[Federal Register: November 3, 2009 (Volume 74, Number 211)]
[Rules and Regulations]
[Page 56721-56726]
[DOCID:fr03no09-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 51 and 52

[EPA-HQ-OAR-2009-0021; FRL-8972-7]
RIN 2060-AP46

Administrative Stay of Clean Air Interstate Rule for Minnesota;
Administrative Stay of Federal Implementation Plan To Reduce Interstate
Transport of Fine Particulate Matter and Ozone for Minnesota

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule administratively stays the effectiveness, for
Minnesota and Minnesota sources only, of two rules issued under section
110 of the Clean Air Act (CAA) related to the interstate transport of
pollutants. On May 12, 2005, EPA issued the Clean Air Interstate Rule
(CAIR) requiring Minnesota and other states in the eastern U.S. to
submit State Implementation Plan (SIP) revisions to limit sulfur
dioxide (SO2) and nitrogen oxides (NOX) emissions
in order to eliminate the significant contribution of these states to
nonattainment for fine particulate matter (PM2.5) and/or
ozone, and eliminates interference with maintenance of attainment, in
downwind states. On April 28, 2006, EPA issued Federal Implementation
Plans (CAIR FIPs) to serve as a backstop until replaced by approved
SIPs. Subsequently, the U.S. Court of Appeals for the District of
Columbia Circuit reversed and remanded CAIR. Among other things, the
Court held that EPA had not properly addressed possible errors in
analysis supporting the inclusion of Minnesota in CAIR for fine
particulate matter. In this final rule, EPA is administratively staying
the effectiveness of CAIR and the CAIR FIP with respect to Minnesota
and sources in Minnesota only, pending further rulemaking in response
to the remand.

DATES: The effective date of this final rule is December 3, 2009.

ADDRESSES: Docket: EPA has established a docket for this final rule
under Docket ID No. EPA-HQ-OAR-2009-0021. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, e.g., confidential
business information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
www.regulations.gov or in hard copy at the EPA Docket Center EPA/DC,
EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the EPA
Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jeb Stenhouse, Program Development
Branch, Clean Air Markets Division, Office of Atmospheric Programs,
Mail Code 6204J, Environmental Protection Agency, Washington, DC 20460,
telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, and e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Outline

I. Background
II. What Is the Scope of this Final Rule?
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act
    L. Judicial Review

I. Background

    Section 110(a)(2)(D)(i)(I) of the CAA requires that a state's SIP
prohibit emissions by any source or other type of emissions activity in
the state that will ``contribute significantly to nonattainment in, or
interfere with maintenance by, any other State'' with respect to any
national ambient air quality standard (NAAQS). 42 U.S.C.
7410(a)(2)(D)(i)(I). On May 12, 2005, EPA issued CAIR (70 FR 25162, May
12, 2005). In that rule, EPA found that 28 states and Washington, DC
contribute significantly to nonattainment, and interfere with
maintenance, of the NAAQS for fine particulate matter and/or ozone in
downwind states. CAIR required these upwind states to revise their SIPs
to include control measures to reduce emissions of SO2 and/
or NOX and thereby meet the requirements of section
110(a)(2)(D)(i)(I). One of the states included in CAIR for fine
particulate matter, but not for ozone, was the State of Minnesota.
Minnesota was thus required to reduce annual SO2 and annual
NOX emissions in accordance with the requirements of the
rule. Further, in CAIR, EPA offered to administer, as a remedy through
which states could comply with CAIR, SO2 annual,
NOX annual, and NOX ozone season trading programs
that states could choose to incorporate in their SIPs. CAIR included
model rules for these trading programs and provided that states could
adopt the model rules in their SIPs and thereby incorporate the trading
programs in the SIPs.
    On April 28, 2006, EPA issued the CAIR FIPs (71 FR 25330, April 28
2006). In the April 28, 2006, notice, EPA promulgated FIPs to implement
the emission reduction requirements of CAIR in each state covered by
CAIR until the FIP is replaced by an approved SIP. EPA issued the CAIR
FIPs to provide a federal backstop for CAIR. EPA decided to adopt as
the FIP for

each state in the CAIR region (including Minnesota) the SIP model
trading programs in CAIR, modified slightly to allow for federal,
instead of state, implementation.
    A number of petitioners brought legal challenges to several aspects
of CAIR and of the CAIR FIPs in the U.S. Court of Appeals for the
District of Columbia Circuit. Among the parties challenging the rule
was Minnesota Power, an electric utility operating in Minnesota, who
argued that EPA erred in the analysis of the contribution of Minnesota
sources to downwind nonattainment and thus in including Minnesota in
CAIR for fine particulate matter.
    On July 11, 2008, in North Carolina v. EPA, 531 F.3d 896, 926-30
(DC Cir. 2008), the D.C. Circuit ruled on these challenges and vacated
and remanded CAIR and the CAIR FIPs. Of particular relevance here, the
Court granted Minnesota Power's petition and remanded to EPA the issue
of the inclusion of Minnesota and Minnesota sources in CAIR and the
CAIR FIPs because the Court concluded that EPA had failed to fully
address alleged errors in its contribution analysis for Minnesota. Id.
at 926-27. In addition, the Court granted petitions of several other
parties and remanded to EPA issues concerning: EPA's interpretation of
the requirement in section 110(a)(2)(D)(i)(I) that SIPs must prohibit
``interference with maintenance'' with respect to any NAAQS (id. at
909-11); the lawfulness of the CAIR trading programs for NOX
and SO2 as a remedy that will assure that States abate
emissions that significantly contribute to downwind nonattainment or
interfere with maintenance (id. at 907-8); the 2015 deadline for states
to remedy their failure to eliminate their significant contribution
(id. at 911-12); the SO2 and NOX budgets used for
the trading programs (id. at 916-21); and EPA's authority to terminate
or limit Title IV allowances through a trading program under section
110(a)(2)(D)(i)(I) or through a requirement that, to comply with
section 110(a)(2)(D)(i)(I), SIPs have Title IV allowance retirement
provisions (id. at 921-22).
    On September 24, 2008, EPA filed a petition for rehearing with the
DC Circuit. This petition sought rehearing of a number of the Court's
findings, but did not seek rehearing of the findings regarding
Minnesota. On October 31, 2008, EPA sent a letter to Minnesota Power
indicating its intent to stay the effectiveness of CAIR with respect to
sources located in Minnesota until the Agency determined whether
Minnesota should be included in CAIR. This letter was also submitted to
the Court during briefing on the petitions for rehearing.
    On December 23, 2008, the DC Circuit granted EPA's petition for
rehearing only with regard to the vacatur and remanded CAIR without
vacatur. This decision means that CAIR and the CAIR FIPs remain in
effect while EPA develops a replacement rule consistent with the July
11, 2008, opinion.

II. What Is the Scope of This Final Rule?

    In this final rule, EPA is only staying the effectiveness of CAIR
and the CAIR FIPs with respect to Minnesota and sources in Minnesota.
EPA intends to conduct further rulemaking in response to the Court's
remand of CAIR and the CAIR FIPs. EPA intends that the stay with
respect to Minnesota and Minnesota sources will remain in effect
pending such further rulemaking.
    EPA believes that the stay in this final rule is appropriate in
light of several factors related to EPA's consideration, following the
July 11, 2008 decision, of the issue concerning Minnesota's inclusion
in CAIR. First, as discussed above, EPA did not seek rehearing of the
Court's July 11, 2008 decision regarding the contribution analysis for
Minnesota. Instead, before the Court ruled on the petitions for
rehearing, EPA stated its intention to stay CAIR for Minnesota and
sources in Minnesota pending a final agency determination concerning
Minnesota's inclusion in CAIR. This information was presented to the
Court during the rehearing process that resulted in the December 23,
2008 decision to remand CAIR without vacatur. This final rule carries
out EPA's stated intent.
    Second, the issue of whether Minnesota significantly contributes to
nonattainment for fine particulate matter in any downwind state,
contrary to one of the requirements for SIPs in section
110(a)(2)(D)(i)(I), is logically severable from the other issues
(described above) that were remanded to EPA by the DC Circuit in North
Carolina. This issue relates solely to whether EPA properly decided
whether Minnesota should be covered by-CAIR for fine particulate
matter. In contrast, the other remanded issues affect multiple states
and relate either to another requirement in section 110(a)(2)(D)(i)(I)
or to whether the specific emission reduction requirements in CAIR were
proper or adequate as a remedy for each state's 110(a)(2)(D)(i)(I)
problems. One of the other remanded issues concerns the Court's
determination that EPA failed to give independent meaning to the
requirement, in section 110(a)(2)(D)(i)(I), that states also eliminate
emissions that interfere with maintenance in downwind states. North
Carolina, 531 F.3d at 910. The remaining remanded issues concern
various aspects of the remedies (e.g., the trading programs) EPA may
approve in SIPs for states determined to have failed to meet the
significant contribution requirement and raise complex questions about
precisely what is required for each state to eliminate its
significantly contributing emissions prohibited by section
110(a)(2)(D)(i)(I). The issue about Minnesota and Minnesota sources
concerns the discrete question of whether EPA erred in its analysis of
the contribution of Minnesota sources to downwind nonattainment areas
and is logically severable from all the other remanded issues.
    Third, as discussed in detail below, EPA finds that the stay with
respect to Minnesota and Minnesota sources can be implemented
immediately without disrupting the operation of the trading programs
under CAIR and the CAIR FIPs and the allowance market. The stay is thus
consistent with the Court's July 11, 2008 and the December 28, 2008
decisions leaving the CAIR and CAIR FIPs in place as promulgated while
EPA develops a replacement rule. In addition, as noted above, the Court
was aware of EPA's intent to stay CAIR with respect to Minnesota and
Minnesota sources when it issued the December 28, 2008 decision.
    Minnesota sources are currently subject to the CAIR annual
SO2 and annual NOX trading programs, and the
major issue in implementing the stay is how to treat, during the stay
period, allowances that are usable in the trading programs and have
already been allocated and recorded for Minnesota sources. As explained
below, SO2 and NOX allowances must be treated
differently.
    In the CAIR SO2 trading program as promulgated, sources
(including those in Minnesota) are not issued new allowances but
instead must use title IV allowances for compliance in the trading
program.\1\ Under title IV, allowances were allocated to sources,
generally during 1993 in perpetuity, with each allowance authorizing in
the Acid Rain Program one ton of emissions in the year for which the
allowance was allocated or any year thereafter. In the CAIR
SO2 trading program, the same allowances are usable and
authorize emissions in the same years, but those allowances allocated
for years before

2010 authorize one ton of emissions, those allocated for 2010 through
2014 authorize one-half ton of emissions, and those allocated for 2015
and thereafter authorize 0.35 ton of emissions. Implementation of the
stay adopted in this final rule does not involve EPA making any changes
in this final rule with regard to Minnesota sources' title IV
allowances. Under the stay, these sources retain the title IV
allowances that they currently hold (including any allocations for 2010
and thereafter that the sources have not transferred). Moreover, like
any other title IV allowance that has not already been used or retired,
title IV allowances allocated to Minnesota sources continue to be
usable in either the Acid Rain Program or the CAIR SO2
trading program and retain the above-described emission tonnage
authorizations because those authorizations depend on the year for
which the allowances were issued and the trading program in which they
are used, not on whether the entity to which the allowances were
allocated is subject to CAIR.
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    \1\ While CAIR SO2 opt-in units are allocated new
CAIR SO2 allowances, the Minnesota FIP does not allow for
opt-in units.
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    In contrast, the CAIR NOX annual trading program
provides for the issuance of new CAIR NOX allowances and
such allowances for 2009 have already been allocated for existing
Minnesota sources and recorded in the sources' compliance accounts in
the allowance tracking system for that program under the CAIR FIP for
Minnesota. For the reasons discussed below, implementation of the stay
in this final rule requires that an amount of 2009 CAIR NOX
allowances equivalent to the amount that has already been allocated and
recorded for these sources be removed from the CAIR NOX
annual trading program and that no more CAIR NOX allowances
be allocated to Minnesota sources for the period that the stay is in
place. However, as discussed below, EPA finds that this can be
accomplished without disruption of the trading program and the
allowance market.
    While the stay in this final rule is in place, Minnesota sources
will not need to use any of their allowance allocations to authorize
their annual NOX emissions. If those allowances that have
already been recorded were not removed from the trading program and if
allowances for future years continued to be allocated and recorded for
Minnesota sources, the full amount of these allowances could be traded
for use by non-Minnesota sources to authorize their own annual
NOX emissions. This would increase the total amount of
allowances available each year for use by sources in the states that
will continue to be subject to the NOX annual trading
program under CAIR or the CAIR FIPs. As a result, the total amount of
CAIR NOX allowances available each year for sources in these
states would exceed the sum of the NOX annual trading
budgets under CAIR and the CAIR FIPs for these states. If this were
allowed, the CAIR NOX annual trading program would not
achieve the NOX emission reductions intended under CAIR and
the CAIR FIPs and reflected in the state NOX annual trading
budgets.
    EPA could have accomplished the removal from the trading program of
the amount of the 2009 CAIR NOX allowances allocated and
recorded for Minnesota sources under the FIP for the CAIR
NOX annual trading program by simply requiring those sources
to surrender those specific allowances. However, EPA understands that,
although most of the CAIR NOX allowances allocated and
recorded for sources in Minnesota are still held in the sources'
compliance accounts, at least one Minnesota source has traded some of
its recorded allowance allocations.\2\ Consequently, the final rule
requires that each Minnesota source with a recorded allowance
allocation in the CAIR NOX annual trading program hold an
amount of CAIR NOX allowances issued for the same year as
the recorded allocation (i.e., 2009) equal to the amount of the
recorded allocation, regardless of whether the allowances held are the
same ones that were allocated to the Minnesota source. Further, under
the final rule, the Administrator will deduct, and thereby retire,
these required allowance holdings, and no additional allowance
allocations from the state NOX annual trading budget for
Minnesota will be recorded.
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    \2\ According to EPA's allowance tracking system, a total amount
of 29,875 CAIR NOX allowances were allocated to Minnesota
sources for 2009, and 68 of such allowances were sold (in a single
transfer on March 7, 2008) by the recipient of the allocation to
another party.
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    For the reasons outlined in the following paragraphs, EPA believes
that this approach of requiring Minnesota sources to hold 2009 CAIR
NOX allowances equal in amount to such sources' allocations
will achieve the allowance removal necessary to implement the stay
without disrupting the operation of the CAIR NOX annual
trading program under CAIR and the CAIR FIPs, the allowance market, and
the participation of non-Minnesota sources in the program. EPA also
believes that it is reasonable that Minnesota sources be given the
responsibility of holding in their compliance accounts the allowances
that the Administrator needs to remove.
    First, each Minnesota source with a recorded allocation for 2009
can meet this responsibility by continuing to hold its allocated 2009
CAIR NOX allowances that it has not transferred and--to the
extent necessary to replace any of its allocated 2009 CAIR
NOX allowances that have been included in the few trades of
Minnesota-source-allocated allowances that have occurred--by obtaining
other 2009 CAIR NOX allowances. EPA does not believe it
needs to require Minnesota sources to hold for deduction exactly the
same CAIR NOX allowances that were allocated to such
sources. Because all CAIR NOX allowances issued for a given
year (here, 2009) under the CAIR NOX annual trading program
under CAIR and the CAIR FIPs are fungible, deduction of the same amount
of CAIR NOX allowances issued for 2009 has the desired
effect of removing the extra allowances for 2009 whether the deducted
allowances are the ones allocated to Minnesota sources or those
allocated to other sources. In short, a deduction--but no
reallocation--of CAIR NOX allowances is necessary to
implement the stay of the effectiveness of CAIR and the CAIR FIP rule
with regard to Minnesota and Minnesota sources.
    Further, this approach avoids disruption of the trading program,
the allowance market, and the participation of non-Minnesota sources
because no allowance transfers that have occurred will be reversed or
invalidated. Any party that purchased allocated CAIR NOX
allowances from a Minnesota source will retain the ability to use,
hold, or transfer those purchased allowances, and any planning, based
on such purchased allowances, for compliance with the requirement to
hold allowances covering emissions will not be affected.
    EPA believes that it is reasonable to make Minnesota sources
responsible for holding 2009 CAIR NOX allowances for
deduction in order to implement the stay. The burden of doing so will
be minimal because, as discussed above, these sources have transferred,
and so will have to replace, only a few of their allocated 2009 CAIR
NOX allowances and most of these sources will simply
continue to hold their existing 2009 CAIR NOX allocations.
Further, these sources benefit from the stay in that they would remain
subject to CAIR but for the stay. In summary, the stay can be
implemented--through removal from the CAIR NOX annual
trading program of the amount of Minnesota sources' 2009 CAIR
NOX allowances--without

disrupting the trading program (including sources' compliance planning)
or the allowance market or unreasonably burdening Minnesota and non-
Minnesota sources.
    EPA received several comments on the proposed rule for a stay of
CAIR and the CAIR FIP for Minnesota and Minnesota sources. All of the
comments supported the proposal.\3\ One commenter also requested
clarification of the amount of allowances for 2009 that EPA will deduct
from each Minnesota source's compliance account. The amount of 2009
CAIR NOX allowances deducted will be equal to the amount
originally recorded as the allocation for 2009 for the source. As is
stated explicitly in the text of this final rule, EPA will not deduct,
pursuant to the final rule, any other allowances. Any source in
Minnesota holding any allowances in addition to 2009 CAIR
NOX allowances in the amount of its 2009 CAIR NOX
allocation will retain such additional allowances and may hold them or
transfer them at any time, as the source prefers.
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    \3\ In addition, some commenters provided comments, along with
supporting information, that Minnesota was improperly included in
CAIR and that the stay should remain in effect until EPA
prolmulgates a replacement rule for CAIR consistent with the Court's
decisions. One commenter also attached to its comment on the
proposal a copy of comments presented during the CAIR FIPs
rulemaking, concerning the applicability and allowance allocation
provisions in the CAIR FIP trading programs. In this rulemaking, EPA
is only staying CAIR and the CAIR FIPs with respect to Minnesota and
sources in Minnesota, without specifying at this time how long the
stay will remain in effect, and is not taking any action regarding
any other issues concerning CAIR and the CAIR FIPs. These comments
thus are beyond the scope of this rule and do not require a
response. EPA will respond to these comments in the context of the
Agency's rulemaking in response to the remand of CAIR and the CAIR
FIPs.
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    Although the proposed rule set June 30, 2009, as the date on which
Minnesota sources must hold these allowances for deduction, that date
has passed. Instead, EPA is adopting in this final rule midnight of the
date 30 days after the Federal Register publication date for this final
rule (which EPA is also setting as the final rule's effective date) as
the earliest, reasonable time and date on which to require the holding
of such allowances. EPA believes that the requirement to hold such
allowances as of midnight of December 3, 2009 will provide sufficient
time for Minnesota sources to obtain the proper amount of CAIR
NOX allowances, particularly in light of the few trades of
Minnesota-source-allocated allowances that have occurred. Moreover,
EPA's preferred approach, as explained in the proposed rule, is
removing these allowances from the trading program as quickly as
possible. None of the commenters opposed that general approach.

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the EO.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320(b). This action does not impose any
information collection burden on any state, local, or tribal
governments or the private sector and instead temporarily relieves
Minnesota sources of any information collection burden under the CAIR
trading programs.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) 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 organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise that is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
rule does not impose any requirements on small entities and instead
temporarily relieves Minnesota sources (including any small entities in
Minnesota) of the allowance-holding and other requirements under the
CAIR trading programs, except for the one-time requirement to hold
allowances equal to the sources' 2009 CAIR NOX allowance
allocations.

D. Unfunded Mandates Reform Act

    This action contains no federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (URMA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. This action does not impose any new obligations or enforceable
duties on any state, local, or tribal governments or the private sector
and instead temporarily relieves Minnesota sources of the allowance-
holding and other requirements under the CAIR trading programs, except
for the one-time requirement to hold allowances equal to the sources'
2009 CAIR NOX allowance allocations. Therefore, this action
is not subject to the requirements of sections 202 and 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of URMA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This action does
not impose any new obligations or enforceable duties on any small
governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This rule does not impose any new
obligations or enforceable duties on any state, local, or tribal
governments and instead temporarily relieves Minnesota sources of the
allowance-holding and other requirements under the CAIR trading
programs, except for the one-time requirement to hold allowances equal
to the sources' 2009 CAIR NOX allowance allocations. Thus,
Executive Order 13132 does not apply to this rule.
    In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and state and local
governments, EPA specifically solicited comments on the proposed action
from state and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have
substantial direct effects on tribal governments, on the

relationship between the federal government and Indian Tribes, or on
the distribution of power and responsibilities between the federal
government and Indian Tribes, as specified in Executive Order 13175.
This action does not significantly or uniquely affect the communities
of Indian Tribal governments. As discussed above, this action imposes
no new requirements that would impose compliance burdens and instead
temporarily relieves Minnesota sources of the allowance-holding and
other requirements under the CAIR trading programs, except for the one-
time requirement to hold allowances equal to the sources' 2009 CAIR
NOX allowance allocations. Thus, Executive Order 13175 does
not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it imposes no
new requirements and instead temporarily relieves Minnesota sources of
the allowance-holding and other requirements under the CAIR trading
programs, except for the one-time requirement to hold allowances equal
to the sources' 2009 CAIR NOX allowance allocations.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through the Office of Management and Budget, explanations
when the Agency decides not to use available and applicable voluntary
consensus standards.
    This action does not involve technical standards. Therefore, EPA
did not consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of its programs,
policies, and activities on minorities and low-income populations in
the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
impose any new requirements and only temporarily relieves Minnesota
sources of the allowance-holding and other requirements under the CAIR
trading programs, except for the one-time requirement to hold
allowances equal to the sources' 2009 CAIR NOX allowance
allocations.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801, et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2). This rule will be effective on December 3, 2009.

L. Judicial Review

    Section 307(b)(1) of the CAA indicates which U.S. Courts of Appeal
have venue for petitions of review of final actions by EPA. This
section provides, in part, that petitions for review must be filed in
the U.S. Court of Appeals for the District of Columbia Circuit if (i)
the agency action consists of ``nationally applicable regulations
promulgated, or final action taken, by the Administrator,'' or (ii)
such action is locally or regionally applicable, if ``such action is
based on a determination of nationwide scope or effect and if in taking
such action the Administrator finds and publishes that such action is
based on such a determination.''
    Any final action related to CAIR is ``nationally applicable''
within the meaning of section 307(b)(1). Through CAIR and the CAIR
FIPs, EPA interprets section 110 of the CAA, a provision that has
nationwide applicability. In addition, the determination of whether a
state (here, Minnesota) is covered by CAIR is based on a common core of
factual findings and analyses concerning the transport of pollutants
between different states. Finally, EPA has established uniform
approvability criteria that would be applied to the SIP revisions
submitted by all states subject to CAIR. For these reasons, the
Administrator also is determining that any final action regarding CAIR
is of nationwide scope and effect for purposes of section 307(b)(1).
Thus, any petitions for review of this final rule must be filed in the
Court of Appeals for the District of Columbia Circuit within 60 days
from the date the final rule is published in the Federal Register.

List of Subjects

40 CFR Part 51

    Administrative practice and procedure, Air pollution control,
Environmental protection, Intergovernmental relations, Nitrogen oxides,
Ozone, Particulate matter, Reporting and recordkeeping requirements,
Sulfur dioxide.

40 CFR Part 52

    Administrative practice and procedure, Air pollution control,
Environmental protection, Intergovernmental relations, Nitrogen oxides,
Ozone, Particulate matter, Reporting and recordkeeping requirements,
Sulfur dioxide.

    Dated: October 15, 2009.
Lisa P. Jackson,
Administrator.

0
For the reasons set forth in the preamble, parts 51 and 52 of chapter I
of title 40 of the Code of Federal Regulations are amended as follows:

PART 51--REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF
IMPLEMENTATION PLANS

0
1. The authority citation for part 51 continues to read as follows:

    Authority:  23 U.S.C. 101; 42 U.S.C. 7401-7671q.

0
2. Section 51.123 is amended by adding a new paragraph (a)(3) to read
as follows:

Sec.  51.123  Findings and requirements for submission of State
implementation plan revisions relating to emissions of oxides of
nitrogen pursuant to the Clean Air Interstate Rule.

    (a) * * *
    (3) Notwithstanding the other provisions of this section, such
provisions are not applicable as they relate to the State of Minnesota
as of December 3, 2009.
* * * * *

0
3. Section 51.124 is amended by redesignating paragraph (a) as
paragraph (a)(1) and adding a new paragraph (a)(2) to read as follows:

Sec.  51.124  Findings and requirements for submission of State
implementation plan revisions relating to emissions of sulfur dioxide
pursuant to the Clean Air Interstate Rule.

    (a) * * *
    (2) Notwithstanding the other provisions of this section, such
provisions are not applicable as they relate to the State of Minnesota
as of December 3, 2009.
* * * * *

0
4. Section 51.125 is amended by adding a new paragraph (a)(3) to read
as follows:

Sec.  51.125  Emissions reporting requirements for SIP revisions
relating to budgets for SO2 and NOX emissions.

    (a) * * *
    (3) Notwithstanding the other provisions of this section, such
provisions are not applicable as they relate to the State of Minnesota
as of December 3, 2009.
* * * * *

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
5. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

0
6. Section 52.35 is amended by adding a new paragraph (e) to read as
follows:

Sec.  52.35  What are the requirements of the Federal Implementation
Plans (FIPs) for the Clean Air Interstate Rule (CAIR) relating to
emissions of nitrogen oxides?

* * * * *
    (e) Notwithstanding paragraphs (a) and (b) of this section, such
paragraphs are not applicable as they relate to sources in the State of
Minnesota as of December 3, 2009, except as provided in Sec.
52.1240(b).

0
7. Section 52.36 is amended by adding a new paragraph (d) to read as
follows:

Sec.  52.36  What are the requirements of the Federal Implementation
Plans (FIPs) for the Clean Air Interstate Rule (CAIR) relating to
emissions of sulfur dioxide?

* * * * *
    (d) Notwithstanding paragraph (a) of this section, such paragraph
is not applicable as it relates to sources in the State of Minnesota as
of December 3, 2009.

0
8. Section 52.1240 is amended by adding a new paragraph (b) to read as
follows:

Sec.  52.1240  Interstate pollutant transport provisions; What are the
FIP requirements for decreases in emissions of nitrogen oxides?

* * * * *
    (b) Notwithstanding paragraph (a) of this section, such paragraph
is not applicable as it relates to sources in the State of Minnesota as
of December 3, 2009, except that:
    (1) The owner and operator of each source referenced in such
paragraph in whose compliance account any allocation of CAIR
NOX allowances was recorded under the Federal CAIR
NOX Annual Trading Program in part 97 of this chapter shall
hold in that compliance account, as of midnight of December 3, 2009 and
with regard to each such recorded allocation, CAIR NOX
allowances that are usable in such trading program, issued for the same
year as the recorded allocation, and in the same amount as the recorded
allocation. The owner and operator shall hold such allowances for the
purpose of deduction by the Administrator under paragraph (b)(2) of
this section.
    (2) After December 3, 2009, the Administrator will deduct from the
compliance account of each source in the State of Minnesota any CAIR
NOX allowances required to be held in that compliance
account under paragraph (b)(1) of this section. The Administrator will
not deduct, for purposes of implementing the stay, any other CAIR
NOX allowances held in that compliance account and, starting
no later than December 3, 2009, will not record any allocation of CAIR
NOX allowances included in the State trading budget for
Minnesota for any year.

0
9. Section 52.1241 is amended by redesignating the existing text as
paragraph (a) and adding a new paragraph (b) to read as follows:

Sec.  52.1241  Interstate pollutant transport provisions; What are the
FIP requirements for decreases in emissions of sulfur dioxide?

* * * * *
    (b) Notwithstanding paragraph (a) of this section, such paragraph
is not applicable as it relates to sources in the State of Minnesota as
of December 3, 2009.

[FR Doc. E9-25596 Filed 11-2-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 210 (Wednesday, October 30, 2019)]
[Notices]
[Pages 58158-58160]
[FR Doc No: 2019-23666]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3953]

Providing Regulatory Submissions in Electronic Format:
Investigational New Drug Application Safety Reports; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format: IND Safety Reports.'' The
draft guidance describes the electronic format sponsors will be
required to use when they electronically submit to FDA investigational
new drug (IND) safety reports to the Center for Drug Evaluation and
Research (CDER) or the Center for Biologics Evaluation and Research
(CBER) for serious and unexpected suspected adverse reactions that are
required under the Agency's regulations. FDA is establishing the
electronic format requirements described in this guidance under the
Federal Food, Drug, and Cosmetic Act (FD&C Act). The draft guidance,
once finalized and effective, will require sponsors submitting the
specified IND safety reports electronically to submit the reports to
FDA using the FDA Adverse Event Reporting System (FAERS) as structured
data elements and will provide sponsors with a reporting format that is
consistent with the International Council for Harmonisation (ICH)
E2B(R2) format guidelines and reporting requirements to other
regulatory agencies. Additional technical specification documents and
instructions for submitting IND safety reports, including ``Electronic
Submission of IND Safety Reports Technical Conformance Guide'' and an
updated technical specifications document entitled ``Specifications for
Preparing and Submitting Electronic ICSRs and ICSR Attachments'' are
available on the FAERS Electronic Submission web page (available at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm).

DATES: Submit either electronic or written comments on the draft
guidance by December 30, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your

comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-3953 for ``Providing Regulatory Submissions in Electronic
Format: IND Safety Reports.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Meredith K. Chuk, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, MD 20993-0002,<PHONE_NUMBER>; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format: IND
Safety Reports.'' The draft guidance describes the electronic format
sponsors will be required to use when they electronically submit to FDA
IND safety reports to CDER and CBER for serious and unexpected
suspected adverse reactions that are required under 21 CFR
312.32(c)(1)(i). FDA is establishing the electronic format requirements
described in this guidance under section 745A(a) of the FD&C Act. In
section 745A(a) of the FD&C Act, Congress granted explicit statutory
authorization to FDA to specify in guidance the format for the
electronic submissions required under that section. The draft guidance,
once finalized, will require sponsors submitting the specified IND
safety reports electronically to submit the reports to FDA using FAERS
as structured data elements. Additional technical specification
documents and instructions for submitting IND safety reports, including
``Electronic Submission of IND Safety Reports Technical Conformance
Guide'' and an updated technical specifications document entitled
``Specifications for Preparing and Submitting Electronic ICSRs and ICSR
Attachments,'' are available on the FAERS Electronic Submission web
page (available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm)).
    The draft guidance, when finalized, will represent the current
thinking of FDA on ``Providing Regulatory Submissions in Electronic
Format: IND Safety Reports.'' The electronic format requirements
specified in this guidance will be effective 24 months after the
publication of the final guidance on this topic. Before the effective
date of this requirement, FDA will accept the IND safety reports
described in this guidance to FAERS as part of a voluntary submission
program.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information under 21 CFR 312.10 for submitting waiver
requests and under 21 CFR 312.32 for submitting IND safety reports and
reporting serious and unexpected adverse events has been approved under
OMB control number 0910-0014. The collection of information for
submitting Forms FDA 3500 and 3500A has been approved under OMB control
number 0910-0291. The collection of information for submitting periodic
adverse drug experience reports has been approved under OMB control
number 0910-0230.

The collection of information for FDA adverse event reporting and
electronic submissions using the Electronic Submission Gateway and the
Safety Reporting Portal has been approved under OMB control number
0910-0645.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: October 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23666 Filed 10-29-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Rules and Regulations]
[Pages 27586-27590]
[FR Doc No: 2012-11391]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-1999-F-0021; formerly 1999F-2673]

Irradiation in the Production, Processing and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; denial of requests for a hearing and response to
objections.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is denying requests for
a hearing on the final rule that amended the food additive regulations
to provide for the safe use of ionizing radiation for the control of
microbial pathogens in seeds for sprouting. After reviewing objections
to the final rule and requests for a hearing, FDA has concluded that
the objections do not justify a hearing or otherwise provide a basis
for revoking the regulation.

FOR FURTHER INFORMATION CONTACT: Teresa A. Croce, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register of August 16, 1999 (64 FR 44530), FDA
published a notice announcing the filing of a food additive petition
(FAP 9M4673) submitted by Caudill Seed Co., Inc., to amend the
regulations in part 179 Irradiation in the Production, Processing, and
Handling of Food (21 CFR part 179) by providing for the safe use of
ionizing radiation to control microbial pathogens in seeds for
sprouting. In response to this petition, FDA issued a final rule in the
Federal Register of October 30, 2000 (65 FR 64605), permitting the
irradiation of seeds for sprouting to control microbial pathogens in
alfalfa and other sprouting seeds at an absorbed dose not to exceed 8.0
kiloGray (kGy) (hereafter referred to as the ``seeds for sprouting
rule''). FDA based its decision on data in the petition and in its
files. The preamble to the final rule advised that objections to the
final rule and requests for a hearing were due within 30 days of the
publication date (i.e., by November 29, 2000).

II. Objections and Requests for a Hearing

    Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 348(f)(1)) provides that, within 30 days after publication of an
order relating to a food additive regulation, any person adversely
affected by such order may file objections, ``specifying with
particularity the provisions of the order deemed objectionable, stating
reasonable grounds therefor [sic], and requesting a public hearing upon
such objections.''
    Under the food additive regulations at 21 CFR 171.110, objections
and requests for a hearing are governed by part 12 (21 CFR part 12) of
FDA's regulations. Under Sec.  12.22(a), each objection must meet the
following conditions: (1) Must be submitted on or before the 30th day
after the date of publication of the final rule; (2) must be separately
numbered; (3) must specify with particularity the provision of the
regulation or proposed order objected to; (4) must specifically state
each objection on which a hearing is requested; failure to request a
hearing on an objection constitutes a waiver of the right to a hearing
on that objection; and (5) must include a detailed description and
analysis of the factual information to be presented in support of the
objection if a hearing is requested; failure to include a description
and analysis for an objection constitutes a waiver of the right to a
hearing on that objection.
    Following publication of the final rule permitting the irradiation
of seeds for sprouting to control food-borne pathogens, FDA received
numerous submissions within the 30-day objection

period. FDA received a letter from Public Citizen (letter to Docket No.
4602, November 15, 2000) containing eight numbered objections with a
request for a hearing on each objection, and a letter by Jonathan
Sprouts, Inc. (letter to Docket No. 5055, December 19, 2000),
expressing concern over the labeling of sprouts grown from seeds that
have been irradiated. The remaining submissions expressed general
opposition to the final rule. Those submissions are brief form letters
which state either one or a combination of the following general
concerns: That no toxicity studies were performed directly on the
consumable sprouts, that nutrition data was submitted for irradiation
doses of 6 kGy and not the petitioned maximum of 8 kGy, or that the
lack of labeling for sprouts grown from irradiated seeds was a concern.
Those concerns were raised with more specificity by the other two
submissions and will be addressed as part of the response to those
submissions in section IV of this document.

III. Standards for Granting a Hearing

    Specific criteria for deciding whether to grant or deny a request
for a hearing are set out in Sec.  12.24(b). Under that regulation, a
hearing will be granted if the material submitted by the requester
shows, among other things, the following: (1) There is a genuine and
substantial factual issue for resolution at a hearing; a hearing will
not be granted on issues of policy or law; (2) the factual issue can be
resolved by available and specifically identified reliable evidence; a
hearing will not be granted on the basis of mere allegations or denials
or general descriptions of positions and contentions; (3) the data and
information submitted, if established at a hearing, would be adequate
to justify resolution of the factual issue in the way sought by the
requestor; a hearing will be denied if the data and information
submitted are insufficient to justify the factual determination urged,
even if accurate; (4) resolution of the factual issue in the way sought
by the person is adequate to justify the action requested; a hearing
will not be granted on factual issues that are not determinative with
respect to the action requested (e.g., if the action would be the same
even if the factual issue were resolved in the way sought); (5) the
action requested is not inconsistent with any provision in the act or
any FDA regulation; and (6) the requirements in other applicable
regulations, e.g., 21 CFR 10.20, 12.21, and 12.22, and in the notice
issuing the final regulation or the notice of opportunity for hearing
are met.
    A party seeking a hearing is required to meet a ``threshold burden
of tendering evidence suggesting the need for a hearing'' (Costle v.
Pacific Legal Foundation, 445 U.S. 198, 214 (1980), reh. denied, 446
U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc.,
412 U.S. 609, 620-21 (1973)). An allegation that a hearing is necessary
to ``sharpen the issues'' or to ``fully develop the facts'' does not
meet this test (Georgia Pacific Corp. v. U.S. EPA, 671 F.2d 1235, 1241
(9th Cir. 1982)). If a hearing request fails to identify any factual
evidence that would be the subject of a hearing, there is no point in
holding one. In judicial proceedings, a court is authorized to issue
summary judgment without an evidentiary hearing whenever it finds that
there are no genuine issues of material fact in dispute and a party is
entitled to judgment as a matter of law (see Rule 56, Federal Rules of
Civil Procedure). The same principle applies in administrative
proceedings (see Sec.  12.28).
    A hearing request must not only contain evidence, but that evidence
should raise a material issue of fact concerning which a meaningful
hearing might be held (Pineapple Growers Association v. FDA, 673 F.2d
1083, 1085 (9th Cir. 1982)). Where the issues raised in the objection
are, even if true, legally insufficient to alter the decision, the
Agency need not grant a hearing (see Dyestuffs and Chemicals, Inc. v.
Flemming, 271 F.2d 281, 286 (8th Cir. 1959), cert. denied, 362 U.S. 911
(1960)). A hearing is justified only if the objections are made in good
faith and if they ``draw in question in a material way the
underpinnings of the regulation at issue'' (Pactra Industries v. CPSC,
555 F.2d 677, 684 (9th Cir. 1977)). A hearing need not be held to
resolve questions of law or policy (see Citizens for Allegan County,
Inc. v. FPC, 414 F.2d 1125, 1128 (DC Cir. 1969); Sun Oil Co. v. FPC,
256 F.2d 233, 240 (5th Cir.), cert. denied, 358 U.S. 872 (1958)).
    Even if the objections raise material issues of fact, FDA need not
grant a hearing if those same issues were adequately raised and
considered in an earlier proceeding. Once an issue has been so raised
and considered, a party is estopped from raising that same issue in a
later proceeding without new evidence. The various judicial doctrines
dealing with finality, such as collateral estoppel, can be validly
applied to the administrative process (see Pac. Seafarers, Inc. v. Pac.
Far East Line, Inc., 404 F.2d 804, 809 (DC Cir. 1968), cert. denied,
393 U.S. 1093 (1969)). In explaining why these principles ought to
apply to an agency proceeding, the U.S. Court of Appeals for the
District of Columbia Circuit wrote: ``The underlying concept is as
simple as this: Justice requires that a party have a fair chance to
present his position. But overall interests of administration do not
require or generally contemplate that he will be given more than one
fair opportunity.'' Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d
316, 322 (DC Cir. 1972; see also Costle v. Pacific Legal Foundation,
445 U.S. at 215-217.
    In summary, a hearing request must present sufficient credible
evidence to raise a material issue of fact and the evidence must be
adequate to resolve the issue as requested and to justify the action
requested.

IV. Analysis of Objections and Response to Hearing Requests

    The letter from Public Citizen contains eight numbered objections
and requests a hearing on each of them. Where Public Citizen's
objections overlap, FDA has combined its response. The letter from
Jonathan Sprouts, Inc., raised one objection and requested a hearing on
its objection. FDA addresses each of the objections below, as well as
the evidence and information filed in support of each, comparing each
objection and the information submitted in support of it to the
standards for granting a hearing in Sec.  12.24(b).

A. Application of 100-Fold Safety Factor

    The first objection raised by Public Citizen in response to the
seeds for sprouting rule contends that the Agency failed to apply a
100-fold safety factor, as required by Sec.  170.22 (21 CFR 170.22),\1\
for the irradiation of seeds for sprouting. While FDA agrees that Sec.
170.22 states that FDA will use a 100-fold safety factor when applying
animal data to man, FDA notes that Sec.  170.22 provides for use of a
different safety factor ``where evidence is submitted which justifies
use of a different safety factor.''
---------------------------------------------------------------------------

    \1\ Section 170.22 states: ``In accordance with section
409(c)(5)(C) of the Act, the following safety factors will be
applied in determining whether the proposed use of a food additive
will be safe: Except where evidence is submitted which justifies use
of a different safety factor, a safety factor in applying animal
experimentation data to man of 100 to 1, will be used; that is, a
food additive for use by man will not be granted a tolerance that
will exceed 1/100th of the maximum amount demonstrated to be without
harm to experimental animals.''
---------------------------------------------------------------------------

    The Agency has determined that use of a different safety factor is
appropriate based on the considerable body of data available from
studies involving irradiated foods fed to laboratory animals and
reviewed by FDA. FDA's Bureau of Foods Irradiated Foods

Committee (BFIFC) determined that the studies involving irradiated
foods that they evaluated did not appear to show adverse effects (Ref.
1). These studies, taken as a whole, serve as an independent method to
assess toxicological safety. The studies included in that evaluation
are those which have been relied on by the Agency in previous
evaluations of the safety of other irradiated foods, such as lettuce,
spinach, molluscan shellfish, shell eggs, meat, and poultry (see 73 FR
49593, August 22, 2008; 70 FR 48057, August 16, 2005; 65 FR 45280, July
21, 2000; 62 FR 64107, December 3, 1997; 55 FR 18538, May 2, 1990; and
51 FR 13376, April 18, 1986), and additional data and information from
FDA files or other published reports regarding studies in which animals
were fed a wide variety of foods irradiated at different doses.
    The Agency's analysis incorporates the principle that toxicological
data collected from studies on a given food may be applied to the
toxicological evaluation of foods of a similar generic class and that
data from foods irradiated at high doses can be applied to the
toxicological evaluation of foods of similar generic class receiving
lower doses (Ref. 2). The Agency's analysis also draws upon the
integrated toxicological database derived from the extensive body of
work reviewed by the Agency (see 51 FR 13376 at 13378) and by WHO \2\
in previous evaluations of the safety of irradiated foods (Refs. 3 and
4).
---------------------------------------------------------------------------

    \2\ During the early 1980s, a joint Food and Agriculture
Organization/International Atomic Energy Agency, World Health
Organization (FAO/IAEA/WHO) Expert Committee evaluated the
toxicological and microbiological safety and nutritional adequacy of
irradiated foods. The Expert Committee concluded that irradiation of
any food commodity at an average dose of up to 10 kGy presents no
toxicological hazard (Ref. 3). In the 1990s, WHO reanalyzed the
safety data including additional studies (see 51 FR 13376 at 13378)
and concluded that the integrated toxicological database is
sufficiently sensitive to evaluate safety and that no adverse
toxicological effects due to irradiation were observed in the dose
ranges tested (Ref. 4).
---------------------------------------------------------------------------

    In light of the substantial data and the toxicological assessments
that have been reviewed by FDA, the Agency concludes that under Sec.
170.22 the Agency is not required to apply the 100-fold safety factor
to the use of ionizing radiation for seeds for sprouting. This
collective information is sufficient to justify the use of a different
safety factor. Further, the applicability of Sec.  170.22 is a legal
issue, and a hearing will not be granted on issues of law (Sec.
12.24(b)(1)).

B. Application of the National Academy of Sciences-National Research
Council Principles and Procedures

    Public Citizen's second objection asserts that FDA did not follow
the ``principles and procedures for establishing the safety of food
additives stated in current publication of the National Academy of
Sciences-National Research Council,'' as required by Sec.  170.20.
    The Agency has consistently taken the position that many
scientifically valid types of data may properly support a finding that
the proposed use of a food additive is safe. The Agency pointed out in
the molluscan shellfish final rule (70 FR 48057 at 48068) that the
National Academy of Sciences-National Research Council testing
standards and guidelines have been stated in relatively general terms
and that in practice, FDA has applied exposure and toxicological
criteria that were both current for the time and appropriate for
assessing the safety of a particular food additive.
    In its objection, Public Citizen asserts that FDA failed to
properly interpret its own regulation, but has provided no new
information that would refute the Agency's reasoning. The objection
implies that the Agency is obligated to explicitly discuss its
consideration of National Academy of Sciences-National Research Council
guidelines in its rules, but there is nothing in Sec.  170.20 that
imposes such an obligation on the Agency. Further, the applicability of
Sec.  170.20 is a legal issue, and a hearing will not be granted on
issues of law (Sec.  12.24(b)(1)). Public Citizen has not provided a
basis for a hearing and FDA is denying their request for a hearing
based on this objection.

C. Toxicology Issues

    Public Citizen objects to the seeds for sprouting final rule
because the petitioner, Caudill Seed Co. Inc., submitted, ``[n]o
conventional animal toxicity studies on sprouts from irradiated
seeds.'' Additionally, Public Citizen asserts that the references
contained within FAP 9M4673 ``do not address the potential toxicity of
irradiated sprouts.''
    The Agency agrees that the petition did not include toxicological
studies conducted using irradiated sprouts. As noted in the seeds for
sprouting final rule (65 FR 64605), the Agency has reviewed both the
data included in its database, as well as the published references,
submitted by the petitioner, of toxicology studies related to
irradiated foods. FDA has consistently taken the position that various
scientifically validated types of data may properly support a safety
determination for a proposed use of a food additive (see Sec.  170.20).
In the case of food irradiation, the Agency has taken advantage of the
extensive research and large body of knowledge, such as the information
compiled by BFIFC and other studies in FDA's files, concerning the
principles of radiation chemistry and the chemical composition of
foods.
    Public Citizen also contends that FDA's statement that the
``petitioner submitted published articles and other study reports
containing data and information related to seeds for sprouting * * * in
the areas of radiation chemistry [and] toxicity'' in the final rule is
incorrect. Public Citizen's claim is without merit. The petitioner
provided articles on the toxicity of irradiated foods along with their
submission, which are listed and summarized in the toxicology
memorandum (Ref. 5). As previously stated, in reviewing the
petitioner's application, FDA considered the articles submitted by the
petitioner in addition to relevant international reports and relevant
scientific articles in FDA's files (see e.g. Refs. 2, 6, and 7).
However, FDA does agree that there were no toxicological studies
conducted using irradiated seeds for sprouting. FDA has consistently
taken the position that it is unnecessary for a safety analysis to be
performed involving the specific food to be irradiated. As noted in the
meat final rule (62 FR 64107 at 64112), the Agency relies on scientific
studies evaluating the extent to which safety data on an irradiated
food type can be extrapolated to other food types and the extent to
which individual studies of irradiated foods can be evaluated as a
whole (Ref. 4). Thus, data and information derived from studies of
irradiated foods in general are sufficient to support a determination
of safety for irradiated seeds for sprouting. Public Citizen's
suggestion that such information is not sufficient to support a
determination of safety is unsupported by specific data or other
factual information.
    Public Citizen failed to include any new information or data that
would refute the Agency's findings about the toxicity of irradiated
seeds for sprouting. The request for a hearing merely alleges that
there is a potential for harm, without providing any evidence that the
Agency has not considered previously. A hearing will not be granted on
the basis of mere allegations or general descriptions of positions and
contentions (Sec.  12.24(b)(2)). The objectors must, at a minimum,
raise a material issue

concerning which a meaningful hearing might be held.

D. Radiolysis Products

    Public Citizen alleges that there are unsubstantiated statements
contained in the review memorandum and final rule regarding radiolytic
byproducts. There are two parts to this objection; the Agency will
address each part as follows.
    The first statement to which Public Citizen objects is found in the
Chemistry Memorandum from K. Morehouse to J. Ziyad dated February 23,
2000 (Ref. 8), asserting that ``radiolysis products which may have been
formed by irradiation of the seeds will be `diluted' in the final
product * * *. Also, it is likely that the water-soluble products will
be removed by the growth medium.'' Public Citizen claims that this
statement is unfounded because no data was cited regarding the dilution
potential of radiolytic byproducts.
    The Agency disagrees that the statement was unsubstantiated. The
full statement is as follows: ``As the seeds mature and form sprouts,
radiolysis products which may have been formed by irradiation of the
seeds will be ``diluted'' in the final product. For example, alfalfa
seeds contain only 7.4 percent water whereas alfalfa sprouts contain
88.3 percent water (see Table I of Ref. 8). Also, it is likely that
water-soluble products will be removed by the growth medium.''
    ``Table I,'' referred to in the previous quotation, contains the
nutrient composition for alfalfa seeds and raw alfalfa sprouts. This
data was obtained from a published study which determined the nutrient
content of various seeds and sprouts (Ref. 9). It is apparent from the
data supplied that as the seeds sprout to the final product, they
absorb water, in the case of alfalfa sprouts the water content
increases from 7.4 percent to 88.3 percent. It follows that any
byproducts would be diluted by the absorption of water, which is the
growth medium for sprouts. The same study asserts that it is possible
for sugars to leach into the growth medium during the sprouting
procedure; therefore, it is likely that other water-soluble products
could also be removed by the growth medium. Furthermore, Public Citizen
did not provide any information related to the safety of irradiated
seeds for sprouting that the Agency had not considered, and the
objection contains no information that would cause the Agency to change
its safety determination. An objector must make an adequate proffer of
evidence to support its allegations and to show that they provide a
basis on which to call into question the Agencies conclusions (Sec.
12.24(b)(2)). Public Citizen has not provided a basis for a hearing,
and FDA is denying Public Citizen's request for a hearing based on this
objection.
    Public Citizen also objects to the Agency's conclusion that because
the concentrations and types of radiolysis products formed by the
irradiation of seeds for sprouting will be comparable to those products
produced by the irradiation of foods of similar composition the
chemical compositions of sprouts grown from irradiated seeds will not
differ in any significant manner from sprouts grown from seeds that
have not been irradiated. Public Citizen feels that these statements
are unsupported and is requesting a hearing based on this matter.
    FDA disagrees with the allegation that the statements made in the
final seed for sprouting rule (65 FR 64605) are unsupported. Through
information compiled by FDA and the materials submitted with each food
additive petition involving irradiation (see e.g., section IV.A of this
document), FDA has established that the effect ionizing radiation has
on the characteristics of foods are a direct result of the chemical
reactions induced by the absorbed radiation. This large body of data
includes studies regarding the effects of ionizing radiation on
different foods under various conditions of irradiation allowing FDA to
extrapolate data obtained from one food to other foods (for more
information see 73 FR 49593 at 49594 and 70 FR 48057 at 48059).
Research has established that the types and amounts of products
generated depend on the chemical constituents of the food and the
conditions of radiation (Refs. 6, 7, and10). See the final rule
permitting the irradiation of meat (62 FR 64107) for a more in depth
discussion of radiation chemistry, nutrition, toxicology, and
microbiology related to irradiation of foods under various conditions
of use. Additionally, the review memorandum and the evidence reviewed
and discussed therein, support the statement that radiolytic byproducts
would be formed in low amounts in seeds for sprouting (Ref. 8). The
Agency also notes that ionizing radiation causes fewer chemical changes
in dry material (i.e. the seeds for sprouting) than in fresh fruits and
vegetables due to the increased water content of the fresh items (Ref.
6).
    Public Citizen's assertion provides no basis to challenge FDA's
assessment of the safety of irradiated seeds for sprouting. A hearing
will not be granted on the basis of mere allegations or general
descriptions of positions and contentions (Sec.  12.24(b)(2)). The
objector must, at a minimum, raise a material issue concerning which a
meaningful hearing might be held. Public Citizen has not provided a
basis for a hearing; therefore, FDA is denying their request for a
hearing based on this objection.

E. Nutritional Considerations

    In its request for a hearing, Public Citizen questions the
nutritional adequacy of the irradiated seeds for sprouting and cites an
FDA toxicology review memorandum (Ref. 5) in which the reviewer
describes the data submitted by the petitioner as ``crude'' and notes a
discrepancy between laboratory assessments in the vitamin A content of
sprouts grown from irradiated seeds. Moreover, Public Citizen objects
to the final rule on the grounds that nutritional assessments were
conducted on sprouts grown from seeds that were irradiated at 6 kGy,
rather than the petitioned maximum of 8 kGy.
    As noted in the final rule, there were no relevant losses in the
vitamin A content when comparing the sprouts grown from irradiated
seeds to the control sprouts, which were grown from non-irradiated
seeds. Rather, the vitamin A content was higher in all instances
comparing the sprouts grown from irradiated seeds to the control seeds
(65 FR 64605). The final rule also indicated that any vitamin loss that
occurs in sprouts grown from irradiated seeds is expected to be
inconsequential when compared to the total dietary nutrient consumption
(Ref. 5).
    In response to Public Citizen's objection based on the studies
conducted at 6 kGy as opposed to 8 kGy, the Agency notes that there
were no nutritional losses associated with sprouts grown from seeds
irradiated at 6 kGy. Changes in the level of vitamins associated with
irradiation are gradual with each increasing dose; scientific evidence
does not support a threshold effect above which significant losses
would occur (Ref. 6). Therefore, it is reasonable to anticipate that
sprouts grown from seeds irradiated at 8 kGy would not lead to
nutritionally relevant losses either. Furthermore, the Codex
Alimentarius Commission (Codex) published its standard for irradiated
foods in 1983 for adoption by Codex member countries (Ref. 11). This
standard was based on the conclusion that the irradiation of any food
commodity at an overall average dose of up to 10 kGy presents no
concerns (Ref. 3). The Codex standard was revised in

2003,\3\ at which time Codex integrated the joint FAO/IAEA/WHO study
group conclusion that food irradiated to any dose appropriate to
achieve the intended technological effect is both safe to consume and
nutritionally adequate (i.e. at doses up to and above 10 kGy) (Ref.
12).
---------------------------------------------------------------------------

    \3\ It should be noted that the revisions of the Codex standards
in 2003 do not impact this rulemaking.
---------------------------------------------------------------------------

    Overall, Public Citizen's request for a hearing suggests that there
is potential for harm from possible nutritional losses from the
irradiation of seeds for sprouting, without providing any evidence to
support this suggestion. An objector must make an adequate proffer of
evidence to support its allegations and to show that they provide a
basis on which to call into question the Agency's conclusions. A
hearing will be denied if the Commissioner of Food and Drugs concludes
that the data and information submitted are insufficient to justify the
factual determination urged, even if accurate (Sec.  12.24(b)(3)).
Public Citizen does not submit or otherwise identify any factual data
that would cause the Agency to alter its conclusions about the
nutritional changes in irradiated seeds. Therefore, FDA is denying the
request for a hearing based on this objection.

F. Labeling Concerns

    The final objection to the seeds for sprouting rule was submitted
by Jonathan Sprouts, Inc, objecting to the lack of a requirement that
sprouts grown from seeds that have been irradiated be labeled as
treated by irradiation. Some of the general objections FDA received to
the seeds for sprouting final rule also raised this point. Most of
these objections were brief and expressed general dissatisfaction
regarding FDA's decision on labeling, but did not provide any
substantive data or information. Jonathan Sprouts, Inc., claimed that
there are morphological differences between sprouts grown from
irradiated versus non-irradiated seeds, which, they claim, support the
need for labeling sprouts grown from seeds that have been irradiated;
however, they failed to provide any additional data or information to
substantiate their claim.
    The Agency specifically discussed in the seeds for sprouting rule
the labeling of irradiated seeds for sprouting and sprouts grown from
such seeds (65 FR 64605 at 64606). The FDA evaluated the need for
special labeling against the labeling provisions for food treated by
ionizing radiation in Sec.  179.26(c) (21 CFR 179.26(c)). Specifically,
Sec.  179.26(c) states that ``the label and labeling of retail packages
of foods irradiated * * * shall bear the * * * logo along with either
the statement `Treated with radiation' or * * * `Treated by
irradiation.''' (emphasis added). Thus, the requirement applies only to
the food that has been irradiated. It was noted in the seeds for
sprouting rule that the irradiated article, the unsprouted seed, is not
what is generally consumed and that the nutritional and flavor
characteristics of the sprouts is based upon the fact that the
irradiated seeds were grown into sprouts; therefore, sprouts grown from
irradiated seeds do not require labeling as they are not the food that
is being irradiated.
    Additionally, neither Jonathan Sprouts, Inc., nor any of the other
objectors that raised this point, provided any evidence that sprouts
grown from irradiated seeds differ from sprouts grown from seeds that
were not irradiated. An objector must make an adequate proffer of
evidence to support its allegations and to show that they provide a
basis on which to call into question the Agency's conclusions (Sec.
12.24(b)(2)). Therefore, the Agency is denying Jonathan Sprouts'
objection.

V. Summary and Conclusion

    Section 409 of the Federal Food, Drug and Cosmetic Act requires
that a food additive be shown to be safe prior to marketing. Under
Sec.  170.3(i), a food additive is ``safe'' if ``there is a reasonable
certainty in the minds of competent scientists that the substance is
not harmful under the intended conditions of use.'' In the Agency's
October 30, 2000, seeds for sprouting rule, FDA concluded that the
studies conducted, based on its evaluation of the data submitted in the
petition and other relevant material, that this use of irradiation is
safe for its intended use in seeds for sprouting.
    The petitioner has the burden to demonstrate the safety of the
additive to gain FDA approval. However, once FDA makes a finding of
safety in an approval document, the burden shifts to an objector, who
must come forward with evidence that calls into question FDA's
conclusion (see section 409(f)(1) of the Federal Food, Drug, and
Cosmetic Act).
    Despite their allegations, neither Public Citizen nor Jonathan
Sprouts, Inc., has established that FDA overlooked significant
information contained within the record in reaching its conclusion that
the use of irradiation for microbial control of pathogens in seeds for
sprouting is safe. In such circumstances, FDA has determined that the
objections do not raise any genuine and substantial issue of fact that
can be resolved by an evidentiary hearing (Sec.  12.24(b)).
Accordingly, FDA is denying the requests for a hearing.

VI. References

    The following references are on display in the Division of Dockets
Management (HFA-303) Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20857, under Docket No. FDA-1999-F-0021
(formerly 1999F-2673) and may be seen by interested persons between 9
a.m. and 4 p.m., Monday through Friday.

1. Memorandum to file, FAP 4M4428, from David G. Hattan, Acting
Director, Division of Health Effects Evaluation, dated November 20,
1997.
2. Taub, I.A. et al., ``Factors Affecting Radiolytic Effects In
Food,'' Radiation Physics and Chemistry, 14:639-653, 1979.
3. WHO, ``Wholesomeness of Irradiated Food: Report of a Joint FAO/
IAEA/WHO Expert Committee,'' World Health Organization Technical
Report Series, No. 659, World Health Organization, Geneva, 1981.
4. WHO, ``Safety and Nutritional Adequacy of Irradiated Food,''
World Health Organization, Geneva, 1994.
5. Memorandum to the file, FAP 9M4673, from I. Chen, FDA, to J.
Ziyad, FDA, dated February 28, 2000.
6. Diehl, J.F., ``Safety of Irradiated Foods,'' 2nd Edition, Marcel
Dekker, New York, 1995.
7. Merritt, C., Jr., ``Qualitative and Quantitative Aspects of Trace
Volatile Components in Irradiated Foods and Food Substances,''
Radiation Research Reviews, 3:353-368, 1972.
8. Memorandum to the file, FAP 9M4673, from K. Morehouse, FDA, to J.
Ziyad, FDA, dated February 23, 2000.
9. Kylen, A.M. and R.M. McCready, ``Nutrients in Seeds and Sprouts
of Alfalfa, Lentils, Mung Beans and Soybeans,'' Journal of Food
Science, 40:1008-1009, 1975.
10. Diehl, J.F., ``Radiolytic Effects in Foods,'' pp. 279-357, in
Preservation of Food by Ionizing Radiation, vol. I, E.S. Josephson
and M.S. Peterson, eds., CRC Press, Boca Raton, FL, 1982.
11. Codex 1983, ``Codex General Standard for Irradiated Foods (CODEX
STAN 106-1983)'' Codex Alimentarius Commission, Food and Agriculture
Organization and World Health Organization, Rome, 1983.
12. WHO, ``High-Dose Irradiation: Wholesomeness of Food Irradiated
With Doses Above 10 kGy,'' World Health Organization Technical
Report Series, No. 890, World Health Organization, Geneva, 1999.

    Dated: May 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11391 Filed 5-10-12; 8:45 am]
BILLING CODE 4160-01-P