[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Rules and Regulations]
[Pages 50617-50622]
[FR Doc No: 2012-20667]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0766; FRL-9354-3]
RIN 2070-AJ28

Pesticide Tolerance Crop Grouping Program III; Revisions to
General Tolerance Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule revises the current pesticide tolerance crop
grouping regulations, which allow for the establishment of tolerances
for multiple related crops based on data from a representative set of
crops. This rule expands upon existing stone fruit and tree nut crop
groups by establishing new crop subgroups and adding new commodities.
This is the third in a series of planned crop group updates expected to
be promulgated over the next several years.

DATES: This final rule is effective October 22, 2012.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2006-0766 is available
electronically at http://www.regulations.gov, or in hard copy at the
OPP Docket in the Environmental Protection Agency Docket Center (EPA/
DC), located in EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460. The Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPP Docket is<PHONE_NUMBER>. Please review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 305-7390; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the agency taking?

    This final rule, under the provisions of section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, amends EPA's
regulations governing crop group tolerances for pesticides.
Specifically, the rule expands upon existing stone fruit and tree nut
crop groups by adding new commodities and establishes crop subgroups
for the new stone fruit crop group. This final rule is the third in a
series of planned crop group updates expected to be promulgated in the
next several years.

B. What is the agency's authority for taking this action?

    EPA is authorized to establish tolerances for pesticide chemical
residues in food under FFDCA section 408. EPA establishes tolerances
for each pesticide based on the potential risks to human health posed
by that pesticide. A tolerance is the maximum permissible residue level
established for a pesticide in raw agricultural produce and processed
foods. The crop group regulations currently in 40 CFR 180.40 and 180.41
enable the establishment of tolerances for a group of crops based on
residue data for certain crops that are representative of the group.
Crop group regulations are promulgated under section 408(e)(1)(C) which
authorizes EPA to establish ``general procedures and requirements to
implement [section 408].'' 21 U.S.C. 346a(e)(1)(C).

C. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer or food manufacturer. The following list of North
American Industrial Classification System (NAICS) codes is not intended
to be exhaustive, but rather provides a guide to help readers determine
whether this document might apply to them. Potentially affected
entities may include, but are not limited to:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112).
     Pesticide manufacturing (NAICS code 32532).

D. What are the incremental costs and benefits of this action?

    EPA prepared an analysis of the potential costs and benefits
associated with the establishment of crop groupings when it issued the
first proposed rule in this series of rulemakings, which published in
the Federal Register of May 23, 2007 (77 FR 28920). This analysis is
contained in ``Economic Analysis Proposed Expansion of Crop Grouping
Program,'' a copy of which is available in the docket for this action.
In general, the Agency anticipates that revisions to the crop grouping
program will result in no appreciable costs or negative impacts to
consumers, specialty crop producers, pesticide registrants, human
health, or the environment. The impacts of this rule are measured
primarily on a qualitative basis. However, the rule is expected to
reduce the cost of generating residue data for pesticide registration
and new food uses, because it will have the effect of reducing the
number of residue chemistry studies, because fewer representative crops
would need to be tested under a crop grouping scheme than would
otherwise be required.
    Benefits of the rule can be shown through an example of the impact
of the changes to Crop Group 3 that were accomplished in a prior
rulemaking (72 FR 69150, December 7, 2007). That rulemaking expanded
Crop Group 3, Bulb Vegetable, from 7 to 25 crops, an increase of 18
from the original crop group. Prior to the expansion of that subgroup,
adding tolerances for 18 new crops would have required at least 18
field trials at a cost of approximately $5.4 million (assuming $300,000
per field trial).
    This action is intended to promote more extensive use of crop group
tolerances; in particular, it will assist in making available lower-
risk pesticides for minor crops both domestically and in countries that
export food to the United States. In addition, expanding crop groups
will greatly increase the efficiency of IR-4 and EPA in registering
pesticides on specialty crops and reduce the administrative costs of
both the IR-4 testing process and the EPA review process.

II. The Proposed Rule

    EPA published a notice of proposed rulemaking in the Federal
Register of November 9, 2011 (76 FR 69693) (FRL-8887-8). Written
comments were received from three parties in response to the proposal:
A private citizen; The Embassy of the Republic of Korea; and from the
American Pistachio Growers trade association.

III. Response to Comments

    In this section, EPA describes the major provisions of the proposed
rule, the comments received on each provision and EPA's responses to
those comments, including EPA's determination if any modification of
the proposed rule is warranted.

A. Crop Group 12-12: Stone Fruit Group

    1. Revise the proposed crop group name. The final rule retains the
pre-existing Crop Group 12 and adds a new group titled ``Crop Group 12-
12: Stone Fruit Group.'' Although the new group was proposed as ``Crop
Group 12-11: Stone Fruit Group,'' this change has been effected in
order to reflect the correct year of establishment, which is 2012.
Therefore, this final rule adds a new stone fruit group, ``Crop Group
12-12: Stone Fruit Group,'' but retains the pre-existing Crop Group 12.
    2. Add commodities. The final rule expands the stone fruit crop
group from the existing 11 commodities to 22 commodities in Crop Group
12-12: Stone Fruit Group.
    EPA received one comment from a private citizen that noted that the
commodity chokecherry, which was proposed to be included in the revised
Crop Group 12-12: Stone Fruit Group and Cherry subgroup 12-12A, is
already established in Crop Group 13-07: Berry and Small Fruit Group
and Large Shrub/Tree Berry Subgroup 13-07C. As a general practice, the
Agency will avoid having a commodity as a member of more than one crop
group. Accordingly, EPA revisited the proposal to include chokecherry
in the revised crop group.
    Although chokecherry is a stone fruit, its fruit size is closer to
elderberry and mulberry, the representative commodities for Large
Shrub/Tree Berry Subgroup 13-07C, rather than sweet or tart cherry, the
representative commodities for Cherry Subgroup 12-12A. The diameter for
chokecherry is 0.3 inches (0.8 cm), elderberry is 0.3-0.5 inches (0.8-
1.3 cm), mulberry is 0.5 inches (1.3 cm), and sweet cherry is 1.4
inches (3.6 cm). Cherry, the commodity proposed as the representative
for chokecherry in the revised Crop Subgroup 12-12A, has a diameter
that is approximately 4.7 times larger than the chokecherry, while both
elderberry and mulberry are approximately the same size as chokecherry.
The application of pesticides on commodities with smaller diameters
(surface area to volume ratio) often results in higher residues than on
larger commodities. Therefore, the EPA has determined that it is
appropriate to retain chokecherry in the previously established Crop
Group 13-07 and Subgroup 13-07C and will not include chokecherry in
Crop Group 12-12: Stone Fruit Group or Cherry Subgroup 12-12A.
    Additionally, a comment was received from the Embassy of the
Republic of Korea requesting that Chinese jujube (Ziziphus jujuba
Mill.) be reconsidered as a member of Crop Group 12-12: Stone Fruit
Group. Chinese jujube was originally included in the petition to the
Agency as a proposed member of the revised stone fruit crop group.
However, when EPA first reviewed the available supporting information,
EPA concluded that it might be more appropriate to include Chinese
jujube in a future proposed tropical fruit, edible peel crop group. The
Agency noted that Chinese jujube is a member of a different plant
family (Rhamnaceae instead of Rosaceae) as a rationale for this
decision. Further information about the original petition

to the Agency to include Chinese jujube and EPA's previous review of
the commodity can be found in the docket, identified by document ID No.
EPA-HQ-OPP-2006-0766-0044.
    However, after reviewing the Korean data submitted with the comment
and literature from the United States, EPA finds that Chinese jujube
growth and cultural practices are similar to some stone fruits, such as
cherries and small varieties of plums, and should therefore be similar
to other stone fruit in terms of pesticide residue exposure.
    Chinese jujube is a traditional East Asian fruit crop mainly
cultivated in temperate regions of China, Korea, Taiwan, and Japan.
Chinese jujube has large leaf canopies shading the small sized fruits,
and the fruit is botanically considered a stone fruit or ``drupe.'' The
Chinese jujube is also deciduous; the crop loses its leaves in the fall
and has a dormant period in the winter, similar to other members of
Crop Group 12-12: Stone Fruit Group. Additionally, the flower to
harvest time as well as the fruit shape, size, and smooth skin texture
is similar to the plum.
    The Chinese jujube was introduced into the United States from China
in 1908, and it is widely distributed in the southern states as both an
ornamental crop and potential minor food crop. Improved varieties of
Chinese jujube are available to growers from commercial nursery catalog
companies, and there has been recent research in cultivating the crop
in the United States as a potential profitable minor crop. For these
reasons, EPA concludes it would be appropriate to include Chinese
jujube as a member of Crop Group 12-12: Stone Fruit Group, and as a
member of the Plum Subgroup 12-12C.
    Finally, EPA has revised the taxonomic names for several
commodities in Crop Group 12-12: Stone Fruit Group, in order to reflect
the currently accepted taxonomic name or names. Based on the decision
to remove chokecherry and add Chinese jujube to the revised Crop Group
12-12: Stone Fruit Group, the final rule expands Crop Group 12-12:
Stone Fruit Group to include 22 commodities.
    3. Create new subgroups. The final rule retains the proposed
addition of three subgroups to Crop Group 12-12: Stone Fruit Group, and
updates the names of the subgroups to reflect the correct year that the
subgroups are being established. Based on the information considered,
chokecherry has been removed from inclusion in Crop Subgroup 12-12A,
and Chinese jujube has been added to Crop Subgroup 12-12C. Therefore,
the three subgroups are being established as follows:
    i. Cherry Subgroup 12-12A. (Representative commodities--Sweet
cherry or Tart cherry). Five commodities are included in this subgroup.
    ii. Peach Subgroup 12-12B. (Representative commodity--Peach). Two
commodities are included in this subgroup.
    iii. Plum Subgroup 12-12C. (Representative commodities--Plum or
Prune plum). Fifteen commodities are included in this subgroup.
    EPA adopts these proposals as final, with the changes noted in this
section.

B. Crop Group 14-12: Tree Nut Group

    1. Revise the proposed crop group name. The final rule retains the
pre-existing Crop Group 14 and adds a new group titled ``Crop Group 14-
12: Tree Nut Group.'' Although the new group was proposed as ``Crop
Group 14-11: Tree Nut Group,'' this change has been effected in order
to reflect the correct year of establishment, which is 2012. Therefore,
this final rule adds a new tree nut group, ``Crop Group 14-12: Tree Nut
Group,'' but retains the pre-existing Crop Group 14.
    2. Add commodities. The final rule expands the tree nut crop group
from the existing 12 commodities to 39 commodities in Crop Group 14-12:
Tree Nut Group.
    EPA received one comment from the American Pistachio Growers trade
association that supported including pistachio in the revised tree nut
crop group. They noted that including pistachio will, ``* * * provide
the pistachio growers with the ability to use crop tools necessary to
combat pests,'' and further noted that, ``* * * growers, processors,
marketers, and consumers * * * will benefit from including pistachios
in the tree nut group.'' EPA agrees with these comments.
    EPA has revised the taxonomic names for several commodities in Crop
Group 14-12: Tree Nut Group, in order to reflect the currently accepted
taxonomic name or names. Therefore, EPA adopts these proposals as
final, with the changes noted in this section.

IV. The Final Rule

    After fully considering all comments, EPA is finalizing the
proposed rule with the revisions discussed previously. Other than these
revisions, EPA is finalizing the rule as proposed, based on the
rationale set forth in the proposed rule.

V. Implementation

    When a crop group is amended in a manner that expands or contracts
its coverage of commodities, EPA will (1) retain the pre-existing crop
group in 40 CFR 180.41; (2) insert the revised crop group immediately
after the pre-existing crop group in the Code of Federal Regulations;
and (3) title the revised crop group in a way that clearly
differentiates it from the pre-existing crop group.
    The revised crop group will retain roughly the same name and number
as the pre-existing group, except the number will be followed by a dash
and the final digits of the year established (e.g., Crop Group 8-10).
    EPA will initially retain pre-existing crop groups that have been
superseded by revised crop groups. EPA will not establish new
tolerances under the pre-existing groups. Further, EPA plans to
eventually convert tolerances for any pre-existing crop group to
tolerances with coverage under the revised crop group. This conversion
will be effected both through the registration review process and in
the course of evaluating new uses for a pesticide. EPA requests that
petitioners for tolerances address this issue in their petitions. For
existing petitions for which a Notice of Filing has been published, the
Agency will attempt to conform these petitions to this rule.

VI. Statutory and Executive Order Reviews

A. Executive Orders 12866 and 13563

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993) and was therefore not reviewed
by the Office of Management and Budget (OMB) under Executive Orders
12866 and 13563, entitled ``Improving Regulation and Regulatory
Review'' (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This rule does not impose any new information collection
requirements that would require additional review or approval by OMB
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. Burden
is defined at 5 CFR 1320.3(b). An Agency may not conduct or sponsor,
and a person is not required to respond to a collection of information
that requires OMB approval under PRA, unless it has been approved by
OMB and displays a currently valid OMB control number. The OMB control
numbers for EPA's regulations in title 40 of the CFR, after appearing
in the Federal Register, are listed in 40 CFR part 9, and included on
the related collection instrument, or form, if applicable.

    The information collection activities associated with the
submission of a petition to request a tolerance are already approved
under OMB control number 2070-0024 (EPA ICR No. 0597.10), and the
changes to the crop grouping regulations do not change the covered
activities such that additional OMB review or approval is required.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
generally requires an agency to prepare a regulatory flexibility
analysis of any rule subject to notice and comment rulemaking
requirements under the Administrative Procedure Act (APA), 5 U.S.C.
551-553, or any other statute unless the agency certifies that the rule
will not have a significant economic impact on a substantial number of
small entities. Under the RFA, small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For the purpose of assessing the impacts of this final rule on
small entities, a small entity is defined as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
rule does not have any direct adverse impacts on small businesses,
small non-profit organizations, or small local governments. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities'' (5 U.S.C. 603
and 604). Thus, an agency may certify under section 605(b) of the RFA
if the rule relieves regulatory burdens or otherwise has a positive
economic effect on all of the small entities subject to the rule.
    As discussed previously, this rule provides regulatory relief and
regulatory flexibility. The new crop groups ease the process for
pesticide manufacturers to obtain pesticide tolerances on greater
numbers of crops. Pesticides will be more widely available to growers
for use on crops, particularly specialty crops.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act (UMRA), 2
U.S.C. 1531-1538, EPA has determined that this final rule does not
contain a Federal mandate that may result in expenditures of $100
million or more for state, local and tribal governments, in the
aggregate, or the private sector in any one year. Accordingly, this
rule is not subject to the requirements of sections 202, 203, 204, and
205 of UMRA.

E. Executive Order 13132

    This action will not have ``federalism implications'' as specified
in Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), because this action will not have substantial direct effects
on the states, on the relationship between the national government and
the States, or on the distribution of power and responsibilities among
the various levels of government, as specified in the Order. Thus,
Executive Order 13132 does not apply to this final rule.

F. Executive Order 13175

    This action will not have ``tribal implications'' as specified in
Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments:'' (65 FR 67249, November 9, 2000), because
it will not have any effect on tribal governments, on the relationship
between the Federal government and the Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in the Order. Thus,
Executive Order 13175 does not apply to this final rule.

G. Executive Order 13045

    EPA interprets Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997) as applying only to those regulatory actions
that concern health or safety risks, such that the analysis required
under section 5-501 of the Order has the potential to influence the
regulation. Executive Order 13045 does not apply to this rule because
this action is not designated as an ``economically significant
regulatory action'' as defined by Executive Order 12866 (see Unit
III.A.), nor does it establish an environmental standard, or otherwise
have a disproportionate effect on children.

H. Executive Order 13211

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

I. National Technology Transfer and Advancement Act

    This action does not involve technical standards that would require
the consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act (NTTAA),
15 U.S.C. 272 note.

J. Executive Order 12898

    This action does not have an adverse impact on the environmental
and health conditions in low-income and minority communities.
Therefore, this action does not involve special consideration of
environmental justice related issues as specified in Executive Order
12898, entitled ``Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act, 5 U.S.C. 801 et seq., EPA
will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
pesticides and pests.

    Dated: July 31, 2012.
James Jones,
Assistant Administrator for Chemical Safety and Pollution Prevention.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q). 346a and 371.

0
2. Section 180.41 is amended as follows:
0
a. Redesignate paragraphs (c)(17) through (c)(26) as paragraphs (c)(18)

through (c)(27), respectively, and add a new paragraph (c)(17).
0
b. Redesignate newly redesignated paragraphs (c)(21) through (c)(27) as
paragraphs (c)(22) through (c)(28), respectively, and add a new
paragraph (c)(21).
    These amendments read as follows:

Sec.  180.41  Crop group tables.

* * * * *
    (c) * * *
    (17) Crop Group 12-12: Stone Fruit Group.
    (i) Representative commodities. Sweet cherry or Tart cherry; Peach;
and Plum or Prune plum.
    (ii) Commodities. The following Table 1 is a list of all
commodities included in Crop Group 12-12.

              Table 1--Crop Group 12-12: Stone Fruit Group
------------------------------------------------------------------------
                  Commodities                     Related crop subgroup
------------------------------------------------------------------------
Apricot (Prunus armeniaca L.)..................  12-12C
Apricot, Japanese (Prunus mume Siebold & Zucc.)  12-12C
Capulin (Prunus serotina Ehrh. var. salicifolia  12-12A
 (Kunth) Koehne).
Cherry, black (Prunus serotina Ehrh.)..........  12-12A
Cherry, Nanking (Prunus tomentosa Thunb.)......  12-12A
Cherry, sweet (Prunus avium (L.) L.)...........  12-12A
Cherry, tart (Prunus cerasus L.)...............  12-12A
Jujube, Chinese (Ziziphus jujuba Mill.)........  12-12C
Nectarine (Prunuspersica (L.) Batsch var.        12-12B
 nucipersica (Suckow) C.K. Schneid).
Peach (Prunus persica (L.) Batsch var. persica)  12-12B
Plum (Prunus domestica L. subsp. domestica)....  12-12C
Plum, American (Prunus americana Marshall).....  12-12C
Plum, beach (Prunus maritima Marshall).........  12-12C
Plum, Canada (Prunus nigra Aiton)..............  12-12C
Plum, cherry (Prunus cerasifera Ehrh.).........  12-12C
Plum, Chickasaw (Prunus angustifolia Marshall).  12-12C
Plum, Damson (Prunus domestica L. subsp.         12-12C
 insititia (L.) C.K. Schneid.).
Plum, Japanese (Prunus salicina Lindl.; P.       12-12C
 salicina Lindl. var. salicina).
Plum, Klamath (Prunus subcordata Benth.).......  12-12C
Plum, prune (Prunus domestica L. subsp.          12-12C
 domestica).
Plumcot (Prunus hybr.).........................  12-12C
Sloe (Prunus spinosa L.).......................  12-12C
Cultivars, varieties, and/or hybrids of these..
------------------------------------------------------------------------

     (iii) Crop subgroups. The following Table 2 identifies the crop
subgroups for Crop Group 12-12, specifies the representative
commodities for each subgroup, and lists all the commodities included
in each subgroup.

               Table 2--Crop Group 12-12: Subgroup Listing
------------------------------------------------------------------------
    Representative commodities                   Commodities
------------------------------------------------------------------------
                  Crop subgroup 12-12A. Cherry subgroup
------------------------------------------------------------------------
Cherry, sweet or Cherry, tart.....  Capulin; Cherry, black; Cherry,
                                     Nanking; Cherry, sweet; Cherry,
                                     tart; cultivars, varieties, and/or
                                     hybrids of these.
------------------------------------------------------------------------
                  Crop subgroup 12-12B. Peach subgroup
------------------------------------------------------------------------
Peach.............................  Peach; Nectarine; cultivars,
                                     varieties, and/or hybrids of these.
------------------------------------------------------------------------
                   Crop subgroup 12-12C. Plum subgroup
------------------------------------------------------------------------
Plum or Prune plum................  Apricot; Apricot, Japanese; Jujube,
                                     Chinese; Plum; Plum, American;
                                     Plum, beach; Plum, Canada; Plum,
                                     cherry; Plum, Chickasaw; Plum,
                                     Damson; Plum, Japanese; Plum,
                                     Klamath; Plumcot; Plum, prune;
                                     Sloe; cultivars, varieties, and/or
                                     hybrids of these.
------------------------------------------------------------------------

* * * * *
    (21) Crop Group 14-12. Tree Nut Group.
    (i) Representative commodities. Almond and Pecan.
    (ii) Commodities. The following is a list of all commodities
included in Crop Group 14-12.

                    Crop Group 14-12: Tree Nut Group
------------------------------------------------------------------------

-------------------------------------------------------------------------
African nut-tree (Ricinodendron heudelotii (Baill.) Heckel)
Almond (Prunus dulcis (Mill.) D.A. Webb)
Beechnut (Fagus grandifolia Ehrh.; F. sylvatica L.)
Brazil nut (Bertholletia excelsa Humb. & Bonpl.)
Brazilian pine (Araucaria angustifolia (Bertol.) Kuntze)
Bunya (Araucaria bidwillii Hook.)

Bur oak (Quercus macrocarpa Michx.)
Butternut (Juglans cinerea L.)
Cajou nut (Anacardium giganteum Hance ex Engl.)
Candlenut (Aleurites moluccanus (L.) Willd.)
Cashew (Anacardium occidentale L.)
Chestnut (Castanea crenata Siebold & Zucc.; C. dentata (Marshall)
 Borkh.; C. mollissima Blume; C. sativa Mill.)
Chinquapin (Castaneapumila (L.) Mill.)
Coconut (Cocos nucifera L.)
Coquito nut (Jubaea chilensis (Molina) Baill.)
Dika nut (Irvingia gabonensis (Aubry-Lecomte ex O'Rorke) Baill.)
Ginkgo (Ginkgo biloba L.)
Guiana chestnut (Pachira aquatica Aubl.)
Hazelnut (Filbert) (Corylus americana Marshall; C. avellana L.; C.
 californica (A. DC.) Rose; C. chinensis Franch.)
Heartnut (Juglans ailantifolia Carri[egrave]re var. cordiformis (Makino)
 Rehder)
Hickory nut (Carya cathayensis Sarg.; C. glabra (Mill.) Sweet; C.
 laciniosa (F. Michx.) W. P. C. Barton; C. myristiciformis (F. Michx.)
 Elliott; C. ovata (Mill.) K. Koch; C. tomentosa (Lam.) Nutt.)
Japanese horse-chestnut (Aesculus turbinate Blume)
Macadamia nut (Macadamia integrifolia Maiden & Betche; M. tetraphylla
 L.A.S. Johnson)
Mongongo nut (Schinziophyton rautanenii (Schinz) Radcl.-Sm.)
Monkey-pot (Lecythis pisonis Cambess.)
Monkey puzzle nut (Araucaria araucana (Molina) K. Koch)
Okari nut (Terminalia kaernbachii Warb.)
Pachira nut (Pachira insignis (Sw.) Savigny)
Peach palm nut (Bactris gasipaes Kunth var. gasipaes)
Pecan (Carya illinoinensis (Wangenh.) K. Koch)
Pequi (Caryocar brasiliense Cambess.; C. villosum (Aubl.) Pers; C.
 nuciferum L.)
Pili nut (Canarium ovatum Engl.; C. vulgare Leenh.)
Pine nut (Pinus edulis Engelm.; P. koraiensis Siebold & Zucc.; P.
 sibirica Du Tour; P. pumila (Pall.) Regel; P. gerardiana Wall. ex D.
 Don; P. monophylla Torr. & Fr[eacute]m.; P. quadrifolia Parl. ex Sudw.;
 P. pinea L.)
Pistachio (Pistacia vera L.)
Sapucaia nut (Lecythis zabucaja Aubl.)
Tropical almond (Terminalia catappa L.)
Walnut, black (Juglans nigra L.; J. hindsii Jeps. ex R. E. Sm.; J.
 microcarpa Berland.)
Walnut, English (Juglans regia L.)
Yellowhorn (Xanthoceras sorbifolium Bunge)
Cultivars, varieties, and/or hybrids of these
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* * * * *
[FR Doc. 2012-20667 Filed 8-21-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Rules and Regulations]
[Pages 60870-60872]
[FR Doc No: 2017-27625]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2017-0695, FRL-9972-39-Region 1]

Finding of Failure To Submit a Section 110 State Implementation
Plan for Interstate Transport for the 2012 Annual National Ambient Air
Quality Standards for Fine Particles; Massachusetts

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action finding that Massachusetts failed to submit an infrastructure
State Implementation Plan (SIP) to satisfy certain interstate transport
requirements of the Clean Air Act (CAA) with respect to the 2012 annual
fine particles (PM2.5) national ambient air quality standard
(NAAQS). Specifically, these requirements pertain to significant
contribution to nonattainment, or interference with maintenance, of the
2012 annual PM2.5 NAAQS in other states. This finding of
failure to submit establishes a 2-year deadline for the EPA to
promulgate a Federal Implementation Plan (FIP) to address the
interstate transport SIP requirements pertaining to significant
contribution to nonattainment, interference with maintenance,
interference with Prevention of Significant Deterioration, and
interference with visibility protection, unless, prior to the EPA
promulgating a FIP, the state submits, and the EPA approves, a SIP that
meets these requirements.

DATES: This final rule is effective on January 25, 2018.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R01-OAR-2017-0695. All documents in the dockets are
listed on http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., Confidential Business
Information (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 at http://www.regulations.gov or at the U.S.
Environmental Protection Agency, EPA New England Regional Office,
Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post
Office Square--Suite 100, Boston, MA. The EPA requests that if at all
possible, you contact the individuals listed in the FOR FURTHER
INFORMATION CONTACT section to view the hard copy of the docket. The
Regional Office's official hours of business are Monday through Friday,
8:30 a.m. to 4:30 p.m., excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Alison C. Simcox, Environmental
Scientist, Air Quality Planning Unit, Air Programs Branch (Mail Code
OEP05-02), U.S. Environmental Protection Agency, Region 1, 5 Post
Office Square, Suite 100, Boston, Massachusetts 02109-3912; (617) 918-
1684; [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Notice and Comment Under the Administrative Procedures Act (APA)

    Section 553 of the APA, 5 U.S.C. 553(b)(3)(B), provides that, when
an agency for good cause finds that notice and public procedure are
impracticable, unnecessary or contrary to the public interest, the
agency may issue a rule without providing notice and an opportunity for
public comment. The EPA has determined that there is good cause for
making this rule final without prior proposal and opportunity for
comment because no significant EPA judgment is involved in making a
finding of failure to submit SIPs, or elements of SIPs, required by the
CAA, where states have made no submissions or incomplete submissions,
to meet the requirement. Thus, notice and public procedure are
unnecessary. The EPA finds that this constitutes good cause under 5
U.S.C. 553(b)(3)(B).

B. How is the Preamble Organized?

Table of Contents

I. General Information
II. Background and Overview
    A. Interstate Transport SIPs
    B. Background on the 2012 Annual PM2.5 NAAQS
III. Finding of Failure To Submit for Massachusetts
IV. Environmental Justice Considerations
V. Statutory and Executive Order Reviews

II. Background and Overview

A. Interstate Transport SIPs

    CAA section 110(a) imposes an obligation upon states to submit SIPs
that provide for the implementation, maintenance and enforcement of a
new or revised NAAQS within three years following the promulgation of
that NAAQS. Section 110(a)(2) lists specific requirements that states
must meet in these SIP submissions, as applicable. The EPA refers to
this type of SIP submission as the ``infrastructure'' SIP because it
ensures that states can implement, maintain and enforce the air
standards. Within these requirements, section 110(a)(2)(D)(i) contains
requirements to address interstate transport of NAAQS pollutants. A SIP
revision submitted for this sub-section is referred to as an
``interstate transport SIP.'' In turn, section 110(a)(2)(D)(i)(I)
requires that such a plan contain adequate provisions to prohibit
emissions from the state that will contribute significantly to
nonattainment of the NAAQS in any other state (``prong 1'') or
interfere with maintenance of the NAAQS in any other state (``prong
2''). Section

110(a)(2)(D(i)(II) requires that such a plan contain adequate
provisions to prohibit emissions from the state that will interfere
with measures required of any other state to prevent significant
deterioration of air quality (``prong 3'') or that will interfere with
measures required of any other state to protect visibility (``prong
4''). These are the requirements relevant to this finding.
    Pursuant to CAA section 110(k)(1)(B), the EPA must determine no
later than six months after the date by which a state is required to
submit a SIP whether a state has made a submission that meets the
minimum completeness criteria established per section 110(k)(1)(A). The
EPA refers to the determination that a state has not submitted a SIP
submission that meets the minimum completeness criteria as a ``finding
of failure to submit.'' If the EPA finds a state has failed to submit a
SIP to meet its statutory obligation to address section
110(a)(2)(D)(i), pursuant to section 110(c)(1) the EPA has not only the
authority, but the obligation, to promulgate a FIP within two years to
address the CAA requirement. This finding therefore starts a two-year
clock for promulgation by the EPA of a FIP, in accordance with section
110(c)(1), unless prior to such promulgation the state submits, and the
EPA approves, a submittal to meet the requirements of section
110(a)(2)(D)(i) for the 2012 annual PM2.5 NAAQS. The EPA
will work with the state subject to this finding of failure to submit
and provide assistance as necessary to help the state develop an
approvable submittal in a timely manner. The EPA notes this action does
not start a mandatory sanctions clock pursuant to CAA section 179
because this finding of failure to submit does not pertain to a part D
plan for nonattainment areas required under section 110(a)(2)(I) or a
SIP call pursuant to section 110(k)(5).

B. Background on the 2012 Annual PM2.5 NAAQS

    On December 14, 2012, the EPA promulgated a revised primary annual
PM2.5 NAAQS to provide increased protection of public health
and welfare from fine particle pollution.\1\ In that action, the EPA
revised the primary annual PM2.5 standard, strengthening it
from 15.0 micrograms per cubic meter ([mu]g/m\3\) to 12.0 [mu]g/m\3\,
which is attained when the three-year average of the annual arithmetic
means does not exceed 12.0 [mu]g/m\3\. Infrastructure SIPs addressing
the revised standard were due on December 14, 2015. CAA Sec.
110(a)(1).
---------------------------------------------------------------------------

    \1\ 78 FR 3086; January 15, 2013.
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III. Finding of Failure To Submit for Massachusetts

    To date, Massachusetts has not submitted a good neighbor SIP for
the 2012 annual PM2.5 NAAQS. Accordingly, the EPA is issuing
a finding that Massachusetts has failed to submit a SIP addressing the
requirements of section 110(a)(2)(D)(i) of the CAA, 42 U.S.C.
7410(a)(2)(D)(i) (prongs 1-4), for the 2012 annual PM2.5
NAAQS.

IV. Environmental Justice Considerations

    This notice is making a procedural finding that Massachusetts has
failed to submit a SIP to address CAA section 110(a)(2)(D)(i) for the
2012 annual PM2.5 NAAQS. The EPA did not conduct an
environmental analysis for this rule, because this rule would not
directly affect the air emissions from particular sources. Because this
rule will not directly affect the air emissions from particular
sources, it does not affect the level of protection provided to human
health or the environment. Therefore, this action will not have
potential disproportionately high and adverse human health or
environmental effects on minority, low-income or indigenous
populations.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 regulatory action,
because it is not a significant regulatory action under Executive Order
12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the provisions of the PRA, 44 U.S.C. 3501 et seq. This final rule does
not establish any new information collection requirement apart from
what is already required by law.

D. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA. The RFA applies only to
rules subject to notice and comment rulemaking requirements under the
APA, 5 U.S.C. 553, or any other statute. This rule is not subject to
notice and comment requirements, because the agency has invoked the APA
``good cause'' exemption under 5 U.S.C. 553(b).

E. Unfunded Mandates Reform Act of 1995 (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action implements mandates specifically and
explicitly set forth in the CAA under section 110(a) without the
exercise of any policy discretion by the EPA.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

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

    This action does not have tribal implications as specified in
Executive Order 13175. This rule responds to the requirement in the CAA
for states to submit SIPs under section 110(a) to address CAA section
110(a)(2)(D)(i) for the 2012 annual PM2.5 NAAQS. No tribe is
subject to the requirement to submit an implementation plan under
section 110(a) within 3 years of promulgation of a new or revised
NAAQS. Thus, Executive Order 13175 does not apply to this action.

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

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045, because it does not concern an environmental
health risk or safety risk.

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

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

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

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low-income
or indigenous populations, because it does not affect the level of
protection provided to human health or the environment. The EPA's
evaluation of environmental justice considerations is contained in
section IV of this notice.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

M. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 26, 2018. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Interstate transport,
Particulate matter, Reporting and recordkeeping requirements.

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

    Dated: December 11, 2017.
Deborah A. Szaro,
Acting Regional Administrator, EPA New England.
[FR Doc. 2017-27625 Filed 12-22-17; 8:45 am]
 BILLING CODE 6560-50-P


Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Potassium Salts of Hops Beta acids (K-HBAs)

                Docket ID Number: EPA-HQ-OPP-2014-0374 (NOF),
                              Date: July 15, 2015

Section 408(c)(2)(A)(i) of FFDCA allows the U.S. Environmental Protection Agency (EPA or the Agency) to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if the EPA determines that the exemption is "safe." Section 408(c)(2)(A)(ii) of FFDCA defines "safe" to mean that "there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information." This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, the EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption, and to "ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue...." Additionally, FFDCA section 408(b)(2)(D) requires that the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."
The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, the EPA determines the toxicity of pesticides. Second, the EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.
I.  Summary of Petitioned-for Tolerance Exemption
In the Federal Register of September 05, 2014 (79 FR 53012) (FRL-9914-98), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 3E8217) by Interregional Research Project Number 4, on behalf of BetaTec Hop Products, Inc.  (the Petitioner), 500 College Road East, Suite 201W, Princeton, New Jersey, 08540. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of potassium salts of hops beta acids (K-HBAs) in or on honey and honeycomb. The notice referenced a summary of the petition prepared by the Petitioner, which is available in Docket ID Number EPA-HQ-OPP-2014-0374 via http://www.regulations.gov.
II. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, the EPA reviewed the available scientific data and other relevant information on K-HBAs, and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. The EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
A.  Overview of Potassium Salts of Hops Beta Acids

K-HBAs are derived from the resin components of the cones of female hop plants, Humulus lupulus.  The three major components of hop beta acids (HBA) are lupulone (30-55% with an isopropyl side chain), colupulone (20-55% with an isobutyl side chain); and adlupulone (5-10% with a secbutyl side chain). K-HBAs are classified as a biochemical pesticide because they are naturally occurring, have a non-toxic mode of action against the target pest(s), and are structurally similar, and/or functionally identical to a naturally-occurring active ingredient. K-HBAs are intended to be applied inside bee hives to the brood supers via plastic strips. The strips will be treated with a 16% solution of K-HBAs (two strips per hive; 1.92 g/strip).

There is a long history of safe use of HBA. Humans are exposed to HBA from its use as a preservative on meats (estimated range 4.4 mg/kg of cooked meat - 5.5 mg/kg of frankfurter) (Ref 10,) and the presence of HBAs in the beer brewing process (Ref 14).  HBAs are considered to be Generally Recognized As Safe (GRAS) by FDA (Ref 10). In addition, HBAs have been shown to inhibit inflammations in mice and exhibit anticarcinogenic activity without any known side effects (Ref 2).

EPA granted a Section 18 Emergency Exemption in 2011 for K-HBA in over 20 States to control Varroa mites (Varroa destructor) in honeybee hives. The Section 18 was renewed in 2012 and 2013 in up to 37 States to control Varroa mites (Ref 3).

Based on the data submitted in support of this petition (summarized in Unit II. B., below) and the comprehensive risk assessment conducted by the Agency (References 1-3, below), EPA concludes that there is a reasonable certainty of no harm from aggregate exposures to potassium salts of hops beta acids, including the consumption of food treated with this active ingredient in accordance with label directions and good agricultural practices. EPA has made this determination because available toxicology data indicate that the active ingredient is of low acute toxicity and is not a developmental toxicant, a mutagen, or toxic via repeat oral exposure.

B.  Biochemical Pesticide Toxicology Data Requirements

All applicable mammalian toxicology data requirements supporting the request for an exemption from the requirement of a tolerance for residues of K-HBAs in or on honey and honeycomb have been fulfilled with data submitted by the petitioner. The following is a summary of EPA's review of the toxicity profile of this biochemical:

Acute Toxicity: The applicant did not submit any Guideline studies in support of the Tier I toxicity data requirements for the TGAI/EP. In lieu of Guideline studies, the applicant submitted rationales submitted by data and information from the technical literature.

   1.   In lieu of an acute oral toxicity study, the registrant submitted a rationale supported by toxicity and exposure information obtained from the technical literature in fulfillment of the acute oral toxicity data requirement for the TGAI/EP. A single intragastric (oral gavage) administration of hops beta acids (as lupulon) to mice and rats resulted in LD50s of 1500 mg/kg and 1800 mg/kg, respectively. These data classify HBA in Toxicity Category III for acute oral toxicity (Ref 2).

   2.   In lieu of an acute dermal toxicity study, the applicant submitted a rationale supported by toxicity and exposure information (Ref 2) obtained from the technical literature in fulfillment of the acute dermal toxicity data requirement for the TGAI. Much of the information was not useable in that it did not specifically address the acute dermal toxicity route of exposure. The submitted information (Ref 2 and Ref 8) did not specifically address the acute dermal toxicity route of exposure. In addition, humans were used as the test subjects and the study was not submitted to the Human Studies Review Board (HSRB) for a review of its suitability for use in supporting a pesticide registration.  In the absence of this information, the Biochemical Pesticides Branch (BPB) reviewer notes that acute dermal exposure to Hops Beta Acids is highly unlikely and would only occur to the beekeeper/applicator, as the end use product is for Commercial applicators only.  There are no residential uses and therefore, based on the method of application (manually applied via plastic strips inside beehives), non-occupational exposure to Hops Beta Acids will be minimal. Commercial/Occupational exposure is mitigated by protective clothing normally worn by beekeepers, including gloves, protective suits, and a hat with a face mask or netting. Precautionary statements on the label must require the use of gloves and eye protection for beekeepers/applicators.

   3.   In lieu of an acute inhalation study, the registrant did not generate or submit Guideline studies for either the TGAI or the EP but addressed the data requirement with information from the open literature.  Inhalation exposure to the active ingredient is highly unlikely based on the non-volatile nature of the active ingredient and method of application (manual application of treated plastic strips into beehives.  Inhalation exposure to the active ingredient will be minimal. The applicant also provided the following exposure rationale: "HopGuard (the end-use product containing 16% Hops Beta Acids), is non-volatile, viscous, is not sprayed, and there is no dust associated with the strips so inhalation exposure is highly unlikely."  Based on these data, K-HBAs are classified as Toxicity Category IV for acute inhalation toxicity.

   4.   A guideline primary eye irritation study was conducted using potassium salts of Hops Beta Acids (the TGAI) on rabbits.  The normal pH of the test substance is pH 11 and was adjusted to pH 9 prior to use.  Each of three test rabbits was administered a 0.1 mL of the test substance to the conjunctival sac of the right eye; the left eyes were used as the controls.  Test and control eyes were observed for signs of irritation for 21 days post treatment.  Corneal opacity, iritis, and conjunctivitis were observed a 1-hour post treatment.  By Day 21 post treatment, none of the ocular responses had completely resolved in any of the test eyes. Based on these data, K-HBAs are classified as Corrosive, Toxicity Category I, for primary eye irritation.

   5.  In lieu of a primary dermal irritation study, the applicant submitted the following rationale supported by toxicity and exposure information (Ref 2) obtained from the technical literature in fulfillment of the primary dermal irritation data requirement for the TGAI/EP: "Contact with growing hop plants is known to cause an allergic contact dermatitis and is attributed to the myrcene oil in fresh hop oil. Growing hop plants can also cause a mechanical dermatosis attributed to the rough climbing hairs on the stem and secretions of the yellow glandular hairs on hops.  It is hypothesized that the hop maturing process may turn certain hop proteins into allergens, in rare cases leading to a diagnosis of immunological contact urticaria.  Hops Beta Acids were not implicated in this process (Ref 2). Based on the rationale (Ref 2) submitted above, and the mitigation of exposure with appropriate PPE, it is recommended that Toxicity Category I PPE precautionary language for acute dermal toxicity be placed on the label. More importantly, oils, rough climbing hairs and secretions from the yellow glandular hairs of fresh hops are not present in the final, extracted hops beta acids active ingredient.

   6.  In response to the hypothesis described above, EPA believes that any potential proteins that may hypothetically turn into allergens by the hops plant maturing process would be removed during the hops beta acids extraction process.  Furthermore, hops beta acids do not contain protein and even in the unlikely event that proteins were present in the hops beta acids as a result of the extraction process, the proteins would likely be denatured and therefore would not pose the threat of developing into a potential allergen.

   7.  In lieu of a dermal sensitization study, the applicant submitted a rationale supported by toxicity and exposure information (Ref 2) obtained from the technical literature in fulfillment of the dermal sensitization data requirement for the TGAI/EP but addressed the data requirement with information from the open literature. Much of the information was not useable in that it did not specifically address primary dermal sensitization.  However, the applicant did provide the following exposure rationale: "Contact with growing hop plants is known to cause an allergic contact dermatitis and is attributed to the myrcene oil in fresh hop oil. Growing hop plants can also cause a mechanical dermatosis attributed to the rough climbing hairs on the stem and secretions of the yellow glandular hairs on hops.  It is hypothesized that the hop maturing process may turn certain hop proteins into allergens, in rare cases leading to a diagnosis of immunological contact urticaria.  Hops Beta Acids were not implicated in this process (Ref 2). Based on the rationale (Ref 2) and the mitigation of exposure with appropriate PPE.  It is recommended that Toxicity Category I PPE precautionary language for acute dermal toxicity be placed on the label, based on the results of the Primary Dermal Irritation study. Commercial/Occupational exposure is mitigated by protective clothing normally worn by beekeepers, including gloves, protective suits, and a hat with a face mask or netting.  Precautionary statements on the label must require the use of gloves and eye protection for beekeepers/applicators.  More importantly, oils, rough climbing hairs and secretions from the yellow glandular hairs of fresh hops are not present in the final, extracted hops beta acids active ingredient.  In response to the hypothesis described above, EPA believes that any potential proteins that may hypothetically turn into allergens by the hops plant maturing process would be removed during the hops beta acids extraction process.  Furthermore, hops beta acids do not contain protein and even in the unlikely event that proteins were present in the hops beta acids as a result of the extraction process, the proteins would likely be denatured and therefore would not pose the threat of developing into a potential allergen.

Mutagenicity:  Mutagenicity studies and information were not submitted by the applicant.  However, the Agency does not consider mutagenicity studies or information to be required. HBAs are not structurally-related to known mutagens, nor are they in a chemical class known to contain a known mutagen. Significant exposure (occupational and non-occupational) to female humans is highly unlikely, based on the method of product application (manual insertion of HBA-treated strips into beehives), the requirement for appropriate PPE (gloves and eye protection worn by workers/applicators),
low application rate (two strips per hive; 1.92 g/strip), and appropriate PPE (gloves and eye protection) worn by workers/applicators.  Moreover, residues of HBA have been shown not to exceed 0.44 ppm in honey (observed in only one sample in three field studies between 2010 and 2012). When fed to rats in drinking water at up to 50 ppm daily for 7 months, HBAs have been shown to have potent anticarcinogenic activity against experimentally-induced colon cancers with no observed toxic effects (Ref 13). This subchronic exposure in drinking water (50 ppm) is approximately 114X greater than the residues detected in one sample of honey (0.44 ppm).  Mutagenicity resulting from exposure, if any, to HBAs is considered by the Agency to be highly unlikely.

Subchronic Toxicity: In fulfilling the 90-day oral data requirement, the applicant did not submit Guideline studies for the TGAI. Repeated, subchronic exposure to the active ingredient is highly unlikely based on the method of application (manual application of treated plastic strips into beehives).  Dietary exposure also, is highly unlikely, based on the lack of residues in edible honey (see residue studies above).  In three different studies conducted over three years, only one honey sample from one honey super was shown to have residues of hops beta acids (0.44 ppm), and the residue level was only slightly above the analytical limits of detection (0.41 ppm) and well below the Limit of Quantitation (1.2 ppm).  Additional information provided by the registrant (Ref 2; discussed in paragraphs 1-4 below), supports the rationale that HBAs have minimal subchronic toxicity:

   1. When fed to rats in drinking water at up to 50 ppm daily for 7 months, HBAs have been shown to have potent anticarcinogenic activity against experimentally-induced colon cancers with no observed toxic effects (Ref 13). This subchronic exposure in drinking water (50 ppm) is approximately 114X greater than the residues detected in one sample of honey (0.44 ppm).

   2. Hops beta acids are approved by the USDA/FSIS for use on ready to eat meat products at up to 5.5 mg/kg (Ref 1, Ref 2 and Ref 3) to control pathogens, and has been approved for use on control Listeria moncytogenes on frankfurters at up to 2.5 mg/pound on cooked meat and poultry products (Ref 1, Ref 2. and Ref 3).

   3. In a review of information used to support FDA GRAS status, it was stated that there is a long history of dietary exposure to HBAs [comprised primarily of lupulone (C26H38O4), adlupulone (C25H37O4), and colupulone (C28H38O4)], via beer consumption (FDA, 2001). The same notice provided estimates of dietary intake, via the use of hops beta acids as antimicrobial agents in cooked ready-to-eat meats and on frankfurters, to be up to 0.27 mg per person per day. A review of the literature in support of the FDA GRAS status demonstrated that no estrogenic activity was observed for polarity extracts of hops beta acids (FDA, 2001).

   4. The active ingredient occurs naturally in the lupulin glands of the flowers (cones) of hops (Humulus lupulus and contain up to 10% hops beta acids (Ref 14). Hops are used extensively in the brewing of beer and have been used to inhibit acute localized inflammations in mice at concentrations of up to 0.4 ppm (intravenous injection) with no side effects (Ref 6).

In lieu of a Guideline study, the applicant submitted a rationale supported by toxicity and exposure information obtained from the technical literature (Ref 2) in fulfillment of the 90-day dermal toxicity data requirement for the TGAI/EP: "Contact with growing hop plants is known to cause an allergic contact dermatitis and is attributed to the myrcene oil in fresh hop oil. Growing hop plants can also cause a mechanical dermatosis attributed to the rough climbing hairs on the stem and secretions of the yellow glandular hairs on hops.  It is hypothesized that the hop maturing process may turn certain hop proteins into allergens, in rare cases leading to a diagnosis of immunological contact urticaria.  Hops Beta Acids were not implicated in this process (Ref 2). HBAs is highly unlikely based on the method of application (manually inserted into beehives), low application rate, lack of appreciable residues in honey, and appropriate PPE (gloves and eye protection) worn by beekeepers/applicators.

The applicant did not submit Guideline studies for the 90-day inhalation data requirement for either the TGAI. However, the Agency does not consider 90-day inhalation studies or information to be required.  Repeated, subchronic inhalation exposure to the active ingredient is highly unlikely based on the non-volatile nature of the active ingredient and method of application (manual application of treated plastic strips into beehives. Non-occupational exposure to the active ingredient does not occur.  The applicant also provided the following exposure rationale: "HopGuard (the end-use product containing 16% Hops Beta Acids), is non-volatile, viscous, is not sprayed, and there is no dust associated with the strips so inhalation exposure is highly unlikely."

Developmental Toxicity: The applicant did not submit Guideline studies for the TGAI. Based on 40 CFR part 158.2050, if the use of the product under widespread and commonly recognized practice will not result in significant exposure to female humans or susceptible populations for the following reasons (discussed in detail under mutagenicity): Occupational and non-occupational exposure is expected to be minimal due to the method of application and the lack of appreciable residues in honey. Hops Beta Acids are applied inside the hive to the brood supers, on plastic strips treated with a 16% solution of Hops Beta Acids (two strips per hive; 1.92 g/strip). Residues have been shown not to exceed 0.44 ppm in honey (see residues studies above), well below any known acute (1500 mg/kg; Ref 5) or subchronic (50 ppm in drinking water (; Ref 13) endpoints for Hops Beta Acids.  No additional data are required at this time.  Developmental toxicity resulting from exposure, if any, to Hops Beta Acids is considered by the Agency to be highly unlikely.

III.  Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs the EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Food Exposure: Dietary exposure is highly unlikely based on the lack of residues in edible honey. In three different studies conducted over three years, only one honey sample from one honey super was shown to have residues of HBAs (0.44 ppm), and the residue level was only slightly above the analytical limits of detection (0.41 ppm) and well below the Limit of Quantitation (1.2 ppm). The acute oral toxicity LD50 = 1500 mg/kg (Chin and Anderson, 1950), a level that is approximately 3409X the level found in one sample of honey. According to the National Honey Board (NHB, 2014), annual U.S. per capita honey consumption was approximately 1.3 lbs (approximately 0.6 kg or 600 mg) in 2013. Assuming a 70 kg standard human and the lower acute oral toxicity endpoint (LD50 = 1500 mg/kg), and a honey residue level of 0.44 mg/kg, a human would need to consume [(1500 mg/kg x 70 kg)/0.44 mg/kg) = 2.39 x 10[6] kg] (approximately 5 lbs) of honey in one serving to reach the acute toxicity endpoint of 1500 mg/kg.  The 5 lb level of honey consumption is approximately 3.9X greater than the annual U.S. per capita consumption of honey in 2013. When fed to rats in drinking water at up to 50 ppm daily for 7 months, HBAs have been shown to have potent anticarcinogenic activity against experimentally-induced colon cancers with no observed toxic effects (Lamy et. al., 2007). This subchronic exposure in drinking water (50 ppm) is approximately 114X greater than the residues detected in one sample of honey (0.44 ppm).

HBAs are approved by the USDA/FSIS for use on ready to eat meat products at up to 5.5 mg/kg to control pathogens, and have been approved for use on control Listeria moncytogenes on frankfurters at up to 2.5 mg/pound on cooked meat and poultry products (Ref 2).

There is a long history of oral/dietary exposure of humans to K-HBAs via its use as a preservative on meats and its presence in beer making, without any reported toxic effects.  HBAs are considered to GRAS by Ref 10). HBAs have been shown to inhibit inflammations in mice and exhibit anticarcinogenic activity without any known side effects (Ref 2).

Drinking Water Exposure:  K-HBAs are formulated into a viscous liquid and coated on fiber strips which are placed inside the beehive. The product is not sprayed or applied in any way that it would be expected to contact any source of drinking water. When fed to rats in drinking water at up to 50 ppm daily for 7 months, HBAs have been shown to have potent anticarcinogenic activity against experimentally-induced colon cancers with no observed toxic effects (Ref 2).

Other Non-occupational Exposure: Non-occupational exposure to K-HBAs is not expected because this biochemical is formulated into a viscous liquid and coated on fiber strips which are placed inside the beehive. The product is not sprayed or applied in any way that it would be expected to contact any beekeepers directly or through any type of drift. Exposure to applicators us also limited and mitigated through personal protective equipment when handling bees. There is no anticipated exposure to other agricultural workers because the strip would be on the inside of the hive. However, minimal to no risk is expected for the general population, including infants and children, due to the low toxicity of this chemical.

IV.  Cumulative Effects from Substances with a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."

The EPA has not found K-HBAs to share a common mechanism of toxicity with any other substances, and K-HBAs do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, the EPA has assumed that K-HBAs do not have a common mechanism of toxicity with other substances. Following from this, the EPA concludes that there are no cumulative effects associated with K-HBAs that need to be considered. For information regarding the EPA's efforts to determine chemicals that have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the EPA's website at http://www.epa.gov/pesticides/cumulative.

V.  Determination of Safety for the United States Population, Infants and Children

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, the EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that the EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure, unless the EPA determines that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, the EPA either retains the default value of 10X, or uses a different additional or no safety factor when reliable data are available to support a different additional or no safety factor.

Because there are no threshold effects associated with this biochemical, an additional margin of safety for infants and children is not necessary.

EPA has determined that there are no foreseeable dietary risks to the U.S. population, including infants and children, from the use of K-HBAs as a pesticide (miticide) in or on honey and honeycomb when label instructions and good agricultural practices are followed. The available data and information indicate that the chemical is of minimal toxicity and not a developmental toxicant. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of K-HBAs when it is used as labeled and in accordance with good agricultural practices. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion because the data and information available on K-HBAs do not demonstrate significant toxic potential to mammals, including infants and children.

VI.  Conclusions
EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of K-HBAs. Therefore, an exemption is established for residues of the biochemical pesticide potassium salts of hops beta acids when used in or on honey and honeycomb in accordance with label directions and good agricultural practices.

VII.  References

   1. EPA (2015) Science Review of a Response to Product Chemistry Deficiencies in Support of the Registration of HopGuard TGAI, HopGuard Liquid, and HopGuard. US EPA. U.S. Environmental Protection. May 21, 2015

   2. EPA (2014) Science Review in Support of the Registration of HopGuard TGAI, HopGuard Liquid, and HopGuard, Hops Beta Acids Resin, a New Active Ingredient. Review of Residue Studies, Tier I Toxicity and Tier I Non-Target Organism Studies and Rationales.  US EPA. U.S. Environmental Protection. December 04, 2014.

   3. EPA (2014) Science Review in Support of the Registration of HopGuard TGAI, HopGuard Liquid, and HopGuard, Hops Beta Acids Resin, a New Active Ingredient.  Review of a TGAI, an MP, an EP, and a Tolerance Exemption for the New Active Ingredient. US EPA. U.S. Environmental Protection. September 02, 2014.

   4. Breed, M. D., E. Guzman-Nova, and G. J. hunt.  2004.  Defensive behavior of honey bees:  organization, genetics, and comparisons with other bees.  Annual Review of Entomology 49:  271-296.

   5. Chin, Y-C., and H. H. Anderson.  1950.  Toxicology and pharmacology of lupulon.  Arch. Int. Pharmacodyn. 82(1):  1-15.

   6. Cleemput, M. V., A. Heyerick, C. Libert, K. Swerts, J. Philippe, D. D. Keukeleire, G. Haegeman, and K. D. Bosscher.  2009.  Hop bitter acids efficiently block inflammation independent of GR-alpha, PPAR-alpha, or PPAR-gamma.  Molecular Nutrition and Food Research 53:  1143-1155.

   7. Dong, N. T. K and R. B. Ogle.  2003.  Effect of brewery waste replacement of concentrate on the performance of local and crossbred growing Muscovy ducks.  Asian-Australian Journal of Animal Science 16(10):  1510-1517.

   8. Dumas, E. R., A. E. Mchaud, C. B. Bergeron, J. L. LaFrance, S. Mortillo, and S. Gafner.  2009.  Deodorant effects of a supercritical hops extract:  antibacterial activity against Corynebacterium xerosis and Staphylococcus epidermidis and efficacy testing of a hops/zinc ricinoleate stick in humans through the sensory evaluation of axillary deodorancy.  Journal of Cosmetic Dermatology 8:  197-204.

   9. Estrada, J. L., F. Gorzalo, C. Cecchini, and E. Casqueta.  2002.  Contact urticaria from hops (Humulus lupus) in a patient with previous urticaria-angiodema from peanut, chestnut, and banana.  Contact Dermatitis 48:  127.

   10. FDA, 2001.  Agency response letter GRAS Notice No. GRN 000063.  CFSAN/Office of Premarket Approval. March 15, 2001.

   11. Huszcza, E., A. Bartmanska, M. Aniol, W. Maczka, A. Zolnierczyk, and C. Wawrzenczyk.  2008.  Degradation of hop bitter acid by fungi.  Waste management 28(8):  1406-1410.

   12. Krings, A.  2002.  Keys to the vines of Carolina wetlands.  Vulpia 1:  23-40.

   13. Lamy, V., S. Roussl, M. Chaabi, F. Gosse', N. Schall, A. Lobstein, and F. Raul.  2007.  Carcinogenesis 28:  1575-1581.

   14. Moir, M. M.  2000.  Journal of the American Society of Brewery Chemists 58(4):  131-146.


[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Notices]
[Page 67275-67278]
[DOCID:fr18de09-105]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61144; File No. SR-NYSEAmex-2009-85]

Self-Regulatory Organizations; NYSE Amex, Inc.; Notice of Filing
of Proposed Rule Change To Establish the NYSE Amex Realtime Reference
Prices Service

December 10, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on November 30, 2009, the NYSE Amex, Inc. (``NYSE Amex'' or
``Exchange''), filed with the Securities and Exchange Commission
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to establish the NYSE Amex Realtime Reference
Prices service and to establish a flat monthly fee and a per-query fee
for that service. The service allows a vendor to redistribute on a
real-time basis last sale prices of transactions that take place on the
Exchange (``NYSE Amex Realtime Reference Prices''). The text of the
proposed rule change is available at the Exchange, the Commission's
Public Reference Room, and http://www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
a. The Service
    The NYSE Amex Realtime Reference Prices service will provide a low-
cost service that makes real-time prices widely available to casual
investors, provides vendors with a useful real-time substitute for
delayed prices; and relieves vendors of administrative burdens. The
product responds to the requirements for distribution of real-time last
sale prices over the Internet for reference purposes, rather than as a
basis for making trading decisions.
    The NYSE Amex Realtime Reference Prices service will allow Internet
service providers, traditional market data vendors, and others (``NYSE
Amex-Only Vendors'') to make available NYSE Amex Realtime Reference
Prices on a real-time basis.\4\ The NYSE Amex Realtime Reference Price
information includes last sale prices for all securities that trade on
the Exchange, updated in real-time. In addition, the product also
includes open, high and low prices and cumulative volume. The Exchange
anticipates that it will update these data elements every second,
though initially it will update them once per minute. The product does
not include bid/ask quotations or the size of each trade.
---------------------------------------------------------------------------

    \4\ The Exchange notes that it will make the NYSE Amex Realtime
Reference Prices available to vendors no earlier than it makes those
prices available to the processor under the CTA and Nasdaq/UTP
Plans.
---------------------------------------------------------------------------

    The Exchange will not permit NYSE Amex-Only Vendors to provide NYSE
Amex Realtime Reference Prices in a context in which a trading or
order-routing decision can be implemented unless the NYSE Amex-Only
Vendor also provides consolidated displays of Network A last sale
prices available in an equivalent manner, as Rule 603(c)(1) of
Regulation NMS requires.
    The service would eliminate some of the administrative burdens
associated with the distribution of real-time CTA prices. The service
would feature a flat, fixed monthly vendor fee, no user-based fees, no
vendor reporting requirements, and no professional or non-professional
subscriber agreements.

b. The Fees
    The Exchange proposes to establish a $10,000 monthly flat fee that
entitles an NYSE Amex-Only Vendor to receive access to the NYSE Amex
Realtime Reference Prices datafeed. For that fee, the NYSE Amex-Only
Vendor may provide unlimited NYSE Amex Realtime Reference Prices to an
unlimited number of the NYSE Amex-Only Vendor's subscribers and
customers. The Exchange does not propose to impose any device or end-
user fee for the NYSE Amex-Only Vendors' distribution of NYSE Amex
Realtime Reference Prices.
    In addition, the Exchange proposes to establish as an alternative
to the fixed monthly fee a fee of $.004 for each real-time reference
price that a NYSE Amex-Only Vendor disseminates to its customers. The
Exchange proposes to limit a NYSE Amex-Only Vendor's exposure under
this alternative fee by setting $10,000, the same amount as the
proposed fixed monthly rate, as the maximum fee that an NYSE Amex-Only
Vendor would have to pay for real-time reference prices that it
disseminates in any calendar month pursuant to the per-query fee.
    In order to take advantage of the per-query fee, a NYSE Amex-Only
Vendor must document in its Exhibit A that it has the ability to
measure accurately the number of queries and must have the ability to
report aggregate query quantities on a monthly basis.
    The Exchange will impose the per-query fee only on the
dissemination of real-time reference prices. NYSE Amex-Only Vendors may
provide delayed data services in the same manner as they do today.
    The per-query charge is imposed on NYSE Amex-Only Vendors, not end-
users, and is payable on a monthly basis. NYSE Amex-Only Vendors may
elect to disseminate NYSE Amex Realtime Reference Prices pursuant to
the per-query fee rather than the fixed monthly fee.
c. Justification of Fees
    The proposed flat monthly fee and per-query fee for the NYSE Amex
Realtime Reference Prices service enable Internet service providers and
traditional vendors to contribute to the Exchange's operating costs in
a manner that is appropriate for the distribution of last sale price
information in the form taken by the proposed service.
    In setting the level of the NYSE Amex Realtime Reference Prices
fee, the Exchange took into consideration several factors, including:
    (1) The fees that Nasdaq, NYSE and NYSE Arca are charging for
similar services;
    (2) Consultation with some of the entities that the Exchange
anticipates will be the most likely to take advantage of the proposed
service;
    (3) The contribution of market data revenues that the Exchange
believes is appropriate for entities that are most likely to take
advantage of the proposed service;
    (4) The contribution that revenues accruing from the proposed fee
will make to meet the overall costs of the Exchange's operations;
    (5) The savings in administrative and reporting costs that the NYSE
Amex Realtime Reference Prices service will provide to NYSE Amex-Only
Vendors; and
    (6) The fact that the proposed fees provide alternatives to
existing fees under the CTA and Nasdaq/UTP Plans, alternatives that
vendors will purchase only if they determine that the perceived
benefits outweigh the cost.
    The Exchange believes that the levels of the fixed monthly fee and
the per-query fee are consistent with the approach set forth in the
order by which the Commission approved ArcaBook fees for NYSE Arca.\5\
In the ArcaBook Approval Order, the Commission stated that ``when
possible, reliance on competitive forces is the most appropriate and
effective means to assess whether the terms for the distribution of
non-core data are equitable, fair and reasonable, and not unreasonably
discriminatory.'' \6\ It noted that if significant competitive forces
apply to a proposal, the Commission will approve it unless a
substantial countervailing basis exists.
---------------------------------------------------------------------------

    \5\ See Release [sic] No. 59039 (December 2, 2008), 73 FR 74770
(December 9, 2008) (SR-NYSEArca-2006-21) (the ``ArcaBook Approval
Order'').
    \6\ Id. at 74771.
---------------------------------------------------------------------------

    NYSE Amex Realtime Reference Prices constitute ``non-core data.''
The Exchange does not require a central processor to consolidate and
distribute the product to the public pursuant to joint-SRO plans.
Rather, the Exchange distributes the product voluntarily.
    In the case of NYSE Amex Realtime Reference Prices, both of the two
types of competitive forces that the Commission described in the
ArcaBook Approval Order are present: The Exchange has a compelling need
to attract order flow and the product competes with a number of
alternative products.
    The Exchange must compete vigorously for order flow to maintain its
share of trading volume. This requires the Exchange to act reasonably
in setting market data fees for non-core products such as NYSE Amex
Realtime Reference Prices. The Exchange hopes that NYSE Amex Realtime
Reference Prices will enable vendors to distribute NYSE Amex last sale
price data widely among investors, and thereby provide a means for
promoting the Exchange's visibility in the marketplace.
    In addition to the need to attract order flow, the availability of
alternatives to NYSE Amex Realtime Reference Prices significantly
constrain the prices at which the Exchange can market NYSE Amex
Realtime Reference Prices. All national securities exchanges, the
several Trade Reporting Facilities of FINRA, and ECNs that produce
proprietary data, as well as the core data feed, are all sources of
competition for NYSE Amex Realtime Reference Prices. Currently, the New
York Stock Exchange, NYSE Arca and the Nasdaq Stock Market offer
similar services.
    The information available in NYSE Amex Realtime Reference is
included in the CTA core data feed, which also includes the size of
trades, as well as last sale information from other markets. Even
though NYSE Amex Realtime Reference Prices omits size and provides
prices that are not consolidated with those of other markets, investors
may select it as a less expensive alternative to the CTA Plan's
consolidated last sale price services for certain purposes. (Rule
603(c) of Regulation NMS requires vendors to make the core data feeds
available to customers when trading and order-routing decisions can be
implemented.)
d. Administrative Requirements
    The Exchange proposes to require the NYSE Amex-Only Vendor to
identify the NYSE Amex trade price by placing the text ``NYSE Amex
Data'' in close proximity to the display of each NYSE Amex Realtime
Reference Price or series of NYSE Amex Realtime Reference Prices, or by
complying with such other identification requirement as to which NYSE
Amex may agree.
    The NYSE Amex-Only Vendor may make NYSE Amex Realtime Reference
Prices available without having to differentiate between professional
subscribers and nonprofessional subscribers, without having to account
for the extent of access to the data, and without having to report the
number of users.
e. Contracts
    NYSE Amex proposes to allow NYSE Amex-Only Vendors to provide NYSE
Amex Realtime Reference Prices without requiring the end-users to enter

into contracts for the benefit of the Exchange.
    Instead, the Exchange proposes to require NYSE Amex-Only Vendors to
provide a readily visible hyperlink that will send the end-user to a
warning notice about the end-user's receipt and use of market data. The
notice would be similar to the notice that vendors provide today when
providing CTA delayed data services.
    The Exchange will require NYSE Amex-Only Vendors to enter into the
form of ``vendor'' agreement into which the CTA and CQ Plans require
recipients of the Network A datafeeds to enter (the ``Network A Vendor
Form''). The Network A Vendor Form will authorize the NYSE Amex-Only
Vendor to provide the NYSE Amex Realtime Reference Prices service to
its subscribers and customers.
    The Network A Participants drafted the Network A Vendor Form as a
one-size-fits-all form to capture most categories of market data
dissemination. It is sufficiently generic to accommodate NYSE Amex
Realtime Reference Prices. The Commission has approved the Network A
Vendor Form.\7\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release Nos. 28407 (September 6,
1990), 55 FR 37276 (September 10, 1990) (File No. 4-281); 49185
(February 4, 2004), 69 FR 6704 (February 11, 2004) (SR-CTA/CQ-2003-
01).
---------------------------------------------------------------------------

    The Exchange will supplement the Network A Vendor Form with an
Exhibit C that will provide above-described terms and conditions that
are unique to the NYSE Amex Realtime Reference Prices service. The
proposed Exhibit C is attached to the proposed rule change as Exhibit
5. The supplemental Exhibit C terms and conditions would govern:
     The restriction against providing the service in the
context of a trading or order routing service;
     The replacement of end-user agreements with a hyperlink to
a notice;
     The substance of the notice; and
     The ``NYSE Amex Data'' labeling requirement.
2. Statutory Basis
    The bases under the Securities Exchange Act of 1934 (the ``Act'')
for the proposed rule change are the requirement under Section 6(b)(4)
\8\ that an exchange have rules that provide for the equitable
allocation of reasonable dues, fees and other charges among its members
and other persons using its facilities and the requirements under
Section 6(b)(5) \9\ that the rules of an exchange be designed to
promote just and equitable principles of trade and not to permit unfair
discrimination between customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b)(4).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposed rule change would benefit investors by facilitating
their prompt access to widespread, free, real-time pricing information
contained in the NYSE Amex Realtime Reference Prices service. In
addition, the Exchange believes that the proposed fee would allow
entities that provide market data to large numbers of investors, which
are the entities most likely to take advantage of the proposed service,
to make an appropriate contribution towards meeting the overall costs
of the Exchange's operations.
    The Exchange notes that its proposed fee compares favorably with
the fees that Nasdaq, NYSE and NYSE Arca are charging for similar
services. Because the proposed fee is substantially lower than those of
Nasdaq, NYSE and NYSE Arca, it offers any vendor that wishes to provide
its customers with a single market's data (as opposed to a more
expensive consolidated data service) a less expensive alternative to
Nasdaq, NYSE and NYSE Arca.

B. Self-Regulatory Organization's Statement on Burden on Competition

    NYSE Amex Realtime Reference Prices proposes to provide an
alternative to existing fees and does not alter or rescind any existing
fees. In addition, it amounts to a competitive response to the products
that Nasdaq, NYSE and NYSE Arca have commenced to make available. For
those reasons, the Exchange does not believe that the proposed rule
change will result in any burden on competition that is not necessary
or appropriate in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has discussed the proposed rules change with those
entities that the Exchange believes would be the most likely to take
advantage of the proposed NYSE Amex Realtime Reference Prices service
by becoming NYSE Amex-Only Vendors. While those entities have not
submitted formal, written comments on the proposal, the Exchange has
incorporated some of their ideas into the proposal and the proposed
rule change reflects their input. The Exchange has not received any
unsolicited written comments from members or other interested parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-NYSEAmex-2009-85 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEAmex-2009-85. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for

inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEAmex-2009-85 and should
be submitted on or before January 8, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-30079 Filed 12-17-09; 8:45 am]

BILLING CODE 8011-01-P