 |
 |
>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 > >