Source: https://www.federalregister.gov/documents/2003/09/30/03-24844/zinc-phosphide-pesticide-tolerance
Timestamp: 2017-09-26 20:49:31
Document Index: 295924178

Matched Legal Cases: ['art 180', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', 'art 178', 'art 178']

Federal Register :: Zinc Phosphide; Pesticide Tolerance
Zinc Phosphide; Pesticide Tolerance
This regulation is effective September 30, 2003. Objections and requests for hearings, identified by docket ID number OPP-2003-0319, must be received on or before December 1, 2003.
68 FR 56189
56189-56195 (7 pages)
OPP-2003-0319
FRL-7329-9
03-24844
https://www.federalregister.gov/d/03-24844 https://www.federalregister.gov/d/03-24844
This regulation establishes tolerances for residues of phosphine resulting from the use of the rodenticide zinc phosphide in or on alfalfa, forage; alfalfa hay; barley, grain; barley, hay; barley, straw; bean, dry, seed; beet, sugar, roots; beet, sugar, tops; potato; timothy, forage; timothy, hay; wheat, forage; wheat, grain; wheat, hay; and wheat, straw. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
Sidney Jackson, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone number: (703) 305-7610; e-mail address: jackson.sidney@epa.gov.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. Potentially affected entities may include, but are not limited to:
1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0319. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​. A frequently updated electronic version of 40 CFR part 180 is available at http: //www.access.gpo.gov/​nara/​cfr/​cfrhtml_​00/​Title_​40/​40cfr180_​00.html/​, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm/.
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​Start Printed Page 56190 to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.
In the Federal Register of July 9, 2003 (68 FR 40939) (FRL-7314-1), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of pesticide petitions (PP 2E6419, PP 1E6306, PP 1E6270, PP 1E6337, PP 9E5082, PP 0E6199, and PP 1E6292) by IR-4, 681 U. S. Highway #1 South, North Brunswick, NJ 08902-3390. That notice included a summary of the petitions prepared by the registrant, HACO, Inc., P.O. Box 7190, Madison, WI 53707. The Agency received a number of comments on the notice of filing published on July 9, 2003 (68 FR 40939). All comments were in favor of establishing the food tolerances proposed in the notice.
The petitions requested that 40 CFR 180.284 be amended by establishing tolerances for residues of phosphine resulting from the use of the rodenticide zinc phosphide, in or on alfalfa, forage and alfalfa, hay at 0.1 parts per million (ppm); barley, grain and barley, hay at 0.05 ppm, and barley, straw at 0.2 ppm; bean, dry at 0.05 ppm; beet, sugar, roots at 0.05 ppm and beet, sugar, tops at 0.2 ppm; potato at 0.05 ppm; timothy, forage and timothy, hay at 0.05 ppm; and wheat, grain, wheat, hay, and wheat, straw at 0.05 ppm.
EPA is also deleting several established tolerances in § 180.284(b) that are no longer needed, as a result of this action. The tolerance deletions are time-limited tolerances established under section 18 emergency exemptions that are superceded by the establishment of general tolerances for zinc phosphide under § 180.284(a).
The following deletions to § 180.284(b) are replaced in § 180.284(a):
1. Delete the time-limited tolerances for barley, grain at 0.01 ppm, barley, hay at 0.20 ppm, and barley straw at 0.02 ppm. Tolerances for barley, grain at 0.05 ppm, barley, hay at 0.2 ppm, and barley, straw at 0.2 ppm are established by this action under § 180.284(a).
2. Delete the time-limited tolerances for beet, sugar, roots at 0.05 ppm and beet, sugar, tops at 0.1 ppm. Tolerances for sugar, beet, roots are established at 0.05 ppm and sugar, beet, tops at 0.2 ppm under § 180.284(a).
3. Delete the time-limited tolerance for potato at 0.05 ppm. A tolerance for potato is established at 0.05 ppm under § 180.284(a).
4. Delete the time-limited tolerances for timothy, forage and timothy, hay at 0.1 ppm. Tolerances for timothy, forage and timothy, hay are established at 0.5 ppm under § 180.284(a).
5. Delete the time-limited tolerances for wheat, grain, wheat, hay and wheat, straw at 0.01 ppm. Tolerances for wheat, grain, wheat, hay, wheat, straw, and wheat, forage are established at 0.05 ppm under § 180.284(a).
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for tolerances for residues of phosphine resulting from the use of the rodenticide zinc phosphide on alfalfa, forage and alfalfa, hay at 0.2 ppm; barley, grain at 0.05; barley, hay at 0.2 ppm; barley, straw at 0.2 ppm; bean, dry, seed at 0.05 ppm; beet, sugar, roots at 0.05 ppm; beet, sugar, tops at 0.2 ppm; potato at 0.05 ppm; timothy, forage and timothy, hay at 0.5 ppm; and wheat, forage, wheat, grain, wheat hay, and wheat, straw at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by zinc phosphide are discussed in Table 1 of this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.
870.3100 90-Day oral toxicity rodents NOAEL = 0.1 milligram/kilogram/day (mg/kg/day) LOAEL = 1.0 mg/kg/day based on increased mortality and kidney hydronephrosis in male rats
870.3150 90-Day oral toxicity in nonrodents Waived
870.3200 21/28-Day dermal toxicity Waived
870.3700 Prenatal developmental in rodents Maternal NOAEL = 2.0 mg/kg/day Maternal LOAEL = 4.0 mg/kg/day based on mortality Developmental NOAEL = >4.0 mg/kg/day Developmental LOAEL = not established
870.370 Prenatal developmental in nonrodents Waived
870.3800 Reproduction and fertility effects Waived
870.4100 Chronic toxicity rodents Waived
870.4100 Chronic toxicity dogs Waived
870.4200 Carcinogenicity rats Waived
870.4300 Carcinogenicity mice Waived
870.5375 Mutagenicity-mouse lymphoma Positive for gene mutation, with and without S9 mammalian metabolic mutation
870.5385 Chromosomal aberration Negative for gene mutation
870.5500 Mutagenicity-Ames Negative for gene mutation, with and without S9 mammalian metabolic mutation
870.620 Acute neurotoxicity screening battery NOAEL = >10 mg/kg/day LOAEL = not established
870.6200 Subchronic neurotoxicity screening battery NOAEL = 0.1 mg/kg/day LOAEL = 2.0 mg/kg/day based on clinical toxicity (not neurotoxicity)
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for zinc phosphide used for human risk assessment is shown in Table 2 of this unit:Start Printed Page 56192
Table 2.— Summary of Toxicological Dose and Endpoints for Zinc Phosphide for Use in Human Risk Assessment
Acute dietary (general population including infants and children) NOAEL = 2.0 mg/kg/day UF = 100 Acute RfD = 0.02 mg/kg/day Developmental Toxicity Study-Rat LOAEL = 4.0 mg/kg/day based on maternal deaths on gestation day 10 (i.e., after 4 doses) though day 16
Chronic dietary (all populations) NOAEL= 0.1 g/kg/day UF = 1,000 Chronic RfD = 0.0001 mg/kg/day 90-Day Oral Toxicity Study-Rats LOAEL = 1.0 mg/kg/day based on increased mortality, increased absolute and relative liver weight, and hematological alterations
Short-term dermal (1 to 7 days) Intermediate-term (1 week to several months) Long-term dermal (several months to lifetime) (Residential) Not applicable Dermal exposure is not expected since baits are not absorbable and Zn phosphide powder is too polar to be absorbed through the skin
Short-term inhalation (1 to 7 days) Intermediate-term inhalation (1 week to several months) Long-term inhalation (several months to lifetime) (Residential) Not applicable Inhalation exposure is not expected. End-use baits are not powdery or respirable
Cancer (oral, dermal, inhalation) Not applicable Not applicable
1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.284(a)) for residues of phosphine resulting from the use of zinc phosphide, in or on a variety of raw agricultural commodities including: Grape (0.01 ppm), grass (rangeland) (0.1 ppm), and sugarcane (0.01 ppm). Tolerances with regional registration are established 40 CFR 180.284(c) for zinc phosphide residues in or on globe artichokes (0.01 ppm), sugar beet (roots) (0.04 ppm), and sugar beet tops (0.02 ppm). Section 18 tolerances at 40 CFR 180.284(b) currently exist for zinc phosphide residues in or on: Alfalfa forage, alfalfa hay, barley grain, barley hay, barley straw, sugar beets (tops), sugar beet roots, timothy, hay, timothy, forage, potato, wheat grain, wheat hay, and wheat straw.
Based on residue data from field trials conducted in support of the subject tolerances, EPA concludes that acute and chronic dietary exposure associated with the proposed uses of zinc phoshide is unlikely. Residues were below the Level of Quantitation (LOQ) (<0.05 or <0.1 ppm) in crops, except for the livestock feed items alfalfa forage, sugar beet tops, and timothy forage. Alfalfa forage, sugar beet tops, and timothy hay are not direct human food items; rather, they are used as animal feeds. Because residues of zinc phosphide ingested by livestock would be immediately converted to phosphine and metabolized to naturally occurring phosphorus compounds, residues of zinc phosphide in livestock feeds are not expected to result in residues of zinc phosphide in livestock commodities. Also, the act of processing and washing will not allow for unreacted zinc phosphide to remain in or on food items. In addition, residues are not expected in wheat and barley grain since zinc phosphide will be applied to barley and wheat prior to the formation of seed heads.
2. Dietary exposure from drinking water. No drinking water risk assessment was performed for zinc phosphide because no residues are expected in either ground water or surface water.
Zinc phosphide is currently registered in pellet and bait form for use on residential non-food sites to control mammals (primarily rodents) in areas such as commercial establishments, public areas (parks), dumps, and homes. A detailed residential exposure assessment is contained in the Reregistration Eligibility Decision (RED) Document, EPA 738-R-98-006, July 1998, for zinc phosphide.
There were no endpoints identified for zinc phosphide use in a residential assessment except for accidental ingestion. The residential exposure assessment evaluated exposure from accidental ingestion of zinc phosphide. No other residential exposure assessment was either expected or, if expected, found to have any hazard potential.
Although having considered that accidental ingestion of zinc phosphide baits may occur with respect to a very small number of children, EPA has concluded that this potential exposure is not appropriate for inclusion in evaluating the safety of aggregate exposure of consumers and major identifiable subgroups of consumers to zinc phosphide. Unlike other residential uses (such as a turf use) that potentially may result in exposures to significant groups of children, the subgroup of children that may consume baits in childproof bait stations is very tiny. This small subgroup of children would not qualify as a major identifiable subgroup of consumers.
4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular Start Printed Page 56193pesticide's residues and “other substances that have a common mechanism of toxicity.”
EPA does not have, at this time, available data to determine whether zinc phosphide has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to zinc phosphide and any other substances, and zinc phosphide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that zinc phosphide has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/​pesticides/​cumulative/​.
3. Conclusion. EPA has waived a significant portion of the data normally required in establishing a tolerance for a pesticide chemical, in evaluating the petitions for zinc phosphide. This data waiver is based on data showing that dietary exposure is unlikely to result from agricultural uses of zinc phosphide. Based on these exposure data, EPA concludes there are reliable data supporting a conclusion that no additional safety factor is necessary to protect the safety of infants and children.
Zinc phosphide has both food and non-occupational uses; therefore, the considerations for aggregate exposure are those from food, drinking water, and residential (non-occupational) sources.
The Agency has concluded that there will be no human dietary exposure from the proposed or registered uses of zinc phosphide. Thus, exposure to zinc phosphide from food is not a component of the acute and chronic aggregate exposure assessment.
1. Acute risk. The Agency has concluded that there will be no human dietary exposure from the proposed or registered uses of zinc phosphide. Thus, exposure to zinc phosphide from food is not a component of the acute and chronic aggregate exposure assessment.
2. Chronic risk. The Agency has concluded that there will be no human dietary exposure from the proposed or registered uses of zinc phosphide. Exposure to zinc phosphide from food and water is not a component of the acute and chronic aggregate exposure assessment
There are no residential uses for zinc phosphide that result in chronic residential exposure to zinc phosphide. Based on the use pattern, chronic residential exposure to residues of zinc phosphide is not expected. There is no potential for chronic dietary exposure to zinc phosphide in food and drinking water.
3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account chronic dietary food and water (considered to be a background exposure levels) plus indoor and outdoor residential exposure. No short-term or intermediate-term dermal, oral or inhalation toxicological endpoints were identified for zinc phosphide.
Further, no incidental oral exposure is expected given the conditions of use. Although potentially accidental ingestion of zinc phosphide bait may occur in rare instances, the subgroup of children that are exposed in such a manner is not a major identifiable subgroup of consumers.
4. Aggregate cancer risk for U.S. population. Since chronic exposure and risk associated with the use of zinc phosphide is negligible, no risk of cancer is expected from the use of zinc phosphide.
5. Determination of safety. There is no drinking water, residential, nor dietary component to acute and chronic aggregate exposure to zinc phosphide residues. Based on these exposure assessments, EPA concludes that there is a reasonable certainty that no harm will result to adults, infants and children from aggregate exposure to zinc phosphide residues.
Acceptable methods are available for enforcement and data collection purposes for plant commodities. The Pesticide Analytical Manual (PAM), Vol. II lists, under aluminum phosphide, a colorimetric method and a gas liquid chromatography with flame photometric detection (GLC/FPD) method as Methods A and B, respectively. Both methods determine the level of phosphine liberated when zinc phosphide is exposed to dilute acid solutions. EPA has determined that Method A is acceptable for enforcement. Data submitted in support of the established tolerances were collected by one of these two methods. Data submitted in support of the proposed tolerances were collected by the GLC/FPD method or a similar method
There are no international harmonization issues associated with this action since there are no Codex, Mexican or Canadian maximum residue levels (MRLs) or tolerances for zinc phosphide on any crop.
Therefore, the tolerances are established for residues of phosphine resulting from the use of zinc phosphide in or on alfalfa, forage and alfalfa, hay at 0.2 ppm; barley, grain, at 0.05 ppm, barley, hay and barley, straw at 0.2 ppm; bean, dry, seed at 0.05 ppm; beet, sugar, roots at 0.05 ppm and beet, sugar, tops at 0.2 ppm; potato at 0.05 ppm; timothy, forage and timothy, hay at 0.5 ppm; and wheat, forage, wheat, grain, wheat hay, and wheat, straw at 0.05 ppm.
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue Start Printed Page 56194to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0319 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before December 1, 2003.
3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0319, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid 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 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.
This final rule establishes a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and Start Printed Page 56195responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
2. Section 180.284 is amended by adding commodities to the table in paragraph (a) and removing the following entries from the table in paragraph (b): “barley, grain,” “barley, hay,” “barley, straw,” “beet, sugar, roots,” “beet, sugar, tops,” “potato,” “timothy, forage,” “timothy, hay,” “wheat, grain,” “wheat, hay,” and “wheat, straw” to read as follows:
(a) General. * * *
Alfalfa, forage 0.2
Alfalfa, hay 0.2
Barley, hay 0.2
Barley, straw 0.2
Beet, sugar, tops 0.2
Timothy, hay 0.5
Timothy, forage 0.5
[FR Doc. 03-24844 Filed 9-26-03; 11:11 am]