[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                           
------------------------------------------------------------------------
                                               Examples of Regulated    
                 Category                             Entities          
------------------------------------------------------------------------
Industry.................................  Nut processors who fumigate  
                                            with propylene oxide        
                                           Food processors who use      
                                            fumigated nuts in food      
------------------------------------------------------------------------

    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  
------------------------------------------------------------------------
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