[Federal Register Volume 62, Number 163 (Friday, August 22, 1997)]
[Rules and Regulations]
[Pages 44575-44579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22393]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300539; FRL-5739-5]
RIN 2070-AB78
Coat Protein of Cucumber Mosaic Virus and the Genetic Material
Necessary for its Production; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION:: Final rule.
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SUMMARY:: This rule establishes an exemption from the requirement of a
tolerance for residues of the biological pesticide Coat Proteins of
Cucumber Mosaic Virus and the Genetic Material necessary for its
production in or on all raw agricultural commodities. Asgrow Seed
Company submitted a petition to EPA under the Federal Food, Drug and
Cosmetic Act as amended by the Food Quality Protection Act of 1996
requesting the tolerance exemption. This regulation eliminates the need
to establish a maximum permissible level for residues of Coat Proteins
of Cucumber Mosaic Virus and the genetic material necessary for its
production.
DATES:: This regulation is effective August 22, 1997. Objections and
requests for hearings must be received by EPA on or before October 21,
1997.
ADDRESSES:: Written objections and hearing requests, identified by the
docket control number [OPP-300539], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified
[[Page 44576]]
by the docket control number, [OPP-300539], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epamail.epa.gov. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1 file format or ASCII file format. All copies
of electronic objections and hearing requests must be identified by the
docket control number [OPP-300539]. No Confidential Business
Information (CBI) should be submitted through e-mail. Copies of
electronic objections and hearing requests on this rule may be filed
online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT:: By mail: Linda Hollis, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7501W), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 5th fl., CS#1 2800
Crystal Drive, Arlington, VA 22202, (703) 308-8733. Email:
hollis.linda@epamail.epa.gov
SUPPLEMENTARY INFORMATION:: In the Federal Register of April 2, 1997
(62 FR 15688-15689) EPA issued a notice pursuant to section 408(d), of
the Federal Food Drug & Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
announcing the filing of a pesticide tolerance petition by Asgrow Seed
Compan, California. The notice contained a summary of the petition
prepared by the petitioner and this summary contained conclusions and
arguments to support its conclusion that the petition complied with the
Food Quality Protection Act (FQPA) of 1996. The petition requested that
40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of the biological pest control
agent Coat Protein of Cucumber Mosaic Virus and the genetic material
necessary for its production in or on all raw agricultural commodities.
There were no comments or requests for referral to an advisory
committee received in response to the notice of filing.
The data submitted in the petition and other material have been
evaluated. The toxicology data requirements in support of this
exemption from the requirement of a tolerance were satisfied via data
waivers from the open scientific literature.
I. Risk Assessment and Statutory Findings
New 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 tolerance is ``safe''. Section 408(c)(2)(A)(ii) 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. Section 408(c)(2)(B) requires 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...'' 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 us in residential settings.
II. 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.
Additionally, section 408(b)(2)(D)(v) 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.'' All available information
indicates that viral coat proteins in food have no human toxicity and
EPA is not aware of any other substances within or outside of the food
supply that might have a common mechanism of human toxicity with
residues of viral coat proteins produced in plants as part of a plant-
pesticide.
Data waivers were requested for acute toxicity, genotoxicity,
reproductive and developmental toxicity, subchronic toxicity and
chronic toxicity data. The data waivers were accepted based on the long
history of mammalian consumption of the entire plant virus particle in
foods, without causing any deleterious human health effects [See OPP-
300367A; FRL-5716-6]. Virus-infected plants currently are and have
always been a part of both the human and domestic animal food supply
and there have been no findings which indicate that plant viruses are
toxic to humans and other vertebrates. Further, plant viruses are
unable to replicate in mammals or other vertebrates, thereby
eliminating the possibility of human infection. More importantly,
however, this tolerance exemption will apply to that portion of the
viral genome coding for the whole coat protein and any subcomponent of
the coat protein expressed in the plant. This component alone is
incapable of forming infectious particles.
The genetic material necessary for the production of the plant-
pesticides active and inert ingredients are the nucleic acids (DNA)
which comprise (1) genetic material encoding these viral coat proteins
and their regulatory regions. Regulatory regions: are the genetic
material that control the expression of the genetic material encoding
the proteins, such as promoters, terminators, and enhancers. DNA is
common to all forms of plant and animal life and the Agency knows of no
instance where these nucleic acids have been associated with toxic
effects related to their consumption as a component of food. These
ubiquitous nucleic acids as they appear in the subject plant-
pesticide's inert ingredient has been adequately characterized by the
applicant and supports EPA's conclusion that no mammalian toxicity is
anticipated from dietary exposure to the genetic material necessary for
the production of the coat protein of Cucumber Mosaic Virus and inert
plant pesticidal ingredients.
III. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-
[[Page 44577]]
occupational exposures, including drinking water from groundwater or
surface water and exposure through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses).
1. Dietary exposure-- a. Food. The use of viral coat protein
mediated resistance will not result in any new dietary exposure to
plant viruses. Entire infectious particles of Cucumber Mosaic Virus,
including the coat protein component, are found in the fruit, leaves
and stems of most plants. Viruses are ubiquitous in the agricutural
environment at levels higher than will be present in transgenic plants.
Virus infected food plants have historically been a part of the human
and domestic animal food supply with no observed adverse effects to
human health and infants and children upon consumption. Therefore, the
lack of toxicity associated with plant viruses and the history of
contamination of the food supply by virus coat proteins provides a
scientific rationale for exempting from the requirement of a tolerance
transgenic plants expressing virus coat proteins and leads the Agency
to conclude that the use of Coat Protein of Cucumber Mosaic Virus and
the genetic material necessary for its production will not pose a
dietary risk of concern under normal conditions. Moreover, there is no
evidence which indicates that adverse effects due to aggregate exposure
of viral coat proteins (with substances outside the food supply)
through dietary, non-food oral, dermal and inhalation occurs. This
conclusion is suppported by the EPA's Scientific Advisory Panel's
discussion regarding the Agency's Regulatory approach for plant
pesticides which concluded:
i. The levels of virus in the agricultural environment are much
higher than those levels present in transgenic plants.
ii. The existing contamination of the current food supply provides
a scientific rationale for exempting from the requirement of a
tolerance transgenic plants which express viral coat proteins.
b. Drinking water exposure. Potential non-occupational exposures in
drinking water is negligible. Viral coat proteins produced in plants as
part of a plant-pesticide are an integral part of the living tissue of
the plant. As such, these components are subject to degradation and
decay, a process which occurs fairly rapidly. Viral coat proteins
produced in plants as part of a plant-pesticide do not persist in the
environment or bioaccumulate. The rapid turnover of these substances in
the environment limits their ability to present anything other than a
very negligible exposure in drinking water drawn from either surface or
groundwater sources.
2. Other non-occupational exposure. Other non-occupational exposure
of engineered coat proteins via residential and indoor uses, e.g., uses
around homes, parks, recreation areas, athletic fields and golf
courses, will be minimal to non-existent as the coat protein is
expressed only within the plant tissues.
a. Dermal exposure. Due to the nature of viral coat proteins
produced in plants as part of a plant-pesticide, exposure through any
route (i.e. dermal, respiratory) other than dietary is unlikely to
occur. Physical contact with the plant or raw agricultural food from
the plant may present some limited opportunity for dermal exposure.
However, on a per person basis, the potential amounts involved in this
exposure is negligible in comparison to exposure through the dietary
route. Additionally, viral coat proteins produced in plants as part of
a plant-pesticide are unlikely to cross the barrier provided by the
skin.
b. Inhalation exposure. The occurrence of respiratory exposure of
viral coat proteins produced in plants as part of a plant- pesticide is
negligible in comparison to potential exposure through the dietary
route. In some cases, viral coat proteins may be present in pollen,
thus affording exposure to those individuals in areas exposed to wind-
blown pollen. However, it is unlikely that exposure to the pollen is
equivalent to exposure to viral coat proteins produced in plants as
part of a plant- pesticide. Viral coat proteins, when present in
pollen, will likely be integrated into the tissue of pollen grain and
are unlikely to cross the barrier provided by the mucous membrane of
the respiratory tract and thus are not additive to dietary exposure.
Moreover, exposure through inhalation via wind-blown pollen occurs to
the whole virus particle and there is no evidence which suggests that
exposure to whole plant viruses by wind-blown pollen results in any
adverse effects. Therefore, it is unlikely that exposure to pollen that
may contain viral coat proteins produced in plants as part of a plant-
pesticide would result in adverse effects.
IV. Safety Factors
Rather than relying on available animal experimentation data to
support a tolerance exemption for viral coat proteins, EPA relied on
the long history of safe human consumption of food containing plant
viruses as the appropriate information base for this tolerance
exemption. Because the EPA did not rely on animal data, determination
of appropriate safety factors to be used in a human risk assessment was
not considered.
V. Infants and Children
Consistent with section 408(b)(2)(C) of the FFDCA, EPA has assessed
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.
Based on all available information, the Agency concludes that viral
coat proteins produced in plants as part of a plant-pesticide are
ubiquitous in foods, including those foods consumed by infants and
children. Moreover, there is no reason to believe that plant viral coat
proteins are likely to occur in different amounts in foods, consumed by
children and infants. Children are exposed as part of a normal diet to
viral coat proteins and there is no evidence which indicates that viral
coat proteins would have a diferent effect on children that on adults.
Further, there is no evidence which suggests that such exposure to
either adults or infants and children leads to any harm.
VI. Other Considerations
1. Endocrine disrupters. The Agency has no information to suggest
that Coat Proteins of Cucumber Mosaic Virus and the genetic material
necessary for its production will have an effect on the immune and
endocrine systems. The Agency is not requiring information on the
endocrine effects of this biological pesticide at this time;Congress
has allowed 3 years after August 3, 1996, for the Agency to implement a
screening program with respect to endocrine effects.
2. Analytical method. The Agency proposes to establish an exemption
from the requirement of a tolerance without any numerical limitation;
therefore, the agency has concluded that an analytical method is not
required for enforcement purposes for Coat Protein of Cucumber Mosaic
Virus and the genetic material necessary for its production.
VII. Determination of Safety for U.S. Population, Infants and
Children
For the U.S.population, including infants and children, Cucumber
Mosaic Virus Coat Protein and the genetic material necessary for its
production has no known adverse effects. Extensive use and experience
show the safety of foods containing viral coat proteins. There has been
no evidence in the many years of human experience with the growing and
[[Page 44578]]
consumption of food from plants containing viral coat proteins which
indicates that adverse effects due to aggregate exposure through the
dietary, non-food oral, dermal and inhalation routes occur. Therefore,
EPA concludes that there is reasonable certainty that no harm will
result to the U.S. population from aggregate exposure to residues of
viral coat proteins produced in plants as part of a plant-pesticide
including all anticipated dietary exposures and all other exposures for
which there is reliable information. The Agency has arrived at this
conclusion because, as discussed above, no toxicity to mammals has been
observed for coat protein of Cucumber Mosaic Virus and the genetic
material necessary for its production. Thus, a tolerance for this Coat
Protein of Cucumber Mosaic Virus and the Genetic Material necessary for
its production is not necessary to protect the public health.
Therefore, 40 CFR part 180 is amended as set forth below.
VIII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d) as
was provided in the old section 408 and in section 409. However, the
period for filing objections is 60 days, rather than 30 days. EPA
currently has procedural regulations which governs the submission of
objections and hearing requests. These regulations will require some
modification to reflect the new law. However, until those modifications
can be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
Any person may, by October 21, 1997, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
hearing clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the hearing clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issues(s) on which a hearing is
requested, the requestor's contentions on such issues, and a summary of
any evidence relied upon by the objector (40 CFR 178.27). A request for
a hearing will be granted if the Administrator determines that the
material submitted shows the following: There is a genuine and
substantial issue of fact; there is a reasonable possibility that
available evidence identified by the requestor would, if established
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issues(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32). Information submitted in connection with an objection or
hearing request may be claimed confidential by marking any part or all
of that information as CBI. Information so marked will not be disclosed
except in accordance with procedures set forth in 40 CFR part 2. A copy
of the information that does not contain CBI must be submitted for
inclusion in the public record. Information not marked confidential may
be disclosed publicly by EPA without prior notice.
IX. Public Docket
A record has been established for this rulemaking under docket
control number [OPP-300539]. A public version of this record, which
does not include any information claimed as CBI, is available for
inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 1132 of the Public
Information and Records Integrity Branch, Information Resources and
Services Division(7506C), Office of Pesticide Programs, Environmental
Protection Agency, Crystal Mall#2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing request, EPA will transfer any
copies of objections and hearing requests received electronically into
printed, paper form as they are received and will place the paper
copies in the official rulemaking record. The official rulemaking
record is the paper record maintained at the Virginia address in
Addresses at the beginning of this document.
X. Regulatory Assessment Requirements
This final rule establishes an exemption from the tolerance
requirement under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). 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., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require and
prior consultation as specified by Executive Order 12875, entitiled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629), February 16,
1994), or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). In additions, since
tolerance exemptions that are established on the basis of a petition
under FFDCA section 408(d), such as the 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.
Nevertheless, the Agency previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
XI. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General
[[Page 44579]]
Accounting Office prior to publication of the rule in today's Federal
Register. This 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: August 14, 1997.
Stephen L. Johnson,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.1186 is added to subpart D to read as follows:
Sec. 180.1186 Coat protein of cucumber mosaic virus and the genetic
material necessary for its production; exemption from the requirement
of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the biological plant pesticide Coat Protein of Cucumber
Mosaic Virus and the genetic material necessary for its production in
or on all food commodities.
[FR Doc. 97-22393 Filed 8-21-97; 8:45 am]
BILLING CODE 6560-50-F
