[Federal Register Volume 61, Number 98 (Monday, May 20, 1996)]
[Rules and Regulations]
[Pages 25151-25153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12500]
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[[Page 25152]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 6E4647/R2220; FRL-5357-8]
RIN 2070-AB78
Propylene Oxide; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes a time-limited tolerance for
residues of the fumigant propylene oxide in or on the raw agricultural
commodities almonds, Brazil nuts, filberts, pecans, pistachio nuts, and
walnuts. As a practical matter, this regulation reduces the maximum
permissible residue level for propylene oxide in or on these nuts from
300 ppm to 150 ppm. The regulation to establish a maximum permissible
level for residues of the fumigant was requested in a petition
submitted by Aberco, Inc., 9430 Lanham Severn Road, Seabrook, MD 20706.
EFFECTIVE DATE: This regulation becomes effective May 20, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 6E4647/R2220], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. A copy of any objections and hearing
requests filed with the Hearing Clerk should be identified by the
document control number and submitted to: Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington , DC 20460. In person, bring copy of objections and hearing
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202. Fees accompanying objections shall be labeled ``Tolerance
Petition Fees'' and forwarded to: EPA Headquarters Accounting
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh,
PA 15251. An electronic copy of objections and hearing requests filed
with the Hearing Clerk may be submitted to OPP 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 [PP 6E4647/R2220]. No
Confidential Business Information (CBI) should be submitted through e-
mail. Information not marked confidential may be disclosed publicly by
EPA without prior notice. Copies of electronic objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Walter C. Francis, Acting
Chief, Antimicrobial Program Branch, Registration Division (7505C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location and telephone number:
Rm. 250, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202 (703)
305-3661; e-mail: francis.walter @epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
Regulated Entities
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Examples of Regulated
Category Entities
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Industry................................. Nut processors who fumigate
with propylene oxide
Food processors who use
fumigated nuts in food
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This table is not exhaustive, but is a guide to the entities EPA
believes are regulated by this action.
EPA issued a notice published in the Federal Register of February
1, 1996 (61 FR 3697), which announced that Aberco, Inc., 9430 Lanham-
Severn Road, Seabrook, MD 20706 had submitted a pesticide petition (PP
6E4647) to EPA requesting that the Administrator, pursuant to section
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), establish a tolerance for residues of the fumigant propylene
oxide, in or on the raw agricultural commodity nutmeats (except
peanuts) when such foods are to be further processed into a final food
form, at 300 parts per million (ppm).
All of the comments received in response to this notice of filing
supported the issuance of the proposed tolerance.
On April 3, 1996 Aberco, Inc. amended the petition by requesting
that the proposed maximum permissible level for residues of propylene
oxide be reduced to 150 ppm. Because this is a reduction of a
previously proposed tolerance level, an additional period of public
comment is not necessary.
The scientific data evaluated for propylene oxide were obtained
from the EPA Integrated Risk Information System (IRIS) (1990) and
Meylan et al. (EPA, 1986).
Propylene oxide is classified as a B2 carcinogen with an oral slope
factor of 1.53E-1 based on benign and malignant tumors in female rats
when exposed by gavage.
Because nuts treated with propylene oxide are not sold directly to
consumers but are intended to be added to foods that may be further
processed (e.g. candy, cereal, baked goods, ice cream), EPA conducted
its risk assessment based on information related to anticipated
residues at the point of sale to consumers. Under normal conditions of
transport and distribution, the average time between release of the
treated nuts into commerce and the shipping, processing, and retailing
of the final food form containing the nuts is approximately 18 days.
Taking into account the percent of the nut commodities treated: almonds
(3 percent); Brazil nuts (8 percent); filberts (1 percent); pecans(3
percent); pistachio nuts (1 percent); and walnuts (7 percent), and
using a standard off gassing kinetic equation based on a 150 ppm level
at the time of shipment from the fumigation site and a transport time
of 18 days, the anticipated residues for propylene oxide at the point
of consumer purchase are 3.3 ppm.
Based on IRIS and a 1985 report prepared by the World Health
Organization (Environmental Health Criteria 56), the cancer endpoint is
the most restrictive and conservative measurement of risk. The cancer
unit potency or Q* of 0.153 mg/kg/day-1 is over 1,000 times
more restrictive that the estimate of an RfD using the No Observed
Effect Level (NOEL) of 9 mg/kg/day obtained from a chronic rat study.
The theoretical maximum residue contribution (TMRC) for all proposed
tolerances (almonds, Brazil nuts, filberts, pecans, pistachio nuts, and
walnuts) is 0.002 mg/kg/day for the overall U.S. population. The
anticipated residue contribution (ARC) to the U.S. population is
0.000002 mg/kg/day, resulting in a lifetime cancer risk from treated
nuts of 3 x 10-7. This value assumes anticipated residues of
3.3 ppm at the point of consumer purchase. During the 2 year timeframe
covered by this time-limited tolerance, the cancer risk would be 8.6
x 10-9.
The Agency believes that the current cancer risk assessment
demonstrates negligible risk.
The pesticide is useful for the purposes for which the tolerance is
sought. The nature of the residue is adequately understood and an
analytical method for propylene oxide (gas
[[Page 25153]]
chromatography) previously developed for tolerance petitions 5H5087 and
6H5119 is available in JAOAC, Vol 54, p. 560, 1971.
Additional residue data on propylene oxide and propylene
chlorohydrin (2-PCH) are required for a permanent tolerance. These data
are required to precisely determine the off-gassing kinetics and to
allow the Agency to accurately verify the time interval from fumigation
to the point of consumer purchase. At the present time, however, the
Agency believes there are adequate data to support a time-limited
tolerance while these studies are being developed. Additional
toxicological data may be required based on a review of the required
residue data. Further, EPA has concerns about the adequacy of the
current analytical method. Therefore, a revised analytical method must
be developed to address the 2-PCH known to form during fumigation of
foods with propylene oxide. Revised enforcement or confirmatory methods
for propylene chlorohydrin, as well as for propylene oxide per se must
also be developed. Any additional tolerance proposals for propylene
oxide will be considered on a case-by case basis.
There are presently no actions pending against the continued
registration of this chemical.
Based on the information and data considered, the Agency has
determined that the tolerances established by amending 40 CFR part 180
will protect the public health. Therefore, the tolerance is established
as set forth below. Since the Agency has no evidence that other
varieties of nuts are treated with propylene oxide, tolerances are
being established only for specific nuts.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections to the 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 above (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 issue(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 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 issue(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32).
A record has been established for this rulemaking under the docket
number [PP 6E4647/R2220] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall 2,
1921 Jefferson Davis Highway, Arlington, VA.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
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 rule-making record
which will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
address in ``ADDRESSES'' at the beginning of this document.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), it has
been determined that this rule is not ``significant'' and is not
subject to OMB review.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: May 9, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.491 is added to read as follows:
Sec. 180.491 Propylene Oxide; tolerance for residues.
A time-limited tolerance to expire on May 20, 1998 is established
for residues of the fumigant propylene oxide, in or on the following
raw agricultural commodities.
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Parts per
Commodity million
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Almonds.................................................... 150
Brazil Nuts................................................ 150
Filberts................................................... 150
Pecans..................................................... 150
Pistachio Nuts............................................. 150
Walnuts.................................................... 150
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[FR Doc. 96-12500 Filed 5-17-96; 8:45 am]
BILLING CODE 6560-50-F