The U.S. Small Business Administration is amending its regulations governing appeals before the SBA's Office of Hearings and Appeals (OHA). OHA is SBA's administrative tribunal that provides an independent, quasi-judicial forum to appeal various types of decisions. The matters addressed on appeal include: SBA formal size determinations; contracting officer designations of North American Industry Classification System (NAICS) codes for procurements government-wide; certain SBA determinations relating to 8(a) BD program eligibility, graduation, suspension, and termination; Service-Disabled Veteran-Owned Small Business Concern status appeals, SBA employee dispute appeals; and employee salary offsets.

In order to increase transparency and understanding of its appeals process, SBA is amending its hearings and appeals regulations to codify current practices, and to clarify certain existing regulations, particularly for the manypro selitigants who file appeals with OHA. Some of these revisions change existing procedures; however, we believe these revisions have minimal impact on the public.

Among other things, these amendments codify OHA's longstanding practices on access to appeal files and protective orders as well as its practice of citing its prior decisions as precedent. These amendments also permit the filing and service of pleadings by e-mail; limit the number of pages for each appeal petition unless OHA approves in advance; and clarify the time period for filing an appeal. SBA is also adding provisions promoting the use of alternative dispute resolution procedures generally, and a new subpart on SBA employee dispute resolution procedures.

Consideration of Comments.SBA is publishing this rule as a direct final rule because it believes that this rule is routine and non-controversial. This rule merely codifies existing procedures and clarifies practices that are also purely procedural in nature. Because this rule affects only the procedural regulations of SBA's Office of Hearings and Appeals, SBA believes that notice and comment is unnecessary. Thus, SBA believes there is good cause to bypass notice and comment and proceed to a direct final rule pursuant to 5 U.S.C. 553(b). SBA believes that this direct final rule will not elicit any significant adverse comments. However, if such comments are received, SBA will publish a timely notice of withdrawal in theFederal Register.

SBA is adding a definition for “business day” to § 134.101. SBA is making several non-substantive revisions to § 134.102 on OHA's jurisdiction. These revisions include: removing from § 134.102(k) a lengthy definition that also appears in § 134.101; removing and reserving § 134.102(d), (f), and (m) to conform to the 2009 elimination of OHA appeals of SBA enforcement actions against SBA lenders, intermediaries, and non-lending technical assistance providers, 73 FR 75524, Dec. 11, 2008; removing and reserving § 134.102(n) to conform to the 2008 elimination of OHA appeals for Small Disadvantaged Business determinations, 73 FR 57495, Oct. 3, 2008; adding to § 134.102(r) a reference to new subpart H and updating websiteinformation; and adding to § 134.102(t) a list of the means by which the Administrator may refer a proceeding to OHA. SBA is removing and reserving § 134.103, on time periods and deadlines, and placing these rules in § 134.202(d).

SBA is shortening the subpart heading to read “Subpart B—Rules of Practice”. Section 134.201 sets out where to locate the rules applying to specific types of OHA proceedings and how to determine which rule governs in the event of conflicting rules. SBA is making non-substantive revisions to this section to list more of the proceedings to which specific rules apply and to increase clarity.

Section 134.202(a) governs the commencement of cases initiated by a party other than SBA. The current rule provides a 45-day deadline for filing an appeal petition and an incomplete list of the types of proceedings that have different deadlines. SBA is amending § 134.202(a) by replacing the 45-day deadline with a reference to the regulations governing the specific type of appeal. SBA is also adding a new rule providing that, where the SBA action or determination being appealed contains a different time period (or deadline) for filing an appeal petition than does the applicable regulation, then the longer time period (or later deadline) governs. Thus, a petitioner will have the benefit of the longer time period or deadline.

SBA is adding to § 134.202 new paragraph (d) on the calculation and modification of time periods and deadlines. The new § 134.202(d) provides a clearer explanation of the rules currently at § 134.103 and a detailed example of how to count days. OHA staff receive many inquiries on how to count days and where to find this rule. SBA believes the revisions, example, and relocation to § 134.202(d) will reduce the number of inquiries.

Section 134.203 sets out the components of an appeal petition. SBA is adding the word “appeal” to the section heading, a reference to § 134.102 in § 134.203(a)(1), and the petitioner's e-mail address to the requirements of § 134.203(a)(5). SBA is removing current § 134.203(a)(7) and the second sentence of current § 134.203(b). The provisions in those places are redundant.

New § 134.203(d) will limit an appeal petition to 20 pages unless prior leave is granted, and requires a table of authorities only if more than 20 authorities are cited. New § 134.203(d) also provides additional guidance to petitioners, such as that it is unnecessary to attach documents already submitted to SBA, because SBA will submit these directly to OHA.

New § 134.203(e) has the heading, “Motion for a more definite appeal petition.” It revises the regulation currently at § 134.205. Section 134.203(e) will shorten, from 15 to five days, the time period for the respondent (almost invariably the SBA) to file this motion; will permit the Judge to order a more definite appeal petition on his or her own initiative; and will permit the Judge to dismiss an appeal with prejudice for the petitioner's failure to comply with such an order. New § 134.203(f) informs petitioners that OHA issues a Notice and Order after an appeal petition is filed and that, should a party not receive this document, it should contact OHA.

Section 134.204 concerns the filing and service of pleadings and other submissions. SBA is amending § 134.204 to include introductory text stating that a submission requires filing, service, and a certificate of service. The only substantive change is the addition of e-mail to the permitted methods of filing and service set out in § 134.204(a). Revised § 134.204(b) includes OHA's e-mail address for filings and a reference to 28 U.S.C. 1746, a provision helpful to parties in preparing exhibits. Current § 134.204(e) has been moved to § 134.204(c)(4) and revised to include a reference to the section on protective orders. Section 134.204(d), on the certificate of service, has been revised for clarity and to accommodate e-mail service.

SBA is moving current § 134.205 to § 134.203(e), as discussed above, and replacing § 134.205 with a new section that has the heading, “The appeal file, confidential information, and protective orders.” New § 134.205 fully states in one place OHA's longstanding practices involving confidential information and access to appeal files.

New § 134.205(a) sets out the typical contents of an appeal file, and § 134.205(b) describes the procedure for a party to file with OHA pleadings containing the party's own confidential information, including service of redacted copies on other non-government parties. New § 134.205(c) explicitly refers members of the public to the Freedom of Information Act (FOIA), 5 U.S.C. 552, for access to appeal files. Section 134.205(d) codifies OHA's practice of permitting a party in a pending appeal to examine and copy its own submissions in the appeal file, as well as any other information there that would not be exempt from disclosure under the FOIA. This “party access” is a matter of due process, and parties typically use it to ensure that the appeal file does contain all of the party's own submissions, including any sent previously to the SBA office that issued the determination being appealed.

Section 134.205(e) codifies OHA's longstanding practice of issuing protective orders that set out the terms under which outside counsel may have access to all information in a pending appeal file except for tax returns and privileged information. New § 134.205(f) codifies OHA's longstanding practice of publishing its decisions even though these decisions may contain confidential information, and procedures to request a redacted public decision. The only substantive change from current practice in new § 134.205 is that OHA's Web site will contain detailed information on its protective order procedure.

Section 134.206 concerns respondents' pleadings. SBA has made three revisions to this section. The first removes the last sentence in § 134.206(a)(1), a sentence rendered unnecessary by the addition of subpart H. The second rewrites § 134.206(b) to codify OHA practices in cases where the appeal of an SBA determination requires the Agency to file and serve an administrative record, practices which for many years have been set out in the initial notice and order. The third adds § 134.206(e) to codify OHA practice relating to petitioners' replies to responses.

SBA is amending § 134.207 to include references to § 134.211 and to explicitly state that the Judge, on his or her own initiative, may order an amendment or a supplemental pleading. SBA is amending § 134.209 to note that false statements in pleadings are subject to criminal penalties, and that misconduct is subject to sanctions, with a reference to § 134.219.

Section 134.211 governs motion practice. SBA is changing two deadlines in this section. First, the deadline for responses to a motion, in § 134.211(c), changes from 20 days after service of the motion to 15 days. The 20-day period for response is much longer than needed, and can delay the issuance of a decision. Further, a party needing more time to respond to a motion has the option of moving for more time under § 134.211(f). Second, the deadline for filing a motion to extend time, in § 134.211(f), has been changed from “two days” before the original deadline to “two business days”. This change will eliminate the uncertainty in counting back days when a weekend or a Federal holiday is encountered. Other revisions in this section are to clarify existing procedures.

SBA is changing the words “summary decision” in the heading and text of § 134.212 to “summary judgment”, to more accurately reflect the procedures described therein, and to avoid confusion with the summary decision set out in § 134.226(a)(3). SBA also is shortening the deadline, in § 134.212(a), for filing a response to either the original motion or a cross-motion from the current 20 days after service to 15 days. A party needing more time to respond may move for more time under § 134.211(f). New § 134.212(a)(4) establishes a deadline of 15 days for the respondent to file its answer or response under § 134.206 in the event the respondent has not yet made this filing, the Judge denies a motion for summary judgment, and the Judge does not establish a different deadline. Other revisions to § 134.212 clarify the rule.

SBA is amending § 134.213(c) by adding a reference to the section on protective orders. SBA is amending § 134.214, on subpoenas, by shortening the deadlines related to motions to quash from 10 days to five days; and by removing two unneeded sentences.

Section 134.216 concerns alternative dispute resolution (ADR). SBA adds two new provisions to this section to further Federal policy encouraging administrative agencies to use ADR (see5 U.S.C. 571-572), and SBA's firm commitment to the greater use of ADR (see64 FR 27843, May 21, 1999). The first provision adds new § 134.216(b) to permit a Judge to offer ADR to the parties. The second provision adds new § 134.216(c) to permit designation of either a Judge or an OHA attorney to serve as a neutral in ADR procedures. An OHA-provided neutral will not be involved in the adjudication if mediation fails to resolve all issues in a case.

SBA is revising the last sentence of § 134.218(c) to clarify that a denial of a motion for recusal may be appealed “within 5 days” rather than “immediately”.

SBA is amending § 134.219 to list five sanctions a Judge may apply for misconduct by a party or its counsel. These sanctions include: Ordering a pleading or evidentiary filing to be struck from the record; dismissing an appeal with prejudice; suspending counsel from practice before OHA; filing a complaint with the applicable State bar; and taking any other action that is appropriate to further the administration of justice.

SBA is amending § 134.222, on oral hearings, to delete paragraph (a)(3), a provision applicable only to administrative wage garnishment cases, which OHA no longer hears; and to correct typographical errors in § 134.222(d). SBA is amending § 134.223 to clarify that the weight given to hearsay evidence is at the Judge's discretion.

SBA is removing and reserving § 134.224, on standards for decision. The standard for decision is provided in the regulations pertaining to each specific type of case, and this section causes confusion. SBA is removing § 134.225(b), on public access to the record, as unnecessary given its inclusion in § 134.205.

SBA is amending § 134.226(a) to add two new provisions that codify, in part, existing practices. New § 134.226(a)(2) provides that all OHA decisions create precedent, unless either a regulation governing a specific type of appeal provides otherwise, or the Judge designates a particular decision as not to be cited as precedent. The practice of citing its prior decisions as precedent has been an accepted part of OHA's quasi-judicial function since OHA's inception in 1983. SBA believes it appropriate to codify the practice.

New § 134.226(a)(3) permits issuance of an abbreviated version of a decision where the Judge finds that a full decision would not advance understanding of law, regulation, or policy and the underlying facts and law are of a routine and non-complex nature. OHA's longstanding practice is to issue short decisions and orders dismissing appeals in appropriate cases, and this rule codifies the practice.

SBA makes several changes to subpart C. First, SBA amends § 134.302(b) to correct an SBA official's title. Second, SBA amends § 134.305 to require that a size appeal include a copy of the size determination being appealed, and to add an e-mail address and fax number for service to the Associate General Counsel for Procurement Law. Third, SBA is amending § 134.306(b) to permit a contracting officer to provide an electronic link to the solicitation in lieu of a paper copy. Fourth, SBA makes a technical revision to § 134.315 to conform to a revision made in § 134.225.

Finally, SBA adds new section § 134.318 regarding NAICS appeals. This section references certain sections of part 121 that apply to NAICS appeals, clarifies the effect of OHA's decision in a NAICS appeal, and permits early, summary dismissal of a NAICS appeal in certain instances to codify current, longstanding practice.

SBA amends § 134.403 to permit service of the appeal petition by e-mail, and to make various editorial revisions.

SBA is also deleting § 134.404 as redundant, and replacing it with a new section providing a 45-day deadline for filing an 8(a) appeal. The 45-day deadline does not represent any change, as it is the default deadline in current § 134.202. Because SBA is revising § 134.202 to direct parties to the regulations governing specific appeals, the regulations governing 8(a) appeals will need to contain the deadline. Thus, it is being added here. SBA is also revising § 134.405 to eliminate the reference to § 134.202 contained there.

In § 134.406, SBA makes revisions to paragraphs (c) and (e). Section 134.406(c) concerns the content of the administrative record in 8(a) appeals. The revised rule adds a heading to § 134.406(c) and divides it into paragraphs (c)(1) to (c)(3) for ease of use. The revised rule also adds one sentence at the end of new paragraph (c)(1) and two sentences at the end of new paragraph (c)(2) to codify and make more transparent longstanding practices regarding SBA claims of privilege and petitioner objections. Section 134.406(e) concerns remands in 8(a) appeals. The revised rule adds a heading to § 134.406(e) and divides it into paragraphs (e)(1), (e)(2), and (e)(4) for ease of use. SBA also adds new paragraph (e)(3) to codify the longstanding practice of remanding an 8(a) appeal where the SBA determination being appealed raises a new ground not included in the initial SBA determination. Apart from these revisions, and the correction of an SBA official's title in paragraph (e)(1), there are no other changes to the text of § 134.406.

SBA is amending § 134.505 to require the appeal petition in Service-Disabled Veteran-Owned (SDVO) Small Business Concern (SBC) cases to include a copy of the determination being appealed and the petitioner's e-mail address. The revisions also provide the e-mail addresses for the SBA officials whom the petitioner must serve.

SBA corrects cross-references in §§ 134.601, 134.602, 134.606, and 134.611 to conform with redesignations made to this subpart in 1998 and 2005. 63 FR 35766, June 30, 1998; 70 FR 8927, Feb. 24, 2005.

SBA is adding Subpart H setting forth the rules of practice for OHA appeals of SBA Employee Disputes. Subpart H replaces the portions of Standard Operating Procedure (SOP) 37 71 that deal with OHA appeals, and codifies several items of longstanding OHA practice.

OMB has determined that this rule does not constitute a “significant regulatory action” under Executive Order 12866. This rule codifies current practices of the SBA's Office of Hearings and Appeals and clarifies other practice rules. As such, the rule has no effect on the amount or dollar value of any Federal contract requirements or of any financial assistance provided through SBA. Therefore, the rule is not likely to have an annual economic effect of $100 million or more, result in a major increase in costs or prices, or have a significant adverse effect on competition or the United States economy. In addition, this rule does not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency, materially alter the budgetary impact of entitlements, grants, user fees, loan programs or the rights and obligations of such recipients, nor raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

For purposes of Executive Order 12988, SBA has drafted this rule, to the extent practicable, in accordance with the standards set forth in section 3(a) and 3(b)(2) of that Order, to minimize litigation, eliminate ambiguity, and reduce burden. This rule has no preemptive or retroactive effect.

This rule does not have Federalism implications as defined in Executive Order 13132. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various layers of government, as specified in the Order. As such it does not warrant the preparation of a Federalism Assessment.

For purposes of the Paperwork Reduction Act, 44 U.S.C. Ch. 35, SBA has determined that this rule does not impose new reporting or record keeping requirements.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-12, requires administrative agencies to consider the effect of their actions on small entities, small nonprofit enterprises, and small local governments. Pursuant to the RFA, when an agency issues a rule, the agency must prepare a regulatory flexibility analysis which describes the impact of the rule on small entities.

However, section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

This rulemaking addresses the rules of practice governing cases before the Small Business Administration's (SBA) Office of Hearings and Appeals (OHA). OHA is SBA's administrative tribunal, and these regulations are procedural by nature. This rule codifies current practices to make them more transparent, and clarifies other rules. The increased clarity and transparency of OHA's procedural rules will benefit small businesses litigating matters before OHA, especially those litigatingpro se.Few of these revisions change existing procedures, and those that do have minimal effect on small entities.

Therefore, within the meaning of the RFA, SBA certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities because the rulemaking is procedural and imposes no significant additional requirements on small entities.

The Commission is amending: (1) Its Informal and Other Procedures1 to establish a new subpart (“Regulation P”),2 to establish a set of procedures to facilitate requests by registered public accounting firms for interim Commission review of PCAOB inspection reports (§ 202.140), and to redesignate existing Rule 12 (§ 202.11) as Rule 190 (§ 202.190); (2) its Rules of Organization and Program Management3 to provide delegations of authority to the Chief Accountant related to these reviews (§ 200.30-11); and (3) its Rules of Practice4 to reflect the new delegations of authority (§ 201.430 and § 201.431).

The Act established the PCAOB to oversee the audit of companies that are subject to the securities laws, and related matters, in order to protect the interests of investors and further the public interest in the preparation of informative, accurate, and independent audit reports. The PCAOB operates under the comprehensive oversight and enforcement authority of the Commission.5

Consistent with that oversight, Section 104(h) of the Act provides for the opportunity of a registered public accounting firm to request interim Commission review with respect to PCAOB inspection reports. The Commission is adopting new rules to implement the Act's provisions relating to these interim review requests.

Section 104 of the Act requires the PCAOB to conduct a continuing program of inspections of each registered public accounting firm.6 That section of the Act directs the PCAOB to publish a written report of its findings for each inspection.7

As required by the Act, PCAOB rules provide that a registered public accounting firm may review and respond to a draft inspection report.8 However, when the PCAOB first publishes its report, no portions of the inspection report that deal with criticisms of, or potential defects in, the quality control systems of the firm under inspection shall be made public if those criticisms or defects are addressed by the firm, to the satisfaction of the PCAOB, not later than 12 months after the date of the inspection report.9

Section 104 of the Act also provides that a registered public accounting firm may seek interim review by the Commission, pursuant to such rules as the Commission may promulgate, if the firm either:

(1) Has responded to the substance of particular items in the PCAOB's draft inspection report and disagrees with the assessments contained in any final report prepared by the PCAOB following that response, or

(2) Disagrees with the PCAOB's determination that quality control criticisms or defects identified in the inspection report have not been addressed to the satisfaction of the PCAOB within 12 months of the date of the inspection report.10

To implement Section 104 of the Act as to the PCAOB's basic inspection program, the Commission approved a set of rules proposed by the PCAOB.12 These rules provide that the PCAOB will make a draft inspection report available for review by the firm that is the subject of the report, and the firm may submit a written response to the draft report, which will become part of the inspection report.13 A separate PCAOB rule implements the Act's 12-month delay of publication of any portions of an inspection report that deal with criticisms of, or defects in, the inspected firm's quality control systems.14 During that 12-month period, the firm that is the subject of the report may submit evidence or otherwise demonstrate to the PCAOB that it has improved its quality control systems and remedied the defects in question. If the PCAOB determines that the firm has addressed the quality control defects and criticisms in the final report satisfactorily, the portion of the report that dealt with those defects and criticisms will not be made public.15

On the other hand, if the inspected firm has failed to address those defects and criticisms to the satisfaction of the PCAOB within the 12-month period mandated by Sections 104(g) and (h) of the Act, the PCAOB will take one of the following actions:

(1) If the inspected firm failed to make any submission to the PCAOB concerning the firm's efforts to address the quality control defects or criticisms, the PCAOB will make those portions of the report public upon expiration of the 12-month period;

(2) If the firm made a submission to the PCAOB concerning the firm's efforts to address the quality control defects or criticisms, but did not seek timely interim Commission review of an adverse PCAOB determination concerning those defects or criticisms,the PCAOB will make public those portions of the report that deal with criticisms of or potential defects in quality control systems that the firm has not addressed to the satisfaction of the Board upon expiration of a 30-day period during which the firm may seek Commission review; or

(3) If the inspected firm made a timely request for interim Commission review, the PCAOB will make public those portions of the report that deal with criticisms of or potential defects in quality control systems that the firm has not addressed to the satisfaction of the Board 30 days after the firm formally requested interim Commission review, unless the Commission, by rule or order, directs otherwise.16

We are adopting new Rule 140 to provide procedures for firms to follow in requesting interim Commission review with respect to a PCAOB inspection report, including examples of the types of information that would facilitate the Commission's review. Consistent with the time periods in the Act, the rule specifies that a request for interim Commission review must be submitted to the Commission's Office of the Secretary, with a copy to the PCAOB, within 30 days following either the date the firm is provided a copy of the final inspection report (with respect to a review sought pursuant to Section 104(h)(1)(A) of the Act), or the date the firm receives notice of the PCAOB's adverse determination with respect to remediation of quality control defects or criticisms (with respect to a review sought pursuant to Section 104(h)(1)(B) of the Act).17

The review request should be marked “Request for Interim Commission Review with Respect to PCAOB Inspection Report.” Firms seeking interim Commission review should submit, along with the review request, information that, to the extent possible, is focused on the specific matters for which review is requested, and that clearly and succinctly addresses the issues raised by the PCAOB. Generally, we expect that this information would include, but may not necessarily be limited to:

• The particular inspection report that is the subject of the request,

• The specific assessments or determinations that are the subject of the request,

• The alleged errors or deficiencies in the assessments or determinations and the reasons they are believed to be in error or deficient,

• If the action relates to an adverse determination by the PCAOB with respect to remediation of quality control defects or criticisms, any actions the firm took to address criticisms or defects identified in the inspection report,18 and

• Any supporting documentation relevant to the review including, but not limited to, any documents previously submitted to the PCAOB that the firm wishes the Commission to consider.

The rule directs the firm to provide a copy of its review request to the PCAOB simultaneously with its submission to the Commission. This is consistent with directions throughout the new rule for the firm and the PCAOB to provide copies of the information they submit to the Commission to the other party simultaneous with their submission to the Commission to provide an opportunity for both parties to be informed of each other's respective positions.

With respect to interim reviews contemplated by Section 104(h)(1)(A) of the Act, PCAOB Rule 4008 is silent regarding whether a final inspection report would be made public before an inspected firm has an opportunity to review the final inspection report and determine whether to request interim Commission review. In order to prevent the release of any final report before the inspected firm has an opportunity to seek Commission review, the new rule provides that the PCAOB shall not make a final inspection report publicly available until the firm that is the subject of the report has had 30 calendar days in which to seek interim Commission review, unless the firm consents in writing to earlier publication of the report. As noted above, this is consistent with the provision in PCAOB Rule 4009 that delays publication of unresolved quality control defects or criticisms for 30 calendar days in certain circumstances. New Rule 140 also provides for a similar delay of publication with respect to the possibility of a review request pursuant to Section 104(h)(1)(B) of the Act.

We do not believe that matters potentially subject to interim Commission review should be subject to publication, absent consent by the firm, before the firm's time to seek that review has expired, and we see no sufficient reason to vary this result based on whether review would be pursuant to Section 104(h)(1)(A) of the Act or Section 104(h)(1)(B) of the Act.19 We understand this procedure may require the PCAOB to adjust its processes to account for the 30-day period for a firm to request review before initial publication of the final inspection report. However, given the standard of review articulated below with respect to the Commission's processing of such reviews, as well as the fact that the Commission may decline to grant review requests, we do not believe providing for an initial stay of the publication of a final inspection report will result in needless delays or routine appeals simply to delay publication.

New Rule 140 also provides that a timely review request by a firm will operate as an automatic stay of publication of the portions of the final inspection report that are the subject of the firm's review request (with respect to requests pursuant to Section 104(h)(1)(A) of the Act) or the portions of the inspection report that deal with criticism of or potential defects in the quality control systems of the firm that are the subject of the firm's review request (with respect to requests pursuant to Section 104(h)(1)(B) of the Act) unless the Commission determines otherwise, in its own discretion.

At the end of the 30-day review request period, the PCAOB shall make publicly available any portions of the final inspection report that are not the subject of the firm's review request (with respect to Section 104(h)(1)(A) of the Act) or criticisms of or potential defects in the quality control systems of the firm that are not the subject of the firm's review request (with respect to Section 104(h)(1)(B) of the Act), unless the Commission otherwise determines that such a result would not be necessary or appropriate. This helps to ensure timely publication of the portions of the report that are notsubject to review. Further, if the firm fails to make a timely review request, the PCAOB shall make publicly available the final inspection report (with respect to Section 104(h)(1)(A) of the Act) or the portions of the inspection report that deal with criticism of or potential defects in the quality control systems of the firm (with respect to Section 104(h)(1)(B) of the Act).

If a timely request for interim review with respect to an inspection report is made, the Commission will notify the firm and the PCAOB within 30 calendar days of the receipt of the request as to whether the Commission in its discretion will grant the request for interim review. We believe this provides an appropriate period of time to evaluate the initial review request while balancing the interest in timely publication of inspection determinations. In considering whether to grant a review request, among the factors that the Commission may consider are whether the review request makes a reasonable showing that review is appropriate or otherwise presents a concern. We do not intend to routinely grant review requests absent some indication of concern.

If the Commission does not grant the review request, the stay of publication is terminated upon notification to the firm and the PCAOB. If the Commission notifies the firm and the PCAOB that the request for interim review has been granted, the stay of publication shall continue unless the Commission determines otherwise in its own discretion, or unless the firm consents in writing to the PCAOB, with a copy to the Commission to earlier publication.

Rule 140 provides that where the Commission has notified the firm and the PCAOB that it is granting the request for an interim review, the PCAOB may submit responsive information or documents with the Commission, with a copy to the firm, within 15 calendar days of receipt of such notice. We believe this period of time should be reasonable given that the PCAOB drafted the final inspection report and considered the evidence for its decision.

The Commission also may request additional information, and provide a period of up to seven calendar days to respond to such request, from the firm in question, the PCAOB, and any associated person of the firm. The Commission may grant the firm or the PCAOB a period of up to seven calendar days to respond to any information obtained. This period of time is selected to balance the interest for an opportunity to respond with the expediency needed to complete the review and, if applicable, have the underlying findings or determinations published. Likewise, if the firm or the PCAOB fails to respond timely to a request from the Commission, such failure may make it impossible for the Commission to complete its review and therefore could result in a determination adverse to the non-responsive party.20

The information provided by the firm, together with any additional information provided by the PCAOB or associated persons, provides a basis for Commission consideration of the review. Rule 140 provides that, based on this information, the Commission shall consider whether the PCAOB's assessments or determinations are arbitrary and capricious, or otherwise not consistent with the purposes of the Act.

Congress did not prescribe a standard of review for PCAOB inspection reports in the Act. Therefore, in establishing this standard of review, the Commission is informed by the approach that the courts have generally taken in reviewing agency action in the absence of a statutorily prescribed standard of review.21 Further, an arbitrary and capricious standard of review creates an incentive for the firm to fully address and pursue areas of concern in the inspection report with the PCAOB, under its rules, prior to requesting review by the Commission.

At the end of its review, the Commission shall inform the firm seeking review and the PCAOB in writing that the Commission:

(1) Does not object to all or part of the PCAOB's assessments or determination and the stay of publication is terminated; or

(2) Remands to the PCAOB with instructions that the stay of publication is permanent or that the PCAOB take such other actions as the Commission deems necessary or appropriate with respect to publication, including, but not limited to, revising the final inspection report or determinations before publication.

To further encourage expediency in the review process, the rule provides that the review is to be completed and written notice provided to the firm and the PCAOB no more than 75 calendar days after notification to the firm and the PCAOB that the Commission is granting the request for an interim review, unless the Commission extends the period of review for good cause. The default 75-day period allows for the maximum 15-day period in the rule for the PCAOB to respond, an opportunity for the Commission to determine if additional information is needed, the ability, if appropriate, to have at least one request for additional information and an opportunity for the other party to respond (up to seven days under the rule each), and an opportunity for the Commission to review and complete the request.

Consistent with the purpose of providing an opportunity for review before public disclosure of all or a portion of an inspection report by the PCAOB, Rule 140 provides that, unless otherwise determined by the Commission, the decision to grant or deny a review request and the results of the Commission's review shall be non-public, and the information or documents submitted, created, or obtained by the Commission or its staff in the course of the review shall be deemed non-public.22 Further Section 104(h)(2) provides that any decision of the Commission with respect to interim review under Section 104(h) is not subject to judicial review.23 Finally, again consistent with the limited purposes of review under Section 104(h), any action taken by the Commission relates solely to the publication of the relevant inspection report and does not imply that the firm is exonerated or that no action may ultimately result from the inspection or from an investigation by the Commission, the PCAOB, or any other party.

The Commission is establishing a separate subpart in the Commission's Informal and Other Procedures—Regulation P—to include procedural rules relating to the PCAOB in one central location. The intention is to designate Rules in Regulation P according to the Section of the Act to which they primarily relate. As such, the procedural rule regarding interiminspection report reviews, which relates primarily to Section 104 of the Act, is being designated as Rule 140. In addition, the Commission is redesignating its existing procedural rule relating to the PCAOB budget process from Rule 11 to Rule 190 given the process relates primarily to Section 109 of the Act.

In connection with adopting Rule 140, the Commission also is adopting Rule 30-11 of our Rules of Organization and Program Management to delegate authority to the Commission's Chief Accountant to process interim reviews subject to Rule 140. Among other matters, the Chief Accountant is delegated authority to grant or deny requests for interim review, to extend the time periods for the PCAOB or the firm to respond under the rule, to request additional information in conjunction with the review, to make a determination with respect to the review, and to notify the PCAOB and the firm of the results of the review. This delegation of authority is intended to conserve Commission resources by permitting the Chief Accountant to fulfill the Commission's review requirements in a timely manner. Nevertheless, the staff may submit matters to the Commission for consideration, as it deems appropriate.24 Further, we expect that the Commission staff will process interim Commission reviews with respect to inspection reports as efficiently and expeditiously as possible to avoid any unnecessary delay in making the inspection report available to the public, as required by the Act.

The Commission finds, in accordance with Section 553(b)(3)(A) of the Administrative Procedure Act (“APA”),25 that this revision relates solely to agency organization, procedure, or practice. It is, therefore, not subject to the provisions of the APA requiring notice and opportunity for public comment.26 The Regulatory Flexibility Act,27 therefore, does not apply. Similarly, because these rules relate to “agency organization, procedure or practice that does not substantially affect the rights or obligations of non-agency parties,” analysis of major status under the Small Business Regulatory Enforcement Fairness Act is not required.28 The rules do not contain any collection of information requirements as defined by the Paperwork Reduction Act of 1995, as amended.29

The Commission intends, after the Commission's initial experience under the new procedures, to issue a notice of comment in the future so the Commission can consider any such comments, along with the Commission's initial experience, in order to determine whether changes in pursuit of enhancements or efficiencies would be warranted.

We are sensitive to the costs and benefits imposed by our rules and amendments, and we have identified certain costs and benefits of these rules.

The potential benefits of the rule amendments include clarification and increased transparency of the Commission's review and oversight procedures with respect to the PCAOB30 and the interim review procedures set forth in Rule 140, and the benefits of process: Notice, opportunity to be heard, efficiency, and fairness. Rule 140 establishes a set of procedures for registered public accounting firms to follow in requesting interim Commission review with respect to a PCAOB inspection report, as required by the Act. The rule benefits inspected firms by informing them of the procedures to follow in initiating the review process and obtaining Commission review with respect to inspection findings and determinations with which they disagree. Commission review with respect to the PCAOB's inspection reports would allow the Commission to protect the public interest in the quality of PCAOB reports. It could provide a further incentive for the PCAOB to exercise diligence in its inspection and remedial determination process, including encouraging the PCAOB to make determinations on the basis of reasoned support and sound analysis. The review procedure also benefits inspected firms by protecting against publication of inspection findings that the Commission ultimately may remand to the PCAOB for reconsideration.

There also are potential costs of the rule. Firms involved in Commission review proceedings may incur additional costs beyond those already incurred in complying with PCAOB procedures for seeking review of the inspection report's findings at the PCAOB level. However, a request for interim review of a PCAOB inspection report by the Commission is optional. Thus, a registered public accounting firm would incur these costs only if it expected the benefits from the review process to justify the costs.

The PCAOB also may incur additional costs as a result of the rule amendments, for example by adjusting its inspection process in anticipation of review requests and providing information to the Commission, especially at the Commission's request. The imposition of additional costs, beyond those already incurred by the PCAOB, could lead to higher accounting support fees assessed against issuers to cover the PCAOB's recoverable budget expenditure. To the extent the PCAOB has been publishing inspection reports before it has been feasible for firms to request interim review of findings, the public may experience a delay in publication from existing practice. However, to the extent those reports have included findings that would be remanded under Rule 140, providing an opportunity for those findings to be corrected may increase public confidence in the findings, including that the findings would not be further subject to change upon publication.

Section 23(a)(2) of the Exchange Act requires us, when adopting rules under the Exchange Act, to consider the impact on competition of any rule we adopt. The rule amendments are intended to provide additional guidance with respect to the Commission's oversight responsibilities under Sections 104 and 107 of the Sarbanes-Oxley Act. The rule amendments provide procedures for requesting Commission review with respect to inspection reports issued by the PCAOB.

Section 3(f) of the Securities Exchange Act of 193431 requires us, when engaging in rulemaking that requires us to consider or determine whether anaction is necessary or in the public interest, to consider, in addition to the protection of investors, whether the action will promote competition and capital formation. We are not aware of any effect the rule amendments will have on competition, and capital formation. They are designed to enhance the transparency of the Commission's and the PCAOB's administrative practices, by facilitating the public's understanding of the Commission's oversight responsibilities with respect to PCAOB, and by promoting public confidence in the PCAOB's auditor oversight functions. The amendments may increase the efficiency of the PCAOB inspection process. Rule 140, which sets forth the administrative procedures relating to the Commission's review with respect to PCAOB inspection reports, applies to all registered public accounting firms that seek administrative review by the Commission. Therefore, the Commission does not expect the rules to have an anti-competitive effect.

The Commission is amending its Informal and Other Procedures under the authority set forth in Sections 3, 101(c)(5), 104, and 107 of the Act; and Sections 4A and 23 of the Exchange Act. The amendments to the Commission's Rules of Organization and Program Management and Rules of Practice are adopted pursuant to the authorities set forth therein.

Background

DEA is correcting an inadvertent error that occurred in a Final Rule that scheduled the substance n-Benzylpiperazine (BZP) as a schedule I controlled substance. In a Notice of Proposed Rulemaking, published on September 8, 2003 (68 FR 52872), DEA proposed the control of BZP in schedule I of the Controlled Substances Act (CSA). A Final Rule, published on March 18, 2004 (69 FR 12794), finalized the placement of BZP in schedule I of the CSA.

Each of these rules contained a misstatement in the “Supplementary Information” section, with regard to the potency differences between BZP and amphetamine. In each rule, it was erroneously stated that BZP is 10 to 20 times more potent than amphetamine. In actuality, the converse is true (i.e.,BZP is 10 to 20 times less potent than amphetamine.) Therefore this Rulemaking corrects this misstatement in the Final Rule. Under separate rulemaking, DEA is publishing a correction to the Notice of Proposed Rulemaking, published September 8, 2003 (68 FR 52872).

DEA emphasizes that these errors were made solely in the rules as published in theFederal Register. Both DEA and the U.S. Department of Health and Human Services (HHS) considered the correct BZP potencies during their scheduling deliberations. The correct potencies were included in both the HHS scientific and medical evaluation document, and in DEA's scheduling document, which were used to make the determination for control. The public docket for BZP contains both of these review documents. In addition, DEA has already published on the agency's Web site the correct figures regarding relative potency.

The determination of control of BZP was made after consideration of all the available data and all eight factors and the criteria for schedule I as specified in 21 U.S.C. 811 and 812. The amphetamine-like property of BZP was determined following the collective review and consideration of all the available evidence including drug discrimination and self-administration and other information. These studies were briefly mentioned in the rules controlling BZP as a schedule I controlled substance and were discussed in detail in the scientific and medical evaluation and schedulingdocuments prepared by both HHS and DEA.

Although the potency difference between BZP and amphetamine was discussed in the rules proposing and finalizing control of BZP as a part of the scientific background information, comparisons of potency differences are only one piece of background scientific data used to evaluate the abuse potential of drugs or other substances. In addition, potency itself is not one of the factors determinative of control. In fact, there are many examples of substances of varying potencies in each schedule, including stimulants and opiates previously scheduled under the CSA.

Even though the scheduling of BZP was finalized more than six years ago, DEA has been advised that in criminal proceedings, for sentencing purposes, courts have sought to ascertain: (1) The controlled substance, for which a sentencing guideline equivalency exists, that is the most closely analogous to BZP (which is d-amphetamine) and (2) the relative potency of BZP to that of the most analogous controlled substance. As indicated above, DEA has already published on the agency's Web site the correct figures regarding relative potency. This correction is being issued to provide such an official statement in theFederal Registerfor ease of reference by courts, litigants, and others who need the information for sentencing purposes.

This correction does not address the scheduling of 2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) which was also placed into schedule I as a result of the above cited rulemakings.

Accordingly, the publication on Thursday, March 18, 2004, of the Final Rule [Docket No. DEA-247F], at 69 FR 12794 [FR Doc. 04-6110], is corrected in the preamble as follows:

On page 12795, in the first column, paragraph 4, sentences 4 and 5 are corrected to read as follows: “BZP is about 20 times less potent than amphetamine in producing these effects. However, in subjects with a history of amphetamine dependence, BZP was found to be about 10 times less potent than amphetamine.”

I. Introduction and Background

The purpose of this interim final rule is to establish the TRICARE Retired Reserve program that implements section 705 of the National Defense Authorization Act for Fiscal Year 2010 (NDAA-10) (Pub. L. 111-84). Section 705 added new section 1076e to Title 10, United States Code. Section 1076e allows members of the Retired Reserve who are qualified for non-regular retirement, but are not yet 60 years of age, as well as certain survivors to qualify to purchase medical coverage equivalent to the TRICARE Standard (and Extra) benefit unless that member is either enrolled in, or eligible to enroll in, a health benefits plan under Chapter 89 of Title 5, United States Code.

A.Establishment of the TRICARE Retired Reserve Program(paragraph 199.25(a)). This paragraph describes the nature, purpose, statutory basis, scope, and major features of TRICARE Retired Reserve, a premium-based medical coverage program that was made available for purchase worldwide by certain members of the Retired Reserve, their family members and their surviving family members. TRICARE Retired Reserve is authorized by 10 U.S.C. 1076e.

The major features of the program include making coverage available for purchase by any Retired Reserve member who is qualified for non-regularretirement, but is not yet 60 years of age, unless that member is either enrolled in, or eligible to enroll in, a health benefit plan under Chapter 89 of Title 5, United States Code, as well as certain survivors of Retired Reserve members as specified below. The amount of the premium that qualified members and qualified survivors pay is prescribed by the Assistant Secretary of Defense for Health Affairs (ASD(HA)) and determined using an appropriate actuarial basis. There is one premium for member-only coverage and a second premium for member and family coverage. Additionally, TRICARE rules outlined in Part 199 of Title 32 of the CFR relating to the TRICARE Standard and Extra programs apply unless otherwise specified. Certain special TRICARE programs are not part of TRICARE Retired Reserve including the Extended Health Care Option (ECHO) program and the Supplemental Health Care Program (see§ 199.16) except when referred by a Military Treatment Facility (MTF) provider for incidental consults and the MTF provider maintains clinical control over the episode of care. The TRICARE Retiree Dental Program is already available independently for purchase by Retired Reserve members under 10 U.S.C. 1076c as implemented by 32 CFR 199.22.

Under TRICARE Retired Reserve, qualified members (or their qualified survivors) may purchase either the member-only type of coverage or the member and family type of coverage by submitting a completed request in the appropriate format along with an initial payment of the applicable premium at the time of enrollment. When their coverage becomes effective, TRICARE Retired Reserve beneficiaries receive the TRICARE Standard (and Extra) benefit. TRICARE Retired Reserve features the deductible and cost sharing provisions of the TRICARE Standard (and Extra) plan for retired members and dependents of retired members. Both the member and the member's covered family members are provided access priority for care in military treatment facilities on the same basis as retired members and their family members who are not enrolled in TRICARE Prime.

B.Qualifications for TRICARE Retired Reserve coverage(paragraph 199.25(b)). This paragraph defines the statutory conditions under which members of a Reserve component may qualify to purchase TRICARE Retired Reserve coverage. The Reserve components of the armed forces have the responsibility to determine and validate a member's qualifications to purchase TRICARE Retired Reserve coverage. The member's Service personnel office is responsible for keeping the Defense Enrollment Eligibility Reporting System (DEERS) current with eligibility data.

A member qualifies to purchase TRICARE Retired Reserve coverage if the member meets both of the following conditions:

(a) is a member of the Retired Reserve of a Reserve component of the armed forces who is qualified for a non-regular retirement at age 60 under chapter 1223 of title 10, U.S.C., but is not age 60; and

(b) is not enrolled, or eligible to enroll, in a health benefits plan under chapter 89 of title 5 U.S.C.

If a qualified member of the Retired Reserve dies while in a period of TRICARE Retired Reserve coverage, the immediate family member(s) of such member shall remain qualified to continue existing or purchase new TRICARE Retired Reserve coverage until the date on which the deceased member of the Retired Reserve would have attained age 60 as long as they meet the definition of immediate family member specified below. This applies regardless of whether either member-only coverage or member and family coverage was in effect on the day of the TRICARE Retired Reserve member's death.

C.TRICARE Retired Reserve premiums(paragraph 199.25(c)). Members are charged premiums for coverage under TRICARE Retired Reserve that represent the full cost of providing the TRICARE Standard (and Extra) benefit under this program. The total annual premium amounts shall be determined by the ASD(HA) using an appropriate actuarial basis and are established and updated annually, on a calendar year basis, by the ASD(HA) for qualified members of the Retired Reserve for each of the two types of coverage, member-only coverage and member-and-family coverage. Premiums are to be paid monthly. The monthly rate for each month of a calendar year is one-twelfth of the annual rate for that calendar year.

A surviving family member of a Retired Reserve member who qualified for TRICARE Retired Reserve coverage as described herein will pay premium rates at the member-only rate if there is only one surviving family member to be covered by TRICARE Retired Reserve and at the member and family rate if there are two or more survivors to be covered.

The appropriate actuarial basis used for calculating premium rates shall be one that most closely approximates the actual cost of providing care to the same demographic population as those enrolled in TRICARE Retired Reserve as determined by the ASD(HA). TRICARE Retired Reserve premiums shall be based on the actual costs of providing benefits to TRICARE Retired Reserve members and their family members during the preceding years if the population of Retired Reserve members enrolled in TRICARE Retired Reserve is large enough during those preceding years to be considered actuarially appropriate. Until such time that actual costs from those preceding years become available, TRICARE Retired Reserve premiums shall be based on the actual costs during the preceding calendar years for providing benefits to the population of retired members and their family members in the same age categories as the Retired Reserve population in order to make the underlying group actuarially appropriate.

An adjustment may be applied to cover overhead costs for administration of the program by the government. Additionally, premium adjustments may be made to cover the prospective costs of any significant program changes or any actual experience in the costs of administering the TRICARE Retired Reserve program.

A surviving family member of a Retired Reserve member who qualified for TRICARE Retired Reserve coverage as described herein will pay premium rates at the member-only rate if there is only one surviving family member to be covered by TRICARE Retired Reserve and at the member and family rate if there are two or more survivors to be covered.

For the portion of calendar year 2010 during which the program is in effect, the monthly premium for member-only coverage will be $388.31/month (annual premium $4,659.72/year), and the monthly premium for member and family coverage will be $976.41/month (annual premium $11,716.92/year). The 2010 premiums are based on the actual costs during calendar years 2007 and 2008 for providing benefits to the population of retired members and their family members in the same age categories as the Retired Reserve population in order to make the underlying group actuarially appropriate. The historical costs were trended forward to 2010 and a two-percent adjustment was applied to cover overhead costs for administration of the program by the government.

For calendar year 2011, the monthly premium for member-only coverage will be $408.01/month (annual premium $4,896.12/year), and the monthly premium for member and family coverage will be $1,020.05/month (annual premium $12,240.60/year). The 2011 premiums are based on the actual costs during calendar years 2008 and2009 for providing benefits to the population of retired members and their family members in the same age categories as the Retired Reserve population in order to make the underlying group actuarially appropriate. The historical costs were trended forward to 2011 and a two-percent adjustment was applied to cover overhead costs for administration of the program by the government.

D.Procedures(paragraph 199.25(d)). The Director, TRICARE Management Activity (TMA), may establish procedures for the following:

E.Preemption of State laws(paragraph 199.25(e)). This paragraph explains that the preemptions of State and local laws established for the TRICARE program also apply to TRICARE Retired Reserve. Any State or local law or regulation pertaining to health insurance, prepaid health plans, or other health care delivery, administration, and financing methods is preempted and does not apply in connection with TRICARE Retired Reserve.

This includes State and local laws imposing premium taxes on health insurance carriers, underwriters or other plan managers, or similar taxes on such entities. Preemption does not apply to taxes, fees, or other payments on net income or profit realized by such entities in the conduct of business relating to DoD health services contracts, if those taxes, fees or other payments are applicable to a broad range of business activity. For the purposes of assessing the effect of Federal preemption of State and local taxes and fees in connection with DoD health services contracts, interpretations shall be consistent with those applicable to the Federal Employees Health Benefits Program under 5 U.S.C. 8909(f).

F.Administration(paragraph 199.25(f)). This paragraph provides that the Director, TRICARE Management Activity, may establish other rules andprocedures necessary for the effective administration of TRICARE Retired Reserve and may authorize exceptions to requirements of this section, if permitted by law, based on extraordinary circumstances.

G.Terminology.The following terms are applicable to the TRICARE Retired Reserve program.

Executive Order 12866 requires certain regulatory assessments for any significant regulatory action that would result in an annual effect on the economy of $100 million or more, or have other substantial impacts. The Congressional Review Act establishes certain procedures for major rules, defined as those with similar major impacts. The Regulatory Flexibility Act (RFA) requires that each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation that would have significant impact on a substantial number of small entities. This interim final rule is not subject to any of those requirements because it would not have any of these substantial impacts.

This rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3511).

We have examined the impact(s) of the interim final rule under Executive Order 13132 and it does not have policies that have federalism implications that would 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. The preemption provisions in the rule conform to law and long-established TRICARE policy. Therefore, consultation with State and local officials is not required.

This rule is being published as an interim final rule with comment period as an exception to our standard practice of soliciting public comment under a proposed rule first, in order to comply with the requirements of the National Defense Authorization Act for Fiscal Year 2010, Public Law 110-417, section 705, which was enacted on October 28, 2009. This section provides in pertinent part that this provision applies “to coverage for months beginning on or after October 1, 2009.” In order to provide coverage as soon possible consistent with statutory entitlement, the ASD(HA) has determined that obtaining prior public comment is unnecessary, impractical, and contrary to the public interest. Public comments are welcome and will be considered before publication of the final rule.

On January 6, 1997, the Office of the Secretary of Defense published a final rule in theFederal Register(62 FR 627-631) clarifying the TRICARE exclusion of unproven drugs, devices and medical treatments and procedures and adding a definition of rare diseases to be used in the TRICARE Program. TRICARE defined a rare disease as one which affects fewer than one in 200,000 Americans. Upon further review, TRICARE is revising the definition to be in compliance with the definition of other federal agencies. The Office of Rare Diseases was initially established as part of the National Institutes of Health in 1993 to promote research and collaboration on rare and orphan diseases. The Rare Diseases Act of 2002 (Pub. L. 107-280) codified the establishment of the Office of Rare Diseases by adding a section 404F to the Public Health Service Act (42 U.S.C. 283h). This statute defines a rare disease as “any disease or condition that affects less than 200,000 persons in the United States.” Additionally, Section 526(a)(2) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360bb(a)(2)), provides, in part, that the term “rare disease or condition” means any disease or condition which affects less than 200,000 persons in the United States. This rule modification will result in the definition used by the TRICARE program for a rare disease to be consistent with the definition used by the National Institutes of Health and the Food and Drug Administration.

The Department of Defense published a proposed rule on July 24, 2009 (74 FR 36639-36640). No comments were received on the proposed rule before the comment period closed.

Section 801 of title 5, United States Code (U.S.C.), and Executive Order (E.O.) 12866 requires certain regulatory assessments and procedures for any major rule or significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. It has been certified that this rule is not an economically significant rule, or a significant regulatory action under the provisions of E.O. 12866.

It has been certified that his rule does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate or by the private sector, of $100 million or more in any one year.

The Regulatory Flexibility Act (RFA) requires each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This final rule will not significantly affect a substantial number of small entities for purposes of the RFA.

This rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).

This final rule has been examined for its impact under E.O. 13132 and it does not contain policies that have federalism implications that would 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, consultation with State and local officials is not required.

This final rule introduces new definitions and addresses revisions or omissions in policy or procedure inadvertently missed in previous regulatory changes pertaining to diabetic education.

Diabetes self-management training (DSMT) is an interactive, collaborative process involving beneficiaries with diabetes, their physician(s), and their educators. The educational process should provide the beneficiary with the knowledge and skills needed to perform self-care, manage crises, and make lifestyle changes required to manage the diabetes successfully.

TRICARE had previously classified DSMT as a counseling service that was not medically necessary. Since all services provided under the TRICARE program must be medically necessary and appropriate, DSMT was excluded from coverage. In developing the TRICARE policy on self-management, however, it was determined that diabetes educational services are consistent with the medically necessary and appropriate provision and it was decided to conform with Medicare's policy on DSMT. As such, TRICARE removed “diabetic self-management training” programs as an excluded benefit effective July 1, 1998. Although the policy change conflicted with existing regulation language, TRICARE determined to move forward with the policy change because TRICARE was expanding and not restricting a benefit, and the change was in line with Medicare's benefit. This final rule corrects the failure to amend the language of the regulation and brings the regulation into conformance with the current policy.

Section 199.4 provides basic program benefits.

Section 199.4(d)(3)(ix) Diabetic self-management training (DSMT) is added as a benefit under other covered services and supplies. This addition brings the regulation into conformance with the current policy.

Section 199.4(g)(39) is revised to remove diabetic self-education programs as an exclusion.

Section 199.6 addresses authorized providers.

Section 199.6(c)(3)(iii)(L) adds Nutritionist to the list of individual professional providers of medical care authorized to provide services to CHAMPUS beneficiaries.

Section 199.6(c)(3)(iii)(M) adds Registered Dietitian to the list of individual professional providers of medical care authorized to provide services to CHAMPUS beneficiaries.

A proposed rule (74 FR 44798-44800) was published on August 31, 2009, and provided a 60-day comment period. No comments were received.

Section 801 of Title 5, United States Code (U.S.C.), and Executive Order (E.O.) 12866, require certain regulatory assessments and procedures for any major rule or significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. It has been certified that this rule is not a significant regulatory action.

Public Law (Pub. L.) 96-354, “Regulatory Flexibility Act” (RFA) (5 U.S.C. 601), requires that each Federal agency prepare a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This final rule will not have a significant impact on a substantial number of small entities. Therefore, this final rule is not subject to the requirements of the RFA.

This rule does not contain a “collection of information” requirement, and will not impose additional information collection requirements on the public under Pub. L. 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35).

Section 202 of Public Law 104-4, “Unfunded Mandates Reform Act,” requires that an analysis be performed to determine whether any Federal mandate may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector of $100 million in any one year. It has been certified that this final rule does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year, and thus, this final rule is not subject to this requirement.

E.O. 13132, “Federalism,” requires that an impact analysis be performed to determine whether the rule has federalism implications that would 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. It has been certified that this final rule does not have federalism implications, as set forth in E.O. 13132.

The Department of Defense updated coverage for screening with the use of the breast MRI for women in a designated high risk category as advised by the American Cancer Society. In the process of providing this additional coverage, it was discovered that because of statutory wording, there was a group of high risk women that are standard beneficiaries under the age of 35 for whom this coverage could not be provided without an amendment in the Code of Federal Regulations (CFR). Amending the CFR will provide coverage for breast MRI screening for all Department of Defense beneficiaries in the high risk category recommended by the American Cancer Society.

The Department of Defense published a proposed rule on July 24, 2009 (74 FR 36638-36639). A single comment was received asking that the language be written more clearly. The final rule includes language in section (g)(37)(viii) that is more precise in terms of which cancers will be covered and notes that cervical and breast cancer screenings will be provided in accordance with the standards based on the guidelines from the U.S. Department of Health and Human Services.

E.O. 12866 requires a comprehensive regulatory impact analysis be performed on any economically significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. The Regulatory Flexibility Act (RFA) requires each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation that would have a significant impact on a substantial number of small entities. This rule is not an economically significant regulatory action and will not have a significant impact on a substantial number of small entities for purposes of the RFA, thus this final rule is not subject to any of these requirements. This rule, although not economically significant, is a significant rule under E.O. 12866 and has been reviewed by the Office of Management and Budget. Amending the CFR will provide coverage for breast MRI screening for all Department of Defense beneficiaries in the high risk category, if necessary. It is critically important that we eliminate any potential gaps in coverage for high risk individuals as quickly as possible.

This rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).

It has been certified that this rule does not contain a Federal mandate that may result in the expenditure by State, local and tribunal governments, in aggregate, or by the private section, of $100 million or more in any one year.

We have examined the impact(s) of the final rule under E.O. 13132 and it does not have policies that have Federalism implications that would 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 variouslevels of government, therefore, consultation with State and local officials is not required.

Regulatory Information

On October 9, 2009, we published a notice of temporary deviation request for comments entitled “Drawbridge Operation Regulations; Elizabeth River, Eastern Branch, Norfolk, VA” in theFederal Register(74 FR 52143) and a notice of proposed rulemaking (NPRM) entitled “Drawbridge Operation Regulations; Elizabeth River, Eastern Branch, Norfolk, VA” in theFederal Register(74 FR 52158). We received 861 comments on the published deviation and NPRM.

On March 3, 2010, we published another notice of temporary deviation request for comments entitled “Drawbridge Operation Regulations; Elizabeth River, Eastern Branch, Norfolk, VA” in theFederal Register(75 FR 9521) and a supplemental notice of proposed rulemaking (SNPRM) entitled “Drawbridge Operation Regulations; Elizabeth River, Eastern Branch, Norfolk, VA” in theFederal Register(75 FR 9557). We received four comments on the published deviation and SNPRM. No public meeting was requested, and none was held.

On behalf of the Cities of Chesapeake and Norfolk Virginia, the Virginia Department of Transportation (VDOT) who owns and operates the lift-type Berkley Bridge requested a temporary change to the existing bridge regulations. In the closed to navigation position, the Berkley Bridge has a vertical clearance of 48 feet above mean high water. The current regulation set out in Title 33 CFR Part 117.1007(b) and (c) allows the Berkley Bridge, mile 0.4, in Norfolk, Virginia to remain closed one hour prior to the published start of a scheduled marine event regulated under § 100.501, and remain closed until one hour following the completion of the event unless the Patrol Commander designated under § 100.501 allows the bridge to open for commercial vessel traffic. In addition, the bridge shall open on signal any time except from 5 a.m. to 9 a.m. and from 3 p.m. to 7 p.m., Monday through Friday, except Federal holidays, and shall open at any time for vessels with a draft of 18 feet or more, provided that at least 6 hours advance notice has been given to the Berkley Bridge Traffic Control Room at (757) 494-2490, as required by 33 CFR 117.1007(b) and (c). Vessel traffic on this waterway consists of pleasure craft, tug and barge traffic, and ships with assist tugs seeking repairs. There is no alternate waterway route.

Due to a temporary closure of two area bridges, there has been a significant increase in vehicular traffic on the Berkley Bridge causing back-ups, delays, and congestion on the bridge and its approaches. The NPRM proposed opening the draw of the Berkley Bridge on signal at 9 a.m., 11 a.m., 1 p.m., and 2:30 p.m. from October 9, 2009 to October 5, 2012, andpermitted VDOT to monitor, measure, and identify congested roadway locations during heavy traffic periods. By implementing scheduled bridge openings, we anticipated a decrease in vehicular traffic congestion during the daylight hours.

Concurrent with the publication of the Notice of Proposed Rulemaking, a Test Deviation [USCG-2009-0754] was issued to allow VDOT to test the proposed schedule and to obtain data and public comments. The test period was in effect during the entire Notice of Proposed Rulemaking comment period. Also, a count of the delayed vessels during the closure periods was taken to determine the impact of the proposed regulation on navigation.

The Berkley Bridge is the principle arterial route in and out of the City of Norfolk and serves as the major evacuation highway in the event of emergencies. The average daily traffic volumes at the Berkley Bridge for the last quarter of calendar year 2008, as submitted by VDOT with its request for schedule change, are as follows:

The traffic counts revealed that from October 2008 to December 2008, the Berkley Bridge experienced a seven percent (or 23,560-car) increase in traffic flow. The Coast Guard received 861 responses to the NPRM. The vast majority of those responses (850) were supplied from an internet Web site survey posted by VDOT. Of the 850 VDOT-sponsored surveys, 484 had written comments in addition to responses to the survey with the other 366 comments containing only responses to the survey questionnaire. The remaining 11 responses consisted of 7 paper comments and 4 e-mails.

All but five of the favored the new schedule presented in the temporary deviation and NPRM. Many responses stated that planned openings would permit motorists to better plan their commutes and thereby avoid delays.

Four local maritime facilities and the Virginia Maritime Association (VMA), who represents waterborne commerce in the Port of Hampton Roads, responded with their concerns opposing the new schedule. These organizations expressed concerns that the proposed regulatory actions created unsafe conditions for navigation particularly for vessels carrying hazardous cargoes, vessels with a draft of greater than 18 feet, and vessels delayed through due to uncontrollable external factors. The maritime community offered recommendations for changes that they believe will provide a reasonable balance between marine and land based transportation.

The Coast Guard has reviewed the additional bridge data supplied by VDOT. The information indicated that the test deviation reduced the amount of time the bridge opened for vessels. Between October 20, 2009, and December 30, 2009, there were approximately 85 vessel passages requiring 69 bridge openings. Most of these openings were provided for commercial vessels, with a maximum of four vessels transiting through a single bridge opening.

With an average of fewer than two openings per day (1.23) during the test deviation, VDOT contended that when bridge openings in 2009(during the test deviation) were compared to the same months in 2008 (before the test deviation) there was a 30 percent reduction in the total number of minutes the bridge was opened for vessels and the number of openings also decreased by 21 percent. In 2009, the Berkley Bridge averaged 97,135 vehicles per day.

VDOT, VMA and the local maritime facilities (VDOT/VMA) identified a need for mariners to have more access transiting through the Berkley Bridge. The parties recommended operating procedures for inclusion in the regulatory language. The recommended operating procedures and the Coast Guard responses are as follows:

1. The bridge is to open on signal at any time for vessels carrying hazardous cargo.

2. The bridge is to open at any time for vessels with a draft of 18 feet or more, provided that at least 6 hours advance notice has been given to the Berkley Bridge Traffic Control Room.

VMA stated that certain vessels and conditions make safe bridge transits more difficult and dangerous. VMA/VDOT recommended establishing provisions that would exempt vessels from only transiting at the scheduled opening time.

The Coast Guard proposed the following: The draw shall open on signal at any time for vessels carrying, in bulk, cargoes regulated by 46 CFR subchapters D or O, or Certain Dangerous Cargoes as defined in 33 CFR 160.204; and for all other vessels, the draw shall open on signal at any time, except from 5 a.m. to 7 p.m., Monday through Friday, except Federal holidays. During these times: The draw shall open for commercial vessels with a draft of 18 feet or more, provided at least 6 hours notice was given to the Berkley Bridge Traffic Control Room at (757) 494-2490.

3. If a vessel has made prior arrangements for a delayed opening, and there are vessels awaiting transit, the opening may be delayed if the master(s) of the waiting vessel(s) agree to a delayed opening to accommodate the delayed vessel. Otherwise the opening will accommodate the waiting vessel(s) only, and close upon their clearing the bridge.

VMA stated that communication between vessels is important to scheduling a single opening at the Berkley Bridge. The Coast Guard asserts that communication between vessels and the bridge tender should be coordinated to insure and maintain the safety of navigation. However, specific regulatory language controlling communication between vessels is unwarranted and not within the scope of drawbridge operating regulations.

4. An opening will be provided to a transiting vessel up to, but no more than, 30 minutes following the scheduled opening time provided the transiting vessel has communicated their estimated time of arrival to the Berkley Bridge tender prior to the scheduled opening time.

VMA stated that the timing of large vessel movements is affected by a number of uncontrollable and external factors. The effects of winds, currents, and tides have an important impact on safe navigation and those conditions.

In addition, VMA indicated that the current test deviation creates a situation whereby marine traffic will stack up while waiting for an opening, thus creating vessel congestion, a navigational hazard.

For these situations, the Coast Guard proposed the following: If the bridge is not opened during a particular scheduled opening per paragraph (d)(3)(ii) and a vessel has made prior arrangements for a delayed opening, the draw tender may provide a single opening up to 30 minutes past that scheduled opening time for that signaling vessel, except at 2:30 p.m. The draw tender may provide a single opening up to 20 minutes past the 2:30 p.m. scheduled opening time for a signaling vessel that made prior arrangements for a delayed opening. A vessel may make prior arrangements for a delayed opening by contacting the Berkley Bridge Traffic Control Room at (757) 494-2490.

5. The bridge is to open at any time if, in the professional judgment of the vessel operator, the environmental or operating conditions compromise navigational safety.

The Coast Guard responded to this comment by indicating that under 33 CFR 117.31, “Drawbridge operations foremergency vehicles and emergency vessels”, paragraph (b)(2) adequately provides for unscheduled vessel openings of the bridge in the event of a marine emergency.

The supplemental proposed rule was also rephrased to integrate the restricted morning and evening rush hour times (from 5 a.m. to 9 a.m. and from 3 p.m. to 7 p.m.) with the test deviation period from 9 a.m. to 3 p.m. The Coast Guard suggested the following paragraph: For all other vessels, the draw shall open on signal at any time, except from 5 a.m. to 7 p.m., Monday through Friday, except Federal holidays.

Based on all of the comments received, the Coast Guard issued the SNPRM.

The Coast Guard received four responses to the SNPRM and the second temporary deviation, two e-mails and one each by letter and to the Web site athttp://www.regulations.gov.

VMA, who represents waterborne commerce in the Port of Hampton Roads, responded in writing with its support of the revised proposed regulation and its statement that the current operating regulation incorporates the minimum degree of flexibility that the maritime industry can accept. VDOT also indicated that the operating schedule in the temporary deviation and the revised proposed regulation has improved the flow of vehicular traffic while still meeting the minimum needs of navigation.

VMA, VDOT and two private citizens expressed concerns about unscheduled openings that caused vehicular traffic congestion. The unscheduled openings were provided for Government vessels, vessels with a draft of 18 feet or more that provided at least 6 hours advance notice and for vessels hauling dangerous cargo.

The Coast Guard reviewed the bridge data supplied by VDOT. The information indicated that during the deviation test period (from March 3, 2010 to July 1, 2010), that a total of 260 potential bridge openings for vessels could have been provided Monday through Friday, except Federal holidays, at 9 a.m., 11 a.m., 1 p.m. and 2:30 p.m. The data showed the bridge actually opened only 88 of the 260 potential openings. The data also revealed that seven bridge openings were provided approximately 15 minutes past the scheduled opening times of 9 a.m., 11 a.m. and 1 p.m. and that the average opening usually lasted 12 minutes; a later opening at 2:30 p.m. would add to the traffic congestion during the rush hour. A majority of these openings were provided for commercial vessels, with a maximum of four vessels transiting through a single bridge opening.

These subsequent changes to the operating procedures appear to have reduced vehicular traffic congestion while still providing for the reasonable needs of navigation. Based on the information provided, we will implement a final rule with no changes to the SNPRM.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation is unnecessary. We reached this conclusion based on the fact that the proposed changes have only a minimal impact on maritime traffic transiting the bridge. Mariners can still plan their trips in accordance with the scheduled bridge openings, and to minimize delays, vessels that can pass under the bridge without a bridge opening may do so at all times.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

We reached this conclusion based on the fact that the proposed changes have only a minimal impact on maritime traffic transiting the bridge. Mariners can plan their trips in accordance with the scheduled bridge openings, to minimize delays and vessels that can pass under the bridge without a bridge opening may do so at all times.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the SNPRM we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions andInterference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminates ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g.,specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (32)(e) of the Instruction.

Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

The Copyright Office makes a non-substantive correcting amendment to the final rule governing exemption to prohibition on circumvention of copyright protection systems for access control technologies which was published July 27, 2010.

For the reason set forth in the preamble, 37 CFR part 201 is corrected by making the following technical amendment:

In this document EPA denies objections by the NRDC to EPA's establishment of certain pesticide tolerances. This action may also be of interest to agricultural producers, food manufacturers, or pesticide manufacturers. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS) code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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

In addition to accessing an electronic copy of thisFederal Registerdocument through the electronic docket athttp://www.regulations.gov, you may access thisFederal Registerdocument electronically through the EPA Internet under the “Federal Register” listings athttp://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site athttp://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objectionor request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0190 in the subject line on the first page of your submission. All requests must be in writing, and must be received by the Hearing Clerk as required by 40 CFR part 178 on or before October 5, 2010.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described inADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2005-0190, by one of the following methods:

•Federal eRulemaking Portal:http://www.regulations.gov. Follow the on-line instructions for submitting comments.

•Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

This action is being taken in response to a remand to EPA of a final order denying objections filed by the NRDC to regulations establishing pesticide tolerances for pymetrozine under section 408 of the FFDCA, 21 U.S.C. 346a. (70 FR 46706, August 10, 2005); (Ref. 1). The order was remanded to EPA by the U.S. Court of Appeals, Ninth Circuit, for an explanation of the basis for EPA's decision on the FFDCA's provision requiring a presumptive additional tenfold (10X) safety factor for the protection of infants and children. (NCAP v. EPA, 544 F.3d 1043, 1052 (9th Cir. 2008)). Specifically, the court held that EPA did not provide “enough information” on why in evaluating the risk of pymetrozine it chose to deviate from this presumptive safety factor. (Id.). In response to the remand, EPA is again denying the objections. In light of new data received on pymetrozine, EPA has now determined that the presumptive safety factor for infants and children should be retained; however, the objections are denied because retention of this additional safety factor does not show the pymetrozine tolerances to be unsafe.

Because EPA has taken new information into account in issuing this decision upon remand, EPA is issuing the remand decision as a regulation under FFDCA section 408(d)(4)(i). Any person may file objections to a FFDCA section 408(d)(4)(i) regulation with EPA and request a hearing on those objections. (Id.). If this decision was issued as a revised final order on NRDC's objections under FFDCA section 408(g)(2)(C), (21 U.S.C. 346a(g)(2)(C)), then any party who wished to contest EPA's determination would have no opportunity to submit factual contentions to the record concerning the new information prior to seeking judicial review.

EPA's authority for issuing pesticide tolerances is contained in FFDCA section 408(d) and the statutory provisions governing the administrative review process for tolerances is in FFDCA section 408(g)(2). (21 U.S.C. 346a(d) and (g)(2)).

In this Unit, EPA provides background on the relevant statutes and regulations governing NRDC's objections as well as on pertinent Agency policies and practices. Unit III.A. summarizes the requirements and procedures in section 408 of the FFDCA and applicable regulations pertaining to pesticide tolerances. Unit III.B. provides an overview of EPA's risk assessment process. It contains an explanation of how EPA identifies the hazards posed by pesticides, how EPA determines the level of exposure to pesticides that pose a concern (“level of concern”), how EPA measures human exposure to pesticides, and how hazard, level of concern conclusions, and human exposure estimates are combined to evaluate risk. Further, this unit presents background information on the EPA's policy with regard to the statutory safety factor for the protection of infants and children.

1.In general. EPA establishes maximum residue limits, or “tolerances,” for pesticide residues in food under section 408 of the FFDCA. (21 U.S.C. 346a). Without such a tolerance or an exemption from the requirement of a tolerance, a food containing a pesticide residue is “adulterated” under section 402 of the FFDCA and may not be legally moved in interstate commerce. (21 U.S.C. 331, 342). Monitoring and enforcement of pesticide tolerances are carried out by the U.S. Food and Drug Administration and the U.S. Department of Agriculture (USDA). Section 408 was substantially rewritten by the Food Quality Protection Act of 1996 (FQPA), which added the provisions discussed below establishing a detailed safety standard for pesticides and additional protections for infants and children. (Public Law 104-170, 110 Stat. 1489 (1996)).

2.Safety standard for pesticide tolerances. A pesticide tolerance may only be promulgated by EPA if the tolerance is “safe.” (21 U.S.C. 346a(b)(2)(A)(i)). “Safe” is defined by the statute 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.” (21 U.S.C. 346a(b)(2)(A)(ii)). The statute explains that aggregate exposure to a pesticide includes “dietary exposure under the tolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non-occupational sources.” (21 U.S.C. 346a(b)(2)(D)(vi)).

In making the safety determination for a tolerance, risks to infants and children are given special consideration. Specifically, section 408(b)(2)(C) creates a presumptive additional safety factor for the protection of infants and children. It directs that “[i]n the case of threshold effects, ... an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.” (21 U.S.C. 346a(b)(2)(C)). EPA is permitted to “use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.” (Id.). The additional safety margin for infants and children is referred to throughout this document as the “children's safety factor.”

3.Procedures for establishing, amending, or revoking tolerances. Tolerances are established, amended, or revoked by rulemaking under theunique procedural framework set forth in the FFDCA. Generally, a tolerance rulemaking is initiated by the party seeking to establish, amend, or revoke a tolerance by means of filing a petition with EPA. (See 21 U.S.C. 346a(d)(1)). EPA publishes in theFederal Registera notice of the petition filing and requests public comment. (21 U.S.C. 346a(d)(3)). After reviewing the petition, and any comments received on it, EPA may issue a final rule establishing, amending, or revoking the tolerance, issue a proposed rule to do the same, or deny the petition. (21 U.S.C. 346a(d)(4)).

Once EPA takes final action on the petition by establishing, amending, or revoking the tolerance or denying the petition, any person may file objections with EPA and seek an evidentiary hearing on those objections. (21 U.S.C. 346a(g)(2)). Objections and hearing requests must be filed within 60 days after date of publication in theFederal Register. (Id.). EPA's final order on the objections is subject to judicial review. (21 U.S.C. 346a(h)(1)).

1.The safety determination-risk assessment. To assess risk of a pesticide tolerance, EPA combines information on pesticide toxicity with information regarding the route, magnitude, and duration of exposure to the pesticide. The risk assessment process involves four distinct steps:

• Identification of the toxicological hazards posed by a pesticide;

• Determination of the “level of concern” with respect to human exposure to the pesticide;

• Estimation of human exposure to the pesticide; and

• Characterization of the risk posed to humans by the pesticide based on comparison of human exposure to the level of concern.

a.Hazard identification.In evaluating toxicity or hazard, EPA reviews toxicity studies, primarily in laboratory animals, to identify any adverse effects on the test subjects. Animal studies typically involve investigating a broad range of endpoints including gross and microscopic effects on organs and tissues, functional effects on body organs and systems, effects on blood parameters (such as red blood cell count, hemoglobin concentration, hematocrit, and a measure of clotting potential), effects on the concentrations of normal blood chemicals (including glucose, total cholesterol, urea nitrogen, creatinine, total protein, total bilirubin, albumin, hormones, and enzymes such as alkaline phosphatase, alanine aminotransfersase and cholinesterases), and behavioral or other gross effects identified through clinical observation and measurement. EPA examines whether adverse effects are caused by either short-term (e.g., acute) or longer-term (e.g., chronic) pesticide exposure and the effects of pre-natal and post-natal exposure in animals.

EPA also considers whether the adverse effect has a threshold — a level below which exposure has no appreciable chance of causing the effect. For non-threshold effects, EPA assumes that any exposure to the substance increases the risk that the adverse effect may occur. At present, EPA only considers one adverse effect, the chronic effect of cancer, to potentially be a non-threshold effect. (Ref. 2 at 4-9). Not all carcinogens, however, pose a risk at any exposure level (i.e., “a non-threshold effect or risk”). Advances in the understanding of the mode of action of carcinogenesis have increasingly led EPA to conclude that some pesticides that cause carcinogenic effects in animal studies only cause such effects above a certain threshold of exposure.

b.Level of concern/dose-response analysis.Once a pesticide's potential hazards are identified, EPA determines a toxicological level of concern for evaluating the risk posed by human exposure to the pesticide. In this step of the risk assessment process, EPA essentially evaluates the levels of exposure to the pesticide at which effects might occur. An important aspect of this determination is assessing the relationship between exposure (dose) and response. The assessment of this relationship is often referred to as the dose-response analysis. EPA follows differing approaches to identifying a level of concern for threshold and non-threshold hazards.

i.Threshold effects. In examining the dose-response relationship for a pesticide's threshold effects, EPA evaluates an array of toxicity studies on the pesticide. In each of these studies, EPA attempts to identify the lowest observed adverse effect level (LOAEL) and the next lower dose at which there are no observed adverse effect levels (NOAEL). Generally, EPA will use the lowest NOAEL from the available studies as a starting point (called the Point of Departure) in estimating the level of concern for humans. (Ref. 2 at 9 (The Point of Departure “is simply the toxic dose that serves as the ‘starting point’ in extrapolating a risk to the human population.”)). At times, however, EPA will use a LOAEL from a study as the Point of Departure when no NOAEL is identified in that study and the LOAEL is close to, or lower than, other relevant NOAELs. The Point of Departure is in turn used in choosing a level of concern. EPA will make separate determinations as to the Points of Departure, and correspondingly levels of concern, for both short and long exposure periods as well as for the different routes of exposure (oral, dermal, and inhalation).

In estimating and describing the level of concern, the Point of Departure is at times used differently depending on whether the risk assessment addresses dietary or non-dietary exposures. (Pymetrozine is not expected to result in any meaningful non-dietary exposure and thus risk assessment of non-dietary exposure is not further discussed in this document.) For dietary risks, EPA uses the Point of Departure to calculate an safe or acceptable level of exposure designated as the reference dose (RfD). The RfD is calculated by dividing the Point of Departure by applicable safety or uncertainty factors. Typically, EPA uses a baseline safety/uncertainty factor of 100X. That value includes a factor of ten (10X) where EPA is using data from laboratory animals to reflect potentially greater sensitivity in humans than animals and a factor of 10X to account for potential variations in sensitivity among members of the human population as well as other unknowns. Additional safety factors may be added to address data deficiencies or concerns raised by the existing data. Under the FQPA, an additional safety factor of 10X is presumptively applied to protect infants and children, unless reliable data support selection of a different factor. This FQPA additional safety factor largely replaces pre-FQPA EPA practice regarding additional safety factors. (Ref. 3 at 4-11).

In implementing FFDCA section 408, EPA's Office of Pesticide Programs, also calculates a variant of the RfD referred to as a Population Adjusted Dose (PAD). A PAD is the RfD divided by any portion of the FQPA safety factor that does not correspond to one of the traditional additional safety factors used in general Agency risk assessments. (Ref. 3 at 13-16). The reason for calculating PADs is so that other parts of the Agency, which are not governed by FFDCA section 408, can, when evaluating the same or similar substances, easily identify which aspects of a pesticide risk assessment are a function of the particular statutory commands in FFDCA section 408. Today, RfDs and PADs are generally calculated for both acute and chronic dietary risks although traditionally a RfD or PAD was only calculated for chronic dietary risks. Throughout this document general references to EPA'scalculated safe dose are denoted as a RfD/PAD.

ii.Non-threshold effects. For risk assessments for non-threshold effects, EPA does not use the RfD/PAD approach to choose a level of concern if quantification of the risk is deemed appropriate. Rather, EPA calculates the slope of the dose-response curve for the non-threshold effects from relevant studies using a linear, low-dose extrapolation model that assumes that any amount of exposure will lead to some degree of risk. This dose-response analysis will be used in the risk characterization stage to estimate the risk to humans of the non-threshold effect. Linear, low-dose extrapolation is typically used as the default approach for estimating the risk to carcinogens, unless there are mode of action data indicating a threshold response (or nonlinearity).

c.Estimating human exposure. Risk is a function of both hazard and exposure. Thus, equally important to the risk assessment process as determining the hazards posed by a pesticide and the toxicological level of concern for those hazards is estimating human exposure. Under FFDCA section 408, EPA is concerned not only with exposure to pesticide residues in food but also exposure resulting from pesticide contamination of drinking water supplies and from use of pesticides in the home or other non-occupational settings. (See 21 U.S.C. 346a(b)(2)(D)(vi)).

i.Exposure from food. There are two critical variables in estimating exposure in food: (1) The types and amount of food that is consumed; and (2) the residue level in that food. Consumption is estimated by EPA based on scientific surveys of individuals' food consumption in the United States conducted by the USDA. (Ref. 2 at 12). Information on residue values comes from a range of sources including crop field trials, data on pesticide reduction (or concentration) due to processing, cooking, and other practices, information on the extent of usage of the pesticide, and monitoring of the food supply. (Id. at 17).

In assessing exposure from pesticide residues in food, EPA, for efficiency's sake, follows a tiered approach in which it, in the first instance (i.e., Tier 1), assesses exposure using the worst case assumptions that 100 percent of the crops for which tolerances exist or are proposed are treated with the pesticide and 100 percent of the food from those crops contain pesticide residues at the tolerance level. (Id. at 11). When such an assessment shows no risks of concern, a more complex risk assessment is unnecessary. By avoiding a more complex risk assessment, EPA's resources are conserved and regulated parties are spared the cost of any additional studies that may be needed. If, however, a Tier 1 assessment suggests there could be a risk of concern, EPA then attempts to refine its exposure assumptions to yield a more realistic picture of residue values through use of data on the percent of the crop actually treated with the pesticide and data on the level of residues that may be present on the treated crop. These latter data are used to estimate what has been traditionally referred to by EPA as “anticipated residues.” EPA refinement of an exposure assessment “can have dramatic effects on the level of exposure predicted, reducing worst case estimates by 1 or 2 orders of magnitude or more.” (73 FR 42683, 42687, July 23, 2008). More information on how EPA refines estimates of exposure from pesticides in food can be found in the following EPA publication, “A User's Guide to Available EPA Information on Assessing Exposure to Pesticides in Food.” (Ref. 2; see also 73 FR at 42687).

ii.Exposure from water. EPA may use either or both field monitoring data and mathematical water exposure models to generate pesticide exposure estimates in drinking water. Monitoring and modeling are both important tools for estimating pesticide concentrations in water and can provide different types of information. Monitoring data can provide estimates of pesticide concentrations in water that are representative of specific agricultural or residential pesticide practices and under environmental conditions associated with a sampling design. Although monitoring data can provide a direct measure of the concentration of a pesticide in water, it does not always provide a reliable estimate of exposure because sampling may not occur in areas with the highest pesticide use, and/or the sampling may not occur when the pesticides are being used.

In estimating pesticide exposure levels in drinking water, EPA most frequently uses mathematical water exposure models. EPA's models are based on extensive monitoring data and detailed information on soil properties, crop characteristics, and weather patterns. (69 FR 30042, 30054-30065 (May 26, 2004)). These models calculate estimated environmental concentrations of pesticides using laboratory data that describe how fast the pesticide breaks down to other chemicals and how it moves in the environment. These concentrations can be estimated continuously over long periods of time, and for places that are of most interest for any particular pesticide. Modeling is a useful tool for characterizing vulnerable sites, and can be used to estimate peak concentrations from infrequent, large storms.

Typically EPA uses a two-tiered approach to modeling pesticide concentrations in surface and ground water. The first tier model uses high-end and worst-case assumptions as a screen to identify pesticides that will not result in residues in water that pose a concern. If the first tier model suggests that pesticide levels in water may be unacceptably high, a more refined model is used as a second tier assessment. Second tier models substitute more detailed information for the high-end or worst-case assumptions used in first tier models. For example, a second tier model may incorporate information on the maximum percentage of acreage surrounding a drinking water reservoir that may be devoted to agriculture instead of assuming that 100 percent of the watershed is, in fact, farmland.

iii.Residential exposures. Generally, in assessing residential exposure to pesticides EPA relies on its Residential Standard Operating Procedures (SOPs). (Ref. 4). The SOPs establish models for estimating application and post-application exposures in a residential setting where pesticide-specific monitoring data are not available. SOPs have been developed for many common exposure scenarios including pesticide treatment of lawns, garden plants, trees, swimming pools, pets, and indoor surfaces including crack and crevice treatments. The SOPs are based on existing monitoring and survey data including information on activity patterns, particularly for children. Where available, EPA relies on pesticide-specific data in estimating residential exposures.

d.Risk characterization.The final step in the risk assessment is risk characterization. In this step, EPA combines information from the first three steps (hazard identification, level of concern/dose-response analysis, and human exposure assessment) to quantitatively estimate the risks posed by a pesticide. Separate characterizations of risk are conducted for different durations of exposure. Additionally, separate and, where appropriate, aggregate characterizations of risk are conducted for the different routes of exposure (dietary and non-dietary).

For threshold dietary risks, EPA typically estimates risk by expressing human exposure as a percentage of the RfD/PAD. Exposures lower than 100 percent of the RfD/PAD are generallynot of concern. Under current procedures, EPA aggregates pesticide exposure from food and drinking water prior to comparing exposure to the RfD/PAD.

2.EPA policy on the children's safety factor. As the above brief summary of EPA's risk assessment practice indicates, the use of safety factors plays a critical role in the process. This is true for the use of traditional 10X safety factors to account for potential differences between animals and humans when relying on studies in animals (inter-species safety factor) and potential differences among humans (intra-species safety factor) as well as the use of FQPA's additional 10X children's safety factor.

In applying the children's safety factor provision, EPA has interpreted it as imposing a presumption in favor of applying an additional 10X safety factor. (Ref. 3 at 4, 11). Thus, EPA generally refers to the additional 10X factor as a presumptive or default 10X factor. EPA has also made clear, however, that this presumption or default in favor of the additional 10X is only a presumption. The presumption can be overcome if reliable data demonstrate that a different factor is safe for children. (Id.). In determining whether a different factor is safe for children, EPA focuses on the three factors listed in section 408(b)(2)(C) — the completeness of the toxicity database, the completeness of the exposure database, and potential pre- and post-natal toxicity. In examining these factors, EPA strives to make sure that its choice of a safety factor, based on a weight-of-the-evidence evaluation, does not understate the risk to children. (Id. at 24-25, 35).

1.In general.NRDC challenged a December 27, 2001, action establishing tolerances for pymetrozine on cotton seed; cotton gin byproducts; fruiting, cucurbit, leafy, and Brassica vegetables; turnip greens; hops; and pecans. (66 FR 66786, December 27, 2001). Given pymetrozine's exposure pattern and toxicological characteristics, EPA determined that pymetrozine potentially presented acute, short-term, chronic, and cancer risks and EPA quantitatively assessed these risks in making its safety determination. (Id. at 66791-66792). All of these risks were found to be below the Agency's level of concern. (Id.).

2.Children's safety factor determination.For pymetrozine, EPA concluded there was uncertainty regarding its effects on the young because a DNT was outstanding and a NOAEL had not been identified in an acute neurotoxicity study. (66 FR at 66791; 64 FR 52438, 52444, September 29, 1999). EPA determined, however, that these uncertainties were partially offset by a number of factors. First, EPA noted that there was no increased sensitivity in young animals observed in the pre- and post-natal studies conducted with pymetrozine, and that these studies showed no evidence of abnormalities in the fetal nervous system. (Ref. 5 at 5). Second, the evidence on pymetrozine's neurotoxicity was mixed. Although the acute neurotoxicity study had identified behavioral effects at 125 milligrams per kilogram of body weight per day (mg/kg bw/day), the subchronic neurotoxicity only showed “indefinite evidence” of neurotoxicity at significantly higher doses (201 mg/kg/day for males, 228 mg/kg/day for females). (Id. at 2). Third, exposure data were deemed adequate not to underestimate exposure. (Id. at 5). Weighing all of this evidence, EPA determined that the safety of infants and children would be protected by an additional 3X safety factor applied to all risk assessments; (66 FR at 55791) and a second additional 3X safety factor for assessing acute risks to the general population, including infants and children. The second additional safety factor was only applied to the acute assessment because it was only in an acute neurotoxicity study that a NOAEL had not been identified. (64 FR at 52444). Given the two 3X safety factors for acute risk, EPA essentially retained the full 10X FQPA safety factor for the acute risk assessment. The second additional 3X safety factor was not retained as to the acute assessment for women of child-bearing age because this assessment was based on an acute study in which a NOAEL was obtained. (Id.).

Since December 2001, EPA has established an additional tolerance for pymetrozine on asparagus. (70 FR 43292, July 27, 2005). Because section 408 requires EPA, in setting a pesticide tolerance, to consider aggregate exposure to the pesticide, “including dietary exposure under . . . all other tolerances for the pesticide chemical residue,” in this subsequent action EPA took into account exposure to pymetrozine under challenged tolerances established on December 27, 2001 (cotton seed; cotton gin byproducts; fruiting, cucurbit, leafy, and Brassica vegetables; turnip greens; hops; and pecans). In its action on the asparagus tolerance in 2005, EPA concluded that the additional exposure from the new tolerance, when aggregated with exposure under existing tolerances, was safe. (70 FR at 43297).

With regard to the children's safety factor in this subsequent action, EPA relied on a revised analysis taking into account its Children's Safety Factor Policy, which had not been released at the time of the December 27, 2001 tolerance action. This revised analysis focused on how the expected dose level in the requested DNT study compared to the existing Points of Departure for acute and chronic risks. The dose levels in the DNT study are generally guided by the results of the two-generation study in rats because it is a study involving the young and is conducted in the same species as the DNT study. Noting that the Points of Departure for acute risk were generally in the same order of magnitude of the NOAEL in the reproduction study, EPA concluded that full additional 10X safety factor should be retained for acute risk assessments because the DNT study could potentially lower the existing Point of Departure significantly and thus EPA lacked reliable data to choose a factor other than the default value. EPA reasoned that if the DNT study showed adverse effects at the lowest dose tested (presumably a dose in the range of the current Point of Departure), then a revised Point of Departure would be tenfold lower than the existing Point of Departure once EPA compensated for a lack of NOAEL in the DNT study. The opposite conclusion was reached for chronic risks because the Point of Departure for chronic risk assessment was already 30X lower than the expected low dose in the DNT study. Due to this significant difference in the chronic Point of Departure and the expected low dose in the DNT study, the results of the DNT study were unlikely to affect the chronic Point of Departure and thus an additional safety factor was not needed to protect infants and children in the absence of the DNT study. (Ref. 6).

On four occasions in the first half of 2002, the NRDC and various other parties filed objections with EPA to final rules under section 408 of the FFDCA, (21 U.S.C. 346a), establishing pesticide tolerances for various pesticides. The objections applied to 14 pesticides and 112 separate pesticide tolerances. The challenged tolerances included the tolerances for pymetrozine addressed intoday's regulation. The objections to the pymetrozine tolerances were filed on February 25, 2002, and grouped with objections to tolerances for halosulfuron-methyl.

Although NRDC's petitions raised dozens of issues, most of the issues related to two main claims: (1) That EPA had not properly applied the additional 10X safety factor for the protection of infants and children in section 408(b)(2)(C); and (2) that EPA had not accurately assessed the aggregate exposure of farm children to pesticide residues. Many of the issues were not fact-specific to the challenged tolerances but rather represented a generic challenge to EPA's implementation of the FQPA.

Two specific issues raised by NRDC are worthy of greater description because they later figured in the judicial review of EPA's disposition of the objections. First, as to several of the pesticides, NRDC argued that EPA had unlawfully removed the 10X children's safety factor because EPA had required that a DNT study be submitted for the pesticides but such study had not yet been completed. Specifically as to pymetrozine, NRDC asserted that:

EPA denied NRDC's objections in two separate orders. The first was issued on May 26, 2004, and addressed only the tolerances for imidacloprid. (69 FR 30042, May 26, 2004). The second was released on August 10, 2005 and addressed the tolerances for the remaining 14 pesticides. (70 FR 46706, August 10, 2005). The second order relied heavily on the imidacloprid order because in the process of resolving the claims pertaining to imidacloprid, EPA resolved many of NRDC's generic attacks on EPA's interpretation of the FQPA. (70 FR at 46711, 46716, 46725, 46726, 46730).

As to the DNT study and the children's safety factor, EPA rejected “NRDC's contention that an EPA finding that a DNT study is needed in evaluating the risks posed by the pesticide is outcome-determinative as regards to retaining the children's safety factor until such time as the DNT study is submitted and reviewed.” (70 FR at 46724). EPA carefully reviewed all of the evidence cited by NRDC regarding the DNT study and concluded that NRDC had not shown that the DNT was so critical to the protection of children that in the absence of that study EPA was conclusively precluded from exercising its statutory authority to make a case-by-case determination regarding the appropriate children's safety factor. EPA specifically did not address the specific factual considerations relating to its individual children's safety factor decisions as to pymetrozine (and the other pesticides), noting that “NRDC has offered no pesticide-specific arguments as to the pesticides in this proceeding as to why the absence of a DNT study requires the retention of the default 10X additional factor.” (Id.)

With regard to whether reliance on drinking water models precluded lowering of the children's safety factor, EPA exhaustively reviewed the underlying factual basis for its models, the scientific peer review they had received, and how the models had worked in practice. EPA concluded that “they are based on reliable data and have produced estimates that EPA can reliably conclude will not underestimate exposure to pesticides in drinking water.” (70 FR at 46726). Accordingly, NRDC's claim that only actual pesticide-specific water monitoring data could provide “reliable data” on the levels of pesticides in drinking water was rejected.

1.NRDC's petition for review. In August, 2005, NRDC and the Northwest Coalition for Alternatives to Pesticides (NCAP) filed petitions for review of EPA's August 10, 2005 order. NRDC had not challenged the May 26, 2004 imidacloprid order. The petitions were filed in the Second and Ninth Circuits and the matter was assigned to the Ninth Circuit. The consolidated petitions sought review as to EPA's denial of NRDC's objections as they pertained to the tolerances of the following seven pesticides: acetamiprid, fenhexamid, halosulfuron-methyl, isoxadifen-ethyl, mepiquat, pymetrozine, and zeta-cypermethrin.

NRDC/NCAP's brief argued that EPA had unlawfully removed or lowered the children's safety factor as to these seven pesticides and that EPA's establishment of tolerances for the seven pesticides was arbitrary and capricious. (Ref. 9). As to the contentions regarding the children's safety factor, NRDC/NCAP made several independent claims as to why EPA's action was unlawful. These claims were:

2.The Ninth Circuit's decision. On September 19, 2008, the Ninth Circuit unanimously determined that:

Although NRDC/NCAP's petition for review concerned seven pesticides, the court only remanded to EPA the tolerance decisions on acetamiprid, mepiquat, and pymetrozine. The petition for review was denied as to the other four pesticides because the remand only pertained to pesticides for which there was a question concerning EPA's pesticide-specific choice of a children's safety factor in the absence of a required DNT study. As to fenhexamid and isoxadifen-ethyl, a DNT study had not been required by EPA. For halosulfuron-methyl and zeta-cypermethrin tolerances, a DNT study had been required and had not been submitted at the time of the tolerance action; however, by the time of the oral argument, the circumstances had changed. As to zeta-cypermethrin, the DNT study had been submitted and reviewed by EPA and EPA had established further tolerances in reliance on the DNT study. As to halosulfuron-methyl, EPA had withdrawn the requirement for a DNT study. EPA notified the court that there was no longer a live controversy as to the tolerances for halosulfuron-methyl and zeta-cypermethrin and NRDC/NCAP and the court agreed the petition was moot as to these pesticides. (544 F.3d at 1048 n.4; Refs. 10 and 11).

On remand, EPA has determined that NRDC's objections should again be denied because the remanded objections do not show that the pymetrozine tolerances are not safe. EPA has now received and reviewed a DNT study on pymetrozine. The results of the DNT study, when considered in combination with the rest of the pymetrozine database, convince EPA that the 10X children's safety factor should be retained for pymetrozine. EPA evaluated the risk of pymetrozine, taking into account the additional 10X children's safety factor and has concluded that pymetrozine tolerances are safe. A summary of EPA's reasons for retaining the 10X children's safety factor and of EPA's risk assessment is provided below.

A DNT study with pymetrozine was performed in Wistar-derived rats. (Ref. 12). Dose levels in the study were 0 (control), 100, 500, or 2,500 parts per million (ppm). To translate these doses to humans they are expressed in terms of the daily dose in milligrams of pymetrozine per kilogram of body weight of the experimental animals. Additionally, because of significant body weight changes between fetuses during the period of gestation and post-natal animals during lactation, that weight change is incorporated into the expression of dose by using separate dose calculations for gestation and lactation. Expressed in these terms, the doses in the pymetrozine DNT study were 0/0 (gestation/lactation), 8.1/16.8, 38.7/82.6, and 173.1 milligrams/kilogram of body weight/day (mg/kg/day). No dose is provided for the high dose group of lactation animals because higher than expected mortality was observed during littering, resulting in an insufficient number of litters. Therefore, the study was terminated for the high dose group prior to lactation.

Effects in pups, as well as maternal animals, were evaluated through both in-life and post-mortem observations. To investigate potential neurotoxic effects, the in-life observations included monitoring of motor activity, testing of acoustic startle response, learning and memory evaluation, and use of a functional observation battery (FOB). The FOB is a noninvasive procedure designed to detect gross functional deficits resulting from exposure to chemicals and to better quantify neurotoxic effects detected in other studies. The FOB consists of six types of observations: home cage, handling, open field, sensory, neuromuscular, and physiological responses. Post-mortem evaluation included examination of the major portions of the central and peripheral nervous system for any sign of neuropathology.

The primary effect seen in the maternal animals was loss of the litter. At the 38.7 mg/kg/day dose, total litter loss was experienced between birth and post-natal-day 5 by 5 out of 29 treated maternal animals (17.2%) compared to 2 out of 30 controls (6.7%). On gestation day 24, one maternal animal with staining around the nose was sacrificed due to difficult parturition, and another animal was pale. Food consumption was decreased (↓21%; statistical significance of p≤0.01) during lactation days 1-5. However, body weights at this dose were comparable to controls throughout treatment. At the 8.1/16.8 mg/kg/day dose, no treatment-related effects were seen on litter loss, survival, clinical signs, body weight, body weight gain, food consumption, or reproductive performances. EPA determined that the maternal LOAEL is 38.7 mg/kg/day and the maternal NOAEL is 8.1 mg/kg/day.

Pymetrozine caused a dose-dependent increase in the number of pups dying during post-natal-days 1-5; 57 pups at 8.1/16.8 mg/kg/day, 95 pups at 38.7/82.6 mg/kg/day, and 151 pups at 173.1 mg/kg/day, compared to 48 pups in the controls. This was due to the increase in the number of whole litter losses at 8.1/16.8 mg/kg/day (3 litters), 38.7/82.6 mg/kg/day (5 litters), and 173.1 mg/kg/day (4 litters) compared to controls (2 litters). When whole litter losses are excluded, no treatment-related findings were observed on litter size or viability.

Treatment had no adverse effects on pup body weight, body weight gain, food consumption, developmental landmarks, clinical signs, FOB, motor activity, auditory startle reflex, learning and memory, or brain weights. However, measurement of brain morphometry showed the following differences (p≤0.05) from controls: (i) Increased thickness of the corpus callosum in the 38.7/82.6 mg/kg/day males on post-natal-day 12 (↑15%) and in the 8.1/16.8 mg/kg/day males on post-natal-day 63 (↑4-13%); (ii) increased thickness of the inner granular and molecular layers of the pre-pyramidal fissure in the cerebellum in the 38.7/82.6 mg/kg/day males on post-natal-day 63 (↑4-19%); and (iii) increased thickness of the dorsal cortex in the 8.1/16.8 mg/kg/day females on post-natal-day 12 (↑4-10%).

EPA determined that the offspring LOAEL is 8.1 mg/kg/day, the lowest dose tested, based on morphometric changes in the brains of female pups on post-natal-day 12 and male pups on post-natal-day 63. The offspring NOAEL was not established.

In evaluating the children's safety factor for pymetrozine, EPA considered the completeness of the toxicity and exposure databases as well as the potential for pymetrozine to cause pre- or post-natal toxicity, particularly where such toxicity indicates increased sensitivity in juvenile animals compared to adult animals. (Ref. 13)

1.Toxicity database. With the receipt of the DNT study, the toxicity databasefor pymetrozine is complete in terms of the requirements in place at the time of the challenged pymetrozine tolerance action in 2001. However, since that time, EPA has amended data requirements pertaining to registration of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act, (7 U.S.C. 136 et seq.), and establishment of tolerances under the FFDCA. (72 FR 60934, October 26, 2007). Several new requirements apply to agricultural pesticides such as pymetrozine but the only new data requirement for pymetrozine that has not yet been fulfilled is the requirement for an immunotoxicity study.

In the absence of this study, EPA examined the pymetrozine database to evaluate pymetrozine's immunotoxic potential. EPA concluded that the liver is the primary target organ of pymetrozine and that apparent immunotoxic effects are the result of exceedingly high doses.

Potential immune organ effects include atrophy of the thymus in the subchronic rat and dog studies at 360 and 54 mg/kg/day, respectively; decreased thymus weight in the chronic mouse study at 675 mg/kg/day; increased leucocytes in the subchronic rat study at 360 mg/kg/day; and hyperplasia of the splenic lymphocyte follicles in the reproduction study at 136.9 mg/kg/day. Clear NOAELs were identified for these potential immunotoxic effects at higher doses than the endpoint that was selected for risk assessment, i.e., the 8.1 mg/kg/day LOAEL from the DNT study based on brain morphometric changes in the offspring. Lymphocytic infiltration in the prostrate and thyroid was observed at 14 mg/kg/day in the subchronic dog study but these organs are not a primary part of the immune system and the lymphocytic infiltration is considered an immune system reaction to other toxic effects on these organs and not an immunotoxic effect.

The Agency does not believe that conducting a functional immunotoxicity study will result in a lower Point of Departure than the endpoint currently selected for overall risk assessment (i.e. the extrapolated NOAEL from the DNT study—see discussion below in Unit VII.C.1.a.) based on:

The other concern with the toxicity database is that a NOAEL was not identified for juvenile animals in the DNT study. The LOAEL in that study was based on differences from controls in the measurement of brain morphometrics. The concern with this effect, however, is lessened somewhat here in that no effects were seen in other barometers of effects on developmental neurology such as developmental landmarks, clinical signs, FOB, motor activity, auditory startle reflex, learning and memory, or brain weights.

2.Potential pre- and post-natal toxicity. No indications of qualitative or quantitative sensitivity in the young were seen in the developmental studies in rats and rabbits or in the two generation reproduction study in rats. NOAELs were identified for all effects in the young seen in these studies. On the other hand, EPA has assumed that quantitative sensitivity was detected in the DNT study in rats given that toxicity was observed in the juveniles (brain morphometric changes) in the absence of maternal toxicity. This is a conservative assumption on EPA's part in that the maternal animals' brains were not examined for morphometric changes.

3.Exposure database. EPA's exposure estimate is based mainly on a 2005 exposure assessment performed for the last pymetrozine tolerance action. (70 FR 43292, July 27, 2005). For the acute exposure assessment, EPA used the very conservative approach of assuming pymetrozine was used on all foods with a tolerance and residues were at the tolerance level. The chronic exposure assessment is more refined in that for most crops EPA relied on average values from pesticide residue field trials for all commodities and data on the percentage of crops that are treated with pymetrozine for most of the more heavily-consumed commodities. Because several years have passed since the 2005 pymetrozine tolerance action, EPA updated the percent crop treated data in assessing exposure. Although pymetrozine is licensed for use on ornamentals, EPA expects exposure to the public, including children, from this use to be negligible because pymetrozine may only be applied by commercial applicators (hence, no applicator exposure for the public) and post-application contact with ornamentals is infrequent and brief compared with, for example, turf.

4.Conclusion. The primary factor of concern from the above is the weakness in the toxicity database due to the failure to identify a NOAEL in the DNT study. This deficiency is heightened by the fact that, although pre- and post-natal animals were generally not more sensitive than adults, the DNT study showed quantitative sensitivity in rat pups due to the identification of adverse brain morphometric changes in rat pups at a dose that did not cause maternal toxicity. Although the brain morphometric effects seen at the LOAEL in the DNT study were not confirmed by other barometers of developmental neurotoxicity, the absence of a NOAEL for these effects creates sufficient uncertainty that reliable data are not available to revise the default 10X children's safety factor. Therefore, EPA is retaining the full 10X children's safety factor in assessing risk based on the DNT study. As discussed in Unit VII.C.1. below, the DNT study provides the Point of Departure for both acute and chronic risk assessments. Retention of the full children's safety factor reduces any concerns from lack of an immunotoxicity study as the NOAELs from the potential immunotoxic organ effects are all greater than 1000X higher than the level of concern (aPAD and cPAD) when the 10X children's safety factor is taken into account. Despite the lack of a NOAEL in the DNT study and the increased sensitivity in juveniles shown in that study, EPA does not believe that the weight of the evidence supports an additional safety factor higher than 10X given that the brain morphometric effects seen at the LOAEL in the DNT study were not confirmed by any other measures of neurological effect.

Given the new data on developmental neurotoxicity and EPA's revised children's safety factor determination, EPA has recalculated the risks of pymetrozine taking this information into account. EPA last assessed the risks of pymetrozine in connection with a tolerance rulemaking for pymetrozine on asparagus in 2005. (70 FR 43292, July 27, 2005). The new information affects the hazard identification and dose-response aspects of the risk assessment for acute and chronic non-cancer risk. EPA has also updated the exposure assessment performed for the 2005 assessment because exposure information is needed in completing a revised acute and chronic risk assessment.

1.Hazard identification/dose response—a.Point of Departure.As previously explained, EPA chooses a Point of Departure from toxicology studies for use in calculating a safe level of exposure to humans. This safe levelof exposure is called a Reference Dose (RfD) or Population-Adjusted Dose (PAD). In the 2002 tolerance rulemaking, EPA used the following Points of Departure: for acute risk to the general population (including infants and children) a LOAEL of 125 mg/kg/day from the acute neurotoxicity study in rats; for acute risk to pre-natal infants (focusing on exposure to females of child-bearing age) a NOAEL of 10 mg/kg/day from the rabbit developmental study; and for chronic risk to the general population (including infants and children) a NOAEL of 0.377 from the chronic toxicity study in rats. The same Points of Departure were used in risk assessment for the 2005 rulemaking.

The Points of Departure have been changed based on a review of the DNT study. EPA determined that the LOAEL of 8.1 mg/kg/day from the DNT study (no NOAEL was established) would be used as the Point of Departure for both acute risk (all population groups including infants and children and women of child-bearing age) and chronic risk (again, all population groups). As described above, the effect seen at the LOAEL was changes in brain morphometrics in the offspring. The LOAEL from the DNT study was chosen for the Point of Departure for assessing acute risk because it is lower than either of the two doses previously used (the LOAEL from the acute neurotoxicity study and the NOAEL from the rabbit developmental study). Selection of this LOAEL for the Point of Departure for acute risk assessment is conservative because the brain morphometric changes were observed in the absence of impacts on other parameters, including developmental landmarks, clinical signs, FOB, motor activity, acoustic startle response, learning and memory, or brain weight. It is additionally conservative because EPA has assumed that these brain changes could occur from a single dose.

The Agency is using the LOAEL from the DNT study as the Point of Departure for chronic risk because brain morphometric changes may be the result of single or multiple doses and this LOAEL produces the most protective cPAD. Previously, EPA used the NOAEL from the chronic rat study as the Point of Departure but the LOAEL from that study is based on hepatic hypertrophy and EPA no longer considers hepatic hypertrophy in the absence of liver pathology or changes in relevant clinical chemistry parameters to be an adverse effect. Hepatocellular hypertrophy is often an adaptive and reversible effect in response to the presence of a chemical (i.e. induction of microsomal enzymes in the liver). Although there are other NOAELs in the pymtrozine database at or slightly below the LOAEL from the DNT study, once an additional safety factor (see above) is retained to address the lack of a NOAEL in the DNT study, reliance on the LOAEL from this study produces the most protective cPAD.

b.Dose response.To calculate both the aPAD and cPAD, EPA divided the LOAEL from the DNT study by 1,000, representing a 10X factor to account for inter-species variability, a 10X factor to account for intra-species variability, and an additional 10X safety factor for the protection of infants and children due to the lack of a NOAEL in the DNT study. As noted above, the retention of the full 10X children's safety factor is conservative given the fact that the brain morphometric changes were noted in the absence of any confirming clinical or neuropathological signs.

2.Exposure. As explained in Unit VII.B. above, EPA relied on the exposure assessment for the 2005 pymetrozine tolerance rulemaking updated to incorporate more recent percent crop treated information. Residue levels in drinking water were estimated for that exposure assessment based upon EPA's screening level drinking water models. This assessment is very conservative with regard to acute exposure, and, while more refined for chronic exposure, still retains significant conservatisms. (Refs. 13 and 14).

3.Safety Determination.Table 1 below shows how exposure to pymetrozine residues in food and drinking water compared to the aPAD and cPAD for the general population and major population subgroups based on age. The highest subgroups for acute and chronic exposure are shown in bold.

Given the data and analysis underlying the derivation of the pymetrozine aPAD and cPAD and the pymetrozine exposure assessment, EPA concludes that its finding that exposure for the highest exposed population subgroup is below the aPAD and cPAD shows that there is a reasonable certainty of no harm from aggregate exposure to pymetrozine for all population subgroups including infants and children. (Refs. 13 and 14).

Because EPA's revised risk assessment - which incorporates both the DNT study and the 10X children's safety factor - shows pymetrozine exposure to be safe, NRDC's objection to the establishment of the pymterozine tolerances is denied.

This final rule reaffirms, over objections, tolerances established under section 408(d) of 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, entitledRegulatory Planning and Review(58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq., nor does it require any special considerations under Executive Order 12898, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of 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. 601et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation and Coordination with Indian Tribal Governments(65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not 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).

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).

The Congressional Review Act, 5 U.S.C. 801et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. Here, the underlying rule establishing pymetrozine tolerances is currently in effect. (See 66 FR 66786, December 27, 2001). The EPA order denying objections to that rule, however, has been remanded to EPA for a further explanation of the basis for EPA's decision on the objections. Importantly, the court remanded the matter to EPA without vacating the underlying rule. Today's action reaffirming the prior rule responds to the judicial remand and does not affect the status of the underlying rule. EPA will submit a report containing today's action reaffirming the pymetrozine tolerance regulation 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 theFederal Register. The reaffirmed pymetrozine tolerance regulation is not a “major rule” as defined by 5 U.S.C. 804(2).

1. Objections to the Establishment of Tolerances for Pesticide Chemical Residues: Halosulfuron-methyl and Pymetrozine Tolerances (filed February 25, 2002).

2. USEPA, A User's Guide to Available EPA Information on Assessing Exposure to Pesticides in Food (June 21, 2000).

3. Office of Pesticide Programs, USEPA, Office of Pesticide Programs' Policy on the Determination of the Appropriate FQPA Safety Factor(s) For Use in the Tolerance Setting Process (February 28, 2002).

4. Office of Pesticide Programs, USEPA, Standard Operating Procedures (SOPs) for Residential Exposure Assessments (Draft December 19, 1997).

5. Office Of Prevention, Pesticides and Toxic Substances, USEPA, Memorandum from Brenda Tarplee to Michael Doherty, Pymetrozine - Report of the FQPA Safety Factor Committee (July 21, 1999).

6. Office Of Prevention, Pesticides and Toxic Substances, USEPA, Memorandum from Brenda Tarplee to Michael Doherty, Pymetrozine - 3rd Report of the Hazard Identification Assessment Review Committee (February 9, 2003).

7. NRDC, Objections to the Establishment of Tolerances for Pesticide Chemical Residues: Isoxadifen-ethyl, Acetamiprid, Propiconazole, Furilazole, Fenhexamid, and Fluazinam Tolerances (filed May 20, 2002).

8. NRDC, Objections to the Establishment of Tolerances for Pesticide Chemical Residues: Imidacloprid, Mepiquat, Bifenazate, Zeta-cypermethrin, and Diflubenzuron Tolerances (filed March 19, 2002).

9. Petitioners' Brief,NCAP v. EPA, Case Nos. 75255, 76807 (9th Cir. March 6, 2006).

10. Letter from Kent E. Hanson, U.S. Department of Justice to Cathy Catterson, Clerk of the Court, United States Court of Appeals, Ninth Circuit, Notice of Supplemental Authority inNorthwest Coalition for Alternatives to Pesticides v. EPA, Nos. 04-75255 & 04-76807 (May 25, 2007).

11. Letter from Aaron Colangelo, U.S. Department of Justice to Cathy Catterson, Clerk of the Court, United States Court of Appeals, Ninth Circuit, Response to EPA's Notice of Supplemental Authority inNorthwest Coalition for Alternatives to Pesticides v. EPA, Nos. 04-75255 & 04-76807 (May 29, 2007).

12. Office Of Prevention, Pesticides and Toxic Substances, USEPA, Memorandum from Robert J. Mitkus to Daniel Peacock, Pymetrozine - Review of Developmental Neurotoxicity Study in Rats (July 13, 2005).

13. Office Of Prevention, Pesticides and Toxic Substances, USEPA, Memorandum from Christina Swartz to Daniel B. Peacock and Meredith F. Laws, Pymetrozine. Updated Aggregate Human Health Risk Assessment (April 2, 2010).

14. Office Of Prevention, Pesticides and Toxic Substances, USEPA, Memorandum from Christina Swartz to Daniel B. Peacock and Meredith F.Laws, Pymetrozine - Acute, Chronic and Cancer Combined Dietary (Food + Drinking Water) Exposure and Risk Assessments (April 2, 2010).

In this document EPA denies objections by the Natural Resources Defense Council (“NRDC”) to EPA’s to establishment of certain pesticide tolerances. This action may also be of interest to agricultural producers, food manufacturers, or pesticide manufacturers. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The NAICS codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

In addition to accessing an electronic copy of thisFederal Registerdocument through the electronic docket athttp://www.regulations.gov, you may access thisFederal Registerdocument electronically through the EPA Internet under the “Federal Register” listings athttp://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site athttp://www.gpoaccess.gov/ecfr.

In this order, EPA denies objections filed by the NRDC to regulations establishing pesticide tolerances for acetamiprid and mepiquat under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA previously denied NRDC’s objections in an order dated August 10, 2005. (70 FR 46706 (August 10, 2005)). NRDC sought judicial review of the August, 2005 order, and the U.S. Court of Appeals, Ninth Circuit, remanded the order to EPA on the sole ground that EPA had not provided an adequate explanation as to one aspect of its decision. (NCAP v. EPA, 544 F.3d 1043, 1052 (9th Cir. 2008)). Specifically, the court held that EPA did not provide “enough information” on why it chose to deviate from the presumptive ten-fold (10X) additional safety factor for the protection of infants and children in FFDCA section 408(b)(2)(C). (Id.). In response to the remand, EPA is again denying the objections; however, EPA has not provided further information on its decision on the children’s safety factor because that issue is now either moot or not outcome-determinative with regard to the challenged tolerances.

EPA’s authority for issuing pesticide tolerances is contained in FFDCA section 408(d) and the statutory provisions governing the administrative review process for tolerances is in FFDCA section 408(g)(2). (21 U.S.C. 346a(d) and (g)(2)).

In this unit, EPA provides background on the relevant statutes and regulations governing NRDC’s objections as well as on pertinent Agency policies and practices. Unit III.A. summarizes the requirements and procedures in section 408 of the FFDCA and applicable regulations pertaining to pesticide tolerances. Unit III.B. provides an overview of EPA’s risk assessment process. It contains an explanation of how EPA identifies the hazards posed by pesticides, how EPA determines the level of exposure to pesticides that pose a concern (“level of concern”), how EPA measures human exposure to pesticides, and how hazard, level of concern conclusions, and human exposure estimates are combined to evaluate risk. Further, this unit presents background information on the EPA’s policy with regard to the statutory safety factor for the protection of infants and children.

1.In general. EPA establishes maximum residue limits, or “tolerances,” for pesticide residues in food under section 408 of the FFDCA. (21 U.S.C. 346a). Without such a tolerance or an exemption from the requirement of a tolerance, a food containing a pesticide residue is “adulterated” under section 402 of the FFDCA and may not be legally moved in interstate commerce. (21 U.S.C. 331, 342).

2.Safety standard for pesticide tolerances.A pesticide tolerance may only be promulgated by EPA if the tolerance is “safe.” (21 U.S.C. 346a(b)(2)(A)(i)). “Safe” is defined by the statute 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.” (21 U.S.C. 346a(b)(2)(A)(ii)). In making this safety determination, risks to infants and children are given special consideration. Specifically, this provision creates a presumptive additional safety factor for the protection of infants and children. It directs that “[i]n the case of threshold effects, ... an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.” (21 U.S.C. 346a(b)(2)(C)). EPA is permitted to “use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.” (Id.). The additional safety margin for infants and children is referred to throughout this Order as the “children's safety factor.” These provisions on pesticide safety were a part of major revisions to section 408 enacted by the Food Quality Protection Act of 1996 (FQPA). (Pub. L. 104-170, 110 Stat. 1489).

3.Procedures for establishing, amending, or revoking tolerances. Tolerances are established, amended, or revoked by rulemaking under the unique procedural framework set forth in the FFDCA. Generally, a tolerance rulemaking is initiated by the party seeking to establish, amend, or revoke a tolerance by means of filing a petition with EPA. (See 21 U.S.C. 346a(d)(1)). EPA publishes in theFederal Registera notice of the petition filing and requests public comment. (21 U.S.C. 346a(d)(3)). After reviewing the petition, and any comments received on it, EPA may issue a final rule establishing, amending, or revoking the tolerance, issue a proposed rule to do the same, or deny the petition. (21 U.S.C. 346a(d)(4)).

Once EPA takes final action on the petition by establishing, amending, or revoking the tolerance or denying the petition, any person may file objections with EPA and seek an evidentiary hearing on those objections. (21 U.S.C. 346a(g)(2)). Objections and hearing requests must be filed within 60 days. (Id.). EPA's final order on the objections is subject to judicial review. (21 U.S.C. 346a(h)(1)).

1.The safety determination - risk assessment. To assess risk of a pesticide tolerance, EPA combines information on pesticide toxicity with information regarding the route, magnitude, and duration of exposure to the pesticide. The risk assessment process involves four distinct steps: Identification of the toxicological hazards posed by a pesticide; determination of the “level of concern” with respect to human exposure to the pesticide; estimation of human exposure to the pesticide; and characterization of the risk posed to humans by the pesticide based on comparison of human exposure to the level of concern.

a.Hazard identification. In evaluating toxicity or hazard, EPA reviews toxicity studies, primarily in laboratory animals, to identify any adverse effects on the test subjects. Animal studies typically involve investigating a broad range of endpoints including gross and microscopic effects on organs and tissues, functional effects on bodily organs and systems, effects on blood parameters (such as red blood cell count, hemoglobin concentration, hematocrit, and a measure of clotting potential), effects on the concentrations of normal blood chemicals (including glucose, total cholesterol, urea nitrogen, creatinine, total protein, total bilirubin, albumin, hormones, and enzymes such as alkaline phosphatase, alanine aminotransfersase and cholinesterases), and behavioral or other gross effects identified through clinical observation and measurement. EPA examines whether adverse effects are caused by either short-term (e.g., “acute”) or longer-term (e.g., “chronic”) pesticide exposure and the effects of pre-natal and post-natal exposure in animals. EPA also considers whether the adverse effect has a threshold - a level below which exposure has no appreciable chance of causing the effect.

b.Level of concern/dose-response analysis. Once a pesticide’s potential hazards are identified, EPA determines a toxicological level of concern for evaluating the risk posed by human exposure to the pesticide. In this step of the risk assessment process, EPA essentially evaluates the levels of exposure to the pesticide at which effects might occur. An important aspect of this determination is assessing the relationship between exposure (dose) and response (often referred to as the dose-response analysis). EPA follows differing approaches to identifying a level of concern for threshold and non-threshold hazards. Because this document is only concerned with pesticide hazards that pose a hazard above a defined threshold, only such threshold effects are discussed.

In examining the dose-response relationship for a pesticide’s threshold effects, EPA evaluates an array of toxicity studies on the pesticide. In each of these studies, EPA attempts to identify the lowest observed adverse effect level (LOAEL) and the next lower dose at which there are no observed adverse affect levels (NOAEL). Generally, EPA will use the lowest NOAEL from the available studies as a starting point (called “the Point of Departure”) in estimating the level of concern for humans. (Ref. 1 at 9 (The Point of Departure “is simply the toxic dose that serves as the ‘starting point’ in extrapolating a risk to the human population.”)). At times, however, EPA will use a LOAEL from a study as the Point of Departure when no NOAEL is identified in that study and the LOAEL is close to, or lower than, other relevant NOAELs. The Point of Departure is inturn used in choosing a level of concern. EPA will make separate determinations as to the Points of Departure, and correspondingly levels of concern, for both short and long exposure periods as well as for the different routes of exposure (oral, dermal, and inhalation).

In estimating and describing the level of concern, the Point of Departure is at times used differently depending on whether the risk assessment addresses dietary or non-dietary exposures. For dietary risks, EPA uses the Point of Departure to calculate an acceptable level of exposure or reference dose (RfD). The RfD is calculated by dividing the Point of Departure by applicable safety or uncertainty factors. Typically, EPA uses a baseline safety/uncertainty factor of 100X. That value includes a factor of ten (10X) where EPA is using data from laboratory animals to reflect potentially greater sensitivity in humans than animals and a factor of 10X to account for potential variations in sensitivity among members of the human population as well as other unknowns. Additional safety factors may be added to address data deficiencies or concerns raised by the existing data. Under the FQPA, an additional safety factor of 10X is presumptively applied to protect infants and children, unless reliable data support selection of a different factor. This FQPA additional safety factor largely replaces pre-FQPA EPA practice regarding additional safety factors. (Ref. 2 at 4-11).

In implementing FFDCA section 408, EPA's Office of Pesticide Programs, also calculates a variant of the RfD referred to as a Population Adjusted Dose (PAD). A PAD is the RfD divided by any portion of the FQPA safety factor that does not correspond to one of the traditional additional safety factors used in general Agency risk assessments. (Ref. 2 at 13-16). The reason for calculating PADs is so that other parts of the Agency, which are not governed by FFDCA section 408, can, when evaluating the same or similar substances, easily identify which aspects of a pesticide risk assessment are a function of the particular statutory commands in FFDCA section 408. Today, RfDs and PADs are generally calculated for both acute and chronic dietary risks although traditionally a RfD or PAD was only calculated for chronic dietary risks. Throughout this document general references to EPA's calculated safe dose are denoted as a RfD/PAD.

Because this order only addresses dietary risks, EPA’s approach to non-dietary risk assessment is not further discussed.

c.Estimating human exposure. Risk is a function of both hazard and exposure. Thus, equally important to the risk assessment process as determining the hazards posed by a pesticide and the toxicological level of concern for those hazards is estimating human exposure. Under FFDCA section 408, EPA is concerned not only with exposure to pesticide residues in food but also exposure resulting from pesticide contamination of drinking water supplies and from use of pesticides in the home or other non-occupational settings. (See 21 U.S.C. 346a(b)(2)(D)(vi)).

i.Exposure from food. There are two critical variables in estimating exposure in food:

• The types and amount of food that is consumed; and

• The residue level in that food.

Consumption is estimated by EPA based on scientific surveys of individuals' food consumption in the United States conducted by the United States Department of Agriculture. (Ref. 1 at 12). Information on residue values comes from a range of sources including crop field trials, data on pesticide reduction (or concentration) due to processing, cooking, and other practices, information on the extent of usage of the pesticide, and monitoring of the food supply. (Id. at 17).

In assessing exposure from pesticide residues in food, EPA, for efficiency's sake, follows a tiered approach in which it, in the first instance (i.e., “Tier 1”), assesses exposure using the worst case assumptions that 100 percent of the crops for which tolerances exist or are proposed are treated with the pesticide and 100 percent of the food from those crops contain pesticide residues at the tolerance level. (Id. at 11). When such an assessment shows no risks of concern, a more complex risk assessment is unnecessary. By avoiding a more complex risk assessment, EPA's resources are conserved and regulated parties are spared the cost of any additional studies that may be needed. If, however, a Tier 1 assessment suggests there could be a risk of concern, EPA then attempts to refine its exposure assumptions to yield a more realistic picture of residue values through use of data on the percent of the crop actually treated with the pesticide and data on the level of residues that may be present on the treated crop. These latter data are used to estimate what has been traditionally referred to by EPA as “anticipated residues.” More information on how EPA refines estimates of exposure from pesticides in food can be found in U.S. EPA,A User's Guide to Available EPA Information on Assessing Exposure to Pesticides in Food(June 21, 2000). (See 73 FR 42683, 42687 (July 23, 2008)).

ii.Exposure from water. EPA may use either or both field monitoring data and mathematical water exposure models to generate pesticide exposure estimates in drinking water. Monitoring and modeling are both important tools for estimating pesticide concentrations in water and can provide different types of information. Monitoring data can provide estimates of pesticide concentrations in water that are representative of specific agricultural or residential pesticide practices and under environmental conditions associated with a sampling design. Although monitoring data can provide a direct measure of the concentration of a pesticide in water, it does not always provide a reliable estimate of exposure because sampling may not occur in areas with the highest pesticide use, and/or the sampling may not occur when the pesticides are being used.

In estimating pesticide exposure levels in drinking water, EPA most frequently uses mathematical water exposure models. EPA's models are based on extensive monitoring data and detailed information on soil properties, crop characteristics, and weather patterns. (69 FR 30042, 30058-30065 (May 26, 2004)). These models calculate estimated environmental concentrations of pesticides using laboratory data that describe how fast the pesticide breaks down to other chemicals and how it moves in the environment. These concentrations can be estimated continuously over long periods of time, and for places that are of most interest for any particular pesticide. Modeling is a useful tool for characterizing vulnerable sites, and can be used to estimate peak concentrations from infrequent, large storms.

Typically EPA uses a two-tiered approach to modeling pesticide concentrations in surface and ground water. The first tier model uses high-end and worst-case assumptions as a screen to identify pesticides that will not result in residues in water that pose a concern. If the first tier model suggests that pesticide levels in water may be unacceptably high, a more refined model is used as a second tier assessment. Second tier models substitute more detailed information for the high-end or worst-case assumptions used in first tier models. For example, a second tier model may incorporate information on the maximum percentage of acreage surrounding a drinking water reservoir that may be devoted to agriculture instead ofassuming that 100 percent of the watershed is, in fact, farmland.

iii.Residential exposures. Generally, in assessing residential exposure to pesticides EPA relies on its Residential Standard Operating Procedures (SOPs). (Ref. 3). The SOPs establish models for estimating application and post-application exposures in a residential setting where pesticide-specific monitoring data are not available. SOPs have been developed for many common exposure scenarios including pesticide treatment of lawns, garden plants, trees, swimming pools, pets, and indoor surfaces including crack and crevice treatments. The SOPs are based on existing monitoring and survey data including information on activity patterns, particularly for children. Where available, EPA relies on pesticide-specific data in estimating residential exposures.

d.Risk characterization. The final step in the risk assessment is risk characterization. In this step, EPA combines information from the first three steps (hazard identification, level of concern/dose-response analysis, and human exposure assessment) to quantitatively estimate the risks posed by a pesticide. Separate characterizations of risk are conducted for different durations of exposure. Additionally, separate and, where appropriate, aggregate characterizations of risk are conducted for the different routes of exposure (dietary and non-dietary).

For threshold dietary risks, EPA typically estimates risk by expressing human exposure as a percentage of the RfD/PAD. Exposures lower than 100 percent of the RfD/PAD are generally not of concern. Under current procedures, EPA aggregates pesticide exposure from food and drinking water prior to comparing exposure to the RfD/PAD.

Prior to developing appropriate modeling techniques for combining pesticide exposures from food and drinking water, EPA evaluated aggregate dietary exposure and risk in two separate steps. (Ref. 4 at 3-5). First, EPA would compare pesticide exposure from food to the safe level of exposure (i.e., the RfD/PAD). If pesticide exposure from food was less than 100 percent of the RfD/PAD, then EPA would calculate what was called a Drinking Water Level of Comparison (DWLOC) and compare the pesticide exposure concentration in water to the DWLOC. The DWLOC represented the maximum safe concentration of pesticide residue that could be present in drinking water taking into account the level of pesticide exposure from food. The DWLOC was calculated by subtracting pesticide exposure in food from the RfD/PAD and dividing that amount by the maximum water consumption level. So long as the actual pesticide concentration in drinking water was below the DWLOC, aggregate exposure to the pesticide (exposure from food and water) was generally regarded as safe. A numerical example may help explicate this procedure. (To simplify the example, units of exposure are expressed in terms of milligrams of pesticide per day (mg/day) instead of the more standard milligrams of pesticide per kilogram of human body weight per day (mg/kg/day).) Suppose the safe level of exposure to a pesticide (i.e., the RfD/PAD) is 10 mg/day and consumption of food results in exposure to residues of this pesticide at a level of 2 mg/day. Under these facts, exposure to the pesticide from food represents 20 percent of the RfD/PAD. If it is assumed that a person drinks 2 liters of water per day, the DWLOC can be calculated by subtracting pesticide exposure from food from the RfD/PAD (10 mg/day - 2 mg/day = 8 mg/day) and dividing by 2 liters. The resulting DWLOC of 4 mg/liter is the maximum safe concentration of pesticide in drinking water. It follows that so long as actual water concentrations of the pesticide do not exceed 4 mg/liter, EPA can conclude that aggregate dietary exposure to the pesticide from food and water do not exceed the RfD/PAD. If the actual level of the pesticide residue in drinking water were 0.1 mg/liter, then the pesticide concentration in drinking water would be 2.5 percent of the allowable amount or DWLOC ((0.1 mg/liter ÷ 4 mg/liter) x 100 percent) and would represent 2 percent of the RfD/PAD (((2 liters/day x0.1 mg/liter) ÷ 10 mg/kg/day) x 100 percent).

2.EPA policy on the children's safety factor. As the brief summary of EPA's risk assessment practice in this unit indicates, the use of safety factors plays a critical role in the process. This is true for the use of traditional 10X safety factors to account for potential differences between animals and humans when relying on studies in animals (inter-species safety factor) and potential differences among humans (intra-species safety factor) as well as the use of the FQPA’s additional 10X children's safety factor.

In applying the children's safety factor provision, EPA has interpreted it as imposing a presumption in favor of applying an additional 10X safety factor. (Ref. 2 at 4, 11). Thus, EPA generally refers to the additional 10X factor as a presumptive or default 10X factor. EPA has also made clear, however, that this presumption or default in favor of the additional 10X is only a presumption. The presumption can be overcome if reliable data demonstrate that a different factor is safe for children. (Id.). In determining whether a different factor is safe for children, EPA focuses on the three factors listed in section 408(b)(2)(C) - the completeness of the toxicity database, the completeness of the exposure database, and potential pre- and post-natal toxicity. In examining these factors, EPA strives to make sure that its choice of a safety factor, based on a weight-of-the-evidence evaluation, does not understate the risk to children. (Id. at 24-25, 35).

1.In general. NRDC challenged a January 23, 2002 action establishing tolerances for mepiquat on cotton gin byproducts and meat byproducts of cattle, goats, hogs, horses and sheep. (67 FR 3113 (January, 23, 2002)). Given mepiquat's exposure pattern and toxicological characteristics, EPA determined that mepiquat potentially presented acute and chronic risks and EPA quantitatively assessed these risks in making its safety determination. (67 FR at 3116). All of these risks were found to be below the Agency's level of concern. (Id.).

2.Children’s safety factor determination. For mepiquat, EPA identified increased uncertainty regarding effects on the young because a developmental neurotoxicity (DNT) study was outstanding. (65 FR 1790, 1794 (January 12, 2000)). EPA concluded, however, that this uncertainty was offset by a number of factors and removed the additional 10X safety factor. First, EPA noted that no increased sensitivity in young animals was observed in the pre- and post-natal studies with mepiquat. (65 FR at 1794). In fact, in two out of the three studies involving young animals no effects were seen in the offspring at all (developmental study in rats; 2-generation reproduction study in rats). (Ref. 5 at 2). Further, even in the third study concerning pre- and post-natal effects there were reasons to accord reduced weight to the pre- or post-natal effects observed given that effects were seen in the offspring and the parents only at the highest dose tested (developmental study in rabbits). (Id.). Second, although neurotoxic behavioral effects in adult animals were found (triggering the DNT study requirement), there was no evidence reflecting specialconcern for developing fetuses or the young such as “neuropathy in adult animals; [central nervous system] malformations following prenatal exposure; brain weight or sexual maturation changes in offspring; and/or functional changes in offspring.” (65 FR at 1794). Finally, exposure estimates were found not to understate exposure given that the estimates for food were “Tier 1” conservative assumptions which would not underestimate exposure. (65 FR at 1793).

1.In general. NRDC challenged a March 27, 2002, action establishing tolerances for acetamiprid on dried citrus pulp, the citrus fruit crop group, cotton gin byproducts, cotton undelinted seed, grapes, the fruiting vegetable crop group, the leafy brassica vegetable crop group, the leafy vegetable crop group, the pome fruit group, tomato paste, as well as various animal products. (67 FR 14649 (March 27, 2002)). Given acetamiprid 's exposure pattern and toxicological characteristics, EPA determined that acetamiprid potentially presented acute, chronic, short-term, and intermediate-term risks and EPA quantitatively assessed these risks in making its safety determination. (Id. at 14656-14657). All of these risks were found to be below the Agency's level of concern. (Id.).

2.Children’s safety factor determination. For acetamiprid, two factors increased uncertainty or raised concern about the impacts on children: That a DNT study was outstanding; and that increased sensitivity in the young was observed in the 2-generation reproduction study. (67 FR at 14655). EPA concluded, however, that these concerns were offset by other considerations. First, the DNT study had been required based only on neurotoxic behavioral effects seen in adults, and not out of a special concern for developing fetuses or the young. Second, the increased sensitivity observed in the 2-generation reproduction study was only qualitative. Sensitivity is considered to be qualitative only when effects occur at the same dose levels in adult and juvenile animals but the effects in the juvenile animals are qualitatively more severe than the effects in the adults. Third, the other two studies investigating pre- or post-natal effects in the young showed either no adverse effects even at levels that showed toxicity in parental animals, or adverse effects of the same qualitative nature at the same dose in parental and young animals. (Id.). Finally, exposure estimates were judged unlikely to underestimate exposure, especially because “highly conservative” “Tier 1” assumptions were used for exposure in food. (67 FR at 14654). Weighing all of these considerations EPA retained a 3X additional safety factor to address chronic risks and waived the factor entirely for acute risks. No additional factor was deemed necessary as to acute risks because qualitative sensitivity in the young was only observed in a study involving chronic dosing and as to an adverse effect related to repeat dosing.

Since January, 2002, EPA has received no further tolerance petitions concerning mepiquat and EPA has undertaken no tolerance rulemakings for mepiquat.

Since March, 2002, EPA has received several petitions for additional acetamiprid tolerances and has established tolerance regulations on four occasions. Because section 408 requires EPA in setting a pesticide tolerance to consider aggregate exposure to the pesticide, “including dietary exposure under . . . all other tolerances for the pesticide chemical residue,” in each of these subsequent actions EPA took into account exposure to acetamiprid under challenged tolerances established on March 27, 2002 (dried citrus pulp, the citrus fruit crop group, cotton gin byproducts, cotton undelinted seed, grapes, the fruiting vegetable crop group, the leafy brassica vegetable crop group, the leafy vegetable crop group, the pome fruit group, tomato paste, as well as various animal products). Each of the subsequent tolerance rulemakings is described below.

1.2005 - Tolerances for tuberous and corm vegetables. On April 13, 2005, EPA established tolerances for acetamiprid on tuberous and corm vegetables. (70 FR 19283 (April 13, 2005)). EPA concluded that the additional exposure from these new tolerances, when aggregated with exposure under existing tolerances, was safe.

With regard the children’s safety factor, EPA relied on a revised analysis taking into account its Children’s Safety Factor Policy, which had not been released at the time of the risk assessment for the NRDC-challenged tolerances and recently-submitted data on acetamiprid and other similar pesticides. EPA concluded that the presumptive 10X children’s safety factor could be removed entirely. (70 FR at 19289). Although increased sensitivity to the young had been observed in the 2-generation rat study and a recently-submitted DNT study had not been fully evaluated, EPA determined that other factors outweighed these concerns. As to the increased sensitivity, EPA noted that: “i. There is a clear NOAEL for [the effects seen in] the offspring, and; ii. These effects occurred in the presence of parental toxicity and only at the highest dose tested.” (Id.). Further, EPA noted that either the NOAEL for the offspring in the reproduction study or some lower NOAEL was used in each risk assessment for acetamiprid. That meant the standard 10X factor to account for intra-human variability (in addition to the 10X factor for inter-species variability) was applied to the clearly-defined NOAEL for offspring effects or to some lower NOAEL. As to the recently-submitted DNT, EPA stated that a “preliminary review of the study indicates the results are not likely to have a significant impact on risks for the currently proposed use, or on existing uses of acetamiprid . . . [and that] developmental neurotoxicity data received and reviewed for other compounds in this chemical class indicate that the results of the required DNT will not likely impact the regulatory doses selected for the proposed uses of acetamiprid.” (Id.). Finally, EPA relied upon the fact that the exposure assessment for acetamiprid was conservative in that it assumed all foods with tolerances are treated with acetamiprid and bear tolerance-level residues (i.e., a Tier 1 assessment).

2.2007 - Tolerances for almond hulls, et al. On November 28, 2007, EPA established tolerances for acetamiprid on almond, hulls; fruit, stone, group 12, except plum, prune; nut, tree, group 14; pea and bean, succulent shelled, subgroup 6B; pistachio; plum, prune, dried; plum, prune, fresh; vegetable, cucurbit, group 9; and vegetable, legume, edible podded, subgroup 6A. (72 FR 67256 (November 28, 2007)). EPA concluded that the additional exposure from these new tolerances, when aggregated with exposure under existing tolerances, was safe.

With regard to the children’s safety factor, EPA relied on a revised analysis taking into account its now-completed review of the acetamiprid DNT study. EPA again concluded that the presumptive 10X children’s safety factor could be removed entirely. Although qualitatively increased sensitivity to the young had been observed in the 2-generation rat study and the DNT study, EPA “characterized the degree of concern for the effects observed in the acetamiprid DNT and the 2-generationreproduction study as low, noting that there is a clear NOAEL for the offspring effects in both studies, the toxicology database is complete, and regulatory doses [Points of Departure] were selected to be protective of potential offspring effects in both the DNT and the 2-generation study.” (72 FR at 67260). Specifically, as to the last consideration, EPA cited the fact that the Points of Departure for calculating the RfD/PADs were at or below the clearly-defined NOAELs from the 2-generation reproduction and DNT studies. That means that at least a 100-fold margin of safety was being provided with respect to the clearly-defined NOAELs from these studies. Further, even though the exposure assessment was more refined than in prior acetamiprid tolerance actions, EPA still relied on conservative values from field trial studies and drinking water modeling.

3.2008 - Tolerances for bushberries, et al. On January 16, 2008, EPA established tolerances for acetamiprid on the bushberry subgroup 13-07B; the caneberry subgroup 13-07A; the low growing berry subgroup 13-07G; the onion, bulb, subgroup 3-07A; and the onion, green, subgroup 3-07B. (73 FR 2809 (January 16, 2008)). EPA concluded that the additional exposure from these new tolerances, when aggregated with exposure under existing tolerances, was safe. EPA relied upon its November 28, 2007 acetamiprid rulemaking to make its safety determination, noting that the tolerances in this action had been included in the risk assessment performed to support the 2007 action. (73 FR at 2811).

4.2010 - Tolerances for small vine climbing fruit, et al. On February 10, 2010, EPA established tolerances for acetamiprid on the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F; and tea, dried. (75 FR 6576 (February 10, 2010)). EPA concluded that the additional exposure from these new tolerances, when aggregated with exposure under existing tolerances, was safe. With regard the children’s safety factor, EPA concluded that the presumptive 10X children’s safety factor could be removed entirely based on the rationale in the 2007 acetamiprid rulemaking. (75 FR at 6581).

On four occasions in the first half of 2002, the NRDC and various other parties filed objections with EPA to final rules under FFDCA section establishing pesticide tolerances for various pesticides. (69 FR 30042 (May 26, 2004)). The objections applied to 14 pesticides and 112 separate pesticide tolerances. The challenged tolerances included the tolerances for mepiquat and acetamiprid addressed in today’s order. The objections to the mepiquat tolerances were filed on March 19, 2002, and grouped with objections to tolerances for imidacloprid, bifenazate, zeta-cypermethrin, and diflubenzuron. The objections to the acetamiprid tolerances were filed on May 21, 2002, and grouped with objections to tolerances for isoxadifen-ethyl, propiconazole, fenhexamid, and fluazinam.

Although NRDC’s petitions raised dozens of issues, most of the issues related to two main claims: That EPA had not properly applied the additional 10X safety factor for the protection of infants and children in section 408(b)(2)(C); and that EPA had not accurately assessed the aggregate exposure of farm children to pesticide residues. Many of the issues were not fact-specific to the challenged tolerances but rather represented a generic challenge to EPA’s implementation of the FQPA.

Two specific issues raised by NRDC are worthy of greater description because they later figured in the judicial review of EPA’s disposition of the objections. First, as to several of the pesticides, NRDC argued that EPA had unlawfully removed the 10X children’s safety factor because EPA had required that a DNT study be submitted for the pesticides but such study had not yet been completed. NRDC framed the issue as follows:

EPA denied NRDC’s objections in two separate orders. The first was issued on May 26, 2004, and addressed only the tolerances for imidacloprid. (69 FR 30042 (May 26, 2004). The second was released on August 10, 2005 and addressed the tolerances for the remaining 14 pesticides. (70 FR 46706 (August 10, 2005)). The second order relied heavily on the imidacloprid order because, in the process of resolving the claims pertaining to imidacloprid, EPA resolved many of NRDC’s generic attacks on EPA’s interpretation of the FQPA.

As to the DNT study and the children’s safety factor, EPA rejected “NRDC's contention that an EPA finding that a DNT study is needed in evaluating the risks posed by the pesticide is outcome-determinative as regards to retaining the children's safety factor until such time as the DNT study is submitted and reviewed.” (70 FR at 46724). EPA carefully reviewed all of the evidence cited by NRDC regarding the DNT study and concluded that NRDC had not shown that the DNT was so critical to the protection of children that in the absence of that study EPA was conclusively precluded from exercising its statutory authority to make a case-by-case determination regarding the appropriate children’s safety factor. EPA specifically did not address the factual considerations relating to its individual children’s safety factor decisions as to mepiquat and acetamiprid (and the other pesticides), noting that “NRDC has offered no pesticide-specific arguments as to the pesticides in this proceeding as to why the absence of a DNT study requires the retention of the default 10X additional factor.” (Id.)

With regard to whether reliance on drinking water models precluded lowering of the children’s safety factor, EPA exhaustively reviewed the underlying factual basis for its models, the scientific peer review they had received, and how the models had worked in practice. EPA concluded that “the models are based on reliable data and will produce estimates that are unlikely to underestimate exposure to pesticides in drinking water.” (Id. at 46726). Accordingly, NRDC’s claim that only actual pesticide-specific water monitoring data could provide “reliable data” on the levels of pesticides in drinking water was rejected.

1.NRDC’s Petition for Review. In August, 2005, NRDC and the Northwest Coalition for Alternatives to Pesticides (NCAP) filed petitions for review of EPA’s August 10, 2005 order. No challenge had been filed to the May 26, 2004 order. The petitions were filed in the Second and Ninth Circuits and the matter was assigned to the Ninth Circuit. The consolidated petitions sought review as to EPA’s denial of NRDC’s objections as they pertained to the tolerances of the following seven pesticides: acetamiprid, fenhexamid, halosulfuron-methyl, isoxadifen-ethyl, mepiquat, pymetrozine, and zeta-cypermethrin.

NRDC/NCAP’s brief argued that EPA had unlawfully removed or lowered the children’s safety factor as to these seven pesticides and that EPA’s establishment of tolerances for the seven pesticides was arbitrary and capricious. (Ref. 8). As to the contentions regarding the children’s safety factor, NRDC/NCAP made several independent claims as to why EPA’s action was unlawful. These claims were:

NRDC argued EPA’s decision was arbitrary and capricious because EPA determined that additional data were needed on the pesticides but EPA had not waited for submission of that data before establishing the pesticide tolerances and because EPA had not offered a sufficient explanation of its decisions on the children’s safety factor.

2.The Ninth Circuit’s decision. On September 19, 2008, the Ninth Circuit unanimously determined that:

Although NRDC/NCAP’s petition for review concerned seven pesticides, the court only remanded to EPA the tolerance decisions on acetamiprid, mepiquat, and pymetrozine. The petition for review was denied as to the other four pesticides because the remand only pertained to pesticides for which there was a question concerning EPA’s pesticide-specific choice of a children’s safety factor in the absence of a required DNT study. As to the fenhexamid and isoxadifen-ethyl tolerances, a DNT study had not been required by EPA. For halosulfuron-methyl and zeta-cypermethrin tolerances a DNT study had been required and had not been submitted at the time of the tolerance action; however, by the time of the oral argument, the circumstances had changed. As to zeta-cypermethrin, the DNT study had been submitted and reviewed by EPA and EPA had established further tolerances in reliance on the DNT study. As to halosulfuron-methyl, EPA had withdrawn the requirement for a DNT. EPA notified the court that there was no longer a live controversy as to the tolerances for halosulfuron-methyl and zeta-cypermethrin and NRDC/NCAP and the court agreed the petition was moot as to these pesticides. (544 F.3d at 1048 n.4; Refs. 9, 10).

On remand, EPA has determined that NRDC’s objections should again be denied. NRDC’s objections to the acetamiprid tolerances are now moot for the same reasons that the objections to the zeta-cypermethrin and halosulfuron-methyl tolerances were found to be moot. The objections to the mepiquat tolerance are denied because all issues which could have affected EPA’s decision on that tolerance have been resolved by the Ninth Circuit.

Like zeta-cypermethrin, EPA has received a DNT study for acetamiprid and relied on that study in establishing additional tolerances for acetamiprid. (72 FR 67256 (November 28, 2007); 73 FR 2809 (January 16, 2008); 75 FR 6576 (February 10, 2010)). In establishing new tolerances for acetamiprid, EPA concluded that aggregate exposure under the new tolerances as well as all existing tolerances (including the ones challenged in NRDC’s 2002 objections) is safe. No objections to these new acetamiprid tolerances were filed within the 60 day statutory timeframe for objections. Accordingly, just as the Ninth Circuit concluded (and NRDC agreed) that there was no live controversy concerning the zeta-cypermethrin tolerances and “EPA’s [alleged] failure to explain why it had reliable data in the absence of [a DNT study],” (544 F.3d at 1408), there is no live controversy as to whether EPA provided an adequate explanation for its now-superseded tolerance decision that it had reliable data to reduce or remove the children’s safety factor for acetamiprid in the absence of a DNT study.

EPA has not taken regulatory action as to mepiquat subsequent to the challenged tolerance action and, thus, NRDC’s challenge to the mepiquat tolerance is not moot. Nonetheless, due to the circumstances of the mepiquat tolerance, EPA does not need to address the merits of the only remaining objection before EPA — that EPA lacks reliable data justifying removal of the children’s safety factor for mepiquat. As EPA ruled in a prior order, it may “refuse to adjudicate the merits of claims where it can be shown that the claims - even if true - do not justify the relief requested.” (72 FR 39318, 39323-39324 (July 18, 2007)). That principle applies to the mepiquat objection because, as explained below, even if EPA retains the 10X children’s safety it would not change EPA’s safety determination. Thus, NRDC’s objection to the removal of the children’s safety factor, even if upheld, would not support the relief it requested - “that EPA refrain from establishing the new tolerances for . . .mepiquat . . . until the pesticide tolerances have been assessed and determined to be safe[,] consistent with the requirements of the FQPA.” (Ref. 6 at 22).

An EPA decision to retain the 10X children’s safety factor has the effect of decreasing the “safe dose” or RfD/PAD by a factor of 10. Thus, if prior to application of the 10X children’s safety factor, the level of exposure from a particular pesticide constituted 5 percent of the RfD/PAD, after application of the safety factor the level of exposure to the pesticide would rise by a factor of 10 to 50 percent of the RfD/PAD. Similarly, a pesticide which had an exposure level at 50 percent of the RfD/PAD before applying the 10X children’s safety factor, would have an exposure level of 500 percent of the RfD/PAD after application of the factor. Only in the latter case, would retention of the children’s safety factor raise a safety concern. Thus, for pesticides with sufficiently low risks, the decision on retention or removal of the children’s safety factor is not outcome-determinative as to EPA’s safety finding. (71 FR 43906, 43916-43917 (August 2, 2006)).

Mepiquat is one of those low risk pesticides. As EPA noted in the challenged tolerance document, acute exposure to mepiquat from residues in food equaled 1.5 percent of the acute RfD/PAD and acute exposure to mepiquat in water was an infinitesimal. (67 FR at 3115; 65 FR 1790, 1793 (January 12, 2000) (acute exposure to mepiquat in drinking water is 0.031 percent of the allowable amount - i.e. the acute DWLOC was 6,000 ppb and estimated acute exposure level was 1.9 ppb); see Unit III.B.1.d. (explaining how allowable amounts of pesticide residues in drinking water were calculated)). Similarly, chronic exposure to mepiquat from residues in food equaled 0.3 percent of the chronic RfD/PAD and chronic exposure to mepiquat in water was also infinitesimal. (67 FR at 3115; 65 FR at 1794 (chronic exposure to mepiquat in drinking water is 0.018 percent of the allowable amount — i.e. the chronic DWLOC was 6,000 ppb and the estimated chronic exposure level was 1.1 ppb)). Retention of the 10X children’s safety would raise the percentage exposure to approximately 15 percent of the acute RfD/PAD and 3 percent of the chronic RfD/PAD. Because these exposure levels would still be well below the applicable RfD/PADs, they would not change EPA’s determination that the petitioned-for mepiquat tolerances are safe. Accordingly, because NRDC’s objection to removal of the children’s safety factor does not justify its request for EPA to refrain from establishing the mepiquat tolerances, it is denied.

As indicated previously, this action announces the Agency's final order regarding objections filed under section 408 of FFDCA. The FFDCA specifically directs that objections be resolved by “order,” and thus this action is an adjudication and not a rule. (21 U.S.C. 346a(g)(2)(C)). The regulatory assessment requirements imposed on rulemaking do not, therefore, apply to this action.

The Congressional Review Act, (5 U.S.C. 801et seq.), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule for purposes of 5 U.S.C. 804(3).

1. USEPA,A User's Guide to Available EPA Information on Assessing Exposure to Pesticides in Food(June 21, 2000).

2. Office of Pesticide Programs, USEPA, Office of Pesticide Programs' Policy on the Determination of the Appropriate FQPA Safety Factor(s) For Use in the Tolerance Setting Process (February 28, 2002).

3. Office of Pesticide Programs, USEPA, Standard Operating Procedures (SOPs) for Residential Exposure Assessments (Draft December 19, 1997).

4. Office of Pesticide Programs, USEPA, “Estimating the Drinking Water Component of a Dietary Exposure Assessment” (November 2, 1999).

5. Office of Prevention, Pesticides and Toxic Substances, USEPA, Memorandum from Brenda Tarplee to Margarita Collantes, “Mepiquat Choloride - Report of the FQPA Safety Factor Committee” (November 1, 1999).

6. NRDC, Objections to the Establishment of Tolerances for Pesticide Chemical Residues: Imidacloprid, Mepiquat, Bifenazate, Zeta-cypermethrin, and Diflubenzuron Tolerances (filed March 19, 2002).

7. NRDC, Objections to the Establishment of Tolerances for Pesticide Chemical Residues: Isoxadifen-ethyl, Acetamiprid, Propiconazole, Furilazole, Fenhexamid, and Fluazinam Tolerances (filed May 20, 2002).

8. Petitioners’ Brief,NCAPv.EPA, Case Nos. 75255, 76807 (9th Cir. March 6, 2006).

9. Letter from Kent E. Hanson, U.S. Department of Justice to Cathy Catterson, Clerk of the Court, United States Court of Appeals, Ninth Circuit, Notice of Supplemental Authority inNorthwest Coalition for Alternatives to Pesticidesv.EPA, Nos. 05-75255 & 05-76807 (May 25, 2007).

10. Letter from Aaron Colangelo, U.S. Department of Justice to Cathy Catterson, Clerk of the Court, United States Court of Appeals, Ninth Circuit, Response to EPA’s Notice of Supplemental Authority inNorthwest Coalition for Alternatives to Pesticidesv.EPA, Nos. 05-75255 & 05-76807 (May 29, 2007).

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

EPA Region 2 is publishing this direct final Notice of Deletion of the Peter Cooper Corporation (Markhams) Superfund Site (Markhams Site) from the NPL. The NPL constitutes Appendix B of 40 CFR part 300, which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in 300.425(e) (3) of the NCP, sites deleted from the NPL remain eligible for Fund-financed remedial actions if future conditions warrant such actions.

Because EPA considers this action to be noncontroversial and routine, this action will be effective September 20, 2010 unless EPA receives adverse comments by September 7, 2010. Along with this direct final Notice of Deletion, EPA is co-publishing a Notice of Intent to Delete in the “Proposed Rules” section of theFederal Register. If adverse comments are received within the 30-day public comment period on this deletion action, EPA will publish a timely withdrawal of this direct final Notice of Deletion before the effective date of the deletion, and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent to Delete and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Markhams Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the Site from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:

i. Responsible parties or other persons have implemented all appropriate response actions required;

ii. All appropriate Fund-financed response under CERCLA has been implemented, and no further responseaction by responsible parties is appropriate; or

iii. The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.

Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to deletion of the Site:

(1) EPA consulted with the State of New York prior to developing this direct final Notice of Deletion and the Notice of Intent to Delete co-published today in the “Proposed Rules” section of theFederal Register.

(2) EPA has provided New York State 30 working days for review of this notice and the parallel Notice of Intent to Delete prior to their publication today, and the State, through the NYSDEC, has concurred on the deletion of the Site from the NPL.

(3) Concurrently with the publication of this direct final Notice of Deletion, a notice of the availability of the parallel Notice of Intent to Delete is being published in a major local newspaper,Dunkirk Observer. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent to Delete the Site from the NPL.

(4) The EPA placed copies of documents supporting the proposed deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this deletion action, EPA will publish a timely notice of withdrawal of this direct final Notice of Deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent to Delete and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

The following information provides EPA's rationale for deleting the Site from the NPL:

The Markhams Site, EPA ID No. NYD980592547, is located off Bentley Road, in the Town of Dayton, Cattaraugus County, New York. The Site is approximately 103 acres in size and is bordered to the northwest by Bentley Road; to the northeast by a wooded property and farm field; to the southeast by a railroad right-of-way; and to the southwest by hardwood forest. Site access is restricted by a locked cable gate at the Bentley Road entrance. Surrounding property is rural, consisting of small farm fields, open meadow and forests.

The Site was used for the disposal of wastes remaining after the manufacturing process from the Peter Cooper Corporation (PCC), a former animal glue and adhesives plant located in Gowanda, New York. Materials disposed at the Site were reported to consist of “cookhouse sludge,” residue pile material and vacuum filter sludge. Cookhouse sludge was so named because of a cooking cycle that occurred just prior to extraction of the glue. It was derived primarily from chrome-tanned hides obtained from tanneries and leather finishers. Residue pile material is described as air-dried cookhouse sludge, which was stabilized to a dry, granular form. Vacuum filter sludge reportedly was produced during dewatering of cookhouse sludge. The waste material has been shown to contain elevated levels of chromium, arsenic, zinc, and several organic compounds.

PCC purchased the Site in 1955 and sold the Site, among other assets including its corporate name, in 1976 to a foreign company, Rousselot Gelatin Corporation, and its parent, Rousselot, S.A. of Paris, France. Rousellot Gelatin subsequently changed its name to the Peter Cooper Corporation. From approximately 1955 until September 1971, it was reported that approximately 9,600 tons of waste material from the Gowanda plant were placed at the Site over an approximately 15-acre area.

In addition, PCC transferred approximately 38,600 additional tons of waste materials from the Gowanda plant to the Site pursuant to a New York State Supreme Court Order (8th J.D. Cattaraugus County) dated June 1971. PCC arranged the material into several waste piles approximately 20 feet high and covering a total of approximately seven acres, mostly in the original disposal area.

The NYSDEC completed preliminary site investigations in 1983 and 1985 and identified the presence of arsenic, chromium and zinc in soil samples.

At that time, the Site did not meet the New York State statutory definition for an inactive hazardous waste disposal site and NYSDEC could not use State funds to implement a remedial program. Consequently, the NYSDEC removed the Site from its Registry of Inactive Hazardous Waste Disposal Sites and transferred the Site to EPA for further evaluation.

In 1993, EPA conducted a Site Sampling Inspection, which included the collection and analysis of soil and surface water samples from the Site. Chromium and arsenic were detected in soils above background concentrations within the waste piles. In 1999, EPA determined a Hazard Ranking System score for the Site so that it could be evaluated for potential listing on the National Priorities List (NPL). The Site was proposed to the NPL on April 23, 1999 (64 FR 19968) and subsequently added on February 4, 2000 (65 FR 5435).

On September 29, 2000, EPA issued a Unilateral Administrative Order (UAO) to several potentially responsible parties (PRPs) to perform the RI/FS for the Site, subject to EPA oversight. The RI characterized the physical properties of the soil fill piles, soils around the perimeter of the fill piles (perimeter surface soils), native subsurface soils, wetland sediments, groundwater, and soil gas.

The PRPs, through their consultants, Benchmark Environmental Engineering and Science PLLC (Benchmark) and Geomatrix Consultants, performed the Remedial Investigation (RI) from November 2000 to December 2003 and the final RI report was submitted to EPA in February 2005. The chemicals of concern (COCs) in site media included: arsenic, total chromium and hexavalentchromium (metal COCs). The results of the RI suggest that low concentrations of metal COCs can leach from the waste fill. However, the data from native soil samples (non-waste fill) collected below the waste fill indicate that metals have not migrated substantially in native soil. Arsenic and total chromium concentration detected in the surface soil samples from the cover of the fill piles were above soil criteria. Soil testing below the fill piles identified decreasing concentrations of metal COCs with depth. Metal COCs were reported to exceed the NYS Groundwater Quality Standards and Guidance Values (GWQS/GVs) in one groundwater monitoring well MW-2S for arsenic, chromium, zinc and benzene (with benzene only slightly above the GWQS/GVs). In the RI report, difficulties in obtaining representative samples from monitoring well MW-2S were identified. Suggested possible explanations for these difficulties were the age of the well and construction materials. The report concluded that the groundwater analytical results collected from well MW-2S during the first and second sampling events might not be representative of Site groundwater. To address the limitations of the sampling from monitoring well MW-2S, the ROD required that any groundwater monitoring program at the Site include replacing well MW-2S and conducting analytical sampling for metals. Monitoring well MW-2S was decommissioned by the PRPs contractor in September 2008. MW-2S was found to be constructed of steel casing and screen, and was found to be visibly rusted/rotted on removal. MW-2S was replaced with a new PVC replacement well (MW-2SR). Site data indicate that transport of metal COCs and organic compounds is not considered significant at the Site.

The RI concluded that all groundwater from the Site ultimately discharges to Wetland F before reaching the southwestern property boundary located more that 500 feet across the wetland. Site-related chemicals in the overburden groundwater are transported beneath the Site to the southwest in the direction of Wetland F. Water quality data indicate subsurface conditions are not conducive to transport of metal COCs. Although chromium was widely detected in soils across the Site, chromium concentrations were not elevated in groundwater (except in monitoring well MW-2S). Hexavalent chromium was detected at a low concentration in one of 18 samples analyzed: the detection was not confirmed in the second sampling event. The lack of hexavalent chromium in groundwater suggests conditions are not suitable for the oxidation of chromium (Cr+3) to hexavalent chromium (Cr+6). The slightly alkaline subsurface soil conditions and relatively low concentrations of manganese inhibit reactions that can produce hexavalent chromium. These results are indicative that the area of groundwater contamination is limited to a relatively small area, under the waste piles.

Based on the results of the RI report a risk assessment was performed for the Site. The risk assessment determined that if infiltration of rainwater through the waste/fill material is not curtailed, then the quality of Site groundwater would continue to degrade, resulting in a potential future risk from groundwater ingestion.

A Feasibility Study (FS) was then completed by the PRPs and submitted to EPA in August 2006. The FS Report identified and evaluated effective remedial alternatives for the Site, consistent with the guidelines presented in “Guidance for Conducting Remedial Investigations and Feasibility Studies under CERCLA.” The FS evaluated five alternatives, including no action, institutional controls, two containment alternatives and an excavation/off-site disposal remedies. The remedial alternatives were developed to satisfy the Remedial Action Objectives (RAO) for the Site:

• Minimize or eliminate contaminant migration from contaminated soils to the groundwater.

• Prevent direct contact with waste fill materials.

• Mitigate erosion and migration of waste material from the exposed surface.

Based upon the results of the RI/FS, a Proposed Plan, and a Public Meeting, a Record of Decision (ROD) was signed in December 2006. The major components of the selected remedy included consolidation of various waste/fill piles into a single waste/fill area, followed by capping with a low-permeability soil cover. Specifically, the ROD called for:

• Consolidating the waste/fill piles into seven acres or less, followed by capping the consolidated wastes with a low permeability soil cover, consistent with the requirements of 6 NYCRR Part 360, including seeding with a seed mixture to foster natural habitat, and replacement of waste piles moved during consolidation with native soil.

• Imposing institutional controls in the form of an environmental easement/restrictive covenant filed in the property records of Cattaraugus County that will at a minimum require: (a) Restricting activities on the Site that could compromise the integrity of the cap; and (b) restricting the use of groundwater as a source of potable or process water unless groundwater quality standards are met.

• Developing a site management plan that provides for the proper management of all remedy components post-construction, such as institutional controls, and also includes: (a) Monitoring of groundwater to ensure that, following the soil consolidation and capping, the contamination is attenuating and groundwater quality continues to improve; (b) an inventory of any site use restrictions; (c) necessary provisions for ensuring the easement/covenant remains in place and is effective; (d) provision for any operation and maintenance required of the components of the remedy; and (e) the owner/operator or entity responsible for maintenance of the Site to complete and submit periodic certifications concerning the status of the institutional and engineering controls for the Site.

• Evaluating site conditions at least once every five years to ensure that the remedy continues to protect public health and the environment.

In 2008, EPA concluded Consent Decree negotiations with the PRPs related to the performance of the design and implementation of the remedy called for in the ROD. On February 19, 2008, the Consent Decree was entered in United States District Court (approved by the Judge). On March 12, 2008 Benchmark Environmental Engineering and Science PLLC (Benchmark) was approved as the supervising contractor to conduct the remedial design and construction work at the Site.

The PRPs prepared a Remedial Design (RD) Report which was approved by EPA on July 3, 2008. The RD report outlined the following remedial construction measures: mobilization, site preparation, waste/fill consolidation and grading, and cover system (barrier layer material placement and compaction, topsoil and seeding, and passive gas venting).

Zoladz Construction Company, Inc. was approved as the subcontractor for the Remedial Action (RA) and mobilized to the site on July 30, 2008. Site preparation work included clearing, grubbing and access improvements required for consolidation and covering work. Vegetation was stripped from the surface of the waste fill where cover soils were placed.

Waste/fill consolidation involved relocation of the various waste/fill piles located at various areas across the center of the site into a single area. Regraded and consolidated waste/fill were placed in maximum 12-inch lifts and compacted with rollers to 90% modified density.

A total of approximately 40,000 cubic yards of waste/fill were consolidated and compacted. The waste fill consolidated area has a footprint of approximately four acres, with an average peak elevation (including cover soil) of 14 feet above surrounding grade.

The final landfill cap meets the grading requirements of 6 NYCCR Part 360-2.13(q)2(ii) which requires that the barrier component of the cap have a slope of no less than 4 percent to promote positive drainage and no more than 33 percent to minimize erosion.

The final cover system was constructed to function with minimum maintenance, promote drainage, and minimize erosion. The cover system was designed with an 18-inch thick recompacted low permeability (less than 1 × 10−6cm/sec) soil barrier layer and 6 inches of topsoil.

Barrier soil was placed and compacted to provide a thickness of 18 inches across the final waste surface. Barrier layer soil was compacted with rollers. Smooth drum rollers were used for temporary sealing of the lifts and for the stockpiled soils.

Following the final grading and compaction of the barrier layer, topsoil was placed to a depth of six inches (after placement and rolling). Topsoil was placed and graded to a smooth, even surface and was rolled and raked to remove ridges and fill in depressions, ruts and low spots. A conservation seed mixture was used to foster a natural habitat and minimize maintenance requirements. Fifty trees, including 25 hardwood trees, 13 poplars and 12 birch trees were replanted at various locations across the Site to provide shelter for the wildlife and stimulate repopulation of the wooded areas outside of the consolidated area.

Results of subsurface soil data indicated that metal COCs have not migrated into native soils beneath the waste fill piles. The consolidated waste piles were removed and underlying native soils were scraped and consolidated into one central area. As a result, contaminated-specific soil cleanup values for the Site were not developed. Groundwater is being monitored through post-remedial groundwater and surface water sampling. The primary objectives of the remedy are to reduce or eliminate any direct contact threat associated with the contaminated soils/fill and minimize or eliminate contaminant migration from contaminated soils to the groundwater.

The primary components at the Site to be monitored and maintained include groundwater and surface water quality, the waste/fill consolidation area cover system (the Cap), and gas vents. These goals are being met through the Operation, Maintenance and Monitoring (OM&M) Plan that describes personnel requirements, responsibilities, duties, and specifics post-construction sampling, analysis, and monitoring to be conducted to monitor the effectiveness of the remedy.

The OM&M plan requires groundwater and surface water sampling to be conducted on a semiannual (spring and fall) basis for the first two years of monitoring; sampling may be reduced to annually if the data support the reduction. The semiannual samples were collected starting in June and December 2009. Results indicate that the cover system has minimized contaminant migration from contaminated soils to the groundwater. In addition, the total metals concentrations reported from both sampling events for the metal COCs arsenic, total chromium, and hexavalent chromium were nondetectable or below NYSDEC Groundwater Quality Standards and Guidance Values (GWQS/GVs).

As per the OM&M plan, semiannual inspection of the landfill was conducted concurrently with the sampling described above. Inspection reports submitted on February 5, 2010, indicated that the final cover system appears to be in good condition, with the gas-venting system intact and operational. Semiannual inspections will continue as part of the OM&M plan.

The ROD requires the implementation of institutional controls (ICs). The ICs involve filing of an Environmental Easement to restrict the use of on-site groundwater as a source of potable or process water (unless groundwater quality standards are met) and to restrict activities on the Site that could compromise the integrity of the cap.

The owner of record of the Site, Peter Cooper Corporation (PCC) is an inactive Delaware Corporation. A search for potential corporate successors was conducted and none were found. The PRPs consistent with the obligation to use reasonable best efforts to implement the ICs: Commenced an action in Supreme Court, Cattaraugus County, against the Peter Cooper Corporation to secure an Order from the court to provide the PRPs with access to the Site and to give permission to implement the ICs by filing the Easement in the Office of the Clerk of Cattaraugus County. The Court granted legal access to the Site on July 1, 2008. The ICs were filed with the Clerk's office on July 13, 2008 and a stamped copy was sent to EPA.

Hazardous substances remain at this Site above levels which would allow for unlimited use and unrestricted exposure. Pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act, Section 121(c), EPA must conduct five-year reviews. The first Five-Year Review Report will be completed prior to July 2013, which is five years from the initiation of construction for the remedy.

Public participation activities for this Site have been satisfied as required in CERCLA § 113(k) and Section 117. As part of the remedy selection process, the public was invited to comment on EPA's proposed remedies. All other documents and information which EPA relied on or considered in recommending this deletion are available for the public to review at the information repositories identified above.

Public participation activities for this Site have been satisfied as required in CERCLA Section 113(k), 42 U.S.C. 9613(k), and Section 117, 42 U.S.C. 9617. The ROD was subject to a public review process. All other documents and information that EPA relied on or considered in recommending this deletion are available for the public to review at the information repositories.

One of the three criteria for site deletion is when responsible parties or other persons have implemented all appropriate response actions required (40 CFR 300.425(e)(1)(I)). EPA, with the concurrence of the State of New York through NYSDEC, has determined that all required and appropriate response actions have been implemented by the responsible parties.

The EPA, with concurrence of the State of New York, has determined that all appropriate responses under CERCLA have been completed, and that no further response actions, under CERCLA, other than O&M and five-year reviews, are necessary. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective September 20, 2010, unless EPA receives adverse comments by September 7, 2010. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion and it will not take effect, and EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

Section 1007(a)(2) of the Legal Services Corporation Act (“Act”), 42 U.S.C. 2996f(a)(2), requires the Corporation to establish maximum income levels for individuals eligible for legal assistance, and the Act provides that other specified factors shall be taken into account along with income.

Section 1611.3(c) of the Corporation's regulations establishes a maximum income level equivalent to one hundred and twenty-five percent (125%) of the Federal Poverty Guidelines. Since 1982, the Department of Health and Human Services has been responsible for updating and issuing the Federal Poverty Guidelines. The figures for 2010 set out below are equivalent to 125% of the current Federal Poverty Guidelines as published on August 3, 2010 (75 FR 45628).

In addition, LSC is publishing charts listing income levels that are 200% of the Federal Poverty Guidelines. These charts are for reference purposes only as an aid to grant recipients in assessing the financial eligibility of an applicant whose income is greater than 200% of the applicable Federal Poverty Guidelines amount, but less than 200% of the applicable Federal Poverty Guidelines amount (and who may be found to be financially eligible under duly adopted exceptions to the annual income ceiling in accordance with sections 1611.3, 1611.4 and 1611.5).

LSC notes that these 2010 Income Guidelines are substantively unchanged from the 2009 Income Guidelines. This is because HHS' Poverty Guidelines for the remainder of 2010 are unchanged from the 2009 Poverty Guidelines which have been in place since last year.

This is a summary of the Commission's Memorandum Opinion and Order, MB Docket No. 04-258, adopted June 25, 2010, and released June 29, 2010. The full text of this Commission document is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, 800-378-3160 or via the company's Web site,http://www.bcpiweb.com.

TheReport and Orderin this proceeding had denied the counterproposal of Sanpete's predecessor in interest to reallot and change the community of license of its Station KLGL(FM) from Channel 229C at Richfield, Utah, to Channel 229C at Mount Pleasant, Utah, because the proposed transmitter site was unavailable due to its location in a national forest.See71 FR 29886 (May 24, 2006). The counterproposal was also denied because it would create “white” and “gray” loss areas of 1,103 and 1,057 persons, respectively. The Memorandum Opinion and Order grants the Sanpete Counterproposal because Sanpete demonstrated that its proposed transmitter site is not located in the Mani-La National Forest. Likewise, Sanpete showed that its proposal would not create any “white” loss area. Rather the counterproposal would create a “gray” loss population of 1,057, but the staff found that this “gray” loss population was outweighed by the provision of a first local service to a community with a population of 2,707.

The reference coordinates for Channel 229C at Mount Pleasant, Utah, are 39-37-52 NL and 111-19-47 WL. Sanpete's Counterproposal was formerly a rule change to Section 73.202(b), the FM Table of Allotments. As a result of changes to the Commission's processing rules, modifications of FM channels for existing stations are no longer listed in Section 73.202(b) and are instead reflected in the Media Bureau's Consolidated Data Base System (CDBS).See Revision of Procedures Governing Amendments to FM Table of Allotments and Changes of Community of License in the Radio Broadcast Services,Report and Order, 71 FR 76208 (December 20, 2006). The CDBS will reflect Channel 229C at Mount Pleasant, Utah, as the reserved assignment of Station KLGL in lieu of Channel 229C at Richfield.

Micro's rule making petition had proposed the substitution of FM Channel 229C for Channel 244C at Levan, Utah, and the modification of its Station KCFM license to specify operation on Channel 229C. To accommodate this substitution, Micro had proposed to substitute Channel 244C for Channel 229C at Richfield, Utah, and to modify the license for Station KLGL(FM), accordingly. The Memorandum Opinion and Order affirmed the dismissal of Micro's rule making petition because it was technically defective at the time it was filed. Specifically, Station KLGL had both a license and a construction permit at the time that the rulemaking petition was filed, and the proposed Channel 244C at the construction permit site at Richfield was short-spaced to two vacant allotments at Beaver, Utah, and Mesquite, Nevada.

This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,see44 U.S.C. 3506(c)(4).

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act,see5 U.S.C. 801(a)(1)(A).

Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

On September 26, 2008, the National Mobility Equipment Dealers Association (NMEDA) wrote to NHTSA requesting that the agency correct certain references in 49 CFR Part 595 Subpart C, “Make Inoperative Exemptions, Vehicle Modifications to Accommodate People with Disabilities.” This regulation sets forth exemptions from the “make inoperative” provision (49 U.S.C. 30122(c)) of the National Traffic and Motor Vehicle Safety Act (49 U.S.C. Chapter 301, “Safety Act”) to permit, under limited circumstances, vehicle modifications that take the vehicles out of compliance with certain Federal motor vehicle safety standards (FMVSSs) when the vehicles are modified to be used by persons with disabilities. Modifiers are exempted from the make inoperative provision of the Safety Act to the extent that the modifications affect the vehicle's compliance with the FMVSSs specified in 49 CFR 595.7(c).

Since the time that 49 CFR part 595 subpart C was issued in 2001, various standards referenced in 595.7(c) have been amended, some in a way that affected the numbering of the paragraphs in the standards. Because conforming changes were not always made to 595.7(c) to reflect the renumbered standard, some of the references in section 595.7(c) are outdated and incorrect. NMEDA asks NHTSA to address these incorrect references in 595.7(c).

This document makes the necessary corrections. There is no safety impact associated with this amendment. After reviewing the NMEDA letter, we have determined that references to FMVSS No. 101,Controls and displays,FMVSS No. 114,Theft protection,and FMVSS No. 208,Occupant crash protection,are in need of correction. The regulation is amended such that its references are aligned with FMVSS No. 101 as amended on August 17, 2005 (70 FR 48305) and on May 15, 2006 (71 FR 27971), with FMVSS 114 as amended on April 7, 2006 (71 FR 17752), and with FMVSS No. 208 as amended on January 6, 2003 (68 FR 513). We are also correcting the agency's address in § 595.6(a).