[Federal Register: August 8, 2008 (Volume 73, Number 154)]
[Notices]
[Page 46302-46307]
[DOCID:fr08au08-69]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0429]

Food Labeling; Current Trends in the Use of Allergen Advisory
Labeling: Its Use, Effectiveness, and Consumer Perception; Public
Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a public
hearing on the use of advisory labeling of allergens in foods. FDA is
developing a long-term strategy to assist manufacturers in using
allergen advisory labeling that is truthful and not misleading, conveys
a clear and uniform message, and adequately informs food-allergic
consumers and their caregivers. To that end, FDA is soliciting comments
and information to assist the agency in determining how manufacturers
currently use advisory labeling, how consumers interpret different
advisory labeling statements, and what wording is likely to be most
effective in communicating to consumers the likelihood that an allergen
may be present in a food. The agency is also interested in receiving
comments about whether consumers find advisory labeling helpful for
making food purchasing decisions. This public hearing is the first step
in closing existing knowledge gaps in developing our long-term
strategy.

DATES: The public hearing will be held on September 16, 2008, from 9
a.m. to 4:30 p.m. The closing date for registration is September 8,
2008. See section V of this document for other dates associated with
participation in the hearing. Submit written or electronic comments
(i.e., submissions other than notices of participation and written
material associated with an oral presentation) by January 14, 2009. The
administrative record of the hearing will remain open until January 14,
2009.

ADDRESSES: Public hearing. The public hearing will be held at the
Harvey W. Wiley Federal Building, Food and Drug Administration, Center
for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College
Park, MD 20740-3835, (Metro stop: College Park on the Green Line).
    Registration. Submit electronic notices of participation for the
hearing to http://www.cfsan.fda.gov/register.html. We encourage you to
use this method of registration, if possible. Submit written notices of
participation by mail, fax, or e-mail to Isabelle Howes, U.S.
Department of Agriculture Graduate School, 600 Maryland Ave., SW.,
suite 330, Washington, DC 20024-2520, FAX:<PHONE_NUMBER>, or e-mail:
<EMAIL_ADDRESS>You may also submit oral notices of
participation by phone to Isabelle Howes, U.S. Department of
Agriculture Graduate School (see FOR FURTHER INFORMATION CONTACT).
    Written material associated with an oral presentation. Submit
written material associated with an oral presentation by mail, fax, or
e-mail to Isabelle Howes.
    Comments. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. For additional information on submitting comments,
see section VI in this document.

FOR FURTHER INFORMATION CONTACT:
    For questions about registration or written material associated
with an oral presentation, or to register orally: Isabelle Howes, 202-
314-4713.
    For all other questions about the hearing or if you need parking or
special accommodations due to a disability: Juanita Yates, Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 301-
436-1731, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Food allergies affect approximately two percent of adults and about
five

percent of infants and young children in the United States. Currently,
there is no cure for food allergies. The only successful method to
manage food allergies is avoidance of foods containing allergens.
Consumers can attempt to avoid food substances to which they are
allergic by reading ingredient labels to see whether a food product
contains an allergenic ingredient. However, allergenic substances may
be inadvertently incorporated into food products that are not
formulated to contain these substances; consequently, their presence is
not required to be declared on food labels. FDA is concerned with food
allergens, including food allergens inadvertently incorporated into
manufactured foods, due to the number of reports concerning consumers
who have experienced adverse reactions following exposure to an
allergenic substance in a food. This concern has prompted several
agency actions targeting food manufacturers, including: (1) Issuing a
notice to manufacturers entitled ``Label Declaration of Allergenic
Substances in Foods'' in 1996 (Ref. 1); (2) forming an FDA/state
partnership in 1998 to increase industry's understanding of food
allergens and to identify effective manufacturing controls; and (3)
issuing a food allergen guidance document in 2001 (Ref. 2). Information
on these initiatives is available at the FDA Web site on allergens at
http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
    FDA stated in the 1996 notice to manufacturers that it is aware
that some manufacturers are voluntarily labeling their products with
statements such as ``may contain (allergen).'' FDA advised that,
because adhering to current good manufacturing practices (CGMPs) is
essential for effective reduction of adverse allergic reactions,
advisory labeling\1\ should not be used in lieu of adherence to CGMPs.
The agency urged food manufacturers to take all steps necessary to
eliminate cross-contact\2\ and to ensure the absence of allergens in
their finished food products. In addition, FDA encouraged manufacturers
to declare voluntarily any allergenic ingredient of a flavor, spice, or
color by identifying the allergenic ingredient in the ingredient list.
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    \1\ The purpose of advisory labeling is generally to alert food-
allergic consumers to the possibility of allergen cross-contact.
Although these labels vary by content, common formulations include
``This product was processed on machinery used to process
(allergen)'' and ``May contain (allergen).'' While this document
uses, where appropriate, the term ``advisory labeling,'' FDA
considers the term ``advisory labeling'' to be synonymous with
``precautionary labeling,'' a term sometimes used to describe these
circumstances.
    \2\ Cross-contact occurs when a residue or other trace amount of
a food allergen is present on a food contact surface or production
machinery, or is air-borne, and unintentionally becomes incorporated
into a product not intended to contain the allergen. Cross-contact
may also result from customary methods of growing and harvesting
crops, as well as from the use of shared storage, transportation, or
production equipment. FDA considers the term ``cross-contact'' to be
synonymous with ``cross-contamination,'' a term sometimes used to
describe these circumstances.
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A. Food Allergen Labeling and Consumer Protection Act of 2004

    On August 2, 2004, the United States Congress enacted the Food
Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title
II of Public Law No. 108-282). FALCPA amended the Federal Food, Drug,
and Cosmetic Act (the act) by imposing new labeling requirements on
packaged foods that contain ``major food allergens.'' Section 201(qq)
of the act (21 U.S.C. 321(qq)) defines ``major food allergen'' as milk,
eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and
soybeans or any other ingredient that contains protein derived from one
of these foods or food groups. FALCPA requires that the labels of foods
that contain an ingredient that is a major food allergen declare this
ingredient in one of two ways: (1) By including the name of the food
source from which the allergen is derived in parentheses following the
common or usual name of the major food allergen in the list of
ingredients in instances when the name of the food source of the major
food allergen does not appear elsewhere in the ingredient statement or
is not used in the common or usual name of the ingredient, or (2) by
placing the word ``Contains'' followed by the name of the food source
from which the major food allergen is derived immediately after or
adjacent to the list of ingredients.
    These allergen labeling requirements assist consumers in avoiding
substances to which they are allergic. However, as previously discussed
in this section, allergenic substances may be inadvertently
incorporated into food products that are not formulated to contain
them. FALCPA does not require the use of advisory labeling, including
statements describing the potential presence of unintentional
ingredients in food products resulting from the food manufacturing
process.

B. Information Available to FDA Regarding Advisory Labeling

    FDA has gathered information on advisory labeling by conducting its
own consumer research and reviewing other published consumer research.
Additionally, the agency investigated cross-contact that occurs during
manufacturing and examined manufacturers' use of advisory labeling to
alert consumers to the possibility that a food may contain allergens.
The information FDA has collected provides insight into the types of
advisory statements currently used by manufacturers and the reasons
manufacturers use advisory labeling. Furthermore, the consumer research
provides an understanding as to how consumers perceive particular
advisory statements and what wording consumers prefer and find
credible. FDA's findings are summarized as follows:
1. Cross-Contact and Use of Advisory Labeling
    FDA has found that unintentional cross-contact of foods with major
food allergens may occur at almost any step of the manufacturing
process and for various reasons (Ref. 3). Cross-contact can occur due
to allergens in raw ingredients or in processing aids, allergens in
reworked product,\3\ and allergen carry-over from the use of shared
equipment. Such potential sources of unintentional allergen cross-
contact exist regardless of the manufacturer's size or food product.
Many food manufacturers have allergen-control measures in place, such
as the use of dedicated facilities or dedicated production lines, to
prevent the cross-contact of major food allergens with their products.
Manufacturers also use a variety of advisory statements on package
labels, such as, ``May contain (allergen),'' ``Produced in a plant that
processes (allergen),'' ``Produced on shared equipment that processes
(allergen),'' and ``Processed on equipment that also processes
(allergen).'' These manufacturers use advisory labeling for a variety
of reasons, such as to advise consumers of the potential presence of an
allergen, to avoid the need to develop and use multiple labels, or to
reduce legal liabilities.
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    \3\ As a verb, ``rework'' refers to the practice of
reintroducing food product material that has been through some or
all of the manufacturing process into an earlier stage of the
production process of a subsequently produced food product. As a
noun or adjective, ``rework'' refers to the food product material
that is reintroduced into the production process.
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2. Consumer Studies
    FDA surveyed food-allergic adults or their caregivers and non-food-
allergic adults to learn which of the following food-allergen advisory
statements they preferred (Ref. 4):

    (1) ``Allergy Information: May contain peanuts.''
    (2) ``May Contain Peanuts.''
    (3) ``Manufactured on the same equipment as foods that contain
peanut.''
    (4) ``Produced in a facility with an allergy control plan. The
possibility of contact with allergenic ingredients has been minimized.
May still contain trace amount of peanut.''
    Survey participants preferred the statement ``Allergy Information:
May contain peanuts'' over the other three statements. This finding is
similar to other research that shows that people prefer warning
information that is preceded by signal words, such as ``Allergy
Information,'' possibly because signal words help to quickly draw
people's attention to important information (Ref. 5).
    FDA also conducted an experiment that compared the four statements
listed previously relative to buying, eating, or serving a food item
(Ref. 4). The experiment yielded two important findings. The first
important finding was that participants thought the risk of the food
containing allergens was greater when any of the four advisory
statements was on the food label than when there was no allergen
advisory statement. The second important finding was that participants
answered the questions about buying, eating, or serving the product
differently depending on which advisory statement they were responding
to. The experimental results showed that participants who looked at
food packages bearing the advisory statements ``Allergy information:
May contain peanuts'' or ``May contain peanuts'' believed these foods
were more likely to contain peanuts. In contrast, participants looking
at food packages with the other two statements believed those foods
were less likely to contain peanuts.\4\
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    \4\ It is important to keep in mind that these two consumer
research studies focused on the presence of peanuts. Peanut allergy
can produce severe allergic responses, and even those not affected
by peanut allergy appear to be aware that peanut allergy is serious
for those with the allergy. The research results may have been
different had a food allergen other than peanut been the subject of
the advisory statements.
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    FDA also reviewed research conducted by the Food Allergy &
Anaphylaxis Network (FAAN). FAAN's consumer surveys explored how
consumers with food allergies responded to advisory labeling by either
heeding it or ignoring it (Ref. 6). According to FAAN's consumer
surveys, consumers with food allergies are increasingly ignoring
advisory labeling. Additional FAAN research examined retail packaged
foods bearing various advisory labeling statements for peanuts and then
analyzed the products to determine the prevalence of peanut residue.
FAAN's analysis found detectable peanut residues in some of the
products with allergy advisory statements. This finding is important
because it indicates that allergic consumers who ignore advisory
labeling statements are risking their health by consuming foods that
have advisory labeling because some of these foods contain allergens.

C. Other Initiatives on Food Allergen Advisory Labeling

    The use of advisory labeling has steadily increased in the United
States. As mentioned in section I.B.1. of this document, different food
companies use different advisory statements and have different reasons
for using advisory labeling. FDA is aware that voluntary criteria for
determining when to use advisory labeling exist in the United States.
In 2001, in response to food allergy concerns, the Food Allergy Issues
Alliance (Ref. 7), a private group of representatives from industry, a
trade group, a consumer group, and academia recommended using the
following criteria to evaluate a food to determine whether advisory
labeling is appropriate:
     Whether the presence of a major food allergen is
documented through visual examination or analytical testing of the
processing line, equipment, ingredient or product, or other means;
     Whether the risk of presence of a major food allergen is
unavoidable even when current good manufacturing practices are
followed;
     Whether a major food allergen is present in some, but not
all, of the product; and
     Whether the presence of a major food allergen is
potentially hazardous.
    FDA is aware that other countries have developed or are currently
developing criteria to ensure uniformity in the use of advisory
labeling to warn consumers that a food may inadvertently contain an
allergen. The Canadian government is currently reviewing precautionary
statements for food allergens and making recommendations regarding
their use on the labels of packaged foods. For example, Canada is
updating its policy to restrict the options for different precautionary
statements. The proposed options for precautionary statements in Canada
are: (1) ``may contain (allergen)'' or (2) ``not suitable for
consumption by persons with an allergy to (allergen)'' (Ref. 8).
Further, where incoming ingredients have been labeled with a
precautionary statement, manufacturers are advised to use the same
statement on the finished product label unless the allergen in the
finished product is not likely to represent a health risk.
    Similar initiatives are evolving in Australia and New Zealand. An
industry forum has developed the Voluntary Incidental Trace Allergen
Labeling (VITAL) procedure to provide a risk-based approach for food
manufacturers to use in assessing the impact of allergen cross-contact
and to provide appropriate allergen advisory labeling (Ref. 9). The
VITAL Allergen Action Level Grid (``Vital Grid'') determines whether
allergens present in a food due to incidental cross-contact should be
labeled and, if so, whether this labeling should state whether an
allergen may be present or whether an allergen is actually present
(i.e., identified as an ingredient). VITAL uses a three-level grid to
determine if the presence of residual protein from allergenic
substances through unavoidable cross-contact warrants advisory
labeling. The VITAL Action Levels are: (1) Action Level 1--Green Zone--
advisory labeling is not required for the allergen under evaluation;
(2) Action Level 2--Yellow Zone--advisory labeling stating that the
allergen under evaluation may be present is advised; and (3) Action
Level 3--Red Zone--significant levels of the allergen are likely to be
present in the food; therefore, listing the allergen in the ingredient
list is advised.

D. Need for Long-Term United States Strategy to Manage Allergen
Advisory Labeling

    As previously discussed in this document, FDA has reviewed
available information and data and found that the use of advisory label
statements is not uniform. In addition, research indicated a range of
consumer understanding and behavior with regard to advisory labeling.
Research also indicated that some food products that contain advisory
labeling have been shown to contain detectable residues of food
allergens (Ref. 6). Allergic consumers who ignore advisory label
statements assume the risk of potential adverse reactions by consuming
these food products. If manufacturers choose to use advisory labeling
to inform consumers of the potential presence of food allergens in the
finished products, such labeling must be truthful and not misleading
and should provide clear, uniform, and accurate information to food-
allergic consumers about the potential presence of food allergens. As
currently used in the marketplace,

advisory labeling may not be protecting the health of allergic
consumers; therefore, FDA believes that it is in the best interest of
the public health, especially for food-allergic consumers, that FDA
develop a long-term strategy to address allergen advisory labeling.

II. Purpose and Scope of the Hearings

    FDA is developing a long-term strategy to assist manufacturers in
using allergen advisory labeling that is truthful and not misleading,
conveys a clear and uniform message, and adequately informs allergic
consumers and their caregivers. To that end, FDA is soliciting comments
and information to assist the agency in determining how manufacturers
currently use advisory labeling, how consumers interpret different
advisory labeling statements, and what wording is most effective in
communicating to consumers the likelihood that an allergen may be
present in a food. The agency is also interested in learning whether
consumers find advisory labeling helpful for making food purchasing
decisions.
    The scope of this hearing is determined by this document. FDA
invites general comments on the issues and questions listed in section
III of this document.

III. Issues and Questions for Discussion

    The following issues and questions will be discussed at the public
hearing:
    Issue 1: FDA is developing a long-term strategy to assist
manufacturers in ensuring that allergen advisory labeling is truthful
and not misleading, conveys a clear and uniform message, and adequately
informs allergic consumers and their caregivers. To help us better
understand under what circumstances manufacturers use advisory
labeling, we ask the following questions:
    Question 1. What manufacturing circumstances prompt manufacturers
to place advisory statements on a food label? What manufacturing
circumstances do not prompt manufacturers to include an advisory
statement? Why?
    Question 2. If we decide to develop guidance for using advisory
labeling, should we incorporate any of the guidelines from the Food
Allergy Issues Alliance or the principles of the VITAL system? If so,
why?
    Question 3. Are there circumstances under which there is no
possibility of cross-contact with a food allergen? If so, what are
they?
    Question 4. When manufacturers declare an allergenic ingredient in
the ingredient list or in the ``Contains'' statement, do they also use
an advisory statement indicating the presence of that ingredient? If
so, why? What do allergic consumers think of such labeling? Do
consumers consume the food product if they are allergic to the allergen
referred to in the advisory statement? Is the presence of both an
advisory statement and a ``Contains'' statement that include the same
allergen on the same food label confusing? Why or why not?
    Question 5. What criteria and considerations does a small firm rely
on when determining whether to use advisory labeling? Are these the
same criteria and considerations that a large firm relies on? How
frequently does a small firm use advisory labeling compared to a large
firm? If we decide to develop guidance for using advisory labeling,
what options should we investigate to consider the circumstances of
small firms?
    Question 6. How do manufacturers decide whether to label their
finished products with advisory labeling when their incoming
ingredients are labeled with advisory statements?
    Issue 2: FDA is also assessing whether advisory labeling is useful
to consumers and how consumers interpret advisory labeling statements.
Currently, industry uses many different advisory statements, such as
``May contain (allergen),'' ``(allergen) traces,'' ``Produced on shared
equipment that processes (allergen),'' and ``Produced in a plant that
processes (allergen).'' We are concerned that allergic consumers may be
risking their health by ignoring labeling designed to inform them of
the potential presence of allergens in foods. To help us better
understand what type of advisory labeling is most effective in helping
consumers avoid adverse allergic reactions, we ask the following
questions:
    Question 7. Consumer research suggests that different advisory
statements convey different degrees of potential for the inadvertent
presence of an allergen in a food. What message do manufacturers want
to convey by an advisory statement generally?
    Question 8. What specific advisory statements adequately inform
consumers of the potential risk of cross-contact with allergenic
materials? What advisory statements most accurately communicate to
consumers and their caregivers the potential risk of the presence of
the allergen? Why?
    Question 9. If you are a food-allergic consumer or caregiver to
such a consumer, do you ever ignore advisory statements? If so, which
types of statements, and why?
    Question 10. In addition to the information and data mentioned in
this document, what additional information or data are available that
would assist us in understanding consumers' perceptions of, use of, and
need for specific advisory statements and advisory labeling in general?
    Issue 3: FDA is assessing how advisory statements should be worded
to be the most effective in communicating the likelihood that an
allergen may be present in a food. Consumer focus group research shows
that the elements essential for an effective warning or safe handling
statement are: a description of the hazard, handling instructions for
avoiding the hazard, and an instructional statement that describes
conditions under which the hazard occurs and what action to take if the
hazard is not avoided (Ref. 10). This same research indicates that
label messages are more credible when consumers know the reason for the
message. The agency has previously used this consumer study information
to craft the warning statements and safe handling statements found in
21 CFR 101.17. To help us better understand how advisory statements
should be worded to be the most effective in communicating the
likelihood that an allergen may be present in a food, we ask the
following questions:
    Question 11. What elements are needed in an advisory statement to
adequately inform consumers of the potential for the inadvertent
presence of an allergen and would communicate to allergic consumers a
consistent and effective message regarding the risk of consuming the
product?
    Question 12. How would the use of consistent and effective advisory
labeling affect consumer understanding of the potential for an allergen
to be present in a food?

IV. Notice of Hearing Under 21 CFR Part 15

    Under authority delegated by the Commissioner of Food and Drugs
(the Commissioner), the Associate Commissioner for Policy and Planning
finds that it is in the public interest to permit persons to present
information and views at a public hearing regarding the use of allergen
advisory labeling and is announcing that the public hearing will be
held in accordance with part 15 (21 CFR part 15). The presiding officer
will be the Commissioner or his designee. The presiding officer will be
accompanied by a panel of FDA employees with relevant expertise.
    Persons who wish to participate in the hearing (either by making a
presentation or as a member of the audience) must file a notice of
participation (see DATES, ADDRESSES, FOR FURTHER INFORMATION

CONTACT, and section V of this document). Under authority delegated by
the Commissioner, the Associate Commissioner for Policy and Planning
has determined under Sec.  15.20(c) that advance submissions of oral
presentations are necessary for the panel to formulate useful questions
to be posed at the hearing under Sec.  15.30(e), and that the
submission of a comprehensive outline or summary is an acceptable
alternative to the submission of the full text of the oral
presentation. For efficiency, we request that individuals and
organizations with common interests consolidate their requests for oral
presentation and request time for a joint presentation through a single
representative. After reviewing the notices of participation and
accompanying information, we will schedule each oral presentation and
notify each participant of the time allotted to the presenter and the
approximate time that the presentation is scheduled to begin. If time
permits, we may allow interested persons who attend the hearing but did
not submit a notice of participation in advance to make an oral
presentation at the conclusion of the hearing. The hearing schedule
will be available at the hearing.
    After the hearing, the schedule and a list of participants will be
placed on file in the Division of Dockets Management (see ADDRESSES)
under the docket number listed in brackets in the heading of this
document.
    To ensure timely handling of any mailed notices of participation,
written material associated with presentations, or comments, any outer
envelope should be clearly marked with the docket number listed in
brackets in the heading of this document along with the statement
``Food Labeling; Current Trends in the Use of Allergen Advisory
Labeling: Its Use, Effectiveness, and Consumer Perception; Public
Hearing; Request for Comments.''
    Under Sec.  15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
    Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10, subpart C)). Under Sec.  10.205,
representatives of the electronic media may be permitted, subject to
the procedures and limitations in Sec.  10.206, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec.  15.30(b). For additional information about
transcripts, see section VII in this document.
    Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the appropriate contact person
(see FOR FURTHER INFORMATION CONTACT).
    To the extent that the conditions for the hearing, as described in
this document, conflict with any provisions set out in part 15, this
document acts as a waiver of these provisions as specified in
Sec. Sec.  10.19 and 15.30(h). In particular, Sec.  15.21(a) states
that the notice of hearing will provide persons an opportunity to file
a written notice of participation with the Division of Dockets
Management within a specified period of time. If the public interest
requires, e.g., if a hearing is to be conducted within a short period
of time, the notice may name a specific FDA employee and telephone
number to whom an oral notice of participation may be given. If the
public interest requires, the notice may also provide for submitting
notices of participation at the time of the hearing. In this document,
the conditions for the hearing specify that notices of participation be
submitted electronically to an agency Web site, to a contact person who
will accept notices of participation by mail, telephone, fax, or e-
mail, or in person on the day of the hearing (as time and space
permits). In addition, the conditions for the hearing specify that
written material associated with an oral presentation be provided to a
contact person who will accept it by mail, fax, or e-mail rather than
to the Division of Dockets Management. We are using these procedures to
facilitate the exchange of information between participants and the
agency. Under authority delegated by the Commissioner, the Associate
Commissioner for Policy and Planning finds under Sec.  10.19 that no
participant will be prejudiced, the ends of justice will thereby be
served, and the action is in accordance with law if notices of
participation are submitted by any of the procedures listed in this
document.

V. How to Participate in the Hearing

    Registration by submission of a notice of participation is
necessary to ensure participation and will be accepted on a first-come,
first-served basis. The closing date for registration is September 8,
2008. The notice of participation may be submitted electronically,
orally, or by fax, mail, or e-mail (see ADDRESSES and FOR FURTHER
INFORMATION CONTACT). We encourage you to submit your notice of
participation electronically. A single copy of any notice of
participation is sufficient.
    The notice of participation must include your name, title, business
affiliation (if applicable), address, telephone number, fax number (if
available), and e-mail address (if available). If you wish to request
an opportunity to make an oral presentation during the open public
comment period of the hearing, your notice of participation also must
include the title of your presentation, the sponsor of the oral
presentation (e.g., the organization paying travel expenses or fees),
if any; and the approximate amount of time requested for the
presentation. Presentations will be limited to the questions and
subject matter identified in section III of this document, and,
depending on the number of requests received, we may be obliged to
limit the time allotted for each presentation (e.g., 5 minutes each).
    Under Sec.  15.20(c), if you request an opportunity to make an oral
presentation, you must submit your presentation (either as the full
text of the presentation or as a comprehensive outline or summary). You
may submit your presentation by e-mail, fax, or mail. A single copy of
your presentation is sufficient. See ADDRESSES and FOR FURTHER
INFORMATION CONTACT for information on where to send your presentation.
    Persons who wish to request an opportunity to make an oral
presentation must submit a notice of participation by August 26, 2008,
and also must submit either the full text of the oral presentation or a
comprehensive outline or summary of the oral presentation by September
8, 2008. Individuals who request an opportunity to make an oral
presentation will be notified of the scheduled time for their
presentation prior to the hearing. All other persons wishing to attend
the hearing must submit a notice of participation by September 8, 2008.
Persons requiring special accommodations due to a disability must
submit a notice of participation by September 8, 2008, and should
inform the contact person of their request (see FOR FURTHER INFORMATION
CONTACT). Persons wishing to park onsite should inform the contact
person of their request by September 10, 2008.
    We will also accept notices of participation onsite on a first-
come, first-served basis; however, space is limited and registration
will be closed when the maximum seating capacity is

reached. Requests for an opportunity to make a presentation from
individuals or organizations that did not make such a request in
advance may be granted if time permits.
    Persons who submit a notice of participation in advance of the
hearing should check in at the on-site registration desk between 8 a.m.
and 9 a.m. Persons who wish to submit a notice of participation on-site
on the day of the hearing may do so at the registration desk between 8
a.m. and 9 a.m. We encourage all participants to attend the entire
hearing. Because the hearing will be held in a Federal building,
hearing participants must present photo identification and plan
adequate time to pass through the security system.
    We may post all submissions and received comments without change to
http://www.regulations.gov, including any personal information
provided.

VI. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments for consideration at or
after the hearing in addition to, or in place of, a request for an
opportunity to make an oral presentation (see section V of 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.

VII. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
It may be viewed at the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. A transcript will also be available in either hardcopy or on CD-
ROM after submission of a Freedom of Information request. Written
requests are to be sent to Division of Freedom of Information (HFI-35),
Office of Management Programs, Food and Drug Administration, 5600
Fishers Lane, rm. 6-30, Rockville, MD 20857.

VIII. References

    We have placed the following references on display in the Division
of Dockets Management (see ADDRESSES) and interested parties may see
them 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 site after this document publishes in the
Federal Register.)
    1. Center for Food Safety and Applied Nutrition, U.S. Food and
Drug Administration, ``Notice to Manufacturers, Label Declaration of
Allergenic Substances in Foods,'' June 10, 1996.
    2. Food and Drug Administration, 2001, ``Statement of Policy for
Labeling and Preventing Cross-contact of Common Food Allergens;
Compliance Policy Guide[rdquo,] accessible at http://www.fda.gov/
ora/compliance_ref/cpg/cpgfod/cpg555-250.htm
    3. Center for Food Safety and Applied Nutrition, U.S. Food and
Drug Administration, ``Report to the Committee on Health, Education,
Labor, and Pensions, United States Senate and the Committee on
Energy and Commerce, United States House of Representatives,'' July
2006, accessible at http://www.cfsan.fda.gov/~acrobat/alrgrep.pdf
    4. Verrill, Linda and Conrad J. Choini[egrave]re. (2009). ``Are
Food Allergen Advisory Statements Really Warnings?: Variation in
Consumer Preferences and Consumption Decisions,'' Journal of Food
Products Marketing. 15(2) (accepted for publication).
    5. Wogalter, M.S., M.J. Kalsher, R. Rashid, (1999), ``Effect of
Signal Word and Source Attribution on Judgments of Warning
Credibility and Compliance Likelihood,'' International Journal of
Industrial Ergonomics. 1999 24:185-192.
    6. Hefle, S.L., T.J. Furlong, L. Niemann, H. Lemon-Mule, S.
Sicherer, S.L. Taylor, (2007), ``Consumer Attitudes and Risks
Associated With Packaged Foods Having Advisory Labeling Regarding
the Presence of Peanuts,'' Journal of Allergy and Clinical
Immunology, 120(1):171-176.
    7. Food Allergy Issues Alliance, ``Food Allergen Labeling
Guidelines,'' May 2001.
    8. Canadian Food Inspection Agency, ``Precautionary Labelling
Regarding Food Allergens in Pre-packaged Foods'' September 25, 2007,
accessible at http://www.inspection.gc.ca/english/fssa/invenq/
inform/20070925e.shtml on March 26, 2008.
    9. Australian Food and Grocery Council Allergen Forum, ``Food
Industry Guide to Allergen Management and Labelling,'' 2007 revised
edition, accessible at http://www.allergenbureau.net/downloads/
allergen-guide/Allergen_Guide_2007.pdf on March 26, 2008.
    10. Levy, A.S., ``Review of Research Communicating Warning
Information,'' Consumer Studies Branch, Office of Scientific
Analysis and Support, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, June 1997.

    Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18280 Filed 8-7-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Page 64959]
[FR Doc No: 2011-27079]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4037-DR; Docket ID FEMA-2011-0001]

Delaware; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Delaware (FEMA-4037-DR), dated September 30,
2011, and related determinations.

DATES: Effective Date: September 30, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 30, 2011, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Delaware resulting from Hurricane Irene during the period of
August 25-31, 2011, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of Delaware.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Regis Leo Phelan, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Delaware have been designated
as adversely affected by this major disaster:

    Kent and Sussex Counties for Public Assistance.
    All counties within the State of Delaware are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

    Dated: October 13, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-27079 Filed 10-18-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39111-39113]
[FR Doc No: 2018-16902]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2018-0002; Internal Agency Docket No. FEMA-B-1844]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

David I. Maurstad,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                  Location and case                                                                               Online location of letter of        Date of         Community
        State and county                 No.              Chief executive officer of community       Community map repository             map revision              modification         No.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona:
    Mohave.....................  Town of Colorado     The Honorable Joseph Allred, Mayor, Town of  Town Hall, 25 South Central   https://msc.fema.gov/portal/   Nov. 2, 2018.......       040059
                                  City (18-09-         Colorado City, P.O. Box 70, Colorado City,   Street, Colorado City, AZ     advanceSearch..
                                  1337X).              AZ 86021..                                   86401..
    Mohave.....................  Unincorporated       The Honorable Gary Watson, Chairman, Board   Mohave County Administration  https://msc.fema.gov/portal/   Nov. 2, 2018.......       040058
                                  Areas of Mohave      of Supervisors, Mohave County, 700 West      Building, 700 West Beale      advanceSearch..
                                  County, (18-09-      Beale Street, Kingman, AZ 86402..            Street, Kingman, AZ 86402..
                                  1337X).
California:
    Riverside..................  City of Riverside,   The Honorable Rusty Bailey, Mayor, City of   Public Works Department,      https://msc.fema.gov/portal/   Oct. 22, 2018......       060260
                                  (18-09-0497P).       Riverside, 3900 Main Street, Riverside, CA   3900 Main Street, 4th         advanceSearch..
                                                       92522..                                      Floor, Riverside, CA 92522..
    Riverside..................  Unincorporated       The Honorable Chuck Washington, Chairman,    Riverside County Flood        https://msc.fema.gov/portal/   Oct. 22, 2018......       060245
                                  Areas of Riverside   Board of Supervisors, Riverside County,      Control and, Water            advanceSearch..
                                  County, (18-09-      4080 Lemon Street, 5th Floor, Riverside,     Conservation District, 1995
                                  0497P).              CA 92501..                                   Market Street, Riverside,
                                                                                CA 92501..
Hawaii: Honolulu...............  City and County of   The Honorable Kirk Caldwell, Mayor, City     Department of Planning and    https://msc.fema.gov/portal/   Oct. 30, 2018......       150001
                                  Honolulu, (18-09-    and County of Honolulu, 530 South King       Permitting, 650 South King    advanceSearch..
                                  1196P).              Street Room 306, Honolulu, HI 96813..        Street, Honolulu, HI 96813..
Illinois:
    Cook.......................  Village of           The Honorable Paul Braun, Mayor, Village of  Public Works Service Center,  https://msc.fema.gov/portal/   Oct. 26, 2018......       170091
                                  Flossmoor, (18-05-   Flossmoor, 2800 Flossmoor Road, Flossmoor,   1700 Central Park Avenue,     advanceSearch..
                                  2185P).              IL 60422..                                   Flossmoor, IL 60422..
    Cook.......................  Village of           The Honorable Richard Hofeld, Mayor,         Public Works, 17755 South     https://msc.fema.gov/portal/   Oct. 26, 2018......       170109
                                  Homewood, (18-05-    Village of Homewood, 2020 Chestnut Road,     Ashland Avenue, Homewood,     advanceSearch..
                                  2185P).              Homewood, IL 60430..                         IL 60430..
Minnesota: Olmsted.............  City of Rochester,   The Honorable Ardell F. Brede, Mayor, City   City Hall, 201 4th Street     https://msc.fema.gov/portal/   Oct. 18, 2018......       275246
                                  (18-05-0869P).       of Rochester, City Hall, 201 4th Street      Southeast, Rochester, MN      advanceSearch..
                                                       Southeast Room 281, Rochester, MN 55904..    55904..
Nevada: Clark..................  Unincorporated       The Honorable Steve Sisolak, Chairman,       Clark County, Office of the   https://msc.fema.gov/portal/   Oct. 18, 2018......       320003
                                  Areas of Clark       Board of Commissioners, Clark County, 500    Director of Public Works,     advanceSearch..
                                  County, (18-09-      South Grand Central Parkway, 6th Floor,      500 South Grand Central
                                  0773P).              Las Vegas, NV 89106..                        Parkway, Las Vegas, NV
                                                                                89155..
Oregon: Multnomah..............  City of Portland,    The Honorable Ted Wheeler, Mayor, City of    Bureau of Environmental       https://msc.fema.gov/portal/   Nov. 2, 2018.......       410183
                                  (18-10-0454P).       Portland, 1221 Southwest 4th Avenue, Room    Services, 1221 Southwest      advanceSearch..
                                                       340, Portland, OR 97204..                    4th Avenue, Room 230,
                                                                                Portland, OR 97204..
Virginia: Roanoke..............  City of Roanoke,     The Honorable Sherman P. Lea, Sr., Mayor,    Engineering Department        https://msc.fema.gov/portal/   Oct. 11, 2018......       510130
                                  (18-03-0502P).       City of Roanoke, 215 Church Avenue           Municipal Building, 215       advanceSearch..
                                                       Southwest, Room 456, Roanoke, VA 24011..     Church Avenue, Roanoke, VA
                                                                                24011..
Wisconsin: Dane................  City of Verona, (18- The Honorable Luke Diaz, Mayor, City of      City Hall, 111 Lincoln        https://msc.fema.gov/portal/   Oct. 5, 2018.......       550092
                                  05-0637P).           Verona, Verona City Center, 111 Lincoln      Street, Verona, WI 53593..    advanceSearch..
                                                       Street, Verona, WI 53593..
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[FR Doc. 2018-16902 Filed 8-7-18; 8:45 am]
 BILLING CODE 9110-12-P


  U.S. Department of Labor  -  Occupational Safety and Health Administration
NATIONAL ADVISORY COMMITTEE FOR OCCUPATIONAL SAFETY AND HEALTH (NACOSH) Heat Injury and Illness Prevention Work Group
                  Type of Meeting: NACOSH Work Group Meeting
  NACOSH Heat Injury and Illness Prevention Work Group Agenda: June 30, 2022
Andy Levinson  -  Designated Federal Official -<EMAIL_ADDRESS>Long  -  Alternate Designated Federal Official -<EMAIL_ADDRESS>              Cynthia Lewis  -  NACOSH Chair -<EMAIL_ADDRESS>          Rebecca Reindel  -  Work Group Chair -<EMAIL_ADDRESS>          Kathleen Dobson  -  Work Group Chair -<EMAIL_ADDRESS>          Jennifer Levin  -  Committee Counsel -<EMAIL_ADDRESS>         Carla Marcellus  -  NACOSH Support -<EMAIL_ADDRESS>     NACOSH Work Group Agendas are subject to change without prior notice

1:00  -  1:15 PM
Welcome
Andrew Levinson, Designated Federal Official
Kathleen Dobson and Rebecca Reindel, Work Group Chairs

1:15  -  1:40 PM
Report out and discussion of Task #1  -  Recommendations on OSHA's Heat Illness Prevention Materials
Kathleen Dobson, Work Group Chair
1:40 - 2:00 PM
Report out and discussion of Task #2  -  Recommendations on Potential Elements of Heat Injury and Illness Prevention Rulemaking
Rebecca Reindel, Work Group Chair
2:00  -  3:00 PM
Discussion, next steps, and presentation to NACOSH
Kathleen Dobson and Rebecca Reindel, Work Group Chairs


8/ 126/ 05 RFP/ CAIR segment The requirements for RFP under subparts 1 and 2, as described above, are the minimum required for an area. More reductions may be necessary for attainment within the nonattainment area. Moreover, an upwind area that contributes to nonattainment in a downwind area in the same State may need more reductions in a shorter time in order for the downwind area to reach attainment by its required attainment date. Although we believe most 8 hour nonattainment areas will attain the standard by their statutory attainment dateAs we noted above in section IV. D. 8., we recognize that some areas classified under subpart 2 may need additional time beyond the statutory attainment date for their area to attain as expediously as practicable. As discussed in the Phase 1 Rule ( 69 FR at 23959, col. 3), iIn the event an area cannot practicably attain by the maximum date for its classification, the Clean Air Act provides the opportunity for more time. An area regulated under subpart 2 can receive a later maximum attainment date through a State request to bump up to a higher classification ( e. g. from moderate to serious). The Act requires EPA to grant a State request to reclassify an area to a higher classification; the State plan still must provide for attainment as expeditiously as practicable. Although bump up means that certain additional specified requirements apply, an area may already be meeting most or all of these specified requirements due to controls previously adopted to implement the 1 hour ozone standard. This is because some areas had 1 hour classifications that were higher ( and more restrictive) than the areas' 8 hour classification, 1 and because the Phase 1 final implementation rule for the 8 hour O3 NAAQS contains antibacksliding provisions generally requiring areas to continue implementating measures required for the 1 hour classification. Although thereThere may not be additional mandatory control measures required because the areas may already have such measures in place. However, an area that needs more time to attain may also need additional emission reductions to reach attainment. These reductions may be achieved through implementation of measures that are necessary to demonstrate RFP requirements or additional reductions beyond RFP may be needed. Preliminary analyses indicate that already required control measures ( e. g., motor vehicle and nonroad engine rules, CAIR, etc.) may largely or fully fulfill reasonable further progress requirements for many areas and that they will provide substantial progress toward attainment for most areas. Many areas may have significant creditable reductions as a result of federal motor vehicle and non road rules, the NOx SIP Call, and the Clean Air Interstate Rule. With the statutory 2 exceptions enumerated above, assured emissions reductions that will occur in an area after the base year can be credited toward meeting an RFP emission reduction milestone. To reduce interstate ozone transport, the CAIR ( described above in section IV. B.) established statewide ozone season NOx budgets for 25 States and the District of Columbia ( eastern part of the United States where all 8 hour nonattainment areas are classified as moderate or below). As noted above, the first phase of NOx reductions under CAIR starts in 2009 ( covering 2009 2014); the second phase of NOx reductions begins in 2015 ( covering 2015 and thereafter). With respect to timing of reductions, the following table shows how summertime NOx reductions from local CAIR sources that will be achieved by May 1, 2009, or earlier can assist in demonstrating RFP.

Type of 8 hour nonattainment area RFP Requirement* Relationship of CAIR and RFP Subpart 1 areas with attainment dates within 5 years of designation Meet RFP through showing of expeditious attainment No separate RFP requirement, so creditability of CAIR reductions not relevant Subpart 1 areas with attainment dates 6 10 years from designation Must demonstrate RFP through their attainment date CAIR reductions in 2009 or earlier can help fulfill RFP requirement Subpart 2 marginal areas No subpart 2 RFP requirement for marginal areas Not relevant Subpart 2 moderateand above areas that previously achieved 15% RFP for 1 hour ozone standard Subject to subpart 1 RFP; must demonstrate RFP through their attainment date CAIR NOx reductions in 2009 or earlier can help fulfill RFP requirement Subpart 2 moderateand above areas that did not implement 15% VOC reductions for 1 hour ozone standard 15% VOC reduction required between 2002 and 2008; continued progress required through attainment date CAIR 2009 NOx reductions can help demonstrate continued progress after 2008 to attainment date. * RFP requirement descriptions in table are abbreviated; RFP requirements are more precisely described elsewhere in preamble and rule text. CAIR provisions do not require emission reductions prior to January 1, 2009. However, some sources may elect to apply CAIRlevel NOx controls earlier than that date. If such controls are made enforceable in the SIP ( e. g., through a specific rule), the State may take RFP credit for such emission reductions for the period ending December 31, 2008. The RFP provisions in the Act for both subpart 1 and subpart 2 areas require that actual emissions be reduced from the baseline to the milestone year. Therefore, only projected actual emission reductions may be credited toward the State's RFP obligation. In developing their RFP plans, States will have to provide their best estimate of the CAIR affected sources that are expected to actually apply controlsreduce emissions to meet the CAIR requirements and those that are expected to meet CAIR through holding allowances and not actually reducing emissions. Local CAIR NOx reductions by May 1, 2015, could assist in meeting RFP in the event an area received an attainment date extension to 2015 or beyond.


LOAEL = 650 mg/kg/day based on an increased incidence of abortion
confirmed in a range-finding study.

Developmental NOAEL =650 mg/kg/day [highest dose tested].

LOAEL could not be determined - no effects observed at highest dose
tested.

870.3700c

Prenatal developmental

[rat]	42233919 [1989]

Unacceptable/core

supplemental [Initial rating]

0, 20, 60, 160 mg/kg/day	Maternal NOAEL = 60 mg/kg/day

LOAEL = 160 mg/kg/day based on reductions in food consumption, mean body
weights and body weight gain.

Developmental NOAEL could not be determined

LOAEL = could not be determined.

870.3700d

Prenatal developmental

[rat]	44175302

Acceptable

Information supplemental to MRID# 42233919	Maternal NOAEL = 60 mg/kg/day

LOAEL = 160 mg/kg/day based on reductions in food consumption, mean body
weights and body weight gain.

Developmental NOAEL = 60 mg/kg/day

LOAEL = 160 mg/kg/day based on the incidence of post implantation loss

870.3800

Reproduction and fertility effects

[rat]	42233920 [1990]

Unacceptable/core supplemental

0, 100, 300, 1000 ppm	Parental/Systemic NOAEL = 300 ppm

LOAEL = 1000 ppm based on decreased body weights and body weight gains.

Reproductive NOAEL = 300 ppm

LOAEL = 1000 ppm based on decreased incisor eruption on day 10
postpartum.

Offspring NOAEL was not reported

LOAEL was not reported.

870.4100a

Chronic toxicity

[rat]	42233912 [1991]

Acceptable/guideline

0, 150, 450, 1350 ppm

M: 0, 9.4, 36.2, 99.9 mg/kg/day

F: 0, 11.9, 57.7, 157.8 mg/kg/day	NOAEL = 36.2/11.9 [M/F] mg/kg/day

LOAEL = 57.7/99.9 [M/F] mg/kg/day  based on decreased body weight and
increased incidence of arteritis in male rats and  decreased body weight
and significant increased incidence of "ground-glass" foci in the liver
in female rats.

870.4100b

Chronic toxicity [dog]

	42233911 [1991]

Acceptable/guideline

0, 150, 450, 1350 ppm

M: 0, 4.9, 14.7, 44.6 mg/kg/day

F: 0, 5.0, 15.7, 47.0 mg/kg/day	NOAEL = 14.7 mg/kg/day

LOAEL = 44.6mg/kg/day based on decreased prostate weight.

870.4200

Carcinogenicity

[rat]	42233916 [1991]

Acceptable/guideline

0, 200, 750, 20000 ppm

M: 0, 8.8, 33.9, 94.6 mg/kg/day

F: 0, 11.3, 46.3, 132.5 mg/kg/day	NOAEL [systemic] = 33.9/11.3 [M/F]
mg/kg/day

LOAEL [systemic] = 94.6/46.3 [M/F] mg/kg/day based on  decreased body
weight, gross and microscopic lesions in blood vessels, and liver
lesions in males and decreased body weight, gross and microscopic
lesions blood vessels, bone marrow hypercellularity, and liver lesions
in females.

There was no evidence of carcinogenicity

870.4300

Carcinogenicity

[mouse]	42233914 [1991]

Acceptable/guideline

0, 10, 100, 1000 mg/kg/day	NOAEL = 100 mg/kg/day

LOAEL [systemic] = 1000 mg/kg/day based on decreased body weight gain in
males.

There was no evidence of carcinogenicity

Gene Mutation

870.5100a	42233921 [1985]

Acceptable	Negative for inducing reverse gene mutation in either
Salmonella his-mutants or E. coli trp-cells exposed beyond precipitating
concentrations [500 ug/plate], up to the limit dose, 5000 ug/plate,
w/without metabolic activation.

Gene Mutation

870.5100b	42233926 [1989]

Acceptable	Negative for inducing reverse gene mutation in Salmonella TA
strains and E. coli WP2 uvr A exposed, with/without activation, up to
5000 ug/plate.

In vitro mammalian cell gene mutation test

870.5300a	42233923 [1987]

Acceptable	Negative for inducing forward mutation at the
hypoxanthine-guanine phosphoribosyl transferase locus in Chinese hamster
lung [V79] cells treated up to cytotoxic levels [230 ug/mL/-S9; 300
ug/mL/+S9].

In vitro mammalian cell gene mutation test

870.5300b	42233927 [1991]

Acceptable	Negative for inducing forward mutation at the
hypoxanthine-guanine phosphoribosyl transferase [HGPRT] locus in Chinese
hamster lung [V79] exposed, with/without activation, up to cytotoxic
concentrations [180 ug/mL/-S9; 333 ug/mL/+S9].

In vitro mammalian chromosome aberration test

870.5375a	42233924 [1986]

Unacceptable	Reportedly positive for chromosome aberrations at the
highest doses tested [160 ug/mL/-S9; 170 ug/mL/+S9].

In vitro mammalian chromosome aberration test

870.5375b	42233925 [1987]

Acceptable	[Confirmatory repeat of Study LMP-180 C, MRID 422339-24].
Positive for increased chromosome aberrations at high doses [160
ug/mL/-S9; 170 ug/mL/+S9].

In vitro mammalian chromosome aberration test

870.5375c	42233928 [1991]

Acceptable	Presumptively [weakly] positive, but only in activated
cultures treated at the HDT, in human lymphocyte cultures treated up to
the highly toxic dose, 422 ug/mL; negative in the absence of activation
at all doses.

Mammalian erythrocyte micronucleus test

870.5395a	42233930 [1991]

Acceptable	Negative for inducing micronuclei in bone marrow cells of
mice administered test article i.p.  up to severely toxic levels [200
mg/kg].

Mammalian erythrocyte micronucleus test

870.5395b	42233931 [1989]

Acceptable	Negative for inducing micronuclei in bone marrow cells of
mice treated orally at the limit dose, 5000 mg/kg.

Mutagenicity - DNA damage/repair in vitro

870.5500	42233922 [1986]

Unacceptable	Reportedly negative for inducing unscheduled DNA synthesis
[as measured by liquid scintillation counting] in rat hepatocytes
cultured [for only 3 hours] at doses up to 250 ug/mL, a weakly cytotoxic
level.

Other Effects - Morphologic transformation of cells in culture

870.8800	42233929 [1986]

Acceptable	Negative for transformation in Syrian hamster embryo cells
treated, in the presence and absence of activation,  up to cytotoxic
concentrations [265 ug/mL/+S9; 50 ug/mL/-S9]

870.7485

Metabolism and pharmacokinetics

[rat]	42233932 [1994]

Acceptable

10 mg/kg single dose; 10 mg/kg 14-day repeated dose; 10 mg/kg 7-day
repeated dose; 500 mg/kg single dose	Oral administration of dimethomorph
results in rapid excretion into the urine and feces of rats.  For all
treatment protocols, most [80-90%] of the radiolabel administered was
excreted in the feces.  A considerably smaller amount [6-16%] was
excreted in the urine and only minimal levels [0.1-0.4%] were detected
in the organs and tissues.  Rapid absorption may be inferred by the
rapid excretion of metabolites in the urine and bile.  Saturation of
absorption following single high doses [500 mg/kg] was indicated by
large amounts [(50%] of radioactivity in the feces being associated with
parent compound.  For low- or high-dose treatment, urinary excretion in
female rats tended to be greater [up to 2-fold in low-dose rats] than
that of male rats.  Retention of dimethomorph or
[14C]-dimethomorph-derived radioactivity was generally (1% for most
tissues although the liver exhibited slightly higher levels [1.4%] and
higher levels in the gastrointestinal tract organs was due to
radioactivity in the lumenal contents.  Urinary metabolites resulted
from demethylation of the dimethoxyphenyl ring and oxidation of the
morpholine ring.  Biliary excretion exhibited first-order kinetics with
a low-dose [10 mg/kg] half-life of approximately 3 hours and a high-dose
[500 mg/kg] half-life of 11 hours for males and about 6 hours for
females.  Biliary metabolites accounted for most of the fecal excretion
following low-dose treatment.  The major biliary metabolites were
glucuronides of one and possibly two of the compounds produced by
demethylation of the dimethoxyphenyl ring.  The report provided a
proposed metabolic pathway for dimethomorph.

870.7600

Dermal penetration

[rat]	43917221 [1995]

Acceptable/guideline

7.73 [2.5% w/v aqueous suspension] or 79.62 [25% w/v aqueous suspension]
mg/kg.	The total amount of dimethomorph absorbed [expressed as percent
of [14C]-dose] from rats at various times following dermal
administration of [14C]-dimethomorph at 7.73 [0.15 mg/cm2] or 79.62
mg/kg [1.58 mg/cm2] is less than 5% of the dose and it appears that the
absorption is concentration dependent.  Dermal absorption was 0.05%,
0.07% and 0.27% of the administered dose from rats 4, 8, and 24 hours
after dermal treatment at 7.73 mg/kg, respectively.  Dermal absorption
was 0.02%, 0.16% and 0.12% of the dose 4, 8, and 24 hours after dermal
treatment at 79.62 mg/kg, respectively.  Dermal absorption was
approximately 0.4 and 1 mg/kg in terms of weight equivalent at 7.73 and
79.62 mg/kg, respectively.  Six days after dermal treatment, the percent
total absorption of the dose in the 7.73 and 79.62 mg/kg was 4.76 and
1.20%, respectively.  Mean percent recovery of 14C for dose levels of
7.73 and 79.62 mg/kg was 104.1% and 92.1%, respectively.  Majority of
the radioactivity was found in skin swabs and gauze wash [80.9 to
81.8%].  The percent of the dose in the skin decreased with dose; at
7.73 mg/kg 17.5% and at 79.62 mg/kg 9.99%

Appendix B:  Rationale for Toxicology Data Requirements  TC \l1
"Appendix II – Rationale for Toxicology Data Requirements

Guideline Number:  870.7800

Study Title:  Immunotoxicity

Rationale for Requiring the Data

	The immunotoxicity study is a new data requirement under 40CFR §158 as
a part of the data requirements for registration of a pesticide (food
and non-food uses).

	The Immunotoxicity Test Guideline (OPPTS Guideline 870.7800) prescribes
functional immunotoxicity testing, and is designed to evaluate the
potential of a repeated chemical exposure to produce adverse effects
(such as suppression) on the immune system.  Immunosuppression is a
deficit in the ability of the immune system to respond to a challenge of
bacterial or viral infections such as tuberculosis (TB), Severe Acquired
Respiratory Syndrome (SARS), or neoplasia.  Because the immune system is
highly complex, studies not specifically conducted to assess immunotoxic
endpoints are inadequate to characterize a pesticide’s potential
immunotoxicity.  While data from hematology, lymphoid organ weights, and
histopathology in routine chronic or subchronic toxicity studies may
offer useful information on potential immunotoxic effects, these
endpoints alone are insufficient to predict immunotoxicity.

Practical Utility of the Data

How will the data be used?

	Immunotoxicity studies provide critical scientific information needed
to characterize potential hazard to the human population on the immune
system from pesticide exposure.  Since epidemiologic data on the effects
of chemical exposures on immune parameters are limited, and are
inadequate to characterize a pesticide’s potential immunotoxicity in
humans, animal studies are used as the most sensitive endpoint for risk
assessment.  These animal studies can be used to select endpoints and
doses for use in risk assessment of all exposure scenarios, and are
considered a primary data source for reliable reference dose
calculation.  For example, animal studies have demonstrated that
immunotoxicity in rodents is one of the more sensitive manifestations of
TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) among developmental,
reproductive and endocrinologic toxicities.  Additionally, the EPA has
established an oral reference dose (RfD) for tributyltin oxide (TBTO),
based on observed immunotoxicity in animal studies (IRIS, 1997).

How could the data impact the Agency's future decision-making?

	If the immunotoxicity study shows that the test material poses either a
greater or a diminished risk than that given in the interim decision’s
conclusion, the risk assessments for the test material may need to be
revised to reflect the magnitude of potential risk derived from the new
data.

 	If the Agency does not have these data, a 10X database uncertainty
factor may be applied for conducting a risk assessment from the
available studies.

Guideline Number:  870.6200

Study Title:  Acute and Subchronic Neurotoxicity

Rationale for Requiring the Data

	The acute and subchronic neurotoxicity studies are a new data
requirement under 40CFR §158 as a part of the data requirements for
registration of a pesticide (food and non-food uses).

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ticide’s potential neurotoxicity.  While data on clinical signs of
toxicity or histopathology in routine chronic or subchronic toxicity
studies may offer useful information on potential neurotoxic effects,
these endpoints alone may be insufficient to detect more subtle
neurological effects.

Practical Utility of the Data

How will the data be used?

	Neurotoxicity studies provide critical scientific information needed to
characterize potential hazard to the human population on the nervous
system from pesticide exposure.  Since epidemiologic data on the effects
of chemical exposures on neurological parameters are limited, and may be
inadequate to characterize a pesticide’s potential neurotoxicity in
humans, animal studies are used as the most sensitive endpoint for risk
assessment.  These animal studies can be used to select endpoints and
doses for use in risk assessment of all exposure scenarios, and are
considered a primary data source for reliable reference dose
calculation.

How could the data impact the Agency's future decision-making?

	If the neurotoxicity study shows that the test material poses either a
greater or a diminished risk than that given in the interim decision’s
conclusion, the risk assessments for the test material may need to be
revised to reflect the magnitude of potential risk derived from the new
data.

 	If the Agency does not have these data, a 10X database uncertainty
factor may be applied for conducting a risk assessment from the
available studies.

AppendiX C:  Human Research REFERENCE

	The Pesticide Handlers Exposure Database, Version 1.1 (Electronic
Database); The PHED Task Force, 1995; (Task Force members: Health
Canada, US Environmental Protection Agency, and the National
Agricultural Chemicals Association); released February, 1995.

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