization data.

CFR citation: 40 CFR 721.10279.

Chemical name: Benzene, ethenyl-, polymer with 1,3-butadiene.

CAS number: 1195978-93-8.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymer additive. Based on analogous high molecular weight polymers, EPA identified concerns for potential lung overload from exposure to the PMN substance via inhalation. Specifically, EPA predicts potential toxicity to consumers and the general population from inhalation of respirable particles of 10 microns or less of the PMN substance where the average number molecular weight is greater than 10,000 daltons. Further, based on the physical/chemical properties of the PMN substance, EPA has concluded, if the PMN substance were manufactured where the average number molecular weight is less than 1,000 daltons, the PMN substance may be considered persistent, bio-accumulative, and toxic (PBT), as described in the New Chemical Program's PBT category (64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates, if the PMN substance were manufactured where the average number molecular weight is less than 1,000 daltons, that the PMN substance will persist in the environment more than six months and estimates a bioaccumulation factor of greater than or equal to 1,000. For the manufacturing method, processing method, and use described in the PMN, significant inhalation exposures are unlikely, and the PMN is not considered to be a PBT. Accordingly, EPA has not determined that the proposed manufacturing method, processing method, or use of the substance as described in the PMN notice may present an unreasonable risk. EPA has determined, however, that any manufacturing method, processing method, or use of the PMN substance where greater than 5 percent of the particles are in the respirable range of 10 microns or less and the average number molecular weight is greater than 10,000 daltons may cause serious health effects. EPA has also determined that any manufacturing method, processing method, or use of the PMN substance where the average number molecular weight is less than 1,000 daltons may cause significant adverse environmental effects and may be characterized as a potential PBT substance. 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 following testing would help characterize the possible human health effects and potential PBT attributes of the PMN substance: A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) with a 60-day holding period (for the PMN substance where greater than 5 percent is in the respirable range of 10 microns or less and the average number molecular weight is greater than 10,000 daltons) and the tiered testing described in the New Chemicals Program's PBT Category (64 FR 60194; November 4, 1999) (FRL-6097-7) (for the PMN substance where the average number molecular weight is less than 1,000 daltons). Test reports should include protocols approved by EPA, certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10280.

During review of the PMNs submitted for the chemical substances that are subject to these proposed SNURs, EPA concluded that for 15 of the 17 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 proposed SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are being proposed pursuant to §  721.160.

In the other 2 cases, where the uses were 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 proposing 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 proposed rule:

• EPA would 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 would 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 would 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 would 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/existingchemicals/pubs/tscainventory/index.html.

EPA is issuing these SNURs by notice and comment procedure, as described in § 721.170(d)(4). In accordance with § 721.170(d)(4)(ii)(A), persons are being given the opportunity to submit comments on or before January 27, 2012 on whether EPA should establish notification requirements.

To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 15 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. EPA is soliciting comments on whether any of the uses proposed as significant new uses are ongoing.

As discussed in the Federal Register of April 24, 1990, 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 proposed rule rather than as of the effective date of the final rule. If uses begun after publication of the proposed rule 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 final, and then argue that the use was ongoing before the effective date of the final rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances that would be regulated through these proposed SNURs will have to cease any such activity before the effective date of the rule if and when finalized. 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 these proposed SNURs before the effective date. If a person were to meet the conditions of advance compliance under §  721.45(h), the person would be 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. There are two exceptions:

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 also 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 the TSCA section 5(e) consent orders for 15 of the chemical substances regulated under this proposed 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.

In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists tests required or recommended in each of the section 5(e) consent orders underlying the proposed 5(e) SNURs, and lists tests recommended for the substances subject to the proposed 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 OPPTS 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. To access the European standard, EN 15051 method, issued by The European Committee for Standardization (CEN), please go to http://www.cen.eu/cen/products. To access EPA Method 1320, please go to http://www.epa.gov/osw/hazard/testmethods/sw846/pdfs/1320.pdf.

When physical/chemical properties of test material and/or material characterization tests are recommended for nanoscale substances that are the subject of this proposed rule, you should take into consideration the characterizations identified in the Guidance Manual for the Testing of Manufactured Nanomaterials: OECD's Sponsorship Programme, which is available at http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2009)20/rev&doclanguage=en.

The recommended testing specified in Unit IV. of this document 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.

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 to EPA on EPA Form No. 7710-25 in accordance with the procedures set forth in § 721.25 and § 720.40. Forms and information are available on-line 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 proposed rule. EPA's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2010-0279.

The following is a listing of the documents that have been placed in the proposed rule phase of the docket under docket ID number EPA-HQ-OPPT-2010-0279, which is available for inspection as specified under ADDRESSES .

1. Cheng, X., Kan, A.T., and Tomson, M.B. Napthalene Adsorption and Desorption from Aqueous C 60 Fullerene. Journal of Chemical & Engineering Data. 2004, 49 (3), 675-683.

2. Brant, J., Lecoanet, H., Hotze, M., and Wiesner, M. Comparison of Electrokinetic properties of Colloidal Fullerenes (n-C 60 ) Formed Using Two Procedures. Environmental Science & Technology 2005, 39 (17), 6343-6351.

This proposed rule would establish SNURs for several new chemical substances that were the subject of PMNs, and, in some cases, TSCA section 5(e) consent orders. 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 would amend the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in these proposed SNURs, if the SNURs are subsequently issued as final rules. 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 would 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 these SNURs would not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is discussed in this unit. 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 proposed 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 (FY) 2005, eight in FY 2006, six in FY 2007, eight in FY 2008, and seven in FY 2009. During this 5-year period, three small entities submitted a SNUN. In addition, the estimated reporting cost for submission of a SNUN (see Unit X.) is minimal regardless of the size of the firm. Therefore, the potential economic impacts of complying with these SNURs would not be 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 would be impacted by this proposed rule. As such, EPA has determined that this proposed rule would 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 would 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 proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would 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 proposed 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 proposed 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), 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).

Therefore, it is proposed that 40 CFR part 721 be amended as follows:

This is a summary of a Public Notice released by the Office of General Counsel on December 8, 2011. The full text of this document is available for public inspection and copying during regular business hours in the Commission's Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street SW., Room CY-B402, Washington, DC 20554, telephone (202) 488-5300, facsimile (202) 488-5563 or via email FCC@BCPIWEB.com. The full text may also be downloaded at http://www.fcc.gov. Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

■ Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://fjallfoss.fcc.gov/ecfs2/.

■ Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

■ All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

■ Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

■ U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington, DC 20554.

Documents will be available for public inspection and copying during business hours at the FCC Reference Information Center, Portals II, Room CY-A257, 445 12th Street SW., Washington, DC 20554. The documents may also be purchased from BCPI, telephone (202) 488-5300, facsimile (202) 488-5563, TTY (202) 488-5562, email fcc@bcpiweb.com.

People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (tty). The Commission has designated this proceeding as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. 47 CFR 1.1200 et seq.; Amendment of Certain of the Commission's Part 1 Rules of Practice and Procedure and Part 0 Rules of Commission Organization, Notice of Proposed Rulemaking, 25 FCC Rcd 2430, 2439-40 (2010). Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with § 1.1206(b) of the Commission's rules. In proceedings governed by § 1.49(f) of the Commission's rules or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format ( e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

This Public Notice seeks comment on the Commission's Preliminary Plan for Retrospective Analysis of Existing Rules, released on November 7, 2011. The Preliminary Plan describes the Commission's ongoing process of identifying outmoded or counterproductive rules and provides an overview of recent and current proceedings that include retrospective analysis. The Commission seeks comment generally on the Preliminary Plan.

The Commission is committed to being a responsive, efficient and effective agency that harnesses and promotes the technological and economic opportunities of the new millennium. As part of the Commission's goal to be a model of excellence in government, the agency has, since 2009, undertaken far-reaching initiatives designed to achieve its statutory objectives while removing burdens on industry and promoting innovation and job growth.

In furtherance of these objectives, the Commission seeks comment on the following questions: What additional steps should the Commission take to identify rules that should be changed, streamlined, consolidated, or removed? How can the Commission further reduce burdens on industry and consumers while fostering competition, diversity and innovation? Are there Commission rules or reporting requirements that are duplicative or that have conflicting requirements among its bureaus and offices or with other agencies? Are there Commission rules or reporting requirements that could be modified to better accomplish their regulatory objectives? In addition, commenters are encouraged to submit other suggestions that may help the Commission develop better regulations and processes. Commenters are asked to specifically identify the rules or reporting requirements they are addressing and to provide specific suggestions for ways the Commission should modify such rules or reporting requirements, including alternative language where possible.

The HOS requirements for motorcoach operators have not been substantially revised in several decades. The FMCSA did not include changes to the motorcoach HOS requirements in its April 28, 2003 final rule (68 FR 22456) concerning HOS requirements for truck drivers or in subsequent revisions of that rule because the Agency did not have enough data and information on motorcoach operations to form the basis of a rulemaking. Motorcoach operations differ significantly from trucking operations and the information upon which the Agency relied for its truck drivers' rule did not address the unique fatigue issues associated with the scheduling and operating practices of the motorcoach industry.

The current HOS rules for passenger-carrying commercial motor vehicle (CMVs) operations allow up to 10 hours of driving time following 8 consecutive hours off duty. Driving is prohibited after the operator has accumulated 15 hours of on-duty time following 8 consecutive hours off duty (15-hour rule). However, miscellaneous off-duty periods during the day are not counted in the 15-hour window. Therefore, the amount of time between the beginning of the work day and driver completing all driving tasks may exceed 15 hours.

With regard to weekly limitations, drivers of passenger-carrying CMVs are prohibited from driving after accumulating: 60 hours of on-duty time in any 7 consecutive days if the employing motor carrier does not operate CMVs every day of the week; or, 70 hours in any period of 8 consecutive days if the employing motor carrier operates CMVs every day of the week.

The listening session is open to the public. Speakers' remarks will be limited to 5 minutes each. The public may submit material to the FMCSA staff at the session for inclusion in the public docket, FMCSA-2011-0373.

The Agency seeks data and answers relating to the following issues and questions. The comments sought below may be submitted in written form at the session and summarized verbally, if desired.

1. Driving Time. FMCSA seeks information or data that examine fatigue and safety differences associated with different driving time periods.

2. Duty Time/Driving Window. FMCSA solicits information on patterns of work for motorcoach drivers.

3. Time-On-Task (TOT) Function. The Agency seeks comments and information on methods for evaluating fatigue associated with the time motorcoach operators spend on the actual driving task during the work day. The Agency is interested in suggestions for estimating TOT effects, especially information on where it might obtain data on exposure and other motorcoach driver characteristics that would enable it to estimate how or whether crash risk varies over successive hours of daily driving.

4. Cumulative Fatigue. The Agency seeks comments and information on the effects of cumulative fatigue during the work week, particularly in the form of scientific studies or data that would allow evaluation of cumulative fatigue and its impact on workplace safety, motorcoach driver safety performance, and productivity.

FMCSA will webcast the listening session on the Internet. Specific information on how to participate via the Internet and the telephone access number will be on the FMCSA Web site at http://www.fmcsa.dot.gov. FMCSA will docket the transcripts of the webcast and a separate transcription of the listening session that will be prepared by an official court reporter.