Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Rules and Regulations 29431 

■ 2. The table in § 9.1 is amended by 

removing under the undesignated center 

heading ‘‘Significant New Uses of 

Chemical Substances’’ § 721.5995. 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

§ 721.5995 [Removed] 

■ 4. Remove § 721.5995. 

[FR Doc. 2010–12596 Filed 5–25–10; 8:45 am] 

BILLING CODE 6560–50–S 

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. 

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 plantincorporated protectant, coat protein 

gene of plum pox virus. Interregional 

Research Project Number 4 of Rutgers 

University (on behalf of the United 

States Department of AgricultureAgricultural Research ServiceAppalachian 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 


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29432 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Rules and Regulations 

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, IR4 (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, posttranscriptional gene silencing (PTGS), to 

be primed to resist virus infection, 

should it occur. Although nonengineered 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 plantincorporated 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 


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Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Rules and Regulations 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 plantincorporated 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, RNADependent 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 nonoccupational 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 nonoccupational 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 


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29434 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Rules and Regulations 

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 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Rules and Regulations 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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 174—[AMENDED] 

■ 1. The authority citation for part 174 

continues to read as follows: 

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

■ 2. Section 174.531 is added to subpart 

W to read as follows: 

§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 plantincorporated 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0920; FRL–8827–7] 

Diquat Dibromide; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of diquat, 

derived from applications of diquat 

dibromide, in or on canola meal and 

canola seed. Syngenta Crop Protection, 

Inc. requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). This regulation also 

corrects minor errors in the regulations 

for diquat at 40 CFR 180.266. 

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–2009–0920. 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 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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 those engaged in the 

following activities: 

• 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 to provide 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 EPA’s tolerance 

regulations at 40 CFR part 180 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, 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–2009–0920 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 


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