Witchweed ( Striga. spp.) is a parasitic plant that feeds off the roots of its host, causing degeneration of corn, sorghum, and other grassy crops. Within the United States, witchweed is only found in parts of North Carolina and South Carolina. The witchweed quarantine and regulations, contained in 7 CFR 301.80 through 301.80-10 (referred to below as the regulations), quarantine the States of North Carolina and South Carolina and restrict the interstate movement of certain articles from regulated areas in those States for the purpose of preventing the spread of witchweed.

In an interim rule effective February 4, 2003, and published in the Federal Register on February 10, 2003 (68 FR 6603-6605, Docket No. 02-042-1), we amended the list of regulated areas in the regulations by adding and removing areas in North Carolina and South Carolina. These actions were necessary to prevent the artificial spread of witchweed from areas where the weed has been detected and to remove restrictions that are no longer necessary on the interstate movement of regulated articles from areas where witchweed has been eradicated.

We solicited comments concerning the interim rule for 60 days ending April 11, 2003. We received one comment by that date, from a weed specialist with the North Carolina Department of Agriculture and Consumer Services. The commenter informed us that one of the farms in Cumberland County that was listed in the interim rule has been released from quarantine by the State of North Carolina and thus should no longer be listed as a regulated area in the regulations. Given that the witchweed regulated areas described in our regulations are derived from, and are intended to be consistent with, the regulated areas described by our State cooperators in their quarantine regulations, we have removed the farm cited by the commenter from the list in § 301.80-2a of regulated areas in North Carolina. Similarly, following the close of the comment period, the State of South Carolina brought to our attention that it had amended its witchweed quarantine by adding two farms in Horry County and by removing three farms, one in Horry County and two in Marion County. Again, for consistency with the regulated areas described by our State cooperators in their quarantine regulations, we have amended the list in § 301.80-2a of regulated areas in South Carolina to reflect the changes made by the State of South Carolina. We have also reordered the listing of regulated areas in South Carolina so that they appear in alphabetical order, and have made several nonsubstantive editorial changes for clarity or to correct typographical errors.

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

This final rule also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Pursuant to the administrative procedure provisions in 5 U.S.C. 553, we find good cause for making this rule effective less than 30 days after publication in the Federal Register . The interim rule adopted as final by this rule was effective on February 4, 2003. This rule amends the description of the regulated areas in the interim rule. Immediate action is necessary to amend the description of the regulated areas in order to prevent the artificial spread of witchweed from areas where the weed has been detected and to remove restrictions that are no longer necessary on the interstate movement of regulated articles from areas where witchweed has been eradicated. Therefore, the Administrator of the Animal and Plant Health Inspection Service has determined that this rule should be effective upon publication in the Federal Register .

The Mexican fruit fly ( Anastrepha ludens ) is a destructive pest of citrus and many other types of fruit. The short life cycle of the Mexican fruit fly allows rapid development of serious outbreaks that can cause severe economic losses in commercial citrus-producing areas.

The Mexican fruit fly regulations, contained in 7 CFR 301.64 through 301.64-10 (referred to below as the regulations), were established to prevent the spread of the Mexican fruit fly to noninfested areas of the United States. The regulations impose restrictions on the interstate movement of regulated articles from the regulated areas.

In an interim rule effective on December 13, 2002, and published in the Federal Register on December 23, 2002 (67 FR 78127-78128, Docket No. 02-121-1), we amended the regulations by adding the Monterey Park area of Los Angeles County, CA, as a regulated area. In a second interim rule effective on January 17, 2003, and published in the Federal Register on January 24, 2003 (68 FR 3373-3374, Docket No. 02-121-2), we amended the regulations by expanding the regulated area to include the South Pasadena area of Los Angeles County, CA.

Based on trapping surveys by inspectors of California State and county agencies and by inspectors of the Animal Plant Health Inspection Service, we have determined that the Mexican fruit fly has been eradicated from the Monterey Park and South Pasadena areas of Los Angeles County, CA. The last findings of Mexican fruit fly in the Los Angeles County, CA, regulated area was October 12, 2002, in Monterey Park and December 2, 2002, in South Pasadena. Since then, no evidence of Mexican fruit fly infestation has been found in the area.

Accordingly, we are amending the regulations in § 301.64-3 by removing that portion of Los Angeles County, CA, from the list of areas regulated for the Mexican fruit fly.

Immediate action is warranted to relieve restrictions that are no longer necessary. A portion of Los Angeles County, CA, was regulated to prevent the Mexican fruit fly from spreading to noninfested areas of the United States. Since we have concluded that the Mexican fruit fly no longer exists in that portion of Los Angeles County, immediate action is warranted to remove the area from the list of regulated areas and to relieve restrictions on the interstate movement of regulated articles from that area. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register .

We will consider comments we receive during the comment period for this interim rule ( see DATES above). After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule.

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

This rule amends the Mexican fruit fly regulations by removing a portion of Los Angeles County, CA, from the list of regulated areas. County records indicate that within that area there are approximately 389 small entities that may be affected by this rule. These include 351 fruit sellers, 3 growers, 33 nurseries, 1 certified farmers' market, and 1 swapmeet. These 389 entities comprise less than 1 percent of the total number of similar entities operating in the State of California.

We expect that the effect of this interim rule on the small entities referred to above will be minimal. Small entities located within the regulated area that sell regulated articles do so primarily for local intrastate, not interstate, movement, so the effect, if any, of this rule on these entities appears likely to be minimal. In addition, the effect on any small entities that may move regulated articles interstate has been minimized during the quarantine period by the availability of various treatments that allow these small entities, in most cases, to move regulated articles interstate with very little additional cost. Thus, just as the previous interim rules establishing the regulated area in Los Angeles County, CA, had little effect on the small growers in the area, the lifting of the quarantine in this interim rule will also have little effect.

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

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

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

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

Background

User fees to reimburse the Animal and Plant Health Inspection Service (APHIS) for the costs of providing veterinary diagnostic services and import- and export-related services for animals, animal products, birds, germ plasm, organisms, and vectors are contained in 9 CFR part 130. Section 130.20 lists user fees we charge for endorsing health certificates for animals, birds, or animal or nonanimal products exported from the United States.

On March 21, 2003, we published a proposal in the Federal Register (68 FR 13861-13872, Docket No. 02-040-1) to establish a new certificate category and user fee that would cover all of the costs associated with endorsing export health certificates that do not require verification of tests or vaccinations for ruminants, except for ruminants exported for slaughter to Mexico or Canada, which would continue to be covered by a separate category. In that document, we also proposed to make several miscellaneous changes to clarify the existing regulations.

We solicited comments concerning our proposal for 60 days ending May 20, 2003. We received two comments by that date. They were from a representative of a State government and a private citizen. They are discussed below.

One commenter stated that he or she was opposed to the new user fees based on his or her dissatisfaction with APHIS in general, but did not offer any specific information regarding user fees to which we could respond. Another commenter also stated that he or she was opposed to the new user fees and, moreover, the application of any user fee for export-related services, because he or she believes that those fees reduce the competitiveness of United States livestock in international trade. That commenter urged APHIS to seek funding from Congress to meet the needs of Veterinary Services without the use of user fees.

In response to that comment, we note that APHIS has received no directly appropriated funds to provide import- and export-related services for animals, animal products, birds, germ plasm, organisms, and vectors since fiscal year (FY) 1992. Rather, the Food, Agriculture, Conservation, and Trade Act of 1990 authorized the United States Department of Agriculture to prescribe and collect user fees for those services. Therefore, to continue to provide those services, we must recover our costs from the customers who benefit from them. As our costs increase, we must increase our user fees. We realize that any increase in user fees will increase the up-front cost of doing business for exporters. However, we do not anticipate that exports will decline significantly as a result of the new user fees set forth in this final rule. As discussed below under the heading “Executive Order 12866 and Regulatory Flexibility Act,” the increase in user fees represents a small amount of the average export value of cattle and is small compared to the total value of livestock usually included on a single health certificate, as most certificates are issued for more than one animal and the new user fee will apply to a single certificate, regardless of the number of animals covered.

Our proposal concerned the establishment of a specific user fee, not the administration of our user fee program in general or the allocation of tax dollars for our export-related services. As a result, we are not making any changes to the rule in response to those comments. However, we are making two changes in this document to correct errors contained in our proposal. In § 130.20, the table in paragraph (b) lists user fees we charge to endorse export health certificates that require verification of tests or vaccinations. When we set out that table in our proposal, we inadvertently omitted the row of user fees for certificates that require verification of 1-2 tests or vaccinations for nonslaughter horses exported to Canada. We did not intend to remove that row of user fees. Therefore, we have restored the correct user fees for that service in this final rule. Furthermore, when we set out the table in § 130.20(a) in our proposal, we inadvertently omitted part of the title for the new user fee category we are establishing in this final rule. Therefore, we have set out the complete title for this category in this document, which is “Ruminants, except slaughter animals moving to Canada or Mexico.”

In addition, we are also making several miscellaneous changes in this document to clarify the existing regulations. In our proposal, we proposed to amend the user fee tables in 7 CFR part 354 and 9 CFR parts 97 and 130 by removing columns that list fees for fiscal years 2001 and 2002. Because this final rule will take effect on the first day of fiscal year 2004 (October 1, 2003), we are also amending the tables in 7 CFR part 354 and 9 CFR parts 97 and 130 by removing the columns that list fees for fiscal year 2003.

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

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

APHIS charges flat-rate user fees to individuals, firms, corporations, and other entities for the endorsement of export health certificates for animals, birds, or animal or nonanimal products. These user fees vary, depending on whether or not the importing country requires verification of tests and the type and quantity of animals, birds, or products covered by the certificate. There is one user fee schedule for certificates that require verification of tests or vaccinations and another schedule for certificates that do not require such verification.

Certifications for ruminants that do not require verification of tests or vaccinations, other than certifications for slaughter ruminants exported to Mexico or Canada, have been covered by a miscellaneous “catchall” user fee certificate category. (Ruminants exported to Mexico and Canada for slaughter are covered by a separate user fee that includes all slaughter animals, except poultry, exported to those two countries). Based on our review of the costs associated with endorsing export health certificates, we have determined that the user fee charged for the miscellaneous certificate category does not cover all of our costs to endorse such certificates for ruminants. As a result, we are establishing a new certificate category and user fee for that service, which will increase the amount charged to endorse certificates that do not require verification of tests or vaccinations for ruminants, except slaughter ruminants exported to Mexico or Canada. Under the miscellaneous user fee category, the fiscal year 2004 user fee will be $24 for each endorsement; under the new certificate category, the user charged for each endorsement will be $33, an increase of $9. We are making this change to ensure that we recover our costs for providing that service, which include direct labor costs, administrative support costs, billing and collection costs, Agency overhead, departmental charges, and a reserve component.

This final rule will affect entities that export ruminants, other than slaughter ruminants exported to Mexico or Canada, to countries that do not require that export health certificates include verification of tests or vaccinations. Because entities who export ruminants to Mexico or Canada for immediate slaughter are covered by a separate user fee category, such entities will not be affected by this final rule. Whether or not an importing country requires verification of tests or vaccinations for ruminants depends upon such factors as the type of animal exported, the time of year exportation occurs, and the health status of an animal's herd or State of origin. A representative overview of countries that import ruminants from the United States (including Brazil, Canada, China, the Dominican Republic, Japan, Mexico, Nicaragua, the Philippines, and Turkey) indicates that most countries require that export health certificates include verification of testing or vaccinations for ruminants. 1 For example, importing countries almost always require U.S.-origin ruminants to be tested for brucellosis and tuberculosis, and frequently require those animals to be tested for such diseases as anaplasmosis, bluetongue, Johne's disease, leptospirosis, and vesicular stomatitis, among others. However, two countries, Mexico and Canada, do not currently require verification of tests or vaccinations for some cattle, sheep, and goats, under certain conditions.

As shown in table 1, below, trade statistics indicate that the majority of U.S.-origin cattle, sheep, and goats are exported to Mexico and Canada. For example, 56.6 percent of purebred cattle, 99.6 percent of not purebred cattle, 99.5 percent of sheep, and 82.3 percent of goats exported from the United States during 1999-2001 were shipped to Mexico or Canada. Of those animals listed in table 1, animals categorized as “not purebred cattle” (which include feeder cattle, cattle exported for immediate slaughter, and other not purebred cattle) comprise the single largest category, accounting for 83 percent of the total number of cattle, sheep, and goats exported from the United States during 1999-2001.

Because Mexico and Canada are the principal markets for ruminants exported from the United States that do not require health certificates to include verification of tests or vaccinations, we can expect that entities who export cattle, sheep, and goats to those two countries will be most affected by this final rule. As a result, this analysis focuses on the importation requirements of Mexico and Canada for U.S.-origin cattle, sheep, and goats.

Mexico does not require verification of tests or vaccinations for the following ruminants imported from the United States: Steers and spayed heifers shipped as feeder cattle; slaughter cattle, unless from Texas or Missouri; sheep other than rams; and goats other than breeding stock. Because Texas and Missouri are not designated as brucellosis Class-Free States, cattle imported for slaughter from those two States must be tested for that disease. Breeding cattle imported into Mexico from any State are required to be tested for brucellosis only if the animal is less than 6 months of age, or is an official calfhood vaccinate less than 20 months of age raised for dairy production or a vaccinate less than 24 months of age raised for beef. However, all breeding cattle, except for those animals under 1 month of age, must be tested for tuberculosis. For sheep and goats, Mexico requires that breeding and feeder rams be tested for brucellosis and breeding goats be tested for tuberculosis.

As mentioned above, animals other than poultry exported to Mexico and Canada for slaughter are covered by a separate user fee category. As a result, exporters of slaughter ruminants, including slaughter cattle, exported to Mexico or Canada will not be affected by this final rule. Slaughter cattle account for the majority of not purebred cattle exported to Mexico from the United States. 2 As shown in table 1, the annual value of not purebred cattle exported to Mexico from the United States is estimated to be about $71 million. APHIS export certification data indicate that approximately 62 percent of not purebred cattle shipped to Mexico were exported from the United States for purposes other than slaughter. 3 We can expect, therefore, that the annual value of not purebred cattle exported to Mexico that will be affected by this final rule will be approximately $44 million ($70.77 million multiplied by 0.62).

This final rule will have a negligible economic impact on exporters of sheep and goats shipped to Mexico, as over 99 percent of sheep and 96 percent of goats from the United States to Mexico are intended for slaughter and are not, therefore, covered by the certificate category and user fee established in this document.

Ruminants exported to Canada that do not require testing or vaccination are feeder cattle from Hawaii, Montana, and Washington; sheep and goats intended for immediate slaughter; and some purebred cattle, sheep, and goats, depending on the health status of the State or herd from which the animal originated and the time of year the animals are shipped.

Canada requires feeder cattle imported from most States to be tested for tuberculosis and anaplasmosis, and requires certain feeder cattle to be tested for brucellosis and bluetongue. Brucellosis testing is not required for steers and spayed heifers and official calfhood vaccinates that were vaccinated with Strain 19 vaccine. For all other cattle, brucellosis testing requirements depend on the brucellosis status of the animal's herd and State. Currently, all States except Missouri and Texas are classified as brucellosis Class-Free. As a result, feeder cattle exported to Canada from all States except Missouri and Texas are exempt from brucellosis testing. Bluetongue testing requirements depend on whether the animal comes from a low-, medium-, or high-incidence State and/or the time of year the animal is exported. For example, feeder cattle imported into Canada between October 1 and December 31 are not required to be tested for bluetongue, regardless of the State of origin.

As an alternative to the foregoing testing requirements, Canada accepts shipments of untested feeder cattle under its Restricted Feeder Cattle Program. 4 To participate in this program, a State must meet certain requirements, including being free of brucellosis and tuberculosis and classified as a low risk for bluetongue, and must submit to Canada summary data for anaplasmosis. Currently, Hawaii, Montana, and Washington are allowed to export untested feeder cattle to Canada under the Restricted Feeder Cattle Program. Cattle imported by Canada under this program may only enter the country between October 1 and March 31.

Testing requirements for breeding cattle exported to Canada depend on an animal's particular circumstances. For example, brucellosis and anaplasmosis testing requirements depend on the health status of the herd and State, and bluetongue testing requirements depend on the State's classification and/or the time of year the animal is exported to Canada. Breeding cattle need not be tested for tuberculosis if the entire herd from which the animal originated is tested within the 12 months preceding exportation.

Sheep and goats exported to Canada for immediate slaughter need not be tested for bluetongue. For all other sheep and goats, testing for bluetongue depends on the status of the exporting State and/or the time of year of the export. For example, Canada does not require sheep and goats exported from any State between October 1 and December 31 to be tested for bluetongue, assuming that the animals have resided only in the United States or Canada.

As shown in table 1, “not purebred cattle,” which predominantly consist of feeder cattle, account for the single largest category of ruminants exported to Canada that could be affected by this final rule. Because Hawaii, Montana, and Washington are the only States currently allowed to export feeder cattle to Canada without tests or vaccinations under the Restricted Feeder Cattle Program, we can expect that exporters of ruminants from those three States will be most affected by this final rule. Table 2 shows approximate average annual values of feeder cattle exported to Canada from Hawaii, Montana, and Washington, 1999-2001. These values are for cattle classified under Harmonized Schedule code 010290 (not purebred), and, therefore, may include animals exported for immediate slaughter and other not purebred animals; however, the majority of cattle under this classification are imported by Canada under its Restricted Feeder Cattle Program for feeding and subsequent slaughter.

Montana's livestock exporters, in particular, have benefitted from the Restricted Feeder Cattle Program. A total of 127,643 restricted feeder cattle were shipped to Canada from Montana during the 1999-2000 season. In the 2000-2001 season, Montana shipped 133,240 head. 5 The total value of feeder cattle exported from the three States to Canada, shown in table 2 to be approximately $96 million, comprises two-thirds of the approximately $146 million shown in table 1 for all “not purebred cattle” exported to Canada.

Statistics on other ruminants exported to Canada and affected by this final rule are not available. However, as mentioned above, exports of such ruminants, which include certain breeding stock, are not nearly as important as exports of not purebred cattle.

The total value of ruminant exports that could be affected by this final rule and for which statistics are available is approximately $140 million annually. This figure accounts for about 54 percent of the cattle, sheep, and goats exported from the United States. 6 However, even though a sizable percentage of U.S. ruminant exports may be affected by the user fee increase, we do not expect that this final rule will have a significant impact on a substantial number of entities. The $9 increase in user fees for the endorsement of certificates that do not require verification of tests or vaccinations for ruminants represents a small amount of the average export value of cattle. Furthermore, the $9 increase in user fees is small compared to the total value of livestock usually included on a single health certificate, as most health certificates are issued for more than one animal and the new user fee of $33 will apply for all animals covered by a single certificate.

This final rule will have the largest effect on exporters of “not purebred cattle” intended for export to Mexico and Canada. Table 3 shows the average value for each animal for those ruminant categories. The $9 increase in user fees represents approximately 2 percent of the average value of “not purebred cattle” exported to Mexico and Canada from the United States.

However, these percentages overstate the impact of the user fee increase, as numerous animals are usually exported using a single certificate. For example, from 1999 through 2001, the average number of feeder cattle exported to Canada per certificate numbered 798 head. 7 Based on this average number of cattle per certificate, the $9 user fee increase would account for only 0.002 percent of the total value of livestock included in a single health certificate. 8

The Regulatory Flexibility Act requires agencies to consider the economic impact of their rules on small entities, such as small businesses, organizations, and governmental jurisdictions. This final rule could affect livestock operations that export ruminants to Mexico or Canada, which include such entities as cattle ranches and farms, sheep and goat farms, and cattle feedlots.

Under the standards established by the Small Business Administration (SBA), a business, firm, organization, or other entity engaged in cattle ranching and farming, sheep farming, or goat farming is considered small if the entity has annual sales of $750,000 or less. 9 In 1997, there were 651,542 cattle farms and 29,790 sheep and goat farms. Of those entities, 99 percent of cattle farms (656,181) and 99 percent of sheep and goat farms (29,938) are small entities under the SBA's standards. 10

Cattle feedlots are considered small under the SBA's standards if their annual sales are $1.5 million or less. 11 Over 97 percent of feedlots (95,000 of 97,091) have capacities of fewer than 1,000 head, and average annual sales of about 420 head. 12 Assuming each head sold for $1,000, fewer-than-1,000 head capacity feedlots would generate, on average, $420,000 in sales. Clearly, most feedlots that export ruminants to Mexico or Canada are small entities under the SBA's standards.

The $9 increase in user fees for the endorsement of ruminant export health certificates that do not require verification of testing or vaccination, except for ruminants exported from Mexico or Canada, will not have a significant economic impact on a substantial number of entities, large or small, given the value, and number, of animals usually listed on a single health certificate. Although the majority of entities affected by this final rule are small entities, and the majority of cattle, sheep, and goats exported by the United States do not require testing or vaccination, the user fee increase is small compared to the average total value of livestock normally included on a single health certificate.

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

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

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

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

You may obtain copies of the standard referenced in this final rule and referred to as ANSI/AHAM DW-1 (American National Standard, Household Electric Dishwashers, ANSI/AHAM DW-1-1992) from the Association of Home Appliance Manufacturers (AHAM), 1111 19th Street, NW., Suite 402, Washington, DC 20036, (202) 872-5955. Information regarding this rulemaking is also available on the Buildings Program Web site at the following address: http://www.eere.energy.gov/buildings/appliance_standards/.

Title III of EPCA established the Energy Conservation Program for Consumer Products Other Than Automobiles (Program). The products currently subject to this Program (“covered products”) include residential dishwashers, the subject of today's final rule. (42 U.S.C. 6291 et seq. )

Under the Act, the Program consists of three parts: Testing, labeling, and the Federal energy conservation standards. The Department, in consultation with the National Institute of Standards and Technology (NIST), may amend or establish test procedures as appropriate for each of the covered products. (42 U.S.C. 6293) The purpose of the test procedures is to measure energy efficiency, energy use, or estimated annual operating cost of a covered product during a representative average use cycle or period of use. The test procedures must not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

If DOE amends a test procedure, EPCA requires DOE to determine whether the new test procedure would change the measured energy efficiency or measured energy use of any covered product as determined under the existing test procedure. (42 U.S.C. 6293(e)(1)) If DOE determines that a change would result, DOE must amend the applicable energy conservation standard during the rulemaking that establishes the new test procedure. (42 U.S.C. 6293(e)(2)) In setting any new energy conservation standard, DOE is required to measure, with the new test procedure, the energy efficiency or energy use of a representative sample of covered products that minimally comply with the existing standard. The average energy efficiency or energy use of these representative samples under the new test procedure shall constitute the amended energy conservation standard for the applicable covered products. (42 U.S.C. 6293(e)(2))

Effective 180 days after DOE prescribes or establishes an amended or new test procedure for a covered product, no manufacturer, distributor, retailer, or private labeler may make any representation with respect to the energy use, efficiency, or cost of energy consumed by the product, unless the product has been tested in accordance with such amended or new DOE test procedure and the representation fairly discloses the results of that testing. (42 U.S.C. 6293(c)(2)) This restriction on representations will take effect 180 days after the date this final rule is “prescribed” ( i.e. , the date this rule is published in the Federal Register ). Because this final rule itself will become effective 30 days after its publication in the Federal Register , a manufacturer, distributor, retailer, or private labeler may begin using the new test procedure to make representations with respect to the energy use, efficiency, or cost of energy consumed by the product beginning with the effective date of this rule.

On December 18, 2001, the Department published a final rule amending the dishwasher test procedure that had been in effect since 1987 (hereafter referred to as the “2001 final rule”). 66 FR 65091. That rulemaking tightened some testing specifications, changed the definitions of compact and standard models, and reduced the average number of use cycles per year from 322 to 264. It did not, however, finalize the revised test procedure that the Department had proposed to measure the energy consumption of the newer soil-sensing models. Manufacturers were unable to adequately test these models with the existing test load of clean dishes. In the 2001 final rule, the Department concluded that it needed to conduct additional research regarding how to test accurately the variety of soil-sensing technologies used, and to collect more data regarding consumer dishwasher behavior. In the following year, the Department worked with industry and other stakeholders to explore possible approaches and to collect additional data to support the development of a new test method. In addition, the Department hired an independent research organization, Arthur D. Little, Inc. (ADL), whose technology and innovation business has become known as TIAX LLC, to collect and evaluate all available surveys and studies regarding consumer dishwasher use. The ADL research addressed both frequency of use and frequency of pre-rinsing the dish load. DOE placed the December 18, 2001, ADL report and the March 5, 2002, ADL research addendum on its Building Research and Standards website for stakeholder review and comment.

The Department published a Notice of Proposed Rulemaking (NOPR) on September 3, 2002 (hereafter referred to as the September 2002 NOPR or NOPR), defining two types of dishwashers, soil-sensing and non-soil-sensing, according to whether a dishwasher could automatically adjust its wash cycle in response to the amount of food left on the dish load. 67 FR 56232. The Department did not propose any changes to the existing test procedure for non-soil-sensing dishwashers, which still would use clean dishes, tested during the normal cycle. However, using the recommendations from the ADL research, the Department proposed for soil-sensing dishwashers a new test procedure using soiled dishes instead of clean ones. The procedure required that manufacturers or private labelers run a series of three tests using heavy, medium, and light soil loads in order to test a dishwasher's soil-sensing mechanism at different soil levels. This procedure allowed the energy factor for a soil-sensing dishwasher to become an aggregated number, the average of the energy consumption figures from the three soiled test loads, weighted according to user frequency. For soiling the dishes, the test procedure required the same food soils used in the ANSI/AHAM DW-1 performance test, but with fewer soiled place-settings for each of the three test levels. 67 FR 56243.

In the September 2002 NOPR, DOE also proposed adding a method for calculating the standby power consumption for all dishwashers, both soil-sensing and non-soil-sensing, and including that energy in the estimated annual operating cost and estimated annual energy use calculations, but not in the energy factor. 67 FR 56242, 56244. The NOPR provided instrumentation requirements for measuring standby power and proposed changing the electrical energy supply requirements to 120 volts ±2 percent, instead of 115 volts. The NOPR also proposed a further reduction in the average number of use cycles from 264 to 215 per year based on new consumer use data.

This final rule adopts most of the test procedure provisions proposed in the September 2002 NOPR, and also incorporates certain changes that were presented and discussed at the October 22, 2002, public hearing with some modifications as discussed below. A few additional changes in test specifications resulted from information learned when NIST began testing two soil-sensing dishwashers using the proposed test procedure. The Department used NIST testing to verify that the test procedure language was clear and that the test was able to capture the machine's energy performance.

The following are the major revisions to the dishwasher test procedure included in this final rule:

1. Updated representative average dishwasher use

2. New three-level test procedure for soil-sensing dishwashers:

• Detergent and rinse agent

• Specifications for dish load

3. New test procedure to measure standby power consumption:

• “Standby mode” definition

• New measurement procedures

• New instrumentation requirements

• Corrected calculation procedure for the estimated annual energy use

4. New definitions:

• Non-soil-sensing dishwashers

• Soil-sensing dishwashers

• Sensor heavy response

• Sensor light response

• Sensor medium response

• Truncated sensor heavy response

• Truncated sensor light response

• Truncated sensor medium response

5. Modifications to improve the clarity and repeatability of the test procedure:

• Clarify the definition of water-heating dishwasher

• Retain testing voltage of 115 Volts

• Reword definition of dryer energy, E D

• Reword calculation of the number of standby hours per year, H s , and duration of wash cycle, L

• Correct typographical error in equation for Energy Factor (EF)

• Reword flow rate tolerance

• Reduce 140 °F tolerance from ±5 °F to ±2 °F

• Revise format of measurement descriptions of machine electrical energy consumption and water consumption

This final rule defines two types of dishwashers, soil-sensing and non-soil-sensing models, provides a new test procedure for soil-sensing dishwashers, and makes some modifications applicable to both soil-sensing and non-soil sensing test procedures. Manufacturers or private labelers must calculate the energy factor for soil-sensing models using a weighted average of the results from three tests with three different soiled loads of dishes: Heavy, medium, and light. The test procedure for non-soil-sensing models requires only one test using a load of clean dishes. In addition, manufacturers or private labelers must use a new test method to calculate the standby power consumption of any dishwasher that uses standby power technology (including both soil-sensing and non-soil-sensing dishwashers) and must add that value to the Estimated Annual Operating Cost (EAOC) and Estimated Annual Energy Use (EAEU) figures. At this time, however, the energy factor for dishwashers will not include the standby power consumption amounts. This final rule also reduces the representative average number of use cycles per year in the calculations for the EAOC to 215, down from 264 cycles per year.

The new test procedure for soil-sensing dishwashers reflects the combined efforts of many stakeholders who have worked with the Department to find a more accurate way of testing dishwasher models which use smart technology to sense and adjust the length of the wash cycle according to the soil level of the dish load. A series of meetings and discussions and the sharing of DOE draft proposals for comment on the web revealed a coincidence of views on the major features of the test procedure among stakeholders at the October 22, 2002, public hearing on the NOPR. The Association of Home Appliance Manufacturers (AHAM) commented that it was in general agreement with the NOPR. (Public Hearing Tr. p. 39)  1 The Consortium for Energy Efficiency (CEE) also stated that it was very supportive of the proposed test for soil-sensing dishwashers. (Public Hearing Tr. p. 89)

Although AHAM and CEE would like to see standby power energy consumption included in the energy factor at some point in the future, these stakeholders agreed that the more important goal at this time was the completion of a test procedure for soil-sensing models as quickly as possible. (AHAM No. 33 at 4; CEE No. 35 at 1)  2 The following sections discuss specific components of the new test procedure and changes that the Department made to the NOPR as a result of stakeholder comments.

One figure needed for computing the EAOC is a number the Department selects to represent the average number of times consumers run their dishwashers in the course of one year. In 1983, DOE amended the dishwasher test procedure to reduce the representative average use from 416 cycles per year to 322 cycles per year based on surveys of consumer use conducted prior to 1982. In 2001, DOE further reduced the representative average use from 322 cycles per year to 264 cycles per year based on the Soap and Detergent Association's data for available years between 1985 and 1995. (66 FR 65092, December 18, 2001) For this rulemaking, DOE commissioned a study by ADL to identify new consumer use data that could be used to evaluate the 264 cycle requirement and update it if appropriate. The findings of this study established that consumer use ranged from 200 to 233 cycles per year. (ADL No. 25 at 20) Therefore, in the September 2002 NOPR, DOE proposed 215 as the average number of dishwasher use cycles per year, selecting the approximate midpoint of the 200-233 cycle range.

At the October 22, 2002, public hearing, the Oregon Office of Energy (OOE) stated that the American Water Works Association (AWWA) had data obtained by sub-metering consumers that could establish the number of dishwasher cycles per year more accurately than surveys. (OOE, Public Hearing Tr. p. 124) Following the public hearing, DOE obtained the AWWA data and found: (1) That water use specific to dishwashers was not listed separately from other appliances and (2) that the study was not nationally representative. Later, in a written comment, OOE stated that further research into the data from AWWA on dishwasher cycles per year determined that the dishwasher data was combined with, and inseparable from, household lavatory and kitchen sink water use. As a result, OOE concluded “that the data and analysis presented by ADL at the October 22nd public hearing probably represents the best basis for establishing today's annual dishwasher use, in cycles per year.” (OOE No. 36 at 2) As a result of DOE's own analysis and OOE's comment, the Department has decided not to use the AWWA data in this rulemaking.

AHAM commented that DOE should consider selecting 208 cycles per year, a value that exactly represents using a dishwasher four times per week (4 cycles per week × 52 weeks = 208 cycles per year). It stated that since that number is reasonably close to DOE's proposal of 215, and still within the range of 200 to 233 supported by ADL research, the selection of 208 cycles per year would aid the consumer in understanding the content of the Federal Trade Commission's (FTC) EnergyGuide label. (AHAM No. 33 at 3) The OOE, however, stated that it concurred with the Department's proposed cycles-per-year estimate of 215, and found no issue in not using four cycles per week on EnergyGuide labels, in spite of the resulting mathematical difference between 208 and 215. It believed that the annual dollar cost difference of slightly more than a dollar, if consumers noticed it at all, would be a negligible difference. (OOE No. 36 at 2)

While the Department recognizes that the FTC generally rounds average use to an integer value and the number 208 would represent a perfect four wash cycles per week, the Department does not believe that the number of cycles per year should be selected on the basis of numerical alignment.

The best data available to DOE establishes a consumer use range from 200 to 233 cycles per year, and DOE proposed a midpoint in this range because “this range is appropriate but no definitive number within that range appears to be better than any other.” 67 FR 56235. Comment was divided on the best number to use in this range, but none of the comments offered any persuasive argument or analysis for adopting a number different from the one DOE had proposed. Therefore, DOE is retaining 215 cycles per year as the representative average number of use cycles per year. This number represents a significant drop from the current value of 264 cycles per year and is appropriate because it is based on an analysis of the best available data. Section 430.23(c) of subpart B of the test procedure now includes 215 as the value of “N”, the representative average number of dishwasher cycles per year used in the formula for calculating the EAOC.

At the October 22nd public hearing and in the written comments DOE received, there was general agreement regarding the major components of the proposed procedure for testing soil-sensing dishwashers. The new test procedure adopts a three-level soil test based on the soils used in ANSI/AHAM DW-1. The energy factor for a soil-sensing dishwasher will be computed using a weighted average of the normal wash responses from testing the dishwasher three separate times with three soil levels: heavy, medium, and light. Those conducting the tests will measure and calculate the energy consumption responses for each of the three cycles ( i.e. , sensor heavy, sensor medium, and sensor light for soil-sensing dishwashers) in the same way as the test procedure for non-soil-sensing dishwashers which uses clean dishes in the normal cycle. However, DOE will base the machine energy and water energy components for a soil-sensing dishwasher on a weighted average of the three energy consumption tests, according to the frequency with which consumers wash light, medium, and heavy loads. Thus, under sections 5.1.2, 5.2.2, and 5.3.2 of the test procedure, the energy factor will be a number computed from the three test cycles to represent the normal energy efficiency of the soil-sensing machine.

From available survey data, ADL determined the following distributions of typical soil levels for U.S. households using dishwashers: 5 percent heavy level of soil, 33 percent medium level of soil, and 62 percent light level of soil. (Review of Survey Data to Support Revisions to DOE's Dishwasher Test Procedure, December 18, 2001; ADL No. 25 at 8) The Department is using the distribution of these three soil level categories to establish the weighting factors, F, as follows: for the heavy response, F hr = 0.05; for the medium response, F mr = 0.33; and for the light response, F lr = 0.62. The resulting equation for the machine energy, M, for soil-sensing dishwashers is:

The resulting equation for the amount of water used, V, for soil-sensing dishwashers is:

AHAM submitted a written comment supporting the weighting factors for the three soil levels, stating that “the proposed test procedure aligns well with actual consumer practices.” (AHAM No. 33 at 2) Along with supporting the soil weighting factors, the OOE also agreed with the Department's selection of the soils and soiling method specified for industry use in the ANSI/AHAM DW-1 standard, commenting that it is confident that AHAM's DW-1 test method is the best basis for a methodology that can deliver repeatable results for these models. (OOE No. 36 at 2)

In addition to supporting the overall test methodology, commenters recommended two changes regarding the amount of detergent and rinse agent (also referred to as rinse additive or rinse aid) used in the proposed test. In its comment, Maytag Corporation suggested the Department reduce by at least half the amount of detergent which DOE specified in the September 2002 NOPR because of the smaller size of the test loads. The firm commented that the ANSI/AHAM DW-1 soiled dish load which industry uses as a performance test “is 10-12 place settings and the 0.5 percent detergent concentration that is stated in the ANSI/AHAM DW-1 test protocol is based on that amount of soil level. The detergent amount is to improve cleanability not to impact energy consumption.” (Maytag No. 32 at 1) AHAM also indicated that, because the soil levels in the DOE test procedure are so much smaller than the soil level in the original ANSI/AHAM DW-1 procedure, the amount of detergent stated in the September 2002 NOPR should be reduced accordingly: to one-half the amount of detergent used in the AHAM performance test. (AHAM No. 33 at 6) Maytag also stated, “Rinse additive should not be used in the test for the following reason. Rinse additive is usually released into the dishwasher in the last rinse before the heated dry [cycle] and is used to help improve drying and reduce spotting. It does not impact energy consumption of the dishwasher.” (Maytag No. 32 at 1) The OOE commented that since the use of rinse aid has no demonstrated impact on energy or water use, to require it for energy use testing would amount to a senseless waste of money and chemicals. (OOE No. 36 at 4) The Department agrees with these comments regarding the reduction of unnecessary chemical use and is therefore reducing the amount of detergent by half in section 2.8 of the test procedure and omitting the instruction to use rinse agent that DOE had proposed in section 2.7 of the NOPR.

This final rule reflects the consensus on the appropriateness of the current soil loads and weighting factors of the new test procedure as proposed, and incorporates the above changes regarding detergent and rinse agent.

In the September 2002 NOPR, DOE proposed incorporating the August 20, 1999, “Addendum to Appendix A of AHAM DW-1-1992” by reference into the final rule to specify the type of dishes to be used in the test procedure. At the October 22 public hearing, however, AHAM stated that because some dishes in the ANSI/AHAM DW-1 Addendum are no longer available, DOE should use a new reference list which will be included in the ANSI/AHAM DW-1 revision currently under consideration. (Public Hearing Tr. p. 54) AHAM further suggested that since the new list is not yet available as part of ANSI/AHAM DW-1 for formal incorporation by reference, the Department should publish the specific table containing the recommended dishware, glassware, and flatware in the rule to address manufacturers' concerns about availability. (Public Hearing Tr. p. 54)

There was considerable discussion at the public hearing that confirmed both the comparability of the new list of dishware with what is currently being used during testing, and also the availability problems regarding the ANSI/AHAM DW-1 Addendum list as DOE had proposed in the September 2002 NOPR. The Department agrees that it would be best to use the most current list of available dishware, and therefore has directly included that list in the text of the test procedure as section 2.7. This test load list supercedes the specifications for dishware included in ANSI/AHAM DW-1. Thus, when testing soil-sensing dishwashers, ANSI/AHAM DW-1 should be used for determining the types and quantities of soils and the size of a place setting, but the table in section 2.7 of the test procedure should be used for determining the specific types of dishware, glassware, and flatware. The insertion of this table in section 2.7 (previously the section for detergent and rinse agent) alters the numbering sequence for sections 2.7 through 2.9 as they appeared in the September 2002 NOPR, and creates a new section 2.10 for preconditioning requirements (previously section 2.9). The following sections of the test procedure now include references to section 2.7 for specifying the test load of dishware, glassware, and flatware: sections 1.2, 1.13, 2.6.2, 2.6.3.1, 2.6.3.2, and 2.6.3.3 of Appendix C to Subpart B, and paragraph (f) of section 430.32 of Subpart C.

The Department presented a comprehensive method for computing standby power consumption in the September 2002 NOPR. Later, however, DOE learned that the International Electrotechnical Commission (IEC) was circulating a July 12, 2002, committee draft document for measuring standby power in household electrical appliances which contained some alternate technical specifications. (IEC No. 39 at 6-9, 14-15) The IEC is a worldwide organization which publishes international standards and promotes international cooperation on questions concerning standardization in the electrical and electronic fields. Thus, in order to make the proposed dishwasher test procedure as consistent as possible with international specifications that the IEC is developing on standby power, DOE presented at the October 22 public hearing an enhanced version of the original method set out in the September 2002 NOPR, based on specifications the Department adapted from the draft IEC document. These changes addressed the definition for “standby mode” and the instrumentation requirements, as well as the measurement and calculation procedures. (Public Hearing Tr. p. 131). The Department used the discussions at the hearing and comments received to improve the test procedure as described below.

AHAM commented that the definition of standby mode in the September 2002 NOPR, “the power consumption condition when the dishwasher is connected to the main electricity supply and the door lock is unlatched” (67 FR 56242), would not be appropriate for all dishwashers. (AHAM No. 30FF at 4). AHAM stated that some new models of dishwashers may not be in the standby mode when a door is unlatched, and that some did not even have traditional doors. As a result of this comment, DOE presented for discussion at the public hearing the following alternative definition which was based on the draft definition in the IEC document: “  ‘Standby mode ’ means the lowest power consumption mode which cannot be switched off or influenced by the user, a non-operational mode not affected by the dishwasher's primary function which may persist for an indefinite time when the dishwasher is connected to the main electricity supply and used in accordance with the manufacturer's instructions.” (Public Hearing Tr. p. 132)

At the public hearing, AHAM also presented the IEC draft definition but did not include the words “a non-operational mode not affected by the dishwasher's primary function” which the IEC draft had listed as a note in its draft, but not as part of the definition itself. (AHAM No. 30FF at 4) The AHAM representative explained at the hearing that the inclusion of those words seemed like adding “redundant and unnecessary verbiage to the definition because you've already defined the fact that you're in the non-operational mode by saying it's the lowest power consumption mode that can't be switched off.” (Public Hearing Tr. p. 138) The Department reviewed the text and agrees that the words AHAM cited are redundant for defining standby mode. Overall, there was broad support among commenters for drawing from the IEC expertise on this issue. For example, the OOE commented that it supported DOE's test procedure being consistent with the IEC definition. (Public Hearing Tr. p. 129) In light of the discussion at the public hearing and the comments received, the Department agrees with the criticisms of the “standby mode” definition in the September 2002 NOPR and believes that the IEC draft definition for standby mode is the better choice. Therefore, the Department has adopted it in section 1.14 of this rule. The Department's text, however, specifically names dishwashers in the definition, rather than using the more general term “appliance” which the IEC uses in its broader definition for standby mode.

The September 2002 NOPR proposed a procedure for the measurement of standby power which required measuring the standby energy consumption using a watt-hour meter and prorating the value over the measurement period. (67 FR 56243) Based on an AHAM comment and the IEC draft document containing a procedure for measuring standby power, DOE presented revisions to the September 2002 NOPR at the October 22 public hearing. These revisions added provisions for measuring stable standby power consumption using a wattmeter and for measuring unstable standby power consumption using a watt-hour meter.

The modified measurement method, which is set forth in section 4.4 of the test procedure, requires allowing the dishwasher's standby power consumption to stabilize for five minutes, and then monitoring the dishwasher for an additional five minutes to determine whether the dishwasher's standby power consumption meets the criteria for stability (discussed below). If stable, the standby power could be measured directly using a wattmeter to obtain an instantaneous reading in watts. AHAM had recommended this alternative to measuring standby power in watt-hours and prorating the value for the measurement period as a way to simplify, and perhaps improve, the accuracy of the measurement. (AHAM No. 33 at 5)

The Department presented the criteria for stability as a power level drift of not more than 1 percent from the maximum observed value during the monitoring period with no cyclic or pulsing behavior. (Public Hearing Tr. p. 154) AHAM pointed out that the U.S. Technical Advisory Group had submitted comments to the IEC recommending a 5 percent drift instead of a 1 percent drift, stating that “at the levels that you're monitoring, typically three to five watts, a drift of five percent is almost negligible. One percent drift is extremely tight.” (Public Hearing Tr. p. 156) The Department followed up with the IEC committee and learned that the IEC was in the process of revising its July 12, 2002, committee draft and had accepted the 5 percent drift as a revised specification. The March 7, 2003, IEC committee draft included the 5 percent specification in section 4.3.1. (IEC No. 40 at 8) In the interest of harmonization, and because DOE agrees based on the data and comments presented that the 1 percent drift tolerance is too restrictive, DOE is changing the 1 percent drift tolerance to 5 percent drift tolerance in section 4.4 of the test procedure.

The modified procedure, which is based on the March 7, 2003, IEC committee draft document, provides instructions for measuring the standby power for dishwashers which fail to meet the stability criteria presented above. In the case where the standby power varies over a cycle, the energy must be accumulated over a period of one or more complete cycles and prorated over a period of at least five minutes in order to get the average standby power. (Public Hearing Tr. p. 154) The final rule also includes the editorial change of replacing “not less than 5 minutes” with “at least 5 minutes” to express the required time interval consistently throughout section 4.4, and retains the original NOPR method for measuring standby power using a watt-hour meter.

The Department is making these modifications to provide more flexibility in testing, to increase harmonization with the IEC, and to maintain accuracy and improve clarity of the procedure. The Department believes that permitting the use of a single point measurement using a wattmeter has no negative impact on measurement accuracy and is an acceptable alternative to measuring in watt-hours and prorating the value for the measurement period. Thus, section 4.4 of the test procedure now includes two measurement options, allowing standby power measurements using a wattmeter or a watt-hour meter.

Section 3.5 of the September 2002 NOPR defined the instrumentation requirements for the standby power meter. At the October 22 public hearing, DOE stated that it was considering an additional requirement: “The meter shall have a maximum error no greater than 1 percent of the measured value.” This specification establishes a level of accuracy for the instrumentation used to measure standby power. It is the same level of accuracy already required of the watt-hour meter used for measuring the machine electrical energy consumption of the dishwasher to ensure reliable results and does not present a significant test burden. There were no written or public hearing comments regarding this proposed requirement.

Discussion at the public hearing, however, did explore the differences in the RMS (root mean squared) value and the crest factor value (a measure of the instrument's capability to get good readings during power fluctuations). The NOPR proposed a value of 5 RMS whereas the IEC draft proposed a value of 3 or more RMS. Whirlpool Corporation recommended 3 RMS, commenting that 5 RMS would potentially increase the cost of the measuring equipment beyond what is practical for this level. (Public Hearing Tr. p. 152) The OOE raised the question of whether independently modifying the requirements for total harmonic distortion (THD) and the crest factor created a conflict in the specifications, and recommended that the test procedure be consistent with the IEC whenever possible. (Public Hearing Tr. p. 154)

Following the public hearing, DOE contacted an equipment manufacturer of power meters, Yokogawa Electric Corporation, to determine if there was any conflict in the specifications as written in the NOPR and to discuss whether 5 RMS was unnecessarily restrictive. From this discussion, DOE learned that it is important to match the crest factor with RMS and that the way DOE had written the specification in the NOPR was incorrect. The manufacturer also confirmed that the 5 RMS requirement would be more restrictive than necessary for ensuring accurate testing and would require manufacturers or private labelers to purchase equipment that was considerably more expensive.

As a result of this discussion and the public comments, DOE has concluded that reducing the crest factor requirement to 3 or more RMS would still ensure accurate testing, while at the same time reduce unnecessary manufacturer expense and establish a testing value consistent with the IEC. Therefore, DOE has adopted this change. For clarification purposes, DOE also restructured the format of the instrumentation section to present the requirements for each of the power meters separately. The requirements for the watt-hour meter to measure the machine electrical energy consumption of the dishwasher are in section 3.5. The requirements for the standby wattmeter to measure standby power are in section 3.6. The requirements for the standby watt-hour meter to measure standby power are in section 3.7.

The September 2002 NOPR provided equations for incorporating standby power into the calculations of the EAOC and EAEU. Those equations only calculated the per-cycle energy consumption and did not calculate values for annual usage. In written comments, AHAM suggested a change in the way DOE calculated the EAEU in the NOPR, editing the equations for EAEU to include the number of cycles per year so that the energy consumption is calculated for annual consumption. (AHAM No. 30FF at 7) The Department agrees that this change improves the utility of the EAEU equations proposed in the NOPR. The revised equations for EAEU in section 10 CFR 430.23(c)(3) now reflect the total annual energy use of the dishwasher.

It should be noted that only the EAOC and EAEU calculations include standby power consumption; the energy factor calculation does not include it at this time. As currently defined in the test procedure, the energy factor represents the amount of energy used during a cycle. Since standby power is energy consumed outside the wash cycle of a dishwasher, it is not a parameter in the energy factor calculation. Stakeholders supported this as an initial strategy. Both AHAM and CEE commented that they supported the proposal to include standby power in the EAOC and EAEU. However, they also voiced strong support for including standby power in the energy factor whenever in the future the energy efficiency standard for dishwashers is revised. (AHAM No. 33 at 4; CEE No. 35 at 1)

The Department presented nine new definitions in the September 2002 NOPR (67 FR 56242), all of which elicited comments. The change in the definition for “standby mode” was discussed in the previous section. This section addresses all other definitions.

For this test procedure, the Department developed definitions for two types of dishwashers: non-soil-sensing dishwasher and soil-sensing dishwasher. The designation of dishwasher type determines whether a dishwasher will be tested with clean or soiled dishes. The two definitions use the ability or lack of ability to adjust automatically any energy consuming aspect of a wash cycle based on the soil load of the dishes as the determinant for distinguishing dishwasher type.

AHAM questioned the wording of these proposed definitions and recommended that the Department change the more general phrase of “wash cycle” to “normal wash cycle,” since the test procedure only tests the normal cycle. (Public Hearing Tr. p. 88) However, in order to provide a clear definition for the purposes of classification, DOE believes that a dishwasher should be classified as a soil-sensing dishwasher if it can sense soils and respond to that information, regardless of the cycle type. Using the more narrow specification of “normal cycle” in the definition could provide an incentive for manufacturers to have a separate button activating the use of a soil sensor so that the normal cycle would operate as a non-soil-sensing dishwasher. This cycle configuration would enable a dishwasher to be tested on the normal cycle with clean dishes, thus avoiding the more difficult and costly test method using soils. For these reasons, DOE is retaining the original definitions with the more general reference to “wash cycle” and is not adding the word “normal” to sections 1.5 and 1.12.

In the September 2002 NOPR, the Department proposed a set of six definitions to characterize the energy consumption test cycles that would result when soil-sensing dishwashers were tested with the three levels of soil used in the test procedure in sections 1.9, 1.10, 1.11, 1.15, 1.16, 1.17, and 1.18. AHAM recommended that the Department change this entire set of soil-sensing cycle definitions, suggesting that the word “response” replace the word “cycle.” It believes that the word “response” more accurately characterizes the way that a dishwasher will react to the varying soiled loads in the soil-sensing tests, since there is no actual button or setting which can initiate the cycle in the way that a traditional cycle can be selected by a dishwasher user. (AHAM No. 33 at 8)

The Department agrees that changing the word “cycle” to “response” would more accurately reflect the way a dishwasher is challenged to react to the heavy, medium, and light soil levels, and therefore DOE has adopted this change. However, by using the word “response” as part of the term to be defined, the Department believes that the later words in the proposed definitions, “that constitutes the response,” become redundant and should be eliminated. Thus, DOE has made conforming changes to the NOPR definitions set out in section 1 of this final rule. In addition, the Department has modified references to these terms throughout the test procedure to reflect the change, specifically in section 2.6.3 and its subsections, sections 5.1.2 and 5.2.2, and section 5.6.

Discussion at the October 22nd public hearing brought forth one issue that DOE had not raised in the September 2002 NOPR. CEE questioned the clarity of the existing definition of the normal cycle for water-heating dishwashers in section 1.19 of the regulations proposed in the NOPR, believing that the language as written offered a possible testing “loophole.” (Public Hearing Tr. p. 174) It was the intent of the definition, already in effect with the December 18, 2001, final rule, to require that all water-heating dishwashers heat water to 120 °F during testing. However, the wording of the definition using the phrase “may operate” did not seem to require it definitively. CEE suggested that under the current definition, one might interpret the requirement to allow the testing of a water-heating dishwasher using 50 °F water, instead of the 120 °F temperature, thereby reducing its apparent energy consumption. The CEE representative stated, “Our position is that it leaves too much wiggle room for someone to abuse that. * * * We would suggest that you require at least one cycle be heated to 120 degrees.” (Public Hearing Tr. p. 170)

Much discussion ensued at the hearing as stakeholders offered their interpretations of the definition. Whirlpool, for example, commented that a reading of the definition could be that the test procedure did not require a dishwasher that uses cold inlet, defined as nominal 50 °F, to heat at least one wash phase to 120 °F. (Public Hearing Tr. p. 173) The stakeholders at the hearing agreed that the intent of the definition was to require the necessary water-heating in at least one cycle, and several offered suggestions as to how the language might be clarified to make sure that the definition includes that requirement. AHAM and CEE submitted additional suggestions in written comments for revising the definitions. AHAM's and CEE's definitions proposed replacing the word “may” with the word “must.” (AHAM No. 33 at 9; CEE No. 35 at 2) After reviewing the suggested changes, the Department selected the wording submitted by AHAM for use in section 1.9 of this test procedure. The Department believes that AHAM's proposed language most clearly states the requirement that all water-heating dishwashers must heat to at least 120 °F, regardless of the inlet temperature. The change in this definition represents a clarification of language to support the original intent of the test procedure, not a new definition.

OOE also questioned in written comments whether there is any justification for even providing the option of testing water heating dishwashers with 50 °F inlet temperature, since it would lengthen the dishwashing test cycle significantly. (OOE No. 36 at 5) Dropping the 50 °F testing option, however, was not discussed at the public hearing as part of the discussion to tighten the definition. Commenters' concern focused on closing the testing loophole that may have existed within the definition of water-heating dishwashers for conducting 50-degree tests, and not on eliminating the 50-degree testing option entirely. Since the new definition for water-heating dishwashers in this final rule clarifies the testing procedure for those models, the Department believes that it is appropriate to retain the option to test a dishwasher using cold water. The Department does not wish to restrict manufacturers from developing a dishwasher that heats cold water (nominal 50 °F) as long as it can meet the testing requirements.

The September 2002 NOPR proposed changing the testing voltage from 115 volts within 2 percent of the nameplate frequency to 120 volts ±2 percent to be consistent with manufacturers' instructions which specify 120 volts in the installation procedures. AHAM commented that although this change was potentially a good one, at this time, it would endanger the compliance of minimally compliant models. While AHAM conceptually supported a test voltage revision to 120 volts ±2 percent, it was concerned with the impact of this proposed change on the ratings of all dishwashers, especially on minimally compliant models. AHAM explained that since wattage use increases based on the square of the voltage, the tested power consumption could increase by 3 to 5 percent. Therefore, to avoid triggering the statutory requirement that the applicable energy conservation standard (presently 2.174 kWh per cycle maximum) be amended, AHAM recommended that DOE retain the existing voltage ranges. (AHAM No. 30FF at 4) OOE also recommended keeping 115 volts for the time being and suggested that DOE examine this issue in more detail when developing a new efficiency standard. (OOE No. 36 at 3)

The Department agrees that it would be more appropriate to address this change during a standards rulemaking at a future time, since it would alter the power consumption of all models and potentially impact compliance. The Department is therefore retaining the 115 volt specification in section 2.2.1 of the test procedure. In order to make the test procedure instructions more clear and precise, DOE is rewriting the existing tolerance “within two percent of 115 volts” as “115 volts ±2 percent,” and the existing tolerance in section 2.2.2 as “240 volts ±2 percent.” This wording change does not change in any way the meaning or effect of the existing tolerance.

In testing two soil-sensing dishwashers using the proposed test procedure, NIST found that more detailed instructions were necessary to complete the determination of the drying energy, E D , for soil-sensing dishwashers. NIST observed that while the new test procedure required testing soil-sensing dishwashers with three different soil levels, it did not specify how to compile the drying energy from the heavy response, medium response, and light response. Although there was no negative comment on this issue at the October 22nd public hearing or in written comments in response to the September 2002 NOPR, DOE is correcting this omission by defining the drying energy, E D , for soil-sensing dishwashers as the mathematical average of the three soil level tests. This approach compiles the results of three tests to represent the normal cycle for a soil-sensing dishwasher and is consistent with the procedure for calculating representative machine energy and water consumption values. For non-soil-sensing dishwashers, the procedure is unchanged. The instructions for determining the E D for soil-sensing and non-soil-sensing dishwashers are in section 5.2 of this rule.

The Department also determined that an additional clarification was necessary regarding the definition of the drying energy, E D , that the NOPR described as “the energy consumed after the normal cycle is interrupted to eliminate the power-dry portion of the cycle.” 67 FR 56241. The definition provides instructions on when to begin recording the drying energy: at the point separating the truncated normal cycle from the normal cycle. 67 FR 56241. Rather than representing the energy consumed by the drying portion of the cycle, the Department was concerned that use of the word “eliminate” could inaccurately suggest that the drying cycle is stopped entirely, resulting in zero drying energy. Because DOE's intent is to capture the drying energy for the normal cycle, the Department concluded that the definition should clearly state that E D is the energy consumed using the power-dry feature. With this non-substantive clarification, the Department believes the revised definition will clearly instruct manufacturers or private labelers to measure the energy consumed during the drying cycle, correcting an oversight in the computation method for drying energy presented in the September 2002 NOPR. The revised definition, located in section 430.23 (c)(1)(i) of the test procedure, specifies E D as the drying energy consumed after the termination of the last rinse option.

The test procedures for both soil-sensing, non-soil-sensing dishwashers calculate the number of standby hours per year, H s , by subtracting the number of hours that the dishwasher is in use from the total number of hours per year. The estimated usage value is the product of the representative average number of use cycles per year, N, (215 in this final rule), and the average duration of the test wash cycle, L. In a written comment, OOE called attention to an inconsistency in the way that the manufacturers calculated the duration of the normal wash cycle for determining the number of standby hours. It stated that the computation proposed in the September 2002 NOPR for the number of standby hours was inconsistent with the method of calculating annual energy use because it multiplied the number of cycles times the normal cycle time to get the number of hours the dishwasher was operating and did not take into account any use of the truncated normal cycle. 67 FR 56244. OOE recommended “that the treatment of normal cycle time be consistent with normal cycle energy use computations—namely, that half of the normal cycles be with heated drying, and half without. It would be highly inappropriate to be inconsistent in this regard.” (OOE No. 36 at 4, emphasis in original)

Although this change was not discussed at the hearing, the Department believes this suggested change corrects an oversight in the NOPR concerning the computation method for standby power. Not making this change would result in a slight overestimation of the annual wash time because the use of the truncated normal cycle shortens the wash time. By more accurately dividing the time spent in a wash cycle and the time spent in standby mode (for both conventional and soil-sensing dishwashers), DOE is making the calculation consistent with the current method of averaging the normal and truncated normal cycle values. Therefore, the Department has changed the definition of “L” in section 5.6 of this final rule in response to this comment to improve the accuracy in estimating the duration of the wash cycle.

In written comments after the public hearing, AHAM requested that DOE change the words “sensor medium cycle” to “sensor medium response” in the definition of L. (AHAM No. 33 at 10) The Department will make this change which is consistent with the modification to the definition of “sensor medium response” in this rule. The Department will also make conforming changes with the additions of “sensor heavy response” and “sensor light response” to the definition of L. The Department has also modified the equation of H s published in the NOPR by replacing “215 cycles/year” with “N” and defining “N” in section 5.6 of the final rule as “the representative average dishwasher use of 215 cycles per year.” This change has no effect on the value calculated, but gives a clearer presentation of the equation, and is consistent with the definition of N presented in section 430.23 (c)(1)(i) for computing the EAOC.

This final rule corrects a typographical error, a missing equal sign in the equation for EF on the first column of page 56242 of the September 2002 NOPR. (67 FR 56242)

In section 3.3 of the September 2002 NOPR, the specifications for the water meter stated that the maximum error can be no greater than 1.5 percent for all water flow rates from one to five gallons per minute. AHAM suggested that the specification be changed to plus or minus 1.5 percent of the actual measured flow rate. This would “reflect the actual range of dishwasher operating flow rates for the tested product instead of a blanket range of one to five gallons per minute.” (AHAM No. 33 at 7) Following the October 22nd public hearing, OOE submitted a comment endorsing this change. (OOE No. 36 at 4) The Department recognizes that the revised specification has the potential to reduce the testing burden for manufacturers or private labelers because the flow meter would only need to meet the specification of a maximum error of 1.5 percent at the test flow rate. Because it is irrelevant how the flow meter operates at flow rates outside of the testing range, manufacturers or private labelers would no longer be required to ensure a maximum error of 1.5 percent at flow rates outside of the test range. The Department believes this revision retains the original testing accuracy while potentially reducing instrumentation costs. Therefore, DOE has made this change in section 3.3 of the test procedure.

Section 2.3.2 of the existing test procedure requires a tolerance of plus or minus 2 °F for maintaining the water supply temperature when testing with 120 °F inlet water temperature. Section 2.3.1 requires plus or minus 5 °F when testing with 140 °F inlet water temperature. Because water temperature is an important factor in calculating energy consumption, AHAM proposed that the tolerance at 140 °F be reduced to plus or minus 2 °F as well. (AHAM No. 33 at 7) This change narrows the testing band and thereby reduces variability in the test procedure. Because of this, and because industry suggested the change and does not view it as a test burden, DOE is incorporating the change into section 2.3.1 of this final rule.

The measurement instructions presented in sections 4.2 and 4.3 of the September 2002 NOPR contained some minor inconsistencies regarding the placement order of machine electrical energy consumption, “M”, and water consumption, “W”. With some minor rewording, the Department has improved the clarity of the instructions and the consistency of the format. These editorial modifications improve the description of the measurements without changing any test procedure requirements.

In the interest of making the new test procedure effective and available for use as soon as possible, Whirlpool, AHAM, OOE, and CEE recommended that the new rule take effect 30 days after publication of the rule. (Whirlpool No. 34 at 2; AHAM No. 33 at 6; OOE No. 36 at 4; CEE No. 35 at 1) Because the new test procedure will enable manufacturers or private labelers to test soil-sensing machines with greater accuracy, DOE agrees with this comment and has adopted a 30-day effective date to facilitate accuracy in testing and labeling. Thus, as early as 30 days after this final rule is published in the Federal Register , a manufacturer, distributor, retailer, or private labeler may begin using the new test procedure to make representations with respect to the energy use, efficiency, or cost of energy consumed by a dishwasher model. As noted above, effective 180 days after this final rule is published in the Federal Register , no manufacturer, distributor, retailer, or private labeler may make any representation with respect to the energy use, efficiency, or cost of energy consumed by a dishwasher model, unless the dishwasher has been tested in accordance with the new DOE test procedure and the representation fairly discloses the results of that testing.

In the September 2002 NOPR, DOE requested comments regarding the possibility that the Department would at some future time “require manufacturers to produce reports concerning the testing of soil-sensing models pursuant to the amended test procedure.” (67 FR 56238-56239) AHAM commented that the requirement of additional reports would be “misguided,” believing that present reporting requirements adequately communicate energy usage of residential dishwashers. (AHAM No. 33 at 4) It commented that existing penalties would continue to deter incorrect reporting, and did not support new reporting requirements that would increase the complexity of, or the effort for, reporting energy usage. (AHAM No. 33 at 4) Whirlpool reiterated that it would not want to have to create additional documentation other than modifications to documents that it was already submitting. (Public Hearing Tr. p. 199)

The Department agrees that current reporting requirements do appear to cover the information necessary for conveying the energy usage of both non-soil-sensing and soil-sensing machines and will not require additional reports to DOE at this time. Although this final rule requires that the EAOC and EAEU must be calculated to include standby power, it does not require these figures be submitted to the DOE as part of a certification report. At the October 22 public hearing, there were no objections to calculating the EAEU in addition to the EAOC that manufacturers or private labelers already calculate. Manufacturers or private labelers should maintain their test records, including the EAOC and EAEU, as part of their permanent appliance files on each dishwasher model.

This final rule clarifies one change in a reporting requirement. The December 18, 2001, final rule (66 FR 65097) changed the definitions of compact and standard dishwashers, making place-setting capacity the determining factor instead of the width of the dishwasher. That final rule, however, did not eliminate the existing requirement in section 430.62(a)(4)(vi) to report the width of a dishwasher to DOE in certification reports. Because the width measurement no longer determines whether a dishwasher is a compact or standard model, DOE is not requiring manufacturers or private labelers to measure and report it. Instead, they must report in their certification reports whether a dishwasher is a compact or standard model, determined according to the number of ANSI/AHAM DW-1 place settings it will hold at one time. (Section 430.62(a)(4)(vi)) This is a conforming change in light of the 2001 final rule.

Recognizing that the proposed new test procedure would alter the energy factors for soil-sensing models, the Department requested in the September 2002 NOPR that manufacturers or private labelers provide the Department with information on whether soil-sensing models that minimally comply with energy conservation standards when tested under the current test procedure would comply with the standards using the proposed new test procedure. AHAM submitted a written comment that one of the proposed changes in the test procedure would affect compliance for some dishwasher models: The proposal to change the test voltage from 115 volts to 120 volts. (67 FR 56243) If that change were made, AHAM stated that a significant number of units would no longer comply with the current energy conservation standards, since the 120 volts requirement would affect energy consumption by between three and five percent. However, if the test voltage were to remain at 115 volts, AHAM stated that it was not aware of any units that would fall out of compliance with the applicable energy conservation standards by using the proposed new test procedure. (AHAM No. 33 at 8) This issue was discussed at the October 22 public hearing, and the manufacturers agreed that aside from changing the voltage, the new test procedure would not create any compliance issues. AHAM commented at the public hearing, “We feel very confident that our response represents the entire industry in saying that there are not products that would approach minimal compliance from a soil sensor standpoint.” (Public Hearing Tr. p. 115) When DOE asked the stakeholders at the hearing to confirm the Department's understanding that there are no soil-sensing models that are minimally compliant with the existing standard or that would fall out of compliance once the new test procedure is used, AHAM responded, “correct.” (Public Hearing Tr. p. 115)

Since DOE has decided to maintain the test voltage at 115V and the comments and information DOE received demonstrate there are no dishwasher models that “minimally comply” with the energy conservation standards using the existing test procedure and that would fall out of compliance once the new test procedure is used, the Department is not required by EPCA section 323(e)(2) to make any changes to energy conservation standards at this time. The Department has therefore determined that although today's amended test procedure will alter the measured efficiency or measured energy use of some dishwasher models, it is not necessary to test models with the new test procedure or to consider or make any modifications to energy conservation standards.

The previous sections of this Supplementary Information discussed comments concerning issues which directly affect this rulemaking. Many comments submitted to DOE in this proceeding, however, made suggestions which fell outside the scope and authority of this rulemaking, but raised interesting questions for the future. For example, although stakeholders reached a general consensus that the Department is using the best available data and information to determine the weighted soil loads at this time, Consumers Union (CU) and OOE questioned the process by which DOE would update that data in the future, if consumer pre-rinsing habits change. (CU No. 27 at 1; OOE No. 36 at 4) Because pre-rinsing consumes significant amounts of water, and overall a household uses less energy if dishes are not pre-rinsed before they are placed in a dishwasher, it is possible and desirable that consumer pre-rinsing habits will decrease over time. For example, CU expressed concern about the high percentage weighting which the light soil load receives in the test procedure and felt that the energy efficiency standard should also encourage the most efficient use patterns possible, rather than reflect the current widespread practice of pre-rinsing dishes. It urged the Department to establish a specific goal for improving consumer behavior, and to include in the rulemaking a system for making periodic adjustments to the weighting factors. It recommended that DOE conduct a survey of consumer rinsing practices at least every four years, beginning in 2006. (CU No. 27 at 1) However, AHAM stated that based on industry experience, customer usage habits do not change quickly. It commented that the dishwasher industry has lobbied consumers for years to reduce or eliminate pre-rinsing with little success, as the number of pre-rinsers has consistently hovered around two-thirds. AHAM believes that pre-rinsing practices and the associated soil levels going into the dishwasher are likely to remain stable for a long period of time. (AHAM No. 30FF at 6) The Department recognizes the importance of accurate consumer use data and urges stakeholders to inform DOE of any new information or studies. Interested parties can petition the Department to amend the test procedure when changes in consumer practices justify it. (42 U.S.C. 6293(b)(2))

General Electric (GE) requested that the ENERGY STAR® requirements stay at the current levels after the new test procedure takes effect. (GE No. 30EE at 1) Although the ENERGY STAR program is outside the scope of this test procedure rulemaking, the issue was discussed at the October 22nd public hearing. A DOE representative of the ENERGY STAR program explained that currently, the ENERGY STAR level for dishwashers is set at a level 25 percent higher (more efficient) than the minimum Federal energy efficiency standard. Recognizing that this rulemaking concerns test procedures and not energy efficiency standards, the DOE representative stated that ENERGY STAR levels would be revised only if the new test procedure also resulted in changes to the applicable energy conservation standards. As discussed above, no changes in applicable energy conservation standards are necessitated or are being made at this time. As far as standby energy was concerned, the DOE representative indicated that the ENERGY STAR program is also interested in how test results with the new test procedure come in, and how that would play into any future ENERGY STAR criteria. (Public Hearing Tr. p. 74-75)

Representatives of Energy Efficient Strategies and the Australian Greenhouse Office together submitted extensive comments addressing components of the dishwasher test procedure and broader issues concerning the U.S. testing and labeling program for appliances. Their comments addressed the following: Requiring both non-soil-sensing and soil-sensing dishwashers to use the soil test; the importance of assessing wash performance along with energy consumption to prevent the subversion of the test; incorporating the use of a reference machine with which to compare test results; measuring the energy of low power modes in addition to standby; and following the IEC test procedure as much as possible. They believed the dishwasher test procedure as proposed in the September 2002 NOPR would be too complex and prohibitively expensive from the manufacturers' perspective. Rather than relying on unquantifiable consumer behavior to set three different test levels, they stated that it would be better to use an arbitrarily selected soil load such as the IEC soil load of dishes that would provide a realistic basis for testing all dishwashers—an artificial but fair rating point for comparing products. (Australia No. 37 at 5)

These comments touch on many important questions. However, DOE rejects these suggestions. The rule DOE has decided to finalize today has received extensive scrutiny from U.S. manufacturers and stakeholders and earned significant consensus support. The commenters have not demonstrated that DOE's proposed test procedure is too complex or expensive; in fact, stakeholder consensus in support of the new test procedure and other modifications demonstrates otherwise. DOE further believes that the best empirical data available to it supports DOE's final rule. Finally the issue of coupling an assessment of wash performance with energy consumption testing is outside the scope of the Department's current appliance testing program and outside the scope of this rulemaking.

Today's final rule will produce a more accurate and complete picture of dishwasher energy consumption by providing two test procedures according to dishwasher type. Manufacturers or private labelers first determine whether a dishwasher is a soil-sensing or non-soil-sensing model according to the definitions in sections 1.12 and 1.5 of the rule, and then follow instructions specific to that type of model. They must test soil-sensing dishwashers using a three-level, soil-based test which will yield an energy factor that is based on a range of challenges to the machines' automatic sensing systems. For non-soil-sensing dishwashers, manufacturers or private labelers still will use the original test procedure with clean dishes to determine the energy factor as the average of the test results from the normal and truncated normal cycles. In addition, manufacturers or private labelers must calculate the standby power consumption for any dishwasher using energy in standby mode and add that figure to the EAOC and EAEU totals, but not to the energy factor.

The test procedure for soil-sensing dishwashers requires manufacturers or private labelers to use ANSI/AHAM DW-1 to specify the size and composition of the place settings and the quantities and types of soils which they must apply to the dishes for the series of three soil tests: Heavy, medium and light. This final rule specifies in section 2.7 of the test procedure the type of dishware for manufacturers or private labelers to use, and in section 2.8 requires only half the detergent used in the ANSI/AHAM DW-1 performance test and no rinse agent. After they run a preconditioning cycle (section 2.10), the test procedure for standard size dishwasher models requires manufacturers or private labelers to conduct the following three tests in this order: First, the test for a dishwasher's heavy response, using four soiled place settings; second, the test for the medium response, using two soiled place settings; and third, the test for the light response, using one half the soil load for a single place setting. (Section 2.6.3) Tests of compact models follow the same order, but reduce the soiled loads for the heavy and medium tests by half. The light soil load is the same as for standard models. During each of the three test runs, the test procedure requires manufacturers or private labelers to calculate the machine energy consumption, drying energy consumption, water consumption, and water energy consumption. For soil-sensing dishwashers, the energy factor will combine the results of the three tests, averaged with the following weighted percentages which represent the frequency of those consumer loads: 0.05 for the heavy response, 0.33 for the medium response, and 0.62 for the light response. (Sections 5.1.2 and 5.2.2)

The test procedure defines standby mode and details the equipment and method for calculating standby energy consumption. (Section 4.4) Two options are available for measuring standby energy consumption, depending on whether the power is stable. If the stability criteria in section 4.4 are met, manufacturers or private labelers can measure the standby power directly using a wattmeter. If the standby power consumption is not stable, that is, there is excessive variation in the power levels, then the manufacturers or private labelers must measure the power consumption using a watt-hour meter over a period of at least five minutes. Then they calculate the average standby power by dividing the value measured using the watt-hour meter by measurement period. These changes provide the means to obtain a quantitative value for the level of standby power which the dishwasher consumes. Manufacturers or private labelers must add this standby power amount to the machine and water energy computed for the normal cycle and representative normal cycle for soil-sensing models, and include those amounts in the EAOC and EAEU.

By combining standby power consumption with the energy consumed by the wash cycle, this test procedure will calculate information that will provide consumers with more realistic and accurate estimates of the complete operating cost and energy use of each dishwasher. With the soil test, soil-sensing dishwashers have a test procedure that challenges the cycle responses which the sensing technology controls. It will provide a better approximation of the actual energy consumption of soil-sensing models as consumers use them than did the original test which used clean dishes and did not engage the action of the soil-sensing mechanisms to take a dishwasher beyond the lightest wash cycles.

In this rule, the Department finalizes amendments to test procedures that are used to implement energy conservation standards for dishwashers. The Department has reviewed the rule under the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 et seq. , the regulations of the Council on Environmental Quality, 40 CFR parts 1500-1508, and the Department's regulations for compliance with NEPA, 10 CFR part 1021. The Department has determined that this rule falls into a class of actions that are categorically excluded from review under NEPA. This rule will not affect the quality or distribution of energy usage and, therefore, will not result in any environmental impacts. The Department has therefore determined that this rule is covered by Categorical Exclusion A5, for rulemakings that interpret or amend an existing rule without changing its environmental effect, as set forth in the Department's NEPA regulations in appendix A to subpart D, 10 CFR part 1021. Accordingly, neither an environmental impact statement nor an environmental assessment is required.

Today's final rule is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866, “Regulatory Planning and Review” 58 FR 51735 (October 4, 1993). Accordingly, today's action is not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget.

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

Today's final rule is not a significant regulatory action, nor will it have a significant adverse effect on the supply, distribution, or use of energy. Therefore, today's final rule is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires that an agency prepare an initial regulatory flexibility analysis for every rule which the agency must propose for public comment, by law, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. A regulatory flexibility analysis examines the impact of the rule on small entities and considers alternative ways of reducing negative impacts. 5 U.S.C. 605.

Today's rule prescribes test procedures that will be used to test compliance with energy conservation standards and labeling. Because the rule affects only test procedures and not the minimum energy efficiency standard levels for dishwasher models, the Department believes that it will not have a significant economic impact. Instead, it will provide common testing methods for all dishwasher manufacturers or private labelers, and will improve the accuracy of information provided to consumers. The overall size of the dishwasher manufacturing industry also negates the necessity for a regulatory flexibility analysis. The Small Business Administration (SBA) considers an entity to be a small business if, together with its affiliates, it employs fewer than a threshold number of workers specified in 13 CFR part 121 according to the North American Industry Classification System (NAICS) codes. The threshold number for NAICS classification 335228, which includes dishwashers with other major household appliances, is 500 workers. Using this SBA size standard, the Department determined that there are very few small entities among dishwasher manufacturers or private labelers. Furthermore, two such companies identified as small do not manufacture or distribute any dishwasher models that would be affected by the new test procedure. Because the companies presently have no models using soil-sensing technology or standby power, their testing requirements would not change as a result of this rule. Therefore, DOE certifies that today's rule would not have a “significant economic impact on a substantial number of small entities,” and the preparation of a regulatory flexibility analysis is not warranted.

Executive Order 13132, “Federalism,” (64 FR 43255, August 4, 1999), requires that regulations, rules, legislation, and any other policy actions be reviewed for any substantial direct effects on States, on the relationship between the Federal Government and the States, or in the distribution of power and responsibilities among various levels of government. If there are substantial direct effects, then this Executive Order requires preparation of a Federalism assessment to be used in all decisions involved in promulgating and implementing a policy action.

The rule published today would not regulate or otherwise affect the States. Accordingly, DOE has determined that preparation of a Federalism assessment is unnecessary.

DOE has determined under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” (52 FR 8859, March 18, 1988), that this rule will not result in any takings which might require compensation under the Fifth Amendment to the United States Constitution.

No new information or record keeping requirements are imposed by this rulemaking. Accordingly, no OMB clearance is required under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

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

DOE reviewed today's final rule under the standards of section 3 of the Executive Order and determined that, to the extent permitted by law, the final regulations meet the requirements of those standards.

Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91), the Department of Energy must comply with section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788). Section 32 provides in essence that, where a rule contains or involves use of commercial standards, the rulemaking must inform the public of the use and background of such standards.

The September 2002 NOPR proposed a new test procedure for soil-sensing dishwashers. This test procedure incorporated a commercial standard ( i.e. , ANSI/AHAM DW-1-1992) that previously had been incorporated into the test procedure applicable to dishwashers generally, and therefore the public already had been informed about the use and background of that standard and DOE already had performed any consultation required prior to its incorporation into a test procedure. The September 2002 NOPR also proposed incorporating an August 20, 1999 addendum to ANSI/AHAM DW-1-1992, and therefore DOE stated that as required by section 32 of the Federal Energy Administration Act of 1974, it would consult with the Attorney General and the Chairman of the Federal Trade Commission concerning its impact on competition, prior to prescribing a final rule. (67 FR 56240) This addendum specified the kind of test load (dishware and flatware) to be used in the test procedure. However, so that the test procedure will use the most up to date specifications for currently available dishware and flatware, the Department has decided not to incorporate this addendum in its test procedure. Instead, the Department is listing the specified dishware and flatware in the text of the test procedure as set forth in this final rule. Because the final rule does not incorporate by reference any new industry standards, the Department is not required by section 32(c) to consult with the Attorney General and the Chairman of the Federal Trade Commission concerning the impact on competition of any such new standards. Therefore, the Department has not done so.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and tribal governments and the private sector. The Act also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under the Act (62 FR 12820). The rule published today does not contain any Federal mandate, so these requirements do not apply.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. No. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any proposed rule or policy that may affect family well-being. Today's final rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

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

As required by 5 U.S.C. 801, DOE will submit to Congress a report regarding the issuance of today's final rule prior to the effective date set forth at the outset of this notice. The report will state that it has been determined that the rule is not a “major rule” as defined by 6 U.S.C. 801(2).

The Secretary of Energy has approved issuance of this final rule.

Pursuant to the provisions of the 1970 UNESCO Convention, codified into U.S. law as the Convention on Cultural Property Implementation Act (Pub. L. 97-446, 19 U.S.C. 2601, et seq. ) (the Act), the United States, after a request was made by the Government of Cyprus on September 4, 1998, imposed emergency import restrictions on Byzantine ecclesiastical and ritual ethnological material from Cyprus for a period of 5 years from the date of the request. These restrictions and the list of materials covered by them were published in the Federal Register (64 FR 17529, April 12, 1999) by the U.S. Customs Service in Treasury Decision (T.D.) 99-35. The T.D. amended § 12.104g(b) of the Customs Regulations which lists emergency import restrictions on cultural property imposed under the Act. The restrictions became effective on April 12, 1999.

Under 19 U.S.C. 2603(c)(3), emergency restrictions may be extended for a period of 3 years upon a determination by the United States that the emergency condition continues to apply with respect to the articles covered by the restrictions. On August 25, 2003, the Acting Assistant Secretary for Educational and Cultural Affairs, Department of State, issued the determination that the emergency condition continues to apply to the articles covered in T.D. 99-35. Accordingly, Customs and Border Protection is amending § 12.104g(b) to reflect the extension of the emergency import restrictions for a 3-year period; this extension of restrictions commences on September 4, 2003. The list of ethnological materials contained in T.D. 99-35 and an accompanying image database may also be found at the following Internet website address: http://exchanges.state.gov/culprop.

Based on the foregoing, importation of these materials continues to be restricted unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met. For example, these materials may be permitted entry if accompanied by appropriate export certification issued by the Government of Cyprus or by documentation showing that exportation from Cyprus occurred before April 12, 1999.

The document also amends 19 CFR 12.104g(a) and 104g(b), in the third column heading of the lists set forth in those sections, by removing the words “T.D. No.” and replacing them with the words “Decision No.” This change is made in recognition of the fact that import restrictions are now published by CBP Decisions as opposed to Treasury Decisions. A conforming change is also made to the text of 19 CFR 12.104g(b).

This amendment to the regulations is being issued in accordance with § 0.2(a) of the Customs Regulations (19 CFR 0.2(a)) pertaining to the authority of the Secretary of Homeland Security (or his/her delegate) to prescribe regulations not involving customs revenue functions in accordance with the delegation of such authority by the Secretary of the Treasury.

Because the amendment to the Customs Regulations contained in this document extends emergency import restrictions already imposed on the referenced cultural property of Cyprus under the terms of the Convention on Cultural Property Implementation Act (Pub. L. 97-446, 19 U.S.C. 2601 et seq. ), in accordance with the 1970 UNESCO Convention and in furtherance of a foreign affairs function of the United States, pursuant to the Administrative Procedure Act (5 U.S.C. 553(a)(1)), no notice of proposed rulemaking or public procedure is necessary and a delayed effective date is not required.

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply. Accordingly, this final rule is not subject to the regulatory analysis or other requirements of 5 U.S.C. 603 and 604.

This amendment does not meet the criteria of a “significant regulatory action” as described in E.O. 12866.

The principal author of this document was Bill Conrad, Regulations Branch, Office of Regulations and Rulings, Bureau of Customs and Border Protection.

Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408, filed NADA 141-204 for the concurrent use in dogs of their SENTINEL (milbemycin oxime and lufenuron ) FLAVOR TABS, approved under NADA 141-084, with their CAPSTAR (nitenpyram) Tablets, approved under NADA 141-175, to kill adult fleas and prevent flea eggs from hatching. Novartis Animal Health US also filed NADA 141-205 for the concurrent use in dogs and cats of their PROGRAM (lufenuron) FLAVOR TABS, approved under NADA 141-035, with CAPSTAR Tablets to kill adult fleas and prevent flea eggs from hatching. Supplemental NADAs were also filed to NADA 141-035, NADA 141-084, and NADA 141-175 to provide appropriate labeling for the concurrent uses of these products under NADA 141-204 and NADA 141-205, and to NADA 141-035 for use of lufenuron flavor tablets in puppies and kittens as young as four weeks of age. The NADAs and supplemental NADAs are approved as of, June 11, 2003, and the regulations are amended in 21 CFR 520.1288, 520.1446, and 520.1510 to reflect the approval. The basis of approval is discussed in the freedom of information summaries.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and effectiveness data and information submitted to support approval of these applications may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under sections 512(c)(2)(F)(ii) or (iii) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii) or (iii)), these NADAs and supplemental NADAs qualify for 3 years of marketing exclusivity beginning Jue 11, 2003.

The agency has determined under 21 CFR 25.33(d)(1) that these actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither environmental assessments nor environmental impact statements are required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801 808.

Hampton Bay Days, Inc. will sponsor the Hampton Bay Days Festival on September 5-7, 2003 on the Hampton River, Hampton, Virginia. The festival will include water ski demonstrations, personal watercraft and wake board competitions, paddle boat races, classic boat displays, fireworks displays and a helicopter rescue demonstration. A fleet of spectator vessels is expected to gather nearby to view the festival events. In order to ensure the safety of participants, spectators and transiting vessels, 33 CFR 100.508 will be in effect for the duration of the festival activities. Under provisions of 33 CFR 100.508, vessels may not enter the regulated area without permission from the Coast Guard Patrol Commander. Spectator vessels may enter and anchor in the special spectator anchorage areas if they proceed at slow, no wake speed. The Coast Guard Patrol Commander will allow vessels to transit the regulated area between festival events. Because these restrictions will be in effect for a limited period, they should not result in a significant disruption of maritime traffic.

In addition to this notice, the maritime community will be provided extensive advance notification via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

The supplemental information is organized in the following order:

EPA is approving, as part of the Wisconsin ozone SIP, rules that would allow sources to use emissions averaging and an emissions cap as a option for complying with ozone season limits on emissions of NO X . These limits apply to large electricity generating units in Southeast Wisconsin. EPA approved the rules setting the NO X emissions limits into Wisconsin's SIP on November 13, 2001 (66 FR 56931). The limits are expressed in mass of allowable emissions per unit of heat input (pounds per million Btu).

Emissions averaging will allow units subject to the NO X emissions limits of NR 428 of the Wisconsin Administrative Code to create emissions averaging plans in which the compliance of multiple sources would be assessed collectively. Participating sources would need to submit such plans to the Wisconsin Department of Natural Resources (WDNR) at least 90 days prior to the start of the ozone season, and would need to identify the participating units, their owners or operators, applicable emissions limitations, projected heat input and emissions rate, and projected mass emissions for the ozone season. The plan would establish an aggregate ozone season emissions rate limit for participating units through a formula that sums allowable emissions for each unit (based on projected heat input and each source's individual emissions rate), and divides it by the total projected heat input. To provide an environmental benefit from averaging, the formula subtracts 0.01 pounds/mmbtu from each unit's allowable emissions.

As a result, total emissions under an averaging plan would be lower than they would be if each unit demonstrated compliance on an individual basis. However, individual units would be allowed to exceed emissions rates specified in the NO X reduction rules, while other units would emit less than allowed under the rules. Thus, averaging allows companies to minimize the cost of emissions reductions by allocating reductions at the units that can achieve them most inexpensively.

In addition, units participating in an averaging plan are subject to a mass emission limitation, beginning with the 2008 ozone season. This feature of the program “caps” the aggregate ozone season NO X emissions of participating sources at a level that could not be exceeded regardless of heat input. This level is determined by the participating units' share of actual heat input during the 1995, 1996 and 1997 ozone seasons, multiplied by 15,912 tons, an amount consistent with the state's one-hour ozone attainment demonstration.

Within 60 days of the end of each ozone season, owners or operators of the participating units must submit compliance reports demonstrating compliance with the plan's emission rate and mass emission limit.

The Midwest Environmental Advocates provided adverse comments on EPA's proposed approval of Wisconsin's averaging program. The Natural Resources Defense Council requested clarification of an issue related to the proposed approval of the new categorical emissions limit for new integrated gasification combined cycled units. In addition, EPA received two positive comments on the proposed rulemaking from citizens. This section responds to the adverse comments and to the request for clarification.

The Midwest Environmental Advocates noted areas where Wisconsin's averaging program may differ from the EPA's guidance on Improving Air Quality with Economic Incentive Programs, EPA-452/R-01-001, January 2001 (EIP Guidance). The comments by Midwest Environmental Advocates are addressed in detail below, and in many cases EPA disagrees that Wisconsin's averaging program is inconsistent with the EIP. In general, EPA notes that the EIP Guidance is neither a law nor a regulation. While it provides important guidance on the development of economic incentive programs, differences between a SIP submittal and the EIP Guidance are not necessarily sufficient reason to disapprove a SIP submittal.

Comment: Wisconsin's NO X averaging program should not be approved because it would not result in clear environmental benefit, as required under the EIP Guidance.

Response: The averaging program should be considered as an element of Wisconsin's overall NO X reduction rules. EPA has determined that these rules will achieve the results that the state attributed to them in the one-hour ozone attainment plan (proposed rule, July 2, 2001, 66 FR 34878; final rule November 13, 2001, 66 FR 56931). The averaging portion of the rules provides compliance provisions that make it possible for sources subject to the rules to comply with them in a timely way, which otherwise would not be possible. Therefore, the averaging program is an essential element in an overall package that will lead to actual emissions decreases, and conforms with the EIP Guidance provisions on environmental benefit. Moreover, units that enter into NO X averaging plans must collectively accept a lower NO X emissions limit than they would have individually, which will promote further reductions in actual emissions.

Comment: Wisconsin's NO X averaging program fails to take source compliance margins into account, contrary to the EIP Guidance. The averaging program could lead to the disappearance of the margin between actual and allowable emissions that would occur in the absence of the averaging program, creating the potential for “an overall increase in actual emissions, despite a theoretical decrease in allowable emissions.”

Response: The EIP Guidance (section 6.5(g)) states that in areas that have a required attainment demonstration, no provisions for considering compliance margins are necessary if the relevant attainment plan “includes the emissions from compliance margins as actual emissions” and “the relevant emissions inventories include emissions from the compliance margins for all sources covered under the EIP.” Since the Milwaukee-Racine attainment and ROP plan and associated NO X emissions inventories assume that the NO X sources covered by the averaging program all emit as much as allowed, the compliance margin is already taken into account, and emissions will be reduced even if sources emit the maximum allowed. See “Technical Support Document for the Post-1999 Rate-of-Progress Plan Revision to the State Implementation Plan for the Milwaukee-Racine, Wisconsin Area,” from Jacqueline Nwia to Randall Robinson, June 7, 2001, p. 27 (Docket WI 108-7338).

Comment: The rules require that excess emissions reductions used in an averaging plan be “beyond those required to meet all State and Federal requirements,” but they do not require that reductions be in excess of those that would have occurred in the absence of the EIP, for instance due to upgrades, replacement or repair. The use of such reductions in averaging would frustrate the goal of achieving additional reductions.

Response: Since it is difficult to determine which emissions-reducing upgrades, replacements, and repairs are motivated by an averaging program and which would occur in its absence, it is reasonable for the state to allow all reductions that are not otherwise required to be used in emissions averaging. It is sufficient to show that the overall effect of the program is to create lower emissions than would occur in the program's absence, even if some of the specific reductions used in an averaging plan would have occurred in any case. The EIP guidance requirement that economic incentive programs produce a clear environmental benefit is met because of the role that the averaging program plays in making compliance with the NO X reduction rules possible, by the reduced emissions rate on sources that participate in averaging, and by the imposition of an emissions cap.

Comment: It is unclear that the imposition of an emissions cap results in “any appreciable environmental benefit that would not have otherwise been achieved by complying with the state's one-hour ozone attainment plan.”

Response: The one-hour ozone attainment plan is a tool for managing air quality, through projecting the impacts of regulations and economic changes on emissions of ozone precursors and on concentrations of ozone in ambient air. The attainment plan, however, does not impose requirements on sources. While the attainment plan includes projections of future emissions, based on projected activity levels and allowable emissions rates, these future emissions and activity levels are not regulatory requirements on sources. This SIP revision will create a new emissions cap, consistent with the attainment demonstration, for sources that participate in emissions averaging. This emissions cap provides certainty, which would not otherwise exist, that emissions from participating sources will be capped despite the potential for activity level increases beyond those projected.

Comment: The emissions cap does not apply until 2008, by which time it is likely that other factors will reduce NO X emissions in the Milwaukee-Racine area.

Response: It may be true that other programs or events will reduce future emissions beyond what is required under Wisconsin's current NO X rules. However, for the purpose of this rulemaking, EPA cannot assume the implementation of these future programs prior to 2008, and therefore counts the 2008 emissions cap as an environmental benefit.

Comment: The program “fails to account for the relationship between NO X averaging plans and Title V permits.” A unit operating under a Title V permit might use emissions averaging to increase its emissions, violating the facility's Title V permit and constituting a major modification necessitating new source review.

Response: Any unit that increases emissions sufficiently to violate its permit would be subject to enforcement, and any unit that increases emissions sufficiently to constitute a major modification would be subject to new source review, notwithstanding averaging for the purpose of compliance with the NO X emissions limits contained in NR 428.04(2) and NR 428.05(3). The averaging program cannot be used for compliance with any other requirement, and it cannot be used to avoid any requirement. Proper use of the averaging program for compliance with the NR 428 NO X emissions limits will be consistent the Title V permit, because when these limits are included in the permits of sources eligible for averaging, the permits will specify that averaging is a compliance option.

Comment: “The proposed SIP revision does not explicitly require units participating in averaging plans to modify their Title V permit accordingly.” Unless the public can determine from a facility's Title V permit whether a unit is part of an averaging plan, which other units are included in the plan, and how to determine the applicable emissions limits among and between those units, public participation in the Title V permit process will be undermined.” Moreover, “the public is charged with obtaining a copy of an averaging plan from the participating parties,” potentially inhibiting the public's ability to assess a source's compliance status.

Response: While NR 428 does not itself contain a requirement that units participating in averaging plans modify their Title V permits, NR 407, which is part of Wisconsin's SIP, does require that new requirements and compliance options be incorporated into permits as they are issued. Therefore, permits issued for sources that may use averaging must authorize the use of the averaging program as a compliance option. The Clean Air Act does not require that the details of averaging plans be included in Title V permits, but rather that the Title V permit identify whether a unit may use emissions averaging as a compliance option. EPA agrees with the commenter that the public should have access to the averaging plan when viewing a company's Title V permit, and the public should not have to obtain the averaging plan from the source. The WDNR has clarified, in a letter dated May 28, 2003, that it will keep any prospective averaging plan, DNR comments on the plan, the final plan, and all compliance reports, in the Title V permit file for each participating source. It should also be noted that participants in an emissions averaging plan must provide public notice of the plan in a local newspaper at least 60 days prior to the start of the ozone season.

Comment: The proposed SIP revision fails to include provisions preventing a unit receiving excess emissions credits from increasing emissions sufficient to constitute a major modification without undergoing PSD or NSR review.

Response: The PSD and NSR programs require sources to undergo review when increasing emissions sufficient to constitute a major modification. Nothing in Wisconsin's averaging program changes this requirement.

Comment: EPA's “justifications for failing to apply agency guidance [on averaging among sources not under common ownership] are insufficient because they fail to address the purported purpose behind the unified owner requirement.” The unified owner requirement “is meant to ensure enforcement and compliance.” A cap, whatever its environmental benefits, cannot substitute for lack of enforceability.

Response: A cap provides assurances that if enforcement of average emission rates proves difficult, the state and EPA can nonetheless protect the environment by enforcing against any violation of the cap.

Comment: Saying that WDNR staff will be able to review averaging plants is irrelevant because the guidance prohibits emissions averaging between facilities owned by different companies to ensure enforcement and compliance. Given the difficulty of predicting activity levels, “merely making sure that projected activity levels are reasonable does not ensure that day to day averaging is achieved.”

Response: The commenter is correct that projecting reasonable activity levels does not ensure that day to day averaging is achieved. In looking at the question of whether Wisconsin will be able to check the reasonableness of projected activity levels, EPA is seeking to ensure that averaging plan participants will not be able to deliberately “game” the system by projecting excessive activity by a unit with a reduced emissions rate. In the situation where non-compliance occurs because a unit has a lower-than-projected activity level, emissions will be lower than projected. This situation is of less concern if the activity levels projected are reasonable and similar to those of previous years, than if intentionally-erroneous significant growth in activity levels were projected. In the latter situation, emissions could increase even if activity levels are lower than the inflated projections of the averaging plan. It is important to note that it is a violation of the NO X averaging rules to exceed the allowable aggregate emissions rate, regardless of whether total emissions are greater or less than projected.

Comment: “Wisconsin's air management program is already under-staffed and under-funded,” is late in issuing permits, and is having difficulty ensuring compliance with the Title V program. “Even if DNR staff review of averaging plans could adequately address the concerns in EPA guidance, air management staff are not in a position to adequately complete this task.”

Response: The staff time required to verify that a small number of averaging plans contain reasonable projections of activity levels is minimal. EPA is confident that Wisconsin staff can perform this function, regardless of staffing and funding problems that may affect the Title V program.

Comment: A company operating a high-emissions unit cannot ensure that sufficient reductions exist unless it controls the low emission unit creating those credits. The fact that eligible facilities operate close to capacity is irrelevant, since activity levels can change.

Response: The commenter is correct that in averaging plans involving multiple owners, the ability to comply of all participants in the averaging plan can be compromised if the owner of the unit with a reduced emission rate does not maintain sufficient activity level. Averaging plan participants must take the risk of failing to comply with the averaging plan as a result of unexpected reductions in activity level by sources with reduced emissions rates. EPA could bring enforcement actions for such non-compliance, even though non-compliance with the emissions rate would be accompanied by lower actual emissions than projected.

Comment: The proposed SIP fails to indicate that all units participating in an averaging plan are in violation each and every day within the plan's averaging period if the aggregate NO X emissions exceed the averaging plan's emission limits, multiplied by the number of participating units, as required under the EIP guidance.

Response: NR 428(j) states that “all emissions units participating in an ozone season NO X emissions averaging program may be considered out of compliance” if the averaging plan aggregate emissions rate or emissions cap is exceeded. Furthermore, “each emissions unit is considered out of compliance for each day of non-compliance until corrective action is taken to reduce emissions and achieve compliance.” In the case of a violation of the averaging plan's aggregate emission rate or emissions cap, these provisions would give Wisconsin the ability to bring enforcement actions for violations for each participating unit, for each day during the ozone season up to the point when corrective action was taken. These provisions provide significant deterrence, are consistent with the requirements of the Clean Air Act and Title V regulations, and are substantially consistent with the EIP guidance. While the EIP guidance might be interpreted to indicate that a source may be in violations for each day of the ozone season even after corrective action is taken, EPA is willing to be flexible on this point.

Comment: The proposed rules do not indicate that source shutdowns and production activity curtailments are not eligible as emission reductions, nor that a source's emissions reductions must be “permanent,” as required under the EIP.

Response: Given the structure of Wisconsin's averaging program, such provisions against counting source shutdowns and curtailments are unnecessary, and not required under the EIP. In Wisconsin's averaging program, compliance depends on emissions rates, not total emissions. Therefore, shutdowns and curtailments intrinsically do not generate reductions that can be used in averaging programs. Regarding the permanence of emissions reductions, the EIP states that “permanent” means that a source “commits to actions or achieves reductions for a future period of time as defined in the EIP” (EIP Guidance, Section 4.2(a)). In Wisconsin's program, sources must commit to making reductions during the period defined by the NO X reduction rules—the ozone season. Thus, averaging plans in Wisconsin must use reductions that meet the EIP's general definition of permanent. The EIP also provides an additional definition of permanent specifically for averaging. In addition to the general definition, in an averaging program “the source's emission reduction must last throughout the life of the program defined in the SIP” (EIP Guidance, Table 4.3(b)). If “the life of the program” is defined as the period of time during which the program will be in operation, then Wisconsin's program, which has an indefinite life, would not seem to meet this requirement. However, EPA believes that a more reasonable interpretation is that the reduction must last through a time period defined by the program—the ozone season. In this case, Wisconsin's program does require permanent reductions.

Comment: The proposed SIP revision would allow geographic shifting of emissions without protecting communities of concern from emissions increases, as required under the EIP. In addition, EPA should determine whether the proposed SIP revision satisfies the environmental justice requirements in Executive Order 12898.

Response: The EIP does not require special protections for communities of concern in trading or averaging programs that involve emissions of NO X , because NO X , unlike volatile organic compounds, is not a pollutant that raises significant concerns about localized impacts. NO X emissions impact regional concentrations of ozone, but do not cause elevated ozone concentrations on a local level. NO X emissions are also associated with emissions of nitrogen oxides (NO 2 ), a criteria pollutant for which the Clean Air Act provides a variety of protections for local communities. Wisconsin has no NO 2 nonattainment areas, and any significant increases in NO 2 emissions at sources subject to the averaging plan would be subject to New Source Review. Since the averaging program creates no adverse local impacts, there is no potential to create “disproportionately high and adverse human health or environmental effects * * * on minority populations and low-income populations,” as addressed in Executive Order 12898.

Comment: Wisconsin's NO X averaging rule “may frustrate the state's new 8-hour attainment needs”. EPA should disapprove this SIP revision until Wisconsin submits an 8-hour attainment demonstration plan.

Response: The NO X averaging rule is a necessary component of Wisconsin's NO X control rules, which will reduce NO X emissions and contribute to reductions in ambient ozone concentrations. The rule contributes to Wisconsin's efforts to meet the 8-hour attainment standard; it does not frustrate them.

Comment: “The proposed SIP revision appears to be promulgated for one company,” raising “issues of the appropriateness and legality of regulation created and implemented for individual companies.”

Response: Several companies are eligible to use the NO X averaging program, and EPA anticipates that more than one company will be involved in emissions averaging. In any case, as long as the program is protective of the environment, it would not be a cause for concern if only one company chose to use the program.

Comment: “The direct final rule approves inclusion of a new categorical emission limit for new integrated gasification combined cycle (IGCC) units in the Wisconsin SIP. We call upon EPA to clarify that this emissions limit does not and cannot, pre-ordain, or substitute for, BACT or LAER analysis required under the NSR and PSD requirements of the Clean Air Act.”

Response: None of the emissions limits in Wisconsin's NO X rules, including the categorical emission limit for new integrated gasification combined cycle (IGCC) units, do or can predetermine or substitute for BACT or LAER analysis required under the NSR and PSD requirements of the Clean Air Act.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget.

For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001).

This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action also does not have federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act.

This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTA), 15 U.S.C. 272 note, requires Federal agencies to use technical standards that are developed or adopted by voluntary consensus to carry out policy objectives, so long as such standards are not inconsistent with applicable law or otherwise impracticable. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Absent a prior existing requirement for the state to use voluntary consensus standards, EPA has no authority to disapprove a SIP submission for failure to use such standards, and it would thus be inconsistent with applicable law for EPA to use voluntary consensus standards in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Therefore, the requirements of section 12(d) of the NTTA do not apply.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 28, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

An analysis of lodging and meal cost survey data reveals that the listing of maximum per diem rates for locations within the continental United States (CONUS) should be updated to provide for the reimbursement of Federal employees' expenses covered by per diem. As a result of this analysis, the incidental expense under the per diem expenses will be increased from $2 to $3 for all per diem localities.

This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

This final rule is not required to be published in the Federal Register for notice and comment; therefore, the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. , does not apply.

The Paperwork Reduction Act does not apply because the changes to the FTR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.

Inspection of Public Comments: Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, call telephone number: (410) 786-7195.

To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, PO Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 or by faxing to (202) 512-2250. The cost for each copy is $10. As an alternative, you can view and photocopy the Federal Register document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the Federal Register .

This Federal Register document is also available from the Federal Register online database through GPO access, a service of the U.S. Government Printing Office. The Web site address is http://www.access.gpo.gov/nara/index.html .

We are publishing this final rule with comment period to address the issues of manufacturer recordkeeping requirements and price recalculations under the Medicaid drug rebate program. We decided to issue a final rule with comment period rather than a final rule to give interested parties an additional opportunity to provide comments on these provisions. We believe the additional comment period is appropriate given the time that has elapsed between the publication of the September 19, 1995 proposed rule (60 FR 48442) and the publication of this rule.

We are publishing this rule to address concerns regarding the administration of the Medicaid drug rebate program for manufacturers and States. In the absence of a regulatory recordkeeping requirement, manufacturers are in effect required to retain pricing data for an indefinite period. The 3-year recordkeeping requirement will enable manufacturers to close their books within a reasonable timeframe. This recordkeeping requirement will mirror the 3-year timeframe established for States to retain records at 42 CFR 433.32.

We believe establishing a timeframe for manufacturers to submit revised pricing data to us also streamlines the administration of the Medicaid drug rebate program. Due to recalculations involving hundreds of millions of State and Federal Medicaid dollars and over 10 years of paperwork, we believe it is essential that a standard timeframe be established within which manufacturers and CMS, or States, are permitted to submit revised drug prices. This timeframe will also assist States that would otherwise be required to retain their drug utilization data indefinitely to verify changes in rebate amounts resulting from retroactive manufacturer recalculations. Therefore, as of the effective date of this rule, manufacturers will have 12 quarters from the quarter in which the data were originally due to submit revised pricing data to us. This timeframe is described in further detail in section IV of the preamble, “Provisions of the Final Rule.”

In this rule, we intend the terms “manufacturer,” “average manufacturer price (AMP),” and “best price (BP)” to have the same meaning as described and set forth in the national drug rebate agreements signed by manufacturers and the Secretary (on behalf of States). We also have used these terms in guidance documents that we have issued over the years pertaining to the Medicaid drug rebate program. We do not intend to alter these definitions in this rule. Rather, the primary purpose of this rule is to establish procedural requirements pertaining to manufacturer recordkeeping and pricing changes. We will set forth regulatory definitions of these terms in a subsequent document we will publish in the Federal Register .

On September 19, 1995, we published a proposed rule (60 FR 48442) in the Federal Register that specified requirements for State Medicaid agencies and conditions under which Federal payments would be made under the Medicaid program for covered outpatient drugs. The rule also specified the conditions for approval and renewal of rebate agreements with drug manufacturers participating in the Medicaid program.

In the September 1995 proposed rule, we also discussed prior period adjustments and pricing changes. A prior period adjustment is a change in the unit rebate amount based on a manufacturer's revised AMP or BP data for a prior rebate period after that rebate period's pricing data have been submitted to us. The prior period adjustments generally consist of a manufacturer's changes to pricing data resulting from sales data not being available before pricing submissions to us or changes in the methodology used to establish AMP or BP. We use the manufacturer's pricing data to generate the unit rebate amount for each 9-digit national drug code, which States use to calculate rebate amounts due from manufacturers. Any changes to a manufacturer's AMP or BP result in changes to the unit rebate amount and rebates due from the manufacturer. Thus, the prior period adjustments are necessary to correct rebate amounts that are owed by manufacturers or credits due to manufacturers.

Since the publication of the September 1995 proposed rule, States have expressed concerns regarding pricing changes and recalculations under the Medicaid drug rebate program. We have received requests for pricing recalculations for drug prices submitted as far back as 1991. The statute does not specifically provide for such recalculations; however, we have permitted the recalculations where revisions were made to conform to the statute or rebate agreement. Unfortunately, there is a significant burden on States and manufacturers to maintain pricing data and supporting documentation for timeframes dating back to 1991. We have seen a recent increase in the number of these requests and the dollar value of the recalculations. In addition, manufacturers have expressed concerns regarding recordkeeping burdens. In response to these concerns, we are finalizing the recordkeeping requirements and the time limit on pricing recalculations proposed in the September 1995 rule. We will address the remaining provisions of the September 1995 rule in a subsequent rule we will publish in the Federal Register .

Section 1927 of the Social Security Act (the Act) authorizes the Medicaid drug rebate program. Section 1927 of the Act was amended by section 4401 of the Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90) and section 13602 of the Omnibus Budget Reconciliation Act of 1993 (OBRA ‘93). Under section 1927 of the Act, manufacturers that have entered into a national rebate agreement must provide each State Medicaid program with rebate period payments (or other periodic rebate payments, as determined by the Secretary).

Section 1927(b) of the Act gives the Secretary the authority to publish regulations that establish manufacturer recordkeeping requirements and the time limit for manufacturer pricing changes. To implement these provisions, we will require that a manufacturer must retain pricing data for 3 years from the date the manufacturer reports that period's data to us. Although the statute sets forth requirements on data reported to us by manufacturers, it does not provide recordkeeping requirements for manufacturer data. In the national drug rebate agreement, we did not establish a timeframe during which records must be maintained. The 3-year time period comports with the requirements for the maintenance of records on State Medicaid expenditures imposed on States. Section 433.32 requires that States retain records for 3 years from the date of submission of a final expenditure report for Federal financial participation.

Section 1927(b)(3)(A)(i) requires that manufacturers submit pricing information no later than 30 days after the end of each quarter. However, it does not establish a time limitation regarding pricing changes. While we recognize the need to permit manufacturers to submit revised prices within a timeframe, States and manufacturers should be protected from potential liabilities resulting from no time limit. We will require that manufacturers submit changes to AMP or BP within 3 years from the date that period's data are due. The timeframe for pricing changes set forth in this final rule is more fully described in section IV of the preamble, “Provisions of the Final Rule.”

In the September 19, 1995 proposed rule, we solicited comments on proposed requirements for State Medicaid agencies, the conditions under which Federal payments would be made under the Medicaid program for covered outpatient drugs, and the conditions for approval and renewal of rebate agreements with drug manufacturers. In this final rule with comment period, we are finalizing two of the provisions of the September 1995 proposed rule. We will address the remaining provisions of the September 1995 proposed rule and will publish a subsequent rule in the Federal Register .

In the September 1995 proposed rule, we proposed to add to part 447 a new subpart I entitled “Payment for Outpatient Prescription Drugs Under Drug Rebate Agreements.” Within that subpart, we proposed a new § 447.534(g) to establish a 3-year recordkeeping requirement for manufacturer data pertaining to AMP and BP calculations. We also proposed a new § 447.534(h) to establish a 3-year time limit for manufacturers to report revised AMP or BP to us.

We received 19 timely comments in response to the September 19, 1995 proposed rule. We received comments from State government officials and representatives of the pharmaceutical industry including manufacturers, pharmacists, attorneys, and consultants. Although we received comments on a variety of topics pertaining to the proposed rule, we are addressing only the comments that pertain to the manufacturer recordkeeping requirements and the 3-year limitation on price recalculations set forth in this final rule with comment period. These comments and our responses are summarized below:

Comment: One commenter noted that the 3-year records retention standard will provide a useful records management timeframe.

Response: We agree; therefore, we are issuing this final rule with comment period to establish the 3-year recordkeeping requirements for manufacturers.

Comment: One commenter expressed the opinion that the burden for calculating the amount of rebate adjustments should rest with the manufacturer when the adjustment results from changes to AMP or BP, rather than the State.

Response: The State has never been responsible for calculating the amount of rebate adjustments. The manufacturer is responsible for recalculating the amount of rebate adjustments.

Comment: One commenter noted the need to clarify the 3-year timeframe as it applies to prior period adjustments.

Response: We concur with the need to provide clarification. We define the 3-year limitation as equivalent to 12 quarters because the Medicaid drug rebate program operates on a quarterly basis. Pricing information is exchanged and processed on a quarterly basis and rebates are due and paid on a quarterly basis. Therefore, wherever we refer in this document to a 3-year timeframe for recalculations and pricing changes, we interpret it as 12 quarters from the quarter in which the data were due.

Comment: One commenter noted that 3 years is too long a timeframe for applying retroactive prior period adjustments and recommended that the allowed retroactive period not exceed 24 months.

Response: We recognize the potential burden for States and manufacturers to apply prior period adjustments during a 3-year retroactive timeframe, as opposed to a 24-month timeframe. Nevertheless, as we discussed earlier in the “Background” section of this preamble, we continue to believe that a 3-year timeframe is reasonable because it comports with requirements for maintenance of records on State Medicaid expenditures. Furthermore, it is consistent with the manufacturer's recordkeeping requirements set forth in this document.

Comment: One commenter noted that the 3-year prior period adjustment standard will provide a useful records management timeframe. Other commenters expressed appreciation for the 3-year time limitation, saying that it is essential to enable a manufacturer to close its books for a fiscal year.

Response: As discussed earlier in the “Background” section of this preamble, we agree.

This final rule with comment period incorporates two of the provisions in the proposed rule issued on September 19, 1995. We will address the remaining provisions of the September 1995 proposed rule in a subsequent document we will publish in the Federal Register . This rule adopts the following provisions in the September 1995 proposed rule:

Under part 447, “Payments for Services,” we are adding a new subpart I, entitled “Payment for Outpatient Prescription Drugs Under Drug Rebate Agreements.” We are reserving § 447.500 through § 447.532 and § 447.536 through § 447.550.

Under § 447.534, “Manufacturer reporting requirements,” we are reserving paragraphs (a) through (f). We are redesignating paragraph (g) in the September 1995 proposed rule as paragraph (h) and are reserving the newly redesignated paragraph (g). We are also redesignating paragraph (h) as paragraph (i). We are revising newly redesignated paragraphs (h) and (i).

Under § 447.534(h), we are establishing a requirement that manufacturers must retain for 3 years from the date the manufacturer reports that rebate period's data to us, all records (written or electronic) of these data, and any other materials from which the calculations of the AMP and BP were derived. A manufacturer must retain records beyond the 3-year period if one or more of the following circumstances exist:

• The records are the subject of an audit or of a government investigation of which the manufacturer is aware related to average manufacturer price or best price.

• The audit findings or investigation related to the AMP and BP have not been resolved.

If the audit findings or investigation have been resolved, manufacturers are not required to retain historical pricing data that fall outside the 3-year recordkeeping requirement. We want to clarify that § 447.534(h) was not designed to address recordkeeping requirements when a manufacturer is the subject of an audit or government investigation by the Office of Inspector General (OIG) or any other government entity. In the September 1995 proposed rule, we proposed requiring manufacturers to retain data beyond the 3-year timeframe if the records are the subject of an audit. Because we did not specifically address OIG investigations in the September 1995 proposed rule, we want to clarify this point in this final rule. Therefore, we are revising § 447.534(h) from the language in the September 1995 proposed rule to specify that manufacturers must retain data beyond 3 years if the records are the subject of an audit or a government investigation.

Under § 447.534(i), we are establishing a 3-year time limitation for a manufacturer to submit drug pricing changes. We define the 3-year period as 12 quarters. Therefore, we require that the manufacturer report to us changes to AMP or BP for a period not to exceed 12 quarters from the quarter in which the data were due.

The terms of the Medicaid Drug Rebate Agreement require manufacturers to submit pricing data for each calendar quarter no later than 30 days after the end of that quarter. For example, for data pertaining to the second quarter of 2003 (April 1, 2003 through June 30, 2003), the due date for submitting pricing data is July 30, 2003, which falls during the third quarter of 2003.

For purposes of implementing the 3-year timeframe for reporting pricing changes to us, we define 3 years as 12 quarters from the quarter in which the data were due. For example, data from the second quarter of the year 2000 (April 1, 2000 through June 30, 2000) were due July 30, 2000 (the third quarter of 2000). Twelve quarters from the third quarter of 2000 (the quarter in which the data were due) is the third quarter of 2003. Based on the due date for submitting pricing data, data submitted during the third quarter of 2003 were due on July 30, 2003. Therefore, pricing changes pertaining to data from the second quarter of 2000 were due to us no later than July 30, 2003.

As with all pricing data submitted under the Medicaid drug rebate program, if CMS, the Office of Inspector General, or another authorized government agency reviews a manufacturer's pricing data and determines that adjustments or revisions are necessary, irrespective of the quarter, the manufacturer is bound under the Medicaid Drug Rebate Agreement to comply with that determination.

Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the “DATES” section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

Under paragraph (h) of § 447.534, there are two recordkeeping requirements:

(1) A manufacturer must retain records (written or electronic) for 3 years from the date the manufacturer reports that rebate period's data to CMS. The records must include these data and any other materials from which the calculations of the average manufacturer price and best price are derived, including a record of any assumptions made in the calculations.

(2) A manufacturer must retain records beyond the 3-year period if one or more of the following circumstances exist: (A) The records are the subject of an audit or of a government investigation of which the manufacturer is aware related to average manufacturer price or best price, and (B) The audit findings or investigation related to the average manufacturer price and best price have not been resolved.

Under paragraph (i), there is a reporting requirement: A manufacturer must report to CMS changes to average manufacturer price or best price for a period not to exceed 12 quarters from the quarter in which the data were due.

These information collection requirements already exist. The recordkeeping requirements are in the contract between the drug manufacturer and CMS and are in any event usual and customary business practices. The regulation specifies timeframes; however, under the contract, we did not establish a timeframe.

The reporting requirement is currently approved under OMB number 0938-0578. The regulation merely adds a time limit in which the manufacturer must report changes; currently, there is none.

If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following:

We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.

Executive Order 12866 (as amended by Executive Order 13258, which merely assigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We believe this rule will have an economically significant effect. We believe the rule will save $90 million annually over the next 5 years ($50 million Federal savings and $40 million State savings as shown in the table below). This figure represents 0.4 percent of total Medicaid drug expenditures in Federal fiscal year 2002. We consider this rule to be a major rule.

The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million or less in any 1 year. For purposes of the RFA, pharmaceutical manufacturers with 750 or fewer employees are considered small businesses according to the Small Business Administration's size standards matched to North American Industry Classification System, effective October 1, 2002, http://www.sba.gov/size/sizetable2002.html). Use of the Small Business Administration's size standards matched to North American Industry Classification System is in compliance with the Small Business Administration's regulation that set forth size standards for health care industries at 65 FR 69432. Individuals and States are not included in the definition of a small entity. This rule will not have a significant impact on small businesses.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. This rule will not have a significant impact on small rural hospitals because the provisions contained herein do not pertain to hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. We anticipate this rule will impact State governments through increased Medicaid savings, in the aggregate, of $40 million per year. We anticipate this rule will impact the private sector, in the aggregate, by less than $110 million. We anticipate this rule will cost drug manufacturers, in the aggregate, $90 million per year.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We do not anticipate this rule will impose direct requirement costs on State governments.

We anticipate the rule will cost drug manufacturers $90 million in the aggregate. To derive this estimate, we examined the rebate adjustment data from several States for the four quarters from the third quarter of 2001 through the second quarter of 2002. We separated the data from adjustments for each quarter into two parts:

• Adjustments over the previous 12 quarters; and

• Adjustments beyond the previous 12 quarters. From those data, we estimated the percentage of total rebate adjustments within 12 quarters nationally. We then projected what percentage of total adjustments would not occur given the 12-quarter limit. Then we estimated the national rebate adjustments by quarter by calculating the adjustments as a percentage of total rebates by State and multiplying that by the total national rebates. We then multiplied the projected total national rebate adjustments by the projected percentage of rebates that would not occur within 12 quarters to estimate the total impact of the proposal. Over the four quarters of data (third quarter of 2001 through the second quarter of 2002), we found that that resulted in approximately $90 million.

The estimated number of drug manufacturers currently participating in the Medicaid Drug Rebate Program is approximately 550. As previously indicated, businesses with 750 employees or fewer are considered small businesses. At this time, we are unable to determine how many of the 550 drug manufacturers have 750 or fewer employees. No single manufacturer will be affected significantly by this rule. As a group, the participating drug manufacturers will probably have a mixed reaction to this rule. We anticipate that some drug manufacturers will likely object to a narrowing of their window of opportunity to submit pricing changes to us. We are unable to quantitatively address the burden to manufacturers with respect to recordkeeping. Absent this rule, manufacturers are in effect required to retain their pricing and sales records indefinitely. Therefore, some of the manufacturers may be relieved that we are setting forth clear guidelines for records retention that closely mirror the industry standard for records retention.

We do not anticipate that this rule will adversely affect a drug manufacturer's participation in the Medicaid Drug Rebate program nor impact the current level of access and availability of prescription drugs for Medicaid beneficiaries. There is no impact to contractors or providers.

We anticipate the rule will result in $50 million in Federal Medicaid savings and save State Medicaid programs $40 million in the aggregate. This rule will have a positive effect on the State Medicaid agencies. State Medicaid agencies are having difficulty fully funding their Medicaid programs. They will likely be relieved that we are setting forth a rule that will limit their fiscal vulnerability for manufacturers implementing retroactive pricing changes that result in greatly increased costs to their programs.

We are unable to quantitatively address the burden to States with respect to recordkeeping. Absent this rule, States are in effect required to retain drug utilization data indefinitely in order to verify the revised or reduced rebates from manufacturers attributable to retroactive pricing changes. Therefore, we expect that a majority of the States will be relieved that we are setting forth clear guidelines for manufacturer records retention.

This rule will not adversely affect a State's ability to obtain manufacturers rebates nor impact the current level of access and availability of prescription drugs for Medicaid beneficiaries. There is no impact to Medicaid providers or contractors.

We considered not publishing this final rule. However, we believe this rule is necessary to address the burden to States and manufacturers with respect to recordkeeping in the Medicaid drug rebate program. We chose to issue this rule given the concerns repeatedly expressed by manufacturers and States regarding the recordkeeping requirements and the time limit on pricing changes.

Another alternative would be to establish a longer or a shorter time limitation for recordkeeping and pricing changes. We did not choose a longer recordkeeping timeframe because it would not relieve a reasonable amount of the burden to manufacturers. In addition, a longer time limit on pricing changes would not sufficiently alleviate States' fiscal vulnerability with regard to retroactive pricing changes. We did not choose a shorter recordkeeping timeframe because it would create a disparity among Federal recordkeeping requirements. The 3-year timeframe set forth for both requirements mirrors existing records retention requirements for States. Furthermore, because the recordkeeping and pricing change provisions are interrelated, we believe the timeframes should be the same for these provisions.

For these reasons, we are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined, and we certify, that this rule will not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the National Flood Insurance Program, 42 U.S.C. 4001 et seq. ; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59 et seq. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the Federal Register .

In addition, the Federal Emergency Management Agency has identified the special flood hazard areas in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in the identified special flood hazard area of communities not participating in the NFIP and identified for more than a year, on the Federal Emergency Management Agency's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives a 6-month, 90-day, and 30-day notification addressed to the Chief Executive Officer that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications have been made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless they take remedial action.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, October 26, 1987, 3 CFR, 1987 Comp.; p. 252.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778, October 25, 1991, 56 FR 55195, 3 CFR, 1991 Comp.; p. 309.

This is a synopsis of the Commission's Report and Order, MB Docket No. 03-110, adopted August 20, 2003, and released August 27, 2003. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., CY-B402, Washington, DC, 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail qualexint@aol.com.

On May 6, 2003, at 68 FR 23947-48, 1 the Board published a notice of proposed rulemaking (NPR) in this proceeding seeking comments on the Board's proposal to remove the regulations at 49 CFR 1137.1 concerning divisions of revenue cases between carriers participating in a joint rate. The NPR indicated that the regulations were issued in response to the enactment of the Railroad Revitalization and Regulatory Reform Act of 1976 (4R Act). The 4R Act amended former section 15(6) of the Interstate Commerce Act by adding provisions that would expedite the handling of divisions of revenue cases. In response, the Interstate Commerce Commission (ICC) issued the original divisions of revenue rules in Expeditious Handling of Divisions of Revenue Cases, 353 I.C.C. 349 (1976). 2 As noted in the notice of proposed rulemaking, section 15(6) was recodified at former 49 U.S.C. 10705, which was later modified by the Staggers Rail Act of 1980. Former section 10705 in general required that evidentiary proceedings in cases brought by complaint be completed in 9 months and a final decision be issued within 180 days after the close of the record. 3

The NPR noted that, under the ICC Termination Act of 1995, Pub. L. 104-88, 109 Stat. 803 (1995), section 10705 had been modified. Although the Board retains jurisdiction over divisions of joint rates, the provision for the filing of a notice of intent and the deadlines for gathering evidence and issuing a final decision have been removed.

In proposing to remove the rules at section 1137.1, the Board stated that agency records indicated that there had not been a divisions of revenue complaint in over 20 years, 4 and, accordingly, retaining the regulations appeared to be administratively inefficient. Furthermore, the rules contained the notice of intent and deadline provisions that no longer had a statutory basis. The Board noted that the general rules for filing complaints at 49 CFR part 1111 appeared adequate for divisions complaints. Comments were sought on whether the rules should be retained, updated, or eliminated.

In response to the notice, the Board received one comment, from the Association of American Railroads (AAR). The AAR supports the proposal for the reasons expressed in the NPR. It submits that the Board's current general complaint rules are sufficient for any potential divisions complaint.

The regulations at 49 CFR 1137.1 concerning divisions of revenue cases will be removed. It would be administratively inefficient to retain rules that are outdated and have not been used in over 20 years where general complaint rules are in place. The only party responding to the NPR supports the elimination of the rules. Finally, parties in a prospective complaint can propose on a case-by-case basis to use any evidence they consider relevant, including the evidence referenced in the former guidelines.

This action will not significantly affect either the quality of the human environment or the conservation of energy resources.

The Migratory Bird Treaty Act (MBTA) of July 3, 1918 (40 Stat. 755; 16 U.S.C. 703 et seq. ), authorizes and directs the Secretary of the Department of the Interior, having due regard for the zones of temperature and for the distribution, abundance, economic value, breeding habits, and times and lines of flight of migratory game birds, to determine when, to what extent, and by what means such birds or any part, nest, or egg thereof may be taken, hunted, captured, killed, possessed, sold, purchased, shipped, carried, exported, or transported.

In the August 8, 2003, Federal Register (68 FR 47424), we proposed special migratory bird hunting regulations for the 2003-04 hunting season for certain Indian tribes, under the guidelines described in the June 4, 1985, Federal Register (50 FR 23467). The guidelines respond to tribal requests for Service recognition of their reserved hunting rights, and for some tribes, recognition of their authority to regulate hunting by both tribal members and nonmembers on their reservations. The guidelines include possibilities for:

(1) On-reservation hunting by both tribal members and nonmembers, with hunting by non-tribal members on some reservations to take place within Federal frameworks but on dates different from those selected by the surrounding State(s);

(2) On-reservation hunting by tribal members only, outside of usual Federal frameworks for season dates and length, and for daily bag and possession limits; and

(3) Off-reservation hunting by tribal members on ceded lands, outside of usual framework dates and season length, with some added flexibility in daily bag and possession limits.

In all cases, the regulations established under the guidelines must be consistent with the March 10-September 1 closed season mandated by the 1916 Migratory Bird Treaty with Canada.

In the May 6, 2003, Federal Register (68 FR 24324), we requested that tribes desiring special hunting regulations in the 2003-04 hunting season submit a proposal including details on:

(a) Harvest anticipated under the requested regulations;

(b) Methods that would be employed to measure or monitor harvest (such as bag checks, mail questionnaires, etc.);

(c) Steps that would be taken to limit level of harvest, where it could be shown that failure to limit such harvest would adversely impact the migratory bird resource; and

(d) Tribal capabilities to establish and enforce migratory bird hunting regulations.

No action is required if a tribe wishes to observe the hunting regulations established by the State(s) in which an Indian reservation is located. We have successfully used the guidelines since the 1985-86 hunting season. We finalized the guidelines beginning with the 1988-89 hunting season (August 18, 1988, Federal Register [53 FR 31612]).

Although the proposed rule included generalized regulations for both early- and late-season hunting, this rulemaking addresses only the early-season proposals. Late-season hunting will be addressed in late-September. As a general rule, early seasons begin during September each year and have a primary emphasis on such species as mourning and white-winged dove. Late seasons begin about October 1 or later each year and have a primary emphasis on waterfowl.

The following paragraphs provide a brief summary of information on the status and harvest of waterfowl excerpted from various reports. For more detailed information on methodologies and results, you may obtain complete copies of the various reports at the address indicated under ADDRESSES or from our Web site at http://migratorybirds.fws.gov.

Federal, provincial, and State agencies conduct surveys each spring to estimate the size of breeding populations and to evaluate the conditions of the habitats. These surveys are conducted using fixed-wing aircraft and encompass principal breeding areas of North America, and cover over 2.0 million square miles. The Traditional survey area is comprised of Alaska, Canada, and the northcentral United States, and includes approximately 1.3 million square miles. The Eastern survey area includes parts of Ontario, Quebec, Labrador, Newfoundland, Nova Scotia, Prince Edward Island, New Brunswick, New York, and Maine, an area of approximately 0.7 million square miles.

Habitat conditions for breeding waterfowl have greatly improved over last year in most of the prairie survey areas. These improved conditions are reflected in the numbers of ponds counted this year. The estimate of May ponds (U.S. Prairies and Prairie and parkland Canada combined) of 5.2 ± 0.2 [SE] million is 91% higher than last year (P < 0.001) and 7% above the long-term average (P = 0.034). Numbers of ponds in Canada (3.5 ± 0.2 million) and the United States (1.7 ± 0.1 million) were above 2002 estimates (+145% in Canada and +30% in the U.S.; P < 0.001). Canadian ponds were similar to the 1974-2002 average (P = 0.297), while ponds in the United States were 10% above the 1974-2002 average (P = 0.037).

Most prairie areas had warm temperatures and abundant rain this spring. Two areas of dramatic improvement over the past several years were south-central Alberta and southern Saskatchewan, where conditions went from poor to good after much-needed precipitation relieved several years of drought. Other areas in the prairies also improved compared with 2002, but to a lesser extent. However, years of dry conditions in parts of the United States and Canadian prairies, combined with agricultural practices, have reduced the quality and quantity of residual nesting cover and overwater nest sites in many regions. This could potentially limit production for both dabbling and diving ducks, if the warm spring temperatures and good moisture of 2003 do not result in rapid growth of new cover. Eastern South Dakota was the one area of the prairies where wetland habitat conditions were generally worse than last year, mostly due to low soil moisture, little winter precipitation, and no significant rains in April. This region received several inches of rain in May, but most birds had probably flown to other regions with more favorable wetland conditions.

In the northern part of the traditional survey area, habitat was in generally good condition and most areas had normal water levels. The exception was northern Manitoba, where low water levels in small streams and beaver ponds resulted in overall breeding habitat conditions that were only fair. Warm spring temperatures arrived much earlier this year than the exceptionally late spring last year. However, a cold snap in early May may have hurt early nesting species such as mallards and pintails, particularly in the northern Northwest Territories.

This spring, habitat conditions in the eastern survey area ranged from excellent to fair. In the southern and western part of this survey area, water and nesting cover were plentiful and temperatures were mild. Habitat quality decreased to the north, especially in northern and western Quebec, where many shallow marshes and bogs were either completely dry or reduced to mudflats. Beaver pond habitat was also noticeably less common than normal. To the east in Maine and most of the Maritime provinces, conditions were excellent, with adequate water and vegetation, and warm spring temperatures.

Weather and habitat conditions during the summer months can influence waterfowl production. Good wetland conditions increase renesting and brood survival. July wetland conditions were rated fair to good over most of Prairie Canada, the Dakotas, and eastern Montana, but poor conditions prevailed in eastern South Dakota, south-central Manitoba, central Saskatchewan, and north-central Montana.

However, uniformly good conditions were found in the northern portions of the prairie provinces, and spring and summer rains made for good-to-excellent conditions along the border of Saskatchewan and eastern Montana. Results of the July Production Survey indicate that the number of ponds in Prairie Canada and the north-central United States combined was 2.5 ± 0.1 million ponds. This was 35 percent above last year's estimate of 1.8 ± 0.1 million ponds, but still 8 percent below the long-term average. July ponds in Prairie Canada were estimated to be 1.5 ± 0.1 million. This was 47 percent above last year's estimate of 1.0 ± 0.1 million but 16 percent below the long-term average. July ponds in the north-central United States were estimated at 1.0 ± 0.1 million. This was 21 percent above last year's estimate of 0.8± 0.1 million, but similar to the long-term average.

In the traditional survey area, the total duck population estimate was 36.2 ± 0.7 million birds, 16 percent above ( P < 0.001) last year's estimate of 31.2 ± 0.5 million birds, and 9 percent above ( P < 0.001) the 1955-2002 long-term average. Mallard abundance was 7.9 ± 0.3 million birds, which was similar to last year's estimate of 7.5 ± 0.2 million birds ( P = 0.220) and the long-term average ( P = 0.100). Blue-winged teal abundance was estimated to be 5.5 ± 0.3 million birds. This value was 31 percent above last year's estimate of 4.2 ± 0.2 million birds ( P <0.001) and 23 percent above the long-term average ( P = 0.001). Estimates of shovelers (3.6 ± 0.2 million; +56%) and pintails (2.6 ± 0.2 million; +43%) were above 2002 estimates ( P < 0.001), while estimates of gadwall (2.5 ± 0.2 million), wigeon (2.6 ± 0.2 million), green-winged teal (2.7 ± 0.2 million), redheads (0.6 ± 0.1 million), canvasbacks (0.6 ± 0.1 million), and scaup (3.7 ± 0.2 million) were unchanged from 2002 estimates ( P ≥ 0.149). Gadwall (+55%) and shovelers (+72%) were above their 1955-2002 averages ( P < 0.001), as were green-winged teal (+46%; P < 0.001), which were at their second highest level since 1955. Pintails (-39%) and scaup (-29%) remained well below their long-term averages ( P < 0.001). Wigeon, redheads, and canvasbacks were unchanged from their long-term averages ( P ≥ 0.582).

The eastern survey area comprises strata 51-56 and 62-69. The 2003 total duck population estimate for this area was 3.6 ± 0.3 million birds. This estimate is 17 percent lower than that of last year (4.4 ± 0.3 million birds, P = 0.065), but is similar to the 1996-2002 average ( P = 0.266). Numbers of the individual species were similar to those of last year and the 1996-2002 average, with the exception of mergansers (0.6 ± 0.1 million), which decreased 30 percent from the 2002 estimate ( P = 0.035).

The number of broods in the north-central United States and Prairie Canada combined was 434,900, 23 percent higher than last year, and 7 percent below the long-term average. The number of broods in Prairie Canada and the north-central United States were 142 percent and 18 percent above last year's estimates, respectively. Brood indices in Prairie Canada were 24 percent below the long-term average, while brood counts were 31 percent above the long-term average in the north-central United States. Reflecting the lower concentration of ducks in the Canadian boreal forest this year compared to 2002, the brood index in this region was 72 percent lower than last year, and 76 percent below the long-term average. The late-nesting index, that is, the number of pairs and lone drakes without broods seen during July surveys, was 17 percent higher than last year, and 51 percent lower than the long-term average, for all areas combined. The late-nesting index was down 43 percent and 30 percent relative to last year in boreal Canada and Prairie Canada, respectively, but up 67 percent in the north-central United States. Late nesting indices were below the long-term average by 74 percent in boreal Canada, by 43 percent in the north-central United States, and by 46 percent in Prairie Canada.

The size of the mid-continent mallard population, which comprises mallards from the traditional survey area, plus Michigan, Minnesota, and Wisconsin, was 8.8 million birds. This is similar to that of 2002 (8.6 million). The 2003 mid-continent mallard fall-flight estimate is 10.3 million birds, statistically similar to the 2002 estimate of 9.1 million birds. These estimates were based on revised mid-continent mallard population models and, therefore, differ from those previously published.

For further discussion on the implications of this information for this year's selection of the appropriate hunting regulations in the United States, see the August 19, 2003, Federal Register (68 FR 50016).

We provide information on the population status and productivity of North American Canada geese ( Branta canadensis ), brant ( B. bernicla ), snow geese ( Chen caerulescens ), Ross's geese ( C. rossii ), emperor geese ( C. canagicus ), white-fronted geese ( Anser albifrons ) and tundra swans ( Cygnus columbianus ). The timing of snowmelt and goose nesting activities in most areas of the Arctic and subarctic was near average in 2003. Only Alaska's North Slope, Banks and adjacent Arctic Islands, and Akimiski Island reported substantially delayed nesting phenology this year. Although Alaska's Yukon-Kuskokwim Delta experienced an early spring snowmelt, we observed poor production of young by brant, cackling Canada geese, and emperor geese, likely due to low wetland levels and high fox predation. Conditions in 2003 were especially favorable for greater snow geese. Of the 25 populations for which current primary population indices were available, 8 populations (Atlantic Population, Aleutian, Dusky, and 3 temperate-nesting populations of Canada geese; Pacific Population White-fronted Geese; and Eastern Population Tundra Swans) displayed significant positive trends, and only Short Grass Prairie Population Canada geese displayed a significant negative trend over the most recent 10-year period. Forecasts for production of geese and swans in North America in 2003 varied regionally, but generally will be similar to or higher than in 2002.

For the 2003-04 migratory bird hunting season, we proposed regulations for 28 tribes and/or Indian groups that followed the 1985 guidelines and were considered appropriate for final rulemaking. Some of the proposals submitted by the tribes had both early- and late-season elements. However, as noted earlier, only those with early-season proposals are included in this final rulemaking; 19 tribes have proposals with early seasons. Comments and revised proposals received to date are addressed in the following section. The comment period for the proposed rule, published on August 8, 2003, closed on August 18, 2003. Because of the necessary brief comment period, we will respond to any comments received on the proposed rule and/or these late-season regulations not responded to herein in the September late-season final rule.

We received two comments regarding the notice of intent published on May 6, 2003, which announced rulemaking on regulations for migratory bird hunting by American Indian tribal members. The Wisconsin Department of Natural Resources endorsed the 2003 seasons proposed by the Great Lakes Indian Fish and Wildlife Commission. The Michigan Department of Natural Resources commented on the establishment of tribal regulations on 1836 Treaty areas. Michigan believed it was premature of the Service to establish waterfowl regulations in areas covered by the 1836 Treaty until such time as the issue of 1836 Treaty hunting rights are affirmed by a court of competent jurisdiction.

Service Response: We have addressed this issue several times in the last few years. Our position is that the Federal Government does recognize the Treaty of 1836 as reserving to the affected tribes or bands hunting rights in the ceded territory. Further, the Federal courts have already confirmed the retention of reserved fishing rights in the territory ceded by the Treaty of 1836 in United States v. Michigan, 471 F.Supp. 192 (W.D. Mich. 1979), remanded, 623 F.2d 448 (6th Cir. 1980), order modified, 653 F.2d 277 (6th Cir. 1981), cert. denied, 454 U.S. 1124 (1981). That case and cases dealing with other treaty cessions, such as Lac Courte Oreilles v. Wisconsin ( i.e. , both the 1837 and the 1842 Treaties), provide persuasive precedent for the belief that hunting as well as fishing rights were reserved by the tribes in the Treaty of 1836. We have not altered our position on this matter.

NEPA considerations are covered by the programmatic document, “Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds (FSES 88-14),” filed with the Environmental Protection Agency on June 9, 1988. We published a Notice of Availability in the Federal Register on June 16, 1988 (53 FR 22582) and our Record of Decision on August 18, 1988 (53 FR 31341). Copies are available from the address indicated under ADDRESSES . In addition, an August 1985 Environmental Assessment titled “Guidelines for Migratory Bird Hunting Regulations on Federal Indian Reservations and Ceded Lands” is available under ADDRESSES .

Section 7 of the Endangered Species Act, as amended (16 U.S.C. 1531-1543; 87 Stat. 884), provides that, “The Secretary shall review other programs administered by him and utilize such programs in furtherance of the purposes of this Act” (and) shall “insure that any action authorized, funded or carried out * * * is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of [critical] habitat * * *” Consequently, we conducted consultations to ensure that actions resulting from these regulations would not likely jeopardize the continued existence of endangered or threatened species or result in the destruction or adverse modification of their critical habitat. Findings from these consultations are included in a biological opinion and may have caused modification of some regulatory measures previously proposed. The final frameworks reflect any modifications. Our biological opinions resulting from this Section 7 consultation are public documents available for public inspection at the address indicated under ADDRESSES .

Collectively, the rules covering the overall frameworks for migratory bird hunting are economically significant and have been reviewed by the Office of Management and Budget (OMB) under Executive Order 12866. This rule is a small portion of the overall migratory bird hunting frameworks and was not individually submitted and reviewed by OMB under Executive Order 12866. As such, a cost/benefit analysis was initially prepared in 1981. This analysis was subsequently revised annually from 1990-96, and then updated in 1998. We will update again in 2004. It is further discussed below under the heading Regulatory Flexibility Act. Results from the 1998 analysis indicate that the expected welfare benefit of the annual migratory bird hunting frameworks is on the order of $50 to $192 million. Copies of the cost/benefit analysis are available upon request from the address indicated under ADDRESSES .

These regulations have a significant economic impact on substantial numbers of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). We analyzed the economic impacts of the annual hunting regulations on small business entities in detail as part of the 1981 cost-benefit analysis discussed under Executive Order 12866. This analysis was revised annually from 1990-95. In 1995, the Service issued a Small Entity Flexibility Analysis (Analysis). The Analysis was subsequently updated in 1996 and 1998 and will be updated again in 2004. The primary source of information about hunter expenditures for migratory game bird hunting is the National Hunting and Fishing Survey, which is conducted at 5-year intervals. The 1998 Analysis was based on the 1996 National Hunting and Fishing Survey and the U.S. Department of Commerce's County Business Patterns, from which it was estimated that migratory bird hunters would spend between $429 million and $1.084 billion at small businesses in 2003. Copies of the Analysis are available upon request from the address indicated under ADDRESSES .

This rule is a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. For the reasons outlined above, this rule has an annual effect on the economy of $100 million or more. However, because this rule establishes hunting seasons, we do not plan to defer the effective date under the exemption contained in 5 U.S.C. 808 (1) and this rule will be effective immediately.

On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. While this rule is a significant regulatory action under Executive Order 12866, it is not expected to adversely affect energy supplies, distribution, or use. Therefore, it is not a significant energy action and no Statement of Energy Effects is required.

We examined these regulations under the Paperwork Reduction Act of 1995. We utilize the various recordkeeping and reporting requirements imposed under regulations established in 50 CFR part 20, Subpart K, in the formulation of migratory game bird hunting regulations. Specifically, OMB has approved the information collection requirements of the Migratory Bird Harvest Information Program and assigned clearance number 1018-0015 (expires 10/31/2004). This information is used to provide a sampling frame for voluntary national surveys to improve our harvest estimates for all migratory game birds in order to better manage these populations. OMB has also approved the information collection requirements of the Sandhill Crane Harvest Questionnaire and assigned control number 1018-0023 (expires 10/31/2004). The information from this survey is used to estimate the magnitude and the geographical and temporal distribution of harvest, and the portion it constitutes of the total population. A Federal agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We have determined and certify, in compliance with the requirements of the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq. , that this rulemaking will not “significantly or uniquely” affect small governments, and will not produce a Federal mandate of $100 million or more in any given year on local or State government or private entities. Therefore, this proposed rule is not a “significant regulatory action” under the Unfunded Mandates Reform Act.

The Department, in promulgating this proposed rule, has determined that this rule will not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of Executive Order 12988.

In accordance with Executive Order 12630, these rules, authorized by the MBTA, do not have significant takings implications and do not affect any constitutionally protected property rights. These rules will not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property. In fact, these rules allow hunters to exercise privileges that would be otherwise unavailable; and, therefore, reduce restrictions on the use of private and public property.

Due to the migratory nature of certain species of birds, the Federal Government has been given responsibility over these species by the MBTA. Annually, we prescribe frameworks from which the States make selections and employ guidelines to establish special regulations on Federal Indian reservations and ceded lands. We develop the frameworks in a cooperative process with the States and the Flyway Councils. This process allows States to participate in the development of frameworks from which they will ultimately make season selections, thereby having an influence on their own regulations. This process preserves the ability of the States and Tribes to determine which seasons meet their individual needs. Further, any State or Tribe may be more restrictive than the Federal frameworks at any time. These rules do not have a substantial direct effect on fiscal capacity, change the roles or responsibilities of Federal or State governments, or intrude on State policy or administration. Therefore, in accordance with Executive Order 13132, these regulations do not have significant federalism effects and do not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

Due to the migratory nature of certain species of birds, the Federal government has been given responsibility over these species by the MBTA. Thus, in accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951) Executive Order 13175, and 512 DM 2, we have evaluated possible effects on Federally recognized Indian tribes and have determined that there are no effects on Indian trust resources. However, by virtue of the tribal proposals received in response to the May 6, 2003, request for proposals and the August 8, 2003, proposed rule, we have consulted with all the tribes affected by this rule.

The rulemaking process for migratory game bird hunting must, by its nature, operate under severe time constraints. However, we intend that the public be given the greatest possible opportunity to comment on the regulations. Thus, when the preliminary proposed rulemaking was published, we established what we believed were the longest periods possible for public comment. In doing this, we recognized that when the comment period closed, time would be of the essence. That is, if there were a delay in the effective date of these regulations after this final rulemaking, the tribes would have insufficient time to communicate these seasons to their member and non-tribal hunters and to establish and publicize the necessary regulations and procedures to implement their decisions. We, therefore, find that “good cause” exists, within the terms of 5 U.S.C. 553(d)(3) of the Administrative Procedure Act, and these regulations will take effect immediately upon publication.

Therefore, under the authority of the Migratory Bird Treaty Act of July 3, 1918, as amended (40 Stat. 755; 16 U.S.C. 703 et seq. ), we prescribe final hunting regulations for certain tribes on Federal Indian reservations (including off-reservation trust lands), and ceded lands. The regulations specify the species to be hunted and establish season dates, bag and possession limits, season length, and shooting hours for migratory game birds.

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

In accordance with § 679.20(a)(5)(i)(A)( 1 ) and the American Fisheries Act (AFA) (Public Law 105-277, Division C, Title II), NMFS specified a pollock incidental catch allowance equal to 3.5 percent of the pollock total allowable catch after subtraction of the ten percent Community Development Quota reserve in the final 2003 harvest specifications for groundfish in the BSAI (68 FR 9907, March 3, 2003).

As of August 6, 2003, the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that approximately 21,887 metric tons (mt) of pollock remain in the incidental catch account. Based on projected harvest rates of other groundfish species and the expected incidental catch of pollock in those fisheries, the Regional Administrator has determined that 6,500 mt of pollock specified in the incidental catch account will not be necessary as incidental catch. Therefore, NMFS is apportioning the projected unused amount, 6,500 mt, of pollock from the incidental catch account to the directed fishing allowances established pursuant to § 679.20(a)(5)(i)(A). Pursuant to the pollock allocation requirements set forth in § 679.20(a)(5)(i), this transfer will increase the allocation to catcher vessels harvesting pollock for processing by the inshore component by 3,250 mt, to catcher/processors and catcher vessels harvesting pollock for processing by catcher processors in the offshore component by 2,600 mt and to catcher vessels harvesting pollock for processing by motherships in the offshore component by 650 mt. Pursuant to § 679.20(a)(5)(i)(A)( 4 ), no less than 8.5 percent of the 2,600 mt allocated to catcher processors in the offshore component, 221 mt, will be available for harvest only by eligible catcher vessels delivering to listed catcher processors. Pursuant to § 679.20(a)(5)(i)(A)( 4 )( iii ), an additional 13 mt or 0.5 percent of the catcher/processor sector allocation of pollock will be available to unlisted AFA catcher/processors.

Pursuant to § 679.20(a)(5)(i)(A)( 3 ), Table 1 revises the final 2003 BS subarea allocations for the seven inshore catcher vessel pollock cooperatives that have been approved and permitted by NMFS and the open access AFA vessels for the 2003 fishing year consistent with this reallocation.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is contrary to the public interest. This requirement is contrary to the public interest as it would delay the implementation of these measures in a timely fashion in order to allow full utilization of the pollock TAC, and therefore reduce the public's ability to use and enjoy the fishery resource.

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

This action is taken under 50 CFR 679.20, and is exempt from review under Executive Order 12866.

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

The 2003 TAC of Atka mackerel for gears other than jig in the Eastern Aleutian District and the Bering Sea subarea is 9,753 metric tons (mt) as established by the final 2003 harvest specifications for Groundfish of the BSAI (68 FR 9907, March 3, 2003).

As of August 7, 2003, 2,100 mt remain in the 2003 Eastern Aleutian District and Bering Sea subarea TAC of Atka mackerel for gears other than jig. Current information shows the catching capacity of vessels expected to fish Atka mackerel in Statistical Area 541 of the BSAI is about 2,500 mt per day. Regulations at § 679.23(b) specifies that the time of all openings and closures of fishing seasons, other than the beginning and end of the calendar fishing year, is 1200 hrs, A.l.t. However, the Administrator, Alaska Region, NMFS, has determined that the B season allowance of the Atka mackerel TAC could be exceeded if a 24-hour fishery were allowed to occur. NMFS intends that the seasonal allowance not be exceeded and, therefore, cannot allow a 24-hour directed fishery.

NMFS, in accordance with § 679.25(a)(1)(i) and § 679.25(a)(2)(i)(A), is adjusting the B season for Atka mackerel in the Eastern Aleutian District and Bering Sea subarea by opening the fishery at 2400 hrs, A.l.t., September 1, 2003, and closing the fishery at 1200 hrs, A.l.t., September 2, 2003, at which time directed fishing for Atka mackerel will be prohibited. This action has the effect of opening the fishery for 12 hours.

Regulations at § 679.20(a)(8)(iii)(C) require the HLA fisheries in areas 542 and 543 open 48 hours after the seasonal closure of area 541. To provide for openings in the subsequent HLA fisheries at 1200 hrs, A.l.t., the fishery in the Eastern Aleutian District and Bering Sea subarea is being opened at 2400 hrs, A.l.t., September 1, 2003, and closed at 1200 hrs, A.l.t., September 2, 2003.

In accordance with § 679.25(a)(2)(iii), NMFS has determined that prohibiting directed fishing at 1200 hrs, A.l.t., September 2, 2003, after a 12-hour opening is the least restrictive management adjustment to achieve the 2003 Atka mackerel TAC in Eastern Aleutian District and Bering Sea subarea and will allow other fisheries to continue in noncritical areas and time periods. Pursuant to § 679.25(b)(2), NMFS has considered data regarding catch per unit of effort and rate of harvest in making this adjustment.

In accordance with § 679.20(a)(8)(iii)(C), the Regional Administrator is opening the first directed fisheries for Atka mackerel within the HLA in areas 542 and 543. These regulations require the opening to occur 48 hours after the closure of the area 541 Atka mackerel directed fishery. The Regional Administrator has established the opening date for the second HLA directed fisheries in areas 542 and 543 as 48 hours after the closure of the first HLA fisheries. NMFS is opening directed fishing for Atka mackerel in the HLA of areas 542 and 543 in accordance with the periods listed under the DATES section of this notice and as justified below.

In accordance with § 679.20(a)(8)(iii), vessels using trawl gear for directed fishing for Atka mackerel have previously registered with NMFS to fish in the HLA fisheries in areas 542 and/or 543. NMFS has randomly assigned each vessel to the directed fishery or fisheries for which they have registered. NMFS has notified each vessel as to which fishery each vessel has been assigned by NMFS. A notification of vessel assignments was published elsewhere in this issue.

In accordance with § 679.20(a)(8)(ii)(C)(1), the B season harvest limit of the seasonal TAC in areas 542 and 543 are 8,147 mt and 5,547 mt, respectively. Based on those seasonal apportionments and the proportion of the number of vessels in each platoon compared to the total number of vessels participating in the HLA directed fishery for area 542 or 543 during the B season, the harvest limit for each HLA directed fishery for areas 542 and 543 are as follows: For the first directed fishery in area 542, 4,074 mt; for the first directed fishery in area 543, 2,774 mt; for the second directed fishery in area 542, 4,074 mt; for the second directed fishery in area 543, 2,774 mt.

In accordance with § 679.20(a)(8)(iii)(E), the Regional Administrator has established the closure dates of the Atka mackerel directed fisheries in the HLA for areas 542 and 543 based on the amount of the harvest limit and the estimated fishing capacity of the vessels assigned to the respective fisheries. Consequently, NMFS is prohibiting directed fishing for Atka mackerel in the HLA of areas 542 and 543 in accordance with the periods listed under the DATES section of this notice.

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

In accordance with § 679.20(a)(8)(iii)(A), 10 vessels using trawl gear for directed fishing for Atka mackerel have registered with NMFS to fish in the 2003 B season HLA fisheries in areas 542 and/or 543. In accordance with § 679.20(a)(8)(iii)(B) the Administrator, Alaska Region, has randomly assigned each vessel to the HLA directed fishery for Atka mackerel for which they have registered and is now notifying each vessel of its assignment.

Vessels assigned to participate in the first HLA directed fishery in area 542 and/or the second HLA directed fishery in area 543 in accordance with the vessel's registration under § 679.20(a)(8)(iii)(A) are as follows: Federal Fishery Permit number (FFP) 3423 Alaska Warrior, FFP 3819 Alaska Spirit, FFP 2134 Ocean Peace, FFP 3835 Seafisher, and FFP 2800 U.S. Intrepid.

Vessels assigned to participate in the first HLA directed fishery in area 543 and/or the second HLA directed fishery in area 542 in accordance with the vessel's registration under § 679.20(a)(8)(iii)(A) are as follows: FFP 2443 Alaska Juris, FFP 2733 Seafreeze Alaska, FFP 4093 Alaska Victory, FFP 3400 Alaska Ranger, and FFP 1879 American No. 1.

This action responds to the best available information. The Assistant Administrator for Fisheries, NOAA, finds that the need to immediately implement this action that notifies each vessel of their fishery assignment to allow the harvest of the B season HLA limits established for area 542 and area 543 constitutes good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) and 50 CFR 679.20(a)(8)(iii), as such procedures would be unnecessary and contrary to the public interest. Similarly, the need to implement these measures in a timely fashion that notifies each vessel of their fishery assignment to allow the harvest of the B season HLA limits established for area 542 and area 543 constitutes good cause to find that the effective date of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

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