In an effort to improve the Authority's decision-making processes, the Authority established an internal workgroup to study and evaluate the policies and procedures in effect concerning the review of arbitration awards. In order to solicit the input of arbitrators and practitioners, the workgroup held several focus groups, specifically: One focus group in Washington, DC with arbitrators; two focus groups in Washington, DC with practitioners; and focus groups in Chicago, Illinois and Oakland, California with both arbitrators and practitioners. In addition, through a survey, the Authority solicited input from parties to recent Authority decisions; the Authority also solicited general input through engagetheflra@flra.gov.

Subsequently, the Authority proposed revisions to parts 2425 (concerning review of arbitration awards) and 2429 (concerning miscellaneous and general requirements) of the Authority's regulations. The proposed rule was published in the Federal Register, and public comment was solicited on the proposed changes (75 FR 22540) (April 29, 2010). Formal written comments were submitted by three agencies, five exclusive representatives, one arbitrator, and four other individuals. All comments have been considered prior to publishing the final rule, and most comments are specifically addressed in the section-by-section analysis below. Several revisions to the proposed rule have been made in response to suggestions and comments received.

The final rule, like the proposed rule, clarifies the processing of arbitration cases before the Authority. The final rule incorporates one significant change, based on consideration of a comment received. Specifically, based on a comment that parties should not be required to jointly request an expedited, abbreviated decision under § 2425.7, the final rule deletes the requirement of a separate, joint request. Instead, the final rule allows an excepting party to request, in its exceptions, such a decision, and an opposing party to state, in its opposition, whether the opposing party supports or opposes such a request. Under the final rule, the Authority may issue an expedited, abbreviated decision even absent an excepting party's request and without regard to whether an excepting party's request is opposed.

The proposed rule has also been modified in several other respects, primarily in response to specific comments. All of the changes from the proposed rule are described in the following sectional analyses of the final rule.

Sectional analyses of the amendments and revisions to part 2425, Review of Arbitration Awards, and part 2429, Miscellaneous and General Requirements, are as follows:

The final rule as promulgated is the same as the proposed rule.

With regard to § 2425.2(b), comments regarding the change in the Authority's practice of calculating the due date for exceptions were generally positive. One commenter suggested that the Authority further clarify this section by adding, after the proposed rule's wording, “The time limit for filing an exception to an arbitration award is thirty (30) days[,]” the following: “after the date of service of the award.” The final rule incorporates this suggestion.

One commenter supported the proposed wording of § 2425.2(b) but questioned whether it is consistent with 5 U.S.C. 7122(b), which provides that an award shall be final and binding if no exception is filed “during the 30-day period beginning on the date the award is served on the party[.]” However, the Authority has discretion to interpret 5 U.S.C. 7122(b) to mean that “the 30-day period beginning on the date the award as served” counts “day one” of the thirty-day period as being the day after the award is served. Cf. AFGE v. FLRA, 802 F.2d 47, 47-48 (2nd Cir. 1986) (interpreting provision of 5 U.S.C. 7123(a) stating “during the 60-day period beginning on the date on which the order was issued” to exclude issuance date of order in calculating 60-day period). Consequently, the commenter's question does not raise a concern that requires amending the proposed rule.

With regard to § 2425.2(c), one commenter generally supported the proposed rule. In addition, one commenter suggested modifying the proposed wording of § 2425.2(c)(1) to clarify that, if there is no legible postmark on an envelope containing an arbitration award that has been served by regular mail, then the date of service will be the date of the award. The commenter similarly suggested modifying the proposed wording of § 2425.2(c)(2) to clarify that, if there is no indication of the date on which an award was deposited with a commercial-delivery service, then the date of service will be the date of the award. The final rule incorporates these two suggestions.

In addition, the final rule corrects a typographical error from the proposed rule. Specifically, the final rule refers to “2429.22” rather than “2492.22.”

However, as discussed further below, several additional commenters made suggestions that the final rule does not incorporate.

First, one commenter expressed concern that, as e-mail or fax transmissions of awards may occur outside post-office hours, they could occur late at night or on weekends, including weekends with a Monday holiday, and the excepting party could lose several days of the thirty days allowed for exceptions. The commenter also asserted that both e-mail and fax transmissions are subject to errors and electrical failures, e.g., the arbitrator could type the address incorrectly, an intermediate server could be inoperative, or there could be a power failure at the receiving end of a fax. The commenter suggested revising § 2425.2(c)(3) as follows: “If the award is served by e-mail or fax, then the date of service is the date of successful and complete transmission, and the excepting party will not receive an additional five days for filing exceptions. However, if the arbitrator transmits his/her decision on a non-workday or on a workday after 5 pm, then the decision will be considered as having been served on the following workday.”

Second, and similarly, one commenter suggested that, when an award is sent by e-mail, a second method of service should also be used in calculating the date of service so that the award does not remain unread while its recipient is out of the office or otherwise unavailable.

Third, one commenter stated that overseas organizations are sometimes subject to slow delivery of mailed arbitration awards, and suggested that the proposed rule should be revised to state that timeliness of exceptions for overseas parties will be calculated based on the date of receipt, not the date of mailing. The commenter further suggested that the date of receipt could then be established by an affidavit or sworn declaration. According to the commenter, such an approach would “avoid the artificial constructs of mailing dates established by case[s] such as” United States Immigration and Naturalization Service, 33 FLRA 885 (1989).

Fourth, and finally, one commenter suggested modifying § 2425.2(c) to add, after “the arbitrator's selected method is controlling for purposes of calculating the time limit for filing exceptions[,]” the following: “provided that the arbitrator gives the parties advance notice of the service method selected.” Similarly, the commenter suggested adding a subparagraph (6) that would state: “If the arbitration award is served by more than one method, and if the parties did not reach an agreement as to an appropriate method(s) of service of the award, and if the arbitrator failed to provide the parties with advance notice of the arbitrator's selected method of service of the award, then the last method of service used will determine the date of service of the arbitration award for purposes of calculating the time limits for exceptions.”

With regard to these comments, the Authority purposely drafted the proposed rule to leave to the parties (or, absent agreement by the parties, to the arbitrator) decisions regarding how arbitration awards will be served. If parties have concerns similar to those set forth by the commenters, then the parties can agree to a method of service that does not present such concerns. Given the Authority's view that the determination of appropriate methods of service is best left to the parties, the final rule does not adopt these commenters' suggestions.

With regard to § 2425.3(a), one commenter noted that the Authority's current regulations provide that “a” party may file exceptions, and that the use of “[a]ny” party in the proposed rule may create unintended ambiguity. As the proposed rule is not intended to change the Authority's existing standards regarding who may file oppositions (or exceptions), and to avoid any unintended ambiguity, the final rule modifies the proposed rule to state that “[a]” party may file an opposition.

Also with regard to § 2425.3(a), one commenter “assumes that it would continue to allow the agency or primary national subdivision to file oppositions (and exceptions) for its activities.” As stated above, the proposed rule is not intended to change the Authority's existing standards with respect to who may file oppositions (or exceptions). No change is necessary to the final rule in this regard.

Upon review of the proposed rule, the Authority clarifies § 2425.4(a)(3) to state that the excepting party is required to provide copies of documents that are not readily accessible to the Authority, and to give examples of such documents. In this connection, as § 2425.4(b) gives examples of the types of documents that are readily accessible to the Authority—and thus not required to be submitted with exceptions—the Authority believes that it will provide further clarity to the parties to also give examples of the types of documents that are not readily accessible to the Authority and, thus, required to be included with exceptions.

In addition, as discussed further below in connection with § 2425.7, the final rule is modified to no longer require parties to jointly request an expedited, abbreviated decision. Rather, the excepting party may request, in its exceptions, such a decision, and the opposing party may state, in its opposition, whether it agrees with or opposes the request. Accordingly, § 2425.4 is modified to create a new subsection (a)(4), which requires the excepting party to provide arguments in support of any request for an expedited, abbreviated decision within the meaning of § 2425.7. As a result, § 2425.4(a)(4) and (5) from the proposed rule have been renumbered § 2425.4(a)(5) and (6) in the final rule.

Further, in § 2425.4(b), the final rule deletes, as unnecessary, the word “actual” before “copies.”

Moreover, as discussed further below, one commenter asserted in connection with § 2429.5 that the word “material” implies that the Authority will consider “immaterial” matters that were not raised before an arbitrator. As such, the word “material” has been deleted from both § 2429.5 and § 2425.4(c).

With regard to § 2425.4(a)(3), one commenter stated that the party that files exceptions should be required to serve the other party with copies of any documents that are submitted to the Authority. According to the commenter, without such a requirement, the opposing party may not be able to discern which documents have already submitted and which documents the opposing party will need to submit. However, as § 2429.27 of the Authority's regulations already requires the excepting party to serve such copies on the other party, there is no need to modify the proposed rule in this regard.

With regard to §§ 2425.4(a)(5) and 2425.4(b), commenters approved of these changes. Consistent with the revision to § 2425.4(a)(3) to clarify that an excepting party is required to provide documents that are not readily accessible to the Authority, the wording, “Notwithstanding subsection (a)(3) of this section,” has been deleted from § 2425.4(b), as that wording is no longer necessary.

With regard to § 2425.4(c), one commenter supported this change. However, two commenters expressed concerns.

The first commenter did not specifically cite § 2425.4(c), but made comments that relate to it. Specifically, the commenter expressed a concern that the proposed rule would require parties to present “the entire Law Library of Congress” to the arbitrator in order “to avoid something being left out.” The same commenter questioned why an award could not be challenged where an arbitrator has reached a conclusion that is not based on evidence or legal issues presented at arbitration.

The second commenter stated that the proposed rule “expands” the Authority's current practice of declining to resolve issues that were not raised before an arbitrator. Specifically, the commenter asserted that the wording concerning “challenges to an awarded remedy that could have been, but were not, presented to the arbitrator” is particularly problematic. According to this commenter, in many cases, unions request numerous possible remedies, some of which may not be clear, and frequently request “any and all proper relief[.]” The commenter stated that it may not be reasonable for a responding party to be required to anticipate any remedy that an arbitrator may fashion. In addition, the commenter stated that some agencies have expedited arbitration procedures where there is no transcript or post-hearing brief, and this will make it difficult for a party to demonstrate that a particular argument was submitted before the arbitrator. Accordingly, the commenter suggests adding the following wording to the end of proposed § 2425.4(c): “However, this prohibition does not apply where one party could not reasonably foresee a defect or basis for filing exceptions recognized in § 2425.4(c).”

With regard to the concerns raised by these two commenters, § 2425.4(c) is intended merely to incorporate in regulations—not to expand—the Authority's existing practice under the current version of § 2429.5 of the Authority's regulations. Under that practice, parties are required to raise arguments—including challenges to remedies—only to the extent that they could reasonably know to do so. See, e.g., U.S. DHS, U.S. Customs & Border Prot., JFK Airport, Queens, N.Y., 64 FLRA 841, 843 (2010) (as agency challenged potential award of overtime on one ground before arbitrator, it could not challenge award of overtime on another ground for the first time before Authority). Thus, if a party could not reasonably know to raise an argument or a challenge to an awarded remedy, then the party would not be precluded from filing an exception raising that argument or challenge. With regard to the latter commenter's concern regarding proving that an issue was raised below in an expedited proceeding with no record, the party could assert in its exceptions that it raised an issue below and explain why it cannot provide evidence to support that assertion. Cf. U.S. DOJ, Fed. Bureau of Prisons, U.S. Penitentiary, Atlanta, Ga., 57 FLRA 406, 408-09 (2001) (Chairman Cabaniss dissenting on other grounds) (agency stated in exceptions that it raised argument before arbitrator, and Authority found, “absent evidence in the record to the contrary,” that argument was properly before Authority). Thus, there is no need to modify the proposed rule in the manner suggested by the latter commenter.

With regard to § 2425.4(d), one commenter supported the use of forms, particularly when expedited, abbreviated decisions are requested under § 2425.7.

One commenter recommended that the requirements for oppositions be as explicit as the requirements for filing exceptions. According to the commenter, the proposed rule as written provides for interpretation by the opposing party as to what should be included in and with an opposition filing.

However, unlike exceptions, which are provided for by 5 U.S.C. 7122, oppositions are entirely optional. As such, the Authority purposely worded § 2425.5 to not impose specific, mandatory filing requirements, and there is no basis for modifying the rule as suggested.

Nevertheless, the Authority has decided that § 2425.5 can be clarified. In this connection, the final rule adds a statement that the opposing party should submit copies of documents only if they are not readily accessible (such as those discussed in the revision to § 2425.4(a)), not copies of readily accessible documents (such as those discussed in § 2425.4(b)).

In addition, as discussed above in connection with § 2425.4 and below in connection with § 2425.7, the final rule has been modified to eliminate the requirement of joint requests for expedited, abbreviated decisions. Instead, the final rule allows an excepting party to request such a decision, and § 2425.5 has been modified to provide that the opposing party should state whether it supports or opposes such a request and to provide supporting arguments.

As an initial matter, the final rule corrects a typographical error from the proposed rule. Specifically, the final rule states “through (b)(2)(iv)[,]” rather than “through (iv)[.]”

In addition, the Authority has decided to change § 2425.6 to reflect the fact that a party's failure to support a properly raised ground for review may be subject to “denial” rather than “dismissal[.]” As such, the final rule adds the words: (1) “or denial” after “or dismissal[,]” and “or support” after “raise[,]” in the title of § 2425.6; and (2) “or denial” after the word “dismissal” in the text of § 2425.6(e).

With regard to § 2425.6(b)(2), commenters generally supported listing the private-sector grounds for finding arbitration awards deficient. However, two commenters raised questions about two of those grounds.

The first commenter stated that the ground of “incomplete, ambiguous, or contradictory” set forth in § 2425.6(b)(2)(iii) appears to be inconsistent with controlling Supreme Court precedent, citing United States Steelworkers of America v. Enterprise Wheel and Car Corp., 363 U.S. 593 (1960). In this connection, the commenter stated that ambiguity or imprecision in a private-sector arbitration award is not an appropriate basis for judicial review. The commenter suggested deleting this reference from the regulations, alleging that it represents a significant expansion of the Authority's role in reviewing arbitration awards beyond what was contemplated by Congress. In addition, the commenter asserted that adding this reference is bad policy because it will undermine the finality of the arbitration process and result in additional appeals and costs to the parties. In this connection, the commenter stated that, even if Authority decisions set forth this ground, setting it forth in regulations will result in an “undesirable expansion of the Authority's interference in the arbitration process,” which will result in more, not less, litigation and expense. Alternatively, the commenter suggested that the Authority add the word “materially” before “incomplete, ambiguous, or contradictory” in order to make clear that de minimis errors or omissions in arbitration awards will not serve as the basis for submitting exceptions. The commenter further stated that the regulation is somewhat ambiguous because it is unclear whether it is aimed at empowering the Authority to correct arbitrator decisions that are incomplete, ambiguous, or contradictory, or merely arbitrator awards (i.e., remedies) that are unclear. The commenter suggested that, if the Authority keeps the provision, then it would be appropriate to clarify its intent.

In response to that commenter, the private-sector ground of “incomplete, ambiguous, or contradictory” that the Authority has discussed in its decisions requires that the award be so incomplete, ambiguous, or contradictory as to make implementation of the award impossible. E.g., AFGE, Local 1395 , 64 FLRA 622, 624 (2010). As such, minor incompleteness, ambiguity, or imprecision in the award would not provide a basis for setting aside the award, as long as the award is sufficiently clear so that the parties know how to implement it. Nevertheless, as clarification is warranted in this regard, and in an attempt to avoid an increase in the number of exceptions that allege that an award is deficient merely because it is incomplete, ambiguous, or contradictory in some manner, the final rule adds, after “contradictory[,]” the words “as to make implementation of the award impossible.”

The second commenter questioned whether the “public policy” ground set forth in § 2425.6(b)(2)(iv) has any place in Federal-sector arbitration review because “[a]t best, it is redundant, mirroring the `contrary to law, rule, or regulation'” ground. In this regard, the commenter asserted that the “public policy” ground must be well defined and dominant, and is to be ascertained by reference to the laws and legal precedents and not from general consideration of supposed public interests. According to the commenter—citing United Paperworkers International Union, AFL-CIO v. Misco, Inc., 484 U.S. 29 (1987), and W.R. Grace & Co. v. Local Union 759, International Union of United Rubber Workers, 461 U.S. 757, 766 (1983)—courts' refusal to enforce an arbitrator's interpretation of a contract that contravenes public policy has its roots in the general common-law doctrine that courts may refuse to enforce contracts that violate law or public policy. The commenter noted that, in the Federal sector, parties are not required to bargain over proposals that are inconsistent with Federal law or government-wide regulation, and both the negotiability appeal process and the agency-head review process are intended to ensure that unlawful provisions do not end up in contracts. Thus, the commenter asserted that there is “no real need” to set forth this ground, and if it is listed as an independent ground, then the Authority should clarify how an award found deficient as contrary to public policy would not also be found to be contrary to law.

In response to that commenter, the Authority is required to assess whether awards are deficient on private-sector grounds. See 5 U.S.C. 7122(a)(2). Although the public-policy ground likely overlaps to some degree with the “contrary to law, rule, or regulation” ground that the Authority applies, it is not clear that they are entirely coextensive. As such, it is appropriate to list it as a ground, and to provide guidance as to its meaning through Authority decisional law and informal guidance. Accordingly, no change is necessary to the final rule in this regard.

With regard to § 2425.6(e)(1), one commenter suggested deleting the word “or” and adding, after the word “award”: “, or fails to meet any statutory or regulatory time limit[.]” In effect, the commenter's suggestion would add a statement that untimely exceptions will be dismissed. However, the purpose of § 2425.6 is to set forth the substantive grounds for review, and to provide that an exception is subject to dismissal or denial either if a party fails to raise and support a recognized ground, or if the award involves a matter over which the Authority lacks jurisdiction. Discussing timeliness and other types of deficiencies would be outside the scope of this purpose. Accordingly, no change is made to the final rule in this regard.

Another commenter suggested that § 2425.6 should clarify that no exception may be based on an argument or claim that was not advanced to the arbitrator, unless the arbitrator's award initially “injects” the basis for the exception. This point is sufficiently made in §§ 2425.4(c) and 2429.5, and there is no need to repeat it in § 2425.6. Accordingly, no change is made to the final rule in this regard.

Finally, one commenter stated that the Authority should provide arbitrators and parties with the types of arbitration awards over which the Authority lacks jurisdiction, “so that the arbitrator's award is final without the option of an appeal” if the Authority lacks jurisdiction over the case. To the extent that the commenter has suggested that the regulation should provide that those types of awards automatically become final, without allowing any filing of exceptions, there must be some mechanism for the Authority to determine whether an award concerns a matter over which the Authority lacks jurisdiction. Accordingly, it is inappropriate to modify § 2425.6 to provide that any type of award automatically becomes final without an opportunity to file exceptions with the Authority. Thus, no change is made to the final rule in this regard. However, under the final rule and consistent with current practice, the Authority will continue to dismiss exceptions in cases where it lacks jurisdiction.

As an initial matter, the Authority has decided to delete the use of the term “short-form” from the final rule because that term is used internally at the Authority and is unlikely to have meaning to many people outside the Authority. Instead, § 2425.7 and other pertinent sections of the final rule refer to “expedited, abbreviated” decisions.

One commenter suggested deleting the word “briefly” because even an expedited, abbreviated decision will fully resolve the parties' arguments; it will just do so without a full explanation of the background, award, arguments, and analysis of those arguments. In the alternative, the commenter suggested substituting the word “summarily” for “briefly.” The final rule adopts the commenter's suggested deletion of the word “briefly” because it is redundant.

Another commenter suggested a more fundamental change to § 2425.7. Specifically, the commenter suggested that, rather than requiring a joint request for an expedited, abbreviated decision, “a request from one party (i.e. the excepting party)” should be sufficient. The commenter also noted that the proposed rule does not address how the Authority will expedite the process and issue a decision and provides no timeline, even if only a target, for the issuance of this type of decision.

Upon consideration of the commenter's suggestion that the proposed rule delete the requirement of a joint request, the final rule provides that the excepting party may request an expedited, abbreviated decision, and that the opposing party may state whether it agrees with or opposes the request. In this connection, particularly given that the Authority may issue this type of decision without any request from the parties, it is appropriate to delete the requirement of a joint request. As such, the final rule allows the excepting party to state whether it is willing to accept an abbreviated Authority decision in exchange for a more expedited decision. An added benefit to deleting the requirement of a joint request is that it reduces the possibility for procedural deficiencies that may attend the creation of a new filing, which could delay the processing of this type of case, contrary to the intent of § 2425.7. Accordingly, the final rule deletes the requirement of a joint request and makes clear that the excepting party may make this request.

With regard to the commenter's statement that the proposed rule does not state how the Authority will expedite the process and provides no timeline for when it will issue a decision, these matters are best left for development through practice, rather than regulation. Thus, no change is made to the final rule in this regard.

Another commenter suggested that § 2425.7 be modified to make the sentence beginning, “Even absent the parties' joint request,” the first sentence of a second paragraph that would then state: “Parties are encouraged to provide a short position statement as to why a short-form decision is appropriate or inappropriate for that particular case. The Authority will consider factors such as: (1) The novelty of the disputed issues; (2) the potential impact of the decision on other cases; (3) the need, if any, to clarify previously issued decisions; (4) the impact an extended timeline for decision will have on labor-management relations.”

As discussed previously, § 2425.4(a)(4) has been modified to state that the excepting party must provide supporting arguments for any request for an expedited, abbreviated decision under this section, and § 2425.5 has been modified to state that the opposing party should state whether it supports or opposes such a request and provide supporting arguments. With regard to the commenter's suggestion regarding the factors that the Authority should consider, § 2425.7 is broadly worded to state that the Authority will consider “all of the circumstances of the case,” and sets forth certain examples. It is unnecessary to modify the proposed rule to list additional examples, although parties may provide in their briefs whatever arguments that they believe support issuing or not issuing this type of decision. No change is made to the final rule in this regard.

One commenter stated that Authority decisions in arbitration cases may be subject to further review, for example by the Equal Employment Opportunity Commission. Thus, the commenter suggested that § 2425.7 should specify that if a case involves an alleged violation of a civil-rights statute, then an expedited, abbreviated decision would not be appropriate. However, as discussed above, the proposed rule is broadly worded and does not preclude parties from listing these sorts of reasons why an abbreviated decision would not be appropriate in a particular case. Accordingly, no change is made to the final rule in this regard.

Finally, one commenter agreed with the proposed rule, but suggested that the Authority should decide all of its cases in chronological order. This suggestion is contrary to the intent of § 2425.7, which is to provide for a mechanism for quickly deciding newly filed cases. Accordingly, no change is made to the final rule in this regard.

One commenter supported the provision of assistance from the Authority's Collaboration and Alternative Dispute Resolution Program (CADR), “as long as that is a final step and the end of the appeal process by either party.” To the extent that the commenter has suggested that parties' decision to use CADR should waive their ability to have the Authority resolve their exceptions, this suggestion would discourage parties from using CADR. Accordingly, no change is made to the final rule in this regard.

Another commenter stated that, after reviewing exceptions and any opposition, if the Authority determines that CADR would be appropriate in a particular case, then the Authority should contact the parties and encourage or suggest the use of CADR, rather than waiting for parties to jointly request it. According to the commenter, parties will rarely jointly request CADR on their own, which will result in missed opportunities to save government resources that could be saved through greater and more effective use of CADR.

It is unnecessary to specify in regulations how the Authority will proceed with regard to contacting parties in appropriate cases. The Authority's current negotiability regulations do not specify how contacts between CADR and parties proceed, and it is appropriate not to so specify here. Accordingly, no change is made to the final rule in this regard. However, the Authority will seek to develop a practice or process that encourages the use of CADR in arbitration cases.

One commenter approved of the opportunity for CADR but suggested that “the requirements and relevant material regarding alternative dispute resolution be set forth explicitly in the regulation rather than an exterior source such as a website.” The commenter also suggested that, to avoid delay on the part of the opposing party “after an opposition has been filed,” CADR “should have the right to stop the tolling and require the submission of the opposing party's opposition.” In this connection, the commenter stated that requiring an opposing party to place its position “on the table” can assist in the settlement process.

With regard to the commenter's suggestion that the regulation set forth “the requirements and relevant material regarding alternative dispute resolution[,]” the proposed rule is intentionally modeled after the Authority's negotiability regulations concerning CADR. Accordingly, no change is made to the final rule in this regard.

With regard to the commenter's suggestion that CADR should have the authority to stop the tolling and require the submission of the opposing party's opposition, to the extent that the commenter has suggested that CADR should have the authority to immediately demand an opposition statement, this suggestion could discourage some parties from choosing to use CADR because it could result in some opposing parties forfeiting a portion of their time for filing an opposition. Accordingly, no change is made to the final rule in this regard.

Finally, one commenter suggested clarifying how long the time limits will be tolled in cases where CADR assists the parties, and asked whether the party filing an opposition would get a full thirty days in the event that CADR's efforts prove unsuccessful. In negotiability cases where parties agree to use CADR, their case is held in abeyance and their filing deadlines are tolled, but the negotiability regulations do not set forth the details of this practice. Rather, the Authority has found it appropriate to let these details be worked out through practice, and it is appropriate to do so in the arbitration context as well. Accordingly, no change is made to the final rule in this regard.

One commenter approved of this regulation but suggested that the Authority reference its “subpoena and enforcement power[.]” It is unnecessary to reference any Authority “powers” in this section. Accordingly, no change is made to the final rule in this regard.

Another commenter stated that the Authority should be circumspect in implementing this section so as not to provide the excepting party a second chance to fully meet the requirements of § 2425.4 and thereby supplement the record. In this connection, the commenter did not object to the Authority seeking clarification where administrative errors are identified, but stated that providing an excepting party an opportunity to “more effectively formulate its exception” could undercut the finality of the arbitration process.

Although the commenter has raised valid concerns, there is no need to modify the rule. Instead, as the commenter's own comment suggests, these concerns are appropriately taken into account in “implementing” this regulation. Accordingly, no change is made to the final rule in this regard.

Finally, one commenter suggested that arbitrators should be qualified to review parties' documentation and testimony to determine whether they are “FLRA worthy.” The commenter stated that, if an arbitrator is not trained to make this determination, then: Training should be provided; any decisions about the adequacy of evidence should be resolved during the formal arbitration proceedings; and the arbitrator should ensure that the parties provide adequate evidence prior to an exception being filed with the Authority.

To the extent that the commenter has suggested that the Authority should regulate how the arbitration process works and/or provide arbitrators with the authority to determine the content of filings with the Authority, the former would be an unwarranted intrusion by the Authority in the arbitration process, and the latter would be an unwarranted intrusion by the arbitrator in the exceptions process. Accordingly, no change is made to the final rule in this regard.

One commenter acknowledged that this regulation merely restates the Authority's current regulations, but suggested deleting the words “and making such recommendations” because the commenter did not recall ever seeing an Authority decision where the Authority made a “recommendation” regarding an award. In this connection, the commenter stated that the Authority denies an exception, remands an arbitration award, or sets the award aside in whole or in part. However, 5 U.S.C. 7122 expressly provides that the Authority may “make such recommendations concerning the award as it considers necessary,” and it is appropriate to include the discussion of “recommendations” in § 2425.10 as well. Accordingly, no change is made to the final rule in this regard.

One commenter asserted that clarification is needed because the word “material” implies that the Authority will consider “immaterial” evidence. The commenter recommended changing the first sentence of § 2429.5 to the following: “The Authority will not consider any evidence, issue, assertion, argument, affirmative defense, remedy, or challenge to an awarded remedy, that could have been but was not presented * * *”.

The commenter's statement that the use of “material” implies that the Authority will consider “immaterial” evidence is correct. As the Authority did not intend to imply that it will consider immaterial evidence, the final rule deletes the word “material[.]” To the extent that the commenter's suggested wording would result in other, minor changes to the wording of the existing regulation, there is no basis for modifying the remaining wording, and that wording remains unchanged in the final rule.

One commenter repeated the arguments that the commenter made in connection with § 2425.4(c), specifically, that the proposed rule expands the Authority's basis for refusing to decide arguments raised on appeal if those arguments were not previously made to the arbitrator; that it may not always be reasonable for a party to anticipate an awarded remedy; and that parties often have expedited arbitration procedures that do not provide for records that will enable a party to demonstrate that it raised an issue before the arbitrator. For the reasons discussed in connection with § 2425.4(c), it is unnecessary to modify § 2429.5 in response to these concerns.

Another commenter stated that the Authority should entirely withdraw the proposed amendment to § 2429.5. According to the commenter, the amended wording will greatly increase the litigation burden associated with arbitration and undermine Congress's intent in 5 U.S.C. 7121 that Federal workplace disputes be resolved through a quick, efficient, and inexpensive negotiated grievance procedure. In this connection, the commenter asserted that many negotiated grievance procedures provide for the simultaneous submission of post-hearing briefs and do not provide for reply briefs, which minimizes parties' time and expense in connection with litigation but results in parties not challenging remedies that are sought only in post-hearing briefs. The commenter also asserted that the proposed rule's use of the word “could” in connection with whether a challenge “could” have been presented to an arbitrator will force parties whose agreements do not provide for reply briefs to arbitrators to choose between: (1) Moving for permission to file, and filing, a reply brief with the arbitrator, which would prolong litigation and impose additional costs; or (2) filing exceptions with the Authority to challenge an awarded remedy, and run the risk of the opposing party asserting that the challenge should be dismissed because it could have been, but was not, presented to the arbitrator. According to the commenter, parties could modify their collective bargaining agreements to expressly permit reply briefs in arbitration, but reopening and modifying agreements may only be done at certain times and under certain conditions, and would impose time and expense. According to the commenter, the proposed amendment would discourage the use of faster, less costly, expedited arbitration procedures because parties will be encouraged to raise arguments that they otherwise would not raise. The commenter also asserted that the proposed wording will impose new burdens on the Authority because it will require the Authority to develop case law addressing when a challenged remedy “could” have been presented to an arbitrator. Further, the commenter stated that parties are unable to determine what an awarded remedy will be before an award actually issues, and questioned whether the wording “challenges to an awarded remedy” would require parties to file reply briefs (as discussed above) as well as post-award briefs to the arbitrator to challenge an awarded remedy. The commenter also asserted that the proposed wording imposes burdens not only in the arbitration context, but also in other processes where simultaneous briefs are filed, which would require greater expenditures of time for parties to file motions and for triers of fact to rule on those motions.

With regard to the commenter's concerns, as discussed previously, the proposed amendments to § 2429.5 merely incorporate into regulation the Authority's existing practice under § 2429.5. Thus, they do not impose any new, additional burdens on parties. With regard to the commenter's concern about the fact that post-hearing briefs often are submitted simultaneously, the Authority takes, and will continue to take, this factor into account in determining whether a party could have raised an issue before an arbitrator. E.g., U.S. Dep't of Labor, 60 FLRA 737, 738 (2005) (agency could file exception regarding issue that was raised for the first time in union's post-hearing brief to arbitrator, which was submitted at the same time as agency's post-hearing brief). The proposed revisions to § 2429.5 would not change this practice, and would not impose a new burden on parties to move to request an opportunity for additional filings or to file post-award requests with an arbitrator. With regard to the commenter's statement that the proposed amendment will prolong litigation by encouraging parties to submit additional arguments to arbitrators that they otherwise would not submit, parties should be raising any arguments that they wish to raise to an arbitrator and giving the arbitrator the opportunity to resolve those issues. The Authority believes that clarifying the meaning of § 2429.5 will encourage the finality of arbitration awards and preclude parties from prolonging litigation by filing exceptions with the Authority on issues that they could, and should, have raised to an arbitrator. As for the commenter's assertion regarding other, non-arbitration contexts, as discussed previously, the proposed amendment to § 2429.5 merely incorporates into regulation the Authority's existing practice.

One commenter suggested eliminating the last sentence of § 2429.21(a) and inserting the following new subparagraph: “(b) When the period of time prescribed or allowed under this subchapter is 7 days or less, intermediate Saturdays, Sundays, and Federal legal holidays shall be excluded from the computations.” However, the Authority's current regulations already have a § 2429.21(b), and there is no need to separate out this one sentence from the rest of § 2429.21(a). Further, the wording set forth in the proposed rule is identical to the existing wording of § 2429.21(a), with the exception of the deletion of “except as to the filing of exceptions to an arbitrator's award under § 2425.1 of this subchapter,” which merely reflects the change in how the Authority will calculate the timeliness of exceptions. For these reasons, the final rule as promulgated is the same as the proposed rule.

As an initial matter, the final rule corrects a typographical error from the proposed rule. Specifically, the final rule states that “5 days shall be added to the prescribed period[,]” rather than “5 days shall be added to the proscribed period[.]”

One commenter stated that mail to many government offices is subjected to off-site screening for hazardous substances, which sometimes delays mail for as long as a month. In fact, the commenter asserted that this occurred in connection with a recent Authority decision to which the commenter was a party. The commenter recommended adding the following wording: “; and further provided that if a party certifies under oath that it did not actually receive a notice or other paper until more than 5 days after the date of mailing or deposit with the commercial delivery service, that larger number of days shall be added to the pr[e]scribed period.”

The commenter's statement raises valid concerns regarding off-site irradiation of mail. However, as discussed in connection with § 2425.2, the determination of how an award should be served is left to the agreement of the parties, and parties that have concerns regarding receipt of regular mail can make arrangements to have an award served by some other method that does not present the same concerns. Accordingly, a change to the wording is not warranted, and the final rule does not incorporate the commenter's suggestion.

Two commenters made additional suggestions that do not pertain to particular regulations.

The first commenter stated that if “an arbitration award has been previously awarded by the FLRA to Union employees at a similar facility,” then that award should be precedential, and the Authority should, “within the five day screening process by FLRA staff[,]” automatically deny any exceptions to a second, similar award. In this connection, the commenter stated that, during the arbitration process, the arbitrator could review the previous, similar case(s) and subsequent Authority decision(s), and include those findings in the “Opinion and Award.”

To the extent that the commenter has suggested that the Authority should automatically deny exceptions to an arbitration award merely because that award resolves issues similar to those that were resolved in a previous arbitration award, it is well established that arbitration awards are not precedential. E.g., U.S. Dep't of Veterans Affairs, Med. Ctr., W. Palm Beach, Fla., 63 FLRA 544, 548 (2009). Accordingly, there is no basis for modifying the proposed rule in this connection.

The second commenter suggested that the Authority post a “Q&A” or “FAQ” on the Authority's Web site that might assist agency and union representatives in avoiding procedural mistakes. The Authority does not believe that the commenter's suggestion warrants any modifications to the proposed rule, but will take the suggestion into account in developing other, non-regulatory guidance for parties and arbitrators.

The Authority is an independent regulatory agency, and as such, is not subject to the requirements of E.O. 12866.

The Authority is an independent regulatory agency, and as such, is not subject to the requirements of E.O. 13132.

Pursuant to section 605(b) of the Regulatory Flexibility Act, 5 U.S.C. 605(b), the Chairman of the Authority has determined that this regulation, as amended, will not have a significant impact on a substantial number of small entities, because this rule applies only to Federal employees, Federal agencies, and labor organizations representing Federal employees.

This rule change will not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This action is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The amended regulations contain no additional information collection or record-keeping requirements under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq.

Section 218(a) of the Nuclear Waste Policy Act of 1982, as amended (NWPA), requires that “[t]he Secretary [of the Department of Energy (DOE)] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the NWPA states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 218(a) for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the NRC approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule in 10 CFR part 72, which added a new Subpart K within 10 CFR part 72, entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L within 10 CFR part 72, entitled “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on March 9, 2000 (65 FR 12444), that approved the NAC-MPC cask design and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as CoC No. 1025.

On January 16, 2009, and as supplemented on February 11, April 1, April 30, September 22, 2009, and January 8, 2010, the certificate holder (NAC) submitted an application to the NRC that requested an amendment to CoC No. 1025. NAC requested modifications to the cask design that included the following changes to the configuration of the NAC-MPC storage system as noted in Appendix B of the TS: (1) Incorporation of a single closure lid with a welded closure ring for redundant closure into the TSC design; (2) modification of the TSC and basket design to accommodate up to 68 LACBWR spent fuel assemblies (36 undamaged Exxon fuel assemblies and up to 32 damaged fuel cans (in a preferential loading pattern)) that may contain undamaged Exxon fuel assemblies and damaged Exxon and Allis Chalmers fuel assemblies and/or fuel debris; (3) the addition of zirconium alloy shroud compaction debris to be stored with undamaged and damaged fuel assemblies; (4) minor design modifications to the VCC incorporating design features from the MAGNASTOR system for improved operability of the system while adhering to ALARA principles; (5) an increase in the concrete pad compression strength from 4,000 psi to 6,000 psi; (6) added justification for the 6-ft soil depth as being conservative; and (7) other changes to incorporate minor editorial corrections in CoC No. 1025 and Appendices A and B of the TS. Also, the Definitions in TS 1.1 will be revised to include modifications and newly defined terms; the Limiting Conditions for Operation and associated Surveillance Requirements in TS 3.1 and 3.2 will be revised; and editorial changes will be made to TS 5.2 and 5.4.

As documented in the final SER, the NRC staff performed a detailed safety evaluation of the proposed CoC amendment request and found that an acceptable safety margin is maintained. In addition, the NRC staff has determined that there continues to be reasonable assurance that public health and safety and the environment will be adequately protected.

This direct final rule revises the NAC-MPC System listing in 10 CFR 72.214 by adding Amendment No. 6 to CoC No. 1025. The amendment consists of the changes described above, as set forth in the revised CoC and TS. The particular TS which are changed are identified in the SER.

The amended NAC-MPC System cask design, when used under the conditions specified in the CoC, the TS, and NRC regulations, will meet the requirements of part 72; thus, adequate protection of public health and safety will continue to be ensured. When this direct final rule becomes effective, persons who hold a general license under 10 CFR 72.210 may load spent nuclear fuel into NAC-MPC System casks that meet the criteria of Amendment No. 6 to CoC No. 1025 under 10 CFR 72.212.

Certificate No. 1025 is revised by adding the effective date of Amendment Number 6.

This rule is limited to the changes contained in Amendment 6 to CoC No. 1025 and does not include other aspects of the NAC-MPC System. The NRC is using the “direct final rule procedure” to issue this amendment because it represents a limited and routine change to an existing CoC that is expected to be noncontroversial. Adequate protection of public health and safety and the environment continues to be ensured. The amendment to the rule will become effective on October 4, 2010. However, if the NRC receives significant adverse comments on this direct final rule by August 20, 2010, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published elsewhere in this issue of the Federal Register. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or TS.

For detailed instructions on filing comments, see the companion proposed rule published elsewhere in this issue of the Federal Register.

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC will revise the NAC-MPC System cask design listed in § 72.214 (List of NRC-approved spent fuel storage cask designs). This action does not constitute the establishment of a standard that contains generally applicable requirements.

Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended (AEA), or the provisions of Title 10 of the Code of Federal Regulations. Although an Agreement State may not adopt program elements reserved to NRC, it may wish to inform its licensees of certain requirements via a mechanism that is consistent with the particular State's administrative procedure laws but does not confer regulatory authority on the State.

The Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883), directed that the Government's documents be in clear and accessible language. The NRC requests comments on this direct final rule specifically with respect to the clarity and effectiveness of the language used. Comments should be sent to the address listed under the heading ADDRESSES, above.

Under the National Environmental Policy Act of 1969, as amended, and the NRC regulations in subpart A of 10 CFR part 51, the NRC has determined that this rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC has prepared an environmental assessment and, on the basis of this environmental assessment, has made a finding of no significant impact. This rule will amend the CoC for the NAC-MPC System cask design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. Amendment No. 6 to the NAC-MPC System CoC will include the following changes to the configuration of the NAC-MPC storage system as noted in Appendix B of the TS: (1) Incorporation of a single closure lid with a welded closure ring for redundant closure into the TSC design; (2) modification of the TSC and basket design to accommodate up to 68 LACBWR spent fuel assemblies (36 undamaged Exxon fuel assemblies and up to 32 damaged fuel cans (in a preferential loading pattern)) that may contain undamaged Exxon fuel assemblies and damaged Exxon and Allis Chalmers fuel assemblies and/or fuel debris; (3) the addition of zirconium alloy shroud compaction debris to be stored with undamaged and damaged fuel assemblies; (4) minor design modifications to the VCC incorporating design features from the MAGNASTOR system for improved operability of the system while adhering to ALARA principles; (5) an increase in the concrete pad compression strength from 4,000 psi to 6,000 psi; (6) added justification for the 6-ft soil depth as being conservative; and (7) other changes to incorporate minor editorial corrections in CoC No. 1025 and Appendices A and B of the TS. Also, the Definitions in TS 1.1 will be revised to include modifications and newly defined terms; the Limiting Conditions for Operation and associated Surveillance Requirements in TS 3.1 and 3.2 will be revised; and editorial changes will be made to TS 5.2 and 5.4.

The environmental assessment and finding of no significant impact on which this determination is based are available for inspection at the NRC Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, MD. Single copies of the environmental assessment and finding of no significant impact are available from Jayne M. McCausland, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6219, e-mail Jayne.McCausland@nrc.gov.

This direct final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget, Approval Number 3150-0132.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR PART 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's CoC, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in 10 CFR 72.214. On March 9, 2000 (65 FR 12444), the NRC issued an amendment to part 72 that approved the NAC-MPC System cask design by adding it to the list of NRC-approved cask designs in 10 CFR 72.214. On January 16, 2009, and as supplemented on February 11, April 1, April 30, September 22, 2009, and January 8, 2010, the certificate holder (NAC) submitted an application to the NRC that requested an amendment to CoC No. 1025. Specifically, the amendment will include the following changes to the configuration of the NAC-MPC storage system as noted in Appendix B of the TS: (1) Incorporation of a single closure lid with a welded closure ring for redundant closure into the TSC design; (2) modification of the TSC and basket design to accommodate up to 68 LACBWR spent fuel assemblies (36 undamaged Exxon fuel assemblies and up to 32 damaged fuel cans (in a preferential loading pattern)) that may contain undamaged Exxon fuel assemblies and damaged Exxon and Allis Chalmers fuel assemblies and/or fuel debris; (3) the addition of zirconium alloy shroud compaction debris to be stored with undamaged and damaged fuel assemblies; (4) minor design modifications to the VCC incorporating design features from the MAGNASTOR system for improved operability of the system while adhering to ALARA principles; (5) an increase in the concrete pad compression strength from 4000 psi to 6000 psi; (6) added justification for the 6-ft soil depth as being conservative; and (7) other changes to incorporate minor editorial corrections in CoC No. 1025 and Appendices A and B of the TS. Also, the Definitions in TS 1.1 will be revised to include modifications and newly defined terms; the Limiting Conditions for Operation and associated Surveillance Requirements in TS 3.1 and 3.2 will be revised; and editorial changes will be made to TS 5.2 and 5.4.

The alternative to this action is to withhold approval of Amendment No. 6 and to require any Part 72 general licensee, seeking to load spent nuclear fuel into NAC-MPC System casks under the changes described in Amendment No. 6, to request an exemption from the requirements of 10 CFR 72.212 and 72.214. Under this alternative, each interested Part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

Approval of the direct final rule is consistent with previous NRC actions. Further, as documented in the SER and the environmental assessment, the direct final rule will have no adverse effect on public health and safety. This direct final rule has no significant identifiable impact or benefit on other Government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of the direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security. No other available alternative is believed to be as satisfactory, and thus, this action is recommended.

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and NAC. These entities do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).

The NRC has determined that the backfit rule (10 CFR 72.62) does not apply to this direct final rule because this amendment does not involve any provisions that would impose backfits as defined in 10 CFR chapter I. Therefore, a backfit analysis is not required.

Under the Congressional Review Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.

The Administrator has broad authority to regulate the safe and efficient use of the navigable airspace (49 U.S.C. 40103(a)). The Administrator is also authorized to issue air traffic rules and regulations to govern the flight, navigation, protection, and identification of aircraft for the protection of persons and property on the ground, and for the efficient use of the navigable airspace (49 U.S.C. 40103(b)). The Administrator may also conduct investigations and prescribe regulations, standards, and procedures in carrying out the authority under this part (49 U.S.C. 40113). The Administrator is authorized to protect civil aircraft in air commerce (49 U.S.C. 44070(a)(5)).

Under § 44701(a)(5), the Administrator promotes safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for other practices, methods, and procedures necessary for safety in air commerce and national security. Also, § 44718 provides that under regulations issued by the Administrator, notice to the agency is required for any construction, alteration, establishment, or expansion of a structure or sanitary landfill, when the notice will promote safety in air commerce, and the efficient use and preservation of the navigable airspace and airport traffic capacity at public use airports. This statutory provision also provides that, under regulations issued by the Administrator, the agency determines whether such construction or alteration is an obstruction of the navigable airspace, or an interference with air navigation facilities and equipment or the navigable airspace. If a determination is made that the construction or alteration creates an obstruction or otherwise interferes, the agency then conducts an aeronautical study to determine adverse impacts on the safe and efficient use of the airspace, facilities, or equipment.

On June 13, 2006, the FAA published an NPRM that proposed to amend the regulations governing objects that may affect the navigable airspace (71 FR 34028). The FAA proposed to: Establish notification requirements and obstruction standards for transmitting on certain frequencies; revise obstruction standards for civil airport imaginary surfaces to more closely align these standards with FAA airport design and instrument approach procedure (IAP) criteria; revise current definitions and include new definitions; require proponents to file with the FAA a notice of proposed construction or alteration for structures near private use airports that have an FAA-approved IAP; and increase the number of days in which a notice must be filed with the FAA before beginning construction or alteration. The comment period closed on September 11, 2006.

The following is a discussion of the major changes contained in the final rule. The provisions of the final rule that were modified based on comments the FAA received are discussed in the “Discussion of the Final Rule” section. Most of the amendments implemented by the rule are intended to simplify the existing regulations.

This rule adds § 77.29 to incorporate the specific factors listed in P.L. 100-223 for consideration during an aeronautical study. The specific factors are listed in Appendix A to this preamble. Including this language in part 77 does not add or remove any of the factors currently considered in an aeronautical study.

This rule provides for an FAA Determination of Hazard or Determination of No Hazard to become effective 40 days after the date of issuance, unless a petition for discretionary review is received by the FAA within 30 days of issuance. In addition, the rule stipulates that a Determination of No Hazard to air navigation will expire 18 months after the effective date of the determination, or on the date the proposed construction or alteration is abandoned. Also, the rule specifies that a Determination of Hazard to Air Navigation does not expire.

This final rule adds information about the processing of petitions for discretionary review. It also excludes determinations for temporary structures and recommendations for marking and lighting from the discretionary review process. Because of the nature of temporary structures, it is not possible to apply the lengthy discretionary review process to these structures. Also, since marking and lighting recommendations are simply recommendations, there is a separate process for a waiver of, or deviation from, the recommendations.

This rule expands the requirements for notice to be sent to the FAA for proposed construction or alteration of structures on or near private use airports that have an IAP. Accordingly, if a private use airport has an FAA-approved IAP, then a construction sponsor must notify the FAA of a proposed construction or alteration that exceeds the notice criteria in § 77.17. This action will give the FAA enough time to adjust the IAP, if needed, and to inform those who use the IAP.

Also, IAPs at private use airports or heliports are not currently listed in any aeronautical publication. Sponsors of construction or alteration at or near a private use airport or heliport should consult the FAA Web site to determine whether an FAA-approved IAP is listed for that airport.1 If the airport is listed on the Web site, the sponsor must file notice with the FAA.

Lastly, this rule incorporates minor edits to the regulatory text to distinguish FAA surveillance systems from communication facilities.

The FAA received approximately 115 comments from individuals, aviation associations, industry spectrum users, airlines, and other aviation businesses. Many commenters, including the Air Transport Association, generally supported the NPRM. Commenters supported specific proposals concerning evaluating the aeronautical impact of proposed construction on IAPs at private use airports; evaluating antenna installations that might affect air traffic or navigation; and the update and reformat of the regulations. Comments that did not support the proposed rule, and suggested changes, are discussed more fully in the “Discussion of the Final Rule” section.

The FAA received substantive comments on the following general areas of the proposal:

The FAA's primary focus during the obstruction evaluation process is safety and efficiency of the navigable airspace. It is critical for the agency to be notified of pending construction of physical objects that may affect the safety of aeronautical operations. (See 49 U.S.C. 44718.) In today's National Airspace System (NAS), however, electromagnetic transmissions can adversely affect on-board flight avionics, navigation, communication, and surveillance facilities. The FAA has extensive authority to prescribe regulations and minimum standards necessary for safety in air commerce. (See 49 U.S.C. § 44701(a)(5).) In addition, the FAA has broad authority to develop policy and plans for the use of the navigable airspace. (See 49 U.S.C. 40103.) The FAA relied on these authorities in proposing the notice requirements for broadcast transmissions in the specified bands. As stated in the proposal, broadcast transmission on certain frequencies can pose serious safety threats to avionics and ground based facilities. At the same time, the FAA recognizes the authority of the National Telecommunications and Information Administration (NTIA) and the Federal Communications Commission (FCC) to manage use of the radio spectrum.

The FAA concludes that its proposal to require notice for the proposed frequency bands was too broad. The proposed frequencies from the NPRM are listed in Appendix B to this preamble. The proposed frequencies in the shared (Federal and Non-Federal) bands are managed by an existing process involving several Federal agencies with an interest in spectrum use, which NTIA oversees under the Department of Commerce. It is not the FAA's intent to add a duplicative review and coordination process to that already stated above. In addition, the FAA has determined that some of the proposed frequencies originally listed and not in shared bands do not present concern. Therefore, the agency withdraws the proposed notice and obstruction standards on the shared frequency bands and those frequency bands that, historically, have not posed electromagnetic concerns,3 when operating under typical specifications.

FM broadcast service transmissions operating in the 88.0-107.9 MHz frequency band pose the greatest concern to FAA navigation signals. The FAA, FCC and NTIA are collaborating on the best way to address this issue. A resolution of this issue is expected soon. Therefore, the proposals on FM broadcast service transmissions in the 88.0-107.9 MHz frequency band remain pending. The FAA will address the comments filed in this docket about the proposed frequency notice requirements and proposed EMI obstruction standards when a formal and collaborative decision is announced.

This rule does include evaluating electromagnetic effect (§§ 77.29 and 77.31), and it codifies the agency's current practices of studying the effects on aircraft navigation and communication facilities. These amendments in no way should be construed to affect the authority of NTIA and the FCC.

Automation improvements to the FAA's obstruction evaluation program allow the public to file notices of proposed construction electronically, which facilitates the aeronautical study process and has reduced the overall processing time for these cases. The FAA proposed to require that notices of proposed construction or alterations must be filed with the FAA at least 60 days before construction starts or the application filing date for a construction permit, whichever is earliest. The current rule requires 30 days, which the FAA found inadequate for cases to be processed, particularly if additional information, via public comment period, was necessary to complete the study. At the time the FAA published the NPRM, the automation system was in the early stages, and the full benefits of the automation were not yet known. Commenters were split on their support of this proposal, depending on their interests. Comments from the aviation industry largely supported the extended time period. Comments filed by the building industry, however, opposed the extended time period, saying it was too long and would cause undue delay.

The FAA has seen great success with the automation system and concludes that requiring notice to be filed 60 days before construction or the permit application is not necessary. There are cases where circulating the proposal for public comment may be necessary and, consequently, these cases may require up to 45 days for processing. Therefore, the FAA adopts the requirement that notice must be filed with the FAA for proposed construction or alteration at least 45 days before either the date that construction begins, or the date of the construction permit application, whichever is earliest.

Because applications are required within 45 days of construction, the FAA, Department of Defense, and Department of Homeland Security should work together to conduct timely reviews. To that end, the FAA will respond to inquiries from applicants regarding the status of applications, the reason(s) for any delay, and the projected date of completion. As appropriate, the FAA will engage with other Federal Agencies such as the Department of Defense, the Department of Homeland Security, the Department of Energy, and the Department of Interior to expedite any further regulatory modifications and improvements to 14 CFR Part 77 to ensure there is a predictable, consistent, transparent, and timely application process for the wind industry.

Several commenters recommended separate notice requirements for reviewing a temporary structure that might be necessary under emergency-type circumstances. An example submitted in the comments was a construction crane that was necessary to replace air conditioning units on the roof of factories. The commenters contend that it is neither logical nor feasible to shut down a factory for 30 days while the FAA studies this temporary structure.

Situations like the one presented by these commenters are not uncommon. Regardless of whether the structure is temporary, it remains critical for the FAA to have notice of tall structures that can affect aeronautical operations. In most cases, the proponent of the structure contacts the FAA Obstruction Evaluation (OE) specialist and identifies the need for a quick review, for which the agency readily responds. While the FAA regrets any past delay in taking quick action on a particular case, the agency declines to set-up special procedures to address such cases. On the FAA's OE Web site,4 the agency lists the contact information for the FAA specialist. If a sponsor is concerned with the time frame for the FAA's review, the agency encourages the sponsor to contact the FAA specialist directly.

The NPRM proposed, for a visual runway used by small aircraft or restricted to day-only instrument operations, that the width of the imaginary approach surface expand uniformly to 1,250 ft. If the runway is a visual runway, used by other than small aircraft or for instrument night circling, the surface width expands uniformly from 1,500 ft. to 3,500 ft. If the runway is a non-precision instrument or precision instrument runway, the surface width expands uniformly to 4,000 ft. and 16,000 ft., respectively. Other changes include removing approach surface widths of 1,500 ft. and 2,000 ft., and increasing the width for some non-precision runways from 2,000 ft. to 4,000 ft. The NPRM also proposed expanding the width of the primary approach surface of a non-precision instrument runway or precision instrument runway from 500 feet to 1,000 ft.

Many commenters opposed the proposed expansion of the primary surface. They argued that the proposed expansion would require airport operators to remove existing structures that would fall within the proposed expanded surface, which would result in a financial burden to airport owners and managers. Southwest Airlines, on the other hand, supported the proposal and stated the ability to study and review more proposed structures is positive for airport safety.

Several comments stated that the imaginary surfaces in part 77 do not comport clearly with the surfaces used for obstacle clearance under the United States Standard for Terminal Instrument Procedures (TERPS) and, therefore, makes the part 77 surfaces useless as a project planning tool for airport development.

Similarly, another commenter argued that the Required Navigation Performance (RNP) lateral protection area is greater than the width of the primary surface and the RNP procedures TERPS surface is outside the part 77 imaginary surface. The commenter contends that an obstacle can adversely impact an RNP procedure, but not be characterized as an obstruction. This commenter recommends that the imaginary surfaces be expanded to include RNP procedures.

Several commenters specifically questioned whether current obstructions that fall within the newly expanded primary surface could impact an instrument procedure and result in the airport losing the instrument procedure. One airport authority was concerned about marking and lighting recommendations for existing structures that will now fall under the expanded primary surface.

The FAA proposed these changes to more closely align regulatory provisions in part 77 with TERPS criteria and airport design standards. The inconsistency between IAP criteria, airport design standards, and part 77 surfaces has been a source of confusion for both airport managers and the FAA. These specific proposals would not have altered the notice criteria. Instead, the proposals were meant to identify more proposed structures as obstructions that the FAA could study to determine if they would adversely affect the NAS.

However, since publication of the NPRM, the FAA has begun a coordinated effort to consolidate all agency requirements for the treatment of obstacles in the airport environment. Once completed, the new requirements will form the basis for revised civil airport imaginary surfaces. Thus, it would not be prudent to codify the proposals. Further, amending or expanding any of the civil airport imaginary surfaces at this time would not be in the best interest of the public. The FAA, therefore, withdraws all proposed modifications to the civil airport imaginary surfaces, including the chart format. The FAA will keep the civil airport imaginary surfaces rule as it is currently described in 14 CFR 77.25.

The NPRM specifically states that OEI procedures were not a part of the rulemaking. The NPRM further notes that the FAA has tasked the Airport Obstruction Standards Committee (AOSC) with examining this issue. Comments from the Air Transport Association, individual airlines, local airport authorities, and aviation organizations, asked the FAA to address OEI procedures. These comments have been forwarded to the AOSC for consideration. As appropriate, the FAA will advise the aviation industry and other interested persons, through the AOSC, of any policy changes.

The NPRM proposed replacing the term “utility runway” with the phrase “runway used by small aircraft”. In addition, the NPRM proposed amending the definitions for precision, non-precision, and visual runways, as these definitions were no longer up-to-date with industry practices. The term “utility runway” is not widely used in industry so the NPRM proposed replacing the term. In addition, the NPRM proposed amending the definitions for precision and non-precision runways to address approaches that use other than ground based navigational aids, such as flight management systems (FMS) and global navigation satellite systems (GNSS). Because of technological advances, the former definitions for precision and non-precision runways are no longer accurate.

By removing the term “utility runway”, commenters stated the portions of the rule that include the term became confusing. They note that the runway classifications and corresponding widths for the primary and approach surfaces in the tables in § 77.19(d)(e) are difficult to understand.

Several commenters confused the proposed definitions for precision and non-precision instrument runways with the definitions for precision and non-precision instrument approach procedures.5 One commenter suggested the non-precision runway definition should exclude a runway that has a developed instrument approach procedure with visibility minimums of one statute mile. This commenter contends that many small, general aviation airports have published procedures with one mile visibility under the current obstruction criteria of a utility runway. The commenter also notes that if the FAA adopts the proposal to limit non-precision runways to procedures with visibility minimums of one statute mile, then these small airports would need to have the more demanding primary surfaces and approach criteria. The commenter further says this could result in financial hardship for these airports and the airports may need to double the designated airspace around the runway. Another commenter stated that the new definition for a non-precision runway conflicts with FAA Advisory Circular 150/5300-13, Airport Design.

Commenters also indicated that the new definition and associated surfaces would take runways that currently qualify as utility into the non-precision category. They say these modifications could result in unfunded economic burdens on outlying airports with IAPs to utility runways that experience lower traffic densities. Additionally, commenters noted that many of these airports are configured with minimal infrastructure and could face significant airport expansion to obtain IAP services if the runway is categorized as non-precison.

Several commenters also stated that the proposed definitions of precision and non-precision runways try to redefine the current precision and non-precision instrument procedures because satellite technology could, in the future, enable non-precision approaches to become precision approaches.

Although the FAA proposed to revise these definitions, on further review, the agency has determined it should not revise them at this time. The definitions were proposed to support implementing satellite-based navigation. However, as the satellite-based navigation program has evolved during development of this rulemaking, the agency has learned of unintended consequences of the proposed definitions. For example, changing the runway definition creates infrastructure requirements that may be needed as the technology evolves. The FAA believes a more measured approach is needed before making any changes to the definitions. Thus, the agency will not adopt the proposed revisions to the definitions in this final rule.

The NPRM proposed a provision for which an extension to the expiration date for a Determination of No Hazard may be granted. Specifically, it proposed that for structures not subject to FCC review, a Determination of No Hazard can be extended for a maximum of 18 months, if necessary. If more than 18 months is necessary, then a new aeronautical study would be initiated. For structures that require an FCC construction permit, the NPRM proposed that a Determination of No Hazard can be extended for up to 12 months, provided the sponsor submits evidence that an application for a construction permit was filed within 6 months of the date of issuance. The NPRM also proposed that if the FCC extends the original FCC construction completion date, the sponsor must request an extension of the FAA's Determination of No Hazard.

Many commenters found that the two time periods (18 and 12 months) were confusing. The FAA's review of this matter concluded that it is not necessary to continue the distinction between structures subject to FCC review from structures that do not need this review, simply to extend the expiration date. Therefore, for simplification and standardization, the FAA amends the time period for extensions to determinations of structures to 18 months, regardless of whether an FCC construction permit is necessary.

In addition, the FAA unintentionally omitted a section of the current rule from the NPRM. That section states that if the FCC denies a construction permit, the final determination expires on the date of the denial. The FAA has reinserted that section in this final rule.

The effective date of this final rule is 180 days from the date the rule is published in the Federal Register. The FAA needs this time to amend the automation system it uses to evaluate obstructions, amend relevant FAA orders, train employees, and educate the public.

One commenter said the requirement to file notice should extend to structures that would penetrate an imaginary surface relative to a planned or proposed airport. Specifically, this commenter seeks to incorporate the imaginary surfaces for evaluating obstructions under § 77.19(a) in the notice requirements for structures that are on or around a planned airport.

Section 77.9 requires notice for construction on an existing airport or an airport under construction. This section specifies an imaginary surface extending from the runway (in increments of 20,000 feet, 10,000 ft., or 5,000 ft., depending on the length of the airport's runway or heliport) at a specific slope for which notice is required if it would penetrate one of the surfaces for either an existing airport or an airport under construction. The above referenced surfaces, for which the longest surface would extend approximately 3.78 miles from the end of the runway, do not apply to a planned airport for which construction has yet to begin.

The effect of this commenter's request would be to require notice for up to approximately 3.5 miles (for the longest runway) for any construction that penetrates the 100 to 1 surface for a planned or proposed airport.

This comment is outside the scope of the NPRM. The essence of this comment would be a new notice requirement for planned or proposed airports. To accommodate this comment without providing the public an opportunity to comment on its impact would violate the Administrative Procedure Act.

Notwithstanding the above scope issue, to apply the imaginary surface from the notice requirements to planned or proposed airports would be difficult to implement. A planned or proposed airport can be at varying stages of development, with runway(s) location and configuration undetermined, navigational aids not sited, and instrument approach and departure procedures yet to be developed. It would be impossible for the FAA to study (and apply the obstruction standards) with any degree of certainty, to a proposed structure when the above listed airport issues are not defined. In addition, airport development can be subject to environmental laws and lengthy processes with alternative plans that must be analyzed. The FAA cannot “reserve” airspace on such speculative plans. The agency does study the impact of structures that are identified as obstructions on planned or proposed airports that are on file with the FAA. As the details of a planned airport become part of the “plan on file” with the FAA or the Airport Layout Plan, on which the FAA can rely, the FAA includes those details during the study.

Several commenters questioned the proposed removal of the regulatory provisions addressing antenna farms and whether any antenna farms currently exist. The FAA has not established any antenna farm area. Moreover, the regulations governing structures addresses the FAA needs here. Thus, this rule removes the provisions governing antenna farms.

One commenter questioned why an object that is shielded by another structure is not subject to the notice requirements. This commenter contends that if the structure that shields an unreported structure is dismantled, there is no record of the first structure, nor is there any requirement to notify the FAA of this structure if the shielding structure is dismantled.

Section 77.15(a) provides that notice is not required for a structure if the shielding structure is of a substantial and permanent nature and is located in a congested area of a city, town, or settlement where the shielded structure will not adversely affect safety in air navigation. This exception does not apply in areas where there are only one or two other structures. The FAA has not experienced a situation like the one described by the commenter that can be attributed to this exception. This rule does expand the current supplemental notice requirements in § 77.11, and specifies that if a construction or alteration is abandoned, dismantled, or destroyed, notice must be provided to the FAA within 5 days after the construction is abandoned, dismantled, or destroyed. In the rare case where a shielding structure is abandoned, dismantled, or destroyed, the proponent must notify the FAA so that appropriate actions concerning adjacent structures can be initiated.

Prior to this rule, part 77 provided that a proposed or existing structure was an obstruction to air navigation if it was higher than 500 ft. above ground level (AGL). The minimum altitude to operate an aircraft over non-congested areas is 500 feet above the surface.6 Consequently, an aircraft could be operating at 500 ft. AGL and encounter a structure that was 500 ft. AGL that might not have been studied by the FAA during the obstacle evaluation process. The FAA adopts the proposal that lowers the height of a structure identified as an obstruction from above 500 ft. to above 499 ft. Accordingly, all structures that are above 499 ft. tall will be obstructions, and the FAA will study them to determine their effect on the navigable airspace. This will ensure that all usable airspace at and above 500 ft. AGL is addressed during the aeronautical study and that this airspace is protected from obstructions that may create a hazard to air navigation.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. According to the 1995 amendments to the Paperwork Reduction Act (5 CFR 1320.8(b)(2)(vi)), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number. As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the FAA submitted a copy of the new information collection requirements(s) discussed below to OMB for its review. Notice of OMB approval for this information collection will be published in a future Federal Register document.

Title 49 U.S.C. 44718 states, “By regulation or by order when necessary, the Secretary of Transportation shall require a person to give adequate public notice, in the form and way the Secretary prescribes, of the construction, alteration, establishment, or expansion, of a structure or sanitary landfill when public notice will promote:

This final rule implements the requirement for notification by requiring that notice be submitted to the FAA for proposed construction or alteration of structures on or near private use airports that have an IAP. Accordingly, if a private use airport has an FAA-approved IAP, then a construction sponsor is required to notify the FAA of a proposed construction or alteration that exceeds the notice criteria in § 77.17. This action will give the FAA adequate time to adjust the IAP, if needed, and to inform those who use the IAP. While IAPs at private use airports or heliports are not currently listed in any aeronautical publication, sponsors of construction or alteration at or near a private use airport or heliport can consult the FAA Web site7 to determine whether an FAA-approved IAP is listed for that airport. If the airport is listed on the Web site, the sponsor must file notice with the FAA. The intent of these changes is to improve safety and promote the efficient use of the National Airspace System.

The FAA estimates that on average, 3,325 Form 7460-1s would be filed annually. It is estimated to take 19 minutes, or 0.32 hours, to fill out each form. Hence, the estimated hour burden is: 0.32 hours × 3,325 = 1,064 hours.

The average cost for a firm to prepare the form itself is approximately $40 per form. It is estimated that 20 percent of the forms filed would be filed this way. Thus, the estimated average annual reporting burden for companies to process this form in-house would be: (FAA Form 7460-1) $40 × 665 = $26,600.

The average cost for a company to outsource this function to a contractor is approximately $480 per report. It is estimated that 80 percent of the forms filed would be filed this way. Thus, the estimated average annual reporting burden for companies to outsource this function is: (FAA Form 7460-1) $480 × 2,660 = $1,276,800.

It is estimated that roughly 30 percent of firms filing FAA Form 7460-1 will need to perform a site survey to complete the form. The cost of a site survey is $790. Thus, the estimated annual reporting burden for companies who require a site survey would be: (FAA Form 7460-1) $790 × 998 = $788,420.

Hence, the total annual cost to firms that fill out FAA Form 7460-1 is $2,091,820.

In the proposed rule, the FAA asked for comments on the information collection burden. You may view the FAA's specific request in the proposed rule.8 The FAA received comments from multiple commenters. The following is a summary of the comments with the FAA's response:

Several commenters stated that the FAA underestimated the costs, in terms of time and paperwork, associated with preparing a Form 7460-1, as well as the costs of filing an OE notice, so the FAA should revise its estimates. One commenter surveyed its members and the survey indicated that the cost of processing a Form 7460-1 in-house was $406 and took about 1.6 hours per form. Further, the average hourly labor cost was found to be $36 per hour. The commenter also stated that in addition to maps, a site survey is needed to complete Form 7460-1, which ensures the accuracy of the location and costs an average of $768. Another commenter supported the notion of including the cost of a site survey in the cost estimation for filing a Form 7460-1. Another commenter suggested that the FAA increase its estimate for processing a Form 7460-1 in-house to $40.

The FAA omitted the cost of a site survey in the preliminary analysis because a site survey is not required to complete a Form 7460-1. However, a site survey must be completed if it is requested by the FAA's Flight Procedure Office. The agency has revised the cost analysis to reflect the wider range of costs as supplied by the commenters. The FAA also revised its cost and paperwork analyses to include the cost of filing a form in-house, as well as the costs of a site survey.

A few commenters claimed that the FAA underestimated the time and paperwork costs associated with filing additional notices. Another commenter believed that the FAA underestimated the paperwork burden that will be placed on radio spectrum users.

The FAA completed a paperwork reduction package for the proposed rule, which did show the estimated paperwork costs. The paperwork costs were also shown in the initial regulatory evaluation and were available for review in the docket. However, the FAA has elected not to adopt the radio frequency notice requirements in this final rule. As a result, there will be no additional paperwork burden placed on radio spectrum users at this time.

A commenter stated that requiring applicants to provide notice to the FAA 60 days in advance could also increase the number of filings because of the rule change. Another commenter stated that extending the notice period for all proposed projects will cause undue delay in securing FAA approval and will delay the ability of utilities to develop new sites.

The FAA has reduced the filing time period from 60 days to 45 days. This should mitigate the delay expected by the commenters and allow them to continue their operations without much change. Thus, the FAA does not expect any delays in construction or operational deficiencies resulting from the final rule.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to comply with International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified no new differences with these proposed regulations.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 directs that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by state, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule. Readers seeking greater detail should read the full regulatory evaluation, a copy of which is in the docket for this rulemaking.

In conducting these analyses, the FAA has determined that this final rule has benefits that justify its costs and is not economically significant under Executive Order 12866; however, it is otherwise “significant” because of concerns raised by the National Telecommunications and Information Administration (NTIA) and the Federal Communications Commission (FCC) regarding the FAA's evaluation of potential electromagnetic effect during aeronautical studies. The final rule, if adopted, will not have a significant economic impact on a substantial number of small entities, will not create unnecessary obstacles to international trade, and will not impose an unfunded mandate on state, local, tribal governments, or on the private sector.

This final rule amends 14 CFR part 77. These amendments refer to the rules for obstruction evaluation standards, aeronautical studies, and notice provisions about objects that could create hazards to air navigation.

The FAA estimates the cost of this final rule to private industry will be approximately $20.9 million ($14.1 million, present value) over the next 10 years. The estimated cost of the final rule to the FAA will be approximately $18.7 million ($12.6 million, present value) over the next 10 years. Therefore, the total cost associated with the final rule will be approximately $39.6 million ($26.8 million, present value) over the next 10 years.

The final rule will enhance protection of aircraft approaches from unknown obstructions and unknown alteration projects on or near private use airports with FAA-approved instrument approach procedures (IAPs). The FAA contends that these qualitative benefits justify the costs of the final rule.

The Regulatory Flexibility Act of 1980 establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the business, organizations, and governmental jurisdictions subject to regulation.” To achieve that principle, the Act requires agencies to solicit and consider flexible regulatory proposals and to explain the rationale for their actions. The Act covers a wide range of small entities, including small businesses, not-for-profit organizations and small governmental jurisdictions.

Agencies must perform a review to determine whether a proposed or final rule will have a significant economic impact on a substantial number of small entities. If the determination is that it will, the agency must prepare a regulatory flexibility analysis (RFA) as described in the Act.

However, if an agency determines that a proposed or final rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the 1980 Act provides that the head of the agency may so certify and an RFA is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

While the FAA does not maintain data on the size of businesses that file notices, the FAA estimates that approximately 40 percent of the OE notices will be filed by small businesses (comprised of business owners and private use airport owners) as defined by the Small Business Administration. Thus, in 2010 when the rule is expected to take effect, the FAA expects approximately 2,400 more OE notices will be filed by affected parties. Of those applications filed, approximately 960 notices are estimated to be filed by small businesses (using 40 percent assumption).

For those small businesses that are inexperienced in submitting the necessary paperwork, the FAA believes they would either hire a consultant or spend as much as the consultant fee ($480) in staff time to understand, research, complete, and submit the form(s). For the purpose of this regulatory flexibility assessment, the FAA assumes that it will cost all small entities approximately $480 per case to meet the requirements of part 77.

It is unlikely that any individual small entity will file more than three OE notices in a calendar year. As a result, the FAA estimates that in virtually all cases, the cost of this rule to small businesses will not exceed $1500 per small entity, a cost the FAA does not consider significant. Therefore, as the FAA Administrator, I certify that this rule will not have a significant economic impact on a substantial number of small entities.

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this final rule and determined that it will have only a domestic impact and, therefore, will not create unnecessary obstacles to the foreign commerce of the United States.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by state, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $136.1 million in lieu of $100 million. This final rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.

The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. The FAA determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, does not have federalism implications.

FAA Order 1050.1E identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 312f and involves no extraordinary circumstances.

The FAA has analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). We have determined that it is not a “significant energy action” under the executive order because it is not a “significant regulatory action” under Executive Order 12866, and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

You can get an electronic copy of rulemaking documents using the Internet by—

1. Searching the Federal eRulemaking Portal (http://www.regulations.gov);

2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/; or

3. Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.

You can also get a copy by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue, SW., Washington, DC 20591, or by calling (202) 267-9680. Make sure to identify the amendment number or docket number of this rulemaking.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://DocketsInfo.dot.gov.

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. If you are a small entity and you have a question regarding this document, you may contact your local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. You can find out more about SBREFA on the Internet at http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS. The complete regulators description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the Federal Register expensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. The advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs and the effective dates of the associated Takeoff Minimums and ODPs. This amendment also identifies the airport and its location, the procedure, and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPS and Takeoff Minimums and ODPS, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPS contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPS and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedures before adopting these SIAPS, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—-(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule ” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAP and the corresponding effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs.

The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

§§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35 [Amended]

By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:

Section 14(a)(3)(B)(vi) of the CPSA, as added by section 102(a)(2) of the Consumer Product Safety Improvement Act of 2008 (CPSIA), Public Law 110-314, directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies to assess children's products for conformity with “other children's product safety rules.” Section 14(f)(1) of the CPSA defines “children's product safety rule” as “a consumer product safety rule under [the CPSA] or similar rule, regulation, standard, or ban under any other Act enforced by the Commission, including a rule declaring a consumer product to be a banned hazardous product or substance.” Under section 14(a)(3)(A) of the CPSA, each manufacturer (including the importer) or private labeler of products subject to those regulations must have products that are manufactured more than 90 days after the Federal Register publication date of a notice of the requirements for accreditation, tested by a third party conformity assessment body accredited to do so, and must issue a certificate of compliance with the applicable regulations based on that testing. Section 14(a)(2) of the CPSA, as added by section 102(a)(2) of the CPSIA, requires that certification be based on testing of sufficient samples of the product, or samples that are identical in all material respects to the product. The Commission also emphasizes that, irrespective of certification, the product in question must comply with applicable CPSC requirements (see, e.g., section 14(h) of the CPSA, as added by section 102(b) of the CPSIA).

The Commission also is recognizing limited circumstances in which it will accept certifications based on product testing conducted before the third party conformity assessment body is accepted as accredited by the CPSC. The details regarding those limited circumstances can be found in part IV of this document below.

This notice provides the criteria and process for Commission acceptance of accreditation of third party conformity assessment bodies for testing pursuant to 16 CFR part 1611, Standard for the Flammability of Vinyl Plastic Film, which sets a minimum standard for flammability of vinyl plastic film which are subject to the requirements of the Flammable Fabrics Act (15 U.S.C. 1191 et seq.) (FFA).

Section 3(a)(2) of the CPSA defines a children's product as “a consumer product designed or intended primarily for children 12 years of age or younger.” Although vinyl plastic film used in wearing apparel or fabric is often for general use (that is, it is produced for general consumption rather than being produced specifically for use by children), some vinyl plastic film wearing apparel or fabric is “designed or intended primarily for children 12 years of age or younger.” (For convenience, we will refer to vinyl plastic film products designed or intended primarily for use in wearing apparel or fabric for children 12 years of age or younger as “youth vinyl plastic film products.”) Youth vinyl plastic film products are subject to the third party testing and certification requirements in section 14(a)(2) of the CPSA. Accordingly, this notice of requirements addresses the accreditation of conformity assessment bodies to test youth vinyl plastic film for conformity with 16 CFR part 1611.

Although section 14(a)(3)(B)(vi) of the CPSA directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies to assess conformity with “all other children's product safety rules,” this notice of requirements is limited to the regulations identified immediately above.

The CPSC also recognizes that section 14(a)(3)(B)(vi) of the CPSA is captioned as “All Other Children's Product Safety Rules,” but the body of the statutory requirement refers only to “other children's product safety rules.” Nevertheless, section 14(a)(3)(B)(vi) of the CPSA could be construed as requiring a notice of requirements for “all” other children's product safety rules, rather than a notice of requirements for “some” or “certain” children's product safety rules. However, whether a particular rule represents a “children's product safety rule” may be subject to interpretation, and the Commission staff is continuing to evaluate which rules, regulations, standards, or bans are “children's product safety rules.” The CPSC intends to issue additional notices of requirements for other rules which the Commission determines to be “children's product safety rules.”

This notice of requirements applies to all third party conformity assessment bodies as described in section 14(f)(2) of the CPSA. Generally speaking, such third party conformity assessment bodies are: (1) Third party conformity assessment bodies that are not owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body for certification purposes; (2) “firewalled” conformity assessment bodies (those that are owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body for certification purposes and that seek accreditation under the additional statutory criteria for “firewalled” conformity assessment bodies); and (3) third party conformity assessment bodies owned or controlled, in whole or in part, by a government.

The Commission requires baseline accreditation of each category of third party conformity assessment body to the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) Standard 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories.” The accreditation must be by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement (ILAC-MRA), and the scope of the accreditation must include testing in accordance with the regulations identified earlier in part I of this document for which the third party conformity assessment body seeks to be accredited.

(A description of the history and content of the ILAC-MRA approach and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the CPSC staff briefing memorandum “Third Party Conformity Assessment Body Accreditation Requirements for Testing Compliance with 16 CFR Part 1501 (Small Parts Regulations),” dated November 2008 and available on the CPSC's Web site at http://www.cpsc.gov/library/foia/foia09/brief/smallparts.pdf.)

The Commission has established an electronic accreditation registration and listing system that can be accessed via its Web site at http://www.cpsc.gov/ABOUT/Cpsia/labaccred.html.

The Commission stayed the enforcement of certain provisions of section 14(a) of the CPSA in a notice published in the Federal Register on February 9, 2009 (74 FR 6396); the stay applied to testing and certification of various products, including vinyl plastic film. On December 28, 2009, the Commission published a notice in the Federal Register (74 FR 68588) revising the terms of the stay. One section of the December 28, 2009, notice addressed “Consumer Products or Children's Products Where the Commission Is Continuing the Stay of Enforcement Until Further Notice,” due to factors such as pending rulemaking proceedings affecting the product or the absence of a notice of requirements. The vinyl plastic film testing and certification requirements were included in that section of the December 28, 2009, notice. As the factor preventing the stay from being lifted in the December 28, 2009, notice with regard to testing and certifications of vinyl plastic film was the absence of a notice of requirements, publication of this notice has the effect of lifting the stay with regard to 16 CFR part 1611.

The Commission noted in the December 28, 2009, notice that the stay of enforcement did not extend to guaranties under the FFA. The manufacturer or supplier of vinyl plastic film may issue a guaranty, based on reasonable and representative testing, that the vinyl plastic film complies with FFA standards. The holder of a valid guaranty is not subject to criminal prosecution under section 7 of the FFA (penalties) for a violation of section 3 of the FFA (prohibited transactions).

The reasonable and representative tests sufficient for the issuance of an FFA guaranty are generally performed by the manufacturer; those tests are sufficient for the issuance of a general conformity certification for nonchildren's products under section 14(a)(1) of the CPSA. However, because section 14(a)(2) of the CPSA requires children's products subject to a children's product safety rule to be tested by an accredited third party conformity assessment body, reasonable and representative tests sufficient for the issuance of an FFA guaranty which are performed by a manufacturer are not sufficient for the issuance of a certification of compliance with 16 CFR part 1611 for youth vinyl plastic film products (unless the manufacturer's facility is a CPSC-accredited firewalled conformity assessment body).

This notice of requirements is effective on July 21, 2010. Further, as the publication of this notice of requirements effectively lifts the stay of enforcement with regard to testing and certifications related to 16 CFR part 1611, each manufacturer of a children's product subject to 16 CFR part 1611 must have any such product manufactured after October 19, 2010 tested by a third party conformity assessment body accredited to do so and must issue a certificate of compliance with 16 CFR part 1611 based on that testing. (Under the CPSA, the term “manufacturer” includes anyone who manufactures or imports a product.)

This notice of requirements is exempt from the notice and comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 553 (see section 14(a)(3)(G) of the CPSA, as added by section 102(a)(2) of the CPSIA (15 U.S.C. 2063(a)(3)(G)).

For a third party conformity assessment body to be accredited to test children's products for conformity with the test methods in the regulations identified earlier in part I of this document, it must be accredited by an ILAC-MRA signatory accrediting body, and the accreditation must be registered with, and accepted by, the Commission. A listing of ILAC-MRA signatory accrediting bodies is available on the Internet at http://ilac.org/membersbycategory.html. The accreditation must be to ISO Standard ISO/IEC 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories,” and the scope of the accreditation must expressly include testing to the regulations in 16 CFR part 1611, Standard for the Flammability of Vinyl Plastic Film. A true copy, in English, of the accreditation and scope documents demonstrating compliance with the requirements of this notice must be registered with the Commission electronically. The additional requirements for accreditation of firewalled and governmental conformity assessment bodies are described in parts II.B and II.C of this document below.

The Commission will maintain on its Web site an up-to-date listing of third party conformity assessment bodies whose accreditations it has accepted and the scope of each accreditation. Subject to the limited provisions for acceptance of “retrospective” testing noted in part IV below, once the Commission adds a third party conformity assessment body to that list, the third party conformity assessment body may commence testing of children's products to support the manufacturer's certification that the product complies with the regulations identified earlier in part I of this document.

In addition to the baseline accreditation requirements in part II.A of this document above, firewalled conformity assessment bodies seeking accredited status must submit to the Commission copies, in English, of their training documents showing how employees are trained to notify the Commission immediately and confidentially of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over the third party conformity assessment body's test results. This additional requirement applies to any third party conformity assessment body in which a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body owns an interest of ten percent or more. While the Commission is not addressing common parentage of a third party conformity assessment body and a children's product manufacturer at this time, it will be vigilant to see if this issue needs to be addressed in the future.

As required by section 14(f)(2)(D) of the CPSA, the Commission must formally accept, by order, the accreditation application of a third party conformity assessment body before the third party conformity assessment body can become an accredited firewalled conformity assessment body.

In addition to the baseline accreditation requirements of part II.A of this document above, the CPSIA permits accreditation of a third party conformity assessment body owned or controlled, in whole or in part, by a government if:

• To the extent practicable, manufacturers or private labelers located in any nation are permitted to choose conformity assessment bodies that are not owned or controlled by the government of that nation;

• The third party conformity assessment body's testing results are not subject to undue influence by any other person, including another governmental entity;

• The third party conformity assessment body is not accorded more favorable treatment than other third party conformity assessment bodies in the same nation who have been accredited;

• The third party conformity assessment body's testing results are accorded no greater weight by other governmental authorities than those of other accredited third party conformity assessment bodies; and

• The third party conformity assessment body does not exercise undue influence over other governmental authorities on matters affecting its operations or on decisions by other governmental authorities controlling distribution of products based on outcomes of the third party conformity assessment body's conformity assessments.

The Commission will accept the accreditation of a governmental third party conformity assessment body if it meets the baseline accreditation requirements of part II.A of this document above and meets the additional conditions stated here. To obtain this assurance, CPSC staff will engage the governmental entities relevant to the accreditation request.

The Commission has established an electronic accreditation acceptance and registration system accessed via the Commission's Internet site at http://www.cpsc.gov/about/cpsia/labaccred.html. The applicant provides, in English, basic identifying information concerning its location, the type of accreditation it is seeking, and electronic copies of its ILAC-MRA accreditation certificate and scope statement, and firewalled third party conformity assessment body training document(s), if relevant.

Commission staff will review the submission for accuracy and completeness. In the case of baseline third party conformity assessment bodies and government-owned or government-operated conformity assessment bodies, when that review and any necessary discussions with the applicant are satisfactorily completed, the third party conformity assessment body in question is added to the CPSC's list of accredited third party conformity assessment bodies at http://www.cpsc.gov/about/cpsia/labaccred.html. In the case of a firewalled conformity assessment body seeking accredited status, when the staff's review is complete, the staff transmits its recommendation on accreditation to the Commission for consideration. (A third party conformity assessment body that may ultimately seek acceptance as a firewalled third party conformity assessment body also can initially request acceptance as a third party conformity assessment body accredited for testing of children's products other than those of its owners.) If the Commission accepts a staff recommendation to accredit a firewalled conformity assessment body, the firewalled conformity assessment body will then be added to the CPSC's list of accredited third party conformity assessment bodies. In each case, the Commission will notify the third party conformity assessment body electronically of acceptance of its accreditation. All information to support an accreditation acceptance request must be provided in the English language.

Subject to the limited provisions for acceptance of “retrospective” testing noted in part IV of this document below, once the Commission adds a third party conformity assessment body to the list, the third party conformity assessment body may then begin testing of children's products to support certification of compliance with the regulations identified earlier in part I of this document for which it has been accredited.

The Commission will accept a certificate of compliance with the standard for vinyl plastic film included in 16 CFR part 1611, Standard for the Flammability of Vinyl Plastic Film, based on testing performed by an accredited third party conformity assessment body (including a government-owned or -controlled conformity assessment body, and a firewalled conformity assessment body) prior to the Commission's acceptance of its accreditation if:

• At the time of product testing, the product was tested by a third party conformity assessment body that was ISO/IEC 17025 accredited by an ILAC-MRA member at the time of the test. For firewalled conformity assessment bodies, the firewalled conformity assessment body must be one that the Commission accredited by order at or before the time the product was tested, even though the order will not have included the test methods in the regulations specified in this notice. If the third party conformity assessment body has not been accredited by a Commission order as a firewalled conformity assessment body, the Commission will not accept a certificate of compliance based on testing performed by the third party conformity assessment body before it is accredited, by Commission order, as a firewalled conformity assessment body;

• The third party conformity assessment body's application for testing using the test methods in the regulations identified in this notice is accepted by the CPSC on or before September 20, 2010;

• The product was tested on or after July 21, 2010 with respect to the regulations identified in this notice;

• The accreditation scope in effect for the third party conformity assessment body at the time of testing expressly included testing to the regulations identified earlier in part I of this document;

• The test results show compliance with the applicable current standards and/or regulations; and

• The third party conformity assessment body's accreditation, including inclusion in its scope the standards described in part I of this notice, remains in effect through the effective date for mandatory third party testing and manufacturer certification for conformity with 16 CFR part 1611.

Section 14(a)(3)(B)(vi) of the CPSA, as added by section 102(a)(2) of the Consumer Product Safety Improvement Act of 2008 (CPSIA), Public Law 110-314, directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies to assess children's products for conformity with “other children's product safety rules.” Section 14(f)(1) of the CPSA defines “children's product safety rule” as “a consumer product safety rule under [the CPSA] or similar rule, regulation, standard, or ban under any other Act enforced by the Commission, including a rule declaring a consumer product to be a banned hazardous product or substance.” Under section 14(a)(3)(A) of the CPSA, each manufacturer (including the importer) or private labeler of products subject to those regulations must have products that are manufactured more than 90 days after the Federal Register publication date of a notice of the requirements for accreditation, tested by a third party conformity assessment body accredited to do so, and must issue a certificate of compliance with the applicable regulations based on that testing. Section 14(a)(2) of the CPSA, as added by section 102(a)(2) of the CPSIA, requires that certification be based on testing of sufficient samples of the product, or samples that are identical in all material respects to the product. The Commission also emphasizes that, irrespective of certification, the product in question must comply with applicable CPSC requirements (see, e.g., section 14(h) of the CPSA, as added by section 102(b) of the CPSIA).

The Commission also is recognizing limited circumstances in which it will accept certifications based on product testing conducted before the third party conformity assessment body is accepted as accredited by the CPSC. The details regarding those limited circumstances can be found in part IV of this document below.

This notice provides the criteria and process for Commission acceptance of accreditation of third party conformity assessment bodies for testing pursuant to the following regulations:

• 16 CFR part 1630, Standard for the Surface Flammability of Carpets and Rugs (FF 1-70).

• 16 CFR part 1631, Standard for the Surface Flammability of Small Carpets and Rugs (FF 2-70).

Section 3(a)(2) of the CPSA defines a children's product as “a consumer product designed or intended primarily for children 12 years of age or younger.” Although most carpets and rugs are general use products because they are produced for general consumption rather than being produced specifically for use by children, some carpets and rugs are “designed or intended primarily for children 12 years of age or younger.” (For convenience, we will refer to carpets and rugs designed or intended primarily for children 12 years of age or younger as “youth carpets and rugs.”) Youth carpets and rugs are subject to the third party testing and certification requirements in section 14(a)(2) of the CPSA. Accordingly, this notice of requirements addresses the accreditation of conformity assessment bodies to test youth carpets and rugs for conformity with 16 CFR parts 1630 and/or 1631.

Although section 14(a)(3)(B)(vi) of the CPSA directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies to assess conformity with “all other children's product safety rules,” this notice of requirements is limited to the regulations identified immediately above.

The CPSC also recognizes that section 14(a)(3)(B)(vi) of the CPSA is captioned as “All Other Children's Product Safety Rules,” but the body of the statutory requirement refers only to “other children's product safety rules.” Nevertheless, section 14(a)(3)(B)(vi) of the CPSA could be construed as requiring a notice of requirements for “all” other children's product safety rules, rather than a notice of requirements for “some” or “certain” children's product safety rules. However, whether a particular rule represents a “children's product safety rule” may be subject to interpretation, and the Commission staff is continuing to evaluate which rules, regulations, standards, or bans are “children's product safety rules.” The CPSC intends to issue additional notices of requirements for other rules which the Commission determines to be “children's product safety rules.”

This notice of requirements applies to all third party conformity assessment bodies as described in section 14(f)(2) of the CPSA. Generally speaking, such third party conformity assessment bodies are: (1) Third party conformity assessment bodies that are not owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body for certification purposes; (2) “firewalled” conformity assessment bodies (those that are owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body for certification purposes and that seek accreditation under the additional statutory criteria for “firewalled” conformity assessment bodies); and (3) third party conformity assessment bodies owned or controlled, in whole or in part, by a government.

The Commission requires baseline accreditation of each category of third party conformity assessment body to the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) Standard 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories.” The accreditation must be by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement (ILAC-MRA), and the scope of the accreditation must include testing in accordance with the regulations identified earlier in part I of this document for which the third party conformity assessment body seeks to be accredited.

(A description of the history and content of the ILAC-MRA approach and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the CPSC staff briefing memorandum “Third Party Conformity Assessment Body Accreditation Requirements for Testing Compliance with 16 CFR Part 1501 (Small Parts Regulations),” dated November 2008 and available on the CPSC's Web site at http://www.cpsc.gov/library/foia/foia09/brief/smallparts.pdf.)

The Commission has established an electronic accreditation registration and listing system that can be accessed via its Web site at http://www.cpsc.gov/ABOUT/Cpsia/labaccred.html.

The Commission stayed the enforcement of certain provisions of section 14(a) of the CPSA in a notice published in the Federal Register on February 9, 2009 (74 FR 6396); the stay applied to testing and certification of various products, including carpets and rugs. On December 28, 2009, the Commission published a notice in the Federal Register (74 FR 68588) revising the terms of the stay. One section of the December 28, 2009, notice addressed “Consumer Products or Children's Products Where the Commission Is Continuing the Stay of Enforcement Until Further Notice,” due to factors such as pending rulemaking proceedings affecting the product or the absence of a notice of requirements. The carpets and rugs testing and certification requirements were included in that section of the December 28, 2009, notice. As the factor preventing the stay from being lifted in the December 28, 2009, notice with regard to testing and certifications of carpets and rugs was the absence of a notice of requirements, publication of this notice has the effect of lifting the stay with regard to 16 CFR parts 1630 and/or 1631.

The Commission noted in the December 28, 2009, notice that the stay of enforcement did not extend to guaranties under the Flammable Fabrics Act (15 U.S.C. 1191 et seq.) (FFA). The manufacturer or supplier of a carpet or rug may issue a guaranty, based on reasonable and representative tests, that the carpet or rug complies with FFA standards. The holder of a valid guaranty is not subject to criminal prosecution under section 7 of the FFA (penalties) for a violation of section 3 of the FFA (prohibited transactions).

The reasonable and representative tests sufficient for the issuance of an FFA guaranty are generally performed by the manufacturer; those tests are sufficient for the issuance of a general conformity certification for nonchildren's products under section 14(a)(1) of the CPSA. However, because section 14(a)(2) of the CPSA requires children's products subject to a children's product safety rule to be tested by an accredited third party conformity assessment body, reasonable and representative tests sufficient for the issuance of an FFA guaranty which are performed by a manufacturer are not sufficient for the issuance of a certification of compliance with 16 CFR part 1630 and/or part 1631 for youth carpets and rugs (unless the manufacturer's facility is a CPSC-accredited firewalled conformity assessment body).

This notice of requirements is effective on July 21, 2010. Further, as the publication of this notice of requirements effectively lifts the stay of enforcement with regard to testing and certifications related to 16 CFR parts 1630 and/or 1631, each manufacturer (including the importer) or private labeler of a children's product subject to 16 CFR parts 1630 and/or 1631 must have any such product manufactured after October 19, 2010 tested by a third party conformity assessment body accredited to do so and must issue a certificate of compliance with 16 CFR parts 1630 and/or 1631 based on that testing.

This notice of requirements is exempt from the notice and comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 553 (see section 14(a)(3)(G) of the CPSA, as added by section 102(a)(2) of the CPSIA (15 U.S.C. 2063(a)(3)(G)).

For a third party conformity assessment body to be accredited to test children's products for conformity with the test methods in the regulations identified earlier in part I of this document, it must be accredited by an ILAC-MRA signatory accrediting body, and the accreditation must be registered with, and accepted by, the Commission. A listing of ILAC-MRA signatory accrediting bodies is available on the Internet at http://ilac.org/membersbycategory.html. The accreditation must be to ISO Standard ISO/IEC 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories,” and the scope of the accreditation must expressly include testing to the regulations in 16 CFR part 1630, Standard for the Surface Flammability of Carpets and Rugs (FF 1-70), and/or 16 CFR part 1631, Standard for the Surface Flammability of Small Carpets and Rugs (FF 2-70). A true copy, in English, of the accreditation and scope documents demonstrating compliance with the requirements of this notice must be registered with the Commission electronically. The additional requirements for accreditation of firewalled and governmental conformity assessment bodies are described in parts II.B and II.C of this document below.

The Commission will maintain on its Web site an up-to-date listing of third party conformity assessment bodies whose accreditations it has accepted and the scope of each accreditation. Subject to the limited provisions for acceptance of “retrospective” testing noted in part IV below, once the Commission adds a third party conformity assessment body to that list, the third party conformity assessment body may commence testing of children's products to support certification by the manufacturer or private labeler of compliance with the regulations identified earlier in part I of this document.

In addition to the baseline accreditation requirements in part II.A of this document above, firewalled conformity assessment bodies seeking accredited status must submit to the Commission copies, in English, of their training documents showing how employees are trained to notify the Commission immediately and confidentially of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over the third party conformity assessment body's test results. This additional requirement applies to any third party conformity assessment body in which a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body owns an interest of ten percent or more. While the Commission is not addressing common parentage of a third party conformity assessment body and a children's product manufacturer at this time, it will be vigilant to see if this issue needs to be addressed in the future.

As required by section 14(f)(2)(D) of the CPSA, the Commission must formally accept, by order, the accreditation application of a third party conformity assessment body before the third party conformity assessment body can become an accredited firewalled conformity assessment body.

In addition to the baseline accreditation requirements of part II.A of this document above, the CPSIA permits accreditation of a third party conformity assessment body owned or controlled, in whole or in part, by a government if:

• To the extent practicable, manufacturers or private labelers located in any nation are permitted to choose conformity assessment bodies that are not owned or controlled by the government of that nation;

• The third party conformity assessment body's testing results are not subject to undue influence by any other person, including another governmental entity;

• The third party conformity assessment body is not accorded more favorable treatment than other third party conformity assessment bodies in the same nation who have been accredited;

• The third party conformity assessment body's testing results are accorded no greater weight by other governmental authorities than those of other accredited third party conformity assessment bodies; and

• The third party conformity assessment body does not exercise undue influence over other governmental authorities on matters affecting its operations or on decisions by other governmental authorities controlling distribution of products based on outcomes of the third party conformity assessment body's conformity assessments.

The Commission will accept the accreditation of a governmental third party conformity assessment body if it meets the baseline accreditation requirements of part II.A of this document above and meets the additional conditions stated here. To obtain this assurance, CPSC staff will engage the governmental entities relevant to the accreditation request.

The Commission has established an electronic accreditation acceptance and registration system accessed via the Commission's Internet site at http://www.cpsc.gov/about/cpsia/labaccred.html. The applicant provides, in English, basic identifying information concerning its location, the type of accreditation it is seeking, and electronic copies of its ILAC-MRA accreditation certificate and scope statement, and firewalled third party conformity assessment body training document(s), if relevant.

Commission staff will review the submission for accuracy and completeness. In the case of baseline third party conformity assessment bodies and government-owned or government-operated conformity assessment bodies, when that review and any necessary discussions with the applicant are satisfactorily completed, the third party conformity assessment body in question is added to the CPSC's list of accredited third party conformity assessment bodies at http://www.cpsc.gov/about/cpsia/labaccred.html. In the case of a firewalled conformity assessment body seeking accredited status, when the staff's review is complete, the staff transmits its recommendation on accreditation to the Commission for consideration. (A third party conformity assessment body that may ultimately seek acceptance as a firewalled third party conformity assessment body also can initially request acceptance as a third party conformity assessment body accredited for testing of children's products other than those of its owners.) If the Commission accepts a staff recommendation to accredit a firewalled conformity assessment body, the firewalled conformity assessment body will then be added to the CPSC's list of accredited third party conformity assessment bodies. In each case, the Commission will notify the third party conformity assessment body electronically of acceptance of its accreditation. All information to support an accreditation acceptance request must be provided in the English language.

Subject to the limited provisions for acceptance of “retrospective” testing noted in part IV of this document below, once the Commission adds a third party conformity assessment body to the list, the third party conformity assessment body may then begin testing of children's products to support certification of compliance with the regulations identified earlier in part I of this document for which it has been accredited.

The Commission will accept a certificate of compliance with the standards for carpets and rugs included in 16 CFR part 1630, Standard for the Surface Flammability of Carpets and Rugs (FF 1-70), and/or 16 CFR part 1631, Standard for the Surface Flammability of Small Carpets and Rugs (FF 2-70), based on testing performed by an accredited third party conformity assessment body (including a government-owned or -controlled conformity assessment body, and a firewalled conformity assessment body) prior to the Commission's acceptance of its accreditation if:

• At the time of product testing, the product was tested by a third party conformity assessment body that was ISO/IEC 17025 accredited by an ILAC-MRA member at the time of the test. For firewalled conformity assessment bodies, the firewalled conformity assessment body must be one that the Commission accredited by order at or before the time the product was tested, even though the order will not have included the test methods in the regulations specified in this notice. If the third party conformity assessment body has not been accredited by a Commission order as a firewalled conformity assessment body, the Commission will not accept a certificate of compliance based on testing performed by the third party conformity assessment body before it is accredited, by Commission order, as a firewalled conformity assessment body;

• The third party conformity assessment body's application for testing using the test methods in the regulations identified in this notice is accepted by the CPSC on or before September 20, 2010;

• The product was tested on or after July 21, 2010 with respect to the regulations identified in this notice;

• The accreditation scope in effect for the third party conformity assessment body at the time of testing expressly included testing to the regulations identified earlier in part I of this document;

• The test results show compliance with the applicable current standards and/or regulations; and

• The third party conformity assessment body's accreditation, including inclusion in its scope the standards described in part I of this notice, remains in effect through the effective date for mandatory third party testing and manufacturer/private labeler certification for conformity with 16 CFR parts 1630 and/or 1631.

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in 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 under FOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Test Guidelines referenced in this document electronically, please go to http://www.epa.gov/oppts and select “Test Methods and Guidelines.”

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. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or 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-2009-0692 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 20, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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 in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2009-0692, 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.

In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 9E7580) by Bayer CropScience, 2 T.X. Alexander Dr., P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy (CAS No. 345642-79-7) when used as an inert ingredient (surfactant) in pesticide formulations applied pre-harvest to all crops without limitation. That notice referenced a summary of the petition prepared by Bayer CropScience, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has limited the amount in formulation to 10%. This limitation is based on the Agency's risk assessment which can be found at http://www.regulations.gov in document “Decision Document for Petition Number 9E7580; Poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy (CAS Reg. No. 345642-79-7)” in docket ID number EPA-HQ-OPP-2009-0692.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

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

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with section 408(c)(2)(A) of FFDCA, and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

The available toxicity data include an acute toxicity battery, a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OPPTS Harmonized Test Guideline 870.3650), and two mutagenicity studies (OPPTS Harmonized Test Guideline 870.5100). In addition, sufficient toxicity data are available on the metabolite. Acute studies (OPPTS Harmonized Test Guidelines 870.1100 and 870.1200 (acute inhalation study not provided)) showed low acute toxicity (Toxicity Category III) with an oral LD50 >2000 milligrams/kilogram (mg/kg) and acute dermal LD50 >2000 mg/kg. Irritation studies (OPPTS Harmonized Test Guidelines 870.2400 and 870.2500) on rabbits revealed slight skin irritation (Toxicity Category IV) and severe eye irritation (Toxicity Category II). In addition, a skin sensitization study (OPPTS Harmonized Test Guidelines 870.2600) in guinea pigs showed skin sensitization when exposed to poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy.

In an OPPTS Harmonized Test Guideline 870.3650 poly(oxy-1,2-ethanediyl), α-isotridecyl-ω -methoxy was administered by gavage prior to mating through postnatal day 4 (~6-7 weeks). Clinical signs of toxicity included increased incidences of oral and urine staining (≥150 milligrams/kilogram/day (mg/kg/day)) and a slight decrease in body weight and body weight gain (300 mg/kg/day male rats, pre-mating period); however, no treatment-related effects were observed during the remainder of the study. Additionally female rats (≥150 mg/kg/day) exhibited a decrease in hind-limb strength and rearing in open-field.

At necropsy females in the high dose (300 mg/kg/day) group showed a statistically significant increase in absolute and relative adrenal weight, relative kidney weight, and absolute liver weight. Females in the mid and high dose group (≥150 mg/kg/day) showed a statistically significant increase in relative liver weight. In the absence of any collaborative blood or histopathologic findings the effect seen in the liver is considered as an adaptive response. An increased incidence of minimal to moderate epithelial cell hyperplasia was noted in the non-glandular epithelium of the stomach of high-dose male and female rats indicating local irritation which is likely due to the irritation induced by gavage treatment of chemicals with irritative properties.

A LOAEL was not established for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy in male Wistar rats. The NOAEL for male rats is the highest dose tested, 300 mg/kg/day. The NOAEL for female rats is 45 mg/kg/day based on the functional observational battery observations (i.e. decrease in rearing in open field and hind limb grip strength) seen at the LOAEL of 150 mg/kg/day.

The OPPTS 870.3650 study on poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy was also used to evaluate reproductive and developmental toxicity. No test material-related effects were observed on reproductive (e.g., mating, fertility, or gestation indices, days to insemination, gestation length, or number of implants) or developmental (e.g., mean litter size, viability, clinical signs of toxicity, or body weight of the pups) parameters at any dose tested; therefore, the NOAEL for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω -methoxy for reproductive and developmental parameters is 300 mg/kg/day (highest dose tested).

Evidence of neurotoxicity was observed in the OPPTS 870.3650 study which showed a decrease in rearing in open field and hind limb grip strength for mid- and high-dose female rats (≥ 150 mg/kg/day). No evidence of immunotoxicity was observed in the database.

There are no carcinogenicity studies available in the database; however, poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy tested negative in two mutagenicity assays (OPPTS Harmonized Test Guideline 870.5100) and no evidence of specific target organ toxicity was observed in the OPPTS 870.3650 study. In addition, no evidence of carcinogenicity was observed in studies on the metabolite α-isotridecyl-ω-hydroxy-poly(oxy-1 ,2-ethanediyl) (CAS Reg. No. 9043-30-5) (Federal Register, August 5, 2009 (74 FR 38935, FRL-8430-1)). The Agency does not anticipate poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy to be carcinogenic.

Based on available information the Agency has concluded that poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy has a higher toxicity than its metabolite; therefore, conducting the risk assessment on the parent would be protective of the metabolite.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level - generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD) - and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

The POD for the risk assessment for all durations and routes of exposure was from the OPPTS Harmonized Test Guideline 870.3650 toxicity study in rats. The NOAEL was 45 mg/kg/day and the LOAEL was 150 mg/kg/day based on rearing in the open field and hind limb grip strength. A 300 fold uncertainty factor was used for the chronic exposure (10X interspecies extrapolation, 10X for intraspecies variability and 3X FQPA factor).

The residential, occupational, and aggregate level of concern (LOC) is for MOEs that are less than 300 and is based on 10X interspecies extrapolation, 10X for intraspecies variability and 3X FQPA factor. Dermal absorption was estimated to be 10% based on the large molecular weight of the chemical and the lack of water solubility. A 100% inhalation was assumed.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy in food as follows:

i. Acute exposure. No adverse effects attributable to a single exposure of poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy was seen in the toxicity databases. Therefore, acute dietary risk assessments for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy is not required.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used food consumption information from the United States Department of Agriculture (USDA) [1994-1996 and 1998] Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no residue data were submitted for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient.

The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentrations of active ingredient in agricultural products is generally at least 50% of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient. In the case of poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy, EPA made a specific adjustment to the dietary exposure assessment to account for the use limitations of the amount of poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy that may be in formulations (no more than 10% by weight in pesticide formulations) and assumed that the poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy are present at the maximum limitations rather than at equal quantities with the active ingredient. This remains a very conservative assumption because surfactants are generally used at levels far below this percentage.

Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity. Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100% of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient. In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

iii. Cancer. Based on the lack of evidence of carcinogenicity and specific organ toxicity in available studies, along with the lack of carcinogenicity in metabolite studies, poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy is not expected to pose a cancer risk to humans. Therefore, a cancer dietary exposure assessment is not necessary to assess cancer risk.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy. Tolerance level residues and/or 100% were assumed for all food commodities.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, and tables).

There are no known or anticipated residential uses and therefore, a residential risk assessment was not conducted.

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

EPA has not found poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy to share a common mechanism of toxicity with any other substances, and poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The OPPTS Harmonized Test Guideline 870.3650 study on poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy was also used to evaluate reproductive and developmental toxicity. There was no evidence of increased susceptibility of infants and children in the available database. No test material-related effects were observed on reproductive or developmental parameters at any dose tested; therefore, the NOAEL for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω -methoxy for reproductive and developmental parameters is 300 mg/kg/day (highest dose tested). The parental systemic toxicity NOAEL is 45 mg/kg/day and the LOAEL of 150 mg/kg/day is based on clinical signs of neurotoxicity.

3. Conclusion. Although there is no evidence of increased susceptibility in infants and children, in order to be protective in the absence of a developmental neurotoxicity study and the extrapolation from subchronic to chronic, a 3X FQPA safety factor has been retained.

EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF was reduced to 3X. That decision is based on the following findings:

i. There is no evidence that poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy results in increased susceptibility in in utero rats in an OPPTS Harmonized Test Guideline 870.3650 study, a combined repeated dose toxicity study with reproduction/developmental toxicity test parameters.

ii. Evidence of neurotoxicity was observed in the OPPTS 870.3650 Harmonized Test Guideline study which showed a decrease in rearing in open field and hind limb grip strength in females in the mid- and high-dose groups (≥ 150 mg/kg/day). EPA concluded that the 3X FQPA database uncertainty factor is adequate because the evidence of neurotoxicity was observed only in females while males had no effects at doses up to and including 300 mg/kg/day and a lack of a significant dose response in females. No chronic toxicity or carcinogenicity studies are available in the database; however, the Agency notes that surfactants are surface-active materials that can damage the structural integrity of cellular membranes at high dose levels. Thus, surfactants are often corrosive and irritating in concentrated solutions. The observed toxicity seen in the repeated dose studies, such as microscopic lesions or decreased body weight gain, are attributed to the corrosive and irritating nature of these surfactants. The Agency has considerable toxicity information on surfactants, which indicates that the effects do not progressively increase in severity over time. In addition, use of the full 10X interspecies factor will actually provide an additional margin of safety because it is not expected that humans' response to local irritation/corrosiveness effects would be markedly different from animals. No evidence of immunotoxicity was observed in the database.

iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 10% in formulation and a default 100 ppb concentration in drinking water. The I DEEM models uses highly conservative assumption and assumes that all crop/crop groups are treated with all pesticide classifications (e.g., fungicides, insecticides, herbicides). There are no currently approved uses of poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy in pesticide products; therefore, this is a highly conservative estimate. In addition, it is unlikely that poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy will appear in drinking water. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy in drinking water. These assessments will not underestimate the exposure and risks posed by poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy.

iv. Sufficient data exist on the metabolite α-isotridecyl-ω-hydroxy-poly(oxy-1 ,2-ethanediyl) (CAS Reg. No. 9043-30-5) and it has recently been assessed by the Agency (Federal Register, August 5, 2009 (74 FR 38935, FRL-8430-1)). Based on available information it has been concluded that poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy has a higher toxicity than its metabolite and therefore, conducting the risk assessment on the parent would be protective of the metabolite.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy from food and water will utilize 84.9% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy.

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

A short-term adverse effect was identified; however, poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy is not currently used as an inert ingredient in pesticide products that are registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy.

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

An intermediate-term adverse effect was identified; however, poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy is not currently used as an inert ingredient in pesticide products that are registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy.

5. Aggregate cancer risk for U.S. population. The Agency has not identified any concerns for carcinogenicity relating to poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy. Therefore, an aggregate cancer risk was not conducted.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy residues.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy in or on any food commodities. EPA is establishing a limitation on the amount of poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy that may be used in pesticide formulations. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide for sale or distribution that contains greater than 10% of poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy by weight in the pesticide formulation.

The Agency is not aware of any country requiring a tolerance for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for poly(oxy-1,2-ethanediyl), α-isotridecyl-ω-methoxy (CAS Reg. No. 345642-79-7) when used as an inert ingredient (surfactant) in pesticide formulations applied to growing crops at a maximum of 10% in pesticide formulations.

This final rule establishes a tolerance 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, entitled Regulatory 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, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection 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. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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. 601 et 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, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation 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. 801 et 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. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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 under FOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

Under FFDCA section 408(g), 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 objection or 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-2010-0528 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 20, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0528, 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.

In the Federal Register of February 4, 2010 (75 FR 5792) (FRL-9110-5) and June 8, 2010 (75 FR 32465) (FRL-8827-5), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP 9F7590 and PP 9F7528, respectively, by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. The petitions requested that 40 CFR 180.582 be amended by increasing tolerances for residues of the fungicide pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester, in or on soybean, forage at 11.0 parts per million (ppm) (PP 9F7590), and soybean, hay at 14.0 ppm (PP 9F7590), and by establishing tolerances for residues for alfalfa, forage at 10 ppm (PP 9F7528), alfalfa, hay at 30 ppm (PP 9F7528), poultry, fat at 0.1 ppm (PP 9F7528); poultry, meat byproducts at 0.1 ppm (PP 9F7528); poultry, meat at 0.1 ppm (PP 9F7528); and poultry, eggs at 0.1 ppm (PP 9F7528). These notices referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket at http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pyraclostrobin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyraclostrobin follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Pyraclostrobin has a low to moderate acute toxicity via the oral, dermal, and inhalation routes of exposure. Pyraclostrobin produces moderate eye irritation, is a moderate dermal irritant, and is not a dermal sensitizer. The main target organs for pyraclostrobin are the upper gastrointestinal tract (mainly the duodenum and stomach), the spleen/hematopoiesis, and the liver. In the 90-day mouse oral toxicity study, thymus atrophy was seen at doses of 30 milligrams/kilogram (mg/kg) or above, but similar effect was not found in the mouse carcinogenicity study at doses as high as 33 mg/kg. In reproductive and developmental studies, there was evidence of increased qualitative susceptibility following in utero exposure in the rabbit, but not in rats. In both the acute and subchronic neurotoxicity studies, there were no indications of treatment-related neurotoxicity. EPA classified pyraclostrobin as “Not Likely to be Carcinogenic to Humans” based on no treatment-related increase in tumors in both sexes of rats and mice, which were tested at doses that were adequate to assess carcinogenicity, and the lack of evidence of mutagenicity.

Specific information on the studies received and the nature of the adverse effects caused by pyraclostrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Revised Pyraclostrobin: Human Health Risk Assessment for Proposed Uses on Cotton and Belgian Endive” at page 15 in docket ID number EPA-HQ-OPP-2006-0522.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for pyraclostrobin used for human risk assessment can be found at http://www.regulations.gov in document “Pyraclostrobin: Human Health Risk Assessment for Proposed Uses on Grain Sorghum (PP#8F7385); Increase of Tolerance for the Stone Fruit Crop Group 12 to Satisfy European Union (EU) Import Requirement (PP#8F7390); and Establishment of a Permanent Import Tolerance for Coffee (PP#8E7394)” at page 17 in docket ID number EPA-HQ-OPP-2008-0713.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyraclostrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing pyraclostrobin tolerances in 40 CFR 180.582. EPA assessed dietary exposures from pyraclostrobin in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA performed a slightly refined acute dietary exposure assessment for pyraclostrobin. EPA assumed that 100% of crops covered by existing or proposed tolerances were treated with pyraclostrobin and that these crops either had tolerance-level residues or residues at the highest level found in field trials. Experimentally derived processing factors were used for fruit juices, tomato, and wheat commodities but for all other processed commodities Dietary Exposure Evaluation Model (DEEMTM) default processing factors were assumed.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA performed a refined chronic dietary exposure assessment for pyraclostrobin. EPA used data on average percent crop treated (PCT) (when available) and either tolerance-level residues or average field trial residues. Experimentally derived processing factors were used for fruit juices, tomato, and wheat commodities, but for all other processed commodities DEEMTM default processing factors were assumed.

iii. Cancer. EPA classified pyraclostrobin as “Not Likely to be Carcinogenic to Humans” based on no treatment-related increase in tumors in both sexes of rats and mice, which were tested at doses that were adequate to assess carcinogenicity, and the lack of evidence of mutagenicity. Accordingly, an exposure assessment to evaluate cancer risk is unnecessary.

iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

The Agency estimated the PCT for existing uses as follows:

In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which pyraclostrobin may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for pyraclostrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pyraclostrobin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of pyraclostrobin for acute exposures are estimated to be 35.6 parts per billion (ppb) for surface water and 0.02 ppb for ground water and for chronic exposures for non-cancer assessments are estimated to be 2.3 ppb for surface water and 0.02 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 35.6 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 2.3 ppb was used to assess the contribution to drinking water.

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

Pyraclostrobin is currently registered for the following uses that could result in residential exposures: Residential turf grass and recreational sites. EPA assessed residential exposure using the following assumptions: Residential and recreational turf applications are applied by professional pest control operators (PCOs) only and, therefore, residential handler exposures do not occur. There is, however, a potential for short- and intermediate-term post-application exposure of adults and children entering lawn and recreation areas previously treated with pyraclostrobin. Exposures from treated recreational sites are expected to be similar to, or in many cases lower than, those from treated residential turf sites so a separate exposure assessment for recreational turf sites was not conducted. EPA assessed exposures from the following residential turf post-application scenarios:

(1) Short-/intermediate-term adult and toddler post-application dermal exposure from contact with treated lawns.

(2) Short-/intermediate-term toddlers' incidental ingestion of pesticide residues on lawns from hand-to-mouth transfer.

(3) Short-/intermediate-term toddlers' object-to-mouth transfer from mouthing of pesticide-treated turfgrass.

(4) Short-/intermediate-term toddlers' incidental ingestion of soil from pesticide-treated residential areas. The post-application risk assessment was conducted in accordance with the Residential Standard Operating Procedures and recommended approaches of the Health Effects Division's Science Advisory Council for Exposure.

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

EPA has not found pyraclostrobin to share a common mechanism of toxicity with any other substances, and pyraclostrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pyraclostrobin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for pre-natal and post-natal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Pre-natal and post-natal sensitivity. The pre-natal and post-natal toxicology database for pyraclostrobin includes the rat and rabbit developmental toxicity studies and the 2-generation reproduction toxicity study in rats. In reproductive and developmental studies there was evidence of increased qualitative susceptibility following in utero exposure in the rabbit, but not in rats. In the 2-generation reproduction study, the highest dose tested did not cause maternal systemic toxicity, nor did it elicit reproductive or offspring toxicity. There is low concern for pre-natal developmental effects seen in the rabbit because there are clear NOAELs for maternal and developmental effects, this toxicity endpoint is used to establish the acute dietary RfD, and the developmental effect was seen at the same dose level as that produced for the maternal effect.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for pyraclostrobin is considered adequate to support toxicity endpoint selection for risk assessment and FQPA evaluation. However, under the current 40 CFR 158.500 data requirement guidelines, the immunotoxicity data (780.7800) is required as a condition of approval. In the absence of specific immunotoxicity studies, EPA has evaluated the available pyraclostrobin toxicity data to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity. For pyraclostrobin, a complete battery of subchronic, chronic, carcinogenicity, developmental and reproductive studies, and acute and subchronic neurotoxicity screening studies are available for consideration. The immunotoxic potential of pyraclostrobin has been well characterized in relationship to other adverse effects seen in the submitted toxicity studies. Under the conditions of the studies, the results do not indicate the immune system to be the primary target. Other than the high-dose thymus effects seen in the 90-day mouse study, no significant evidence of pyraclostrobin-induced immunotoxicity was demonstrated in the studies conducted either in adult animals or in the offspring following pre-natal and post-natal exposures. Increased spleen weights observed in 28-day and 90-day rat studies were accompanied with mild hemolytic anemia (a hematopoieses response) indicating these effects are unrelated to an immunotoxic response. Currently, the point of departure in establishing the chronic RfD is 3.4 mg/kg/day. The Agency does not believe that conducting a special series 870.7800 immunotoxicity study will result in a NOAEL less than 3.4 mg/kg/day. A similar conclusion was reached in an earlier action on pyraclostrobin. (See 72 FR 52108, 52120 (September 12, 2007)) (FRL-8144-4). In light of these conclusions, EPA does not believe an additional uncertainty or safety factor is needed to address the lack of the required immunotoxicity study.

ii. There is no indication that pyraclostrobin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that pyraclostrobin results in increased quantitative susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. Although there is qualitative evidence of increased susceptibility in the prenatal development study in rabbits, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of pyraclostrobin. The degree of concern for pre-natal and/or post-natal toxicity is low.

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary food exposure assessments were performed using tolerance-level or highest field trial residues and 100% crop treated. The chronic dietary food exposure assessments were performed using tolerance-level or average field trial residues and 100% CT or average PCT. Average PCT is conservatively derived from multiple data sources and is averaged by year and then across all years. The field trials represent maximum application rates and minimum PHIs. A limited number of experimentally derived processing factors from pyraclostrobin processing studies were also used to refine the analysis. The results of the refined chronic dietary analysis are based on reliable data and will not underestimate the exposure and risk. Conservative surface water modeling estimates were used. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pyraclostrobin.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to pyraclostrobin will occupy 81% of the aPAD for females 13 to 49 years old, and 3% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pyraclostrobin from food and water will utilize 24% of the cPAD for children 1 to 2 years old the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of pyraclostrobin is not expected.

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

Pyraclostrobin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pyraclostrobin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 230 for adults and 120 for children 1 to 2 years old. The aggregate MOE for adults is based on the residential turf scenario and includes combined food, drinking water, and post-application dermal exposures. The aggregate MOE for children includes food, drinking water, and post-application dermal and incidental oral exposures from entering turf areas previously treated with pyraclostrobin. MOEs above 100 are considered to be of no concern.

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

Pyraclostrobin is currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to pyraclostrobin.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 230 for adults and 120 for children 1 to 2 years old. The endpoints and points of departure (NOAELs) are identical for short- and intermediate-term exposures, so the aggregate MOEs for intermediate-term exposure are the same as those for short-term exposure. MOEs above 100 are considered to be of no concern.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, pyraclostrobin is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to pyraclostrobin residues.

There are adequate residue analytical methods for tolerance enforcement. The analytical methods for plant commodities are liquid chromatography with tandem mass spectroscopy/mass spectroscopy detector (LC/MS/MS) and high pressure liquid chromatography with ultraviolet detector (HPLC/UV), which both measure pyraclostrobin and its desmethoxy metabolite. The analytical methods for live stock commodities, gas chromatography with mass spectroscopy detector (GC/MS) and LC/MS/MS, convert pyraclostrobin and related metabolites to chlorophenylpyrazolol (BF 500-5) and hydroxylated chlorophenylpyrazolol (BF 500-8) in goats and chlorophenylpyrazolol (BF 500-5) and hydroxylated chlorophenylpyrazolol (BF 500-9) in poultry.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

There are currently no proposed or established Codex, Canadian, or Mexican Maximum Residue Limits (MRLs) for residues of pyraclostrobin on alfalfa and soybeans. However, there are Canadian MRLs for various livestock commodities, including poultry meat, meat byproducts and eggs. The U.S. tolerance and Canadian MRL expressions are the same for both plant and livestock commodities, but several of the recommended changes in tolerances on livestock commodities will result in differences between the U.S. tolerances and the respective Canadian MRLs, due to increase in poultry dietary burden as a result of registration of alfalfa.

Therefore, tolerances are established for residues of pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenyl]methoxy-, methyl ester, in or on alfafa, forage at 10 ppm; alfalfa, hay at 30 ppm; poultry, fat at 0.1 ppm; poultry, meat byproducts at 0.1 ppm; poultry, meat at 0.1 ppm; poultry, eggs at 0.1 ppm; and tolerances are increased for residues in or on soybean; forage at 11 ppm; and soybean, hay; at 14 ppm.

This final rule establishes tolerances 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, entitled Regulatory 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, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection 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. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

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, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation 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. 801 et 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. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

a. Revise the introductory text of paragraph (a)(1).

b. Add alphabetically the commodities “Alfalfa, forage” and “Alfalfa, hay” to the table in paragraph (a)(1).

c. Revise the entries for “Soybean, forage” and “Soybean, hay.” in the table in paragraph (a)(1).

d. Add alphabetically four commodities to the table in paragraph (a)(2).

You may be potentially affected by this action if you manufacture (defined by statute to include import) or process elemental mercury used in flow meters, natural gas manometers, or pyrometers. Potentially affected entities may include, but are not limited to, manufacturers of instruments and related products for measuring, displaying, and controlling industrial process variables (North American Industrial Classification System (NAICS) code 334513). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5 for SNUR-related obligations. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, TSCA section 12(b) (15 U.S.C. 2611(b)) export notification requirements are triggered by publication of a proposed SNUR. Therefore, on or after October 11, 2009, any persons who export or intend to export elemental mercury are subject to the export notification provisions of TSCA section 12(b) (see 40 CFR 721.20) and must comply with the export notification requirements in 40 CFR part 707, subpart D. EPA also notes that, pursuant to the Mercury Export Ban Act of 2008 (Pub. L. 110-414), the export of elemental mercury from the United States will be prohibited as of January 1, 2013, unless an exemption is obtained under TSCA section 12(c)(4).

EPA proposed this SNUR for elemental mercury used in flow meters, natural gas manometers, and pyrometers on September 11, 2009 (74 FR 46707) (FRL-8432-3). EPA's response to public comments received on the proposed rule appear in Unit III.C. Please consult the September 11, 2009, Federal Register document for further background information for this final rule.

This final SNUR will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of elemental mercury for any of the following significant new uses: Flow meters, natural gas manometers, or pyrometers. This rule does not affect the manufacturing and processing of elemental mercury for use in these articles when they are in service as of September 11, 2009. EPA believes this SNUR is necessary because manufacturing, processing, use, or disposal of mercury associated with these uses may produce significant changes in human and environmental exposures. The rationale and objectives for this SNUR are explained in Unit IV.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit II.C., the general SNUR provisions are found at 40 CFR part 721, subpart A.

General provisions for SNURs appear under 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. However, 40 CFR 721.45(f) does not apply to this SNUR.

As a result, persons subject to the provisions of this rule are not exempt from significant new use reporting if they import or process elemental mercury as part of an article (see 40 CFR 721.5). Conversely, the exemption from notification requirements for exported articles (see 40 CFR 707.60(b)) remains in force. Thus, persons who export elemental mercury as part of an article are not required to provide export notification.

Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities on which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

Persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B.

1. Mercury. This rule applies to elemental mercury (CAS No. 7439-97-6), which is a naturally occurring element. Because of its unique properties (e.g., exists as a liquid at room temperature and forms amalgams with many metals), elemental mercury has been used in many industrial processes and consumer products. In addition to its useful characteristics, mercury also is known to cause adverse health effects in humans and wildlife. These effects can vary depending on the form of mercury to which a person or animal is exposed, as well as the magnitude, length, and frequency of exposure.

The most prevalent human and wildlife exposure to mercury results from ingesting fish contaminated with methylmercury. Methylmercury is an organo-metallic compound that is formed via the conversion of elemental or inorganic mercury compounds by certain microorganisms and other natural processes. For example, elemental mercury may evaporate and be emitted into the atmosphere. Atmospheric mercury can be deposited directly into water bodies or watersheds, where it can be washed into surface waters via overland run-off. Once deposited in sediments, certain microorganisms and other natural processes can convert elemental mercury into methylmercury. Methylmercury bioaccumulates, which means that it is taken up and concentrated in the tissues of aquatic, mammalian, avian, and other wildlife. Methylmercury is a highly toxic substance; a number of adverse health effects associated with exposure to it have been identified in humans and in animal studies. Most extensive are the data on neurotoxicity, particularly in developing organisms. Fetuses, infants, and young children generally are more sensitive to methylmercury's neurological effects than adults.

In 2004, EPA and the Food and Drug Administration (FDA) issued a national consumption advisory concerning mercury in fish. The advisory contains recommended limits on the amount of certain types of fish and shellfish that pregnant women and young children can safely consume. By 2005, all fifty states had issued fish consumption advisories for fish from certain water bodies known to be contaminated by methylmercury (http://www.epa.gov/mercury/advisories.htm).

In addition to methylmercury, exposure to elemental mercury can also pose health risks. Elemental mercury primarily causes health effects when it is breathed as a vapor that can be absorbed through the lungs. These exposures can occur when elemental mercury is spilled or products that contain elemental mercury break, resulting in release of mercury to the air, particularly in warm or poorly-ventilated indoor spaces.

For additional detailed background information (e.g., chemistry, environmental fate, exposure pathways, and health and environmental effects), as well as references pertaining to elemental mercury that EPA considered before proposing this rule, please refer to EPA's proposed SNUR for mercury switches in motor vehicles, issued in the Federal Register of July 11, 2006 (71 FR 39035) (FRL-7733-9), or in the docket for the 2006 proposal under docket identification number EPA-HQ-OPPT-2005-0036. All documents in the docket are listed in the docket's index which is available at http://www.regulations.gov.

2. Mercury uses. Elemental mercury has been used in thousands of products and applications. Over the past two decades, there has been a dramatic drop in elemental mercury use by industries in the United States. In response to increased concerns about exposure to anthropogenic sources of mercury in the environment and also because of the availability of suitable mercury-free products, Federal and State governments have made efforts to limit the use of elemental mercury in certain products. Various states have banned or restricted the manufacture or sale of products containing mercury (see http://www.epa.gov/epawaste/hazard/tsd/mercury/laws.htm). On October 5, 2007, EPA issued a final SNUR for elemental mercury used in convenience light switches, anti-lock braking system switches, and active ride control system switches in certain motor vehicles (72 FR 56903) (FRL-8110-5).

In the past, elemental mercury was used in the manufacture of flow meters, natural gas manometers, and pyrometers. The latest information available to EPA indicates that the manufacture of these mercury-containing articles has ceased (Ref. 1). In proposing this rule, EPA asked for public comment on ongoing processing or availability of these articles and received no comments indicating that the manufacturing, import, processing, sale, or use of these articles occurs.

i. Flow meters containing elemental mercury. Flow meters are instruments which measure the flow rate of liquids or gases. Historically, they have been used in civil engineering applications, e.g., water treatment plants, sewage plants, and power stations. Flow meters contained up to 5 kilograms (kg) of elemental mercury. At present, the sale of mercury-containing flow meters is banned in six states: California, Maine, Massachusetts, New Hampshire, New York, and Vermont (Ref. 4). Many mercury-free alternatives exist, including differential pressure meters, positive displacement meters, velocity meters, and mass meters. EPA found sufficient information to conclude that mercury-containing flow meters are no longer manufactured in or imported into the United States (Ref. 1).

ii. Natural gas manometers containing elemental mercury. A manometer is an instrument used to measure the pressure of gases or liquids. For purposes of this rule, a natural gas manometer means a mercury-containing instrument used in the natural gas industry to measure the pressure differential of natural gas in a pipeline. Mercury manometers have been used in the natural gas industry on individual wells, pipeline junctions, pipeline manifolds, compressor stations, and distribution points. The manometers contain between 3.2 and 54.5 kg of mercury. A common design for manometers is a U-shaped tube with one end opened to the atmosphere and the other connected to a process. Contained in the tube is a liquid (mercury, in the past). Pressure differential is measured by comparing the liquid levels in each of the two vertical sections of the tube. Seven states have enacted broad bans on the sale of mercury manometers (Ref. 4), and Louisiana prohibits the sale of mercury-containing natural gas manometers (Ref. 2). Available information indicates that bellows orifice meters have replaced mercury meters in the natural gas industry. EPA found sufficient information to conclude that mercury-containing manometers are no longer manufactured in or imported into the United States (Ref. 1).

iii. Pyrometers containing elemental mercury. A pyrometer is an instrument that is similar to a thermometer but is typically used to measure extremely high temperatures in industrial processes such as in foundries, for pottery and ceramic kiln work, and in automotive applications. Historically, pyrometers contained mercury in sensing units in amounts ranging between 5 and 10 grams of mercury. In recent years, California, Maine, Massachusetts, New Hampshire, New York, and Vermont have banned the sale of mercury-containing pyrometers (Ref. 4). EPA found sufficient information to conclude that mercury-containing pyrometers are no longer manufactured, or imported into the United States (Ref. 1).

3. Potential exposure and release from these uses. The typical lifecycle of flow meters, natural gas manometers, and pyrometers includes several stages: Manufacture, distribution in commerce, use, and waste management (landfilling or recycling). At any point in the lifecycle, there is potential for mercury to be released as liquid or vapor. Workers and others can be exposed to the mercury and it can be released into water, air, or onto land as the mercury is transported, stored, and handled during manufacturing. While the flow meters, manometers, and pyrometers are in use, the mercury can vaporize or spill due to breakage during transport, installation, maintenance, refilling, or repair. For example, beginning in the 1920s, mercury-containing manometers were used in the Louisiana natural gas industry, and mercury releases to the environment have been attributed to these manometers. (Ref. 3). Other opportunities for release can occur at the end of the lifecycle of flow meters, manometers, and pyrometers, as the devices are removed from equipment and facilities and handled during waste management.

EPA is designating as significant new uses, use of elemental mercury in flow meters, natural gas manometers, or pyrometers. However, use of elemental mercury in these articles when they are in service as of September 11, 2009, will not be covered as a significant new use under this SNUR. Definitions of “flow meter,” “natural gas manometer,” and “pyrometer” can be found at 40 CFR 721.10068 of the regulatory text for this final rule.

This action will amend 40 CFR 721.10068 and require persons who intend to manufacture or process elemental mercury for a use designated by this rule as a significant new use to notify EPA at least 90 days before commencing the manufacturing or processing of elemental mercury for such significant new use. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

For this SNUR, EPA is not including the general “article” exemption at 40 CFR 721.45(f). Thus, persons importing or processing elemental mercury (including when part of an article) for a significant new use will be subject to the notification requirements of 40 CFR 721.25. EPA is not including this exemption because flow meters, natural gas manometers, and pyrometers are articles, and a primary concern associated with this SNUR is potential exposures associated with the lifecycle of these uses. Further, it is possible to reclaim elemental mercury from certain articles, which could be used to produce flow meters, natural gas manometers, and pyrometers. EPA notes that, in accordance with TSCA section 12(a) and 40 CFR 721.45(g), persons who manufacture or process elemental mercury solely for export will be exempt from the notification requirements of 40 CFR 721.25, if when distributing the substance in commerce, it is labeled in accordance with TSCA section 12(a)(1)(B). Further, EPA notes that the exemption from the TSCA section 12(b) notification requirements for exported articles (see 40 CFR 707.60(b)) remains in force. Thus, persons who export elemental mercury as part of an article will not be required to provide export notification.

EPA believes elemental mercury is no longer used to manufacture flow meters, natural gas manometers, or pyrometers, but some of these articles may remain in service in the United States (no public comments were received in response to the proposed rule indicating the ongoing use of such articles). The ongoing use of such articles, including maintenance and servicing activities, falls outside the scope of this significant new use rule. Thus, the manufacturing and processing of elemental mercury for use in these articles, provided they are in service as of September 11, 2009, will not be covered by the rule. For example, if an article that is in service as of September 11, 2009, is removed from service for maintenance or servicing, including the addition of new mercury, and then placed back into service, any manufacturing or processing of mercury associated with that maintenance or servicing will not be covered by the rule. Otherwise, the addition of new mercury to these existing articles after September 11, 2009, could potentially trigger a significant new use notice under this rule (e.g., if it involved processing of the mercury), which is not EPA's intent.

EPA received three comments on the proposed rule that was issued in the Federal Register of September 11, 2009 (74 FR 46707). Copies of all comments received are in the public docket for this rule. All three commenters expressed general support for the proposed rule. No comments provided any data or made any assertions that manufacture, import, processing, distribution, or use of elemental mercury in these articles is ongoing. A discussion of specific comments suggesting changes to the proposal and EPA's response follows:

1. Comment. One commenter believed the language on the requirement to notify EPA “at least 90 days” before commencing a subject activity created ambiguities, and should be changed to “within 90 days.” The commenter also thought the factors used to determine a significant new use should be more specific, perhaps by establishing a quantity determination. Finally, the commenter thought the proposed SNUR should be expanded to include mercury-containing products currently in use.

Response. The requirement to notify EPA at least 90 days before (≥ 90 days) commencement is specified by TSCA section 5(a)(1); EPA does not see any ambiguity. Similarly, the factors used to determine a significant new use noted by the commenter are those specified by TSCA section 5(a)(2). EPA notes these are the factors EPA uses when it makes a determination on a significant new use; chemical manufacturers and processors are subject to the new regulations at 40 CFR 721.10068. The commenter's recommended regulation of current uses (if any) of these mercury-containing articles is outside the scope of this TSCA section 5(a) regulation. As discussed in the proposed rule, EPA considered and rejected regulating elemental mercury in these articles under TSCA section 6(a).

2. Comment. Another commenter recommended that EPA use this rule to mandate all states to develop a mercury reduction plan. The commenter also asked EPA to work with the FDA to ban the use of mercury in all vaccines.

Response. The actions recommended by the commenter are outside the scope of this regulation.

3. Comment. The third commenter proposed EPA take three additional steps in this rulemaking: (1) Require that current owners of manometers and flowmeters disclose the number of meters and their location to EPA; (2) classify the sale of replacement parts as a significant new use; and (3) phase out the use of old manometers through an incentive program for removal.

Response. The disclosure requirement proposed by the commenter is outside the scope of this regulation. As noted previously, EPA considered and rejected regulating elemental mercury in these articles under TSCA section 6(a). The disclosure requirement proposed by the commenter would require a separate rulemaking by EPA under TSCA section 6(a) authority. EPA believes inventories of these articles in use are minimal or non-existent. Regarding the second recommendation, EPA is not aware of any large inventories of either mercury-containing replacement parts or existing equipment that would be kept in service for prolonged periods by their use. EPA wishes to clarify that depending on the exact nature of these replacement parts, if any exist, and the circumstances of their eventual end use, they may or may not fall under the scope of this regulation. Only flow meters, natural gas manometers and pyrometers in service as of September 11, 2009, are specifically exempt. The commenter's third proposal for a phase-out and waste recovery program is outside the scope of this significant new use regulation.

As summarized in Unit III.A, EPA has concerns regarding the adverse health effects presented by mercury in humans and wildlife, as well as its environmental fate and the exposure pathways. EPA is encouraged by the discontinuation of the use of elemental mercury in the manufacturing of flow meters, natural gas manometers, and pyrometers. However, EPA is concerned that the manufacturing or processing of elemental mercury for use in flow meters, natural gas manometers, or pyrometers could be reinitiated in the future. Accordingly, EPA wants the opportunity to evaluate and control, where appropriate, activities associated with those uses, if such manufacturing or remanufacturing were to occur again. The required notification provided by a SNUN will provide EPA with the opportunity to evaluate activities associated with a significant new use and an opportunity to protect against unreasonable risks, if any, from exposure to mercury.

Based on the considerations in Unit IV.A., EPA has the following objectives with regard to the significant new uses that are designated in this rule:

1. EPA will receive notice of any person's intent to manufacture or process elemental mercury for any of the described significant new uses before that activity begins.

2. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing of elemental mercury for any of the described significant new uses.

3. EPA will be able to regulate prospective manufacturers or processors of elemental mercury before the described significant new uses of the chemical substance occur, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7.

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.

To determine what would constitute a significant new use of elemental mercury, EPA considered the four factors listed in section 5(a)(2) of TSCA. The latest information available to EPA indicates that there is no ongoing use of elemental mercury in the manufacture or remanufacture of flow meters, natural gas manometers, or pyrometers. Resumption of these uses of elemental mercury could result in a significant increase in the magnitude and duration of exposure to workers and the surrounding environment at facilities of all types in the lifecycle, as well as an increase in releases which could contribute additional mercury to the atmosphere for long-range transport. Resumption of these uses could also result in exposures to workers who had not previously worked in these facilities when elemental mercury was commonly used, as well as exposures to workers who are not currently being exposed to mercury in the manufacture of flow meters, natural gas manometers, or pyrometers. Increases in mercury releases could lead to increases in mercury concentrations in the environment, resulting in overall ecosystem degradation, as well as a deleterious effect on human health from consumption of mercury-contaminated fish.

EPA believes that any of these renewed uses of elemental mercury would increase the magnitude and duration of exposure to humans and the environment over that which would otherwise exist. Based upon the relevant factors as discussed in this unit, EPA has determined that any manufacturing or processing of elemental mercury for use in flow meters, natural gas manometers, or pyrometers is a significant new use.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule. If uses begun after publication of the proposed rule were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, persons who began or begin commercial manufacture or processing of the elemental mercury for a significant new use designated in this rule will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires. EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), that person would be considered to have met the requirements of the final SNUR for those activities.

Accordingly, this final rule specifies that uses after the date of publication of the proposed rule, September 11, 2009, are subject to this rule. Although the September 11, 2009, date was correctly specified in the regulatory text of the proposed rule document, in several instances in the preamble text to the proposed rule document, the effective date of the final rule was incorrectly given as the applicable date of the SNUR provisions of this rule. No comment was received on the issue.

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25). However, as a general matter, EPA recommends that SNUN submitters include data that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture, processing, use, distribution in commerce, or disposal. EPA encourages persons to consult with the Agency before submitting a SNUN. As part of this optional pre-notice consultation, EPA would discuss specific data it believes may be useful in evaluating a significant new use. SNUNs submitted for significant new uses without any test data may increase the likelihood that EPA will take action under TSCA section 5(e) to prohibit or limit activities associated with this chemical.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on:

1. Human exposure and environmental releases that may result from the significant new uses of the chemical substance.

2. Potential benefits of the chemical substance.

3. Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

As stated in Unit II.C., according to § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be submitted to EPA, on EPA Form No. 7710-25 in accordance with the procedures set forth in §§ 721.25 and 720.40. This form is available from the Environmental Assistance Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Forms and information are also available electronically at http://www.epa.gov/opptintr/newchems.

EPA evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of the chemical substance included in this rule. EPA's economic analysis, which is briefly summarized here, is available in the public docket (Ref. 1).

The costs of submission of a SNUN will not be incurred by any company until a company decides to pursue a significant new use as defined in this SNUR. In the event that a SNUN is submitted, costs are estimated at approximately $8,000 per SNUN submission, and includes the cost for preparing and submitting the SNUN, and the payment of a user fee. Businesses that submit a SNUN are either subject to a $2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than $40 million when combined with those of the parent company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). In its evaluation of this rule, EPA also considered the potential costs a company might incur by avoiding or delaying the significant new use in the future, but these costs have not been quantified.

The following documents are specifically referenced in the preamble for this rulemaking. In addition to these documents, other materials may be available in the docket established for this rulemaking under Docket ID No. EPA-HQ-OPPT-2008-0483, which you can access through http://www.regulations.gov. Those interested in the information considered by EPA in developing this rule, should also consult documents that are referenced in the documents that EPA has placed in the docket, regardless of whether the other documents are physically located in the docket.

1. EPA, 2009. Economic Analysis for the Proposed Significant New Use Rule for Mercury-Containing Flow Meters, Nanometers, and Pyrometers. Washington, D.C. OPPT/EETD/EPAB, July 21, 2009.

2. La. Rev. Stat. Ann. section 2575 (2006).

3. State of Louisiana Mercury Risk Reduction Plan, prepared by the Louisiana Department of Environmental Quality, 2007. Available as of May 13, 2010 at http://www.ldeq.org/portal/Portals/0/organization/MercuryReportforweb.pdf.

4. Mercury Reduction and Education Legislation in the IMERC-Member States, prepared by Terri Goldberg and Adam Wienert, NEWMOA, June 2008. Available as of May 13, 2010 at http://www.newmoa.org/prevention/mercury/imerc/legislation-2008.htm.

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that this final SNUR is not a “significant regulatory action,” because it does not meet the criteria in section 3(f) of the Executive Order. Accordingly, this action was not submitted to OMB for review under Executive Order 12866.

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument, or form, if applicable.

The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average 110 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new,” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since a SNUR requires a person who intends to engage in such activity in the future to first notify EPA by submitting a SNUN, no economic impact will occur unless someone files a SNUN to pursue a significant new use in the future or forgoes profits by avoiding or delaying the significant new use. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 1,000 SNURs, the Agency receives on average only 5 notices per year. Of those SNUNs submitted, only one appears to be from a small entity in response to any SNUR. Therefore, EPA believes that the potential economic impact of complying with a SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general determination that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local, or Tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action will not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538).

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).

This final rule will not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This rule will not significantly or uniquely affect the communities of Indian Tribal governments, nor will it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this final rule.

This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.

In addition, since this action does not involve any technical standards; section 12(d) of the National Technology Transfer and Advancement Act of 1995 section 12(d) (15 U.S.C. 272 note), does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

The Congressional Review Act, 5 U.S.C. 801 et 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 the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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

The 2010 TAC of northern rockfish allocated to catcher/processors participating in the rockfish limited access fishery in the Central GOA is 152 metric tons (mt) as established by the final 2010 and 2011 harvest specifications for groundfish of the GOA (75 FR 11749, March 12, 2010), and as posted as the 2010 Rockfish Program Allocations at http://alaskafisheries.noaa.gov/sustainablefisheries/goarat/default.htm.

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2010 TAC of northern rockfish allocated to catcher/processors participating in the rockfish limited access fishery in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 102 mt, and is setting aside the remaining 50 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for northern rockfish by catcher/processors participating in the rockfish limited access fishery in the Central Regulatory Area of the GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of northern rockfish for catcher/processors participating in the rockfish limited access fishery in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 15, 2010.

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

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

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

The 2010 TAC of Pacific ocean perch allocated to catcher/processors participating in the rockfish limited access fishery in the Central GOA is 663 metric tons (mt) as established by the final 2010 and 2011 harvest specifications for groundfish of the GOA (75 FR 11749, March 12, 2010), and as posted as the 2010 Rockfish Program Allocations at http://alaskafisheries.noaa.gov/sustainablefisheries/goarat/default.htm.

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2010 TAC of Pacific ocean perch allocated to catcher/processors participating in the rockfish limited access fishery in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 598 mt, and is setting aside the remaining 65 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch by catcher/processors participating in the rockfish limited access fishery in the Central Regulatory Area of the GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific ocean perch for catcher/processors participating in the rockfish limited access fishery in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 15, 2010.

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

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

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

The 2010 TAC of “other rockfish” in the Western Regulatory Area of the GOA is 212 metric tons (mt) as established by the final 2010 and 2011 harvest specifications for groundfish of the GOA (75 FR 11749, March 12, 2010).

In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2010 TAC of “other rockfish” in the Western Regulatory Area of the GOA has been reached. Therefore, NMFS is requiring that “other rockfish” caught in the Western Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b).

“Other rockfish” in the Western Regulatory Area of the GOA means slope and demersal shelf rockfish.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting the retention of “other rockfish” in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 15, 2010.

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

This action is required by § 679.20 and § 679.21 and is exempt from review under Executive Order 12866.

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

The 2010 TAC of Pacific ocean perch in the Western Regulatory Area of the GOA is 2,895 metric tons (mt) as established by the final 2010 and 2011 harvest specifications for groundfish of the GOA (75 FR 11749, March 12, 2010).

In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2010 TAC of Pacific ocean perch in the Western Regulatory Area of the GOA has been reached. Therefore, NMFS is requiring that Pacific ocean perch caught in the Western Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting the retention of Pacific ocean perch in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 15, 2010.

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

This action is required by § 679.20 and § 679.21 and is exempt from review under Executive Order 12866.