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Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: June 21, 2000 (Volume 65, Number 120)]
[Notices]
[Page 38550-38553]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn00-65]

[[Page 38550]]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-947; FRL-6589-5]


Notice of Filing a Pesticide Petition to Establish a Tolerance
for Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-947, must be
received on or before July 21, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-947 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Driss Benmhend,
Biopesticides and Pollution Prevention Division (7511C), Office of
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg.,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 308-9525; e-mail address: benmhend.drissa@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of this
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number PF-947. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-947 in the subject line on the
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC
20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by
e-mail to: ``opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-947. Electronic comments may
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under ``FOR FURTHER INFORMATION
CONTACT.''

[[Page 38551]]

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data supports granting of the petition. Additional data
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: May 31, 2000.
Janet L. Andersen,
Director, Biopesticides Pollution and Prevention Division, Office of
Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The petition summary
announces the availability of a description of the analytical methods
available to EPA for the detection and measurement of the pesticide
chemical residues, or an explanation of why no such method is needed.
    EPA has received a pesticide petition 0F6144 from BioTechnologies
for Horticulture, Inc., 100 Independence Mall West, Philadelphia, PA
19106-2399, proposing pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180 to establish an exemption from the requirement of a tolerance for
the biochemical pesticide 1-methylcyclopropene (1-MCP).
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
BioTechnologies for Horticulture, Inc. (BTH) has submitted the
following summary of information, data, and arguments in support of
their pesticide petition. This summary was prepared by BioTechnologies
for Horticulture, Inc. EPA has not fully evaluated the merits of the
pesticide petition. The summary may have been edited by EPA if the
terminology used was unclear, the summary contained extraneous
material, or the summary unintentionally made the reader conclude that
the findings reflected EPA's position and not the position of the
petitioner.

BioTechnologies for Horticulture, Inc.

0F6144

A. Product Name and Proposed Use Practices

    1-MCP has a non-toxic mode of action. 1-MCP acts as an inhibitor of
the natural plant hormone ethylene by blocking the attachment of
ethylene to the ethylene receptor in flowers and post-harvested fruits
and vegetables thereby counteracting many of the deleterious effects of
ethylene. 1-MCP works by blocking the effects from both internal and
external sources of ethylene. 1-MCP does not function by directly
harming target organisms.
    1-MCP is very effective at counteracting many of the undesirable
effects of ethylene on harvested fruits and vegetables, like
accelerating ripening and softening of climacteric fruit, accelerated
de-greening and softening of non-climacteric fruit, accelerated
senescence and loss of green color in fresh cut vegetables, russet
spotting of lettuce, abscission of leaves, and physiological disorders
in fruits.
    1-MCP treatments of post-harvested fruit and vegetables will occur
indoors in enclosed areas, and are expected to occur mostly in
commercial food storage facilities, a number of which are controlled
atmosphere facilities which utilize relatively low levels of oxygen and
relatively high levels of carbon dioxide.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues.
EthylBloc technology is a powdered end-use product containing
0.14% 1-MCP active ingredient. 1-MCP is released as a gas when
EthylBloc product is added to water. EPA has classified 1-MCP
as a plant growth regulator structurally related to naturally occurring
plant-containing materials, and eligible for a reduced data set
requirement. 1-MCP is regulated by the EPA's Biopesticides and
Pollution Prevention Division (BPPD), and EthylBloc is
currently registered to BTH for indoor use on flowers, potted plants,
and bedding (EPA Reg. No. 71297-1).
    2. Magnitude of residue at the time of harvest the method used to
determine the residue. Estimates of residues of 1-MCP found in
foodstuffs following treatment with EthylBloc are projected
to be extremely low, below reasonable quantifiable concentrations. Low
concentrations of 1-MCP passively diffuse in and out of plant tissues
and, like naturally occurring ethylene, bind to ethylene receptors. A
reasonable worst case estimate of 1-MCP present in plant tissue at any
one time can be calculated by assuming that all ethylene receptors in
the plant are occupied by 1-MCP. The concentration of ethylene binding
sites in plant vegetative tissue range from 1.9 x 10-9 to
6.8 x 10-9 moles/kilograms (mol/kg) fresh weight for the
leaf portion of plants, and 3.2 x 10-11 to 7.0 x
10-11 mol/kg fresh weight for the edible portion of plants
(e.g., apple pulp and tomato fruit). An estimate of 1-MCP residues
(molecular weight 54 g/mole) in the leaf and edible portions of plants
can be determined as follows:
    Leaf:
    6.8 x 10-9 moles/kg x 54 g/mole x 1.0 (100% sites) =
0.00000037 g/kg (0.37 parts per billion (ppb))
    Edible portion:
    7.0 x 10-11 moles/kg x 54 g/mole x 1.0 (100% sites) =
0.000000004 g/kg (0.004 ppb)
    Assuming that 1-MCP occupies all ethylene binding sites in a plant,
the quantitative estimates indicate that only 0.37 ppb 1-MCP residues
could be retained in the plant tissue, and considerably less than this
(0.004 ppb) could be retained in the edible portion of the fruit. In
addition, these calculations may have overestimated the actual residue
concentrations that consumers would be potentially exposed to, since
there would be a finite time between post-harvest treatment of fruits
and vegetables and the arrival of the food commodities at the
consumer's table. This additional time period would

[[Page 38552]]

allow 1-MCP to diffuse off ethylene receptors and out of the plant
tissue. Given that the estimates of 1-MCP residues would conservatively
range between 0.004 and 0.4 ppb, standard residue methods, which
normally have a limit of detection of about 10 ppb, will not have the
sensitivity to measure 1-MCP residues. The detection limit for the
analysis of 1-MCP in the end-use EthylBloc formulation is 10
ppb (MRID 444647-02). The predicted residues of 1-MCP in food are low
and well below reasonable analytical detection limits.
    Further evidence of very low predicted 1-MCP residue levels is
obtained from preliminary studies that measured airborne 1-MCP
concentrations in food chambers having sizes of approximately one cubic
meter or greater. The collective results of these studies indicate that
1-MCP remains present in the air at or near nominal levels over the 6
to 24 hr exposure periods, and imply that 1-MCP does not non-
specifically bind to the food in the storage rooms. This supports the
above arguments that very low residues of 1-MCP would be expected on
food treated with 1-MCP. Even if one assumed a 10% deposition rate of
the airborne 1-MCP on the stored food, which is the variability of the
measured results, only 0.9 ppb 1-MCP would be calculated to be on/in
the apples. Finally, in the extreme worst case, if one assumed that all
(100%) of the 1-MCP in the chamber was on the food, which is not
possible given the above measurements of 1-MCP in the storage room air,
then only 9 ppb 1-MCP would be calculated to be in/on the apples.
    Overall, there is no reasonable expectation of detectable residues
of 1-MCP on food commodities following post-harvest treatment with
EthylBloc.
    3. Analytical method. A statement of why an analytical method for
detecting and measuring the levels of the pesticide residue are not
needed. An analytical method for residues of 1-MCP is not applicable,
as this document proposes an exemption from the requirement of a
tolerance.

C. Mammalian Toxicological Profile

    1. Acute toxicity. Since 1-MCP is a gas at room temperature, most
acute toxicity studies were conducted with EthylBloc end-use
product. EthylBloc exhibits low acute toxicity. The rat oral
LD50 is greater than 5,000 milligrams/kilograms (mg/kg)
product, and the rabbit dermal LD50 is greater than 2,000
mg/kg product. In addition, EthylBloc is not a skin
sensitizer in guinea pigs, shows no dermal irritation in rabbits, and
shows mild-to-moderate ocular irritation in rabbits. No mortalities or
any toxic effects were observed in a rat acute inhalation toxicity
study conducted with 165 parts per million (ppm) 1-MCP in the air.
    2. Genotoxicity. Short-term assays for genotoxicity consisting of a
bacterial reverse mutation assay (Ames test), a mouse lymphoma forward
mutation assay, and a mouse in vivo micronucleus assay have been
conducted using EthylBloc end-use product as the test
material. These studies showed a lack of genotoxicity for
EthylBloc/1-MCP.
    3. Other tests. No additional mammalian toxicity testing has been
conducted. BTH has requested waivers from the requirements to submit
further mammalian toxicity studies on the basis of the favorable
toxicological profile for EthylBloc, its non-toxic mode of
action (i.e., ethylene receptor binding), its low use rates (30-1,000
ppb v/v 1-MCP in air), its predicted low residue levels (0.004-0.4
ppb), and the predicted insignificant levels of exposure based on the
confined nature of the proposed use (i.e., indoor use in enclosed
chambers some of which will contain very low oxygen levels which
absolutely necessitates no entry). No data were found in the literature
that would indicate EthylBloc or 1-MCP has any adverse
effects on mammals or wildlife. No incidents of hypersensitivity or any
other adverse effects have been observed in individuals handling the
material over the past several years.

D. Aggregate Exposure

    1. Dietary exposure. Any dietary exposure resulting from
application of 1-MCP would be through food consumption.
    i. Food. Residues in treated fruits and vegetables are predicted to
be low (i.e., 0.004-0.4 ppb). Residues would be expected to continue to
decline while treated food items remain in storage, and after food is
removed from storage and before consumption. Cooking and/or processing
would be expected to further lower the residues on treated food.
    ii. Drinking water. Since 1-MCP would only be used indoors in
enclosed storage areas, there is little if any potential for drinking
water exposure.
    2. Non-dietary exposure. EthylBloc is to be used only
indoors in enclosed commercial treatment areas. EthylBloc is
currently registered for use on flowers also for use indoors and in
enclosed areas. Non-dietary exposure to 1-MCP via lawn care, topical
treatments, etc., is not expected to occur. Thus, the potential for
non-occupational exposure to the general population is virtually non-
existent.

E. Cumulative Exposure

    EPA is required to consider the potential for cumulative effects of
1-MCP and other substances that have a common mechanism of toxicity.
Consideration of a common mode of toxicity is not appropriate given
that there is no indication of mammalian toxicity for 1-MCP and no
information that indicates toxic effects, if any, would be cumulative
with any other compounds. Since 1-MCP exhibits a non-toxic mode of
action in post-harvested fruits and vegetables, it is appropriate to
consider only the potential risks of 1-MCP in this exposure assessment.

F. Safety Determination

    1. U.S. population. Since there are no anticipated residues in
drinking water or from other non-occupational sources, and no reliable
information exists on cumulative effects due to a common mechanism of
toxicity, the aggregate exposure to 1-MCP is adequately represented by
the dietary route. The lack of toxicity of 1-MCP (administered as
EthylBloc end-use product) has been demonstrated by the
results of acute toxicity testing in mammals in which
EthylBloc end-use product caused no adverse effects when
dosed orally or dermally, and when 1-MCP was administered via
inhalation. Anticipated residues in consumed treated fruits and
vegetables are predicted to be low, below reasonable levels of
analytical detection. Moreover, 1-MCP exhibits close similarity to the
naturally occurring plant hormone ethylene, and to other plant-based,
naturally occurring cyclopropene and cyclopropane derivatives. Thus,
dietary exposure to 1-MCP should pose negligible risks to human health.
    2. Infants and children. Based on the lack of toxicity and low
exposure, there is a reasonable certainty that no harm to infants,
children, or adults will result from aggregate exposure to 1-MCP
residues. Exempting 1-MCP from the requirement of tolerances should
pose no significant risk to humans or the environment.

G. Effects on the Immune and Endocrine Systems

    BTH has no information to suggest that 1-MCP will adversely affect
the immune or endocrine systems.

H. Existing Tolerances

    There are no other established U.S. tolerances or exemptions from
tolerances for 1-MCP.

[[Page 38553]]

I. International Tolerances

    No maximum residue levels have been established for phosphorous 1-
MCP by Codex Alimentarius Commission.
[FR Doc. 00-15166 Filed 6-20-00; 8:45 am]
BILLING CODE 6560-50-F

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