Washington The Washington Department of Ecology submitted data consisting of paired samples of fecal coliform and enterococci measurements collected in Puget Sound, the Strait of Juan Ddel Fuca, and the Pacific Ocean embayments. The Department of Ecology considers this information as sufficient to demonstrate that use of the State's fecal coliform criterion of 14/ 100 ml ensures that enterococci concentrations are below the 1986 bacteria criteria, and requested that EPA consider the State's fecal coliform criterion to be as protective of human health as the 1986 bacteria criteria. As discussed in section V. A. 1 of the preamble, EPA reviewed these data and has determined that the Washington fecal coliform criterion of 14/ 100 ml is as protective of human health as the 1986 bacteria criteria. The Washington fecal coliform criterion applies to all marine waters with primary contact recreation use, and thus applies to all coastal recreation waters.

Therefore, Washington is not included in the rule.

Text Was Moved From Here: 1 Maine EPA is also making a minor change with respect to including Maine in today's final rule.

As explained in the preamble to the proposal ( 69 FR 41733), EPA intended to exclude Maine's Class SA waters from coverage under the rule; however, EPA failed to list Maine's Class SA waters as excluded in the regulatory text of 40 CFR 131.41( e)( 2). EPA has corrected this Page 69 of 102 omission in today's final rule.

Text Moved Here: 1 Other States EPA identified two other States or Territories that, at the time of proposal, intended to adopt EPA's 1986 bacteria criteria by September 30, 2004. These were Illinois and the Virgin Islands. However, neither Illinois nor the Virgin Islands adopted the criteria and received EPA approval as of the signature of today's rule.

End Of Moved Text C. Under What Conditions Will States and Territories Be Removed from Today's Rule?

State and Territorial standards for bacteria approved by EPA pursuant to Clean Water Act sections 303( c) and 303( i) will be in effect for Clean Water Act purposes, and the Federal criteria for 40 CFR 131.41 will no longer apply. EPA recognizes that once it approves the water quality standards of the State or Territory, the Code of Federal Regulations will still include a reference to the State in 40 CFR 131.41 until EPA formally withdraws the State or Territory from the Federal rule, and thereby the Code of Federal Regulations. However, the State and Territorial standards for bacteria approved by EPA pursuant to Clean Water Act sections 303( c) and 303( i)

will be in effect for Clean Water Act purposes ( and not the Federal criteria at 40 CFR 131.41)

between the time EPA approves the State standards and formal withdrawal of the State or Territory from the rule. Page 70 of 102 A State or Territory may adopt and submit partial water quality standards for EPA's review and approval under today's rule. EPA envisions two types of partial water quality standards submittals with different results. If a State adopts and submits water quality standards that meet all the requirements discussed in today's rule but the standards apply only to a portion of the State's coastal recreation waters, EPA expects to approve the State standards for the coastal recreation waters to which they apply, and today's Federal standards would continue to apply to all coastal recreation waters that are not addressed in the submittal. The combination of the approved State and Federal standards serve to meet the requirements of Clean Water Act section 303( i). If a State adopts and submits standards for all of its coastal recreation waters but the standards do not satisfy all of the considerations described in today's rule as necessary for EPA to make a determination that the State standards are as protective of human health as the 1986 bacteria criteria, EPA expects to disapprove the entire the submittal and today's Federal standards would continue to apply to the State's coastal recreation waters. For example, a State maymight adopt water quality standards that contain only a geometric mean for marine waters of 35/ 100 ml for enterococci and not a single sample maximum provision. This would not be sufficient to satisfy section 303( i). EPA anticipates that it would be administratively unworkable to approve State standards in piecemeal fashion and to supplement piecemeal State standards with components of today's rule, as in the example of a State that hasadopts a State geometric mean andbut must still retain a Federal single sample maximum for its coastal recreation waters.

VI. Response to Additional Significant Public Comments EPA has prepared a Comment Response Document, which addresses the comments that EPA received and is included in the docket for today's rule. Below, EPA provides a summary of Page 71 of 102 its responses to four additional categories of significant comments.

A. 1986 Bacteria Criteria Some commenters raised concerns about EPA's 1986 bacteria criteria. The bulk of the comments questioned the reliability of the studies on which EPA based the criteria. Some remarked that the studies evaluated in the criteria document did not appropriately select test sites because the test sites were all located on the East Coast and therefore may not represent conditions on the West Coast; the test sites had only one source of pollution ( human); and no control sites were used. In addition, commenters characterized the data as anecdotal rather than clinical in nature ( e. g., blood and stool samples) and suggested that the studies did not ensure that the reported illnesses were due to pathogens relating to bathing in the water. Others questioned EPA's chosen risk levels. One commenter suggested other possible indicators. Others commented on the lack of EPA follow up epidemiological studies since 1986.

EPA acknowledges these comments, but notes that Clean Water Act section 303( i)

requires States and Territories with coastal recreation waters to adopt water quality criteria for bacteria as protective of human health as the criteria published by EPA under Clean Water Act section 304( a). Section 303( i) was added to the Clean Water Act in 2000 by the BEACH Act.

At the time the BEACH Act was enacted, the current Clean Water Act section 304( a) criteria were EPA's 1986 bacteria criteria because that isthese are EPA's only currently recommended bacteria criteria for protection of primary contact recreation waters. The legislative history makes it clear that Congress recognized that EPA's 1986 bacteria criteria have flaws, but also that Congress wanted States to adopt standards based on them by April 10, 2004, despite those flaws,

presumably because Congress thought the 1986 bacteria criteria are better than what it Page 72 of 102 characterized as " outdated" criteria used by some States. ( See H. Rep. No. 106 98, at 6 ( 1999);

see generally S. Rep. No. 106 366 ( 2000) and H. Rep. No. 106 98.)

EPA had reviewed its original studies supporting its recommended 1986 water quality criteria for bacteria and the literature on human health research conducted since EPA completed the original studies of health effects associated with swimming in marine and freshwater, as discussed in on pages 10 13 of the Implementation Guidance for Ambient Water Quality Criteria for Bacteria ( EPA 823 B 02 003, May 2002 Draft) . Based on these reviews, EPA has confirmed that the 1986 EPA recommended water quality criteria for bacteria are protective of human health against acute gastrointestinal illness.

The epidemiological studies used to develop the criteria were themselves peer reviewed.

The marine studies were peer reviewed in the Journal of the American Public Health Association.

EPA's Office of Research and Development reviewed the freshwater studies. The Harvard School of Public Health evaluated the epidemiology test protocol for both fresh and marine studies, and the University of Pittsburgh Center for Excellence provided an independent review of the results of the epidemiology studies. Finally, the 1986 bacteria criteria were reviewed by the public when EPA published a Federal Register notice concerning the criteria ( 49 FR 21987, May 24, 1984).

While Congress directed in Clean Water Act section 303( i) that, by April 9, 2004, States and Territories adopt criteria as protective as EPA's current criteria, Congress also recognized that " EPA's 1986 criteria need to be updated to improve the scientific basis for identifying pathogens in coastal waters." S. Rep. No. 106 366, at 2. To address this concern, Congress amended Clean Water Act section 304( a) to require EPA to " publish [ within five years of Page 73 of 102 enactment of the BEACH Act] new or revised water quality criteria for pathogens and pathogen indicators ( including a revised list of testing methods, as appropriate), based on the results of the studies conducted . . . for the purpose of protecting human health in coastal recreation waters."

See Clean Water Act section 304( a)( 9). Thus, while Congress recognized that the 1986 bacteria criteria need improvement, Congress still required States and Territories to adopt water quality standards as protective of human health as the 1986 bacteria criteria. EPA is currently conducting epidemiological studies on potential health risks resulting from exposure to pathogens or pathogen indicators in coastal recreation waters, as required under this section of the Clean Water Act. Once EPA publishes these new criteria, EPA expects that States and Territories will begin to adopt water quality standards as protective of human health as the new criteria for coastal and Great Lakes recreation waters, as required by Clean Water Act section 303( i)( 1)( B).

B. Economics Some commenters noted that, if the rule imposes single sample maximums as " not to

beexceeded values, the geometric mean component of the criteria would be significantly different from the geometric mean values in most State current fecal coliform bacteria criteria for recreation. For fecal coliform criteria to protect recreational uses, most State criteria include a geometric mean value and a threshold value not to be exceeded in more than 10% of the samples.

Some commenters state that there will be a substantially largesubstantial cost difference to regulated entities if the rule imposes single sample maximums for E. coli or enterococci as "

notto be exceeded" values, noting that EPA's economic analysis in the proposal does not address the cost of controlling discharges from combined sewer overflows, sanitary sewer overflows, and municipal separate storm sewer systems to meet such single sample maximums, and that EPA's Page 74 of 102 cost estimates for controlling these sources in other regulatory and policy actions are not based on a single sample maximum as a never to be exceeded criterion for Clean Water Act purposes.

Today's rule does not treat single sample maximums as a requirement that may never be exceeded in all instances. Single sample maximums are values that indicate, with a certain degree of confidence, that a waterbody may exceed the geometric mean. The State can collect additional data on a receiving water if it believes that the violation of the single sample maximum does not indicate violation of the geometric mean, as described in the preamble to today's rule.

For its economic analysis, EPA evaluated the potential controls for publicly owned treatment plants and industrial facilities likely to discharge bacteria to meet permit limits based on the single sample maximums as never to be exceeded values to provide a conservatively high estimate of cost. In reality, States and Territories have flexibility in implementing the criteria in National Pollutant Discharge Elimination System permits. EPA also assumed that none of the States covered by the rule had adopted E. coli or enterococci as the applicable water quality standard whereas several of the States in today's rule have water quality standards for E. coli or enterococci already in place for some of their coastal recreation waters. This also led to a higher estimate of cost than may actually be incurred. EPA addresses discharges of bacteria from municipal separate storm sewers, combined sewer overflows, sanitary sewer overflows, and nonpoint sources ( e. g., agriculture) to coastal waters in existing regulations and policies, and has tallied potential control costs to comply with those regulations and policies as part of analyses for those actions. In general, the best management practices or treatment controls for wet weather discharges that are designed to meet fecal coliform standards in a waterbody are also the best management practices or treatment controls used to address E. coli and enterococci. Because of Page 75 of 102 the substantial variability in bacterial indicators and the site specific effectiveness of control measures, EPA is not able to determine at this time if additional measures will ultimately be necessary to meet criteria based on the new indicators. Compliance with pathogen standards is best achieved through an adaptive management approach based on cost effective management practices and control measures coupled with on going monitoring and revision of control plans as necessary.

C. Analytical Methods EPA received a few comments on the topic of analytical methods. One commenter expressed concern that EPA has not published EPA approved analytical methods for measuring enterococci and E. coli in effluent. EPA recognizes that it has not yet published analytical methods for measuring enterococci and E. coli in effluents. EPA published its methods for measuring enterococci and E. coli in ambient waters on July 21, 2003, and is now in the process of proposing methods for measuring these pathogen indicators in effluent. EPA has completed its inter laboratory study of method 1600 for enterococci and method 1603 for E. coli in secondary treated effluents, and has determined that the variability found in this study support publication of a proposed method for effluents. EPA is moving expeditiously to promulgate these methods.

Three commenters noted that the inter laboratory study for enterococci and E. coli methods discussed above did not address pulp and paper effluents, and that these effluents are suspected of containing E. coli and enterococci independent of fecal matter. As a result, the commenters suggest that EPA complete validation studies of enterococci and E. coli methods for pulp and paper effluents before requiring States to implement the criteria in National Pollutant Discharge Elimination System permits for pulp and paper facilities. EPA disagrees that it must Page 76 of 102 complete additional validation studies before States use the criteria for permits. EPA has completed its inter laboratory validation for EPA Methods 1600 and 1603 for effluents, and is in the process of proposing these methods. In addition, EPA is currently completing its interlaboratory validation for EPA Methods 1103.1 and 1106.1 in effluents, and intends to propose them after the validation process is completed. EPA did not specifically use pulp and paper effluent matrices in the study. EPA method validation studies typically include several representative matrices and are not intended to include every potential effluent matrix to which a method may be applicable. In addition, EPA notes that its National Pollutant Discharge Elimination System regulations do not require that compliance monitoring for National Pollutant Discharge Elimination System permits be based on EPA approved methods. 40 CFR 122.41( j)( 4)

provides that monitoring results must be conducted according to test procedures approved under 40 CFR Part 136 unless other test procedures have been specified in the permit. States implementing the criteria in National Pollutant Discharge Elimination System permits may thus specify some other analytical method that the permittee is to use for compliance monitoring. Of course, any such method must be scientifically defensible, which usually means that it has been tested and verified by some other recognized standard setting or method development body.

Permittees who believe that a particular method is not appropriate or reliable for their effluent may present documentation of this concern to the permitting authority for consideration in determining compliance monitoring requirements.

D. Effective Date Section 553 of the Administrative Procedure Act provides that a substantive rule shall be published not less than 30 days before its effective date, except under certain circumstances. EPA Page 77 of 102 is promulgating today's rule with an effective date of 30 days after publication in the Federal Register in order to make the water quality criteria effective as soon as possible and available for use in assessing beach safety and for other Clean Water Act purposes. This will serve to protect human health at coastal recreation waters.

EPA received two comments on this issue. One commenter requested that EPA delay promulgating the rule until July 2005 and another commenter suggested that EPA delay the effective date for 90 days so that a State could complete its own promulgation of water quality standards based on the 1986 bacteria criteria. EPA disagrees that it should allow more than 30 days because this would delay the time at which States and Territories will begin using today's water quality criteria to govern decisions about opening and closing beaches and for other Clean Water Act purposes. EPA understands the interest of the commenters in having their State standards serve as the effective standards for Clean Water Act purposes. If a State adopts, and EPA approves, standards satisfying Clean Water Act section 303( i) shortly after the effective date of this rule, the State criteria will immediately replace the criteria in today's rule for Clean Water Act purposes within the State, consistent with 40 CFR 131.41( d)( i). EPA does not expect that a short window during which Federal standards are in effect will unduly disrupt on going State water quality standards programs. Therefore, EPA is making the rule effective 30 days after publication in the Federal Register.

VII. Alternative Regulatory Approaches and Implementation Mechanisms States and Territories have considerable discretion in designating uses. A State or Territory may find that changes in use designations are warranted. EPA will review any new or revised use designations adopted by States or Territories for coastal recreation waters covered by Page 78 of 102 this rule to determine if the standards meet the requirements of the Clean Water Act and implementing regulations. In adopting recreation uses, the States and Territories may wish to consider additional categories of recreation uses. If States and Territories change the designated use of a waterbody consistent with Clean Water Act section 303( c) and the regulations at 40 CFR Part 131, such that they are no longer designated for swimming, bathing, surfing, or similar water contact activities, then the waterbody would not be covered by the Clean Water Act definition of " coastal recreation waters" or this rule.

EPA reminds the States and Territories that they must conduct use attainability analyses as required by 40 CFR 131.10( g) when adopting water quality standards that do not include the uses specified in Clean Water Act section 101( a)( 2) or with subcategories of the designated uses specified in Clean Water Act section 101( a)( 2) that require less stringent criteria ( see 40 CFR 131.10( j)), than those currently in effect.

VIII. Economic Analysis These water quality standards may serve as a basis for development of National Pollutant Discharge Elimination System permit limits. Many of the affected jurisdictions ( i. e., States and Territories) are the National Pollutant Discharge Elimination System permitting authorities, which retain considerable discretion in implementing standards. EPA evaluated the potential costs to National Pollutant Discharge Elimination System dischargers in affected jurisdictions associated with State and Territorial implementation of today's standards. This analysis is documented in `` Economic Analysis for Final Water Quality Standards for Coastal Recreation Waters,'' which can be found in the record for this rulemaking.

Any National Pollutant Discharge Elimination System permitted facility that discharges to Page 79 of 102 waterbodies affected by this rule could potentially incur compliance costs. The types of affected facilities may include industrial facilities and publicly owned treatment works ( POTWs) discharging sanitary wastewater to surface waters ( i. e., point sources). In addition, EPA addresses discharges of bacteria from municipal separate storm sewer systems, combined sewer overflows, and sanitary sewer overflows to coastal waters in existing regulations and policies, and has tallied potential control costs as part of the analyses for those actions. EPA expects that States and municipalities will continue to use the same types of controls to come into compliance with the revised criteria as are currently used for compliance with existing regulations and policies. Available evidence suggests that if discharges are controlled in such a way that fecal coliform criteria are met, it is likely that enterococci and E. coli criteria would also be met, and there would not be an increase in impaired waters, resulting in additional Total Maximum Daily Loads, though not enough is known about the relationship between sources, controls, and the various indicators to conclude this with any certainty at this time. EPA did not evaluate the costs of this rule to Concentrated Animal Feeding Operations because the regulations for Concentrated Animal Feeding Operations prohibit discharges except in unusual circumstances ( i. e., very large storms) and therefore those entities are unlikely to incur any additional costs as a result of today's rule. EPA did not evaluate the potential for costs to nonpoint sources, such as agricultural runoff. Finally, EPA did not attempt to quantify the potential benefits of the rule.

EPA recognizes that a State or Territory may decide to require controls for nonpoint sources ( e. g., agricultural runoff). However, it is difficult to model and evaluate the potential costs impacts of this rule to those sources because they are intermittent, highly variable, and occur under different hydrologic or climatic conditions than continuous discharges from industrial and municipal Page 80 of 102 facilities, which EPA evaluates under critical low flow or drought conditions. Also, data on instream and discharge levels of bacteria after States have implemented controls to meet current water quality standards based on fecal coliform are not available. Therefore, trying to determine which sources would not achieve standards based on E. coli or enterococci after complying with existing regulations and policies may not be possible, and would be extremely time and resource intensive. Finally, it is likely that controls needed to meet existing criteria ( assumed for the purpose of costing to be fecal coliform for all States covered by the rule) would also address water quality problems indicated by criteria for E. coli or enterococci.

A. Identifying Affected Facilities EPA identified approximately 734 point source facilities that may be affected by the rule. Of these potentially affected facilities, 306 are classified as major dischargers, and 428 are minor dischargers. EPA did not include general permit facilities in its analysis because data for such facilities are extremely limited, and flows are usually negligible. Furthermore, EPA could not determine if any of these facilities with general permits actually discharge to the affected water bodies because facility location information is not available in EPA's Permit Compliance System database.

Of the facilities located in jurisdictions included in the rule, EPA evaluated that subset of facilities with individual permits that discharge within two miles of coastal waters or the Great Lakes may be affected. EPA identified these facilities by relating facility information to the potentially affected waters using Geographic Information System software. EPA also assumed that only wastewater treatment plants or facilities with similar effluent characteristics ( i. e., facilities having the potential to discharge bacteria in the form of fecal matter) may be affected. For those Page 81 of 102 facilities for which latitude/ longitude data are not included in the Permit Compliance System, EPA included only facilities for which the receiving waterbody name in the Permit Compliance System indicates a coastal water ( e. g., Pacific Ocean, Lake Erie). Table 5 summarizes these potentially affected facilities by type and category.

Table 5. Potentially Affected Facilities1 Category Number of Facilities Total Major2 Minor Municipal Other3 Coastal 242 233 100 575 Great Lakes 64 75 20 159 Total 306 308 120 734 1. Facilities from States and Territories included in the rule that discharge within two miles of coastal waters or the Great Lakes.

2. No major industrial facilities are affected by the rule. However, 4 other facilities ( SIC codes 9711 and 9999) are included because their names indicate that they are wastewater treatment plants.

3. Includes the following standard industrial classifications: eating places ( 5812), drinking places ( 5813), operators of nonresidential buildings ( 6512), operators of apartment buildings ( 6513), operators of dwellings other than apartment buildings ( 6514), operators of residential mobile home sites ( 6515), hotels and motels ( 7011), recreational vehicle parks and campsites ( 7033), organization hotels and lodging houses ( 7041), physical fitness facilities ( 7991),

amusement and recreation services ( 7999), skilled nursing care facilities ( 8051), general medical and surgical hospitals ( 8062), elementary and secondary schools ( 8211), colleges, universities, and professional schools ( 8221),

civic, social, and fraternal associations ( 8641), private households ( 8811). Also includes the following SICs if the facility name suggests that they may discharge sanitary waste: operative builders ( 1531), sanitary services, not elsewhere classified ( 4959), real estate agents and managers ( 6531), business associations ( 8611), religious organizations ( 8661), services not elsewhere classified ( 8999), air and water resource and solid waste management ( 9511), national security ( 9711), and nonclassifiable establishments ( 9999). Page 82 of 102 B. Method for Estimating Potential Compliance Costs To estimate costs, EPA evaluated the 15 major municipal facilities with design flows greater than 120 mgd, thus ensuring that the facilities with the potential for the largest costs would be evaluated. For the remaining facilities, EPA evaluated a sample of facilities to represent discharger type and category.

The Permit Compliance System does not contain E. coli or enterococci effluent data for any of the sample facilities. Therefore, to evaluate potential costs associated with the E. coli criteria,

EPA assumed that 100% of the fecal coliform measured at the sample facilities is E. coli because E.

coli is a type of fecal coliform. EPA assumed that all potentially affected facilities need effluent limits that are required to meet both the applicable geometric mean and single sample maximum values promulgated in today's rule. Based on the last 3 years of data, EPA thus estimated that facilities with average monthly effluent levels exceeding a geometric mean of 126/ 100 ml, or maximum daily levels exceeding 235/ 100 ml, would most likely need treatment controls to meet potential permit limits based on today's rule.

Enterococci are fecal bacteria in the fecal streptococcus group, and their relationship to fecal coliform bacteria is uncertain. Therefore, for coastal facilities, EPA used data and information in the literature regarding the ratio of fecal coliform to enterococci in untreated sewage, and the inactivation of both of these bacteria at minimum disinfection levels, to identify the concentrations of fecal coliform ( as related to enterococci) that may indicate a need for controls. Data in the literature indicate that the ratio of fecal coliform to fecal streptococcus in untreated sewage ranges from about 4 to 28. EPA used the most conservative ( i. e., erring on the side of overestimating costs) ratio of 4 ( i. e., fecal coliform levels are 4 times fecal streptococcus levels) to estimate the Page 83 of 102 fecal coliform levels at which facilities would need treatment to comply with the enterococci criteria. A ratio of 4 translates to fecal coliform levels of 140 fecal coliform per 100 ml ( 4

35 =

140/ 100 ml); however, for consistency with the Great Lakes analysis, EPA estimated costs based on meeting a more stringent value of 126 fecal coliform per 100 ml. In addition, EPA assumed that coastal facilities with maximum fecal coliform effluent values exceeding 235 colonies per 100 ml would need treatment controls ( even though 235 / 4 = 59, which is more stringent than the single sample maximum value of 104 in the final rule).

Experiences from four facilities currently having effluent limitations to meet E. coli and enterococci criteria, as well as the current fecal coliform criteria, suggest that chlorination processes can be upgraded or adjusted to treat the levels of bacteria necessary for compliance with effluent limitations based on today's rule. Therefore, EPA estimated that optimization of existing disinfection processes would enable the sample facilities to comply with the rule. Process optimization usually involves process analysis and process modifications, and EPA's cost estimates include both capital and operating and maintenance costs.

C. Results Based on the results for the 15 facilities with flows greater than 120 mgd, and extrapolating the sample results to the remaining potentially affected facilities, EPA estimated a total annual cost of approximately $ 20 million ($ 13 million for coastal facilities, and $ 7 million for Great Lakes facilities). EPA estimates that approximately 70 major and 20 minor permittees could incur control costs as a result of permit modifications to include limits based on the criteria in today's rule.

IX. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review Page 84 of 102 Under Executive Order 12866, ( 58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is " significant" and therefore subject to Office of Management and Budget ( OMB) review and the requirements of the Executive Order. The Order defines " significant regulatory action" as one that is likely to result in a rule that may:

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

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

( 3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or ( 4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, it has been determined that this rule is a " significant regulatory action" because the rule raises novel policy issues arising out of the BEACH Act. action." As such, this action was submitted to OMB for review. Changes made in response to OMB suggestions or recommendations are documented in the public record.

B. Paperwork Reduction Act This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.). It does not include any information collection,

reporting, or record keeping requirements. Page 85 of 102 Burden means the total time, effort or financial resources expended by persons to generate,

maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information;

and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR Part 9.

C. Regulatory Flexibility Act The Regulatory Flexibility Act ( RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 ( SBREFA), 5 U. S. C. 601 et seq., generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations and small governmental jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: ( 1) a small business according to RFA default definitions for small business ( based on Small Business Administration size standards); ( 2) a small governmental jurisdiction that is a government Page 86 of 102 of a city, county, town, school district or special district with a population of less than 50,000; and ( 3) a small organization that is any not for profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. As discussed below, these water quality standards do not directly apply to any discharger, including small entities.

Clean Water Act section 303( i)( 2)( A) requires that if a State or Territory fails to adopt water quality criteria and standards in accordance with paragraph ( 1)( A) that are as protective of human health as the criteria for pathogen indicators for coastal recreation waters published by the Administrator, the Administrator shall promptly propose regulations for the State or Territory setting forth revised or new water quality standards for pathogen indicators described in paragraph ( 1)( A) for coastal recreation waters of the State or Territory. These State standards ( or EPApromulgated standards) are implemented through various water quality control programs including the National Pollutant Discharge Elimination System program, which limits discharges to navigable waters except in compliance with a National Pollutant Discharge Elimination System permit. The Clean Water Act requires that all National Pollutant Discharge Elimination System permits include any limits on discharges that are necessary to meet applicable water quality standards.

In cases in which a discharger ( including a small entity) is discharging pathogens into waters subject to these standards, the permitting authority will need to determine whether the discharge is or may be discharged at a level which will cause, contribute to, or have the reasonable potential to cause an exceedance of the applicable water quality standard. In making that determination, the Page 87 of 102 permitting authority would need to consider the factors listed in 40 CFR 122.44( d)( 1)( ii). Whether a permitting authority will need to require a water quality based effluent limit depends on the analysis of these factors, which will vary based on the specific facts of each permit decision. Based on that analysis, if the permitting authority finds that the discharger causes, contributes to, or has the reasonable potential to cause an exceedance of the applicable water quality standard, after the application of any required technology based effluent limits, then the permitting authority will need to impose a water quality based effluent limit to meet the applicable water quality standard. ( See Clean Water Act section 301( b)( 1)( C); 40 CFR 122.44( d).) Therefore, as a practical matter,

today's rule may or may not necessitate a change in the permit, depending on the specific circumstances. While the Clean Water Act and its implementing regulations may trigger the need for new or revised discharge limits based on the water quality standards in today's rule to be placed on small entities in some cases, the standards themselves do not directly apply to any discharger,

including small entities.

Although not required by the Regulatory Flexibility Act, EPA conducted a screening analysis to evaluate the potential for today's rule to have a significant impact on a substantial number of small entities, as part of its general practice to assess and reduce burden on small entities wherever possible. The screening analysis, which is included in the docket for today's rule, In the " Economic Analysis for Final Water Quality Standards for Coastal Recreation Waters," EPA presents an analysis which supports a conclusion that today'' s rule will not have a significant impactlikely affect only a substantial number offew small entities. EPA identified the universe of National Pollutant Discharge Elimination System permitted entities that are small in size. EPA evaluated the severity of potential economic impacts on those small entities by comparing their Page 88 of 102 estimated compliance costs to revenues, sales, or household income, depending on the type of entity. EPA observed that only one small government ( a major facility) may incur annual costs that equal or exceed 1% and 3% of annual revenues. For small businesses, the impact ratio exceeds 1%

for two facilities, and 3% for only one. Thus, given the few facilities for which impact ratios exceed 1% and 3%, the combined results for small governments and businesses support a conclusion that there will not be a significant impact on a substantial number of small entities.( See the docket for today's rule.)

D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA), P. L. 104 4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local,

and Tribal governments and the private sector. The definition of " State" for the purposes of the Unfunded Mandates Reform Act includes " a territory or possession of the United States." Under section 202 of the Unfunded Mandates Reform Act, EPA generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with " Federal mandates"

that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $ 100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the Unfunded Mandates Reform Act generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost effective or least burdensome alternative that achieves the objectives of the rule.

The provisions of section 205 do not apply when they are inconsistent with applicable law.

Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost effective or least burdensome alternative if the Administrator publishes with the final rule an Page 89 of 102 explanation of why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the Unfunded Mandates Reform Act a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

Today's rule contains no Federal mandates ( under the regulatory provisions of Title II of the Unfunded Mandates Reform Act) that may result in expenditures to State, local and Tribal governments, or the private sector, in the aggregate of $ 100 million or more in any one year.

Therefore, this rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act.

EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, this rule is not subject to the requirements of section 203 of the Unfunded Mandates Reform Act.

E. Executive Order 13132: Federalism Executive Order 13132, entitled " Federalism" ( 64 FR 43255, August 10, 1999), 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 Page 90 of 102 the States, or on the distribution of power and responsibilities among the various levels of government."

This final rule does not have Federalism implications. It 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. EPA's authority and responsibility to promulgate Federal water quality standards when State standards do not meet the requirements of the Clean Water Act is well established and has been used on various occasions in the past. The final rule does not substantially affect the relationship of EPA and the States and Territories, or the distribution of power or responsibilities between EPA and the various levels of government. The final rule does not alter the States' or Territories' considerable discretion in implementing these water quality standards.

Further, this rule does not preclude the States and Territories from adopting water quality standards that meet the requirements of the Clean Water Act, either before or after promulgation of the final rule, thus eliminating the need for Federal standards. Thus, Executive Order 13132 does not apply to this rule.

Although Executive Order 13132 does not apply to this rule, in the spirit of Executive Order 13132 and consistent with EPA's policy to promote communication between EPA and State and local governments, EPA did consult with representatives of the States and Territories subject to Clean Water Act section 303( i) in developing this rule. Prior to this rulemaking action, EPA had numerous phone calls, meetings and exchanges of written correspondence with the States to discuss EPA's concerns with the States' bacteria criteria, compliance with the BEACH Act, and the Federal rulemaking process. In June 2000, EPA and the Association of State and Interstate Water Pollution Page 91 of 102 Control Administrators ( ASIWPCA) established a State/ EPA Work Group on Water Quality Standards, composed of selected senior State and EPA managers, to provide input to EPA on water quality standards issues. The group has met approximately three times per year since then,

beginning with a meeting in September 2000. At every meeting the group has discussed the scientific, programmatic, and policy aspects of bacteria criteria for both coastal and non coastal recreation waters, and has provided useful input to EPA on these topics. Members of this group,

together with other interested State participants, have also served as an ad hoc work group since 2001 to assist EPA in developing draft detailed scientific and policy guidance ( Implementation Guidance for Ambient Water Quality Criteria for Bacteria ( EPA 823 B 02 003, May 2002 Draft))

concerning adoption and implementation of EPA's recommended criteria for bacteria. Today's final rule reflects State and Territorial input, and EPA has responded to State and Territorial comment on various topics in the preamble to today's rule and in the Comment Response Document, which is part of the record for this rule.

F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments Executive Order 13175, entitled " Consultation and Coordination with Indian Tribal Governments" ( 65 FR 67249, November 6, 2000), 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."

This final rule does not have Tribal implications. It 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. There are four authorized Indian Tribes with coastal or Great Page 92 of 102 Lakes waters; however, they have not yet adopted water quality standards, and therefore, have no designated coastal recreation waters within their jurisdiction. These Tribes are therefore not subject to today's rule. Thus, Executive Order 13175 does not apply to this rule.

EPA has contacted those Tribes identified as having coastal or Great Lakes waters to inform them of the potential future impact this could have on Tribal waters.

G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks Executive Order 13045: " Protection of Children from Environmental Health Risks and Safety Risks" ( 62 FR 19885, April 23, 1997) applies to any rule that: ( 1) is determined to be " economically significant" as defined under Executive Order 12866, and ( 2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the rule on children, and explain why the regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. As explained in section II. B of the preamble to today's rule, EPA developed the water quality criteria promulgated in today's rule based on concentrations of E. coli and enterococci from EPA sponsored epidemiological studies reflecting all reported illnesses, including those of children.

In the marine and freshwater studies, the range of the number of children under age 10 was between Page 93 of 102 15% and 25% of the total study population. Children in the age range 10 to 19 years old made up a slightly higher percentage of the study population. During the studies, information on gastroenteritis, respiratory symptoms, and other symptoms were collected for all participants,

including children. EPA designed the 1986 bacteria criteria to protect all age groups.

H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use This rule is not a " significant energy action" as defined in Executive Order 13211, " Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use" ( 66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply,

distribution, or use of energy. EPA estimates that compliance with the final rule will create a negligible increase in nationwide energy consumption for point source facilities discharging to coastal recreation waters in affected States. In section VIII, EPA presented its estimated incremental costs to permitted facilities as a result of the final rule. Some of these costs include energy use associated with increased maintenance of disinfection tanks. EPA estimates that the increased energy use from these activities would be about 99,000 kilowatt hours. Net production by electric power generation facilities in the United States in 2002 was 3,858,452 million kilowatt hours ( Energy Information Administration, Department of Energy,

http:// www. eia. doe. gov/ neic/ quickfacts/ quickelectric. htm). EPA estimates that the additional energy requirements of EPA's rule are insignificant ( i. e., 0.000003% of national energy generation).

I. National Technology Transfer and Advancement Act As noted in the proposal, section 12( d) of the National Technology Transfer and Advancement Act of 1995 (" NTTAA"), Pub. L. 104 113, section 12( d) ( 15 U. S. C. 272 note)

directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would Page 94 of 102 be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e. g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

While ambient water quality criteria may be considered technical standards, EPA is not aware of any voluntary consensus standards relating to bacteria criteria to protect human health and none were brought to our attention in comments on the proposed rule. Furthermore, even if there were such voluntary consensus standards, the BEACH Act specifically directs EPA to promulgate Federal standards based on its own bacteria criteria, in accordance with Clean Water Act section 304( a), in cases where States fail to do so. Therefore, EPA is not considering the use of any voluntary consensus standards.

J. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect,

the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A " major rule" cannot take effect until 60 days after it is published in the Federal Register. This action is not a " major rule" as defined by 5 U. S. C. 804( 2). This rule will be effective [ INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. Page 95 of 102 List of Subjects in 40 CFR Part 131 Environmental protection, Intergovernmental relations, Reporting and recordkeeping requirements,

Water pollution control. Water Quality Standards for Coastal and Great Lakes Recreation Waters page 96 of 102 Page 96 of 102 Dated:

Michael O. Leavitt,

Administrator.

For the reasons set out in the preamble, 40 CFR part 131 is amended as follows:

PART 131 WATER QUALITY STANDARDS 1. The authority citation for part 131 continues to read as follows:

Authority: 33 U. S. C. 1251 et seq.

Subpart D  [ Amended]

2. Section 131.41 is added to Subpart D to read as follows:

§ 131.41 Bacteriological criteria for those states not complying with Clean Water Act section 303( i)( 1)( A).

( a) Scope. This section is a promulgation of the Clean Water Act section 304( a) criteria for bacteria for coastal recreation waters in specific States. It is not a general promulgation of the Clean Water Act section 304( a) criteria for bacteria. This section also contains a compliance schedule provision.

( b) Definitions. ( 1) Coastal Recreation Waters are the Great Lakes and marine coastal waters ( including coastal estuaries) that are designated under section 303( c) of the Clean Water Act for use for swimming, bathing, surfing, or similar water contact activities. Coastal recreation waters do not Page 97 of 102 include inland waters or waters upstream from the mouth of a river or stream having an unimpaired natural connection with the open sea.

( 2) Designated bathing beach waters are those coastal recreation waters that, during the recreation season, are heavily used ( based upon a comparisonn evaluation of use within the State) and may have: a lifeguard, bathhouse facilities, or public parking for beach access. States may include any other waters in this category even if the waters do not meet these criteria.

( 3) Moderate use coastal recreation waters are those coastal recreation waters that are not designated bathing beach waters but typically, during the recreation season, are used by at least half of the number of people as at typical designated bathing beach waters within the State. States may also include light use or infrequent use coastal recreation waters in this category.

( 4) Light use coastal recreation waters are those coastal recreation waters that are not designated bathing beach waters but typically, during the recreation season, are used by less than half of the number of people as at typical designated bathing beach waters within the State, but are more than infrequently used. States may also include infrequent use coastal recreation waters in this category.

( 5) Infrequent use coastal recreation waters are those coastal recreation waters that are rarely or occasionally used.

( 6) New pathogen discharger for the purposes of this section means any building, structure, facility,

or installation from which there is or may be a discharge of pathogens, the construction of which commenced on or after [ INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION]. It does not include relocation of existing combined sewer overflow outfalls.

( 7) Existing pathogen discharger for the purposes of this section means any discharger that is not a new pathogen discharger. Page 98 of 102 ( c) EPA's section 304( a) ambient water quality criteria for bacteria.

( 1) Freshwaters:

A Indicatord B Geometric Mean C Single Sample Maximum ( per 100 ml)

C1 Designated bathing beach ( 75%

confidence level) C2 Moderate use coastal recreation waters ( 82%

confidence level) C3 Light use coastal recreation waters ( 90% confidence level) C4 Infrequent use coastal recreation waters ( 95%

confidence level)

E. colie 126/ 100 mla 235b 298b 409b 575b Enterococcie 33/ 100 mlc 61b 78b 107b 151b Footnotes to table in paragraph ( c)( 1):

a. This value is for use with analytical methods 1103.1, 1603, or 1604 or any equivalent method that measures viable bacteria.

b. Calculated using the following: single sample maximum = geometric mean * 10^( confidence level factor * log standard deviation), where the confidence level factor is: 75%: 0.68; 82%: 0.94; 90%:

1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.4.

c. This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.

d. The State willmay determine which of these indicators applies to its freshwater coastal recreation waters. Until a State makes that determination, E. coli will be the applicable indicator.

e. These values apply to E. coli or enterococci regardless of origin unless a sanitary survey shows that sources of the indicator bacteria are non human and an epidemiological study shows that the indicator densities are not indicative of a human health risk.

( 2) Marine waters: Page 99 of 102 A Indicator B Geometric Mean C Single Sample Maximum ( per 100 ml)

C1 Designated bathing beach ( 75%

confidence level) C2 Moderate use coastal recreation waters ( 82%

confidence level) C3 Light use coastal recreation waters ( 90% confidence level) C4 Infrequent use coastal recreation waters ( 95%

confidence level)

Enterococcic 35/ 100 mla 104b 158b 276b 501b Footnotes to table in paragraph ( c)( 2):

a. This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.

b. Calculated using the following: single sample maximum = geometric mean * 10^( confidence level factor * log standard deviation), where the confidence level factor is: 75%: 0.68; 82%: 0.94; 90%:

1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.7.

c. These values apply to enterococci regardless of origin unless a sanitary survey shows that sources of the indicator bacteria are non human and an epidemiological study shows that the indicator densities are not indicative of a human health risk.

( 3) As an alternative to the single sample maximum in paragraph ( c)( 1) or ( c)( 2) of this section,

States may use a site specific log standard deviation to calculate a single sample maximum for individual coastal recreation waters, but must use at least 30 samples from a single recreation season to do so.

( d) Applicability. ( 1) The criteria in paragraph ( c) of this section apply to the coastal recreation waters of the States identified in paragraph ( e) of this section and apply concurrently with any ambient recreational water criteria adopted by the State, except for those coastal recreation waters where State regulations determined by EPA to meet the requirements of Clean Water Act section Page 100 of 102 303( i) apply, in which case the State's criteria for those coastal recreation waters will apply and not the criteria in paragraph ( c) of this section.

( 2) The criteria established in this section are subject to the State's general rules of applicability in the same way and to the same extent as are other Federally adopted and State adopted numeric criteria when applied to the same use classifications.

( e) Applicability to specific jurisdictions. ( 1) The criteria in paragraph ( c)( 1) of this section apply to fresh coastal recreation waters of the following States: Illinois, Minnesota, New York, Ohio,

Pennsylvania, Wisconsin.

( 2) The criteria in paragraph ( c)( 2) of this section apply to marine coastal recreation waters of the following States: Alaska, California ( except for coastal recreation waters within the jurisdiction of Regional Board 4), Florida, Georgia, Hawaii ( except for coastal recreation waters within 300 meters of the shoreline), Louisiana, Maine ( except for SA waters and SB and SC waters with human sources of fecal contamination), Maryland, Massachusetts, Mississippi, New York, North Carolina, Oregon, Puerto Rico ( except for waters classified by Puerto Rico as intensely used for primary contact recreation and for those waters included in § 131.40), Rhode Island, United States Virgin Islands.

( f) Schedules of compliance. ( 1) Paragraph ( f) applies to any State that does not have a regulation in effect for Clean Water Act purposes that authorizes compliance schedules for National Pollutant Discharge Elimination System permit limitations needed to meet the criteria in paragraph ( c) of this section. All dischargers shall promptly comply with any new or more restrictive water quality based effluent limitations based on the water quality criteria set forth in this section.

( 2) When a permit issued on or after [ INSERT DATE 30 DAYS AFTER DATE OF Page 101 of 102 PUBLICATION] to a new pathogen discharger as defined in paragraph ( b) of this section contains water quality based effluent limitations based on water quality criteria set forth in paragraph ( c) of this section, the permittee shall comply with such water quality based effluent limitations upon the commencement of the discharge.

( 3) Where an existing pathogen discharger reasonably believes that it will be infeasible to comply immediately with a new or more restrictive water quality based effluent limitations based on the water quality criteria set forth in paragraph ( c) of this section, the discharger may request approval from the permit issuing authority for a schedule of compliance.

( 4) A compliance schedule for an existing pathogen discharger shall require compliance with water quality based effluent limitations based on water quality criteria set forth in paragraph ( c) of this section as soon as possible, taking into account the dischargers'discharger's ability to achieve compliance with such water quality based effluent limitations.

( 5) If the schedule of compliance for an existing pathogen discharger exceeds one year from the date of permit issuance, reissuance or modification, the schedule shall set forth interim requirements and dates for their achievement. The period between dates of completion for each requirement may not exceed one year.

If the time necessary for completion of any requirement is more than one year and the requirement is not readily divisible into stages for completion, the permit shall require, at a minimum, specified dates for annual submission of progress reports on the status of interim requirements.

( 6) In no event shall the permit issuing authority approve a schedule of compliance for an existing pathogen discharge which exceeds five years from the date of permit issuance, reissuance, or modification, whichever is sooner. Page 102 of 102 ( 7) If a schedule of compliance exceeds the term of a permit, interim permit limits effective during the permit shall be included in the permit and addressed in the permit's fact sheet or statement of basis. The administrative record for the permit shall reflect final permit limits and final compliance dates. Final compliance dates for final permit limits, which do not occur during the term of the permit, must occur within five years from the date of issuance, reissuance or modification of the permit which initiates the compliance schedule.


N N S N O N 11 15 01 MEMORANDUM SUBJECT: Tebuthiuron. List A Reregistration Case 0054. PC Code 105501. Product Chemistry Chapter for the Tolerance Renewal Eligibility Decision [TRED] Document. DP Barcode D277104.

FROM: K. Dockter, Chemist Reregistration Branch 2 Health Effects Division [7509C]

THRU: Alan Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division [7509C]

TO: Paula Deschamp, Risk Assessor Reregistration Branch 2 Health Effects Division [7509C]

Tebuthiuron {N[ 5( 1,1 dimethylethyl) 1,3,4 thiadiazol 2 yl] N, N' dimethylurea} is a nonselective herbicide.

Empirical formula: C9H16N4OS Molecular weight: 228.3 CAS Registry No.: 34014 18 1 PC Code: 105501 Chemical structure by J. Punzi A search of REFS conducted 10/ 12/ 01 identified a single tebuthiuron technical [T] registered under PC Code 105501, the Dow Agrosciences LLCo Spike* Technical 99 % T; EPA Reg. No. 2719 109. It is subject to a TRED.

The Reregistration Eligibility Decision Document issued 6/ 94. 2 The Registration Standard issued 7/ 87.

The product chemistry data base is essentially complete. There are no reported impurities of toxicological concern in tebuthiuron. The Series 830 physical and chemical properties are given in the table below.

GLN MRID Data 6302 Color 40493802 off white 6303 Physical state " crystalline solid 6304 Odor " pungent 7200 MP " 161.5 164 C 7300 Bulk density " 0.579 g/ cc 7840 Water solubility " 2.5 mg/ mL @ 25 C 7950 vp " 2 x 10 6 mm Hg @ 25 C 7550 log Pow " 1.79 6313 Stability " stable for 3 yrs & for 6 mo. @ normal and elevated temperatures, respectively. No light instability or corrosiveness to metal has been observed.

cc: Reg. Std. file, RF, Dockter, S. Piper, R. Fricke. RD\ I Tebuthiuron TRED Team. 7509C: RRB2: Rm712N: 57886: KD/ kd Tebuthiuron. TRED [982] = D277104. mem.


[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Proposed Rules]
[Pages 45991-45992]
[FR Doc No: 2012-18832]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 161 and 165

[USCG-2012-0632 (previously published as CGD01-04-133)]
RIN 1625-AA11

Regulated Navigation Area; Buzzard's Bay, MA; Navigable Waterways
Within the First Coast Guard District

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability and request for comments.

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SUMMARY: The Coast Guard announces the availability of a draft
Environmental Assessment (EA) considering the reasonably foreseeable
environmental impacts and socioeconomic effects of implementing a
Regulated Navigation Area in Buzzard's Bay, MA. We request your
comments on the draft EA.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before September 4,
2012 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0632 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand Delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: Mr. John Mauro, Coast Guard First
District Waterways Management Branch, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>or Mr. Luke Dlhopolsky, Civil Engineering Unit,
Environmental Protection Specialist, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

    Authority:  This Draft Environmental Assessment has been
prepared in accordance with the National Environmental Policy Act
(NEPA) (42 United States Code (U.S.C.) 4321 et. seq.); Council on
Environmental Quality (CEQ) Regulations for Implementing NEPA (40
Code of Federal Regulations (CFR) parts 1500-1508) and associated
CEQ guidelines; Department of Homeland Security Management Directive
5100.1, Environmental Planning Program; and United States Coast
Guard (USCG) Commandant Instruction (COMDTINST) M16475.1D, National
Environmental Policy Act Implementing Procedures and Policy for
Considering Environmental Impacts.

Public Participation and Request for Comments

    We encourage you to submit comments and related material on the
draft EA. All comments received will be posted, without change, to
http://www.regulations.gov and will include any personal information
you have provided.
    Submitting Comments: If you submit a comment, please include the
docket number for this notice (USCG-2012-0632) and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online, or by fax, mail or hand delivery, but please use only
one of these means. We recommend that you include your name and a
mailing address, an email address, or a telephone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Notices'' and insert ``USCG-2012-0632'' in the ``Keyword'' box. Click
``Search'' then click on the balloon shape in the ``Actions'' column.
If you submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period.
    Viewing the Comments and Draft EA: To view the comments and draft
EA, go to http://www.regulations.gov, click on the ``read comments''
box, which will then become highlighted in blue. In the ``Keyword'' box
insert ``USCG-2012-0632'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. We have an agreement with the Department of
Transportation to use the Docket Management Facility.
    Additionally, the EA can be found online at: http://www.uscg.mil/d1/prevention/EnvironmentalAssessment.asp.
    Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act, system of records notice regarding our public dockets in
the January 17, 2008, issue of the Federal Register (73 FR 3316).

Background and Purpose

    On August 30, 2007 the USCG published a Final Rule to implement
amendments to the existing Regulated

Navigation Area (RNA) (2007 Final Rule) applicable to First Coast Guard
District waters. (72 FR 50052; corrected by 72 FR 70780). The purpose
of these amendments was to further reduce the probability of an
incident that could result in the discharge or release of oil or
hazardous material, or cause serious harm, to navigable waters of the
United States. As part of the process to implement the 2007 Final Rule,
the USCG prepared a Categorical Exclusion Determination as defined in
its Agency Procedures for Implementing the National Environmental
Policy Act. In a ruling on May 17, 2011, the 1st U.S. Circuit Court of
Appeals determined that the USCG ``failed to comply with its
obligations under the National Environmental Policy Act'' when it
failed to prepare an Environmental Impact Statement (EIS) or an
Environmental Assessment (EA).
    The Coast Guard has completed a draft EA in order to cure the
procedural deficiency. This analysis indicates that an Environmental
Impact Statement (EIS) will not be necessary for implementation of any
of the action alternatives. The Coast Guard anticipates that a Finding
of No Significant Impact (FONSI) will be appropriate for implementation
of the 2007 Final Rule preferred alternative.
    We are seeking public input on the draft EA, including comments on
the completeness and adequacy of the document, and on the measures and
operating conditions described in the EA as alternatives designed to
reduce or eliminate potential environmental impacts. The Coast Guard
will consider public comments on the EA in determining the preferred
alternative and whether to issue a Finding of No Significant Impact
(FONSI), or to conduct additional NEPA analysis.

    Dated: July 18, 2012.
D.B. Abel,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2012-18832 Filed 8-1-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Rules and Regulations]
[Page 5697-5698]
[DOCID:fr04fe10-9]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

14 CFR Part 314

RIN 2105-AD94

Employee Protection Program; Removal

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Final rule.

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SUMMARY: This rule removes the procedural regulations of the Department
of Transportation Employee Protection Program. These regulations are
removed because the underlying program was repealed by an act of
Congress and the program has been terminated.

DATES: Effective Date: February 4, 2010.

FOR FURTHER INFORMATION CONTACT: Bernard Diederich, Office of the
General Counsel, 1200 New Jersey Ave., SE., Washington, DC 20590, (202)
366-9159.

SUPPLEMENTARY INFORMATION: The Congress in 1978 established the
Employee Protection Program, to be administered by the U.S. Department
of Transportation. Section 43 of the Airline Deregulation Act of 1978,
Public Law 95-504, 92 Stat. 1750, codified at 49 U.S.C. App. 1552
(1991).
    The Program was intended to compensate covered airline employees
who might have lost their employment or had their compensation reduced
as a result of a bankruptcy or major employment contraction, if the
major cause of the bankruptcy or major contraction was the change in
regulatory structure provided by the Airline Deregulation Act. DOT
established regulations to support the Program, based on the
regulations previously established by the Civil Aeronautics Board,
which previously handled the Program. 45 FR 49,291 (July 24, 1980); 47
FR 9,744 (March 5, 1982); 50 FR 2,426 (January 16, 1985). The
regulations were codified at 14 CFR Part 314. DOT conducted hearings
under the regulations and issued a final DOT order with findings in
initial selected cases, finding no basis to support any compensation
under the Program. DOT Order 91-9-20, dated September 18, 1991, in DOT
dockets 40201, 39783, 38978, 38883, and 38571.
    While appeals and processing of the Program were underway, the
Program was repealed by Act of Congress, effective August 7, 1998.
Section 199(a)(6) of the Workforce Investment Act of 1998, Public Law
105-220, 112 Stat. 1059. The Program was codified as subchapter I of
chapter 421 of title 49, United States Code, which was repealed at
subsection (a)(6) of the Workforce Investment Act. See also 144 Cong.
Rec. H6689 (daily ed. July 29, 1998).
    Accordingly, DOT has halted all action in the Program and is
removing the Program regulations. DOT lacks a statutory basis for any
further action on the Program.

Regulatory Analyses and Notices

A. Administrative Procedure Act

    The Department has determined that this rule may be issued without
a prior opportunity for notice and comment because providing prior
notice and comment would be unnecessary, impracticable, or contrary to
the public interest. The Program was repealed by an Act of Congress in
1998, thus there would not be any harm to any identifiable beneficiary
by repealing the rule. The Department has ceased all actions under the
regulations. Thus, this rule should be rescinded. For the same reasons,
the Department finds that there is good cause to make the rule
effective immediately.

B. Executive Order 12866 and Regulatory Flexibility Act

    The Department has determined that this action is not considered a
significant regulatory action for purposes of Executive Order 12866 or
the Department's regulatory policies and procedures. This rule is being
adopted solely to rescind a rule that is no longer necessary due to the
Congress repealing the program's statutory authority. Given the absence
of compliance costs to anyone, I certify that final rule does not have
a significant economic impact on a substantial number of small
entities.

C. Executive Order 13132

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13132 (``Federalism''). This
final rule does not have a substantial direct effect on, or sufficient
federalism implications for, the States, nor would it limit the
policymaking discretion of the States. Therefore, the consultation
requirements of Executive Order 13132 do not apply.

D. Executive Order 13175

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13175 (``Consultation and
Coordination with Indian Tribal Governments''). Because this final rule
does not significantly or uniquely affect the communities of the Indian
tribal governments and does not impose substantial direct compliance
costs, the funding and consultation requirements of Executive Order
13175 do not apply.

E. Paperwork Reduction Act

    This rule contains no information collection requirements under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

F. Unfunded Mandates Reform Act

    The Department of Transportation has determined that the
requirements of Title II of the Unfunded Mandates Reform Act of 1995 do
not apply to this rulemaking.

List of Subjects in 14 CFR Part 314

    Administrative practice and procedure, Air transportation, Aviation
safety, Hazardous materials transportation, Investigations, Law
enforcement, Penalties.

0
Accordingly, under the authority of Section 199(a)(6) of the Workforce
Investment Act of 1998, Public Law 105-220, 112 Stat. 1059, the
Department of Transportation amends 14 CFR chapter 2 by removing part
314:

PART 314--[REMOVED AND RESERVED]

    Issued in Washington, DC, on January 27, 2010.
Susan Kurland,
Assistant Secretary for Aviation and International Affairs.
[FR Doc. 2010-2281 Filed 2-3-10; 8:45 am]
BILLING CODE 4910-9X-P