Document ID: EPA-HQ-OPP-2008-0763-0003
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of Tolerance: Coat Protein of Plum Pox Virus
Posted Date: 2010-05-26T04:00Z

[Federal Register: May 26, 2010 (Volume 75, Number 101)]
[Rules and Regulations]               
[Page 29431-29435]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my10-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2008-0763; FRL-8826-9]

 
Coat Protein of Plum Pox Virus; 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 the coat protein of plum pox virus in or 
on stone fruit and almond when expressed in these food commodities by 
the plant-incorporated protectant, coat protein gene of plum pox virus. 
Interregional Research Project Number 4 of Rutgers University (on 
behalf of the United States Department of Agriculture-Agricultural 
Research Service-Appalachian Fruit Research Station) submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of the coat protein of plum pox virus under the FFDCA.

DATES: This regulation is effective May 26, 2010. Objections and 
requests for hearings must be received on or before July 26, 2010, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0763. All documents in the 
docket are listed in the docket index available at 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, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8263; e-mail address: greenway.denise@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR 
part 174 through the Government Printing Office's e-CFR site at http://
www.gpoaccess.gov/ecfr. To access the harmonized test guidelines 
referenced in this document electronically, please go to http://
www.epa.gov/oppts 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(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-2008-0763 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 26, 2010. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2008-0763, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

     In the Federal Register of November 14, 2008 (73 FR 67512) (FRL-
8388-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a

[[Page 29432]]

pesticide tolerance petition (PP 7E7231) by Interregional Research 
Project Number 4 (IR-4), Rutgers University, 500 College Rd. East, 
Suite 201 W., Princeton, NJ 08540 (on behalf of the United States 
Department of Agriculture-Agricultural Research Service-Appalachian 
Fruit Research Station (USDA-ARS-AFRS), 2217 Wiltshire Rd., 
Kearneysville, WV 25430). The petition requested that 40 CFR part 174 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of the coat protein of plum pox virus. This 
notice referenced a summary of the petition prepared by the petitioner, 
IR-4 (on behalf of USDA-ARS-AFRS), which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    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 section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which require 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.... 
'' Additionally, section 408(b)(2)(D) of FFDCA 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 section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness, and reliability 
and the relationship of this information to human 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

    The coat protein of plum pox virus is produced by a plant-infecting 
Potyvirus in Prunus species, which include plum (cultivated and native 
or wild species), peaches, almonds, nectarines, and cherries. Such 
stone fruits are a natural source and sink for plum pox virus. When the 
gene that is responsible for producing the coat protein in infected 
plants is genetically engineered into uninfected plum trees, the plants 
become resistant to the devastating disease this virus causes, which is 
known as ``Plum Pox.'' The C5 HoneySweet Plum (C5 plum) tree has been 
genetically engineered to contain the gene responsible for the coat 
protein. Ribonucleic acid (RNA) fragments derived from the virus coat 
protein gene cause the plant's natural protection mechanism, post-
transcriptional gene silencing (PTGS), to be primed to resist virus 
infection, should it occur. Although non-engineered plants initiate 
PTGS upon infection with the virus, the serious damage caused by the 
virus (such as fruit degradation and leaf chlorosis) is not prevented.
    The exemption from the requirement of a tolerance for residues of 
nucleic acids that are part of a plant-incorporated protectant 
established under 40 CFR 174.507 covers the coat protein gene 
(sometimes called the ``transgene'') of plum pox virus. The reason for 
establishing an exemption from the requirement of a tolerance for 
residues of the coat protein of plum pox virus (as opposed to the coat 
protein gene) is that insertion of the gene into the C5 plum includes 
an open reading frame, and so the production of this protein, and thus 
residues of the protein in or on food, is theoretically possible. In 
the unlikely event that any protein is produced, dietary exposure could 
result. However, no virus coat protein has been detected in the C5 plum 
during years of extensive field trials, which is likely attributed to 
the early initiation of the PTGS protective mechanism in the C5 plum 
plants (Ref. 1). That is, while the coat protein of plum pox virus is 
produced in non-transgenic Prunus species infected with plum pox virus, 
it has not been observed (but is theoretically possible) in the 
transgenic plums.

B. Mammalian Toxicity and Allergenicity Assessment

    To determine whether the coat protein of plum pox virus could 
potentially cause toxicity or allergenicity, the petitioner submitted 
results of an amino acid sequence similarity study. This study used two 
methods to compare the deduced amino acid sequence of the plum pox 
virus coat protein (as it could potentially be produced in the C5 plum) 
with sequence databases of known food allergens, toxins, and 
antinutrients. In the first analysis for overall similarity to toxins, 
allergens and anti-nutrients, none of the sequence analyses produced 
alignments greater than 35% identity over a window of 80 amino acids. 
In the second analysis specifically for allergen epitopes (regions of 
potential binding for triggering allergic reactions), there were no 
matching regions of eight amino acids, which is considered the 
threshold needed to indicate a potential hazard. These studies follow 
the guidance of the Codex Alimentarius for the safety assessment of 
foods derived from biotechnology (Ref. 2). Therefore, these data 
demonstrated that no food allergenicity, toxicity, or antinutrient 
effects would be expected from dietary exposure to the transgene, the 
overlapping plum DNA, or the protein (if it were produced) in the C5 
plum.

C. In vitro Digestibility

    Based upon the results of the submitted amino acid sequence 
similarity studies discussed in Unit III.B., the fact that plum pox 
virus coat protein has been in the human diet without adverse effects, 
and the reasonable expectation that no plum pox coat protein will be 
expressed in the C5 plum, the Agency granted the petitioner's waiver 
request for an in vitro digestibility study.

D. Hypersensitivity

    The petitioner reported that since research began with the C5 plum 
in 1992, approximately 80 trees have been tested. Neither Agricultural 
Research Service (ARS) production staff, numbering approximately 20 
people in the United States (West Virginia), nor personnel performing 
testing in Spain, Poland, Romania, the Czech Republic, and Chile, have, 
to the knowledge of EPA, experienced hypersensitivity or other adverse 
effects. Therefore, no

[[Page 29433]]

hypersensitivity effects are expected from exposure to the coat protein 
of plum pox virus (if it were produced) in the C5 plum. The Agency 
expects to be notified if such a hypersensitivity incident were to 
occur.

E. Additional Information

    The petitioner submitted scientifically based rationales, described 
in Unit. III.E., to justify the requested waivers of the following 
microbial pesticide toxicology data requirements: Tier I - acute oral 
toxicity/pathogenicity (Harmonized Test Guideline 885.3050), acute 
dermal toxicity/pathogenicity (Harmonized Test Guideline 885.3100), 
acute pulmonary toxicity/pathogenicity (Harmonized Test Guideline 
885.3150), and acute injection toxicity/pathogenicity (Harmonized Test 
Guideline 885.3200). The Agency uses the microbial pesticide data 
requirements (see 40 CFR 158.2130) because the C5 plum has virus 
sequences similar to microbial products based on plant viruses. Basing 
the decision to grant the requested waiver of the data requirements on 
the available data and information without requiring further toxicity 
testing and residue data is similar to the Agency position regarding 
toxicity testing and the requirement of residue data for microbial 
products based on plant viruses from which this plant-incorporated 
protectant was derived (see 40 CFR 158.2130). For microbial products, 
further toxicity testing and residue data are triggered by significant 
adverse acute effects in studies such as the mouse oral toxicity study, 
to verify the observed adverse effects and clarify the source of these 
effects (Tiers II & III).
    Several pertinent issues were considered by the Agency concerning 
the potential for dietary hazards from the C5 plum before determining 
whether to grant the petitioner's waiver requests. When considering 
registrations for plant-incorporated protectants to be used in food 
commodities, the potential for dietary exposure to novel proteins that 
may possess toxic, allergenic, or antinutrient properties must be 
evaluated. Sufficient information demonstrating that plant viruses are 
both in the human diet and exist in the human intestine without 
negative effects was reviewed by the Agency. Since Potyviruses contain 
other proteins in addition to coat protein and are not the only plant 
viruses found in food commodities, humans can be exposed to a wide 
range of plant virus proteins (Ref. 3). Proteins of plant viruses, 
including the coat protein from plum pox virus, neither act as 
antinutrients when ingested, nor possess any properties that lead to 
toxicity or allergenicity (Ref. 4). Therefore, based on the lack of 
hazard from existing dietary exposure to plant viruses and the low 
expected potential for expression of the plum pox coat protein, there 
is a reasonable certainty of no harm from the aggregate exposure to the 
residues of the coat protein of plum pox virus, should it be expressed.
    Another consideration is the product of the coat protein gene of 
plum pox virus as inserted into the C5 plum. In the natural virus 
infection, its replication intermediates do not require DNA since a 
virus-encoded, RNA-Dependent RNA-polymerase is used. To express the 
gene in a plant, a DNA copy must be made and incorporated into the 
plant's genome, so that the plant will express messenger ribonucleic 
acid (mRNA) homologous to the virus coat protein only. Often for a 
Potyvirus, this means also adding a start codon and short leader 
sequence since the viral start codon is distant from the coat protein 
sequence in the normal viral RNA genome (Ref. 4). As discussed in Unit 
III.B., a full sequence analysis and comparison with known toxins, 
allergens, and antinutrients demonstrated that neither the coat protein 
gene nor the plum pox coat protein gene inserted into the C5 plum were 
sufficiently homologous to trigger an adverse reaction.
    Consideration of the low potential for production of protein is 
important since the silenced inserted gene has an open reading frame. 
Although there are known instances where suppression of gene-silencing 
can occur (e.g., PTGS inhibition such as produced by some other plant 
viruses, and low temperature growth), there are no foreseeable events 
that would lead to a breakdown in resistance under field conditions for 
the C5 plum. PTGS virtually eliminates the possibility of translation 
of virus coat protein from viral mRNA. When the coat protein gene 
insert is transcribed to the mRNA for the coat protein of plum pox 
virus, the mRNA is quickly cleaved and thus cannot be translated into 
the protein. If the plant becomes infected with the virus, the PTGS 
mechanism rapidly degrades the mRNA from the virus and prevents the 
production of new virions within the plant's tissues (Ref. 1).
    In light of these considerations, the Agency granted the 
petitioner's requests to waive the listed data requirements.

F. References

    1. Ravelonandro, M., J. Kundu, P. Briard, M. Monison and R. Scorza. 
2007. The Effect of Co-Existing Prunus Viruses on Transgenic Plum Pox 
Virus Resistant Plums. ISHS Acta Horticulturae 738: International 
Symposium on Biotechnology of Temperate Fruit Crops and Tropical 
Species, pp. 653-656.
    2. Codex Alimentarius (2003) Foods Derived from Biotechnology, 
United Nations, Food and Agriculture Organization, World Health 
Organization.
     3. Zhang, T., M. Breitbart, W. H. Lee, J.-Q. Run, C. L. Wei, S. W. 
L. Soh, M. L. Hibberd, E. T. Liu, F. Rohwer, Y. Ruan. 2006. RNA Viral 
Community in Human Feces: Prevalence of Plant Pathogenic Viruses. PLOS 
Biology 4(1):108-118.
    4. Shukla, D. D., C. W. Ward. A. A. Brunt. 1994. The Potyviridae. 
CAB International. University Press. Cambridge, UK.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA 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).
    The Agency has considered available information on the aggregate 
exposure levels of consumers (and major identifiable subgroups of 
consumers) to the pesticide chemical residue and to other related 
substances. These considerations include dietary exposure under the 
tolerance exemption for residues of the coat protein of plum pox virus, 
all other exemptions in effect for residues of virus coat proteins and 
virus coat protein gene plant-incorporated protectants, and exposure 
from non-occupational sources. Exposure to the coat protein of plum pox 
virus via the inhalation or dermal routes is not likely, since PTGS 
virtually eliminates the possibility of translation of the coat protein 
of plum pox virus from viral mRNA. In the event the protein is 
expressed in the C5 plum, it would be contained within plant cells, 
either eliminating the possibility of dermal and inhalation exposure, 
or reducing those exposure routes to negligible levels. This same 
evidence supports the Agency's conclusion that oral exposure from 
drinking water would be highly unlikely. Even if exposure occurred 
through an unlikely route, such as inhalation, the potential for the 
coat protein of plum pox virus to be an allergen is low, as evidenced 
by the lack of sequence homology with known allergens and the lack of 
hypersensitivity incidents in

[[Page 29434]]

individuals handing C5 plum trees, fruits, and other plant tissues 
during 18 years of research. Exposure via residential or lawn use to 
infants and children is also not expected because the use sites for the 
coat protein gene of plum pox virus are agricultural. In the unlikely 
event that the C5 plum expresses any viral coat protein, oral exposure 
from ingestion of fresh or processed fruit could occur, but as 
discussed in Unit. III.E., the protein would not be expected to cause 
any adverse reactions.

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 not found the coat protein of plum pox virus to share a 
common mechanism of toxicity with any other substances, and the coat 
protein of plum pox virus does not appear to produce a toxic 
metabolite. For the purposes of this tolerance exemption action, 
therefore, EPA has assumed that the coat protein of plum pox virus does 
not have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that 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 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 unless EPA 
determines that a different margin of safety will be safe for infants 
and children.
    Based on its review and consideration of all of the data and other 
information submitted by the petitioner discussed in Unit III., in 
addition to its previous knowledge of plant viruses and plant virus 
coat proteins discussed in Unit III.E., EPA concludes that there is a 
reasonable certainty that no harm will result to the United States 
population, including infants and children, from aggregate exposure to 
residues of the coat protein of plum pox virus. This includes all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. The Agency has arrived at this conclusion 
because the data available on the coat protein of plum pox virus 
demonstrate a lack of toxicity and pathogenicity. Plum pox Potyvirus 
(including the coat protein of plum pox virus) is not known to produce 
any recognized toxins, novel proteins, antinutrients, virulence 
factors, or enzymes normally associated with pathogen invasiveness or 
toxicity in mammals. Thus, there are no threshold effects of concern 
and, as a result, the Agency has concluded that the additional tenfold 
margin of safety for infants and children is unnecessary in this 
instance.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

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 U.N. 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 a MRL for the coat protein of plum 
pox virus.

VIII. Conclusions

     The Agency concludes that there is a reasonable certainty that no 
harm will result to the United States population, including infants and 
children, from aggregate exposure to residues of the coat protein of 
plum pox virus. Therefore, an exemption is established for residues of 
the coat protein of plum pox virus in or on the food commodities of 
fruit, stone, Group 12; and almond.

 IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of FFDCA 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 section 408(d) of FFDCA, such as the tolerance 
exemption 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 section 408(n)(4) of FFDCA. 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

[[Page 29435]]

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) (Public Law 
104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 7, 2010.
Steven Bradbury,
Acting Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

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

0
2. Section 174.531 is added to subpart W to read as follows:

Sec. 174.531  Coat protein of plum pox virus; exemption from the 
requirement of a tolerance.

    Residues of the coat protein of plum pox virus in or on the food 
commodities of fruit, stone, Group 12; and almond, are exempt from the 
requirement of a tolerance in these food commodities when expressed by 
the plant-incorporated protectant, coat protein gene of plum pox virus, 
and used in accordance with good agricultural practices.

[FR Doc. 2010-12579 Filed 5-25-10; 8:45 am]
BILLING CODE 6560-50-S