Document ID: EPA-HQ-OPP-2006-0313-0003
Agency: epa
Document Type: Rule
Title: Tobacco Mild Green Mosaic Tobamovirus (TMGMV); Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2007-06-27T04:00Z

[Federal Register: June 27, 2007 (Volume 72, Number 123)]
[Rules and Regulations]               
[Page 35178-35181]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn07-19]                         

[[Page 35178]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0313; FRL-8134-5]

 
Tobacco Mild Green Mosaic Tobamovirus (TMGMV); Temporary 
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the tobacco mild green 
mosaic tobamovirus (TMGMV) on grass and grass hay when applied/used as 
a bioherbicide against the weed tropical soda apple. Interregional 
Research Project Number 4 (IR4), on behalf of BioProdex, Inc. submitted 
a petition to EPA under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), 
requesting the temporary tolerance exemption. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of TMGMV. The temporary tolerance exemption expires on June 
30, 2009.

DATES: This regulation is effective June 27, 2007. Objections and 
requests for hearings must be received on or before August 27, 2007, 
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-2006-0313. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: Rebecca Edelstein, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 605-0513; e-mail 
address: edelstein.rebecca@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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2006-0313 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before August 27, 2007.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0313, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (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'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 July 7, 2006 (71 FR 38643) (FRL-8069-7), 
EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 6E7029) by BioProdex, Inc., Gainesville Technology 
Enterprise Center (GTEC), Box 5, Suite 205, 2153 SE Hawthorne

[[Page 35179]]

Road, Gainesville, FL 32641. The petition requested that 40 CFR part 
180 be amended by establishing a temporary exemption from the 
requirement of a tolerance for residues of TMGMV. The docket for this 
action includes a summary of the petition prepared by the petitioner 
IR-4 on behalf of BioProdex, Inc. There were no comments received in 
response to the notice of filing.
    Section 408(c)(2)(A)(i) of the 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 the 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), 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), 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 the 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 the 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.
    TMGMV is a tobamovirus, a type of plant virus, and tobamoviruses 
have no known toxicity or pathogenicity to any organisms other than 
plants. They are unable to infect animals because they lack cell 
surface binding site receptors common to animal viruses. Tobamoviruses 
enter plant cells only through open wounds (e.g., those produced by 
feeding insects or by mechanical methods) or by cell-to-cell transfer 
(Fraenkel-Conrat, et. al., 1988). Almost all living things are 
routinely exposed to plant viruses, including tobamoviruses, through 
plants and plant products (e.g., foods). TMGMV is known to infect about 
20 plants, including peppers (Plant Viruses Online, 2005; Wetter, C., 
2005); therefore, humans are likely already exposed to TMGMV through 
food. Throughout the available literature, there are no reports of 
adverse effects in animals resulting from ingestion or exposure to 
TMGMV. TMGMV has not been reported to multiply in insects nor in any 
other known animal. One reference provided by the registrant may show 
replication of TMV (another tobamovirus) in cultured, immune-
suppressed, monkey kidney cell lines (Atherton, J.G., 1968). However, 
this was an artificial system and does not indicate that plant viruses 
can normally replicate in animal cells. The specific mode of action of 
TMGMV is such that only some species within the plant family Solanaceae 
are susceptible to this virus. Laboratory animals such as rabbits, 
mice, chickens, and guinea pigs are routinely used for producing 
antibodies against tobamoviruses without causing adverse effects to the 
animals. In addition, there are no reports of humans that handle and 
administer the viruses or of these laboratory animals developing any 
nasal, eye, skin, or pulmonary allergies, or any other adverse 
reactions to the viruses.
    In support of this tolerance exemption, mammalian toxicology 
requirements were satisfied by publicly available information submitted 
by BioProdex, summarized in the paragraph above. Specifically, the 
information provided supports the lack of toxicity to mammals and 
humans of tobamoviruses, the fact that only certain plants (and no 
animals) are susceptible to TMGMV, and that TMGMV poses little to no 
risk to humans.
    1. Acute oral toxicity/pathogenicity (OPPTS 885.3050). To satisfy 
this requirement, the registrant submitted supporting public literature 
rather than a study, which shows that plant viruses, including TMGMV, 
are found in food ingested daily by humans and animals, and according 
to the published literature, no known adverse effects or deaths have 
occurred in any species as a result of such dietary exposures.
    2. Acute dermal toxicity/pathology (OPPTS 885.3100). The registrant 
submitted supporting public literature rather than a study to fulfill 
this requirement, showing that plant viruses, including TMGMV, are 
ubiquitous in plants, and they are not known to cause acute dermal 
toxicity or pathogenicity to mammals.
    3. Acute eye irritation (OPPTS 870.2400). The registrant submitted 
supporting public literature rather than a study to fulfill this 
requirement, showing that plant viruses, including TMGMV, are 
ubiquitous in plants, and they are not known to cause acute eye 
irritation or pathogenicity to mammals.
    4. Acute pulmonary toxicity/pathogenicity (OPPTS 885.3150). To 
fulfill this requirement, the registrant submitted supporting public 
literature rather than a study, which shows that plant viruses, 
including TMGMV, are ubiquitous in plants, and they are not known to 
cause acute pulmonary toxicity or pathogenicity to mammals.
    5. Acute injection toxicity/pathogenicity (OPPTS 885.3200). To 
fulfill this requirement, the registrant submitted supporting public 
literature rather than a study, showing the following:
    i. TMGMV, like all tobamoviruses, can evoke immune responses and 
produce antibodies if properly injected into laboratory animals such as 
rabbits, mice, chickens, and guinea pigs without causing adverse 
effects to the animals; and
    ii. There are no reports of humans that handle and administer 
tobamoviruses or laboratory animals developing adverse reactions to the 
virus.
    6. Hypersensitivity incidents (OPPTS 885.3400). Workers handling 
TMGMV on a daily basis since 1999 have not had a single incidence of 
hypersensitivity. In addition, some workers have been handling 
tobamoviruses for nearly 40 years without encountering hypersensitivity 
to any of these viruses. There are no reports of hypersensitivity in 
humans or other animals to tobamoviruses in the literature.
    7. Cell culture (OPPTS 885.3500). To satisfy this requirement, the 
registrant submitted the following information, supported by public 
literature. Tobamoviruses are unable to infect animal cells since the 
cell surface plays an important role in infection of animal cells; 
during infection, animal viruses interact specifically with receptors 
on the animal cell surface. Tobamoviruses,

[[Page 35180]]

on the other hand, lack recognition for these receptors and only enter 
plant cells through open wounds or via cell-to-cell transfer through 
intercellular connections (Fraenkel-Conrat, et. al., 1988). There is 
one report in the literature of growing Tobacco mosaic tobamovirus 
(TMV; a different tobamovirus from the one that is the subject of this 
tolerance exemption) in cultured, immune-suppressed, monkey kidney cell 
lines (Atherton, J.G., 1968). However, this was an artificial system 
and does not indicate that tobamoviruses can normally replicate in or 
infect animal cells.
    Based on the published literature, in accordance with Tier I 
toxicology data requirements set forth in 40 CFR 158.740(c), the Tier 
II and Tier III toxicology data requirements were not triggered in 
connection with this action.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the 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).

A. Dietary Exposure

    1. Food. Virus-infected food plants have always been a part of the 
human and domestic animal food supply (Dewan and Pearson, 1995; 
McKinney, 1929; Provvidenti and Gonsalves, 1984; Palukaitis, 1991; 
Jones et al., 1934; Beemster and de Bokx, 1987). Most plants may be 
infected by at least one virus, and components of plant viruses are 
often found in the produce of crop plants. Even plants that show no 
disease symptoms are often found to be infected with viruses (Jones et 
al., 1934; Fulton, 1986). In addition, a common agricultural practice 
used since the 1920s for protection against viral disease involves 
intentionally inoculating healthy plants with a mild form of a virus in 
order to prevent infection by a more virulent form (Fulton, 1986). A 
great deal of information supports the ubiquitous appearance of plant 
viruses in foods, and to date there have been no reports of adverse 
human or animal health effects associated with consumption of plant 
viruses in food. Furthermore, the proposed experimental use permit 
(EUP) is not expected to result in increased exposures of TMGMV to the 
general population: The intended use of TMGMV is in rangelands, grass 
pastures, sod-production fields, Conservation Reserve areas, and other 
natural areas in Florida, and the only residues anticipated on food 
with this EUP are on grass and grass hay. In addition, these residues 
on grass or grass hay would only be incidental to application to the 
target organism since grass is not a host for TMGMV; therefore, TMGMV 
cannot infect grass or replicate in grass. Accordingly, the Agency 
concludes that when TMGMV is used as intended, there is reasonable 
certainty that no harm will result to humans from all anticipated 
exposures through food to any residues resulting from such use.
    2. Drinking water exposure. TMGMV is not intended for use in 
drinking water. However, in the event that TMGMV would reach water 
consumed by humans, for the reasons enumerated above, the Agency 
concludes that when TMGMV is used as intended, there is reasonable 
certainty that no harm will result to humans from all anticipated 
exposures through water to any residues resulting from such use.

B. Other Non-Occupational Exposure

    EPA concludes that dermal or inhalation exposure to the general 
population as a result of this EUP is not likely to occur, based on the 
proposed uses and limited acreage. Moreover, the general population, 
including infants and children, are exposed to plant viruses daily in 
food with no known adverse effects ever being reported. Therefore, the 
Agency concludes that in the unlikely event that there is non-
occupational, non-dietary exposure to TMGMV, such exposure would pose 
no risks to the general population, including infants and children.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that EPA consider 
available information on the cumulative effects of a particular 
pesticide's residues and other substances that have a common mechanism 
of toxicity when establishing, modifying, or revoking a tolerance. 
These considerations include the possible cumulative effects on infants 
and children of such residues and other substances with a common mode 
of toxicity. Because there is no indication of mammalian toxicity or 
pathogenicity from TMGMV, we conclude that there are no cumulative 
effects for this virus and any other substance.

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

    1. U.S. population. For all of the reasons discussed above, there 
is reasonable certainty that no harm will result to the U.S. 
population, including infants and children, from aggregate exposure to 
residues of TMGMV. This includes all anticipated dietary exposures and 
all other exposures for which there is reliable information.
    2. Infants and children. Section 408(b)(2)(C) of the FFDCA provides 
that EPA shall apply an additional tenfold margin of exposure (MOE) for 
infants and children in the case of threshold effects to account for 
prenatal and postnatal toxicity and the completeness of the data base 
on toxicity and exposure, unless EPA determines that a different MOE 
will be safe for infants and children. MOEs, which are often referred 
to as uncertainty (safety) factors, are incorporated into EPA risk 
assessments either directly, or through the use of a MOE analysis or by 
using uncertainty factors in calculating a dose level that poses no 
appreciable risk. As previously mentioned in the toxicological profile, 
humans, including infants and children, have been exposed to plant 
viruses through food, where they are commonly found, with no known or 
reported adverse effects. As discussed above, the Agency has concluded 
that TMGMV is non-toxic to mammals, including infants and children. 
Because there are no threshold levels of concern to infants, children, 
and adults when TMGMV is used as labeled, the Agency concludes that the 
additional MOE is not necessary to protect infants and children.

VII. Other Considerations

A. Endocrine Disruptors

    At this time, the Agency is not requiring information on the 
endocrine effects of this active ingredient, TMGMV. The Agency has 
considered, among other relevant factors, available information 
concerning whether the virus may have an effect in humans similar to an 
effect produced by a naturally occurring estrogen or other endocrine 
effects. Plant viruses cannot infect mammals, and there is no known 
metabolite that acts as an ``endocrine disruptor'' produced by this 
virus. Therefore, there is no impact via endocrine-related effects on 
the Agency's safety findings in this final rule.

B. Analytical Method

    Through this action, the Agency is proposing to establish a 
temporary exemption from the requirement of a tolerance for residues of 
TMGMV on grass and grass hay for the purposes of an EUP. The Agency 
reached this decision based on the reasons discussed

[[Page 35181]]

above, including lack of toxicity to mammals, and therefore concludes 
that an analytical method for detecting TMGMV is not required for 
enforcement purposes.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exist for the virus TMGMV.

D. References

    1. Atherton, J.G. 1968. Formation of tobacco mosaic virus in an 
animal cell culture. Archiv fur die gesamte Virusforschung 24:406-418.
    2. Beemster ABR, de Bokx JA. Survey of properties and symptoms. In: 
de Bokx JA, van der Want JPH. Viruses of Potatoes and Seed Potato 
Production. Wageningen: Pudoc, 1987:84-93.
    3. Dewan C, Pearson MN. Natural field infection of garlic by garlic 
yellow streak virus in the Pukekohe area of New Zealand and associated 
problems with the introduction of new garlic cultivars. New Zealand 
Journal of Crop and Horticultural Science 1995; 23:97-102.
    4. Fraenkel-Conrat, H., Kimball, P.C., and Levy, J.A. 1988. 
Virology, 2nd edition. Prentice Hall, Englewood Cliffs, NJ (Virus 
cellular receptors and cell membrane changes, p. 299-300).
    5. Fulton R. Practices and precautions in the use of cross 
protection for plant virus disease control. Annual Review of 
Phytopathology 1986; 24:67-81.
    6. Jones L, Anderson E, Burnett G. The latent virus of potatoes. 
Journal of Phytopathology 1934; 7:93-115.
    7. McKinney HH. Mosaic diseases in the Canary Islands, West Africa, 
and Gibraltar. Journal of Agricultural Research 1929; 39:557-78.
    8. Palukaitis P. Virus-mediated genetic transfer in plants. In: 
Levin M, Strauss H. Risk Assessment in Genetic Engineering. New York: 
McGraw-Hill, 1991:140-62.
    9. Provvidenti R, Gonsalves D. Occurrence of zucchini yellow mosaic 
virus in cucurbits from Connecticut, New York, Florida, and California. 
Plant Disease 1984; 68:443-6.
    10. Palukaitis P. Virus-mediated genetic transfer in plants. In: 
Levin M, Strauss H. Risk Assessment in Genetic Engineering. New York: 
McGraw-Hill, 1991:140-62.
    11. Plant Viruses Online, 2005. http://image.fs.uidaho.edu/vide/descr801.htm
.

    12. Wetter, C., 2005. Tobacco mild green mosaic virus. In: AAB 
Description of Plant Viruses No. 35. http://www.dpvweb.net/dpv/showdpv.php?dpvno=351
.

VIII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 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 with Indian Tribal Governments (65 FR 67249, November 6, 
2000) do not apply to this rule. In addition, This 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).

IX. 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 180

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

    Dated: June 15, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.

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

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1276 is added to subpart D to read as follows:

Sec.  180.1276  Tobacco mild green mosaic tobamovirus (TMGMV); 
temporary exemption from the requirement of a tolerance.

    A temporary exemption from the requirement of a tolerance is 
established for residues of tobacco mild green mosaic tobamovirus in or 
on all grass and grass hay.
[FR Doc. E7-12338 Filed 6-26-07; 8:45 am]

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