Document ID: EPA-HQ-OPP-2007-0433-0008
Agency: epa
Document Type: Rule
Title: 1-Methylcyclopropene; Amendment to an Exemption from the Requirement of a Tolerance
Posted Date: 2008-04-09T04:00Z

[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.

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

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1220 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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