The Bipartisan Campaign Reform Act of 2002 (“BCRA”), Pub. L. 107-155, 116 Stat. 81 (2002), amended the Federal Election Campaign Act of 1971, as amended, 2 U.S.C. 431 et seq. (the “Act”), by adding a new category of communications, “electioneering communications,” to those already regulated by the Act. See 2 U.S.C. 434(f)(3). Generally speaking, electioneering communications are broadcast, cable or satellite communications that refer to a clearly identified candidate for Federal office, are publicly distributed within 60 days before a general election or 30 days before a primary election, and are targeted to the relevant electorate. See 2 U.S.C. 434(f)(3)(A)(i); 11 CFR 100.29(a)(1) through (3). Electioneering communications carry certain reporting obligations and funding restrictions. See 2 U.S.C. 434(f)(1) and (2), and 441b(a) and (b)(2).

BCRA exempts certain communications from the definition of “electioneering communication,” 2 U.S.C. 434(f)(3)(B)(i) to (iii), and specifically authorizes the Commission to promulgate regulations exempting other communications as long as the exempted communications do not promote, support, attack or oppose (“PASO”) a candidate, 2 U.S.C. 434(f)(3)(B)(iv), citing 2 U.S.C. 431(20)(A)(iii).

On October 23, 2002, the Commission promulgated regulations to implement BCRA's electioneering communications provisions. Final Rules and Explanation and Justification for Regulations on Electioneering Communications, 67 FR 65190 (Oct. 23, 2002) ( “EC E&J” ). In Shays v. FEC, 337 F. Supp. 2d 28 (D.D.C. 2004), aff'd, No. 04-5352, 2005 WL 1653053 (D.C. Cir. July 15, 2005) ( “Shays” ), the District Court held that one regulation limiting electioneering communications to communications publicly distributed for a fee failed review under Chevron, U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (1984) ( “Chevron” ), and one regulation exempting section 501(c)(3) organizations failed to satisfy the Administrative Procedure Act, 5 U.S.C. 706(2) (“APA”). Shays, 337 F. Supp. 2d at 124-29. The District Court remanded the case for further action consistent with its decision. The U.S. Court of Appeals for the District of Columbia Circuit affirmed the District Court, holding that the “for a fee” regulation failed Chevron review. Shays v. FEC, No. 04-5352, slip op. at 52-57, 2005 WL 1653053, at *28-31 (D.C. Cir. July 15, 2005). The Commission did not appeal the District Court's decision regarding an exemption from the “electioneering communication” definition for section 501(c)(3) organizations. The Commission is issuing this NPRM to comply with the District Court and Court of Appeals decisions with respect to both regulations.

In 11 CFR 100.29(b)(3)(i), the Commission defined “publicly distributed” as “aired, broadcast, cablecast or otherwise disseminated for a fee through the facilities of a television station, radio station, cable television system, or satellite system” (emphasis added). The Commission included the requirement that the communication be publicly distributed for a fee, in part, because “[m]uch of the legislative history and virtually all of the studies cited in legislative history and presented to the Commission in the course of this rulemaking focused on paid advertisements in considering what should be included within electioneering communications.” EC E&J at 65192 (citations to studies omitted). Both the District Court and the Court of Appeals in Shays determined that the “for a fee” language in the definition of “publicly distributed” operated much like an exemption to the definition of “electioneering communication.” Shays, 337 F. Supp. 2d at 128-29; No. 04-5352, slip op. at 55, 57, 2005 WL 1653053, at *30, 31. The District Court found that the exemption exceeded the Commission's statutory authority to create exemptions because it could potentially include communications that PASO a Federal candidate. Shays, 337 F. Supp. 2d at 128-29. Both the District Court and the Court of Appeals held that the “for a fee” provision is inconsistent with the plain text of BCRA and thus violated Chevron step one. 1 Shays, 337 F. Supp. 2d at 129; No. 04-5352, slip op. at 54, 2005 WL 1653053, at *29.

Additionally, the Court of Appeals observed that “excluding federal candidates from broadcasts promoting blood drives and other worthy causes for 90 days out of every two years (30 days before the primary plus 60 days before the general election) would hardly seem unreasonable given that such broadcasts ‘could associate a Federal candidate with a public-spirited endeavor in an effort to promote or support a candidate'—a risk the FEC itself acknowledged in the very same rulemaking, in justifying its refusal to promulgate a general exemption for [public service announcements] (whether paid or unpaid).” Shays, No. 04-5352, slip op. at 56, 2005 WL 1653053, at *30 (citation omitted). Thus an exemption that is limited to non-PASO communications may, in practice, exempt comparatively few communications from the definition of “electioneering communications.” Additionally, many other types of communications that would be covered by an exemption for communications that are not publicly distributed for a fee are also already exempt under the statutory press exemption, which exempts “a communication appearing in a news story, commentary, or editorial distributed through the facilities of any broadcasting station.” 2 U.S.C. 434(f)(3)(B)(i).

Consequently, the Commission proposes to eliminate the phrase “for a fee” from the definition of “publicly distributed” at 11 CFR 100.29(b)(3)(i). The Commission seeks comment on whether this approach of removing “for a fee” from the “electioneering communication” definition without exempting such communications would require extensive monitoring of radio and television programming to ensure that it either fits the statutory press exemption or otherwise avoids the reach of the “electioneering communication” rules. Would the Commission have to distinguish “commentary” from free time donated to political committees or candidates, which was approved in Advisory Opinions (“AOs”) 1982-44 and 1998-17?

The Commission is also considering another alternative that is not reflected in the proposed rules below. This alternative would include deleting “for a fee” from the definition of “publicly distributed” and would also include a new exemption for communications for which the broadcast, cable or satellite entity does not seek or obtain compensation for publicly distributing the communications, unless the communications promote, support, attack or oppose a Federal candidate. An important rationale that underlies this alternative proposal is that broadcasters donate airtime to organizations to broadcast communications in the public interest, such as public service announcements promoting a wide range of worthy endeavors. Subjecting these communications to the electioneering communication regulations may discourage broadcasters from performing an important public service in providing free airtime for these ads. An exemption that is limited to non-PASO communications may, in practice, exempt comparatively few communications from the definition of “electioneering communications.” Must the Commission provide some definition of PASO for the exemption to be meaningful and explicable to the regulated community or is the PASO standard self-executing and understandable without further definition by the Commission? The Commission seeks comment on whether this alternative proposal is preferable to the proposed rules that would delete “for a fee” from the definition of “publicly distributed” without an exemption for unpaid advertisements that do not PASO Federal candidates.

In 2002, the Commission exempted from the “electioneering communication” definition any communication that is paid for by any organization operating under section 501(c)(3) of the Internal Revenue Code. See current 11 CFR 100.29(c)(6). The Commission explained that it “believes the purpose of BCRA is not served by discouraging such charitable organizations from participating in what the public considers highly desirable and beneficial activity, simply to foreclose a theoretical threat from organizations that has not been manifested, and which such organizations, by their very nature, do not do.” EC E&J at 65200. Under the Internal Revenue Code, organizations described in section 501(c)(3) may not “participate in, or intervene in (including the publishing or distributing of statements), any political campaign on behalf of (or in opposition to) any candidate for public office.” See 26 U.S.C. 501(c)(3).

In considering a challenge to the exemption for section 501(c)(3) organizations, the Shays District Court examined whether the exemption complies with BCRA. The District Court found the record unclear as to whether the regulation's reliance on the Internal Revenue Code prohibitions would impermissibly exempt advertisements that PASO Federal candidates. On this basis, the District Court held that it could not determine whether or not the regulation fails Chevron review. 2 See Shays, 337 F. Supp. 2d at 127.

The District Court held that the exemption for section 501(c)(3) organizations violated the APA because the Explanation and Justification for 11 CFR 100.29(c)(6) led the court to conclude that the Commission “failed to conduct a reasoned analysis.” See Shays, 337 F. Supp. 2d at 127-28. Specifically, the District Court found the EC E&J deficient because it did not address the “compatibility” of the Internal Revenue Service's (“IRS's”) enforcement of the section 501(c)(3) prohibition on political activity and FECA's requirements. The District Court identified three specific omissions from the EC E&J: (1) It did not discuss whether or not public communications that PASO a Federal candidate would be viewed by the IRS as political activity in which section 501(c)(3) organizations may not engage; (2) it did not discuss the risk, if any, that limited lobbying activity permitted for section 501(c)(3) organizations could give rise to advertisements that PASO a Federal candidate; and (3) it did not address the implications of allowing the IRS “to take the lead in campaign finance law enforcement.”  3 See Shays, 337 F. Supp. 2d at 128. The District Court remanded this regulation to the Commission for further action consistent with its order. Id . at 130. Instead of appealing this aspect of the District Court decision, the Commission chose to initiate this rulemaking to address the three concerns expressed by the District Court. In addition to the District Court's concerns, a well-developed administrative record will inform the Commission's reconsideration of an exemption for section 501(c)(3) organizations.

The Shays District Court stated that “the validity of the Commission's regulation depends on whether or not the tax laws and regulations, as well as their enforcement, effectively prevent Section 501(c)(3) groups from issuing public communications that promote or oppose a candidate for federal office.” Shays, 337 F. Supp. 2d at 127. The District Court also specified that the EC E&J failed to discuss “whether or not the IRS viewed as political activity ‘public communications’ that support or oppose a candidate as those concepts are understood under this nation's campaign finance laws.” Id . at 128. Thus the task before the Commission, if it decides to retain current 11 CFR 100.29(c)(6), is to make a finding based on a well-developed record that section 501(c)(3) organizations cannot make PASO communications when acting lawfully within their tax-exempt status.

In response to the 2002 NPRM concerning electioneering communications, Notice of Proposed Rulemaking on Electioneering Communications, 67 FR 51131 (Aug. 7, 2002), several section 501(c)(3) organizations submitted comments and addressed the issue of whether these organizations pay for PASO communications. One commenter asserted that section “501(c)(3)[ ] [organizations] could never legally broadcast advertisements that contain even the slightest suggestion of support for or opposition to any candidates due to the substantial restrictions under federal law.”  4 The commenter said it knew of “no examples where 501(c)(3)s have broadcast the so-called “sham issue ads” that BCRA attempts to ban or regulate.” In contrast, another commenter stated that it does engage in issue advocacy that includes broadcast advertisements that refer to candidates and officeholders, and implied that these advertisements may well PASO a candidate. 5

In addition, the record in Shays v. FEC includes press reports describing a radio ad run by a section 501(c)(3) organization, the Federation for American Immigration Reform (“FAIR”), that appears to attack or oppose a Federal candidate. See Memorandum in Support of Plaintiffs' Motion for Summary Judgment at 78 n.138, Shays v. FEC, 337 F. Supp. 2d 28 (D.D.C. 2004). The text of the ad reportedly included the following: “This is an urgent message about our jobs. Senator Spence Abraham is again pushing a bill to import hundreds of thousands more foreign workers to take American jobs—our jobs. * * * Recently Abraham killed the requirement that employers hire Americans first. He clearly thinks it's OK to favor foreign workers. Why treat Americans so badly? Money. Abraham has raised big political money from huge corporations that want cheap, foreign labor. And his newest bill gives them everything they want. Is your job next? Let's try to convince Abraham not to sell our jobs. His bill could be voted on any day. So call now: 1-800-xxx-xxxx. That's 1-800-xxx-xxxx. Tell him you've had enough of his big foreign labor bills, like S. 2045. This message sponsored by the Federation for American Immigration Reform. Visit our website at fairUS.org.”  6

In a Technical Advice Memorandum the IRS “reluctantly conclude[d]” that television advertisements by a section 501(c)(3) organization that would be generally understood to “support or oppose a candidate in an election campaign” did not constitute intervention in a political campaign because the communication was core to the organization's mission. See Technical Advice Memorandum 89-36-002, 1989 WL 596078 (Sept. 8, 1989).

While these statements and examples are helpful to the Commission in understanding the interaction between tax law and campaign finance law as they pertain to communications by section 501(c)(3) organizations, they provide a limited record for the Commission to exempt all section 501(c)(3) organizations' communications. For example, how should the Commission interpret the Technical Advice Memorandum, which does not have precedential authority? To the extent that section 501(c)(3) organizations pay for advertisements similar to the one by FAIR described above, do the section 501(c)(3) organizations broadcast their advertisements during the 30- and 60-day electioneering communication windows? Is the FAIR advertisement typical of grass roots lobbying advertisements by section 501(c)(3) organizations or is it atypical?

The Commission invites comments that would shed more light on these issues. Specifically, the Commission is seeking data as to whether section 501(c)(3) organizations have a history of airing ads close to elections, particularly those that satisfy the definition of “electioneering communication.” The Commission is not aware that any of the advertisements addressed in the legislative history of BCRA, including those analyzed in the Brennan Center for Justice's Buying Time: Television Advertising in the 2000 Federal (or 1998 Congressional) Elections, or the record in McConnell v. FEC, 540 U.S. 93 (2003), were made by section 501(c)(3) organizations, and seeks comment on whether there are, in fact, communications from section 501(c)(3) organizations in this record. Additionally, since the Commission promulgated the current 11 CFR 100.29(c)(6), to what extent have section 501(c)(3) organizations availed themselves of this exemption? If commenters are able to submit the texts of advertisements by section 501(c)(3) organizations that would meet the definition of “electioneering communications,” the Commission seeks comment on whether the advertisements would be consistent with the section 501(c)(3) organization's tax-exempt status.

In addition to reconsidering the adequacy of an administrative record that could support current 11 CFR 100.29(c)(6), this NPRM also proposes an amendment to the current rule. Proposed section 100.29(c)(6) would provide an exemption for communications by section 501(c)(3) organizations subject to two limitations. First, the exemption would not apply to communications that PASO a Federal candidate. Second, the exemption would not apply to section 501(c)(3) organizations that are directly or indirectly established, financed, maintained or controlled by a Federal candidate or officeholder. Would limiting the exemption to non-PASO communications adequately address the District Court's concerns because the exemption no longer turns on the IRS's view on political activities? How common is it for Federal candidates to directly or indirectly establish, finance, maintain, or control a section 501(c)(3) organization? Is there a greater potential that section 501(c)(3) organizations that are established, financed, maintained, or controlled by Federal candidates would pay for communications that PASO Federal candidates?

The Commission is not proposing to define “PASO” in this rulemaking. In rejecting a vagueness challenge to the PASO standard, the Supreme Court in McConnell held that PASO provisions, at least with respect to political parties, “provide explicit standards for those who apply them and give the person of ordinary intelligence a reasonable opportunity to know what is prohibited.” McConnell, 124 S. Ct. at 675 n. 64. In light of the Supreme Court's ruling in McConnell, is the PASO standard essentially self-executing and understandable without further definition by the Commission or, given that the proposed regulation would apply to entities beyond political parties, must the Commission provide some definition of PASO for the proposed regulation to be meaningful and explicable to broadcasters and the regulated community?

The Commission has applied the PASO standard to an advertisement that was the subject of an advisory opinion, concluding that the advertisement did not PASO the Federal candidate who appeared in the advertisement. See AO 2003-25, at 3. That advertisement presented a Federal candidate's endorsement of a candidate for mayor, and the script read as follows:

Another example of a communication by a section 501(c)(3) organization that may illustrate the application of the PASO standard can be found in Advisory Opinion 2004-14. The script for one of the television advertisements read as follows:

The policy rationale behind the proposed rules is that, to the extent possible, the Commission does not want to discourage section 501(c)(3) organizations from performing a public service in pursuing their charitable endeavors. The Commission, however, is considering whether applying the PASO limitation would severely limit the benefit of such an exemption for section 501(c)(3) organizations. In Shays v. FEC, the Court of Appeals suggested that public service announcements (“PSAs”) that associate a Federal candidate with a public-spirited endeavor could promote or support that candidate. Shays v. FEC, No. 04-5352, slip op. at 56, 2005 WL 1653053, at *30 (D.C. Cir. July 15, 2005). Given that many broadcast advertisements by section 501(c)(3) organizations are PSAs that might be viewed as PASO communications, what utility does the proposed exemption have if the exemption does not include such PSAs? Additionally, many section 501(c)(3) organizations may lack familiarity with the nuances of campaign finance law. Would section 501(c)(3) organizations find the PASO standard confusing or difficult to apply, making it less likely that they would avail themselves of the proposed exemption if the Commission were to adopt it? Finally, if a fuller record shows that section 501(c)(3) organizations make a significant number of PASO communications during the 30 and 60 day windows, or if the record fails to resolve the issue one way or another, is there a substantial policy rationale for having a section 501(c)(3) exemption?

The Shays District Court identified a second deficiency in the Commission's promulgation of the 501(c)(3) exemption: “the FEC did not note that tax laws permit Section 501(c)(3) organizations to engage in limited lobbying activities, or discuss the risk, if any, that such activities could run afoul of 2 U.S.C. 434(f)(3)(B)(iv).” Shays, 337 F. Supp. 2d at 128 ( citing 26 U.S.C. 501(c)(3), (h)). The District Court refers to the requirement in section 501(c)(3) of the Internal Revenue Code that “no substantial part of the activities of [the organization] is carrying on propaganda, or otherwise attempting, to influence legislation.” 7

Under IRS regulations, the definition of “grass roots lobbying communications” as applied to section 501(c)(3) organizations is “any attempt to influence any legislation through an attempt to affect the opinions of the general public or any segment thereof.” 26 CFR 56.4911-2(b)(2)(i). An element of that definition is “encouraging recipients to take action” which includes a communication that “states that the recipient should contact a legislator” or that “specifically identifies one or more legislators who will vote on the legislation as: Opposing the communication's view with respect to the legislation; being undecided with respect to the legislation; being the recipient's representative in the legislature; or being a member of the legislative committee or subcommittee that will consider the legislation * * * [but] does not include naming the main sponsor(s) of the legislation for purposes of identifying the legislation.” Id . at 56.4911-2(b)(2)(iii)(B) and (D) (specifying other types of communications that are considered as “encouraging recipients to take action,” but that are not relevant to this issue). Given the IRS's definition of “grass roots lobbying communications,” to what extent, if any, may the permitted grass roots lobbying communications result in some section 501(c)(3) organizations making communications that PASO a Federal candidate?

In order to consider the issues surrounding grass roots lobbying communications, the Commission seeks comment on how frequently section 501(c)(3) organizations make grass roots lobbying communications. One research survey addressing this question entitled “SNAP: Strengthening Nonprofit Advocacy Project” was submitted to the Commission in the 2002 rulemaking. 8 This research project, conducted by Tufts University, OMB Watch and Charity Lobbying in the Public Interest, reports that it surveyed 2,735 randomly selected section 501(c)(3) organizations that file IRS Form 990, excluding hospitals, universities, religious organizations, and private foundations. Of the organizations surveyed, 63% responded. According to this report, 78% of the organizations that responded engage in grassroots lobbying. As to the frequency of their grassroots lobbying, 63% reported low (19%), very low (22%), or none (22%).

An analysis of data from the National Center for Charitable Statistics, which was drawn from reports filed with the IRS, found that 1.5% of section 501(c)(3) organizations (or 3,515 organizations) reported lobbying expenditures in 1998, and these organizations reported devoting only 1.2% of their total expenses to lobbying that year. Only 702 organizations reported grass roots lobbying expenditures, although only organizations making the section 501(h) election are required to report that information disaggregated from total lobbying expenditures. In 1998, 43% of the section 501(c)(3) organizations that reported lobbying expenditures (or approximately 1,500 organizations) made the section 501(h) election. The median total lobbying expenditures was $8,000, and the median total grassroots lobbying expenditures was $4,246. See Jeff Krehely, Assessing the Current Data on 501(c)(3) Advocacy: What IRS Form 990 Can Tell Us, in Exploring Organizations and Advocacy: Strategies and Finances 37-50 (Elizabeth J. Reid and Maria D. Montilla eds., 2001). 9

How should the Commission interpret these findings? Are there any other reports, studies, or evidence regarding lobbying by 501(c)(3) organizations that the Commission should consider?

The District Court in Shays held that the effect of the current exemption in 11 CFR 100.29(c)(6), as explained in the EC E&J, is that “the FEC would do nothing until the IRS investigated and decided whether or not the organization violated the tax laws.” Shays, 337 F. Supp. 2d at 128. The District Court concluded that the Commission failed to consider the effectiveness of, and the problems presented by, adopting an enforcement policy that relies on the IRS's enforcement of the tax code. Id.

In addressing the extent to which the Commission could or should rely on IRS enforcement of the tax code as a safeguard for ensuring that section 501(c)(3) organizations do not make communications that would support or oppose a Federal candidate, the Commission is considering statements and testimony from several sources, including section 501(c)(3) organizations and the Government Accountability Office (“GAO”). Several section 501(c)(3) organizations, commenting on the 2002 NPRM, stated that the possibility of an IRS revocation of their 501(c)(3) status because of their political activities was a strong deterrent to their engaging in activity that may be viewed as supporting or opposing candidates. 10 See EC E&J at 65199. One commenter stated that IRS's enforcement is vigorous and noted that the “IRS has repeatedly stated and successfully argued in court that this prohibition [on participation or intervention in political campaigns] is a “zero tolerance” rule.” Comment of Independent Sector.

A report by the GAO provides a different perspective, suggesting that the IRS lacks the resources for adequate oversight and enforcement. In 2002, the GAO issued a report noting that the IRS had little data on the compliance of section 501(c)(3) organizations, and recognizing the need for improved monitoring of compliance and for “better understanding of the type and extent of compliance problems in the charitable community.” U.S. Gen. Accounting Office, Tax Exempt Organization: Improvements Possible in Public, IRS, and State Oversight of Charities, GAO 02-526 (Apr. 2002). 11

The Commission seeks comments and other reports, documents or evidence that would shed light on the appropriateness of the current rule's deference to IRS determinations and actions in this area and that would assist the Commission in deciding whether to retain the current rule.

This mix of views regarding IRS enforcement, along with the questions raised above concerning the interaction between PASO communications and lobbying, leave the Commission without a clear record at this time regarding whether or not section 501(c)(3) organizations make PASO communications. Consequently, under proposed 11 CFR 100.29(c)(6), the Commission would make its own judgment as to whether a communication PASOs a candidate, without regard for how the IRS may view the same communication, and without waiting for the IRS to consider enforcement action. Thus, the proposed rule would not delegate “the first response to potential violations to the IRS.” See Shays, 337 F. Supp. 2d at 128.

The Commission seeks comment on whether the proposed rule adequately addresses the deficiencies identified by the District Court in Shays in relying on the IRS's enforcement of the tax code applicable to section 501(c)(3) organizations.

As an alternative to the proposed modifications to the current section 501(c)(3) exemption, the Commission also seeks comment on whether it should repeal both of the regulatory exemptions from the electioneering communications rules, 11 CFR 100.29(c)(5) and (6), and instead rely solely on the exemptions that Congress established in BCRA. These regulatory exemptions include not only the section 501(c)(3) exemption in current 11 CFR 100.29(c)(6), but also an exemption for communications paid for by candidates for State or local office in connection with an election to State or local office that do not PASO any Federal candidates in current 11 CFR 100.29(c)(5). The Commission is also considering the proposed revisions to the State candidate exemption in the proposed rules that follow. The proposed revisions seek to clarify the exemption and harmonize its structure with proposed 11 CFR 100.29(c)(6).

BCRA establishes several exemptions from the electioneering communications provisions. Certain communications appearing in a news story, commentary, or editorial are exempt under 2 U.S.C. 434(f)(3)(B)(i) and current 11 CFR 100.29(c)(2). Communications that constitute a reportable expenditure or independent expenditure are exempt under 2 U.S.C. 434(f)(3)(B)(ii) and current 11 CFR 100.29(c)(3). Finally, candidate debates are exempt under 2 U.S.C. 434(f)(3)(B)(iii) and current 11 CFR 100.29(c)(4). Under this proposal, these statutory exemptions would remain in the regulations, while current 11 CFR 100.29(c)(5) and (c)(6) would be repealed.

The Commission is also considering exempting from the “electioneering communication” definition all communications that do not PASO a Federal candidate. This proposal, which is not reflected in the proposed rules that follow, would employ the exemption authority provided to the Commission by Congress in 2 U.S.C. 434(f)(3)(B)(iv) to its full extent. The Commission seeks comments on whether this proposal's broad view of the Commission exemption authority is consistent with Congressional intent. Such an exemption would focus on the content of the communication and treat all communicators equally, in contrast to current 11 CFR 100.29(c)(5) and (c)(6), which are limited to particular speakers. Does this equality of treatment help justify the exemption? What form would the administrative record need to take to support such an exemption? Would such an exemption be consistent with the standard in 2 U.S.C. 434(f)(3)(A)(i)(I) that requires only a reference to a clearly identified candidate for Federal office? Would it effectively elevate the PASO standard as the primary determinant for electioneering communications? Must the Commission provide some definition of PASO for the exemption to be meaningful and explicable to the regulated community or is the PASO standard self-executing and understandable without further definition by the Commission?

On August 26, 2004, the Commission published a Notice of Availability seeking public comment on a Petition for Rulemaking (“Petition”) received by the Commission. The Petition requested the Commission revise its electioneering communications regulation by exempting the promotion and advertising of political documentary films, books, plays and similar means of expression that may otherwise meet the definition of an electioneering communication under 11 CFR 100.29. See Notice of Availability of Rulemaking Petition: Exception for the Promotion of Political Documentary Films from “Electioneering Communications,” 69 FR 52461 (Aug. 26, 2004) ( “Notice of Availability” ). The documentary films, books and plays at issue in the Petition are not themselves subject to the electioneering communication rules because these items are not broadcast or disseminated through a cable or satellite system, but appear in movie theaters or other non-broadcast environments. 12 The premise for the Petition is that advertisements for such films, books, and plays would not be covered by the statutory exemption for communications “appearing in a news story, commentary, or editorial distributed through the facilities of any broadcast station.” 2 U.S.C. 434(f)(3)(B); see also 11 CFR 100.29(c)(2).

The comment period ended September 27, 2004. The Commission received seven comments, including a letter from the Internal Revenue Service indicating that it had “no comments.” These comments are available at http://www.fec.gov/law/law_rulemakings.shtml under “Electioneering Communications Exception for Promotion of Political Documentaries.”

The Petition and some commenters argued that political documentary films and books might often refer to clearly identified candidates for Federal office, and that applying the electioneering communication rules to the broadcast, cable or satellite TV and radio advertisement of such items could stifle free speech. The Petition suggested that the Commission should create a specific exemption in 11 CFR 100.29(c) for all advertisements and promotion of political documentary films, books, plays and “other forms of political expression that may involve references to Federal candidates.” See Notice of Availability at 52461. One commenter suggested a narrower exemption for advertising of such political documentaries except for the four weeks preceding an election, but would require disclosure of funding of all political documentaries. Another commenter noted that the Petition only sought an exemption for works deemed “political,” and argued that a broader exemption for the promotion of documentary films, books and plays, regardless of whether the works are “political” was appropriate.

Two commenters also raised questions as to whether these documentaries are already covered by the current press exemption in 11 CFR 100.29(c)(2), and whether advertisements promoting them would also be covered by the press exemption. One of these commenters asserted that an additional rulemaking is unnecessary because the Commission has already stated that the press exemption in section 100.29(c)(2) applies to a documentary, and the commenter believes that by extension, the press exemption applies to the promotion of that documentary. See Reader's Digest Ass'n v. FEC , 509 F. Supp. 1210, 1215 (S.D.N.Y. 1981). The other commenter suggested a rulemaking was appropriate to revise section 100.29(c)(2) to specify that advertising for such documentary films falls within the scope of this press exemption. In contrast, other commenters were opposed to any specific exemption for advertising of documentary films as inconsistent with existing campaign finance law.

After considering the Petition and the comments received, the Commission has decided to open a rulemaking on this issue, as part of its revision of the electioneering communication rules in response of the Shays court opinions. Proposed 11 CFR 100.29(c)(7) would exempt communications promoting movies, books or plays, as long as the communications are run within the ordinary course of business of the persons that pay for such communications, and the communications do not PASO a Federal candidate. As urged by one of the commenters, the proposed rules would expand the exemption beyond “political” works to include advertising for any movie, book or play.

While the proposed rule applies to “movies” generally, the Commission seeks comment as to whether this reference should be understood to mean only movies appearing in theatres, or whether it should also apply to movies available for rental on DVD or video, or available on pay-per-view. Likewise, should the exemption apply only to printed books or should it also apply to books that are made available in audio and on-line formats? Furthermore, should the exemption be based on the actual or projected release date of the movie or book? For example, should the exemption only apply to movies that are shown during, or are being released within six months of, the electioneering communication window and to books that are in print during, or within six months of, the electioneering communications window? This sort of temporal limitation would be intended to prevent circumvention of the electioneering communication provisions by advertising a movie that either does not exist or is not intended for public distribution. Are any of these limitations necessary? Would they be sufficient to prevent circumvention?

The proposed rule would limit the exemption to persons who promote movies, books or plays “within the[ir] ordinary course of business.” Should the Commission limit this exemption so that it applies only to persons who are the publisher of a book or the producer, distributor or promoter of a movie or play? Would this limitation unfairly exclude first-time distributors? Should the Commission extend the exemption to any person who promotes movies, books or plays without regard to whether such advertisements are in the ordinary course of business? Should the Commission limit the exemption to entities not directly or indirectly established, financed, maintained, or controlled by any Federal candidate, individual holding Federal office, or any political committee, including political party committees? Does the Commission have the statutory authority to promulgate the exemption without it being conditioned on the promotional communications not PASOing a Federal candidate? The Commission seeks comment on whether such communications in the past have in fact PASOed a Federal candidate.

The Commission also seeks information as to whether any persons refrained from advertising movies, books or plays on television or radio during the 2003-2004 election cycle because of concerns that advertisements would violate electioneering communications rules. How significant a burden would it be for advertisements that run during the 30/60-day window to avoid clearly identifying a candidate? See MUR 5467, In the Matter of Michael Moore, et al. (where, in response to allegations that the Respondents intended to run advertisements promoting a film during the electioneering communications period that would contain references to clearly identified Federal candidates, the Respondents stated that the distributors of the film had decided prior to the filing of the complaint not to broadcast advertisements for the film during the electioneering communications period that would contain a reference to any clearly identified Federal candidate).

The Commission certifies that the attached proposed rule, if promulgated, would not have a significant economic impact on a substantial number of small entities. The basis for this certification is that the changes proposed in the electioneering communications regulation would only affect individuals and a small number of non-profit organizations. First, the proposed changes to the definition of “publicly distributed” would only affect the small number of advertisements that are run on broadcast, cable or satellite TV or radio where the airtime is donated without charge. To the extent this proposed rule affects media organizations donating the time or running their own programming, they do not fall within the definition of “small business.” There are very few small businesses or organizations that receive donated time for advertising and might be affected by the proposed rule. Second, the proposed changes to the exemption for communications paid for by section 501(c)(3) non-profit organizations would not affect a substantial number of small organizations because these organizations may not be able to afford expensive radio and television advertising and, to the extent they can, they are already limited in what campaign activity they may engage in under the Internal Revenue Code. The changes in this proposed rule affect only communications made by these organizations that promote, support, attack or oppose a Federal candidate within a limited window of time before a Federal election. There are not a substantial number of small organizations that make such communications. Therefore, the proposed rule will not affect a substantial number of small organizations.

For reasons set out in the preamble, Subchapter A of Chapter 1 of title 11 of the Code of Federal Regulations would be amended as follows:

In the Rules and Regulations section of this issue of the Federal Register , we publish a temporary rule setting forth regulations to implement section 2002 of the Miscellaneous Trade and Technical Corrections Act of 2004, Pub. L. 108-429, 118 Stat. 2434 (“the Act”), signed by President Bush on December 3, 2004. Section 2002 of the Act revised section 5382(a) of the Internal Revenue Code of 1986 (IRC), 26 U.S.C. 5382(a), which sets forth standards regarding what constitutes proper cellar treatment of natural wine. The revision of section 5382(a) took effect on January 1, 2005, and includes new certification requirements for imported natural wine produced after December 31, 2004. The Alcohol and Tobacco Tax and Trade Bureau (TTB) is responsible for the administration of the IRC provisions relating to wine.

The temporary regulations published elsewhere in this issue of the Federal Register involve amendments to parts 4, 24, and 27 of the TTB regulations (27 CFR parts 4, 24, and 27). The text of the temporary regulations serves as the text of these proposed regulations. The preamble to the temporary regulations explains the proposed regulations.

We request comments from everyone interested. We are particularly interested in comments on the effect these regulatory requirements might have on U.S. importers who do not obtain their wine directly from foreign producers, and we would welcome any suggestions for alternative approaches that would be consistent with the restrictions on disclosing taxpayer and return information in 26 U.S.C. 6103. We are particularly interested in comments on the effect these regulatory requirements might have on U.S. importers who do not obtain their wine directly from foreign producers. All comments must reference Notice No. 51 and must include your name and mailing address. They must be legible and written in language acceptable for public disclosure. Although we do not acknowledge receipt, we will consider your comments if we receive them on or before the closing date. We regard all comments as originals.

All comments are part of the public record and subject to disclosure. Do not enclose any material in your comments that you consider confidential or inappropriate for public disclosure.

You may submit comments in any of five ways:

• Mail: You may send written comments to TTB at the address listed in the ADDRESSES section of this document.

• Facsimile: You may submit comments by facsimile transmission to 202-927-8525. Faxed comments must—

(1) Be on 8.5- by 11-inch paper;

(2) Contain a legible, written signature; and

(3) Be no more than five pages long. This limitation ensures electronic access to our equipment. We will not accept faxed comments that exceed five pages.

• E-mail: You may e-mail comments to nprm@ttb.gov . Comments transmitted by electronic mail must—

(1) Contain your e-mail address;

(2) Reference Notice No. 51 on the subject line; and

(3) Be legible when printed on 8.5- by 11-inch paper.

• Online form: We provide a comment form with the online copy of this document on our Web site at http://www.ttb.gov/alcohol/rules/index.htm . Select the “Send comments via email” link under Notice No. 51.

• Federal e-Rulemaking Portal: To submit comments to us via the Federal e-rulemaking portal, visit http://www.regulations.gov and follow the instructions for submitting comments.

You may also write to the Administrator before the comment closing date to ask for a public hearing. The Administrator reserves the right to determine, in light of all circumstances, whether to hold a public hearing.

You may view copies of the temporary rule, this document, and any comments we receive by appointment at the TTB Library at 1310 G Street, NW., Washington, DC 20220. You may also obtain copies at 20 cents per 8.5- x 11-inch page. Contact our librarian at the above address or telephone 202-927-2400 to schedule an appointment or to request copies of comments.

For your convenience, we will post the temporary rule, this document, and any comments we receive on the TTB Web site. We may omit voluminous attachments or material that we consider unsuitable for posting. In all cases, the full comment will be available in the TTB Library. To access the online copy of this document and the submitted comments, visit http://www.ttb.gov/alcohol/rules/index.htm . Select the “View Comments” link under this document's number and title to view the posted comments.

The collections of information contained in the temporary rule were submitted to the Office of Management and Budget (OMB) for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). Pending the review of public comments, OMB has approved the information collections under control number 1513-0119. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

The collections of information in this regulation are in § 4.45 and § 27.140. The first information collection involves consumer information under the Federal Alcohol Administration Act. The second information collection is required by the Internal Revenue Code of 1986 in connection with the importation of wine from foreign countries. Failure to provide the required information may result in administrative sanctions against the importer. The likely respondents are individuals and business or other for-profit institutions, including partnership, associations, and corporations.

• Estimated total annual reporting and/or recordkeeping burden: 6,600 hours.

• Estimated average annual burden per respondent/recordkeeper: 1.65 hours.

• Estimated number of respondents and/or recordkeeping: 4,000.

• Estimated annual number of responses: 20,000.

Comments on the collection of information may be sent by e-mail to OMB at Alexander_T._Hunt@omb.eop.gov , or by paper mail to Office of Management and Budget, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503. A copy should also be sent to TTB by any of the methods previously described. Comments should be submitted within the time frame that comments are due regarding the substance of the regulation.

Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the information collection burden; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the information collection burden on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimate of capital or start up costs and costs of operations, maintenance, and purchase of services to provide information.

Pursuant to the requirements of the Regulatory Flexibility Act (5 U.S.C. chapter 6), we certify that this notice of proposed rulemaking will not have a significant economic impact on a substantial number of small entities. The only new regulatory requirements involve reporting and recordkeeping and, as described above, the burdens associated with theses requirements are expected to be minimal. Accordingly, a regulatory flexibility analysis is not required. Pursuant to section 7805(f) of the Internal Revenue Code, we will submit this notice of proposed rulemaking to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small businesses.

We have determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required.

The principal author of this document was Jennifer K. Berry, Regulations and Procedures Division, Alcohol and Tobacco Tax and Trade Bureau. However, other personnel participated in its development.

For the reasons discussed in the preamble, TTB proposes to amend 27 CFR parts 4, 24, and 27 as follows:

As authorized by the VOCA, OVC generally provides federal financial assistance to states for the purpose of compensating and assisting victims of crime, provides funds for training and technical assistance services for victims of federal crimes, and provides funding and services for victims of terrorism and mass violence. This program is funded by fines, fees, penalty assessments, and bond forfeitures paid by federal offenders, as well as gifts from private individuals, deposited into the Crime Victims Fund in the U.S. Treasury.

These proposed regulations concern the administration of the ITVERP, as authorized by a 2000 VOCA amendment codified at 42 U.S.C. 10603c (the “Statute”).

Over the years, hundreds of nationals of the United States, and officers and employees of the U.S. government, have been killed or injured in heinous acts of international terrorism occurring outside the United States. Victims of acts of international terrorism occurring outside the United States face unique obstacles in securing assistance, compensation, and support, which is more readily available to victims of violent crime and domestic or international terrorism occurring within U.S. borders. Victims and family members often face immediate needs, such as covering medical care, funeral and burial, short-term lodging, and emergency transportation expenses. Language and cultural barriers can impair victims' ability to secure appropriate support. Moreover, resources for victim assistance vary widely from one country to the next. Many of the countries that have established victim reimbursement programs compensate only their own citizens, leaving American citizens without benefits. Although OVC provides funding to states to administer victim compensation programs, the programs administered by each state vary considerably; survivors of the same act of international terrorism occurring abroad may be residents of many different states, and thus receive different levels of compensation for similar injuries. Partially in recognition of this disparity of treatment, VOCA was amended so that states shall no longer be required to compensate victims of international terrorism occurring outside the United States, and the federal government shall oversee an expense reimbursement program for these victims. See Victims of Trafficking Violence Protection Act, Pub. L. 106-386, div. C, § 2003(c)(1), 114 Stat. 1464, 1544 to 1546; USA PATRIOT Act, Pub. L. 107-56, tit. VI, subtit. B, § 624(c), 115 Stat. 272, 373.

To be eligible to receive a reimbursement under this program, an individual victim of international terrorism abroad must be (as of the date on which the act of international terrorism occurred) either a national of the United States or an officer or employee of the U.S. government, which could include foreign nationals working for the U.S. government who may be killed or injured in an international terrorist attack. The term “national of the United States” has the meaning given the term in section 101(a) of the Immigration and Nationality Act (8 U.S.C. 1101(a)). The term “officer or employee of the United States Government” is defined in § 94.12 of these proposed regulations.

In addition, the Statute expressly requires that the individual victim must have suffered “direct physical or emotional injury or death as a result of an act of international terrorism occurring on or after December 21, 1988, with respect to which an investigation or prosecution was ongoing or was commenced after April 24, 1996.” No victim, however (or victim's family) may recover under this subpart, if the victim is found to be “criminally culpable” for the terrorist act. For the purposes of this program, the Attorney General shall determine whether there is a reasonable indication that an act of international terrorism has occurred.

The Statute provides that a victim eligible for reimbursement is “a person who suffered direct physical or emotional injury or death” as a result of an act of international terrorism. Pursuant to this requirement of “direct injury,” individuals present during the act of terrorism, as well as qualifying emergency responders who otherwise meet the eligibility requirements and deal with the immediate aftermath of the event, are covered. Accordingly, under the Statute, family members who were not present during the act of terrorism would not be “direct[ly]” injured and therefore could be reimbursed only on behalf of a victim who was present, and not in their own right. An analogous provision of VOCA, however, relating to “direct harm,” recognizes that family members also can be “direct[ly]” injured when the immediate victim at the time of or as a result of the act is a minor, incompetent, incapacitated, or is killed. See generally 42 U.S.C. 10607(e)(2). These regulations essentially incorporate that recognition into the eligibility provisions.

The determination that there is a reasonable indication that an act of international terrorism has occurred will ordinarily be made by the Attorney General, as soon as is practicable. The Attorney General may delegate the authority to make this determination, pursuant to 5 U.S.C. 301 and 28 U.S.C. 510. The Attorney General or official to whom authority is delegated will consult with the Director of National Intelligence, or such official to whom authority is delegated, in making this determination. In certain instances in which such a determination is not made until after a significant amount of time has passed, the Director of OVC may, at his discretion, extend the deadline for filing a claim.

In all cases, notice of the Attorney General's determination that there is a reasonable indication that an act of international terrorism has occurred, which would make reimbursement available under the ITVERP, will be posted on the OVC Web site at www.ovc.gov. Note: The determination that there is a reasonable indication that an act of international terrorism has occurred is only for the purposes of determining eligibility for reimbursement of expenses under this program. Such a determination should not be understood to apply in any other proceeding or matter, nor should it create any inference that prosecution is warranted.

The Statute provides that eligible victims of international terrorism may be reimbursed “for expenses associated with that victimization.” The language of the Statute restricts the ITVERP program to one that directly reimburses victims for actual out-of-pocket expenses. As shown in a chart appended to this regulation, there are five major categories of expenses for which claimants can seek reimbursement under the ITVERP: (1) Medical, including dental and rehabilitation costs; (2) mental health care; (3) property loss, repair, and replacement; (4) funeral and burial costs; and (5) miscellaneous expenses. Thus, under this proposed rule, reimbursement is not available for lost wages or non-monetary losses, such as for pain and suffering, loss of enjoyment of life, loss of consortium, etc.

In order to be eligible for payment, either a victim or an individual legally designated to represent a victim must submit application materials, that will have been approved in advance by the Office of Management and Budget (“OMB”). These materials are designed to be simple, but ordinarily will require submission of sufficient information to determine eligibility under the Statute and these regulations, legally justify a claim and, as appropriate, verify unreimbursed expenses incurred. It is anticipated that all such materials will be available electronically via the OVC Web site. Because the Statute authorizes that reimbursement may be made to victims of acts of international terrorism that occurred as early as December, 1988, there will likely be cases in which victims no longer have the original receipts for items or services for which they are seeking reimbursement. In cases of international terrorism that occurred before the establishment of the ITVERP (and also in cases in which the records have been destroyed or lost), at the discretion of the Director, OVC may accept an itemized list of expenses. In such cases, the victim, or his representative, must certify that original receipts are unavailable, and attest that the items and amounts submitted in the list are true and correct to the best of claimant's knowledge.

Other individuals, such as friends, family members, or attorneys, may assist the victim or representative in preparation of the application. But, in no instance (with a limited exception for interim emergency payments) shall individuals who do not meet the definition of a “victim” be allowed to file a claim or accept payment under a claim, unless that individual is a representative of the victim. OVC will communicate directly with the appropriate claimant concerning the disposition of each claim, fully explain reasons for denial of any claim, and provide referrals of alternate sources of assistance, as appropriate.

If necessary, a victim may submit supplemental documentation requesting payment for additional expenses after the initial claim is filed. Any intentional false claim for reimbursement may be subject to prosecution under 18 U.S.C. 1001 (false statement made to the United States Government).

Recognizing that victims of international terrorism abroad may have difficulty accessing the resources needed to address immediate financial needs, OJP has included a provision in the proposed ITVERP regulations that would allow victims to apply for immediate partial reimbursement. A victim may apply for an interim emergency payment in cases in which the time that it would take for OVC to do a complete review of a claim would cause substantial hardship. Such payment may be used to cover immediate expenses such as those of medical care, funeral and burial, short-term lodging, and emergency transportation.

A chart detailing the categories of expenses and applicable limits may be found below, at the end of these regulations.

Under the terms of the Statute and Title VIII of the Omnibus Diplomatic Security and Antiterrorism Act of 1986, the amount of expenses reimbursed to a victim must be reduced by any amount of reimbursement that the victim receives under Title VIII in connection with the same act of international terrorism. OJP looked at the types of compensation and benefits that are considered collateral sources under Title VIII, 10 U.S.C. 1051(b), which provides that—

Consistent with this section, OJP has determined that sources that provide reimbursement for specific expenses under the ITVERP—e.g., health, property, and funeral insurance—are considered collateral sources. Life insurance proceeds are not considered a collateral source, as they do not compensate for specific expenses. This definition of collateral sources is consistent with other provisions relating to crime victim reimbursement programs under VOCA.

Any lump sum payment from the United States or a foreign government source that provides general compensation will be considered a collateral source, unless that payment is in the nature of reimbursement for a specific category of expenses that is not covered under the ITVERP. For example, if a claimant receives payment from a government to provide compensation for a claimant's car that is destroyed as a result of an act of international terrorism, such payment is not considered a collateral source under the ITVERP, which does not reimburse for that particular expense.

In cases in which another organization chooses to provide supplemental reimbursement in a certain category, beyond the ITVERP limit in that category, the supplemental reimbursement will not be considered a collateral source, and thus will not reduce the amount that the claimant receives from the ITVERP. For example, if reimbursement in the category of “mental health” were limited to 12 months, state compensation programs providing additional compensation in excess of the limit under ITVERP would not be counted as collateral sources. Thus, for example, if an eligible victim's mental health expenses extended beyond 12 months, and a state wished to reimburse him for an additional period of time, OJP would not consider the state reimbursement to be a collateral source, and would not reduce the award under the ITVERP. The victim could receive the maximum reimbursement within that category under the ITVERP in addition to the state reimbursement.

The Statute provides that reimbursement will be denied to “any individual who is criminally culpable for the terrorist act.” Thus, no victim (or family member thereof) who is responsible for an act of international terrorism will be allowed to be reimbursed. For example, neither a “suicide bomber” nor his family will be reimbursed following his injury or death.

Similarly, reimbursement may be reduced or denied, at the discretion of the Director, to specific individuals whose illegal or grossly reckless conduct at the time of the act of international terrorism materially contributed to their death or injury; this is not intended to apply to individuals such as international relief and humanitarian aid workers within organizations whose primary purpose is to provide charitable aid or a service in the public interest—often under dangerous conditions.

If, after conducting a review of a claimant's written appeal, the Assistant Attorney General determines that an oral hearing is warranted, the hearing may be conducted by an individual to whom the Assistant Attorney General has delegated that responsibility.

Prior to drafting these regulations, OJP consulted with individuals and working groups comprised of federal and state government officials, victims of international terrorism, victim advocates, and non-governmental victim organizations on various concepts related to compensation for victims of international terrorism. OJP officially convened working group meetings in June 2001 and February 2002. In addition, many other discussions, informal meetings, and draft reviews were held by OJP throughout the development of these regulations, from February 2001 until the publication of these proposed regulations in the Federal Register . Federal government agencies participating in these working groups and discussions included the Department of State, the Federal Bureau of Investigation, the United States Agency for International Development, the Department of Defense, the Office of Personnel Management, and the National Transportation Safety Board. State crime victim compensation program representatives from New Jersey, Virginia, Oklahoma, and Idaho also participated in working group meetings, as did a representative from the National Association of Crime Victim Compensation Boards. OJP also sought input from victims who would be eligible to apply for this program.

Whenever possible, OJP attempted to address the concerns raised during the working group sessions and in meetings with various groups. For example, in response to concerns that it would cause hardship for some victims who may be unable to produce receipts for expenses incurred, the proposed ITVERP regulations allow, at the discretion of the Director, victims to certify that the receipts are unavailable, and to provide an itemized list of expenses.

In certain instances, however, concerns were raised that could not be fully addressed, such as the suggestion that, in drafting regulations for the ITVERP, OJP replicate the September 11th Victim Compensation Fund of 2001. The statute authorizing the September 11th Victim Compensation Fund is radically different, however, from the statute authorizing the ITVERP, in the scope of compensation that is mandated. For instance, the September 11th Victim Compensation Fund was not an expense-based program, as the ITVERP is required by statute to be. In noting that various individuals and groups participated in meetings and discussions with OJP staff, OJP does not wish to imply that these individuals or groups have or have not endorsed the provisions contained within these proposed regulations.

This regulation has been drafted and reviewed in accordance with Exec. Order No. 12866, section 1(b), 58 FR 51735 (Sept. 30, 1993), Principles of Regulation. OJP has determined that this rule is a “significant regulatory action” under Executive Order No. 12866, and accordingly, this rule has been reviewed by the Office of Management and Budget.

This regulation will not have a substantial direct effect on the states, on the relationship between the national government and the states, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Exec. Order No.13132, 64 FR 43255 (Aug. 4, 1999), it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

This rule has no cost to state, local, or tribal governments, nor to the private sector. The ITVERP is funded by fines, fees, penalty assessments, and forfeitures paid by federal offenders, as well as gifts from private individuals, deposited into the Crime Victims Fund in the U.S. Treasury, and set aside in the Antiterrorism Emergency Reserve Fund, whose funds may not be obligated in an amount above $50 million in any given year. The cost to the federal government consists both of administrative expenses and amounts reimbursed to victims. Both types of costs depend on the number of claimants, prospective as well as retroactive. Because of the statutory cap on spending and the number of potential retroactive claimants (approximately 900), it is expected that the program may spend the statutory maximum of $50 million each year for the first 2-3 years of the program's operation.

These proposed regulations will not have a significant economic impact on a substantial number of small entities. These regulations have no cost to state, local, or tribal governments, nor to the private sector. The ITVERP is funded by fines, fees, penalty assessments, and bond forfeitures paid by federal offenders, as well as gifts from private individuals, deposited into the Crime Victims Fund in the U.S. Treasury. Therefore, an analysis of the impact of these regulations on such entities is not required under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

The collection of information requirements contained in these proposed regulations have been submitted to the Office of Management and Budget, pursuant to the Paperwork Reduction Act (44 U.S.C. 3506). Applicants seeking reimbursement from this program will be required to submit an official application form (the International Terrorism Victim Expense Reimbursement Program Application), that has been created by OJP. This application is a new information collection instrument that will be used to collect necessary information from and about the victims and claimants regarding expenses incurred by them, to be used by OJP in making a reimbursement determination. The total number of respondents (including both direct victims and family members) for this collection is estimated to be 2,000. This represents the estimated number of claimants who are currently eligible to request reimbursement under the ITVERP. The total initial public burden associated with this initial information collection is estimated to be approximately 1,500 hours. The amount of time for an average respondent to respond/reply is estimated to be approximately 45 minutes.

Written comments regarding the application form should be directed to OMB, Office of Information and Regulation Affairs, Attention: Department of Justice Desk Officer, Washington, DC 20503, (202) 395-5806. Suggestions or questions regarding the application form, including requests for copies of the proposed information collection instrument with instructions, should be directed by U. S. mail, to: ITVERP, Office for Victims of Crime, U.S. Department of Justice, 810 7th Street, NW., Washington, DC 20531; by facsimile at: (202) 514-6383; or by e-mail, at: ITVERP@usdoj.gov.

Your comments are solicited to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including whether the information will have practical utility; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including making available appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, such as permitting electronic submission of responses. OMB is required to make a decision concerning the collection of information contained in these proposed regulations between 30 and 60 days after publication of this document in the Federal Register . Therefore, to ensure full consideration by OMB, comments should be received within 30 days of publication. This does not affect the deadline for the public to submit comments to the Department on the proposed regulations.

This rule 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.

Accordingly, for the reasons set forth in the preamble, Title 28 of the Code of Federal Regulations is proposed to be amended to add a new Part 94, to read as follows:

For additional information, see the direct final rule which is published in the Rules section of this Federal Register .

In addition to the publicly available docket materials available for inspection electronically in Regional Material in EDocket, and the hard copy available at the Regional Office, which are identified in the ADDRESSES section above, copies of the state submittal and EPA's technical support document are also available for public inspection during normal business hours, by appointment at The Bureau of Air Quality Control, Department of Environmental Protection, First Floor of the Tyson Building, Augusta Mental Health Institute Complex, Augusta, ME 04333-0017.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at your estimate.

5. Provide specific examples to illustrate your concerns.

6. Offer alternatives.

7. Make sure to submit your comments by the comment period deadline identified.

8. To ensure proper receipt by EPA, identify the appropriate regional file/rulemaking identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

The following outline is provided to aid in locating information in this document.

On March 24, 2005, Maine Department of Environmental Protection (DEP) submitted an exemption request from the requirements for NO X control contained in Section 182(f) of the Clean Air Act (CAA or Act) for the Northern Maine area (specifically, Oxford, Franklin, Somerset, Piscataquis, Penobscot, Washington, Aroostook, and portions of Hancock and Waldo Counties). On April 19, 2005 and June 28, 2005, Maine DEP submitted additional analyses to EPA justifying its waiver request, which EPA is using as a basis for this proposal. All submittals are available in the docket.

The area for which Maine is requesting a waiver, along with the rest of the State of Maine, are part of the Ozone Transport Region as provided for in section 184(a) of the Act. In addition, the waiver area is designated unclassifiable/attainment for the 8-hour ozone standard. Section 182(f) in combination with section 184 (relating to ozone transport regions) of the Act requires States in the OTR, such as Maine, to adopt reasonably available control technology (RACT) rules for major stationary sources of nitrogen oxides and to provide for nonattainment area new source review for new sources and modifications that are major for NO X . This exemption request, is based on a demonstration that NO X emissions in this area are not impacting Maine's ozone nonattainment areas or any other ozone nonattainment area in the OTR during times when elevated ozone levels are monitored in those areas. As such, additional reductions in NO X emissions from this area beyond what the State regulations already provide for are not necessary for future attainment in any of Maine's ozone nonattainment areas or other ozone nonattainment area in the OTR. Thus, as provided for in section 182(f)(2), additional NO X reductions in these areas would constitute excess reductions that can be waived under the Act. A Technical Support Document (TSD) has been prepared for this action. The TSD is available in the docket.

The air quality planning requirements for the reduction of NO X emissions are set out in section 182(f) of the Act. Section 182(f) of the Act requires states with areas designated and classified as moderate nonattainment and above for ozone, or in ozone transport regions, to impose the same control requirements for major stationary sources of NO X as apply to major stationary sources of volatile organic compounds (VOC). These requirements include the adoption of RACT rules for major stationary sources and nonattainment area NSR for major new sources and major modifications. Section 182(f) provides further that these requirements do not apply for nonattainment areas inside an ozone transport region if EPA determines that reductions of NO X from such areas would not contribute to net ozone benefits in the OTR. In addition, implementation of NO X controls may be limited if EPA determines it is necessary to avoid achieving excess reductions. Also, NO X -related general conformity provisions do not apply in an area that is granted a section 182(f) exemption. The area for which Maine is requesting a NO X waiver is designated unclassifiable/attainment for the 8-hour ozone standard and does not have any 8-hour ozone conformity requirements.

The area for which Maine DEP has requested a waiver includes the following counties: Oxford, Franklin, Somerset, Piscataquis, Penobscot, Washington, and Aroostook. Also included in the area requested for a waiver are the portions of Waldo and Hancock Counties that are designated unclassifiable/attainment for the 8-hour ozone standard. In Waldo County, this includes the following towns: Belfast, Belmont, Brooks, Burnham, Frankfort, Freedom, Jackson, Knox, Liberty, Lincolnville, Monroe, Montville, Morrill, Northport, Palermo, Prospect, Searsmont, Searsport, Stockton Springs, Swanville, Thorndike, Troy, Unity, Waldo, and Winterport. In Hancock County, this includes the following towns and townships: Amherst, Aurora, Bucksport, Castine, Dedham, Eastbrook, Ellsworth, Franklin, Great Pond, Mariaville, Orland, Osborn, Otis, Penobscot, Verona, Waltham, Oqiton Township (T4 ND), T3 ND, T39 MD, T40 MD, T41 MD, T32 MD, T34 MD, T35 MD, T28 MD, T22 MD, T16 MD, T8 SD, T9 SD, T10 SD, and T7 SD.

As stated above, each of the counties or partial counties for which Maine DEP is seeking an exemption is within the OTR. For attainment areas within the OTR, the application of NO X requirements under the CAA may be limited if it is shown that additional NO X reductions are excess to the attainment needs throughout the region. EPA believes, in the case of these areas in Maine at the northern extremity of the OTR, that NO X requirements can be waived because the Maine DEP has submitted an acceptable demonstration that additional reductions beyond what the state regulations already provide for are not necessary for the nonattainment areas in the state to attain, because emissions from this area are not contributing to the ozone nonattainment problem in any other nonattainment area in the OTR, and because reductions in this area are not necessary for purposes of showing future attainment anywhere in the OTR. Maine DEP has made this showing through air modeling trajectory analyses, NO X emission analysis, and meteorological analyses. Most of this same geographic area in Maine received approval by EPA of a similar NO X waiver request under the 1-hour ozone standard on December 26, 1995 (60 FR 66748). At this time, the 1-hour NO X waiver remains as approved in 1995. The implementation policy for the 8-hour ozone standard (69 FR 23951) requires areas to request a separate waiver under the 8-hour ozone standard. This is the only area in the OTR that received a NO X waiver under the 1-hour ozone standard, and is the first area in the OTR to request a NO X waiver under the 8-hour ozone standard.

If the EPA Administrator determines, under section 182(f) of the Act, that additional reductions of NO X are excess, the area at issue shall automatically ( i.e. , a State would not need to submit an exemption request for each requirement) be exempt from the following requirements (as applicable): Inspection and Maintenance program NO X requirements, the NO X -related general conformity provisions, the NO X -related transportation conformity provisions in 40 CFR part 93, NO X RACT, and nonattainment area NSR for new sources and modifications that are major for NO X .

I/M is not required in any portion of Northern Maine, therefore, EPA's action on this request has no impact on I/M requirements.

The transportation conformity rule requires emissions analysis of motor vehicle NO X emissions for ozone nonattainment and maintenance areas in order to determine the conformity of transportation plans and programs to state implementation plan requirements. The waiver area is currently designated unclassifiable/attainment for the 8-hour standard, and does not need to do transportation conformity. General conformity is also not required in this area. Because conformity is not required in this area, EPA's action on this request has no impact on any conformity requirements.

The criteria established for the evaluation of an exemption request from the section 182(f) requirements are set forth in a memorandum from Stephen D. Page, Director, OAQPS, dated January 14, 2005, and titled: “ Guidance On Limiting Nitrogen Oxides Requirements Related To 8-Hour Ozone Implementation. ”

On March 24, 2005, the Maine DEP submitted an exemption request from the requirements contained in section 182(f) of the CAA for Northern Maine. In all, EPA received three submittals from Maine. The initial request dated March 24, 2005, and a first supplement dated April 19, 2005, and a second supplement dated June 28, 2005.

This exemption request is based on a demonstration that NO X emissions in this multi-county area are not impacting Maine's two 8-hour ozone nonattainment areas or other 8-hour ozone nonattainment areas in the OTR during times when elevated 8-hour ozone levels are monitored in those areas. As such, additional reductions in NO X emissions from these counties ( i.e. , NO X reductions beyond what the state regulations provide for) are not necessary for the two nonattainment areas in the State to attain and are also not necessary for 8-hour ozone attainment purposes anywhere in the OTR. Under these circumstances, as section 182(f)(2) provides, such additional reductions may be waived as excess reductions.

Maine submitted a detailed technical analysis showing that NO X emissions from the proposed NO X waiver area do not impact either of the two 8-hour nonattainment areas in Maine or any other 8-hour ozone nonattainment in the OTR. The request relies on several different techniques to prove Maine's case, with the primary technique being back trajectories using the HYSPLIT trajectory model.

Maine DEP created back trajectories for each day that experienced an 8-hour ozone exceedance in either of Maine's nonattainment areas during 1998 through 2004 time period. When 8-hour exceedances for a given day were recorded in either of Maine's 8-hour nonattainment areas, back trajectories were run from locations in each of the nonattainment areas. For each ozone exceedance that was analyzed, back trajectories were run for each hour that recorded ozone in excess of 0.08 parts per million, and run for multiple heights in the atmosphere. In all, Maine DEP ran over 1000 back trajectories for 61 separate exceedance days during 1998 to 2004.

Maine then analyzed each of these back trajectories to see if there was potential impact from the NO X waiver area. These trajectory analyses show convincingly that the source region for Maine's 8-hour ozone exceedances are to the south and west of southern Maine. The trajectories also show convincingly that the proposed NO X waiver area does not contribute to Maine's 8-hour ozone nonattainment problems. This is identical to the conclusion that was reached for 1-hour ozone exceedances in southern Maine for the 1-hour NO X waiver approved by EPA in 1995.

In addition, Maine provided NO X emission inventory data for the entire OTR and additional meteorological analyses to add further evidence that the proposed NO X waiver area does not contribute to ozone nonattainment in the two nonattainment areas of Maine or anywhere in the OTR. Whenever there are 8-hour ozone exceedances in New Hampshire or Massachusetts, the two states nearest to Maine, the winds are not from Maine. Therefore, Maine does not contribute to ozone nonattainment in Massachusetts, nor New Hampshire, the only two states in the OTR, outside Maine, where it is reasonable to expect that Maine's emissions might potentially contribute to ozone nonattainment. Moreover, EPA has performed extensive air quality modeling throughout the Northeast over the past several years in support of its Clean Air Interstate Rule (CAIR), and the ozone modeling domain used for the CAIR rule covers much of northern Maine. In the CAIR rulemaking, EPA did not find that Maine was significantly contributing to future ozone nonattainment anywhere in the CAIR domain, which includes the rest of the OTR plus most of the eastern half of the United State. Thus, the State of Maine was not included in the CAIR rule. EPA's CAIR modeling plus the data provided in Maine's submittals support this proposed approval of Maine's NO X waiver request.

EPA's review of this request indicates that a NO X waiver is justified for Northern Maine. A TSD has been prepared on this action and contains a detailed analysis of Maine's request. EPA is proposing to approve the exemption request for the Northern Maine area from the Section 182(f) NO X requirements. EPA is soliciting public comments on the issues discussed in this notice or on other relevant matters. These comments will be considered before taking final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to the EPA New England Regional Office listed in the ADDRESSES section of this notice.

EPA is proposing to approve the exemption request for the Northern and Western Maine area from the section 182(f) NO X requirements based upon the evidence provided by the State and the State's compliance with the requirements outlined in the applicable EPA guidance. This action proposes to exempt Oxford, Franklin, Somerset, Piscataquis, Penobscot, Washington, Aroostook, and portions of Hancock and Waldo counties from the requirements of nonattainment area NSR for new sources and modifications that are major for NO X , and NO X RACT on existing sources. If EPA determines based on future air quality analyses that NO X controls in this area are necessary for ozone attainment purposes, rulemaking may be initiated which may mean that this NO X exemption no longer applies.

EPA is soliciting public comments on the issues discussed in this proposal or on other relevant matters. These comments will be considered before EPA takes final action. Interested parties may participate in the federal rulemaking procedure by submitting written comments to the EPA New England Regional Office listed in the ADDRESSES section of this action, or by submitting comments electronically, by mail, or through hand delivery/courier following the directions in the SUPPLEMENTARY INFORMATION, I. General Information section of this action.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). The proposed exemption does not create any new requirements, but allows suspension of the indicated requirements for the life of the exemption. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule suspends certain requirements, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have federalism implications because it does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state request to waive certain requirements, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove this submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a waiver request to require VCS in a submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. )

Regulated entities. Entities that will potentially be affected by the proposed amendments are those that produce HCl and are major sources of hazardous air pollutants (HAP) as defined in section 112 of the Clean Air Act (CAA). The regulated categories and entities include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that we are now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your facility, company, business, organization, etc., is regulated by this action, you should carefully examine the applicability criteria in section 63.8985 of the HCl Production NESHAP. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Submitting CBI. Do not submit this information to EPA through EDOCKET, regulations.gov or e-mail. Send or deliver information identified as CBI only to the following address: Roberto Morales, OAQPS Document Control Officer, Mailcode C404-02, U.S. EPA, Research Triangle Park, NC 27709, Attention Docket ID No. OAR-2002-0057. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

Tips for Preparing Your Comments. When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns, and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• Make sure to submit your comments by the comment period deadline identified.

World Wide Web (WWW). The text of today's document will also be available on the WWW through the Technology Transfer Network (TTN). Following signature, a copy of this action will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules http://www.epa.gov/ttn/oarpg. The TTN provides information and technology exchange in various areas of air pollution control.

Outline. The information presented in this preamble is organized as follows:

Section 112 of the CAA requires us to list categories and subcategories of major sources and area sources of HAP and to establish NESHAP for the listed source categories and subcategories. Hydrochloric acid production and fume silica production were listed as source categories under the production of inorganic chemicals group on EPA's initial list of major source categories (57 FR 31576, July 16, 1992). We later combined these two source categories for regulatory purposes and renamed the combined source category “HCl Production” (66 FR 48174, September 18, 2001). The next revision to the source category list will reflect this change. Major sources of HAP are those that have the potential to emit greater than 10 tons per year (tpy) of any one HAP or 25 tpy of any combination of HAP. The CAA requires the national emission standards for HAP to reflect the maximum degree of reduction in HAP emissions that is achievable. This level of control is commonly known as the maximum achievable control technology (MACT).

On April 17, 2003, EPA published final standards (68 FR 19076) for the control of HAP from HCl production (40 CFR part 63, subpart NNNNN). The final rule contains emission limitations and standards applicable to HCl and chlorine (Cl 2 ). These limits apply to each new or existing HCl process vent, HCl storage tank, HCl transfer operation, and leaks from equipment in HCl service located at a major source of HAP.

After promulgation, some applicability- and compliance-related issues, in addition to several inadvertent omissions and typographical errors, were identified. We are proposing today's amendments to address these issues.

We are proposing to amend 40 CFR part 63, subpart NNNNN, to change the applicability provisions, to clarify testing, monitoring, and reporting requirements, and to correct inadvertent omissions and typographical errors. A summary of each of the proposed amendments to 40 CFR part 63, subpart NNNNN, and the rationale for each is presented below.

In order to avoid regulatory overlap, the HCl Production NESHAP exempts certain HCl production facilities that are part of other source categories and subject to other Federal standards. We intended the HCl Production NESHAP to cover only those HCl production facilities that were not subject to any other MACT standards and not to cover those HCl production facilities that were subject to other MACT standards. Today's proposed amendments would change the applicability provisions to rectify three situations that came to our attention after promulgation of the HCl Production NESHAP in which this intent was not satisfied.

First, the proposed amendments would address the HCl Production NESHAP's exemptions for HCl production facilities that are subject to certain other regulations, including 40 CFR part 63, subpart EEE (the Hazardous Waste Combustors NESHAP), and 40 CFR 266.107, subpart H (regulations issued under the Resource Conservation and Recovery Act governing the Burning of Hazardous Wastes in Boilers and Industrial Furnaces). 1 As currently worded, the exemptions are overly broad, because neither of the final rules covers emissions of HCl from HCl storage tanks, HCl transfer operations, or leaks from equipment in HCl service at these facilities. This leaves these emission points not subject to any Federal standards, which was not our intent. Therefore, we are proposing to amend subpart NNNNN of 40 CFR part 63 to exempt facilities that are subject to subpart EEE of 40 CFR part 63 or subpart H of 40 CFR part 266 and that meet the applicability requirements of subpart NNNNN from only the HCl process vent provisions of subpart NNNNN, rather than from all of the requirements of subpart NNNNN. Because the purpose of 40 CFR 63.8985(b) and (c) is to provide exemptions from all of the requirements of subpart NNNNN for entire HCl production facilities subject to certain other rules, we are proposing to remove 40 CFR 63.8985(b)(4) and (c)(3) to eliminate the overly broad exemptions and instead to add new paragraphs to 40 CFR 63.9000(c) to accomplish the proposed amendments. The purpose of 40 CFR 63.9000(c) is to exempt certain emission streams from subpart NNNNN. Under proposed 40 CFR 63.9000(c), plants that are subject to subpart EEE of 40 CFR part 63 or subpart H of 40 CFR part 266 and that meet the other applicability provisions of subpart NNNNN would be affected sources under subpart NNNNN but would be exempt from the process vents provisions of subpart NNNNN.

Second, the proposed amendments would revise the HCl Production NESHAP's exemptions for specific emission streams to eliminate duplicative regulation. Some emission points that are not themselves subject to subpart EEE of 40 CFR part 63 have their emissions controlled under subpart EEE because their emissions are routed directly through equipment that is subject to subpart EEE (e.g., an HCl process vent emission stream routed to a hazardous waste combustor for use as supplemental combustion air). Currently, these emissions (e.g., from the combustor) are regulated by both subpart EEE and subpart NNNNN of 40 CFR part 63. To rectify this situation, we are proposing to add a new paragraph to 40 CFR 63.9000(c) to include an emission stream-specific exemption for HCl process vents, HCl storage tanks, and HCl transfer operations that are routed directly to hazardous waste combustors subject to subpart EEE. This means that under the proposal, HCl production facility emission streams that are routed to subpart EEE hazardous waste combustors would be exempt from the requirements of subpart NNNNN.

Finally, the proposed amendments would remove the HCl Production NESHAP's exemption for HCl production facilities subject to 40 CFR 264.343(b), subpart O (Incinerators), which will no longer be necessary. A combustor that burns hazardous waste and meets the subpart NNNNN of 40 CFR part 63 definition of an HCl production facility would be defined as a halogen acid furnace (currently subject to 40 CFR 266.107, subpart H, and that would be subject to 40 CFR part 63, subpart EEE, under EPA's proposal at 69 FR 21198), not an incinerator (subject to 40 CFR 264.343(b), subpart O). As discussed above, we are proposing to amend the applicability provisions of the HCl Production NESHAP to properly address HCl production facilities that are subject to subpart H. Therefore, the exemption for subpart O will no longer be necessary, and we are proposing to remove 40 CFR 63.8985(c)(2), which provided this exemption. Consequently, we are proposing to incorporate the exemption provided in 40 CFR 63.8985(c)(1) into 40 CFR 63.8985(c), thus removing 40 CFR 63.8985(c)(1).

We are proposing to clarify the meaning of “equipment in HCl service,” which is defined in the HCl Production NESHAP as “each pump, compressor, agitator, pressure relief device, sampling connection system, open-ended valve or line, valve, connector, and instrumentation system that contains 30 weight percent or greater of liquid HCl or 5 weight percent or greater of gaseous HCl at any time” (see 40 CFR 63.9075). This definition could be interpreted to include equipment that is located at the same plant site as an “HCl production facility” (see 40 CFR 63.8985(a)(1)) but is not part of the HCl production facility. We intended to include only equipment that meets the above definition and is located within an HCl production facility. Therefore, we are proposing to amend the definition of “equipment in HCl service” in 40 CFR 63.9075 to clarify that the definition applies only to equipment within an HCl production facility.

The HCl Production NESHAP specifies the emission limits for existing and new HCl process vents, HCl storage tanks, and HCl transfer operations in two forms—a percent reduction and an outlet concentration—and allows HCl production facilities to comply with either one. However, the wording of the emission limits could be construed to require the use of an add-on control device even when an emission point meets the outlet concentration emission limit without an add-on control device. It was not our intent to require add-on control devices when they are unnecessary for compliance. While a percent reduction emission limit would need to be achieved through the use of an add-on control device, we recognize that an outlet concentration emission limit could be achieved through other means (e.g., process changes, pollution prevention). Therefore, we are proposing to amend table 1 to subpart NNNNN of 40 CFR part 63 to clarify that it is not necessary to use an add-on control device in order to meet the outlet concentration form of the emission limits. In addition, we are proposing to amend tables 3 and 5 to subpart NNNNN to specify the sampling port location and continuous compliance requirements, respectively, for sources that are not equipped with an add-on control device. Also, we are proposing to amend 40 CFR 63.9015(a) to require that emission points meeting the outlet concentration limits without the use of a control device conduct subsequent performance tests when process changes are made that could reasonably be expected to change the outlet concentration. Finally, we are proposing to amend 40 CFR 63.9050 by adding paragraph (c)(9), which specifies that compliance reports must include verification that no process changes that could reasonably be expected to change the outlet concentration have been made since the last performance test.

The HCl Production NESHAP is silent on the issue of how maintenance is to be conducted on HCl storage tank control devices. This could lead to uncertainty over whether an HCl storage tank would need to be emptied before the associated control device could be disconnected for maintenance purposes. It was not our intent that an HCl storage tank would need to be emptied prior to maintenance because the standing losses associated with a full or partially-full HCl storage tank are low, when compared to the emissions that occur from filling and emptying the tank. To clarify our intent, we are proposing to amend 40 CFR 63.9000, by adding paragraph (d), to allow HCl production facilities to perform planned routine maintenance on each HCl storage tank control device for up to 240 hours per year without emptying the contents of the tank. During this time, the storage tank emission limitations would not apply. Also, we are proposing to amend 40 CFR 63.9050, by adding paragraph (c)(10), and 40 CFR 63.9055, by adding paragraph (b)(6), to specify the reporting and recordkeeping requirements for planned routine maintenance events. These provisions are consistent with other NESHAP to which plant sites containing HCl production facilities may be subject.

The HCl Production NESHAP requires the submission of a Notification of Compliance Status (NOCS) to the Administrator when a performance test is conducted (see 40 CFR 63.9045(a), table 7 to subpart NNNNN of 40 CFR part 63, and 40 CFR 63.9(h)). It could be interpreted that 40 CFR 63.9045(e) and (f) require the submission of a separate NOCS for each performance test that is conducted (e.g., on each emission point). It is more efficient and no less effective for HCl production facilities to submit one NOCS for the entire affected source, rather than one NOCS for each emission point tested, and it was not our intent to require unnecessary paperwork. Therefore, we are proposing to amend 40 CFR 63.9045 to change the submission procedures for NOCS. We are proposing to allow NOCS to be submitted within 240 calendar days of the compliance dates for subpart NNNNN of 40 CFR part 63. The amendment would allow for the submission of only one NOCS per affected source because the notification is due 60 days after all performance tests are required to be conducted. We are also proposing to amend table 7 to subpart NNNNN to reflect this change to the NOCS submission procedures.

The HCl Production NESHAP requires submission of the initial site-specific monitoring (40 CFR 63.9005(d)) and LDAR (LDAR; table 1 to subpart NNNNN of 40 CFR part 63) plans to the Administrator with a source's NOCS. The final rule does not, however, specify when or how revisions to these plans should be submitted, only that they should be submitted (40 CFR 63.9055(b)(5)). Submission of revisions to these plans is most efficiently done in conjunction with the semi-annual compliance report required by 40 CFR 63.9050. Therefore, we are proposing to amend 40 CFR 63.9050(c) by adding paragraph (c)(8) to require submission of revisions to site-specific monitoring plans and LDAR plans with semi-annual compliance reports, if revisions have been made during the reporting period.

We are proposing to add an exemption which was inadvertently omitted from the HC1 Production NESHAP. In the preamble to the final rule (68 FR 19082), we indicated that we would include an exemption for HC1 production facilities subject to 40 CFR 63.994, subpart SS. Because this exemption was not included in the final rule text, we are proposing to amend the rule to include it. Because we are proposing to remove 40 CFR 63.8985(b)(4), we are proposing to replace it with the exemption for 40 CFR 63.994, subpart SS.

We are proposing to remove the phrase “/Cl 2 ” from 40 CFR 63.8990(b)(4) to reflect a change made between the proposed rule and the final rule which was retained incorrectly in the final rule. The proposed rule used the term “in HCl/Cl 2 service,” but we wrote this term as “equipment in HCl service” in the final rule. We are proposing to make the same change in the first column of table 1, item 4 of subpart NNNNN of 40 CFR part 63.

We are proposing to correct an inaccurate reference in 40 CFR 63.9025(a) regarding operating parameters. The reference should be to 40 CFR 63.9020(e), which requires operating parameters to be established, rather than to 40 CFR 63.9020(d). This was a typographical error in the final rule.

We are proposing to correct an inaccurate reference in the definition of “HCl production facility” in 40 CFR 63.9075. The reference to 40 CFR 63.8985(a)(i) should be to 40 CFR 63.8985(a)(1) because 40 CFR 63.8985(a)(i) does not exist. This was a typographical error in the final rule.

Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), EPA must determine whether the regulatory action is “significant” and, therefore, subject to review by the Office of Management and Budget (OMB) and the requirements of the EO. The EO defines a “significant regulatory action” as one that is likely to result in a rule that may:

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

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

(3) Materially alter the budgetary impact of entitlement, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the EO.

Pursuant to the terms of EO 12866, OMB has notified EPA that it considers this a “significant regulatory action” within the meaning of the EO. EPA has submitted this action to OMB for review. Changes made in response to OMB suggestions or recommendations will be documented in the public record.

The OMB has approved the information collection requirements in the 2003 NESHAP for HCl production under the requirements of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , and has assigned OMB control number 2060-0529. EPA has prepared a revision to the currently approved information collection request (ICR), and you may obtain a copy of the currently approved ICR and the revised ICR from Susan Auby by mail at the U.S. EPA, Office of Environmental Information, Collection Strategies Division (2822T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460, by e-mail at auby.susan@epa.gov, or by calling (202) 566-1672. Copies may also be downloaded off the internet at http://www.epa.gov/icr. Most of the proposed amendments are not expected to have an impact on the ICR burden. However, the ICR has been revised because two of today's proposed rule amendments are expected to change the burden slightly. The proposed exemption for individual emission streams that are routed to 40 CFR part 63, subpart EEE, hazardous waste combustors is expected to decrease the reporting and recordkeeping burden for some sources. The planned routine maintenance allowance is expected to increase the reporting and recordkeeping burden for all sources. Overall, the total annual reporting and recordkeeping burden is expected to be 733 hours (1 percent) lower than for the final rule.

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

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as a small business according to Small Business Administration (SBA) size standards by the North American Industry Classification System (NAICS) category of the owning parent entity. The small business size standard for the affected industries (NAICS 325181, Alkalies and Chlorine Manufacturing, and NAICS 325188, All Other Basic Inorganic Chemical Manufacturing) is a maximum of 1,000 employees for an entity.

After considering the economic impact of today's proposed rule on small entities, I certify that this action will not have a significant impact on a substantial number of small entities. In accordance with the RFA, as amended by the SBREFA, 5 U.S.C. 601, et seq. , we conducted an assessment of the final rule on small businesses within the industries affected by the final rule. This analysis allowed us to certify that there would not be a significant impact on a substantial number of small entities from the implementation of the final rule. There is nothing contained in the proposed amendments that will impact small businesses in any way not considered in the analysis of the final rule; this means that the proposed amendments have no incremental impact on small businesses beyond what was already examined in the final rule. We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least-costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. Today's proposed amendments contain no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, or Tribal governments. EPA has determined that the proposed amendments do not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any 1 year. Thus, today's proposed amendments are not subject to the requirements of sections 202 and 205 of the UMRA.

Executive Order 13132 (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the EO to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” The proposed amendments do not have federalism implications. They will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in EO 13132. None of the affected facilities are owned or operated by State governments. Thus, EO 13132 does not apply to the proposed amendments.

Executive Order 13175 (65 FR 67249, November 6, 2000) requires EPA to develop an accountable process to ensure “meaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications.” The proposed amendments will not have Tribal implications, as specified in EO 13175. They will not have substantial direct effects on Tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. No Tribal governments own facilities subject to the HC1 Production NESHAP. Thus, EO 13175 does not apply to these proposed amendments.

Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under EO 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, EPA must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. EPA interprets EO 13045 as applying only to regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. The proposed amendments are not subject to EO 13045 because they are based on technology performance and not on health or safety risks. Nor are the proposed amendments “economically significant” under EO 12866, as discussed in section III(A) of this preamble.

Today's action is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) of 1995 (Public Law 104-113; 15 U.S.C 272 note), directs EPA to use voluntary consensus standards in their regulatory and procurement activities unless to do so would be inconsistent with applicable law or otherwise impracticable. Voluntary consensus standards are technical standards (such as material specifications, test methods, sampling procedures, or business practices) developed or adopted by one or more voluntary consensus bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. The proposed amendments do not involve changes to the technical standards in the final rule. Therefore, EPA is not considering the use of any voluntary consensus standards in the proposed amendments.

For the reasons set forth in the preamble, title 40, chapter I, part 63 of the Code of Federal Regulations is proposed to be amended as follows:

Background

The Migratory Bird Treaty Act of 1918 (Act) (16 U.S.C. 703-711) and the Fish and Wildlife Improvement Act of 1978 (16 U.S.C. 712) implement migratory bird treaties between the United States and Great Britain for Canada (1916, amended), Mexico (1936, amended), Japan (1972, amended), and Russia (then the Soviet Union, 1978). These treaties protect certain migratory birds from take, except as permitted under the Acts. The Acts authorize the Secretary of the Interior to regulate take of migratory birds in the United States. Under this authority, the U.S. Fish and Wildlife Service controls the hunting of migratory game birds through regulations in 50 CFR part 20.

Deposition of toxic shot and release of toxic shot components in waterfowl hunting locations are potentially harmful to many organisms. Research has shown that ingested spent lead shot causes significant mortality in migratory birds. Since the mid-1970s, we have sought to identify shot types that do not pose significant toxicity hazards to migratory birds or other wildlife. We addressed the issue of lead poisoning in waterfowl in an Environmental Impact Statement in 1976, and again in a 1986 supplemental EIS. The 1986 document provided the scientific justification for a ban on the use of lead shot and the subsequent approval of steel shot for hunting waterfowl and coots that began that year, with a complete ban of lead for waterfowl and coot hunting in 1991. We have continued to consider other potential candidates for approval as nontoxic shot. We are obligated to review applications for approval of alternative shot types as nontoxic for hunting waterfowl and coots.

We have received applications for approval of four shot types as nontoxic for hunting waterfowl and coots. Those shot types are:

1. Tungsten-Iron-Copper-Nickel (TICN) shot, of 40-76 percent tungsten, 10-37 percent iron, 9-16 percent copper, and 5-7 percent nickel (70 FR 3180, January 21, 2005);

2. Iron-Tungsten-Nickel (ITN) alloys composed of 20-70 percent tungsten, 10-40 percent nickel, and 10-70 percent iron (70 FR 22625, May 2, 2005);

3. Tungsten-Bronze (TB) shot made of 60 percent tungsten, 35.1 percent copper, 3.9 percent tin, and 1 percent iron (70 FR 22624, May 2, 2005, Note: This formulation differs from the Tungsten-Bronze nontoxic shot formulation approved in 2004.); and

4. Tungsten-Tin-Iron (TTI) shot composed of 58 percent tungsten, 38 percent tin, and 4 percent iron.

The metals in these shot types have already been approved in other nontoxic shot types. In considering approval of these shot types, we were particularly concerned about the solubility and bioavailability of the nickel and copper in them. In addition, because tungsten, tin, and iron have already been approved at very high proportions of other nontoxic shot types with no known negative effects of the metals, we will propose approval of all alloys of these four metals.

The data provided to us indicate that the shot types are nontoxic when ingested by waterfowl and should not pose a significant danger to migratory birds, other wildlife, or their habitats. We conclude that they raise no particular concerns about deposition in the environment or about ingestion by waterfowl or predators.

The process for submission and evaluation of new shot types for approval as nontoxic is given at 50 CFR 20.134. The list of shot types approved as nontoxic for use in hunting migratory birds is provided in the table at 50 CFR 20.21(j). With this proposed rule, we also propose to revise the listing of approved nontoxic shot types in § 20.21(j) to include the cumulative approvals of the shot types considered in this proposed rule with the other nontoxic shot types already in the table.

Many hunters believe that some nontoxic shot types do not compare favorably to lead and that they may damage some shotgun barrels, and a small percentage of hunters have not complied with nontoxic shot regulations. Allowing use of additional nontoxic shot types may encourage greater hunter compliance and participation with nontoxic shot requirements and discourage the use of lead shot. The use of nontoxic shot for waterfowl hunting has increased in recent years (Anderson et al. 2000), but we believe that compliance will continue to increase with the availability and approval of other nontoxic shot types. Increased use of nontoxic shot will enhance protection of migratory waterfowl and their habitats. More important, however, is that the Fish and Wildlife Service is obligated to consider all complete nontoxic shot submissions.

We also propose to add a column to the table of approved shot types that lists the field testing device suitable for each shot type. The information in this column is strictly informational, not regulatory. Because these regulations are used by both waterfowl hunters and law enforcement officers, we believe that information on suitable testing devices is a useful addition to the table.

The taxonomic family Anatidae, principally subfamily Anatinae (ducks) and their habitats, comprise the affected environment. Waterfowl habitats and populations in North America in 2004 were described by the U.S. Fish and Wildlife Service (Garrettson et al. 2004). In the Breeding Population and Habitat Survey traditional survey area (strata 1-18, 20-50, and 75-77), the total-duck population estimate was 32.2 ± 0.6 (± 1 standard error) million birds, 11 percent below the 2003 estimate of 36.2 ± 0.7 million birds, and 3 percent below the 1955-2003 long-term average. Mallards ( Anas platyrhynchos ) were estimated at 7.4 ± 0.3 million, similar to last year's estimate of 7.9 ± 0.3 million birds and to the long-term average. Blue-winged teal ( A. discors ) numbered 4.1 ± 0.2 million, 26 percent below last year's estimate of 5.5 ± 0.3 million and 10 percent below the long-term average. Among other duck species, only northern shovelers ( A. clypeata , 2.8 ± 0.2 million) and American wigeon ( A. americana , 2.0 ± 0.1 million) were both 22 percent below their 2003 estimates. As in 2003, gadwall ( A. strepera , 2.6 ± 0.2 million, +56 percent), green-winged teal ( A. crecca , 2.5 ± 0.1 million, +33 percent), and northern shovelers (+32 percent) were above their long-term averages. Northern pintails ( A. acuta , 2.2 ± 0.2 million, −48 percent), scaup ( Aythya affinis and A. marila , 3.8 ± 0.2 million, −27 percent), and American wigeon (−25 percent) were well below their long-term averages in 2004.

Waterfowl hunting occurs in habitats used by many taxa of migratory birds, as well as by aquatic invertebrates, amphibians and some mammals. Fish also may be found in many hunting locations. In 2004, total May ponds in Prairie Canada, and the north-central United States combined were estimated at 3.9 ± 0.2 million, which was 24 percent lower than the figure for 2003 and 19 percent below the long-term average. Pond numbers in both Canada (2.5 ± 0.1 million) and the U. S. (1.4 ± 0.1 million) were below 2003 estimates (−29 percent in Canada, and −16 percent in the United States), and pond numbers in Canada were 25 percent below the long-term average for the region.

The projected mallard fall flight index was 9.4 ± 0.1 million birds, similar to the 2003 estimate of 10.3 ± 0.1 million. The 2004 total duck population estimate for the eastern survey area (strata 51-56 and 62-69) was 3.9 ± 0.3 million birds. This estimate was similar to the 2003 estimate of 3.6 ± 0.3 million birds, and to the 1996-2003 average. Individual species estimates for this area were similar to 2003 estimates and to 1996-2003 averages, with the exception of American wigeon (0.1 ± 0.1 million) and goldeneyes ( Bucephala clangula and B. islandica , 0.4 ± 0.1 million), which were 61 percent and 42 percent below their 1996-2003 averages, respectively, and ring-necked ducks ( Aythya collaris , 0.7 ± 0.2 million), which increased by 67 percent relative to the 2003 estimate of their numbers.

Spherical Precision, Inc. of Tustin, CA, submitted Tungsten-Iron-Copper-Nickel (TICN) shot for approval. The advance notice of proposed rulemaking for this group of alloys was published in the Federal Register on January 21, 2005, under RIN 1018-AU04 (70 FR 3180). This is an array of layered alloys or metals of 40-76 percent tungsten, 10-37 percent iron, 9-16 percent copper, and 5-7 percent nickel. TICN shot has a density ranging from 10.0 to 14.0 grams per cubic centimeter (g/cm 3 ), is noncorrosive, and is magnetic. Spherical Precision estimates that the volume of TICN shot for use in hunting migratory birds in the United States will be approximately 50,000 pounds (lb) (22,700 kilograms (kg)) during the first year of sale, and perhaps 100,000 lb (45,400 kg) per year thereafter.

ENVIRON-Metal of Sweet Home, OR, submitted Iron-Tungsten-Nickel (ITN) alloys, which are cast alloys containing 10-70 percent iron, 20-70 percent tungsten, and 10-40 percent nickel. The advance notice of proposed rulemaking for this group of alloys published in the Federal Register on May 2, 2005, under RIN 1018-AU09 (70 FR 22625). The proposed shot types have densities ranging from about 8.5 to about 13.5 g/cm 3 . The compositions of the alloys are shown in table 1.

ENVIRON-Metal estimated that the yearly volume of ITN shot types with densities between those of steel (7.86 g/cm 3 ) and lead (11.3 g/cm 3 ) expected for use in hunting migratory birds in the United States is approximately 200,000 lb (113,500 kg) during the first year of sale. In the second year and beyond, sales upwards of 500,000 lb (227,000 kg) per year are anticipated. ITN shot types with densities greater than that of lead may ultimately attain sales levels of 1,000,000 lb (454,000 kg) per year.

The Olin Corporation of East Alton, IL, submitted Tungsten-Bronze (TB) shot for approval. The advance notice of proposed rulemaking for this shot type was published in the Federal Register on May 2, 2005, under RIN 1018-AU13 (70 FR 22624). This is a sintered composite with an average composition of 60 percent tungsten, 35.1 percent copper, 3.9 percent tin, and 1 percent iron. The copper and tin make up 39 percent of the shot as a 90:10 ratio, respectively, in the form of a bronze alloy. The shot has a density of 12.0 g/cm 3 , compared to 11.1-11.3 g/cm 3 for lead, and 7.9 g/cm 3 for steel. Olin estimated that the yearly volume of the TB shot in hunting migratory birds in North America will be approximately 300,000 lb (136,200 kg).

Tungsten-Tin-Iron (TTI) shot, submitted by Nice Shot, Inc., of Albion, PA, is a cast alloy composed of 58 percent tungsten, 38 percent tin, and 4 percent iron. This shot type has a density of 11.0 g/cm 3 . Nice Shot, Inc. estimated that approximately 5,000 lb (2,270 kg) of TTI shot are expected to be sold for use in hunting migratory birds in the United States during the first year of sale. TTI shot contains less than 1 percent lead, and will not be coated.

Each of the four shot types has a residual lead level of less than 1 percent. To inhibit corrosion, TICN shot may be coated with tin, and ITN shot may be surface-coated with thin petroleum-based films. Neither TB nor TTI shot will be coated.

All of the metals in these shot types have been approved in other nontoxic shot types, and the submitters asserted that the four shot types pose no adverse toxicological risks to waterfowl or other forms of terrestrial or aquatic life. Our particular concern in considering approval of these shot types is the solubility and bioavailability of the nickel and copper in them.

The metals in the four shot types are insoluble under hot and cold (Weast 1986). Neither manufacturing the shot nor firing shotshells containing the shot will alter the metals or change how they dissolve in the environment. The shot types are not chemically or physically altered by firing from a shotgun.

Iron is naturally widespread. It comprises approximately 2 percent of the composition of soils and sediments in the United States. The iron in the shot types is not soluble.

Elemental tungsten and iron are virtually insoluble in water, and therefore do not weather and degrade in the environment. Tungsten is stable in acids and does not easily form compounds with other substances. Preferential uptake by plants in acidic soil suggests uptake of tungsten when it has formed compounds with other substances rather than when it is in its elemental form (Kabata-Pendias and Pendias 1984).

Elemental copper can be oxidized by organic and mineral acids that contain an oxidizing agent. Elemental copper is not oxidized in water (Aaseth and Norseth 1986).

Nickel is common in fresh waters, though usually at concentrations of less than 1 part per billion (p/b) in locations unaffected by human activities. Pure nickel is not soluble in water, and resists corrosion at temperatures between −20 °C and 30 °C (Chau and Kulikovsky-Cordeiro 1995). Free nickel may be part of chemical reactions, such as sorption, precipitation, and complexation. “Under anaerobic conditions, typical of deep groundwater, precipitation of nickel sulfide keeps nickel concentrations low” (Eisler 1998). Reactions of nickel with anions are unlikely. Complexation with organic agents is poorly understood (U.S. Environmental Protection Agency [EPA] 1986). Water hardness is the dominant factor governing nickel effects on biota (Stokes 1988).

Tin is only very slightly soluble at pH values from 4 to 11, as found in natural settings. Tin occurs naturally in soils at 2 to 200 mg/g (parts per thousand or ppt) with areas of enrichment at concentrations up to 1,000 mg/g (WHO 1980). In general, however, soil concentrations in the United States are between 1 and 5 parts per million (p/m) (Kabata-Pendias and Pendias 1984).

Calculation of the estimated environmental concentration (EEC) of a candidate shot in a terrestrial ecosystem is based on 69,000 shot per hectare (50 CFR 20.134). These calculations assume that the shot dissolves promptly and completely after deposition.

The maximum EEC for TICN shot for tungsten in soil is 21.3 p/m. This is below the EEC for several other tungsten-based shot types that we have previously approved. We are not aware of any problems associated with those shot types. The U.S. EPA does not have a biosolids application limit for tungsten.

For TICN shot, if the shot are completely dissolved in dry, porous soil, the maximum EEC for iron is 7.40 p/m. Iron is naturally widespread, comprising approximately 2 percent of the composition of soils and sediments in the United States. The EEC for iron from TICN shot is much lower than that level.

For copper in TICN shot, the maximum EEC in soils is 3.36 p/m. In comparison, the ceiling concentration limit for biosolids application for copper is 4,300 p/m (EPA 2000).

The maximum EEC for nickel in TICN shot in soils is 1.62 p/m. This concentration is a small fraction of the EPA biosolids application limit of 420 p/m (EPA 2000).

If TICN shot is coated with tin, the EEC for tin in dry soils is 1.31 p/m. There is no EPA biosolids application limit for tin, but it occurs naturally in soils at 2 to 200 p/m, with areas of enrichment at concentrations up to 1,000 p/m (WHO 1980). In general, soil concentrations in the United States are between 1 and 5 p/m; the suggested maximum concentration in surface soil tolerated by plants is 50 p/m dry weight (Kabata-Pendias and Pendias 1984).

The terrestrial EECs for the iron and tungsten from any ITN alloy (table 2) are below those from approved shot types, and we do not believe they are a problem in soils. Though data on iron concentrations in biosolids are unavailable, natural soil background concentrations range from 5,000 to 50,000 p/m. This is equivalent to 32,500 to 325,000 kg per hectare (kg/h). We do not believe that the worst-case additional 8.01 kg of iron per hectare (about 0.025 percent of natural background concentrations) would have any effect on plants or animals, especially since the iron in the shot is not in a soluble form.

Data from biosolid studies indicate that tungsten generally is present at 40 to 180 p/m, about four times the worst EEC for tungsten from ITN shot. Therefore, it is unlikely that tungsten from the shot would exceed concentrations obtained from biosolid applications.

The estimated soil concentration (p/m soil) of nickel for ITN alloy 4 (the highest in nickel) is a very small fraction of the 420 p/m maximum concentration allowed for terrestrial application of biosolids and is two orders of magnitude less than the maximum cumulative loading rate for nickel of 420 kg/h per year ( http://www.epa.gov/cgi-bin/claritgw ). We do not believe that nickel from ITN shot would pose an environmental problem in soils.

Based on the maximum concentration of each metal in any formulation of TB shot, the increased concentrations in soils for the metals are 14.4 p/m for tungsten, 8.43 p/m for copper, 0.94 p/m for tin, and 0.24 p/m for iron. The EEC for tungsten is lower than the value for ITN shot, and considerably lower than the values for previously approved shot types. As noted earlier, the ceiling concentration limit for biosolids application for copper is 4,300 p/m (EPA 2000). The EEC for iron from TB shot is extremely small.

The EEC for tungsten in TTI shot in soil (the increase in soil concentration) is 12.77 mg/kg or p/m. This is below the EEC for several other tungsten-based shot types that we have previously approved. We are not aware of any problems associated with those shot types. The EPA does not have a biosolids application limit for tungsten. Data from biosolid studies indicate that tungsten generally is present at 40 to 180 p/m, about four times the worst EEC for tungsten from ITN shot. Therefore, it is unlikely that tungsten from the shot would exceed concentrations obtained from biosolid applications.

The EEC for tin in dry soils is 8.37 p/m. In general, soil concentrations in the United States are between 1 and 5 p/m; the suggested maximum concentration in surface soil tolerated by plants is 50 p/m dry weight (Kabata-Pendias and Pendias 1984), about six times the worst-case concentration to be expected from TTI shot.

If the shot are completely dissolved in dry, porous soil, the maximum EEC for iron is 0.88 p/m. Iron is naturally widespread, comprising approximately 2 percent of the composition of soils and sediments in the United States. The EEC for iron from TTI shot is much lower than that level.

Though data on iron concentrations in biosolids are unavailable, natural soil background concentrations range from 5,000 to 50,000 p/m. This is equivalent to 32,500 to 325,000 kg per hectare. We do not believe that the extremely small addition of the insoluble iron from TTI shot would have any effect on plants or animals, especially because the iron in the shot is not in a soluble form.

The EEC for water assumes that 69,000 number 4 shot are completely dissolved in 1 hectare of water 1 foot (ft) (30.48 cm) deep. The submitter then calculates the concentration of each metal in the shot if the shot pellets dissolve completely. For our analyses, we assume complete dissolution of the shot type containing the highest proportion of each metal in the range of alloys submitted.

For TICN shot, the EEC for tungsten is 4.541 milligrams per liter (mg/l). The EPA has set no acute or chronic criteria for tungsten in aquatic systems.

The EEC for iron from TICN shot in water is 1.579 mg/l. The chronic water quality criterion for iron in fresh water is 1 mg/l (EPA 1986). EPA has no criterion for salt water.

For copper, the aquatic EEC is 0.717 mg/l. This value is above both the acute and chronic criteria for freshwater and saltwater. This issue is discussed in the “In Vitro Solubility Evaluation of TICN Shot” section.

The aquatic EEC for nickel from TICN shot is 0.346 mg/l. The EPA (1986) acute criterion for nickel in fresh water is 1,400 micrograms per liter (μg/l); the chronic criterion is 160 μg/l. The acute and chronic criteria for salt water are 75 and 8.3 μg/l, respectively. Based on the EEC, the maximum release of nickel from TICN shot would be well below the fresh water acute criterion for protection of aquatic life.

For the tin in TICN shot, the aquatic EEC is 0.280 mg/l. The lowest published standard for tin in water is the 4 mg/l water quality standard for the state of Minnesota. Even in the worst case, the tin concentration from dissolved TICN shot would be well below this standard.

The aquatic EECs for the metals in ITN shot are shown in table 3. The EEC for nickel exceeds aquatic water quality criteria (table 4). However, corrosion studies demonstrated that corrosion rates for all types of ITN shot are relatively low in both fresh water and seawater. This corrosion is discussed under “In Vitro Solubility Evaluation of ITN Shot.”

The aquatic EECs for metals in TB shot are shown in table 5. The EEC for copper is considerably above the criteria for protection of fresh water and salt water life. However, a solubility study for this shot type demonstrated that corrosion of TB shot is low. This is discussed under “In Vitro Solubility Evaluation of TB Shot.”

The EEC for tungsten is 2.72 milligrams per liter (mg/1). The EPA has set no acute or chronic criteria for tungsten in aquatic systems.

The aquatic EEC for tin is 1.78 mg/1. The lowest published standard for tin in water is the 4 mg/1 water quality standard for the state of Minnesota. Tin concentration from dissolved TTI shot would be well below this standard.

The EEC for iron from TTI shot in water is 0.19 mg/1. The chronic water quality criterion for iron in fresh water is 1 mg/1 (EPA 1986). EPA has no criterion for salt water.

When nontoxic shot is ingested by waterfowl, both physical breakup of the shot, and dissolution of the metals that comprise the shot, may occur in the highly acidic environment of the gizzard. In addition to the standard Tier 1 application information, Spherical Precision provided the results of an in vitro gizzard simulation test conducted to quantify the release of metals in solution under the prevailing pH conditions of the avian gizzard. The metal concentrations released during the simulation test were, in turn, compared to known levels of metals that cause toxicity in waterfowl. The evaluation followed the methodology of Kimball and Munir (1971) as closely as possible. The average amount of copper and nickel released from eight TICN shot per day are 1.87 mg and 1.77 mg, respectively.

The maximum tolerable level of dietary copper during the long-term growth of chickens ( Gallus domesticus ) and turkeys ( Meleagris species) has been reported to be 300 p/b (Committee on Mineral Toxicity in Animals (CMTA) 1980). At the maximum tolerable level for chronic exposure of 300 ppb for poultry, a 1.8 kg chicken consuming 100 g of food per day (Morck and Austic 1981) would consume 30 mg copper per day (16.7 mg of copper per kg of body weight per day). The average amount of copper released from eight TICN shot is 1.87 mg per day, which is well below concentrations that cause copper toxicosis in waterfowl. A bird would have to ingest 129 TICN shot to exceed the maximum tolerable level.

No reproductive or other effects were observed in mallards that consumed the equivalent of 102 mg of nickel as nickel sulfate each day for 90 days (Eastin and O'Shea 1981). Therefore, the average amount of nickel released from eight TICN shot/day of 1.77 mg will pose no risk of adverse effects to waterfowl. Additionally, metallic nickel likely has a lower absorption from the gastrointestinal tract than does the nickel sulfate used in the mallard reproduction study, further decreasing the absorbed dose of TICN shot compared to the published toxicity study described above.

We concluded that TICN shot is very resistant to degradation, and that it poses no risk to waterfowl if ingested in the field. The slow breakdown rate of 1.53 mg per shot per day only permits the release of 0.233 mg of copper and 0.221 mg of nickel per shot per day, both of which are concentrations that are orders of magnitude below toxic levels of concern for copper and nickel in waterfowl.

Fresh water, seawater, and an “artificial gizzard” environment (Kimball and Munir, 1971) were evaluated to determine their corrosion rates on each of the six alloys, plus steel as a standard. The “artificial gizzard” test, although developed for lead alloy evaluation, proved to reliably simulate the mallard gizzard for both steel and ITN alloys and constitutes a very conservative approach for evaluation of nontoxic shot. This test resulted in corrosion/erosion rates up to twice those measured in steel and Tungsten-Nickel-Iron mallard in-vivo studies (January 4, 2001, 66 FR 737).

The ITN alloys with relatively low concentrations of tungsten and nickel corrode in a manner similar to that of steels. Corrosion rates of such steels are roughly linear over a wide range of exposure time. This corrosion is in contrast with that of alloys such as stainless steel, tungsten-nickel iron, or “high-alloy” varieties of ITN, which readily form passivating oxide layers that impede further corrosion. Assuming that the short-term rate of shot weight loss would continue for one month in a static aqueous environment (a conservative assumption, because natural fresh water and seawater environments are dynamic, and because corrosion products forming on metal surfaces tend to progressively retard corrosion rates), the actual EECs are presented in table 6. These data show that the nickel concentration from ITN shot actually will be well below both the acute and chronic criteria for nickel in aquatic settings.

ENVIRON-Metal also provided the results of an in-vitro gizzard simulation test conducted to quantify the release of metals in solution under the prevailing pH conditions of the avian gizzard (table 7). These data also demonstrate that the hazards from these alloys to wildlife would be very minimal.

The EEC for copper EEC was over 138 times the freshwater acute criterion of 13 g/l, and 200 times the freshwater chronic criterion of 9.0 g/l. However, Olin noted that the very conservative assumptions used to calculate the copper EEC are only an indication of the likely effect of deposition of TB shot in an aquatic setting. Therefore, as an addendum to the application for TB shot, Olin had an in-vitro dissolution test in water conducted. The test was conducted to quantify the release of metals from TB shot at pH values of 5.6, 6.6, and 7.6 in synthetic buffered waters. The highest EEC for copper from the dissolution evaluations was 0.15 μg/l at pH 5.6. The hardness-adjusted chronic water quality criterion for copper was 9.7 μg/l, approximately 65 times the worst-case EEC. Therefore, detrimental effects in aquatic systems from dissolution of TB shot would be highly unlikely.

Olin provided the results of an in-vitro gizzard simulation test conducted to quantify the release of metals in solution under the prevailing pH conditions of the avian gizzard. The simulation test demonstrated that a number 4 TB shot would release about 0.67 mg of the alloy per day. This, in turn, would mean release of approximately 0.24 mg of copper per day.

Olin pointed out that the theoretical availability of copper from this in-vitro gizzard simulation test should be considered maximal when compared to the Irby et al. (1967) study results or the CMTA (1980) guideline. Unlike the in-vivo gizzard, which resembles an open corrosion system in which the products of the corrosion process are constantly being eliminated (Kimball and Munir 1971), the test design for this in-vitro gizzard simulation was a closed corrosion system. Therefore, fine pieces of shot that would be released, and normally discarded from the gizzard, remained in the dissolution medium and potentially yielded more copper. Additionally, the analytical samples were analyzed for total metals with no filtration or centrifugation prior to analysis. As a result, the fine pieces of shot that were not fully dissolved and would normally be excreted were included in the total copper concentrations reported.

We have previously approved as nontoxic other shot types that contain tungsten, iron, and tin. Previous assessments of nontoxic shot types indicated that the potential release of iron, tungsten, or tin from TICN, ITN, or TB shot should not harm aquatic or terrestrial systems and we believe the small amount of tin in TB shot is not likely to harm waterfowl. The solubility testing further indicates that the release of nickel from ITN shot and copper from TICN or TB shot is not sufficient to present a hazard to aquatic systems or to biota. We propose to approve the four shot types as nontoxic. Our approval is based on the toxicological report, acute toxicity studies, reproductive/chronic toxicity studies, and other published research. The available information indicates that the four shot types are nontoxic when ingested by waterfowl and that they pose no significant danger to migratory birds, other wildlife, or their habitats.

Iron is an essential nutrient. Iron toxicosis in mammals is primarily a phenomenon of overdosing of livestock. Maximum recommended dietary levels of iron range from 500 p/m for sheep to 3000 p/m for pigs (National Research Council [NRC] 1980). The amount of iron in any of the four shot types would not pose a hazard to mammals.

Chickens require at least 55 p/m iron in the diet (Morck and Austic 1981). There were no ill effects on chickens fed 1,600 p/m iron in an adequate diet (McGhee et al. 1965), and chicks tolerated 1,600 p/m iron in the diets that included adequate copper, although decreased weight gains and increased mortality were observed in copper-deficient diets (McGhee et al. 1965). At the maximum tolerable level for chronic exposure of 1,000 p/m for poultry (NRC 1980), a 1.8 kg chicken consuming 100 grams of food per day (Morck and Austic 1981) would consume 100 mg iron per day (56 mg per kg of body weight per day).

Deobald and Elvehjem (1935) reported that 4,500 p/m iron in the diet produced rickets in chicks. Adverse effects were not observed when turkey poults were fed diets amended with 440 p/m iron (Woerpel and Balloun 1964).

Turkey poults fed 440 p/m in the diet suffered no adverse effects. The tests, in which eight number 4 tungsten-iron shot were administered to each mallard in a toxicity study indicated that the 45 percent iron content of the shot had no adverse effects on the test animals (Kelly et al. 1998).

We are not aware of acute toxicity data for iron in waterfowl. Zinc-coated iron shot appeared to have little or no effect on ducks dosed with eight number 6 shot; mortality and weight loss for treated ducks were comparable to those for control animals (Irby et al. 1967).

Game-farm mallards administered eight number 4 pellets of tungsten-iron shot, indicated no adverse effects from either the tungsten or the iron (Kelly et al. 1998). This shot formulation has a much greater iron content (45 percent) than do the shot types considered here.

Tungsten salts are toxic to mammals. Lifetime exposure to 5 p/m tungsten as sodium tungstate in drinking water produced no discernible adverse effects in rats (Rattus species) (Schroeder and Mitchener 1975). However, with 100 p/m tungsten as sodium tungstate in drinking water, rats had decreased enzyme activity after 21 days (Cohen et al. 1973).

Tungsten may be substituted for molybdenum in enzymes in mammals. Ingested tungsten salts reduce growth, and can cause diarrhea, coma, and death in mammals ( e.g. Bursian et al. 1996, Cohen et al. 1973, Karantassis 1924, Kinard and Van de Erve 1941, National Research Council 1980, Pham-Huu-Chanh 1965), but elemental tungsten is virtually insoluble and therefore essentially nontoxic. Tungsten powder added to the food of young rats at 2, 5, and 10 percent by mass for 70 days did not affect health or growth (Sax and Lewis 1989). A dietary concentration of 94 p/m did not reduce weight gain in growing rats (Wei et al. 1987). Exposure to pure tungsten through oral, inhalation, or dermal pathways is not reported to cause any health effects (Sittig 1991).

Acute tungsten toxicosis results in death from respiratory paralysis, often preceded by diarrhea and coma. Chronic intoxication is most evident in reduced growth rates. However, the most sensitive sign is reduced xanthine oxidase activity. Xanthine oxidase is an enzyme that is dependent upon molybdenum for proper functioning. It is thought that tungsten readily substitutes for molybdenum, with subsequent reduction in enzyme activity; supplemental dietary molybdenum will reverse the symptoms. The National Research Council Committee on Animal Nutrition recommends a maximum tolerable dose of 20 p/m tungsten in the diet for effective rearing of livestock (NRC 1980).

The LD50 of tungsten as sodium tungstate (Na 2 WO 4 ) administered by intraperitoneal injection is 112 p/b body weight in male rats and 79 p/b body weight in mice (Mus species) (Pham-Huu-Chanh 1965). This would classify tungsten as “very toxic” when administered intraperitoneally as a soluble salt. Kinard and Van de Erve (1941) showed that Na 2 WO 4 is the most toxic tungsten salt, when compared with tungsten oxide and ammonium paratungstate.

Tungsten administered in the diet had no effects on rats until reaching 150 p/m diet when carcinoma incidence was increased in female Sprague-Dawley rats (Wei et al. 1987). Higgins et al. (1956a, b) noted that dietary concentrations of 45 or 94 p/m tungsten produced no adverse effects on weight gain in growing rats. Other studies with rats indicate that dietary exposure to 5,000 p/m tungsten oxide (WO 3 ) or Na 2 WO 4 results in 90 percent and 80 percent mortality, respectively, by the 70th day of exposure (NRC 1980). However, lifetime exposure of rats to 5 p/m tungsten as Na 2 WO 4 in drinking water resulted in no observable adverse effects (Schroeder and Michener 1975). At 100 p/m tungsten as Na 2 WO 4 in drinking water, rats had decreased enzyme activity after 21 days of exposure (Cohen et al. 1973).

Goats (Capra hircus) appear to be less tolerant of dietary tungsten. A 5-month exposure to 22.5 p/m dietary tungsten as Na 2 WO 4 resulted in depressed liver xanthine oxidase activity in growing kids. Milk production in goats and cows (Bos species) was unaffected by a single oral exposure to 25.0 p/b body weight of Na 2 WO 4 (Owen and Proudfoot 1968). Anke and Groppel (1985) established that goats require at least 0.06 p/m tungsten in their diets for optimal reproduction.

Chickens given a complete diet showed no adverse effects of 250 p/m sodium tungstate administered for 10 days in the diet. However, 500 p/m in the diet reduced xanthine oxidase activity and reduced growth of day-old chicks (Teekell and Watts 1959). Adult hens had reduced egg production and egg weight on a diet containing 1,000 p/m tungsten (Nell et al. 1981). Ecological Planning and Toxicology (1999) concluded that the No Observed Adverse Effect Level for tungsten for chickens should be 250 p/m in the diet; the Lowest Observed Adverse Effect Level should be 500 p/m. Kelly et al. (1998) demonstrated no adverse effects on mallards dosed with tungsten-iron or tungsten-polymer shot according to nontoxic shot test protocols.

Breeder hen exposure to 250 p/m tungsten as sodium tungstate for 10 days had no adverse effects, but increasing the diet to 500 p/m tungsten for an additional 20 days resulted in decreased xanthine oxidase activity (Teekell and Watts 1959). Similarly, day-old chicks on a 500 p/m tungsten diet with adequate molybdenum showed reduced rate of gain (Selle 1942).

Nell et al. (1981) fed laying hens diets containing 1,000 p/m tungsten (unspecified salt) for five months; control diets contained 0.4 p/m tungsten. Hens were artificially inseminated and eggs were collected and set weekly. Three of 40 hens on the high-tungsten diet died, and the remaining 37 had reduced egg production and egg weight. Egg fertility and hatchability were not affected. Liver tungsten was significantly elevated in treated birds, although there was no effect on body weight.

Day-old white leghorn chickens placed on a molybdenum-deficient diet for 35 days showed a decreased rate of growth and increased mortality at 45 p/m tungsten as sodium tungstate (Higgins et al. 1956a, b). However, this is not an accurate reflection of tungsten toxicity because low molybdenum levels potentiate the effects of tungsten (NRC 1980).

Ecological Planning and Toxicology (1999) concluded that the No Observed Adverse Effect Level (NOAEL) for tungsten for chickens should be 250 p/m in the diet; the Lowest Observed Adverse Effect Level should be 500 p/m. An adult chicken fed a diet of 1,000 p/m tungsten for 150 days would ingest about 100 mg of tungsten per day, or a total of 15 grams. In the USFWS guidelines for a reproduction study for shot, mallards would receive eight number 4 shot on four dosing periods. A total of 32 TICN shot during the course of the study, each containing 0.2006 grams of tungsten, would result in a total exposure of 6.42 grams of tungsten, if the tungsten in the shot is totally dissolved. This estimated exposure of 6.42 grams of tungsten during a TICN shot mallard reproductive study is about 43 percent of the 15 grams demonstrated to cause reproductive effects in chickens.

The effects of ingestion of tungsten by mallards as elemental metal in a shot pellet were studied by Ringelman et al. (1993). Birds were given pellets of 39 percent tungsten, 44.5 percent bismuth, and 16.5 percent tin by weight, per bird. No evidence of toxicity or other histological changes were reported. Tungsten was not detected in liver or kidney tissue.

Dosing mallards with eight number 4 Iron-Tungsten shot (with 55 percent tungsten) also produced no tungsten toxicity in the ducks (Kelly et al. 1998). In that study, birds received eight number 4 pellets by oral gavage and were observed for changes in serum enzymes, organ weights, histology of tissues and accumulation of metals in bone. Tungsten was detected in femur, liver, and kidneys of dosed ducks, but no other significant changes were measured. Iron-Tungsten shot eroded by 55 percent and Tungsten-Polymer shot eroded by 80 percent over the course of the study; however, tissue concentrations were lower in the Tungsten-Polymer birds than in the Iron-Tungsten group. The shot were 55 percent tungsten for the Iron-Tungsten formulation and 95.5 percent tungsten for the polymerized shot. The amount of tungsten in TICN shot (40-76 percent) is similar to that in the Iron-Tungsten shot (55 percent). Tungsten-Nickel-Iron shot in the study by Ecotoxicology & Biosystems Associates, Inc. (2000), conducted with a proportion of tungsten similar to that in TICN shot, was not toxic.

Kraabel et al. (1996) surgically embedded tungsten-bismuth-tin shot in the pectoralis muscles of ducks to simulate wounding by gunfire and to test for toxic effects of the shot. The shot produced no toxic effects nor induced adverse systemic effects during the 8-week study.

Copper is a dietary essential for all living organisms. In most mammals, ingestion of one TICN shot pellet would result in release of 8 to 25 mg of copper, not all of which would be absorbed. In humans, ingestion of a pellet could mobilize approximately 8 mg of copper. These low levels of copper would not pose any risk to mammals.

Copper requirements in birds may vary depending on intake and storage of other minerals (Underwood 1971). The maximum tolerable level of dietary copper during the long-term growth of chickens and turkeys is 300 p/m (CMTA 1980). Eight-day-old ducklings were fed a diet supplemented with 100 p/m copper as copper sulfate for eight weeks. They showed greater growth than controls, but some thinning of the caecal walls (King 1975). Studying day-old chicks, Poupoulis and Jensen (1976) reported that no gizzard lining erosion could be detected in chicks fed 125 p/m of copper for four weeks, but they detected slight gizzard erosion in chicks fed 250 p/m copper. The authors found that it required 500 to 1,000 p/m of copper to depress growth and weight gain of chicks. Jensen et al. (1991) found that 169 p/m copper in the diet produced maximal weight gain in chickens.

Stevenson and Jackson (1979) studied the influence of dietary copper addition on the body mass and reproduction of mature domestic chickens. Hens fed on a diet containing 250 p/m copper for 48 days showed a similar rate of food intake as control hens that had no copper in their diet. Additionally, the mean number of eggs laid daily did not differ between hens fed 250 p/m copper and the controls. After 4 months of being fed at dietary copper levels in excess of 500 p/m, negative effects on the daily food intake, body mass loss, and egg-laying rates were observed.

At the 300 p/m level for chronic exposure for poultry, a 1.8 kg chicken consuming 100 g of food per day (Morck and Austic 1981) would consume 30 mg of copper per day (16.7 mg of copper per kg of body weight/day). One number 4 TICN shot contains a maximum of 31.7 mg of copper. However, at the 0.233 mg of copper per shot per day release rate from the solubility testing, a bird would have to ingest at least 128 TICN shot to exceed the maximum tolerable level. Thus, the copper release from the TICN shot appears to be well below the level that could cause copper toxicosis in waterfowl. The average amount of copper released from 8 TB nontoxic shot per day is 7.87 mg, so a bird would have to ingest over 30 shot to exceed the maximum tolerable level.

Day-old poults fed diets containing 500 p/m ration for 24 weeks showed reduced growth and increased gizzard histopathology (Kashani et al. 1986). Growing domestic turkeys showed no long-term effects when fed 300 p/m copper in the daily diet, but 800 p/m of copper in the diet for 3 weeks inhibited growth with no adverse effects on survival (Supplee 1964). No effect of feeding 400 p/m of copper as copper sulfate to turkey poults in the daily diet for 21 weeks was reported, and it was concluded that poults could tolerate 676 p/m of copper without deleterious effects. Growth was reduced in poults fed 800 p/m and 910 p/m of copper over the same time (Vohra and Kratzer 1968). Their conclusion was supported by another study that found that copper in the diet of domestic turkeys had to rise to 500 to 750 p/m level before signs of slight toxicity appeared, assuming that adequate methionine also was present (Christmas and Harms 1979).

Henderson and Winterfield (1975) reported acute copper toxicity in 3-week-old Canada geese (Branta canadensis) that had ingested water contaminated with copper sulfate. The authors calculated the copper intake to be about 600 mg copper sulfate/kg body weight, or 239 mg copper/kg. The amount of copper released from eight number 4 shot would be 42.26 mg, which is much less that the 239 p/b toxic level.

Irby et al. (1967) dosed 24 Mallard ducks with 8 number 6 pure copper shot to observe if they were toxic over a 60-day exposure period. They calculated that the total mass of copper in the gizzard was 0.6 gram, and observed that none of the ducks died from copper toxicosis after 60 days. TB shot is 35.1 percent copper by weight, so eight shot would contain 0.64 grams of copper.

International Nontoxic Composites, Inc. (2003) reported that pure copper control shot breaks down at the rate of 18.42 mg copper per gram of shot per day, or 11.05 mg copper per day for 0.6 grams of copper shot, under in vitro gizzard simulation test conditions. However, TB shot releases only 4.35 mg copper per gram of shot per day or 7.87 mg of copper per day for 1.81 grams of shot under the same test conditions. This indicates that TB shot should not be a hazard for wildlife that consume it.

The EPA (2002) provided both acute and chronic freshwater quality criteria for copper, which are functions of water hardness. The freshwater acute criterion for a water body with hardness of 100 mg/l, for example, is 13 μg/l, and the chronic criterion is 9.0 μg copper per liter. The EPA acute and chronic saltwater quality criteria are not affected by hardness, and are 4.8 and 3.1 μg/l.

Deficiencies have been reported in diets ranging from 2 to 40 billion p/b nickel (NRC 1980). The dietary requirement for nickel has been set at 50 to 80 p/b for the rat and chick (Nielsen and Sandstead 1974). Humans consume up to 900 μg per day as a normal dietary intake (Nieboer et al. 1988). Though it is necessary for some enzymes, nickel competes with zinc, calcium, and magnesium for binding sites on most of the metal-dependent enzymes, resulting in various levels of inactivation, although it is essential for functioning of some enzymes, particularly urease (Andrews et al. 1988, Nieboer et al. 1988). Water-soluble nickel salts are poorly absorbed from the gastrointestinal tract, averaging only 3 percent to 6 percent assimilation efficiency in rats (Nieboer et al. 1988).

Rats fed nickel carbonate concentrations up to 1,000 p/m for 3 to 4 months did not show treatment-related effects, nor was body weight of pups affected (Phatak and Patwardhan 1950). Elevated nickel concentrations in pups were observed in the 500 and 1,000 p/m treatment groups. Young rats were fed nickel catalyst (finely divided nickel suspended in vegetable oil and supported on kieselguhr) at 250 p/m for 16 months with no effects (Phatak and Patwardhan 1952).

Rats fed 1,000 p/m nickel sulfate for 2 years exhibited mild effects, such as reduced body weight and liver weight, but increased heart weight (Ambrose et al. 1976). Also, there was an increase in the number of stillborn pups and a decrease in weanling weights through three generations. Nickel chloride was most toxic to rats. Young rats decreased food consumption and lost body weight within 13 days in diets containing 1,000 p/m nickel as nickel chloride (Schnegg and Kirchgessner 1976).

Calves showed weight loss and decreased feed intake, organ size, and nitrogen retention when fed 1,000 p/m nickel and nickel carbonate for 8 weeks (O'Dell et al. 1970a, 1971). Calves fed 250 p/m nickel did not show effects. Lactating dairy cows were not affected by 50 or 250 p/m dietary nickel (Archibald 1949, O'Dell et al. 1970b). Soluble nickel salts are very toxic to mammals, with an oral LD50 of 136 p/b in mice, and 350 p/b in rats (Fairchild et al. 1977). Nickel catalyst (finely divided nickel in vegetable oil) fed to young rats at 250 p/m for 16 months, however, produced no detrimental effects (Phatak and Patwardhan 1952).

Water-soluble nickel salts are poorly absorbed if ingested by rats (Nieboer et al. 1988). Nickel carbonate caused no treatment effects in rats fed 1,000 p/m for 3 to 4 months (Phatak and Patwardhan 1952). Rats fed 1,000 p/m nickel sulfate for 2 years showed reduced body and liver weights, an increase in the number of stillborn pups, and decrease in weanling weights through three generations (Ambrose et al. 1976). Nickel chloride was even more toxic; 1,000 p/m fed to young rats caused weight loss in 13 days (Schnegg and Kirchgestiner 1976).

In chicks from hatching to 4 weeks of age, 300 p/m nickel as nickel carbonate or nickel acetate in the diet produced no observed adverse effects, but concentrations of 500 p/m or more reduced growth (Weber and Reid 1968). A diet containing 200 p/m nickel as nickel sulfate had no observed effects on mallard ducklings from 1 to 90 days of age. Diets of 800 p/m or more caused significant changes in physical condition of the ducklings (Cain and Pafford 1981).

Mallard ducklings fed 1,200 p/m nickel as nickel sulfate from 1 to 90 days of age experienced reduced growth rates, tremors, paresis, and death (71 percent within 60 days) (Cain and Pafford 1981). Weights of ducklings receiving 200 and 800 p/m nickel were not significantly different than controls, but the humerus weight/length ratio, a measure of bone density, was significantly lower than controls among females in the 800 p/m group and all birds in the 1,200 p/m group. There was no mortality in the 200 and 800 p/m groups.

Breeding pairs of mallards were fed diets containing 0, 12.5, 50, 200, and 800 p/m nickel as nickel sulfate for 90 days (Eastin and O'Shea 1981). No treatment-related effects were observed on egg production, hatchability, or survival of ducklings. At the end of the 90-day treatment period, there were no significant differences in hematocrit, concentrations of hemoglobin, plasma triglycerides, cholesterol, or plasma activities of ornithine carbamoyl transferase and alanine aminotransferase. The only treatment-related observation was a black, tarry feces in the 800 p/m group. Assuming a mean daily consumption of 128 grams per bird (Heinz 1979), the 800 p/m treatment group would have consumed 102 mg nickel each day and 9.2 grams of nickel during the course of the 90-day study. In the nontoxic shot Tier 2 approval process, birds could be given eight number 4 shot. For ITN shot, each shot would contain 0.02206 grams of nickel, so each duck would receive 0.176 grams of nickel, assuming complete solubilization of the nickel from the shot during the study. This is a very small fraction of the 9.2 grams of total nickel exposure or 102 mg per day experienced by the mallards in the Eastin and O'Shea (1981) study. Therefore, we expect no effect of the nickel on birds ingesting the shot.

No reproductive or other effects were observed in mallards consuming the equivalent of 102 mg of nickel as nickel sulfate each day for 90 days (Eastin and O'Shea 1981). Therefore, the 15.3 mg of nickel in each TICN shot, if completely eroded and absorbed in 24 hours, would not be expected to affect waterfowl. Based on the 0.221 mg of nickel per shot per day rate of release from the solubility study, a mallard would have to ingest in excess of 450 TICN shot to exceed the 102 mg nickel amount. Additionally, metallic nickel likely has a lower absorption from the gastrointestinal tract than does the nickel sulfate used in the mallard reproduction study, further decreasing the absorbed dose of TICN shot compared to the published toxicity study described above.

Adult mallards dosed with eight tungsten-nickel-iron number 4 pellets were fed a whole kernel corn and grit and observed for signs of toxicity for 30 days following dosing (January 4, 2001; 66 FR 737). No adverse effects were observed on body weight, food consumption or clinical chemistry, hematology, and histopathology. The tungsten-nickel-iron pellets lost an average of 7.9 percent of their initial weight during the study, releasing nickel at a rate of 1.85 mg per day per bird, for a total of 55.5 mg over the 30-day study.

In a Tier 2 dosing study under the regulations governing approval of nontoxic shot, mallard ducks would each be given eight number 4 TICN shot (each containing 0.02206 grams of nickel) during the study. A duck would be exposed to 0.176 grams of nickel during the study if the nickel were completely dissolved. This is much less than the nickel exposure experienced by the mallards in the Eastin and O'Shea (1981) study. We conclude that the nickel in TICN shot will not be significant to waterfowl that ingest the shot.

Water hardness is the dominant factor governing nickel effects on aquatic biota (Stokes 1988). Toxicity of nickel to aquatic organisms is dependent upon water hardness, pH, and organic content, as well as other minor environmental parameters (Allen and Hansen 1996). In soft water, as little as 7 p/b nickel may be acutely toxic to fish fry, while in harder waters toxicity thresholds may be an order of magnitude higher (Stokes 1988).

The EPA (1986) acute water quality criteria reflect this insensitivity of aquatic organisms to nickel. For a water body with hardness of 50 mg/l (generally associated with highly oligotrophic systems that would not support large numbers of waterfowl), the criterion is 1,400 μg/l. However, early fish life stages are more sensitive to nickel (Stokes 1988), which is reflected in the order of magnitude lower Freshwater Chronic Criterion of 160 μg/l at a hardness of 50 mg/l (EPA 1986).

The saltwater chronic criterion of 8.3 μg/l is much lower than the measured mysid shrimp (Mysidopsis bahia) chronic value, which is from the only chronic saltwater study in the EPA guidelines (EPA 1986).

Toxicity of nickel to aquatic organisms is dependent upon water hardness, pH, and organic content, as well as other minor environmental parameters (Allen and Hansen 1996). In soft water, as few as 7 p/b may be acutely toxic to fish fry, but in harder waters toxicity thresholds may be an order of magnitude higher. General toxicity ranges for aquatic organisms are as variable, with an acute toxicity of as low as 82 μg/l for some oligochaetes to 138,000 μg/l for some gastropods; chronic toxicity values range from fewer than 100 μg/l for some green algae to 10,000 μg/l for filamentous algae (Stokes 1988).

The freshwater criterion maximum concentration is dependent on hardness. For a water body with hardness of 50 mg/l (generally associated with highly oligotrophic systems that would not support large numbers of waterfowl), this results in a criterion of 1,400 μg/l. However, because early fish life stages are more sensitive to nickel, the freshwater chronic criterion is 160 μg/l at a hardness of 50 mg/l (EPA 1986).

It is generally agreed that inorganic tin and tin compounds are comparatively harmless (Eisler 1989). Inorganic tin and its salts are poorly absorbed, their oxides are relatively insoluble, and they are rapidly lost from tissues (see Eisler 1989 for reviews). Reviews indicate that elemental tin is not toxic to birds (Cooney 1988, Eisler1989). Tin shot designed for waterfowl hunting is used in several European countries. We are aware of no reports that suggest that tin shot causes toxicity problems for wildlife.

Tin (II) chloride was toxic to juvenile eels at 6.0 mg/l and 1.2 mg/l, with death coming at 2.8 and 50 hours, respectively. This inorganic tin salt was also toxic to daphnids, at concentrations of 2.5 mg/l or more. Metelev et al. (1971) found that 1 g/l of Tin (II) chloride dihydrate (530 mg of tin per liter) was lethal to all fish species tested (Bandman 1993).

Grandy et al. (1968) and the Huntingdon Research Centre (1987) conducted 30-day and 28-day, respectively, acute toxicity tests on mallard ducks by placing tin pellets inside the digestive tract or tissues of ducks. They reported that all treated ducks survived without deleterious effects.

Ringelmann et al. (1993) examined the effects of Tungsten-Bismuth-Tin shot consumption in ducks. The authors found no signs of toxicosis, and tin was not detected in the liver or kidney (<6 p/m) during the 32-day test period. In a 30-day dosing study of game-farm mallards dosed with eight number 4 size tin shot, there were no overt signs of toxicity or treatment-related effects on body weight. Tin was not detected in any tissues (Gallagher et al. 1999).

The 2 percent tin in bismuth-tin shot produced no toxicological effects in ducks during reproduction. It did not affect the health of ducks, the reproduction by male and female birds, or the survival of ducklings over the long term (Sanderson et al. 1997).

Chronic and acute studies documenting the nontoxic properties of 99.9 percent tin shot were conducted for the application for USFWS approval of tin shot as a nontoxic alternative. A 150-day chronic toxicity/reproductive study conducted for tin shot revealed no adverse effects in mallards dosed with eight number 4 sized shot. Additionally, there were no significant changes in egg production, fertility, or hatchability of birds dosed with tin when compared to steel-dosed birds. A 30-day acute study was also completed by the International Tin Research Institute ( Federal Register 64:17308, 1999). Treatment mallards were dosed with eight number 4 tin shot and hematocrit and hemoglobin concentrations, body weight and indications of toxicity were compared to those of control (no shot) and steel shot-dosed birds. No adverse effects were seen in ducks dosed with tin. Hematocrit and hemoglobin concentrations did not differ from those of either negative control group, nor were there treatment-related effects on body weight. Ducks dosed with tin exhibited no sign of toxicity.

In a study by Kraabel et al. (1996), shot pellets containing 39 percent tungsten, 44.5 percent bismuth, and 16.5 percent tin were embedded into the breast muscle of mallards. There were no adverse systemic effects observed in the study and the localized inflammatory reactions surrounding the shot were reduced in the tin-containing shot when compared to the steel shot control group.

Based on the toxicological report and toxicity tests, we concluded that shot that was 99.9 percent tin posed no significant danger to migratory birds or other wildlife and their habitats (65 FR 76886, December 7, 2000). Temporary approval was given because field detection techniques had not been approved, not due to any toxicity concerns. In support of the nontoxic application, chronic and acute toxicity tests demonstrated no adverse effects of tin shot on mallards. We do not believe the tin in any of the proposed shot types that contain it will pose toxicological risks due to wildlife.

We propose to extend the past approvals of some nontoxic shot types to broader alloys. We have, for example, approved nontoxic shot of almost 100 percent tungsten, and steel shot is essentially 100 percent iron. We are not aware of any synergistic effects of these metals, and approval of other shot types containing them in different proportions has indicated that negative effects on wildlife, fish, or their habitats from approval of alloys of these metals are very unlikely. Therefore, we propose to approve alloys containing any proportion of tungsten and 1 percent or more iron.

Similarly, as noted above, we gave temporary approval to shot of 100 percent tin (65 FR 76885), though the submitter did not seek final approval of that shot type. We also propose to approve shot alloys with any proportions of tungsten and tin and at least 1 percent iron.

Approving additional nontoxic shot types will likely result in a minor positive long-term impact on waterfowl and wetland habitats. Approval of the four shot types and additional alloys as nontoxic would have a positive impact on the waterfowl resource.

The impact on endangered and threatened species of approval of the four shot types and the additional alloys would be very small, but positive. The metals in all four shot types and the additional alloys have been approved in other nontoxic shot types, and we see no potential effects on threatened or endangered species due to approval of these shot types.

Previously approved shot types have been shown in test results to be nontoxic to the migratory bird resource, and we believe that they cause no adverse impact on ecosystems. There is concern, however, about noncompliance and potential ecosystem effects. The use of lead shot has a negative impact on wetland ecosystems due to the erosion of shot, causing sediment/soil and water contamination and the direct ingestion of shot by aquatic and predatory animals. Though we believe noncompliance is of concern, approval of the four shot types and the additional alloys will have little impact on the resource.

We foresee no negative cumulative impacts of approval of the four shot types and the additional alloys for waterfowl hunting. Their approval should help to further reduce the negative impacts of the use of lead shot for hunting waterfowl and coots.

For a complete list of the literature cited in this proposed rule, contact the person listed under FOR FURTHER INFORMATION CONTACT .

In accordance with the Administrative Procedures Act and our nontoxic shot approval regulations, we seek comments on this proposal. Of particular relevance is information regarding the potential impacts of these shot types and the approval of alloys of metals already approved in other formulations on migratory birds, other wildlife, and their habitats.

In addition, Executive Order 12866 requires each agency to write regulations that are easy to understand. We invite comments on how to make this rule easier to understand, including answers to questions such as the following: (1) Are the requirements in the rule clearly stated? (2) Does the rule contain technical language or jargon that interferes with its clarity? (3) Does the format of the rule (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce its clarity? (4) Would the rule be easier to understand if it were divided into more (but shorter) sections? (A “section” appears in bold type and is preceded by the symbol “§ ” and a numbered heading; for example, “§ 20.134 Approval of nontoxic shot types.”) (5) Is the description of the rule in the SUPPLEMENTARY INFORMATION section of the preamble helpful in understanding the rule? What else could we do to make the rule easier to understand?

You may submit written comments on this proposal to the location identified in the ADDRESSES section, or you may submit electronic comments to the internet address or the e-mail address listed in the ADDRESSES section. We must receive your comments before the date listed in the DATES section. While our normal practice is to open public comment periods on our proposed rules for 60 days, in this case we are opening the comment period for only 30 days. We believe a 30-day comment period will be sufficient because we have approved several other nontoxic shot types through the rulemaking process and have received very few comments on those rulemaking actions and because the changes in this proposed rule should not be controversial. Following review and consideration of comments, we will issue a final rule on the proposed regulation changes.

When submitting electronic comments, please include your name and return address in your message, identify it as comments on the nontoxic shot proposed rule, and submit your comments as an ASCII file, preferably as part of the e-mail text. Include RIN 1018-AU04 in the subject line of your message. Do not use special characters or any encryption. Written comments on this proposed rule must be on 8 1/2 -inch by 11-inch paper.

We make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home address from the rulemaking record, which we will honor to the extent allowable by law. In some circumstances, we would withhold from the rulemaking record a respondent's identity, as allowable by law. If you wish us to withhold your name or address, you must state this prominently at the beginning of your comment. We will not accept anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety. Comments will become part of the Administrative Record for the review of the application. You may inspect comments at the mailing address in ADDRESSES during normal business hours.

The Draft Environmental Assessment (DEA) for approval of the four shot types is available from the Division of Migratory Bird Management, U.S. Fish and Wildlife Service, 4501 North Fairfax Drive, Room 4091, Arlington, VA 22203-1610. You may call 703-358-1825 to request a copy of the DEA.

The complete file for this rule is available, by appointment, during normal business hours at the same address. You may make an appointment at 703-358-1825 to review the files.

In compliance with the requirements of section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(C)), and the Council on Environmental Quality's regulations for implementing NEPA (40 CFR 1500- 1508), though all of the metals in these shot types have been approved in other shot types and are not likely to pose adverse toxicity effects on fish, wildlife, their habitats, or the human environment, we have prepared Draft Environmental Assessments for this action. We will finalize the Environmental Assessments before we publish a final rule on this action.

Section 7 of the Endangered Species Act (ESA) of 1972, as amended (16 U.S.C. 1531 et seq. ), provides that Federal agencies shall “insure that any action authorized, funded or carried out * * * is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of (critical) habitat.” We have concluded that because all of the metals in these shot types have been approved in other shot types and will not be available to biota in significant amounts due to use of any of the four shot types, this action will not affect endangered or threatened species.

This rule is not a significant regulatory action subject to Office of Management and Budget (OMB) review under Executive Order 12866. This rule will not have an annual economic effect of $100 million or more or adversely affect an economic sector, productivity, jobs, the environment, or other units of government. Therefore, a cost-benefit economic analysis is not required. This action will not create inconsistencies with other agencies' actions or otherwise interfere with an action taken or planned by another agency. No other Federal agency has any role in regulating nontoxic shot for migratory bird hunting. The action is consistent with the policies and guidelines of other Department of the Interior bureaus. This action will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients because it has no mechanism to do so. This action will not raise novel legal or policy issues because the Service has already approved several other nontoxic shot types.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires the preparation of flexibility analyses for rules that will have a significant economic impact on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. This rule proposes to approve four additional types of nontoxic shot that may be sold and used to hunt migratory birds. We have determined, however, that this rule will have no effect on small entities since the approved shot merely will supplement nontoxic shot types already in commerce and available throughout the retail and wholesale distribution systems. We anticipate no dislocation or other local effects, with regard to hunters and others.

This proposed rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule will not have an annual effect on the economy of $100 million or more; will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. We have examined this regulation under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501) and found it to contain no new information collection requirements. OMB has assigned control number 1018-0067 to the collection of information that shot manufacturers are required to provide to us for the nontoxic shot approval process. This approval expires December 31, 2006. For further information, see 50 CFR 20.134.

We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq. , that this rulemaking will not significantly or uniquely affect small governments or produce a Federal mandate of $100 million or more in any given year. Therefore, this rule does not constitute a significant regulatory action under the Unfunded Mandates Reform Act.

In promulgating this rule, we have determined that these regulations meet the applicable standards provided in Sections 3(a) and 3(b)(2) of Executive Order 12988.

In accordance with Executive Order 12630, this rule, authorized by the Migratory Bird Treaty Act, does not have significant takings implications and does not affect any constitutionally protected property rights. This rule will not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property. A takings assessment is not required.

This rule does not have a substantial direct effect on fiscal capacity, change the roles or responsibilities of Federal or State governments, or intrude on State policy or administration. In accordance with Executive Order 13132, this regulation does not have significant federalism effects, nor does it have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951) and 512 DM 2, we have determined that this rule has no effects on Federally recognized Indian tribes.

For the reasons discussed in the preamble, we propose to amend part 20, subchapter B, chapter I of Title 50 of the Code of Federal Regulations as follows: