On October 28, 2000, the President signed the Appropriations Act, which provides that 180 days after the date of its enactment, U.S. establishments that slaughter or process ratites (such as ostriches, emus, and rheas) or squabs for distribution into commerce as human food will be subject to the requirements of the PPIA (21 U.S.C. 451, et seq. ), rather than the voluntary poultry inspection program under section 203 of the AMA (7 U.S.C. 1622). This provision of the Appropriation Act is effective on April 26, 2001.

Ratites are members of a superorder (Ratitae) of flightless birds that have small or rudimentary wings and flat breastplates, e.g., ostriches, emus, and rheas. Squabs are young pigeons that have not yet flown.

Ratites are currently inspected under the Voluntary Poultry Inspection Regulations as an experimental program. Operators who wish to continue to slaughter or process ratites or squabs after April 26, 2001, for transport or sale in commerce must apply to FSIS for a grant of inspection for mandatory inspection service (§§ 381.6 and 381.16). As of April 26, 2001, grants of voluntary inspection for ratites and squabs will no longer be valid. Fees for ratite and squab inspection services will no longer be charged, except for overtime and holiday inspection services. Applications for mandatory inspection must be submitted on an FSIS application form available from any FSIS District Office or from FSIS Headquarters, Washington, DC 20250. FSIS will give notice in writing to each applicant granted (or denied) inspection.

Under the regulations that implement the PPIA, before being granted Federal inspection, an establishment must have written Sanitation Standard Operating Procedures (SOPs) (§ 381.22(a)) and a Hazard Analysis and Critical Control Point (HACCP) plan that the establishment has validated (§ 381.22 (b) and (c)). Establishments can receive conditional grants of inspection for a period of not more than 90 days while they validate their HACCP plans (§ 381.22(b)).

This interim final rule will be effective on April 26, 2001. Within 18 months of that date, imported ratite or squab products will have to originate in countries that are eligible to export poultry to the United States and will have to be processed in establishments certified by the government of the foreign country as eligible to export to the United States. Currently, these countries include Canada, France, Great Britain, and Israel. Hong Kong and Mexico have not yet been approved by the United States to slaughter poultry; therefore, they are only eligible to export to the United States processed poultry products that originate from Canada, France, Great Britain, Israel, or the United States (§ 381.196).

All countries exporting or wanting to export ratite and squabs products to the United States, regardless of their current eligibility status regarding meat and poultry product exports to the United States, may do so for the next 18 months subject to the following. Countries already eligible to export poultry to the United States will be able to export ratites and squabs as soon as they certify to FSIS those establishments eligible to export to the United States. These countries are Canada, Israel, Great Britain, and France. Animal health restrictions continue to apply so there is no change with regard to the eligibility of specific products based on APHIS regulations.

Countries eligible to export meat to the United States will be permitted to export ratites to the United States provided the animals are slaughtered in an establishment certified to export to the Unites States and provided the countries submit a request for establishing equivalency. Certified establishments are required to meet FSIS HACCP and Pathogen Reduction requirements. At this point, Australia and New Zealand, which are both eligible to export meat to the United States, have indicated that they want to export ratites.

Countries not eligible to export meat or poultry to the United States will need to submit a request for equivalency and FSIS will need to make an equivalency determination according to 9 CFR Part 327.

As indicated above, however, each country desiring to begin or continue exporting such products to the United States will have to apply for an equivalence determination of its ratite and squab inspection system. Countries' ratite and squab export inspection systems must be found to be equivalent with the U.S. domestic inspection system within 18 months of the effective date of the Agency's new mandatory ratite and squab inspection requirements (April 26, 2001).

After the 18 month period has ended, all shipments of ratites and squabs from eligible countries must be accompanied with the appropriate veterinary health certificate (§ 381.197) and must be presented to FSIS for import reinspection prior to entry (§ 381.199).

Countries wanting to export ratites and squab to the United States should make a written request to export poultry to FSIS through the United States Embassy located in the country. FSIS will conduct both a document review and an on-site audit to determine if the country operates an equivalent poultry inspection system.

During the review, FSIS will work cooperatively with the Animal and Plant Health Inspection Service, which approves the entry of poultry products according to the disease status of the exporting country.

If the country's export inspection system is found to be equivalent with the U.S. domestic inspection system, FSIS will publish a proposal in the Federal Register to list the country as eligible to export poultry products to the United States. After the public has had 60 days to comment on this proposed rule, FSIS will review all of the public comments and make a final determination of equivalence. The determination to list a country as equivalent, and, therefore, eligible to export poultry products to the United States, is published as a final rule in the Federal Register , along with FSIS's responses to the public comments. At that time, the country's inspection service may certify establishments for export of poultry products, including ratites and squabs, to the United States.

FSIS is making a number of technical changes in its regulations, which it believes are noncontroversial, to provide for the inspection of ratites and squabs. The Agency is amending 9 CFR 362.1(d) to remove squab from the definition of “Poultry” in the Voluntary Poultry Inspection Regulations. FSIS is also amending § 362.1(e) to include ratites and squabs with chickens, turkeys, ducks, geese, and guineas in the definition of “Poultry Product.” The Agency is also amending § 381.1(b) to include ratites and squabs within the definition of “Poultry” in the Poultry Products Inspection Regulations.

FSIS is amending § 381.36(b) to require a pen for the ante mortem inspection of ratites. It is necessary to specify that a pen be available for ratites because ante mortem inspection of ratites is done on an individual bird basis, rather than a lot basis as is done for other amenable poultry.

The Agency is amending § 381.66 to exempt ratites from the chilling requirements of § 381.66 paragraphs (b), (c), and all of (d), except for (d)(1). Ratites are air-chilled rather than water-chilled, as is the case with most amenable poultry.

FSIS is amending § 381.67 to include squabs with young chickens under traditional inspection procedures. The two types of birds are of similar size and weight and thus can be inspected in a similar manner.

The Agency is amending § 381.70 to permit an exception to examining and inspecting ratites on the day of slaughter for humane reasons or, for low volume establishments, under certain conditions. This amendment allows the humane handling of ratites to be the same as that for livestock.

FSIS is amending § 381.71 to provide information on how suspect and condemned ratites are to be handled. This amendment is necessary because the treatment of suspect and condemned ratites is different than the treatment of suspect and condemned birds of other amenable species.

FSIS is amending § 381.72 to reflect the fact that ratites showing disease symptoms at ante mortem will be handled differently than other diseased poultry.

The Agency is amending § 381.76 to add Ratite Inspection as the fifth post mortem poultry inspection system. This amendment is necessary because inspection of ratites must be done in a different manner than inspection of other amenable poultry species. Thus, inspection of ratites cannot be done under the existing four inspection systems.

FSIS is amending § 381.96 to provide that ratite carcasses and parts that are shipped unpacked must bear the official brand. This addition is necessary because ratites are the only species of amenable species that are likely to be shipped unpacked.

Finally, FSIS is proposing to make some editorial changes to § 362.1 to correct inaccuracies and to provide for greater clarity.

Currently, ratites and squabs are inspected on a voluntary, fee-for-service basis under section 203 of the AMA. The interim final rule will amend § 362.1(d) to remove squab from the definition of poultry in the Voluntary Poultry Inspection Regulations and will amend § 381.1 to include ratites and squabs under the Agency's mandatory poultry inspection requirements.

Congress mandated, in the FY 2001 Agriculture Appropriation Act, that 180 days from the date of enactment (April 26, 2001) U.S. establishments that slaughter or process ratites or squabs will come under mandatory inspection by FSIS.

Ratites and squabs are considered non-amenable species and are currently inspected by the Agency on a voluntary, fee-for-service basis. 1 These species are also inspected on a mandatory or voluntary basis under State programs. Ratites are an order of flightless birds that includes ostriches, emus, rheas, cassowaries, and kiwis. The most economically important species of ratites are the ostrich and the emu. Squabs are young domesticated pigeons that have never flown. Ratite and squab meat is valued for its flavor and nutritional characteristics.

Since 1992, when FSIS first granted a request for voluntary inspection for ostriches, approximately 166 establishments have been issued a grant of inspection for ratite operations. Currently 99 establishments possess a grant of inspection. In 1999, there were a total of 48,286 (76%) ratites inspected in Federal establishments and 14,427 (24%) ratites inspected in State establishments, or a total of 62,713 ratites inspected (Table 1). Ostriches made up the largest share (69%) of the ratites inspected under the Federal program, whereas emus made up the largest share (56%) of the ratites inspected under State programs.

In 1999, states with a large share of ratites inspected under the Federal program were California, Georgia, Illinois, Louisiana, Oklahoma, and Texas. Alabama, California, Mississippi, North Carolina, Ohio, and Texas inspected a large share of ratites under State programs. There were almost an equal number of establishments involved in slaughter of ratites under the Federal (99) and State (95) inspection programs.

Ostrich is the largest bird in the world, standing about seven to eight feet tall and weighing 300-400 pounds when fully grown. Industry representatives indicate that there were about 600 ostrich growers 1998, down from 1000 growers in 1996. There is significant uncertainty about the annual production of ostriches and other ratites at this time. The Agency requests reliable information on the annual number of ratites and squab produced and the number of producers.

Ostriches are slaughtered at an average age of 12 months. The average weight at slaughter is 350 pounds. Ostrich meat is sold as steaks, fillets, medallions, roasts, and ground meat. Currently, ostriches are processed in establishments that are equipped to process other red meat species such as cattle, sheep, goats, and swine.

A mature emu reaches a height of 5 to 6 feet tall, weighing 90 to 120 pounds. In 1999, 22,813 emus were inspected under Federal and State programs (Table 1). There are a number of valuable products derived from emus in addition to their meat.

There is also significant uncertainty about the annual production of emus. Some source indicate that there may be as many as 500,000 birds on 5,000 to 6,000 farms in the U.S., with the majority of them in Texas, Oklahoma, and elsewhere in the Southwest.

Squabs are young domesticated pigeons that have never flown. Squabs usually weigh 1 pound or less at the time of slaughter (about 4 weeks old). In 1999, California and Oregon were the only two states that inspected squabs under the Federal voluntary inspection program. In that year, 175,496 squabs were inspected (Table 1). During that same period 1,122,131 squabs were inspected under the inspection programs of California and South Carolina.

FSIS considered two options in developing its interim final rule. The first option the Agency considered was to only change the definition of poultry in the Poultry Products Inspection Regulations to include ratites and squabs. This approach may have caused confusion in the industry because it would be difficult to apply some of the current poultry regulations to ratites and squabs, e.g., chilling and certain handling requirements.

The Agency's second option was to make the changes required by statute and other changes as noted above. FSIS selected this option because it will provide a more orderly transition from voluntary inspection to mandatory inspection of ratites and squabs than the first option at little or no additional cost.

There are three primary benefits that may result from extending mandatory inspection services to ratites and squabs: industry growth, public health, and industry cost savings.

Having the inspection mark on the ratite and squab products could lead to greater consumer confidence and acceptability of the products. Demand could be expected to increase as a result. Establishments that are able to capitalize on the change in consumer preference may realize increased sales of these products. To the extent that inspection promotes growth in the ratite and squab industry, society could benefit also from the increased employment and earnings of workers in these establishments. Studies are not available to identify the potential growth in the industry that may occur.

The public health benefits of inspection are related to the reduction in risk associated with consumption of all ratite and squab meat that must be inspected using the same procedures employed in the meat and poultry industries. HACCP systems, Sanitation SOPs, and process control practices have been shown to reduce contamination by harmful foodborne pathogens.

A shift to the mandatory inspection system will eliminate the payment of fees for inspection services. This is not a benefit from an economic perspective as the costs of inspection are transferred elsewhere in the economy. Since FSIS will recover these costs through appropriated funds, the change to a mandatory inspection system results in an income transfer from the public to the ratite and squab industry. The total cost savings to the industry would be about $2 million in 2001, with the possibility of increasing over time with the expansion of the industry.

The compliance cost of extending mandatory inspection to ratite and squab species will be negligible. All establishments involved in slaughtering amenable species, as of January 25, 2000, must be in compliance with the provisions of Pathogen Reduction/Hazard Analysis Critical Control Point (PR/HACCP) final rule. Under the provisions of the rule, all slaughter establishments under mandatory inspection are required to have HACCP plans and meet process control requirements. Nearly all establishments that slaughter and process ratites and squabs because they also slaughter other species under mandatory inspection have already implemented HACCP, Sanitation SOPs, and other measures consistent with the requirements of this rule. These establishments will still be required to make changes to their HACCP or sanitation procedures to include ratites and squabs. Establishments that have not included ratites and squabs in their HACCP plans  2 would incur minimal costs associated with HACCP plan modification.

As poultry is subject to mandatory Federal inspection, ratites and squabs will be subject to E. coli testing requirements. Establishments that slaughter more than one kind of poultry and livestock are required to test the kind of species slaughtered in the greatest number. The number of establishments where ratites and squabs will be the species being slaughtered in the greatest number is very low. Consequently, very few establishments will be required to perform additional E. coli testing for process control verification. The costs per establishment for E. coli testing are shown in Table 2. The Agency is requesting information on the number of establishments where ratites or squabs are, or would become, the major species for slaughter.

For those establishments slaughtering and processing ratites and squabs under voluntary inspection, the transition to mandatory inspection will not require changes in equipment and processing methods. Ratites are currently being slaughtered and processed in establishments that are equipped to process cattle, sheep, goats, and swine. Squabs are processed using the same equipment and procedures as those used for young chickens.

The Agency estimates that 50% of the Federal establishments (50 establishments) and 25% of the State establishments (24 establishments) may be required to make minor changes in their HACCP plan to accommodate mandatory inspection requirements for ratites.

The Agency seeks comment or further information pertaining to its cost figures for mandatory inspection.

Other additional costs that would apply to all establishments applying for Federal mandatory inspection will be the application cost. This cost will be negligible, as it is limited to a one-time cost for filling out an application, about $10. The total compliance cost to the establishments identified above are estimated to be $105,100.

FSIS is aware that some State inspected ratite product may contain sodium nitrite and/or sodium nitrate even though the Food and Drug Administration (FDA) regulations do not authorize such use of these substances for ratite products. However, once ratites are officially defined as poultry under PPIA regulations, such use will not be allowed in FSIS inspected products. FSIS does not have information on the types or amounts of product affected by this change, but is seeking information.

The Agency anticipates the need to conduct baseline microbiological and chemical residue studies. These studies constitute the major costs to the Agency totaling $600,000.

The microbiological studies would help the Agency determine the prevalence of harmful bacteria or pathogens in ratites and squabs. These studies can also be used to develop performance standards for pathogen reduction. The costs of a microbiological baseline testing for ratites are $110,000 and for squabs, $95,000 (Tables 3 and 4).

Chemical residue studies would help the Agency determine the presence of violative chemical and drug residues in ratites and squabs. Chemical residue testing would be necessary to determine how these additional species would be incorporated in the Agency's annual residue testing program. FSIS' one-time costs for chemical residue studies for ratites and squabs are $210,000 and $185,000, respectively (Tables 3 and 4).

Under voluntary inspection, establishments pay for inspection services. The funds for mandatory inspection activities are appropriated from Federal tax revenues. The transition from voluntary to mandatory inspection changes the source of inspection program funding. The Agency estimates that the industry cost of inspection of ratites and squabs for 1999 in Federal establishments was $1,975,000, of which ratites accounted for $1,959,000 and squabs, $16,400, including overhead (Tables 3 and 4).

When ratite and squab inspection becomes mandatory, it is possible that the volume of ratites and squabs inspected at Federally inspected establishments will increase beyond what is currently being inspected. First, there may be significant volumes of ratites and squabs that are currently slaughtered and consumed without inspection that would be brought under inspection. Second, an establishment currently under a State inspection program that is shipping ratites and squabs in interstate commerce would have to shift to Federal inspection to maintain its markets. It is expected that 25% of the establishments under State voluntary inspection would migrate to the Federal mandatory program. The analysis does not take into account the potential increase in the demand for inspection services. Both species currently account for an extremely small share of meat and poultry inspection. Changes in the required level of inspection program personnel are not expected to be significant in the near-term.

The estimated total cost of inspection in State establishments is $554,400 for 14,427 ratites and 1,122,131 squabs for FY 1999. Under the current agreement the Agency has with state having a voluntary inspection program, the Agency pays half of the inspection program costs, or $277,191 (Table 5).

Under a mandatory program, states would no longer be able to collect fees for inspection services. States may decide to terminate their ratite and squab inspection program. If this occurs, FSIS will take over inspection at the facilities operating under a State program and thereby absorb the total costs of inspection at these establishments. For those states that do not have a State voluntary program for ratites and squabs, the impact of a Federal mandatory inspection program will be minimal. The payment of these costs at previously State inspected establishments is an income transfer similar to that occurring for Federally inspected establishments.

The total transfer payment to Federal and State establishments is $2,252,000 (1,975,000 plus 277,000).

In large part, the costs of ratite and squab inspection are transferred from producers to taxpayers. As the burden of paying for inspection service is eliminated, establishments may transfer these cost savings to consumers through lower prices.

Countries that previously had little interest in export certification may petition FSIS if additional species come under mandatory inspection. Foreign establishments that specialize in exotic species may seek to broaden their markets by exporting to the United States. The Agency may need to evaluate the equivalence of a greater number of foreign food regulatory inspection systems.

Because this interim final rule has been determined to be significant, the Office of Management and Budget (OMB) has reviewed it under Executive Order 12866.

The Administrator, FSIS, has determined that this interim final rule would not have a significant economic impact, as defined by the Regulatory Flexibility Act (5 U.S.C. 601), on a substantial number of small entities.

Small establishments will not be adversely affected by this interim final rule. Few establishments slaughter and process ratites or squabs exclusively. They usually slaughter and process both amenable and non-amenable species. For small slaughtering establishments as well as large ones, ratites and squabs do not comprise all or even most of their business. Of the 100 establishments that slaughter or process ratites and squabs, only two slaughter over 90% of the squabs consumed in the market. There are no establishments that dominate the slaughtering of ratites. Small entities will benefit along with the rest of the industry with the increased marketability of their product and the cost savings realized because they will no longer have to pay fees to either FSIS or the state for voluntary inspection service.

This interim final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This interim final rule: (1) Preempts 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. However, the administrative procedures specified in 9 CFR 306.5, 381.35, and 590.320 through 590.370, respectively, must be exhausted before any judicial challenge of the application of the provisions of this proposed rule, if the challenge involves any decision of an FSIS employee relating to inspection services provided under the PPIA.

Executive Order 13132, “Federalism,” requires that Agencies assess the federalism implications of their policy statements and actions, i.e., the effects of those statements and actions 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. The Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) preempt State and local laws in regard to the manufacture and distribution of meat and poultry products. Therefore, FSIS policy statements and actions impact federalism within the context of these statutory preemptions.

States and local jurisdictions are preempted by the FMIA and PPIA from imposing any marking, labeling, packaging, or ingredient requirements on federally inspected meat and poultry products that are in addition to, or different than, those imposed under the FMIA and the PPIA. States and local jurisdictions may, however, exercise concurrent jurisdiction over meat and poultry products that are within their jurisdiction and outside official establishments for the purpose of preventing the distribution of meat and poultry products that are misbranded or adulterated under the FMIA and PPIA, or, in the case of imported articles, that are not at such an establishment, after their entry into the United States.

Specifically, under section 301 of the FMIA and section 5 of the PPIA, a State may administer State meat and poultry inspection programs provided that it has developed and is effectively enforcing State meat and poultry inspection requirements at least equal to those imposed under titles I and IV of the FMIA and sections 1-4, 6-10, and 12-22 of the PPIA. These titles contemplate continuous ongoing programs. When States can no longer effectively enforce meat and poultry inspection requirements at least equal to Federal requirements, they must be “designated” by the Secretary to receive Federal inspection.

When FSIS revises its meat and poultry inspection requirements, States that administer their own inspection programs may be impacted, since they must continue to enforce requirements equal to those of FSIS. To minimize any additional costs States must incur to modify their inspection programs, FSIS grants the States significant flexibility under the “equal to” provisions of the FMIA and PPIA. Further, States are eligible to receive up to 50 percent Federal matching funds to cover the costs of their inspection programs.

Title: Mandatory Inspection of Ratites and Squabs.

Type of Collection: New.

The paperwork and recordkeeping requirements in this final rule will be approved on an emergency basis by OMB under control number 0583-01120. FSIS is seeking comments on the paperwork and recordkeeping requirements in this interim final rule so that the Agency may receive a three-year approval for these requirements.

Abstract: FSIS has reviewed the paperwork and record keeping requirements in this interim final rule in accordance with the Paperwork Reduction Act. Under this proposed rule, FSIS is requiring several information collection and record keeping activities. FSIS is requiring that establishments slaughtering and processing ratites and squabs apply for Federal Inspection. Also, these establishments will need to develop and maintain Sanitation SOPs, HACCP plans, and perform testing for E. coli.

Estimate of Burden: FSIS estimates that the time to apply for inspection would be two hours. The time to develop a Sanitation SOP will be two days (16 hours) and five minutes to file. FSIS estimates that an establishment will spend about 5 minutes a day developing an average of eight monitoring records, per Sanitation SOP, and two minutes a day filing each record. The time to develop a HACCP plan or process schedule would take an average of two days (16 hours) and five minutes to file. FSIS estimates that an establishment will spend about five minutes a day developing an average of eight monitoring records, per HACCP plan or process schedule, and two minutes a day filing each record. The time to record E. coli testing results would be five minutes a day.

Respondents: Meat and poultry product establishments and irradiation facilities.

Estimated Number of Respondents: 105 (100 ratite and 5 squab establishments).

Estimated Number of Responses per Respondent: 8,252.

Estimated Total Annual Burden on Respondents: 54,758 hours.

Copies of this information collection assessment can be obtained from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection Service, USDA, 112 Annex, 300 12th SW., Washington, DC 20250.

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the collection of information including the validity of the methodology and assumptions used: (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Comments are requested by July 2, 2001. To be most effective, comments should be sent to OMB within 30 days of the publication date.

The PDR retains a copy service to reproduce for a fee publicly available documents whatever their format. Since the NRC's Agency-wide Document Access and Management System (ADAMS) was implemented in November 2000, making recently released documents available in full text online, there has been a significant reduction in the volume of document reproduction. The total volume of copying has fallen from over 3,000,000 pages a year to 1,600,000 in 2000. Based on first quarter data, the projected level of copying for 2001 will be just under 1,000,000 pages. Since the copy service contract is at no cost to the government, the contractor must provide all supplies and equipment. The NRC believes that the price increase is reasonable and in line with the prices charged by other Federal agencies. A market survey showed that the average price is 20 cents per page for paper-to-paper copies and 27 cents for microfiche-to-paper copies.

The contractor will offer two new services to the public: copying documents from ADAMS to CD-ROM and copying color documents from ADAMS to paper. The contractor will be able to accept orders directly online from ADAMS through the new ADAMS Online Order Module scheduled to be released shortly.

Because this amendment concerns an agency practice and procedure, the NRC has determined that notice and comment under the Administrative Procedures Act, 5 U.S.C. 553(b) (A) and (B), is unnecessary and that good cause exists to dispense with the comment.

The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22 (c) (1) and (2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

This final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

A regulatory analysis has not been prepared for this final rule because the final rule makes only minor conforming changes to the regulations that reference Section 202 of the Energy Reorganization Act and minor changes to other regulations.

The NRC has determined that these amendments do not involve any provisions which would impose backfits as defined in 10 CFR 50.109(a)(1); therefore a backfit analysis need not be prepared.

In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB.

The FAA has received reports that Pratt & Whitney Model PW4000 series engines with certain early-production fan blades (Phase 0/1, FB2B or FB2T) installed on Airbus Model A310-324, A310-325, and A300 B4-622R series airplanes do not produce the amount of thrust indicated in the AFM. This thrust shortfall is due to erosion of the fan blade's leading edge. The flight crew has no indication of this shortfall in thrust. This condition results in acceleration and climb performance less than that specified in the AFM, which, if not corrected, could result in an overrun of the runway or impact with an obstacle or terrain.

The Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, has requested that Airbus prepare revisions to the AFM to take into account the reduction in performance associated with PW4000 series engines fitted with early-production fan blades and to incorporate the necessary adjustments in performance. Those revisions are expected to be available from Airbus in mid-2001. Meanwhile, Airbus has issued the following Temporary Revisions (TR) to the AFM, each dated January 22, 2001:

These TR's contain performance adjustments for the AFM for Model A310-324, A310-325, and A300 B4-622R series airplanes equipped with one or more Pratt & Whitney Model PW4000 series engine with early-production fan blades. The DGAC classified these TR's as mandatory and issued French airworthiness directive 2001-086(B), dated March 7, 2001, in order to assure the continued airworthiness of these airplanes in France.

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

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD is being issued to prevent acceleration and climb performance less than that specified in the AFM, which could result in runway overruns or impact with obstacles or terrain. This AD requires revising the Performance section of the FAA-approved AFM's for Model A310-324, A310-325, and 300 B4-622R series airplanes to incorporate certain adjustments in performance.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

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

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

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

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NM-68-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Boeing Model 727-100, -100C, and -200 series airplanes was published in the Federal Register on December 6, 1999 (64 FR 68062). For certain airplanes, that action proposed to require a one-time inspection of certain fuselage circumferential skin joints to determine the type of fasteners installed, and replacement of any aluminum fasteners with steel fasteners, if necessary; or modification of certain fuselage circumferential skin joints; as applicable. For certain other airplanes, that action also proposed to require repetitive inspections to detect corrosion, sealant deterioration, cracking, or disbonding; repair, if necessary; and modification of certain fuselage circumferential skin joints.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One commenter requests that Boeing Model 727 series airplanes, line numbers 153, 339, 416, and 540, be deleted from the applicability section of the proposed AD; and that paragraphs (c) and (d) of the proposal, which apply only to those airplanes, also be deleted. The commenter states that the manufacturer of those airplanes has determined that they cannot be repaired, and they were taken out-of-service.

The FAA does not concur with the commenter's request; however, the FAA agrees with the commenter's intent. Part 39 of the Federal Aviation Regulations (14 CFR part 39) states that, “No person may operate a product to which an airworthiness directive applies except in accordance with the requirements of that airworthiness directive.” The Part 39 regulation provides compliance relief for airplanes that are not being operated, because affected airplanes need only be in compliance prior to return to operation. In light of this fact, the airplanes having the line numbers listed above have been deleted from the Cost Impact paragraph, below; however, the applicability section and paragraphs (c) and (d) will remain in the final rule should these airplanes be returned to operation.

One commenter requests that issuance of the final rule be delayed until the FAA and the B-727 Working Group (Cargo Airline Association members) can develop a solution for the airplanes that have been converted from a passenger configuration to an all-cargo configuration. The commenter states that, if the FAA and industry are to work cooperatively to enhance safety, the more appropriate course of action would have been to place the issues addressed in the proposed rule before the Working Group, in lieu of issuing the proposed rule. The commenter notes that the FAA has worked successfully with this group in the past to identify and correct any cargo conversion problems.

The FAA does not concur. To delay this action would be inappropriate, since the FAA has determined that an unsafe condition exists and that inspections must be conducted to ensure continued safety.

A second commenter requests that the proposed AD be revised to allow for the structural benefits of the installation of the freighter conversion external doubler and the numerous inspections that are currently part of the basic airplane maintenance program, as well as the additional inspections required by AD 98-23-51, amendment 39-10932 (63 FR 67771, December 9, 1998). (That AD requires inspection/modification of fuselage skin longitudinal lap joints and is applicable to Model 727 series airplanes.) This revision of the proposal would be specific to those areas covered by the external doubler and, as such, would exempt converted freighters from the requirements of the proposed rule in the area covered by the external cargo door doubler. The commenter states that the report provided with its comments was used to obtain approval of an alternative method of compliance (AMOC) for AD 98-23-51. The report shows that the external doubler used in the cargo door modification is able to carry the loads that the skin and lap joints currently carry, even in the event that the lap joints in that area were to fail. The commenter notes that these same data can be used for the circumferential skin joints that are the subject of this AD.

The FAA does not concur to revise the final rule for the following reasons:

1. Paragraph (a) is applicable to airplanes on which the modification recommended in Boeing Service Bulletin 727-53-0084, Revision 2, dated June 5, 1972, and the additional actions (including additional fastener replacement locations) specified in Boeing Document No. D6-54860, Revision C, dated December 11, 1989, “Aging Airplane Service Bulletin Structural Modification Program—Model 727;” or the modification specified in Boeing Service Bulletin 727-53-0084, Revision 3, dated September 28, 1989; HAS been accomplished. Operators that have modified their airplanes in accordance with Revision 3 of the service bulletin may have had the steel fasteners removed and replaced with aluminum rivets. Paragraph (a) requires operators to inspect their airplanes to determine the type of fastener installed, and, if aluminum fasteners are found, replace them with the correct steel fasteners. The need to accomplish these actions is not affected by the freighter conversion referenced by the commenter.

2. The actions specified in paragraph (b) of the final rule are essentially the same as those required by paragraph (a) of AD 90-06-09 amendment 39-6488 (55 FR 8370, March 7, 1990). But paragraph (b) of this final rule requires that future modifications be accomplished in accordance with Revision 4 of the referenced service bulletin, which ensures that the correct steel fasteners will be installed. If the installation of the cargo conversion interferes with the ability to accomplish these actions, the operator should request approval of an AMOC, as provided by paragraph (g)(1) of this AD.

3. The AMOC approved for AD 98-23-51 was for the longitudinal lap joints. The report the commenter provided supports that AMOC request and addresses the structural integrity of the longitudinal lap joints with the cargo door doubler, but it does not demonstrate that the cargo door doubler provides an acceptable level of safety for the circumferential skin joints. Based on this, the FAA finds that the technical data presented does not justify revising the final rule. The FAA will consider approval of AMOC's if the appropriate technical justification is submitted.

4. Paragraphs (c), (d), and (f) of the final rule address four airplanes that were inadvertently omitted from the applicability specified in AD 90-26-09. AD 90-26-09 requires that inspections be accomplished, and cracks repaired, in the same areas specified in this AD. The FAA has reviewed its files regarding AMOC's to this AD and has found several that pertain to airplanes that have been converted from a passenger configuration to an all-cargo configuration. Because the four airplanes that were omitted from the applicability of AD 90-26-09 have not been converted to an all-cargo configuration (some have the original equipment manufacturer's cargo door, not an after-market door), there is no concern about inspecting through the doubler to the lower skin on those airplanes. No change to the final rule is necessary in this regard.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 549 airplanes of the affected design in the worldwide fleet. Based on a records review, the FAA estimates that only 374 of those airplanes are still in service. The FAA estimates that 280 airplanes of U.S. registry still in service will be affected by this AD.

The number of airplanes that will be subject to the required one-time inspection to determine the type of fasteners installed is unknown. For affected airplanes, it will take approximately 45 work hours per airplane to accomplish the required one-time inspection, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this inspection on U.S. operators is estimated to be $2,700 per airplane.

For affected airplanes, it will take approximately 192 work hours per airplane to accomplish the required modification of the cold-bonded doublers of certain fuselage circumferential skin joints, at an average labor rate of $60 per work hour. Required parts will cost approximately $1,250. Based on these figures, the cost impact of this modification on U.S. operators is estimated to be $12,770 per airplane.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 98-07-03, Amendment 39-10421 (63 FR 14026, March 24, 1998), which applies to certain serial-numbered Bell Model 412 helicopters and Agusta Model AB412 helicopters, was published in the Federal Register on January 22, 2001 (66 FR 6494). That action proposed to require a reduction of the Vne limitation until an inspection of the yoke assembly for static and dynamic overload damage and installation of a redesigned yoke flapping stop are accomplished and includes periodic and special inspections to detect a yoke overload. A correction to a technical bulletin date referenced in that AD was issued on July 10, 1998 (63 FR 38742, July 20, 1998).

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or the FAA's determination of the cost to the public. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed except for clarifying changes that were made in paragraph (a) to better explain the intent of the AD and editorial changes in paragraph (d). The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

The FAA estimates that 135 helicopters of U.S. registry will be affected by this AD, that it will take approximately 6.5 work hours per helicopter to install the placard, inspect the yoke assembly, and install the yoke. Required parts will cost approximately $511 per helicopter. Based on these figures, the total cost impact of this AD on U.S. operators is estimated to be $121,635.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all CASA Model CN-235 series airplanes was published in the Federal Register on January 22, 2001 (66 FR 6497). That action proposed to require installing a second electrical connector in the electrical Master Central Unit.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that 1 airplane of U.S. registry will be affected by this AD, that it will take approximately 8 work hours to accomplish the required installation, and that the average labor rate is $60 per work hour. Required parts will cost approximately $877. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $1,357.

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

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

The Securities and Exchange Commission (“Commission”) is publishing guidance on how Rule 17a-4(f) (17 CFR 240.17a-4(f)) under the Securities Exchange Act of 1934 (“Exchange Act”) is consistent with the Electronic Signatures in Global and National Commerce Act of 2000.

The Electronic Signatures in Global and National Commerce Act of 2000 (the “Electronic Signatures Act”)  1 seeks to promote electronic commerce by providing greater legal certainty to transactions effected by electronic means. To this end, the Electronic Signatures Act provides that the legal validity of a signature or contract cannot be denied solely because it is in electronic form. 2 It also encourages electronic record storage by providing that any statute, regulation, or other rule of law that requires the retention of contracts or other records relating to transactions in or affecting interstate or foreign commerce may, with certain exceptions, be complied with by storing the documents electronically. 3 However, the Electronic Signatures Act requires that the electronically stored documents must accurately reflect the information in the contracts or transactional records and be accessible to all persons entitled to review them under statute, regulation, or rule of law in a form that is capable of being accurately reproduced for later reference. 4 The Electronic Signatures Act does not define how these requirements are to be met. Instead, it preserves the ability of regulatory agencies to interpret them with respect to statutes under which such agencies have rulemaking authority. 5

On March 1, 2001, the Electronic Signatures Act became effective with respect to any existing state or federal regulatory requirement that a contract or transactional record be retained. 6 This effective date is delayed, however, if an agency has announced, proposed or initiated, but not completed, a rulemaking proceeding under the authority preserved in the Electronic Signatures Act. 7 On February 28, 2001, the Commission announced that it would act shortly to provide interpretive guidance and, where appropriate, propose or adopt rules consistent with the Electronic Signatures Act, thereby delaying the effective date with respect to Commission recordkeeping rules to June 1, 2001. 8

Since 1939, the Commission has required broker-dealers, through rules authorized under the Exchange Act, to make and maintain certain records deemed necessary to ensure compliance with federal securities laws and regulations. 9 In 1997, after requests by industry representatives, the Commission amended its record retention rule to allow broker-dealers to store these records using any electronic storage medium, subject to certain requirements set forth in the rule. 10 These requirements are safeguards designed to ensure the accuracy, accessibility, and accurate reproduction of the electronically stored records. The rule's evolution from a strictly paper requirement to its present electronic storage provisions reflects the Commission's approach of promoting the use of available technologies to the benefit of broker-dealers and investors.

In anticipation of the June 1, 2001 effective date for the electronic storage provisions of the Electronic Signatures Act, we are publishing this release to explain how the electronic storage requirements of the broker-dealer record retention rule meet, and are consistent with, the requirements of the Electronic Signatures Act.

Section 17(a)(1) of the Exchange Act authorizes the Commission to issue rules requiring broker-dealers to make and keep for prescribed periods, and furnish copies thereof, such records as necessary or appropriate in the public interest, for the protection of investors or otherwise in furtherance of the purposes of the Exchange Act. 11 In 1939, the Commission adopted Rules 17a-3 (17 CFR 240.17a-3) and 17a-4 (17 CFR 240.17a-4), pursuant to this authority. 12 Rule 17a-3 requires broker-dealers to make certain records, including trade blotters, asset and liability ledgers, income ledgers, customer account ledgers, securities records, order tickets, trade confirmations, trial balances, and various employment related documents. 13 Rule 17a-4 specifies the manner and length of time that the records created in accordance with Rule 17a-3, and certain other records produced by broker-dealers, must be maintained. 14 In combination, Rules 17a-3 and 17a-4 require broker-dealers to create, and preserve in an accessible manner, a comprehensive record of each securities transaction they effect and of their securities business in general. These rules impose minimum recordkeeping requirements that are based on standards a prudent broker-dealer should follow in the normal course of business. The requirements are an integral part of the investor protection function of the Commission, and other securities regulators, in that the preserved records are the primary means of monitoring compliance with applicable securities laws, including antifraud provisions and financial responsibility standards.

Originally, Rule 17a-4 had a paper-only requirement for the initial retention of records; now, the rule allows broker-dealers to choose between storing records in paper form, on microfilm or microfiche (“micrographic media”) or using electronic storage media. This progression from paper to electronic media is indicative of how the Commission encourages the use of technological innovation when both broker-dealers and investors will benefit. 15

As mentioned, Rule 17a-4, when adopted in 1939, required broker-dealers to maintain records in paper form for the first two years of the specified retention period, and on microfilm thereafter. 16 In 1970, the Commission amended the rule to allow the records to be stored immediately on microfilm. 17 This amendment recognized that broker-dealers were increasingly using automated systems in their back office operations, and that the records generated on such systems could be transferred to microfilm more quickly than to paper, and at substantially less expense. As the Commission noted at the time, “the retention of reels of microfilm as against bulky hard copy records should enable an organization to effect substantial savings in storage space and man hours.”  18 The rule specifies certain requirements on the use of microfilm intended to “preserve the basic safeguards designed by [Rules 17a-3 and 17a-4] for the protection of public investors.”  19 Broker-dealers who use micrographic media must: (1) Maintain facilities to protect the records and reproduce them in an easily readable format; (2) arrange the records and their indexes in a manner that permits the immediate location of a particular record; and (3) store a second copy of the records in a separate location.

In 1991, the Securities Industry Association (“SIA”), on behalf of its broker-dealer members, requested that the Division of Market Regulation (“Division”) amend Rule 17a-4 to permit broker-dealers to store records electronically. 20 The following year, the SIA requested that the Division not recommend enforcement action if broker-dealers stored records using an electronic storage technology known as optical disk. 21 In its no-action request, the SIA set forth a list of safeguards that it believed were appropriate. These safeguards included that the storage system: be non-rewriteable and non-erasable (or write once, read many “WORM”); automatically verify the accuracy of stored information; serialize and time-date the records; and create indexes of the records. The SIA estimated that the savings realized by switching from microfilm to optical disk would range from $250,000 a year for a medium-sized firm to $1.6 million a year for a large firm.

In 1993, the Division issued a no-action letter in response to the SIA's 1992 request. The no-action letter permitted broker-dealers to meet the record retention requirements of Rule 17a-4 using optical disk storage technology. 22 This allowed broker-dealers to take advantage of the savings and of the increased productivity and quicker access to archived records provided by optical disk. At the same time, the Division recognized that the use of an electronic storage system raised audit and examination concerns. Consequently, the Division established certain conditions for using optical disk to help ensure that records stored in this manner would be accurate and accessible for examination purposes. These conditions were consistent with the safeguards proposed by the SIA in its 1992 no-action request. For example, the optical disk technology stores digital information by employing a laser heat source to burn a pattern on the disk, which makes the records non-rewriteable and non-erasable. The letter also required: (1) Broker-dealers to file an undertaking signed by a third-party in which the third-party represents that it will access the records at the request of the Commission; (2) the optical disk system to automatically verify the quality and accuracy of the recording process; (3) the optical disk system to serialize the original and any duplicate units of the storage medium and time-date information stored on the medium; and (4) the optical disk system to have the capacity to download indices and records.

In 1997, the Commission, in many respects, codified the Division's no-action letter by amending paragraph (f) of Rule 17a-4 to allow broker-dealers to store records electronically. 23 However, one significant difference was that the final rule did not limit broker-dealers to using optical disk. Instead, it allowed them to employ any electronic storage medium, subject to certain requirements. For the most part, these requirements are the same safeguards proposed by the SIA in its 1992 no-action request and later required by the Division in its 1993 no-action letter. It is these requirements of Rule 17a-4 that we now find meet, and are consistent with, the Electronic Signatures Act. 24

In a notice published in the Federal Register of September 11, 2000 (65 FR 54855), FDA announced that a food additive petition (FAP 0A4722) had been filed by Alcide Corp., 8561 154th Ave., NE., Redmond, WA 98052. The petition proposed to amend the food additive regulations in § 173.325 Acidified sodium chlorite solution (21 CFR 173.325) to provide for the safe use of acidified sodium chlorite solutions as a component of a post-chill carcass spray or dip when applied to poultry meat, organs, or related parts or trim.

FDA has evaluated data in the petition and other relevant material. Based on this information, the agency concludes that the proposed use of the additive is safe, that the additive will achieve its intended technical effect, and, therefore, that the regulation in § 173.325 should be amended as set forth below.

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in § 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

In the notice of filing, FDA gave interested parties an opportunity to submit comments on the petitioner’s environmental assessment. FDA received no comments in response to that notice.

The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (address above) written objections by June 6, 2001. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

On October 2, 2000 (65 FR 58698), EPA published a notice of proposed rulemaking for the State of New York. The notice proposed approval of revisions to the State Implementation Plan (SIP) for New York's enhanced inspection and maintenance (I/M) program. The formal SIP revision was submitted on May 24, 1999 and additional information was submitted on October 7, 1999 and October 29, 1999. A description of New York's submittals and EPA's rationale for our proposed action were presented in the proposal and will not be restated here.

One comment was submitted to the docket during the comment period for the notice of proposed rulemaking published in the October 2, 2000 Federal Register . Copies of the original comment letter are available at EPA's Region II Office at the address listed in the ADDRESSES section of this document.

The commentor, an emissions inspection and automotive repair station owner, commented on problems he has been experiencing with his NYTEST equipment including the responsiveness of the New York State Department of Environmental Conservation (NYSDEC) and the equipment manufacturer. Through discussions with the NYSDEC, EPA has learned that the State has been working with the commentor to address his concerns. These comments to the docket do not address the approvability of New York's I/M program nor do they address the emissions reduction effectiveness of the NYTEST test type. Therefore, these comments will not be addressed in this document.

EPA is approving New York's enhanced I/M program SIP revision pursuant to section 348 of the NHSDA and the Clean Air Act. By so doing, EPA is finding that New York has adequately remedied the six de minimus deficiencies previously identified and has demonstrated that its decentralized I/M program network is substantially as effective as a centralized program network in achieving emission reductions according to the following:

• 88 percent as effective for HC emission reductions.

• 84 percent as effective for CO emission reductions.

• 86 percent as effective for NO X emission reductions.

In addition, EPA is affording emissions reduction credit to the NYTEST as follows:

• 95 percent of IM240 credit for HC.

• 99 percent of IM240 credit for CO.

• 99 percent of IM240 credit for NO X .

EPA is approving the latest revisions to the enhanced I/M program regulations. Specifically, these are found at 6NYCRR Part 200, General Provisions, Section 200.9 and Part 217, Motor Vehicle Emissions, Subparts 217-1, 217-2, and 217-4, that became effective on May 22, 1997. These are also found at 15NYCRR Part 79, Motor Vehicle Inspection, Sections 79.1-79.15, 79.17, 79.20, 79.21, 79.24-79.26, that became effective on June 4, 1997.

This approval removes the interim status of EPA's interim approval promulgated on October 24, 1997 (64 FR 32411).

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this final action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This final 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 final 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). For the same reason, this final rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This final rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it 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 final rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this final rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. 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 . This rule is not a “major” rule as defined by 5 U.S.C. 804(2). This rule will be effective June 6, 2001.

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 July 6, 2001. 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).)

On February 6, 1998, October 20, 2000, October 31, 2000 and November 16, 2000 the State of Maryland submitted formal revisions to its SIP. The SIP revisions consist of a new regulation which replaces the existing regulation for control of VOC from EPOs (COMAR 26.11.19.19), establish VOC RACT regulations for facilities that recycle bakery and confectionary waste (COMAR 26.11.19.28), adopt by reference the EPA definition of VOC (COMAR 26.11.01.01B(53)), update the Maryland regulation references to the federal definition of VOC at 40 CFR 51.100(s) and the federal PSD regulations at 40 CFR 52.21 PSD (COMAR 26.11.01.01B(37) and (53) and COMAR 26.11.06.14) and include other miscellaneous revisions (COMAR 26.11.01.01B(6-1) and COMAR 26.11.06.06A(1)(d)) . These regulatory revisions became effective on October 2, 2000, October 16, 2000, June 30, 1997 and September 22, 1997.

The amendment to COMAR 26.11.01.01B adds the definition of “commercial bakery oven” to the general definitions section of the Maryland air regulations. EPA approved Maryland's commercial bakery oven RACT regulation, including a definition for “commercial bakery oven”, found at COMAR 26.11.19.21 on October 15, 1997 (62 FR 53544). The definition for “commercial bakery oven” found in COMAR 26.11.19.21 is identical to the definition being added at COMAR 26.11.01.01B(6-1). The addition of the definition for the term “commercial bakery oven” is approvable.

The amendment to COMAR 26.11.01.01B(53) adopts by reference the EPA definition of “volatile organic compound” found at Title 40, Part 51.100(s) of the Code of Federal Regulations (CFR), as per the 1996 edition. The amendment ensures that Maryland's definition of the term is identical to the federal definition. EPA defines VOCs as any organic compound that contributes to ground-level ozone formation and lists as exclusions the compounds that have negligible photochemical reactivity. As EPA completes its reactivity testing, the list of exempt compounds expands. In the past, each time that EPA amended its' definition of VOC to include another exempt compound Maryland then had to amend its definition of VOC to add the newly exempted compound. Amending Maryland's definition requires draft regulations to be prepared, processed, put through public hearing and comment, adopted and then submitted to EPA. Since Maryland accepts the EPA test results on VOC exempt compounds it is appropriate for Maryland to adopt the federal definition of VOC as it appears in 40 CFR § 51.100 (s) as of a specified date.

COMAR 26.11.01.01B(53) was subsequently amended to update the federal reference for incorporation of the EPA definition of VOC found at 40 CFR § 51.100(s) from the 1996 to the 1999 edition of the CFR.

The amendments to COMAR 26.11.01.01B(37) and COMAR 26.11.06.14 update the reference for incorporation of the federal PSD regulations found at 40 CFR § 52.21 from the 1993 to the 1996 edition and then again from the 1996 to the 1999 edition. These revisions are approvable.

The amendment to COMAR 26.11.06.06 A(1)(d) will clarify the general VOC regulation and will affect VOC sources that are currently, or will be in the future, subject to a RACT regulation in Chapter 19, VOCs from Specific Processes. The amendment will exempt any source that is subject to a source specific regulation in Chapter 19 from the general VOC requirements in COMAR 26.11.06.06. These modifications are approvable.

The amendment to COMAR 26.11.19.19 will replace the existing regulation and adopt a new regulation for control of VOCs from expandable polystyrene operations (EPO). On October 15, 1997 (62 FR 53544) EPA approved a new regulation which established VOC RACT for EPOs. The existing regulation requires VOC emissions to be reduced through the use of various control options including incineration and a combination of low VOC beads (7 percent or less) and recycled material use. Since the adoption of the existing regulation, the bead manufacturers have been successful in producing an “ultra low VOC” bead (6 percent or less). These “ultra low VOC” beads, however, cannot be used for all products. But the production of the “ultra low VOC” bead has made available other cost-effective compliance options for specific product types at the EPO facilities. The existing regulation is being replaced with a new regulation which allows the use of conventional VOC control methods and adds the use of ultra low VOC beads as an additional alternative control option. This regulation will further reduce VOC emissions, encourage use of recycled materials and is approvable.

A new regulation, COMAR 26.11.19.28, is being added for the control of VOC emissions from bread and snack food drying operations. The purpose of the regulation is to establish RACT standards for facilities that recycle bakery and confectionary waste products for use as animal feed. The facilities dry the waste products to reduce moisture content and in the process VOCs are released. The new regulation requires a source with VOC emissions of 25 tons or more per year to install a control device with 85% or more removal efficiency to reduce emissions from the dryer stack. The regulation applies statewide and includes compliance testing, monitoring and recordkeeping requirements. The regulation will reduce VOC emissions and is approvable.

A more detailed analysis of Maryland's submittal is contained in a Technical Support Document (TSD) which is available from the Region III office listed in the ADDRESSES section of this notice.

EPA is approving revisions to the Maryland SIP that replace the existing regulation and adopt a new regulation for control of VOC from EPOs (COMAR 26.11.19.19), establish VOC RACT regulations for facilities that recycle bakery and confectionary waste (COMAR 26.11.19.28), adopt by reference the EPA definition of VOC found at 40 CFR 51.100(s) (COMAR 26.11.01.01B(53)), update the Maryland regulation references to the federal definition of VOC at 40 CFR 51.100(s) (COMAR 26.11.01.01B(53)) and the federal PSD regulations at 40 CFR 52.21 (COMAR 26.11.01.01B(37) and 26.11.06.14), add a definition for the term “commercial bakery oven” (COMAR 26.11.01.01B(6-1) and other miscellaneous revisions (COMAR 26.11.06.06A(1)(d)). The revisions became effective on October 2, 2000, October 16, 2000, June 30, 1997 and September 22,1997.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment since the revisions are administrative changes to the state regulations. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on July 6, 2001 without further notice unless EPA receives adverse comment by June 6, 2001. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

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. 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 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), nor will it have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely 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 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. 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 . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 6, 2001. 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 granting full approval of the State of Marylands' volatile organic compounds regulations and miscellaneous revisions may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

We are approving the South Carolina State Plan, as submitted on September 19, 2000, for the control of air emissions from HMIWIs, except for those HMIWIs located in Indian Country. When EPA developed our New Source Performance Standard (NSPS) for HMIWIs, we also developed EG to control air emissions from older HMIWIs. (See 62 FR 48348-48391, September 15, 1997, 40 CFR part 60, subpart Ce [Emission Guidelines and Compliance Times for HMIWIs] and subpart Ec [Standards of Performance for HMIWIs for Which Construction is Commenced After June 20, 1996]). The South Carolina DHEC developed a State Plan, as required by sections 111(d) and 129 of the Clean Air Act (the Act), to adopt the EG into their body of regulations, and we are acting today to approve it.

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in a separate document in this Federal Register publication, we are proposing to approve the revision should significant, material, and adverse comments be filed. This action is effective July 6, 2001, unless by June 6, 2001, adverse or critical comments are received. If we receive such comments, this action will be withdrawn before the effective date by publishing a subsequent notice that will withdraw the final action. All public comments received will be addressed in a subsequent final rule based on this action serving as a proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. If no such comments are received, this action is effective July 6, 2001.

A HMIWI State Plan is a plan to control air pollutant emissions from existing incinerators which burn hospital waste or medical/infectious waste. The plan also includes source and emission inventories of these incinerators in the State.

States are required under sections 111(d) and 129 of the Act to submit State Plans to control emissions from existing HMIWIs in the State. The State Plan requirement was triggered when EPA published the EG for HMIWIs under 40 CFR part 60, subpart Ce (see 62 FR 48348, September 15, 1997).

Under section 129, EPA is required to promulgate EG for several types of existing solid waste incinerators. These EG establish the Maximum Achievable Control Technology (MACT) standards that States must adopt to comply with the Act. The HMIWI EG also establishes requirements for monitoring, operator training, permits, and a waste management plan that must be included in State Plans.

The intent of the State Plan requirement is to reduce several types of air pollutants associated with waste incineration.

The State Plan establishes control requirements which reduce the following emissions from HMIWIs: particulate matter; sulfur dioxide; hydrogen chloride; nitrogen oxides; carbon monoxide; lead; cadmium; mercury; and dioxin/furans. These pollutants can cause adverse effects to the public health and the environment. Dioxin, lead, and mercury bioaccumulate through the food web. Serious developmental and adult effects in humans, primarily damage to the nervous system, have been associated with exposures to mercury. Exposure to dioxin and furans can cause skin disorders, cancer, and reproductive effects such as endometriosis. Dioxin and furans can also affect the immune system. Acid gases affect the respiratory tract, as well as contribute to the acid rain that damages lakes and harms forests and buildings. Exposure to particulate matter has been linked with adverse health effects, including aggravation of existing respiratory and cardiovascular disease and increased risk of premature death. Nitrogen oxide emissions contribute to the formation of ground level ozone, which is associated with a number of adverse health and environmental effects.

The criteria for approving a HMIWI State Plan include requirements from sections 111(d) and 129 of the Act and 40 CFR part 60, subpart B. Under the requirements of sections 111(d) and 129 of the Act, a State Plan must be at least as protective as the EG regarding applicability, emission limits, compliance schedules, performance testing, monitoring and inspections, operator training and certification, waste management plans, and recordkeeping and reporting. Under section 129(e), State Plans must ensure that affected HMIWI facilities submit Title V permit applications to the State by September 15, 2000. Under the requirements of 40 CFR part 60, subpart B, the criteria for an approvable section 111(d) plan include demonstration of legal authority, enforceable mechanisms, public participation documentation, source and emission inventories, and a State progress report commitment.

The South Carolina DHEC adopted the Federal EG and NSPS into Chapter 61 of the South Carolina Code, Regulation No. 61-62.5, Standard Number 3.1, “Hospital/Medical/Infectious Waste Incinerators.” The State rules were effective on May 26, 2000. The South Carolina State Plan contains:

1. A demonstration of the State's legal authority to implement the section 111(d)/129 State Plan;

2. State rule, Standard Number 3.1, as the enforceable mechanism;

3. An inventory of approximately 4 known designated facilities, along with estimates of their potential air emissions;

4. Emission limits that are as protective as the EG;

5. A compliance date of May 26, 2001;

6. Testing, monitoring, reporting and recordkeeping requirements for the designated facilities;

7. Records from the public hearing on the State Plan; and,

8. Provisions for progress reports to EPA.

The EG for existing HMIWIs affect any HMIWI built on or before June 20, 1996. If your facility meets this criterion, you are subject to these regulations.

You must meet the requirements listed in South Carolina Regulation No. 61-62.5, Standard Number 3.1, summarized as follows:

1. Determine the size of your incinerator by establishing its maximum design capacity.

2. Each size category of HMIWI has certain emission limits established which your incinerator must meet. See Table I of Section III (Emission Limitations) of Standard Number 3.1, to determine the specific emission limits which apply to you. The emission limits apply at all times, except during startup, shutdown, or malfunctions, provided that no waste has been charged during these events.

3. There are provisions to address small rural incinerators (if your unit is applicable).

4. You must meet a 10% opacity limit on your discharge, averaged over a six-minute block.

5. You must have a qualified HMIWI operator available to supervise the operation of your incinerator. This operator must be trained and qualified through a State-approved program, or a training program that meets the requirements listed under Section IX (Operator Training and Qualification Requirements) of Standard Number 3.1.

6. Your operator must be certified, as discussed in 5 above, no later than May 26, 2001.

7. You must develop and submit to South Carolina DHEC a waste management plan. This plan must be developed under guidance provided by the American Hospital Association publication, An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities, 1993, and must be submitted to South Carolina DHEC no later than 60 days following the initial performance test for the affected unit.

8. You must conduct an initial performance test to determine your incinerators compliance with these emission limits. This performance test must be completed no later than May 26, 2001, and as required under 40 CFR 60.37e and Section IV (Performance Specifications) of Standard Number 3.1.

9. You must install and maintain devices to monitor the parameters listed under Table IV of Section V (Monitoring Requirements) of Standard 3.1.

10. You must document and maintain information concerning pollutant concentrations, opacity measurements, charge rates, and other operational data. This information must be maintained for a period of five years.

11. You must submit an annual report to South Carolina DHEC containing records of annual equipment inspections, any required maintenance, and unscheduled repairs. This annual report must be signed by the facilities manager.y

EPA compared the South Carolina rules (Chapter 61 of the South Carolina Code, Regulation No. 61-62.5, Standard Number 3.1) against our HMIWI EG. EPA finds the South Carolina rules to be at least as protective as the EG. The South Carolina State Plan was reviewed for approval against the following criteria: 40 CFR 60.23 through 60.26, Subpart B—Adoption and Submittal of State Plans for Designated Facilities; 40 CFR 60.30e through 60.39e, Subpart Ce—Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators; and, 40 CFR 62.14400 through 62.14495, Subpart HHH—Federal Plan Requirements for Hospital/Medical/Infectious Waste Incinerators Constructed on or before June 20, 1996. The South Carolina State Plan satisfies the requirements for an approvable section 111(d)/129 plan under subparts B and Ce of 40 CFR part 60 and subpart HHH of 40 CFR part 62. For these reasons, we are approving the South Carolina HMIWI State Plan.

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. 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 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), nor will it have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely 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 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. 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. section 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. section 804(2).

Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 6, 2001. 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).)

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person . The Agency has established an official record for this action under docket control number OPP-301122. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of July 28, 1998 (63 FR 40273)(FRL-5799-3), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP 7G4906) for tolerance by KIM-C1, LLC, 6333 East Liberty Avenue, Fresno, California 93727. This notice included a summary of the petition prepared by KIM-C1, the registrant.

The petition requested that 40 CFR part 180 be amended by establishing a time-limited tolerance for residues of the plant growth regulator N- (2-chloro-4-pyridinyl)- N ′ -phenylurea, in or on almond, apple, blueberry, cranberry, fig, grapes, kiwifruit, olive, pear, and plums (fresh) at 0.01 part per million (ppm). The tolerance will expire on April 1, 2004.

One comment was received in response to the Notice of Filing. The comment was received on December 7, 2000 as a letter dated December 1, 2000 from Mr. Robert Bianco, Desert Grape Growers League of California. The League requested that the Agency reduce the number of table grape acres, investigate allegations regarding taste, and that the Experimental Use Permit be crop destruct. In response to the first issue, it is noted that the registrant has subsequently submitted a revised testing program that incorporates a reduced number of table grape acres. Regarding the issue of requiring a crop destruct condition on the grapes treated in the Experimental Use Permit due to a difference in taste of the harvested grapes, the Agency has determined that requiring a crop destruct condition may be imposed only in response to concerns relating to human health.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of N -(2-chloro-4-pyridinyl)- N ′ -phenylurea on almond, apple, blueberry, cranberry, fig, grapes, kiwifruit, olive, pear, and plums (fresh) at 0.01 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by N- (2-chloro-4-pyridinyl)- N ′ -phenylurea are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 × 10 - 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for N- (2-chloro-4-pyridinyl)- N ′ -phenylurea used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses. Risk assessments were conducted by EPA to assess dietary exposures from N- (2-chloro-4-pyridinyl)- N ′ -phenylurea in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. An acute exposure assessment is unnecessary because no toxicological endpoint was selected.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: This chronic dietary DEEM® analysis was a Tier 1 (assumptions: time-limited tolerance level residues of the subject commodities and 100% crop treated). The DEEM® default concentration factors were used for the processed commodities of all the subject crops. The resulting dietary food exposures occupy 1.5% of the cPAD for the most highly exposed population subgroup, non-nursing infants. These results should be viewed as conservative (health protective) risk estimates. Refinements such as the use of percent crop-treated information (this is a limited acreage EUP use) and/or anticipated residue values would yield lower estimates of chronic dietary exposure.

iii. Cancer . No concern for cancer risks were identified. Data from available studies do not indicate a treatment-related tumor problem and cancer risk endpoints have not been identified.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for N- (2-chloro-4-pyridinyl)- N ′ -phenylurea in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of N- (2-chloro-4-pyridinyl)- N ′ -phenylurea.

The Agency uses the Generic Estimated Environmental Concentration(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System(PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to N- (2-chloro-4-pyridinyl)- N ′ -phenylurea they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the EECs of N- (2-chloro-4-pyridinyl)- N ′ -phenylurea for acute and chronic exposures are estimated to be 4.7 parts per billion (ppb) (peak and 56-day average) for surface water and 26 ppb (acute and chronic) for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

N- (2-Chloro-4-pyridinyl)- N ′ -phenylurea is not registered for use on any sites that would result in residential exposure.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether N- (2-chloro-4-pyridinyl)- N ′ -phenylurea has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, N- (2-chloro-4-pyridinyl)- N ′ -phenylurea does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that N- (2-chloro-4-pyridinyl)- N ′ -phenylurea has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. Safety factor for infants and children — In general . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Conclusion . There is an adequate toxicity database for N -(2-chloro-pyridinyl)- N ′ -phenylurea for this EUP and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. For the purposes of the experimental use permit only, the FQPA safety factor will be retained (10X) and applied to all groups for assessing chronic dietary risk.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Not applicable; no acute dietary endpoint was identified.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to N- (2-chloro-4-pyridinyl)- N ′ -phenylurea from food will utilize 0.3% of the cPAD for the U.S. population, 1.5% of the cPAD for non-nursing infants and 1.0% of the cPAD for children (1-6 years). There are no residential uses for N- (2-chloro-4-pyridinyl)- N ′ -phenylurea that result in chronic residential exposure to N- (2-chloro-4-pyridinyl)- N ′ -phenylurea. In addition, there is potential for chronic dietary exposure to N- (2-chloro-4-pyridinyl)- N ′ -phenylurea in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

N- (2-Chloro-4-pyridinyl)- N ′ -phenylurea is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

N- (2-Chloro-4-pyridinyl)- N ′ -phenylurea is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

5. Aggregate cancer risk for U.S. population . No concern for cancer risks were identified. Data from available studies do not indicate a treatment-related tumor problem and cancer risk endpoints have not been identified.

6. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to N- (2-chloro-4-pyridinyl)- N ′ -phenylurea residues.

1. Plants . The proposed enforcement method is a high performance liquid chromatography using ultraviolet detection (HPLC/UV) procedure which measures parent N- (2-chloro-4-pyridinyl)- N ′ -phenylurea. For the purpose of the Experimental Use Permit, the method has been adequately validated. The limit of quantitation (LOQ) is 0.01 ppm and the limit of detection is 0.003 ppm.

2. Animals . Depending on the results of a ruminant metabolism study, an enforcement method for the regulated residue in animal commodities may be required to support a Section 3 registration with permanent tolerances.

Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no Codex, Canadian, or Mexican IRLs for N- (2-chloro-4-pyridinyl)- N ′ -phenylurea.

There are no conditions for the registration.

Therefore, the time-limited tolerance is established for residues of N- (2-chloro-4-pyridinyl)- N ′ -phenylurea in or on almond, apple, blueberry, cranberry, fig, grapes, kiwifruit, olive, pear, and plums (fresh) at 0.01 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301122 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before July 6, 2001.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900),Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301122, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.”

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 this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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 Associate Director 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.

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

The Associate Director 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.

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.

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

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

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.

The piping plover ( Charadrius melodus ), named for its melodic mating call, is a small, pale-colored North American shorebird. It weighs 43-63 grams (1.5-2.5 ounces) and is 17-18 centimeters (cm) (6-7 inches (in.)) long (Haig 1992). Its light, sand-colored plumage blends in well with the sandy beach, its primary habitat. Plumage and leg color help distinguish this bird from other plover species. During the breeding season, the legs are bright orange, and the short, stout bill is orange with a black tip. There are two single dark bands, one around the neck and one across the forehead between the eyes. The female's neck band is often incomplete and is usually thinner than the male's (Haig 1992). In winter, the bill turns black, the legs fade to pale orange, and the black plumage bands on the head and neck are lost. Chicks have speckled gray, buff, and brown down, black beaks, pale orange legs, and a white collar around the neck. Juveniles resemble wintering adults and obtain their adult plumage the spring after they fledge (USFWS 1994).

Dominant plants within Great Lakes piping plover habitat include marram grass ( Ammophila brevigulata ), beach wormwood ( Artemesia campestris ), silverweed ( Potentilla anserina ), Lake Huron tansy ( Tanacetum huronense ), pitcher's thistle ( Cirsium pitcheri ), beach pea ( Lathyrus maritimus var. glaber ), sea rocket ( Cakile edentula ), sedges ( Carex spp.), goldenrods ( Solidago spp.), sand cherry ( Prunus pumila ), bearberry ( Arctostaphylus uva-ursi ), creeping juniper ( Juniper horizontalis ), cottonwood ( Populus deltoides ), and willow ( Salix spp.).

The breeding range of the piping plover extends throughout the northern Great Plains, the Great Lakes, and the Atlantic Coast in the United States and Canada. Based on this distribution, three breeding populations of piping plovers have been described: the Northern Great Plains population, the Great Lakes population, and the Atlantic Coast population.

The northern Great Plains breeding range extends from southern Alberta, northern Saskatchewan, and southern Manitoba, south to eastern Montana, the Dakotas, southeastern Colorado, Iowa, Minnesota, and Nebraska, and east to Lake of the Woods in north-central Minnesota. The majority of the United States pairs in this population are in the Dakotas, Nebraska, and Montana (USFWS 1994). Occasionally, Great Plains birds nest in Oklahoma and Kansas. On the Atlantic coast, piping plovers nest from Newfoundland, southeastern Quebec, and New Brunswick to North Carolina. Sixty-eight percent of all nesting pairs breed in Massachusetts, New York, New Jersey, and Virginia (USFWS 1999). In the Great Lakes watershed, piping plovers formerly nested throughout much of the north-central United States and south-central Canada on beaches in Illinois, Indiana, Michigan, Minnesota, Ohio, Pennsylvania, New York, Wisconsin, and in Ontario, Canada. Currently they are limited to northern Michigan and, recently, at one site in northern Wisconsin.

Piping plovers are migratory birds. They leave the breeding grounds between late July and early September and head for their wintering grounds, where they spend more than eight months of the year. Although the breeding ranges of the three piping plover populations are separate, their wintering ranges overlap and extend along the Atlantic and Gulf Coasts from North Carolina to Mexico and into the West Indies and Bahamas. Resightings of color-banded birds from the Great Lakes breeding population have occurred along the coastlines of North and South Carolina, Georgia, Florida, Louisiana, and Texas.

Pre-settlement populations of piping plovers in the Great Lakes are estimated at 492-682 breeding pairs (Russell 1983), although these estimates may be high (F. Cuthbert, professor, University of Minnesota, Minneapolis, pers. comm., 2000). In recent decades, piping plover populations have declined drastically, especially in the Great Lakes, coinciding with industrial development, urbanization, and increased recreational pressures. In 1973, the piping plover was placed on the National Audubon Society's Blue List of threatened species. By that time, piping plovers had been extirpated from beaches in Illinois, Indiana, Ohio, New York, Pennsylvania, and Ontario, and only a few birds were continuing to nest in Wisconsin (Russell, 1983). By 1977, the Great Lakes breeding population had decreased to 31 nesting pairs (Lambert and Ratcliff 1981) and by the time the species was listed under the Endangered Species Act in 1985, the Great Lakes breeding population had dwindled to only 17 breeding pairs, and the breeding areas had been reduced from sites in eight States to only portions of northern Michigan.

Since the species was listed, the Great Lakes breeding population has gradually increased and expanded its range within Michigan and into Wisconsin. In 1999, 31 pairs of piping plovers nested on the Great Lakes shoreline of northern Michigan and 1 pair nested in northern Wisconsin (Stucker and Cuthbert, 1999). In 2000, 30 pairs were documented, all in northern Michigan (Stucker et al. 2000). The slow population increase over the past 15 years has been aided by intense State, Tribal, Federal, and private conservation actions directed at the protection of the piping plover. Activities such as habitat surveys, beach restoration, public education, habitat protection and enhancement, and the protection of nests from predators and disturbance through the use of predator exclosure fencing have all contributed to the improving status of the Great Lakes piping plover.

Great Lakes piping plovers nest on shoreline and island sandy beaches with sparse vegetation and the presence of small stones (greater than 1 cm (0.4 in.)) called cobble. Piping plovers spend 3 to 4 months a year on the breeding grounds. Nesting in the Great Lakes region begins in early to mid-May. Plovers lay 3 to 4 eggs in a small depression they scrape in the sand among the cobblestones and are, therefore, very difficult to see. Both sexes are involved in incubating the eggs, which hatch in about 28 days. Young plovers can walk almost as soon as they hatch, but remain vulnerable to predation and disturbance for another 21-30 days until they are able to fly.

Nesting piping plovers are highly susceptible to disturbance by people and pets on the beach. Human disturbance disrupts adult birds' care of their nests and young and may inhibit incubation of eggs (USFWS 1994). Furthermore, adults may leave the nest to lure away an intruder, leaving the eggs or chicks vulnerable to predators and exposure to weather. Ultimately, disturbance may lead to the abandonment of nests (USFWS 1994). As a result of disturbance and other natural and human-caused factors such as high water levels, flooding, eroding beaches, and beach-front commercial, recreational, and residential development, reproduction of Great Lakes piping plovers has been severely affected, resulting in perilously low numbers of nesting plovers (USFWS 1994).

This rule applies only to the breeding range of the Great Lakes population in the United States.

On December 30, 1982, we published a notice of review in the Federal Register (47 FR 58454) that identified vertebrate animal taxa being considered for addition to the List of Threatened and Endangered Wildlife. We included the piping plover in that review list as a Category 2 Candidate species, indicating that we believed the species might warrant listing as threatened or endangered, but that we had insufficient data to support a proposal to list at that time. Subsequent review of additional data indicated that the piping plover warranted listing, and in November, 1984, we published a proposed rule in the Federal Register (49 FR 44712) to list the piping plover as endangered in the Great Lakes watershed and as threatened along the Atlantic Coast, the Northern Great Plains, and elsewhere in their range. The proposed listing was based on the decline of the species and the existing threats, including habitat destruction, disturbance by humans and pets, high levels of predation, and contaminants.

After a review of the best scientific data available and all comments received in response to the proposed rule, we published the final rule (50 FR 50726) on December 11, 1985, listing the piping plover as endangered in the Great Lakes watershed (Illinois, Indiana, Michigan, northeastern Minnesota, New York, Ohio, Pennsylvania, Wisconsin, and Ontario, Canada) and as threatened along the Atlantic coast (Quebec, Newfoundland, Maritime Provinces, and States from Maine to Florida), and in the Northern Great Plains region (Iowa, northwestern Minnesota, Montana, Nebraska, North Dakota, South Dakota, Alberta, Manitoba, and Saskatchewan). All piping plovers on migratory routes outside of the Great Lakes watershed or on their wintering grounds are considered threatened. We did not designate critical habitat for the species at that time.

After 1986, we focused our efforts on recovery by forming two recovery teams, the Great Lakes/Northern Great Plains Piping Plover Recovery Team and the Atlantic Coast Piping Plover Recovery Team. In 1988 the Great Lakes and Northern Great Plains (USFWS 1988b) and Atlantic Coast (USFWS 1988a) Recovery Plans were published. In 1994, the Great Lakes/Northern Great Plains Recovery Team began to revise the Recovery plan for these two populations (USFWS 1994). The 1994 draft included updated information on the species and was distributed for public comment. Subsequently, we decided that the recovery of these two inland populations would benefit from separate recovery plans. Individual recovery plans for the Great Lakes and Northern Great Plains populations are presently under development.

The final listing rule for the piping plover indicated that designation of critical habitat was not determinable. Thus, designation was deferred. No further action was subsequently taken to designate critical habitat for piping plovers. On December 4, 1996, Defenders of Wildlife (Defenders) filed a suit ( Defenders of Wildlife and Piping Plover v. Babbitt, Case No. 96CV02965) against the Department of the Interior and the Service over the lack of designated critical habitat for the Great Lakes population of the piping plover. Defenders filed a similar suit ( Defenders of Wildlife and Piping Plover v. Babbitt, Case No. 97CV000777) for the Northern Great Plains piping plover population in 1997. During November and December 1999, and January 2000, we began negotiating a schedule for piping plover critical habitat decisions with Defenders. On February 7, 2000, before the settlement negotiations were concluded, the United States District Court for the District of Columbia issued an order directing us to publish a proposed critical habitat designation for nesting and wintering areas of the Great Lakes population of the piping plover by June 30, 2000, and for nesting and wintering areas of the Northern Great Plains piping plover population by May 31, 2001. A subsequent order, after requesting the court to reconsider its original order relating to final critical habitat designation, directs us to finalize the critical habitat designations for the Great Lakes population by April 30, 2001, and for the Northern Great Plains population by March 15, 2002. For biological and practical reasons, we chose to propose critical habitat for the Great Lakes breeding birds and for all wintering birds in two separate rules published concurrently.

On July 6, 2000, we published a proposed determination for the designation of critical habitat for the Great Lakes breeding population of the piping plover (65 FR 41812). A total of approximately 305 km (189 mi) (extending 1 km (0.6 mi) inland) was proposed as critical habitat for this piping plover population in 27 counties in Minnesota, Wisconsin, Michigan, Illinois, Indiana, Ohio, Pennsylvania, and New York. The comment period was open until September 5, 2000. During this 60-day comment period, we held seven public hearings (Ashland, Wisconsin, on July 17; Green Bay, Wisconsin, on July 18; Newberry, Michigan, on July 19; Traverse City, Michigan, on July 20; Indiana Dunes, Indiana, on July 24; Cleveland, Ohio, on July 25; and Watertown, New York, on July 27). On September 19, 2000, we published a document (65 FR 56530) announcing the reopening of the comment period on the proposal to designate critical habitat for the Great Lakes breeding population of the piping plover and a notice of the availability of the draft economic analysis on the proposed determination. Our intention was for this comment period to be reopened for 60 days, but the document stated that the comment period closed on October 19, 2000, or 30 days. Therefore, on September 28, 2000, we published a document (65 FR 58258) correcting the closing date of the reopened comment period to November 20, 2000.

Critical habitat is defined in section 3 of the Act as (i) the specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features (I) essential to the conservation of the species and (II) that may require special management consideration or protections; and (ii) specific areas outside the geographic area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. “Conservation” means the use of all methods and procedures that are necessary to bring an endangered or a threatened species to the point at which listing under the Act is no longer necessary.

Critical habitat receives protection under section 7 of the Act through the prohibition against destruction or adverse modification of critical habitat with regard to actions carried out, funded, or authorized by a Federal agency. Section 7 also requires conferences on Federal actions that are likely to result in the destruction or adverse modification of proposed critical habitat. In our regulations at 50 CFR 402.02, we define destruction or adverse modification as “. . . the direct or indirect alteration that appreciably diminishes the value of critical habitat for both the survival and recovery of a listed species. Such alterations include, but are not limited to, alterations adversely modifying any of those physical or biological features that were the basis for determining the habitat to be critical.” Aside from the added protection that may be provided under section 7, the Act does not provide other forms of protection to lands designated as critical habitat. Critical habitat designation would not afford any additional protections under the Act against activities on private or other non-Federal lands that do not involve a Federal nexus because the requirement for consultation under section 7 of the Act does not apply to activities on these types of lands.

In order to be included in a critical habitat designation, the habitat must first be “essential to the conservation of the species.” Critical habitat designations identify, based on the best scientific and commercial data available, habitat areas that provide essential life cycle needs of the species (i.e., areas on which are found the primary constituent elements, as defined at 50 CFR 424.12(b)).

Within the geographic area occupied by the species, we will designate only areas currently known to be essential. Essential areas should already have the features and habitat characteristics that are necessary to sustain the species (primary constituent elements). We will not speculate about what areas might be found to be essential if better information became available, or what other areas may become essential over time. If the information available at the time of designation does not show that an area provides essential life cycle needs of the species, then the area should not be included in the critical habitat designation. Within the geographic area occupied by the species, we will not designate areas that do not now have the primary constituent elements, as defined at 50 CFR 424.12(b), that provide essential life cycle needs of the species.

Our regulations state that, “The Secretary shall designate as critical habitat areas outside the geographic area presently occupied by the species only when a designation limited to its present range would be inadequate to ensure the conservation of the species” (50 CFR 424.12(e)). Accordingly, unless the best scientific and commercial data demonstrates that the conservation needs of the species require designation of critical habitat outside of occupied areas, we will not designate critical habitat in areas outside the geographic area occupied by the species. However, if unoccupied areas are essential to the recovery of the species, they may be designated as critical habitat.

The Service's policy on Information Standards Under the Endangered Species Act, published in the Federal Register on July 1, 1994 (59 FR 34271), provides criteria, establishes procedures, and provides guidance to ensure that decisions made by the Service represent the best scientific and commercial data available. It requires Service biologists, to the extent consistent with the Act and with the use of the best scientific and commercial data available, to use primary and original sources of information as the basis for recommendations to designate critical habitat. When determining which areas are critical habitat, a primary source of information should be the listing package for the species. Additional information may be obtained from a recovery plan, articles in peer-reviewed journals, conservation plans developed by States and counties, scientific status surveys and studies, and biological assessments or other unpublished materials (i.e. gray literature).

Habitat is often dynamic, and species may move from one area to another over time. Furthermore, we recognize that designation of critical habitat may not include all of the habitat areas that may eventually be determined to be necessary for the recovery of the species. For these reasons, it should be understood that critical habitat designations do not signal that habitat outside the designation is unimportant or may not be required for recovery. Areas outside the critical habitat designation will continue to be subject to conservation actions that may be implemented under section 7(a)(1) and to the regulatory protections afforded by the section 7(a)(2) jeopardy standard and the section 9 take prohibition, as determined on the basis of the best available information at the time of the action. Federally funded or assisted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans, or other species conservation planning efforts if new information available to these planning efforts calls for a different outcome.

In determining areas that are essential to conserve the Great Lakes breeding population of the piping plover, the best scientific and commercial data available included information solicited from knowledgeable biologists and available information pertaining to habitat requirements of the species. In an effort to map areas essential to the conservation of the species, we used data of known piping plover breeding locations, records of historical nesting sites, International Census data, and those areas that were identified in the 1988 recovery plan and 1994 draft recovery plan as essential for the recovery of the population. We have chosen the 35 critical habitat units in order to protect adequate habitat to meet the recovery criteria, contained in the recovery plan and draft recovery plan, of 100 breeding pairs in Michigan and 50 breeding pairs in the other Great Lakes States combined. In addition, information provided in comments on the proposed designation and draft economic analysis were evaluated and taken into consideration in the development of this final designation.

In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12, in determining which areas to propose as critical habitat, we are required to base critical habitat determinations on the best scientific and commercial data available. We also are required to consider those physical and biological features that are essential to the conservation of the species and that may require special management considerations and protection. Such features include, but are not limited to: space for individual and population growth, and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction, and rearing of offspring; and habitats that are protected from disturbance or are representative of the historical geographical and ecological distributions of a species.

The primary constituent elements for the Great Lakes breeding population of the piping plover are those habitat components that are essential for successful foraging, nesting, rearing of young, intra-specific communication, genetic exchange, roosting, dispersal, or sheltering.

The primary constituent elements required to sustain the Great Lakes breeding population of the piping plover are found on Great Lakes islands and mainland shorelines that support open, sparsely vegetated sandy habitats, such as sand spits or sand beaches, that are associated with wide, unforested systems of dunes and inter-dune wetlands. In order for habitat to be physically and biologically suitable for piping plovers, it must have a total shoreline length of at least 0.2 km (0.12 mi) of gently sloping, sparsely vegetated (less than 50 percent herbaceous and low woody cover) sand beach with a total beach area of at least 2 hectares (ha) (5 acres (ac)).

Appropriately sized sites must also have areas of at least 50 meters (m) (164 feet (ft)) in length where (1) the beach width is more than 7 m (23 ft), (2) there is protective cover for nests and chicks, and (3) the distance to the treeline (from the normal high water line to where the forest begins) is more than 50 m (164 ft). Beach width is defined as the distance from the normal high water line to the foredune (a low barrier dune ridge immediately inland from the beach) edge, or to the sand/vegetation boundary in areas where the foredune is absent. The beach width may be narrower than 7 m (23 ft) if appropriate sand and cobble areas of at least 7 m (23 ft) exist between the dune and the treeline.

Protective cover for nests and chicks consists of small patches of herbaceous vegetation, cobble (stones larger than 1 cm (0.4 inches (in)) diameter), gravel (stones smaller than 1 cm (0.4 in) diameter), or debris such as driftwood, wrack, root masses, or dead shrubs. These areas must have a low level of disturbance from human activities and from domestic animals. As the nesting season progresses, the level of disturbance tolerated by piping plovers increases. A lower level of disturbance is required at the beginning of the nesting period during nest site selection, egg laying, and incubation. Beach activities that may be associated with a high level of disturbance include, but are not limited to, walking pets off leash, loud noise, driving all terrain vehicles (ATVs), or activities that significantly increase the level of people using the beach. The level of disturbance is relative to the proximity to the nest, intensity, and frequency of these and other similar activities.

The dynamic ecological processes that create and maintain piping plover habitat are also important primary constituent elements. These geologically dynamic lakeside regions are controlled by processes of erosion, accretion, plant succession, and lake-level fluctuations. The integrity of the habitat depends upon regular sediment transport processes, as well as episodic, high-magnitude storm events. By their nature, Great Lakes shorelines are in a constant state of change; habitat features may disappear, or be created nearby. The critical habitat boundaries reflect these natural processes and the dynamic character of Great Lakes shorelines.

All of the designated critical habitat areas are considered essential to the conservation of the Great Lakes breeding population of the piping plover as described in the approved 1988 Recovery Plan for the Great Lakes and Northern Great Plains Piping Plover (Plan) and the 1994 Draft Revised Recovery Plan for the Great Lakes Piping Plover. The designation encompasses those areas considered necessary to achieve the recovery goals of 150 breeding pairs (USFWS 1988b, 1994) for this population.

To identify critical habitat units, we first examined those sites identified as “essential habitat” in the approved Recovery Plan and draft revised Recovery Plan. We began by evaluating those essential habitat areas that are currently (at least once during the past 5 years) or were recently (in the last 5 to 15 years) occupied by piping plovers in the Great Lakes. Through site visits and consultation with local habitat experts, we determined which of these sites still contain the primary constituent elements. Piping plover occupied habitat in the Great Lakes has declined from historical occupation of more than 70 sites in eight States to approximately 32 sites in two States (Wemmer 2000). The currently occupied sites and recently occupied (since 1985) sites in Michigan may have the capacity to support an estimated 56 to 136 breeding pairs (Wemmer 2000). Because of this severe reduction in range and numbers of piping plovers, we have determined it is essential to the conservation of this species to include all currently occupied habitat and all recently occupied habitat that still contains the primary constituent elements in this critical habitat designation.

As we proceed with recovery efforts, expansion of the present small population will require more habitat than is currently occupied by piping plovers along the Great Lakes (Wemmer 2000, USFWS 1988b, 1994). In an effort to protect sufficient habitat to allow for the expansion of the species, our second step was to evaluate the essential habitat areas outlined in the Recovery Plan that are documented as historical piping plover habitat. In addition to evaluating those areas identified by the Recovery Plan as essential habitat, we solicited information from habitat experts on areas that contain the primary constituent elements and that would provide suitable piping plover nesting habitat. Based upon consultation with Great Lakes piping plover habitat experts, we determined which historically occupied sites contain the primary constituent elements and are suitable for supporting nesting piping plovers. We designated historically occupied habitat in the Great Lakes watershed (in the United States) that still contain the primary constituent elements.

Much known historical habitat in the Great Lakes region has been destroyed or altered in such ways that it can no longer support piping plovers (Wemmer 2000, USFWS 1988b). As a result, suitable habitat areas that are currently/recently occupied, or that were documented to be historically occupied, are not sufficient to meet the conservation goals outlined in the approved Recovery Plan and draft revised Recovery Plan. Thus, as a final step, we evaluated those essential habitat areas identified in the Recovery Plan where occupation has not been documented, but habitat features similar to currently occupied sites occur. To reach the minimum amount of habitat sufficient to meet the recovery plan goals, we designated those areas that are known to contain the primary constituent elements as critical habitat. Critical habitat designation is effective year-round, even if the primary constituent elements are temporarily obscured by snow, ice, or other temporary features.

In defining critical habitat boundaries, it was not possible to exclude all existing human-made features and structures, such as buildings, roads, marinas, piers, parking lots, bridges, boat ramps, lighthouses, and other such human-made features, within the area designated. These features do not contain most or all of the primary constituent elements and thus are not considered to be critical habitat despite their being within the geographic boundaries. Federal actions limited to those features, therefore, would not trigger a section 7 consultation, unless they affect the species and/or primary constituent elements within a critical habitat unit.

In summary, in determining areas that are essential to the conservation of the Great Lakes breeding population of the piping plover, we used the best scientific and commercial information available to us. The critical habitat areas described below constitute our best assessment of areas needed for the species' conservation and recovery.

At this time, the critical habitat units discussed below are our best appraisal of areas needed for the conservation of the Great Lakes breeding population of the piping plover. Very little suitable piping plover habitat remains in the Great Lakes region, and all the areas identified here are essential for the recovery of the species because these areas represent the habitat necessary to achieve the recovery goal of 100 breeding pairs in Michigan and 50 breeding pairs in the other Great Lakes States combined. Critical habitat designations may be subsequently revised if new information becomes available after this final rule is published. Any additional areas of critical habitat will be designated, or other changes made to this designation, only after a formal proposal and opportunity for public comment.

The approximate length of proposed critical habitat shoreline identified by land ownership is shown in Table 1. Critical habitat includes Great Lakes piping plover habitat throughout the species' breeding range in the United States. Lands proposed as critical habitat are under private, State, municipal, Tribal, and Federal ownership, with Federal lands including lands managed by the National Park Service, U.S. Forest Service, U.S. Coast Guard, U.S. Army Corp of Engineers, and by us. Estimates reflect the total area within critical habitat unit boundaries.

Critical habitat has been designated in 35 units in the Great Lakes region. All critical habitat unit boundaries extend 500 meters (1640 feet) inland from the normal high water line, although the inland edge of the area that contains the primary constituent elements may vary depending on the extent of the open dune system. This area is needed to provide foraging habitat as well as incorporate cobble pans between the dunes where piping plovers occasionally nest. A brief description of each unit and reasons for designating it as critical habitat are presented below and in Table 2. More detailed descriptions are included with the maps.

This unit encompasses approximately 83.5 km (50 mi) of Lake Superior shoreline in Chippewa, Luce, and Alger Counties on the Upper Peninsula of Michigan. It includes long stretches of habitat that have been recently used by piping plovers in addition to areas currently used by plovers. Approximately 47 km (29.2 mi) are part of Muskallonge State Park and Lake Superior State Forest, approximately 36 km (22.4 mi) are privately owned, and approximately 0.5 km (0.3 mi) are part of Whitefish Point National Wildlife Refuge. This unit also includes a small area of municipal property at Crisp Point. This unit extends from just southwest of Whitefish Point, around and including the Point, and westward to the Pictured Rocks National Lakeshore property boundary, excluding the area from the junction of Highway 58 and Morris Road to the breakwall north of the harbor near the former Coast Guard station in Grand Marais.

This unit encompasses approximately 1.7 km (1.1 mi) of Lake Michigan shoreline in Mackinac County on the Upper Peninsula of Michigan. It includes areas that are currently occupied by piping plovers. The majority of the unit (1.1 km (0.7 mi)) is within the Hiawatha National Forest and is being considered for a Research and Natural Area. The rest of the unit (approximately 0.6 km (0.4 mi)) is privately owned land. This unit extends from the mouth of the Pointe Aux Chenes river to the Hiawatha National Forest property boundary.

This unit encompasses approximately 3 km (1.8 mi) of Lake Michigan shoreline in western Mackinac and eastern Schoolcraft Counties on the Upper Peninsula of Michigan. It includes areas that are currently occupied by piping plovers. Approximately 0.8 km (0.5 mi) of the designated shoreline is owned by Port Inland Stone and Dolomite Quarry and the remaining 2.2 km (1.4 mi) are part of the Lake Superior State Forest. This unit extends from the westernmost breakwall at the Port Inland Gaging Station to the mouth of Swan Creek.

This unit encompasses approximately 32 km (19.2 mi) of Lake Michigan shoreline in Emmet County, Michigan, and includes Temperance and Waugoshance islands. It includes areas that are currently occupied by piping plovers and supports about half of the current Great Lakes piping plover population. Approximately 8.5 km (5.3 mi) are privately owned and 1 km (0.6 mi) is municipal land (Bliss Township beach and Cross Village beach). The remaining 22.5 km (14 mi) are part of Wilderness State Park. This unit extends from the junction of the northeast corner of T39N R5W section 28 and the Lake Michigan shoreline in Wilderness State Park, including Waugoshance and Temperance Islands, to the southwest boundary of T37N R6W section 5 south of Cross Village.

This unit encompasses approximately 7 km (4.3 mi) of Lake Michigan shoreline in Emmet County, Michigan. It includes areas of suitable piping plover nesting habitat and areas that are currently occupied by piping plovers. The entire designated area is under private ownership. It extends from the junction of the Lake Michigan shoreline and the northwest boundary of T36N R6W section 30 to the junction of the shoreline and the southeast corner of T35N R6W section 9.

This unit encompasses approximately 2 km (1.2 mi) of Lake Michigan shoreline in Emmet County, Michigan. It includes areas of historical piping plover habitat. Approximately 0.7 km (0.4 mi) is privately owned land and 1.3 km (0.8 mi) are part of Petoskey State Park. This unit extends from the mouth of Tannery Creek to Mononaqua Beach.

This unit encompasses approximately 1.1 km (0.7 mi) of Lake Michigan shoreline in Charlevoix County, Michigan. It includes areas of suitable piping plover nesting habitat. The entire designated area is a city park owned by the city of Charlevoix. It includes all Lake Michigan shoreline within T34N R8W section 14.

This unit encompasses approximately 1.3 km (0.8 miles) of Lake Michigan shoreline in Charlevoix County, Michigan. It includes areas that are currently occupied by piping plovers. The entire designated area is within Fisherman's Island State Park. This unit extends from the junction of the line separating T34N R8W section 31 and T33N R8W section 6 from the Lake Michigan shore to the Fisherman's Island State Park property boundary at the end of Lakeshore Drive, including Fisherman Island.

This unit encompasses approximately 5 km (3.1 mi) of Lake Michigan shoreline on Beaver Island in Charlevoix County, Michigan. It includes areas that are currently occupied, as well as areas that have been recently used by piping plovers. Approximately 4.4 km (2.7 mi) are privately owned and 0.6 km (0.4 mi) is part of Beaver Islands State Wildlife Research Area. This unit extends from Indian Point southward to the junction of the dividing line of T39 N R10W and T38N R10W and the Lake Michigan shoreline.

This unit encompasses approximately 0.8 km (0.5 mi) of Lake Michigan shoreline on Beaver Island in Charlevoix County, Michigan. It includes areas that have been recently used by piping plovers. Approximately 0.3 km (0.2 mi) is part of the Beaver Islands State Wildlife Research Area and the remaining 0.5 km (0.3 mi) is privately owned land. This unit encompasses Greenes Bay on the western side of Beaver Island.

This unit encompasses approximately 1.8 km (1.1 mi) of Lake Michigan shoreline on High Island in Charlevoix County, Michigan. It includes areas that are currently occupied by piping plovers. The entire designated area is part of the Beaver Islands State Wildlife Research Area. This unit includes all Lake Michigan shoreline within T39N R11W section 32 and T38N R11W section 5 on the western side of the island and within T39N R11W section 27 on the northeastern corner of the island.

This unit encompasses approximately 5.1 km (3.2 mi) of Lake Michigan shoreline in Leelanau County, Michigan. It includes areas that are currently occupied by piping plovers and areas of suitable piping plover nesting habitat. Approximately 1.9 km (1.2 mi) are part of Leelanau State Park, and the remaining 3.2 km (2.0 mi) are privately owned land. This unit extends from the northwest end of Cathead Bay southward to just north of Christmas Cove, excluding lands of the Magic Carpet Woods Association HCP.

This unit encompasses approximately 6 km (3.8 mi) of Lake Michigan shoreline on South Fox Island in Leelanau County, Michigan. It includes areas that were historically occupied by piping plovers. The entire designated area is part of the Beaver Island State Wildlife Research Area. This unit includes all Lake Michigan shoreline within T34N R13W sections 15, 16, and 21 on the south end of the island and within T35N R13W section 30 on the north end of the island.

This unit encompasses approximately 3.3 km (2.1 mi) of Lake Michigan shoreline on North Manitou Island in Leelanau County, Michigan. It includes areas that are currently occupied by piping plovers. The entire designated area is part of Sleeping Bear Dunes National Lakeshore. This unit includes Dimmick's Point and Donner's Point on the southern end of North Manitou Island.

This unit encompasses approximately 18.6 km (11.6 mi) of Lake Michigan shoreline in Leelanau County, Michigan. It includes areas of suitable piping plover nesting habitat. Approximately 4.8 km (3.0 mi) are municipal beach in Glen Arbor Township, and the remaining 13.8 km (8.6 mi) are part of Sleeping Bear Dunes National Lakeshore. This unit extends from Crystal Run to the southern Sleeping Bear Dunes National Lakeshore property boundary.

This unit encompasses approximately 18.6 km (11.6 mi) of Lake Michigan shoreline in Benzie County, Michigan. It includes areas that are currently occupied by piping plovers, areas that were historically occupied, and areas of suitable piping plover nesting habitat. The majority of the unit (13.8 km (8.6 mi)) is part of Sleeping Bear Dunes National Lakeshore, 3.8 km (2.4 mi) are private land, and the remaining 1.0 km (0.6 mi) is U.S. Coast Guard land that is managed by The Nature Conservancy, a private conservation organization. This unit extends from Esch Road to the Sleeping Bear Dunes National Lakeshore property boundary at Sutter Road. The unit then continues from the Point Betsie Natural Area northern property boundary south to include all shoreline within T26N R16W section 4.

This unit encompasses approximately 13.4 km (8.3 mi) of Lake Michigan shoreline in Mason County, Michigan. It includes areas that were historically occupied by piping plovers. At least one pair of piping plovers were sighted in the area in 1999, but no nests were found. Approximately 7.4 km (4.6 mi) are part of the Manistee National Forest/ Nordhouse Dunes Wilderness Area, and the remaining 6.0 km (3.7 mi) are part of Ludington State Park. This unit extends from the mouth of Cooper Creek to the mouth of the Big Sable River.

This unit encompasses approximately 2.5 km (1.6 mi) of Lake Michigan shoreline in Muskegon County, Michigan. It includes areas that were historically occupied by piping plovers. In the early 1950s, several pairs of piping plovers were reported nesting in this unit, but the last known nesting was in 1953. The entire designated area is part of Muskegon State Park. This unit extends from the north breakwall of the canal joining Muskegon Lake and Lake Michigan to the northern Muskegon State Park property boundary at the shoreline.

This unit encompasses approximately 3.0 km (1.9 mi) of Lake Huron shoreline in Chippewa County, Michigan. It includes areas that were historically occupied by piping plovers. The entire designated area is within Lake Superior State Forest. This unit extends from the Lake Superior State Forest boundary to the mouth of Joe Straw Creek.

This unit encompasses approximately 5.2 km (3.3 mi) of Lake Huron shoreline in Cheboygan County, Michigan. It includes areas that were historically occupied by piping plovers and currently serve as foraging areas. Approximately 3 km (1.9 mi) are part of Cheboygan State Park, and approximately 1.6 km (1 mi) are Nature Conservancy property. The remaining 0.6 km (0.4 mi) is privately owned land. This unit extends from the junction of the Lake Huron shoreline and the western boundary of T38N R1W section 22 near Lighthouse Point to just west of Cordwood Point.

This unit encompasses approximately 3.7 km (2.3 mi) of Lake Huron shoreline in Presque Isle County, Michigan. It includes areas of suitable piping plover nesting habitat. The entire designated area is part of P.H. Hoeft State Park. This unit includes Lake Huron shoreline within T35N R5E section 6 northwestward to the junction of Nagel Road and Forty Mile Road.

This unit encompasses approximately 2.8 km (1.7 mi) of Lake Huron shoreline in Presque Isle County, Michigan. It includes areas of suitable piping plover nesting habitat. Most of this designated area is within Thompson's Harbor State Park with a small portion of privately owned land. This unit extends along the Lake Huron shoreline from Black Point to Grand Lake Outlet.

This unit encompasses approximately 2.0 km (1.2 mi) of Lake Huron shoreline in Iosco County, Michigan. It includes areas used for foraging by transient piping plovers and suitable nesting habitat. The entire designated area is part of Tawas Point State Park. This unit extends from the Tawas Sate Park boundary on the east side of Tawas Point including all shoreline within T22N R8E section 34 and offshore sand spits.

This unit encompasses approximately 0.6 km (0.4 mi) of Lake Superior shoreline on Interstate Island in St. Louis County, Minnesota and Douglas County, Wisconsin. Although piping plover nesting has not been documented on this island, it contains viable piping plover habitat. A portion of the 0.6 km (0.4 mi) of island shoreline on Interstate Island is in Minnesota, and a portion is in Wisconsin. Approximately 0.2 km (0.1 mi) of Interstate Island shoreline is owned by the State of Minnesota and is a State Wildlife Management Area and bird sanctuary. The remaining 0.4 km (0.2 mi) of Interstate Island shoreline is in Wisconsin and is private land owned by C. Rice Coal and Burlington Northern Railroad. This unit is comprised of Interstate Island.

This unit encompasses approximately 4.0 km (2.5 mi) of Lake Superior shoreline in Douglas County, Wisconsin. It includes areas that were historically occupied by piping plovers. Approximately 0.4 km (0.2 mi) of the unit is Army Corps of Engineers land. The rest of the designated area is municipal land belonging to the city of Superior. This unit extends from the mouth of Dutchman Creek to the Douglas and St. Louis County line.

This unit encompasses approximately 25.3 km (15.7 mi) of Lake Superior shoreline in Ashland County, Wisconsin. It includes areas currently occupied by piping plovers. Nesting occurred in this unit in 1998 and 1999. Approximately 11.2 km (6.9 mi) are part of the Apostle Islands National Lakeshore, approximately 9.0 km (5.6 mi) are private land, and the remaining 5.1 km (3.2 mi) are Tribal lands belonging to the Bad River Band of Lake Superior Tribe of Chippewa Indians. This unit extends from the base of Chequamegon Point (where it meets the mainland) to Chequamegon Point Light.

This unit encompasses approximately 6.5 km (4 mi) of Lake Superior shoreline on Michigan Island in Ashland County, Wisconsin. It includes areas of suitable piping plover nesting habitat. The entire designated area is part of the Apostle Island National Lakeshore. This unit includes all Lake Superior shoreline on Michigan Island within T51N R1W sections 28, 20, and 21.

This unit encompasses approximately 1.5 km (0.9 mi) of Lake Michigan shoreline in Marinette County, Wisconsin. It includes areas of suitable piping plover nesting habitat. About one half of the unit is State owned and the other half is municipal property owned by the city of Marinette. This unit extends from the end of Leonard Street at Red Arrow Park to the south end of Seagull Bar including nearshore sand bars.

This unit encompasses approximately 8 km (5 mi) of Lake Michigan shoreline in Manitowoc County, Wisconsin. It includes areas of suitable piping plover nesting habitat. The entire designated area is part of the Point Beach State Forest. This unit extends from the southwest property boundary of Point Beach State Forest to Rawley Point.

This unit encompasses approximately 10.2 km (6.3 mi) of Lake Michigan shoreline in Lake County, Illinois. It includes areas that were historically occupied by piping plovers. Approximately 4.7 km (2.9 mi) are part of the Illinois Beach State Park and Nature Preserve, approximately 1.3 km (0.8 mi) are municipal property (Zion municipal park and Waukegan municipal beach), and the remaining 4.2 km (2.6 mi) are privately owned. This unit extends from 17th Street and the Lake Michigan shoreline in Illinois Beach State Park southward to the northernWaukegan Beach breakwall at North Beach Park, excluding the public beach and campground to just south of the Illinois Beach State Park Lodge and Conference Center.

This unit encompasses approximately 7.9 km (4.9 mi) of Lake Michigan shoreline in Porter County, Indiana. It includes areas that were historically occupied by piping plovers. 5 km (3.1 mi) are part of Indiana Dunes State Park and the remaining 2.9 km (1.8 mi) are part of Indiana Dunes National Lakeshore. This unit extends from the western boundary of the Cowels Bog/Dune Acres Unit, east of the Port of Indiana and the NIPSCO Baily Generating Station and along the Indiana Dunes State Park to Kemil Road at Beverly Shores.

This unit encompasses approximately 3.2 km (2.0 mi) of Lake Erie shoreline in Erie County, Ohio. It includes foraging areas for transient piping plovers and suitable nesting habitat. Approximately 1.2 km (0.7 mi) are part of Sheldon Marsh State Nature Preserve, and the remaining 2.0 km (1.2 mi) are privately owned land. This unit extends from the mouth of Sawmill Creek to the western property boundary of Sheldon Marsh State Natural Area.

This unit encompasses approximately 0.8 km (0.5 mi) of Lake Erie shoreline in Lake County, Ohio. It includes historical nesting habitat and areas of suitable piping plover nesting habitat. The entire designated area is part of Headland Dunes State Nature Preserve. This unit extends from the eastern boundary line of Headland Dunes Nature Preserve to the western boundary of the Nature Preserve and Headland Dunes State Park.

This unit encompasses approximately 6.0 km (3.7 mi) of Lake Erie shoreline in Erie County, Pennsylvania. It includes foraging areas for transient piping plovers and areas that were historically used for nesting. The entire unit is part of the Presque Isle State Park. This unit extends from the lighthouse north of Peninsula Drive on the north side of Presque Isle to the southern terminus of the hiking trail on the southeast side of Gull Point. It includes any new beach habitat that may accrete along the present shoreline portion of the unit.

This unit encompasses approximately 27.4 km (17 mi) of Lake Ontario shoreline in Jefferson and Oswego Counties, New York. It includes areas that were historically occupied by piping plovers. Approximately 12.4 km (7.7 mi) are State land (New York State Department of Environmental Conservation (DEC) Wildlife Management Area/ New York DEC Unique Area and New York State Park), approximately 14.6 km (9.1 mi) are privately owned, and the remaining 0.4 km (0.2 mi) belong to The Nature Conservancy. This unit extends from the mouth of the Salmon River to the Eldorado Road.

Section 7(a) of the Act requires all Federal agencies, including the Service, to ensure that actions they fund, authorize, or carry out do not destroy or adversely modify critical habitat to the extent that the action appreciably diminishes the value of the critical habitat for the survival and recovery of the species. Individuals, organizations, States, Tribes, local governments, and other non-Federal entities are affected by the designation of critical habitat only if their actions occur on Federal lands, require a Federal permit, license, or other authorization, or involve Federal funding.

Section 7(a) of the Act requires all Federal agencies to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened and with respect to its proposed or designated critical habitat. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) of the Act requires Federal agencies to confer with us on any action that is likely to jeopardize the continued existence of a proposed species or result in destruction or adverse modification of proposed critical habitat. Conference reports provide conservation recommendations to assist the agency in eliminating conflicts that may be caused by the proposed action. The conservation recommendations in a conference report are advisory. If a species is listed or critical habitat is designated, section 7(a)(2) requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or to destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency (action agency) must consult with us. Through this consultation we would ensure that the permitted actions do not destroy or adversely modify critical habitat.

When we issue a biological opinion concluding that a Federal action is likely to result in the destruction or adverse modification of critical habitat, we also provide reasonable and prudent alternatives to the project, if any are identifiable. Reasonable and prudent alternatives are defined at 50 CFR 402.02 as alternative actions identified during consultation that can be implemented in a manner consistent with the intended purpose of the action, that are consistent with the scope of the Federal agency's legal authority and jurisdiction, that are economically and technologically feasible, and that we believe would avoid destruction or adverse modification of critical habitat. Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.

Regulations at 50 CFR 402.16 require Federal agencies to reinitiate consultation on previously reviewed actions in instances where critical habitat is subsequently designated and the Federal agency has retained discretionary involvement or control over the action or such discretionary involvement or control is authorized by law. Consequently, some Federal agencies may request reinitiation of consultation with us on actions for which formal consultation has been completed, if those actions may affect designated critical habitat. Further, some Federal agencies may have conferenced with us on proposed critical habitat. We may adopt the formal conference report as the biological opinion when critical habitat is designated, if no significant new information or changes in the action alter the content of the opinion (see 50 CFR 402.10(d)).

Activities on Federal lands that may affect the piping plover or its critical habitat will require section 7 consultation. Activities on private, State or Tribal lands requiring a permit from the U.S. Army Corps of Engineers (Army Corps) under section 404 of the Clean Water Act, or some other Federal action, including funding (e.g from the Federal Highway Administration, Environmental Protection Agency, or Federal Emergency Management Agency) will also continue to be subject to the section 7 consultation process. Federal actions not affecting listed species or critical habitat and actions on non-Federal lands that are not federally funded or permitted do not require section 7 consultation.

Section 4(b)(8) of the Act requires us to evaluate briefly in any proposed or final regulation that designates critical habitat those activities involving a Federal action that may adversely modify such habitat or may be affected by such designation. Activities that may destroy or adversely modify critical habitat include those that alter the primary constituent elements to the extent that the value of critical habitat for both the survival and recovery of the Great Lakes breeding population of the piping plover is appreciably diminished. We note that such activities may also jeopardize the continued existence of the species.

To properly portray the effects of critical habitat designation, we must first compare the section 7 requirements for actions that may affect critical habitat with the requirements for actions that may affect a listed species. Section 7 prohibits actions funded, authorized, or carried out by Federal agencies from jeopardizing the continued existence of a listed species or destroying or adversely modifying the listed species' critical habitat. Actions likely to “jeopardize the continued existence” of a species are those that would appreciably reduce the likelihood of the species' survival and recovery. Actions likely to “destroy or adversely modify” critical habitat are those that would appreciably reduce the value of critical habitat for the survival and recovery of the listed species.

Common to both definitions is an appreciable detrimental effect on both survival and recovery of a listed species. Given the similarity of these definitions, actions likely to destroy or adversely modify critical habitat would almost always result in jeopardy to the species concerned when the area of the proposed action is occupied by the species. In those cases, it is highly unlikely that additional modifications to the action would be required as a result of designating critical habitat. However, critical habitat may provide benefits toward recovery when designated in areas unoccupied by the species.

Designation of critical habitat could affect Federal agency activities. Federal agencies already consult with us on activities that may affect the species to ensure that their actions do not jeopardize the continued existence of the species. These actions include, but are not limited to: (1) Marina and boat launch construction and maintenance; (2) harbor dredging and dredge spoil placement and disposal; (3) fill of interdunal wetlands for residence, driveway, or other construction; (4) waste-water discharge from communities; (5) all-terrain vehicular activity on beaches or the construction of facilities that increase such activity; (6) beach stabilization activities that impede natural overwash processes including beach nourishment, planting of vegetation, and construction and maintenance of seawalls, breakwaters, and other off-shore stabilizing devices; (7) sale, exchange, or lease of Federal land that contains suitable habitat that is likely to result in the habitat being destroyed or appreciably degraded; (8) oil and other hazardous material spills and cleanup; and (9) stormwater and wastewater discharge from communities. Additionally, public access may be temporarily or seasonally restricted on beaches under Federal ownership or jurisdiction to reduce disturbance so that piping plovers in search of suitable nesting sites could utilize them. Some of these closures may be voluntary by governmental and private land managers. Most closures would end prior to the time the public would frequent these beaches.

This section serves in part as a general guide to clarify activities that may affect or destroy or adversely modify critical habitat. However, specific Federal actions should be reviewed by the action agency. If the agency determines the activity may affect critical habitat, they will consult with us under section 7 of the Act. We will work with the agencies and affected public early in the consultation process to avoid or minimize potential conflicts and, whenever possible, find a solution that protects listed species and their habitat while allowing the action to go forward in a manner consistent with its intended purpose.

Subsection 4(b)(2) of the Act allows us to exclude areas from critical habitat designation where the benefits of exclusion outweigh the benefits of designation, provided the exclusion will not result in the extinction of the species. For the following reasons, we believe that in most instances the benefits of excluding areas covered by approved Habitat Conservation Plans (HCPs) from critical habitat designations will outweigh the benefits of including them.

The benefits of including HCP lands in critical habitat are normally small. The principal benefit of any designated critical habitat is that Federal activities in such habitat that may affect it require consultation under section 7 of the Act. Such consultation would ensure that adequate protection is provided to avoid adverse modification of critical habitat. Where HCPs are in place, our experience indicates that this benefit is small or non-existent. Currently approved and permitted HCPs are already designed to ensure the long-term survival of covered species within the plan area. Where we have an approved HCP, lands that we ordinarily would define as critical habitat for the covered species will normally be protected in reserves and other conservation lands by the terms of the HCP and its implementation agreements. The HCP and implementation agreements include management measures and protections for conservation lands that are crafted to protect, restore, and enhance their value as habitat for covered species.

In addition, a 10(a)(1)(B) permit issued by us as a result of an HCP application must itself undergo consultation. While this consultation may not look specifically at the issue of adverse modification of critical habitat, it will look at the very similar concept of jeopardy to the listed species in the plan area. Since HCPs, particularly large regional HCPs, address land use within the plan boundaries, habitat issues within the plan boundaries will have been thoroughly addressed in the HCP and the consultation on the HCP. Our experience is also that, under most circumstances, consultations under the jeopardy standard will reach the same result as consultations under the adverse modification standard. Implementing regulations (50 CFR Part 402) define “jeopardize the continued existence of” and “destruction or adverse modification of” in virtually identical terms. Jeopardize the continued existence of means to engage in an action “that reasonably would be expected to reduce appreciably the likelihood of both the survival and recovery of a listed species.” Destruction or adverse modification means an “alteration that appreciably diminishes the value of critical habitat for both the survival and recovery of a listed species.” Common to both definitions is an appreciable detrimental effect on both survival and recovery of a listed species, in the case of critical habitat by reducing the value of the habitat so designated. Thus, actions satisfying the standard for adverse modification are nearly always found to also jeopardize the species concerned, and the existence of a critical habitat designation does not materially affect the outcome of consultation. Additional measures to protect the habitat from adverse modification are not likely to be required.

Further, HCPs typically provide for greater conservation benefits to a covered species than section 7 consultations because HCPs assure the long term protection and management of a covered species and its habitat, and funding for such management through the standards found in the 5-Point Policy for HCPs (64 FR 35242) and the HCP No Surprises regulation (63 FR 8859). Such assurances are typically not provided by section 7 consultations which, in contrast to HCPs, often do not commit the project proponent to long term special management or protections. Thus, a consultation typically does not accord the lands it covers the extensive benefits an HCP provides.

The development and implementation of HCPs provide other important conservation benefits, including the development of biological information to guide conservation efforts and assist in species recovery and the creation of innovative solutions to conserve species while allowing for development. The educational benefits of critical habitat, including informing the public of areas that are important for the long-term survival and conservation of the species, are essentially the same as those that would occur from the public notice and comment procedures required to establish an HCP, as well as the public participation that occurs in the development of many regional HCPs. For these reasons, then, we believe that designation of critical habitat has little benefit in areas covered by HCPs.

The benefits of excluding HCPs from being designated as critical habitat may be more significant. During two public comment periods on our critical habitat policy, we received several comments about the additional regulatory and economic burden of designating critical habitat. These include the need for additional consultation with the Service and the need for additional surveys and information gathering to complete these consultations. HCP applicants have also stated that they are concerned that third parties may challenge HCPs on the basis that they result in adverse modification or destruction of critical habitat, should critical habitat be designated within the HCP boundaries.

The benefits of excluding HCPs include relieving landowners, communities and counties of any additional minor regulatory review that might be imposed by critical habitat. Many HCPs, particularly large regional HCPs, take many years to develop and, upon completion, become regional conservation plans that are consistent with the recovery of covered species. Many of these regional plans benefit many species, both listed and unlisted. Imposing an additional regulatory review after HCP completion may jeopardize conservation efforts and partnerships in many areas and could be viewed as a disincentive to those developing HCPs. Excluding HCPs provides us with an opportunity to streamline regulatory compliance and confirms regulatory assurances for HCP participants.

A related benefit of excluding HCPs is that it would encourage the continued development of partnerships with HCP participants, including States, local governments, conservation organizations, and private landowners, that together can implement conservation actions we would be unable to accomplish alone. By excluding areas covered by HCPs from critical habitat designation, we preserve these partnerships, and, we believe, set the stage for more effective conservation actions in the future.

In general, we believe the benefits of critical habitat designation to be small in areas covered by approved HCPs. We also believe that the benefits of excluding HCPs from designation are significant. Weighing the small benefits of inclusion against the benefits of exclusion, including the benefits of relieving property owners of an additional layer of approvals and regulation, together with the encouragement of conservation partnerships, would generally result in HCPs being excluded from critical habitat designation under Section 4(b)(2) of the Act.

Not all HCPs are alike with regard to species coverage and design. Within this general analytical framework, we need to individually evaluate completed and legally operative HCPs in the range of the Great Lakes breeding population of the piping plover to determine whether the benefits of excluding these particular areas outweigh the benefits of including them.

Presently, one approved HCP exists for the piping plover in the Great Lakes region. The Magic Carpet Woods Association HCP covers approximately 792 meters (2,600 feet) of shoreline within the proposed Cathead Bay critical habitat unit in Leelanau County, Michigan. This plan addresses the piping plover as a covered species and provides conservation management and protection for the species. We evaluated this plan and determined that the conservation management measures and protection afforded the piping plover are sufficient to assure its conservation on the involved lands. Consequently, we have determined that the benefits of excluding this area outweigh the benefits of inclusion, and have excluded the area covered by the HCP from the fixed critical habitat designation.

In the event that future HCPs covering the Great Lakes breeding population of the piping plover are developed within the boundaries of designated critical habitat, we will work with applicants to ensure that the HCPs provide for protection and management of habitat areas essential for the conservation of the piping plover by either directing development and habitat modification to nonessential areas or appropriately modifying activities within essential habitat areas so that such activities will not adversely modify the primary constituent elements. The HCP development process provides an opportunity for more intensive data collection and analysis regarding the use of particular habitat areas by the piping plover. The process also enables us to conduct detailed evaluations of the importance of such lands to the long term survival of the species.

We will provide technical assistance and work closely with applicants throughout the development of future HCPs to identify lands essential for the long-term conservation of the piping plover and appropriate management for those lands. The take minimization and mitigation measures provided under these HCPs are expected to protect the essential habitat lands designated as critical habitat in this rule. If an HCP that addresses the piping plover as a covered species is ultimately approved, the Service will reassess the critical habitat boundaries in light of the HCP. The Service will seek to undertake this review when the HCP is approved, but funding constraints may influence the timing of such a review.

Should additional information become available that changes our analysis of the benefits of excluding any of these (or other) areas compared to the benefits of including them in the critical habitat designation, we may revise this final designation accordingly.

Similarly, if new information indicates any of these areas should not be included in the critical habitat designation because they no longer meet the definition of critical habitat, we may revise this final critical habitat designation. If, consistent with available funding and program priorities, we elect to revise this designation, we will do so through a subsequent rulemaking.

If you have questions regarding whether specific activities will constitute adverse modification of critical habitat, or requests for copies of the regulations on listed wildlife and inquiries about prohibitions and permits contact the U.S. Fish and Wildlife Service (see addresses section).

In the July 6, 2000, proposed rule (65 FR 41812), we requested all interested parties to submit comments on the specifics of the proposal including information, policy, treatments of HCPs, and proposed critical habitat boundaries as provided in the proposed rule. The first comment period closed on September 5, 2000. The comment period was reopened for 30 days, from September 19 to October 20, 2000 (65 FR 56530), to allow for additional comments on the proposed rule and comments on the draft economic analysis of the proposed critical habitat. Since our intention was to reopen the comment period for 60 days, we published a correction on September 28, 2000 (65 FR 58258), correcting the closing date of the reopened comment period to November 20, 2000. Comments received from July 6 to November 20, 2000, were entered into the administrative record.

We contacted all appropriate State and Federal agencies, Tribes, County governments, elected officials, and other interested parties and invited them to comment. In addition, we invited public comments through the publication of notices in newspapers in Minnesota, Wisconsin, Michigan, Illinois, Indiana, Ohio, Pennsylvania, and New York. In these notices and the proposed rule, we announced the dates and times of seven public hearings to be held on the proposed rule. Their dates and locations are specified above in the section “Previous Federal Actions”. Transcripts of these hearings are available for inspection (see addresses section). We posted copies of the proposed rule and draft economic analysis on our internet site (http://midwest.fws.gov/).

We requested three ornithologists and conservation biologists, who have familiarity with the piping plover and its habitat requirements, to peer review the proposed critical habitat designation. All three responded by the close of the comment period. They provided valuable information about the biology, status, and historical range of the species, and suggested removing some areas from the critical habitat designation that no longer meet the criteria of piping plover critical habitat and provided data on other areas that may deserve critical habitat designation at a later date. These comments are addressed in this section, and relevant data provided by the reviewers have been incorporated throughout the rule.

We received a total of 140 written and 36 oral comments during the 2 public comment periods. Several people submitted comments more than once. In total, oral and written comments were received from 7 Federal agencies, 14 State agencies, 5 Tribal representatives, 3 elected officials, 10 local governments, 31 private organizations, and 97 private individuals. Comments were received from residents in 13 States, with Michigan sources submitting the most of any one State. All comments received were reviewed for substantive issues and new data regarding critical habitat and the biology and status of the Great Lakes breeding population of the piping plover, and economic information. We address all relevant comments received during the comment periods and public hearing testimonies in the following summary of issues. Comments of a similar nature are grouped into a single issue. Comments that we incorporated into this final rule are discussed in the “Summary of Changes from Proposed Rule” section of this document.

The following comments and responses involve issues related to the biological basis for the designation.

(1A) Comment: The broad scale of the proposed critical habitat includes areas that do not contain the primary constituent elements for the Great Lakes piping plover.

Response: We recognize that not all parcels of land within designated critical habitat units will contain the habitat components essential to piping plover conservation. We are required to designate critical habitat based on the best available information and to describe critical habitat (50 CFR 424.12(c)) with specific limits using reference points and specific definable boundaries. In preparation of the final determination, we used information gathered during the public comment period to more accurately define the written critical habitat boundaries. Despite our efforts to exclude areas that do not contain the primary constituent elements for the piping plover from critical habitat unit boundaries, it is not practicable to develop unit boundaries and provide maps and legal descriptions that exclude all developed areas such as towns, housing developments, or other developed lands unlikely to provide for the piping plover. Because of the time constraints imposed by the Court, and the absence of detailed Geographic Information System (GIS) coverage we defined the critical habitat unit boundaries as specifically as practicable but, due to the mapping scale, some areas not essential to the conservation of the piping plover were included within the boundaries of proposed critical habitat. However, developed areas such as buildings, marinas, paved areas, boat ramps, piers, bridges, lighthouses, and similar human-made structures are not being designated as critical habitat.

(1B) Comment: Designating critical habitat for the piping plover will result in such high public animosity that the designation will cause more harm to the species than benefit.

Response: Public support is a vital asset in the protection of endangered species and their habitat, but, by law we must designate essential areas as critical habitat even if it will cause public backlash due to misconceptions about its impacts. In an effort to clear up misunderstandings about critical habitat and to increase public support for piping plovers, we are increasing our education and outreach programs.

(1C) Comment: One person commented that there is a lack of data to support the proposed measures and no data to support that designating critical habitat will result in an increased piping plover population.

Response: In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12, in determining which areas to designate as critical habitat, we are basing this critical habitat determination on the best scientific and commercial data available at the time of designation. The designation indicates the areas that we believe are essential to the conservation of the species. Designation of critical habitat is only one tool to use towards the recovery of the piping plover, and we will continue to work with other Federal agencies, State and local agencies, Tribes, the scientific community, local landowners, and the public to eliminate and reduce the range of threats that endanger this species.

(1D) Comment: Inland lakes are mentioned in the 1988 Recovery Plan as potential breeding habitat around the Great Lakes. Were smaller, inland lakes considered for designation?

Response: Inland lake records of piping plovers in the Great Lakes are very few and from long ago. Cottrille (1957) cites four records of piping plovers at three inland locations in Michigan between 1938 and 1954, but no such sightings have been made in recent years. Additionally, there are no inland lakes in the Great Lakes area that are presently known to contain the primary constituent elements for this population of piping plovers.

(1E) Comment: There is no mention of migratory sites or habitat needs during migration.

Response: Areas used by piping plovers on migratory routes are likely very important for survival to the next breeding season. Extraordinarily little is known, however, about important stop-over sites and habitat needs of the piping plover during migration. Because so little is known about where essential migratory stop-over sites are located, we did not designate migratory habitat in this rule. Important migratory sites may be added to the critical habitat designation (by following the complete proposal process and soliciting public comments) when we have a better understanding of migratory habitat requirements.

(1F) Comment: Why is unoccupied habitat being designated as critical habitat?

Response: The inclusion of unoccupied areas in this critical habitat designation is in accordance with section 3(5)(A) of the Act, which provides that areas outside the geographic area currently occupied by the species may meet the definition of critical habitat upon a determination that they are essential for the conservation of the species. Our regulations also provide for the designation of areas outside the geographical area currently occupied if we find that a designation limited to its present range would be inadequate to ensure the conservation of the species (50 CFR 424.12(e)).

In 2000, there were about 30 breeding pairs of piping plovers in the Great Lakes area, all of which occur in Michigan (Stucker et al. 2000). The Great Lakes and Northern Great Plains Piping Plover Recovery Plan (USFWS 1988b) establishes a recovery goal of 150 breeding pairs in the Great Lakes watershed. This number is considered a minimum for the recovery of the species and eventual removal from the protections of Act. Of these 150 breeding pairs, at least 100 are to be in Michigan and at least 50 in other Great Lakes States. In order to achieve this recovery goal, additional habitat areas are needed beyond those currently occupied by the species. We have designated currently unoccupied areas as critical habitat on the basis of historical piping plover occurrences and the existence of most or all of the primary constituent elements at other sites lacking historical occurrences. Additionally, all of the currently unoccupied areas designated as critical habitat are included as essential habitat in the draft revised Recovery Plan (USFWS 1994).

The following comments and responses involve issues related to public involvement in the designation process and compliance with the Act and other laws, regulations, and policies.

(2A) Comment: Several commenters were supportive of the policy that lands covered by approved HCPs that provide incidental take authorization for the piping plover should be excluded from critical habitat. Other commenters believe that critical habitat designation should occur within the boundaries of such HCPs.

Response: We recognize that critical habitat is only one of many conservation tools for federally listed species. HCPs are one of the most important tools for reconciling land use with the conservation of listed species on non-Federal lands. Section 4(b)(2) of the Act allows us to exclude areas from critical habitat designation where the benefits of exclusion outweigh the benefits of designation, provided the exclusion will not result in the extinction of the species. We believe that in most instances the benefits of excluding HCPs from critical habitat designations will outweigh the benefits of including them. For this designation, we find that the benefits of exclusion outweigh the benefits of designation for the one legally operative HCP issued for the piping plover in the Great Lakes.

We anticipate that future HCPs in the range of the Great Lakes breeding population of piping plovers will include it as a covered species and provide for its long term conservation. We expect that HCPs undertaken by local jurisdictions (e.g. counties, cities) and other parties will identify, protect, and provide appropriate management for those specific lands within the boundaries of the plans that are essential for the long term conservation of the species. Section 10(a)(1)(B) of the Act sates that HCPs must meet issuance criteria, including minimizing and mitigating any take of the listed species covered by the permit to the extent practicable, and that the taking must not appreciably reduce the likelihood of the survival and recovery of the species in the wild. We fully expect that our future analyses of HCPs and section 10(a)(1)(B) permits under section 7 will show that covered activities carried out in accordance with the provisions of the HCP and section 10(a)(1)(B) permits will not result in the destruction or adverse modification of critical habitat designated for the piping plover.

In the event that future HCPs covering the Great Lakes breeding population of the piping plover are developed within the boundaries of designated critical habitat, we will work with applicants to ensure that the HCPs provide for protection and management of habitat areas essential for the conservation of the piping plover by either directing development and habitat modification to nonessential areas or appropriately modifying activities within essential habitat areas so that such activities will not adversely modify the primary constituent elements. The HCP development process provides an opportunity for more intensive data collection and analysis regarding the use of particular habitat areas by the piping plover. We will provide technical assistance and work closely with applicants throughout the development of future HCPs to identify lands essential for the long term conservation of the species and appropriate management of those lands. If the piping plover is a covered species under future HCPs, the plans should provide for the long term conservation of the species. The take minimization and mitigation measures provided under these HCPs are expected to adequately protect the essential habitat lands designated as critical habitat in this rule, such that the value of these lands for the survival and recovery of the Great Lakes breeding population of the piping plover is not appreciably diminished through direct or indirect alterations. If an HCP that addresses the piping plover as a covered species is ultimately approved, the Service will reassess the relevant critical habitat boundaries in light of the protection and management provided by the HCP. The Service will seek to undertake this review when the HCP is approved, but funding constraints may influence the timing of such a review. However, an HCP can proceed without a concurrent amendment to the critical habitat designation should all involved parties agree.

(2B) Comment: Specific lands should be excluded using the exemption afforded pursuant to 4(b)(2) of the Act. The biological benefits of critical habitat are outweighed by the benefits of exclusion.

Response: Section 4(b)(2) of the Act and 50 CFR 424.19 require us to consider the economic impact, and any other relevant impact, of specifying any particular area as critical habitat. We may exclude any area from critical habitat if we determine that the benefits of exclusion outweigh the benefits of designating the area as critical habitat, unless that exclusion will lead to extinction of the species. As discussed in this final rule, we have determined that no significant adverse economic effects will result from this critical habitat designation. Consequently, none of the proposed lands have been excluded from the designation based on economic impacts. As discussed in the response to the comment above, we have excluded the one legally operative HCP from the designation pursuant to section 4(b)(2) of the Act based on other relevant impacts.

(2C) Comment: We received three written requests to extend the comment period for the proposed designation and draft economic analysis.

Our Response: Following the publication of the proposed critical habitat designation on July 6, 2000, we opened a 60 day public comment period which closed on September 5, 2000, held seven public hearings during July, and conducted outreach notifying elected officials, local jurisdictions, interest groups, and property owners. We conducted much of this outreach through legal notices in regional newspapers, telephone calls, letters and news releases mailed to affected elected officials, local jurisdictions, and interest groups, and publication of the proposed determination and associated materials on our internet site. We published a document in the Federal Register on September 19, 2000, announcing the availability of the draft economic analysis and reopening the comment period until October 19, 2000. On September 28, 2000, in order to fulfill our intention that the comment period be reopened for 60 days, we published a document correcting the closing date of the comment period, to November 20, 2000. Because of the court-ordered ten month time frame for completing the designation, we were not able to extend or open an additional public comment period beyond the four and one-half months we provided.

(2D) Comment: We received two requests to hold additional public hearings on the proposed designation.

Our Response: We are required to hold one public hearing on a proposed action, if it is requested. Due to the short time between proposal and the court-ordered deadline for publication of the final rule, we chose to announce public hearings at the time the proposal was published. We published notification of the hearings in the Federal Register as part of the proposal, published legal notices in regional newspapers, posted information on our internet site, and issued news releases about the hearings. During the month of July, 2000, we held seven public hearings throughout the Great Lakes States affected by the proposed critical habitat designation. Additional public hearings were requested in locations near one of the seven hearings. Because of the court-ordered deadline and the broad coverage of the original public hearings, we chose not to hold additional public hearings.

(2E) Comment: One commenter suggested that we post the hearing transcripts and all of the comments received during the public comment period on the internet.

Response: We have not posted copies of hearing transcripts and the comments received on a proposed action on the internet in the past. The volume of public comments received on some proposals is very large, thus it is not practicable to post them on the internet at this time. The hearing transcripts and comments on the proposal to designate critical habitat for the Great Lakes breeding population of the piping plover are available during normal business hours at the U.S. Fish and Wildlife Service offices at: Bishop Henry Whipple Building, 1 Federal Drive, Fort Snelling, Minnesota 55111; and 2651 Coolidge Road, Suite 101, East Lansing, Michigan 48823. Call our Ecological Services office in Fort Snelling at 612-713-5350 for more information on how to view the transcripts and comments.

(2F) Comment: Alternatives to designating critical habitat were not considered.

Response: By law, according to section 4(a)(3) of the Act, we are required to designate critical habitat “to the maximum extent prudent” for all listed species. Furthermore, in the case of the piping plover, we were ordered by the United States District Court for the District of Columbia to designate critical habitat for the Great Lakes breeding population of this species. Other conservation actions are important to the recovery of the piping plover and will be carried out as part of the recovery process, but they are not legal alternatives to designating critical habitat.

(2G) Comment: A few commenters recommended that we postpone issuing a final determination until a more specific and defensible critical habitat proposal can be written and an accurate and quantitative economic analysis be conducted.

Response: We are required to use the best available information in designating critical habitat. We are under a court order to complete the designation of critical habitat for the Great Lakes breeding population of the piping plover by April 30, 2001. We did solicit new biological data and public participation during the comment periods on the proposed rule and draft economic analysis. These comments have been taken into consideration in the development of the final economic analysis and this final determination. Furthermore, we will continue to monitor and collect new information and may revise the critical habitat designation in the future if new information indicates a change is needed, given our available funding and priorities.

(2H) Comment: The maps presented in the proposed rule are difficult to interpret and therefore will be difficult to use in planning efforts.

Response: The maps published in the Federal Register are provided for reference purposes to guide Federal agencies and other interested parties in identifying the general boundaries within which the critical habitat is located. While the verbal descriptions of each critical habitat unit are meant to provide a more precise reference for actual boundaries, we recognize the value to the public and resource managers of more detailed maps. Due to the time constraints of the court ordered deadline and our limited Geographic Information System (GIS) capabilities, we have not been able to produce more detailed maps to match our verbal descriptions. We have made it a priority to complete more detailed GIS maps of the designated areas and make these maps available for public use.

(3A) Comment: Designation of critical habitat will cause private property values to decline and will negatively affect businesses.

Response: The economic analysis indicates that designation of critical habitat for the Great Lakes breeding population on the piping plover will not have a significant economic impact. The economic analysis does acknowledge that the designation of critical habitat may have some effect on private property values. We believe that this short-term effect would occur from market uncertainty and public misperception of the impacts of the critical habitat designation on private land use. We also believe that this short-term effect on property values would diminish over time as the uncertainty and misperceptions are dispelled. We did not find supporting evidence during the preparation of the economic analysis to estimate or document this potential short-term effect on property values. The economic analysis determined that there will be an insignificant impact to businesses.

(3B) Comment: Several commenters expressed concern about a quick response to emergency maintenance activities, specifically emergency erosion control and environmental clean-up, and questioned whether emergency activities are exempt from consultation under section 7 of the Act.

Response: Emergency activities are not exempt from consultation under section 7 of the Act. However, the regulations at 50 CFR 402.05 allow for informal consultation where emergency circumstances mandate the need to consult in an expedited manner. Formal consultation must be initiated as soon as possible after the emergency is under control. In addition, programmatic consultations can be conducted prior to an emergency to address response activities which can be reasonably anticipated.

(3C) Comment: Some commenters voiced concern that they were not directly contacted for their opinions on the economic impacts of critical habitat designations or why their specific land parcels were not addressed.

Response: We did not feel it was necessary to contact every potential stakeholder in order for us to develop a draft economic analysis. Especially in light of the limited resources and time available to us, we believe that we were adequately able to understand the issues of concern to local communities based on public comments submitted on the proposed rule, on transcripts from public hearings, and from detailed discussions among our staff and with representatives from other Federal, State, Tribal, and local government agencies, as well as some landowners. When the draft economic analysis was completed, we reopened the comment period to request public comment, in particular on the adequacy of the economic analysis.

(3D) Comment: Several commenters expressed concern about the impact critical habitat will have on future development projects and the maintenance of existing structures.

Response: The designation of critical habitat does not necessarily restrict further development. Within critical habitat boundaries, Federal agencies must make special efforts to protect the important characteristics of these areas, therefore, if a proposed development project with a Federal nexus were to affect critical habitat of the piping plover, consultation under section 7 of the Act would be required. Because the Great Lakes population of the piping plover is listed as an endangered species under the Act, section 7 consultations would be required for development projects in areas with piping plovers, even if these areas are not designated critical habitat.

Existing human-made structures, such as buildings, parking lots, and boat ramps are not critical habitat, therefore, many maintenance projects on such structures will not affect critical habitat. Only those projects with a Federal nexus that modify the primary constituent elements to such a degree as to cause the habitat to be unsuitable for breeding piping plovers will be affected.

We understand the importance of beach nourishment and dredging for maintaining beach areas and harbors in the Great Lakes. Additionally, these activities, if conducted in an appropriate manner, may be beneficial to nesting piping plovers. These activities, however, do alter the habitat, and thus will likely require consultation. For these types of ongoing activities, programmatic consultations can be conducted to reduce the time necessary for annual consultations.

In those cases where consultation is required, we will work cooperatively with Federal agencies to see that necessary work can proceed in concert with the requirements of the Act to conserve the piping plover and its habitat. In cases where critical habitat has been designated for areas occupied by the piping plover, consultations would likely have been required, regardless of the designation of critical habitat.

(3E) Comment: A number of commenters expressed concern about the impact on recreational activities, tourism, and the possibility of restricted beach access within designated critical habitat.

Response: Most recreational activities on the majority of beaches within critical habitat will not be impacted by critical habitat designation. Since non-Federal activities are not affected by critical habitat designation, beach use would only be affected if a Federal agency funds, authorizes, or carries out an action that will result in a level of human use that precludes successful piping plover breeding. In those cases, we will work with the Federal agency involved to protect potential breeding habitat while having as minimal an effect as possible on people's enjoyment of the areas. On non-Federal lands, recreational beach activities such as walking, jogging, sunning, swimming, and picnicking will not be affected by the critical habitat designation.

The recovery of piping plovers in the Great Lakes area can be consistent with recreational and other economic activities. According to the 1996 National Survey of Fishing, Hunting, and Wildlife Associated Recreation, wildlife observation is one of the fastest growing outdoor activities. The presence of piping plovers on Michigan's beaches should continue to attract bird watchers who are excited to view this rare species in its natural habitat.

The following comments and responses involve issues related to the inclusion or exclusion of specific areas, or our methods for selecting appropriate areas for designation as critical habitat.

(4A) Comment: Several comments pointed out errors in mileages, locations, or descriptions of critical habitat units in the proposed rule.

Response: Corrections have been made in the final rule to reflect these comments, where appropriate.

(4B) Comment: A number of commenters identified specific areas that they thought should not be designated as critical habitat.

Response: Where site specific documentation was submitted to us providing a rationale as to why an area should not be designated as critical habitat, we evaluated that information in accordance with the definition of critical habitat pursuant to section 3 of the Act and made a determination as to whether modifications to the proposal were appropriate. Based on the comments we received, we excluded lands from the final designation that we determined to be nonessential to the conservation of the piping plover (i.e., areas that did not contain the primary constituent elements) or that were located within an approved HCP for the piping plover (refer to the “Summary of Changes from Proposed Rule” section for specific areas that were excluded). None of the proposed lands have been excluded from the final designation based on economic impacts. We included in the final designation those lands that we still consider essential to the recovery of the Great Lakes breeding population of piping plovers.

(4C) Comment: Multiple commenters recommended adding specific lands to critical habitat or further investigating additional areas for suitable habitat.

Response: During the Federal rule-making process for designating critical habitat, we may, based upon information received during the public comment period, remove proposed critical habitat lands from a final designation and refine proposed boundaries. However, according to section 4(b)(4) of the Act, we may not add new critical habitat units without first proposing these lands in the Federal Register and providing a public comment period. Therefore, potential critical habitat units that were not included in the proposal for the Great Lakes population of the piping plover are not designated as critical habitat in this final determination.

Some of the lands recommended for addition to critical habitat were not included in the proposal because we earlier concluded that these lands were not essential for the conservation of the species or did not meet the definition of piping plover critical habitat. After reassessing the requested additional lands on South Fox Island in Michigan, we continue to believe that these lands, at this time, do not meet the definition of critical habitat because they do not contain the primary constituent elements required by piping plovers.

Several of the other requested sites were excluded from the proposed designation because information on current habitat suitability was not available. These sites will require further investigation to determine whether they are essential to the conservation of the species. Data gathered following the publication of the proposed rule indicates that some of the requested lands contain suitable nesting habitat and may be essential to the conservation of the species. For example, we received a comment from the National Park Service requesting that a portion of Sleeping Bear Dunes National Lakeshore on South Manitou Island, Michigan be included in the designation because it is an important piping plover foraging area. We will continue to investigate potential piping plover critical habitat and may revise the critical habitat designation in the future if new information supports a change, and as available funding and other priorities allow. The data on additional sites that were provided to us during the comment period will be important in any future revisions to designated critical habitat.

(5A) Comment: Two people commented that we should also designate critical habitat for piping plovers that breed along the north Atlantic coast.

Response: We are currently required to complete a significant number of listing-related actions, pursuant to court orders and judicially approved settlement agreements. Complying with these court orders and settlement agreements will require the Service to spend nearly all of its listing and critical habitat funding for fiscal year 2001, and a substantial amount in fiscal year 2002. We are currently working to prioritize our critical habitat workload within the ESA listing budget allocated by Congress. The priority for designating critical habitat for the Atlantic Coast breeding population of piping plovers relative to other species and pending litigation has not yet been determined.

(5B) Comment: Piping plovers that nest at Lake of the Woods, Minnesota represent an important genetic link between the Great Lakes and Great Plains populations. Piping plovers at Lake of the Woods should be considered part of the endangered Great Lakes breeding population instead of part of the threatened Great Plains breeding population.

Response: We agree that the piping plovers that nest at Lake of the Woods, Minnesota represent an important link between the Great Lakes and Great Plains populations. Piping plovers that nest at Lake of the Woods are considered part of the Great Plains population because current data suggested that they are more closely associated with plovers in nearby Manitoba, Canada (Haig and Oring, 1988). Proposed critical habitat for piping plovers at Lake of the Woods will be considered in the proposal to designate critical habitat for the Great Plains piping plover, to be published on or before May 31, 2001.

(5C) Comment: Many commenters suggested additional protection for piping plovers, beyond the designation of critical habitat.

Response: Other conservation actions, besides the designation of critical habitat, are crucial to the recovery and survival of the piping plover. These other actions, including public education, predator control, law enforcement, and monitoring are addressed in the 1988 and 1994 Recovery Plans for Piping Plovers Breeding in the Great Lakes and Northern Great Plains. We are currently revising these recovery plans and the public will be provided the opportunity to comment on the draft revised plan.

(5D) Comment: One commenter stated that the effect of critical habitat should include situations that are not funded, authorized, or carried out by a Federal agency.

Response: Once designated, critical habitat has only one regulatory impact: under section 7(a)(2) of the Act, Federal agencies must, in consultation with the Service, ensure that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of critical habitat. By law, the effect of critical habitat does not extend to situations that do not involve a Federal nexus.

Based on a review of public comments received on the proposed determination of critical habitat for the Great Lakes breeding population of the piping plover, we re-evaluated our proposed designation of critical habitat for the piping plover. This re-evaluation resulted in the following changes that are reflected in this final determination.

Based on comments received on the proposal and site visits following the publication of the proposal, we removed three sites—Pensaukee Harbor and Peshtigo Point, Wisconsin and Erie Pier/Hearding Island, Minnesota— from this final critical habitat designation. We determined that these sites do not have, and are unlikely to develop, the features and habitat characteristics that are necessary to sustain the species and thus we no longer consider these areas to be essential for the conservation of the species.

The proposed 1 km (0.6 mi.) inland boundary was intended to incorporate dune blow-out areas and extensive dune-wetland systems. These inland areas provide important foraging habitat, as well as cobble pans between the dunes where plovers occasionally nest. Data gathered during the public comment period indicate that the majority of the dune systems within designated critical habitat do not extend further than 500 m (1,640 ft) inland from the normal high water line. Therefore, in this final determination, the inland boundary for all critical habitat units was changed from the proposed 1 km (0.6 mi) to 500 m (1,640 ft) inland from normal high water line.

Several comments pointed out corrections or clarifications to unit descriptions. We applied this corrected information to the final rule and adjusted the verbal descriptions of 10 units; White Fish Point to Grand Marais (MI-1), Seven Mile Point to Thornswift Nature Preserve (MI-5), Petoskey Sate Park (MI-6), Greenes Bay-Beaver Island (MI-10), High Island (MI-11), South Fox Island (MI-13), Esch Road to Sutter Road and Point Betsie (MI-16), Lighthouse Point to Cordwood Point (MI-20), Thompson's Harbor (MI-22), and Illinois Beach State Park/Waukegan Beach (IL-1). None of the changes resulted in any significant alteration of the units.

The boundaries of several of the units were refined to better reflect the areas that are essential to the conservation of the Great Lakes breeding population of the piping plover. The southeastern boundary of the unit at Long Island-Chequamegon Point, Wisconsin (WI-2) was moved northwestward approximately 5 km (3.1 mi) to the base of Chequamegon Point at the southern boundary of T48N R3W, section 1. This change was the result of discussions with the Bad River Band of Lake Superior Chippewa Indians and the Wisconsin Department of Natural Resources. The revised boundary excludes areas that do not have the required habitat features for nesting piping plovers and, therefore, are not essential to the conservation of the species. Additionally, the description of this unit given in the proposal, although inclusive of the entire peninsula, only calculated the length of the peninsula, not the perimeter shoreline of the peninsula. The calculation of the length of this unit as presented in this final determination includes the entire perimeter of the peninsula, and therefore appears to be larger, when in actuality it has been reduced by approximately 5 km (3.1 mi). The proposal states that the unit was 18 km (11.2 mi) long when, consistent with the verbal description and calculating both sides of the peninsula, it was actually 30.3 km (18.8 mi) long. Therefore, this unit is being reduced from 30.3 km (18.8 mi) to 25.3 km (15.7 mi) in this final determination.

The western boundary of the Indiana Dunes (IN-1) unit was moved approximately 549 meters (1,800 feet) eastward to the western boundary of Indiana Dunes National Lakeshore. This revised boundary excludes lands owned by the Northern Indiana Public Service Company (NIPSCO) that do not have the required habitat features for nesting piping plovers and, therefore, are not essential to the conservation of the species.

The southeastern boundary of the Pennsylvania unit (PA-1) at Gull Point Natural Area/Presque Isle State Park was moved approximately 2.3 km (1.4 mi) north. The refined boundary excludes the public beach area that does not have the required habitat features for nesting piping plovers and, therefore, is not essential to the conservation of the species. Additionally, the length of this unit was miscalculated in the proposed rule. The proposal states that the unit was 1.5 km (0.9 mi) long when, consistent with the verbal description, it was actually 8.3 km (5.1 mi) long. Therefore, this unit is being reduced from 8.3 km (5.1 mi) to 6.0 km (3.7 mi) in this final determination.

In our proposed determination of critical habitat for the Great Lakes population of the piping plover, we asked for public comment on the appropriate relationship between approved HCPs and designated critical habitat. After considering the comments we received, we have chosen to evaluate areas covered by an approved HCP for the piping plover for exclusion under the benefits-balancing test found in section 4(b)(2) of the Act. This section allows us to exclude areas upon determination that the benefits of excluding the area outweigh the benefits of including the are in the critical habitat designation, provided the exclusion would not result in the extinction of the species. Our application of this balancing test to lands covered by HCPs for the piping plover is described in detail in the preamble.

Presently, one approved HCP exists for the piping plover in the Great Lakes region. The Magic Carpet Woods Association HCP covers approximately 792 m (2,600 ft) of shoreline within the proposed Cathead Bay critical habitat unit in Leelanau County, Michigan. This plan addresses the piping plover as a covered species and provides conservation management and protection for the species. We evaluated this plan and determined that the conservation management measures and protection afforded to the piping plover are sufficient to assure its conservation on the involved lands. Among other features, the plan requires residences be set back from the beach, biological monitoring, the presence of a piping plover steward, containing garbage, and restraining pets. Therefore, we have excluded the lands covered by the Magic Carpet Woods Association HCP from the final determination of critical habitat for the Great Lakes breeding population of the piping plover.

Section 4(b)(2) of the Act requires us to designate critical habitat on the basis of the best scientific and commercial data available and to consider the economic and other relevant impacts of designating a particular area as critical habitat. We may exclude areas from critical habitat upon a determination that the benefits of such exclusions outweigh the benefits of specifying such areas as critical habitat. We cannot exclude such areas from critical habitat when such exclusion will result in the extinction of the species.

The economic analysis must examine the incremental economic effects of the critical habitat designation above those effects of the listing. Economic effects are measured as changes in national income, regional jobs, and household income. A draft analysis of the economic effects of the critical habitat designation for the Great Lakes breeding population of the piping plover was prepared (Industrial Economics, Incorporated, 2000) and made available for public review (September 19 to November 20, 2000; 65 FR 56530 and 65 FR 58258). We also completed a final economic analysis that incorporated public comments, information gathered since the draft analysis, and changes to the critical habitat designation. The analysis found that there would be an economic impact from the designation that would vary on a situational level, and that most of the impact would come in the form of new section 7 consultations in unoccupied habitat units. In the economic analysis, we estimate that, over the next ten years, the total costs by landowners associated with consultation and technical assistance attributable to this rulemaking will range between $314,200 and $592,000. Our economic analysis also recognizes that there may be costs from delays associated with reinitiating previously completed consultations after the critical habitat designation is made final. There may also be economic effects due to the reaction of the real estate market to critical habitat designation, as real estate values may be lowered due to a perceived increase in the regulatory burden. However, we believe this impact will be minor and short-term. We have determined that these economic impacts do not warrant excluding any areas from the designation.

A copy of the final economic analysis is included in our administrative record and may be obtained by contacting our office (see ADDRESSES section).

This document has been designated as significant and reviewed by the Office of Management and Budget (OMB), in accordance with Executive Order 12866. OMB makes the final determination of significance under Executive Order 12866.

(a) This rule will not have an annual economic effect of $100 million or more or adversely affect an economic sector, productivity, jobs, the environment, or other units of government. The Great Lakes breeding population of piping plover was listed as an endangered species in 1985. In fiscal years 1992 through 2000, we conducted only one formal section 7 consultation with other Federal agencies to ensure that their actions would not jeopardize the continued existence of the piping plover in the Great Lakes watershed. We have also issued one section 10(a)(1)(B) incidental take permit for an entity that has prepared an HCP involving piping plover habitat.

Approximately 236 km (146 mi) of the areas encompassing proposed critical habitat for the Great Lakes breeding population of piping plovers are currently unoccupied by piping plovers. The remaining 89 km (55 mi) of the total designated critical habitat are currently occupied by piping plovers. Under the Act, critical habitat may not be adversely modified or destroyed by a Federal agency action; it does not impose any restrictions on non-Federal entities unless they are conducting activities funded or otherwise sponsored or permitted by a Federal agency (see Table 3 below). Section 7 requires Federal agencies to ensure that they do not jeopardize the continued existence of the species.

Based upon our experience with the species and its needs, we conclude that any Federal action or authorized action that could potentially cause adverse modification of designated occupied critical habitat would currently be considered “jeopardy” under the Act. Accordingly, the designation of areas within the geographic range occupied by the piping plover will not likely have any incremental impacts on what actions may or may not be conducted by Federal agencies or non-Federal persons that receive Federal authorization or funding. The designation of areas outside the geographic range already occupied by the species may have incremental impacts on what activities may or may not be conducted by Federal agencies or non-Federal persons that receive Federal authorization or funding. However, our analysis did not identify any significant incremental effects. Non-Federal persons that do not have a Federal “sponsorship” of their actions are not restricted by the designation of critical habitat, although they continue to be bound by the provisions of the Act concerning “take” of the species.

(b) This rule will not create inconsistencies with other agencies' actions. As discussed above, Federal agencies have been required to ensure that their actions do not jeopardize the continued existence of piping plovers since the listing in 1985. The prohibition against adverse modification of critical habitat is not expected to impose any substantial additional restrictions to those that currently exist. Because of the potential for impacts on other Federal agency activities, we will continue to review this action for any inconsistencies with other Federal agency actions.

(c) This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. Federal agencies are currently required to ensure that their activities do not jeopardize the continued existence of the species, and, as discussed above, we do not anticipate that the adverse modification prohibition (resulting from critical habitat designation) will have any significant incremental effects in areas of occupied habitat. The critical habitat designation may have some additional effects on the unoccupied areas of proposed critical habitat, but we expect these to be minor.

(d) OMB has determined that this rule may raise novel legal or policy issues and, as a result, this rule has undergone OMB review.

In the economic analysis, we determined that designation of critical habitat will not have a significant effect on a substantial number of small entities. As discussed under Regulatory Planning and Review above, this designation of critical habitat for the Great Lakes breeding population of the piping plover is not expected to have a significant economic impact. As indicated on Table 1 (see Critical Habitat Designation section), we designated property owned by Federal, State, Tribal, and local governments and private property.

Within these areas, the types of Federal actions or authorized activities that we have identified as potential concerns are:

(1) Regulation of activities affecting waters of the United States by the U.S. Army Corps of Engineers under section 404 of the Clean Water Act;

(2) Regulation of water flows, water delivery, and diversion by Federal agencies;

(3) Sale, exchange, or lease of lands owned by a Federal agency;

(4) Road construction and maintenance and right-of-way designation;

(5) Funding of low-interest loans to facilitate the construction of low-income housing by the Department of Housing and Urban Development;

(6) Hazard mitigation and post-disaster repairs funded by the Federal Emergency Management Agency;

(7) Promulgation of air and water quality standards under the Clean Air Act and the Clean Water Act and the cleanup of toxic waste and superfund sites under the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response, Compensation, and Liability Act by the U.S. Environmental Protection Agency;

(8) Issuance of Endangered Species Act section 10(a)(1)(B) permits by the Fish and Wildlife Service; and

(9) Activities funded, carried out, or authorized by any Federal agency.

Some of these activities sponsored by Federal agencies within the critical habitat areas are carried out by small entities (as defined by the Regulatory Flexibility Act) through contract, grant, permit, or other Federal authorization. As discussed above, these actions are largely required to comply with the listing protections of the Act, and the designation of critical habitat is not anticipated to have significant additional effects on these activities in areas of critical habitat occupied by the species. Designation of critical habitat in areas that are unoccupied by this species will not likely result in significant additional effects because only actions involving a Federal nexus will be affected.

For actions on non-Federal property that do not have a Federal connection (such as funding or authorization), the current restrictions concerning take of the species remain in effect, and this final determination will have no additional restrictions.

In the economic analysis, we determined that designation of critical habitat will not cause (a) any effect on the economy of $100 million or more, (b) any increases in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions, or (c) any significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. Refer to the final economic analysis for a discussion of the effects of this determination.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ):

(a) This rule will not “significantly or uniquely” affect small governments. A Small Government Agency Plan is not required. Small governments will be affected only to the extent that any of their actions involving Federal funding or authorization must not destroy or adversely modify the critical habitat in areas where they have not previously undergone consultation to avoid jeopardizing the species.

(b) This rule will not produce a Federal mandate of $100 million or greater in any year, that is, it is not a “significant regulatory action” under the Unfunded Mandates Reform Act. The designation of critical habitat imposes no obligations on State or local governments.

In accordance with Executive Order 12630, this rule does not have significant takings implications, and a takings implication assessment is not required. This determination will not “take” private property and will not alter the long-term value of private property. As discussed above, the designation of critical habitat affects only Federal agency actions. The rule will not increase or decrease the current restrictions on private property concerning take of the piping plover. Due to current public knowledge of the species protection, the prohibition against take of the species both within and outside of the designated areas, and the fact that critical habitat provides no incremental restrictions, we do not anticipate that property values will be affected by the critical habitat designation. While real estate market values may temporarily decline following designation, due to the perception that critical habitat designation may impose additional regulatory burdens on land use, we expect any such impacts to be short term. Additionally, critical habitat designation does not preclude development of HCPs and issuance of incidental take permits. Landowners in areas that are included in the designated critical habitat will continue to have the opportunity to utilize their property in ways consistent with the conservation of the piping plover.

In accordance with Executive Order 13132, the rule does not have significant Federalism effects. A Federalism assessment is not required. In keeping with Department of the Interior and Department of Commerce policy, the Service requested information from and coordinated development of this critical habitat proposal with appropriate State resource agencies in Minnesota, Wisconsin, Michigan, Illinois, Indiana, Ohio, Pennsylvania, and New York, as well as during the listing process. We will continue to coordinate any future designation of critical habitat for the Great Lakes piping plover with the appropriate State agencies. The designation of critical habitat for the piping plover imposes few additional restrictions to those currently in place and, therefore, has little incremental impact on State and local governments and their activities. The designation may have some benefit to these governments in that the areas essential to the conservation of the species are more clearly defined, and the primary constituent elements of the habitat necessary for the conservation of the species are specifically identified. This definition and identification may assist these local governments in long-range planning (rather than waiting for case-by-case section 7 consultations to occur).

In accordance with Executive Order 12988, the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. We designate critical habitat in accordance with the provisions of the Act. The determination uses standard property descriptions and identifies the primary constituent elements within the designated areas to assist the public in understanding the habitat needs of the Great Lakes breeding population of piping plover.

This rule does not contain any information collection requirements for which Office of Management and Budget approval under the Paperwork Reduction Act is required.

We have determined that an Environmental Assessment and/or an Environmental Impact Statement as defined by the National Environmental Policy Act of 1969 need not be prepared in connection with regulations adopted pursuant to section 4(a) of the Endangered Species Act as amended. A notice outlining our reason for this determination was published in the Federal Register on October 25, 1983 (48 FR 49244). This final determination does not constitute a major Federal action significantly affecting the quality of the human environment.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Government” (59 FR 22951), Executive Order 13175, and the Department of the Interior's requirement at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a Government-to-Government basis. We believe that certain Tribal lands are essential for the conservation of the piping plover because they support essential populations and habitat. We coordinated with the Bad River Band of Lake Superior Chippewa Indians in determining which Tribal lands constitute critical habitat, and have included that area in the critical habitat designation.

A complete list of all references cited in this proposed rule is available upon request from the Fort Snelling Regional Office (see ADDRESSES section).

The primary author of this notice is Laura J. Ragan (see ADDRESSES section).