[Federal Register Volume 89, Number 92 (Friday, May 10, 2024)]
[Rules and Regulations]
[Pages 40396-40399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10187]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0887; FRL-11734-01-OCSPP]


Cyflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyflumetofen in or on the following raw agricultural commodities: 
berry, low growing, subgroup 13-07G; fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F; and vegetable, cucurbit, group 
9. The Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 10, 2024. Objections and 
requests for hearings must be received on or before July 9, 2024, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2022-0887, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. 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 and the OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide 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 applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov//.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2022-0887 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
July 9, 2024. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2022-0887, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/.

[[Page 40397]]

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 23, 2023 (88 FR 11401) (FRL-
10579-01-OCSPP), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide 
petition (PP 2E9030) by the Interregional Research Project No. 4 (IR-
4), North Carolina State University, 1730 Varsity Drive, Venture IV, 
Suite 210, Raleigh, NC 27606. The petition requests to amend 40 CFR 
180.677 by establishing tolerances for residues of cyflumetofen (2-
methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-dimethylethyl)phenyl]-
[beta]-oxo-2-(trifluoromethyl)benzenepropanoate), including its 
metabolites and degradates, in or on the following raw agricultural 
commodities: berry, low growing, subgroup 13-07G at 0.6 parts per 
million (ppm); fruit, small, vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 0.6 ppm; and vegetable, cucurbit, group 9 at 2 ppm. 
Upon the establishment of these tolerances, IR-4 requested that EPA 
remove the existing tolerances in 40 CFR 180.677 for residues of 
cyflumetofen (2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-
dimethylethyl)phenyl]-[beta]-oxo-2-(trifluoromethyl)benzenepropanoate) 
in or on cucumber at 0.3 ppm; grape at 0.60 ppm; and strawberry at 0.6 
ppm. That document referenced a summary of the petition prepared by IR-
4, which is available in the docket at https://www.regulations.gov. One 
comment was received in response to the notice of filing. EPA's 
response to the comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
is establishing one tolerance at a different level than petitioned-for. 
The reason for this change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(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. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance 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. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified therein, EPA has reviewed the available scientific data and 
other relevant information in support of this action. EPA has 
sufficient data to assess the hazards of and to make a determination on 
aggregate exposure for cyflumetofen including exposure resulting from 
the tolerances established by this action. EPA's assessment of 
exposures and risks associated with cyflumetofen follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemakings for the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemakings, and EPA considers referral back to those 
sections as sufficient to provide an explanation of the information EPA 
considered in making its safety determination for the new rulemaking.
    EPA has previously published tolerance rulemakings for cyflumetofen 
in which EPA concluded, based on the available information, that there 
is a reasonable certainty that no harm would result from aggregate 
exposure to cyflumetofen and established tolerances for residues of 
that chemical. EPA is incorporating previously published sections from 
these rulemakings as described further in this rulemaking, as they 
remain unchanged.
    Toxicological profile. For a discussion of the Toxicological 
Profile of cyflumetofen, see Unit III.A. of the final rule published in 
the Federal Register of May 8, 2019 (84 FR 20037) (FRL-9990-60).
    Toxicological points of departure/Levels of concern. A summary of 
the toxicological endpoints for cyflumetofen used for human health risk 
assessment is discussed in Unit III.B. of the May 8, 2019, rulemaking.
    Exposure assessment. EPA's dietary exposure assessments have been 
updated to include the additional exposures from the petitioned-for 
tolerances. No acute dietary exposure and risk analyses were performed 
since there were no appropriate toxicological effects attributable to a 
single dose observed in available toxicity studies for either the 
general population or for females 13 to 49 years of age. The chronic 
dietary (food and drinking water) exposure and risk assessment for 
cyflumetofen was conducted using the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID) Version 
4.02. This software uses 2005-2010 food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey/What We Eat in America, (NHANES/WWEIA). An unrefined 
chronic dietary (food and drinking water) analysis was conducted using 
tolerance-level residues, default processing factors, empirical 
processing factors, and 100% crop treated assumptions.
    Drinking water exposure. EPA has revised the cyflumetofen drinking 
water assessment (DWA) since the May 8, 2019, final rule and the final 
rule published in the Federal Register of December 6, 2021 (86 FR 
68915) (FRL-9234-01-OCSPP). The DWA provides updated estimated drinking 
water concentrations (EDWCs) for cyflumetofen residues of concern in 
surface water and groundwater. The use patterns for current and 
proposed uses were modeled using new pesticide in water calculator 
scenarios. The updated EDWCs for use in human health risk assessment 
are 0.59 [mu]g/L for acute exposures, 0.11 [mu]g/L for non-cancer 
chronic exposures and 0.10 [mu]g/L for cancer exposures generated from 
exposure in surface water.
    Non-occupational exposure. There are no new proposed residential 
(non-occupational) uses for cyflumetofen at this time; however, there 
are registered uses of cyflumetofen on commercial vegetable gardens and 
ornamental plants. EPA's residential exposure assessment has changed 
since the May 8, 2019, final rule based on a revised practice. Because 
all current cyflumetofen labels require handlers to wear personal 
protective equipment, EPA assumes that cyflumetofen is applied by 
professional applicators, not residential (homeowner) applicators. 
Therefore, the current assessment does not consider exposure to 
residential handlers or exposure from direct homeowner applications to 
ornamentals or home gardens.
    There are registered uses of cyflumetofen to commercially treat 
garden vegetables that could be subsequently purchased at a retail 
location for transplant into a residential setting and treated 
ornamental plants that can be purchased by consumers. EPA considers 
post-application exposure resulting from this scenario to be negligible 
because residues are

[[Page 40398]]

expected to decline significantly during the time from application in a 
commercial setting to consumer purchase at a retail location. Also, 
there is no dermal hazard for cyflumetofen since no systemic effects 
were observed in the dermal study up to the limit dose. Therefore, a 
quantitative residential post-application dermal risk assessment is not 
required.
    Cumulative exposures. Unlike other pesticides for which EPA has 
followed a cumulative risk approach based on a common mechanism of 
toxicity, EPA has not made a common mechanism of toxicity finding as to 
cyflumetofen and any other substances and cyflumetofen does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this action, therefore, EPA has not assumed that 
cyflumetofen has a common mechanism of toxicity with other substances.
    Safety factor for infants and children. EPA continues to conclude 
that there are reliable data to support the reduction of the Food 
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit 
III.D. of the May 8, 2019, rulemaking for a discussion of the Agency's 
rationale for that determination.
    Aggregate risk and Determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
dietary exposure estimates to the acute population adjusted dose (aPAD) 
and chronic population adjusted dose (cPAD). Short-, intermediate-, and 
chronic-term risks are evaluated by comparing the estimated total food, 
water, and residential exposure to the appropriate points of departure 
(PODs) to ensure that an adequate margin of exposure (MOE) exists.
    An acute dietary risk assessment was not conducted as toxicological 
effects attributable to a single dose were not identified. Therefore, 
cyflumetofen is not expected to pose an acute risk. Chronic dietary 
risks are below the Agency's level of concern of 100% of the cPAD; the 
chronic dietary exposure estimate for all infants, the most highly 
exposed population subgroup, is 7.6% of the cPAD. Because EPA has 
determined that there are no residential exposures, the chronic dietary 
risk is the same as the overall chronic aggregate risk for cyflumetofen 
and is not of concern.
    As stated in Unit III.A. of the May 8, 2019, final rule, EPA 
concluded that the nonlinear approach for assessing potential cancer 
risk is appropriate. The chronic risk resulting from aggregate exposure 
to cyflumetofen is below the Agency's level of concern; therefore, the 
Agency concludes that there is not a cancer risk of concern from 
exposure to cyflumetofen.
    Therefore, based on the risk assessments and information described 
above, EPA concludes that there is a reasonable certainty that no harm 
will result to the general population, or to infants and children, from 
aggregate exposure to cyflumetofen residues. More detailed information 
on this action can be found in the document titled ``Cyflumetofen. 
Human Health Risk Assessment for the Proposed New Use on Vegetable, 
Cucurbit, Group 9, Label Amendment for Vegetable, Fruiting, Group 8-10, 
and Crop Group Expansion of Berry, Low Subgroup 13-07G and Fruit, 
Small, Vine Climbing, Except Fuzzy Kiwifruit, subgroup 13-07F.'' in 
docket ID number EPA-HQ-OPP-2022-0887.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the final rule published in the Federal Register of 
July 1, 2020 (85 FR 39491) (FRL-10009-25).

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4).
    Codex has not established an MRL for residues of cyflumetofen in or 
on cucurbit vegetable group 9, bell pepper or non-bell pepper. Codex 
has established MRLs for residues of cyflumetofen in or on strawberry 
at 0.6 ppm and in or on grape, table and grape, wine at 0.6 ppm. The 
U.S. tolerances for berry, low growing, subgroup 13-07G and fruit, 
small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F are being 
established at 0.6 ppm and are harmonized with the relevant Codex MRLs.

C. Response to Comments

    One comment was received on the notice of filing. The comment is an 
inquiry from the People's Republic of China, requesting that EPA 
explain the reasons for removing the existing tolerances for 
strawberries and grapes and establishing new crop group tolerances for 
berry, low growing, subgroup 13-07G and fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F, thus expanding tolerance 
coverage for these crops. The commenter also requested that the Agency 
provide the test data used for risk assessment of the relevant fruits.
    Under FFDCA section 408, EPA is authorized to establish tolerances 
for pesticide chemical residues in food. EPA establishes tolerances for 
each pesticide based on data on the pesticide residues and assesses 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 commodities 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. Strawberry is a 
representative crop for the crop subgroup 13-07G, and grape is a 
representative crop for the crop subgroup 13-07F.
    The data supporting the strawberry and grape tolerances were 
submitted to the Agency and were reviewed and reported in the document 
titled ``Cyflumetofen. Petition for the Establishment of Permanent 
Tolerances and Registration for Use on Citrus (Crop Group 10-10), Pome 
Fruits (Crop Group 11-10), Tree Nuts (Crop Group 14-12), Grape, 
Strawberry, and Tomato. Summary of Analytical Chemistry and Residue 
Data.'', D408531, D. Wilbur, 09-July-2013. In the current action, EPA 
is expanding the grape tolerance to fruit, small, vine climbing, except 
fuzzy kiwifruit, subgroup 13-07F and expanding the strawberry tolerance 
to berry, low growing, subgroup 13-07G as stated in the document 
``Cyflumetofen. Proposed Section 3 Registration for the New Use on 
Vegetable Cucurbit, Group 9, Label Amendment for Vegetable, Fruiting, 
Group 8-10, and Crop Group Expansion of Berry, Low Subgroup 13-07G and 
Fruit, Small, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F. 
Summary of Analytical Chemistry and Residue Data'' and the document 
``Cyflumetofen. Human Health Risk Assessment for the Proposed New Use 
on Vegetable, Cucurbit, Group 9, Label Amendment for Vegetable, 
Fruiting, Group 8-10, and Crop Group Expansion of Berry, Low Subgroup 
13-07G and Fruit, Small, Vine Climbing, Except Fuzzy Kiwifruit, 
subgroup 13-07F.'' All three documents can be found in docket ID number 
EPA-HQ-OPP-2022-0887.

D. Revisions to Petitioned-For Tolerances

    EPA reviewed the available residue data and is establishing the 
tolerance for

[[Page 40399]]

resides of cyflumetofen in or on vegetable, cucurbit, group 9 at 0.3 
ppm rather than at 2 ppm as IR-4 requested. IR-4 calculated the 
tolerance of 2 ppm by including the metabolite B-1 in the residue 
levels. However, the only residues included in the tolerance expression 
are for the parent compound, cyflumetofen. Using the residues for 
cyflumetofen but not metabolite B-1, EPA calculated the tolerance for 
resides of cyflumetofen in or on vegetable, cucurbit, group 9 to be 
0.06 ppm, which is covered by the established tolerance of 0.3 ppm in 
or on cucumber. Therefore, EPA is establishing the tolerance for 
residues of cyflumetofen in or on vegetable, cucurbit, group 9 at 0.3 
ppm.

V. Conclusion

    Therefore, tolerances are established for residues of cyflumetofen: 
(2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-dimethylethyl)phenyl]-
[beta]-oxo-2-(trifluoromethyl)benzenepropanoate), including its 
metabolites and degradates, in or on berry, low growing, subgroup 13-
07G at 0.6 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 0.6 ppm; and vegetable, cucurbit, group 9 at 0.3 
ppm. EPA is removing the established tolerances for strawberry at 0.6 
ppm; grape at 0.60 ppm; and cucumber at 0.3 ppm as unnecessary upon the 
establishment of the new tolerances.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the National Government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999), and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency 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).

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 action 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, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 6, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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. In Sec.  180.677, amend table 1 to paragraph (a) by:
0
a. Adding in alphabetical order an entry for ``Berry, low growing, 
subgroup 13-07G'';
0
b. Removing the entry for ``Cucumber'';
0
c. Adding in alphabetical order an entry for ``Fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F'';
0
d. Removing the entries for ``Grape'' and ``Strawberry''; and
0
e. Adding in alphabetical order an entry for ``Vegetable, cucurbit, 
group 9''.
    The additions read as follows:


Sec.  180.677  Cyflumetofen; tolerance for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Berry, low growing, subgroup 13-07G.........................         0.6
 
                                * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit,                 0.6
 subgroup 13-07F............................................
 
                                * * * * *
Vegetable, cucurbit, group 9................................         0.3
------------------------------------------------------------------------

* * * * *
[FR Doc. 2024-10187 Filed 5-9-24; 8:45 am]
BILLING CODE 6560-50-P