The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 provides for the regulation of certain biological agents and toxins that have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the primary responsibility for implementing the provisions of the Act within the Department of Agriculture (USDA). Plant Protection and Quarantine (PPQ) select agents and toxins are those that have been determined to have the potential to pose a severe threat to plant health or plant products. Veterinary Services (VS) select agents and toxins are those that have been determined to have the potential to pose a severe threat to animal health or animal products. Overlap select agents and toxins— i.e. , those determined to have the potential to pose a severe threat to public health and to animal health or animal products—are subject to regulation by both APHIS and the Centers for Disease Control and Prevention (CDC), which has the primary responsibility for implementing the provisions of the Act for the Department of Health and Human Services (HHS).

Subtitle B (which is cited as the “Agricultural Bioterrorism Protection Act of 2002” and referred to below as the Act), section 212(a), provides, in part, that the Secretary of Agriculture (the Secretary) must establish by regulation a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products. Paragraph (a)(2) of section 212 requires the Secretary to review and republish the list every 2 years and to revise the list as necessary.

In determining whether to include an agent or toxin on the list, the Act requires that the following criteria be considered:

• The effect of exposure to the agent or toxin on animal or plant health, and on the production and marketability of animal or plant products;

• The pathogenicity of the agent or the toxin and the methods by which the agent or toxin is transferred to animals or plants;

• The availability and effectiveness of pharmacotherapies and prophylaxes to treat and prevent any illness caused by the agent or toxin; and

• Any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.

On August 28, 2007, in accordance with the Act, we published in the Federal Register (72 FR 49231-49236, Docket No. APHIS-2007-0033) a proposal  1 to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products.

We solicited comments concerning our proposal for 60 days ending October 29, 2007. We received 41 comments by that date. On November 16, 2007, we published a notice in the Federal Register (72 FR 64540) to reopen the comment period for an additional 15 days to allow interested persons additional time to prepare and submit comments. We received an additional 21 comments by the December 3, 2007, close of the reopened comment period, for a total of 62 comments. The comments we received on the proposed rule were from academic institutions, professional associations, corporations, nonprofit organizations, individuals, and representatives of State and Federal Government agencies. The comments are discussed below.

The list of PPQ select agents and toxins in 7 CFR 331.3 has included entries for Candidatus Liberobacter asiaticus and Candidatus Liberobacter africanus. In our proposed rule, we proposed to add Candidatus Liberobacter americanus to the list and to remove the entry for Candidatus Liberobacter asiaticus.

Many commenters supported the proposed delisting of Candidatus Liberobacter asiaticus, but opposed the proposed listing of Candidatus Liberobacter americanus, arguing that the presence of citrus greening disease in Florida makes both plant pathogens unlikely agents of bioterrorism. A majority of those commenters also recommended that that Candidatus Liberobacter africanus should also be removed from the list of PPQ select agents and toxins for that same reason. Those commenters pointed out that in the field there are no apparent differences in the biology of the three plant pathogens and that there are few, if any, established polymerase chain reaction primers available to distinguish among them. Only one commenter supported the proposed listing of Candidatus Liberobacter americanus based on the assertion that it is more readily transmittable than Candidatus Liberobacter asiaticus; however, we are unaware of any evidence to support that specific assertion.

In response to the points raised by these commenters, we have reevaluated the available science. We agree with the commenters that it is difficult to distinguish between the three plant pathogens. In fact, in the Citrus Health Response Program developed by APHIS and Florida regulatory officials in consultation with the Florida citrus industry and other stakeholders, the management responses for the three bacterial species are identical. Further, we agree that the presence of citrus greening disease in Florida makes them unlikely agents of bioterrorism, as does the long latency period of the disease. Therefore, in this final rule, in addition to delisting Candidatus Liberobacter asiaticus as proposed, we are also removing Candidatus Liberobacter africanus from the list of PPQ select agent and toxins and have decided not to list Candidatus Liberobacter americanus as we had originally proposed.

The list of PPQ select agents and toxins has included an entry for Xanthomonas oryzae pv. oryzicola . In our proposed rule, we proposed to remove the pathovar designation (pv. oryzicola ) from the currently listed organism and thus regulate both pathovars of Xanthomonas oryzae ( i.e. , both oryzicola and oryzae ).

Several commenters argued that the proposed removal of the pathovar designation from Xanthomonas oryzae pv. oryzicola is unnecessary because the exposure of Xanthomonas oryzae pv. oryzae in the United States carries low risk for significant and ongoing damage, and effective management practices and treatments make establishment unlikely. Most of these commenters also recommended that we remove both pathovars from our list.

We agree that there are effective response and recovery plans in development for treatment and management of these pathovars ( oryzicola and oryzae ). However, we do not believe that this alone is a sufficient reason to remove these agents from the list of select agents and toxins at this time. Both pathovars represent a significant risk to U.S. rice production. Until we obtain more scientific information to allow us to better evaluate the potential consequences of removing the pathovars from the list of select agents and toxins, and until we have identified an effective test that can quickly and conclusively distinguish between the pathovars, we intend to regulate all pathovars of Xanthomonas oryzae as proposed. As more information becomes available, we will be in a better position to reevaluate the commenters' recommendations.

The list of PPQ select agents and toxins has included an entry for Peronosclerospora philippinensis . We proposed to add Peronosclerospora sacchari as a synonym of that organism because recent scientific research has shown that these two organisms are the same.

One commenter did not agree with our proposed addition of Peronosclerospora sacchari as a synonym and cited evidence that Peronosclerospora philippinensis and Peronosclerospora sacchari may have differing host ranges to support his position.

The evidence cited by the commenter is not sufficient to convince us that we should not add Peronosclerospora sacchari as a synonym of Peronosclerospora philippinensis . While we do not believe there is currently sufficient science to confirm the potential speciation pointed to by the commenter, we are open to reconsidering the issue as new data are published.

We proposed to add Phoma glycinicola (formerly Pyrenochaeta glycines ), which causes red leaf blotch of soybean, to the list of PPQ select agents and toxins.

One commenter was opposed to listing Phoma glycinicola as a select agent. The commenter stated that the pathogen is not conducive to widespread movement, effective chemical treatments are available, and the advanced knowledge of plant pathology required to isolate the pathogen makes it unsuitable as a potential weapon of terrorism. However, much of the evidence cited by the commenter was anecdotal and did not provide an adequate basis for not including this aggressive fungus, which is not currently present in the United States, on the list of PPQ select agents and toxins. Therefore, we are adding Phoma glycinicola to the list of PPQ select agents and toxins as proposed. We will review this listing in the future and would consider removing this pathogen from the list of PPQ select agents and toxins should new scientific information become available to support such an action.

We proposed to add Phytophthora kernoviae to the list of PPQ select agents and toxins based, in part, on our identification of this pathogen as a serious threat to the nursery industry and woodland areas.

One commenter argued that Phytophthora kernoviae should not be listed as a select agent based on evidence that it is primarily a forest pathogen and has not been found in the nursery industry as initially believed; accordingly, the effects of exposure on the production and marketability of plant products would be minimal. Further, the commenter stated that evidence suggests that the current regulatory systems and surveys for Phytophthora ramorum could be effectively applied toward the control of Phytophthora kernoviae .

We agree with this commenter's point that current regulatory systems and surveys for Phytophthora ramorum could be effectively applied toward the surveillance for Phytophthora kernoviae . Based on this consideration and due to a clearer understanding of the epidemiology of Phytophthora kernoviae that suggests a reduction in the initially determined host range of the pathogen, we have decided that Phytophthora kernoviae should not be listed as a select agent. We note that a plant pest permit issued under our regulations in 7 CFR part 330 will still be required for the importation or interstate movement of Phytophthora kernoviae , however.

We proposed to add Rathayibacter toxicus , a bacterium that causes gumming disease in ryegrass, to the list of PPQ select agents and toxins.

One commenter supported the proposed listing, but recommended that APHIS develop a reliable diagnostic tool to differentiate between Rathayibacter toxicus and the related, non-toxic species Rathayibacter rathayi . This commenter stated it is critically important to be able to distinguish between the two species for the purposes of cooperative pest surveys and for phytosanitary certification purposes. We agree that it is important to develop a diagnostic tool to distinguish between these two species and note that the USDA's Agricultural Research Service is conducting an ongoing research project focused on the identification, molecular characterization, and detection of foreign and newly emerging domestic bacteria (including Rathayibacter toxicus ). However, this is not a basis for not including Rathayibacter toxicus on the select agent list.

We proposed to remove 10 of the 20 overlap select agents and toxins from the list in 9 CFR 121.4(b). Specifically, we proposed to remove three bacteria (Botulinum neurotoxin producing species of Clostridium, Coxiella burnetii , and Francisella tularensis ), a fungus ( Coccidioides immitis ), a virus (Eastern equine encephalitis virus), and five toxins (Botulinum neurotoxins, Clostridium perfringens epsilon toxin, shigatoxin, staphylococcal enterotoxin, and T-2 toxin).

One commenter was opposed to the removal of botulinum neurotoxins and botulinum neurotoxin producing species of Clostridium from the list of overlap select agents and toxins. The commenter argued that the presence of a select agent in the environment does not minimize the potential for its use as a weapon of bioterrorism, which would result in clear economic and societal consequences.

We do not minimize the fact that botulinum neurotoxins and botulinum neurotoxin producing species of Clostridium can present a significant health risk to livestock; indeed, these neurotoxins are some of the most lethal substances known to animals, and could cause the death of many animals in large herds. However, we do not agree that the intentional use of botulinum neurotoxins would have a significant impact on U.S. export trade in animals and animal products, or have a long-term impact on U.S. agriculture. Based on evidence that transmissibility from animal to animal is negligible and that, historically, outbreaks of botulism occur periodically in the United States, we have determined that botulinum neurotoxins are a poor agroterrorism weapon, and we should, therefore, remove botulinum neurotoxins and botulinum neurotoxin producing species of Clostridium from the list of overlap select agents in our regulations in § 121.4(b). It should be noted, however, that botulinum neurotoxins and botulinum neurotoxin producing species of Clostridium will continue to be regulated by the CDC under its select agent and toxins regulations in 42 CFR part 73 due to their potential threat to human health.

One commenter asked that we clarify which strains of vesicular stomatitis virus (VSV) APHIS considers to be exotic.

Although we did not propose to make any changes in the regulations with respect to VSV, we agree that it would be helpful to clarify which subtypes of VSV we consider to be exotic. Two major serotypes of VSV, New Jersey (VSV-NJ or VSNJV) and Indiana (VSV-IN1 or VSIV), have been reported to cause classical vesicular stomatitis disease in agriculturally significant animals ( i.e. , cattle, horses, and swine) throughout the Americas. Two subtypes of the Indiana serotype, Cocal (VSIV-IN2 or VSIV-2) and Alagoas (VSV-IN3 or VSIV-3), cause vesicular disease in livestock in Brazil and Argentina. In the United States, VSV has not become established, but domestic outbreaks of VSV caused by VSV-NJ and VSV-IN1 occur sporadically in cycles. Therefore, we have clarified in the regulations that the listed VS select agent “vesicular stomatitis virus (exotic)” refers to Indiana subtypes VSV-IN2 and VSV-IN3.

Two commenters involved in the development of veterinary biological products noted that 4 of the 10 overlap select agents and toxins that APHIS had proposed to remove from its list in § 121.4 were agents that the veterinary biologics industry uses to manufacture licensed veterinary biologics or uses in product research and development. Noting that the veterinary biologics industry has a well-established relationship with APHIS' Center for Veterinary Biologics (CVB), the commenters were concerned about what may happen when APHIS no longer has a role in regulating those agents as select agents or toxins. The commenters suggested that:

• The agents should be removed from the CDC select agent list to mirror their delisting by APHIS;

• CDC should exempt the use of the agents in the manufacture of veterinary biologics by CVB-licensed facilities and their investigation use under CVB supervision;

• APHIS should keep the agents on the overlap list; or

• CDC should utilize APHIS/CVB for oversight and inspection of CVB-licensed firms.[P]• APHIS should keep the agents on the overlap list; or[P]• CDC should utilize APHIS/CVB for oversight and inspection of CVB-licensed firms.

We acknowledge that there will be some entities that produce veterinary biologics that will now possess select agents or toxins regulated only by CDC, so the APHIS select agent program will not be part of the inspection process at those facilities unless the facility also possesses VS select agents or toxins. In either case, however, CVB will continue to conduct its own compliance inspections and otherwise exercise oversight of veterinary biologics facilities in keeping with its responsibilities under the Virus-Serum-Toxin Act (VSTA). The compliance inspections conducted by CVB under the VSTA are separate and distinct from the inspections conducted under the select agent program, and there will be no disruption or change in the way CVB conducts those compliance inspections as a result of the removal of select agents and toxins from the overlap list. As for the select agent program, we note that the regulations administered by APHIS and CDC are entirely consistent with each other, so there will be no change in security requirements, registration procedures, restrictions, exemptions, etc. With respect to inspections and other activities conducted under the select agent program, APHIS and CDC have established procedures that ensure close coordination and consistency in the regulation of select agents and toxins. We do not, therefore, believe that it is necessary to make any of the changes suggested by the commenters in order to ensure the continuing efficiency and consistency of the regulation of select agents and toxins by APHIS and CDC.

Several commenters argued that the cost to upgrade security at existing facilities was prohibitive. One commenter stated that the cost of compliance with the regulations at his facility came to almost $150,000. Other commenters asserted that research facilities that possess, use, or transfer a select agent or toxin would be forced to close due to dramatic increases in the cost of research, or that research programs will be impeded by the regulatory requirements or even terminated because researchers and their institutions will not want to deal with the new regulatory requirements or be liable for violations of the regulations.

In our economic analysis for the proposed rule, we stated that an entity that possesses a newly added agent will have to comply with the regulations, and may therefore incur cost. We also noted that the costs to comply with the security requirements are site-specific and will vary accordingly. In this final rule, we reiterate that compliance with the regulations can be achieved in a wide variety of ways, and while some of these methods can be expensive, the regulations do not specify how the physical security needs (limiting access to the agents) are to be met, only that they are to be commensurate with the threat that the select agent or toxin poses. Therefore, an entity can choose the most cost-effective alternative to meeting those needs. Often an entity's standard operating procedures for security are sufficient. Accordingly, research facilities that possess, use, or transfer a select agent or toxin may not be forced to close, as one commenter fears, due to an increased cost of research.

We were required by the Act to establish, by regulation, standards and procedures governing the possession, use, and transfer of listed biological agents and toxins in order to protect animal and plant health, and animal and plant products. Those standards and procedures were established in an interim rule published in the Federal Register on December 13, 2002, and effective on February 11, 2003. To date, the commenters' concerns about the costs or difficulties of complying with the regulations have failed to materialize.

Several commenters argued that the process of registering an entity is excessively time-consuming and that the regulations entail additional recordkeeping requirements. One commenter claimed that the process of approval (Federal Bureau of Investigation (FBI) checks, security plans, lab and greenhouse modifications, training, and inspection) took more than 1 year.

Registered entities must develop and implement a written security plan that provides graded protection in accordance with the risk of the select agent or toxin, given its intended use, and must develop and implement a written biosafety/biocontainment plan that is commensurate with the risk of the agent or toxin, given its intended use. Registered entities must also develop and implement a written incident response plan that describes the entity's response procedures for releases, theft, or loss of a select agent or toxin, etc. These reporting and recordkeeping requirements have been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act. As for the length of time it took the one commenter's facility to become registered, there are a variety of factors that could have contributed to such a lengthy process, but we are unaware of the particular circumstances of the commenter's experience. We do note that the necessary security risk assessment (SRA) checks are provided free of charge by the FBI and take approximately 45 days to complete, and that APHIS and CDC are committed to ensuring that the registration process is conducted as efficiently as possible.

One commenter stated that we need a mechanism that would allow the timely delisting of a newly detected select agent if it is found to be widely distributed and ineradicable.

Given that the Administrative Procedure Act provides that an agency may, with a showing of good cause, make a rule effective in less than 30 days and without prior opportunity for public comment, we do not believe it is necessary for us to establish any new mechanism for delisting or otherwise amending the regulations.

We received many comments that recommended we remove specific PPQ, VS, and overlap select agents from the lists in 7 CFR part 331 and 9 CFR part 121. The PPQ select agents specifically mentioned were Ralstonia solanacearum , race 3, biovar 2; Sclerophthora rayssiae var. zeae ; Synchytrium endobioticum ; and Xylella fastidiosa (citrus variegated chlorosis strain), and the VS select agents mentioned were the bovine spongiform encephalopathy agent and Venezuelan equine encephalitis virus. These commenters supplied detailed information to support their position that these select agents should be delisted; in most cases, the commenters asserted that the continued listing of specific agents they considered low risks for bioterrorism was prohibitive and impeded timely research. Conversely, another commenter submitted information supporting his contention that the agents that cause scrapie and chronic wasting disease should be added to the list of VS select agents and toxins.

We will take the information provided by the commenters into account as we continue to review our regulations and anticipate that we will be providing an opportunity in the future for affected entities and the general public to offer suggestions for adding or eliminating select agents and toxins to or from the lists in our regulations. We will use the information provided by the commenters as we consider the potential regulatory changes that may be part of our next proposed rule.

We are making one other change in this final rule. In the proposed rule, we included an explanatory footnote to the entry for “virulent Newcastle disease virus” in the proposed list of VS select agents and toxins. This footnote read: “A virulent Newcastle disease virus (avian paramyxovirus serotype 1) has an intracerebral pathogenicity index in day-old chicks ( Gallus gallus ) of 0.7 or greater or having an amino acid sequence at the fusion (F) protein cleavage site that is consistent with virulent strains of Newcastle disease virus.” We are replacing the word “having” in the proposed footnote with the word “has.” In addition, we are adding a sentence to further clarify the definition: “A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.” This sentence will provide additional guidance to entities in determining whether they possess a virulent strain of Newcastle disease virus.

We recognize that there may be some entities that are not currently registered under the select agents program, but that possess one of the PPQ select agents being added to the regulations by this final rule. The PPQ select agents we are adding to the regulations in 7 CFR part 331 are:

• Xanthomonas oryzae pv. oryzae ,

• Peronosclerospora sacchari ,[P]• [E T='03']Peronosclerospora sacchari[/E],

• Phoma glycinicola (formerly Pyrenochaeta glycines ), and

• Rathayibacter toxicus.

In addition, although it is not likely, the redefinition of Newcastle disease virus (velogenic) to virulent Newcastle disease virus may lead to new registrants, as it is possible that additional entities may be in possession of a virulent strain of Newcastle disease virus that does not fit the current definition.

Accordingly, entities that currently possess one of those four agents or a strain of Newcastle disease virus that we now define as virulent, if they are not already registered entities, will have to either transfer the organism to a registered entity or become a registered entity themselves as a result of this final rule. Those entities that choose to become registered will need time to come into full compliance with the requirements of the regulations.

This final rule will become effective on November 17, 2008. On and after that date, any individual or entity possessing, using, or transferring any listed agent or toxin must be in compliance with the provisions of each part.

However, to minimize the disruption of research or educational projects ( e.g. , teaching demonstrations) involving listed select agents or toxins that were underway as of the effective date of these regulations, we provide that any individual or entity possessing such agents or toxins as of the effective date (current possessors) will be afforded additional time to reach full compliance with the regulations in each part. Accordingly, by November 17, 2008, the responsible official at all entities that possess a new agent or toxin must provide notice to APHIS regarding their possession of the new agent(s) and toxin(s). By April 14, 2008, all previously unregistered entities must be registered.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

This rule has been reviewed under Executive Order 12866. The 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 Agricultural Bioterrorism Protection Act of 2002, we are amending and republishing the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action implements the findings of the second biennial review of the list.

Certain pathogens or toxins produced by biological organisms that are released intentionally or accidentally can result in disease, wide-ranging and devastating impacts on the economy, disruption to society, diminished confidence in public and private institutions, and large-scale loss of life. People or livestock can be exposed to these agents from inhalation, through the skin, or by the ingestion of contaminated food, feed, or water. Similarly, crops can be exposed to biological pathogens in several ways—at the seed stage, in the field, or after harvest.

Because of its size and complexity, the U.S. food and agriculture system is vulnerable to deliberate attacks, particularly with foreign diseases that do not now occur domestically. The U.S. livestock industry, with revenues of approximately $150 billion annually, is extremely vulnerable to a host of highly infectious and often contagious biological agents that have been eradicated from the United States, or have never existed here. Many of these animal-targeted agents could simply be point-introduced into herds. Given the increasing concentration and specialization in the livestock industries, the introduction of a VS select agent or toxin could cause the immediate halt of movement and export of vast quantities of U.S. livestock and livestock products. Crops, too, are vulnerable. They are grown over very large areas (more than 75 million acres of soybeans were cultivated in the United States in 2006, for example), exacerbating difficulties in surveillance and monitoring. 2

Preparedness for a biological attack against people, crops or livestock is complicated by the large number of potential agents, the long incubation periods of some agents, and the potential for secondary transmission. All of these factors make vital the prevention of the misuse of biological agents and toxins through registration, biosafety, and security measures and the availability of incident response capabilities.

Section 212(a)(2) of the Act requires a biennial review and republication of the select biological agent and toxin list, with revisions as appropriate in accordance with this law. This rule will implement the recommendations of the second biennial review of the list. Expected benefits and costs are examined in accordance with Executive Order 12866. Expected impacts for small entities are also considered, as required by the Regulatory Flexibility Act.

This rule updates the lists of select agents and toxins contained in the regulations in 7 CFR part 331 and 9 CFR part 121. The regulations require registration, biosafety, incident response, and security measures for the possession, use, and transfer of the listed select agents and toxins. The regulations are intended to prevent the misuse of those select agents and toxins, and therefore reduce the potential for those pathogens to harm humans, animals, animal products, plants, or plant products in the United States. Should any select agent or toxin be intentionally introduced into the United States, the consequences would be significant. Direct losses in agriculture could occur as a result of the exposure, such as death or debility of affected production animals, or yield loss for plants. Industry could also be affected through the imposition of domestic and foreign quarantines that result in a loss of markets. The Federal Government and State governments would also incur costs associated with eradication and quarantine enforcement to prevent further spread, and in the case of intentional introduction, law enforcement. In addition, there is the potential for a disruption in the domestic food supply, whether through contamination, consumer perception, or both. Past food safety incidents have shown that consumer perceptions (both domestic and international) about an implicated food product and about the producing country or sector's ability to produce safe food are slow to recover and can have a lasting influence on food demand and global trade. 3 As such, the benefits of the rule are the avoided losses of animals or plants that could be attacked by these organisms or toxic materials (because of the reduced risk of release of the select agents and reduced likelihood of exposure for susceptible animals or plants), the avoided public and private costs of eradication, and the avoided negative effects on products and markets.

The costs associated with the outbreak of a select agent can be very high, as demonstrated, for example, by the losses to agriculture and the food chain from the foot-and-mouth disease (FMD) outbreak in the United Kingdom (UK) in 2001. Those costs amounted to about £3.1 billion ($4.7 billion). In 1999, it was estimated that the potential impacts of an FMD outbreak in California alone would be between $8.5 and $13.5 billion. 4 The bovine spongiform encephalopathy (BSE) crisis in the UK (which has a cattle industry about one-tenth the size of that in the United States) is another example. It has been estimated that the total resource costs to the UK economy as a result of BSE in the first 12 months after the onset of the 1996 crisis were in the range of £740 million to £980 million ($1.2 to $1.5 billion), or just over 0.1 percent of the gross domestic product of the United Kingdom. 5 In addition, the UK lost its entire export market for beef.

These are examples of consequences of natural or accidental disease introduction. Deliberate introduction greatly increases the probability of a select agent or toxin becoming established and causing wide-ranging and devastating impacts on an economy, disruption to society, diminished confidence in public and private institutions, and possible loss of life.

The entities most likely to be affected by this rule include research and diagnostic facilities, Federal, State, and university laboratories, and private commercial and non-profit enterprises. An entity that possesses, uses, or transfers listed select agents or toxins is required to comply with the select agent regulations. The regulations require registering the possession, transfer, or destruction of select agents or toxins. In addition, the entity is also required to ensure that the facility where the agent or toxin is housed has adequate biosafety and containment measures, that the physical security of the premises is adequate, that all individuals with access to select agents or toxins have appropriate training to handle such agents or toxins, and that complete records concerning activities related to the select agents or toxins are maintained.

The changes to the PPQ select agent list include the addition of four organisms to the list, the removal of two organisms from the list, and technical changes for organisms currently listed. An entity that possesses a newly added agent or toxin will have to comply with the select agent regulations, and may therefore incur costs. These primarily involve becoming registered, maintaining an inventory of the agents and toxins, and limiting access to the agent or toxin to those individuals who are qualified, have a need to have access to a select agent or toxin, and have an SRA conducted by the FBI. This rule does not change the process for obtaining the agents or toxins ( i.e. , a permit is required regardless of whether an organism is listed as a select agent) or the bio-containment requirements as set forth in the existing permitting process. Necessary SRA checks are performed free of charge by the FBI and take approximately 45 days to complete. Limiting access to the listed agents or toxins can be achieved in a wide variety of ways. Some of these methods can be very expensive. For example, installing new state-of-the-art electronic surveillance equipment can run into the thousands of dollars even for a relatively small space. However, in most instances the physical security needs can be met with far less rigorous methods. Often an entity's standard operating procedures for security are sufficient. Because many entities deal with select agents or toxins in an area that is fully contained within a larger structure, a lack of entry control equipment may not affect the level of graded protection. It should also be noted that only that portion of a given entity affected by select agent or toxin operations is required to be secured. The select agent regulations do not specify how the physical security needs (limiting access to the agents) are to be met, only that they need to be adequate for the situation. Therefore, an entity can choose the most cost-effective alternative to meet those needs.

The changes should affect only a very small number of entities. The plant pest permit database maintained by APHIS indicates that very few entities currently possess any of the agents that are being added to the PPQ list. It is estimated that less than a total of 10 entities will be affected by changes to the plant list. In addition, most of the entities that do possess the newly added agents are already registered due to their possession of other listed select agents or toxins. After this rule goes into effect, entities will no longer be required to maintain records and security for those agents and toxins that are being removed from the select agent lists by this rule. However, the entities are still required to maintain select agent records for 3 years past the time they were regulated under 7 CFR part 331 or 9 CFR part 121. Additionally, permits are still required under 7 CFR part 330 or 9 CFR part 122 for those agents and toxins that have been removed from the lists. These changes should have little impact.

The changes to the VS select agent list include the removal of agents, the redefinition of an agent, and technical changes to the nomenclature used for some agents in the list to be consistent with current scientific literature. The agents that will be removed are overlap select agents and toxins regulated by both USDA and HHS. Any entity that is in possession of the overlap select agents and toxins that are to be removed, and that does not possess any other overlap agents or toxins or any of the APHIS select agents or toxins, will subsequently possess HHS-only agents and toxins and will thus continue to be subject to select agent regulations as administered by HHS. In addition, the organisms that will be removed from the lists of select agents and toxins (Botulinum neurotoxin producing species of Clostridium, Coxiella burnetii, and Francisella tularensis; the fungus Coccidioides immitis; and Eastern equine encephalitis virus) will continue to be subject to the regulations under 9 CFR part 122. The redefinition of Newcastle disease virus (velogenic) to virulent Newcastle disease virus may lead to new registrants. It is possible that additional entities may be in possession of a virulent strain of Newcastle disease virus that does not fit the current definition. However, these strains have not been circulating in the United States since the 1970s. Those entities most likely to be in possession of virulent Newcastle disease virus are those already in possession of Newcastle disease virus (velogenic) and therefore already registered. Therefore, these changes should have little impact.

The alternative to this rule would be to leave the regulations unchanged. In this case, the lists of select agents in 7 CFR part 331 and 9 CFR part 121 would remain unchanged. However, APHIS has conducted reviews of these lists and concluded that changes are necessary to ensure that the lists contain those biological agents and toxins that have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. These reviews were conducted in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which requires a biennial review and republication of the select biological agent and toxin list, with revisions as appropriate. Therefore, this alternative was rejected.

This rule will update the PPQ, VS, and overlap select agent lists. The regulation of select agents is intended to prevent their misuse and thereby reduce the potential for those agents and toxins to harm animals, animal products, plants, or plant products in the United States. Should any select agent or toxin be intentionally introduced into the United States, the consequences could be significant. Consequences could include disruption of markets, difficulties in sustaining an adequate food and fiber supply, and the potential spread of disease infestations over large areas. In any animal or plant disease outbreak, the Government would incur costs of eradication. Industry would be affected through the imposition of domestic and foreign quarantines that result in a loss of markets and the destruction of animals or plants found to be infected with the disease. Even though entities may be compensated for the destroyed property, repopulating (flocks, herds, fields, etc.) can take time, with additional losses incurred due to idle capital and lost markets. In addition, there is the potential for a disruption in the domestic food supply, whether through contamination, consumer perception, or both. Such a disruption can have a lasting influence on food demand and global trade.

The entities most likely to be affected by this rule are those laboratories and other institutions conducting research and related activities that involve the use of the newly added select agents and toxins. The impact of these changes is expected to be minimal, however. Indications are that very few entities currently possess any of the agents or toxins that are being added to the list of select agents and toxins. Moreover, after this rule goes into effect, entities will no longer be required to maintain records and security for those agents and toxins that are being removed from the select agent lists by this rule. However, the entities are still required to maintain select agent records for 3 years past the time they were regulated under 7 CFR part 331 or 9 CFR part 121. Additionally, permits are still required under 7 CFR part 330 or 9 CFR part 122 for those agents and toxins that have been removed from the lists. Other changes do not affect what select agents or toxins are listed but rather the nomenclature by which those agents and toxins are identified, and therefore should have no economic impact on holders of those organisms or toxic materials.

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

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

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

NAFTA and the NAFTA Implementation Act, Public Law 103-182, redesignated section 214(e) of the Immigration and Nationality Act (INA) to create the “trade NAFTA” (TN) nonimmigrant classification and provide for the temporary entry of qualified business persons from each of the countries that signed the Agreement. The TN nonimmigrant classification permits qualified Canadian and Mexican citizens to seek temporary entry as business persons to engage in professional business activities at a professional level in the United States. 8 CFR 214.6(a). DHS regulations currently require that TN nonimmigrants may be admitted to the United States for a period not to exceed one year. 8 CFR 214.6(e). The regulations further provide that TN professionals may apply for extensions of stay for a maximum period of one year. 8 CFR 214.6(h)(1).

On May 9, 2008, DHS published a notice of proposed rulemaking in the Federal Register at 73 FR 26340 proposing a change in the period of admission and extension of stay granted to TN nonimmigrants from Canada and Mexico engaged in professional business activities. The notice also proposed granting the same period of admission or extension of stay to TN dependents (TD nonimmigrants), removing outdated references to specific filing locations and prior requirements, and replacing the outdated term TC with the current TN term. Written comments to the proposed rule were due on or before June 9, 2008.

In this final rule, DHS is adopting the proposed rule with no changes. The proposed rule was, and this final rule is, intended to improve the administration of the TN program and make it more flexible and attractive to Canadian and Mexican professionals and to employers in the United States. Currently, DHS regulations require TN nonimmigrants, to either seek readmission in TN status or apply for extensions of stay annually if they wish to remain in the United States beyond the period of their initial admission. 8 CFR 214.6(h). This requirement involves the annual submission of documentation and payment of filing fees. By removing these types of administrative requirements on TN employees and their U.S. employers, DHS will further the intent of NAFTA to facilitate the entry of eligible professionals into the United States.

DHS received 80 comments in response to the proposed rule. The majority of commenters (76) supported this rulemaking. Many of these 76 commenters suggested additional changes or enhancements to the TN classification regulations which were not part of the proposed rule. Two commenters opposed the proposed rule. One of these two commenters asked questions about lawful permanent residence and educational opportunities for aliens in the TN classification, but did not express an opinion on the proposed rule. The second of these two commenters simply complained about a perceived slight to U.S. workers contained in another public comment. Many of the received comments raised issues that are beyond the scope of this rulemaking but will be mentioned briefly as part of this disposition of the comments.

Comments on period of admission: The overwhelming majority of the commenters supported increasing the period of admission and extensions of stay granted to TN nonimmigrants from one to three years. Only two commenters opposed this proposal because they thought that jobs should be offered to U.S. workers rather than to foreign nationals. One commenter stated that the U.S. economy is suffering and jobs should thus be reserved for U.S. workers. The other commenter stated that the United States is presently flooded with immigrants and the TN program should be shut down while the country sorts out the problems with illegal immigrants present in the United States, and also made additional comments about aliens, politicians and the U.S. government in general.

Response to comments on period of admission: DHS has not adopted these comments in opposition. This rule does not make it easier to hire TN nonimmigrants by altering eligibility requirements, changing existing filing fee requirements, or expanding the principle of “dual intent.” Rather, this rule simply increases the amount of time granted to a TN nonimmigrant once all eligibility requirements have been established. This rule has nothing to do with permanent immigration or illegal immigrants presently within the United States.

Comments on dual intent: Thirteen commenters requested that TN nonimmigrants be granted “dual intent” and thereby be allowed to pursue permanent resident status while present in the United States in nonimmigrant status similar to the H-1B and L-1 nonimmigrant programs.

Response to comments on dual intent: The dual intent doctrine holds that even though a nonimmigrant visa applicant has previously expressed a desire to enter the United States as an immigrant, and may still have such a desire, that does not of itself preclude USCIS from issuing a nonimmigrant visa to him or her nor preclude his or her being a bona fide nonimmigrant. Matter of H-R-, 7 I&N Dec. 651, 654 (INS Reg. Comm'r 1958). See also INA section 214(h) (limiting dual intent to certain H, L, and V nonimmigrants); 8 U.S.C. 1184(h). Dual intent cannot be provided solely through regulation; it must be authorized by statute and it is not authorized in the TN nonimmigrant context. Furthermore, temporary entry, as defined in Chapter 16 of the NAFTA, Article 1608, is “entry into the territory of a Party by a business person of another Party without the intent to establish permanent residence.” Congressional approval of this Article in the NAFTA treaty indicates that Congress did not intend TNs to have dual intent. Therefore, the commenters' suggestion will not be adopted because it is clearly inconsistent with Article 1608 and Congressional intent.

Comment on inability of Mexican TN nonimmigrants to apply for admission at the border: One commenter requested that Mexican TN nonimmigrants be able to apply for admission at designated ports-of-entry similar to Canadian TN nonimmigrants. Currently, Mexican workers are required to obtain visas from the Department of State (DOS) before entering the United States.

Response to comment on inability of Mexican TN nonimmigrants to apply for admission at the border: DHS appreciates the suggestion made by this commenter but the suggestion is outside the scope of this regulation. This rule deals with increasing the period of time granted to a TN nonimmigrant upon admission or pursuant to a timely filed request for extension of stay from a maximum of one year to a maximum of three years. Any additional regulatory changes, including a change to the place of admission, exceed the scope of this rule The commenter's suggestion, therefore, is not adopted.

Comment on advance approval of Canadian admission requests: One commenter requested that Canadian TN nonimmigrants be permitted to file petitions with USCIS Service Centers for admission as an alternative to requesting admission at U.S. ports-of-entry, so that applications for TN status can be approved in advance of entry dates rather than requiring intended employees to actually apply for status before knowing whether their applications will be approved.

Response to comment on advance approval of Canadian admission requests: DHS appreciates the suggestion made by this commenter. However, such reform exceeds the scope of the changes in the proposed rule and is not adopted in this final rule. The suggestion may be considered for future rulemaking involving TN nonimmigrants.

Comments on erroneous periods of admission: Several commenters suggested that some TN nonimmigrants have erroneously been admitted for three years instead of a validity period of one year. Thus, one commenter requested that this rule should have a retroactive effective date to correct this problem.

Response to comments on erroneous periods of admission: DHS understands these commenters' concerns. However, TN nonimmigrants who were admitted for a period of more than the one-year were granted that period of admission in violation of 8 CFR 214.6(e) as it existed prior to this rulemaking. Petitions must be processed in accordance with the regulations in effect when submitted, and this rule cannot deem those who were erroneously granted more than one year in the past to meet the requirements in this rule by making its provisions retroactive. Therefore, the commenter's suggestion was not adopted. Each TN nonimmigrant erroneously admitted for periods of three years prior to the effective date of this rulemaking is encouraged to correct his or her Form I-94 at a port-of-entry or deferred inspection station to ensure compliance with existing regulations and to ensure that he or she does not remain in the U.S. for a period longer than is authorized by law.

Miscellaneous comments: Several commenters requested a more comprehensive reform of the TN regulations to include the following: more extensive definitions for the positions of Management Consultant and Scientific Technician/Technologist; increased vigilance against TN fraud; the establishment of clear guidelines in determining a “closely related” degree; an increase in the fee for port-of-entry processing of each TN application; a 30-day period during which the TN worker could enter the U.S. before the employment start date and/or remain outside the country without having the TN status invalidated; and work authorization for the spouses of TN nonimmigrants.

Response to miscellaneous comments: DHS appreciates the suggestions made by the commenters. However, such comprehensive reform of the TN program exceeds the scope of the proposed rule, which was simply focused on allowing TN nonimmigrants and their employers a more stable and predictable period of employment. Therefore, the commenters' suggestions are not adopted in this rule.

DHS reviewed this rule in accordance with the Regulatory Flexibility Act and determined that this rule will reduce compliance costs on the regulated industries. This rule will reduce information collection costs for the public, and will reduce USCIS legal costs and the amount of fees collected, because TN and TD status holders will not have to renew their statuses each year. There are no provisions in this rule that add compliance costs. Therefore, DHS certifies that this rule would not have a significant economic impact on a substantial number of small entities.

In accordance with 5 U.S.C. 604, DHS performed a final regulatory flexibility analysis regarding the economic effects of this rule on small entities. DHS has not identified any duplication, overlap, or conflict of this rule with other Federal rules. Since DHS does not foresee the rule having an economic impact on small entities, this rule does not put forth significant alternatives to minimize impacts. The rule benefits the United States by reducing burden in the TN nonimmigrant status program. No cost increases due to the revised requirements are expected. USCIS invited the public to comment on the extent of any potential economic impact of this rule on small entities, the scope of these costs, a more accurate means for defining these costs, and the estimated cost to petitioning firms to comply with the new requirements. In response to those requests, USCIS received no comments. Therefore, DHS certifies that this rule will not have a significant economic impact on a substantial number of small entities. Accordingly, no further regulatory flexibility analysis is required.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

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

This rule has been designated as a “significant regulatory action” by the Office of Management and Budget (OMB) under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, an analysis of the economic impact of this rule has been prepared and submitted to the Office of Management and Budget (OMB) for review.

DHS has determined that this rule decreases the costs imposed by the TN nonimmigrant program on the government as well as the public. The changes made by this rule will result in more satisfaction with the TN program among TN nonimmigrants and their U.S. employers by increasing program flexibility and reducing time and travel restrictions. The expected effect is an increase in the number of TN nonimmigrants in the United States. A small economic benefit may result from the increased availability of scarce workers for U.S. employers in particular fields and industries. This rule will result in cumulative TN application fees decreasing by approximately $2.4 million per year. In addition, the total paperwork burden costs on the public will decrease by about 12,225 hours and $340,000 as a result of fewer required filings. Eventually, DOS and U.S. Customs and Border Protection annual fee collections from TN nonimmigrants will also decrease as a result of this rule. A copy of DHS' complete analysis is available in the rulemaking docket for this rule at www.regulations.gov, under Docket No. USCIS-2007-0056, or by calling the information contact listed above.

This rule will have no substantial direct effects 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. Therefore, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

Under the Paperwork Reduction Act of 1995, Public Law 104-13, 109 Stat. 163 (1995) (PRA), all Departments are required to submit to OMB, for review and approval, any reporting or recordkeeping requirements inherent in a rule. This rulemaking does not impose any new reporting or recordkeeping requirements under the Paperwork Reduction Act. However, by requiring TN and TD status renewals every three years instead of every year, this rule will reduce the volume of Form I-129, Petition for Nonimmigrant Worker, filings, Form I-907, Request for Premium Processing Service, filings, and Form I-539, Application To Extend/Change Nonimmigrant Status, filings per year, and so will reduce the aggregate paperwork burden on the public accordingly. Accordingly, USCIS has submitted the OMB Correction Worksheets (OMB-83C) to the Office of Management and Budget, reducing the burden hours and costs associated with these forms.

In FR Doc. E8-23138 appearing on page 56940 in the Federal Register of Wednesday, October 1, 2008 (73 FR 56940), the following correction is made:

1. On Page 56940, revise the FOR FURTHER INFORMATION CONTACT section to read as follows:

Discussion

On April 2, 2008, the FAA issued AD 2008-08-06, amendment 39-15458 (73 FR 19989, April 14, 2008). That AD applies to all Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes and Model CL-600-1A11 (CL-600), CL-600-2A12 (CL-601), and CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604) airplanes. That AD requires revising the airplane flight manuals (AFMs) to include new cold weather operations limitations and procedures. That AD resulted from reports of uncommanded roll during take-off. The actions specified in that AD are intended to prevent possible loss of control on take-off resulting from even small amounts of frost, ice, snow, or slush on the wing leading edges or forward upper wing surfaces.

The preamble to AD 2008-08-06 specified that we considered the requirements “interim action” and that Transport Canada Civil Aviation (TCCA) advised that it was developing further actions, such as crew awareness and training with regard to winter operations to address the unsafe condition addressed by that AD. That AD explains that we might consider further rulemaking if those further actions are developed, approved, and available. TCCA has now advised us that the manufacturer has developed these actions, and we have determined that further rulemaking is indeed necessary; this AD follows from that determination.

Bombardier has issued the temporary revisions (TRs) listed in the “Temporary Revisions” table. The temporary revisions describe limitations that include tactile inspections for ice during certain weather conditions, limitations and procedures for use of wing and cowl anti-ice during certain taxiing or take-off conditions, and take-off limitations to reduce high-pitch attitudes during rotation. The temporary revisions also describe a limitation, effective November 1, 2008, that requires flightcrew training regarding enhanced take-off procedures and winter operations. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. TCCA mandated the service information and issued Canadian airworthiness directives CF-2008-15R1 and CF-2008-16R1, both dated August 20, 2008 (referred to after this as “the MCAI”), to ensure the continued airworthiness of these airplanes in Canada.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Therefore, we are issuing this AD to supersede AD 2008-08-06. This new AD retains certain requirements of the existing AD. This AD also requires revising the AFMs to include a requirement for flightcrew training regarding enhanced take-off procedures and winter operations.

The Canadian airworthiness directives specify that operators should advise flightcrews of the changes introduced by the TRs; and review the “Pilot's Checklist” to ensure that the instructions regarding selection of the wing anti-ice system to “ON,” as specified in the AFM Limitations section, are incorporated. We do not require these actions because there is no method to determine compliance with these actions.

This AD retains certain requirements of AD 2008-08-06; however, certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this AD, as listed in the following table:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to certain Boeing Model 747-400, 747-400D, and 747-400F series airplanes. That NPRM was published in the Federal Register on June 18, 2008 (73 FR 34663). That NPRM proposed to require installing an extension tube to the existing pump discharge port of the scavenge pump on the outboard side of the center fuel tank in the main fuel tank #2.

We gave the public the opportunity to participate in developing this AD. We considered the comments received.

Boeing concurs with the contents of the NPRM. Air Line Pilots Association, International (ALPA), supports the intent of the NPRM.

ALPA feels that the 60-month compliance time should be reduced to 24 months. ALPA states that a shorter compliance time should be imposed given the number of affected aircraft and the time required for installation of tubing.

We disagree. In developing the compliance time for this NPRM, we considered not only the safety implications of the identified unsafe condition, but the average utilization rate of the affected fleet, the practical aspects of an orderly modification of the fleet during regular maintenance periods, the availability of required parts, and the time necessary for the rulemaking process. The compliance time is determined to be appropriate. Therefore, we have not changed the AD in this regard.

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

We estimate that this AD affects 31 airplanes of U.S. registry. It takes about 16 work-hours per product to comply with this AD. The average labor rate is $80 per work-hour. Required parts cost about $900 per product. Based on these figures, the cost of this AD to the U.S. operators is $67,580, or $2,180 per product.

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

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

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

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

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

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

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

You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.

Discussion

On July 1, 2008, we issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Air Tractor Models AT-402, AT-402A, and AT-402B airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on July 8, 2008 (73 FR 38933). The NPRM proposed to require you to repetitively visually inspect the rudder and vertical fin hinge attaching structure for loose fasteners and inspect the rudder or vertical fin skins, spars, hinges, or brackets for cracks and/or corrosion. This AD would also require you to replace any damaged parts found as a result of the inspections and install an external doubler at the upper rudder hinge. Installation of the external doubler at the upper rudder hinge is terminating action for the repetitive inspection requirements.

We provided the public the opportunity to participate in developing this AD. We received no comments on the proposal or on the determination of the cost to the public.

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial corrections. We have determined that these minor corrections:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We estimate that this AD affects 220 airplanes in the U.S. registry.

We estimate the following costs to do the inspection:

Any required replacements will vary depending upon the damage found, and any replacements required will vary based on the results of the inspection. Based on this, we have no way of determining the potential replacement costs for each airplane or the number of airplanes that will need the replacements based on the result of the inspections.

We estimate the following costs to do installation of the external doubler at the upper rudder hinge:

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 AD.

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

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

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

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

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

We prepared a summary of the costs to comply with this AD (and other information as included in the Regulatory Evaluation) and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES . Include “Docket No. FAA-2008-0749; Directorate Identifier 2008 CE-044-AD” in your request.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2007-0223 R2, dated October 26, 2007, (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

For the reasons described above, EASA issued Emergency AD 2007-0223-E to require repetitive inspections of the blade Leading Edge (L/E) guards for correct bonding until they accumulate more than 1,200 FH time in service. Revision 1 of this AD was issued to clarify the required inspections and follow-up actions depending on findings and to make reference to the latest Dowty Alert Service Bulletin (ASB) revision.

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

Dowty Propellers has issued Alert Service Bulletins D8400-61-A69, dated August 15, 2007; and Revision 1, dated September 18, 2007. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of the United Kingdom, and is approved for operation in the United States. Pursuant to our bilateral agreement with the United Kingdom, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by the United Kingdom and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the required compliance time to detect the unsafe condition is too short for public comment. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-1088; Directorate Identifier 2008-NE-15-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS. The complete regulators' description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C.552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the Federal Register expensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. The advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs and the effective dates of the associated Takeoff Minimums and ODPs. This amendment also identifies the airport and its location, the procedure, and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPS and Takeoff Minimums and ODPS, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPS contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPS and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedures before adopting these SIAPS, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

I. Background

Section 9(e) of the United States Housing Act of 1937 (42 U.S.C. 1437 et seq .) (1937 Act) establishes an Operating Fund for the purpose of making assistance available to PHAs to operate and manage public housing. HUD's regulations implementing section 9(e) of the 1937 Act are located at 24 CFR part 990 (entitled “The Public Housing Operating Fund Program”). The part 990 regulations contain the policies and procedures governing the Operating Fund allocation formula used by HUD to distribute operating subsidies to PHAs.

On September 19, 2005, at 70 FR 54984, HUD published a final rule amending the regulations at 24 CFR part 990 to provide a new formula for distributing operating subsidies to PHAs and to establish requirements that PHAs convert to asset management. The September 19, 2005, final rule provides PHAs with incentives for energy conservation and utility rate reduction. The energy conservation methods may include, but are not limited to, physical improvements financed by a loan from a bank, utility, or governmental entity; management of costs under a performance contract; or a shared savings agreement with a private energy company. The final rule also provided, in § 990.185(a), that the term of the contract under which these energy conservation measures are taken cannot exceed 12 years.

On August 8, 2005, President Bush signed into law the Energy Policy Act of 2005 (Pub. L. 109-58, 119 Stat. 594) (Energy Policy Act). Subtitle D of the Energy Policy Act amended section 9 of the 1937 Act to promote the use in public housing of innovative approaches to achieve programmatic efficiency and reduce utility costs. Specifically, section 151 of the Energy Policy Act amended section 9(e)(2)(C) of the 1937 Act, which governs the treatment of waste and utility savings under the Operating Fund allocation formula. The amendment made by section 151 of the Energy Policy Act provides that qualifying contracts for energy conservation improvements may have terms of not more than 20 years. (See 119 Stat. 647-648.) The Energy Policy Act also amended the Operating Fund treatment of savings resulting from such contracts. It allows for longer payback periods for retrofits, including windows, heating system replacements, wall insulation, site-based generation, advanced energy saving technologies, including renewable energy generation, and other such retrofits.

The Consolidated Appropriations Act, 2008 (Pub. L. 110-161, 121 Stat. 1844, approved December 26, 2007), amended section 9(e)(2)(C) of the 1937 Act (42 U.S.C. 1437g(e)(2)(C)), by adding the following clause:

“(iv) EXISTING CONTRACTS.—The term of a contract described in clause (i) that, as of the date of enactment of this clause, is in repayment and has a term of not more than 12 years, may be extended to a term of not more than 20 years to permit additional energy conservation improvements without requiring the reprocurement of energy performance, contractors.” (See administrative provision, section 229, of title II of Division K, at 121 Stat. 2438.)

This interim rule amends the regulations at 24 CFR 990.185 to provide that, consistent with the amendment to the 1937 Act by section 151 of the Energy Policy Act, the term of an EPC between a PHA and an entity other than HUD may be up to 20 years. Consistent with the amendment made to section 9(e)(C)(2) by the Consolidated Appropriations Act, 2008, this rule also permits the extension of executed EPCs to a term of not more than 20 years without requiring a new competitive procurement process.

The increased maximum contract terms provided by these statutory amendments permit longer payback periods for energy conservation measures. HUD encourages PHAs to utilize the extended contract terms to achieve additional reductions in utility consumption and costs. These statutory changes to EPC terms, as are being codified by this rule, provide PHAs with the ability to fund additional energy measures with a longer payback period, and also provide additional flexibility by allowing a PHA to extend an existing contract without needing to go through procurement.

The provision for entering into EPCs with terms greater than 12 years and for extending the terms of executed EPCs would commence to apply on the effective date of this rule.

The 20-year contract term, consistent with statutory authority, is the maximum term. If state or local laws or regulations restrict terms of EPCs to a shorter period of time, PHAs would still have to comply with the state or local government requirement.

Consistent with the statute, this rule clarifies that to qualify for the incentives under § 990.185, the financing of energy conservation measures by a party other than HUD must be undertaken pursuant to a contract. This rule also clarifies that the term “energy performance contract” encompasses all contracts that qualify under § 990.185, regardless of the energy conservation measure involved or the entity that is the other party to the contract with the PHA.

In accordance with its regulations on rulemaking at 24 CFR part 10, HUD ordinarily publishes its rules for advance public comment. Notice and public procedure are omitted, however, if HUD determines that, in a particular case or class of cases, notice and public procedure are “impracticable, unnecessary, or contrary to the public interest.” (See 24 CFR 10.1.) In this case, HUD is simply conforming its existing regulations to statutory provisions that are already legally effective. In doing so, HUD is not exercising agency discretion, but rather simply following the statutory mandate. Because this is a conforming regulation, advance public notice and comment is unnecessary. However, while HUD found the statutory language to be clear as to meaning and intent and has incorporated the language without change, PHAs may seek further clarification. HUD specifically welcomes comments on the clarity of the conforming amendments, as well as on any other aspect of the rule. HUD will consider all comments submitted by the public in the final rule that follows this interim rule.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments and the private sector. This proposed rule does not impose any federal mandates on any state, local, or tribal government or the private sector within the meaning of UMRA.

Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the rule preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Order. This rule does not have federalism implications and would not impose substantial direct compliance costs on state and local governments nor preempt state law within the meaning of the Order.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. This rule, consistent with recent statutory amendments, provides PHAs with the flexibility to enter into energy performance contracts with terms of not more than 20 years. These revisions impose no significant economic impact on a substantial number of small entities. Therefore, the undersigned certifies that this rule will not have a significant impact on a substantial number of small entities.

Notwithstanding HUD's view that this rule will not have a significant effect on a substantial number of small entities, HUD specifically invites comments regarding any less burdensome alternatives to this rule that will meet HUD's objectives as described in this preamble.

This final rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction; or establish, revise, or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

The Catalog of Federal Domestic Assistance program number is 14.850.

The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets.

Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to Part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to Part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to Part 4022).

This amendment (1) adds to Appendix B to Part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during November 2008, (2) adds to Appendix B to Part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during November 2008, and (3) adds to Appendix C to Part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during November 2008.

For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 7.09 percent for the first 20 years following the valuation date and 6.16 percent thereafter. These interest assumptions represent an increase (from those in effect for October 2008) of 0.91 percent for the first 20 years following the valuation date and 0.91 percent for all years thereafter.

The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 3.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions represent an increase (from those in effect for October 2008) of 0.50 percent in the immediate annuity rate and are otherwise unchanged. For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022).

The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during November 2008, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

On May 8, 2008 the Secretary published a notice of proposed rulemaking (NPRM) for this part in the Federal Register (73 FR 26056). In the summary to the NPRM, on pages 26056 and 26507, the Secretary discussed how the proposed regulations would amend the Department's Privacy Act regulations to exempt from certain Privacy Act requirements investigative material in a new system of records. The new system of records is the Office of Inspector General Data Analytics System (ODAS) and the exemption would apply to materials compiled by the Office of Inspector General (OIG) for law enforcement purposes.

There are no differences between the NPRM and these final regulations.

In response to the Secretary's invitation in the NPRM, the Department received no comments on the proposed regulations.

We have reviewed these final regulations in accordance with Executive Order 12866. Under the terms of the order we have assessed the potential costs and benefits of this regulatory action.

The potential costs associated with the final regulations are those resulting from statutory requirements and those we have determined to be necessary for administering this program effectively and efficiently.

In assessing the potential costs and benefits—both quantitative and qualitative—of these final regulations, we have determined that the benefits of the regulations justify the costs.

We have also determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

We summarized the potential costs and benefits of these final regulations in the NPRM at 73 FR 26058.

These regulations do not contain any information collection requirements.

You can view this document, as well as all other documents of this Department published in the Federal Register , in text and Adobe Portable Document Format (PDF) on the Internet at the following site: http://www.ed.gov/news/fedregister .

To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC area at (202) 512-1530.

The final rule establishes a $25.00 minimum for USPS issuance of individual customer refund checks for the unused postage value in postage meters and PC postage accounts. In addition, the final rule provides a 60-day limit for submission of physical refunds for both PC Postage and postage meter indicia; specifies a 10-day limit and procedure for requesting refunds processed electronically for items bearing a Product Identification Code (PIC) produced by a PC Postage system; and establishes a refund procedure for unused, undated PC Postage indicia.

A revised proposed revision of DMM 604.9.0 was published for comment in the Federal Register , May 9, 2008 (Vol. 73, No. 91, pages 26353-26355).

Comments:

No comments were received on the revised proposed rule.

Throughout this document, “we,” “us,” and “our” means EPA. This SUPPLEMENTARY INFORMATION section is arranged as follows:

We are determining that the Dallas/Fort Worth (DFW) 1-hour ozone nonattainment area is currently attaining the 1-hour ozone National Ambient Air Quality Standard (NAAQS). This determination is based upon certified ambient air monitoring data that show the area has monitored attainment of the 1-hour ozone NAAQS for the 2004-2006 monitoring period. In addition, quality controlled and quality assured ozone data for 2007 and 2008 that are available in the EPA Air Quality System databases show this area continues to attain the 1-hour ozone NAAQS.

The rationale for our action is explained in the Notice of Proposed Rulemaking (NPR) published on July 11, 2008 (73 FR 39897) and will not be restated here. No public comments were received on the NPR.

Pursuant to our determination of attainment and in accordance with our Clean Data Policy  1 , this determination suspends the requirements for the DFW area to submit an attainment demonstration, a RFP plan, or in this case a 5% IOP plan, (40 CFR 51.905(a)), section 172(c)(9) and section 182(c)(9) contingency measures, and other SIPs related to attainment of the 1-hour ozone NAAQS for so long as the area is attaining the standard.

We find that the DFW 1-hour ozone nonattainment area has attained the 1-hour ozone standard. Thus the requirements for submitting the attainment demonstration or 5% IOP plan, RFP plan, section 172(c)(9) and section 182(c)(9) contingency measures, and other SIPs related to attainment of the 1-hour ozone NAAQS are suspended for so long as the area is attaining the standard.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action makes a determination based on air quality data, and results in the suspension of certain Federal requirements. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601, et seq. ).

Because this rule makes a determination based on air quality data, and results in the suspension of certain Federal requirements, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely makes a determination based on air quality data and results in the suspension of certain Federal requirements, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it determines that air quality in the affected area is meeting Federal standards.

The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply because it would be inconsistent with applicable law for EPA, when determining the attainment status of an area, to use voluntary consensus standards in place of promulgated air quality standards and monitoring procedures that otherwise satisfy the provisions of the Clean Air Act. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ). Under Executive Order 12898, EPA finds that this rule involves a determination of attainment based on air quality data and will not have disproportionately high and adverse human health or environmental effects on any communities in the area, including minority and low-income communities.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 15, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action to reclassify the HGB area as a severe ozone nonattainment area and to adjust applicable deadlines may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

This action may affect you if you produce gasoline. The following table gives some examples of entities that may have to follow the regulations.

This table is not intended to be exhaustive, but provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To decide whether your organization might be affected by this action, you should carefully examine today's action and the existing regulations in 40 CFR part 80. If you have any questions regarding the applicability of this action to a particular entity, consult the persons listed in the preceding FOR FURTHER INFORMATION CONTACT section.

The Control of Hazardous Air Pollutants From Mobile Sources final rule (also known as the Mobile Source Air Toxics rule or MSAT2) was published on February 26, 2007 (72 FR 8428). That rule requires that refiners and importers produce gasoline that has an annual average benzene content of 0.62 volume percent (vol%) or less, beginning in 2011. (See § 80.1230(a).) The rule also requires that no refiner or importer have an actual average gasoline benzene level greater than 1.3 vol%. After achieving an actual annual average benzene level of 1.3 vol%, refiners and importers may use benzene credits to reduce their average benzene level to 0.62 vol%. Refiners may generate benzene credits for their own use or to sell to others, in two ways. Once the program begins in 2011, a refiner generates credits (known as standard credits) when its average annual gasoline benzene level is less than 0.62 vol%.

Refiners may also generate credits prior to 2011. These credits are called early credits, and are the subject of this final rule. The MSAT2 rule allows early benzene credits to be generated in any annual averaging period prior to 2011 (i.e., 2008, 2009, and 2010), as well as for the partial year period June 1-December 31, 2007. Early credits are generated on a refinery basis. In order to generate early credits, a refinery must meet several requirements:

(1) Establish a benzene baseline based on the average benzene level of the gasoline produced at the refinery during the two-year period 2004-05. (See § 80.1285.)

(2) Achieve an annual average benzene level at least 10% lower than its baseline level. (See § 80.1275(a).)

(3) Make operational changes or improvements in benzene control technology that will result in real benzene reductions. (See § 80.1275(d).)

Any refining or operational changes may be utilized to comply with the average benzene content requirement. However, in order to generate early credits, the rule specifies four types of operational changes and benzene control technology improvements that would allow a refinery to qualify if it implemented the changes/improvements after 2005 (and if it also met the other related requirements). § 80.1275(d)(1). These operational changes and technology improvements are:

(1) Treating the heavy straight run naphtha entering the reformer using light naphtha splitting and/or isomerization.

(2) Treating the reformate stream exiting the reformer using benzene extraction or benzene saturation.

(3) Directing additional refinery streams to the reformer for treatment as described in (1) and (2) above.

(4) Directing reformate streams to other refineries with treatment capabilities as described in (2) above.

A refinery needs to implement at least one of these listed changes/improvements in order to generate early credits.

This list includes all the strategies we thought would reduce fuel benzene (and thus benzene emissions) and be cost-effective. The provision was intended to preclude refineries from generating early credits solely by benzene reductions achieved through ethanol blending.

The final rule does not provide a way for EPA to consider alternative means of reducing fuel benzene and generating early credits, no matter how effective the alternative. Soon after the rule was finalized, it was brought to our attention that at least one refinery had plans to install benzene alkylation technology (also known as reformate alkylation). Benzene alkylation involves converting benzene into other aromatic compounds by the addition of alkyl groups to the benzene ring. Xylene, toluene and cumene are typical products formed by benzene alkylation. Benzene alkylation is not one of the four operational or technological changes enumerated in the final rule. Although EPA regarded benzene alkylation as a legitimate benzene reduction technology, and one which can be used to comply with the standard, we did not include it in the list of technologies for generation of early credits merely because we did not expect refiners to use it. (See the Regulatory Impact Analysis (EPA420-R-07-002, February 2007), Chapter 6, page 36.)

We therefore considered a request to include benzene alkylation on the list of early credit-generating technologies to have merit, and on March 12, 2008, we published a direct final rulemaking and a parallel proposal that would have revised the February 26, 2007 MSAT2 requirement regarding the benzene control technologies that qualify a refiner to generate early benzene credits to allow benzene alkylation in addition to the four operational or technological changes allowed by the MSAT2 rule. The direct final rule would have also allowed a refiner to submit a request to EPA to approve other benzene-reducing operational changes or technologies for the purpose of generating early credits.

We stated that if we received adverse comment by April 11, 2008, the direct final rule would not take effect and we would publish a timely withdrawal in the Federal Register . Commenters did in fact submit significant adverse comment and we accordingly published a withdrawal of the direct final rule on May 9, 2008. (See 73 FR 26325.) We stated in the direct final rule and the parallel proposed rule that we would address comments in any subsequent final action, which would be based on the parallel proposed rule, without a second comment period on the action. Today's action is based on the parallel proposed rule, and finalizes that proposal, so that refiners using benzene alkylation may generate early credits, and refiners can make site-specific demonstrations to EPA which may result in other technologies being eligible to generate early credits.

We received comments from the Northeast States for Coordinated Air Use Management (NESCAUM) and the New York State Department of Environmental Conservation (NYDEC). The commenters expressed several concerns with the rule. First, they were concerned that the rule continued the 2007 rule's focus on gasoline benzene content rather than benzene vehicle emissions. Second, commenters expressed the related concern that although benzene alkylation reduces gasoline benzene levels, it may not reduce benzene vehicle emissions. One commenter suggested that early credits be discounted to account for vehicular benzene emissions attributable to re-formed benzene. Commenters also expressed concern about increased aromatics emissions from vehicles. Finally, commenters opposed allowing other future refinery operational changes to be approved after petition to and review by EPA for the purpose of generating early credits.

As will be discussed below, benzene alkylation meaningfully reduces gasoline benzene levels and thus directly reduces benzene emissions. For this reason, we believe that allowing refiners to qualify to generate early credits through the use of benzene alkylation is consistent with the intent of technology requirement associated with the early credit provisions. Use of benzene alkylation will not have the adverse effects of concern to the commenters: benzene vehicle emissions will be reduced, and there will not be appreciable increases in aromatics emissions from vehicles.

Fuel aromatics and fuel benzene levels both affect vehicle benzene emissions, but not to anywhere near the same degree. Fuel benzene has more than a 20-fold  1 greater impact on benzene emissions from vehicles than other fuel components, including fuel aromatics levels. In the March 29, 2006 proposed rule, we discussed how non-benzene aromatics account for about 30% by volume of gasoline and contribute about 30% of benzene emissions while benzene constitutes only about one volume percent of the fuel but is responsible for about 25% of the benzene emissions. (The remaining benzene emissions are formed from other (non-aromatic) compounds. See 71 FR 15864). Based on evaluations using the Complex Model, we concluded there that a 20% reduction in aromatics would be needed to achieve the same level of benzene emissions reductions as the 0.62 vol% standard. (See 71 FR 15864.)  2 Thus, in the 2007 final rule, we concluded that fuel benzene control is the most effective means of reducing benzene and overall MSAT emissions because it offers measurable and certain benzene reductions that are not affected by “changes in fuel composition or vehicle technology.” (See 72 FR 8477.)

Reducing fuel benzene through alkylation or any other benzene reduction technology results in greater than 95% reduction in benzene exhaust emissions compared to the benzene emissions caused by the fuel benzene removed. We estimate that there is less than a 1% difference among benzene reduction technologies in their effectiveness at reducing benzene emissions. 3 Because benzene emissions reductions are significant regardless of the fuel benzene reduction technology, there is no reason to discourage the use of one technology over another. For the same reason, we do not agree with the suggestion to discount early credits generated by use of benzene alkylation to account for vehicular emissions.

The commenters' concern about increases in vehicle non-benzene aromatic emissions is also somewhat misplaced. Again, given the small amount of benzene in gasoline (1 vol%) relative to total aromatics (20-40 vol%), the additional contribution of aromatics attributable to alkylating the benzene is minimal, as would be any increase in aromatic emissions. In addition, as we discussed in the 2007 rule, fuel aromatics levels are expected to decrease because of increased ethanol use, so aromatics emission levels should be dropping in any event.

Thus, based on the analyses in the 2007 rule of the impacts of fuel benzene and aromatics reductions on emissions, the slight increase in fuel aromatics content that could result from refineries using benzene alkylation for the purposes of generating early credits under this rule should reduce benzene emissions that would otherwise not be reduced at this time. No deleterious vehicle emissions impacts are expected. It thus is appropriate for refiners using benzene alkylation to reduce fuel benzene levels to be eligible to generate early credits.

With respect to the other portion of today's rule, we continue to believe that allowing a refiner to petition us to use an operating change not currently listed in order to qualify to generate early benzene credits is appropriate. A refiner would have to show in the petition that the operating change would reduce fuel benzene levels which, as just discussed, is the best means of reducing benzene vehicle emissions. The MSAT2 program encourages early fuel benzene reductions in order to get early benzene emissions reductions. This action is not about permitting a refinery to implement a new technology or make an operating change—those actions can happen at any time within or outside of the early credit generation window, regardless of the refinery's intent vis-a-vis generating early credits. Today's action requires the petitioner to show that the change they intend to make reduces fuel benzene levels which directly and significantly reduces benzene vehicle emissions more than any other fuel compositional change. The petition process has the added value of being more timely than a rulemaking, which is important since early credits can only be generated through 2010, and refiners must apply to generate early credits before the start of the annual averaging period in which they first want to generate early credits.

We published a Questions and Answers document related to the MSAT2 program on August 16, 2007. ( http://epa.gov/otaq/regs/toxics/420f07053.pdf ) In that document, we specifically addressed benzene alkylation and indicated that benzene alkylation meets the intent of the technology requirement for early credits. As discussed in the preamble of the final rule, early credits are generated based on innovations in gasoline benzene control technology that result in real benzene reductions prior to the start of the program in 2011. (See 72 FR 8486.) The use of benzene alkylation directly results in lower gasoline benzene levels.

Today's action revises § 80.1275(d)(1) to include benzene alkylation in the list of acceptable reduction operational and technological strategies. We have also included a general provision that allows a refiner to petition EPA to use an operational or technological change that is not listed in the regulation for the purpose of generating early credits. The refiner must demonstrate that the benzene control technology improvement or operational change results in a net reduction in the refinery's average gasoline benzene level, exclusive of benzene reductions due simply to blending practices. The petition must be submitted to EPA prior to the start of the first averaging period in which the refinery plans to generate early credits. EPA expects it would act on such a petition before the end of that averaging period. The refiner must also provide additional information requested by EPA.

The other requirements for generating early credits are unchanged. These include submitting a benzene baseline, reducing the refinery's baseline benzene level by at least 10% in a given averaging period, and not moving gasoline or blendstock streams between refineries for the purpose of generating early credits. (See 72 FR 8486.)

This action allows companies that have alternative means or strategies for reducing gasoline benzene to request EPA approval to use them for the purpose of generating early benzene credits. Average gasoline benzene levels from such refiners will decrease faster and earlier than if they had not generated early credits leading to lower benzene emissions than would have been achieved otherwise. Such credits will also help provide for a robust credit pool when the program starts in 2011. Vehicle benzene emissions will be reduced and there will not be significant increases in vehicle emissions of other aromatics.

This action revises the February 26, 2007 mobile source air toxics rule's requirements that specify the benzene control technologies that qualify a refiner to generate early benzene credits. It allows another specific benzene control technology, benzene alkylation, to be used for the purpose of generating early credits, and allows a refiner to submit a request to EPA to approve other benzene-reducing operational changes or technologies for the purpose of generating early credits. This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. because the amendments in this rule do not change the information collection requirements of the underlying rule.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR Part 9.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of this action on small entities, small entity is defined as: (1) A petroleum refining company with fewer than 1,500 employees or a petroleum wholesaler or broker with fewer than 100 employees, based on the North American Industrial Classification System (NAICS); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule, I certify that this action will not have a significant economic impact on a substantial number of small entities.

This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531- 1538 for State, local, or tribal governments or the private sector. EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. Today's action simply modifies the original rule in a limited manner, and does not significantly change the original rule. Therefore, this action is not subject to the requirements of sections 202 or 205 of the UMRA.

This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This action only applies to parties that produce gasoline.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects 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.”

This final rule does not have federalism implications. It will not have substantial direct effects 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, as specified in Executive Order 13132. The rule amends existing regulatory provisions applicable only to producers of gasoline and does not alter State authority to regulate these entities. The amendments will impose no direct costs on State or local governments. Thus, Executive Order 13132 does not apply to this rule.

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. This rule amends existing regulatory provisions applicable only to producers of gasoline and will impose no direct costs on tribal governments. Thus, Executive Order 13175 does not apply to this action.

Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to Executive Order 13045 because it is not an economically significant regulatory action as defined in Executive Order 12866.

This action is not subject to Executive Order 13211 (66 FR 18355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866.

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) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This rule provides additional means for refiners to qualify to generate early credits by implementing a benzene reducing technology or operational mode. This in turn will reduce vehicle benzene emissions.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A Major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This final rule will be effective on December 15, 2008.

The statutory authority for the fuels controls in today's final rule can be found in sections 202(l) and 211(c) of the Clean Air Act (CAA), as amended. Support for any procedural and enforcement-related aspects of the fuel controls in today's rule, including recordkeeping requirements, comes from sections 114(a) and 301(a) of the CAA.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107-188 (42 U.S.C. 262a) (the Bioterrorism Preparedness Act), requires the HHS Secretary to establish by regulation a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety. In determining whether to include an agent or toxin on the list, the HHS Secretary considers the effect on human health of exposure to an agent or toxin; the degree of contagiousness of the agent and the methods by which the agent or toxin is transferred to humans; the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent illnesses resulting from an agent or toxin; the potential for an agent or toxin to be used as a biological weapon; and the needs of children and other vulnerable populations. The Bioterrorism Preparedness Act requires that the HHS Secretary review and republish the list of select agents and toxins on at least a biennial basis.

The HHS Secretary promulgated the current select agents and toxins lists in a final rule, published on March 18, 2005, and made effective on April 18, 2005. The select agents and toxins lists found in Part 73 are found in two sections. The biological agents and toxins listed in section 73.3 (HHS select agents and toxins) are those biological agents and toxins regulated only by HHS. The biological agents and toxins listed in section 73.4 (Overlap select agents and toxins) are those biological agents and toxins regulated both by HHS and USDA under the provisions of the Agricultural Bioterrorism Protection Act of 2002.

The Agricultural Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107-188 (7 U.S.C. 8401) (the Agricultural Bioterrorism Protection Act), requires the USDA Secretary to establish by regulation a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health or animal or plant products. In determining whether to include an agent or toxin on the list, the USDA Secretary considers the effect of exposure to the agent or toxin on animal or plant health, and on the production and marketability of animal or plant products; the pathogenicity of the agent or the toxicity of the toxin and the methods by which the agent or toxin is transferred to animals and plants; the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; and the potential of an agent or toxin for use as a biological weapon. The USDA Secretary is also required to conduct a biennial review of the USDA select agents and toxins list.

To assist with the biennial review, HHS reviewed recommendations provided by subject matter experts and the Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC). The ISATTAC is comprised of Federal government employees from the CDC, the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the USDA/Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), USDA/CVB (Center for Veterinary Biologics) and the Department of Defense (DOD).

HHS completed its biennial review on February 22, 2007 and on August 28, 2007, we published in the Federal Register (72 FR 49244) a proposal to neither add nor remove any agents or toxins from our select agents and toxins lists. However, we did advise that HHS intended to continue to regulate ten biological agents and toxins that USDA was proposing to no longer regulate.

After conducting its biennial review, on August, 28, 2007 (72 FR 49231) USDA proposed that it would no longer regulate ten of the biological agents and toxins currently listed by them as “overlap” select agents and toxins. Published in today's Federal Register is USDA's final rule that removes from Part 121 of Title 9 of the Code of Federal Regulations the following agents and toxins: Botulinum neurotoxins, Botulinum neurotoxin producing species of Clostridium, Coxiella burnetti, Francisella tularensis, Coccidioides immitis, Eastern equine encephalitis virus, T-2 toxin, Staphylococcal enterotoxins, Shigatoxin, and Clostridium perfringens epsilon toxin.

For the proposed rule, we provided for a 60-day comment period for written comments that ended October 29, 2007. Relevant issues raised by the comments are discussed below. Based on the rationale set forth in the proposed rule, we are affirming the provisions of the proposed rule as a final rule.

Commenters recommended that the following biological agents and toxins be removed from the HHS list to mirror their removal by USDA: (1) Botulinum neurotoxin producing species of Clostridium , (2) Eastern equine encephalitis virus, (3) Botulinum neurotoxins; and (4) Clostridium perfringens epsilon toxin because “they are found naturally in the U.S. and most are ubiquitous and the proposed rule does not give the basis for maintaining these naturally occurring agents.” One commenter further argued that Clostridium perfringens epsilon toxin should be removed because “the use of this toxin as a bioterrorism weapon is highly unlikely due to several factors including the method and effectiveness of administration, the lack of potential secondary transmission to uninfected individuals.” We made no changes based on these comments. The potential negative impact of exposure to a select agent or toxin to the public health may be different from its impact on agriculture. As a part of its review using subject matter experts, HHS determines whether a select agent or toxin has the potential to pose a significant public health threat based on the effect of the exposure to the agent or toxin to humans, the degree of contagiousness that an agent will have with respect to humans, availability of treatments for humans, and the susceptibility by vulnerable human populations. Based on these criteria, HHS confirmed its prior determination that these agents and toxins have the potential to pose a significant public health threat because they have acute toxicity, have lethality in humans, can easily be produced in large quantities, and can be transferred by an aerosol method. In contrast, USDA's evaluations and determinations that it would remove these agents and toxins from its regulation is detailed in their Federal Register notice published on August 28, 2007 (See 72 FR 49231) and today's Federal Register that:

• Botulinum neurotoxin producing species of Clostridium ( i.e. , C. botulinum, C. butyricum and C. baratii ) are widely distributed in soil, sediments of lakes and ponds, and decaying vegetation. The species may be found in any region of the world and some species may occasionally colonize the intestinal tract of birds and mammals under natural conditions. The neurotoxins produced by these agents produce the infectious toxicosis of botulism. There is a well known and established history of infection and toxicosis in agricultural species associated with C. botulinum in the United States, and UDSA concluded that Botulinum neurotoxin producing species do not pose a serious threat to American agriculture.

• Based on evidence that transmissibility from animal to animal is negligible and that, historically, outbreaks of botulism occur periodically in the United States, USDA determined that botulinum neurotoxins are a poor agroterrorism weapon, and USDA should therefore remove Botulinum neurotoxins and Botulinum neurotoxin producing species of Clostridium from the list of overlap select agents in its regulations in § 121.4(b).

• Eastern equine encephalitis virus has been recognized as an important veterinary pathogen that infects equines and birds during sporadic outbreaks. Infection results in central nervous system dysfunction and may result in moderate to high morbidity and mortality. The virus is maintained naturally in nature in marshes and swamps in an enzootic bird-mosquito-bird cycle, and is endemic in the United States along the Atlantic and Gulf coasts. Eastern equine encephalitis virus does not play a major role in agricultural species of concern, and equine species are considered a dead-end host of the virus.

• Additionally, the working group concluded that because the following overlap select agents and toxins are naturally found in the United States, do not pose a significant impact to animal health, and are not likely candidates for use in an agroterrorism event directed toward animal health, these select agents and toxins would have a limited socio-economic impact on American agriculture, and thus should be removed from the list: Botulinum neurotoxin producing species of Clostridium, Clostridium perfringens epsilon toxin, Francisella tularensis , Staphylococcal enterotoxin, shigatoxin, and T-2 toxin.

One commenter further proposed that (1) “CDC provides an exemption for the use of the agents noted above in the manufacture of veterinary biologics in facilities licensed by the USDA's Center for Veterinary Biologics (CVB) or their investigational use by biologics firms under CVB supervision,” (2) “that they remain on the overlap list” or (3) “if they remain on the CDC Select Agent list and are removed from the Overlap list that CDC utilize the CVB for oversight and inspection of CVB licensed firms.” We made no changes based on these comments. The regulations currently provide that products that are, bear, or contain listed select agents or toxins that are cleared, approved, licensed, or registered under the Virus-Serum-Toxin Act (21 U.S.C. 151-159) are exempt from the provisions of this part insofar as their use meets the requirements of that Act. Veterinary biologics licensed by USDA's Center for Veterinary Biologics are licensed under the authority of the Virus-Serum-Toxin Act. The regulations also provide that on a case-by-case basis the HHS Secretary may exempt from the requirements of the part 73 regulations an investigational product that is, bears, or contains a select agent or toxin, when such product is being used in an investigation authorized under any Federal Act and additional regulation under part 73 is not necessary to protect public health and safety. See 42 CFR 73.5(d). While we and USDA do everything we can to minimize disruption due to select agent oversight, CDC has determined that it would not be appropriate to utilize CVB for oversight and inspection of registered entities that only have select agents and toxins on the HHS list.

Several commenters noted a typographical error on page 49245 that listed the aggregate amount for Botulinum neurotoxins as “05. mg.” This was a typographical error and we were not proposing to change the aggregate amount for Botulinum neurotoxins under the control of a principal investigator, a treating physician or veterinarian, or a commercial manufacturer or distributor that would meet the exclusion provisions for part 73. The maximum aggregate amount of Botulinum neurotoxins under the control of a principal investigator, a treating physician or veterinarian, or a commercial manufacturer or distributor that meets the requirement for exclusion under 42 CFR 73.4 will continue to be 0.5 mg.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the HHS consider the impact of paperwork and other information collection burdens imposed on the public. We have determined no new information collection requirements are associated with this proposed rule.

This final rule has been reviewed under Executive Order 12866, and has been determined not to be significant. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires an agency to review regulations to assess their impact on small entities unless the agency determines that a rule is not expected to have a significant impact on a substantial number of small entities. This rule will have no costs because it merely changes the designation of ten select agents and toxins from being regulated by both HHS and USDA to being regulated solely by HHS. We hereby certify this proposed rule will not have a significant economic impact on a substantial number of small businesses.

The Unfunded Mandates Reform Act at 2 U.S.C. 1532 requires that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in expenditure by State, local, or tribal governments, in the aggregate, or by the private sector of $100 million or more (adjusted for inflation) in any given year. This proposed rule is not expected to result in any one-year expenditure that would exceed this amount.

This Final Rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Would preempt all State and local laws and regulations that are inconsistent with this rule; (2) would have no retroactive effect; and (3) would not require administrative proceedings before parties may file suit in court challenging this rule.

This Final Rule has been reviewed under Executive Order 13132, Federalism. The notice does not propose any regulation that would preempt State, local, and Indian tribe requirements, or that would have any substantial direct effects 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.

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

NMFS closed the directed fishery for Atka mackerel by vessels participating in the BSAI trawl limited access fishery in the Eastern Aleutian District and the Bering Sea subarea on September 1, 2008 (73 FR 51242, September 2, 2008).

NMFS has determined that approximately 152 mt of the 2008 Atka mackerel TAC specified for vessels participating in the BSAI trawl limited access fishery in the Eastern Aleutian District and the Bering Sea subarea remain in the directed fishing allowance. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully utilize the 2008 TAC of Atka mackerel in these areas specified for vessels participating in the BSAI trawl limited access fishery, NMFS is terminating the previous closure and is opening directed fishing for Atka mackerel by vessels participating in the BSAI trawl limited access fishery in the Eastern Aleutian District and the Bering Sea subarea. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance will be reached after 72 hours. Consequently, NMFS is prohibiting directed fishing for the 2008 TAC of Atka mackerel in these areas specified for vessels participating in the BSAI trawl limited access fishery effective 1200 hrs, A.l.t., October 13, 2008.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA) finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of the Atka mackerel fishery in the Eastern Aleutian District and the Bering Sea subarea for vessels participating in the BSAI trawl limited access fishery. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 8, 2008. The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

Without this inseason adjustment, NMFS could not allow the fishery for Atka mackerel fishery in the Eastern Aleutian District and the Bering Sea subarea by vessels participating in the BSAI trawl limited access fishery to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until October 27, 2008.

This action is required by § 679.20 and § 679.25 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

NMFS closed the directed fishery for pollock in Statistical Area 610 of the GOA under § 679.20(d)(1)(iii) on October 6, 2008 (73 FR 59538, October 9, 2008).

NMFS has determined that approximately 750 metric tons of pollock remain in the directed fishing allowance. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully utilize the 2008 TAC of pollock in Statistical Area 610, NMFS is terminating the previous closure and is reopening directed fishing for pollock in Statistical Area 610 of the GOA. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance will be reached after 48 hours. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 610 of the GOA effective 1200 hrs, A.l.t., October 14, 2008.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of pollock in Statistical Area 610 of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 9, 2008.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

Without this inseason adjustment, NMFS could not allow the fishery for pollock in Statistical Area 610 of the GOA to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until October 27, 2008.

This action is required by § 679.20 and § 679.25 and is exempt from review under Executive Order 12866.