Section 101(a)(15)(F)(i) of the Immigration and Nationality Act (Act) establishes the F nonimmigrant visa classification for foreign students who wish to come to the United States temporarily to attend an academic or language training institution. Section 101(a)(15)(M)(i) of the Act establishes the M nonimmigrant visa classification for foreign students who wish to come to the United States temporarily to attend a vocational education institution. An F or M nonimmigrant student may enroll in a particular school only if the Attorney General has approved the school for the attendance of F and M nonimmigrants. The Service exercises the Attorney General's authority to approve, or withdraw the approval of, schools that desire to admit F and M nonimmigrant students. The current regulations are codified in 8 CFR 214.3 and 214.4.

On October 30, 2001, the President issued Homeland Security Directive No. 2 (Directive 2) requiring the Service to conduct periodic reviews of all institutions approved to accept nonimmigrant students.

More recently, section 502 of the Enhanced Border Security and Visa Entry Reform Act of 2002 (Border Security Act), Public Law 107-173, enacted May 14, 2002, requires the Service to review all schools approved by the Service for attendance by F or M nonimmigrant students within 2 years of the passage of the Border Security Act. The Border Security Act also requires the Service to conduct periodic reviews of the approval of schools every 2 years thereafter.

The Service's proposed SEVIS implementation rule, 67 FR 34862 (May 16, 2002), establishes the regulatory framework for SEVIS and provides that the use of SEVIS will become mandatory for all schools on a mandatory compliance date of January 30, 2003. Once the final SEVIS implementation rule is adopted, and the mandatory compliance date is reached, all Service-approved schools will be required to use SEVIS for the admission of new students and for the issuance of new forms for existing students. Once a school is approved and enrolled in SEVIS, it must issue Forms I-20 for all newly enrolled students from SEVIS. Furthermore, if a current student needs a new Form I-20 the school must enter the student into SEVIS at that time in order to issue a SEVIS Form I-20. The school may enter all of its current students prior to January 30, 2003 if it so desires, but is not required to do so. Following the mandatory compliance date, all new incoming foreign students must be entered into SEVIS. Schools must enter all current or continuing students, into SEVIS by the end of the next academic cycle. For example, in a semester academic calendar if a current student is returning for a 2003 summer session, as that would most likely be the next academic cycle, that student must be entered into SEVIS in order to verify current enrollment. Another example might be if the student is within a quarter academic calendar, the 2003 spring quarter would be when that student must be entered into SEVIS.

To facilitate the review of all Service-approved schools and to ensure the enrollment of all eligible schools in SEVIS in a timely manner, the Service has implemented a two-phased process for school review and SEVIS enrollment.

Phase I was a preliminary enrollment period for certain currently accredited schools. 67 FR 44344 (July 1, 2002). Eligible schools who applied during the preliminary enrollment period were granted preliminary access to SEVIS prior to paying the full certification fee or submitting to a full certification review. Preliminary enrollment began on July 1, 2002, and closed with the publication of this rule, as provided in 8 CFR 214.12(b). Those schools that have electronically submitted a Form I-17 in SEVIS, under preliminary enrollment as provided in 8 CFR 214.12 prior to September 25, 2002, will be adjudicated in accordance with the preliminary enrollment requirements. Schools that have begun to fill out Form I-17 in SEVIS and saved the form as a draft, but who have not electronically submitted the form in SEVIS prior to September 25, 2002, will be required to pay the certification fee prior to certification in SEVIS in accordance with this rule.

This interim rule implements Phase II of the transition to SEVIS and provides that all schools not already approved to use SEVIS—including a school that would have been eligible for preliminary enrollment under 8 CFR 214.12 but did not apply for preliminary enrollment—must undergo a certification review, and pay the associated fee, prior to enrollment in SEVIS.

This rule implements Directive 2 and the Border Security Act by requiring each school that is currently approved for attendance by F and M nonimmigrants to undergo a review by the Service for approval in SEVIS no later than the SEVIS mandatory compliance date. This opportunity to review currently-approved schools will help ensure the integrity of the SEVIS program.

The school should begin the review process by accessing the SEVIS Web site at www.ins.usdoj.gov/sevis. By entering the basic contact information required, the school official that will be filing the petition for access to SEVIS will be issued a temporary user ID and password for SEVIS. Using this ID and password, the school official will access SEVIS on-line and complete and electronically submit the Form I-17 and the required fee.

In order to be reviewed by the Service and be granted access to SEVIS prior to the mandatory compliance date, schools are strongly encouraged to submit an electronic Form I-17 to the Service using SEVIS no less than 75 days prior to the compliance deadline. The Service cannot guarantee timely final action on any Form I-17 petition not filed at least 75 days prior to the SEVIS mandatory compliance deadline. In general, Forms I-17 will be adjudicated in a timely manner within 6 months of filing in accordance with the Service's backlog reduction plan. A school that has a Form I-17 pending adjudication in SEVIS after the mandatory compliance date will be unable to issue Forms I-20 until approved and granted SEVIS access.

A school's approval will be automatically withdrawn as of the day following the SEVIS mandatory compliance date if the school has not submitted an electronic Form I-17 to initiate the certification review process by then. If a school's approval is withdrawn, the school may not issue any Forms I-20 for new F or M nonimmigrant students. Currently enrolled students must transfer to a different Service-approved school no later than the next semester, quarter, trimester or other academic term.

The current regulations, in 8 CFR 214.3, provide for a paper-based application process, in which the school seeking Service approval must submit a paper Form I-17 together with specific forms of documentation. The evidentiary requirements are currently contained in 8 CFR 214.3(b) and (c) and the instructions on Form I-17. With the advent of electronic filing of the Form I-17, the school will not be required to present the accompanying documentation until the time of the on-site visit, as discussed below.

The purpose of certification review under this rule is two-fold: both to establish the bona fides of the school with regard to its educational or vocational programs, and also to review the adequacy of the school's past and current efforts to comply with the existing requirements governing foreign students. The Service recognizes that many schools are already accredited by educational organizations recognized by the Department of Education, or are approved by state education agencies. Accordingly, the Service will coordinate with the Department of Education and other appropriate education agencies regarding the documentation needed to establish the bona fides of such schools. However, neither the Department of Education nor other education agencies currently maintain information regarding the compliance of each school with the existing requirements of the Service's regulations governing foreign students. Accordingly, the Service will still need to conduct a certification review for such schools to determine the adequacy of the school's compliance with the foreign student requirements. The Service will review and adjudicate the electronic Form I-17, as supplemented by the results of the completed on-site visit. During the on-site visit any signatures or supporting documentation will be collected and will be provided to the Service with the on-site report. Schools will receive notice of full certification approval, denial, or request for evidence via a SEVIS-generated electronic mail.

If a Service Officer requires clarification, updated documentation or further evidence to properly adjudicate the Form I-17, a request for evidence will be issued. Schools will receive notice of a request for evidence via a SEVIS-generated electronic mail, which will identify specific information or clarification the Service requires.

Approved schools will be enrolled in SEVIS and the Designated School Officials (DSO) listed on the electronic Form I-17 will be issued permanent user ID and passwords. If denied, the petitioner will receive e-mail notification through SEVIS and written notification from the Service.

If a school is denied certification, the school will receive written notice of the reasons for the denial and of the process for seeking review of such denial. The Service intends to issue a notice of proposed rulemaking in the near future to revise the withdrawal and appeal processes for schools in the foreign student program.

This rule provides for an on-site visit as part of the certification. At the time of the on-site review, the school will be able to present supporting documentation evidencing its eligibility for Service approval.

The Service will determine by risk analysis the order in which schools will undergo an on-site review. All vocational (M) schools, flight schools, and language schools will be required to complete an on-site review before the Service will allow them to enroll in SEVIS. However, upon the discretion of the Service, the Service may allow conditional enrollment in SEVIS for accredited schools or for public secondary schools, prior to an on-site visit. Such schools will still be required to pay the associated on-site review fee when filing their Form I-17. If the Service does conditionally enroll schools in SEVIS, prior to an on-site visit, those schools will be subject to the full-scale review and on-site visit at a later date. The Service may request certain supporting information from schools in making a determination for conditional enrollment. Schools granted conditional enrollment may ultimately be denied certification based upon the results of the on-site review.

In general, all schools need to establish that they are bona fide institutions of learning with the financial ability to remain a viable institution. The Service will utilize Department of Education information, as appropriate, to assist in the verification of the school's bona fides. The required supporting documentation is specific to the type of school petitioning. The evidentiary requirements are currently contained in 8 CFR 214.3(b) and (c) and in the instructions on the Form I-17. More detailed information and examples of the evidentiary documentation that the Service will accept from each school type will be made available on the Service's website.

Upon review of the findings of the on-site visit and any supporting documentation, a Service officer will determine the school's eligibility for approval. If the school was required to undergo the certification review, including an on-site visit, prior to enrollment in SEVIS, the school will be enrolled in SEVIS if approved. Schools that were approved for preliminary enrollment by the Service under 8 CFR 214.12, or that are conditionally enrolled in SEVIS under the Service's discretionary authority as provided in this rule under 8 CFR 214.3(h)(2) without an on-site visit, must complete the full certification review process prior to May 14, 2004. Until an on-site visit is conducted, a school enrolled in SEVIS under preliminary enrollment or conditional enrollment will be permitted to operate in SEVIS. After an on-site visit is conducted and the review process is completed, if approved, the school will be fully certified and may continue in SEVIS. If, after the on-site visit, the Service denies full certification, the Service will send electronic notification through SEVIS to the school indicating the reasons for the denial and the process for seeking review of such denial.

This interim rule only governs the initial process for certification of schools prior to enrollment in SEVIS (or, for schools previously approved for preliminary enrollment in SEVIS pursuant to 8 CFR 214.12, for initial certification prior to May 2004). However, both Directive 2 and the Border Security Act require the Service to conduct periodic reviews of all Service-approved schools. Accordingly, every school that completes the certification process under this rule must be reviewed every 2 years thereafter. This is a departure from the current practice, in which a school's approval continues indefinitely, unless the Service affirmatively withdraws the approval. For this reason, the Service is striking the provision in 8 CFR 214.3(e)(2) relating to indefinite approval and inserting a reference to clarify that schools must be approved every two years.

At this time, this rule simply amends 8 CFR 214.3(h) to note that the Border Security Act requires a review of all approved schools every 2 years. The Service will implement, in a separate rulemaking proceeding, more specific procedures for schools to apply for a subsequent certification review—after having completed the initial certification process under this rule.

As the Service will be requiring on-site reviews prior to the initial approval of Form I-17, a new fee is necessary to support the review. The new fee includes the current internal Service cost, $230, for the review of the Form I-17, as well as the cost of the on-site review, $350, for a total of $580.

The primary difference between the Internet system and the paper system is how the school submits Form I-17. Instead of the current, paper-based process of the school having to request the form, fill out the form, and mail to the Service, the school will now electronically complete and submit the form to the Service. As stated above, the $580 fee includes both the base cost of processing of the Form I-17 and the on-site visit. In addition, the cost of the on-site review must be paid for each additional campus listed on the Form I-17B, with the exception of secondary public school systems. The per-campus cost is due to the fact that each campus will be subject to an on-site review. For instance, if School X, when submitting the Form I-17, lists two additional campuses, the total fee paid by School X is $1280 ($580 + $350 + $350). Instructions for electronic payment of the fee will be included on the Internet for schools when applying for review and enrollment in SEVIS.

Federal guidelines require the Service to establish and collect application fees to recover the full cost of providing immigration and naturalization services, rather than supporting these services with tax revenue. This rule requires all schools not already approved to use SEVIS to pay the certification fee prior to certification in SEVIS. If a school pays this fee and is granted enrollment in SEVIS prior to the on-site review, the school will not be required to pay the fee again at the time of that on-site review. All schools must pay the same certification fee.

The fee for initial certification is $580. A certification fee also will be charged for each subsequent 2-year re-certification. While the fee will be re-visited every 2 years to assure that the Service is charging no more and no less than the full costs of the school review, the Service anticipates a fee for re-certification that is comparable to the initial certification fee.

This fee is based on the internal Service cost, $230, plus the average cost of a required site visit to the school to perform a compliance verification, $350. The $230 internal Service cost was established previously and is not changed by this interim rule. See 66 FR 65811 (December 21, 2001).

The additional $350 cost for an on-site visit and compliance verification was calculated, and procurement strategy formulated, as follows: The Service will hire contractors to make the site visits and produce standard reports for the Service to consider before approving any school's use of SEVIS. The Service intends to award multiple contracts to ensure that there is enough capacity to handle a large number of school applicants.

In early June 2002, the Service issued a request for proposals to six vendors who have “schedule contracts” with the General Services Administration (GSA) and are available to perform services of this type for federal departments and agencies. The GSA requires agencies to request proposals from at least three vendors before entering an agreement with a vendor for services, but in this case the Service elected to solicit proposals from six vendors. The statement of work for the vendors describes the type of site visits required. Site visits will include collection of supporting documentation submitted by the school, a tour of the campus, an interview with school officials, and a review of selected school records relating to the school's compliance with applicable standards under 8 CFR 214.3. The statement of work also includes a template to be used on site by the vendor to collect the above mentioned information and prepare a report. In order to expedite the certification process, vendors will be required to deliver these reports to the Service within 10 working days from the time that the site visit is requested. The information in this report will assist the Service in verifying both the bona fides of the school and, in the case of currently approved schools, the continued compliance with recordkeeping and reporting requirements. Each vendor is required to have a nationwide network of qualified and trustworthy employees available to perform these site visits. On this basis, five vendors submitted proposals to the Service to perform these services, with a fixed price per on-site review.

The Service derived the on-site review portion of the fee by taking the three lowest-priced proposals and taking the average of their fixed prices proposed for the first 2 years of the contract. The Service did not take the lowest bid with one contractor, because using only one contractor would not provide sufficient assurance that a large number of reviews could be completed within a short period of time and with the level of quality that is required. The Service also did not give preferential weight to any one bid when calculating this average cost because the Service cannot anticipate the geographic or numerical capacity, quality, or timeliness of any one vendor. The Service believes that this method will take advantage of the economies offered by competitive pricing, without sacrificing quality or capacity to conduct a large number of on-site reviews during a short period of time. In addition, the calculation excluded the highest bid proposed because the Service believes that three vendors should be sufficient. The calculation excluded years 3 through 5 of the vendor proposals because Federal guidelines require the Service to reconsider all fees on a 2 year cycle. Therefore, the Service will review the certification/re-certification fee in 2 years to ensure that it is charging no more and no less than the full costs of providing this service.

While the current regulations at 8 CFR 103.7(b)(1) exempt all publicly owned or operated institutions from the payment of the Form I-17 fee, because the Service will be conducting an on-site review of all approved schools every 2 years, as well as for any schools applying for initial approval, a fee payment is now necessary to fund this comprehensive plan for review. Although public schools were historically exempt from the Form I-17 adjudication fee, there is no adequate basis to continue such an exemption. The Service incurs processing and internal review costs for adjudicating any Form I-17, regardless of whether a school is a public or private institution.

A public secondary school or school system owned or operated as a public educational institution or system by the United States or a state or political subdivision thereof is required to pay only the $580 fee for the entire school system, and not an additional fee for each school within that system. However, public, postsecondary schools with more than one campus must pay a fee for each school or campus.

A school that filed an initial petition for school approval, Form I-17, with the Service, but not via SEVIS under preliminary enrollment, prior to September 25, 2002, and whose petition is still pending approval before the Service on that date, has two options.

The Service will contact the school to determine whether the school would like to re-file the Form I-17 electronically through SEVIS. If the school does intend to re-file electronically, the school would be required to undergo a full-scale review, including an on-site visit prior to being granted enrollment in SEVIS. The school would not have to pay the internal Service cost portion of the Form I-17 processing fee, $230, as it paid that portion of the fee at the time of filing the original Form I-17. However, as such a school would still have to undergo an on-site review, the school would be required to pay the cost of that review, $350 per campus. This additional fee would be paid as part of the electronic Form I-17 submission process.

If the school informs the Service that it does not wish to re-file in SEVIS, the Service will review and adjudicate the paper Form I-17 petition as submitted. If it wishes to enroll foreign students after the mandatory compliance date, such a school must still apply for certification in SEVIS, pay the full amount of the certification fee, and undergo a full scale review in accordance with this rule if it wishes to enroll foreign students after the mandatory compliance date.

All schools will be required to submit a Form I-17 electronically in SEVIS. One of the primary purposes of SEVIS is to transition to electronic filing and reporting. As an e-Gov system, SEVIS requires additional information that was not required in the older, paper-based, process, such as e-mail addresses. However, once a school has entered their Form I-17 electronically and been approved, the Service believes that utilizing SEVIS will reduce the school's burden, for example, by facilitating certain updates to the Form I-17 directly via SEVIS. Accordingly, schools must enter their own data into SEVIS.

This rule is effective on publication in the Federal Register . The Service finds that good cause exists both for adopting this rule without the prior notice and comment period ordinarily required by 5 U.S.C. 553, and for making this rule immediately effective, rather than having it enter into force 30 days after publication. The USA PATRIOT Act, Public Law 107-56, mandates that SEVIS be fully implemented prior to January 1, 2003. Further, the Border Security Act requires the Service to review all schools within 2 years of its enactment. In order to meet the mandate for complete functionality of SEVIS while ensuring the integrity of data in SEVIS, a timely review of all schools is necessary prior to allowing a school to access SEVIS. Additionally, the provision for review of all approved schools is an important part of helping to safeguard against the abuse of the traditional American openness to foreign students by foreign terrorists. Because of the vital national security concerns that underpin Directive No. 2, the USA PATRIOT Act, and the Border Security Act, it would be contrary to the public interest to observe the requirements of 5 U.S.C. 533(b) and (d).

The Commissioner, in accordance with 5 U.S.C. 605(b), has reviewed this regulation and, by approving it, certifies that although this rule will have an economic impact on schools, the impact should not be significant since the $580 is not a substantial amount when considered in relation to the revenue generated by schools during the fiscal year. This money can easily be recouped through student fees or slight budget adjustments. Additionally, the information a school must submit is information that should be readily available to the school. Thus, any economic impact will not be “significant.”

The fee is calculated based on the cost of conducting on-site visits, compliance verification, and staffing requirements.

Section 502 of the Enhanced Security and Visa Entry Reform Act of 2002, Public Law 107-173, dated March 14, 2002, requires the Service to conduct a review of the institutions certified to receive nonimmigrants under section 101(a)(15) (F) or (M) of the Act on a recurring 2-year basis. Although the Service will be charging a fee (to recover the cost of certification), and the fee will have an impact on State public secondary schools and State universities, the Service has drafted the regulation to reduce the impact. For example, in the State of Virginia, the Fairfax County Public School system has 24 public high schools yet the Service would only require that the county pay a fee of $580 instead of $13,920 ($580 x 24 schools). Although the formula would be different for State universities that would require that they pay the $580 fee for each campus, the State universities would more than recoup the cost in the tuition they charge students. The Service estimates that the total cost every two years for the certification of all schools (including State universities and public secondary schools) covered under this rule will be $8.7 million (15,000 schools including universities with multiple campuses x $580 = $8.7 million) plus $162,000 (time spent by the school to undergo a site visit review based on the number of respondents (15,000) x 65 minutes (1.08) per response x $10 (average hourly rate) = $162,000) equaling $8.9 million that is far below the $100 million threshold.

Accordingly, the Service finds that this rule will not result in the expenditure by state, local or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely effect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

This rule is considered by the Department of Justice, Immigration and Naturalization Service, to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, this regulation has been submitted to the Office of Management and Budget for review.

As discussed above, the fee charged by the Service to recover the cost of certification will have an impact on State public secondary schools and State universities. However, the Service has drafted the regulation to reduce the impact. In the case of public secondary schools, the Service will charge one fee per school system, not a fee for each school within that system. Additionally, although State universities will be charged a fee for each campus, such institutions can recoup the cost in the tuition they charge students. Accordingly, the Service finds that this 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. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

The information collection requirement to electronically enroll in SEVIS has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act. The OMB control number for this collection is 1115-0252.

A proposal to amend 14 CFR part 39 by superseding AD 74-08-03, Amendment 39-1806 (39 FR 12245, April 4, 1974) for Bell Model 212 helicopters was published in the Federal Register on June 28, 2002 (67 FR 43572). That action proposed to require, at specified intervals, modifying and visually inspecting certain spar caps and also modifying and inspecting using a tap hammer and by dye-penetrant, respectively, each affected spar cap for a crack, loose fastener, corrosion, or disbond. That action also proposed to require, before further flight, repairing any loose fastener or corrosion and replacing any disbonded or cracked part with an airworthy part and within 24 months, replacing affected spar caps with the cold expansion spar cap.

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.

The FAA estimates that this AD will affect 240 helicopters of U.S. registry, that it will take approximately 4 work hours to modify and 180 work hours to inspect each spar cap and that the average labor rate is $60 per work hour. Required parts will cost approximately $1,369. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $2,978,160.

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 Ente Nazionale per l'Aviazione Civile (ENAC), which is the airworthiness authority for Italy, recently notified FAA that an unsafe condition may exist on certain Vulcanair Models P 68, P 68B, P 68C, P 68C-TC, P 68 “OBSERVER”, AP68TP300 “SPARTACUS”, P68TC “OBSERVER”, AP68TP 600 “VIATOR”, and P68 “OBSERVER 2” airplanes. The ENAC reports several instances of incorrectly installed bolts, missing nuts, and the presence of interference between the forward control lever assembly and the airframe.

If not detected and corrected, these conditions could result in failure of the primary flight controls. Such failure could lead to loss of airplane flight control.

We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Vulcanair P 68 series airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on July 15, 2002 (67 FR 46427). The NPRM proposed to require you to:

The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any comments on the proposed rule or on our determination of the cost to the public.

After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:

We estimate that this AD affects 58 airplanes in the U.S. registry. The actions specified in Vulcanair P68 Series Service Bulletin No. 110 affect 15 U.S.-registered airplanes. The actions specified in Vulcanair P68 Series Service Bulletin No. 111, Rev. 1, affect 58 U.S.-registered airplanes.

We estimate the following costs to accomplish the inspections and modifications of Vulcanair P68 Series Service Bulletin No. 110:

We estimate the following costs to accomplish the inspections of Vulcanair P68 Series Service Bulletin No. 111, Rev. 1:

The FAA has no method of determining the number of necessary adjustments each owner/operator will incur if connecting bolts, linkage, etc. were found incorrectly installed. We estimate the cost to be minor.

The compliance time of this AD is “within the next 30 days after the effective date of the AD.”

The compliance of this AD is presented in calendar time instead of hours TIS because these missing or incorrectly installed parts is due to a lack of quality control at the factory. The problem has the same chance of existing on an airplane with 50 hours TIS as it would for an airplane with 1,000 hours TIS. Therefore, we believe that 30 days will:

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 copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES .

Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, has received a significant number of reports of aileron control stiffness on certain Bombardier Model CL-600-2B19 series airplanes following climb-to-altitude after takeoff during heavy rain or from a runway contaminated by water, snow, or slush. Reports indicate that in all of these incidents, aileron control stiffness disappeared upon descent to lower altitude, and the airplanes landed safely. Reports also indicate that all of these airplanes had accumulated more than 5,000 total flight hours.

TCCA advises that the aileron control cables are routed aft of the control columns and into the respective left and right wheel wells of the main landing gear (MLG). At this point, the cables are routed around the left and right aileron quadrants before being routed to the wings. Both the left and right aileron quadrants and other hardware for the aileron control system, which are located in the aft area of the wheel well, are susceptible to contamination by water, snow, or slush entering the area between the splash shield and each wheel well bin. As an airplane with contamination in the wheel well encounters colder temperatures, it is possible that the aileron control hardware could freeze and consequently jam.

On October 4, 2000, the FAA issued AD 2000-20-03 R1, amendment 39-11928 (65 FR 61083, October 16, 2000), which is applicable to certain Bombardier Model CL-600-2B19 series airplanes. That AD requires installing shields for the aileron quadrants in the wheel bay of the MLG to prevent accumulation of water, ice, or slush on the aileron quadrants and control cable pulleys. The requirements of that AD are not affected by this AD.

TCCA recently notified the FAA that an unsafe condition may exist on all Bombardier Model CL-600-2B19 series airplanes. TCCA advises that since May 2002, six incidents of aileron control stiffness were reported on airplanes on which the requirements of 2000-20-03 R1 had been accomplished. The exact cause of the contamination has not yet been determined. Aileron control stiffness during flight, if not corrected, could result in the reduction or possible loss of controllability of the airplane.

Bombardier has issued Canadair Regional Jet Temporary Revision (TR) RJ/109-2, dated August 9, 2002, of the Canadair Regional Jet Airplane Flight Manual (AFM). The TR describes procedures for advising the flightcrew of operating limitations and procedures to address aileron control stiffness, as follows:

• The Limitations Section specifies that, when an airplane departs from a wet or contaminated runway, the following procedure must be followed: at 10,000 feet mean sea level, or when the static air temperature is less than or equal to 0 Celsius degree (32 Fahrenheit degrees), whichever occurs later, the ailerons must be operated manually every 5,000 feet until the top of the climb;

• The Emergency Procedures Section specifies that, if frozen ailerons are suspected after departing from a wet or contaminated runway, sufficient force must be applied on the affected side to free the jam. If the jam persists, procedures specify descending to warmer temperatures. If unable to clear the jam, procedures specify landing at the nearest suitable airport, and selecting the longest runway available that has minimum turbulence and crosswind;

• The Normal Procedures Section specifies an addition to the “CLIMB CHECK” instructions that are similar to the Limitations Section. However, the Normal Procedures Section includes a note that specifies a roll rate, airplane speed, and expected response when conducting the aileron control check every 5,000 feet until the top of the climb; and

• The Abnormal Procedures Section includes a note specifying that, if frozen ailerons are suspected, the flightcrew must accomplish the “Aileron System Jammed” Emergency Procedures.

TCCA classified this TR as mandatory and issued Canadian airworthiness directive CF-2002-35R1, dated August 16, 2002, in order to assure the continued airworthiness of these airplanes in Canada.

This airplane model is manufactured in Canada and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, TCCA has kept the FAA informed of the situation described above. The FAA has examined the findings of TCCA, 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 aileron control stiffness during flight, which could result in the reduction or possible loss of controllability of the airplane. This AD requires revising the Limitations, Emergency Procedures, Normal Procedures, and Abnormal Procedures Sections, as applicable, of the Canadair Regional Jet AFM to provide the flightcrew with operating limitations and procedures to enable them to maintain controllability of the airplane in the event that aileron control stiffness is encountered during flight. This AD requires accomplishment of the actions specified in TR RJ/109-2, except as discussed below.

Operators should note that the compliance time in the Canadian airworthiness directive specifies amending the Canadair Regional Jet AFM 14 days after the effective date of this AD to address aileron system jams. However, taking into consideration the specifications included in the “Corrective Actions” paragraphs of the Canadian airworthiness directive, we have further clarified the compliance time in this AD, as follows:

• Paragraph (a) of this AD requires inserting the procedures for aileron system jams into certain sections of the AFM “14 days after the effective date of this AD”; and

• Paragraph (b) of this AD requires inserting the procedures for the aileron control check into certain sections of the AFM “upon the accumulation of 5,000 total flight hours, or within 14 days after the effective date of this AD, whichever occurs later.”

Operators also should note that paragraph (b) of this AD, which references the Limitations and Normal Procedures Sections of the TR, requires inserting the procedures for the aileron control check into certain sections of the AFM when an airplane has accumulated 5,000 total flight hours, or within 14 days after the effective date of this AD, whichever occurs later. However, individual pilots may operate other airplanes that have not yet accumulated 5,000 total flight hours, and that are not subject to the limitations and procedures specified in the TR. Therefore, to avoid any confusion or misunderstanding, it is important that airlines have communication mechanisms in place to ensure that pilots are aware, for each flight, whether the Limitations and Normal Procedures apply. To clarify this, we have added Note 1 in this AD accordingly.

In addition, operators should note that both the previously referenced Canadian airworthiness directive and the TR specify revising the AFM by inserting the TR into the AFM. Likewise, this AD requires that same action. However, we have determined that clarification of the detailed specifications of the Canadian airworthiness directive and the TR is necessary. Although paragraph 1.a), “Corrective Actions,” of the Canadian airworthiness directive specifies an amendment to the Emergency Procedures for aileron system jams for all airplanes, the TR specifies such an amendment to both the Emergency Procedures and Abnormal Procedures Sections for those airplanes. In addition, although paragraph 1.b), “Corrective Actions,” of the Canadian airworthiness directive specifies an amendment to the Limitations Section for an aileron control check for airplanes that have accumulated 5,000 or more total flight hours, the TR specifies such an amendment to both the Limitations and Normal Procedures Sections for those airplanes.

After contacting TCCA to receive clarification about these details, we were informed that the intent of the Canadian airworthiness directive and the TR are the same. Likewise, we have determined that the intent of this AD and the service information are essentially the same.

This is considered to be interim action until final action is identified, at which time the FAA may consider further rulemaking.

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 2002-NM-196-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.

Austro Control, which is the airworthiness authority for Austria, notified the FAA that an unsafe condition may exist on Bombardier-Rotax GmbH 912 F and 912 S series reciprocating engines with fuel pump assembly P/N 996.596 installed. Austro Control advises that they have received two reports of in-service fuel leaks at the fuel pump assembly pressure hose nipple. To date, there have been no in-flight engine fires due to fuel pump assembly fuel leaks. However, Austro Control has determined that Bombardier-Rotax GmbH 912 F and 912 S engines having fuel pump assembly P/N 996.596 installed could possibly experience fuel pump assembly fuel leaks which could result in an in-flight engine fire.

Bombardier-Rotax GmbH has issued mandatory service bulletin (MSB) No. SB-912-031, dated October 2001, that specifies procedures for initial and repetitive visual inspections and tests for fuel leakage of fuel pump assembly P/N 996.596, installed on Rotax GmbH type 912 F series reciprocating engines, SN's 4,412.808 to 4,412.815, and type 912 S series reciprocating engines SN's 4,922.504 to 4,922.743. The Austro Control classified this service bulletin as mandatory and issued AD No. 109, in order to assure the airworthiness of these Bombardier-Rotax GmbH engines in Austria.

This engine model is manufactured in Austria and is 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 Austro Control has kept the FAA informed of the situation described above. The FAA has examined the findings of the Austro Control, 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 Bombardier-Rotax GmbH 912 F and 912 S series reciprocating engines of the same type design, this AD is being issued to prevent in-flight fuel leaks of the fuel pump assembly, which could result in an engine fire. This AD requires initial and repetitive visual inspections and tests for fuel leakage of the fuel pump assembly P/N 996.596. The actions must be done in accordance with the service bulletin described previously.

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 should 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.

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 action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NE-18-AD.” The postcard will be date stamped and returned to the commenter.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and 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 .

Section 18 of the Occupational Safety and Health Act of 1970 (the Act), 29 U.S.C. 667, provides that States which wish to assume responsibility for developing and enforcing their own occupational safety and health standards relating to any occupational safety or health issues with respect to which a Federal standard has been promulgated may do so only by submitting and obtaining Federal approval of a State plan. State plans may be “complete” plans covering both the private sector and State and local government employees ( see 29 CFR part 1902) or State plans limited in scope to State and local government employees only ( see 29 CFR part 1956). A State plan consists of the laws, standards and other regulations, and procedures as well as administrative and budgetary information under which the State operates its occupational safety and health program. From time to time after initial plan approval, States may, and in many cases are required to, make changes to their plans as a result of State and Federal legislative, regulatory or administrative actions. State plans and their subsequent modifications are required to be “at least as effective as” the Federal program. ( See section 18(c) of the Act, and 29 CFR 1902.2 and 1956.2.) If a State makes a change to its plan, either on its own initiative or in response to a change in the Federal program or as a result of program monitoring, the State is required to notify OSHA of the change. 29 CFR part 1953 provides the regulatory framework for the submission, review and approval of these changes.

On November 6, 2001, OSHA published notice in the Federal Register and requested public comment (66 FR 56043) on its proposed revisions to 29 CFR part 1953, Changes to State Plans, which were designed to update the rule to reflect current practice and experience since its original issuance and to streamline the process for submission, review and approval of state plan changes. The proposed rule was developed with input from all parties involved in the submission and review of State plan changes and in conjunction with a Federal/State Task Force after interviews with staff in 24 of the 26 States that operate OSHA-approved State plans . The proposed regulatory revisions were presented to the affected States, and their input was incorporated.

The public comment period closed on January 7, 2002. OSHA received one comment on the proposed rule, from Mr. Peter De Luca, Administrator of the Oregon Occupational Safety and Health Division. Mr. De Luca expressed his support of the sections of the proposed regulation regarding delegation of approval authority to Regional Administrators, seeking public comment only on significant differences, and allowing electronic submission of all required documents. However, one area according to Mr. De Luca that “has not received adequate attention * * * is a definition of “at least as effective as.”” He stated that without “adequate guidance” the term “at least as effective as” has often been interpreted to mean “identical to,” and often some State plan innovations are “viewed as less effective until proven otherwise.” According to Mr. DeLuca, States are “burdened with submitting * * * justification documents to defend their programs. Finally, Mr. DeLuca states that the “lack of clarity around ‘at least as effective as’ only stifles and discourages creativity [in State plan States] that could result in greater safety and health for workers.”

OSHA greatly appreciates receiving these views and has carefully considered them in preparing the final rule. OSHA agrees that the principle that State plan requirements are not required to be identical is an important statutory feature of the State plans program. The language and structure of the part 1953 regulation acknowledge the important principle that State plan requirements need not be identical, in providing different procedures for “identical” and “different” State plan changes and in eliminating the requirement for a written plan supplement for “identical” changes. Moreover, throughout its history OSHA has repeatedly acknowledged the latitude of States to develop alternative “at least as effective” requirements.

OSHA believes it would not be practicable or advisable to issue guidance defining the term “at least as effective.” The comparative test comes up a very broad variety of contexts involving a wide variety of State regulations, procedures, and statutory requirements. It would be difficult if not impossible to develop a “one size fits all” definition that works well in all contexts.

OSHA must and should continue to rely on the States to demonstrate that particular State-developed alternative standards or procedures are “at least as effective.” The determination may not always be an easy one. Each different plan change should be evaluated individually on its own merits within the context of that State's program. For example, in making a program change the State may rely, in some instances, on other provisions in the State Plan that are not in the Federal program. Certainly, in enacting a program change, it is the State rather than OSHA that is most likely to have the requisite information to determine if the State's program change is “as effective as” the Federal component.

OSHA believes that its Part 1953 regulation will not unduly impair the State's ability to be “creative” and “innovative” in seeking ways to enhance the health and safety of the workers it covers. OSHA does not view State plan changes as “less effective until proven otherwise,” and we believe that there is nothing in the revised Part 1953 suggesting this. On the contrary, a State makes the initial determination as to whether a particular requirement is “at least as effective” at the time it adopts and begins to enforce the new requirement, and if OSHA disagrees, it must institute an adjudicatory rejection proceeding in which the burden of proof rests with OSHA, not the State.

In light of these comments and the absence of any requests for significant modification, OSHA is proceeding with the promulgation of a final rule which is identical to the proposed rule with only several technical modifications which are described below.

29 CFR part 1953, as originally promulgated, required that whenever a State changed any component of a State's plan that the State was required to provide a copy of the implementing documents, e.g., standards, regulations, operating policies and procedures, administrative and budgetary information, and submit a written description of the change, including the identification of and rationale for any differences from the Federal program (referred to as a plan supplement). This was required whether the change was identical to the Federal regulation, policy or procedure or if it differed. OSHA then reviewed the change; if it met the approval criteria, OSHA was expected to publish a notice announcing the approval of the change; if it did not meet the criteria OSHA initiated procedures to reject the change.

The existing regulation required the submission of a formal written plan supplement even if the State's change to its program is identical to the Federal program component. OSHA is amending this regulation to provide that States must submit written supplements only when the State change is different from the Federal program. State adoption of a standard, regulation, policy or procedure that is identical to the parallel Federal component, an “identical change,” would per se be at least as effective as the Federal program and, if a standard, could not “pose an undue burden on interstate commerce” or otherwise not meet the criteria for approval. (A State submission is considered “identical” if the State adopts the same program provisions and documentation as the Federal program with the only differences being those modifications necessary to reflect a State's unique structure ( e.g. , organizational responsibility within a State and corresponding titles or internal State numbering system).) Therefore, State submission and OSHA review of these changes has been a procedural formality as there is no issue as to approvability. Under the provisions of the revised final rule, States will now be required to submit only documentation attesting to their adoption of the identical Federal change, (such as the cover page of an implementing State directive or a notice of State promulgation) for inclusion in the State Plan documentation and to maintain all other implementing documentation of the actual program change (standard, regulation, policy or procedure) available for review within the State. No formal approval process will be undertaken for such “identical changes.” However, if a State makes a change to its program which differs from ( i.e. , is not identical to) the Federal program, the State must notify OSHA of the change, within an established time frame, provide a copy of all the implementing documents, including documentation as to adoption, and submit a written description of the change, which includes the identification of and rationale for each of the differences from the Federal program. OSHA will then review and either approve or reject the plan change.

The revised final regulation expressly sets forth OSHA's longstanding interpretation of the Act to the effect that States which have submitted and obtained Federal approval of a State plan under section 18(b) may adopt modifications to their State plan (such as new standards, regulations, amendments to State OSHA legislation, or revised enforcement procedures) and may implement these modifications upon adoption, without prior approval of each particular modification by Federal OSHA. Initial Federal approval of a State plan under section 18(b) lifts the barrier of Federal preemption and allows the State to “adopt and enforce standards” under State law. Accordingly, OSHA has always viewed its enabling statute as not requiring pre-enforcement/pre-implementation Federal approval of new standards, regulations or other requirements issued by States with Federally-approved plans. Instead, OSHA reviews these State standards and regulations after they are enacted and subsequently submitted to OSHA for review, and, if there is reason to believe a particular plan modification fails in some way to meet the requirements of the Act, OSHA regulations, both the existing rule and this final revised rule, provide that OSHA will initiate an adjudicative rejection proceeding, in a similar manner to that prescribed by section 18(d) of the Act for Federal rejection of a State plan. 29 CFR 1953.23(d)(2) of the existing regulation now recodified as § 1953.6(e). Upon completion of such a rejection proceeding and any judicial review resulting therefrom, the State plan modification would be excluded from the plan and thus subject to preemption, but until the prescribed process for rejection is completed, the State's health or safety regulation or other State plan modification would remain enforceable. OSHA's longstanding interpretation that section 18 of its enabling statute does not require pre-enforcement/pre-implementation Federal approval for each new safety or health requirement adopted by a State with an approved State plan is consistent with the wording of that statutory provision (which envisions that States with approved plans will “adopt and enforce” their own standards) as well as the Congressional objective set forth in section 2(b)(11) of the Act of “encouraging the States to assume the fullest responsibility for the administration and enforcement of their own occupational safety and health laws.” This interpretation has routinely been incorporated in OSHA Federal Register notices approving or requesting comment on various State plan modifications ( see, e.g, 62 FR 31159 (June 6, 1997) (approval of California hazard communication standard); 50 FR 46460 (November 8, 1985) (New Mexico hearing conservation standard)), and has been judicially upheld in Florida Citrus Packers v. California , 549 F. Supp. 213 (N.D. Cal. 1982). No public comments were received with regard to the inclusion of this interpretation in the proposed regulation. It is therefore included in the final rule, as proposed.

The existing regulation provided that the OSHA Regional Administrators, by authority delegated from the Assistant Secretary, would review and approve State change supplements involving occupational safety and health standards. The Assistant Secretary retained sole authority for review and approval of change supplements not involving standards. The amended regulation simply states that OSHA will review and approve State plan supplements. OSHA will issue appropriate written, publicly available, procedures assigning organizational responsibility for Federal review and approval of State plan supplements. This change provides the Assistant Secretary with the flexibility to modify the strictly internal review procedures without the need for formal rulemaking. It is OSHA's current intent to assign approval authority for all, except the most unusual, plan changes, including standards, to Regional Administrators.

The existing regulation provided for an opportunity for public comment whenever a plan change differs significantly from the Federal program and the publication of a Federal Register notice approving all State plan changes, even those which are identical to a corresponding Federal program component. This revised final rule provides that generally, OSHA will seek public comment only if a State plan change differs significantly from the comparable Federal program component and if OSHA needs additional information on its compliance with the criteria in section 18(c) of the Act, including whether it is at least as effective as the Federal program and, in the case of a standard applicable to products used or distributed in interstate commerce, whether it is required by compelling local conditions or unduly burdens interstate commerce. After public comments are reviewed, a Federal Register notice will be published either approving the State plan modification or announcing OSHA's intention to initiate proceedings to reject it.

The existing regulation discussed four types of plan changes (developmental, in response to Federal program changes, as a result of program evaluation, or at the State's initiative), with the submission and review process for each type addressed separately. Because all plan supplements will be subject to the same review and approval process, OSHA reorganized the regulation to first address the submission of each of the four types of plan supplements, followed by one section on the review and approval of all types of supplements.

The existing regulation required States to submit six copies of all plan supplements. This revised final rule requires States to submit only one copy and provides for the electronic notification and submission of all required documentation.

One minor change has been made to the proposed regulations, to standardize and clarify the time limits for adoption and submission of State plan change supplements or other documentation. Under both the existing rule and the November 6, 2001 proposed revision, State changes in response to new or revised Federal standards were required to be adopted within 6 months of adoption of the Federal standard. However, plan changes in response to changes in the Federal program other than standards were generally required to be both adopted and submitted within six months of notification of the Federal change. (States have been required by OSHA Instruction but not by regulation to submit all new standards within 30 days of adoption.) State-initiated changes not involving standards were required to be submitted within 30 days or 6 months, depending on the nature of the change, under the existing rule, and within 60 days or 6 months under the proposal. Evaluation changes and developmental changes had set time frames for adoption but not for submission in both the existing rule and the proposed revision.

The final regulation has been modified from the proposal to provide uniformity in the time frames for adoption and submission. The regulation continues to provide that State standards in response to Federal standards must be promulgated within six months of Federal adoption. Similarly, changes in response to other Federal program changes requiring adoption will now generally be required to be adopted (rather than submitted) within six months of the Federal change, still allowing some flexibility based on the nature of the change. All changes, regardless of type, must now be submitted within 60 days of adoption (with the exception of emergency temporary standards which, because of their short duration, require submission within 10 days). Section 1953.3(b) contains a general statement of this principle, and it is specifically stated in the sections on submission of the various types of plan changes.

Conforming technical amendments are also being made to sections in Parts 1952, 1954 and 1955 which include references to particular sections in Part 1953, to reflect the revisions.

On September 4, 2001, OSHA published notice in the Federal Register (66 FR 46291) providing a 60 day opportunity for public comment on the information collection requirements associated with Federal regulations governing OSHA-approved State plans (29 CFR parts 1902, 1952, 1953, 1954, 1955, and 1956). This was part of a pre-clearance process under the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(a)), prior to review by the Office of Management and Budget (OMB). No public comments were received, and this Information Collection Request was approved by OMB on February 12, 2002 (Approval Number 1218-0247). The November 6, 2001 Notice of Proposed Rulemaking for this revision of 29 CFR part 1953 included OSHA's proposal to reduce the burden hours associated with the paperwork requirements of this part. The agency received one comment which supported the revision. This final regulation implements a significant reduction of the paperwork required of the States by reducing the number of Federal Program Changes to which they will be required to respond as well as the complexity of those responses. (In addition, an automated system to track plan changes is being implemented which will also reduce the number of direct inquiries to the States for information.) OMB approval of this reduction in burden hours is pending.

OSHA certifies pursuant to the Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) that the proposed revisions will not have a significant economic impact on a substantial number of small entities. These proposed regulations apply only to certain State agencies and would not place small units of government under any new or different requirements, nor would any additional burden be placed upon the State government beyond the responsibilities already assumed as part of the approved plan.

The procedures in 29 CFR part 1953 for submission and approval of plan changes apply only to States which have voluntarily submitted a State plan for OSHA approval under the OSH Act, and accordingly these procedures do not meet the definition of a “Federal intergovernmental mandate” under section 421(5) of UMRA (2 U.S.C. 658(5)).

Executive Order 13132, “Federalism,” (64 FR 43255; Aug. 4, 1999) establishes fundamental Federalism criteria to be applied in formulating and implementing Federal policies, and requires agencies to consult with affected state and local officials in the development of regulatory policies. OSHA has included in the Supplementary Information section of today's notice a general explanation of the relationship between Federal OSHA and the States with approved State plans under the Occupational Safety and Health Act. The proposed rule on which today's final rule is based was developed in coordination with representatives from the State plan States, and opportunities for additional State input have been afforded both during the public comment period and through consultation with the Occupational Safety and Health State Plan Association (OSHSPA), the organization of State agencies which administer Federally-approved plans.

This final rule has been deemed not significant under Executive Order 12866.

This document was prepared under the direction of John L. Henshaw, Assistant Secretary of Labor for Occupational Safety and Health. It is issued under Section 18 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 667), and Secretary of Labor's Order No. 3-2000 (65 FR 50017, August 16, 2000).

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/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .

2. In person . The Agency has established an official record for this action under docket ID number OPP-2002-0216. 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 August 11, 1997 (62 FR 42980) (FRL-5736-1), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 7E4825) by Bayer Corporation, 8400 Hawthorn Rd., Kansas City, MO 64120. This notice included a summary of the petition prepared by Bayer Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.584 be amended by establishing an import tolerance for residues of the fungicide tolylfluanid, (1,1-dichloro-N-[(dimethylamino)-sulfonyl]-1-fluoro-N-(4-methylphenyl) methanesulfenamide), in or on apple at 5.0 parts per million (ppm), grape at 5.0 ppm, hop at 30 ppm, and tomato at 1.0 ppm.

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) of the FFDCA 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) of the FFDCA 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 of the FFDCA 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) of the FFDCA, 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) of the FFDCA, for a tolerance for residues of tolylfluanid in or on apple at 5.0 ppm, grape at 11 ppm, hop at 30 ppm, and tomato at 2.0 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 tolylfluanid are discussed in Table 1 of this unit 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 intra species 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 (SF) 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 SF.

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. In this case because it is an import tolerance only, there is only dietary risk.

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 x 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 tolylfluanid used for human risk assessment is shown in Table 2 of this unit:

1. Dietary exposure from food and feed uses . This activity reflects the establishment of the first U.S. import tolerance for tolylfluanid on apple, grape, hop, and tomato without a U.S. registration. Since there are no other food or feed uses in the United States, the only exposure to occur is dietary.

Risk assessments were conducted by EPA to assess dietary exposures from tolylfluanid 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. The Dietary Exposure Evaluation Model (DEEM TM 7.76) analysis evaluated the individual food consumption as reported by respondents in the United States Department of Agriculture (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 acute Tier 2 (partially refined analysis) exposure assessments: An aPAD of 0.083 mg/kg/day was used for females between 13 and 50 years of age based on developmental toxicity in rabbits. An aPAD of 0.17 was used for the general U.S. population (including infants and children) based on acute neurotoxicity in rats. Anticipated residues were calculated based upon submitted field trial and livestock metabolism data for all proposed uses of tolylfluanid.

The resulting acute dietary exposure estimates do not exceed EPA's level of concern ( < 100% aPAD) at the 95 th exposure percentile for females 13-50 years old (42% aPAD), the general U.S. population (31% of the aPAD) and all other population subgroups. The most highly exposed population subgroup is infants ( < 1 year old, at 100% of the aPAD).

The assessment of acute dietary exposure used the following conservative assumptions likely to generate upper-end estimates of the quantity of tolylfluanid and tolylfluanid residues ingested:

• No import consumption data were used in the assessment (i.e., the assessment assumes that all acute dietary exposure from the proposed commodities is from imported commodities).

• 100% crop treated (CT) was assumed for these imported commodities: All imported grape, apple, hop, and tomato were assumed to have been treated with tolylfluanid and to have tolylfluanid residues at the level of the tolerance.

Inclusion of additional data, such as %CT/import consumption data and/or monitoring data (including metabolites of concern), could be made in order to refine the acute dietary exposure assessment.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the DEEM TM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments:

A cPAD of 0.026 mg/kg/day was used based on the 2-generation rat reproduction study. All dietary exposure from the proposed commodities is from imported commodities. Import share data generated within the Agency were used in the assessment to estimate what proportion of the grape, apple, hop, and tomato consumed in the United States are imported. Modified DEEM TM processing factors based on the results of processing studies were used for raisins and apple and grape juice/juice concentrates. Default DEEM TM processing factors were used for all other processed commodities. Anticipated residues calculations were used based upon submitted field trial and livestock metabolism data.

The assessment of chronic dietary exposure for the general U.S. population and all population subgroups (including infants and children) used the following conservative assumptions to generate upper-end estimates of the quantity of tolylfluanid and tolylfluanid residues ingested:

• 100% CT was assumed for these imported commodities: All imported grape, apple, hop, and tomato were assumed to have been treated with tolylfluanid and to have tolylfluanid residues at the level of the tolerance.

• The calculated ARs (parent and additional metabolites of concern not in tolerance expression) are based on field trial data, submitted by the registrant to support tolerances. Field trial residue data are generally considered by the Agency as an upper-end or a worst case scenario of possible residues and are more suited to the requirements of tolerance setting, because it requires highest rates of application and shortest PHI, than to the requirements of dietary exposure assessment (when a more realistic estimate is desired).

The chronic dietary exposure estimates do not exceed EPA's level of concern ( < 100% cPAD) for the general U.S. population (3% cPAD) and all population subgroups. The most highly exposed population subgroup is children 1-6 years old at 14% of the cPAD.

iii. Cancer . A partially refined, cancer dietary exposure assessment was conducted for the general U.S. population using the same assumptions as were used in the chronic risk assessment (listed in the preceding section). Import share data generated within the Agency were used in the assessment to estimate what proportion of the grape, apple, hop, and tomato consumed in the United States are imported. Modified DEEM TM processing factors based on the results of processing studies were used for raisins and apple and grape juice/juice concentrates. Default DEEM TM processing factors were used for all other processed commodities The cancer risk estimate is 1.2 x 10 - 6 for the general U.S. population.

For cancer dietary risk estimates, the Agency is generally concerned with cancer risks that exceed the range of 1 x 10 - 6 . The following conservative assumptions were used in the cancer dietary exposure assessment:

• The percent import consumption information used for apple, grape and tomato commodities assume that 100% of these imported commodities are treated with tolylfluanid.

• The calculated ARs are based on field trial data, submitted by the registrant to support tolerances. Field trial residue data are generally considered by the Agency as providing an upper-end scenario of possible residues and are more suited to the requirements of tolerance setting, because it requires highest rates of application and shortest PHI, than to the requirements of dietary exposure assessment (when a more realistic estimate is desired).

With additional refinements to the dietary exposure assessment (i.e., country-specific percent import consumption data and/or monitoring data (including metabolites of concern) the Agency expects the estimated cancer risk to be significantly lower.

iv. Anticipated residue and %CT .

Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. Adequate reliable information was not available on the fraction of imported grape, apple, hop, and tomato which were treated with tolylfluanid, therefore the Agency assumed that all these commodities were treated (100% CT). In addition, the Agency must provide for periodic evaluation of any estimates used. As required by section 408(b)(2)(E) of the FFDCA, EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

Section 408(b)(2)(F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of %CT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on %CT. The Agency used %CT information as follows:

Since the tolerances being established are for imported commodities only and a petition for domestic use of tolyfluanid is not currently pending with EPA, the Agency analyzed the amount of imported apple, grape, hop, and tomato, relative to domestic production, and derived a “percent crop imported” figure for each commodity. The Agency based this analysis on import and domestic production data available from the USDA for the years 1995 through 1999. The proportion of imports relative to domestic production for each of the commodities are as follows: Fresh apple—5.6%; apple juice—56.4%; canned apple—0.1%; fresh grape—0.2%, grape juice—43.4%; fresh tomato—16.4%; and processed tomato—4.1%. The Agency's analysis assumed 100% for hop. Tolylfluanid is currently only registered for use in a small number of European countries, however, the estimates stated in this unit reflect total imports of these commodities into the United States, not just imports from Europe. Therefore, the values used in the Agency's risk assessment assume that all imported commodities contain residues of tolyfluanid. These assumptions fulfill Condition 1 by overestimating the portion of imported apple, grape, hop, and tomato with tolylfluanid residues. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency.

2. Dietary exposure from drinking water . Residues in drinking water are not expected to result as a consequence of establishing an import tolerance for tolylfluanid residues in or on apple, grape, hop, and tomato. Tolylfluanid is not registered for use in the United States. Therefore, exposure through drinking water is unlikely.

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). Tolylfluanid 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) of the FFDCA 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 tolylfluanid 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, tolylfluanid 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 tolylfluanid 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. In general . Section 408 of the FFDCA provides that EPA shall apply an additional 10-fold 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 MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity . There is no quantitative or qualitative evidence of increased susceptibility following in utero exposure in the prenatal developmental study in rats. Although there is qualitative evidence of increased susceptibility in the prenatal developmental study in rabbits and in the 2-generation reproduction study in rats, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of tolylfluanid.

3. Conclusion . There is a complete toxicity data base for tolylfluanid and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The RfDs established are protective of pre-/post-natal toxicity following acute and chronic exposures. The Agency therefore concluded that no Special FQPA FS is necessary to protect the safety of infants and children in assessing tolylfluanid exposure and risks. However, a FQPA factor in the form of data base UF (UF DB ) of 3x was applied to the acute RfDs and chronic RfDs to account for the comparative thyroid assay (adult versus young animals) data requirement. 3X is adequate in this case since the observed thyroid hormone changes that necessitated the additional study occurred at a dose level more than three-fold higher than the dose levels (based on developmental and reproductive toxicity) used as the basis for endpoints for risk assessment. Thus, use of an additional 3X FQPA SF will provide at least a 10X margin of safety regarding the effects for which there is some uncertainty and for which additional data is required.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to tolylfluanid will occupy 31% of the aPAD for the U.S. population, 20% of the aPAD for females 13 years and older, 100% of the aPAD for infants < 1year old, and 94% of the aPAD for children between 7 and 12 years old. In addition, there is no potential for acute dietary exposure to tolylfluanid in drinking water. Although this risk assessment projects that infants under 1 year of age will receive the maximum safe exposure, for the reasons detailed in this unit, this assessment is likely to substantially overstate risk.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to tolylfluanid from food will utilize 3% of the cPAD for the U.S. population, 13% of the cPAD for infants < 1 year old, and 14% of the cPAD for children between 1 and 6 years old. There are no residential uses for tolylfluanid that result in chronic residential exposure to tolylfluanid.

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). Tolylfluanid is not registered for use on any sites that would result in residential exposure. Therefore, a short-term aggregate risk was not performed.

4. Intermediate-term risk. Tolylfluanid is not registered for use on any sites that would result in residential exposure. Therefore, an intermediate-term aggregate risk was not performed.

5. Aggregate cancer risk for U.S. population . The cancer risk estimate for the general U.S. population from tolylfluanid is 1.2 x 10 - 6 . In general, the Agency's level of concern for cancer exposure is for risks in the range of 1 x 10 - 6 and this risk estimate is comfortably with this range. Moreover, several conservative assumptions were included in the assessment (enumerated in Unit III.C.1., Dietary exposure from food and feed uses). With additional refinements to the dietary exposure assessment (i.e., country-specific percent import consumption data and/or monitoring data (including metabolites of concern), the Agency expects the cancer risk to be substantially lower.

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 tolylfluanid residues.

For tolylfluanid in/on apple, grape, hop, and tomato, the submitted independent laboratory validation (ILV) using a gas chromatograph (GC)/thermal ionization detector (TID) procedure designated as Method 00441 and entitled Determination of Tolylfluanid in/on Various Raw Agricultural and Processed Commodities has been received and the method has been forwarded to the Agency's laboratory for validation. The petitioner will be required to make any modifications or revisions to the proposed method resulting from EPA's validation.

The petitioners submitted the multiresidue data concerning the recovery of tolylfluanid residues using the Food and Drug Administration (FDA) MRM protocols (PAM Vol. I) and following modified cleanup procedures. These results indicate that tolylfluanid is likely to be recovered through FDA MRM Protocols D and E. The results have been forwarded to the FDA for inclusion in the Pesticide Analytical Method Volume I.

Prior to publication and upon request, the method will be available from the Analytical Chemistry Branch (ACB), BEAD (75053), Environmental Science Center, 701 Mapes Rd., Ft. George C. Meade, MD 20755-5350. Contact Francis D. Griffith, Jr., telephone number: (410) 305-2905; e-mail address: griffith.francis@epa.gov . The analytical standards are also available from the EPA National Standard Repository at the same location.

Based on the proposed uses, a residue enforcement method for livestock commodities is not necessary at this time.

There are no Canadian or Mexican MRLs established for tolylfluanid residues in/on crop commodities. The Codex Alimentarius Commission has established MRLs for tolylfluanid residues in/on various commodities, including currant at 5 ppm, gherkin at 2 ppm, lettuce head at 1 ppm, pome fruits at 5 ppm, strawberry at 3 ppm, and tomato at 2 ppm. The Codex MRLs are expressed in terms of tolylfluanid per se. Although the submitted residue data support the proposed tolerance of 1.0 ppm on tomato, the Agency is establishing this tolerance at 2.0 ppm in order to harmonize with the current Codex MRL.

Therefore, the tolerance is established for residues of tolylfluanid, (1,1-dichloro-N-[(dimethylamino)-sulfonyl]-1-fluoro-N-(4-methylphenyl)methanesulfenamide), in or on apple at 5 ppm, grape at 11 ppm, hop at 30 ppm, and tomato at 2 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, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA 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) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 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 ID number OPP-2002-0216 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 November 25, 2002.

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 (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.

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 20460-0001.

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 20460-0001.

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 ID number OPP-2002-0216, 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 20460-0001. 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 section 408(d) of the FFDCA 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). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 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 section 408(d) of the FFDCA, 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 section 408(n)(4) of the FFDCA. 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).

You may be potentially 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/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/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 ID number OPP-2002-0234. 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, 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.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for combined residues of the herbicide fluroxypyr 1-methylheptyl ester, [1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on sorghum, grain at 0.035 ppm; sorghum, forage at 2.0 ppm; and sorghum, grain, stover at 4.0 ppm. These tolerances will expire and are revoked on December 31, 2005. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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. . . .”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

Due primarily to unusual drought conditions, registered alternative herbicides have proven ineffective. Drought conditions have resulted in poor activation of preemegence herbicides. Available post emergence herbicides are proving ineffective due to the drought hardened condition of the kochia infestations. Kansas has declared a crisis exemption under FIFRA section 18 for the use of fluroxypyr on sorghum for control of kochia.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of fluroxypyr in or on sorghum, grain and its associated commodities. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6). Although this tolerance will expire and is revoked on December 31, 2005, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on sorghum, grain and its associated commodities after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether fluroxypyr meets EPA's registration requirements for use on sorghum or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of fluroxypyr by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than Kansas to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for fluroxypyr, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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 fluroxypyr and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for combined residues of fluroxypyr 1-methylheptyl ester, [1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite furoxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on sorghum, grain at 0.035 ppm; sorghum, forage at 2.0 ppm; and sorghum, grain, stover at 4.0 ppm. The most recent estimated aggregate risks resulting from the use of fluroxypyr 1-methylheptyl ester are discussed in the Federal Register for September 17, 2001 (66 FR 47964) (FRL-6798-5) Final Rule, establishing tolerances for residues of the combined residues of the herbicide fluroxypyr 1-methylheptyl ester and its metabolite fluroxypyr, free and conjugated, all expressed as fluroxypyr, in or on grass, forage at 120 ppm, grass, hay at 160 ppm, and modifying the permanent tolerances for milk from 0.1 ppm to 0.30 ppm and for kidney (cattle, goat, hog, horse, and sheep) from 0.5 ppm to 1.5 ppm because in that prior action, risks were estimated assuming tolerance level residues in all commodities for established tolerances, as well as those for which action was being proposed, such as in this sorghum exemption use. Refer to the September 17, 2001 Federal Register (66 FR 47964) document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon that risk assessment and the findings made in the Federal Register document in support of this action. Below is a brief summary of the aggregate risk assessment.

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. A summary of the toxicological dose and endpoints for fluroxypyr for use in human risk assessment is discussed in Unit IV.A. of the Federal Register of September 17, 2001 (66 FR 47964).

EPA assessed risk scenarios for fluroxypyr under acute, chronic, and short- and intermediate-term exposures. 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 acute exposure assessments: Tolerance level residues were assumed and it was also assumed that 100% of the crops and other commodities with proposed or established fluroxypyr tolerances contained those residues. Anticipated residues, and percent crop treated (PCT) values of less than 100%, were not used.

Using these exposure assessments, EPA concluded that fluroxypyr exposure from food consumption will occupy 1.5% of the acute population adjusted dose (aPAD) for females 13-50 years old, the only population sub-group of concern. A dose and endpoint were not selected for the U.S. population, including infants and children because there were no effects observed in oral toxicology studies including maternal toxicity in the developmental toxicity studies in rats and rabbits that are attributable to a single exposure (dose). Therefore, a risk assessment is not required for this population subgroup.

In addition, despite the potential for acute dietary exposure to fluroxypyr in drinking water, after calculating drinking water levels of concern (DWLOCs) and comparing them to conservative model estimated environmental concentrations (EECs) of fluroxypyr in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 1.

The following assumptions were made for the chronic exposure assessments: Tolerance level residues were assumed and it was also assumed that 100% of the crops and other commodities with proposed or established fluroxypyr tolerances contained those residues. Anticipated residues, and PCT values of less than 100%, were not used.

Using these exposure assumptions EPA concluded that exposure to fluroxypyr from food will utilize 0.6% of the chronic population adjusted dose (cPAD) for the U.S. population, 0.4% of the cPAD for females 13 to 50 years and 2.1% of the cPAD for children 1 to 6 years, the subpopulation at greatest exposure. Based on the use pattern, chronic residential exposure to residues of fluroxypyr is not expected. In addition, there is potential for chronic dietary exposure to fluroxypyr 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 2:

Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluroxypyr 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 were previously addressed.

Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluroxypyr 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 were previously addressed.

The Agency has classified fluroxypyr as “not likely” to be a human carcinogen, therefore this risk assessment is not required.

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 fluroxypyr residues.

Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov .

No Codex, Canadian, or Mexican maximum residue levels (MRLs) have been established for residues of fluroxypyr in or on these commodities. Therefore, no tolerance discrepancies exist between countries for this chemical.

Therefore, the tolerance is established for combined residues of fluroxypyr 1-methylheptyl ester, [1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite furoxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy) acetic acid], in or on sorghum, grain at 0.035 ppm; sorghum, forage at 2.0 ppm; and sorghum, grain, stover at 4.0 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 ID number OPP-2002-0210 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 November 25, 2002.

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 (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your written request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.

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 20460-0001.

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 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.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 the docket ID number OPP-2002-0210, 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 20460-0001. 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 time-limited tolerances under FFDCA section 408. 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). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 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 FIFRA section 18 exemption under FFDCA section 408, such as the tolerances 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).

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/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml _00/Title_40/40cfr180_00.html , a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .

2. In person . The Agency has established an official record for this action under docket ID number OPP-2002-0016. 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 September 9, 1999 (64 FR 49010) (FRL-6095-9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a(d)(3), as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 8E4926) by AVA Chemical Ventures, L.L.C., 65 Aviation Avenue (now at 80 Rochester Avenue, Suite 214), Portsmouth, NH 03801. This notice included a summary of the petition prepared by the petitioner AVA Chemical Ventures, L.L.C. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of sucrose fatty acid esters. EPA has determined that the designation “sucrose fatty acid esters” is too broad, in that it could include other compounds not intended by the registrant, and for which the Agency has not reviewed relevant data. The data and information submitted by the registrant in support of the petition cover an exemption from the requirement of a tolerance for sucrose octanoate esters, which have been identified as the specific type of sucrose fatty acid esters that act as the active ingredient (a.i.) in the petitioner's pending products. EPA's general policy is to establish a tolerance or exemption from the requirement of a tolerance for the actual a.i. contained in the registrant's products. Because the a.i. for which the registrant actually is petitioning is technically defined as sucrose octanoate esters [(α-D-glucopyranosyl-β-D-fructofuranosyl-octanoate), mono-, di-, and triesters of sucrose octanoate], all discussions in this rule and in the resulting tolerance exemption expression refer only to “sucrose octanoate esters [(α-D-glucopyranosyl-β-D-fructofuranosyl-octanoate), mono-, di-, and triesters of sucrose octanoate].” Hereinafter, EPA uses the terms “sucrose octanoate esters” and “SOEs” to mean sucrose octanoate esters [(α-D-glucopyranosyl-β-D-fructofuranosyl-octanoate), mono-, di-, and triesters of sucrose octanoate].

This exemption from the requirement of a tolerance is being issued under the authority of section 408(c) of FFDCA (21 U.S.C. 346a(c)). Under FFDCA section 408, EPA regulates pesticide chemical residues by establishing tolerances limiting the amounts of residues that may be present in or on food, or by establishing exemptions from the requirement of a tolerance for such residues. Food includes articles used for food or drink by humans or other animals. A food containing pesticide residues may not be moved in interstate commerce without an appropriate tolerance or an exemption from the requirement of a tolerance.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for 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(c)(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....” FFDCA section 408(b)(2)(D) specifies other, general factors EPA must consider in establishing an exemption, including the consideration of the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” FFDCA section 408(c)(3) prohibits an exemption unless there is either a practical method for detecting and measuring levels of pesticide chemical residue in or on food or EPA determines that there is no need for such a method and states the reason for such determination.

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information 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.

Sucrose octanoate esters are made from a caprylic fatty acid ester derived from an edible oil or fat, and sucrose. Sucrose is the primary product of photosynthesis (Reference 1) and therefore, common in food crops eaten regularly by humans and animals. Sucrose, also known as table sugar, has an exceedingly long history of human dietary exposure (Reference 1). The octanoate esters are made from octanoic acid (caprylic acid), a common fatty acid in plants, which is produced in small quantities in the human body and is marketed as a human dietary supplement (Reference 1). Sucrose octanoate esters derived from edible vegetable oils, edible tallow or hydrogenated edible tallow have been FDA-approved since 1983 (21 CFR 172.859) when used (as an additive for direct addition to food) as emulsifiers in certain processed foods and as post-harvest protective coatings for certain fruits. FDA expanded in 1995 the range of foods in which SOEs are permitted, to include use in emulsifiers, stabilizers, and texturizers in chewing gum, confections, and frostings; texturizers in surimi-based fabricated seafood products; and emulsifiers in coffee and tea beverages with added dairy ingredients and/or dairy product analogs (60 FR 44755). The applicant collected and summarized the toxicological data associated with the cited FDA food-use approvals and submitted this information in support of their tolerance exemption request (Reference 2). The Agency reviewed both the summaries and the underlying data.

Toxicity information/data submitted in support of this tolerance exemption are referenced below. New studies were contracted by the petitioner only for primary eye irritation and primary dermal irritation. Data waivers were requested and granted for all other toxicity data requirements. Publically available information/data were submitted, in lieu of studies, as part of the scientific justification necessary to support the data waiver requests (References 2, 3, and 4). In addition, the Agency has found additional relevant data from additional public sources including the National Toxicology Program which have been of value to the Agency's review of this petition (Reference 1). The submitted information/data, in combination, were found equivalent to what would normally be provided by guideline studies, and therefore would likely have been adequate to meet each toxicology requirement had they been submitted as such pursuant to 40 CFR 152.90(b)(4). More detailed analyses of these data and information can be found in specific Agency reviews of the studies and technical literature (References 1, 5, and 6).

1. Primary eye irritation (OPPTS 870.2400, 152-13) MRIDs 446101-05 and 446101-06: Following ocular instillation of 0.1 mL of undiluted manufacturing-use product into the eyes of rabbits, moderate to severe eye irritation and mild corneal opacity was observed in the treated eyes of all rabbits at 24 hours post-dosing, and persisted in 1 rabbit to 21 days post-dosing. Mild iritis was exhibited in 3 rabbits at 24 hours post-dosing, and persisted in 1 rabbit to 72 hours. Classification: Acceptable; Toxicity Category I for the manufacturing-use product. In a second primary eye irritation study, following ocular instillation of 0.1 mL of undiluted end-use product into the eyes of rabbits, moderate to severe eye irritation was observed in the treated eyes of all 6 rabbits at 72 hours post-dosing, was mild at 7 days, and cleared by 14 days. Mild corneal opacity was observed in all 6 rabbits at 24 hours, and persisted to 7 days in 1 rabbit, then cleared by 14 days post-dosing. Mild iritis persisted in 4 rabbits to 72 hours, then cleared. Classification: Acceptable; Toxicity Category II for the end-use product.

2. Primary dermal irritation (OPPTS 870.2500, 152-14) MRIDs 446101-03 and 446101-04: Following dermal application of 0.5 mL of undiluted manufacturing-use product to the skin of rabbits, 5 rabbits exhibited very slight erythema and one exhibited well-defined erythema at 1 hour post-treatment. Very slight erythema persisted on 4 rabbits to 24 hours, then cleared. No edema was observed on any rabbit. Classification: Acceptable; Toxicity Category IV for the manufacturing-use product. In a second primary dermal irritation study, following dermal application of 0.5 mL of undiluted end-use product to the skin of rabbits, very slight erythema was exhibited by 6 rabbits at 0.5 hour post-treatment and 5 rabbits exhibited very slight to slight edema. All symptoms cleared by 24 hours. Classification: Acceptable; Toxicity Category IV for the end-use product.

Data waivers were requested for the following studies. Although no acute toxicity studies were conducted by the registrant, acceptable information/data was submitted from the open technical literature to support the data waiver requests.

3. Acute oral toxicity waiver (OPPTS 870.1100, 152-10) MRID 444158-03, and Amendment number 1: Acute oral and dietary toxicity data, previously evaluated in three publications by the Food and Agriculture Organization (FAO) of the United Nations World Health Organization (WHO), were submitted in support of this data waiver request (References 2, and 3). The data contained in these reports demonstrated that SOEs had extremely low oral toxicity (in laboratory studies), even at concentrations substantially higher than are found in human food. Extremely high concentrations were needed to produce toxic symptoms in laboratory studies (LD 50 < 20,000 milligrams/kilogram (mg/kg)). Long-term and short-term dietary studies (100 days to 2.5 years), evaluated in the aforementioned FAO/WHO reports, demonstrated that dietary consumption at levels of up to 3% in the diets of rats, mice and dogs caused no substantial toxicological effects. An acceptable daily intake (ADI) of SOEs for humans was estimated to be up to 16 mg/kg body weight/day, which is equivalent to 1.28 kg of SOEs per day for a 176 lb person. In studies with rats and humans, it was demonstrated that SOEs were rapidly hydrolyzed and absorbed by the body. In addition, the National Toxicology Program lists the octanoic acid oral LD 50 for rats as 10,080 mg/kg (Reference 1). The information/data described above supports waivers from the data requirements for acute oral toxicity studies. The Agency concludes that SOEs have extremely low toxicity. Classification: Acceptable; Toxicity Category IV for the manufacturing-use product and end-use product.

4. Acute dermal toxicity waiver (OPPTS 870.1200, 152-11) MRID 444158-03 and Amendment number 1: A data waiver was granted for this guideline study based on the strength of the supporting information/data submitted by the registrant. In addition, publically available sources list the octanoic acid dermal LD 50 for rabbits as > 5,000 mg/kg (Reference 1). Classification: Acceptable; Toxicity Category IV for the manufacturing-use product and end-use product.

5. Acute inhalation toxicity waiver (OPPTS 870.1300, 152-12) MRID 444158-03 and Amendment number 1: A data waiver was granted for this guideline study based on the strength of the supporting information/data submitted by the registrant (References 2, 3, and 5). Classification: Acceptable; Toxicity Category IV for the manufacturing-use product and end-use product.

6. Hypersensitivity study waiver (OPPTS 870.2600, 152-15) MRID 444158-04: No hypersensitivity incidents (152.16) have been reported for laboratory workers regularly exposed to SOEs for up to 6 years. In addition, the registrant is obliged under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 6(a)(2) to notify the Agency in the event of such incidents. Classification: Acceptable.

7. Genotoxicity and Mutagenicity waiver (OPPTS 870.5300, 870.5195; 152-17, and 152-19) MRID 444158-03 and Amendment number 1: No guideline studies were submitted, but it was determined that none are required because acceptable information/data were submitted from the open technical literature to scientifically justify a waiver of the data requirements for genotoxicity and mutagenicity. This information/data demonstrate that SOEs are not genotoxic and/or mutagenic, nor is the a.i. structurally and/or chemically similar to known mutagens or known classes of mutagens (References. 2, 3, and 5). In addition, a study reported by the National Toxicology Program shows octanoic acid to be negative for genotoxicity/mutagenicity (Reference 1). Classification: Acceptable.

8. Immune response and other Subdivision M toxicity data waivers (OPPTS 880.3800 through 870.4200, 152-18 through 152-29) MRID 444158-03 and Amendment number 1: Due to the low toxicity of SOEs (as demonstrated in the cited open technical literature (References 2, 3, 4, 5, and 6), the Agency granted waivers from all other Subdivision M toxicity data requirements, including the 90-day feeding and teratogenicity studies. In addition, octanoic acid is considered a nonteratogenic compound even at the very high dose rate of 18.75 millimoles/kg (Reference 1).

In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

1. Food . An ADI of SOEs for humans was estimated by FAO/WHO to be up to 16 mg/kg body weight/day, which is equivalent to 1.28 kg of SOEs per day for a 176 lb person (References. 2, 3, and 5). There are no reasonably foreseeable circumstances in which the residue levels of SOEs would ever approach this amount. Sucrose octanoate esters break down into their natural constituents (sugar and fatty acids) shortly after application. The foliar application rate for the product would be at a volume to volume rate of 0.32% to 0.40% (Reference 7) for the a.i.. Likewise the a.i. use rate when applied to honey bees would be 0.25%, and would range from 0.5% to 1.0% when treating mushroom growing media. In studies with rats and humans, it was demonstrated that SOEs were rapidly hydrolyzed and absorbed by the body (Reference 5). Because SOEs are the mono-, di- and tri-esters of sucrose with fatty acids and are derived from sucrose (sugar) and edible tallow or edible vegetable oils, there is a great likelihood of exposure in the normal human diet to SOEs and SOEs' components for most, if not all individuals, including infants and children. Sucrose octanoate esters are a sucrose fatty acid ester, and sucrose fatty acid esters are a normal part of the human diet. Thus SOEs may be considered a normal part of the human diet. To date, there have been no reports of any hypersensitivity incidents or reports of any known adverse reactions in humans resulting from exposure to SOEs, which have been FDA-approved food emulsifiers and post-harvest protective fruit coatings since 1983. Even if there is a significant increase in exposure to SOEs due to their use as a pesticide, the acute toxicity information and data available from the National Toxicology Program and submitted by the registrant demonstrating extremely low mammalian toxicity (Toxicity Category IV) indicate that risk associated with acute exposures by the oral, dermal and inhalation routes would be low to non-existent.

2. Drinking water exposure . No drinking water exposure is expected, as SOEs are not soluble in water, do not persist in the environment, and are biodegradable within approximately five days at approximately 20-27°C, in both aerobic and anaerobic conditions (Reference 5). Because SOEs have extremely low toxicity, have been approved for food use by FDA, and are present as direct food additives in many foods, should exposure through drinking water occur, no risk is anticipated.

The potential for non-dietary exposure to SOEs residues for the general population, including infants and children, is unlikely because potential use sites are commercial, agricultural, and large-scale horticultural. Sucrose octanoate esters' constituent sugars and fatty acids are normal parts of the human diet. Sucrose octanoate esters' toxicity has been determined to be extremely low (except via the ocular exposure route). Therefore, while there exists a great likelihood of prior exposure for most, if not all, individuals to both SOEs and SOEs' components, any increased exposure due to the proposed products would be negligible because the product would very likely be degraded to sugars and fatty acids and/or consumed by microorganisms before the general public would come in contact with treated plants or food products from treated plants.

The Agency has considered the cumulative effects of SOEs and other substances in relation to a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. There is no indication of mammalian toxicity from the submitted information/data (except by the ocular route of exposure) for SOEs. Therefore, no adverse cumulative effects are expected.

1. U.S. population . There is a reasonable certainty that no harm will result from aggregate exposure to residues of SOEs to the U.S. population. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the extremely low levels of mammalian toxicity associated with SOEs (except for risk from ocular exposure, which will be mitigated via precautionary label language). Sucrose octanoate esters have extremely low toxicity (LD 50 > 20,000 mg/kg in laboratory studies of oral exposure), and it is unlikely that any toxic effects will result from exposure to SOEs via the oral, dermal or inhalation pathways when the products are used according to proposed label directions (Reference 5). The amount of SOEs applied to food crops is many orders of magnitude lower than the concentrations of SOEs needed to cause toxicological effects. Because the worst case scenario exposure is far below the level of any dietary toxicity known for SOEs or their components and degradates, EPA has determined that residues will not pose a dietary risk under reasonably foreseeable circumstances and that the setting of a tolerance exemption is appropriate.

2. Infants and children . FFDCA section 408 provides that EPA shall apply an additional ten-fold margin of exposure (safety) for infants and children in the case of threshold effects to account for pre-natal and post-natal toxicity and the completeness of the data base unless EPA determines that a different margin of exposure (safety) will be safe for infants and children. Margins of exposure (safety) are often referred to as uncertainty (safety) factors. In this instance, based on all the available information, the Agency concludes that SOEs are practically non-toxic to mammals, including infants and children (except via ocular exposure). Thus, there are no threshold effects of concern, and so the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. As a result, EPA has not used a margin of exposure (safety) approach to assess the safety of SOEs.

EPA is required under the FFDCA as amended by FQPA to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there is no scientific basis for including, as part of the program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, SOEs may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption.

Based on available data, no endocrine system-related effects have been identified with consumption of SOEs. It is an FDA-approved direct food additive comprised of sugars and fatty acids, having an ADI of 16 mg/kg body weight/day. To date, there is no evidence to suggest that SOEs affect the immune system, function in a manner similar to any known hormone, or that they act as an endocrine disruptor.

The Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation for the reasons stated above, including SOEs' low mammalian toxicity (except by ocular exposure). For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purposes for SOEs.

There are no Codex Maximum Residue Levels (MRLs) established for residues of SOEs.

Based on the toxicology information/data submitted and publically available, there is a reasonable certainty that no harm will result from aggregate exposure of residues of SOEs to the U.S. population, including infants and children, under reasonably foreseeable circumstances, when the biochemical pesticide is used in accordance with good agricultural practices. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the information/data submitted and publically available data demonstrating no toxicity, except from ocular exposure. Potential risk from ocular exposure will be effectively addressed under FIFRA by mitigating precautionary label language. As a result, EPA establishes an exemption from the tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of SOEs in or on all food commodities.

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 ID number OPP-2002-0016 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 November 25, 2002.

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 (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your written request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.

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 20460-0001.

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 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX.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 ID number OPP-2002-0016, 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 20460-0001. 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).

1. USEPA . Brief summary of toxicity information to support registration/tolerance exemptions for sucrose octanoate. R. S. Jones to D. Greenway; August 8, 2002.

2. Barrington, T., and C. L. Hartman . Sucrose fatty acid esters-Safety data in support of petition proposing a temporary (sic) exemption from the requirement of a tolerance for use in all food commodities (MRID 444158-03); October 2, 1997.

3. Barrington, T. and W. L. Biehn . Sucrose fatty acid esters-safety data in support of petition proposing an exemption from the requirement of a tolerance for use in all food commodities, Amendment number 1 to MRID 444158-03; July 13, 1998.

4. Barrington, A. Waiver request; July 12, 2002.

5. USEPA . Science review in support of registration of sucrose octanoate esters. R.S. Jones to D. Greenway; February 14, 2000.

6. USEPA . Sucrose octanoate esters; A request for concurrence on a decision to waive the requirement for 90-day feeding (152-20) and teratogenicity (152-23) studies, based on the Registrant's correspondence of July 12, 2002. D. Greenway to R. S. Jones; August 7, 2002.

7. Barrington, A. Sucrose octanoate esters - per-acre application rates; July 12, 2002.

This final rule establishes an exemption from the tolerance requirement 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). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 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 exemption 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).

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/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00. html , a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .

2. In person . The Agency has established an official record for this action under docket control number OPP-2002-0235. 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 ailable 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 August 14, 2002 (67 FR 52990) (FRL-7191-7), 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 pesticide petitions (PP 1E6227, 1E6241, 1E6283, 1E6291, 1E6320, 1E6329, 1E6333, 1E6334, 1E6335, 1E6399, and 1E6340 ) by the Interregional Research Project Number 4 (IR-4), P.O. Box 231, Rutgers University, New Brunswick, NJ 08903 and PP 4F4379 from Dow Agro Sciences LLC, Indianapolis, IN 46268. This notice included a summary of the petition prepared by Dow Agro Sciences LLC, the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.431 be amended by establishing tolerances for residues of the herbicide clopyralid, 3,6-dichloro-2-pyridinecarboxylic acid, in or on the following commodities: Flax seed at 3.0 part per million (ppm); strawberry at 1.0 ppm; hop, dried cones at 5.0 ppm; rapeseed seed, rapeseed forage, canola seed, mustard seed, and crambe seed at 3 ppm, and canola meat at 6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5 ppm; garden beet tops at 3.0 ppm and garden beet roots at 4.0 ppm; mustard greens at 5.0 ppm; turnip roots at 1.0 ppm and turnip greens at 4.0 ppm; cranberry at 4 ppm; sweet corn, kernel plus cob with husks removed at 1.0 ppm, sweet corn forage at 7.0 ppm, sweet corn stover at 10.0 ppm, pop corn grain at 1.0 ppm, pop corn stover at 10.0 ppm, liver of cattle, goat, horse, and sheep at 3.0 ppm, meat byproducts, except liver, of cattle, goat, horse and sheep at 36.0 ppm, and milk at 0.2 ppm; and the brassica, head and stem, subgroup at 2.0 ppm. EPA is editorially correcting the tolerance expressions to read canola meal and turnip, tops.

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 clopyralid on strawberry at 1.0 ppm; hop, dried cones, at 5.0 ppm; rapeseed seed, rapeseed forage, mustard seed, and crambe seed at 3 ppm, canola meal and flax meal at 6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5 ppm; prunes at 1.5 ppm, garden beet tops at 3.0 ppm and garden beet roots at 4.0 ppm; mustard greens at 5.0 ppm; turnip roots at 1.0 ppm and turnip tops at 4.0 ppm; cranberry at 4.0 ppm; sweet corn, kernel plus cob with husks removed at 1.0 ppm, sweet corn forage at 7.0 ppm, sweet corn stover at 10.0 ppm, pop corn grain at 1.0 ppm, pop corn stover at 10.0 ppm, liver of cattle, goat, horse, and sheep at 3.0 ppm, meat byproducts, except liver, of cattle, goat, horse and sheep at 36.0 ppm, and milk at 0.2 ppm; and the Brassica, head and stem, subgroup at 2.0 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 clopyralid are discussed in the following Table 1 and Table 2 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 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 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 intra species 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 x 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 clopyralid used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.431) for the residues of clopyralid, in or on a variety of raw agricultural commodities. Established, proposed and increased tolerances for clopyralid are adequate for any expected secondary residues in meat, milk, poultry and/or eggs. Risk assessments were conducted by EPA to assess dietary exposures from clopyralid 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. In conducting this acute dietary risk assessment the Dietary Exposure Evaluation Model (DEEM TM ) 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 acute exposure assessments. Residue levels are at the recommended tolerances with the exception of sugar beets. The empirical processing factor of 0.1x was used for sugar-beet representing the 10-fold reduction in residues for refined sugar. One hundred percent of all of the crops are treated with clopyralid.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM TM ) 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. Residue levels are at the recommended tolerances with the exception of sugar beets. The empirical processing factor of 0.1x was used for sugar-beet representing the 10-fold reduction in residues for refined sugar. One hundred percent of all of the crops are treated with clopyralid.

iii. Cancer . Acceptable oral rat and mouse carcinogenicity studies show no evidence of carcinogenic or mutagenic potential. Clopyralid is classified as not likely to be a human carcinogen.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for clopyralid 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 clopyralid.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone Model/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 clopyralid they are further discussed in the aggregate risk sections in Unit III.E of this document.

Based on the FIRST and SCI-GROW models the estimated environmental concentrations (EECs) of clopyralid for acute exposures are estimated to be 46 parts per billion (ppb) for surface water and 9.7 ppb for ground water. The EECs for chronic exposures are estimated to be 18 ppb in surface water and 9.7 ppb 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).

Clopyralid is currently registered for use on the following residential non-dietary sites: Turf and ornamentals (including golf courses). The risk assessment was conducted using the following residential exposure assumptions: the 75 mg/kg/day NOAEL was used in the short-term inhalation, hand-to-mouth, and episodic granular ingestion risk assessments of the residential exposure. The intermediate-term assessment for children's hand-to-mouth exposure was based on the 15 mg/kg/day NOAEL chosen for incidental oral exposure. As no dermal endpoint was selected, a dermal risk assessment was not required for residential exposure. For residential oral and inhalation risk assessments, the target margin of exposure (MOE) was 100 which incorporates the removal of the FQPA Safety Factor. MOEs calculated for residential handler's inhalation exposure and children's oral exposures were well above the target of 100; and therefore, do not exceed the Agency's level of concern.

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 clopyralid 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, clopyralid 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 clopyralid 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. 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 MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity . No increased quantitative or qualitative susceptibility was seen following pre- and/or post-natal exposures. In the developmental study with rats, no developmental toxicity was seen at the HDT (250 mg/kg/day) even in the presence of severe maternal toxicity which manifested as deaths, reduced body weight gain and decreased food consumption. In the two generation reproduction study, offspring toxicity, characterized as decreased pup weight and increased liver weights, occurred only at the HDT (1,500 mg/kg/day) which is higher than the Limit Dose (1,000 mg/kg/day). These changes occurred in the presence of severe parental toxicity (decreased body weight, body weight gain, food consumption and slight focal hyper keratosis of the gastric mucosa). In the developmental rabbit study, hydrocephalus was seen in eight fetuses (3/15 litters) only at the highest dose tested (250 mg/kg/day) in the presence of severe maternal toxicity that manifested as death, decreases in mean body weight and lesions of the gastric mucosa; the developmental NOAEL was 110 mg/kg/day. The available data indicate that a developmental neurotoxicity study would have to be tested at dose levels higher than 250 mg/kg/day because no developmental toxicity was observed in rats at 250 mg/kg/day. In addition, the offspring NOAEL in the two generation reproduction study was 500 mg/kg/day with a LOAEL of 1,500 mg/kg/day. Therefore, it is anticipated that in order to elicit any fetal nervous system abnormalities in a developmental neurotoxicity study, the selected dose levels would have to be higher than 500 mg/kg/day. Since the dose level selections for the developmental neurotoxicity study will be greater than 500 mg/kg/day, the resultant NOAEL will be either comparable to, or higher than the doses currently used in the risk assessment. The NOAEL of 75 mg/kg/day selected for the acute RfD is seven times lower than the offspring NOAEL in the reproduction study. The NOAEL of 15 mg/kg/day selected for the chronic RfD and the residential exposure risk assessments is thirty three times lower than the offspring NOAEL in the reproduction study. Therefore, a developmental neurotoxicity study would not likely change the regulatory doses used for overall risk assessments.

3. Conclusion . EPA determined that an additional factor to protect infants and children was not appropriate. Several factors influenced this decision not to require a development neurotoxicity (DNT) study:

i. Although hydrocephalus was observed at the high dose in the developmental rabbit study, it was seen in the presence of severe maternal toxicity;

ii. No alterations to the fetal nervous system were seen in the developmental rat study at the same dose (250 mg/kg/day);

iii. There was no quantitative or qualitative evidence of increased susceptibility in the two generation reproduction study;

iv. There is no concern nor are there residual uncertainties for pre and/or post natal toxicity; and

v. Although there are no acute or subchronic neurotoxicity studies, there is no evidence of neurotoxicity or neuropathology in adult animals in any of the studies. EPA decided that the FQPA safety factor should be reduced to 1 rather than the statutory default factor of 10 because the existing toxicology database, which is complete, revealed no quantitative or qualitative evidence of increased susceptibility following in utero exposure to rats and rabbits and/or following prenatal/postnatal exposure to rats; and dietary (food and drinking water) and residential exposure assessments will not underestimate the potential exposures for infants, children, and/or women of childbearing age from the use of clopyralid.

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 ground water are less than the calculated DWLOCs, 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 . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to clopyralid will occupy 4% of the aPAD for the U.S. population, 2% of the aPAD for females 13 years and older, 4% of the aPAD for all infants ( < 1 year) and 7% of the aPAD for children 1-6 years. In addition, there is potential for acute dietary exposure to clopyralid 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 aPAD, as shown in the following Table 3:

Section 9004 of the Resource Conservation and Recovery Act (RCRA) authorizes the Environmental Protection Agency (EPA) to approve state Underground Storage Tank Programs to operate in the State in lieu of the Federal Underground Storage Tank (UST) Program. To qualify for final authorization, a state's Program must: (1) Be “no less stringent” than the Federal Program for the seven elements set forth at RCRA Section 9004(a)(1) through (7); and (2) provide for adequate enforcement of compliance with the UST standards of RCRA Section 9004(a). Note that RCRA Sections 9005 (on information-gathering) and 9006 (on Federal enforcement) by their terms apply even in states with Programs approved by the EPA under RCRA Section 9004. Thus, the Agency retains its authority under RCRA Sections 9005 and 9006, 42 U.S.C. 6991d and 6991e, and other applicable statutory and regulatory provisions to undertake inspections and enforcement actions in approved states. With respect to such an enforcement action, the Agency will rely on Federal sanctions, Federal inspection authorities, and Federal procedures rather than the state authorized analogues to these provisions. Moreover, authorization of a state Program is a prospective action only and an authorized state Program only operates in lieu of the Federal Program as of the effective date of the authorization. The Agency may undertake enforcement of the Federal requirements for violations of those Federal requirements which occurred prior to the effective date of authorization of the state's Program. In this case, authorization of the Hawaii UST Program will be effective on September 30, 2002.

On May 23, 2001, the State of Hawaii submitted an official application to obtain final program approval to administer the Underground Storage Tank Program for petroleum and hazardous substances. On October 5, 2001, the EPA published a tentative decision announcing its intent to grant Hawaii final approval. Further background on the tentative decision to grant approval appears at 66 FR 50963-50966, October 5, 2001.

Along with the tentative determination, the EPA announced the availability of the application for public comment and the date of a public hearing on the application. The EPA requested advance notice for testimony and reserved the right to cancel the public hearing for lack of public interest. The hearing was held at Kawananakoa Middle School in Honolulu, Hawaii on November 13, 2001.

Written comments regarding the EPA's approval of Hawaii's Underground Storage Tank Program were received during the comment period from EnviroWatch, Inc. Oral comments regarding the EPA's approval of Hawaii's Underground Storage Tank Program were received during the public hearing from Carroll Cox, President of EnviroWatch, Inc., and Joe Ryan, a resident of Waimanalo.

Additionally, in April 2001, prior to publication of EPA's tentative decision to authorize Hawaii's Underground Storage Tank Program, EPA received a Petition To Withdraw Hawaii Certification and Title VI Complaint of Discriminatory Acts (Petition to Withdraw) challenging the administration and enforcement of environmental programs by the State of Hawaii and seeking withdrawal of authorization for all environmental programs. We have taken into consideration comments in the Petition relating to the Hawaii Underground Storage Tank Program in taking today's action. Today's action is not a final determination on the merits of the Petition to Withdraw. The significant issues raised by the commenters and EPA's responses are summarized below.

1. Comment: EPA received comments relating to the Hawaii Department of Health's (HDOH) implementation of other programs for which Hawaii has been delegated authority by EPA. The comments generally asserted that HDOH has a track record of being unable to properly enforce other federally delegated programs and, thus, that the State would not adequately enforce its underground storage tank program. Specific examples cited included Hawaii's enforcement of the Clean Water Act, including the State's National Pollutant Discharge Elimination System (NPDES) program, Hawaii's investigation into a sewage dumping incident, and the purported failure of the State's Attorney General to give priority to environmental enforcement. The Petition to Withdraw also identified the State's economic condition and the reduction in force of State employees responsible for inspections and enforcement as a reason why the State would not be able to administer and enforce the UST program according to Federal guidelines and rules.

Response: Each environmental program is unique and must be evaluated in light of the particular Federal and state requirements applicable to that program. Among other things, programs differ significantly in the numbers and types of pollutants regulated; the number, size and type of facilities which are regulated; the complexity and scope of regulatory requirements; regulatory mechanisms (for example, use of permits and prohibitions); tools for assessing compliance ( e.g. , inspections, self-monitoring and self-reporting); and enforcement options. Moreover, different programs vary in funding levels and sources, and staffing levels (both number of staff and required qualifications).

Requirements applicable to EPA's authorization of Hawaii's UST program are found generally at 40 CFR part 281. These requirements include criteria for determining whether a state's program is “no less stringent than” the corresponding Federal program. See 40 CFR 281.30 through 281.39. These requirements also include criteria for determining whether a state can adequately enforce its program. See 40 CFR 281.40 through 281.43. EPA has reviewed and evaluated Hawaii's UST authorization application in light of the criteria set forth in 40 CFR part 281. EPA has determined that Hawaii's UST program meets the criteria set forth in 40 CFR part 281 and has determined that authorization of this program is appropriate in light of those criteria.

With respect to HDOH's performance in enforcing its UST program, HDOH began implementation of its field citation program in May 2000. Field citations are issued for easily verifiable and correctable violations of Hawaii's UST rules, and involve lower penalty amounts than are assessed in traditional administrative enforcement actions. Since May 2000, HDOH has conducted 476 state-led field citation inspections and has issued 143 field citations assessing total penalties of $133,450. To date, 122 facilities have paid their assessed penalty for a total of $102,565 in penalties received by HDOH.

Over the past year, HDOH initiated enforcement efforts ( e.g. , warning letters and proposed orders) against recalcitrant owners and operators at approximately 220 facilities who had failed to conduct response activities to address releases that occurred at their facilities prior to 1997. As a result, many of these facilities are currently conducting appropriate release response activities, including site assessments and cleanup. Work has been completed at approximately 25 percent of these facilities and the cases are now closed.

With respect to the portion of the comment related to HDOH's enforcement resources, in Fiscal Year (FY) 2003 (October 1, 2002-September 30, 2003) Hawaii's UST and LUST program budgets are $420,402.00 and $673,551.00 respectively. HDOH has four full time UST inspector positions and has a goal of conducting a minimum of 400 UST facility inspections during FY2003. With approximately 1,100 operating UST facilities, and 400 UST facilities inspected annually, each of these facilities would be inspected at least once every three years to ensure compliance with State UST regulations. In addition to an aggressive FY2003 inspection schedule, HDOH identified ten administrative enforcement actions against non-compliant facilities in FY2002. Three of these cases have settled while an additional eight are in development or pending.

With respect to the comments related to Hawaii's implementation and enforcement of the Clean Water Act, these are the same comments which were raised in the Petition. In response to the Petition, EPA decided to change its schedule of state program audits to perform an audit of Hawaii's NPDES program earlier than originally scheduled. Pursuant to the audit, EPA reviewed Hawaii's statutory authorities as well as enforcement mechanisms, and the audit raised some concerns, particularly related to enforcement. EPA is working with the State to address those concerns. We are also reviewing the issues raised in the Petition, and will respond directly to the Petitioner on those issues.

2. Comment: EPA received comments expressing the concern that the HDOH was unable to ensure that other Hawaii State agencies complied with UST program requirements, including the Federal deadline for upgrading existing tanks (December 22, 1998, pursuant to 40 CFR 280.21), (the corresponding State provision is found at Hawaii Administrative Rules [HAR] 11-281-18, and sets a deadline of January 28, 2000, the effective date of the regulations). These comments focused generally on the failure of HDOH to identify or require closure of an UST by the Hawaii Department of Land and Natural Resources (HDLNR) at a pumphouse near Pearl Harbor's Richardson Field.

Response: The HDOH has the legal authority to bring an enforcement action against another State agency and, in fact, HDOH has taken enforcement action against other State agencies. The EPA is satisfied that appropriate enforcement actions can and will be taken by HDOH against other non-complying State of Hawaii agencies when necessary. HDOH began its UST field citation program in April 2000. Since that time, HDOH has inspected 13 State facilities and has issued field citations to five of those facilities. The field citations assessed penalties ranging from a low of $150 up to a high of $1,750. EPA is confident that HDOH treats all tank owners and operators equally with respect to conducting inspections and taking enforcement action, including State agencies.

EPA has reviewed the situation relating to the UST located at the pumphouse near Pearl Harbor's Richardson Field and is satisfied with HDOH's actions with respect to this UST. Given the dates of service of this UST, which was apparently taken out of service in 1960 prior to the 1962 transfer of the land to HDLNR, HDLNR would not ordinarily have the responsibility for closure of this UST. Under Section 9001(3)(B) of RCRA, 42 U.S.C. 6991(3)(B), for USTs no longer in service after November 8, 1984, the “owner,” who would ordinarily be responsible for closure, is the entity who owned the UST immediately before it was taken out of service. See also Hawaii Revised Statutes (HRS) Chapter 342-L1.

3. Comment: EPA received comments expressing concern that the State has implemented its UST program in a discriminatory manner and that the State does not have an adequate environmental equity policy.

Response: These comments are similar to the issues raised in the Petition To Withdraw Hawaii Certification and Title VI Complaint of Discriminatory Acts (Petition to Withdraw), which was rejected by EPA's Office of Civil Rights (OCR) in October of 2001. While the comments received on EPA's tentative decision to authorize Hawaii's UST program did not provide specifics with respect to these concerns, the Petition to Withdraw specifically referred to the incident relating to mercury contamination emanating from the pumphouse near Richardson Field with respect to the allegations of discriminatory conduct by the State.

As set forth above in response to Comment 2 with respect to HDOH's actions relating to the UST at the pumphouse near Richardson Field, EPA has reviewed those actions and is satisfied that HDOH has acted appropriately. No other specific examples of HDOH acting in a discriminatory manner that specifically relate to HDOH's implementation of the UST program were identified by the comments or the Petition to Withdraw.

With respect to today's decision to authorize Hawaii's UST Program, EPA must ensure that Hawaii has an adequate UST enforcement program. While EPA does not typically review environmental justice policies in the context of determining whether a state has an adequate UST enforcement program, EPA notes that, on January 2, 2002, the HDOH Environmental Health Administration issued an Environmental Equity Policy. This policy confirms that HDOH will “through the implementation of federal and state environmental laws, rules, policies, and programs, ensure the fair and equitable treatment of all persons as it evaluates and addresses the risks and consequences associated with environmental pollution.”

4. Comment: EPA received comments questioning the State's ability and “political strength” to enforce its UST requirements at Federal facilities. Additionally, questions were raised concerning the continued role of EPA with respect to Federal facility enforcement in the State, after authorization of the UST Program.

Response: HDOH conducts inspections of military sites and has issued UST field citations to the military and other Federal facilities for violations of State UST requirements. These Federal facilities have returned to compliance as directed by the citations issued by HDOH. However, disputes have arisen between the facilities and HDOH regarding whether penalties assessed by the State must be paid by Federal facilities and whether the Federal government's sovereign immunity with respect to such penalties has been waived. This dispute regarding the waiver of sovereign immunity with respect to penalties assessed by state agencies is not limited to Hawaii, but is a national issue, affecting all state UST programs. The ability of HDOH to pursue violations and require compliance is not in question.

EPA is continuing to offer assistance to the states, including Hawaii, for Federal facility UST inspections. As to EPA's role after authorization of the program, where appropriate, EPA will continue to exercise its enforcement authority, including the assessment of penalties, since EPA's administrative penalty authority against Federal UST facilities is not in dispute. EPA-lead inspections of Federal UST facilities are conducted jointly with HDOH. In addition, all inspection and enforcement related information gathered in connection with Federal UST facilities is shared between EPA and HDOH.

5. Comment: EPA received comments expressing concern regarding the practical ability of citizens to seek a review of Hawaii's administration of the State's UST Program, once it has been delegated. The commenter was concerned that requests for review of the State's programs are referred to the State, rather than being handled by EPA. The commenter suggested that certain safeguards be implemented in order to ensure adequate review of such requests. These suggestions included requiring administrative review of the State Program upon the filing of a citizen's complaint and including possible sanctions against the State if it is not adequately implementing its Program.

Response: The process for withdrawal of approval of authorized state UST programs is set forth at 40 CFR 281.60 and 281.61. 40 CFR 281.61(b) cross-references the procedures set forth for withdrawal of approval of authorized state hazardous waste programs at 271.23(b) and (c). Both 40 CFR 281.61(b) and 271.23(b) allow interested persons to petition EPA to commence proceedings to withdraw approval of these state programs. EPA must respond in writing to any such petitions. 40 CFR 271.23(b)(1). If EPA determines that proceedings to withdraw approval of an authorized UST program are appropriate, either in response to an interested person's petition or on the Agency's own initiative, EPA may order commencement of such proceedings. Petitions to withdraw approval of authorized state programs are not referred to the affected state for a decision. The only sanction specifically provided in the regulations is withdrawal of the program. Neither the statute nor the regulations provide for sanctions in addition to withdrawal of program approval against a state that is not adequately implementing its UST Program.

6. Comment: EPA received comments criticizing EPA's criteria for deciding whether or not to hold a public hearing on EPA's tentative determination to authorize Hawaii's UST Program. The commenter asserted that the decision whether to hold a public hearing on that tentative determination should not be based on whether there was “sufficient” public interest, since, the commenter argued, that standard was vague and unfair.

Response: The standard for determining whether a public hearing should be held on EPA's tentative decision to authorize a state program is set forth at 40 CFR 281.50(e)(4), which indicates that, if “insufficient public interest is expressed,” EPA may cancel the public hearing. In any event, EPA held a public hearing on its tentative decision to authorize Hawaii's UST Program on November 13, 2001. The hearing was held at Kawananakoa Middle School in Honolulu, Hawaii. Thus, regardless of the standard used to determine whether or not a hearing should be held, the public did in fact have an opportunity to attend a public hearing on EPA's tentative decision to authorize Hawaii's UST Program and the concerns raised by these comments are moot.

7. Comment: EPA received comments expressing concern over whether or not EPA would continue to oversee Hawaii's implementation of its UST Program after authorization. These comments also requested clarification of the timing of approval of Hawaii's UST program and the standards used to determine whether or not to approve authorization.

Response: The effective date of today's decision to authorize Hawaii's UST Program is September 30, 2002. The criteria used to evaluate Hawaii's UST Program are set forth generally at 40 CFR Part 281. These regulations can be found on the web at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr281_00.html.

Pursuant to 40 CFR 281.24, at the time of approval of a state's application for authorization of its UST program, a Memorandum of Agreement (MOA) must be signed by the Regional Administrator and the appropriate official of the state lead agency. The MOA contains proposed areas of coordination between the state and EPA as well as a delineation of separate state and Federal roles and responsibilities. These roles and responsibilities include the following areas: Enforcement, compliance monitoring, EPA oversight, and sharing and reporting of information. In the MOA entered into between EPA and the State of Hawaii with respect to implementation of Hawaii's UST Program, EPA has assumed an oversight role with respect to the State's program. This oversight role will include an annual review of the State's Program in order to assist the State in implementing its Program, and to allow EPA to report to the President, the Congress and the public on the achievements of the State's UST Program. The MOA also envisions that EPA and the State will coordinate regarding desirable technical support that EPA may provide to the State, and regarding targeting of joint efforts to prevent and mitigate environmental problems associated with the improper management of USTs.

8. Comment: EPA received comments expressing concerns regarding Hawaii's UST Program and whether or not the Program was as stringent as the Federal UST program.

Response: EPA has determined that Hawaii's application for authorization of its State UST Program meets the criteria for approval set forth at 40 CFR part 281. As part of this determination, EPA has determined that Hawaii's UST Program is “no less stringent” than the Federal UST program in accordance with 40 CFR part 281, subpart C. EPA has also determined that the State has provided for an adequate enforcement program pursuant to 40 CFR part 281, subpart D, and has provided for public participation in the enforcement process in accordance with 40 CFR 281.42.

With respect to EPA's determination that Hawaii's UST program is “no less stringent” than the Federal UST program, in its Federal Register notice announcing its tentative decision to authorize Hawaii's UST Program, EPA specifically identified certain areas of the Hawaii program which EPA considers broader in scope than the Federal UST program. See 66 FR 50964-50965 (October 5, 2001). While these “broader in scope” provisions are enforceable by the State, they are not part of the authorized program and are thus not enforceable by EPA. EPA has determined that the remaining aspects of the State's UST Program are as stringent or more stringent than the Federal program. EPA notes that Hawaii's deadline for UST owner/operators to upgrade their existing USTs, found at Hawaii Administrative Rules (HAR) 11-281-18, was January 28, 2000, the effective date of the Hawaii regulations. The Federal deadline for upgrading existing tanks, found at 40 CFR 280.21, was December 22, 1998. For USTs which met Hawaii's deadline but failed to meet the Federal deadline, Hawaii and EPA, through the MOA, have agreed that EPA will assume all related enforcement responsibilities.

As explained above, authorization of a state Program is a prospective action only and an authorized state Program only operates in lieu of the Federal Program as of the effective date of the authorization. The Agency may undertake enforcement of the Federal requirements for violations of those Federal requirements which occurred prior to the effective date of authorization of the state's Program. Since the Hawaii UST Program operates in lieu of the Federal UST Program as of September 30, 2002, the Federal deadline for upgrading existing tanks, found at 40 CFR 280.21, December 22, 1998, is not affected by this authorization. EPA may continue to undertake enforcement of violations of the Federal regulation, 40 CFR 280.21, occurring between December 22, 1998 and September 30, 2002. EPA may also enforce the State regulation, HAR 11-281-18, with respect to tanks that continue to be in violation of the upgrade requirement on or after September 30, 2002.

With the exception of those provisions deemed “broader in scope” than the Federal program, the Hawaii program being authorized by today's action consists of the following statutory and regulatory provisions: HRS 128D-4; HRS 342L-1 through 342L-53; and HAR 11-281-01 through 11-281-131.

EPA has also determined that the State has provided for public participation in the enforcement process in accordance with 40 CFR 281.42 and that the State's enforcement program is “adequate” in terms of the factors set forth at 40 CFR part 281, subpart D. Based on these determinations, EPA is authorizing the State's UST Program pursuant to today's rulemaking.

9. Comment: The Petition to Withdraw asserted that the State had denied access to public documents in violation of the Hawaii Uniform Information Practices Act (HRS 92F-1 et seq. ) (UIPA).

Response: EPA notes that the UIPA contains provisions allowing persons aggrieved by denial of access to State governmental records to compel disclosure of the requested information. See HRS 92F-15.

10. Comment: EPA received comments requesting information on how farm tanks and agricultural businesses using USTs are regulated and how spills from such systems would be addressed.

Response: The Federal UST requirements exclude from the definition of “underground storage tank” or “UST” any “[f]arm or residential tank of 1,100 gallons or less capacity used for storing motor fuel for noncommercial purposes.” 40 CFR 280.12. The Federal regulations define “farm tank” as “a tank located on a tract of land devoted to the production of crops or raising animals, including fish, and associated residences and improvements.” 40 CFR 280.12. The Federal definition of “farm tank” also makes clear that a farm tank must be located on the farm property and that the term “farm” includes fish hatcheries, rangeland and nurseries with growing operations. 40 CFR 280.12. Hawaii's definitions of “underground storage tank” or “UST”, “farm” and “farm tank” track the Federal definitions but also indicate that a farm tank must be used only for farm related purposes. See HAR 11-281-03. Thus, EPA has determined that Hawaii's UST Program is broader in scope than the Federal UST program to the extent that Hawaii regulates 1,100 gallon capacity or less USTs storing motor fuel on farms when such USTs are used for non-commercial purposes other than farming purposes.

Spills from tanks which are excluded from the definition of “underground storage tank” or “UST” under Hawaii's UST Program would not be addressed using the corrective action authorities set forth at HAR 11-281 Subchapter 7. However, the State may have additional authorities available to it to address cleanup of such spills under certain circumstances. For instance, HRS 128D-4 provides the State with specific release response and enforcement authorities in order to address certain releases of hazardous substances. Other State and Federal authorities may also exist, depending on the circumstances associated with any particular spill.

I conclude that the State of Hawaii's application for final program approval meets all of the statutory and regulatory requirements established by Subtitle I of RCRA. Accordingly, Hawaii is granted final approval to operate its Underground Storage Tank Program for petroleum and hazardous substances. The State of Hawaii, as of the effective date of this rule, has the responsibility for managing all regulated underground storage tank facilities within its border and carrying out all aspects of the Underground Storage Tank Program where the EPA will have regulatory authority. Hawaii also has primary enforcement responsibility, although the EPA retains the right to conduct enforcement actions under section 9006 of RCRA and to gather information under section 9005 of RCRA.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 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. Under section 202 of the UMRA, the 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 UMRA generally requires the 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 the 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 explanation why that alternative was not adopted. Before the 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 UMRA 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 the 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 UMRA) for State, Local or Tribal Governments or the private sector. The UMRA generally excludes from the definition of “Federal intergovernmental mandate” duties that arise from participation in a voluntary Federal program. Hawaii's participation in the EPA's State Program approval process under RCRA Subtitle I is voluntary. Thus, today's rule is not subject to the requirements of Sections 202 and 205 of the UMRA.

In addition, the EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Although small governments may own and/or operate underground storage tanks, they are already subject to the regulatory requirements under the existing State requirements that the EPA is now approving and, thus, are not subject to any additional significant or unique requirements by virtue of this action. Thus, the requirements of section 203 of the UMRA also do not apply to today's rule.

The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rule-making 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 the purposes of assessing the impacts of today's action on small entities, a small entity is defined as: (1) A small business as specified in the Small Business Administration regulations; (2) a small governmental jurisdiction that is a government 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 this action on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This action does not impose any new requirements on small entities because small entities that own and/or operate underground storage tanks are already subject to the State underground storage tank requirements which the EPA is now approving. This action merely approves for the purpose of RCRA Section 9004 those existing State requirements.

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. The 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 today's Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The Office of Management and Budget has exempted this rule from the requirements of Executive Order 12866.

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks,” applies to any rule that: (1) The Office of Management and Budget determines is “economically significant” as defined under Executive Order 12866; and (2) concerns an environmental health or safety risk that the 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 planned rule on children and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045 because it approves a state program.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), requires the 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 does not have Tribal implications. There are no federally-recognized Indian tribes within the State of Hawaii. The authorization of Hawaii's UST program 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. Even if Indian Country existed within the State, Hawaii would not be approved to implement the RCRA Underground Storage Tank Program in Indian Country and this action would have no effect on the Underground Storage Tank Program that the EPA would implement in Indian Country within the State. Thus, Executive Order 13175 does not apply to this rule.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires the 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.”

Under section 6 of Executive Order 13132, the EPA may not issue a regulation that has Federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal Government provides the funds necessary to pay the direct compliance costs incurred by State and Local Governments, or EPA consults with State and Local Officials early in the process of developing the proposed regulation. The EPA also may not issue a regulation that has Federalism implications and that preempts State law unless the Agency consults with State and Local Officials early in the process of developing the proposed regulation.

This action does not have Federalism implications. It 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, because it affects only one state. This action simply provides the EPA approval of Hawaii's voluntary proposal for its State Underground Storage Tank Program to operate in lieu of the Federal Underground Storage Tank Program in that State. Thus, the requirements of Section 6 of the Executive Order do not apply.

As noted in the proposed rule, 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) directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would 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 the EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This action does not involve technical standards. Therefore, the EPA did not consider the use of any voluntary consensus standards.

Under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , Federal agencies must consider the paperwork burden imposed by any information request contained in a proposed rule or a final rule. This rule will not impose any information requirements upon the regulated community.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

In Title 47 of the Code of Federal Regulations, Parts 40 to 69, revised as of October 1, 2001, § 54.403 is corrected on page 114 by adding paragraph (c) to read as follows:

The final regulations that are the subject of this correction concern the negotiations between a LEC and a building owner to relocate the telecommunications demarcation point(s) to the minimum point of entry (MPOE). The regulations require that the LEC complete the negotiations within 45 days of the building owner's initial request. This requirement was originally adopted in the Competitive Networks Report and Order 66 FR 2322, 2335). However, it was inadvertently changed in the Part 68 Streamlining Report and Order (66 FR 7579, 7592).

As published, the final regulations contain errors, which may prove to be misleading and are in need of clarification.

The Board's decision adopting these regulations (which includes the new rules) is posted on the Board's website, www.stb.dot.gov. In addition, copies of the decision may be purchased from Da -2-Da Legal Copy Service by calling 202-293-7776 (assistance for the hearing impaired is available through FIRS at 1-800-877-8339) or visiting Suite 405, 1925 K Street, NW., Washington, DC 20006.

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