Background

The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA or the Department) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases. The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to below as the regulations) govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States in order to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE).

BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent and is not known to exist in the United States. The disease has been difficult to define experimentally with precision, although risk factors that are independent of the causative agent have been identified and can be mitigated. Much of the available data originated from epidemiological observations and not from controlled studies. Controlled studies are often difficult to conduct because of limitations in experimental models and the length of time necessary to conduct the studies, which may require years. Currently, the most accepted theory is that the agent is a modified form of a normal cell surface component known as prion protein, although other types of agents have been implicated, including virinos. The pathogenic form of the protein is both less soluble and more resistant to degradation than the normal form. The BSE agent is extremely resistant to heat and to normal sterilization processes. It does not evoke any demonstrated immune response or inflammatory reaction in host animals.

Despite the difficulty in defining BSE experimentally with precision, risk factors for BSE that can be mitigated have been identified. These factors are based on technical knowledge and disease epidemiology and do not require definition of the nature of the agent. We believe that risk mitigation measures that address the risk factors for BSE will be effective regardless of the precise nature of the BSE agent.

It appears that BSE is spread primarily through the use of ruminant feed containing protein and other products from ruminants infected with BSE. Ruminants in the United States could be exposed to the disease if materials carrying the BSE agent—such as certain meat, animal products, or animal byproducts from ruminants—were imported into the United States and were fed to ruminants in this country. BSE could also be introduced into the United States if ruminants with BSE were imported into the United States.

Because of these risks, the regulations prohibit the importation of live ruminants and certain ruminant products and byproducts from two categories of regions: (1) Those regions in which BSE is known to exist, which are listed in § 94.18(a)(1) of the regulations; and (2) those regions that present an undue risk of introducing BSE into the United States because their import requirements are less restrictive than those that would be acceptable for import into the United States and/or because the regions have inadequate surveillance. These regions of “undue risk” are listed in § 94.18(a)(2) of the regulations.

The prohibitions on the importation of animals, meat, and other animal products into the United States from regions listed in § 94.18(a)(1) or (a)(2) are set forth in 9 CFR parts 93, 94, 95, and 96. Section 93.401 prohibits the importation of any ruminant that has been in these regions. Except for certain controlled transit movements, paragraph (b) of § 94.18 prohibits the importation of fresh (chilled or frozen) meat, meat products, and most other edible products of ruminants that have been in any of the regions. Paragraph (c) of § 94.18 restricts the importation of gelatin derived from ruminants that have been in any of the regions. Section 95.4 prohibits or restricts the importation of certain byproducts from ruminants that have been in any of the regions, and § 96.2 prohibits the importation of casings, except stomach casings, from ruminants that have been in any of the regions.

Essentially then, under the current regulations, there are three categories of regions with regard to BSE. Currently, a region is considered either: (1) A region free of BSE; (2) a region in which BSE is known to exist; or (3) a region that presents an undue risk of BSE. Imports from free regions are generally not subject to restrictions because of BSE. Imports from BSE-affected regions and those that present an undue risk are governed by the same set of restrictions.

We believe it is appropriate to recognize an additional category of regions with regard to BSE—the BSE minimal-risk region. This category would include (1) those regions in which a BSE-infected animal has been diagnosed, but in which measures have been taken that make it unlikely that BSE would be introduced from the region into the United States, and (2) those regions that cannot be considered BSE free even though BSE has not been detected, but that have taken sufficient measures to be considered minimal risk. For instance, a region listed in § 94.18(a)(2) as an “undue risk” region might have increased its levels of surveillance or import restrictions to the point that the risk of BSE introduction from that region becomes unlikely, but not yet have had mitigation measures in place long enough to be considered BSE-free.

In § 94.0, we would define bovine spongiform encephalopathy (BSE) minimal-risk region by listing the factors we would consider in determining the region's risk status. In a new § 94.18(a)(3), we would list the regions that the Administrator has approved for this designation. At this time, we are proposing to designate one country, Canada, as a BSE minimal-risk region according to the newly proposed factors. (These factors, and the reasons why we believe Canada meets them, are discussed in detail below.) In § 94.18(a)(4), we would explain that a region may request to be designated a BSE minimal-risk region by following the procedures set forth in our regulations in 9 CFR part 92, “Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions.”

On May 20, 2003, the Canadian Food Inspection Agency reported a case of BSE in a beef cow in northern Alberta. Therefore, in order to prevent the introduction of BSE into the United States, we published an interim rule on May 29, 2003 (68 FR 31939-31940, Docket No. 03-058-1), effective retroactively to May 20, 2003, to add Canada to the list of regions where BSE exists. As a result of that action, the importation of ruminants that have been in Canada and the importation of meat, meat products, and certain other products and byproducts of ruminants that have been in Canada are prohibited or restricted.

Following the detection of the BSE-infected cow, Canada conducted an epidemiological investigation of the BSE occurrence, and took action to guard against any spread of the disease, including the quarantining and depopulation of herds and animals determined to possibly be at risk for BSE. Subsequently, Canada asked APHIS to consider reestablishing the importation of ruminants and ruminant products into the United States from that country, based on information made available to APHIS regarding Canada's veterinary infrastructure, disease history, practices for preventing widespread introduction, exposure, and/or establishment of BSE, and measures taken following detection of the disease.

In this document, we are proposing to list Canada as a BSE minimal-risk region based on an analysis we conducted of the conditions considered for such a designation and the information available to us regarding how Canada meets those conditions. The risk document, “Risk Analysis: BSE Risk from Importation of Designated Ruminants and Ruminant Products from Canada into the United States,” also identifies the measures we believe are necessary to mitigate any BSE risk that specific commodities imported from Canada might present to the United States (discussed in this proposed rule, below, under the heading “Importation of Ruminant Commodities from a BSE Minimal-Risk Region”).

You may view the analysis in our reading room (information on the location and hours of the reading room is provided under the heading ADDRESSES at the beginning of this proposed rule). You may also request a copy by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Please refer to the title of the analysis when requesting copies. You may also view the analysis on the Internet by accessing the APHIS Web site at http://www.aphis.usda.gov. At the APHIS Web site, click on the “Hot Issues” button. On the next screen, click on the listing for “Bovine Spongiform Encephalopathy (BSE).” On the next screen, click on the listing for “Risk Analysis: BSE Risk from Importation of Designated Ruminants and Ruminant Products from Canada into the United States.”

In this proposed rule, we first discuss the factors we would consider in classifying a region as a BSE minimal-risk region. We would consider these factors in considering requests from any region to be classified as a BSE minimal-risk region. We then discuss why we believe Canada qualifies as a BSE minimal-risk region. Following that, we discuss mitigations that we would apply to specific commodities from Canada.

APHIS has developed a list of factors we would use to evaluate the BSE risk from a region and classify a region as a BSE minimal-risk region. We would use these factors as a combined and integrated evaluation tool. We are proposing to base the classification on an evaluation of the sum total of these factors, focusing on overall effectiveness of control mechanisms in place ( e.g. , surveillance, import controls, and a ban on the feeding of ruminant protein to ruminants). For regions in which BSE has been diagnosed, we would base our evaluation on the overall effectiveness of such control mechanisms in place at the time BSE was diagnosed in the region, and on actions taken after the diagnosis ( e.g. , an epidemiological investigation of the occurrence). For regions in which BSE has not been diagnosed, we would base our evaluation on the adequacy of surveillance mechanisms to detect disease, efficacy of a feed ban, and effectiveness of programs in place to prohibit entry into and establishment of disease in the region. This approach differs from some of the numerical criteria specified by the Office International des Epizooties (OIE) in its recommendations for a BSE minimal-risk country or zone. (The OIE recommendations are recognized by the World Trade Organization as international recommendations for animal disease control.)

For example, according to OIE recommendations, a ban on the feeding of ruminant protein to ruminants should have been in place for a minimum of 7 years for a region to meet the criteria for BSE minimal risk, even though there is a significant level of variability in current estimates of the BSE incubation period, which should govern the recommended length of time of an effective feed ban. According to this criterion, a region could fail to be classified as a BSE minimal-risk region because it had not had a feed ban in effect for the precise period of time specified, even if it has excelled in surveillance and control mechanisms. We believe it is more appropriate to evaluate the overall combined effect of the factors described below when assessing the BSE risk level of a region.

We propose to define bovine spongiform encephalopathy (BSE) minimal-risk region in § 94.0 to mean a region that:

1. Maintains, and, in the case of regions where BSE was detected, had in place prior to the detection of BSE, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. Such measures include the following:

a. Restrictions on the importation of animals sufficient to minimize the possibility of infected ruminants being imported into the region, and on the importation of animal products and animal feed containing ruminant protein sufficient to minimize the possibility of ruminants in the region being exposed to BSE;

b. Surveillance for BSE at levels that meet or exceed OIE recommendations for surveillance for BSE; and

c. A ban on the feeding of ruminant protein to ruminants that appears to be an effective barrier to the dissemination of the BSE infectious agent, with no evidence of significant noncompliance with the ban.

2. In regions where BSE was detected, conducted an epidemiological investigation following detection of BSE sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE, and continues to take such measures.

3. In regions where BSE was detected, took additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.

Each element of this definition is explained below.

1. The region maintains, and, in the case of regions where BSE was detected, had in place prior to the detection of BSE, risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease.

This factor is important in determining those regions in which a BSE outbreak is unlikely to occur, or, if an outbreak does occur, in which it is likely to be limited. If a region maintains controls designed to minimize BSE introduction or exposure of animals, and, in those regions where BSE has been detected, if the region had such controls in place at the time of detection, it is more likely to present minimal risk than a region that does not have such controls in place. According to our definition of a BSE minimal-risk region, such measures would include importation restrictions, surveillance, and a feeding ban, as follows:

1a. Restrictions on the importation of animals sufficient to minimize the possibility of infected ruminants being imported into the region, and on the importation of animal products and animal feed containing ruminant protein sufficient to minimize the possibility of ruminants in the region being exposed to BSE.

This factor addresses whether the region faces a high risk of initial or recurrent BSE outbreaks from multiple importations of animals or products that may spread BSE. In those regions in which BSE has been detected, it addresses whether the region's BSE outbreak was more likely the result of a point failure in its import controls or possible exposure prior to the implementation of such import controls. Because the incubation period for BSE is generally measured in years, the finding of a case of BSE reflects an exposure that occurred several years in the past.

A region that has prohibited the importation of high-risk animals and products from regions that are affected with or pose an undue risk of BSE will have minimized its possible exposure to the disease. Conversely, a region that continues to import high-risk commodities until a case of BSE is diagnosed has continued exposure and presents a more significant risk. Whether commodities are considered low-risk or high-risk can be based on the commodities' inherent lack of risk, the low risk level of the exporting region, and/or controls on the movement and use of the commodities after entry.

1b. Surveillance for BSE at levels that meet or exceed OIE recommendations for surveillance for BSE.

This factor addresses whether BSE outbreaks are or would be likely to be quickly and reliably identified in a region, helping support a minimal-risk designation, or whether lack of effective surveillance suggests the possibility that BSE-infected animals may be overlooked and the scale of a BSE problem may be greater than is officially recognized.

As noted above, the OIE recommendations are recognized by the World Trade Organization as international recommendations for animal disease control. The OIE Code provides guidelines for surveillance and monitoring systems for BSE, identifying the minimum number of annual investigations recommended based on the adult cattle population of a country.

1c. A ban on the feeding of ruminant protein to ruminants that appears to be an effective barrier to the dissemination of the BSE infectious agent, with no evidence of significant noncompliance with the ban.

The primary source of BSE infection appears to be feed contaminated with the infectious agent. Scientific evidence  1 shows that feed contamination results from the incorporation of ingredients that contain ruminant protein derived from infected animals. Standard rendering processes do not completely inactivate the BSE agent. Therefore, rendered protein such as meat-and-bone meal derived from infected animals may contain the infectious agent. Bans prohibiting incorporation of mammalian or ruminant protein into ruminant feed are imposed to mitigate risk.

This factor distinguishes between regions with effective feed bans and those without them. In a region in which BSE has been detected, if an animal with BSE was born after a feed ban was implemented, it is a sign that the feed ban may not be effectively enforced.

2. In a region in which BSE has been detected, the region conducted an epidemiological investigation following detection of BSE sufficient to confirm the adequacy of measures to prevent the further introduction or spread of BSE, and continues to take such measures.

This factor addresses whether a region adequately investigates a case of BSE to determine if any of the risk factors have changed. If there has been any significant change in risk factors, there might be the possibility of increased incidence of BSE. Such an investigation would include, at the minimum, a traceback from the BSE-infected animal to determine possible herds of origin of the animal, a traceforward of any animals that moved from the BSE-affected herd, a traceforward of feed or rendered material that was derived from the carcass of the infected animal, and an investigation to determine the most likely source of the animal's exposure to BSE.

3. In a region in which BSE has been detected, the region took additional risk mitigation measures, as necessary, following the BSE outbreak based on risk analysis of the outbreak, and continues to take such measures.

This factor addresses whether a region implements all necessary risk mitigation measures to prevent further exposure to BSE. It distinguishes between those regions that thoroughly analyze their situation and address any problems from those that do not take mitigation measures and thus prolong possible exposure to BSE. Depending on the conclusions of the risk analysis conducted following the diagnosis of BSE, additional risk mitigation measures could include a broad eradication program, increased surveillance, or additional import restrictions.

We considered the above factors in combination in evaluating whether Canada qualifies as a BSE minimal-risk region, and discuss below the actions Canada took and continues to take regarding each of the factors.

Canada has maintained stringent import restrictions since 1990, 2 prohibiting the importation of live ruminants and most ruminant products from countries that had not been recognized as free of BSE by either the United States, Canada, or Mexico, which have an agreement to recognize country evaluations conducted by any of the three countries, using the same standards. Canada prohibited the importation of live cattle from the United Kingdom and the Republic of Ireland starting in 1990, and subsequently applied the same prohibitions to other countries as those additional countries identified native cases of BSE. In 1996, Canada made this policy even more restrictive and prohibited the importation of live ruminants from any country that had not been recognized as free of BSE. Some animals were imported into Canada from high-risk countries prior to the imposition of these import restrictions. A total of 182 cattle were imported into Canada from the United Kingdom between 1982 and 1990. Similar to actions taken in the United States, efforts were made in Canada to trace these animals. In late 1993, after Canada identified a case of BSE in one of the imported bovines, all cattle imported from the United Kingdom or the Republic of Ireland that remained alive at that time were killed.

Import restrictions have also been imposed on ruminant products, including import restrictions on meat-and-bone meal that have been in place since 1978. In general, Canada has prohibited the importation of most meat-and-bone meal from countries other than the United States, Australia, and New Zealand. Limited amounts of specialty products of porcine or poultry origin were allowed to be imported into Canada under permit for use in aquaculture feed products. No meat-and-bone meal for livestock feed-associated uses has been imported, except from the United States, Australia, and New Zealand.

Canada has conducted surveillance for BSE since 1992. The OIE Code, Appendix 3.8.4, provides guidelines for surveillance and monitoring systems for BSE, identifying the minimum number of annual investigations recommended based on the adult cattle population of a country. To meet this recommendation, Canada would have to test a minimum of 336 samples annually, based on a population of 5.5 million adult cattle. Canada exceeds this recommendation, and has tested more than this minimum number of samples for the past 7 years. Additionally, Canada exceeds OIE recommendations by conducting active targeted surveillance. (Active targeted surveillance involves sampling animals with risk factors for BSE, even if the animals have not shown clinical signs of disease.)

Canada implemented a feed ban in 1997 that prohibits the feeding of most mammalian protein to ruminants. This ban exceeds what we consider the minimal necessary measure of banning the feeding of ruminant material to ruminants. Under the ban in Canada, mammalian protein may not be fed to ruminants, with certain exceptions. These exceptions include pure porcine or equine protein, blood, milk, and gelatin. The feed ban is essentially the same as the feed ban in place in the United States.

APHIS believes the length of the feed ban in Canada is sufficient to classify that country as a minimal-risk region for BSE. In comparison, classification as a minimal-risk country or zone by OIE criteria requires that a feed ban be in place for 8 years. This value may be set at a conservative level to account for the wide range that has been reported for the incubation period of BSE. Because of the variability in the incubation period for BSE, APHIS chose not to specify an amount of time that a feed ban needed to be in place in a minimal-risk region. Rather, we considered the sum total of the control mechanisms ( e.g., effectiveness of surveillance, import controls, and feed ban) in place at the time of the diagnosis of BSE and the actions taken subsequently ( e.g., epidemiological investigations and depopulation), thereby allowing the actions Canada took with regard to the other factors to compensate for a shorter feed ban. As an example, as discussed above, the level of surveillance in Canada, and the fact that it has been active and targeted, has exceeded OIE recommendations.

Canadian Government authorities inspect rendering facilities, feed manufacturers, and feed retailers to ensure compliance with the feed ban. Rendering facilities are regulated under an annual permit system, and compliance with the regulations is verified through at least one inspection each year. Feed manufacturers or mills, feed retailers, and farms have been inspected on a routine basis. These inspections have shown a high level of compliance. As noted above, Canada has maintained an effective ban on feeding mammalian protein to ruminants, with requirements similar to the feed ban in place in the United States, since 1997. The animal in which BSE was diagnosed in May 2003 was an 6-year-old native-born beef cow in the Province of Alberta that was born before the implementation of the feed ban.

Canada conducted an extensive epidemiological investigation after the one case of BSE in May 2003. This investigation included detailed tracebacks to identify possible herds of origin of the infected animal, traceforwards from the infected herd, and traceforwards of any possible feed or rendered material derived from the carcass of the infected animal. Fifteen premises were quarantined as part of the traceback and traceforward investigations, and cattle on the quarantined premises were slaughtered. Additionally, cattle that were determined to have moved from a quarantined herd to another herd were slaughtered.

The investigation included any possible exposure from the use of rendered material or feed that could have been derived from the carcass of the infected cow. Using a broad definition to include all possible exposures, the rendered material could have been distributed to approximately 1,800 sites, including sites with no ruminants. These included 600 facilities that receive bulk shipments of either rendered protein or feed, and 1,200 individual producers or consumers who purchased finished feed by the bag. A survey was conducted of those entities that were at some risk of having received such rendered material or feed. This survey suggested that 99 percent of the sites surveyed experienced either no exposure of cattle (96 percent of the sites) to the feed or only incidental exposure (3 percent of the sites). The remaining 1 percent represented limited exposures, such as cattle breaking into feed piles, sheep reaching through a fence to access feed, and a goat with possible access to a feed bag.

The investigation included a consideration of several possibilities for the source of the infected cow's exposure to BSE. Although it has not been confirmed, it is assumed, based on the age of the cow, that the infected cow was exposed through contaminated feed. The infected animal was born prior to the implementation of a feed ban within Canada and could have had exposure to contaminated feed at an early age.

The renderers and feed mills associated with the investigation had records of good compliance with the feed ban. The on-farm inquiries demonstrated a very small probability of exposure of ruminants to prohibited feed. Although the possibility exists that the original source of the BSE agent could have been imported, there was no evidence that this was due to an illegal import. The BSE agent could have been from animals imported from the United Kingdom prior to import restrictions established in 1990. The surveillance program was sufficient to confirm the continued existence of adequate measures to prevent further introduction or spread of BSE.

Following the detection of BSE in Canada, a broad eradication program was followed during the epidemiological investigation, in which more than 2,700 head of cattle were culled. As part of the culling activity, more than 2,000 animals 24 months of age or older were tested (those animals less than 24 months of age were not tested), with no further evidence of BSE found in any of these animals.

Because we believe regions, such as Canada, that qualify as BSE minimal-risk regions based on the factors described above, would pose a minimal risk of introducing BSE into the United States, we believe it is warranted to allow the importation from such regions of some animals and animal products and byproducts that are prohibited importation from regions in which BSE exists and regions that present an undue risk of BSE. However, because BSE is a difficult disease to define experimentally with precision, epidemiological evidence suggests that risk factors are specific to the commodity, and multiple risk sources may be associated with a given commodity, we believe it is necessary to also apply individual risk mitigation measures to specified commodities intended for importation from BSE minimal-risk regions.

For example, as noted above and discussed further below, contaminated feed appears to be the most likely pathway of BSE transmission. However, it has not been established with certainty that contaminated feed is the only pathway. Furthermore, we cannot assume complete compliance with a ban on the feeding of ruminant protein to ruminants, which is the most effective mitigation for contaminated feed. Therefore, we believe it is necessary to apply certain other mitigation measures, in addition to implementation of a feed ban, to reduce the risk of the introduction of BSE into the United States. Each of these proposed mitigation measures is discussed below.

We are proposing to add the conditions for importing specified ruminant commodities from a BSE minimal-risk region to the regulations in 9 CFR parts 93, 94, and 95. The measures appropriate for specific commodities intended for importation would be determined by the presence or absence of factors that make it more or less likely the commodity might be contaminated or infected with the BSE. These factors are discussed in the following paragraphs.

Oral ingestion of feed contaminated with the abnormal BSE prion protein is the only documented route of field transmission of BSE. 3 Thus, animals that have not ingested contaminated feed are unlikely to harbor the agent, so feed exposure influences risk. Animals, and the products derived from those animals, are unlikely to have infectious levels of the agent and will present a lower risk if the animals were (a) born after the implementation of an effective feed ban or (b) not fed risk material ( e.g., wild animals or farmed animals that are not fed feeds containing meat-and-bone meal).

The risks associated with feed source and exposure can be mitigated by accepting for import only animals or products derived from animals that have not been fed commercial feed that is likely to be contaminated with infectious levels of the agent.

Levels of infectious agent in certain tissues vary with the age of an animal, so the age of the animal influences risk. Pathogenesis studies, where tissues obtained from orally infected calves were assayed for infectivity, have illustrated this. 4 Infectivity was not detected in most tissues until at least 32 months post-exposure. The exception to this is the distal ileum (a part of the intestines), where infectivity was confirmed from the experimentally infected cattle as early as 6 months post-exposure. In this proposed rule, we take these findings into account when establishing measures to mitigate the risk of infectious levels of the BSE agent being present in animals and animal products imported from a BSE minimal-risk region. For example, with regard to bovines, because BSE infectivity has not been found in most bovine tissues until at least 32 months post-exposure, we believe that by requiring that bovines imported into the United States from BSE minimal-risk regions be less than 30 months of age, the risk of the BSE agent being present at infectious levels in most tissues in the animal is minimized. The 30-month age limit is accepted internationally in BSE standards set by various countries and is consistent with OIE recommendations. Similarly, the proposed regulations would require that imported meat from bovines be derived from animals less than 30 months of age when slaughtered. However, because of evidence that the BSE agent may be present at infectious levels in the distal ileum of infected bovines as early as 6 months post-exposure, we would require that the intestines of bovines imported into the United States be removed at slaughter, and that meat imported from bovines from BSE minimal-risk regions be derived from animals from which the intestines were removed at slaughter.

Although the risks associated with age can be mitigated by accepting for import only animals or commodities derived from animals of an age where even high risk tissues (discussed below) are unlikely to have infectious levels of the BSE agent, restrictions applicable to age alone may not always be possible or sufficient. For instance, in the case of wild cervids, because it is not always possible to determine the age of the cervids, we believe that alternative risk measures, discussed below, are necessary.

Research demonstrates that the incubation period for BSE is apparently linked to the infectious dose received— i.e., the larger the infectious dose received, the shorter the incubation period (EU SSC 2002). While some cases of BSE have been found in animals less than 30 months of age, these are relatively few and have occurred primarily in countries with significant levels of circulating infectivity ( i.e., where infected ruminants are used for feed for other ruminants, which in turn become infected). The conditions, discussed above, for qualifying for a BSE minimal-risk region guard against such circulating infectivity.

Similar observations regarding the importance of the size of the infectious dose were made in sheep and goats (EU SSC 2002). In these animals, infectivity could not be demonstrated in most tissues until at least 16 months post-exposure to the agent.

In summary, infected cattle over 30 months of age or sheep and goats over 16 months of age may have levels of the abnormal prion in affected tissues that are sufficient to infect other animals fed protein derived from these tissues. Infected animals less than 30 months of age or sheep and goats less than 16 months of age are unlikely to have infectious levels of the prion protein (EU SSC 2002; Wells, et al. ; 1994; Wells, et al. ; 1998).

Animals that were born before the feed ban but were not fed risk material, such as wild ruminants or domestic livestock in the minimal-risk region that were fed solely materials that are extremely unlikely to contain the infectious agent, are unlikely to contain infectious levels of BSE.

Some bovine tissues have demonstrated infectivity, whereas others have not. Tissues that have demonstrated infectivity, and thus are likely to contain the infectious agent in infected cattle, are brain, tonsil, spinal cord, eyes, trigeminal ganglia, dorsal root ganglia, and distal ileum. (Please note that, as discussed above, the age of an animal is a key factor in whether the animal is likely or unlikely to be infected. Cattle less than 30 months of age unlikely to be infected with BSE, and, therefore, even the tissues listed above, except for the distal ileum, from such animals are unlikely to contain the infectious agent.) Affiliated tissues or structures such as skull or vertebral column are considered risk materials because of the difficulty in separating out small tissues such as dorsal root ganglia from the vertebral column. Possibilities for cross contamination from risk materials must be considered also. However, even cattle carrying the infectious agent are unlikely to carry that agent in tissues that have not demonstrated infectivity ( e.g., muscle, liver, skin, hide, milk, embryos) or products derived from these tissues  5 (also, Wells, et al. ; 1994; Wells, et al. ; 1998).

The risks associated with tissue localization can be mitigated by accepting only tissues that are unlikely to have infectious levels of the agent, due to the nature of the tissue or the age of the animal (in cattle under 30 months of age, only the distal ileum is such a risk material), or commodities derived from those tissues.

Tissue distribution of the agent varies with species. Results from experimental infections of sheep have shown that the BSE prion is distributed more widely in sheep tissues than in cattle. 6 This distribution is similar to the distribution of scrapie (a transmissible spongiform encephalopathy present in the United States) infections in sheep. In these infections, the agent may be found in the lymphoreticular system and in peripheral nerves (Foster et al. ; 1996; Foster et al. ; 2001).

However, no natural infections with BSE have yet been confirmed in sheep, although testing is ongoing in Europe. Similarly, no natural infections have been confirmed in goats, although actual experiments have not been conducted in the species. In the absence of actual data, distribution of the agent in goat tissues has been assumed to be similar to distribution of the agent in sheep tissues, based on the fact that scrapie acts very similarly in sheep and goats.

Similarly, natural infection of cervids (deer and elk species) with BSE has not been documented, and no challenge studies on cervid susceptibility to BSE have been conducted. In the absence of actual data, it is assumed that distribution of any BSE agent in cervid tissues would be similar to the distribution of the chronic wasting disease agent in cervid tissues, which is a naturally occurring transmissible spongiform encephalopathy.

The possible prevalence of disease in the region of origin will influence the risk. Prevalence of the disease will be lower in a country with adequate prevention and control measures; thus, animals from such a region will be at lower risk of being exposed to infection. The risks associated with prevalence can be mitigated by accepting commodities only from a country with low prevalence that can be classified as minimal or low risk.

We believe the categories of ruminants discussed below from BSE minimal-risk regions are unlikely to be a source of infectivity of the BSE agent if the conditions specified below are met, and we propose to allow for such importation under those conditions in a new § 93.436. In each case where we are proposing to allow importation, the animals would have to arrive through a designated port of entry as listed in current § 93.403(b) (designated ports of entry for ruminants from Canada), or through some other port that has been designated as a port of entry by the Administrator under § 93.403(f). If, in the future, we add other countries to the list of BSE minimal-risk regions in § 94.18(a)(3), we would adjust the list of designated ports accordingly.

In those cases where a ruminant is imported into the United States, and subsequently does not meet one of the conditions set forth in § 93.436 ( e.g., animals that die before reaching the slaughtering establishment; animals that are moved from a feedlot in this country to slaughter after they are 30 months of age), the regulations would provide that the animal must be disposed of in a manner approved by the Administrator.

Section 93.436, paragraph (a), would allow the importation of bovines for immediate slaughter under the following conditions:

• The bovines are less than 30 months of age and are moved directly as a group from the port of entry to a recognized slaughtering establishment (the definition of recognized slaughtering establishment is set forth in § 93.400) for immediate slaughter as a group. (Under the definition of immediate slaughter in § 93.400, the bovines must be slaughtered within 2 weeks of the date of entry. In § 93.400, we would add a definition of as a group to mean collectively, in such a manner that the identity of the animals as a unique group is maintained.)

• The bovines are not known to have been fed ruminant protein, other than milk protein, during their lifetime.

• The bovines are accompanied by a certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so, that certifies the above conditions have been met.

• The bovines are moved as a group from the port of entry to the slaughtering establishment in conveyances sealed at the port of entry with seals of the United States Government, which are broken only at the slaughtering establishment by a USDA representative, and the shipment is accompanied by an APHIS Veterinary Services (VS) Form 17-33, Animals Imported for Immediate Slaughter.

• At the slaughtering establishment, the bovines are slaughtered as a group and each animal's intestines are removed.

• The intestines removed from the bovines are disposed of in a manner approved by the Administrator.

We believe the conditions described above, combined with the fact the exporting region is one of minimal risk for BSE, make it very unlikely that meat derived from bovines meeting those conditions would contain the BSE agent. The requirement that the bovines imported from a BSE minimal-risk region be less than 30 months of age would make it unlikely they would have infectious levels of the prion protein. The requirements that the bovines be moved to slaughter in a sealed conveyance and be slaughtered as a group are designed to ensure that the animals are not diverted while being moved to slaughter and that the intestines are removed at slaughter from all bovines imported from the minimal-risk region. If any bovines not from the minimal-risk region are commingled with the group of bovines from the minimal-risk region at the slaughtering establishment, then those added animals would be treated as if they were from the minimal-risk region and their intestines would have to be removed and disposed of in accordance with our proposed provisions. The requirement that the bovines be slaughtered at a recognized slaughtering establishment (as defined in § 93.400) would ensure the animals are slaughtered at a facility approved by APHIS where slaughtering operations are regularly carried on under Federal or State inspection. The requirement that the intestines be removed from the animal at slaughter and be disposed of in a manner approved by the Administrator would minimize the possibility that such materials will be fed to ruminants. We believe it is necessary to provide the Administrator discretion in the specific means of disposal used, to allow for the use of different but equally effective methods of disposal.

We would apply the slaughtering conditions described above to bovines imported for slaughter in the United States after first being contained at a designated feedlot in this country. However, instead of being moved directly from the port of entry to a recognized slaughtering establishment, such animals would first be moved directly, as a group, to a designated feedlot for feeding, and then directly to a recognized slaughtering establishment. In § 93.400, we would define designated feedlot to mean a feedlot indicated on the declaration required under § 93.407 as the destination of the ruminants imported into the United States. Under current § 93.407, the importer of ruminants (or the importer's agent) must present a declaration at the port of entry that provides information about the ruminants, their origin, and their destination. For identification purposes, prior to being imported into the United States, each bovine would have to have been tattooed inside one ear with letters identifying the exporting country. Bovines from Canada would have to be tattooed with the letters “CAN.”

Therefore, § 93.436(b) would allow the importation of bovines for feeding under the following conditions:

• The bovines are not known to have been fed ruminant protein, other than milk protein, during their lifetime and are less than 30 months of age when imported into the United States.

• The inside of one ear on each animal is permanently and legibly tattooed with letters identifying the exporting country.

• The bovines are accompanied by authorized official certification, as described above, that the above conditions have been met.

• The bovines are moved directly from the port of entry as a group to the designated feedlot and the shipment is accompanied by an APHIS Form VS 1-27, Permit for Movement of Restricted Animals.

• The bovines are moved directly from the designated feedlot to a recognized slaughtering establishment for slaughter, where each animal's intestines are removed. The shipment is accompanied by APHIS Form VS 1-27.

• The intestines removed from the bovines are disposed of in a manner approved by the Administrator.

• The bovines are less than 30 months of age when slaughtered.

Unlike the requirement for bovines moved directly to immediate slaughter, we would not require that the animals be moved from the port of entry to the designated feedlot in sealed conveyances. The only region we are proposing at this time to classify as BSE minimal-risk is the country of Canada. Under the current APHIS regulations and policy, bovines imported from Canada for movement directly to immediate slaughter do not have to be accompanied by the health certificate required under § 93.405 that attests to the animal's health history with regard to various diseases and pests. However, the bovines must be moved to slaughter in a sealed conveyance. ( Please note: The regulations in part 93 use the term “cattle” rather than “bovines.” However, in § 93.400, cattle is defined as animals of the bovine species.) Because of the requirement for direct movement to slaughter in a sealed conveyance, there is little danger the bovines will be diverted on their way to the slaughtering establishment. Those requirements would remain unchanged by this proposed rule, although animals for immediate slaughter would have to be accompanied with the certification with regard to BSE specified in this proposal.

Under the current regulations, however, bovines imported from Canada for other than immediate slaughter do have to be accompanied by a certificate attesting to their health history with regard to various diseases, in order to ensure they do not spread such diseases to other livestock in this country. Because of their acceptable health history, it has not been necessary to require that the animals be moved in a sealed conveyance. This requirement for a health certificate would remain in place for bovines imported from Canada for feeding before slaughter (and be joined with the certification with regard to BSE specified in this proposal). Because of this health certification, and because, with regard to BSE, the bovines would have to be tattooed with the letters CAN, possible diversion is not an issue and we do not consider it necessary to begin to require that feeder bovines be moved from the U.S. port of entry to the designated feedlot in a sealed conveyance.

Additionally, we are not requiring that the bovines be moved from the designated feedlot to slaughter as a group. A shipment of bovines that arrives at a feedlot may contain animals of varying ages. Some will be ready for shipment to slaughter before others. However, we would require that all animals moved from the designated feedlot be moved directly to slaughter, where they would be identifiable as a shipment from a minimal-risk region by the required ear tattoo.

Section 93.436, paragraph (c), would allow the importation of sheep or goats under the following conditions:

• The sheep or goats are less than 12 months of age at the time of importation.

• The sheep or goats are not known to have been fed ruminant protein, other than milk protein, during their lifetime.

• The sheep or goats are accompanied by authorized official certification, as described above, that the above conditions have been met.

• The sheep or goats are moved directly from the port of entry as a group to a recognized slaughtering establishment in conveyances sealed at the port of entry with seals of the United States Government, which are broken only at the slaughtering establishment by a USDA representative, and must be slaughtered as a group. The shipment is accompanied by an APHIS Form VS 17-33.

Although there is no naturally occurring BSE infection of sheep and goats, the species can be infected with the BSE agent experimentally. However, in view of the relatively young age of the sheep and goats that would be allowed importation (we would allow importation of sheep and goats only of 12 months of age or less, the industry standard for commercial shipments of such animals), the likelihood that these sheep or goats could provide a source of infection is extremely low.

We would apply the slaughtering conditions described above to sheep or goats imported for slaughter in the United States after first being contained at a designated feedlot in this country. However, instead of being moved directly from the port of entry to a recognized slaughtering establishment, such animals would be moved to a designated feedlot, and then directly to a recognized slaughtering establishment. For identification purposes, prior to being imported into the United States, each sheep and goat would have to have been tattooed inside one ear with letters identifying the exporting country. Sheep and goats from Canada would have to be tattooed with the letters “CAN.”

Therefore, § 93.436(d) would allow the importation of sheep and goats under the following conditions:

• The sheep and goats are not known to have been fed ruminant protein, other than milk protein, during their lifetime and are less than 12 months of age at the time of importation into the United States.

• The inside of one ear on each animal is permanently and legibly tattooed with letters identifying the exporting country.

• The sheep or goats are accompanied by authorized official certification, as described above, that the above conditions have been met.

• The sheep or goats are moved directly from the port of entry as a group to a designated feedlot and the shipment is accompanied by an APHIS Form VS 1-27.

• The sheep or goats are moved directly from the designated feedlot to a recognized slaughtering establishment for slaughter. The shipment is accompanied by APHIS Form VS 1-27.

• The sheep and goats are less than 12 months of age when slaughtered.

Section 93.436, paragraph (e), would allow the importation of cervids under the following conditions:

• The cervids were members of a herd in which surveillance for transmissible spongiform encephalopathies (TSE's) was conducted by appropriate authorities according to national standards or standards of the region itself if the region is a jurisdiction that has effective oversight of normal animal movements into, out of, or within the region and that, in association with national authorities if necessary, has the responsibility for controlling animal disease locally.

• The herd is not known to have been infected with or exposed to a TSE.

• The cervids were born after the implementation of a ban on feeding of ruminant protein to ruminants.

• The cervids were not known to have been fed ruminant protein, other than milk protein, during their lifetime.

• The cervids are accompanied by authorized official certification, as described above, that the above conditions have been met.

• The cervids are moved from the port of entry as a group directly to a recognized slaughtering establishment in conveyances sealed at the port of entry with seals of the United States Government, which are broken only at the slaughtering establishment by a USDA representative. The cervids must be slaughtered as a group. The shipment is accompanied by an APHIS Form VS 17-33.

As ruminants, cervids are subject to import restrictions because of BSE. We believe that the above conditions are necessary for the importation of cervids intended for immediate slaughter, because, although there have been no confirmed cases of BSE in cervids, it is possible that they are susceptible to BSE. To date, there have been no challenge studies for BSE in cervids ( i.e. , studies in which cervids are intentionally exposed to the BSE agent) to indicate the level of susceptibility of cervids to BSE. Given the stringent controls described above, however, and the fact that there have been no confirmed cases of BSE in cervids, we believe the likelihood BSE would be introduced into the United States through cervid importations is extremely low, and we do not believe that mitigation measures other than those listed above are necessary.

One of the requirements listed above is that the cervids have been members of a herd in which surveillance for TSE's was conducted by appropriate authorities according to national or regional standards. At present, the TSE program for cervids in Canada, the one region we are proposing to classify as BSE-minimal risk at this time, is one that monitors for chronic wasting disease (CWD). However, all sampling done to monitor for CWD would identify animals that might be affected with other TSE's such as BSE.

We are proposing to add a new § 94.19 to list those ruminant products that would be allowed importation from a BSE minimal-risk region and to set forth the conditions for such importation.

In evaluating the risk that ruminant products imported into the United States might present, the same factors affecting the BSE risk of the live animals from which the products are derived are applicable. Additionally, other factors must be considered due to the processing the products undergo. Slaughter methods and the removal of risk material from source animals in the exporting region affect the level of risk associated with meat and meat products from those animals, as do intended use and the demonstrated likelihood of the animal product in question to contain the BSE agent.

Similar to the slaughter requirements for ruminants imported live into the United States for immediate slaughter, it would be necessary to require that most ruminant products intended for importation into the United States from a BSE minimal-risk region come from animals from which intestines were removed during processing. In some cases, however, because of other mitigating factors, such as if no natural infection has been observed in the type of animal, we do not believe it would be necessary to require that the intestines have been removed from the animal from which the product is derived.

We believe that the importation of the categories of meat and other edible products from ruminants from BSE minimal-risk regions discussed below would be unlikely to contain the BSE agent provided the following conditions are met, as certified to on an original certificate issued by a full-time salaried veterinary officer of the national government of the region of origin, or issued by a veterinarian designated or accredited by the national government of the region of origin and endorsed by a full-time salaried veterinary officer of the national government of the region of origin, representing that the veterinarian issuing the certificate was authorized to do so.

As one of the conditions for bringing the commodity into the United States, we are proposing that the meat and edible products, if arriving at a land border port, arrive only at one of the ports we would list in new § 94.19(k). At this time, the only region that would be listed in § 94.18(a)(3) as a BSE minimal-risk region would be the country of Canada. Because the type of shipments that would require inspection under this proposed rule have not been subject to inspection in recent years when arriving at land border ports from Canada, we believe it is advisable to limit their arrival by land from Canada to those U.S. ports staffed with personnel fully trained in the inspection of such shipments.

We would list the following as designated land border ports in § 94.19(k): Eastport, ID; Houlton, ME; Detroit (Ambassador Bridge), Port Huron, and Sault St. Marie, MI; International Falls, MN; Sweetgrass, MT; Alexandria Bay, Buffalo (Lewiston Bridge and Peace Bridge), and Champlain, NY; Pembina and Portal, ND; Derby Line and Highgate Springs, VT; and Blaine (Pacific Highway and Cargo Ops), Lynden, Oroville, and Sumas (Cargo), WA. If, in the future, we add other countries to the list of BSE minimal-risk regions in § 94.18(a)(3), we would adjust the list of designated ports accordingly.

Section 94.19, paragraph (a), would allow the importation of meat under the following conditions:

• The meat is fresh (chilled or frozen) meat from bovines less than 30 months old at the time of slaughter that are not known to have been fed ruminant protein, other than milk protein, during their lifetime.

• The bovines from which the meat is derived were slaughtered in a slaughtering establishment that slaughters only bovines less than 30 months of age or complies with a segregation process approved by the national veterinary authority of the region of origin and the Administrator as adequate to prevent contamination or commingling of the meat with products not eligible for importation into the United States.

• The intestines of the bovines were removed at slaughter.

• The product qualifies as meat according to the definition of meat set forth in USDA's Food Safety and Inspection Service's (FSIS) regulations at 9 CFR 301.2.

• The shipment is accompanied by authorized official certification, as described above, that the above conditions have been met.

We would require that the commodity meet the definition of “meat” according to the FSIS regulations to ensure that, if imported as ground meat, it has not been combined with meat that might contain high-risk tissues from high-risk animals. Under the FSIS definition in 9 CFR 301.2, to be considered “meat,” product that undergoes mechanical separation and meat recovery from the bones of livestock must be processed in such a way that the processing does not crush, grind, or pulverize bones, so that bones emerge comparable to those resulting from hand-deboning and the meat itself meets the criteria of no more than 0.15 percent or 150 mg/100 gm of product for calcium (as a measure of bone solids content) within a tolerance of 0.03 percent or 30 mg. We are proposing to use this standard for the eligibility of meat from bovines (and, as indicated later, for meat from sheep and goats) to ensure that the product contains no mechanically separated meat that might contain high risk-tissues. ( Please note: Except where the FSIS definition of meat is specifically referenced in proposed § 94.19(a)(3) with regard to meat from bovines, and in proposed § 94.19(e)(2) with regard to meat from sheep or goats or other ovines or caprines, the standard dictionary definition of meat is intended throughout this proposed rule.)

To avoid commingling or contamination of meat from bovines under 30 months of age with materials from older bovines, we would require that the slaughtering facility in the region of origin either slaughter only bovines less than 30 months of age or comply with an approved segregation process. Such segregation during slaughtering could be accomplished, for instance, by slaughtering bovines over 30 months of age only at the end of the day on lines and with equipment dedicated exclusively to slaughtering such older animals.

Section 94.19, paragraph (b), would allow the importation of bovine carcasses under the following conditions:

• The products are fresh (chilled or frozen) whole or half carcasses derived from bovines that were less than 30 months of age when slaughtered and that are not known to have been fed ruminant protein, other than milk protein, during their lifetime.

• The bovines from which the carcasses are derived were slaughtered in a slaughtering establishment that slaughters only bovines less than 30 months of age or complies with a segregation process approved by the national veterinary authority of the region of origin and the Administrator as adequate to prevent contamination or commingling with products not eligible for importation into the United States.

• The intestines of the bovines were removed at slaughter.

• The shipment is accompanied by authorized official certification that the above conditions have been met.

Section 94.19, paragraph (c), would allow the importation of fresh (chilled or frozen) bovine liver, provided the product is combined with no other product, is derived from bovines for which no air-injected stunning process was used at slaughter, and is accompanied by authorized official certification that the above conditions have been met. In and of itself, the liver is unlikely to contain infectious levels of the BSE agent, so we are not proposing to require that liver be derived from animals less than 30 months of age or not known to have been fed ruminant protein, other than milk protein, during their lifetime. However, we would prohibit the importation of liver derived from bovines for which an air-injected stunning process was used. The liver, because of its anatomical location and size of its blood vessels, is the organ that could potentially receive emboli or tissue fragments distributed in the animal due to the use of an air-injected stunning process. Because there would be no age limit on the bovines from which the liver is derived, we believe it is necessary to ensure that the liver be free of such potentially high-risk material.

Section 94.19, paragraph (d), would allow the importation of fresh (chilled or frozen) bovine tongues that meet the following conditions:

• The tongues are derived from bovines that were born after the implementation of an effective feed ban.

• The bovines are not known to have been fed ruminant protein, other than milk protein, during their lifetime.

• The tonsils of the bovines were removed at slaughter.

• The tongues are accompanied by authorized official certification that the above conditions have been met.

The tongue itself is unlikely to contain the BSE agent in animals of any age. However, because the tongue and the tonsils are connected, and the tonsils consist of tissue with demonstrated infectivity, we believe it is necessary to require that the tonsils have been removed from bovines greater than 30 months of age from which tongues for importation are derived. To eliminate the need to determine the exact age of the animals from which tongues are derived, we would require that the tonsils have been removed at slaughter from all bovines from which tongues intended for importation from a BSE minimal-risk region are derived.

Section 94.19, paragraph (e), would allow the importation of meat under the following conditions:

• The product is fresh (chilled or frozen) meat from sheep or goats or other ovines or caprines less than 12 months of age at the time of slaughter that are not known to have been fed ruminant protein, other than milk protein, during their lifetime.

• The animals from which the meat is derived were slaughtered in a slaughtering establishment that slaughters only sheep and/or goats or other ovines or caprines less than 12 months of age or complies with a segregation process approved by the national veterinary authority of the region of origin and the Administrator as adequate to prevent contamination or commingling of the meat with products not eligible for importation into the United States.

• The product qualifies as meat according to the definition of meat set forth in USDA's Food Safety and Inspection Service's (FSIS) regulations at 9 CFR 301.2.

• The shipment is accompanied by authorized official certification that the above conditions have been met.

Section 94.19, paragraph (f), would allow the importation of fresh (chilled or frozen) carcasses of ovines and caprines under the following conditions:

• The carcasses are derived from ovines or caprines that were less than 12 months old when slaughtered and that are not known to have been fed ruminant protein, other than milk protein, during their lifetime.

• The ovines or caprines from which the carcasses were derived were slaughtered in a slaughtering establishment that slaughters only ovines and/or caprines less than 12 months of age or complies with a segregation process approved by the national veterinary authority of the region of origin and the Administrator as adequate to prevent contamination or commingling of the carcasses with products not eligible for importation into the United States.

• The carcasses are accompanied by authorized official certification that the above conditions have been met.

Section 94.19, paragraph (g), would allow the importation of hunter-harvested wild ruminant products under the following conditions:

• The product is meat or a dressed (eviscerated and the head is removed) carcass of a wild sheep, goat, cervid, or other ruminant;

• The meat or dressed carcass is intended for personal use, and the hunter provides proof to the U.S. Customs and Border Protection official that the animal was a legally harvested wild (not ranched) animal. Such proof will include the hunting license, tag, or equivalent;

• The game and wildlife service of the jurisdiction where the ruminant was harvested has informed the Administrator that the jurisdiction either: (1) Conducts no type of game feeding program, or (2) has complied with, and continues to comply with, the ban on the feeding of ruminant protein to ruminants in the BSE minimal-risk region.

Meat and meat products from wild animals not maintained on ranches or farms are unlikely to have ingested contaminated commercial feed and are unlikely to have infectious levels of the BSE agent. Also, the nature of hunter-harvested ruminant products to be used for personal use makes it highly unlikely that the product will enter the commercial food chain for animals. (In § 94.0, we would add a definition of personal use to mean only for personal consumption or display and not distributed further or sold.) If the game and wildlife service of the jurisdiction where the ruminant was harvested has not informed the Administrator either that the jurisdiction conducts no game feeding program or has complied with, and continues to comply with, the feed ban, we would direct U.S. inspectors at the designated ports of arrival not to allow such hunter-harvested ruminant products from the jurisdiction to be imported into the United States.

Section 94.19, paragraph (h), would allow the importation of meat and meat products under the following conditions:

• The product is fresh (chilled or frozen) meat derived from cervids that were born after an effective feed ban was implemented, that were not known to have been fed ruminant protein, other than milk protein, during their lifetime, and that were members of a herd not known to be infected with or exposed to a transmissible spongiform encephalopathy.

• If the product is ground meat or sausage, it was derived either from all cervine meat or from cervine meat mixed with nonruminant meat.

• The shipment is accompanied by authorized official certification that the above conditions have been met.

No natural infection of BSE has been documented in cervids, and we believe there is a very low risk that any tissue in cervids is likely to contain the BSE agent. Therefore, we believe it is unnecessary to prohibit the importation of ground meat or sausage that is exclusively cervid meat or cervid meat and nonruminant meat. However, because it has not been proven that cervids are not susceptible to BSE, we believe it is necessary to require that the cervid meat and meat products be derived from cervids that were members of a herd not known to have been infected with or exposed to a transmissible spongiform encephalopathy.

Section 94.19, paragraph (i), would allow the importation of meat under the following conditions:

• The meat is from wild caribou, musk ox, or other cervids harvested within a jurisdiction specified by the Administrator for which the game and wildlife service has informed the Administrator that the jurisdiction either: (1) Conducts no type of game feeding program, or (2) has complied with, and continues to comply with, the ban on the feeding of ruminant protein to ruminants in the BSE minimal-risk region.

• The cervids from which the meat is derived were either slaughtered in a slaughtering establishment that slaughters only cervids eligible for entry into the United States or complies with a segregation process approved by the national veterinary authority of the region of origin and the Administrator as adequate to prevent contamination or commingling of the meat with products not eligible for importation into the United States.

• The shipment is accompanied by authorized official certification that the above conditions have been met.

This meat differs from the meat described above under the heading “Hunter-harvested wild ruminant products” in that, although it is hunter-harvested, it is done so on a larger scale for commercial sale.

Section 94.19, paragraph (j), would allow the importation of gelatin from bones of bovines that were less than 30 months of age when slaughtered and that are not known to have been fed ruminant protein, other than milk protein, during their lifetime, provided the shipment is accompanied by authorized official certification that these conditions have been met.

Section 95.4 of the regulations currently restricts the importation of animal protein, tankage, fat, glands, tallow other than tallow derivatives, and serum from regions where BSE is known to exist or that present an undue risk of BSE. Of these products, we believe that certain tallow and offal could be imported from BSE minimal-risk regions under certain conditions with little likelihood of containing infectious levels of the BSE agent, and are proposing to amend § 95.4 to allow the importation of such materials. We do not have evidence at this time that the other products prohibited under § 95.4 could be imported with little likelihood of containing infectious levels of the BSE agent.

As one of the conditions for importation, the tallow and offal, if arriving at a U.S. land border port, would have to arrive at one of the ports we would list in new § 94.19(k).

In the case of tallow, we would require that it contain less than 0.15 percent protein and be obtained from bovines less than 30 months of age when slaughtered. This product would be considered low risk because it is primarily lipid material with a minimal cellular component. When it is derived from low-risk bovines and the level of protein is low, the material would be unlikely to contain prion protein.

Section 95.4, paragraph (f), would allow the importation of tallow under the following conditions:

• The tallow is composed of less than 0.15 percent protein.

• The tallow was derived from animals that were less than 30 months of age when slaughtered, that were born after the region of origin implemented an effective ban on the feeding of ruminant protein to ruminants, and that were not known to have been ruminant protein, other than milk protein, during their lifetime.

• The tallow is not derived from an animal that died otherwise than by slaughter.

• The intestines were removed from each animal at slaughter.

• The shipment of tallow to the United States is accompanied by authorized official certification that the above conditions have been met.

In the case of offal, we would require that it be derived from cervids born after the implementation of an effective feed ban that were not known to have been fed ruminant protein, other than milk protein. Because the offal would be derived from low-risk animals, we would consider the product to be unlikely to contain the BSE agent. We would limit the importation of offal to cervine offal, because bovine offal could contain the distal ileum, which is a tissue with confirmed infectivity in BSE-infected bovines.

Section 95.4, paragraph (g), would allow the importation of offal from cervids under the following conditions:

• The offal was derived from cervids that were born after the feed ban, that were not known to have been fed ruminant protein, other than milk protein, during their lifetime, and that were members of a herd not known to be infected with or exposed to a transmissible spongiform encephalopathy.

• The shipment of offal to the United States is accompanied by authorized official certification that the above conditions have been met.

Additionally, because offal can encompass a variety of materials, for clarification we would add a definition of offal to § 95.1 to mean the parts of a butchered animal that are removed in dressing, consisting largely of the viscera and the trimmings, which may include, but are not limited to, brains, thymus, pancreas, liver, heart, and kidney.

Although § 95.4 restricts the importation of animal protein, tankage, fat, glands, tallow other than tallow derivatives, and serum from regions where BSE is known to exist or that present an undue risk of BSE (as listed in current § 94.18(a)), paragraph (c) of § 95.4 exempts certain materials from the restrictions, under certain conditions, provided the material is derived from a nonruminant species, or from a ruminant species if the ruminants have never been in a region listed in § 94.18(a). One of the conditions for such importation is that all steps of processing and storing the material be carried out in a facility that has not been used for the processing or storage of any materials derived from ruminants that have been in any region listed in § 94.18(a). A further requirement is that, if the facility processes or handles any material derived from mammals, the facility must have entered into a cooperative service agreement with APHIS to pay for the costs of an APHIS veterinarian to make annual inspections of the facility.

Because we believe the regions we are proposing to include in § 94.18(a)(3) of this proposal present a minimal risk for BSE, we believe that, in lieu of annual APHIS inspections of the facility, such inspections could be carried out by the government agency responsible for animal health in the region, although APHIS would reserve the right to inspect as deemed necessary. Therefore, we are proposing to amend § 95.4(c)(4) to exclude facilities in BSE minimal-risk regions from the requirement for a cooperative service agreement and to require that annual inspections of the facility be carried out by a representative of the government agency responsible for animal health in the region. We would, however, still apply to BSE minimal-risk regions the provisions of § 95.4(c)(5), which require the facility to allow periodic inspections by APHIS.

Additionally, we are proposing to amend § 95.4(c)(6), which currently specifies that each shipment imported into the United States in accordance with § 95.4(c) be accompanied by an original certificate signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region of export certifying that the conditions of that section have been met. Because of the reduced risk of such exports from regions we would consider minimal risk, we are proposing to provide in § 95.4(c)(6) that, for shipments of animal feed, the necessary certification may be signed by a person authorized to issue such certificates by the veterinary services of the national government of the region of origin.

In addition to adding definitions of as a group, designated feedlot, bovine spongiform encephalopathy (BSE) minimal-risk region, offal, and personal use to the regulations, as discussed above, we are proposing to define in § 93.400 the term USDA representative to mean a veterinarian or other individual employed by the United States Department of Agriculture who is authorized to perform the services required by part 93.

This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

Under the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et seq. ) the Secretary of Agriculture is authorized to promulgate regulations to prevent the introduction into the United States or dissemination of any pest or disease of livestock.

On May 20, 2003, the Canadian Food Inspection Agency reported a case of BSE in a beef cow in northern Alberta. To prevent the introduction of this disease into the United States, APHIS issued an interim rule to classify Canada as a region where BSE exists, thereby prohibiting the importation of ruminants and most ruminant products from Canada, effective May 20, 2003.

This proposed rule would amend the regulations by establishing a category of regions that present a minimal risk of introducing BSE into the United States. The rule would set forth factors considered for placing a region in this category, and risk mitigations that would be required for the importation of certain ruminants and ruminant products from such regions. Although the proposed rule would list Canada as the only BSE minimal-risk region at this time, APHIS would evaluate requests and supporting information submitted by other regions for inclusion in this category.

In accordance with Executive Order 12866 and the Regulatory Flexibility Act, we assessed the potential economic costs and benefits of this rule and potential effects on small entities. Although not addressed in the analysis, Canadian producers/suppliers of ruminants and ruminant products would benefit from the resumption of exports to the United States.

Below is a summary of our economic analysis. A copy of the full economic analysis is available for review in our reading room (see the ADDRESSES section at the beginning of this document). You may also view the economic analysis on the Internet by accessing the APHIS Web site at http://www.aphis.usda.gov. At the APHIS Web site, click on the “Hot Issues” button. On the next screen, click on the listing for “Bovine Spongiform Encephalopathy (BSE).” On the next screen, click on the listing for “Economic Analysis, Proposed Rule, Bovine Spongiform Encephalopathy: Minimal Risk Regions and Importation of Commodities (APHIS Docket No. 03-080-1).” We do not have enough data for a comprehensive analysis of the potential economic effect of this proposed rule on small entities. Therefore, in accordance with 5 U.S.C. 603, we have performed an initial regulatory flexibility analysis for this proposed rule. We are inviting comments about this proposed rule as it relates to small entities. In particular, we are interested in determining the number and kind of small entities that would incur benefits or costs from the implementation of this proposed rule and the economic effect of those benefits or costs.

Because Canada is the only region we are proposing to include in the BSE minimal-risk category at this time, ruminant and ruminant product imports from Canada that would be reestablished under the proposed rule are the focus of our analysis. However, this minimal-risk category is not limited to Canada and could include other regions in the future. The analysis also considers effects of the rule for U.S. ruminant and ruminant product exports should other countries not consider our minimal-risk requirements sufficient to safeguard against BSE introduction into the United States and/or do not accept our listing of Canada as a region of minimal risk.

The commodities that would be allowed to enter under the proposed rule are:

• Cattle less than 30 months of age, sheep and goats less than 12 months of age, and cervids of any age, imported in all cases for immediate slaughter;

• Cattle less than 30 months of age and sheep and goats less than 12 months of age imported for feeding at a designated feedlot (for slaughter at less than 30 months and 12 months of age, respectively);

• Meat from cattle, sheep, and goats that have been slaughtered within these age restrictions;

• Meat of cervids either farm-raised or harvested on a game farm or similar facility;

• Meat from wild-harvested caribou, musk ox, or other cervids that has been commercially processed;

• Certain hunter-harvested wild ruminant products for personal use; and

• Certain other products and byproducts, including bovine livers and tongues, gelatin, tallow, and cervid offal.

With respect to Canada, slaughter cattle, feeder cattle, and beef would be the main commodities affected by resumption of ruminant and ruminant product imports. The additional supplies would cause prices to fall. Welfare gains for consumers and losses for producers/suppliers are measured, and net benefits and losses estimated. Since May of this year, U.S. producers/suppliers of ruminants and ruminant products have benefited from high price levels at least partly attributable to the ban on imports from Canada. Estimated price declines for producers/suppliers and consumers/buyers of slaughter cattle, feeder cattle, and beef largely reflect a return to the more normal market conditions that prevailed before Canada's BSE discovery.

Expected effects due to reestablished slaughter cattle and feeder cattle imports from Canada are shown in table 1. (The model and parameters used are explained in the body of the economic analysis.) The estimated effects are near-term, and would occur during the first year or so following the resumption of imports. In the longer term, production and marketing adjustments in response to changed market conditions would create new price-quantity equilibriums.

Reestablished slaughter cattle imports from Canada of 840,000 head would result in a price decline of $1.30 per 100 pounds. This price decline would be accompanied by an increase of about 366,350 head in the number of cattle slaughtered, and a decrease of 474,450 head in the number of slaughter cattle supplied by U.S. entities. These changes translate into an increase in consumer surplus of $455.3 million for buyers of slaughter cattle, and a decrease in producer surplus of $448.7 million for sellers of slaughter cattle, for an annual net benefit of $6.6 million.

Whether a portion of this benefit would be realized by beef consumers would depend upon wholesale and retail margins and elasticities of demand. The price decline would reduce incomes of domestic suppliers who would be competing with slaughter cattle imports from Canada. The estimated price change is small, falling within expected variations of recent USDA price projections. A price decrease of $1.30 per 100 pounds would represent a decline of 1.7 percent and would not significantly affect buyers or sellers of slaughter cattle.

Reestablished feeder cattle imports from Canada totaling 504,500 head would result in a price decline of 72 cents per 100 pounds. This fall in price would be accompanied by an increase of 221,318 head in the number of cattle fed, and a decrease of 283,182 head in the number of cattle supplied to feedlots by U.S. entities. Consumer surplus would rise by $188.2 million for buyers of feeder cattle, and producer surplus would fall by $182 million for sellers of feeder cattle, for an annual net benefit of about $6.2 million.

A price decline resulting from reestablished feeder cattle imports from Canada would benefit the receiving feedlots. The decline would also reduce incomes for domestic suppliers, such as stocker operations, in competition with importers of feeder cattle from Canada. The estimated effects are small. A price decrease of 72 cents per 100 pounds would represent a decline of 0.9 percent and would not result in significant gains or losses for the affected entities.

Beef is modeled as a single aggregate commodity, but two analyses are performed. Boneless beef and certain other ruminant products are allowed to enter the United States from Canada under permit. We do not know whether quantities of boneless beef that enter under permit will reach levels that prevailed prior to the ban. This uncertainty is acknowledged by using two different import levels. The first analysis assumes that boneless beef imports from Canada under permit will reach 2002 levels; the effect of the proposed rule with respect to beef would be in reestablishing beef with bone and whole/half carcass imports. The second analysis assumes that no boneless beef is imported under permit, and all reestablished beef imports from Canada would be attributable to the proposed rule. The two analyses are hypothetical extremes that provide a lower bound and an upper bound of possible effects. Effects for two price levels of beef, $3.00 and $3.50 per pound, are estimated, as shown in table 2.

For beef prices of $3.00 and $3.50 per pound, respectively, annual net benefits of established beef imports would be $23.8 million and $27.8 million (only beef with bone and whole/half carcass imports assumed to be reestablished due to the proposed rule), and $91.3 million and $106.5 million (all beef imports assumed to be reestablished due to the proposed rule). As with reestablished imports of slaughter and feeder cattle, expected price declines due to reestablished beef imports from Canada would not be of a magnitude to significantly affect the economic welfare of producers or consumers. In the first case, price declines of 1.1 cents and 1.3 cents per pound are estimated for assumed beef prices of $3.00 and $3.50 per pound, respectively. In the second case, price declines of 5.2 cents and 6.1 cents per pound are estimated. Even in the latter analysis (all reestablished beef imports from Canada attributable to the proposed rule), the price declines represent less than a 2 percent fall in price.

Other, more minor commodities that would be allowed entry under the proposed rule and for which we have trade data are sheep, goats, and farmed cervids; meat from these ruminants; and bovine tongues and livers. In all cases, reestablished imports from Canada would not significantly affect the U.S. supply of these commodities or the welfare of U.S. entities.

The United States prohibits ruminant imports from BSE-affected regions. Under the proposed rule, the United States would recognize Canada as a minimal-risk region for BSE, under which ruminant imports could resume. U.S. ruminant and ruminant product exports would be placed in jeopardy if importing countries do not agree that the factors the United States would consider justify the categorization of a region as one of minimal risk, and do not agree that the proposed age restrictions and other measures provide an adequate safeguard against the risk of BSE introduction from such a region.

We therefore analyze the economic effects that would occur if the United States would lose major export markets due to this proposed rule and its inclusion of Canada as a minimal-risk region.

Because U.S. ruminant and ruminant product exports to Canada and Mexico would not be jeopardized by this proposed rule, exports to these two countries are excluded from the analysis. Since nearly all U.S. cattle exports are to Canada and Mexico, we can also limit the analysis to possible effects for beef exports.

Canada and Mexico together imported about 36 percent of U.S. beef exports in 2002. Removing these exports from consideration leaves about 64 percent of U.S. beef exports that could be affected by the proposed rule. About 56 percent of U.S. beef exports (over 87 percent, excluding shipments to Canada and Mexico) were sold to Japan and Korea. Given the predominance of these two countries among importers of U.S. beef, the analysis is performed for two levels of export reduction: 32 percent of 2002 exports, or 263,360 tons (loss of one-half of export markets other than Canada and Mexico), and 64 percent, or 546,720 tons (loss of all export markets other than Canada and Mexico). For each of these assumed levels of export reduction, impacts are estimated using the same beef prices, $3.00 and $3.50 per pound. The results of the analysis are shown in table 3.

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this action may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification ( e.g. , reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NM-120-AD.” The postcard will be date stamped and returned to the commenter.

Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2001-NM-120-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

On December 30, 1997, the FAA issued AD 98-01-12, amendment 39-10275 (63 FR 1905, January 13, 1998), applicable to certain Airbus Model A320 series airplanes, to require an inspection to detect moisture and migrated bushings of the guide fittings of the safety locking pins of the passenger doors, removal of any moisture, application of grease, and reinstallation of any migrated bushing. That AD also requires installation of a greasing nipple on the guide fitting of the locking pin and on three telescopic rods on the passenger doors. That action was prompted by reports of difficulty opening the passenger doors due to jamming of the locking pin. The requirements of that AD are intended to prevent such jamming of the locking pin, which could result in inability to open the passenger door.

Since the issuance of AD 98-01-12, the Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, has informed us of additional incidents involving jamming of the forward right door in the up position on certain Model A319, A320, and A321 series airplanes. Investigation revealed migration of the bushings in the upper safety guide fitting which were installed per the requirements of that AD. Jamming of the locking pin of the passenger door could result in inability to open the passenger door and delay of evacuation in an emergency, resulting in possible injury to passengers or crew.

Modification of the upper guide fitting of the locking pin will prevent any possibility of migration of the bushings, and will allow the grease to escape during servicing of the airplane.

Airbus has issued Service Bulletin A320-52-1105, Revision 02, dated May 21, 2002, which describes procedures for modification of the upper guide fitting of the locking pin of the forward and aft passenger/crew doors. The modification involves installing a new single recessed guide bushing with a threaded lubrication fitting. The service bulletin also specifies accomplishment of functional and operational tests after doing the modification. The DGAC classified this service bulletin as mandatory and issued French airworthiness directive 2001-100(B), dated March 21, 2001, to ensure the continued airworthiness of these airplanes in France.

These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept us informed of the situation described above. We have examined the findings of the DGAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, the proposed AD would supersede AD 98-01-12 to continue to require an inspection to detect moisture and migrated bushings of the guide fittings of the safety locking pins of the passenger doors, removal of any moisture, application of grease, and reinstallation of any migrated bushing. The proposed AD also would continue to require installation of a greasing nipple on the guide fitting of the locking pin and on three telescopic rods on the passenger doors. This action would add a requirement for modification of the upper guide fitting of the locking pin, and would expand the applicability in the existing AD. The actions would be required to be accomplished in accordance with the service bulletin described previously, except as discussed below.

The service bulletin and French airworthiness directive recommend doing the modification within 3 years after issuance of the service bulletin and French airworthiness directive, for Model A320 and A321 series airplanes on which Airbus Service Bulletin A320-52-1057 has been incorporated in service; and within 5 years after issuance of the service bulletin and French airworthiness directive, for Model A319, A320, and A321 series airplanes on which Airbus Modification 24389 was done in production. This proposed AD would require that the modification for those airplanes be done within 1 year and 3 years, respectively, after the effective date of the AD. In developing an appropriate compliance time for this proposed AD, we have considered the degree of urgency associated with the subject unsafe condition, in addition to the fact that maintenance schedules vary among operators, depending on the average utilization of the affected fleet and the time necessary to perform the actions. In light of these factors, we find that this compliance time represents an appropriate interval of time for affected airplanes to continue to operate without compromising safety.

There are approximately 168 airplanes of U.S. registry that would be affected by this proposed AD.

The actions that are currently required by AD 98-01-12 take about 4 work hours per airplane (1 work hour per door) to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the currently required actions is estimated to be $260 per airplane.

The new modification that is proposed in this AD action would take about 8 work hours per airplane (2 work hours per door) to accomplish, at an average labor rate of $65 per work hour. Required parts costs would be minimal. Based on these figures, the cost impact of the proposed requirements of this AD on U.S. operators is estimated to be $87,360, or $520 per airplane.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations proposed herein 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. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that 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) if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES .

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this action may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification ( e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NM-273-AD.” The postcard will be date stamped and returned to the commenter.

Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2002-NM-273-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

The FAA has received reports indicating that H-11 steel bolts used to attach the forward cone bolt to the engine flange of Boeing Model 727 airplanes are susceptible to stress corrosion cracking, although no reports of related cracking have been received. Also, the cadmium-plated bolts that were also used in production are not sufficiently wear-resistant for the application. This condition, if not corrected, could compromise the primary load path of the engine support, which could result in separation of the engine from the airplane.

The FAA has reviewed and approved Boeing Alert Service Bulletin 727-71A0402, dated January 18, 2001, which describes procedures for inspecting the bolts that are used to attach the forward cone bolt to the engine flange to determine if H-11 steel bolts or cadmium-plated bolts are installed. The service bulletin also describes procedures for replacing H-11 steel bolts or cadmium-plated bolts with corrosion-resistant steel bolts. Accomplishment of the actions specified in the service bulletin is intended to adequately address the identified unsafe condition.

Since an unsafe condition has been identified that is likely to exist or develop on other products of this same type design, the proposed AD would require accomplishment of the actions specified in the service bulletin described previously, except as discussed below.

Operators should note that, although Boeing Alert Service Bulletin 727-71A040s, dated January 18, 2001, recommends that the affected bolts be inspected and replaced at the next convenient scheduled maintenance period not to exceed 3,000 flight cycles, this proposal would require that the affected bolts be inspected and replaced within 18 months or 3,000 flight cycles from the effective date of this AD, whichever is earlier.

There are approximately 1,148 Model 727 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 715 airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 3 work hours per airplane to accomplish the proposed inspection, and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of the proposed AD on U.S. operators is estimated to be $139,425, or $195 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this proposed AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations proposed herein 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. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that 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) if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this action may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification ( e.g. , reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NM-219-AD.” The postcard will be date stamped and returned to the commenter.

Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2002-NM-219-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to add an airworthiness directive (AD), applicable to all Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, was published as a notice of proposed rulemaking (NPRM) in the Federal Register on March 4, 2003 (68 FR 10188). That NPRM (the “original NPRM”) proposed to supersede AD 2002-22-05, amendment 39-12929 (67 FR 66316, October 31, 2002), which is applicable to all Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. That proposal would have continued to require repetitive inspections to find cracks, fractures, or corrosion of each carriage spindle of the left and right outboard mid-flaps; and corrective action, if necessary. That NPRM also proposed to mandate the previously optional overhaul or replacement of the carriage spindles, which would end the repetitive inspections required by the existing AD. Fractures of the carriage spindles on an outboard mid-flap could result in severe flap asymmetry and consequent reduced control or loss of controllability of the airplane.

Due consideration has been given to the comments received in response to the original NPRM. Some of the comments have resulted in changes to the original NPRM.

One commenter, the manufacturer, asks that the maximum thickness of the nickel plating, as specified in paragraph (d)(2) of the original NPRM, be changed. The commenter provides substantiating data which show that, since the rate of plating is directly related to the rate of hydrogen generation in the plating process, limiting the deposition rate more efficiently minimizes hydrogen generation during plating and reduces the potential for hydrogen embrittlement of the part. The commenter asks that paragraph (d)(2) be changed to read, “After initial application of the plating current and during the plating process, the rate of plating deposit must be maintained between .001-inch-per-hour and a maximum of .002-inch-per-hour.”

The FAA partially agrees with the commenter. The material and configuration of the outboard flap carriage are such that there is increased concern for hydrogen embrittlement in the large diameter of the spindle region. After reviewing the service experience and finding no other existing related requirements, the FAA finds it necessary to include the plating requirements in this AD. Controlling the deposition rate is a direct method of controlling the quality of the plate and generation of hydrogen during the plating process. The absorption and diffusion of hydrogen into the metal during the plating process leads to a condition known as “hydrogen embrittlement.” Metals affected by hydrogen embrittlement have reduced ductility and may prematurely fail during normal usage due to this condition. The original requirement of 0.020-inch-per-plating/baking cycle did not control the deposition rate, and there were wide variations. High deposition rates produce high rates of hydrogen and poor-quality grain structure. The key parameter of 0.002-inch-per-hour maximum deposition rate (which is a more stringent requirement) provides a safeguard against high deposition rates. There is no significant detrimental effect from low deposition rates, so the minimum requirement requested will not be included. Therefore, we have changed paragraph (d)(2) of this supplemental NPRM to read, “The maximum thickness of the nickel plating that is deposited in any one plating/baking cycle must not exceed 0.002-inch-per-hour.”

One commenter asks that the nickel plating requirement specified in paragraph (d)(2) of the original NPRM be removed. The commenter states that if it performs the nickel plating per the new requirement, it must perform a minimum of three plating/baking cycles, which would extend the time necessary for overhaul of the carriage spindle by 15 days. The commenter suggests two alternative methods to use in place of the current proposed requirement, and provides documentation showing those methods.

We do not concur that the nickel plating requirement should be removed. However, as explained under “Request to Change Maximum Thickness of Nickel Plating,” we have changed paragraph (d)(2) of this supplemental NPRM to read, “The maximum deposition rate of the nickel plating that is deposited in any one plating/baking cycle must not exceed 0.002-inch-per-hour.” No other change to the supplemental NPRM is necessary in this regard.

Several commenters request that the compliance time for the overhaul or replacement specified in paragraphs (c), (c)(1), and (c)(2) of the original NPRM be extended as follows:

• One commenter states that the proposed compliance time of 1 year after the effective date of the AD to replace the carriage spindles on Model 737-200C series airplanes is restrictive. The commenter asks that it be changed, due to inspection results, from “1 year after the effective date of this AD” to 24 to 36 months after the effective date, to allow time for procurement/overhaul of the spindles and to schedule the airplane during a heavy maintenance check. The commenter also states that the proposed compliance time of 2 years after the effective date of the AD to replace the spindles on Model 737-400 series airplanes is also restrictive. The commenter asks that the compliance time be changed, due to inspection results, to 36 to 48 months after the effective date, to allow time for procurement/overhaul of spindles and to schedule the airplane during a heavy maintenance check.

• One commenter asks that carriage spindles that were overhauled per Boeing 737 Component Maintenance Manual 57-53-36 before the effective date of AD 2002-22-05, and have not had all finishes and plating removed, be allowed to remain in service on the airplane for 8 years or 12,000 flight cycles, whichever comes later. The commenter adds that it has found no fractured carriage spindles to date. The commenter also asks that we allow 30 months instead of 24 months to overhaul or replace with new, any in-service carriage spindles that have not been overhauled per the referenced service bulletin. The commenter states that this would allow scheduling of the replacement of the carriage spindle during the current maintenance program without undue burden to its in-service operations.

• One commenter states that it currently has 52 Model 737-200 and 26 Model 737-300 series airplanes that would be affected by the original NPRM and has insufficient data for identifying the date each carriage spindle was overhauled or replaced during heavy maintenance visits. The commenter adds that, due to this fact, it would be forced to overhaul/replace the carriage spindles at the earliest time allowed, which is within 1 year for Model 737-200 series airplanes and 2 years for Model 737-300 series airplanes. The commenter notes that the manufacturer is unable to supply new carriage spindles to operators at a rate that would allow the replacement to be done within the time allotted. For Model 737-300 series airplanes, the manufacturer is producing about two carriage spindles per month, and overhaul of the part using an outside vendor takes approximately 3-4 weeks per airplane. With this turnaround time, the commenter would be unable to overhaul the parts in the timeframe required by the original NPRM. The commenter makes no specific request. We infer that the commenter is requesting that the compliance time be extended.

• One commenter asks that the compliance time for the initial overhaul specified in paragraph (c) of the original NPRM be extended to 2.5 years. The commenter states that, in order to install overhauled carriages on an aircraft, the flaps must be removed and reinstalled. The commenter adds that it performs a one-quarter D-check every 2.5 years, and this structural visit is the opportune time to perform such extensive maintenance.

• One commenter asks that the initial compliance times for the overhaul on Model 737-100/200 series airplanes and 737-300/400/500 series airplanes be extended to at least 3 years and 4 years, respectively, for the following reasons:

First, the compliance time for the initial inspection does not appear to account for the nondestructive test (NDT) inspection referenced in both the service bulletin and the existing AD. The commenter adds that the inspection in the referenced service bulletin is effective as an interim action in maintaining airplane safety, which indicates there are no urgent reasons to adhere to the short compliance time specified in the service bulletin for the spindle overhaul/replacement.

Second, the carriage spindle overhaul requirement means, in the commenter's case, that the spindle will have to be shipped off-site, which would require additional spares support. The short initial compliance timeframe creates a surge in demand for spares during the first 1 to 2 years. After that time, all additional spares acquired by the operators would sit on the shelf because that demand would go away for the remainder of the 8-year period until the next overhaul.

Third, due to the short initial compliance time, operators will have to remove the flaps outside the regularly scheduled maintenance visits to gain access. According to the procedures in the Boeing 737-300/-400/-500 Maintenance Planning Document D6-38278, the commenter estimates that the initial compliance time should be between 6 and 8 years for Model 737-300, -400, and -500 series airplanes, and between 6 and 10 years for Model 737-100 and -200 series airplanes.

In conclusion, the commenter states that, with immediate safety concerns already addressed in paragraph (a) of the original NPRM, increasing the compliance time specified in paragraph (c) of the original NPRM would allow accomplishment of the actions at regular maintenance intervals and would avoid a sudden demand for spares.

• One commenter asks that the compliance time specified in paragraph (c)(2)(ii) of the original NPRM (for the spindle overhaul/replacement) be changed to read, “Not later than the next major maintenance (D-check), and, until that time, repeat the NDT inspection of the spindles per the existing AD.” The commenter states that airplanes that have accumulated more than 12,000 total flight cycles, and exceeded the 8-year limitation, will be subject to the proposed 2-year compliance time. The commenter adds that, since no seed units have been provided by Boeing, procurement of the spindle is expensive, and the turnaround time is expected to be 20 days, there is no reason to ground the airplane and send the spindle for overhaul without having any spares.

• One commenter states that it will take about a year to obtain parts after ordering them, and the overhaul cannot be completed until the parts are received. The commenter states that it will be impossible to overhaul/replace the flap carriage within the proposed 2-year compliance time.

• One commenter asks for a change in the compliance time specified in paragraph (c) of the original NPRM from 12,000 flight cycles or 8 years, whichever occurs first, to 20,000 flight cycles or 8 years in-service, whichever occurs first. The commenter states that the additional flight-cycle allowance would allow the work to be done at every other D-check where time and resources to overhaul/replace the spindles are available. The commenter requests that this change apply to both the original inspection and the overhaul/replacement requirements.

• One commenter asks that we evaluate the requirement to overhaul or replace the spindles every 12,000 flight cycles or 8 years, based on inspection results and parts replacement costs. The commenter adds that the repetitive inspection intervals required by paragraph (a) of the proposed AD should be extended from 180 days to 18 months, so the airplane can be scheduled for inspection during heavy maintenance check intervals.

• One commenter states that mandating the overhaul of the carriage spindles every 8 years or 12,000 flight cycles, whichever is sooner, will have a significant cost impact on its fleet. The commenter adds that, under the current maintenance program, the carriage spindles are overhauled every 8 years, which, at current flying rates, equates to about 18,000 flight cycles. Therefore, a 12,000-flight-cycle compliance time would require overhaul at every heavy maintenance check, thereby doubling the overhaul cost. The commenter proposes that the carriage spindles remain in service until the 8-year limit is reached, provided the 180-day repetitive inspections are reinstated once the airplane reaches 12,000 flight cycles. The commenter states that this would provide an equivalent level of safety and give operators a significant cost benefit.

We agree to extend the initial compliance time somewhat. In revising this compliance time, we considered the safety implications, parts availability, and typical maintenance schedules of affected operators. In addition, the repetitive NDT inspections required by the existing AD, and restated in paragraph (a) of this supplemental NPRM, will allow operators more time to schedule maintenance and ensure safety in the interim until accomplishment of the overhaul or replacement. We have extended the compliance time specified in paragraphs (c)(1)(i) and (c)(1)(ii) of this supplemental NPRM to the later of the following: “Before the accumulation of 20,000 total flight cycles on the carriage spindle, or within 8 years since overhaul of the spindle or installation of a new spindle, whichever is first,” or “Within 2 years after the effective date of this AD.” We have extended the compliance time specified in paragraphs (c)(2)(i) and (c)(2)(ii) of this supplemental NPRM to the later of the following: “Before the accumulation of 20,000 total flight cycles on the carriage spindle, or within 8 years since overhaul of the spindle or installation of a new spindle, whichever is first,” or “Within 4 years after the effective date of this AD.” We have also extended the compliance time in paragraph (c) of this supplemental NPRM for the repetitive overhaul or replacement to every 20,000 flight cycles or 8 years, whichever is first. Extending the compliance time will not adversely affect safety but will accommodate the time necessary for the operators to obtain replacement parts and schedule the work.

We do not agree to extend the repetitive inspection intervals required by paragraph (a) of the supplemental NPRM; those inspections end when the overhaul or replacement specified in paragraph (c) of this supplemental NPRM is done. In developing an appropriate compliance time for the repetitive inspections, we considered not only the degree of urgency associated with addressing the subject unsafe condition, but the manufacturer's recommendation as to an appropriate compliance time, and the practical aspect of accomplishing the repetitive inspections within an interval of time that parallels normal scheduled maintenance for the majority of affected operators. No change to the supplemental NPRM is necessary in this regard.

One commenter contends that corrosion associated with the identified unsafe condition is a function of time rather than flight cycles. We infer that the commenter requests that the original NPRM be revised to reflect a compliance time for the spindle overhaul/replacement in terms of calendar time rather than flight cycles. We do not agree to use a calendar date in the AD because the compliance time in this case is a function of fleet utilization, which is unrelated to calendar dates. No change to the supplemental NPRM is necessary in this regard.

One commenter asks that the carriage spindles overhauled before issuance of AD 2002-22-05 (no finish/plating required) remain in service for 8 years or 12,000 flight cycles, whichever comes first. The commenter has been proactive on this issue, and started carriage spindle overhauls prior to the effective date of the original NPRM. The commenter adds that no fractured carriage spindles have been found to date.

We do not agree with the commenter. Although we acknowledge the fact that the commenter has not had any carriage spindle failures and maintains a good track record for diligent completion of AD requirements, many operators have been working to overhaul their fleets before the release of the AD in order to minimize the impact on the fleet. In light of the fact that the finish/plating removal was not required before issuance of AD 2002-22-05, carriage spindles that were overhauled before issuance of that AD may not have had the finishes/platings removed, and would not be compliant with that AD. Therefore, no change to the supplemental NPRM is necessary in this regard.

Two commenters ask that the original NPRM be revised to accept certain AMOCs previously approved for AD 2002-22-05. One commenter states that the original NPRM does not have a provision for such AMOCs, and asks that a paragraph be added for previously approved AMOCs for paragraphs (a) and (b) of the original NPRM. The commenter recognizes that it would not be able to use previously approved AMOCs after paragraph (c) of the supplemental NPRM is accomplished. Another commenter asks that we allow for optional tracking of the carriage part and serial number instead of the aircraft serial number to demonstrate compliance. The commenter states that it currently has an AMOC approved for AD 2002-22-05 that addresses this situation.

We agree with the commenters' requests to accept certain AMOCs approved previously for AD 2002-22-05. We have added a new paragraph (f)(2) to this supplemental NPRM to include AMOCs previously approved for AD 2002-22-05. Regarding optional tracking of the carriage part and serial number instead of the airplane serial number, the commenter may submit substantiating data that support a request for an AMOC for this proposed AD per paragraph (f)(1) of this proposed AD.

One commenter states that paragraph (d) of the original NPRM describes two constraints on the overhaul process. The commenter notes that paragraph (d)(1) of the original NPRM specifies the maximum time allowed before carrying out the hydrogen embrittlement procedure, and paragraph (d)(2) of the original NPRM defines the maximum thickness of nickel plating that can be done at any one plating/baking cycle. The commenter adds that the Boeing Standard Operating Procedures Manual for nickel plating includes the requirements specified in paragraph (d)(1), but the maximum plating requirements specified in paragraph (d)(2) are not included in the Boeing Component Maintenance Manual (CMM) 57-53-56, so compliance cannot be assumed by following the procedures in the CMM. The commenter is concerned that if these elements are required in an AD, there is a possibility that a flap carriage may be overhauled without reference to the AD, and subsequently, since there is no mechanism to prevent it, passed back to the operator without evidence of compliance with requirements. The commenter suggests that, if the relevant amendments are not placed in the CMM (against which the overhaul is to be performed before the effective date of the AD), a component AD against the flap carriage assemblies should be issued to ensure that the overhaul requirements are both complied with and certified as such before the assemblies are passed on to an operator. The commenter adds that the magnetic particle inspection addresses only the carriage, not the carriage spindle.

We do not agree with the commenter. Overhaul manuals are not FAA-approved documents. Updating these manuals is done by the original equipment manufacturer for the benefit of the operators. When an unsafe condition exists, we issue an AD to correct that condition, and, if additional safeguards are required as part of the mandated action, those safeguards are included in the text of the AD, unless mandated in other rulemaking actions. Ultimately, it is the responsibility of the operator to ensure compliance with any ADs that affect the operator's fleet. No change to the supplemental NPRM is necessary in this regard.

One commenter asks that the current inspections that would be required by paragraph (a) of the original NPRM be removed or changed as they are ineffective for finding cracks. The commenter states that it performed the inspections and, approximately 10 days later, a carriage spindle severed during flight. The commenter does not see any benefit in performing the current inspections.

We do not agree with the commenter. The inspections mandated by AD 2002-22-05 are designed to find a fully failed spindle before the second spindle fails due to load redistribution from the failed spindle. AD 2002-22-05 is required to safeguard against a dual-spindle failure. Further, the carriage spindle is manufactured from high strength steel, which is a material not generally conducive to damage tolerance methods. No change to the supplemental NPRM is necessary in this regard.

One commenter asks that paragraph (c) of the original NPRM, which requires repetitive overhaul of the carriage spindles every 12,000 flight cycles or 8 years, whichever is first, be incorporated into an Operator's Time Limit Index (Hard Time Component Program). The commenter states that this can be done by adding the following statement to paragraph (c): “Operators may incorporate the overhaul requirement into the FAA-approved maintenance program if the Principal Maintenance Inspector (PMI) approves that action.” The commenter adds that this would allow the PMI to approve the action, when appropriate, without a concern that it violates the Code of Federal Regulations.

We do not agree with the commenter. To include the overhaul of this part in a particular overhaul program would be an operations-dependent procedure and cannot be done as a general option. The commenter provides no data to substantiate that its request would provide an acceptable level of safety. However, an affected operator may request approval of an AMOC, as provided by paragraph (f)(1) of this AD, if data are submitted to support that an alternative method would provide an acceptable level of safety. No change to the supplemental NPRM is necessary in this regard.

Two commenters ask the Cost Impact section of the original NPRM be changed, as follows:

• One commenter states that the estimated cost of the replacement of the carriage spindle ($45,000 per spindle, and $10,000 per spindle for the overhaul) does not include the out-of-service time and work hours necessary.

• One commenter states that the “short” initial compliance time would require operators to remove flaps outside their routine maintenance program, which would take an additional 192 work hours per airplane. The commenter estimates the additional labor cost at over $500,000. The commenter adds that the overhaul of the carriage spindle will require additional spare carriage spindles over the short initial compliance timeframe. Based on an overhaul turnaround time of 30 days, the commenter estimates it would need up to six shipments of spare carriage spindles at a cost of approximately $1.2 million. All these spares would then not be used for the remainder of the 8-year period until the next overhaul. In addition, the commenter notes that the cost for overhauling the carriage spindle is almost $100,000, based on the cost estimate per airplane provided in the original NPRM.

We do not agree with the commenters. The cost impact information describes only the costs of the specific actions required by this AD. The number of work hours necessary to accomplish the overhaul or replacement, as specified in the cost impact information, is consistent with the service bulletin. This number represents the time necessary to perform only the actions actually required by this AD. We recognize that, in accomplishing the requirements of any AD, operators may incur additional costs due to special circumstances when scheduling maintenance visits. However, because maintenance schedules vary significantly from operator to operator, the hours necessary for access and close-up time, including out-of-service time, are almost impossible to calculate. No change to the supplemental NPRM is necessary in this regard.

Since certain changes described previously expand the scope of the original NPRM, the FAA has determined that it is necessary to reopen the comment period to provide additional opportunity for public comment.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. This regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance (AMOCs). Because we have now included this material in part 39, only the office authorized to approve AMOCs is identified in each individual AD.

We have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.

There are approximately 3,132 airplanes of the affected design in the worldwide fleet. The FAA estimates that 1,384 airplanes of U.S. registry would be affected by this proposed AD.

The inspections that are currently required by AD 2002-22-05 take approximately 10 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the currently required inspections on U.S. operators is estimated to be $899,600, or $650 per airplane.

It would take approximately 2 work hours per airplane to accomplish the new detailed inspection, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the inspection proposed by this AD on U.S. operators is estimated to be $179,920, or $130 per airplane, per inspection cycle.

Should an operator be required to accomplish the overhaul, it would take approximately 32 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the overhaul proposed by this AD is estimated to be $2,080 per airplane.

Should an operator be required to accomplish the replacement, it would take approximately 32 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts would cost approximately $45,000 per carriage spindle. Based on these figures, the cost impact of the replacement proposed by this AD is estimated to be $47,080 per spindle, per airplane.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations proposed herein 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. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that 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) if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this action may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification ( e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NM-225-AD.” The postcard will be date stamped and returned to the commenter.

Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2002-NM-225-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

The FAA has received reports indicating that the roll trim tab on certain Raytheon Model Beech 400A and 400T series airplanes operated to a fully deflected position while the other trim tab remained in neutral. This condition can be caused by premature failure of the relays used on the existing printed circuit board (PCB), which may stick intermittently in either the open or closed position. In most of the cases reported, the autopilot was engaged. In some instances, the flightcrew is alerted to this condition by the illumination of a yellow, boxed letter “A” annunciator on the primary flight display (PFD) and/or slow rotation of the control wheel away from the neutral position. The annunciator on the PFD indicates the spoiler servo torque load is high and may indicate an out-of-trim condition.

Reports indicate that flightcrew action is to disengage the autopilot and attempt to manually retrim the fully deflected roll trim tab. The flightcrews have reported to the manufacturer that this method has proven to be ineffective in some cases due to no movement from the deflected trim tab or no movement from the opposite trim tab. Recently, one crew reported that both trim tabs became fully deflected in opposite directions when the flightcrew attempted to trim one of the tabs from the neutral position. The resultant condition required high spoiler surface deflection angles to compensate for the out-of-trim condition while at cruise.

Intermittent sticking of the relays on the PCB in either the open or closed position could result in the roll trim tab operating to a fully deflected position while the other trim tab remained in neutral, which could result in an out-of-trim condition that could require using considerable control wheel force to keep the wings level, and consequent reduced controllability of the airplane.

The FAA has reviewed and approved Raytheon Service Bulletin SB 27-3464, dated December 2001, which describes procedures for an inspection to determine the part number of the A194 roll trim PCB, and replacement of certain PCBs with improved parts that have demonstrated longer operational capability. Accomplishment of the actions specified in the service bulletin is intended to adequately address the identified unsafe condition.

Since an unsafe condition has been identified that is likely to exist or develop on other products of this same type design, the proposed AD would require accomplishment of the actions specified in the service bulletin described previously, except as discussed below.

The service bulletin specifies that the appropriate part number for the replacement PCB is 128-364122-7; however, this AD allows installation of replacement PCBs having part number 128-364122-7 or higher ( i.e., 128-364122-9, -11, etc.).

There are approximately 467 airplanes of the affected design in the worldwide fleet. The FAA estimates that 430 airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 1 work hour per airplane to accomplish the proposed inspection, and that the average labor rate is $65 per work hour. Based on these figures, the cost impact of the proposed AD on U.S. operators is estimated to be $27,950, or $65 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this proposed AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations proposed herein 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. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that 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) if promulgated, 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. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES .

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

NHTSA has two brake standards for medium and heavy vehicles. Federal Motor Vehicle Safety Standard (FMVSS) No. 105, Hydraulic and electric brake systems, applies to vehicles with hydraulic brakes. FMVSS No. 121, Air brake systems, applies to vehicles with air brakes.

FMVSS No. 105 and 121 have similar brake performance requirements, but the two standards differ with respect to their specifications concerning the use of a roll bar during these tests. Roll bars are sometimes added to vehicles for brake testing if there are concerns about a possible vehicle rollover.

Air braked vehicles—roll bar use in braking-in-a-curve test. On March 10, 1995, NHTSA published a final rule amending FMVSS No. 121 requiring all air braked vehicles to be equipped with antilock brake systems (ABS) (60 FR 13216). The amendments to FMVSS No. 121 included a braking-in-a-curve performance test for truck tractors. Due to concern of potential vehicle rollover, the agency also included a manufacturer's option for using a roll bar structure during performance of that test at lightly loaded vehicle weight (LLVW). Loading of a vehicle to test at the gross vehicle weight rating (GVWR) already afforded manufacturers the opportunity to use a roll bar structure.

Air braked vehicles—roll bar use in straight line stop and parking brake grade holding tests. In response to a petition from the Truck Manufacturers Association, we published a final rule correcting and clarifying the air brake standard (66 FR 64154; December 12, 2001). The December 2001 final rule permitted the use of a roll bar structure for vehicles tested at lightly loaded vehicle weight in certain FMVSS No. 121 tests, including the 60 mph straight-line stop and the parking brake grade holding tests. In extending the option for using a roll bar structure to these tests, we determined that the roll bar option is equally appropriate for tractors as well as single-unit vehicles.

Hydraulic braked vehicles—roll bar use in braking-in-a-curve test. On August 11, 2003, NHTSA published a final rule for braking-in-a-curve test requirements for ABS equipped single-unit trucks and buses with a GVWR greater than 10,000 pounds (68 FR 47485). Again, the concerns regarding possible rollover led NHTSA to grant manufacturers the option to use a roll bar structure for single-unit trucks and buses undergoing the braking-in-a-curve test under FMVSS No. 105.

In this document, we are proposing to amend FMVSS No. 105 to give manufacturers the option of using a roll bar structure for medium and heavy vehicles during additional brake testing at lightly loaded vehicle weight. Performance testing of brake systems at LLVW on vehicles with a GVWR greater than 10,000 pounds may result in vehicle rollover because of the configuration of these vehicles. Trucks and buses with a GVWR greater than 10,000 pounds often have a high center of gravity resulting in a low rollover threshold. Rollover threshold is the lateral acceleration at which a vehicle will roll over and for trucks and buses with a GVWR greater than 10,000 pounds it is usually 0.5 g or less. In contrast, a typical light vehicle has a rollover threshold between 0.8 g and 1.2 g. For tests performed at GVWR, manufacturers can already include roll bar structure weight in the vehicle weight to provide test drivers and technicians additional safety. This proposal would permit, at manufacturer's option, the use of a roll bar structure on these vehicles undergoing testing at LLVW.

Hydraulically-braked vehicles with a GVWR greater than 10,000 pounds must meet the requirements of FMVSS No. 105, including 60 mph straight-line stopping distance requirements and, for heavy school buses, parking brake requirements. During straight line stop testing, an equipment malfunction or a problem with the ABS can create the potential for these trucks and buses to yaw. Because of the low rollover threshold, these vehicles may roll over if they experience yaw at test speeds. During the parking brake test, while the vehicle is in the forward direction on a 20 percent grade, a failure of the brake system on one side of the vehicle can also cause the vehicle to yaw and perhaps roll over.

Currently, heavy school buses are the only vehicles with a GVWR greater than 10,000 pounds required by FMVSS No. 105 to meet the parking brake requirements. However, the agency has requested comments on a proposal that would require all hydraulically braked vehicles with a GVWR greater than 10,000 pounds to have parking brakes that meet these same requirements (67 FR 66098).

The agency also notes that single-unit trucks with a GVWR greater than 10,000 pounds may undergo brake system testing either as completed trucks or as chassis-cabs without bodies or equipment that would normally be installed by a final-stage manufacturer. A completed vehicle is likely to have more structure to protect a test driver than an incomplete vehicle. If a completed truck were to roll over, the impact force would be distributed across the body and cab of the truck. In the absence of a body or additional equipment during testing of a chassis-cab, the vehicle cab would receive a greater impact force during a rollover, increasing the potential of harm to the driver. Permitting the use of a roll bar would allow manufacturers to provide additional protection for the test driver in the event of a rollover.

The same concerns for vehicle rollover present in testing for FMVSS No. 121 are present in testing for FMVSS No. 105. Under FMVSS No. 121, NHTSA gives manufacturers the option of using a roll bar structure on trucks and buses tested at LLVW to improve safety for test drivers and technicians. This proposed amendment would permit the use of a roll bar structure on any vehicle with a GVWR greater than 10,000 pounds during FMVSS No. 105 compliance testing of the parking brake system at LLVW, the service brake system at LLVW, and the service brake system in partial failure mode at LLVW.

The amendments proposed here do not impose any new requirements. Instead, the agency proposal would simply allow manufacturers the option of a roll bar as an added safety measure during the specified compliance tests. Since these proposed amendments would relieve a restriction and promote safety for test drivers, NHTSA proposes that they become effective 30 days after publication of the final rule in the Federal Register .

Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), provides for making determinations whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and to the requirements of the Executive Order. The Order defines a “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budget impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

This rulemaking document was not reviewed by the Office of Management and Budget under E.O. 12866. It is also not considered to be significant under the Department's Regulatory Policies and Procedures (44 FR 11034; February 26, 1979).

This document proposes to amend 49 CFR 571.105 by including a manufacturer's option for the use of a roll bar structure during the performance testing of hydraulic brake systems. The proposed amendment would allow at manufacturer's option the use of a roll bar structure when testing hydraulic braked vehicles with a GVWR greater than 10,000 pounds at lightly loaded vehicle weight. Because of the configuration of these vehicles they are susceptible to roll over during testing. We tentatively conclude that permitting the use of a roll bar structure would help protect drivers and technicians in the event of a rollover during these tests. As noted above, the amendments proposed here do not impose any new requirements. Instead, the agency proposal would simply allow manufacturers the option of a roll bar as an added safety measure during the specified compliance tests. The proposal's impacts are so small that a full regulatory evaluation was not prepared.

In compliance with the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. , NHTSA has evaluated the effects of this proposed action on small entities. I hereby certify that this notice of proposed rulemaking would not have a significant impact on a substantial number of small entities.

The following is the agency's statement providing the factual basis for the certification (5 U.S.C. 605(b)). The amendments proposed herein would primarily affect manufacturers of medium and heavy weight trucks. The Small Business Administration (SBA) regulation at 13 CFR part 121 organizes size standards according to the Standard Industrial Classification (SIC) codes. SIC code number 3711, Motor Vehicles and Passenger Car Bodies, prescribes a small business size standard of 1,000 or fewer employees. SIC codes No. 3714, Motor Vehicle Part and Accessories, prescribes a small business size standard of 750 or fewer employees.

Most of the intermediate and final stage manufacturers of vehicles built in two or more stages have 1,000 or fewer employees. However, the agency expects testing for FMVSS No. 105 to be conducted by the original equipment manufacturers, most, if not all, of which do not qualify as a small business under SBA guidelines. Further, if adopted, the proposed amendments would not require use of the roll bar structure and therefore would not require any increased costs or other burdens on truck manufacturers. The proposed amendments to FMVSS No. 105 would permit the use of a roll bar structure at the manufacturer's option, on test vehicles undergoing brake testing. Accordingly, there would be no significant impact on small businesses, small organizations, or small governmental units by these amendments. For these reasons, the agency has not prepared a preliminary regulatory flexibility analysis.

NHTSA has analyzed this proposed rule in accordance with the principles and criteria set forth in Executive Order 13132, Federalism and has determined that this proposal does not have sufficient Federal implications to warrant consultation with State and local officials or the preparation of a Federalism summary impact statement. The proposal would not have any substantial impact on the States, or on the current Federal-State relationship, or on the current distribution of power and responsibilities among the various local officials.

NHTSA has analyzed this proposal for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this action would not have any significant impact on the quality of the human environment.

This proposed rule does not contain any collection of information requirements requiring review under the Paperwork Reduction Act of 1995 (Pub. L. 104-13).

Under the National Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104-113), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” Society of Automotive Engineers (SAE) Recommended Practice J1626 APR96, Braking, Stability, and Control Performance Test Procedures for Air-Brake-Equipped Truck Tractors, includes an option for using a roll bar structure for testing at LLVW. While the SAE practice applies to air braked trucks, the SAE tests performed at LLVW are similar to tests performed at LLVW under FMVSS No. 105. The proposed amendment would permit the use of a roll bar structure in a similar manner as the SAE recommended practice.

This proposal would not have any retroactive effect. Under 49 U.S.C. 21403, whenever a Federal motor vehicle safety standard is in effect, a State may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard, except to the extent that the state requirement imposes a higher level of performance and applies only to vehicles procured for the State's use. 49 U.S.C. 21461 sets forth a procedure for judicial review of final rules establishing, amending or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.

The Unfunded Mandates Reform Act of 1995 requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). This rulemaking would not result in expenditures by State, local or tribal governments, in the aggregate, or by the private sector in excess of $100 million annually.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

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

This proposed rule is not subject to the Executive Order because it is not economically significant as defined in E.O. 12866 and does not involve decisions based on environmental, health, or safety risks that disproportionately affect children. The proposed rule, if made final, would permit manufacturers to use a roll bar structure when testing medium and heavy hydraulic braked trucks and buses at LLVW.

Executive order 13211 (66 FR 28355, May 18, 2001) applies to any rule that: (1) Is determined to be economically significant as defined under E.O. 12866, and is likely to have a significant adverse effect on the supply of, distribution, or use of energy; or (2) that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. If made final, this rulemaking would permit the voluntary and limited use of a roll bar structure during brake testing. Therefore this proposal was not analyzed under E.O. 13211.

Executive Order 12866 and the President's memorandum of June 1, 1998, require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

• Have we organized the material to suit the public's needs?

• Are the requirements in the rule clearly stated?

• Does the rule contain technical language or jargon that isn't clear?

• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

• Would more (but shorter) sections be better?

• Could we improve clarity by adding tables, lists, or diagrams?

• What else could we do to make the rule easier to understand?

If you have any responses to these questions, please include them in your comments on this proposal.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc. ). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov.

Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments.

Your comments must not be more than 15 pages long (49 CFR 553.21). We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.

Please submit two copies of your comments, including the attachments, to Docket Management at the address given above under ADDRESSES. Comments may also be submitted to the docket electronically by logging onto the Dockets Management System Web site at http://dms.dot.gov. Click on “Help & Information” or “Help/Info” to obtain instructions for filing the document electronically. Please note, if you are submitting comments electronically as a PDF (Adobe) file, we ask that the documents submitted be scanned using Optical Character Recognition (OCR) process, thus allowing the agency to search and copy certain portions of your submissions. 1

If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.

If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, at the address given above under FOR FURTHER INFORMATION CONTACT. In addition, you should submit two copies, from which you have deleted the claimed confidential business information, to Docket Management at the address given above under ADDRESSES. When you send a comment containing information claimed to be confidential business information, you should include a cover letter setting forth the information specified in our confidential business information regulation (49 CFR part 512).

We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under DATES. To the extent possible, we will also consider comments that Docket Management receives after that date. If Docket Management receives a comment too late for us to consider it in developing a final rule (assuming that one is issued), we will consider that comment as an informal suggestion for future rulemaking action.

You may read the comments received by Docket Management at the address given above under ADDRESSES. The hours of the Docket are indicated above in the same location. You may also see the comments on the Internet. To read the comments on the Internet, take the following steps:

(1) Go to the Docket Management System (DMS) Web page of the Department of Transportation ( http://dms.dot.gov/ ).

(2) On that page, click on “search.”

(3) On the next page ( http://dms.dot.gov/search/ ), type in the four-digit docket number shown at the beginning of this document. Example: If the docket number were “NHTSA-1998-1234,” you would type “1234.” After typing the docket number, click on “search.”

(4) On the next page, which contains docket summary information for the docket you selected, click on the desired comments. You may download the comments. However, since the comments are imaged documents, instead of word processing documents, the downloaded comments are not word searchable.

Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc. ). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov.

In consideration of the foregoing, NHTSA proposes to amend 49 CFR part 571 as set forth below.

Toyota petitioned NHTSA to amend the ODB specifications contained in 49 CFR Part 587, for the purpose of harmonization with Economic Commission for Europe (ECE) regulation 96/79/EC, Frontal impact. The specifications for the ODB were published in a March 31, 2000, final rule as the first step towards using an ODB to evaluate the crashworthiness of vehicles (65 Federal Register 17196.) In its petition for reconsideration of the March 2000 final rule, Toyota claimed that the specified barrier height could allow the test vehicle to contact the rigid portion of the barrier, potentially affecting the results of the test. Toyota also argued that the differences in the specifications between Part 587 and the European standard were unduly burdensome on manufacturers performing compliance tests with the ODB.

In its petition for reconsideration, Toyota stated that the specifications in Part 587 allow the fixed rigid barrier portion of the ODB to be higher than the ECE barrier. Toyota argued that because of the height difference, as a vehicle crushes and rotates, it could contact the rigid portion of the barrier (the portions of the concrete block higher than the deformable barrier). The company claimed that this contact could affect the results of the test vehicle. Toyota stated that this possibility is especially true for sport utility vehicles (SUVs) and light trucks and vans (LTVs), which ride higher than passenger cars. Toyota petitioned for the minimum barrier height requirement to be harmonized with the ECE requirement.

Toyota also petitioned for an increase in the sample size of the aluminum honeycomb used to test the crush characteristics of the barrier, the removal of backing sheet material specifications, and a reduction in hole size for deformable face mounting. Toyota claimed that by harmonizing these specifications, separate test runs would not be required to meet the Part 587 and ECE specifications, reducing the burden on manufacturers.

Toyota expressed concern with the potential for contact between the rigid portions of the ODB and the vehicle being tested due to the barrier height specifications. Part 587.18(b) specifies that:

We acknowledge that the barrier height may affect the ODB results for SUVs and LTVs, as this was our intention in establishing this height specification in the March 2000 final rule. For larger, high-riding vehicles, the agency believes that it is important for the rigid barrier height to be sufficiently high to engage the full height of the vehicle's front structure. In testing high-riding LTVs with the ECE barrier in the ODB test configuration, the agency observed that LTVs tended to override the ECE barrier, thus transferring a larger amount of crash energy through their lower load paths. The agency is concerned that this could lead LTV and SUV manufacturers to design unnecessarily stiff lower structures to mitigate intrusion in the ODB test. Stiffening the structure of an LTV or SUV in the region where they are likely to engage with a passenger car would be detrimental to improving vehicle-to-vehicle compatibility. While encouraging a lower load path in LTVs and SUVs would enhance vehicle compatibility through improved load path engagement with passenger cars, the omission of an upper load path for the upper rails during an offset test with the ECE barrier could force some manufacturers to design considerably stiffer lower LTV and SUV structures, negating any gains from aligning the load paths.

By allowing the upper rails of the SUVs and LTVs to engage the upper portion of the Part 587 barrier, manufacturers have more flexibility in designing their front ends to allow a better distribution of force across the full height of the vehicle front structure, thus improving compatibility. Furthermore, Toyota's request for harmonization alone is not sufficient justification to amend Part 587 since the U.S. and European vehicle fleets are very different. The population of SUVs in Europe is around 5 percent of the vehicle population. In contrast, LTVs and SUVs are approximately 50 percent of U.S. vehicle sales and constitute approximately 38 percent of U.S. registrations.

We are also rejecting Toyota's claim that differences in the sample size of the honeycomb used to test the crush characteristics of the barrier, material specifications for backing material, and hole size for deformable face mounting are unduly burdensome. The agency found no difference in the force versus displacement curves for the current sample thickness and the sample thickness proposed by Toyota. (See the test data in this docket.)

Further, Toyota states that the differences in backing material and hole size specifications have no influence on barrier performance. Part 587 does not require manufacturers to follow prescribed specifications. It merely states what specifications the agency will use when we run compliance tests. If differences in specifications have no influence on barrier performance, Toyota and other manufacturers are free to use the ECE specifications in compliance testing.

Conclusion: For the reasons stated above, the agency is denying Toyota's petition for reconsideration.

The snapper-grouper fishery off the southern Atlantic states is managed under the FMP. The FMP was prepared by the Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The Magnuson-Stevens Act requires a regional fishery management council to submit an amendment to a fishery management plan to NMFS for review, approval, disapproval, or partial approval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an amendment, publish a notice in the Federal Register stating that the amendment is available for public review and comment.

In Amendment 6 to the FMP the Council proposed prohibitions on fishing for South Atlantic snapper-grouper in what is currently known as the experimental closed area and on retaining such species in or from the area. NMFS approved these prohibitions, and they became effective June 27, 1994 (59 FR 27242, May 26, 1994). In the experimental closed area, any South Atlantic snapper-grouper taken incidentally by hook-and-line gear must be released immediately by cutting the line without removing the fish from the water.

The experimental closed area is slightly less than 92 square nautical miles in the EEZ offshore from Ft. Pierce to Sebastian Inlet, FL. The geographical coordinates are specified at 50 CFR 622.35(c)(2). The experimental closed area constitutes a portion of the southern part of the Oculina Bank HAPC. In the entire HAPC no person may: (1) use a bottom longline, bottom trawl, dredge, pot, or trap; (2) if aboard a fishing vessel, anchor, use an anchor and chain, or use a grapple and chain; or (3) fish for rock shrimp or possess rock shrimp in or from the area on board a fishing vessel.

The U.S. groundfish fisheries of the GOA in the exclusive economic zone (EEZ) are managed by NMFS under the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP). The FMP was prepared by the North Pacific Fishery Management Council (Council) under the Magnuson-Stevens Act and is implemented by regulations at 50 CFR part 679. General regulations that also pertain to U.S. fsheries appear at subpart H of 50 CFR part 600.

The boundary between GOA statistical and reporting areas 620 and 630 near Kodiak Island, Alaska, is 154°W. longitude from the south side of the Alaska Peninsula, southward to the limits of the EEZ off Alaska. On Kodiak Island, this line of longitude bisects Alitak/Deadman′s/Portage Bay complex, a large, deep bay on the south end of the island. Frequently, substantial pollock fishing takes place in this bay.

This division of the bay into two separate reporting areas is impractical for quota management and enforcement purposes. When either of the two areas is open to pollock fishing, and the other area is closed, vessels will fish in the bay on the “open” side of the line. The area of the Alitak/Deadman′s/Portage Bay complex of Kodiak Island would be much more efficiently enforced if the bay were either all open or all closed.

In addition, because the mouth of the bay is totally contained in area 620, the waters within the bay logically should be included in area 620.

This action revises the description of statistical and reporting areas 620 and 630 in Figure 3b by including all waters of the Alitak/Deadman′s/Portage Bay complex of Kodiak Island within area 620 and excluding all such waters from area 630.

At this time, NMFS has not determined whether the amendment that this proposed rule would implement is consistent with the national standards of the Magnuson-Stevens Act and other applicable laws. NMFS, in making that determination, will take into account the data, views, and comments received during the comment period.

This proposed rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866.

This proposed rule does not duplicate, overlap, or conflict with other Federal regulations.

NMFS prepared an IRFA that describes the impact this action may have on small entities. The need, justification, and economic impacts for the actions in this proposed rule, as well as impacts of the alternatives considered, were analyzed in the RIR/IRFA prepared for this action (see ADDRESSES ). A summary appears below.

The RIR/IRFA evaluates a regulatory amendment to consolidate all waters in the Alitak/Deadman′s/Portage Bay complex on southwestern Kodiak Island within Federal groundfish statistical and reporting area 620.

The current division of the bay complex between areas 620 and 630 means that different parts of the bay open and close on different schedules. Openings and closures in the lower part of the bay complex are driven by Area 620 openings and closures, while openings and closures in the upper part, including Deadman′s and Portage Bays, are driven by openings and closures in Area 630. The part of the bay in Area 620 has tended to be open more days per year in recent years.

Deadman′s Bay has deep water that is suitable for pollock mid-water trawling. The waters are relatively protected, and suitable for small vessels. The deep water in Area 620 is relatively constricted and dotted with pinnacles, making these waters less suitable for pollock fishing. This action would place the pollock grounds in Deadman′s Bay under the Area 620 openings and closing schedule, and should give fishermen more days of access to them in a typical year.

A Regulatory Impact Review was prepared to address the requirements of E.O. 12866 which requires an evaluation of the costs and benefits, and of the significance, of regulatory actions.

The proposed regulatory amendment will reduce fishing costs. Fishermen will have increased opportunities to fish in Deadman′s Bay in most years. The increase in the number of fishing days available in Deadman′s Bay will not be offset by reductions in fishing days anywhere else. Additional fishing days will increase the choices available to fishermen. This should not increase their costs, since they would not take advantage of the new opportunities if it did so. They will take advantage of the opportunities if these decrease their costs.

The amendment will have minor benefits for fisheries management. All of this area is currently surveyed as part of Area 620. Thus, it will be biologically appropriate to add Deadman′s and Portage Bays to Area 620. Moreover, this action will simplify the boundary between Areas 620 and 630 and make enforcement somewhat easier.

Since there are positive benefits, and no identifiable costs, this regulatory amendment is expected to have positive net benefits. This action is not expected to be significant under the criteria specified in E.O. 12866.

An IRFA was prepared to address the requirements of the Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Fairness Act of 1996 (50 CFR 603). The RFA requires an evaluation of the impact of certain Federal actions on small businesses, government jurisdictions, and non-profit organizations.

The directly regulated entities in this action are groundfish catcher vessels targeting pollock with pelagic trawls in Alitak and Deadman′s Bays. The number of vessels active in this fishery over the period from 1999 through 2002 ranged between 0 in 2000, and 30 in 1999. All of these are believed to have been small entities under the Small Business Administration (SBA) criteria NMFS uses to make these determinations for regulatory flexibility analyses. Average GOA trawl catcher vessel groundfish revenues were about $350,000 in 2001. Average ex-vessel revenues from targeted pollock trawling activity in the Alitak/Deadman′s/Portage Bay complex were about $15,000 in 1998, about $18,000 in 1999, nothing in 2000, and about $15,000 in 2001.

The analysis did not reveal any adverse economic impacts on the directly regulated small pelagic trawling operations. This analysis did not reveal any Federal rules that duplicate, overlap, or conflict with the proposed action.

This analysis did not identify any alternatives to the preferred action that accomplished the objectives of the Magnuson-Stevens Act and that were better for small entities. Two alternatives were identified: (1) the status quo and (2) the reassignment of waters in the upper bay complex from Area 630 to Area 620. The status quo alternative did not make any changes that would increase the flexibility or reduce the fishing costs of the small fishing operations active in the area, while alternative 2, by increasing fishing time in Deadman′s Bay in most years, did so. The status quo alternative neither meets the objectives of the proposed action nor increases the fishing opportunities available to fishermen. Alternative 2, the preferred alternative, does both.

This action does not impose new reporting, recordkeeping or other compliance requirements on regulated small entities.

This action does not have any adverse impacts on regulated small entities.

For reasons set out in the preamble, 50 CFR part 679 is proposed to be amended to read as follows:

1. The authority citation for part 679 continues to read as follows: