[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46265-46267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18185]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0917; FRL-9391-2]


Complex Polymeric Polyhydroxy Acids; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Complex Polymeric Polyhydroxy Acids in 
or on all food commodities. This regulation eliminates the need to 
establish a maximum permissible level for residues of Complex Polymeric 
Polyhydroxy Acids (CPPA) under FFDCA.

DATES: This regulation is effective July 31, 2013. Objections and 
requests for hearings must be received on or before September 30, 2013, 
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-2009-0917, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West 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 is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Menyon Adams, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8496; email 
address: adams.menyon@epa.gov.

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 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2009-0917 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 
September 30, 2013. 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-2009-0917, by one of 
the methods provided in 40 CFR 150.17(b).

II. Background and Statutory Findings

    In the Federal Register of January 13, 2010 (75 FR 1775) (FRL-8805-
6), 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 
9F7645) by James R. Yowell of Spring Trading Company (the Petitioner), 
on behalf of Floratine Biosciences Inc., 153 N. Main St., Suite 100, 
Collierville, TN 38017. The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of Complex Polymeric Polyhydroxy Acids. That 
document referenced a summary of the petition prepared by the 
Petitioner, which is available in the docket, http://www.regulations.gov. No comments were received.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA 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 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, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a

[[Page 46266]]

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. . . . '' Additionally, FFDCA section 
408(b)(2)(D) requires that the Agency consider ``available information 
concerning the cumulative effects of a particular pesticide's 
residues'' and ``other substances that have a common mechanism of 
toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, 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.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its risk. EPA has also considered available 
information concerning the variability of the sensitivities of major 
identifiable subgroups of consumers, including infants and children.

A. Overview of Complex Polymeric Polyhydroxy Acids

    Complex Polymeric Polyhydroxy Acids (CPPA) is a complex mixture of 
naturally occurring organic substances found in dead plant materials. 
The components of CPPA are widespread in nature, being found in soils 
and fresh and salt water environments as a result of decaying plant 
materials, and are used to condition agricultural soils.
    Its major components are humic acid, fulvic acid, and tannins, and 
their relative concentrations in soil and water systems are influenced 
by environmental conditions, such as climate, soil types, vegetation, 
and hydrology. CPPA is made by concentrating the organic substances 
from water leached through forest soil using a proprietary 
manufacturing process.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting 
the petition to exempt residues of CPPA from the requirement of a 
tolerance in or on all food commodities have been fulfilled. No acute, 
subchronic, or chronic toxicity endpoints were identified in guideline 
studies or in data obtained from open technical literature. Moreover, 
CPPA is not a mutagen, and is not a developmental toxicant. There are 
no known effects on endocrine systems via oral, dermal, or inhalation 
exposure. For a more in-depth synopses of the data upon which EPA 
relied and its human health risk assessment based on that data can be 
found on pages 8 through 11 and in Appendix A of the draft document 
entitled, ``Biopesticides Registration Action Document, Complex 
Polymeric Polyhydroxy Acids (CPPA),'' available in the docket for this 
action as described under ADDRESSES.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs 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).

A. Dietary Exposure

    The proposed use pattern may result in dietary exposure with 
possible residues in or on agricultural commodities. No significant 
exposure via drinking water is expected beyond what is already present, 
when CPPA is used according to the product label directions because the 
active ingredient biodegrades rapidly (half-life = 25.7 days) in the 
environment, is applied at low application rates, and is not directly 
applied to water.
    Should exposure occur, however, minimal to no risk is expected for 
the general population, including infants and children, due to low 
toxicity of CPPA and its components as demonstrated in the data 
submitted and evaluated by the Agency. In addition, the lack of 
reported incidents in spite of the exposure from use in commercial 
agriculture for years to condition soils and its abundance in nature 
support a conclusion that minimal to no risk is expected.

B. Other Non-Occupational Exposure

    Non-occupational exposure is not expected because CPPA will be 
applied as a commercial plant growth regulator for agricultural 
purposes only.

V. 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 Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA has determined CPPA to have a non-toxic mode of action; 
therefore, 408(b)(2)(D)(v) does not apply.

VI. Determination of Safety for U.S. 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, 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 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 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, EPA either retains the default value of 10X, or uses a 
different additional safety factor when reliable data are available to 
support the choice of a different safety factor.
    As part of its qualitative assessment, EPA evaluated the available 
toxicity and exposure data on CPPA and considered its validity, 
completeness, and reliability, as well as the relationship of this 
information to human risk. EPA considers the toxicity database to be 
complete and has identified no residual uncertainty with regard to 
prenatal and postnatal toxicity or exposure. No hazard was identified 
based on the available studies. Based upon its evaluation, EPA 
concludes that there are no threshold effects of concern to infants, 
children, or adults when CPPA is applied as a plant growth regulator 
and used in accordance with label directions and good agricultural 
practices. As a result, EPA concludes that no additional margin of 
exposure (safety) is necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for 
the reasons stated in Unit VI. and because EPA is establishing an 
exemption from the requirement of a tolerance without any numerical 
limitations.

[[Page 46267]]

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). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established an MRL for CPPA.

VIII. Conclusion

    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 CPPA. Therefore, EPA is 
establishing an exemption from the requirement of a tolerance for 
residues of CPPA in or on all food commodities when applied as a plant 
growth regulator and used in accordance with good agricultural 
practices.

IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance 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 final rule has been exempted from review 
under Executive Order 12866, this final rule 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 final rule 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 exemption from 
the requirement of a tolerance 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

X. 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: July 9, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.

    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. Add Sec.  180.1321to subpart D to read as follows:


Sec.  180.1321  Complex Polymeric Polyhydroxy Acids; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of complex polymeric polyhydroxy acids in or on all food 
commodities when applied as a plant growth regulator and used in 
accordance with good agricultural practices.

[FR Doc. 2013-18185 Filed 7-30-13; 8:45 am]
BILLING CODE 6560-50-P