Notices. Temporary rule; inseason adjustment; closure
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BILLING CODE 4310-55-C DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 070213032-7032-01] RIN 0648-XC26 Fisheries of the Economic Exclusive Zone off Alaska; Shallow-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; inseason adjustment; closure. SUMMARY: NMFS is prohibiting directed fishing for species that comprise the shallow-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA), effective 2400 hrs, Alaska local time, September 1, 2007.
This adjustment is necessary to allow a 12-hour fishery for species that comprise the shallow-water species fishery without exceeding the fourth seasonal apportionment of the 2007 Pacific halibut bycatch allowance specified for the shallow-water species fishery in the GOA. DATES: Effective 1200 hrs, Alaska local time (A.l.t.), September 1, 2007, through 2400 hrs, A.l.t., September 1, 2007. Comments must be received at the following address no later than 4:30 p.m., A.l.t., September 12, 2007.
ADDRESSES: Send comments to Sue Salveson, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region, NMFS, Attn: Ellen Sebastian. Comments may be submitted by: • Mail to: P.O. Box 21668, Juneau, AK 99802; • Hand delivery to the Federal Building, 709 West 9th Street, Room 420A, Juneau, Alaska; • FAX to 907-586-7557; • E-mail to *inseason.fakr@noaa.gov* and include in the subject line of the e-mail the document identifier: goaswx4s12.fo.wpd (E-mail comments, with or without attachments, are limited to 5 megabytes); or • Webform at the Federal eRulemaking Portal: *http://www.regulations.gov* .
Follow the instructions at that site for submitting comments. FOR FURTHER INFORMATION CONTACT: Jennifer Hogan, 907-586-7228. SUPPLEMENTARY INFORMATION: 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. The fourth seasonal apportionment of the 2007 Pacific halibut bycatch allowance specified for the shallow-water species fishery in the GOA is 150 metric tons
(mt)as established by the 2007 and 2008 harvest specifications for groundfish of the GOA (72 FR 9676, March 5, 2007), for the period 1200 hrs, A.l.t., September 1, 2007, through 1200 hrs, A.l.t., October 1, 2007. Regulations at § 679.23(b) specify that the time of all openings and closures of fishing seasons other than the beginning and end of the calendar fishing year is 1200 hrs, A.l.t. Current information shows the expected trawl Pacific halibut bycatch rates observed in groundfish fisheries during the fourth season in the GOA to be 300 mt per day. The Administrator, Alaska Region, NMFS, has determined that the 2007 Pacific halibut bycatch allowance specified for the trawl fisheries could be exceeded if a 24-hour fishery were allowed to occur. NMFS intends that the halibut bycatch allowance not be exceeded and, therefore, will not allow a 24-hour directed fishery. NMFS, in accordance with § 679.25(a)(1)(i) and 679.25(a)(2)(i)(A), is adjusting the trawl shallow-water species fishery in the GOA by prohibiting the fishery at 2400 hrs, A.l.t., September 1, 2007, at which time directed fishing for shallow-water species by vessels using trawl gear in the GOA will be prohibited. This action has the effect of opening the fishery for 12 hours. NMFS is taking this action to allow a controlled fishery to occur, thereby preventing the overharvest of the Pacific halibut bycatch allowance specified for the trawl shallow-water species fishery designated in accordance with the 2007 and 2008 harvest specifications for groundfish in the GOA (72 FR 9676, March 5, 2007) and § 679.21(d). In accordance with § 679.25(a)(2)(iii), NMFS has determined that prohibiting directed fishing at 2400 hrs, A.l.t., September 1, 2007, after a 12-hour opening is the least restrictive management adjustment to allow the fishing industry opportunity to harvest species that comprise the shallow-water species fishery without exceeding the fourth seasonal apportionment of the 2007 Pacific halibut bycatch allowance for the shallow-water species fishery in the GOA. Pursuant to § 679.25(b)(5), NMFS has considered data regarding inseason prohibited species bycatch rates observed in groundfish fisheries in the GOA in making this adjustment. The species and species groups that comprise the shallow-water species fishery are pollock, Pacific cod, shallow-water flatfish, flathead sole, Atka mackerel, skates and “other species.” This inseason adjustment does not apply to fishing for pollock by vessels using pelagic trawl gear in those portions of the GOA open to directed fishing for pollock. This inseason adjustment does not apply to vessels fishing under a cooperative quota permit in the cooperative fishery in the Rockfish Pilot Program for the Central GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and
(f)apply at any time during a trip. Classification 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 inseason adjustment closing of the shallow-water species fishery by vessels using trawl gear in 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 August 20, 2007. 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 the shallow-water species fishery in 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 September 12, 2007. This action is required by § 679.21 and § 679.25 and is exempt from review under Executive Order 12866. Authority: 16 U.S.C. 1801 *et seq.* Dated: August 22, 2007. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. E7-17035 Filed 8-27-07; 8:45 am] BILLING CODE 3510-22-S 72 166 Tuesday, August 28, 2007 Proposed Rules DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 331 9 CFR Part 121 [Docket No. APHIS-2007-0033] RIN 0579-AC53 Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. SUMMARY: In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are proposing 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. 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 would implement the findings of the second biennial review of the list. DATES: We will consider all comments that we receive on or before October 29, 2007. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* , select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2007-0033 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link. • *Postal Mail/Commercial Delivery:* Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2007-0033, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2007-0033. *Reading Room:* You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call
(202)690-2817 before coming. *Other Information:* Additional information about APHIS and its programs is available on the Internet at *http://www.aphis.usda.gov* . FOR FURTHER INFORMATION CONTACT: For information concerning the regulations in 7 CFR part 331, contact Ms. Gwendolyn Burnett, Select Agent Program Compliance Manager, PPQ, APHIS, 4700 River Road Unit 2, Riverdale, MD 20737-1231,
(301)734-5960. For information concerning the regulations in 9 CFR part 121, contact Dr. Frederick D. Doddy, Veterinary Medical Officer, Animals, Organisms and Vectors, and Select Agents, VS, APHIS, 4700 River Road Unit 2, Riverdale, MD 20737-1231,
(301)734-5960. SUPPLEMENTARY INFORMATION: Background 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). 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. 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. Overlap select agents and toxins are those that have been determined to pose a severe threat to both human and animal health or animal products. Overlap select agents 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 this document, we are proposing to amend and republish the list of select agents and toxins based on the findings of our second biennial review of the list. In determining whether to include an agent or toxin in 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 prophylaxis 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. We use the term “select agent and/or toxin” throughout the preamble of this proposed rule. Unless otherwise specified, the term “select agent and/or toxin” will refer to all agents or toxins listed by APHIS. When it is necessary to specify the type of select agent or toxin, we will use the following terms: “PPQ select agent and/or toxin” (for the plant agents and toxins listed in 7 CFR 331.3), “VS select agent and/or toxin” (for the animal agents and toxins listed in 9 CFR 121.3), or “overlap select agent and/or toxin” (for the agents and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4). PPQ Select Agents and Toxins APHIS's Plant Protection and Quarantine
(PPQ)program convened an interagency working group to review the list of PPQ select agents and toxins and develop recommendations regarding possible changes to that list. Using the four criteria for listing found in the Act, the working group revisited the currently listed PPQ select agents and toxins and evaluated a number of plant pathogens for inclusion on the list. Based on this review, APHIS is proposing several amendments to the list of PPQ select agents and toxins listed in 7 CFR 331.3. First, we are proposing to remove *Candidatus* Liberobacter asiaticus, a bacterium causing Huanglongbing or citrus greening disease, from the list. Citrus greening disease has been introduced into the United States and now *C.* Liberobacter asiaticus would have virtually no impact if used as a weapon of terrorism. The bacterium itself is not harmful to humans but the disease has harmed trees in Asia, Africa, the Arabian Peninsula, and Brazil. The Asian strain of the disease, *C.* Liberibacter asiaticus, was found in south Miami-Dade County Florida in early September, 2005. Since that time, this plant pathogen has spread through much of Southern Florida. The disease is primarily spread by the Asian citrus psyllid and the African citrus psyllid as they feed. The Asian citrus pysllid, *Diaphorina citri,* has been present in Florida since 1998. The exact pathway responsible for introducing citrus greening and the Asian citrus psyllid into the United States is still unknown. Once infected, there is no cure for a tree with citrus greening disease. In areas of the world where citrus greening is endemic, citrus trees decline and die within a few years. In order to protect the U.S. citrus industry, there is an urgent need to facilitate timely research on effective means to manage the disease in the United States. For these reasons, we are removing *C.* Liberobacter asiaticus from list of PPQ select agents and toxins. We are proposing to regulate all pathovars of *Xanthomonas oryzae.* Currently, *Xanthomonas oryzae* pv. *oryzicola* is listed. However, both pathovars ( *oryzicola* and *oryzae* ) represent a significant risk to U.S. rice production. By removing the pathovar designation (pv. *oryzicola* ) from the currently listed organism, both pathovars would be covered by the regulations. Originally, we included the pathovar designation because scientific reports indicated the presence of *Xanthomonas oryzae* pv. *oryzae* in the United States. However, current scientific information indicates that this pathovar does not occur in the United States. Entities that currently have possession of *Xanthomonas oryzae* pv. *oryzae* would become regulated as a result of this proposed change to the regulations. We are also proposing to add *Peronosclerospora sacchari* as a synonym of the listed organism *Peronosclerospora philippinensis* because recent scientific research has shown that these two organisms are the same. Entities that currently have possession of *Peronosclerospora sacchari* would become regulated as a result of this proposed amendment to the regulations. In addition to the proposed changes to the existing list, the following pathogens would be added to the list: • *Candidatus* Liberibacter americanus. This bacterial species also causes citrus greening disease and has only been reported in Sao Paulo State, Brazil, where it has been detected in 26 municipalities of Sao Paulo State since its discovery in 2004. The citrus greening disease management plan in place for *C.* Liberobacter asiaticus mentioned above is specific to that one pathogen—not all three. *C.* Liberobacter africanus, which is currently listed, and *C.* Liberobacter asiaticus have different biological characteristics than *C.* Liberibacter americanus, and each of the pathogens has a potential to cause different detrimental effects on citrus production in the United States. There have been no reports of this Liberibacter species in the United States although the psyllid insect vector ( *Diaphorina citri* ) has been reported in both Florida and Texas. Polymerase chain reaction
(PCR)assays can distinguish this species from *C.* Liberobacter africanus and *C.* Liberobacter asiaticus. While we use the spelling “Liberobacter” in the proposed regulations, some sources use the spelling “Liberibacter.” APHIS considers both spellings to be identical for regulatory purposes. • *Phoma glycinicola* (formerly *Pyrenochaeta glycines* ). This fungus causes red leaf blotch of soybean and has been described as very aggressive, having resulted in yield losses up to 75 percent in Ethiopia due to defoliation of some soybean cultivars. The fungus survives in soil for long periods, and the disease may be spread widely through movement of contaminated seed, soil, or other means. This pathogen is not present in the United States, but it has the potential to be a major foliar disease of soybean if introduced. • *Phytophthora kernoviae.* This fungus-like organism is a newly reported pathogen of forest trees and shrubs and has only been reported in England, Wales, and New Zealand. The extent of host damage and speed with which disease symptoms arose in rhododendron, beech, and oak prompted England's Department for Environment, Food and Rural Affairs to identify this pathogen as a serious threat to its woodland areas. Nursery stock shipped to the United States from the European Union must be tested for this pathogen. Pathogen spores are easily spread through airborne mist droplets, rain, wind, or movement of contaminated plant material or soil. *P. kernoviae* is considered more virulent or aggressive in rhododendron than is *P. ramorum,* which causes sudden oak death syndrome. This pathogen could be a highly destructive disease in many common trees and shrubs in the United States if introduced. • *Rathayibacter toxicus.* This bacterium causes gumming disease in ryegrass and is transported into seed heads by species of *Anguina,* a genus of nematodes widely present in the United States. Additionally, if consumed, a neurotoxin produced by this plant pathogen causes illness or death in mammals. Disease management has been expensive and difficult in areas affected by this pathogen, with heavy reliance on use of herbicides on affected grasses. VS Select Agents and Toxins APHIS' Veterinary Services
(VS)program also convened an interagency working group to review the list of VS select agents and toxins and the list of overlap agents and toxins in 9 CFR part 121 in order to update and revise the lists as necessary. We are proposing to remove 10 of the 20 overlap select agents and toxins from the list set out in § 121.4(b). Specifically, we would remove the following bacteria: Botulinum neurotoxin producing species of *Clostridium, Coxiella burnetii,* and *Francisella tularensis;* the fungus *Coccidioides immitis;* Eastern equine encephalitis virus; and the following toxins: Botulinum neurotoxins, *Clostridium perfringens* epsilon toxin, shigatoxin, staphylococcal enterotoxin, and T-2 toxin. The interagency working group considered each of the overlap pathogens with respect to the four criteria for listing found in the Act (as listed above, under “Background”), and based on the group's analysis, APHIS has determined that the 10 overlap select agents and toxins should be removed from the list because they 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. While any one of these considerations alone would not likely be grounds for removing an agent or toxin from the list, the group concluded that all three considerations mentioned above apply to each of the 10 overlap select agents and toxins identified. 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 we have concluded that Botulinum neurotoxin producing species do not pose a serious threat to American agriculture. *Coccidioides immitis* is found naturally and predominantly in the hot, dry regions of the southwestern United States, where winters are relatively mild and the soil is alkaline. The introduction of *Coccidioides immitis* may result in inapparent infection or Coccidioidomycosis. Coccidioidomycosis, however, is not a contagious disease, nor is it a disease of major agricultural concern. While infections do occur in agricultural species, they appear to be limited. *Coxiella burnetii* is a ubiquitous organism that occurs commonly in animal reservoirs that include mammals, birds, and arthropods throughout the United States. Infection in ruminants may result in reproductive failures. Inapparent infection or mild illness does occur, but abortion is the most significant clinical presentation. 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. These select agents and toxins would still be regulated by the CDC under 42 CFR part 73. However, because these select agents and toxins would no longer be subject to regulation under 9 CFR 121.4, they would no longer be overlap select agents and toxins. CDC has initiated rulemaking to revise its regulations to reclassify these select agents and toxins as HHS select agents and toxins. To reflect recent changes in scientific nomenclature, we would amend the list of VS select agents and toxins in § 121.3(b) by replacing *Cowdria ruminantium* with *Ehrlichia ruminantium;* replacing *Mycoplasma mycoides mycoides* with *Mycoplasma mycoides* subspecies *mycoides* small colony ( *Mmm* SC); and replacing *Mycoplasma capricolum/M.* F38/ *M. mycoides capri* with *Mycoplasma capricolum* subsp. *capripneumoniae.* The World Organization for Animal Health
(OIE)defines reportable Newcastle disease as an infection of birds caused by an avian paramyxovirus 1 virus possessing certain *in vivo* and/or molecular characteristics. To be consistent with OIE's guideline for reporting an outbreak of Newcastle disease, we would change how we refer to Newcastle disease in the regulations. Specifically, we would replace references to “Newcastle disease virus (velogenic)” in the list in § 121.3(b) and in the text of §§ 121.3(f)(3)(i), 121.5(a)(3)(i), and 121.9(c)(1) with references to “virulent Newcastle disease virus.” Additionally, we would add a footnote to the entry for virulent Newcastle disease virus in § 121.3(b). In the footnote we would define a virulent Newcastle disease virus as either having an intracerebral pathogenicity index in day-old chicks ( *Gallus gallus* ) of 0.7 or greater, or as having an amino acid sequence at the fusion
(F)protein cleavage site that is consistent with virulent strains of Newcastle disease virus. In § 121.4(d)(3), we list five overlap toxins that cannot exceed a specified amount while under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor. However, because we are proposing to remove from the overlap select agent list the five overlap toxins listed in this paragraph—specifically, botulinum neurotoxins, *Clostridium perfringens* epsilon toxin, shigatoxin, staphylococcal enterotoxins, and T-2 toxin—the paragraph would no longer be necessary. Therefore, we would remove § 121.4(d)(3) in its entirety. Section 121.6 deals with the exemptions for overlap select agents and toxins. Two of the overlap select agents and toxins listed in § 121.6(a)(3)(i) are botulinum neurotoxins and *Francisella tularensis.* To reflect our proposed removal of those two select agents and toxins from our list of overlap select agents and toxins, we would also amend § 121.6 by removing botulinum neurotoxins and *Francisella tularensis* from paragraph (a)(3)(i). Similarly, botulinum neurotoxins and *Francisella tularensis* are included in § 121.9(c)(1), which sets out the reporting requirements for the identification and final disposition of overlap select agents or toxins contained in a specimen presented for diagnosis or verification. We would amend § 121.9 by removing botulinum neurotoxins and *Francisella tularensis* from paragraph (c)(1). Executive Order 12866 and Regulatory Flexibility Act This proposed 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 proposing to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to both human and animal health, 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 would implement 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 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, this 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 72 million acres of soybeans were cultivated in the United States in 2003), exacerbating difficulties in surveillance and monitoring. 1 1 Making the Nation Safer: The Role of Science and Technology in Countering Terrorism. Committee on Science and Technology for Countering Terrorism, Division on Engineering and Physical Sciences, National Research Council. National Academy Press (2002). 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 it vital to prevent the misuse of biological agents and toxins through registration, biosafety, security and incident response measures. This preliminary regulatory impact analysis addresses expected economic effects of this rule. 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. Benefits and Costs This rule would update the select agents and toxins listed in 7 CFR part 331 and 9 CFR part 121. Those parts of the CFR require registration, biosafety, incident response and security measures for the possession, use and transfer of the listed select agents and toxins. These parts are intended to prevent the misuse of those select agents and toxins, and therefore reduce the potential for harm to 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 could 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 in plants. Industry could also be affected through the imposition of domestic and foreign quarantines and the resulting loss of markets. The Federal 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 the safety of an implicated food product and about the producing country or sector's ability to produce safe food can be slow to recover and can have a lasting influence on food demand and global trade. 2 As such, the benefits associated with the rule are the avoided losses to the animals or plants that could be attacked by these organisms, and their products and markets. 2 Buzby, J.C. *Effects of food-safety perceptions on food demand and global trade.* Changing Structure of Global Food Consumption and Trade/WRS-01-1. Economic Research Service/USDA. The costs associated with outbreaks can be very high, as is demonstrated by natural outbreaks associated with select agents. For example, it has been estimated that the losses to agriculture and the food chain from a recent foot-and-mouth disease
(FMD)outbreak in the United Kingdom, including the costs compensated by the government, 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 billion and $13.5 billion. 3 3 Ekboir, J.M. *Potential impact of foot-and-mouth disease in California: the role and contribution of animal health surveillance and monitoring services.* Davis, CA: Agricultural Issues Center, Division of Agriculture and Natural Resources, University of California, Davis, 1999. The above-cited consequences relate to natural or accidental introduction. Deliberate introduction greatly increases the probability of a select agent or toxin becoming established and causing wide-ranging and devastating impacts on the economy, disruption to society, diminished confidence in public and private institutions, and possible loss of life. Any entity that possesses, uses, or transfers listed select agents or toxins is required to comply with the select agent regulations. These entities include research and diagnostic facilities; Federal, State and university laboratories; and private commercial and non-profit enterprises. The regulations include requirements for registering the possession, use, 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; ensure that the physical security of the premises are adequate; ensure that all individuals with access to select agents or toxins have the appropriate education, training, and/or experience to handle such agents or toxins; ensure that all individuals with access to select agents or toxins have an approved security risk assessment; and maintain complete records concerning activities related to the select agents or toxins. While any entity affected by the changes proposed in this rule may incur costs in complying with the select agent regulations, the proposed changes are expected to have minimal impacts. The proposed changes to the PPQ select agent list include the addition of four pathogens to the list, the removal of an organism from the list, and technical changes to the names of organisms currently listed. These changes should only affect a small number of entities. The plant pest permit database maintained by APHIS indicates that very few entities currently possess any of the agents that would be added to the list. In addition, most of the entities that do possess these agents are already registered due to their possession of other listed agents or toxins. The few entities that would be affected by the removal of organisms from the list would no longer be required to comply with the select agent regulations with regard to those removed organisms. The proposed 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 OIE definitions. The agents that are proposed for removal are overlap agents regulated by both USDA and HHS. HHS would continue to regulate these agents as HHS-only agents. Therefore, any entity in possession of these agents would continue to be subject to select agent regulations as administered by HHS. 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 circulated in the United States since the 1970s. In addition, entities most likely to be in possession of virulent Newcastle disease virus are already in possession of Newcastle disease virus (velogenic) and therefore already registered. Alternatives Considered 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. Conclusion This proposed rule would update the PPQ, VS, and overlap select agent and toxin lists. The regulation of select agents and toxins is intended to prevent their misuse and thereby reduce the potential for harm to 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. 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 the costs of eradication or control. Industry would be affected through the imposition of domestic and foreign quarantines and the resulting loss of markets, and the destruction of infected or exposed animals or plants, or animal products or plant products. Even though compensation may be paid for the destroyed property, repopulating (flocks, herds, fields, etc.) may be time-consuming, with additional losses from 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. Entities most likely to be affected by this rule are 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 would be added to the list of select agents and toxins. Entities that would be affected by the removal of agents or toxins from the list would no longer be required to comply with the regulations with regard to those removed agents or toxins. Other changes proposed would not affect what agents or toxins are listed but rather the nomenclature by which those agents and toxins are identified, and therefore would have no economic impact. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities. Executive Order 12372 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.) Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted:
(1)All State and local laws and regulations that are inconsistent with this rule will be preempted;
(2)no retroactive effect will be given to this rule; and
(3)administrative proceedings will not be required before parties may file suit in court challenging this rule. Paperwork Reduction Act This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects 7 CFR Part 331 Agricultural research, Laboratories, Plant diseases and pests, Reporting and recordkeeping requirements. 9 CFR Part 121 Agricultural research, Animal diseases, Laboratories, Medical research, Reporting and recordkeeping requirements. Accordingly, we propose to amend 7 CFR part 331 and 9 CFR part 121 as follows: TITLE 7—[AMENDED] PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS 1. The authority citation for part 331 continues to read as follows: Authority: 7 U.S.C. 8401; 7 U.S.C. 2.22, 2.80, and 371.3. 2. In § 331.3, paragraph
(b)is revised to read as follows: § 331.3 PPQ select agents and toxins
(b)PPQ select agents and toxins: *Candidatus* Liberobacter africanus ( *Candidatus* Liberibacter africanus); *Candidatus* Liberobacter americanus ( *Candidatus* Liberibacter americanus); *Peronosclerospora philippinensis* ( *Peronosclerospora sacchari* ); *Phoma glycinicola* (formerly *Pyrenochaeta glycines* ); *Phytophthora kernoviae* ; *Ralstonia solanacearum,* race 3, biovar 2; *Rathayibacter toxicus;* *Sclerophthora rayssiae* var. * zeae* ; *Synchytrium endobioticum* ; *Xanthomonas oryzae* ; *Xylella fastidiosa* (citrus variegated chlorosis strain). TITLE 9—[AMENDED] PART 121—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS 3. The authority citation for part 121 continues to read as follows: Authority: 7 U.S.C. 8401; 7 U.S.C. 2.22, 2.80, and 371.4. 4. In § 121.3, footnotes 1 and 2 are redesignated as footnotes 2 and 3, respectively, and paragraph
(b)is revised to read as follows: § 121.3 VS select agents and toxins
(b)VS select agents and toxins: African horse sickness virus; African swine fever virus; Akabane virus; Avian influenza virus (highly pathogenic); Bluetongue virus (exotic); Bovine spongiform encephalopathy agent; Camel pox virus; Classical swine fever virus; *Ehrlichia ruminantium* (Heartwater); Foot-and-mouth disease virus; Goat pox virus; Japanese encephalitis virus; Lumpy skin disease virus; Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1); Menangle virus; *Mycoplasma capricolum* subspecies * capripneumoniae* (contagious caprine pleuropneumonia); *Mycoplasma mycoides* subspecies *mycoides* small colony ( *Mmm* SC) (contagious bovine pleuropneumonia); Peste des petits ruminants virus; Rinderpest virus; Sheep pox virus; Swine vesicular disease virus; Vesicular stomatitis virus (exotic). Virulent Newcastle disease virus 4 4 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. 5. Section 121.4 is amended as follows: a. By revising paragraph
(b)to read as set forth below. b. In paragraphs
(c)and (d), by redesignating footnotes 3 and 4 as footnotes 4 and 5, respectively. c. By removing paragraph(d)(3). d. In paragraph (f)(3)(i), by removing the words “ *Botulinum neurotoxins* ,” and “ *Francisella tularensis,* ”. § 121.4 Overlap select agents and toxins.
(b)Overlap select agents and toxins: *Bacillus anthracis;* *Brucella abortus;* *Brucella melitensis;* *Brucella suis;* *Burkholderia mallei;* *Burkholderia pseudomallei;* Hendra virus; Nipah virus; Rift Valley fever virus; Venezuelan equine encephalitis virus. § 121.5 [Amended] 6. In § 121.5, paragraph (a)(3)(i) is amended by removing the words “Newcastle disease virus (velogenic)” and adding the words “virulent Newcastle disease virus” in their place. § 121.6 [Amended] 7. Section 121.6, paragraph (a)(3)(i) is amended by removing the words “ *Botulinum neurotoxins,* ” and “ *Francisella tularensis,* ”. §§ 121.7 and 121.8 [Amended] 8. Sections 121.7 and 121.8 are amended by redesignating footnotes 5, 6, and 7 as footnotes 6, 7, and 8, respectively. § 121.9 [Amended] 9. In § 121.9, paragraph (c)(1) is amended by removing the words “ *Botulinum neurotoxins,* ” and “ *Francisella tularensis,* ”, and by removing the words “Newcastle disease virus (velogenic)” and adding the words “virulent Newcastle disease virus” in their place. §§ 121.12 through 121.16 [Amended] 10. Sections 121.12 through 121.16 are amended by redesignating footnotes 8 through 13 as footnotes 9 through 14, respectively. § 121.20 [Amended] 11. Section 121.20 is amended by redesignating footnote 14 as footnote 15. Done in Washington, DC, this 22nd day of August 2007. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-17039 Filed 8-27-07; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-28053; Directorate Identifier 2007-NE-18-AD] RIN 2120-AA64 Airworthiness Directives; Turbomeca Arrius 2F Turboshaft Engines AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for the products listed above. This proposed AD results from mandatory continuing airworthiness information
(MCAI)provided by the aviation authority of France to identify and correct an unsafe condition on Turbomeca Arrius 2F turboshaft engines. The MCAI states the following: This AD is issued following a case of non-commanded in-flight engine shutdown which occurred on an Arrius 2F turboshaft engine, following the seizing of the gas generator. The result may be an emergency autorotation landing, or, at worst, an accident. Investigations of this event have revealed that the seizing of the gas generator was caused by the fracture of the separator cage of the gas generator front bearing, due to high-cycle fatigue cracks initiated in the lubrication slots of the separator cage. We are proposing this AD to prevent uncommanded shutdown of the engine, which could lead to an accident. DATES: We must receive comments on this proposed AD by September 27, 2007. ADDRESSES: You may send comments by any of the following methods: • *DOT Docket Web Site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. • *Fax:*
(202)493-2251. • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. Examining the AD Docket You may examine the AD docket on the Internet at *http://dms.dot.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Christopher Spinney, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail: *Christopher.spinney@faa.gov;* telephone
(781)238-7175, fax
(781)238-7199. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-28053; Directorate Identifier 2007-NE-18-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments. We will post all comments we receive, without change, to *http://dms.dot.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued AD 2007-0057, dated March 1, 2007, to correct an unsafe condition for the specified products. The EASA AD states: This AD is issued following a case of non-commanded in-flight engine shutdown which occurred on an Arrius 2F turboshaft engine, following the seizing of the gas generator. The result may be an emergency autorotation landing, or, at worst, an accident. Investigations of this event have revealed that the seizing of the gas generator was caused by the fracture of the separator cage of the gas generator front bearing, due to high-cycle fatigue cracks initiated in the lubrication slots of the separator cage. Modification Tf 12 introduces a new gas generator front bearing without lubrication slots on the separator cage. You may obtain further information by examining the EASA AD in the AD docket. Relevant Service Information Turbomeca has issued Mandatory Service Bulletin No. 319 72 4012, Update No. 1, dated September 19, 2006. The actions described in this service information are intended to correct the unsafe condition identified in the EASA AD. FAA's Determination and Requirements of This Proposed AD This product has been approved by the aviation authority of France and is approved for operation in the United States. Pursuant to our bilateral agreement with France, they have notified us of the unsafe condition described in the EASA AD and service information referenced above. We are proposing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This proposed AD would require replacing the engine module 02 with a module that incorporates Turbomeca Modification Tf 12A. That replacement must occur at the next engine shop visit after the effective date of the proposed AD, but no later than April 30, 2008. Modification Tf 12A installs into the engine module 02, a new gas generator front bearing without lubrication slots on the separator cage. Costs of Compliance We estimate that this proposed AD would affect 61 engines installed on aircraft of U.S. registry. We also estimate that it would take about 10 work-hours per engine to perform the proposed actions, and that the average labor rate is $80 per work-hour. Required parts would cost about $111,440 per engine. Based on these figures, we estimate the total cost of the proposed AD to U.S. operators to be $6,846,640. Our cost estimate is exclusive of possible warranty coverage. Authority for This Rulemaking 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. Regulatory Findings We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); 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 proposed AD and placed it in the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **Turbomeca:** Docket No. FAA-2007-28053; Directorate Identifier 2007-NE-18-AD. Comments Due Date
(a)We must receive comments by September 27, 2007. Affected ADs
(b)None. Applicability
(c)This AD applies to Turbomeca Arrius 2F turboshaft engines that have not incorporated Turbomeca Modification Tf 12A. These engines are installed on, but not limited to, Eurocopter EC120B helicopters. Reason
(d)European Aviation Safety Agency
(EASA)AD No. 2007-0057, dated March 1, 2007, states: This AD is issued following a case of non-commanded in-flight engine shutdown which occurred on an Arrius 2F turboshaft engine, following the seizing of the gas generator. The result may be an emergency autorotation landing, or, at worst, an accident. Investigations of this event have revealed that the seizing of the gas generator was caused by the fracture of the separator cage of the gas generator front bearing, due to high-cycle fatigue cracks initiated in the lubrication slots of the separator cage. Modification Tf12 introduces a new gas generator front bearing without lubrication slots on the separator cage. Actions and Compliance
(e)Unless already done, do the following actions.
(1)At the next engine shop visit after the effective date of this AD, but no later than April 30, 2008, replace the engine module 02 with a module that incorporates Turbomeca Modification Tf 12A. Turbomeca Modification Tf 12A installs into the engine module 02 a new gas generator front bearing without lubrication slots on the separator cage.
(2)Use the Instructions to be Incorporated section of Turbomeca Mandatory Service Bulletin No. 319 72 4012, Update No. 1, dated September 19, 2006, to do the actions in paragraph (e)(1) of this AD. Other FAA AD Provisions
(f)Alternative Methods of Compliance (AMOCs): The Manager, Engine Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Related Information
(g)Refer to EASA AD 2007-0057, dated March 1, 2007, for related information.
(h)Contact Christopher Spinney, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail: *Christopher.spinney@faa.gov* ; telephone
(781)238-7175, fax
(781)238-7199, for more information about this AD. Issued in Burlington, Massachusetts, on August 22, 2007. Mark A. Rumizen, Acting Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E7-17003 Filed 8-27-07; 8:45 am] BILLING CODE 4910-13-P MILLENNIUM CHALLENGE CORPORATION 22 CFR Part 1304 Regulations Implementing the Freedom of Information Act AGENCY: Millennium Challenge Corporation. ACTION: Notice of proposed rulemaking. SUMMARY: The purpose of this document is to outline the procedures by which the Millennium Challenge Corporation proposes to implement the relevant provisions of the Freedom of Information Act as required under that statute. This document will assist interested parties in obtaining access to Millennium Challenge Corporation public records. DATES: Submit comments on or before October 29, 2007. FOR FURTHER INFORMATION CONTACT: John Mantini, FOIA Officer, 202-521-3863. ADDRESSES: Send comments to John Mantini, FOIA Officer, Office of the General Counsel, Millennium Challenge Corporation, 875 Fifteenth Street, NW., Washington, DC 20005-2221. SUPPLEMENTARY INFORMATION: The Millennium Challenge Act
(MCA)of 2003 established a new federal agency called the Millennium Challenge Corporation. Congress enacted the Freedom of Information Act
(FOIA)in 1966 and last modified it with the Electronic Freedom of Information Act amendments of 1996. This proposed rule addresses electronically available documents, procedures for making requests, agency handling of requests, records not disclosed, changes in fees, and public reading rooms as well as other related provisions. List of Subjects in 22 CFR Part 1304 Freedom of Information Act procedures. For the reasons set forth in the preamble, the Millennium Challenge Corporation proposes to amend Chapter XIII of title 22 by adding a new part 1304 to read as follows: PART 1304—FREEDOM OF INFORMATION ACT PROCEDURES Sec. 1304.1 General Provisions. 1304.2 Definitions. 1304.3 Records available to the public. 1304.4 Requests for records. 1304.5 Responsibility for responding to requests. 1304.6 Records not disclosed. 1304.7 Confidential commercial information. 1304.8 Appeals. 1304.9 Fees. Authority: 5 U.S.C. 552, as amended. § 1304.1 General Provisions. This part contains the regulations the Millennium Challenge Corporation
(MCC)follows in implementing the Freedom of Information Act
(FOIA)(5 U.S.C. 552) as amended. These regulations provide procedures by which you may obtain access to records compiled, created, and maintained by MCC, along with the procedures that MCC must follow in response to such requests for records. These regulations should be read together with the FOIA, which provides additional information about access to records maintained by MCC. § 1304.2 Definitions.
(a)*Agency* has the meaning set forth in 5 U.S.C. 552(f)(1).
(b)*Commercial use requester* means a requester seeking information for a use or purpose that furthers the commercial, trade, or profit interests of himself or the person on whose behalf the request is made, which can include furthering those interests through litigation. In determining whether a request properly belongs in this category, the FOIA Officer shall determine the use to which the requester will put the documents requested. Where the FOIA Officer has reasonable cause to doubt the use to which the requester will put the records sought, or where that use is not clear from the request itself, the FOIA Officer shall contact the requester for additional clarification before assigning the request to a specific category.
(c)*Confidential commercial information* means records provided to the government by a submitter that arguably contains material exempt from disclosure under Exemption 4 of the FOIA, because disclosure could reasonably be expected to cause substantial competitive harm.
(d)*Direct costs* mean those expenditures by MCC actually incurred in searching for and duplicating records in response to the FOIA request. These costs include the salary of the employee(s) performing the work (basic rate of pay plus a percentage of that rate to cover benefits) and the cost of operating duplicating machinery. Direct costs do not include overhead expenses, such as the cost of space, heating, or lighting of the facility in which the records are stored.
(e)*Duplication* means the process of making a copy of a record in order to respond to a FOIA request, including paper copies, microfilm, audio-video materials, and computer diskettes or other electronic copies.
(f)*Educational institution* refers to a preschool, a public or private elementary or secondary school, an institute of undergraduate higher education, an institute of graduate higher education, an institute of professional education, or an institute of vocational education which operates a program of scholarly research. To qualify for this category, the requester must show that the request is authorized by and is made under the auspices of a qualifying institution and that the records are not sought for a commercial use, but are sought to further scholarly research.
(g)*FOIA* means the Freedom of Information Act, as amended (5 U.S.C. 552).
(h)*FOIA Officer* means the MCC employee who is authorized to make determinations as provided in this part. The mailing address for the FOIA Officer is: Millennium Challenge Corporation, Attn: FOIA Officer, 875 Fifteenth Street, NW., Washington, DC 20005.
(i)*Non-commercial scientific institution* refers to an institution that is not operated on a “commercial” basis as that term is used in paragraph
(a)of this section, and which is operated solely for the purpose of conducting scientific research the results of which are not intended to promote any particular product or industry. To qualify for this category, the requester must show that the request is authorized by and is made under the auspices of a qualifying institution and that the records are not sought for a commercial use, but are sought to further scholarly research.
(j)*Record* means information or documentary material MCC maintains in any form or format, including an electronic form or format, which MCC:
(1)Made or received under federal law or in connection with the transaction of public business;
(2)Preserved or determined is appropriate for preservation as evidence of MCC operations or activities or because of the value the information it contains; and
(3)Controls at the time it receives a request.
(k)*Representative of the news media* means any person actively gathering news for an entity that is organized and operated to publish or broadcast news to the public. The term “news” means information that is about current events or that would be of current interest to the public. For a “freelance journalist” to be regarded as working for a news organization, the requester must demonstrate a solid basis for expecting publication through that organization, such as a publication contract. Absent such showing, the requester may provide documentation establishing the requester's past publication record. To qualify for this category, the requester must not be seeking the requested records for a commercial use. However, a request for records supporting a news-dissemination function shall not be considered to be for a commercial use.
(l)*Requester* means any person, including an individual, corporation, firm, organization, or other entity, who makes a request to MCC under FOIA for records.
(m)*Review* means the process of examining a record to determine whether all or part of the record may be withheld, and includes redacting or otherwise processing the record for disclosure to a requester. It does not include time spent:
(1)Resolving legal or policy issues regarding the application of exemptions to a record; or
(2)At the administrative appeal level, unless MCC determines that the exemption under which it withheld records does not apply and the records are reviewed again to determine whether a different exemption may apply.
(n)*Search* means the time spent locating records responsive to a request, manually or by electronic means, including page-by-page or line-by-line identification of responsive material within a record.
(o)*Submitter* means any person or entity which provides information directly or indirectly to MCC. The term includes, but is not limited to, corporations, state governments and foreign governments.
(p)*Working day* means a Federal workday that does not include Saturdays, Sundays, or Federal holidays. § 1304.3 Records available to the public.
(a)*General.*
(1)It is the policy of MCC to respond promptly to all FOIA requests.
(2)MCC may disclose records that were previously published or disclosed or are customarily furnished to the public in the course of the performance of official duties without complying with this part. These records include, but are not limited to, the annual report that MCC submits to Congress pursuant to section 613(a) of the Millennium Challenge Act of 2003 (22 U.S.C. 7701), press releases, MCC forms, and materials published in the **Federal Register** . MCC should first determine whether the information requested is already available on its Web site, which contains information readily accessible to the public. In such an event, MCC will contact the requesting party, either orally or in writing, to advise the individual of the availability of the information on the public Web site. MCC should document this request and the manner in which it handled the file. Where MCC makes the determination that the information requested is not already publicly accessible, MCC should adhere to the procedures outlined in this part for processing a FOIA request and any administrative appeals received.
(b)*Public Reading room.*
(1)Records that are required to be maintained by MCC shall be available for public inspection and copying at 875 Fifteenth Street, NW., Washington, DC 20005. Reading room records created on or after November 1, 1996 shall be made available electronically via the Web site at *http://www.mcc.gov.*
(2)MCC shall assess fees for searching, reviewing, or duplicating reading room records in accordance with § 1304.9. § 1304.4 Requests for records.
(a)*Request requirements.* Requests for access to, or copies of, MCC records shall be in writing and addressed to the FOIA Officer. Each request shall include the following:
(1)A description of the requested record that provides sufficient detail to enable MCC to locate the record with a reasonable amount of effort;
(2)The requester's full name, mailing address, and a telephone number where the requester can be reached during normal business hours;
(3)A statement that the request is made pursuant to FOIA; and
(4)At the discretion of the requester, a dollar limit on the fees MCC may incur to respond to the request for records. MCC shall not exceed such limit.
(b)*Incomplete Requests.* If a request does not meet all of the requirements of paragraph
(a)of this section, the FOIA Officer may advise the requester that additional information is needed. If the requester submits a corrected request, the FOIA Officer shall treat the corrected request as a new request. § 1304.5 Responsibility for responding to requests.
(a)*General.* In determining which records are responsive to a request, MCC ordinarily will include only records in its possession as of the date it begins its search for records. If any other date is used, the FOIA Officer shall inform the requester of that date.
(b)*Authority to grant or deny requests.* The FOIA Officer shall make initial determinations either to grant or deny in whole or in part a request for records. When the FOIA Officer denies the request in whole or in part, the FOIA Officer shall notify the requester of the denial, the grounds for the denial, and the procedures for appeal of the denial under § 1304.8.
(c)*Consultations and referrals.* When a requested record has been created by another Federal Government agency, that record shall be referred to the originating agency for direct response to the requester. The requester shall be informed of the referral. As this is not a denial of a FOIA request, no appeal rights are afforded to the requester. When a requested record is identified as containing information originating with another Federal Government agency, the record shall be referred to the originating agency for review and recommendation on disclosure.
(d)*Timing and deadlines.*
(1)The FOIA Officer ordinarily shall respond to requests according to their order of receipt.
(2)The FOIA Officer may use multi-track processing in responding to requests. This process entails separating simple requesters that require rather limited review from more lengthy and complex requests. Requests in each track are then processed according to paragraph (d)(1) of this section in their respective track.
(3)The FOIA Officer may provide requesters in the slower track an opportunity to limit the scope of their requests in order to decrease the processing time required. The FOIA Officer may provide such an opportunity by contacting the requester by letter or telephone.
(4)The FOIA Officer shall make an initial determination regarding access to the requested information and notify the requester within twenty
(20)working days after receipt of the request. This 20 day period may be extended if unusual circumstances arise. If an extension is necessary, the FOIA Officer shall promptly notify the requester of the extension, briefly providing the reasons for the extension, the date by which a determination is expected, and providing the requester with the opportunity to modify the request so that the FOIA Officer may process it in accordance with the 20 day period. Unusual circumstances warranting extension are:
(i)The need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request;
(ii)The need to search for, collect, and appropriately examine a lengthy amount of records which are demanded in a single request; or
(iii)The need for consultation with another agency having a substantial interest in the determination of the request, which consultation shall be conducted with all practicable speed.
(iv)If the FOIA Officer has a reasonable basis to conclude that a requester or group of requesters has divided a request into a series of requests on a single subject or related subject to avoid fees, the requests may be aggregated and fees charged accordingly. Multiple requests involving unrelated matters will not be aggregated.
(6)If no initial determination has been made at the end of the 20 day period provided for in paragraph (d)(4) of this section, including any extension, the requester may appeal the action to the FOIA Appeals Officer.
(e)*Expedited processing of request.* The FOIA Officer must determine whether to grant a request for expedited processing within 10 calendar days of its receipt. Requests will receive expedited processing if one of the following listed compelling reasons is met:
(1)The requester can establish that failure to receive the records quickly could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or
(2)The requester is primarily engaged in disseminating information and can demonstrate that an urgency to inform the public concerning actual or alleged Federal Government activity exists.
(f)*Providing responsive records.* The FOIA Officer shall provide one copy of a record to a requester in any form or format requested if the record is readily reproducible by MCC in that form or format by regular U.S. mail to the address indicated in the request, unless other arrangements are made. At the option of the requester and upon the requester's agreement to pay fees in accordance with § 1304.9, the FOIA Officer shall provide copies by facsimile transmission or other express delivery methods. § 1304.6 Records not disclosed.
(a)*Records exempt from disclosure.* Except as otherwise provided in this part, MCC shall not disclose records that are:
(1)Specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy and are in fact properly classified pursuant to such Executive order.
(2)Related solely to the MCC's internal personnel rules and practices.
(3)Specifically exempted from disclosure by a statute other than FOIA if such statute requires the record to be withheld from the public in such a manner as to leave no discretion on the issue, establishes particular criteria for withholding, or refers to particular types of records to be withheld.
(4)Trade secrets and commercial or financial information obtained from a person and privileged or confidential.
(5)Inter-or intra-agency memorandums or letters that would not be available by law to a party other than an agency in litigation with MCC.
(6)Personnel, medical, or similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
(7)Compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information:
(i)Could reasonably be expected to interfere with enforcement proceedings;
(ii)Would deprive a person of a right to a fair trial or an impartial adjudication;
(iii)Could reasonably be expected to constitute an unwarranted invasion of personal privacy;
(iv)Could reasonably be expected to disclose the identity of a confidential source, including a State, local, or foreign agency or authority, any private institution, or a Bank, which furnished information on a confidential basis, and, in the case of a record compiled by criminal law enforcement authority in the course of a criminal investigation or by an agency conducting a lawful national security investigation, information furnished by a confidential source;
(v)Would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law; or
(vi)Could reasonably be expected to endanger the life or physical safety of any individual.
(8)Contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions; or
(9)Geological and geophysical information and data, including maps, concerning wells.
(b)*Reasonably segregable portions.*
(1)MCC shall provide a requester with any reasonably segregable portion of a record after deleting the portions that are exempt from disclosure under paragraph
(a)of this section.
(2)MCC shall make a reasonable effort to estimate the volume of removed information and provide that information to the requester unless providing the estimate would harm an interest protected by the exemption under which the removal is made.
(3)MCC shall indicate the estimated volume of removed information on the released portion of the record unless providing the estimate would harm an interest protected by the exemption under which the removal is made. If technically feasible, MCC shall make the indication at the place in the record where the removal is made.
(c)*Public interest.* MCC may disclose records it has authority to withhold under paragraph
(a)of this section upon a determination that disclosure would be in the public interest. § 1304.7 Confidential commercial information.
(a)*Notice to submitters.* The FOIA Officer shall, to the extent permitted by law, provide a submitter who provides confidential commercial information to the FOIA Officer, with prompt notice of a FOIA request or administrative appeal encompassing the confidential commercial information if the Commission may be required to disclose the information under the FOIA. Such notice shall either describe the exact nature of the information requested or provide copies of the records or portions thereof containing the confidential commercial information. The FOIA Officer shall also notify the requester that notice and an opportunity to object has been given to the submitter.
(b)*Where notice is required.* Notice shall be given to a submitter when:
(1)The information has been designated by the submitter as confidential commercial information protected from disclosure. Submitters of confidential commercial information shall use good faith efforts to designate either at the time of submission or a reasonable time thereafter, those portions of their submissions they deem protected from disclosure under Exemption 4 of the FOIA because disclosure could reasonably be expected to cause substantial competitive harm. Such designation shall be deemed to have expired ten years after the date of submission, unless the requester provides reasonable justification for a designation period of greater duration; or
(2)The FOIA Officer has reason to believe that the information may be protected from disclosure under Exemption 4 of the FOIA.
(c)*Opportunity to object to disclosure.* The FOIA Officer shall afford a submitter a reasonable period of time to provide the FOIA Officer with a detailed written statement of any objection to disclosure. The statement shall specify all grounds for withholding any of the information under any exemption of the FOIA, and if Exemption 4 applies, shall demonstrate the reasons the submitter believes the information to be confidential commercial information that is exempt from disclosure. Whenever possible, the submitter's claim of confidentiality shall be supported by a statement or certification by an officer or authorized representative of the submitter. In the event a submitter fails to respond to the notice in the time specified, the submitter will be considered to have no objection to the disclosure of the information. Information provided by the submitter that is received after the disclosure decision has been made will not be considered. Information provided by a submitter pursuant to this paragraph may itself be subject to disclosure under the FOIA.
(d)*Notice of intent to disclose.* The FOIA Officer shall carefully consider a submitter's objections and specific grounds for nondisclosure prior to determining whether to disclose the information requested. Whenever the FOIA Officer determines that disclosure is appropriate, the FOIA Officer shall, within a reasonable number of days prior to disclosure, provide the submitter with written notice of the intent to disclose which shall include a statement of the reasons for which the submitter's objections were overruled, a description of the information to be disclosed, and a specific disclosure date. The FOIA Officer shall also notify the requester that the requested records will be made available.
(e)*Notice of lawsuit.* If the requester files a lawsuit seeking to compel disclosure of confidential commercial information, the FOIA Officer shall promptly notify the submitter of this action. If a submitter files a lawsuit seeking to prevent disclosure of confidential commercial information, the FOIA Officer shall notify the requester.
(f)*Exceptions to the notice requirements under this section.* The notice requirements under paragraphs
(a)and
(b)of this section shall not apply if:
(1)The FOIA Officer determines that the information should not be disclosed pursuant to Exemption 4 and/or any other exemption of the FOIA;
(2)The information lawfully has been published or officially made available to the public;
(3)Disclosure of the information is required by law (other than the FOIA);
(4)The information requested is not designated by the submitter as exempt from disclosure in accordance with this part, when the submitter had the opportunity to do so at the time of submission of the information or within a reasonable time thereafter, unless the agency has substantial reason to believe that disclosure of the information would result in competitive harm; or
(5)The designation made by the submitter in accordance with this part appears obviously frivolous. When the FOIA Officer determines that a submitter was frivolous in designating information as confidential, the FOIA Officer must provide the submitter with written notice of any final administrative disclosure date, but no opportunity to object to disclosure will be offered. § 1304.8 Appeals.
(a)*Right of appeal.* The requester has the right to appeal to the FOIA Appeals Officer any adverse determination.
(b)*Notice of appeal.* —(1) *Timing for appeal.* An appeal must be received no later than thirty
(30)working days after notification of denial of access to records or after the time limit for response by the FOIA Officer has expired. Prior to submitting an appeal any outstanding fees related to FOIA requests must be paid in full.
(2)*Method of appeal.* An appeal shall be initiated by filing a written notice of appeal. The notice shall be accompanied by copies of the original request and initial denial of access to records. To expedite the appellate process and give the requester an opportunity to present his or her arguments, the notice should contain a brief statement of the reasons why the requester believes the initial denial of access to records to have been in error. The appeal shall be addressed to the Millennium Challenge Corporation, Attn: FOIA Appeals Officer, 875 Fifteenth Street, NW., Washington, DC 20005.
(c)*Final agency determinations.* The FOIA Appeals Officer shall issue a final written determination, stating the basis for his or her decision, within twenty
(20)working days after receipt of a notice of appeal. If the determination is to provide access to the requested records, the FOIA Officer shall make those records immediately available to the requester. If the determination upholds the denial of access to the requested records, the FOIA Appeals Officer shall notify the requester of the determination. § 1304.9 Fees.
(a)*General.* Fees pursuant to the FOIA shall be assessed according to the schedule contained in paragraph
(b)of this section for services rendered by MCC in response to requests for records under this part. MCC's fee practices are governed by the FOIA and by the Office of Management and Budget's Uniform Freedom of Information Act Fee Schedule and Guidelines. All fees shall be charged to the requester, except where the charging of fees is limited under paragraph
(d)of this section or whether a waiver or reduction of fees is granted under paragraph
(c)of this section. Payment of fees should be in U.S. Dollars in the form of either a check or bank draft drawn on a bank in the United States or a money order. Payment should be made payable to the Treasury of the United States and mailed to the Millennium Challenge Corporation, 875 Fifteenth Street, NW., Washington, DC 20005.
(b)*Charges for responding to FOIA requests.* The following fees shall be assessed in responding to requests for records submitted under this part, unless a waiver or reduction of fees has been granted pursuant to paragraph
(c)of this section:
(1)*Duplications.* The FOIA Officer shall charge $0.20 per page for copies of documents up to 81/2 x 14. For copies prepared by computer, the FOIA Officer will charge actual costs of production of the computer printouts, including operator time. For other methods of reproduction, the FOIA Officer shall charge the actual costs of producing the documents.
(2)*Searches* .—(i) *Manual searches.* Search fees will be assessed at the rate of $25.30 per hour. Charges for search time less than a full hour will be in increments of quarter hours.
(ii)*Computer searches.* The FOIA Officer will charge the actual direct costs of conducting computer searches. These direct costs shall include the cost of operating the central processing unit for that portion of operating time that is directly attributable to searching for requested records, as well as the costs of operator/programmer salary apportionable to the search. MCC is not required to alter or develop programming to conduct searches.
(3)*Review fees.* Review fees shall be assessed only with respect to those requesters who seek records for a commercial use under paragraph (d)(1) of this section. Review fees shall be assessed at the rate of $43.63 per hour. Review fees shall be assessed only for the initial record review, for example, review undertaken when the FOIA Officer analyzes the applicability of a particular exemption to a particular record or portion thereof at the initial request level. No charge shall be assessed at the administrative appeal level of an exemption already applied.
(c)*Statutory Waiver.* Documents shall be furnished without charge or at a charge below that listed in paragraph
(b)of this section where it is determined, based upon information provided by a requester or otherwise made known to the FOIA Officer, that disclosure of the requested information is in the public interest. Disclosure is in the public interest if it is likely to contribute significantly to public understanding of government operations and is not primarily for commercial purposes. Requests for a waiver or reduction of fees shall be considered on a case by case basis. In order to determine whether the fee waiver requirement is met, the FOIA Officer shall consider the following six factors:
(1)The subject of the request. Whether the subject of the requested records concerns the operations or activities of the government;
(2)The informative value of the information to be disclosed. Whether disclosure is likely to contribute to an understanding of government operations or activities;
(3)The contribution to an understanding of the subject by the general public likely to result from disclosure. Whether disclosure of the requested information will contribute to public understanding;
(4)The significance of the contribution to public understanding. Whether the disclosure is likely to contribute significantly to public understanding of government operations or activities;
(5)The existence and magnitude of commercial interest. Whether the requester has a commercial interest that would be furthered by the requested disclosure; and, if so
(6)The primary interest in disclosure. Whether the magnitude of the identified commercial interest of the requester is sufficiently large, in comparison with the public interest in disclosure, that disclosure is primarily in the commercial interest of the requester.
(d)Types of requesters. There are four categories of FOIA requesters: Commercial use requesters; educational and non-commercial scientific institutional requesters; representatives of the news media; and all other requesters. These terms are defined in § 1304.2. The following specific levels of fees are prescribed for each of these categories:
(1)*Commercial use requesters.* The FOIA Officer shall charge commercial use requesters the full direct costs of searching for, reviewing, and duplicating requested records.
(2)*Educational and non-commercial scientific institution requesters.* The FOIA Officer shall charge educational and non-commercial scientific institution requesters for document duplication only, except that the first 100 pages of paper copies shall be provided without charge.
(3)*News media requesters.* The FOIA Officer shall charge news media requesters for document duplication costs only, except that the first 100 pages of paper copies shall be provided without charge.
(4)*All other requesters.* The FOIA Officer shall charge requesters who do not fall into any of the categories in paragraphs (d)(1) through
(3)of this section fees which recover the full reasonable direct costs incurred for searching for and reproducing records if that total cost exceeds $14.99, except that the first 100 pages of duplication and the first two hours of manual search time shall not be charged.
(e)*Charges for unsuccessful searches.* If the requester has been notified of the estimated cost of the search time and has been advised specifically that the requested records may not exist or may be withheld as exempt, fees may be charged.
(f)*Nonpayment of fees.* The FOIA Officer may assess interest charges on an unpaid bill, accrued under previous FOIA request(s), starting the thirty-first
(31st)day following the day on which the bill was sent to the requester. Interest will be at the rate prescribed in 31 U.S.C. 3717. MCC will require the requester to pay the full amount owed plus any applicable interest as provided above, and to make an advance payment of the full amount of the remaining estimated fee before MCC will begin to process a new request or continue processing a then-pending request from the requester. The administrative response time limits prescribed in subsection (a)(6) of the FOIA will begin only after MCC has received fee payments described in this section.
(g)*Aggregating requests.* The requester or a group of requesters may not submit multiple requests at the same time, each seeking portions of a document or documents solely in order to avoid payment of fees. When the FOIA Officer reasonably believes that a requester is attempting to divide a request into a series of requests to evade an assessment of fees, the FOIA Officer may aggregate such request and charge accordingly.
(h)*Advance payment of fees.* Fees may be paid upon provision of the requested records, except that payment will be required prior to that time if the requester has previously failed to pay fees or if the FOIA Officer determines the total fee will exceed $250.00. When payment is required in advance of the processing of a request, the time limits prescribed in § 1304.5 shall not be deemed to begin until the FOIA Officer has received payment of the assessed fee. Where it is anticipated that the cost of providing the requested record will exceed $25.00 but fall below $250.00 after the free duplication and search time has been calculated, MCC may, in its discretion may require either:
(1)An advance deposit of the entire estimated charges; or
(2)Written confirmation of the requester's willingness to pay such charges. Dated: August 2, 2007. John C. Mantini, Chief FOIA Officer, Millennium Challenge Corporation. [FR Doc. E7-16143 Filed 8-27-07; 8:45 am] BILLING CODE 9211-03-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2007-0421b; FRL-8452-2] Revisions to the California State Implementation Plan, South Coast Air Quality Management District AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve revisions to the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compound
(VOC)emissions from refinery flares and storage tanks at petroleum facilities. We are proposing to approve local rules to regulate these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act). DATES: Any comments on this proposal must arrive by September 27, 2007. ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-2007-0421b, by one of the following methods: 1. *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the online instructions. 2. *E-mail: steckel.andrew@epa.gov.* 3. *Mail or deliver:* Andrew Steckel (Air-4), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901. *Instructions:* All comments will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through www.regulations.gov or e-mail. www.regulations.gov is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. *Docket:* The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Jerald S. Wamsley, EPA Region IX, at either
(415)947-4111, or *wamsley.jerry@epa.gov.* SUPPLEMENTARY INFORMATION: This proposal addresses SCAQMD Rules 1178—Further Control of VOC Emissions from Storage Tanks at Petroleum Facilities and 1118—Control of Emissions from Refinery Flares. In the Rules and Regulations section of this **Federal Register** , we are approving these local rules in a direct final action without prior proposal because we believe these SIP revisions are not controversial. However, if we receive adverse comments, we will publish a timely withdrawal of the direct final rule and address the comments in subsequent action based on this proposed rule. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment. We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action. Dated: July 3, 2007. Laura Yoshii, Acting Regional Administrator, Region IX. [FR Doc. E7-16819 Filed 8-27-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2007-0285; FRL-8460-1] Approval and Promulgation of Air Quality Implementation Plans; Texas; Shipyard Facilities and Provisions for Distance Limitations, Setbacks, and Buffers in Standard Permits AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve a State Implementation Plan
(SIP)revision for the State of Texas. This revision adds provisions which incorporate the evaluation of emissions from dockside vessels when reviewing applications for permits for new and modified sources and certain other administrative changes to its air permitting requirements. It also adds provisions concerning compliance with distance limitations, setbacks, and buffers at facilities that are authorized to construct or modify under an air quality standard permit. The Commission submitted this amendment to EPA to process as a revision to the Texas SIP. This action is being taken under section 110 of the Federal Clean Air Act (the Act). DATES: Written comments must be received on or before September 27, 2007. ADDRESSES: Comments may be mailed to Mr. Stanley M. Spruiell, Air Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be submitted electronically or through hand delivery/courier by following the detailed instructions in the ADDRESSES section of the direct final rule located in the rules section of this **Federal Register** . FOR FURTHER INFORMATION CONTACT: Mr. Stanley M. Spruiell, Air Permits Section (6PD-R), Environmental Protection Agency, Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733, telephone
(214)665-7212; fax number 214-665-7263; e-mail address *Spruiell.stanley@epa.gov.* SUPPLEMENTARY INFORMATION: In the final rules section of this **Federal Register** , EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action, no further activity is contemplated. If EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the rules section of this **Federal Register** . Dated: August 16, 2007. Richard E. Greene, Regional Administrator, Region 6. [FR Doc. E7-16830 Filed 8-27-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 73 Possession, Use, and Transfer of Select Agents and Toxins AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of proposed rulemaking. SUMMARY: The select agents and toxins listed in 42 CFR part 73 include those regulated only by the U.S. Department of Health and Human Services
(HHS)(42 CFR 73.3), as well as those overlap select agents and toxins regulated by both HHS and the U.S. Department of Agriculture
(USDA)(42 CFR 73.4). In response to USDA's proposal to no longer regulate ten select agents and toxins currently listed as “overlap” agents and toxins, we are proposing to move those ten select agents and toxins from the overlap select agents and toxins section to the HHS select agents and toxins section. DATES: Written comments must be received on or before October 29, 2007. Comments received after October 29, 2007 will be considered to the extent practicable. ADDRESSES: Comments on the changes to the list of select agents and toxins should be marked “Comments on the changes to the list of select agents and toxins” and mailed to: Centers for Disease Control and Prevention, Division of Select Agents and Toxins, 1600 Clifton Road, MS A-46, Atlanta, GA 30333. Comments may be e-mailed to: *SAPcomments@cdc.gov.* FOR FURTHER INFORMATION CONTACT: Robbin Weyant, Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Rd., MS A-46, Atlanta, GA 30333. Telephone:
(404)718-2000. SUPPLEMENTARY INFORMATION: 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),* required 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 considered the effect on human health of exposure to an agent or toxin; the degree of contagiousness of the agent or toxin 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. Once established, 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 list in a final rule amending Part 73 of title 42 of the Code of Federal Regulations, published on March 18, 2005, and made effective on April 18, 2005. The select agents and toxins list found in Part 73 is divided into two sections. The select agents and toxins listed in section 73.3 (HHS select agents and toxins) are those select agents and toxins regulated only by HHS. The select agents and toxins listed in section 73.4 (Overlap select agents and toxins) are those select agents and toxins regulated 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 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 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. HHS completed its biennial review on February 22, 2007 and determined that it would neither add nor remove any agents or toxins from its 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 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). After conducting its biennial review, USDA has proposed that it will no longer regulate ten of the select agents and toxins currently listed as “overlap” select agents and toxins in section 73.4. If their decision becomes final, HHS will move those ten select agents and toxins from section 73.4 to section 73.3. Published in today's **Federal Register** is USDA's proposal to remove 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. Comments regarding USDA's proposal to no longer regulate ten select agents and toxins currently listed as “overlap” agents and toxins should be sent to USDA. Regulatory Analyses Paperwork Reduction Act 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. Executive Order 12866 and Regulatory Flexibility Act This action has been determined not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget. 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. Unfunded Mandates 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. Executive Order 12988 This Notice of Proposed Rulemaking 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. Executive Order 13132 This Notice of Proposed Rulemaking 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. List of Subjects in 42 CFR Part 73 Biologics, Incorporation by reference, Packaging and containers, Penalties, Reporting and Recordkeeping requirements, Transportation. Dated: August 17, 2007. Michael O. Leavitt, Secretary. For the reasons stated in the preamble, we are proposing to amend 42 CFR part 73 as follows: PART 73—SELECT AGENTS AND TOXINS 1. The authority citation for part 73 continues to read as follows: Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of Title II of Public Law No. 107-188, 116 Stat. 637 (42 U.S.C. 262a). 2. Amend paragraph
(b)of § 73.3 by adding the following entries in alphabetical order and revising the entry for *Coccidioides posadasii* to read as follows: § 73.3 HHS select agents and toxins.
(b)* * * Botulinum neurotoxins Botulinum neurotoxin producing species of *Clostridium* *Clostridium perfringens epsilon toxin* *Coccidioides posadasii/Coccidioides immitis* *Coxiella burnetii* Eastern Equine Encephalitis virus *Francisella tularensis* Shigatoxin Staphylococcal enterotoxins T-2 toxin 3. Amend paragraph (d)(3) of § 73.3 by adding the following entries in alphabetical order: 05. mg of Botulinum neurotoxins; 100 mg of *Clostridium perfringens* epsilon toxin; 100 mg of Shigatoxin; 5 mg of Staphylococcal enterotoxins; or 1,000 mg of T-2 toxin. 4. Amend paragraph (f)(3)(i) of § 73.3 by adding the following entries in alphabetical order: Botulinum neurotoxins and *Francisella tularensis.* § 73.5 [Amended] 5. Amend paragraph (a)(3)(i) of § 73.5 by adding the following entries in alphabetical order: Botulinum neurotoxins and *Francisella tularensis.* § 73.4 [Amended] 6. Amend paragraph
(b)of § 73.4 by removing the entries for Botulinum neurotoxins, Botulinum neurotoxin producing species of *Clostridium, Clostridium perfringens* epsilon toxin, *Coccidioides immitis, Coxiella burnetii,* Eastern Equine Encephalitis virus, *Francisella tularensis,* Shigatoxin, Staphylococcal enterotoxins, and T-2 toxin. 7. Remove paragraph (d)(3) of § 73.4. 8. Amend paragraph (f)(3)(i) of § 73.4 by removing the following entries: Botulinum neurotoxins and *Francisella tularensis.* § 73.6 [Amended] 9. Amend paragraph (a)(3)(i) of § 73.6 by removing the following entries: Botulinum neurotoxins and *Francisella tularensis.* [FR Doc. 07-4233 Filed 8-27-07; 8:45 am]
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Traces to 18 documents
U.S. Code
- Rule making§ 553
- Findings, purposes and policy§ 1801
- Purposes§ 3501
- Regulation of certain biological agents and toxins§ 8401
- Jurisdiction of Commission; liability of principal for act of agent; Commodity Futures Trading Commission; transaction in interstate commerce§ 2
- Federal Aviation Administration§ 106
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Purposes§ 7701
- Interest and penalty on claims§ 3717
- Enhanced control of dangerous biological agents and toxins§ 262a
- Public information collection activities; submission to Director; approval and delegation§ 3507
- Definitions§ 601
- Statements to accompany significant regulatory actions§ 1532
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16 references not yet in our index
- 50 CFR 679
- 50 CFR 600
- 7 CFR 331
- 9 CFR 121
- 7 CFR 331.3
- 9 CFR 121.3
- 9 CFR 121.4
- 42 CFR 73.4
- 42 CFR 73
- 7 CFR 3015
- 14 CFR 39
- 22 CFR 1304
- 40 CFR 52
- 42 CFR 73.3
- Pub. L. 107-188
- 116 Stat. 637
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