financial amounts for 2002, 2003, and 2004 should be noted in footnotes.
Final Rule amending the Commission’s
to calculate the total amounts sought in Extraordinary adjustments are events or regulations to update the accounting
Appendix A. transactions that are material to your and reporting requirements for public
12. Has the applicant or any of its business and unusual in nature and utilities and licensees, including
subsidiaries or affiliates received grants, infrequent in occurrence. independent system operators and
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17394 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations
regional transmission organizations.1 FOR FURTHER INFORMATION CONTACT: (3) must specify with particularity the
Order No. 668 amended FERC Form Andrew J. Zajac, Center for Food Safety provision of the regulation or proposed
Nos. 1 and 1–F by adding new and Applied Nutrition (HFS–265), Food order objected to; (4) must specifically
schedules and revising existing and Drug Administration, 5100 Paint state each objection on which a hearing
schedules in the forms. The Branch Pkwy., College Park, MD 20740– is requested; failure to request a hearing
Commission updated the submission 3835, 301–436–1267. on an objection constitutes a waiver of
software used to file FERC Form Nos. 1 SUPPLEMENTARY INFORMATION: the right to a hearing on that objection;
and 1–F to reflect the new financial and (5) must include a detailed
reporting requirements of Order No. I. Introduction description and analysis of the factual
668. FDA published a notice in the Federal information to be presented in support
The annual filing date for FERC Form Register of March 13, 2003 (68 FR of the objection if a hearing is requested;
Nos. 1 and 1–F is April 18. However, in 12087), announcing the filing of food failure to include a description and
light of the software changes made to additive petition, FAP 3M4745, by Ion analysis for an objection constitutes a
implement Order No. 668, the filing Beam Applications to amend the food waiver of the right to a hearing on that
deadline for the 2006 FERC Form Nos. additive regulations in § 179.26 Ionizing objection.
1 and 1–F is extended until May 18, radiation for the treatment of food (21 Following publication of the 7.5 MeV
2007. CFR 179.26) by increasing the maximum x-ray final rule, FDA received about 100
permitted energy level of x-rays for objections within the 30-day objection
Philis J. Posey, treating food from 5 to 7.5 MeV. The period. All but one of these submissions
Acting Secretary. rights to this petition were subsequently expressed general opposition to
[FR Doc. E7–6511 Filed 4–6–07; 8:45 am] transferred to Sterigenics International, increasing the maximum permitted
BILLING CODE 6717–01–P Inc. In response to this petition, FDA energy level of x-rays used to irradiate
issued a final rule in the Federal food and to food irradiation. Most of
Register of December 23, 2004 (69 FR these objections were form letters,
DEPARTMENT OF HEALTH AND 76844) permitting the safe use of 7.5 identically worded, urging FDA to
HUMAN SERVICES MeV x-rays for treating food provided conduct additional studies on the effects
that the x-rays are generated from of 7.5 MeV x-rays on food and objecting
Food and Drug Administration machine sources that use tantalum or ‘‘to the agency’s decision knowing that
gold as the target material, with no some amount of radioactivity could be
21 CFR Part 179 change in the maximum permitted dose created in food treated with 7.5 MeV.’’
[Docket No. 2003F–0088 (formerly 03F– levels or uses currently permitted by While most of these objections
0088)] FDA’s food additive regulations (the 7.5 requested a hearing, no evidence was
MeV x-ray final rule). The preamble to submitted in support of these objections
Irradiation in the Production, the final rule advised that objections to that could be considered in an
Processing and Handling of Food the final rule and requests for a hearing evidentiary hearing. These submissions
were due within 30 days of the expressing general opposition raise no
AGENCY: Food and Drug Administration, publication date (i.e., by January 24, factual issue for resolution and,
HHS. 2005). therefore, do not justify a hearing.1 The
ACTION: Final rule; response to one submission raising specific
objections and denial of requests for a II. Objections and Requests for a
objections was a letter from Public
hearing. Hearing
Citizen with six objections to the 7.5
Section 409(f) of the Federal Food, MeV x-ray final rule. The letter
SUMMARY: The Food and Drug Drug, and Cosmetic Act (the act) (21 requested a hearing on issues raised by
Administration (FDA) is responding to U.S.C. 348(f)) provides that, within 30 each objection. These objections are
objections and is denying requests that days after publication of an order addressed in section IV of this
it has received for a hearing on the final relating to a food additive regulation, document.
rule that amended the food additive any person adversely affected by such
regulations by establishing a new order may file objections, specifying III. Standards for Granting a Hearing
maximum permitted energy level of x- with particularity the provisions of the Specific criteria for deciding whether
rays for treating food of 7.5 million order ‘‘deemed objectionable, stating to grant or deny a request for a hearing
electron volts (MeV) provided that the reasonable grounds therefore, and are set out in § 12.24(b). Under that
x-rays are generated from machine requesting a public hearing upon such regulation, a hearing will be granted if
sources that use tantalum or gold as the objections.’’ FDA may deny a hearing the material submitted by the requester
target material, with no change in the request if the objections to the shows, among other things, the
maximum permitted dose levels or uses regulation do not raise genuine and following: (1) There is a genuine and
currently permitted by FDA’s food substantial issues of fact that can be substantial factual issue for resolution at
additive regulations. After reviewing the resolved at a hearing (Community a hearing; a hearing will not be granted
objections to the final rule and the Nutrition Institute v. Young, 773 F.2d on issues of policy or law; (2) the factual
requests for a hearing, the agency has 1356, 1364 (D.C. Cir. 1985), cert. denied, issue can be resolved by available and
concluded that the objections do not 475 U.S. 1123 (1986)). specifically identified reliable evidence;
raise issues of material fact that justify Under the food additive regulations at a hearing will not be granted on the
a hearing or otherwise provide a basis 21 CFR 171.110, objections and requests basis of mere allegations or denials or
for removing the amendment to the for a hearing are governed by part 12 (21 general descriptions of positions and
regulation. CFR part 12) of FDA’s regulations.
rwilkins on PROD1PC63 with RULES
Under § 12.22(a), each objection must 1A large number of these form letters were
1 Accounting and Financial Reporting for Public submitted after the close of the objection period.
meet the following conditions: (1) Must
Utilities Including RTOs, Order No. 668, FERC Tardy objections fail to satisfy the requirements of
Stats. & Regs. ¶ 31,199 (2005), reh’g denied, Order
be submitted on or before the 30th day 21 U.S.C. 348(f)(1) and need not be considered by
No. 668–A, FERC Stats. & Regs. ¶ 31,215 (2006), after the date of publication of the final the agency (ICMAD v. HEW, 574 F.2d 553, 558 n.8
reh’g denied, 117 FERC ¶ 61,066 (2006). rule; (2) must be separately numbered; (D.C. Cir), cert. denied, 439 U.S. 893 (1978)).
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