>Date:         Wed, 22 May 1996 11:05:35 -0400
>Reply-To: "PARKINSN: Parkinson's Disease - Information Exchange Network"
<[log in to unmask]>
>Sender: "PARKINSN: Parkinson's Disease - Information Exchange Network"
<[log in to unmask]>
>From: [log in to unmask]
>Subject:      Fwd: Propylene Oxide; Pesticide Tolerance
>Comments: To: [log in to unmask], [log in to unmask], [log in to unmask],
>          [log in to unmask], [log in to unmask],
>          [log in to unmask], [log in to unmask], [log in to unmask],
>          [log in to unmask], [log in to unmask], [log in to unmask]
>To: Multiple recipients of list PARKINSN
>              <[log in to unmask]>
>
>I subscribe to an EPA maintained listserv, which almost everyday, delivers
>anywhere from 1-10 (generally) messages like the one below.  These messages
>typically relate to the petition for acceptance of a new pesticide and/or the
>establishment of new/updated tolerance levels for those pesticides.  There
>are also a few other types of messages delivered, but the aforementioned
>types dominate.  These petitiions are entered into the federal register and
>the public given the chance to respond either way.
>
>I have a form letter, which I may sent out later (I've sent it around
>before), in which I protest the concept of any acceptable levels of these
>substances.  The reason for this is obvious given the possible link with
>Parkinson's Disease, of which I happen to be affected (starting around the
>age of 25).  Not only does all this testing involve a substantial,
>unjustified loss of animal life, but I believe, as do many others,it poses
>unacceptable risks to human life, both its duration and most of all, it's
>quality.  These tests which are performed fail to address the following
>issues, all critical to fully understanding possible relationships to
>underlying disease mechanisms:
>
>1.  Most of the testing relates to cancer risk.  It seems that little, if
>any, attention is given to neurological damage.  This is remarkable given
>that pesticides are, by design, created with the purpose of damaging the
>pests nervous system.
>2.  Most tests are performed on animals, not humans, obviously.  Why should a
>'safe' substance be tested on humans, especially given the natural
>similarities between a mouse or rat's physiology and  that of a human
>(sarcasm intended).
>3.  These test are performed in relatively short periods of time compared
>with the length, and subsequent difference in exposure levels and periods, of
>a human lifetime.
>4.  No attempt is made, even were it possible, to simulate the cumulative and
>synergistic effects of literally THOUSANDS of these pesticides, and other
>industrial organic chemicals, all interacting with each other in the "real"
>world.  It is obviious, from the amount of email I receive from the EPA
>listserv, that thousands more are also added to the existing mix each year.
>
>Is anyone becoming just a bit concerned yet?  I feel that in the long run, it
>would behoove us (PD and other disease victims), to become active not only in
>commendable efforts like those to pass the  Udall Bill for PD research, but
>also in pressuring government officials to take a harder, more realistic,
>look at what our creations are doing to us, ALL of us, and the rest of the
>environment and life on earth.
>'Nuff said for now, but not for good.
>
>Wendy Tebay
>"To Hell With PD!"
>
>*******************************
>
>---------------------
>Forwarded message:
>From:   [log in to unmask] (everybody)
>Sender: [log in to unmask]
>Reply-to:       [log in to unmask]
>To:     [log in to unmask] (Multiple recipients of list)
>Date: 96-05-20 19:20:36 EDT
>
>[Federal Register: May 20, 1996 (Volume 61, Number 98)]
>[Rules and Regulations]
>[Page 25152-25153]
>>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
>
>
>-----------------------------------------------------------------------
>
>[[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.
>
>-----------------------------------------------------------------------
>
>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: [log in to unmask]
>    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<SUP>* of 0.153 mg/kg/day<SUP>-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<SUP>-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<SUP>-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.
>
>
>------------------------------------------------------------------------
>                                                              Parts per
>                         Commodity                             million
>------------------------------------------------------------------------
>Almonds....................................................          150
>Brazil Nuts................................................          150
>Filberts...................................................          150
>Pecans.....................................................          150
>Pistachio Nuts.............................................          150
>Walnuts....................................................          150
>------------------------------------------------------------------------
>
>
>[FR Doc. 96-12500 Filed 5-17-96; 8:45 am]
>BILLING CODE 6560-50-F
>
>