[Federal Register: September 2, 2008 (Volume 73, Number 170)]
[Notices]
[Page 51306-51309]
[DOCID:fr02se08-62]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0455]

Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits
and Vegetables; Request for Comments and for Scientific Data and
Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and for scientific data and
information.

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

SUMMARY:  The Food and Drug Administration (FDA) is requesting comments
and scientific data and information that may assist the agency to
improve the guidance to industry set forth in the ``Guide to Minimize
Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' issued
in 1998. Specifically, FDA is seeking information about current
agricultural practices and conditions used to grow, harvest, pack,
cool, and transport fresh produce; risk factors for contamination of
fresh produce associated with these practices; and possible measures
that FDA could implement that would enhance the safety of fresh
produce.

DATES:  Submit written comments and scientific data and information or
electronic comments by December 31, 2008.

ADDRESSES:  Submit written comments and scientific data and information
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments and scientific data and information to
http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section
for electronic access to this document.

FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Food Safety and Fresh Produce

    FDA is responsible for ensuring the safety of all domestic and
imported fresh fruits and vegetables consumed in the United States.
Fresh fruits and vegetables are those that are likely to be sold to
consumers in an unprocessed or minimally processed (i.e., raw) form.
Fresh fruits and vegetables may be intact and whole, such as whole
apples, or cut in the act of harvest, such as heads of lettuce and
bunches of broccoli.
    Because most fresh produce is grown in a natural environment, it is
vulnerable to contamination with pathogens (i.e., bacteria or other
organisms that can cause disease). Factors that may affect the
occurrence of such contamination include agricultural and/or post-
harvest water quality, the use of manure as fertilizer, the presence of
wild or domestic animals in or near fields or packing areas, worker
health and hygiene, environmental conditions, production activities,
and equipment and facility sanitation. Consequently, the manner in
which fresh produce is grown, harvested, packed, cooled, and
transported is crucial to minimizing the risk of microbial
contamination. (We use the term ``microbial contamination'' to refer to
contamination with any microorganism.)
    Data reported to the U.S. Centers for Disease Control and
Prevention (CDC) indicate that between 1973 and 1997 reported outbreaks
of foodborne illness in the United States associated with fresh produce
increased in absolute numbers and as a proportion of all reported
foodborne outbreaks (Ref. 1). (By ``outbreak,'' we mean the occurrence
of two or more cases of a similar illness resulting from the ingestion
of a common food.) Unpublished data compiled by FDA indicate that from
1996 to 2007 there were approximately 72 reported outbreaks of
foodborne illness associated with approximately 20 fresh produce
commodities. Of this total, 13 outbreaks were associated with tomatoes,
11 outbreaks were associated with melons, and 24 outbreaks were
associated with leafy greens such as lettuce and spinach (Ref. 2).
These outbreaks involved a number of pathogens, including Escherichia
coli (E. coli) O157:H7 and Salmonella species, and involved both
domestic and imported produce. These totals include only those
outbreaks in which our investigation has indicated that the
contamination of the produce was not a result of exposure to an
infected food handler or other unsafe food handling practice at the
place of preparation and consumption (i.e., home or restaurant). There
have also been a number of reported outbreaks associated with fresh
produce in 2008.

B. FDA's GAPs/GMPs Guide

    FDA places a high priority on identifying and promoting measures
that can reduce the incidence of foodborne illness associated with
fresh produce. In 1998, FDA and the U.S. Department of Agriculture
issued

guidance to industry entitled ``Guide to Minimize Microbial Food Safety
Hazards for Fresh Fruits and Vegetables'' (Ref. 3), to enhance the
safety of fresh produce, to assist the fresh produce industry in
addressing common risk factors in their operations, and to minimize
potential food safety hazards. (The document is referred to hereinafter
as the ``GAPs/GMPs Guide''--GAPs is an abbreviation of ``good
agricultural practices'' and GMPs is an abbreviation of ``good
manufacturing practices.'') While FDA recognizes current technologies
cannot eliminate all potential food safety hazards associated with
fresh produce that will be eaten raw, the GAPs/GMPs Guide emphasizes
that implementation of risk reduction measures is critical to
minimizing these potential food safety hazards. The agency has worked
with the fresh produce industry and other food safety partners since
the issuance of the GAPs/ GMPs Guide to promote its recommendations and
to advance the scientific knowledge applicable to enhancing the safety
of fresh produce, and the GAPs/GMPs Guide has been used as a basis for
a number of food safety programs, both in the United States and
internationally. Choices by buyers to purchase from producers and other
suppliers that provide self- or third-party audit verification that
they are following the GAPs/GMPs Guide have further promoted adoption
of the guidance.
    Subsequent to the issuance of the GAPs/GMPs Guide, FDA has
undertaken a number of produce safety initiatives that have enhanced
its understanding of the effectiveness of the GAPs/GMPs Guide in
reducing the risk of produce-associated foodborne illness. Examples
include the 2004 ``Produce Safety From Production to Consumption: 2004
Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
Consumption,'' commonly called the ``Produce Safety Action Plan'' (Ref.
4), which focuses on prevention of contamination, minimization of
public health impacts when contamination does occur, communication with
the public and stakeholders, and facilitation and support of research;
the multi-year ``Leafy Greens Safety Initiative'' (Ref. 5), launched in
2006 in collaboration with the State of California, which involves
assessment of practices and conditions at select farms and facilities
in California, including adoption and implementation of good
agricultural practice and good manufacturing practice recommendations
(for packing houses) and requirements (for fresh-cut processing
facilities); and the 2007 ``Tomato Safety Initiative'' (Ref. 6), a
multi-year collaboration similar to the ``Leafy Greens Safety
Initiative'' with the States of Virginia and Florida, as well as
several universities and members of the produce industry.
    Available data and FDA's experience suggest that the GAPs/GMPs
Guide (and other public and private sector efforts) have accurately
identified certain potential sources of microbial contamination of
fresh produce, such as agricultural water and worker health and
hygiene. Data and experience also indicate that the recommendations in
the GAPs/GMPs Guide can be effective when implemented. However, the
fact that outbreaks of foodborne illness associated with fresh produce
continue to occur supports a close examination of the extent to which
the recommendations in the GAPs/GMPs Guide have been implemented; the
extent to which they have been effective, if implemented properly; and
what additional or different interventions might be appropriate to
reduce the risk of future outbreaks. The agency recognized when it
issued the GAPs/GMPs Guide in 1998 that it would need to be updated
``[a]s new information and technological advances expand the
understanding of those factors associated with identifying and reducing
microbial food safety hazards'' (Ref. 3). In the 10 years since the
GAPs/GMPs Guide was released many changes have occurred in the produce
industry, and a great deal of new knowledge and information have become
available. In addition, the agency now has 10 years experience in
implementing this guidance and observing how and the extent to which it
has been implemented by the industry.
    In addition to the initiatives described previously, in 2007 FDA
held two public hearings to inform stakeholders about produce-
associated outbreaks and to solicit comments to inform the agency in
determining the next steps (Ref. 7). In both instances, the agency
asked a series of questions. Among these questions, we asked whether
FDA's current GAPs/GMPs Guide needs to be expanded or otherwise
revised, and if the response was yes, we solicited comments about what
areas need to be expanded or otherwise revised. Comments were generally
in agreement that the basic principles set out in the 1998 guidance
remain sound. However, they were split on whether FDA should update the
GAPs/GMPs Guide and, if so, how it might be revised. Several comments
suggested the GAPs/GMPs Guide should provide more specific and
directive recommendations. A number of comments suggested that the
GAPs/GMPs Guide needs more explicit information to facilitate risk
assessment. Other comments urged FDA to keep the GAPs/GMPs Guide broad
in scope, and to focus instead on education/outreach to promote
adoption of existing recommendations.
    FDA has taken the comments received in response to the 2007 public
hearings into consideration and incorporated relevant suggestions as it
conducts the produce safety activities mentioned in this Federal
Register document and other activities implementing the ``Produce
Safety Action Plan.'' However, because most comments did not provide
substantive information or data in response to this question, FDA has
determined that it would benefit from another, more focused opportunity
for public comment.
    Thus, FDA is now soliciting comments and scientific data and
information on any possible measures and technological advances that
would assist the agency in improving the agency's current GAPs/GMPs
Guide. Specifically, FDA is seeking information and comment on the
issues and questions in section II of this document. When possible,
please provide scientific information and data in support of your
comments. In addition, please provide information as specific as is
feasible about the estimated costs and benefits associated with your
responses (e.g., the costs and benefits of current practices and/or the
cost and benefits of any recommendations you may make). FDA is not
seeking information and comment on issues of traceability in this
document, because FDA plans to do so in the context of a public
meeting.

II. Issues and Questions

    Issue 1: The GAPs/GMPs Guide addresses potential sources of
microbial contamination associated with a range of issues, or
variables, such as: Water (both agricultural water and post harvest
water uses); manure and municipal bio-solids; worker health and
hygiene; packing facility sanitation; transportation; and traceback
(Ref. 3). Data from our experience over the past decade support the
inclusion of many of these issues as risk factors for produce-
associated foodborne illness outbreaks. Some of these potential sources
of contamination in particular, such as worker health and hygiene,
water quality (pre- and post-harvest), domestic and wild animal issues,
and facility and equipment sanitation have been cited frequently by
investigators during inspections at farms and facilities that were
implicated in outbreak investigations. On the other hand,

although there remains a significant potential for contamination, some
issue areas, such as the intentional use of manure or bio-solids as an
agricultural input, have not been cited as a potential source of
contamination to the same extent. The current guidance does not attempt
to rank the potential hazard variables in terms of relative risk or
importance.
    Question 1. Should any future GAPs/GMPs Guide rank or prioritize
among potential issues according to relative risk or importance? If
yes, please offer suggestions of how that information could most
effectively be presented in a way that does not detract from the broad
scope of the current guidance.
    Issue 2: The GAPs/GMPs Guide tends to be arranged by issue area,
while more recent industry commodity specific supply chain guidelines
are divided according to where the commodity is within the supply chain
(e.g., production, packing, distribution) and/or the chronological
order of activities at each step.
    Question 2. How should the GAPs/GMPs Guide be organized to enhance
its usefulness?
    Question 3. While the GAPs/GMPs Guide has been generally accepted
and widely adopted, we know that there are entities in the fresh
produce industry that are not aware of it. What measures can be taken,
and by whom, to expand awareness by the fresh produce industry of the
GAPs/GMPs Guide?
    Question 4. How should the GAPs/GMPs Guide be modified to motivate
all operations to implement? Please include information on economic
impact.
    Question 5. Can the GAPs/GMPs Guide be applied equally to, and
implemented by, domestic and foreign growers and packers? If not,
should the GAPs/GMPs Guide be revised to incorporate additional options
or special considerations (e.g., utilizing draft animals for
agricultural tasks) for application and implementation? Please explain.
    Question 6. Is there a need for additional guidance to assist an
operator in determining which provisions of the Current Good
Manufacturing Practice regulations in part 110 (21 CFR part 110) (e.g.,
post-harvest water quality, disease control, cleanliness, and
supervision) could be implemented voluntarily for operations that
currently are excluded under Sec.  110.19? If so, which ones?
    Issue 3: Written food safety plans, sanitation standard operating
procedures (SSOPs), standard operating procedures (SOPs), and
monitoring records serve as useful tools for both industry and
regulators. Such records assist operators to conduct operations in a
manner that enhances the safety of fresh produce. For growers, an
assessment of factors such as the field environment and agricultural
inputs contributes to the development of written food safety plans and
SOPs, and also helps to determine which factors should be monitored and
the frequency of such monitoring. (The use of the term ``assessment''
refers to an evaluation conducted by, or on behalf of, a grower or
operator to identify measures to enhance food safety.)
    Written food safety plans, SOPs, SSOPs, and monitoring records also
assist regulators to verify consistent and long-term implementation of
certain practices. On-site inspections, either alone or in conjunction
with records review, are another approach to such verification. (The
use of the term ``inspection'' refers to an evaluation conducted by, or
on behalf of, a regulator to evaluate whether operations comply with
applicable guidance or regulations. The term ``audit'' refers to a self
or third-party evaluation of whether operations are consistent with
voluntary guidelines and written food safety plans or SSOPs developed
by the grower, operator, or buyer.)
    Question 7. Should the GAPs/GMPs Guide recommend that growers and/
or other relevant operations develop a written food safety plan,
written SOPs, and/or written SSOPs? If so, please describe the types of
information or recommendations that you believe would be helpful.
    Question 8. Records can be divided into the following two broad
groups: (1) Records to facilitate traceback, and (2) non-traceback or
operational records. Does the GAPs/GMPs Guide provide sufficient
recommendations regarding record keeping? If not, please describe what
would be most helpful and why, e.g., information about the record
keeping regulation (21 CFR 1 subpart J), guidance on what makes a
``good'' record, guidance on periodic record review and verification,
and required or recommended record retention times. What types of
monitoring records or other documentation would be most useful to
industry and regulators?
    Question 9. The recent produce safety initiatives concerning leafy
greens and tomatoes (Refs. 5 and 6) have highlighted the importance of
performing environmental assessments (e.g., assessing water source
quality, water distribution systems, animal presence, and other risk
factors that may be associated with the production environment) before
planting, throughout production, and prior to harvest. Would it be
useful to enhance coverage of these concepts in the GAPs/GMPs Guide? If
yes, please describe.
    Question 10. Several newer produce safety programs, such as the
California Leafy Green Products Handler Marketing Agreement (Ref. 8),
incorporate recommendations (or requirements) for microbial testing.
Does the information on microbial testing in the GAPs/GMPs Guide
provide sufficient information to assist operators in designing a
meaningful and cost effective testing program? If not, please describe
what types of additional information would be most useful, such as how
and where microbial testing might best be used to achieve food safety
objectives, e.g., building a history of agricultural water quality,
making best management decisions, verifying food safety operations.
    Question 11. Some comments submitted in connection with the 2007
public hearings expressed concerns that field management activities
intended to minimize microbial hazards, such as removing vegetation to
reduce animal harborage near the production field, could have a
negative, albeit unintended, impact on the environment and water sheds,
among other areas. What data support these concerns? Could/should the
GAPs/GMPs Guide do more to identify, address, and possibly mitigate
unintended environmental consequences of food safety measures?
    Question 12. Are there existing regulatory requirements at the
Federal, State, or local level that act as a disincentive (or as an
incentive) for growers or other operators to implement agricultural or
manufacturing practices that should be taken into consideration when
updating this guidance to reduce the risk of microbial contamination of
fresh produce? If yes, please identify and explain.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket

management system. Electronic comments or submissions will be accepted
by FDA only through FDMS at http://www.regulations.gov.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
    1. Sivapalasingam, S., et al. ``Fresh Produce: A Growing Cause
of Outbreaks of Foodborne Illness in the United States, 1973 through
1997,'' Journal of Food Protection 67(10): 2342-53, 2004.
    2. U.S. Food and Drug Administration, 1996 to 2007 Produce
Outbreaks (unpublished compilation).
    3. U.S. Food and Drug Administration, ``Guide to Minimize
Microbial Food Safety Hazards for Fresh Fruits and Vegetables,''
October 26, 1998, available at http://www.cfsan.fda.gov/~dms/
prodguid.html.
    4. U.S. Food and Drug Administration, ``Produce Safety From
Production to Consumption: 2004 Action Plan to Minimize Foodborne
Illness Associated with Fresh Produce Consumption,'' October 2004,
available at http://www.cfsan.fda.gov/~dms/prodpla2.html.
    5. U.S. Food and Drug Administration, ``Leafy Greens Safety
Initiative--2nd year,'' October 4, 2007, available at http://
www.cfsan.fda.gov/~dms/lettsaf2.html.
    6. U.S. Food and Drug Administration, ``Tomato Safety
Initiative,'' June 12, 2007, available at http://www.cfsan.fda.gov/
~dms/tomsafe.html.
    7. ``Safety of Fresh Produce; Public Hearings; Request for
Comments'' (72 FR 8750, February 27, 2007), Public hearings held on
March 20, 2007, and April 13, 2007, http://www.regulations.gov/
fdmspublic/component/main?main=DocketDetail&d=FDA-2007-N-0380.
    8. California Leafy Green Products Handler Marketing Agreement,
available at http://www.caleafygreens.ca.gov.

II. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.cfsan.fda.gov/~dms/prodguid.html.

    Dated: August 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20187 Filed 8-29-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 70 (Friday, April 11, 2014)]
[Notices]
[Page 20194]
[FR Doc No: 2014-08177]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC14-72-000.
    Applicants: Aequitas Energy, Inc., Lumens Energy Supply CT LLC.
    Description: Joint Application under Section 203 of the Federal
Power Act, et. al. of Aequitas Energy, Inc., et. al.
    Filed Date: 4/3/14.
    Accession Number: 20140403-5192.
    Comments Due: 5 p.m. ET 4/24/14.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG14-36-000.
    Applicants: CSOLAR IV WEST, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status in New Doc. No. EG14-36.
    Filed Date: 4/3/14.
    Accession Number: 20140403-5178.
    Comments Due: 5 p.m. ET 4/24/14.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2249-003.
    Applicants: Portland General Electric Company.
    Description: Correction to January 30, 2014 Notice of Non-Material
Change in Status of Portland General Electric Company.
    Filed Date: 2/14/14.
    Accession Number: 20140214-5063.
    Comments Due: 5 p.m. ET 4/25/14.

    Docket Numbers: ER14-1654-000.
    Applicants: eBay Inc.
    Description: Cancellation of eBay Market-Based Rate Tariff to be
effective 4/4/2014.
    Filed Date: 4/3/14.
    Accession Number: 20140403-5153.
    Comments Due: 5 p.m. ET 4/24/14.

    Docket Numbers: ER14-1656-000.
    Applicants: CSOLAR IV West, LLC.
    Description: Market-Based Rate Application to be effective 4/4/
2014.
    Filed Date: 4/3/14.
    Accession Number: 20140403-5175.
    Comments Due: 5 p.m. ET 4/24/14.

    Docket Numbers: ER14-1657-000.
    Applicants: Southern California Edison Company.
    Description: Notice of Cancellation of SGIA with Clearvista Energy,
LLC to be effective 6/4/2014.
    Filed Date: 4/4/14.
    Accession Number: 20140404-5004.
    Comments Due: 5 p.m. ET 4/25/14.

    Docket Numbers: ER14-1658-000.
    Applicants: Electric Energy, Inc.
    Description: Revised and Restated Cost-Based Power Contract to be
effective 6/1/2014.
    Filed Date: 4/4/14.
    Accession Number: 20140404-5079.
    Comments Due: 5 p.m. ET 4/25/14.

    Docket Numbers: ER14-1659-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: DR Baseline Net Supply Changes to be effective 6/1/
2014.
    Filed Date: 4/4/14.
    Accession Number: 20140404-5091.
    Comments Due: 5 p.m. ET 4/25/14.

    Docket Numbers: ER14-1660-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Revisions to the PJM Tariff Att DD5.11 re CONE
Periodic Review Deadline to be effective 6/4/2014.
    Filed Date: 4/4/14.
    Accession Number: 20140404-5121.
    Comments Due: 5 p.m. ET 4/25/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 4, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-08177 Filed 4-10-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 35 (Tuesday, February 22, 2011)]
[Proposed Rules]
[Pages 9706-9709]
[FR Doc No: 2011-3862]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2010-1083; FRL-9268-4]

Finding of Substantial Inadequacy of Implementation Plan; Call
for Iowa State Implementation Plan Revision

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: Pursuant to the Environmental Protection Agency's (EPA)
authority in the Clean Air Act (CAA), section 110 (k)(5), to call for
plan revisions, EPA is proposing to find that the Iowa State
Implementation Plan (SIP) is substantially inadequate to maintain the
2006 24-hour National Ambient Air Quality Standard (NAAQS) for
PM2.5 in Muscatine County, Iowa. The specific SIP
deficiencies needing revision are described below. EPA is also
proposing to finalize a timeline for Iowa to revise its SIP to correct
these deficiencies by a date which is no later than 18 months after the
effective date of the final rule.

DATES: Comments must be received on or before March 24, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2010-1083, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Tracey Casburn, Environmental Protection Agency, Air
Planning and Development Branch, 901 North 5th Street, Kansas City,
Kansas 66101.
    4. Hand Delivery or Courier: Deliver your comments to: Tracey
Casburn, Environmental Protection Agency, Air Planning and Development
Branch, 901 North 5th Street, Kansas City, Kansas 66101.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2010-1083. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The

http://www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI 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
in http://www.regulations.gov or in hard copy at the Environmental
Protection Agency, Air Planning and Development Branch, 901 North 5th
Street, Kansas City, Kansas 66101. EPA requests that you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The interested persons wanting to examine
these documents should make an appointment with the office at least 24
hours in advance.

FOR FURTHER INFORMATION CONTACT: Tracey Casburn at<PHONE_NUMBER> or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This section provides
additional information by addressing the following questions:

I. What is the basis for the proposed finding?
II. How can Iowa correct the inadequacy and when must the correction
be submitted?
III. What action is EPA proposing?
IV. Statutory and Executive Order Reviews
V. Statutory Authority

I. What is the basis for the proposed finding?

    EPA promulgated the 2006 24-hour NAAQS for PM2.5 on
October 17, 2006 (71 FR 61144) based on significant evidence and
numerous health studies demonstrating that serious health effects are
associated with exposures to fine particulate matter. The 2006 standard
for 24-hour PM2.5 was set at a level of 35 micrograms
([mu]g) of particulate matter less than 2.5 micrometers ([mu]m) in
diameter, per cubic meter of air. The standard is met when the 3-year
average of the 98th percentile of 24-hour concentrations is equal to or
less than 35[mu]g/m\3\. The computation of this 3-year average of the
98th percentiles of 24-hour concentrations is commonly referred to as
the design value (dv)and is based on the most recent 3 years of quality
assured data.
    Section 110 (a) (2) (B) requires each state to establish and
operate appropriate devices, methods, systems and procedures necessary
to monitor, compile and analyze data on ambient air quality. Pursuant
to this authority, the state maintains a network of air quality
monitors for PM2.5 in accordance with 40 CFR Part 58 which
meets applicable requirements. Monitors called State or Local Air
Monitoring Stations (SLAMS) make up the ambient air quality monitoring
sites whose data are primarily used for determining compliance with the
NAAQS.
    In accordance with section 107(d) (1)(B) of the CAA, no later than
2 years after promulgation of a new or revised NAAQS, the Administrator
must designate all areas, or portions thereof, within each state as
nonattainment, attainment or unclassifiable. This process is commonly
referred to as the ``designations process''.
    With respect to all pollutants, including PM2.5, if
monitoring data demonstrates that an area does not comply with the
NAAQS, or contributes to a violation in a nearby area, that area is
designated as nonattainment. If monitoring data demonstrates that an
area complies with the NAAQS, and the area does not contribute to air
quality problems in nearby areas that do not comply with the NAAQS, the
area is designated attainment. If there is not enough information to
determine if an area is compliant with the NAAQS it is designated as
unclassifiable. On November 13, 2009, EPA promulgated its final
designations for the 2006 24-hour PM2.5 standards (74 FR
58688). These designations were determined based upon air quality
monitoring data for calendar years 2006-2008 (which were the most
recent three years of data prior to the initial designations). The
entire State of Iowa was designated as unclassifiable/attainment (74 FR
58729) at that time based on that set of data.
    On May 20, 2010, the state submitted certified SLAMS monitoring
data, for calendar year 2009, in accordance with 40 CFR Part 58. When
determining the design value (dv) for the current 24-hour
PM2.5 standard based upon air quality monitoring data for
calendar years 2007-2009, EPA concluded that a monitor in the Muscatine
area recorded data violating the standard. The monitor (site
ID 191390015) is located in the City of Muscatine, Muscatine
County, IA, and is the only PM2.5 State or Local Air
Monitoring (SLAM) station in the county. The SLAM stations make up the
ambient air quality monitoring sites that are primarily needed for
NAAQS comparisons. Site ID 191390015 is often referred to as
the ``Garfield School'' monitor and will be referred to as such in this
proposed rulemaking. The 2007-2009 dv for the Garfield School monitor
is 38 [mu]g/m\3\. Historically, the Garfield School monitoring location
has recorded fluctuating PM2.5 values very near or above the
NAAQs. Historical values are shown in Table 1. Preliminary data for
2010 indicate that the Muscatine area continues to violate the 2006 24-
hour standard based on 2008-2010 monitoring data.
    The area was not designated nonattainment at the time of EPA's
initial designations rulemaking for the 2006 24-hour PM2.5
standard in 2009, because, at that time, available certified monitoring
data demonstrated that the dv was compliant with the standard.

    Table 1--Historical Design Values at the Garfield School Monitor

------------------------------------------------------------------------
                                                                 Design
                       Monitoring years                          value
------------------------------------------------------------------------
2001-2003....................................................         35
2002-2004....................................................         35
2003-2005....................................................         38
2004-2006....................................................         34
2005-2007....................................................         36
2006-2008....................................................         35
2007-2009....................................................         38
------------------------------------------------------------------------

    Section 110(k)(5) of the CAA provides, in relevant part, that
``[w]henever the Administrator finds that the applicable implementation
plan for an area is substantially inadequate to attain or maintain the
relevant national ambient air quality standard,* * *the Administrator
shall require that state to revise the plan as necessary to correct
such inadequacies.''
    Because monitor data in the Muscatine area show violations of the
2006 24-hour PM2.5 standards, based upon 2007-2009 data, and
have shown violations of the standard in the past (based upon 2005-2007
data), EPA

believes the SIP is substantially inadequate to maintain the 2006 24-
hour NAAQS for PM2.5 in this area. Therefore, EPA proposes
to require revisions to the SIP as described further below.

II. How can Iowa correct the inadequacy and when must the correction be
submitted?

    EPA believes that the state must submit several specific plan
elements to EPA in order to correct the inadequacy of the SIP
indentified above. These specific elements are: (1) A revised emissions
inventory for all sources (including area sources, mobile sources and
other significant sources) that could be expected to contribute to the
violating monitor because of their size, proximity, or other relevant
factors consistent with 40 CFR 51.114(a); (2) a modeling demonstration
consistent with Appendix W to 40 CFR Part 51 showing what reductions
will be needed to attain and maintain the PM2.5 NAAQS in the
area; (3) adopted measures to achieve reductions determined necessary
to attain and maintain the NAAQS, with enforceable schedules for
implementing the measures as expeditiously as practicable; and (4)
contingency measures as described below.
    The Muscatine area is currently designated as attainment of the
2006 24-hour PM2.5 standards, however, EPA is proposing to
find the SIP substantially inadequate to maintain the 2006 24-hour
NAAQS for PM2.5, due to the monitor in the Muscatine area
(Garfield School) recording data violating the standard (considering
2007-2009 monitoring data). In this instance, the CAA requirements
relating to nonattainment areas are not expressly applicable.
Therefore, consistent with the general SIP requirements in section 110
of the CAA, EPA is proposing to require a SIP revision which includes
adopted measures to achieve reductions determined necessary to attain
and maintain the NAAQS, as well as contingency measures, as described
below.
    EPA is proposing that all adopted measures to achieve reductions,
determined through the modeling demonstration to be necessary to attain
and maintain the 2006 24-hour PM2.5 standard, should be
implemented no later than two years after the issuance of the final SIP
Call. EPA believes that this schedule is reasonable, because the Iowa
Department of Natural Resources has already performed a substantial
portion of its analysis of the nature of the PM2.5 problem
in the area and the types of controls which might be necessary to
address the problem.
    EPA believes that it is reasonable to expect that the design value
during the calendar year after the necessary controls are implemented
should be at or below the 24-hour PM2.5 standard. EPA
proposes that the contingency measures would be triggered if the design
value is above the standard in the calendar year after the
implementation of controls necessary for attainment, or in any
subsequent year. EPA is proposing that the SIP revision contain an
enforceable commitment to adopt and implement sufficient contingency
measures, once triggered, in an expeditious and timely fashion that is
comparable and analogous to requirements for contingency measures in
CAA Section 175A(d). To do so, the SIP revision should clearly identify
measures which could be timely adopted and implemented, a schedule and
procedure for adoption and implementation, and a specific time limit
for action by the state. The schedule for adoption and implementation
should be as expeditious as practicable, but no longer than 24 months
after being triggered. EPA also seeks comments on whether any
additional contingency measure triggers would be appropriate, or
whether contingency measures should be adopted in advance and available
for prompt implementation once triggered.
    Section 110(k)(5) of the CAA provides that after EPA makes a
finding that a plan is substantially inadequate, it may establish a
reasonable deadline for the state to submit SIP revisions correcting
the deficiencies, but the date cannot be later than 18 months after the
state is notified of the finding. Consistent with this provision, EPA
proposes to require the submittal within 18 months following any final
finding of substantial inadequacy. EPA proposes that the 18-month
period would begin on the effective date of the final rulemaking. EPA
seeks comments on the proposed deadline and on whether an alternate
deadline should be established.
    EPA is proposing to require the state to establish a specific date
in its SIP revision by which the Muscatine area will attain the
standard. The date must be as expeditious as practicable based upon
implementation of Federal, state and local measures. As discussed
previously, we expect that the date will be no later than the beginning
of the calendar year after the implementation of controls necessary for
attainment (two years after the finding of substantial inadequacy and
SIP Call). EPA will establish a specific date for attainment at the
same time it takes final action on the state's SIP revision.
    Notwithstanding the date for attainment, the 2006 24-hour
PM2.5 standard can only be achieved when the average of
three consecutive years of data shows those PM2.5
concentrations are at or below the levels of the 2006 24-hour standard.

III. What action is EPA proposing?

    EPA proposes the following actions relating to the Iowa SIP for
PM2.5 for Muscatine County. EPA proposes to:
    1. Find that the SIP is substantially inadequate to maintain the
NAAQS for 24-hour PM2.5 in the area;
    2. Require that Iowa revise and submit to EPA a SIP to meet all of
the applicable requirements of section 110 of the Act with respect to
PM2.5 in the area, including an emissions inventory, modeled
attainment demonstration, adopted control measures and contingency
measures as described in this proposal;
    3. Require the state to submit revisions to the SIP within 18
months of the effective date of the final SIP Call determination;
    4. Require that all adopted measures to achieve reductions
determined necessary to attain and maintain the 2006 24-hour
PM2.5 standard be implemented no later than two years after
the issuance of the SIP Call determination.
    5. Require that the SIP provide for attainment and maintenance of
the 2006 24-hour PM2.5 NAAQS in the Muscatine County, IA
area as expeditiously as practicable, which EPA expects to be no later
than the beginning of the calendar year after the implementation of
controls necessary for attainment (two years after the finding of
substantial inadequacy and SIP Call).
    We are soliciting comments on these proposed actions. Final
rulemaking will occur after consideration of any comments.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, a finding of substantial inadequacy and
subsequent obligation for a state to revise its SIP arise out of
section 110(a) and 110(k)(5). The finding and state obligation do not
directly impose any new regulatory requirements. In addition, the state
obligation is not legally enforceable by a court of law. EPA would
review its intended action on any SIP submittal in response to the
finding in light of applicable statutory and Executive Order
requirements, in subsequent rulemaking acting on such SIP submittal.
For those reasons, this proposed action:

     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the finding of SIP inadequacy would not apply in Indian country
located in the state, and EPA notes that it will not impose substantial
direct costs on tribal governments or preempt tribal law.

V. Statutory Authority

    The statutory authority for this action is provided by sections 110
and 301 of the CAA, as amended (42 U.S.C. 7410 and 7601).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Iowa, Particulate
matter, State Implementation Plan.

    Dated: February 10, 2011.
Karl Brooks,
Regional Administrator, Region 7.
[FR Doc. 2011-3862 Filed 2-18-11; 8:45 am]
BILLING CODE 6560-50-P