On July 8, 2003, we published in the Federal Register (68 FR 40541-40553, Docket No. 02-062-1) a proposed rule that would establish criteria to determine the Federal share of financial responsibility relative to States and other cooperators in an emergency in which an animal or plant pest or disease threatens the agricultural production of the United States.

Comments on the proposed rule were required to be received on or before September 8, 2003. We are extending the comment period for an additional 60 days. This action will allow interested persons additional time to prepare and submit comments.

This rule is issued under Marketing Agreement No. 98 and Marketing Order No. 945, both as amended (7 CFR part 945), regulating the handling of Irish potatoes grown in certain designated counties in Idaho, and Malheur County, Oregon, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, Idaho-Eastern Oregon potato handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as proposed herein would be applicable to all assessable potatoes beginning on August 1, 2003, and continue until amended, suspended, or terminated. This rule would not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule would increase the assessment rate established for the Committee for the 2003-04 and subsequent fiscal periods from $0.0026 to $0.0045 per hundredweight of potatoes handled.

Section 945.40 of the order provides authority for the Committee, with the approval of the Secretary, to incur reasonable expenses for its maintenance and functioning. Section 945.41 requires the Committee to formulate an annual budget estimating its income and expenditures for the upcoming fiscal year and to present such budget to the Secretary for approval. Section 945.42(a) authorizes the Committee to assess handlers for their pro rata share of such expenses and § 945.42(b) provides that the rate of assessment be set by the Secretary based on the recommendation of the Committee. The members of the Committee are producers and handlers of potatoes grown in Idaho and Eastern Oregon. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are therefore in a position to formulate an appropriate budget and assessment rate. The assessment rate was discussed in a public meeting before the Committee members voted to recommend an increase. Thus, all directly affected persons had an opportunity to participate and provide input.

For the 1996-97 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on June 16, 2003, and unanimously recommended 2003-04 expenditures of $149,417 and an assessment rate of $0.0026 per hundredweight of potatoes handled, the same rate currently in effect. The Committee estimated the 2003-04 potato shipments at 36,500,000 hundredweight, which would generate $94,900 in assessment revenue. At that meeting, the Committee discussed increasing the assessment rate to respond to rising Committee expenses, declining assessment revenue, and shrinking operating reserves. After discussion, the Committee postponed any action until later in the fiscal period, believing that assessment revenue and operating reserves were sufficient to maintain Committee operations through the fiscal period.

As a consequence, the Committee conducted a telephone vote on July 18, 2003, and unanimously recommended a revised budget of $145,317 (down from $149,417) and to raise the assessment rate to $0.0045 per hundredweight of potatoes handled (up from $0.0026). In comparison, last fiscal period's budgeted expenditures were $137,094. The recommended assessment rate is $0.0019 higher than the rate currently in effect. The increase is necessary to offset an increase in salaries and operating expenses, declining potato shipments, and the depletion of operating reserves.

The major expenditures recommended by the Committee for the 2003-04 fiscal period include $95,067 for salaries and benefits, $16,500 for transportation, $13,500 for travel, $6,800 for rent and utilities, and $4,800 for office expenses. Budgeted expenses for these items in 2002-2003 were $92,144, $9,000, $14,000, $6,300, and $6,500, respectively. The transportation budget item covers the purchase of a new Committee vehicle and all of the operating and maintenance costs associated with it. The manager uses a Committee vehicle for handler compliance visits throughout the season, and other authorized Committee activities. Travel covers the cost of travel, lodging, and meals for the Committee manager and members when attending Committee meetings and conventions involving Committee authorized business.

The Committee estimates potato shipments for the 2003-04 fiscal period at 36,500,000 hundredweight, which should provide $164,250 in assessment income at the proposed assessment rate. This income would be adequate to cover budgeted expenses. The Committee estimates that monetary reserves will be approximately $33,000 at the beginning of the 2003-04 fiscal period and will potentially increase to $51,933 by the fiscal period end. The order permits an operating reserve in an amount not to exceed approximately one fiscal period's budgeted expenses (§ 945.44). Funds held in reserve would be kept within the maximum permitted by the order.

The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2003-04 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 900 producers of potatoes in the production area and approximately 54 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $5,000,000.

Based on a three-year average fresh potato production of 35,448,000 hundredweight as calculated from Committee records, a three-year average of producer prices of $6.10 per hundredweight reported by the National Agricultural Statistics Service, and 900 Idaho-Eastern Oregon potato producers, the average annual producer revenue is approximately $240,259. It can be concluded, therefore, that most of these producers would be classified as small entities.

In addition, based on Committee records and 2002-03 f.o.b. shipping point prices ranging from $5.00 to $35.00 per hundredweight reported by USDA's Market News Service, many of the Idaho-Eastern Oregon potato handlers may ship over $5,000,000 worth of potatoes. In view of the foregoing, few of the handlers may be classified as small entities as defined by the SBA.

This rule would increase the assessment rate established for the Committee and collected from handlers for the 2003-04 and subsequent fiscal periods from $0.0026 to $0.0045 per hundredweight of potatoes handled. The Committee unanimously recommended 2003-04 expenditures of $145,317 and an assessment rate of $0.0045 per hundredweight. The proposed assessment rate is $0.0019 per hundredweight higher than the rate currently in effect. The quantity of assessable potatoes for the 2003-04 fiscal period is estimated to be 36,500,000 hundredweight. Income derived from handler assessments (approximately $164,250) would be adequate to cover budgeted expenses.

The major expenditures recommended by the Committee for the 2003-04 fiscal period include $95,067 for salaries and benefits, $16,500 for transportation, $13,500 for travel, $6,800 for rent and utilities, and $4,800 for office expenses. Budgeted expenses for these items in 2002-2003 were $92,144, $9,000, $14,000, $6,300, and $6,500, respectively.

The assessment rate increase is necessary to offset increases in salaries and operating expenses, declining potato shipments, and the depletion of operating reserves. The Committee estimates the reserve to be $33,000 at the 2002-03 fiscal period end. At the current rate of $0.0026 per hundredweight, on the estimated potato production of 36,500,000 hundredweight for the 2003-04 fiscal period, the projected income for the 2003-04 fiscal period would be $94,900. This amount, along with the projected reserve of $33,000, would be approximately $19,417 less than required to fund the proposed 2003-04 budget and $9,194 less than the 2002-03 budgeted amount. Thus, the Committee believes that the projected assessment income at the current assessment rate and funds held in reserve would not be sufficient to fund the Committee's operations without increasing the assessment rate.

At the recommended rate of $0.0045 per hundredweight (assessment income of $164,250) and expenditures of $145,317, the Committee may increase its reserve by up to $18,933. The projected reserve would be approximately $51,933 on July 31, 2004, which the Committee determined to be both appropriate and acceptable.

The Committee considered alternate levels of assessment but determined that increasing the assessment rate to $0.0045 per hundredweight would allow the Committee to adequately fund operations and replenish the reserve to an acceptable level. The Committee decided that any assessment rate between $0.0026 per hundredweight and $0.0045 per hundredweight would not be sufficient to accomplish the Committee's goals. Prior to arriving at the budget and assessment rate recommendations, the Committee considered information from various sources, including the Committee's Finance and Executive Committees.

A review of historical information and preliminary information pertaining to the upcoming fiscal period indicates that the producer price for the 2003-04 fiscal period could range between $4.50 and $6.00 per hundredweight of potatoes. Therefore, the estimated assessment revenue as a percentage of total producer revenue could range between 0.1 and 0.075 percent.

This action would increase the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, this cost would be offset by the benefits derived by the operation of the marketing order. In addition, the Committee's meeting was widely publicized throughout the Idaho-Eastern Oregon potato industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the June 16, 2003, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit information on the regulatory and informational impacts of this action on small businesses.

This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large production area commodity handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

A 15-day comment period is provided to allow interested persons to respond to this proposed rule. Fifteen days is deemed appropriate because: (1) The fiscal period is August 1 to July 31 and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable potatoes handled during such fiscal period; (2) handlers usually begin shipping Idaho-Eastern Oregon potatoes on or about August 1; (3) the Committee needs to have sufficient funds to pay its expenses which are incurred on a continuous basis; and (4) handlers are aware of this action which was unanimously recommended by the Committee and is similar to other assessment rate actions issued in past years.

For the reasons set forth in the preamble, 7 CFR part 945 is proposed to be amended as follows:

The regulations in 9 CFR part 93 govern the importation into the United States of specified animals and animal products in order to help prevent the introduction of various animal diseases into the United States. The regulations in part 93 require, among other things, that certain animals, as a condition of entry, be quarantined upon arrival in the United States. The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture operates animal quarantine facilities. We also authorize the use of quarantine facilities that are privately owned and operated for certain animal importations.

The regulations at subpart D of part 93 (9 CFR 93.400 through 93.435, and referred to below as the regulations) pertain to the importation of ruminants. Ruminants include all animals that chew the cud, such as cattle, buffaloes, sheep, goats, deer, antelopes, camels, llamas, and giraffes. Section 93.411 requires that ruminants imported into the United States be quarantined upon arrival for at least 30 days, with certain exceptions. Ruminants from Canada and Mexico are not subject to this quarantine requirement.

In § 93.412, paragraph (a) authorizes the establishment of privately operated quarantine facilities, subject to APHIS approval and oversight. Paragraph (a) provides, in part, that the “quarantine facility must be suitable for the quarantine of such ruminants and must be approved by the Administrator prior to the issuance of any import permit.” This paragraph also provides that APHIS will “supervise the quarantine” at such facilities.

Section 93.434 of the regulations contains standards for approval, operation, and APHIS oversight of privately operated quarantine facilities for sheep or goats. The standards covering quarantine facilities for sheep or goats were first implemented in 1988 (53 FR 21794-21809, Docket No. 88-057, published June 10, 1988), based on considerable interest at that time in importing large numbers of sheep into the United States from New Zealand. Since then, privately operated quarantine facilities have been used from time to time for the importation of sheep and goats into the United States.

APHIS has recently received requests from livestock importers who wish to import cattle into the United States through private quarantine facilities. Because there are no approved privately operated quarantine facilities for cattle in operation at the present time, imported cattle subject to quarantine must enter the United States through facilities maintained by APHIS.

Given the interest in establishing private quarantine facilities for cattle, we are proposing specific standards for the approval, operation, and APHIS oversight of such facilities. The requirements contained in this proposed rule are designed to ensure that the health of the U.S. livestock population is not jeopardized by the release of unhealthy animals or communicable disease agents from quarantine facilities. We would refer to these facilities as “privately owned” instead of “privately operated” to underscore that these facilities are privately owned, operated, and financed, but subject to APHIS approval and oversight.

For purposes of consistency, we are proposing that these standards apply not only to privately owned quarantine facilities for imported cattle, but also to privately owned facilities that wish to handle other imported ruminants. Therefore, we would remove from our regulations the existing standards applicable to privately operated quarantine facilities for sheep or goats.

In this time of shrinking Federal resources, we believe that it is appropriate to allow the establishment of privately owned quarantine facilities for ruminants so long as inspection and other activities related to the quarantine are subject to APHIS oversight and direction. We further believe that these facilities, if carefully regulated and monitored by APHIS, would provide an effective and efficient means of bringing ruminants into the United States without compromising our ability to protect against the introduction of communicable animal diseases. The full text of the proposed regulations appears in the rule portion of this document. Our discussion of the proposed provisions follows.

We are proposing to add to § 93.400 definitions for the terms area veterinarian in charge (AVIC), Federal veterinarian, lot, lot-holding area, nonquarantine area, Office International des Epizooties (OIE), operator, privately owned medium security quarantine facility (medium security facility), privately owned minimum security quarantine facility (minimum security facility), quarantine area, State veterinarian , and temporary inspection facility. We also would make several minor technical changes to the definitions of immediate slaughter and recognized slaughtering establishment.

The area veterinarian in charge (AVIC) would refer to the veterinary official of APHIS who is assigned by the Administrator to supervise and perform the official animal health work of APHIS in a particular State.

A Federal veterinarian would be defined as a veterinarian employed and authorized by the Federal Government to perform the tasks required by the regulations.

The term lot would be defined as a group of ruminants that, while held on a conveyance or premises, has opportunity for physical contact with each other or with each other's excrement or discharges at any time between arrival at the quarantine facility and 60 days prior to export to the United States. A lot-holding area would describe that area in a privately owned medium or minimum security quarantine facility in which a single lot of ruminants is held at one time.

The nonquarantine area would refer to that area of a privately owned medium or minimum security quarantine facility that includes offices, storage areas, and other areas outside the quarantine area, and that is off limits to ruminants, samples taken from ruminants, and any other objects or substances that have been in the quarantine area during the quarantine of ruminants.

The Office International des Epizooties (OIE) would refer to the international organization recognized by the World Trade Organization for setting animal health standards, reporting global animal situations and disease status, and presenting guidelines and recommendations on sanitary measures related to animal health.

We would define an operator as a person other than the Federal Government who owns or operates, subject to APHIS' approval and oversight, a privately owned medium or minimum security quarantine facility.

A privately owned medium security quarantine facility (medium security facility) would refer to a facility that:

• Is owned, operated, and financed by a person other than the Federal Government;

• Is subject to the strict oversight of APHIS representatives;

• Is constructed, operated, and maintained in accordance with the requirements for medium security facilities in § 93.412(d); and

• Provides the necessary level of quarantine services for the holding of ruminants in an indoor, vector-proof environment prior to the animals' entry into the United States. Quarantine services must include testing or observation for any OIE list A diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.

A privately owned minimum security quarantine facility (minimum security facility) would refer to a facility that:

• Is owned, operated, and financed by a person other than the Federal Government;

• Is subject to the strict oversight of APHIS representatives;

• Is constructed, operated, and maintained in accordance with the requirements for minimum security facilities in § 93.412(d);

• Is used for the quarantine of ruminants that pose no significant risk, as determined by the Administrator, of introducing or transmitting to the U.S. livestock population any livestock disease that is biologically transmissible by vectors; and

• Provides the necessary level of quarantine services for the outdoor holding of ruminants, prior to the animals' entry into the United States. Quarantine services must include testing or observation for any OIE list A diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary, to be determined by the Administrator.

The term quarantine area would refer to that area of a privately owned medium or minimum security quarantine facility that comprises all of the lot-holding areas in the facility and any other areas in the facility that ruminants have access to, including loading docks for receiving and releasing ruminants. The quarantine area also would include any areas in the facility that are used to conduct examinations of ruminants and take samples, as well as areas where samples are processed or examined.

A State veterinarian would be defined as a veterinarian employed and authorized by a State or political subdivision of a State to perform the tasks required by the regulations.

The term temporary inspection facility would refer to a facility owned, operated, and financed by a person other than the Federal Government that is located within 1 mile of the port of entry and used for the inspection of ruminants imported into the United States in accordance with § 93.408.

We are also proposing to make several minor technical changes to the footnotes that accompany the existing definitions of immediate slaughter and recognized slaughtering establishment by providing additional information on how to find the names and addresses of the area veterinarian in charge in any State. We also would make a minor change to the definition of immediate slaughter for stylistic purposes.

Section 93.403, paragraph (g), of the regulations provides that sheep to be quarantined at privately operated facilities may be entered into the United States at any air and ocean port designated for the importation of ruminants under § 93.403(a), as well as any other international port or airport so designated by the U.S. Customs Service (now the Bureau of Customs and Border Protection, U.S. Department of Homeland Security). This provision appears in the regulations to ensure that sheep are imported into the United States only at those ports at which appropriate Federal personnel are available to provide necessary services.

We are proposing to amend § 93.403(g), including the paragraph heading, so that it applies to all ruminants, not just sheep, and so that it refers to “privately owned quarantine facilities” instead of “privately operated quarantine facilities,” for consistency with the use of the term “privately owned quarantine facilities” in the proposed standards to appear in § 93.412(d). These changes would clarify near what ports operators could potentially build a privately owned quarantine facility for imported ruminants.

We would make several more technical changes to § 93.403(g). First, for purposes of clarity, we would amend the phrase “may be entered” in § 93.403(g) by substituting the word “imported” in place of “entered.” “Imported” means moved into the United States, whereas “entered” can mean released into the commerce of the United States, which does not occur until release from quarantine. We would change the reference to “U.S. Customs Service” to appear as “Bureau of Customs and Border Protection.” We also would remove the cross references to § 93.433 and § 93.434 that appear in § 93.403(g). Section 93.433 is currently reserved and contains no regulatory text. Section 93.434 provides the standards for the approval of privately operated quarantine facilities for sheep or goats. As mentioned previously, in proposing to establish quarantine standards applicable to ruminants, we would remove from our regulations the existing standards applicable to privately operated quarantine facilities for sheep or goats.

Section 93.404 contains permit requirements for the importation of ruminants and ruminant test specimens for diagnostic purposes from certain regions. Paragraph (a)(1) specifies the information to be included in the application to APHIS for an import permit.

In order that we receive sufficient notice of the importer's intention to utilize the services of a privately owned quarantine facility, we would amend § 93.404(a)(1) to require that the permit application specify the name and address of the quarantine facility in cases where the ruminants are to be quarantined at a privately owned quarantine facility.

Paragraph (a) of § 93.412 authorizes the establishment of privately operated quarantine facilities, subject to APHIS approval and oversight. We are proposing to amend § 93.412(a), including the paragraph heading, by removing references to the word “operated” as it is used in the terms “privately operated quarantine facility” or “privately operated quarantine facilities” and substituting the word “owned” in each instance. We also would amend § 93.412(a) by substituting the word “operator” in place of “importer or his or her agent,” and substituting the words “APHIS representative'or “overseeing APHIS representative” in place of “inspector assigned to supervise,” for purposes of consistency with the new provisions in proposed § 93.412(d). We also would make other minor technical changes, either to be consistent with proposed § 93.412(d), or for stylistic purposes.

Paragraph (c) of § 93.412 provides that amounts collected from the importer, or his or her agent, for quarantine services furnished by APHIS shall be deposited so as to be available to defray such services as they are rendered. We would amend § 93.412(c) and add a reference to “operator” alongside the current reference to importer, and also make a minor stylistic change. As a result, this provision would apply to operators of privately owned quarantine facilities under § 93.412(a) and importers of ruminants who utilize the services of APHIS quarantine facilities under § 93.412(b).

We are proposing to add a new paragraph (d) to § 93.412 that would set forth the standards for the establishment, operation, and maintenance of privately owned medium and minimum security quarantine facilities for ruminants imported into the United States. The risk of the spread of disease into, within, and from these facilities dictates that security, disease detection, and other prevention measures meet certain standards to ensure the biological security of approved facilities.

We are proposing standards for two types of quarantine facilities: Privately owned medium security quarantine facilities (medium security facilities) and privately owned minimum security quarantine facilities (minimum security facilities). Medium security facilities would need to be built to hold ruminants in an indoor, vector-proof environment that protects the animals against the spread of livestock diseases that are biologically transmitted by vectors.

A minimum security facility would allow for the outdoor holding of ruminants in quarantine. Unlike a medium security facility, the quarantine area of a minimum security facility would not have to be constructed to provide a vector-proof environment against livestock diseases that are transmissible by vectors. However, a minimum security facility could only accept imported animals that the Administrator determines pose no significant risk of harboring livestock diseases that are transmissible by vectors. The Administrator would make this determination on a case-by-case basis, taking into account such factors as the prevalence of diseases transmissible by vectors in the exporting country, and whether any steps have been taken in the exporting country to mitigate the disease risk ( i.e. , holding the animals in a vector free zone over a prescribed time period prior to shipment).

Importers wishing to utilize the services of a privately owned quarantine facility would be required to state their intention on their application for a permit to import the ruminants. (See discussion under the heading “Import Permits.”) We would determine whether the animals are eligible for importation and the required level of quarantine security based on review of the application, as well as existing animal import regulations and any protocols that we have with the exporting country. For example, we view certain OIE list A diseases, such as rinderpest and foot-and-mouth disease, to be so serious that § 93.404(a)(2) prohibits the importation of domestic ruminants from regions where those diseases are known to exist. The presence of certain other infectious diseases in the exporting region, such as diseases of the respiratory complex or vesicular diseases such as vesicular stomatitis, could necessitate that the imported ruminants be quarantined in a medium security facility in the absence of mitigating factors such as testing. The Administrator would have the discretion to order testing or observation for any OIE list A diseases and other livestock diseases exotic to the United States, as well as any other diseases, as necessary. The Administrator also would have the discretion to decide what type of quarantine facility (medium or minimum security facility) to use for a particular importation of ruminants, based on the ruminant species and the health conditions in the region or regions from which the ruminants would be exported.

We are proposing that medium and minimum security facilities receive and hold imported ruminants as a “lot” on an “all-in, all-out” basis. The standards we are proposing would allow for medium security facilities to accommodate more than one lot of ruminants at a time, provided certain requirements are met. The option of holding multiple lots of ruminants simultaneously would not be available for minimum security facilities. We would limit minimum security facilities to one lot for purposes of biosecurity since there would be little, if any, separation between lots of animals. Also, because of the potentially larger number of animals that can be accommodated as a single lot at a minimum security facility, it would not be prudent to put such a large number of animals at risk by allowing another lot of imported ruminants to use the facility at the same time.

Proposed § 93.412(d) would be organized by subparagraphs addressing the following: (1) APHIS approval of facilities; (2) compliance agreement; (3) physical plant requirements; (4) operating procedures; (5) environmental quality; (6) other laws; and (7) variances.

We would provide information in § 93.412(d)(1) on how to obtain APHIS approval to operate a medium or minimum security facility, as well as the basis for denying or withdrawing such approval. As explained earlier, obtaining our approval to operate a medium or minimum security facility, as discussed in this proposed rule, would be separate from the import permit application process for specific animal shipments, which is covered in § 93.404 and elsewhere in the regulations.

Under proposed § 93.412(d)(1)(i), interested persons would be required to make written application to the Administrator, c/o National Center for Import and Export, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231. The application would need to include:

• The full name and mailing address of the applicant;

• The location and street address of the facility for which approval is sought;

• Blueprints of the facility;

• A description of the financial resources available for construction, operation, and maintenance of the facility;

• Copies of all approved State permits for construction and operation of the facility (but not local building permits), as well as copies of all approved Federal, State, and local environmental permits;

• The anticipated source(s) and origin(s) of ruminants to be quarantined, as well as the expected size and frequency of shipments; and

• A contingency plan for the possible destruction and disposal of all ruminants capable of being held in the facility.

The written application for facility approval would have to be submitted to APHIS at least 120 days prior to the date of application for local building permits in order to ensure that APHIS has adequate time to evaluate the plans for the facility, assess potential environmental effects, and determine that sufficient APHIS personnel are available to staff the facility.

Requests for approval of a proposed facility would be evaluated on a first-come, first-served basis.

If APHIS determines that an application is complete and merits further consideration, the person applying for facility approval would have to agree to pay the costs of all APHIS services associated with APHIS' evaluation of the application and facility. APHIS charges for evaluation services at hourly rates are listed in 9 CFR 130.30. If the facility is approved by APHIS, the operator would then enter into a compliance agreement, which is explained in more detail under the heading “Compliance Agreement,” under § 93.412(d).

Proposed § 93.412(d)(1)(ii) would set out the criteria for APHIS approval. Before granting approval, we would have to find, based on our own environmental assessment, as well as any required Federal, State, and local environmental permits or evaluations issued by Federal, State, or local authorities, that the operation of the facility would not have significant environmental effects. The operator would have to secure the required permits or evaluations and provide copies to APHIS before we would consider granting approval to build and operate the facility. The facility would also have to comply with all requirements in § 93.412(d). Approval would be subject to the facility meeting any additional conditions that the Administrator believes are necessary to ensure that adequate safeguards are in place to monitor the health status of the ruminants in quarantine and prevent the transmission of livestock diseases into, within, or from the facility. These additional conditions would be set forth in a compliance agreement required under § 93.412(d)(2). The compliance agreement provides us with further assurances that the privately owned quarantine facility would be operated in accordance with the regulations. Finally, the Administrator would have to determine whether sufficient APHIS personnel (including one or more APHIS veterinarians and other animal health technicians) are available to provide continuous oversight and other technical services to ensure the biological security of the facility. In assigning APHIS personnel to a facility, long-term personnel plans and arrangements would need to be made, including the possible hiring of personnel or the transfer of existing personnel. The operator of the facility, not APHIS, would be responsible for hiring other attendants and workers for the care and handling of ruminants and for the maintenance, operation, and administration of the facility.

If a facility meets all of these requirements, APHIS would approve the facility and assign personnel to it. The assignment of APHIS personnel would be handled on a first-come, first-served basis; therefore, the deployment of APHIS personnel at one facility could result in another facility not being staffed due to the lack of necessary APHIS personnel. The Administrator would have sole discretion in determining the number of APHIS personnel to be assigned to a facility.

Proposed § 93.412(d)(1)(iii) would provide that the operator of a medium or minimum security facility, after receiving our approval, would have to continue to comply with all requirements of § 93.412(d), as well as the terms of the compliance agreement, in order for the facility to maintain its approved status.

Proposed § 93.412(d)(1)(iv) would cover the process for APHIS denying an initial application or withdrawing the approval of a medium or minimum security facility already in operation. Before we would deny or withdraw approval, we would first inform the operator, and include the reasons for our action. We would provide an opportunity for a hearing if there is a conflict as to any material fact regarding our action. The withdrawal of approval of an existing facility would become effective pending a final determination in the proceeding if the Administrator determines that such action is necessary to protect the public health, interest, or safety. Such withdrawal would take effect upon oral or written notification, whichever is earlier, to the operator of the facility. In the event of oral notification, we would also provide written confirmation to the operator as promptly as circumstances allow. The withdrawal of approval of a facility would continue in effect pending the completion of the proceeding and any judicial review, unless otherwise ordered by the Administrator.

Under proposed § 93.412(d)(1)(iv), we could deny an initial application or withdraw the approval of an existing facility for failure to comply with the requirements provided in § 93.412(d), or with the terms of the compliance agreement, or for failure to comply with any other requirement under the Animal Health Protection Act (7 U.S.C. 8301-8317) or the regulations thereunder. We would also withdraw approval if the operator notifies us that the facility has ceased operations, or, if the facility has not been used to quarantine ruminants for a period of at least 1 year. The operator's failure to remit outstanding charges for APHIS services at the facility would also be grounds for withdrawing approval. Finally, we could deny approval of an initial application, or withdraw the approval of an existing facility, if the operator or a person responsibly connected with the business of the facility is or has been convicted of a crime under any law regarding the importation or quarantine of any animal, or any crime involving fraud, bribery, extortion, or any other crime involving a lack of integrity needed for the conduct of operations affecting the importation of animals. A person is considered to be responsibly connected with the business of the facility if such person has an ownership, mortgage, or lease interest in the facility's physical plant, or if such person is a partner, officer, director, holder, or owner of 10 percent or more of its voting stock, or an employee in a managerial or executive capacity.

We are proposing that all medium and minimum security facilities operate in accordance with a compliance agreement required under § 93.412(d)(2). We would require that the compliance agreement be executed by the operator or other designated representative of the facility and by the Administrator before the facility could commence operations. The compliance agreement would signify the operator's commitment to follow our regulations, as well as underscore the operator's financial responsibilities with respect to building and operating a privately owned quarantine facility.

Under the compliance agreement, the operator would be bound by § 93.412(d) and subject to the strict oversight of APHIS representatives. The operator would agree to be responsible for the cost of building the facility, as well as any costs associated with its maintenance and operation. These costs would include all expenses associated with the hiring of personnel to attend to the ruminants and maintain and operate the facility; all expenses associated with the care of quarantined ruminants, such as feed, bedding, medicines, inspections, testing, laboratory procedures, and necropsy examinations; all costs associated with the death or destruction and disposition of quarantined ruminants; and all charges for the services of APHIS representatives at the facility, in accordance with § 93.412 of the regulations and 9 CFR part 130.

The compliance agreement would provide that the operator obtained, prior to execution of the agreement, a financial instrument (insurance or surety bond) approved by APHIS that financially guarantees the operator's ability to cover all costs and other financial liabilities and obligations of the facility. This includes financial liability coverage in the event of a worst case scenario in which all quarantined ruminants would have to be destroyed and disposed of because of an animal health emergency, as determined by the Administrator.

The compliance agreement would also provide that, prior to commencing quarantine operations, the operator would deposit with the Administrator a certified check or U.S. money order to cover the estimated costs, as determined by the Administrator, of APHIS professional, technical, and support services at the facility over the duration of the quarantine. The compliance agreement would also provide that if the actual costs incurred by APHIS exceed the deposited amount, the operator would be liable for those additional costs, based on APHIS official accounting records. We would require the compliance agreement to specify that payment for our services received in connection with each lot of ruminants in quarantine must be made prior to the release of the ruminants. The operator would also be responsible for any other costs incurred by us with respect to the quarantine following the release of the ruminants, based on official records, within 14 days of receipt of the bill showing the balance due. Any unobligated funds deposited with us would be returned to the operator after the release of the lot of ruminants from the quarantine facility and termination or expiration of the compliance agreement, or, if requested, credited to the operator's account and applied towards payment of APHIS services at a future date. We would require that, prior to the entry of each subsequent lot of ruminants into the medium or minimum security facility, the operator execute a new compliance agreement with APHIS, as well as deposit a certified check or U.S. money order to cover our estimated costs over the duration of the quarantine for that lot of ruminants.

Proposed § 93.412(d)(3) would set forth the standards for the physical plant at medium and minimum security facilities. These physical plant standards address issues related to location, construction, sanitation, and security. Any requirements that are applicable to only one type of facility would be clearly noted in the regulations. We would inspect a facility to ensure that these standards are met before imported ruminants could be admitted to the facility.

Proposed § 93.412(d)(3)(i) would require that imported ruminants arrive at a port designated for the importation of ruminants under § 93.403(g) (discussed earlier under “Ports of Entry”). Proposed § 93.412(d)(3)(i) also would require that a medium or minimum security facility be located at a site approved by the Administrator and that the specific routes for the movement of ruminants from the port to the medium or minimum security facility be approved in advance by the Administrator. Approval would be based on a consideration of whether the site or routes would put animals in a position that could result in their transmitting communicable livestock diseases.

We have decided for several reasons not to require that the port and the medium or minimum security facility be located within a certain distance of one another. Some ports will be in large metropolitan areas where the nearest concentrations of livestock are many miles away, while other ports may be in towns with rural areas where concentrations of livestock are within very short distances of the port. Considering the diversity of places in which persons may consider locating quarantine facilities, it would be difficult to stipulate a maximum distance from the port. Doing so could prove unjustified and burdensome for the importer in some circumstances or, in other circumstances, allow construction of a quarantine facility in a location that could prove inadequate in ensuring against the spread of disease into or from the quarantine facility.

For medium security facilities only, the facility would have to be situated at least one-half mile from any premises holding livestock in order to prevent the possible transmission of diseases from ruminants in the facility to livestock outside the facility and vice versa. Our experience in operating indoor quarantine facilities for imported animals indicates that a distance of one-half mile is adequate to prevent the transmission of livestock diseases into and from a medium security facility. In the case of a minimum security facility (outdoor facility), the Administrator would establish the required minimum distance between the facility and other premises holding livestock on a case-by-case basis, taking into account such factors as possible diseases of concern and whether or not the facility is to be located in an agricultural region in proximity to other susceptible animals.

All imported ruminants, upon arrival at the port of entry, are subject to inspection in accordance with § 93.408 of the regulations. If the medium or minimum security facility is to be located more than 1 mile from a designated port, the operator would have to make arrangements for the imported ruminants to be held in a temporary inspection facility, which is within 1 mile of the port and approved by the Administrator, to allow for the inspection of the imported ruminants by a Federal or State veterinarian prior to the animals' movement to the quarantine facility. We would require that this inspection take place within 1 mile of the port so that in the event the ruminants are found to be infected with or exposed to a disease that precludes their entry, the lot of ruminants could be expeditiously re-exported, if necessary.

The temporary inspection facility would have to provide adequate space for Federal or State veterinarians to conduct examinations and testing of the imported ruminants. The examination space of the temporary inspection facility would have to be equipped with appropriate animal restraining devices for the safe inspection of ruminants. The temporary inspection facility also could hold no more than one lot of animals at the same time.

In seeking APHIS approval of the temporary inspection facility, the operator would have to provide APHIS with the following information: The location and street address, as well as blueprints or a description of the temporary inspection facility; a description of the financial resources available for its construction (if applicable), operation, and maintenance; copies of all approved State permits for construction and operation of the temporary inspection facility, as well as copies of all approved Federal, State, and local environmental permits; and the anticipated source(s) or origin(s), lot size, and frequency of shipments of imported ruminants to be handled at the facility. Following APHIS approval of the temporary inspection facility, the operator would also provide APHIS with a copy of the local building permit, when obtained.

If the ruminants, upon inspection at the temporary inspection facility, are determined to be infected with or exposed to a disease that precludes their entry into the United States, the ruminants would be refused entry. Ruminants refused entry would remain the responsibility of the operator, but subject to further handling or disposition as directed by the Administrator in accordance with § 93.408.

APHIS' approval to build and operate a medium or minimum security quarantine facility outside the 1-mile boundary of a designated port would be contingent upon APHIS' approval of a temporary inspection facility within 1 mile of the port of entry, as well as approval of the routes for the movement of ruminants from the port to the medium or minimum security facility.

The operator or the operator's designated representative would have the opportunity to confirm with us that the location requirements for the facility would be satisfactory before moving ahead with any firm decisions about the site of the facility.

Proposed § 93.412(d)(3)(ii) would provide the basic construction and design standards for medium and minimum security facilities. We would require that each facility be of sound construction, good repair, and designed to prevent the escape of quarantined ruminants. The facility would have to provide adequate capacity to receive and hold ruminants as a “lot” on an “all-in, all-out” basis.

We are proposing that medium and minimum security facilities must provide separate docks for animal receiving and releasing and for general receiving and pickup of supplies and materials such as feed, bedding, disinfectants, pesticides, and equipment. Alternatively, a single dock may be used for both purposes if the dock is cleaned and disinfected after each use with a disinfectant that is either authorized in 9 CFR part 71, § 71.10(a)(5), or is otherwise approved by the Administrator. Paragraph (a)(5) of § 71.10 authorizes, for general use purposes, disinfectants that are registered under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135 et seq. ) with tuberculocidal claims.

We are proposing that medium and minimum security facilities must be surrounded by double-security perimeter fencing separated by at least 30 feet and of sufficient height and design to prevent the entry of unauthorized persons and animals from outside the facility and to prevent the escape of ruminants in quarantine. The fence's height and design should take into consideration the species of wildlife in the surrounding area, as well as the impact of snowfall and other climatic changes. Double-security fencing would further ensure against possible contact between quarantined ruminants and animals outside the facility.

Medium and minimum security facilities would have to provide pens, chutes, and other animal restraining devices, as appropriate, for inspection and identification of each animal, as well as for segregation, treatment, or both, of any ruminant exhibiting signs of illness. We also are proposing that the lot-holding areas in medium and minimum security facilities be of sufficient size to prevent overcrowding. A medium security facility could hold more than one lot of ruminants at the same time so long as the lots are separated by physical barriers so that ruminants in one lot would not have physical contact with ruminants in another lot, or with their excrement or discharges. A minimum security facility could not hold more than one lot of animals at the same time. These measures would help prevent ruminants infected with or exposed to a disease from spreading it to other ruminants in the facility.

Because of the need for APHIS representatives to examine ruminants and draw samples for testing, we would require that medium and minimum security facilities provide adequate space for such purposes, and that the space include appropriate animal restraining devices for the safe inspection of ruminants. The facility would have to provide sufficient storage space for necessary examination equipment and supplies, work space for preparing and packaging samples for mailing, and storage space for duplicate samples. The facility also would have to provide a secure, lockable office for APHIS use with enough room for a desk, chair, and filing cabinet.

Medium and minimum security facilities would also have to provide sufficient storage space for equipment and supplies used in quarantine operations, including separate, secure storage areas for pesticides and for medical and other biological supplies, as well as a separate storage area for feed and bedding, if feed and bedding are to be stored at the facility.

Medium and minimum security facilities would also have to include work areas for the repair of equipment and for cleaning and disinfecting equipment used in the facility.

Proposed § 93.412(d)(3)(iii) would contain additional physical plant requirements that would apply to medium security facilities only. These additional requirements, which primarily relate to building design, windows and other openings, surfaces, and ventilation and climate control, would help ensure that a medium security facility is capable of providing an indoor environment for ruminants in quarantine that is free of vectors, biologically secure, and safe for the animals.

A medium security facility would have to be constructed so that the quarantine area is located in a secure, self-contained building that includes appropriate control measures against the spread of livestock diseases biologically transmissible by vectors. All entryways into the nonquarantine area of the building would have to be equipped with a secure and lockable door. While ruminants are in quarantine, all access to the quarantine area would have to be from within the building. Each entryway to the quarantine area would have to be equipped with a solid, self-closing door. Separate access would have to be provided within the quarantine area to each lot-holding area so that it is not necessary to move through one lot-holding area to gain access to another lot-holding area. Entryways to each lot-holding area within the quarantine area would also have to be equipped with a solid lockable door. Emergency exits to the outside would be permitted in the quarantine area if required by local fire ordinances. Such emergency exits would have to be constructed so as to permit their opening from the inside of the facility only.

We would require that all windows and other openings in the quarantine area of a medium security facility be double-screened with screening (separated by at least 3 inches or 7.62 centimeters) of sufficient gauge and mesh to prevent the entry or exit of insects and other vectors of livestock diseases, as well as provide ventilation sufficient to ensure the comfort and safety of all ruminants in the facility. All screening would have to be easily removable for cleaning, yet otherwise remain locked and secure at all times in a manner satisfactory to APHIS representatives in order to ensure the biological security of the facility.

We would also require that the floor, wall, and ceiling surfaces in a medium security facility meet certain standards. The floor surfaces with which the ruminants have contact would have to be nonslip and wear-resistant. In addition, all floor surfaces with which the ruminants, their excrement, or discharges have contact would have to slope gradually to the center, where one or more drains of at least 8 inches in diameter are located for adequate drainage, or alternatively, be of slatted or other floor design that allows for adequate drainage. We are also proposing that any floor and wall surfaces in a medium security facility with which the ruminants, their excrement, or discharges have contact would have to be impervious to moisture and be able to withstand frequent cleaning and disinfection without deterioration. Other ceiling and wall surfaces with which the ruminants, their excrement, or discharges do not have contact would have to be able to withstand cleaning and disinfection between shipments of ruminants. Since the animals would be housed in an enclosed building for the duration of the quarantine, the cleaning and disinfection of floor and wall surfaces would be necessary to help maintain the general health of the ruminants in quarantine, as well as reduce the risk of diseases spreading from one lot of ruminants to another. Finally, all floor and wall surfaces would also have to be free of sharp edges that could cause injury to ruminants.

We would also require that a medium security facility be equipped with a heating, ventilation, and air conditioning (HVAC) system that would be capable of controlling and maintaining the ambient temperature, air quality, moisture, and odor at levels not injurious or harmful to the health of ruminants in quarantine. Air supplied to lot-holding areas could not be recirculated or reused for other ventilation needs. The HVAC systems used for lot-holding areas would have to be separate from air handling systems for other operational and administrative areas of the facility. In addition, if a medium security facility is approved to handle more than one lot of ruminants at a time, each lot-holding area would have to be equipped with its own separate HVAC system in order to prevent cross-contamination between the separate lot-holding areas. Physical separation alone is not always an adequate safeguard against the transmission of diseases from one lot to another.

Medium security facilities would have to be adequately illuminated. This would include lighting in the lot-holding areas, as well as other areas where animals would be inspected or examined. We would also require that a medium security facility, including the lot-holding areas, be equipped with a fire alarm and voice communication system so that personnel working in those areas can be readily warned of any potential emergency and vice versa. A medium security facility would also have to provide a television monitoring system or other arrangement sufficient to provide a full view of the lot-holding areas. In addition, we are proposing that a medium security facility would have to be equipped with a communication system between the nonquarantine and quarantine areas of the facility so that persons inside the quarantine area can readily communicate with persons elsewhere in the facility in cases of emergency without necessarily leaving the quarantine area, and vice versa.

Each medium security facility would have to include an area that is of sufficient size to perform necropsies on ruminants. We would require that the necropsy area have adequate lighting and be equipped with hot and cold running water, a drain, a cabinet for storing instruments, a refrigerator-freezer for storing specimens, and an autoclave to sterilize veterinary equipment. The necropsy area would be used to perform postmortem inspection of animals that die in the medium security facility and to collect samples for laboratory diagnosis. Having the capability to conduct necropsies at the facility would reduce the risk of diseases being transmitted to animals outside the facility.

In addition to the storage requirements discussed previously, the feed storage areas of a medium security facility would have to be vermin-proof. Also, if the medium security facility has multiple lot-holding areas, we would require that separate storage space for supplies and equipment be provided for each lot-holding area. This would help prevent equipment and supplies used on quarantined ruminants in one lot from coming in contact with ruminants in another lot or with the equipment or supplies used on those other ruminants. Such contact could cause the spread of diseases between lots of ruminants.

Medium security facilities would have to provide adequate shower facilities for use by those individuals who have access to the quarantine area. In a medium security facility, there would have to be a shower at the entrance to the quarantine area. A shower also would have to be located at the entrance to the necropsy area. We would also require that a clothes-storage and clothes-changing area be located at each end of each shower area. In addition, there would have to be one or more receptacles near each shower so that clothing that has been worn into a lot-holding area or elsewhere in the quarantine area can be deposited in the receptacle(s) prior to entering the shower.

Medium security facilities would have to provide permanent restrooms in both the nonquarantine and quarantine areas of the facility, and also provide an area for breaks and meals within the quarantine area. We would also require that medium security facilities provide a separate area for washing and drying clothes, linens, and towels used in the facility.

Proposed § 93.412(d)(3)(iv) would require that all medium and minimum security facilities meet certain sanitation standards as another safeguard against the transmission of livestock diseases into, within, or from the facility. Operators would have to have adequate equipment and supplies on hand to clean, disinfect, and maintain the facility and control pests. If more than one lot of ruminants is to be held in the facility at the same time (applies to medium security facilities only), then the facility would have to maintain separate equipment and supplies for carrying out such tasks in the different lot-holding areas. We would also require that the facility have a sufficient supply of potable water to meet the watering needs of the ruminants, as well as any cleaning needs at the facility. Water faucets for hoses would have to be located throughout the facility so that personnel would not have to drag hoses across areas that have already been cleaned and disinfected. We also would require that facilities maintain an emergency supply of water for the ruminants in quarantine, as well as a supply of disinfectant that is sufficient to disinfect the entire facility. Disinfectants would have to be authorized under 9 CFR part 71, § 71.10(a)(5), or otherwise approved by the Administrator.

Medium and minimum security facilities would have to be capable of disposing of wastes, including urine, manure, and used bedding, by means of burial, incineration, or public sewer. Other waste material would have to be handled in such a manner that would minimize spoilage and the attraction of pests and then disposed of by incineration, public sewer, or other preapproved manner that prevents the spread of disease. Waste disposal would have to be carried out under the direct oversight of APHIS representatives. Each facility would also have to be capable of disposing of ruminant carcasses in a manner approved by the Administrator and under conditions that would prevent the spread of disease from the carcasses.

If incineration is to be carried out on the premises of a medium or minimum security facility, we are proposing that the incineration equipment would have to be detached from other facility structures and be capable of burning wastes as required. The incineration site would also have to provide an area sufficient for solid waste holding. Incineration also may occur at a local site away from the facility. All incineration activities would have to take place under the direct oversight of an APHIS representative.

We are proposing that medium and minimum security facilities have the capability to adequately control surface drainage and effluent in order to prevent the spread of disease into, within, and from the facility. If a facility is approved to handle more than one lot of ruminants at the same time, we would require that separate drainage systems be provided for each lot-holding area in order to prevent cross-contamination. A facility's capability to adequately control surface drainage and effluent would depend on a number of factors including the water table, water pressure, angles at which the pipes are placed, number and location of drain openings, and the frequency in cleaning manure and other excreta from drains.

Under proposed § 93.412(d)(3)(v), a medium or minimum security facility would ave to exercise certain security measures in order to prevent unauthorized persons, as well as animals, from coming in contact with quarantined ruminants. The facility and premises would have to be locked and secure at all times while the ruminants are in quarantine. In addition, the facility and premises would have to have posted signs indicating that the facility is a quarantine area and that no visitors are allowed. We would also require that the operator furnish us with one or more telephone numbers at which the operator or his or her agent can be reached at all times.

This paragraph would state that APHIS may place seals on any or all entrances and exits of the facility, as necessary to ensure security, and to take all necessary steps to ensure that the seals are broken only in the presence of an APHIS representative. Should someone other than an APHIS representative break such seals, we would consider such action a breach in security and would carry out an immediate accounting of all ruminants in the facility. If a breach of security occurs, we could extend the quarantine period as long as necessary to determine that the ruminants are free of communicable livestock diseases.

In the event that a communicable livestock disease is diagnosed in quarantined ruminants, the Administrator would have the discretion to order the facility to be guarded by a bonded security company, at the expense of the operator of the facility, in a manner that the Administrator deems is necessary to ensure the biological security of the facility.

In the case of medium security facilities only, we would also require that the facility be guarded at all times by one or more representatives of a bonded security company or, alternatively, the facility have an electronic security system that prevents the entry of unauthorized persons into the facility and prevents animals outside the facility from having contact with ruminants in quarantine. If an electronic security system is used, we would require that the system be coordinated through or with the local police so that monitoring of the facility is maintained whenever APHIS representatives are not at the facility. The electronic security system would have to be of the “silent type,” approved by Underwriter's Laboratories, and triggered to ring at the monitoring site and, if the operator chooses, at the facility. The operator would have to provide written instructions to the monitoring agency that specify that the police and an APHIS representative designated by APHIS would have to be notified by the monitoring agency if the alarm is triggered. The operator would have to provide a copy of those instructions to the Administrator. The operator would also have to notify the designated APHIS representative whenever a break in security occurs or is suspected of occurring.

Proposed § 93.412(d)(4) would set forth the operating procedures that medium and minimum security facilities would have to observe with respect to APHIS oversight, personnel, authorized access, sanitary practices, handling of quarantined ruminants, and recordkeeping. We would require that these procedures be followed at all times in order to ensure the overall biological security of the quarantine operation, as well as to maintain the health of the animals in quarantine.

In proposed § 93.412(d)(4)(i), we would make clear that while the facility would be owned, operated, and maintained by the operator, the quarantine of ruminants at the facility would be subject to the strict oversight of APHIS representatives. The deployment of APHIS representatives to oversee and provide other professional, technical, and support services at a facility would be determined solely by the Administrator.

APHIS representatives would retain ultimate authority over the quarantine of ruminants at the facility. If, for any reason, the operator fails to properly care for, feed, or handle the quarantined ruminants as required in § 93.412(a), or in accordance with animal health and husbandry standards provided elsewhere in 9 CFR chapter 1, or fails to maintain and operate the facility as provided in proposed § 93.412(d), APHIS representatives would be authorized to furnish such neglected services or make arrangements for the sale or disposal of quarantined ruminants at the operator's expense, as authorized in § 93.412(a).

Under proposed § 93.412(d)(4)(ii), the operator of a medium or minimum security facility would be responsible for hiring personnel to attend to the animals and otherwise maintain, operate, and administer the facility. We would require that the operator provide us with an updated list of all personnel who have access to the facility. The list would have to include the names, current residential addresses, and identification numbers of each person, and must be updated with any changes or additions in advance of such person having access to the quarantine facility. We also would require that the operator provide us with signed statements from all personnel having access to the facility in which the person agrees to comply with proposed § 93.412(d) and other provisions of part 93, all terms of the compliance agreement, and any related instructions from APHIS representatives pertaining to quarantine operations, including contact with animals both inside and outside the facility. We would require these signed statements so that personnel are made aware of their responsibilities and obligations while working with the animals in quarantine.

To ensure the biological security of medium and minimum security facilities, proposed § 93.412(d)(4)(iii) would restrict facility access to APHIS representatives and other persons specifically authorized to work at the facility. All others would be prohibited from the premises unless specifically granted access by an APHIS representative. We would also require that an APHIS representative accompany at all times any visitors granted access to the facility.

In addition, we would require that all visitors, except veterinary practitioners who enter the facility to provide emergency care, would have to sign an affidavit before entering the quarantine area, if determined necessary by the overseeing APHIS representative, declaring that they will not have contact with any susceptible animals outside the facility for at least 7 days after contact with the ruminants in quarantine, or for a period of time determined by the overseeing APHIS representative as necessary to prevent the transmission of communicable livestock diseases of ruminants.

Proposed § 93.412(d)(4)(iv) sets forth certain sanitary practices that would need to be followed by all those persons granted access to a medium or minimum security facility. We would require that everyone entering the quarantine area of the facility wear clean protective clothing and footwear. Disposable gloves would have to be worn when handling sick animals. Persons would have to wash their hands after removing the gloves. Persons also would have to change out of protective clothing, footwear, and gloves that have become soiled or contaminated.

If determined necessary by the overseeing APHIS representative, we also would prohibit persons having contact with quarantined ruminants from coming in contact with susceptible animals outside the facility for at least 7 days after their last contact with ruminants in quarantine, or, alternatively, for a longer period of time determined necessary by the overseeing APHIS representative. The period of time may vary, depending on the health status of the quarantined ruminants at the time the person had access to that lot of ruminants. The overseeing APHIS representative would be familiar with the health status of the ruminants under quarantine to determine whether there should be a prohibition against contact with animals outside the facility for a period of 7 days or longer.

We would require that any equipment (including tractors) to be used in the quarantine area of a medium or minimum security facility would first have to be cleaned and disinfected, and would then have to remain dedicated to the facility for the entire quarantine period. In addition, any equipment used with quarantined ruminants would have to remain dedicated to that particular lot of ruminants for the duration of the quarantine period or be cleaned and disinfected before coming in contact with ruminants from another lot. Prior to its use on another lot of ruminants or its removal from the quarantine area, such equipment would have to be cleaned and disinfected to the satisfaction of an APHIS representative.

Vehicles would also have to be cleaned and disinfected immediately prior to entering and leaving the quarantine area of the facility. If the facility utilizes a single loading dock, the loading dock would have to be immediately cleaned and disinfected after each use under the oversight of an APHIS representative. And upon the release of a lot of ruminants from quarantine, the operator would be required to clean and disinfect the lot- holding area and other portions of the facility in which the ruminants had access before a new lot of ruminants could be placed in that same area of the facility. When disinfecting equipment, vehicles, or other areas of the facility, operators would have to use a disinfectant that is authorized in 9 CFR part 71, § 71.10(a)(5), or is otherwise approved by the Administrator. These measures would be necessary in order to minimize the risk of transmitting diseases into, within, or from the facility.

In addition to the sanitary practices already discussed, medium security facilities would be subject to the following additional requirements. Any persons granted access to the quarantine area would have to shower when entering and leaving the quarantine area, as well as when moving from one lot-holding area to another within the quarantine area. Persons also would have to shower when leaving the necropsy area, if a necropsy is in the process of being performed or has just been completed, or if all or portions of the examined animal remain exposed in the necropsy area. For medium security facilities that handle more than one lot of animals at the same time, all persons entering the quarantine area of the facility would be prohibited, unless specifically allowed otherwise by the overseeing APHIS representative, from coming in contact with any ruminants in quarantine, other than the lot or lots of ruminants to which the person is assigned or granted access.

The operator of a medium security facility would have to provide a sufficient supply of clothing and footwear to ensure that persons with access to the facility's quarantine area have clean, protective clothing and footwear after showering. We would also make the operator responsible for the proper handling, washing, and disposal of soiled and contaminated clothing worn in the quarantine area in a manner approved by an APHIS representative as adequate to preclude the transmission of diseases within and from the facility. At the end of each workday, all work clothing worn into each lot-holding area and other areas of the quarantine area would have to be collected and bagged until the clothing is washed. Used footwear would have to either be left in the clothes changing area or cleaned with hot water (148 °F minimum) and detergent and disinfected as directed by an APHIS representative.

Our standards for the care and handling of ruminants in a medium or minimum security facility would appear in proposed § 93.412(d)(4)(v). Each lot of ruminants would have to be placed in the facility on an “all-in, all-out” basis. Once in quarantine, no ruminants would be removed from the lot except for diagnostic purposes, and no ruminants could be added to the lot during the quarantine period. These requirements would simplify the management of ruminants in the facility while reducing the risk of disease spread. The operator would be responsible for providing adequate feed and bedding from APHIS-approved sources. The feed and bedding would have to be free of vermin and not spoiled. In addition, breeding of ruminants or collection of germ plasm from ruminants would be prohibited during the quarantine period unless required for an import testing procedure.

Ruminants in quarantine in a medium or minimum security facility would be subject to such tests and procedures as directed by the overseeing APHIS representative to determine whether the ruminants are free of communicable livestock diseases. The use of vaccines for ruminants in quarantine would have to be approved by the APHIS representative, licensed in accordance with 9 CFR part 102, and administered by an APHIS veterinarian or an accredited veterinarian under the direct supervision of an APHIS representative.

The death or suspected illness of ruminants in quarantine would have to be reported to the overseeing APHIS representative. The affected ruminants would have to be disposed of as the Administrator may direct or, depending on the nature of the disease, would have to be cared for as directed by APHIS to prevent the spread of disease. We are proposing that animals that require specialized medical attention or additional postmortem testing may be transported off the quarantine site, if authorized by APHIS. If this occurs, a second quarantine site would be established at the off-site location where the affected animal(s) are being held. In such cases, APHIS could extend the quarantine period until the results of the outstanding tests or postmortems are received.

Should the Administrator determine that an animal health emergency exists at the facility, we would require that arrangements for the final disposition of the infected or exposed lot of ruminants be accomplished within 4 workdays following disease confirmation. The ultimate disposition of the ruminants would then have to occur under the direct oversight of APHIS representatives.

In proposed § 93.412(d)(4)(vi), operators of a medium or minimum security facility would have to follow certain recordkeeping practices while ruminants are in quarantine. For purposes of security, we would require the operator to maintain a current daily log to record the entry and exit of all persons entering and leaving the facility. We would also require that the operator retain the daily security log, as well as any logs maintained by APHIS and deposited with the operator, for at least 2 years following the date of release of the ruminants from quarantine. These logs would have to be made available to APHIS representatives upon request.

To ensure that APHIS would not assent to or facilitate activities that are not in conformance with environmental quality control standards, proposed § 93.412(d)(5) would provide that if APHIS determines that a privately owned medium or minimum security quarantine facility does not meet applicable local, State, or Federal environmental regulations, APHIS may deny or suspend approval of the facility until appropriate remedial measures have been applied.

Proposed § 93.412(d)(6) would put operators of a medium or minimum security facility on notice that they would be responsible for complying with any other applicable Federal, State, and local laws and regulations with respect to the construction, operation, and maintenance of the facility.

In proposed § 93.412(d)(7), we would permit variances from the proposed standards of § 93.412(d) on a case-by-case basis, subject to approval by the Administrator. The Administrator would be authorized to grant a variance to existing facility requirements relating to location, construction and design, sanitation, security, operating procedures, recordkeeping, or other provisions in proposed § 93.412(d), but only if the Administrator determines that there would be no detrimental effect on the health of the ruminants or to the overall biological security of the quarantine operations. The operator would have to submit any request for variance in writing to the Administrator at least 30 days in advance of the arrival of ruminants at the facility. Any variance would also have to be provided for in the compliance agreement.

Section 93.413 generally restricts visitors from entering the quarantine area of a quarantine facility while ruminants are in quarantine. Section 93.413 does provide that importers whose animals are in quarantine may be admitted to the quarantine area, as necessary, subject to any conditions imposed by the inspector in charge. We are proposing to amend § 93.413 by inserting references to “APHIS representative” alongside “inspector in charge.” “APHIS representative” is the term we propose to use in describing APHIS personnel assigned to oversee and provide other technical services at privately owned medium or minimum security quarantine facilities. We also propose to make a minor technical change by revising “quarantine station” to read “quarantine facility or station.”

Section 93.414 restricts the use of milk or cream from quarantined ruminants. We are proposing to amend § 93.414 by inserting “APHIS representative” alongside “inspector in charge” for the same reason as noted previously for amending § 93.413.

We are also proposing to redesignate the footnote numbers of several footnotes that appear in the regulations. Footnote 7, which appears in the heading “Canada” immediately above § 93.417, would be redesignated as footnote 9. Footnote 8, which appears in the heading “Central America And West Indies” immediately above § 93.422, would be redesignated as footnote 10. And footnote 9, which appears in the heading “Mexico” immediately above § 93.424, would be redesignated as footnote 11. These redesignations would be necessary because of two new footnotes that would be added to the regulations if § 93.412(d) is implemented.

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

The regulations for the importation of ruminants appear at 9 CFR part 93, subpart D, §§ 93.400 through 93.435 (the regulations). Section 93.411 requires that ruminants arriving in the United States, with certain exceptions, be quarantined upon arrival for at least 30 days. Ruminants from Canada and Mexico are not subject to this quarantine requirement.

Section 93.412, paragraph (a), authorizes the establishment of privately operated quarantine facilities for ruminants, subject to APHIS approval and oversight. Section 93.434 contains standards for the approval, operation, and oversight of privately operated quarantine facilities for sheep or goats. After these standards were first established in 1988, privately operated quarantine facilities were briefly used for the importation of sheep and goats into the United States. However, there are currently no approved private quarantine facilities for sheep or goats, or for other ruminants. Therefore, imported ruminants subject to quarantine must enter the United States through facilities maintained by APHIS.

We have received requests to import cattle into the United States through quarantine facilities that are privately owned and operated.

Given the current interest in establishing privately owned quarantine facilities for cattle, we are proposing to amend our regulations and publish standards for approval and oversight of such facilities. The standards would have to be consistent with the standards followed at APHIS quarantine facilities to ensure that the health of the U.S. livestock population is not jeopardized by the release of unhealthy animals or communicable disease agents from quarantine facilities.

We are proposing that these standards apply not only to privately owned facilities intended for imported cattle, but for privately owned and operated facilities that wish to handle other imported ruminants, including sheep and goats. Therefore, as part of this proposal, we would remove from our regulations the existing standards for the approval of privately operated quarantine facilities for sheep or goats.

In 2001, about 2,440,000 live cattle worth an estimated $1.1 billion were imported into the United States. Over a 10-year period, 1992-2001, U.S. bovine imports averaged more than 2.2 million head per year, with an annual average value of $1.2 billion. In comparison, the U.S. cattle inventory has averaged about 100 million head over the last 10 years. According to the 1997 Census of Agriculture, the value of U.S. cattle sales in that year was approximately $40.5 billion, based on the sale of 74 million head. Thus, cattle imports represent about 2 percent of the U.S. cattle and calf population, and about 3 percent, by value, of domestic sales.

Almost all U.S. imports of cattle come from Canada and Mexico. In 2001, Canada exported 1,308,670 animals into the United States, while Mexico exported 1,130,168 animals in that same year. The only other sources of imports in 2001 were Norway (350 head) and Australia (12 head). The only other source of imports besides Canada and Mexico in 1999 and 2000 was Australia, which exported a total of 21 and 15 head to the United States in those two years. Based on the historic record, the number of cattle imported into the United States that would be affected by this rule would likely be small, given that ruminants from Canada and Mexico are generally not subject to quarantine as a condition of entry into the United States. However, the number of imports from countries other than Canada and Mexico may be more substantial, depending on the number and type of facilities (medium or minimum security facility) that are approved for operation.

Over the 10-year period, 1991-2000, U.S. sheep imports averaged 39,106 head annually, showing a steady increase from about 23,000 head in 1991, to about 52,000 head in 2000. In 2001, there was a significant increase in sheep imports, to 85,042 head. Canada dominates this market, supplying over 99 percent of U.S. sheep imports over the past 5 years. Very small numbers of sheep are imported from Mexico and New Zealand, and there have been imports previously from Australia, the Republic of South Africa, and the European Union. The annual average value of sheep imports over the 1991-2000 period was approximately $4 million (about $104 per head). Hence, the number of imported sheep affected by this rule would likely be small, given that almost all U.S. imports come from Canada.

Goats imported into the United States numbered only 6 head in 1991, while in 1994, they totaled 28,500 head (27,935 from New Zealand). These extreme import numbers during the early 1990s distort a more steady import pattern over the latter half of the 1990s. Therefore, annual averages over the 6-year period, 1995-2000, are appropriate. During this period, an average of 1,459 goats were imported into the United States yearly. Since 1999, all goat imports have come from Canada. Prior to 1999, Canada dominated the market, but Mexico and New Zealand were also significant in some years. The annual average value of goat imports over the 1996-2001 period was about $535,000 (about $244 per head). Hence, the number of imported goats affected by this rule would likely be small, given that the majority of goats imported into the United States typically come from Canada and Mexico.

U.S. imports of sheep and goats represent a small fraction of total U.S. domestic production of these animals. In 2000, the U.S. sheep population numbered about 7 million, with an approximate value of $668 million. Based on average sheep imports of 39,106 head per year over the 1991-2000 period, U.S. sheep imports represent less than 1 percent of total U.S. domestic production. In 2000, there were approximately 436,000 Angora goats in the United States with a value of about $17 million. Based on average goat imports of 1,459 head per year over the 1995-2000 period, U.S. goat imports comprise less than 1 percent of total U.S. domestic production, and represent about 3.1 percent of the value of domestically-produced goats (signifying the generally higher value of imported goats).

APHIS and other Federal agencies are required to evaluate whether proposed regulations are likely to have a significant economic impact on a substantial number of small entities. Privately owned and operated quarantine facilities have been used from time to time for the importation of sheep and goats into the United States. However, no such approved facilities are currently in operation. Therefore, the standards contained in this proposed rule would not adversely affect any such entities, large or small. However, should one or more privately owned quarantine facilities be approved for operation, importers should benefit by having additional options for the placement of ruminants to be imported into the United States. And, particularly in the case of minimum security facilities, importers may have the opportunity to import ruminants from certain regions in larger lot sizes as compared to the current situation of having the animals placed in an APHIS indoor quarantine facility.

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

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

An environmental assessment has not been prepared for this proposed rule. Because the environmental impacts that could result from implementation of this proposal would vary according to the location and design of the facility being approved, APHIS has determined site-specific environmental assessments must be conducted for each privately owned quarantine facility for ruminants prior to approval of the facility. APHIS will publish a notice in the Federal Register for each environmental assessment we conduct in this regard if this proposed rule is finalized, and we would invite public comment on each site-specific environmental assessment.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. 00-022-1. Please send a copy of your comments to: (1) Docket No. 00-022-1, Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule.

We are proposing standards for the establishment and operation of privately owned quarantine facilities for imported ruminants prior to their release into the United States. Satisfying the proposed requirements in this rule would entail several information collection activities, including an application for facility approval, a compliance agreement explaining the conditions under which the facility must be operated, certification that the facility meets all applicable environmental regulations, and maintenance of certain records covering quarantine operations.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

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

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

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

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

Estimate of burden: Public reporting burden for this collection of information is estimated to average 9.64 hours per response.

Respondents: Operators of privately owned quarantine facilities for ruminants.

Estimated annual number of respondents: 25.

Estimated annual number of responses per respondent: 1.8.

Estimated annual number of responses: 45.

Estimated total annual burden on respondents: 434 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

The Animal and Plant Health Inspection Service is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. For information pertinent to GPEA compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS” Information Collection Coordinator, at (301) 734-7477.

Accordingly, we propose to amend 9 CFR part 93 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 2003-NM-173-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. 2003-NM-173-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

The FAA has received a report that the lower rudder of a Boeing Model 747-400 series airplane made an uncommanded move to the full left position (hardover) during flight. The flight crew used lateral and upper rudder controls to compensate for the lower rudder hardover. The flight crew used these controls and differential engine thrust to land the airplane. Investigation revealed that the yaw damper actuator portion of the lower rudder power control module (PCM) manifold was broken. The broken manifold is attributed to fatigue cracking in the lower rudder PCM, which caused the yaw damper to move out of its correct position and generate the uncommanded lower rudder hardover. An uncommanded left rudder hardover could result in increased pilot workload and possible runway departure upon landing.

The upper rudder PCM has the same design as the lower rudder PCM and can fail in the same manner. An upper rudder PCM failure will result in an upper rudder surface hardover to the left and would create a similar unsafe condition as for a failure of the lower rudder PCM.

The PCM part numbers installed on the 747-400D and 747-400F series airplanes are the same part numbers installed on the affected Model 747-400 series airplane. Therefore those airplanes may be subject to the unsafe condition identified on the Model 747-400 series airplane.

The FAA has reviewed and approved Boeing Alert Service Bulletin 747-27A2397, dated July 24, 2003. This service bulletin describes the following procedures:

• Reviewing airplane maintenance records to determine if each PCM has a main manifold with less than 15,000 total flight hours or 2,000 total flight cycles.

• Performing ultrasonic inspections for cracking of the yaw damper actuator portion of upper and lower rudder PCMs that have 15,000 or more total flight hours and 2,000 or more total flight cycles.

• Recording the results of the ultrasonic inspections and reporting them to Boeing.

• Replacing subject PCMs that have evidence of possible cracking.

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 Boeing service bulletin recommends accomplishing the review of airplane maintenance records and ultrasonic inspection within 6 months of the issue date of the service bulletin. We have determined that that interval would address the identified unsafe condition soon enough to ensure an adequate level of safety for the affected fleet. In developing an appropriate compliance time for this AD, we considered the 6-month compliance time recommended by the manufacturer, as well as the time required for the rulemaking process. In consideration of these factors, we find that 3 months after the effective date of this final rule will fall approximately at the same time for compliance as recommended by the manufacturer. We find that a 3-month compliance time represents an appropriate interval of time for affected airplanes to continue to operate without compromising safety.

We consider this proposed AD interim action. The inspection reports that are required by this AD will enable the manufacturer and the FAA to obtain better insight into the nature, cause, and extent of the cracking, and eventually to develop final action to address the unsafe condition. Once final action has been identified, we may consider further rulemaking.

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. The 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 180 airplanes of the affected design in the worldwide fleet. The FAA estimates that 13 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 airplane maintenance records review, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the proposed airplane maintenance records review on U.S. operators is estimated to be $845, or $65 per airplane.

Should an operator be required to accomplish the inspection, it would take approximately 4 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the proposed inspection is estimated to be $260 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 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.

Comments Invited

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers (FAA Docket No. FAA-2003-15529, and Airspace Docket No. 03-ANM-03) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://dms.dot.gov.

Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2003-15529, and Airspace Docket No. 03-ANM-03.” The postcard will be date/time stamped and returned to the commenter. All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received.

All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the Internet at http://dms.dot.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov or the Federal Register 's Web page at http://www.gpoaccess.gov/fr/index.html.

You may review the public docket containing the proposal; any comments received; and any final disposition in person at the Dockets Office (see address in “Comments Invited” section) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Regional Air Traffic Division, Federal Aviation Administration, 15000 Aviation Boulevard, Hawthorne, CA 90261.

Persons interested in being placed on a mailing list for future NPRM's should call the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (CFR) part 71 (part 71) to establish V-584 between the Helena, MT, VORTAC, and the Missoula, MT, VORTAC. This proposed airway would provide a direct route between Helena, MT, and Missoula, MT, during outages of the Drummond VOR. V-584 would also allow for lower enroute altitudes through the mountainous terrain of Montana.

Domestic VOR Federal airways are published in paragraph 6010(a), of FAA Order 7400.9K dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airway listed in this document would be published subsequently in the order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

This proposed rule is a companion to a direct final rule on the same topic published in the final rules section of this issue of the Federal Register . The companion proposed rule and its related direct final rule are substantively identical. This proposed rule provides the procedural framework to finalize the rule in the event that the direct final rule is withdrawn because FDA receives significant adverse comments.

A significant adverse comment is one that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or why it would be ineffective or unacceptable without a change. In determining whether a significant adverse comment is sufficient to terminate a direct final rulemaking, FDA will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process. Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered adverse under this procedure. A comment recommending additional changes in the rule will not be considered a significant adverse comment, unless the comment states why the rule would be ineffective without the recommended revision. In addition, if a significant adverse comment applies to an amendment, paragraph, or section of the rule and that provision can be severed from the remainder of the rule, FDA may adopt as final those provisions of the rule that are not the subject of a significant adverse comment.

The comment periods for this proposed rule and its related direct final rule run concurrently. We have identified and discussed the proposed regulatory changes in the preambles to both rules. Any comments received under this proposed rule will be treated as comments regarding the direct final rule and vice versa. FDA is publishing a direct final rule because the rule does not contain controversial changes and FDA does not anticipate receiving significant adverse comments about it. If no significant adverse comments are received in response to either rule, FDA will take no further action on the proposed rule. Instead, after the comment period ends, FDA intends to publish a document in the Federal Register to confirm the January 1, 2006, effective date of the direct final rule. This is the applicable uniform effective date for compliance with food labeling requirements published in the Federal Register (see the Federal Register of December 31, 2002 (67 FR 79851), designating January 1, 2006, as the effective date for food labeling regulations issued between January 1, 2003, and December 31, 2004). However, if FDA receives significant adverse comment on either rule, FDA will withdraw the direct final rule and will proceed to respond to all comments received on both rules under this companion proposed rule using the usual notice-and-comment procedures. A full description of FDA's policy on direct final rule procedures appears in a guidance document published in the Federal Register on November 21, 1997 (62 FR 62466).

FDA issued a final rule entitled “Food Labeling: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements” in the Federal Register on September 23, 1997 (62 FR 49826). This rule incorporated by reference under § 101.4(h) (21 CFR 101.4(h)) the two books entitled Herbs of Commerce (1992) (Ref. 1) and International Code of Botanical Nomenclature (Tokyo Code) 1994 (Ref. 2) for industry's use in identifying on product labels the common or usual name of each botanical ingredient contained in dietary supplements. Both books were incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

Section 101.4(h) currently requires that a dietary supplement that contains one or more botanical ingredients (including fungi and algae) state the common or usual name for each of these ingredients on the label. This common or usual name must be consistent with the “standardized common name” listed in Herbs of Commerce (1992) for the corresponding plant from which the botanical ingredient is derived. Therefore, the “standardized common name” of each botanical used as an ingredient of a dietary supplement is its common or usual name for labeling purposes.

Current § 101.4(h)(2) also requires that if no standardized common name for a particular botanical ingredient is listed in Herbs of Commerce (1992), the label must state the Latin binomial name of the plant from which that ingredient is derived. All names in Latin binomial form must be stated on the label in accordance with internationally accepted rules on nomenclature, such as those found in the International Code of Botanical Nomenclature (Tokyo Code) 1994 . Further, the name in Latin binomial form must include the designation of the author or authors who published the Latin name [hereafter referred to as author citation] when a positive identification of the dietary ingredient cannot be made without identifying the author(s).

Since 1997, both of the books incorporated by reference for use by industry in the labeling of dietary supplements that contain botanical ingredients have been updated and now the 2000 editions supersede the earlier ones. Herbs of Commerce, 2nd Edition (2000) (Ref. 3) added standardized common names for approximately 1,500 more botanicals than were included in the earlier edition, and changed the standardized common names for approximately 140 botanicals listed in the earlier edition. The International Code of Botanical Nomenclature (Saint Louis Code) 2000 (Ref. 4) reflects the International Botanical Congress's latest decisions on the rules for the scientific naming of plants. Botanical nomenclature is an evolving science that is influenced by new discoveries and the correction of past misidentifications of plants.

Further, in 2002, Congress passed and the President signed into law the Farm Security and Rural Investment Act of 2002 (Public Law 107-171) [hereafter referred to as the Farm Bill]. Section 10806 of the Farm Bill amended the misbranding provisions in section 403 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343) by adding a new paragraph (u), which states that a dietary supplement is misbranded “[i]f it purports to be or is represented as ginseng, unless it is an herb or herbal ingredient derived from a plant classified within the genus Panax.” Section 10806(b)(1)(A) of the Farm Bill states that “the term ‘ginseng’ may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax.” Section 10806(b)(1)(B) further provides that “only labeling or advertising for herbs or herbal ingredients classified within that genus may include the term ‘ginseng.’”

The Farm Bill requirements about use of the term “ginseng” are in effect today because the law is self-executing. Congress did not direct FDA to issue regulations in order to implement these new requirements; therefore, industry must comply with them currently.

Herbs of Commerce, 2nd Edition (2000) establishes a “standardized common name,” expressed primarily in English, for each plant used in commerce, including fungi and algae. However, in a few instances, the standardized common name is expressed in another language or is the same as the plant's Latin binomial name (i.e., genus and species) when that name has become common. For example, the Spanish word “maté” is the standardized common name for the plant “ Ilex paraguariensis A. St.-Hil.,” and the Latin binomial name “ Phyllanthus amarus ” is the standardized common name for the plant “ Phyllanthus amarus Schumach.” The standardized common name generally applies to the whole plant, but in some instances it applies to a plant part. For example, the standardized common names “mace” and “nutmeg” pertain specifically to the plant parts “aril” and “seed,” respectively, of the same plant “ Myristica fragrans Houtt.”

All standardized common names listed in Herbs of Commerce, 2nd Edition (2000) are printed in boldface letters. In this book under “Section One: Latin Binomials,” each plant name is listed first alphabetically by its Latin binomial name. The plant's corresponding standardized common name is stated after the acronym “SCN” on the first indented line of text underneath its Latin binomial name. Under “Section Two: Standardized Common Names,” each plant name is listed first alphabetically by its standardized common name. The plant's corresponding Latin binomial name is stated on the first indented line of text underneath its standardized common name.

In addition to the standardized common name, Herbs of Commerce, 2nd Edition (2000) identifies the currently recognized Latin binomial name and four other categories of common names for each of the plants listed, as applicable. These other categories are:

• “botanical synonym,”

• “Ayurvedic name,”

• “pinyin name,” and

• “other common name.”

The botanical synonym, if any, represents one or more examples of other Latin binomial names that have been broadly used for the plant in the past. The Ayurvedic name, if any, generally represents the plant's Sanskrit name; however, the Hindi name may be cited if the plant is primarily known by it instead. The pinyin name, if any, may be one or more of the plant's Chinese common names. Other common names, if any, represent any additional names frequently used for the plant.

The “standardized common name” is different and distinct from all of the other categories of common names for a plant. There is only one standardized common name that is selected for each plant listed in Herbs of Commerce, 2nd Edition (2000); however, there may be several names cited within one or more of the other categories of common names that are associated with the same plant.

The International Code of Botanical Nomenclature (Saint Louis Code) 2000 (the Code) establishes the current internationally accepted rules that govern the scientific naming of plants, including fungi and algae. The scientific name, which identifies the plant's genus and species, is expressed in Latin and applies to the whole plant without exception. The Latin binomial name of a plant is followed by the name(s) of the person(s) who described and published the plant name in accordance with the Code's guidelines. The Code refers to such notation about authors as an “author citation.”

FDA is proposing to revise § 101.4(h) to substitute Herbs of Commerce, 2nd Edition (2000) for its 1992 edition, and the International Code of Botanical Nomenclature (Saint Louis Code) 2000 for its 1994 edition, as books incorporated by reference. Requirements on how these references are to be used for dietary supplement labeling purposes remain the same and are not affected by this proposed rule, with one minor exception.

Currently, § 101.4(h)(2) uses the phrase “such as” when referring to the International Code of Botanical Nomenclature as a reference that industry may use to ensure that any Latin binomial name of a botanical ingredient listed on the label of a dietary supplement conforms to the internationally accepted rules of botanical nomenclature. As presently worded, the regulation could be interpreted to allow other references to be consulted for this purpose. We are proposing to revise the language in the Code of Federal Regulations (CFR) to make the International Code of Botanical Nomenclature the only reference that may be used on the rules for determining and formatting the Latin binomial name of a botanical ingredient for dietary supplement labeling purposes. This book is internationally recognized by botany experts from nations around the world as the foremost authoritative reference on botanical nomenclature. We are not aware of any comparable reference that comprehensively addresses the rules on the scientific naming of plants and has as broad international support. The International Code of Botanical Nomenclature is regulated by the Nomenclature Section of an International Botanical Congress. This group meets under the auspices of the International Union of Biological Sciences, of which the U.S. National Research Council/National Academy of Sciences is a member. The XVI International Botanical Congress brought together more than 4,000 scientists from more than 100 countries at its most recent meeting held in Saint Louis, MO in 1999 when the International Code of Botanical Nomenclature (Saint Louis Code) 2000 was voted on and adopted. Therefore, to be in harmony with this international cooperation and to be consistent with FDA's science-based philosophy, FDA is proposing to incorporate by reference the International Code of Botanical Nomenclature (Saint Louis Code) 2000 as the one that industry must follow on the rules to determine and format the Latin binomial names of any botanical ingredients stated on dietary supplement labels.

Some dietary supplements may contain a botanical ingredient that is not listed in the 2000 edition of Herbs of Commerce and therefore does not have a standardized common name. Like the current regulation, in such cases the proposed rule would require that the common or usual name for that botanical ingredient listed on the label be accompanied, in parentheses, by the Latin binomial name of the plant from which it is derived. When needed to positively identify the botanical ingredient, the proposed rule would similarly require that the Latin binomial name also include the author citation, stated in accordance with the internationally accepted rules on botanical nomenclature found in the International Code of Botanical Nomenclature (Saint Louis Code) 2000 .

FDA is aware that there may be instances when a botanical ingredient belongs to a subspecies or variety of a species that is not listed in the 2000 edition of Herbs of Commerce . In those cases, the Latin binomial name and author citation alone will not identify the subspecies or variety of that species. Although not a proposed requirement, FDA encourages industry to voluntarily state the following on dietary supplement labels directly after the Latin binomial name when needed to positively identify a botanical ingredient below the species level: The name of any applicable subspecies, variety, or other subdivision and its corresponding author citation, stated in accordance with the internationally accepted rules on botanical nomenclature found in the International Code of Botanical Nomenclature (Saint Louis Code) 2000 .

FDA is proposing to further revise § 101.4(h) to incorporate statutory restrictions on the use of the term “ginseng” that were imposed by section 10806 of the Farm Bill. Specifically, we are proposing to include the following statement in § 101.4(h): “The use of the term ‘ginseng’ as a common or usual name (or part thereof) for any dietary supplement or dietary ingredient is limited to those that are derived from a plant classified within the genus ‘ Panax .’”

Finally, FDA is proposing to make minor wording changes in § 101.4(h) to improve the reader's understanding, consistent with the principles of plain English, or to improve technical accuracy, consistent with internationally accepted botanical terminology. Examples of changes we are proposing to improve the reader's understanding are using simpler language throughout, substituting the word “must” for “shall,” and dividing very long sentences into shorter ones. To be more technically accurate, the proposal would replace the current wording under § 101.4(h)(2) that refers to the “designation of the author or author(s) who published the Latin name” with the term “author citation” to refer to the “name(s) of the person(s) who described and published the Latin binomial name in accordance with the internationally accepted rules on botanical nomenclature found in the International Code of Botanical Nomenclature (Saint Louis Code) 2000. ” For technical clarity, we are proposing to also add the notation “(i.e., genus and species)” after the first reference to the term “Latin binomial name” under § 101.4(h).

Over the years, FDA has received several inquiries from representatives of the dietary supplement industry about the use of Herbs of Commerce and the International Code of Botanical Nomenclature . These books are references for industry to use in determining the common or usual name of each botanical ingredient or to consult on the rules for determining and formatting any required Latin binomial names corresponding to the botanical ingredients declared on dietary supplement labels. The act of “incorporation by reference,” however, does not imply that all of the botanicals that have standardized common names listed in Herbs of Commerce or that follow the scientific naming rules found in the International Code of Botanical Nomenclature are safe for consumption as dietary supplements or other foods by man or other animals. Citation of these books in the CFR is specific and limited to the sole purpose of identifying authoritative references for industry to use to determine the correct plant nomenclature. Neither reference addresses the safety or uses of plants.

This proposed rule focuses only on the naming of botanical ingredients of dietary supplements for labeling purposes. It is the responsibility of manufacturers and distributors to ensure that the particular botanicals they use as ingredients of dietary supplements are safe for human consumption, do not contain contaminants, are properly identified on the label, are legally marketed, and conform to all governing regulations.

In addition, Herbs of Commerce, 2nd Edition (2000) does not represent an authoritative compilation of botanical dietary ingredients that were marketed in the United States before October 15, 1994 (i.e., botanicals that are not new dietary ingredients under section 413(c) of the act (21 U.S.C. 350b(c))). The book's disclaimer explains that the publisher did not verify whether or not the companies that submitted botanical information for inclusion in this reference had valid documentation that supported such marketing. The book's disclaimer further states: “The listing of a particular species of plant in this work is not, therefore, in and of itself, evidence that such species was marketed in the United States prior to October 15, 1994” (Ref. 3, page xx). This proposed rule does not confer FDA endorsement of Herbs of Commerce, 2nd Edition (2000) for any other purpose than to serve as a reference on the common or usual names of botanical ingredients contained in dietary supplements.

In most cases, Herbs of Commerce, 2nd Edition (2000) assigns a unique standardized common name to each plant. However, the book indicates that the same standardized common name is given to more than one plant when the plants are used interchangeably in commerce. There are over 100 instances in Herbs of Commerce, 2nd Edition (2000) where the same standardized common name applies to two or more different species, subspecies, or varieties of the same genus of plant.

In other cases in Herbs of Commerce, 2nd Edition (2000), a name listed under one of the categories of common names (e.g., Pinyin names) for one botanical may be shared by another botanical from a different genus of plants. For example, the botanical Ammi majus L. has the standardized common name bishop's weed, whereas bishop's weed is also listed as the other common name for the botanical Aegopodium podagraria L. that has the standardized common name ash weed.

Confusion and mistakes in the identity of botanicals can be caused when the ingredients have the same or similar common names. Therefore, it is important that manufacturers know a botanical's true identity, including its Latin binomial name with author citation and its biological and chemical properties, before substituting one botanical for another as an ingredient of a dietary supplement. It is the responsibility of manufacturers and distributors to ensure that any botanical used as an ingredient of a dietary supplement or other food marketed in the United States is safe for consumption and complies with all applicable requirements of the act and related regulations.

The “standardized common names” of botanicals listed in both the 1992 and 2000 editions of Herbs of Commerce are consistent with the Farm Bill's definition of the term “ginseng.” However, both editions note that the term “ginseng” has been used as part of “other common names” associated with botanicals from genera other than Panax , including blue ginseng, lesser ginseng, prince ginseng, and Siberian ginseng. We remind industry that names that include the term “ginseng” may be used as the common or usual name for a botanical ingredient only if the botanical is derived from the plant genus “ Panax .”

FDA has determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environment assessment nor an environmental impact statement is required.

FDA has examined the economic implications of this proposed rule as required by Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive order classifies a regulatory action as significant if it meets any one of a number of specified conditions, including: having an annual effect on the economy of $100 million, adversely affecting a sector of the economy in a material way, adversely affecting competition, or adversely affecting jobs. The Executive order also classifies a regulatory action as significant if it raises novel legal or policy issues. We have determined that this proposed rule is not a significant regulatory action as defined by the Executive order.

We have identified the following major regulatory alternatives or options: (1) Take no action, (2) take the proposed action, and (3) take an alternative action. These options are explained in the next section of this document.

The incorporation by reference citations under § 101.4(h) would remain unchanged. Under this option, the following requirements and provisos apply:

A notice of proposed rulemaking by cross-reference to temporary regulations and notice of public hearing appearing in the Federal Register on Monday, July 21, 2003 (68 FR 43058), announced that a public hearing on proposed rulemaking by cross-reference to temporary regulations that provided guidance on identifying disqualified persons and determining whether a plan year is a nonallocation year under section 409(p) and on the definition of synthetic equity under section 409 (p)(5) would be held on Thursday, November 20, 2003, in room 6718, Internal Revenue Building 1111 Constitution Avenue, NW., Washington, DC. Subsequently, the date of the public hearing has been changed to Monday, November 17, 2003. Written or electronic comments must be received by October 17, 2003. Outlines of oral comments must be received by October 27, 2003.

On May 31, 2002, the Postal Service requested comments concerning changes to the Move Update and Address Matching standards (Advance Notice). 67 FR 38041-38043. The Postal Service did not suggest specific Domestic Mail Manual provisions at that time, but sought public comments on five general proposals. As discussed in that notice, changes to these standards were recommended in the 2001 Mailing Industry Task Force, a workgroup joining mailing industry and Postal Service leaders, as an important means to decrease the volume of UAA mail and thereby hold down postal processing and delivery costs.

Thirty-six comments were submitted in response to the Advance Notice. After review of the comments, the Postal Service is proposing specific DMM changes to the Move Update and Address Matching standards and seeks public comment concerning these revisions.

Consistent with the recommendation of the Mailing Industry Task Force, the Postal Service believes that appropriate revisions to the standards are vital to the continued vitality of the postal system and the interests of mailers. The Postal Service is committed to taking prudent steps in coordination with the mailing industry to create and maintain a cost-efficient mailstream. Over the years, the Service has invested heavily to create an automated mailstream to help drive costs out of the delivery system. However, although an efficient automated mailstream depends on accurate barcodes for success, barcodes are only as accurate as the quality of the addressing information that is their foundation. As discussed in the Advance Notice, revisions to the Move Update and Address Matching standards are needed to improve the level of address quality for mailings entered at discounted rates. The Postal Service remains convinced that high quality addressing, best possible depth of ZIP+4 codes, and (where applicable) accurate delivery point barcodes that result in the delivery of the mailpiece to the intended recipient, in an efficient manner, should be primary objectives for mailers.

The Advance Notice proposed five changes to existing address quality standards, including: (1) Expand the applicability of a Move Update requirement from Presorted and automation rate First-Class Mail to include Periodicals, Standard Mail, and Package Services, (2) increase the minimum frequency of Move Update processing from 180 days to 90 days, (3) remove the use of ancillary service endorsements with individual hardcopy notifications as a stand-alone option to satisfy the Move Update requirement, (4) increase the frequency of Address Matching processing for automation rate mail from 180 days to 90 days, and (5) require the use of monthly (instead of bimonthly) directory updates for address matching software.

In addition to revisions to DMM standards, the Advance Notice also addressed the timing of the changes. When the Move Update requirement for First-Class Mail was instituted in 1997, a 9-month readiness period was provided. The Postal Service recognizes the magnitude of the adjustments that will have to be made both by the industry and the Service to implement the revisions proposed in this notice and will ensure that ample time is provided. It is not the intention of the Postal Service to create unreasonable barriers to discount rate qualification with these changes, but rather to improve the overall cost effectiveness of the mail delivery system and rate stability for all stakeholders.

As stated in the Advance Notice, the evaluation and implementation of these proposals will continue to be stewarded by the Postal Service Product Management Group, within the framework of the Product Redesign effort.

Part A of this notice summarizes the proposed changes and provides an analysis of comments received to the Advance Notice. Part B summarizes the changes to the DMM, followed by the text of the proposed DMM standards.

Several comments were outside the scope of the changes that were proposed. These comments, such as pursuing legislative changes, redefining the characteristics of a mailing list, etc., will not be discussed in this notice. Five proposals were described in the Advance Notice. Each proposal will be discussed separately:

The Postal Service proposes that the Move Update standard, which previously applied only to First-Class Mail, be extended to other classes ( i.e. Periodicals, Standard Mail, and the Bound Printed Matter subclass of Package Services) (Please note, Package Services was originally proposed but was amended to Bound Printed Matter in response to the comments received). Given the growth and significant impact of UAA mail across all classes of mail, the Postal Service believes it is reasonable to adopt the same standard for those seeking to use discounted rates in other classes of mail. However, the Postal Service also desires that this be done in a manner that does not unreasonably impact the mission and flexibility of each class of mail. To this end, the Postal Service will, where feasible, incorporate features suggested in the comments and add tools that can assist the expansion of Move Update to all classes. As one example, suggested in the comments, the Postal Service has already authorized the printing of the Address Change Service (ACS) participant code on the mailpiece in a location other than within the mailer's keyline of the address block. This option became effective October 3, 2002 (see Postal Bulletin 22086, October 3, 2002) and was incorporated into the online version of DMM M013 ( http://pe.usps.gov ).

Six commenters expressed support for the proposed expansion of the Move Update requirement beyond Presorted and automation rate First-Class Mail to other classes of mail.

Several commenters stated that unless the status quo were maintained, specifically use of ancillary service endorsements as a qualifier, they would not be able to meet the proposed Move Update requirement. The Postal Service respectfully disagrees on this point and believes that the methods that will be available upon implementation are flexible and efficient and that they will meet the needs of all mailers seeking discounted rates when Move Update is a requirement. The current list of authorized methods includes the following:

• National Change of Address (NCOA) processing.

• NCOA Link processing (scheduled availability October 1, 2003).

• FASTforward ® MLOCR processing.

• FASTforward ® Mailing List Correction (MLC) processing.

• Address Change Service (ACS).

• Postal Service Certification of Mailer Move Update Process, administered by the National Customer Support Center (NCSC).

• NCSC-approved alternate method for mailers with certain legitimate restrictions to incorporating Postal Service supplied change-of-address information into their mailing address lists.

In addition to the seven authorized Move Update methods listed above, as suggested by four of the commenters, addresses utilizing any of the three alternative addressing formats prescribed in DMM A020 ( e.g. , “John Doe or Current Occupant”) will not be subject to the Move Update standard. The Postal Service agrees that this exemption is warranted because mail bearing an alternative address format does not cause the Postal Service to incur additional redirection processing or disposal costs.

Another step already taken by the Postal Service to assist mailers who may not be able to process electronic ACS data files is the augmentation of ACS with a hybrid hardcopy address correction notification. This ACS option brings both quality and efficiency to the process by providing legible hardcopy printout notifications to mailers who desire them. This option is discussed in detail in the third proposal narrative regarding ancillary service endorsements.

One commenter suggested a phased approach to implementation, with First-Class Mail being the first to incorporate the new requirements in 18 months from the publication date of the final rule, followed by the other mail classes 6 months to 1 year later. The Postal Service believes that there are several sound reasons why the phased approach suggested is not warranted in this case: (1) Since the publication of Federal Register Advance Notice (67 FR 38041-38043), the Postal Service has decided to integrate the changes proposed in this notice into a future formal Product Redesign initiative or omnibus rate case which will provide sufficient time for mailers to incorporate the new requirements, and significantly more time than the nine months allotted for the Move Update requirement originally instituted for First-Class Mail service in 1997, (2) the technical environment and capabilities of the mailing industry are more advanced and progressive than when Classification Reform was being implemented in 1996/97, (3) many mailers who utilize other mail classes also send First-Class Mail items and are familiar with the Move Update requirement, (4) the Postal Service has made significant efforts since 1996 to acquaint the mailing industry with the necessity of effective Move Update methodology, and (5) a uniform implementation will provide needed consistency for all concerned.

A majority of addresses used by mailers today for Periodicals, Standard Mail, and Package Services mail are also used in Presorted and automation rate First-Class Mail and therefore already receive “Move Update treatment”. This is consistent with the policy established in 1997 for First-Class Mail whereby an updated address originally used on another class of mail meets the Move Update requirement for First-Class Mail.

Several commenters stated that incentives would be needed to offset their cost of Move Update processing where it has previously not been a requirement, as well as for the increased frequency requirements of Move Update for First-Class Mail and Address Matching for all classes.

The Postal Service believes that ensuring that mail, regardless of the class of mail, is prepared to the correct recipient and address, and thereby removing UAA mail from the mailstream ultimately leads to cost savings for both the mailer and the Postal Service. In addition to helping control Postal Service costs and their associated impact on rates, the increase in address quality will benefit mailers by reducing wasted mail production costs and loss of business opportunities that result from UAA mail.

One commenter stated that a Move Update requirement for Periodicals was “ludicrous.”

The Postal Service finds this comment somewhat puzzling in that Periodicals mail has long included an address correction requirement. This requirement is found in the printed request for change-of-address information included in the identification statement that each publication must show. This request for change-of-address information may also appear on the label carrier or the container enclosing publications prepared in envelopes, closed wrappers or polybags. This proposal merely formalizes the requirement and methods.

The same commenter also stated that the Move Update requirement should be more “user-friendly” and recognize mailers who have their own processes in place to accurately reflect the relocation of their customers for mailing purposes.

The Postal Service agrees with this position; it was the driving force behind the creation of the Mailer Move Update Process Certification (previously known as the 99% rule alternate method) for Move Update compliance. Under this method, mailers can have their own Move Update process tested by the Postal Service. If the test demonstrates that the mailer's addresses are 99% accurate when compared with the Postal Service change-of-address file, the mailer will be certified as having addresses that meet the Move Update requirement for a period of 1 to 2 years (depending on the length of time the mailer has used this option) from the date of the test.

Eight commenters expressed concerns regarding possible negative impact to Standard Mail.

Although the Postal Service understands this issue, it believes that the requirement is both appropriate and fair for Standard Mail automation rate, Presorted rate, and Enhanced Carrier Route rate eligibility. Many mailers of Standard Mail successfully utilize the NCOA and FASTforward ® MLC systems to improve the quality of their lists. Therefore, this requirement should not have a major impact on their business models. The Postal Service also believes that the choices available to meet the Move Update requirement, along with the wide use of alternative addressing formats on Standard Mail ( e.g. “John Doe or Current Resident”), provide sufficient flexibility for meeting the requirement and will, therefore, not pose a greater challenge for mailers of Standard Mail than for mailers of other classes.

One commenter questioned the proposed application of the Move Update provisions to Standard Mail because unendorsed Standard Mail is disposed of as waste, if undeliverable.

Although it is true that Postal Service procedures call for disposal of such mail (as well as unendorsed BPM), there is a cost associated with this action. The Postal Service incurs an average cost of 4.5 cents per piece for disposal. Additionally, it is doubtful that the sender's intent is for their strategic message not to be delivered and miss potential business opportunities. To continue this scenario is not in the best interests of a cost-efficient mailstream, and the Postal Service maintains that a discount should not be provided for mail bearing addresses where no steps have been taken to mitigate this occurrence.

One commenter voiced concern regarding possible negative impact to Bound Printed Matter (BPM) mailings.

After due consideration, the Postal Service believes that the Move Update requirement is both appropriate and fair for BPM Presorted and Carrier Route qualification, including machinable parcels claiming a parcel barcoded discount or flat-size pieces claiming a POSTNET barcoded discount. The Postal Service does not believe that the Move Update requirement will pose a greater challenge to BPM mailers than to those in using other classes of mail. A majority of BPM consists of the same content as Standard Mail ( e.g. , advertising, catalogs, and directories) and would, except for weight, qualify as Standard Mail. In fact, many mailers “bundle” individual Standard Mail pieces for the same address and create a single addressed BPM mailpiece.

After due consideration of the comments expressed, the Postal Service proposes to expand the Move Update standard to include Periodicals, Standard Mail, and the Bound Printed Matter subclass of Package Services mail.

The Postal Service proposes to increase the minimum frequency of Move Update processing from 180 days to 95 days (90 days was originally proposed but was amended to 95 days in response to the comments received).

Five commenters voiced general support for the proposal, while several other commenters had specific concerns regarding this Move Update provision.

One commenter expressed concern that with the requirement to update addresses more frequently, the existing NCOA licensees would not be able to keep up with the demand for Move Update processing.

The Postal Service believes the existing group of licensees has the capacity to provide the service within the terms of their license (process and return address files within 7 business days of receipt). The Postal Service will continue to monitor this situation and if it determines that a justifiable need exists, it will increase the number of licensees.

One commenter stated that mailers using an NCSC-approved alternate Move Update method would not be able to meet the proposed standard, because they have certain legitimate restrictions on incorporating Postal Service-supplied change-of-address information into their mailing addresses.

The Postal Service believes this change will not have any impact on these alternate processes. Under existing standards, the mailer must contact an addressee within 30 days after receiving the change-of-address information and incorporate the change of address within 30 days of receipt. These timeframes already fall within the proposed requirement.

One commenter voiced concern that the reduced window for processing will have a negative effect due to the planning cycles currently in use by many mailers.

The Postal Service understands that certain operational changes are necessary for the mailing industry to implement this proposal. The UAA mail problem is of such magnitude that it is in the best interests of all stakeholders to modify current practices in order to mitigate it. The Postal Service also recognizes that some mailers who are proactively trying to reduce UAA mail within their own operations have already set quarterly production cycles for their Move Update and Address Matching processing. To allow mailers to continue these processing cycles and not have to periodically make additional processing runs due to variations in calendar dates, the Postal Service proposes that the processing requirement, which is based on the number of day prior to mailing, will be modified from the originally proposed 90 days to 95 days.

The Postal Service proposes to remove the stand-alone use of ancillary service endorsements as an option to satisfy the Move Update standard.

Many of the commenters perceived that the purpose of this proposal was to totally eliminate all use of ancillary service endorsements.

To clarify, this is not the case. All ancillary service endorsements will still be available as mailpiece handling instructions for commercial mail. This proposal is designed to effectively separate basic mailpiece-handling instructions, which is the core function of endorsements, from efficient address correction notification methods where Move Update activity is required. Under this proposal, stand-alone ancillary service endorsement use will not be recognized as a method to satisfy the Move Update standard. Ancillary Service Endorsements may still be used on mail with addresses that are updated via one of the approved Move Update methods ( e.g., Address Change Service, NCOA, FASTforward®, etc. ). More than six years of practical experience with the Move Update requirement for First-Class Mail has shown that individual manual hardcopy notifications generated from the stand-alone use of ancillary service endorsements are the least effective and most costly Move Update method for all concerned.

Additionally, one commenter pointed out that mailers who desire mailpieces to be returned and not forwarded would be penalized by this proposal, as there is currently no electronic ACS option available for returns.

The Postal Service agrees that a post-mailing electronic option should be available in this instance and, if this proposal is adopted, will take the necessary action prior to implementation to make the “Return Service Requested” endorsement available within the ACS system.

Several commenters indicated that, for various reasons, hardcopy address change notices generated from stand-alone ancillary service endorsements are the only method they can use to meet a Move Update requirement. They expressed a concern that the ACS system was not a viable alternative for them.

As previously explained, the Postal Service believes that the options available to comply with Move Update standards are both flexible and efficient enough to meet the needs of all parties seeking discounted rates.

Specifically to this point, at the time Move Update first became a requirement for First-Class Mail automation and Presorted rates, the ability of the Postal Service to provide a robust electronic/hardcopy hybrid ACS service did not exist as it does today. Since the inception of the Move Update standard, the Postal Service has worked to create enough flexibility within the ACS system to meet mailers' needs, while at the same time lowering the cost. There is, for all practical purposes, a limitless supply of ACS participant codes available that can be used in those situations where multiple departments and/or list situations are involved. Additionally, as noted earlier in the Summary section, the option for mailers to print the ACS participant code on the mailpiece itself was made effective on October 3, 2002.

The end-result of these efforts is the ACS printout notification option, which provides printable hardcopy notifications, in an electronic file, to those who desire them. This option provides quality in the form of a computer-generated report, timely fulfillment back to the sender so that the address corrections can be incorporated quickly to prevent future UAA mail, and a cost-effective process for both the mailer and the Postal Service.

The Postal Service is convinced that this ACS hardcopy notification option is a viable alternative to stand-alone ancillary service endorsements since it provides “best practice” efficiency to the business of hardcopy notifications. In addition, effective January 1, 2003, ACS change-of-address information is now available, at no additional charge, on CD-ROM media. This provides small- and medium-sized mailers with an easy, cost-effective method for viewing, searching, and printing change-of-address records in order to update their address files manually.

As put forth in the Advance Notice of May 31, 2002, individual hardcopy address correction notifications triggered from stand-alone use of ancillary service endorsements do not significantly reduce costs for either the mailer or the Postal Service. However, ancillary service endorsements used in conjunction with ACS do provide benefits not obtained by stand-alone use of ancillary service endorsements. Again, these facts cause the Postal Service to conclude that the existing (stand-alone) use of ancillary service endorsements and individual hardcopy notifications or return of UAA mailpieces will no longer be a permissible qualification method in and of itself to meet the Move Update requirement.

The Postal Service proposes to increase the minimum frequency of Address Matching processing for automation rate mail from 180 days to 95 days (90 days was proposed in the Advance Notice but is now amended to 95 days in response to the comments received).

Five commenters voiced general support for the proposal to increase the frequency of the required use of address matching software.

Four commenters recommended that the Postal Service develop a clearly defined schedule when software vendors and end-users must update and implement the Address Matching software changes.

The Postal Service already has a clearly defined process in place for software developers to submit their Address Matching software for Coding Accuracy Support System (CASS) certification. As a condition for CASS certification, all changes in Address Matching software requirements are announced at the annual CASS “Partnership in Tomorrow” meeting each August. Generally, the required changes are effective the following July 31 (11 months later). Furthermore, current DMM A950 sets forth the schedule of frequency of use for Address Matching software and the Postal Service database.

Several commenters urged the Postal Service to set timeframes and deadlines that vendors must meet for providing their updated products to end-users.

Although the Postal Service understands the end-users' point of view, it is reluctant to regulate the business practices between vendors and their customers. The Postal Service is committed to taking the necessary steps to ensure that its product distribution timetables to the various vendors are met. If the vendor does not provide the software updates in a timely manner, the customer must determine whether to pursue a legal remedy or other action. As is the case with other industries, it is reasonable to expect that substandard vendors will lose their place in the market.

One commenter voiced concern that the reduced window for processing will have a negative effect due to the planning cycles currently in use by many mailers.

The Postal Service understands that certain operational changes are necessary for the mailing industry to implement this proposal. The UAA mail problem is of such magnitude that it is in the best interests of mailers and the Postal Service to modify current practices in order to mitigate it. The Postal Service also recognizes that some mailers who are proactively trying to reduce UAA mail within their own operations have set quarterly production cycles for their Move Update and Address Matching processing already. To allow mailers to continue these processing cycles and not have to periodically make additional processing runs due to variations in calendar dates, the processing requirement will be modified from the proposed 90 days to 95 days.

Another option currently available to mailers to assist with narrow processing windows is the use of Z4Change list matching as defined in DMM A950.3.2. Furthermore, in the interest of consistent processing requirements, it is proposed that the 90-day Address Matching standard for Periodicals and Standard Mail sent at carrier route rates be modified to 95 days. It should be noted that although concerns about the frequency of matching were also expressed when the 90-day carrier route rate requirement was first implemented, mailers were able to adjust their mailing processes to meet the list processing window.

Due to the high rate of change in addressing data, the Postal Service believes that the benefits are worth the behavioral changes that the mailing industry and the Postal Service would have to make to reduce UAA mail volumes.

The Postal Service proposes to require the use of monthly (instead of bimonthly) directory updates for address matching software. This proposal goes “hand in hand” with the revisions in the fourth proposal. That is, the adoption of one strategy without the other would sacrifice the desired improvement in efficiency and quality of the Address Matching process.

One commenter felt that there was some confusion regarding the difference between the two.

To clarify, the Postal Service respectfully points out that the fourth proposal from the Advance Notice modifies the cycle time in which addresses must be processed through Postal Service CASS-certified Address Matching software in order to qualify for discounted rates. This proposal modifies the cycle that the address directories used in conjunction with CASS-certified software must be updated prior to processing addresses.

In order to ensure understanding of these standards, the Postal Service will provide further guidance concerning these processes in publications including the CASS Technical Guide, the Postal Bulletin, and the Mailer's Companion.

It should be remembered that the following DMM revisions are proposals only and are presented to assist mailers with their review and comments. The proposed DMM changes below are to the current DMM which includes “organizational” changes made via Postal Bulletin 22104, June 12, 2003. To view the current DMM go to http://pe.usps.gov.

Although exempt from the notice and comment requirements of the Administrative Procedure Act [5 U.S.C. 553(b), (c)] regarding proposed rulemaking by 39 U.S.C. 410(a), the Postal Service invites comments on the following proposed revisions to the Domestic Mail Manual, which is incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.

Several background documents on right whales and the critical habitat designation process can be downloaded from the NOAA Fisheries Web Site at http://www.nmfs.noaa.gov/ .

Right whales in the North Atlantic are one of three populations of endangered right whales worldwide. The other populations occur in the North Pacific and the Southern Hemisphere. The southern right whale is recognized as a separate species and, until recently, the North Atlantic and North Pacific stocks were defined as a single species. However, recent genetic studies provided evidence that supported separating species status for these two populations, one in the North Atlantic and another in the North Pacific. On April 10, 2003, NMFS published a final rule (68 FR 17560) concerning the nomenclature and taxonomy of right whales, which formally acknowledges these scientific findings by changing the species name of the northern right whale as follows: the North Atlantic right whale, Eubalaena glacialis , and the North Pacific right whale, Eubalaena japonica . These technical changes did not affect the listing status of these species under the ESA (all three remain “endangered”).

The North Atlantic right whale is one of the world′s most critically endangered species of large whale (Clapham et al. 1999). Despite nearly three-quarters of a century of international legal protection, the right whale has not shown any recovery towards its pre-exploitation numbers. Recent studies on the current population trend in right whales suggest that, if the population decline is not reversed, the species is likely to become extinct in less than 200 years (Caswell et al. 1999). More than 800 years of uncontrolled and intense hunting is the primary reason that the right whale population has declined to such a precarious level. Today, ship strikes and entanglements in fishing gear are the primary, human-related causes of serious injury and mortality to right whales that impede the species′ recovery.

Exploitation: North Atlantic right whales were the first target of commercial whaling and, consequently, the first large whale species to be hunted to near extinction by such efforts. Several characteristics specifically attributable to the right whale made it a highly desirable resource, such as its large yield of commercially valuable products (e.g., oil and baleen), its slow swimming speed, its distinction of floating when dead, and its generally coastal distribution. These factors also contributed to the whale′s common name, which is said to have originated from the English whalers who designated this species of whale as the “right” (i.e., correct) whale to hunt.

The commercial harvest of right whales began with Basque whalers taking substantial numbers of them as early as the 1500s in the Strait of Belle Isle region (Aguilar, 1986). As the stocks in the eastern North Atlantic became depleted, hunting effort shifted to the western North Atlantic, off the Labrador and New England coasts. This intense period of early whaling may have resulted in a significant reduction in the stock of right whales by the time colonists in the Plymouth area began hunting for right whales in the 1600s (Reeves and Mitchell, 1987). A modest but persistent whaling effort along the coast of the eastern United States lasted three centuries, and the records include one report of 29 whales killed in Cape Cod Bay in a single day during January 1700. The right whales′ vulnerability to over-exploitation was noticed as early as the 19 th century. For example, in 1851, Herman Melville wrote that, although still numerous at that time, the right whale could vanish from the earth under the hunting pressure then being applied to the species. However, Melville′s prophetic observation went largely ignored for over 80 years, and the traditional high-seas Yankee whale fishery made way for a modern, industrial, and efficient whaling fleet. Finally, in 1935, the species had declined to such low levels that the League of Nations was able to get most whaling nations to agree to stop hunting right whales.

Abundance and Trends: An estimate of the pre-exploitation population size of right whales is not available. However, based on historical catch levels, right whale abundance probably exceeded 10,000 animals. The historic range of North Atlantic right whales extended from as far south as Florida and northwestern Africa to as far north as Labrador, southern Greenland, Iceland, and Norway (Kenney, 2002). Commercial whaling severely depleted the population to the point where right whales are no longer abundant in portions of their historical range (e.g., the Strait of Belle Isle, Newfoundland, the coastal waters of Long Island, New York, and Delaware Bay). Therefore, the present range of North Atlantic right whales, from Florida to Nova Scotia, is considerably reduced from its historic extent.

The best estimate of present abundance is about 300 animals. In 1998, the right whale population size was estimated to be 291 individuals (Kraus et al. , 2001) based on a census of individual whales identified using photo-identification techniques. It is assumed that the census of identified and presumed living whales represents a minimum population size estimate. However, the true population size in 1998 may have been higher if: (1) there were animals not photographed and identified; and/or (2) some animals presumed to be dead, actually, were not.

The population growth rate reported for the period 1986-1992 by Knowlton et al. (1994) was 2.5 percent (CV=0.12), which suggested that the species was showing signs of a slow recovery. However, more recent work by Caswell et al. (1999) has suggested that crude survival probability declined from about 0.99 in the early 1980s to about 0.94 in the late 1990s. The decline in survival probability is statistically significant. Additional work conducted in 1999 concluded that survival had indeed declined during the 1990s (Best et al., 2001). Although heterogeneity of capture could negatively bias survival estimates, subsequent review of this study concluded that this factor could not account for all of the observed decline, which appeared to be particularly marked in adult females.

Seasonal Movement and Habitat: Right whales migrate annually between high-latitude feeding grounds and low-latitude calving and breeding grounds. In general, most of the whales spend the spring and early summer off the coast of New England, then, in the latter part of the summer and fall, move to the waters off southern Canada. Some whales may remain in these northern waters throughout the winter, but the majority leave. Therefore, the exact location of a large segment of the population is unknown during the winter. A small fraction of the population, consisting almost entirely of pregnant females and juveniles, migrates south in the winter to the only known calving ground for the species - the coastal waters of Georgia and northeast Florida.

Breeding and Calving: The precise location of a breeding ground for right whales has not been identified. However, as North Atlantic right whales have been observed engaging in breeding-like behavior throughout much of their range, the concept of a specific breeding ground may not be relevant for this species.

The only known current calving ground in the western North Atlantic is in the coastal waters of the southeastern United States, especially the shallow waters from Savannah, Georgia, south to Cape Canaveral, Florida. It has been speculated that other coastal areas, such as Delaware Bay and Cape Cod Bay, may have been calving grounds before the population was decimated by whaling (Kenney, 2002).

Prey: Right whales feed exclusively on zooplankton, especially on large calanoid copepods (mostly of the genera Calanus and Pseudocalanus ). At times, they also feed on juvenile euphausiids (also known as krill), smaller copepods, pteropods (tiny planktonic snails), or the planktonic larval stages of barnacles and other crustaceans (Kenney, 2002).

The waters along the New England coast are a primary feeding habitat for the right whale. Research suggests that right whales must locate and exploit extremely dense patches of zooplankton to feed efficiently (Mayo and Marx, 1990). These dense zooplankton patches are known to occur in the spring, summer, and fall right whale habitats from Cape Cod Bay to the Bay of Fundy.

The right whale was listed as endangered under the Endangered Species Conservation Act, the precursor to the ESA, on June 2, 1970 (35 FR 8495; codified at 50 CFR 17.11). The species was subsequently listed as endangered under the ESA in 1973, and as depleted under the Marine Mammal Protection Act in the same year. NMFS has the lead responsibility for developing, implementing, and monitoring a recovery program for this species.

NMFS published a Final Recovery Plan for the Northern Right Whale (Recovery Plan) in 1991, and a draft, revised Recovery Plan in 2001. Habitat related objectives were identified in the 1991 Recovery Plan, as well as in the 2001 draft revision. One of these objectives was to characterize known habitats of special importance to the species, identify other habitats essential to the conservation of the species, and protect these areas as necessary. Additional objectives of the Recovery Plan concerning habitat include the collection of new data and analysis of available data to assess the need for expanding or modifying the existing critical habitat boundaries.

NMFS was petitioned by the Right Whale Recovery Team to designate critical habitat for right whales on May 18, 1990. A notice was published in the Federal Register on July 12, 1990 (55 FR 28670), requesting information and comments on the petition. The proposed critical habitat designation was published on May 19, 1993 (58 FR 29186), and the final rule was published on June 3, 1994 (59 FR 28793; codified at 50 CFR 226.203). Areas included in the initial critical habitat designation were identified primarily on the basis of use by right whales. The designation recognized and discussed important characteristics of these habitats that relate to aspects of right whale biology, such as foraging, calving, and nursing. Specifically, this designation includes portions of Cape Cod Bay and Stellwagen Bank, the Great South Channel (each off the coast of Massachusetts), and waters adjacent to the coasts of Georgia and the east coast of Florida.

On July 11, 2002, NMFS received a petition dated July 9, 2002, from The Ocean Conservancy requesting that NMFS revise the current critical habitat designation for North Atlantic right whales by expanding its boundaries in both the Northeast and Southeast U.S. The petitioner requests that NMFS expand the existing Southeast critical habitat designation to the following coordinates: 31° 30′ N to 29° 40′ N from the shoreline out to thirty nautical miles; 29° 40′ N to 28° 00′N from the shoreline out to ten nautical miles. The petitioned area would add approximately 2,700 nm2 (5,003.6 km2) to the current critical habitat coverage. The petitioner also requests that NMFS expand and combine both the existing Northeast critical habitat designations (Cape Cod Bay and Great South Channel) into one critical habitat area bounded by the following coordinates: 41° 41.2′N/69° 58.2′W; 41° 00.0′N/69° 05.0′W; 41° 00.0′N/68° 13.0′W; 42° 12.0′N/68° 13.0′W; 42° 12.0′N/70° 30.0′W; 41° 46.8′N/70° 30.0′W; and on the southwest corner by the shoreline of Cape Cod, MA.

The petitioner states that 10 years of new data regarding right whale distribution and causes of mortality along the east coast of the United States show that the current critical habitat designation is not sufficient to protect right whales from further anthropogenic mortality. According to the petitioner, the additional critical habitat contains several features essential to the conservation of the right whale in the western North Atlantic that may require specific protection or management considerations to ensure the survival and recovery of the species. The petitioner stated that the areas petitioned for expanded critical habitat experience high levels of human disturbance in the form of shipping activities, fisheries, military activities, dredging operations, increased pollution, and general habitat disturbance. The essential features associated with the petitioned critical habitat according to the petitioner include the following: space for individual and population growth and for normal behavior; food, water, air, light, minerals or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction and rearing of offspring; and habitats that are protected from disturbance or are representative of the historical, geographical, and ecological distributions of species.

The petitioner acknowledged that some areas in the northeastern U.S. have already received special management attention in the form of fishing regulations, but maintains that essential right whale habitat along the eastern seaboard lacks protection from ship strikes. In addition, the petitioner noted that when several habitats, each satisfying the requirements for designation as critical habitat, are located in proximity to one another, an inclusive area may be designated as critical habitat.

The petitioner stated that the continued high mortality of North Atlantic right whales from ship strikes indicates the immediate need for management actions to reduce ship strikes, maintaining that accurately designated critical habitat boundaries will facilitate the management process. In addition, the petitioner stated that since the time critical habitat was originally designated in the southeastern U.S., extensive and expansive survey efforts have shown that right whales occur further offshore than originally known. The petitioner contended that the importance of this area as the only known calving ground for right whales warrants the revision of critical habitat to protect the animals within this region.

Section 4(b)(3)(D) of the ESA requires that NMFS, to the maximum extent practicable, within 90 days after receiving a petition to revise existing critical habitat, make a finding as to whether the petition presents substantial scientific information indicating that the petitioned action may be warranted and publish the finding in the Federal Register . If the finding is that substantial scientific information is presented, NMFS is required, within 12 months of the date the petition was received, to make a determination on how it intends to proceed with the requested revision and promptly publish notice of such intention in the Federal Register .

On November 19, 2002 (67 FR 69708), NMFS published a notice finding that the subject petition contained substantial scientific information indicating that the requested revision of right whale critical habitat may be warranted and inviting interested persons to submit comments and information concerning revision. NMFS′ finding was based on the agency′s concurrence with petitioner′s statement that extensive and expanded survey efforts in the southeast indicate that right whales occur farther offshore than previously known, and that the draft final recovery plan suggested that data should be analyzed to assess expanding or modifying the critical habitat boundaries.

NMFS received over 2,000 letters and postcards during the comment period. The comments are addressed in the following paragraphs.

Comment 1: Hundreds of people sent form letters and post cards expressing support for the proposed expansion of right whale critical habitat, based on the belief that it will more accurately reflect the distribution and range of the species and provide a mechanism to achieve greater protection. Another commenter suggested that NMFS designate the entire known range of North Atlantic right whales as critical habitat.

Response: Recent NMFS surveys have documented the consistent use of areas outside of the currently designated critical habitats by right whales (Zoodsma et al., 1999; Merrick et al., 2001). However, more analyses of the sightings data and their environmental correlates are necessary to define and designate these areas as critical habitat. Furthermore, the ESA requires that the process for designating critical habitat must focus on the identification of specific habitat features (i.e., primary constituent elements) essential to right whale conservation that may require special management considerations or protection, rather than only on known distribution. If the physical and biological features essential to the conservation of right whales are identified and determined to be distributed outside of current critical habitat boundaries, NMFS will evaluate the addition of areas containing these features to the designated critical habitat, in accordance with the requirements set forth in sections 3(5)(A) and 4(b)(2) of the ESA.

Comment 2: Two commenters recommended that NMFS review the available data and, based on that review, expand the current critical habitat as warranted. In addition, these commenters recommended that NMFS contract or prepare a report similar to the one prepared for the Marine Mammal Commission in 1991, which assesses right whale sighting data and human activities in and around the three existing right whale critical habitat areas. Such a report could be used to identify and evaluate the most appropriate critical habitat boundaries.

Response: NMFS agrees that the available data should be reviewed and, based on that review, NMFS could proceed to revise critical habitat. NMFS intends to proceed with the analyses necessary to evaluate the necessity of revising critical habitat based on the need to protect the habitat features essential to the conservation of right whales. Finally, NMFS will consider the recommendation to solicit a contractor to prepare a report that assesses right whale sighting data and human activities in and around the three existing right whale critical habitat areas.

Comment 3: In addition to supporting the proposed expansion of critical habitat, several commenters suggested that NMFS include other areas shown to be regularly frequented by right whales that are outside of the petitioned area. For example, these commenters specifically suggested including Jeffreys Ledge, Platts Bank, Fippennies Ledge, and Cashes Ledge because of their seasonal use as feeding habitat. Furthermore, these commenters suggested that the Seasonal Area Management (SAM) areas northeast of the Great South Channel should receive equal consideration as critical habitat.

Response: See response to Comment 1.

Comment 4: With respect to the petitioned revision in the Southeast, one commenter expressed support for the need to expand critical habitat beyond the current boundaries because recent surveys have shown regular and significant numbers of right whales in these waters.

Response: See response to Comment 1.

Comment 5: Several commenters expressed support for federal efforts to protect and recover right whales, including the concept of expanding critical habitat based on the availability of new data, but did not support the petitioned revision because the information provided by the petitioner is insufficient. Therefore, these commenters suggest that NMFS conduct further analysis and research on right whale distribution, including the identification of “high-risk” areas. Specifically, these commenters recommend an analysis of all right whale sightings since 1994 using a Sightings-Per-Unit-Effort analysis, which will provide scientists and managers with a more precise representation of spatial and temporal patterns of right whale habitat use.

Response: NMFS agrees that further analysis of the available data is warranted to better understand what areas are most frequented by right whales so that we may better manage the threat of takes. In addition, more analyses of the sightings data and their environmental correlates are necessary to define and designate additional areas as critical habitat. NMFS notes, however, that any revision of critical habitat will reflect habitat features essential to conserving the North Atlantic right whale population.

Comment 6: One commenter expressed concern that a revised and expanded critical habitat would unnecessarily restrict military training/operations in additional open ocean areas.

Response: As Federal agencies, under section 7 of the ESA, the branches of the U.S. military are required to consult with NMFS (or U.S. Fish and Wildlife Service) to ensure that their actions are not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of critical habitat. NMFS does not agree that it is a forgone conclusion that the revision of critical habitat will restrict military operations along the East Coast. A designation or revision of critical habitat assists Federal agencies in planning future actions, since the designation or revision identifies, in advance, those habitat features that will be given special consideration through section 7 consultations. Therefore, potential conflicts between projects and endangered species can be identified early in the planning process.

Comment 7: One commenter expressed opposition to the petitioned revision to critical habitat because he/she believes it is unnecessary and would only lead to more petitions to designate critical habitat until the entire Atlantic Ocean is critical habitat.

Response: The public's right to petition NMFS to designate or revise critical habitat is expressly provided for in the ESA, and the agency can neither prohibit the exercise of this right nor ignore the petitions it receives with respect to such actions. In addition, the regulations at 50 CFR 424.12(g) provide NMFS with the authority to revise existing critical habitat when new data become available. As explained later on in this Notice, NMFS believes that the requested revision of critical habitat, as specified by the petitioner, is not warranted at this time. However, NMFS intends to proceed with the specified activities to determine whether a revision of critical habitat is warranted.

Comment 8: One commenter expressed the belief that a revised critical habitat designation would not be an effective mechanism for reducing the levels of right whale mortalities. In light of the commenter's belief that there is no link between the extent of critical habitat boundaries and levels of anthropogenic mortality, this commenter suggests that NMFS take immediate action to require universal gear modifications as the most effective means for enhancing the protection of right whales.

Response: The revision of critical habitat would likely not directly address the “take” issue to which this comment refers. The designation of critical habitat, in itself, does not necessarily lead to additional management measures. Under the ESA, the only direct impact of a critical habitat designation is through the provisions of section 7. Section 7 applies only to actions with Federal involvement (e.g., authorized, funded, conducted), and, through the consultation process, requires modifications to those projects that would result in the destruction or adverse modification of the primary constituent elements in designated critical habitat areas. Accordingly, NMFS would address the need for management measures for commercial fishing in critical habitat through the ESAs section 7 consultations on the fisheries regulated by NMFS and the Atlantic Large Whale Take Reduction Plan (ALWTRP). Indirectly, critical habitat designations also help focus Federal, state, and private conservation and management efforts in those areas. Recovery efforts may address special considerations needed in critical habitat, including conservation regulations to restrict private as well as Federal activities. Finally, it is important to note that the recommendation for special gear modifications designed to reduce serious injury to or mortality of right whales is more appropriate within the context of NMFS' Atlantic Large Whale Take Reduction Team (ALWTRT) than in the context of a petition to revise critical habitat.

Comment 9: Three commenters expressed opposition to the proposed expansion of critical habitat because it would lead to further regulation of state fisheries while continuing to bypass the shipping industry. In addition, these commenters urged NMFS to implement rules that would specifically protect right whales from ship strikes.

Response: First, the designation or revision of critical habitat does not, in itself, restrict non-Federal activities within the area or mandate any specific management or recovery action; as discussed above, a designation of critical habitat triggers an inter-agency consultation requirement designed to ensure that Federal activities avoid destruction or adverse modification of critical habitat. In addition, a critical habitat designation or revision contributes to the conservation of a species by identifying the physical and biological features within those areas that are essential to conservation of the species, thereby alerting both public and private entities to the importance of the area to the species. Second, the regulations found at 50 CFR 224.103(c) are intended to protect right whales from ship strikes by prohibiting vessels from approaching within 500 yards (460 m) of a right whale. Finally, NMFS is currently working toward developing and implementing a ship strike reduction strategy.

Comment 10: One commenter expressed opposition to the petitioned expansion of critical habitat because he/she felt that the petitioners have not presented sufficient evidence that expanding critical habitat and implementing regulations to reduce vessel speeds within critical habitat will provide protection for right whales.

Response: See response to comment 9.

Comments on the Process for Revising Critical Habitat

Comment 11: One commenter suggested that NMFS advise the relevant regulated communities (i.e., commercial fisheries and shipping) on the possible effects that the petition and any subsequent critical habitat designation may have on future management measures.

Response: NMFS agrees that the relevant regulated communities should be informed about the petition to revise critical habitat, NMFS's responses to the petition, and how the agency intends to proceed with the requested revision. NMFS provided copies of the petition and 90-day notice and finding to team members and interested parties at the recent meeting of the ALWTRT. A presentation was also given at the meeting on critical habitat in general and made specific reference to the petitioned revision. In addition, prior to the meeting, the ALWTRT was made aware of the petitioned action through an email distribution and by posting the relevant documents on the Web Site for the ALWTRP as well as on the NOAA Fisheries home page ( see Electronic Access). NMFS provided similar notice to the shipping community through the Ship Strike Reduction e-mail distribution list and a presentation to the Southeast U.S. Right Whale Recovery Plan Implementation Team.

Comment 12: One commenter expressed concern that neither the petition nor the Federal Register notice provided a substantive discussion of economic impacts. Furthermore, this commenter suggested that NMFS carefully analyze the data relied upon to designate critical habitat and apply designation criteria uniformly to avoid undue economic costs or economic dislocation to the shipping industry as the agency proceeds with ship strike mitigation measures. Finally, this commenter suggested that NMFS articulate to the public that management measures may not have the same or coincident boundaries as those of a revised critical habitat.

Response: Both the ESA and the regulations for designating critical habitat found at 50 CFR 424.12 require NMFS to consider economic impacts, and any other relevant impact, of specifying any particular area as critical habitat. At this time, an analysis of economic impacts is not required, because NMFS has not yet proposed any areas for designation as part of an effort to revise right whale critical habitat. In other words, the agency has not defined the area in which an analysis of economic impacts may be applied. However, NMFS has determined that an economic analysis will be included among the steps the agency has identified for any future revision of critical habitat. NMFS agrees with the final point made by the commenter, and the public will be notified if the agency decides to implement management measures whether or not it revises critical habitat.

Critical habitat is defined in section 3(5)(A) of the ESA as the specific areas within the geographic area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features essential to the conservation of the species and which may require special management considerations or protection. In addition, under section 3(5)(A) of the ESA, critical habitat may include specific areas outside the geographic area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.

NMFS has decided not to designate critical habitat in accordance with the petitioned revision because the information presented in the petition does not adequately support the petitioned new boundaries for critical habitat. The revisions proposed by the petitioner are largely based on where whales have been found and general information on what the whales may be doing in those areas rather than on the specific nature and location of the physical or biological features of the habitat that are essential to the conservation of the species.

For example, in discussing the value of “space” for individual and population growth and for normal behavior, the petitioner states that the requested revision will “cover areas that consistently maintain large numbers of western North Atlantic right whales and the conditions they require for individual and population growth as well as normal behavior” (Petition p. 21). However, the petitioner fails to identify or discuss with the necessary degree of detail what those conditions are that would be necessary for individual and population growth, and normal behavior, or how these features are essential to the conservation of right whales. Therefore, without establishing a nexus between the specific habitat feature and the requested revision, beyond the premise that the area is used by large numbers of right whales, the petition does not support the suggested changes to critical habitat boundaries.

With regard to its discussion of “food, water, air, light, minerals, or other nutritional or physiological requirements,” the petition indicates that right whales require high densities of prey for effective feeding. However, the petition does not present information identifying what those densities are, what features of the habitat lead to the concentration of prey, or evidence that the expanded boundaries incorporate additional areas in which sufficiently high densities of prey are likely to exist.

With regard to its discussion of “cover or shelter,” the petition indicates that the proposed additions to the northern and southern areas “exhibit temperature, salinity, and bathymetric requirements needed to provide shelter for western North Atlantic right whales.” However, the petition does not indicate specifically what those temperature, salinity, and bathymetric features are or provide evidence that the expanded boundaries incorporate additional areas in which those features are likely to exist.

With regard to its discussion of “sites for breeding, reproduction, and rearing of offspring,” the petition indicates that new information suggests that female right whales and calves utilize the waters farther offshore of the Southeastern U.S. than initially documented. While NMFS agrees that new information does indicate females and calves use waters farther offshore than initially believed, the existence of right whales farther offshore is not, in and of itself, a physical and biological feature essential to the conservation of the species. The petition does not indicate what the physical and biological features are of these waters that make them appeal to female right whales and their calves. As a result, the petition does not provide sufficient support for the proposed expansion of the critical habitat area in the southeast U.S.

With regard to its discussion of “habitats that are protected from disturbance or are representative of the historical, geographical, and ecological distributions of species,” the petition indicates that the areas petitioned for inclusion as critical habitat “focus on the most vital portions of the historic range where current data indicate that large numbers of right whales aggregate for extended periods of time.” However, the petition does not support the expanded boundaries by indicating what specific physical and biological features make those areas vital.

Accordingly, based on the language found in section 3(5)(A)(i)(I) of the ESA that defines critical habitat, in part, as specific areas “on which are found those physical or biological features essential to the conservation of the species,” and for the reasons previously discussed, NMFS believes that the petition does not provide sufficient information to support the requested revision. However, a review of scientific information suggests that physical and biological features essential to the conservation of right whales may include, but are not necessarily limited to, the occurrence of copepods and the features that concentrate them in the water off of the Northeast U.S., as well as sea surface temperature and possibly bathymetry in the waters off of the Southeast U.S. Further investigation and analysis needs to be performed regarding the specific nature of those features and/or others, whether they are essential to the conservation of right whales, and, if so, where they are located and whether they may require special management considerations or protection.

Section 4(b)(3)(D)(ii) of the ESA requires that NMFS, within 12 months of the date a petition is received, make a determination on how it intends to proceed with the requested revision and promptly publish notification of such intention in the Federal Register . NMFS made its determination in the previous section of this notice that the requested revision, as specified by the petitioner, is not warranted at this time. However, NMFS intends to continue with planned research activities during 2003 and evaluate new information to determine whether physical and biological features essential to the conservation of the species exist that may warrant a revision of critical habitat. To further investigate those physical or biological features essential to the conservation of the North Atlantic right whale, and to propose any revisions to designated critical habitat that might be supported by new information and analysis, NMFS would have to complete at least the following steps:

(1) In the waters off of the Southeast U.S., continue analysis of right whale distribution data in relation to bathymetry and sea surface temperature derived from Advanced Very High Resolution Radiometer (AVHRR) imagery;

(2) In the waters off of the Northeast U.S., continue its own efforts, as well as collaborate with others working in the Gulf of Maine Ecosystem, to characterize the spatial and temporal distribution of zooplankton;

(3) Examine the available scientific information to assess whether other physical or biological features of the environment are essential to the conservation of the species;

(4) Identify those “specific areas within the geographical area occupied by the species, at the time it is listed..., on which are found” one or more of the physical or biological features determined to be essential for conservation;

(5) Evaluate the current or future special management considerations or protections relevant to the habitat features determined to be essential for conservation;

(6) Evaluate the economic and other relevant impacts of including any particular area in the designation of critical habitat, weigh these benefits and negative impacts, and determine whether exclusion of any area would lead to the extinction of the North Atlantic right whale; and

(7) Identify specific areas outside the geographical areas occupied by the North Atlantic right whale at the time it was listed, that are essential to the conservation of the species, and evaluate the impacts of designating any of these areas as critical habitat.

While NMFS intends to investigate further the nature and location of physical and biological features essential to the conservation of right whales and will evaluate new information to determine whether a proposed rule to revise critical habitat is appropriate, this notice should not be misinterpreted as a commitment to take any particular action because any such commitment would be premature at this time. If a revision of critical habitat is warranted in the future, NMFS will provide notice to the public as required by the ESA.

All references are available upon request ( see FOR FURTHER INFORMATION CONTACT ).

On June 13, 2003, at its 118th meeting, the Council adopted a “control date” of June 13, 2003, as a notice to persons contemplating entering the fisheries for bottomfish species in the EEZ around Guam and CNMI. This action would not impose any restrictions on the public, but is intended solely to notify persons who joined or may join these fisheries after June 13, 2003, that they might be excluded if restrictions are adopted in the future under the Magnuson-Stevens Fishery Conservation and Management Act.

This control date does not commit the Council or NMFS to any particular management regime or criteria for entry into the bottomfish fisheries off Guam and/or CNMI. Fishermen are not guaranteed future participation in either or both fisheries, regardless of their level of participation before or after the control date. The Council may choose a different control date or it may choose a management regime that does not involve a limited access program. Documentation of fish landings and sales may be used to determine eligibility for participation in a limited access fishery. The Council also may choose to take no further action to control entry or access to the fishery, in which case the control date may be rescinded.