[Federal Register Volume 62, Number 158 (Friday, August 15, 1997)]
[Rules and Regulations]
[Pages 43650-43653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21691]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300530; FRL-5738-3]
RIN 2070-AB78


Replicase Protein of Potato Leaf Roll 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 Replicase Proteins 
of Potato Leaf Roll Virus and the genetic material necessary for its 
production in or on all raw agricultural commodities. Monsanto 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 Replicase 
Proteins of Potato Leaf Roll Virus and the genetic material necessary 
for its production.

DATES: This regulation is effective August 15, 1997. Objections and 
requests for hearings must be received by EPA on or before October 14, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300530], 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 by the docket control 
number, [OPP-300530], 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: [email protected]. 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 number [OPP-300530]. 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, telephone number, and e-mail: Rm. 5th fl., CS#1 
2800 Crystal Drive, Arlington, VA 22202, (703) 308-8733, e-mail: 
[email protected]

SUPPLEMENTARY INFORMATION: In the Federal Register of June 25, 1997 (62 
FR 34283-34286)(FRL-5723-2), 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 
Monsanto Corporation, St. Louis, MO. 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 Replicase Protein of Potato Leaf Roll 
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)(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

[[Page 43651]]

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 replicase protein and any 
subcomponent of the replicase 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 have 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 replicase protein of Potato Leaf Roll 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-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 Potato Leaf Roll Virus, 
including the replicase protein component, are found in the fruit, 
leaves and stems of most plants. Viruses are ubiquitous in the 
agricultural 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 
replicase proteins provides a scientific rationale for exempting from 
the requirement of a tolerance transgenic plants expressing replicase 
proteins and leads the Agency to conclude that the use of Replicase 
Protein of Potato Leaf Roll 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 replicase 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 replicase proteins.
    b. Drinking water exposure. Potential non-occupational exposures in 
drinking water is negligible. Replicase 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. Replicase 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 replicase 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, replicase 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 
replicase proteins produced in plants as part of a plant-pesticide is 
negligible in comparison to potential exposure through the dietary 
route. In some cases, replicase proteins may be present in pollen, thus 
affording exposure to those individuals in areas exposed to wind-blown 
pollen. However, it is unlikely

[[Page 43652]]

that exposure to the pollen is equivalent to exposure to replicase 
proteins produced in plants as part of a plant-pesticide. Replicase 
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 replicase 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 replicase 
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 replicase 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 replicase 
proteins and there is no evidence which indicates that replicase 
proteins would have a diferent effect on children than 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 informtion to suggest 
that Replicase Proteins of Potato Leaf Roll 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 Replicase Protein 
of Potato Leaf Roll 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, Replicase 
Protein of Potato Leaf Roll Virus 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 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 replicase 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 replicase protein of Potato Leaf Roll 
Virus and the genetic material necessary for its production. Thus, a 
tolerance for this Replicase Protein of Potato Leaf Roll 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 14, 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-300530]. 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,

[[Page 43653]]

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 
Highway, Arlington, VA 22202.
    Electronic comments can be sent directly to EPA at:
    [email protected]

    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 any 
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.

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 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 7, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 is amended as follows:
    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.1183 is added to subpart D to read as follows:


Sec. 180.1183  Replicase Protein of Potato Leaf Roll Virus and the 
genetic material necessary for its production; Exemption from the 
requirement of a tolerance.

    An exemption fron the requirement of a tolerance is established for 
residues of the biological plant pesticide Replicase Protein of Potato 
Leaf Roll Virus and the genetic material necessary for its production 
in or on all food commodities.
[FR Doc. 97-21691 Filed 8-14-97; 8:45 am]
BILLING CODE 6560-50-F