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