[Federal Register: April 9, 2008 (Volume 73, Number 69)]
[Rules and Regulations]
[Page 19147-19150]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap08-5]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0433; FRL-8357-5]
1-Methylcyclopropene; Amendment to an Exemption from the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an amendment to an exemption from
the requirement of a tolerance for residues of the 1-Methylcyclopropene
(1-MCP) on fruits and vegetables when applied or used outdoors for pre-
harvest treatments. Agrofresh 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 an amendment to
the existing 1-MCP exemption from the requirement of a tolerance at 40
CFR 180.1220. This regulation eliminates the need to establish a
maximum permissible level for residues of 1-Methylcyclopropene.
DATES: This regulation is effective April 9, 2008. Objections and
requests for hearings must be received on or before June 9, 2008, 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-2007-0433. 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 website 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: Driss Benmhend, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9525; e-mail address: benmhend.driss@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.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by 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-2007-0433 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 June 9, 2008.
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-2007-0433, 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
[[Page 19148]]
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 August 8, 2007 (72 FR 44520) (FRL-8138-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 7F7170) by Agrofresh, Inc., 100 Independence Mall,
Philadelphia, PA 19106-2399. The petition requested that 40 CFR
180.1220 be amended to include residues resulting from outdoor pre-
harvest use of 1-Methylcyclopropene. This notice included a summary of
the petition prepared by the petitioner Agrofresh, Inc. There were no
comments received in response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue....
'' Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues'' and ``other substances that have a
common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
1-Methylcyclopropene (1-MCP) is a plant regulator known for
inhibiting ripening and aging of plants, flowers, fruits, and
vegetables caused by the production of ethylene. 1-MCP acts by blocking
the attachment of ethylene to tissue, and thus, prolonging the life of
the food commodity treated. This mode of action is not relevant in
animals, since ethylene receptors are not present in animal tissues.
The toxicity profile of 1-MCP has already been assessed by the
Agency for its pesticidal use and in support of the tolerance exemption
for post-harvest use in or on fruits and vegetables. The final rule was
published on July 26, 2002 (67 FR 48796)(FRL-7187-4). Comprehensive
review of studies submitted and risk assessment conducted on 1-MCP with
regard to its toxicity to human health, done in support of the current
petition and the approved tolerance exemption for post-harvest usage,
have all concluded that this compound has a low acute toxicity.
1. Acute toxicity. 1-MCP exhibits low acute toxicity for all routes
of exposure. It is a category IV for acute oral, dermal, inhalation,
eye and dermal irritations. Moreover, 1-MCP is not a skin sensitizer,
and no hypersensitivity incidents were observed following exposure to
1-MCP.
2. Genotoxicity. 1-MCP was not mutagenic when tested in several
short-term in vitro/in vivo assays, including a bacterial reverse
mutation assay (Ames test), an in vitro mammalian point mutation assay
in Chinese hamster ovary cells, an in vitro cytogenetics assay in human
lymphocytes and an in vivo mouse micronucleus assay following
inhalation exposure. In addition, 1-MCP is not mutagenic when tested as
a suspension in cell media in the Ames test and in the in vitro mouse
lymphoma forward mutation assay (MRID 444647-10) and is not mutagenic
in the in vivo mouse micronucleus assay (MRID 444747-11) following oral
exposure.
3. Developmental toxicity. 1-MCP produces no developmental toxicity
when tested in a standard developmental toxicity study in the rat via
inhalation at concentrations up to and including 2.3 milligram active
ingredient/Liter (mg a.i./L) (or 543 mg a.i./kilogram (kg)/day, 6 hour
(hr) exposure/day). The no observed adverse effect level (NOAEL) for
maternal toxicity was 0.24 mg a.i./L (56 mg a.i./kg/day, 6 hr exposure/
day).
4. Subchronic toxicity. 1-MCP was tested in a 90-day inhalation
study at doses of 0.05, 0.24 and 2.3 mg a.i./kg in the rat. The NOAEL
is 0.05 mg a.i./L (equivalent to 9 to 15 mg a.i./kg/day), based on
minimal to mild effects on spleen and kidney histopathology at 0.24 mg
a.i./L (equivalent to 39 to 66 mg a.i./kg/day). In this study there was
no evidence of neurotoxicity, no effects on the respiratory tract and
no effects on pathology of any endocrine or reproductive organs up to
and including the highest dose tested of 2.3 mg a.i./L (or equivalent
to 380 to 640 mg a.i./kg/day).
5. AgroFresh (the applicant) submitted a request to waive the
immune response from the testing guidelines. A scientific rationale
based on the current toxicological data submitted on 1-MCP was provided
to address this data requirement. The review of the 3-month inhalation
rat study (mentioned in the previous paragraph) indicates no effects on
thymus weight and no effects on the histopathology of the thymus, bone
marrow or spleen that would be attributed to an impact on the immune
system were seen. There were no effects on white blood cell
differential parameters (including monocytes, lymphocytes, segmented
neutrophils or eosinophils) and no basophils were observed which may be
indicative of an allergic reaction. The Agency concluded that 1-MCP did
not induce dysfunction or inappropriate suppressive responses in
components of the immune system. As a result, the Agency granted the
request to waive immune response from the testing guidelines.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or
[[Page 19149]]
buildings (residential and other indoor uses).
A. Dietary Exposure
1. Food. The primary source for human exposure to 1-MCP will be
from ingestion of raw and processed fruits and vegetables treated with
1-MCP before and after the harvest. Studies submitted, conducted in the
field on apples (MRID 470886-12), maize (MRID 470886-11) and tomatoes
(471082-03), showed residues in treated fruits to be extremely low.
Moreover, harvested apples treated with 1-MCP in storage areas (MRID
456090-02), showed also low residue (average residue was 0.004 part per
million (ppm) using an exaggerated treatment rate of 1,200 parts per
billion (ppb) versus the 1,000 ppb proposed label rate). A worst-case
scenario (using the 0.004 ppm average residue concentration found in
treated apples and assuming that concentration is present in 100% of
the diet regardless of crops treated) indicates that a daily diet of
1.5 kg/day could contain 0.006 mg 1-MCP. For the general population
(assuming an average body weight of 60 kg), this would represent a
daily intake of 0.0001 mg 1-MCP/kg body weight which is 90,000 to
150,000-fold less than the 9-15 mg/kg NOAEL indicated in the 90-day
inhalation study. Residues in other treated commodities are expected to
be similar or even lower since the highest treatment rate is
recommended for apples. Processing would be expected to further lower
the residue levels in processed food commodities.
2. Drinking water exposure. No significant drinking water exposure
and residues are expected to result from the pesticidal use of 1-MCP
when applied or used as directed on the label and in accordance with
good agricultural practices. Moreover, review of the study for soil
absorption (OPPTS 835.1220), showed that the field use of 1-MCP should
not result in leaching of 1-MCP residues to ground water.
B. Other Non-Occupational Exposure
There are no residential, school or day care uses proposed for this
product. Since the proposed use pattern is for agricultural food crops,
the potential for non-occupational, non-dietary exposures to 1-MCP by
the general population, including infants and children, is highly
unlikely.
1. Dermal exposure. Non-occupational dermal exposures to 1-MCP when
used as a plant regulator are expected to be negligible because it is
limited to agricultural use.
2. Inhalation exposure. Non-occupational inhalation exposures to 1-
MCP when used as a plant regulator are expected to be negligible
because it is limited to agricultural use.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish an exemption from 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.'' These considerations include the
possible cumulative effects of such residues on infants and children.
EPA has considered the potential for cumulative effects of 1-MCP
and other substances in relation to a common mechanism of toxicity. 1-
MCP cannot share a common mechanism of toxicity with other substances
because this compound is not toxic to mammalian systems. Thus, section
408(b)(2)(D)(v) does not apply.
VI. Determination of Safety for U.S. Population, Infants and Children
A. U.S. Population
There is reasonable certainty that no harm will result from
aggregate exposure to residues of 1-MCP to the U.S. population,
infants, and children. This includes all anticipated dietary exposures
and all other exposures for which there is reliable information. The
Agency arrived at this conclusion based on the low level of mammalian
toxicity of 1-MCP and the already widespread exposure to 1-MCP when
used on pre-harvested and post-harvested fruits and vegetable, without
any reported adverse effects on human health. For these reasons, the
Agency has determined that residues of 1-MCP from pre-harvest treatment
of fruits and vegetables are safe, i.e., there is a reasonable
certainty that no harm will result from aggregate exposure to such
residues.
B. Infants and Children
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of exposure (also referred to as a margin of safety) for
infants and children in the case of threshold effects to account for
prenatal and postnatal toxicity and the completeness of the database
unless EPA determines that a different margin of exposure will be safe
for infants and children. Margins of exposure are often referred to as
uncertainty or safety factors. In this instance, based on all available
information, the Agency concludes that 1-MCP is non-toxic to mammals,
including infants and children. Because there are no threshold effects
of concern to infants, children, and adults when 1-MCP is used as
labeled, the provision requiring an additional margin of safety does
not apply. As a result, EPA has not used a margin of exposure approach
to assess the safety of 1-MCP.
VII. Other Considerations
A. Endocrine Disruptors
EPA is required under section 408(p) of the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) ``may
have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate.''
1-MCP is not known as an endocrine disruptor nor is it related to
any class of known endocrine disruptors. Thus, there is no impact via
endocrine-related effects on the Agency's safety finding set forth in
this final rule for1-MCP.
B. Analytical Method
Through this action, the Agency proposes to establish an exemption
from the requirement of a tolerance for 1-MCP when used on fruit and
vegetable crops. For the very same reasons that support the granting of
this tolerance exemption, the Agency has concluded that an analytical
method is not required for enforcement purposes for these proposed uses
of 1-MCP.
C. Codex Maximum Residue Level
There are no codex maximum residue levels established for 1-MCP.
VIII. Conclusions
The Agency does not expect any human health concerns from exposure
to residues of 1-MCP when applied or used as directed on the label and
in accordance with good agricultural practices. The data submitted by
applicant and reviewed by the Agency support the petition for an
exemption from the requirement of a tolerance, for 1-MCP on pre-
harvested fruits and vegetable, when the product is applied or used as
directed on the label.
IX. 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 final rule has been
exempted from review under
[[Page 19150]]
Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 31, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
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Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Section 180.1220 is revised to read as follows:
Sec. 180.1220 1-Methylcyclopropene; exemption from the requirement of
a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the 1-Methylcyclopropene in or on fruits and vegetables
when:
(a) Used as a post harvest plant growth regulator, i.e., for the
purpose of inhibiting the effects of ethylene.
(b) Applied or used outdoors for pre-harvest treatments.
[FR Doc. E8-7458 Filed 4-8-08; 8:45 am]
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