[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